INUVER 100/6 mikrogramów Roztwór ciśnieniowy do inhalacji

Treść ulotki

1. INUVER 100/6 micrograms per actuation pressurised solution for inhalation
   1. What is Inuver and what is it used for
   2. What you need to know before you take Inuver
   3. How to take Inuver
   4. Possible side effects
   5. How to store Inuver
   6. Contents of the pack and other information
2. INUVER 100/6 micrograms per actuation pressurised solution for inhalation
   1. What is Inuver and what is it used for
   2. What you need to know before you take Inuver
   3. How to take Inuver
   4. Possible side effects
   5. How to store Inuver
   6. Contents of the pack and other information
3. INUVER 100 micrograms/6 micrograms powder for inhalation
   1. What INUVER is and what it is used for
4. INUVER can also be used to treat the symptoms of severe chronic bronchopneumonia
   1. What you need to know before using INUVER
   2. How to use INUVER
   3. Open the cap completely.
   4. Before inhalation, exhale as much as possible.
   5. Lift the inhaler, bring it to your mouth and close your lips around
   6. Breathe rapidly and deeply through your mouth.
   7. If you need to take another dose, repeat the operations from point E.1 to
   8. Possible side effects
   9. How to store INUVER
   10. Package Contents and Other Information
5. INUVER 100 micrograms/6 micrograms powder for inhalation
   1. What INUVER is and what it is used for
6. INUVER can also be used to treat the symptoms of severe chronic obstructive pulmonary disease
   1. What you need to know before you use INUVER
   2. How to use INUVER
   3. Open the cap completely.
   4. Before inhalation, exhale as much as possible.
   5. Lift the inhaler, bring it to your mouth and close your lips around
   6. Breathe rapidly and deeply through your mouth.
   7. If you need to take another dose, repeat the operations from point E.1 to
   8. Possible side effects
   9. How to store INUVER
   10. Package Contents and Other Information
7. INUVER 200/6 micrograms per actuation pressurized solution
   1. What is INUVER and what is it used for
   2. What you need to know before using INUVER
   3. How to use INUVER
   4. Possible side effects
   5. How to store INUVER
   6. Package contents and other information
8. INUVER 200/6 micrograms per actuation pressurized solution
   1. What is INUVER and what is it used for
   2. What you need to know before using INUVER
   3. How to use INUVER
   4. Possible side effects
   5. How to store INUVER
   6. Package contents and other information
9. INUVER 200 micrograms/6 micrograms for inhalation powder for inhalation
   1. What is INUVER and what is it used for
   2. What you need to know before using INUVER
   3. How to use INUVER
   4. Open the cap completely.
   5. Before inhalation, exhale as much as possible.
   6. Breathe in quickly and deeply through your mouth.
   7. If you need to take another dose, repeat the operations from point E.1 to point
   8. Possible side effects
   9. How to store INUVER
   10. Package Contents and Other Information

INUVER 100/6 micrograms per actuation pressurised solution for inhalation

Beclometasone dipropionate/ formoterol fumarate dihydrate
Therapy is reserved for adults.

Read this leaflet carefully before you start to take this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse.

Contents of this leaflet:

• 1. What Inuver is and what it is used for
• 2. What you need to know before you take Inuver
• 3. How to take Inuver
• 4. Possible side effects
• 5. How to store Inuver
• 6. Contents of the pack and other information

1. What is Inuver and what is it used for

Inuver is a pressurized inhalation solution containing two active ingredients that are inhaled
through the mouth and released directly into the lungs.
The two active ingredients are beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which
have an anti-inflammatory action by reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators,
which relax the muscles of the airways and help you breathe more
easily.
These two active ingredients, together, make breathing easier, providing relief from symptoms such as
shortness of breath, wheezing and cough in patients with asthma or COPD and also help to prevent
asthma symptoms.
Asthma
Inuver is indicated in the regular treatment of asthma in adult patients in whom:

• asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators “as needed” or
• asthma responds well to treatment with both inhaled corticosteroids and long-acting bronchodilators.

COPD
Inuver can also be used for the treatment of symptoms of severe chronic obstructive pulmonary disease
(COPD) in adult patients. COPD is a chronic disease of the airways at the
lung level that is mainly caused by cigarette smoking.

2. What you need to know before you take Inuver

Do not take Inuver

• If you are allergic or think you may be allergic to any of the active ingredients of Inuver or if you are allergic to other medicines or inhalable preparations for the treatment of asthma or to any of the excipients of Inuver (listed in section 6: Contents of the pack and other information), contact your doctor for advice.

Warnings and precautions
Talk to your doctor before taking Inuver:

• If you suffer from heart problems, such as angina (chest pain or discomfort), if you have recently had a heart attack (myocardial infarction), if you suffer from heart failure, if you suffer from a narrowing of the arteries of the heart (coronary artery disease), problems with the heart valves or other known heart abnormalities or if you suffer from a condition called obstructive hypertrophic cardiomyopathy (also known as HOCM, a disease characterized by abnormal heart muscle).
• If you suffer from a narrowing of the arteries (also called arteriosclerosis), if you suffer from high blood pressure or if you know you have an aneurysm (an abnormal dilation of the blood vessel walls).
• If you suffer from heart rhythm disorders such as a fast or irregular heartbeat, rapid pulse rate or palpitations or if you have been told that your heart tracing is abnormal.
• If you have an overactive thyroid gland.
• If you have a level of potassium in your blood that is lower than normal.
• If you suffer from any liver or kidney disorder.
• If you suffer from diabetes (inhaling high doses of formoterol can cause an increase in blood glucose levels and, consequently, you may need to perform additional tests to monitor blood sugar levels when you start using this inhaler and from time to time during the duration of treatment).
• If you suffer from a tumor of the adrenal gland (called pheochromocytoma).
• If you are going to have anesthesia. Depending on the type of anesthesia, it may be necessary to stop treatment with Inuver at least 12 hours before anesthesia.
• If you are taking, or have taken, medicines to treat tuberculosis (TB), or if you have viral or fungal infections of the lungs.
• If you need to avoid drinking alcohol for any reason

If you are in any of the situations above, always inform your doctor before using
Inuver.
If you have or have had any medical problems or allergies or if you are not sure you can use Inuver
contact your doctor, or a nurse who is knowledgeable about asthma or a pharmacist before using
the inhaler.
Therapy with beta-agonists, such as formoterol contained in Inuver, can cause a
severe decrease in plasma potassium levels (hypokalemia).

Particular caution must be exercised in patients with severe asthma. This is because a
reduction in blood oxygen and some of the other treatments that may be taken together
with Inuver, such as medicines for the treatment of heart problems or high blood pressure,
known as diuretics, or other medicines used in the treatment of asthma can worsen the
reduction in potassium levels. For this reason, your doctor may periodically monitor
your blood potassium levels.

If you have taken high doses of inhaled corticosteroids for long periods of time, you may
need higher doses of corticosteroids in stressful situations. Stressful situations
include hospitalization following an accident, having suffered serious injuries or before
surgery. In such cases, the doctor may decide whether or not to increase your dose
of corticosteroids and to prescribe steroid tablets or steroid injections.
If you are hospitalized, remember to bring all your medicines and
inhalable products with you, including Inuver and any over-the-counter medicines or tablets, in their original packaging, if possible.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Inuver should not be used in children and adolescents under 18 years of age, until
more data are available.

Other medicines and Inuver
Tell your doctor if you are taking or have recently taken other medicines, including medicines
obtained without a prescription.
Some medicines can increase the effects of Inuver and your doctor may want to keep you under
close observation if you are taking these medicines (including some medicines for the
treatment of HIV: ritonavir, cobicistat).

Do not take this medicine with beta-blockers
If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or canceled.
Instead, the concomitant use of other medicines that contain beta-adrenergic agents (medicines that
have the same function as formoterol) may enhance the effect of formoterol.

Taking Inuver with:

• Medicines for the treatment of heart rhythm abnormalities (quinidine, disopyramide, procainamide), medicines used in the treatment of allergic reactions (antihistamines), medicines used for the treatment of symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (MAOIs) (for example phenelzine and isocarboxazide), tricyclic antidepressants (for example amitriptyline and imipramine), phenothiazines can cause

some changes in the electrocardiogram (ECG, heart tracing). They may also
increase the risk of heart rhythm disturbances (ventricular arrhythmias).

• Medicines for the treatment of Parkinson's disease (L-dopa), for the treatment of hypothyroidism (L-thyroxine), medicines containing oxytocin (which causes uterine contractions) and alcohol can decrease cardiac tolerance to beta-2-agonists, such as formoterol.
• Monoamine oxidase inhibitors (MAOIs), including drugs with similar characteristics such as furazolidone and procarbazine, used in the treatment of mental disorders, can cause an increase in blood pressure.
• Medicines for the treatment of heart disorders (digoxin) can cause a decrease in potassium levels in the blood. This may increase the possibility of heart rhythm abnormalities.
• Other medicines used in the treatment of asthma (theophylline, aminophylline or steroids) and diuretics can cause a decrease in potassium levels in the blood.
• Some anesthetics can cause an increased risk of heart rhythm abnormalities.

Pregnancy, breastfeeding and fertility
There are no clinical data regarding the use of Inuver during pregnancy.
Inuver should not be used if you are pregnant, think you may be pregnant or are planning a pregnancy,
or if you are breastfeeding, unless your doctor has told you to take the
medicine anyway.

Driving and using machines
It is unlikely that Inuver will affect your ability to drive or use machines.

Inuver contains alcohol
Inuver contains 7 mg of alcohol (ethanol) in each actuation which is equivalent to 0.20 mg/kg per dose
of two actuations. The amount in two actuations of this medicine is equivalent to that
contained in less than 1 ml of wine or beer. The small amount of alcohol contained in this medicine
will not produce significant effects.

For those who engage in sports:
The use of the drug without therapeutic necessity constitutes doping and may still
result in a positive doping test.

3. How to take Inuver

Inuver is only for inhalation use.
Use this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Asthma
Your doctor will regularly monitor you to make sure you are taking the optimal dose of Inuver. The doctor will prescribe the lowest dose that provides optimal control of your
symptoms.

Inuver can be prescribed by your doctor with two treatment methods:
a)daily use of Inuver for asthma treatment together with a suitable reliever inhaler to treat sudden worsening of asthma symptoms, such as
shortness of breath, wheezing and cough
b)daily use of Inuver for asthma treatment and further use of Inuver to
treat sudden worsening of asthma symptoms, such as shortness of breath,
wheezing and cough
a)Use of Inuver together with another reliever medicine
Adults and the elderly:
The recommended dose is one or two inhalations twice a day.
The maximum daily dose is 4 inhalations.

Remember: You should always carry your fast-acting reliever inhaler with you to treat
a worsening of asthma symptoms or a sudden asthma attack.
b)Use of Inuver as the only asthma inhaler
Adults and the elderly:
The recommended dose is one inhalation in the morning and one inhalation in the evening
You should also use Inuver as a reliever inhaler to treat sudden asthma symptoms.
If you experience asthma symptoms, take one inhalation and wait a few minutes.
If you do not feel better, take another inhalation.

No more than 6 reliever inhalations should be taken per day.
The maximum daily dose of Inuver is 8 inhalations.
If you feel you need a greater number of inhalations per day to control your asthma symptoms, ask your doctor for advice. It may be necessary to change the therapy.

Use in children and adolescents under 18 years of age:
Children and adolescents under 18 years of age should NOT take this medicine.

Chronic Obstructive Pulmonary Disease (COPD)
Adults and the elderly:
The recommended dose is two inhalations in the morning and two inhalations in the evening.

Patients at risk:
No dose adjustment is necessary in elderly patients. No information is available on the use of
Inuver in patients with impaired hepatic or renal function.

Inuver is effective in the treatment of asthma with a beclometasone dipropionate dosage that
may be lower than that of other inhalation products containing beclometasone
dipropionate. If you were previously using a different inhalation medicine based on
beclometasone dipropionate, your doctor will prescribe the exact dose of
Inuver to take to treat asthma.
Do not increase the dose:
If you feel that the medicine is not very effective, always ask your doctor before
increasing the dosage.

If you take more Inuver than you should:

• An overdose of formoterol may have the following effects: feeling unwell, malaise, rapid heartbeat, palpitations, heart rhythm disturbances, changes in the electrocardiogram (heart tracing), headache, tremors, drowsiness, excess acid in the blood, decreased potassium levels in the blood, high blood glucose levels. Your doctor may perform blood tests to check your potassium and glucose levels.
• An overdose of beclometasone dipropionate may lead to temporary disturbances of the adrenal glands. These problems will resolve spontaneously within a few days, however your doctor may decide to check serum cortisol levels.

Contact your doctor if you experience any of these symptoms.
If you forget to take Inuver:
Take it as soon as you remember. If it is almost time for the next dose, do not take the one you
forgot, but take the next dose at the correct time. Do not double the dose.
If you stop taking Inuver:
Do not decrease the dose or stop taking the medicine.
Even if you feel better, do not stop taking Inuver or decrease the dose. If you intend to
do so, talk to your doctor. It is very important that Inuver is used regularly even in
the absence of symptoms.

If your breathing gets worse:

• If you experience worsening shortness of breath or wheezing (wheezing breathing with a clearly audible whistle), immediately after inhaling the medicine, stop using Inuver immediately and use your fast-acting reliever inhaler immediately. Contact your doctor immediately. The doctor will evaluate the symptoms and, if necessary, decide to start a different treatment. See also section 4. “Possible side effects”.

If your asthma gets worse:
If your symptoms worsen or are difficult to control (for example if you use another
reliever inhaler or Inuver as a reliever inhaler more frequently), or if your reliever
inhaler or Inuver does not improve your symptoms, contact your doctor immediately. Asthma may
have worsened and the doctor may decide to change the dose of Inuver or prescribe a
alternative treatment.
If you have further doubts about the use of this product, ask your doctor or pharmacist.

How to administer:
This medicine is contained in a pressurized canister inserted into a plastic inhaler
equipped with a mouthpiece. On the back of the inhaler there is a dose counter, which indicates the number of
doses remaining. Each time you press on the canister, a dose of medicine is delivered and the
counter decreases by one number. Be careful not to drop the inhaler, as this may
cause a decrease of one unit in the counter numbering.

Checking the operation of the inhaler
Before using the inhaler for the first time or if the inhaler has not been used for 14 days or
more, it is necessary to check the operation of the inhaler, to make sure it is working
correctly.

• 1. Remove the protective cap from the mouthpiece
• 2. Hold the inhaler in a vertical position with the mouthpiece facing down
• 3. Point the mouthpiece away and press firmly on the canister to deliver a dose
• 4. Check the dose counter. If you are using the inhaler for the first time, the number 120 should appear in the counter window.

How to use the inhaler
When possible, remain standing or sitting in an upright position while inhaling.

• 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust and dirt or any other foreign object.
• 2. Exhale as slowly and deeply as possible.
• 3. Hold the canister vertically, with the top of the dispenser upwards, and then place the mouthpiece between your tightly closed lips. Do not bite the mouthpiece.
• 4. Inhale slowly and deeply through your mouth and immediately after starting to inhale, press firmly on the top of the inhaler to release a dose. If you have a weak grip, it may be easier to hold the inhaler with both hands: place your index fingers on the top of the inhaler and both thumbs on the base of the inhaler.
• 5. Hold your breath as long as possible and at the end remove the inhaler from your mouth and exhale slowly. Do not exhale into the inhaler.

If another actuation is necessary, keep the inhaler in a vertical position for
about half a minute and repeat steps 2 to 5.
IMPORTANT: Do not perform steps 2 to 5 too quickly.
After use, close with the protective cap and check the dose counter.

You need to get a new package of medicine when the dose counter indicates the number

• 20. Stop using the inhaler when the dose counter shows the number 0, as the amount ofmedicine remaining in the device may not be sufficient to deliver afull dose.

If after inhalation you notice a mist escaping from the inhaler or from the sides of your mouth, this means
that Inuver has not reached your lungs as it should have. Deliver another dose following the
instructions by repeating the operations from point 2.
To reduce the risk of a fungal infection in your mouth or throat, rinse your
mouth or gargle with water or brush your teeth after each inhalation.
If you think that the effect of Inuver is too strong or not strong enough, tell your doctor or pharmacist.
If you find it difficult to operate the inhaler while starting inhalation, you can use the spacer device
AeroChamber Plus™. Ask your doctor, pharmacist or nurse for information about this
device.
AeroChamberPlus™ and follow the instructions carefully regarding the use and cleaning of the
AeroChamber Plus™ spacer device.

Cleaning
The inhaler should be cleaned once a week. During cleaning, do not remove the
canister from the inhaler and do not use water or other liquids to clean the inhaler.
To clean the inhaler:

• 1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
• 2. Clean the inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or handkerchief.
• 3. Reposition the protective cap on the mouthpiece.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
As with other treatments via inhalation, there is a risk of worsening shortness of breath and
wheezing immediately after using Inuver, and this condition is known as

paradoxical bronchospasm. If this occurs, you must IMMEDIATELY STOP using
Inuverand immediately use your fast-acting “as needed” inhaler to treat the symptoms of
shortness of breath and wheezing. Contact your doctor immediately.
Immediately inform your doctor if you experience any hypersensitivity reaction such as
skin allergy, itching, rash, redness of the skin, swelling of the skin or mucous membranes
especially of the eyes, face, lips and throat.
Other possible side effects are listed below according to their frequency.

Common(incidence less than 1 in 10):
Fungal infections (of the mouth and throat), headache, hoarseness, sore throat.

• pneumonia (lung infection), in patients with COPD

Inform your doctor if you have any of the following symptoms while taking INUVER, they may
be symptoms of a lung infection:

• fever or chills;
• increased mucus production, changes in mucus color;
• increased cough or greater difficulty breathing.

Uncommon(incidence less than 1 in 100):
Palpitations, unusually fast heartbeat and heart rhythm disorders, changes
in the electrocardiogram (ECG), flu-like symptoms, vaginal fungal infections, sinusitis, rhinitis,
inflammation affecting the ear, sore throat irritation, cough and productive cough, asthma attacks.
Nausea, taste abnormalities or alterations, burning of the lips, dry mouth, difficulty
swallowing, indigestion, stomach disorders, diarrhea.
Muscle pain and cramps, facial flushing, increased blood flow in certain areas of the
body, excessive sweating, tremors, restlessness, dizziness, hives.
Alteration of some blood components: reduction in the number of white blood cells, increase
in the number of platelets, reduction in potassium levels in the blood, increase in blood sugar levels, increased levels of insulin, free fatty acids and ketones in the blood.
The following side effects have been reported as “uncommon” in patients with
Chronic Obstructive Bronchopneumopathy:

• Reduction in cortisol levels in the blood; this is caused by the effect of corticosteroids on the adrenal glands.
• Irregular heartbeat.

Rare(incidence less than 1 in 1000):
Feeling of tightness in the chest, lack of heartbeat (caused by premature ventricular
contractions), increase or decrease in blood pressure, kidney inflammation,
swelling of the skin and mucous membranes persisting for several days.

Very rare(incidence less than 1 in 10000):
Shortness of breath, worsening of asthma, decrease in the number of platelets in the blood, swelling
of hands and feet.

Not known
Blurred vision.

The use of high doses of corticosteroids via inhalation for long periods of time may cause
in very rare cases systemic effects:
these include disorders of adrenal gland function (adrenal suppression), reduction
in bone mineral density (thinning of the bones), delayed growth in children and
adolescents, increased eye pressure (glaucoma), cataracts.
Sleep disturbances, depression, restlessness, anxiety, nervousness, hyperexcitability or
irritability: these effects occur predominantly in children but the frequency is unknown.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor, pharmacist or nurse.
You can also report side effects directly through the national reporting system at:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Inuver

Keep this medicine out of the sight and reach of children.
Single pack containing a container of 120 doses
Do not use Inuver for more than 3 months after the date of purchase from the pharmacy and do not use it after the
expiry date printed on the packaging and label.
Do not store the inhaler at a temperature above 25°C.
Double pack containing two containers of 120 doses
Before use: store the inhaler in a refrigerator (2 °C – 8 °C)
After the first use: do not store the inhaler at a temperature above 25°C for a maximum
of 3 months. Do not use this medicine after the expiry date which is reported on the box and
label. Do not freeze.
If the inhaler has been exposed to low temperatures, warm it with your hands for a few minutes before
use. Never heat it with artificial methods.
Caution: The container contains liquid under pressure. Do not expose it to temperatures
above 50°C. Do not puncture the container.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Inuver contains
The active ingredients are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each actuation from the metering valve contains 100 micrograms of beclometasone dipropionate
and 6 micrograms of formoterol fumarate dihydrate.
This is equivalent to an delivered inhaled dose from the mouthpiece of 84.6 micrograms of beclometasone
dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
The excipients are: anhydrous ethanol, hydrochloric acid, propellant: norflurane (HFC-134a).

Description of the appearance of Inuver and contents of the pack
Inuver is a pressurized solution in an aluminum-coated container with a metering valve,
inserted into a polypropylene actuator with a plastic protective cap.
Each pack contains a pressurized container with 120 actuations.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Alternative manufacturers responsible for batch release
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Vienna-Austria
Chiesi S.A.S.

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:

INUVER 100/6 micrograms per actuation pressurised solution for inhalation

Beclometasone dipropionate/ formoterol fumarate dihydrate
Therapy is reserved for adults.

Read this leaflet carefully before you start to take this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse.

Contents of this leaflet:

• 1. What Inuver is and what it is used for
• 2. What you need to know before you take Inuver
• 3. How to take Inuver
• 4. Possible side effects
• 5. How to store Inuver
• 6. Contents of the pack and other information

1. What is Inuver and what is it used for

Inuver is a pressurized inhalation solution containing two active ingredients that are inhaled
through the mouth and released directly into the lungs.
The two active ingredients are beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which
have an anti-inflammatory action by reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators,
which relax the muscles of the airways and help you breathe more
easily.
These two active ingredients, together, make breathing easier, providing relief from symptoms such as
shortness of breath, wheezing and cough in patients with asthma or COPD and also help to prevent
asthma symptoms.
Asthma
Inuver is indicated for the regular treatment of asthma in adult patients in whom:

• asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators “as needed” or
• asthma responds well to treatment with both inhaled corticosteroids and long-acting bronchodilators.

COPD
Inuver can also be used for the treatment of symptoms of severe chronic obstructive pulmonary disease
(COPD) in adult patients. COPD is a chronic disease of the airways at the lung level
which is mainly caused by cigarette smoking.

2. What you need to know before you take Inuver

Do not take Inuver

• If you are allergic or think you may be allergic to any of the active ingredients of Inuver or if you are allergic to other medicines or inhalable preparations for the treatment of asthma or to any of the excipients of Inuver (listed in section 6: Contents of the pack and other information), contact your doctor for advice.

Warnings and precautions
Talk to your doctor before taking Inuver:

• If you suffer from heart problems, such as angina (chest pain or discomfort), if you have recently had a heart attack (myocardial infarction), if you suffer from heart failure, if you suffer from a narrowing of the arteries of the heart (coronary artery disease), problems with the heart valves or other known heart abnormalities or if you suffer from a condition called obstructive hypertrophic cardiomyopathy (also known as HOCM, a disease characterized by abnormal heart muscle).
• If you suffer from a narrowing of the arteries (also called arteriosclerosis), if you suffer from high blood pressure or if you know you have an aneurysm (an abnormal dilation of the blood vessel walls).
• If you suffer from heart rhythm disorders such as a fast or irregular heartbeat, rapid pulse rate or palpitations or if you have been told that your heart tracing is abnormal.
• If you have an overactive thyroid gland.
• If you have a level of potassium in your blood that is lower than normal.
• If you suffer from any liver or kidney disorder.
• If you suffer from diabetes (inhaling high doses of formoterol may cause an increase in blood glucose levels and, consequently, you may need to perform additional tests to monitor your blood sugar levels when you start using this inhaler and from time to time during the entire duration of treatment).
• If you suffer from a tumor of the adrenal gland (called pheochromocytoma).
• If you are going to undergo anesthesia. Depending on the type of anesthesia, it may be necessary to stop treatment with Inuver at least 12 hours before anesthesia.
• If you are taking, or have taken, medicines to treat tuberculosis (TB), or if you have viral or fungal infections of the lungs.
• If you need to avoid drinking alcohol for any reason

If you are in any of the situations described above, always inform your doctor before using
Inuver.
If you have or have had any medical problem or allergies or if you are not sure you can use Inuver
contact your doctor, or a nurse who understands asthma or a pharmacist before using
the inhaler.
Therapy with beta-agonists, such as formoterol contained in Inuver, can cause a
severe decrease in plasma potassium levels (hypokalemia).

Particular caution must be exercised in patients suffering from severe asthma. This is because a
reduction in blood oxygen and some of the other treatments that may be taken together
with Inuver, such as medicines for the treatment of heart problems or high blood pressure,
known as diuretics, or other medicines used in the treatment of asthma can worsen the
reduction in potassium levels. For this reason, your doctor may periodically monitor
your blood potassium levels.

If you have taken high doses of inhaled corticosteroids for long periods of time, you may
need higher doses of corticosteroids in stressful situations. Stressful situations
include hospitalization following an accident, having suffered serious injuries or before
surgery. In such cases, the doctor may decide whether or not to increase your dose
of corticosteroids and to prescribe steroid tablets or steroid injections.
If you are hospitalized, remember to bring all your medicines and
inhalable products with you, including Inuver and any over-the-counter medicines or tablets, in their original packaging, if possible.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Inuver should not be used in children and adolescents under 18 years of age, until
more data are available.

Other medicines and Inuver
Tell your doctor if you are taking or have recently taken other medicines, including medicines
obtained without a prescription.
Some medicines can increase the effects of Inuver and your doctor may want to keep you under
close observation if you are taking these medicines (including some medicines for the
treatment of HIV: ritonavir, cobicistat).

Do not take this medicine together with beta-blockers
If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or canceled.
Instead, the concomitant use of other medicines that contain beta-adrenergic agents (medicines that
have the same function as formoterol) may enhance the effect of formoterol.

Taking Inuver with:

• Medicines for the treatment of heart rhythm abnormalities (quinidine, disopyramide, procainamide), medicines used in the treatment of allergic reactions (antihistamines), medicines used for the treatment of symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (MAO-I) (for example, phenelzine and isocarboxazide), tricyclic antidepressants (for example, amitriptyline and imipramine), phenothiazines can cause

some changes in the electrocardiogram (ECG, heart tracing). They may also
increase the risk of heart rhythm disturbances (ventricular arrhythmias).

• Medicines for the treatment of Parkinson's disease (L-dopa), for the treatment of hypothyroidism (L-thyroxine), medicines containing oxytocin (which causes uterine contractions) and alcohol can decrease cardiac tolerance to beta-2-agonists, such as formoterol.
• Monoamine oxidase inhibitors (MAO-I), including drugs with similar characteristics such as furazolidone and procarbazine, used in the treatment of mental disorders, can cause an increase in blood pressure.
• Medicines for the treatment of heart disorders (digoxin) can cause a decrease in blood potassium levels. This may increase the likelihood of heart rhythm abnormalities.
• Other medicines used in the treatment of asthma (theophylline, aminophylline or steroids) and diuretics can cause a decrease in blood potassium levels.
• Some anesthetics can cause an increased risk of heart rhythm abnormalities.

Pregnancy, breastfeeding and fertility
There are no clinical data regarding the use of Inuver during pregnancy.
Inuver should not be used if you are pregnant, think you may be pregnant or are planning a pregnancy,
or if you are breastfeeding, unless your doctor has told you to take the
medicine anyway.

Driving and using machines
It is unlikely that Inuver will affect your ability to drive or operate machinery.

Inuver contains alcohol
Inuver contains 7 mg of alcohol (ethanol) in each actuation which is equivalent to 0.20 mg/kg per dose
from two actuations. The amount in two actuations of this medicine is equivalent to that
contained in less than 1 ml of wine or beer. The small amount of alcohol contained in this medicine
will not produce significant effects.
.

For athletes:
The use of the drug without therapeutic necessity constitutes doping and may still
result in positive doping tests.

3. How to take Inuver

Inuver is only for inhalation use.
Use this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

Asthma
Your doctor will monitor you regularly to ensure that you are taking the optimal dose of Inuver. The doctor will prescribe the lowest dose that provides optimal control of your
symptoms.

Inuver can be prescribed by the doctor with two treatment modalities:
a)daily use of Inuver for the treatment of asthma together with a suitable inhaler
“as needed” to treat sudden worsening of asthma symptoms, such as
shortness of breath, wheezing and cough
b)daily use of Inuver for the treatment of asthma and further use of Inuver for
treating sudden worsening of asthma symptoms, such as shortness of breath,
wheezing and cough
a)Use of Inuver together with another “as needed” medicine
Adults and the elderly:
The recommended dose is one or two inhalations twice a day.
The maximum daily dosage is 4 inhalations.

Remember: You should always carry your “as needed” fast-acting inhaler with you to treat
a worsening of asthma symptoms or a sudden asthma attack.
b)Use of Inuver as the only inhaler for asthma
Adults and the elderly:
The recommended dose is one inhalation in the morning and one inhalation in the evening
You should also use Inuver as an “as needed” inhaler to treat sudden asthma symptoms.
If you experience asthma symptoms, take one inhalation and wait a few minutes.
If you do not feel better, take another inhalation.

No more than 6 “as needed” inhalations should be taken per day.
The maximum daily dose of Inuver is 8 inhalations.
If you feel you need a higher number of inhalations per day to control your asthma symptoms, ask your doctor for advice. It may be necessary to change the therapy.

Use in children and adolescents under 18 years of age:
Children and adolescents under 18 years of age should NOT take this medicine.

Chronic Obstructive Pulmonary Disease (COPD)
Adults and the elderly:
The recommended dose is two inhalations in the morning and two inhalations in the evening.

Patients at risk:
No dose adjustment is necessary in elderly patients. No information is available on the use of
Inuver in patients with impaired hepatic or renal function.

Inuver is effective in the treatment of asthma with a beclometasone dipropionate dosage that
may be lower than that of other inhalation products containing beclometasone
dipropionate. If you were previously using a different inhalation medicine based on
beclometasone dipropionate, your doctor will prescribe the exact dose of
Inuver to take to treat asthma.
Do not increase the dose:
If you feel that the medicine is not very effective, always ask your doctor before
increasing the dosage.

If you take more Inuver than you should:

• An overdose of formoterol may have the following effects: feeling unwell, malaise, rapid heartbeat, palpitations, heart rhythm disturbances, changes in the electrocardiogram (heart tracing), headache, tremors, drowsiness, excess acid in the blood, decreased potassium levels in the blood, high blood glucose levels. Your doctor may perform blood tests to check your potassium and glucose levels.
• An overdose of beclometasone dipropionate may lead to temporary disorders of the adrenal glands. These problems will resolve spontaneously within a few days, however your doctor may decide to check serum cortisol levels.

Contact your doctor if you experience any of these symptoms.
If you forget to take Inuver:
Take it as soon as you remember. If it is almost time for the next dose, do not take the one you
forgot, but take the next dose at the correct time. Do not double the dose.
If you stop taking Inuver:
Do not decrease the dose or stop taking the medicine.
Even if you feel better, do not stop taking Inuver or decrease the dose. If you intend to
do so, talk to your doctor. It is very important that Inuver is used regularly even in
the absence of symptoms.

If your breathing gets worse:

• If you experience worsening shortness of breath or your breathing becomes wheezing (wheezing breathing with a clearly audible whistle), immediately after inhaling the medicine, stop using Inuver immediately and use your “as needed” fast-acting inhaler immediately. Contact your doctor immediately. The doctor will evaluate the symptoms and, if necessary, decide to start a different treatment. See also section 4. “Possible side effects”.

If your asthma gets worse:
If your symptoms worsen or are difficult to control (for example if you use another
“as needed” inhaler or Inuver as a rescue inhaler more frequently), or if your “as needed” inhaler
or Inuver does not improve your symptoms, contact your doctor immediately. Asthma may
have worsened and the doctor may decide to change the dose of Inuver or prescribe a
alternative treatment.
If you have further questions about the use of this product, ask your doctor or pharmacist.

How to administer:
This medicine is contained in a pressurized canister inserted into a plastic inhaler
equipped with a mouthpiece. On the back of the inhaler there is a dose indicator, which indicates
the number of doses remaining. Each time you press the canister, the dose indicator decreases by a
small amount. The number of doses remaining is displayed in intervals of 20.

• Be careful not to drop the inhaler, as this may cause a decrease of one unit in the numbering of the dose indicator.

Checking the operation of the inhaler
Before using the inhaler for the first time or if the inhaler has not been used for 14 days or
more, it is necessary to check the operation of the inhaler to ensure that it is working
correctly.

• 1. Remove the protective cap from the mouthpiece
• 2. Hold the inhaler in a vertical position with the mouthpiece facing down
• 3. Point the mouthpiece away and press firmly on the canister to deliver a dose
• 4. Check the dose indicator. If you are using the inhaler for the first time, the number 180 should appear in the window of the dose indicator.

How to use the inhaler
When possible, remain standing or sitting in an upright position while inhaling.

• 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust and dirt or any other foreign object.
• 2. Exhale as slowly and deeply as possible.
• 3. Hold the canister vertically, with the top of the dispenser upwards, and then place the mouthpiece between your closed lips. Do not bite the mouthpiece.
• 4. Inhale slowly and deeply through your mouth and immediately after starting to inhale press firmly on the top of the inhaler to release a dose. If you have a weak grip, it may be easier to hold the inhaler with both hands: place your index fingers on the top of the inhaler and both thumbs on the base of the inhaler.
• 5. Hold your breath as long as possible and at the end remove the inhaler from your mouth and exhale slowly. Do not exhale into the inhaler.

If another actuation is necessary, keep the inhaler in a vertical position for
about half a minute and repeat steps 2 to 5.
IMPORTANT: Do not perform steps 2 to 5 too quickly.
After use, close with the protective cap and check the dose indicator.

You need to get a new package of medicine when the dose indicator shows the
number 20. Stop using the inhaler when the dose indicator shows the number 0, as
the amount of medicine remaining in the device may not be sufficient to deliver a
full dose.
If a mist is observed leaking from the inhaler or from the sides of your mouth after inhalation, this means
that Inuver has not reached your lungs as it should. Deliver another dose following the
instructions by repeating the operations from point 2.
To reduce the risk of a fungal infection in your mouth or throat, rinse your
mouth or gargle with water or brush your teeth after each inhalation.
If you think that the effect of Inuver is too strong or not strong enough, tell your doctor or pharmacist.
If you find it difficult to actuate the inhaler while starting inspiration, you can use the spacer device
AeroChamber Plus™. Ask your doctor, pharmacist or nurse for information about this
device.
AeroChamberPlus™ and follow the instructions carefully regarding the use and cleaning of
the AeroChamber Plus™ spacer device.

Cleaning
The inhaler should be cleaned once a week. During cleaning, do not remove the
canister from the inhaler and do not use water or other liquids to clean the inhaler.
To clean the inhaler:

• 1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
• 2. Clean the inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or handkerchief.
• 3. Reposition the protective cap on the mouthpiece.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
As with other treatments via inhalation, there is a risk of worsening shortness of breath and
wheezing immediately after using Inuver, and this condition is known as

paradoxical bronchospasm. If this occurs, you must IMMEDIATELY STOP using
Inuverand immediately use your fast-acting “rescue” inhaler to treat the symptoms of
shortness of breath and wheezing. Contact your doctor immediately.
Immediately inform your doctor if you experience any hypersensitivity reaction such as
skin allergy, itching, rash, skin redness, swelling of the skin or mucous membranes especially of the
eyes, face, lips and throat.
Other possible side effects are listed below according to their frequency.

Common(incidence less than 1 in 10):
Fungal infections (of the mouth and throat), headache, hoarseness, sore throat.

• pneumonia (lung infection), in patients with COPD

Inform your doctor if you have any of the following symptoms while taking INUVER, they may
be symptoms of a lung infection:

• fever or chills;
• increased mucus production, changes in mucus color;
• increased cough or greater difficulty breathing.

Uncommon(incidence less than 1 in 100):
Palpitations, unusually fast heartbeat and heart rhythm disorders, changes
in the electrocardiogram (ECG), flu-like symptoms, vaginal fungal infections, sinusitis, rhinitis,
inflammation affecting the ear, sore throat irritation, cough and productive cough, asthma attacks.
Nausea, taste abnormalities or alterations, burning of the lips, dry mouth, difficulty
swallowing, indigestion, stomach discomfort, diarrhea.
Muscle pain and cramps, facial flushing, increased blood flow in certain areas of the
body, excessive sweating, tremors, restlessness, dizziness, hives.
Alteration of some blood components: reduction in the number of white blood cells, increase
in the number of blood platelets, reduction in potassium levels in the blood, increase in blood sugar levels, increased levels of insulin, free fatty acids and ketones in the blood.
The following side effects have been reported as “uncommon” in patients with
Chronic Obstructive Pulmonary Disease:

• Reduction in blood cortisol levels; this is caused by the effect of corticosteroids on the adrenal glands.
• Irregular heartbeat.

Rare(incidence less than 1 in 1000):
Feeling of tightness in the chest, lack of heartbeat (caused by premature ventricular
contractions), increase or decrease in blood pressure, kidney inflammation,
swelling of the skin and mucous membranes persisting for several days.

Very rare(incidence less than 1 in 10000):
Shortness of breath, worsening of asthma, decreased number of platelets in the blood, swelling
of hands and feet.

Not known
Blurred vision.

The use of high doses of corticosteroids via inhalation for long periods of time may cause
in very rare cases systemic effects:
these include disorders of adrenal gland function (adrenal suppression), reduced
bone mineral density (thinning of the bones), delayed growth in children and
adolescents, increased eye pressure (glaucoma), cataracts.
Sleep disturbances, depression, anxiety, restlessness, nervousness, excitability or
irritability: these effects occur predominantly in children but the frequency is unknown.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor, pharmacist or nurse.
You can also report side effects directly through the national reporting system at:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Inuver

Keep this medicine out of the sight and reach of children.
Do not use Inuver for more than 3 months after the date of purchase from the pharmacy and do not use it after the
expiry date printed on the packaging and label.
Do not store the inhaler at a temperature above 25°C.
If the inhaler has been exposed to low temperatures, warm it with your hands for a few minutes before
use. Never heat it with artificial methods.
Caution: The container contains liquid under pressure. Do not expose it to temperatures above
50°C. Do not puncture the container.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Inuver contains
The active ingredients are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each actuation from the metered-dose valve contains 100 micrograms of beclometasone dipropionate
and 6 micrograms of formoterol fumarate dihydrate.
This is equivalent to a delivered dose inhaled from the mouthpiece of 84.6 micrograms of beclometasone
dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
The excipients are: anhydrous ethanol, hydrochloric acid, propellant: norflurane (HFC-134a).
This medicine contains fluorinated greenhouse gases. Each inhaler contains 11.202 g of
norflurane (HFC-134a) which corresponds to 0.016 tonnes of CO2 equivalent (global warming potential = 1430).

Description of the appearance of Inuver and contents of the pack
Inuver is a pressurized solution in an aluminium-coated container with a metered-dose valve,
inserted into a polypropylene actuator with a plastic protective cap.
Each pack contains one pressurized container with 180 actuations.

Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer responsible for batch release
Chiesi Farmaceutici S.p.A.
Via San Leonardo 96
43122 Parma
Italy

Alternative manufacturers responsible for batch release
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Vienna-Austria
Chiesi S.A.S.
2 rue des Docteurs Alberto et Paolo Chiesi
41260 La Chaussée Saint-Victor - France

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:

INUVER 100 micrograms/6 micrograms powder for inhalation

inhalation
For use in adults only
beclometasone dipropionate anhydrous/formoterol fumarate dihydrate

Read this leaflet carefully before you start to take this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse.

Contents of this leaflet:

• 1. What INUVER is and what it is used for
• 2. What you need to know before you use INUVER
• 3. How to use INUVER
• 4. Possible side effects
• 5. How to store INUVER
• 6. Contents of the pack and other information

1. What INUVER is and what it is used for

INUVER is a powder that is inhaled through the mouth and released directly into the
lungs. It contains two active ingredients: beclometasone dipropionate anhydrous and formoterol
fumarate dihydrate.

• Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which have an anti-inflammatory action, reducing swelling and irritation in the lungs
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which relax the muscles of the airways, widening them and making it easier to inhale and exhale air from the lungs

These two active ingredients make breathing easier, providing relief from symptoms such as shortness of
breath, wheezing and cough in patients with asthma or COPD and also help to prevent the
symptoms of asthma.

Asthma
INUVER is used for the treatment of asthma in adults.
If INUVER has been prescribed to you, it is likely that:

• your asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators “as needed” or
• your asthma responds well to treatment with both corticosteroids and long-acting bronchodilators.

COPD

INUVER can also be used to treat the symptoms of severe chronic bronchopneumonia

obstructive (COPD) in adult patients. COPD is a chronic airway disease at the level of the lungs, mainly caused by cigarette smoking.

2. What you need to know before using INUVER

Do not use INUVER
If you are allergic to beclometasone dipropionate anhydrous or formoterol fumarate dihydrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using INUVER if you have any of the following conditions:

• heart problems, including any type of known heart disease and/or heart function
• heart rhythm disorders, such as increased or irregular heart rate, fast pulse or palpitations, or if you have been told that your electrocardiogram is abnormal
• high blood pressure
• narrowing of the arteries (also known as arteriosclerosis), or if you are aware of having an aneurysm (an abnormal dilation of the blood vessel walls)
• hyperactive thyroid gland
• low levels of potassium in the blood
• any liver or kidney disorders
• diabetes. If you inhale high doses of formoterol, blood glucose levels may increase and, consequently, you may need to undergo additional tests to monitor blood sugar levels both when you start using this inhaler and periodically throughout the duration of treatment.
• adrenal gland tumor (called pheochromocytoma)
• if you are to undergo anesthesia. Depending on the type of anesthesia, it may be necessary to stop treatment with INUVER at least 12 hours before anesthesia.
• If you are taking, or have taken, medications to treat tuberculosis (TB), or if you suffer from known viral or fungal infections of the chest.

If you fall into any of the above cases, always inform your doctor before using INUVER.
If you are not sure if you can use INUVER, consult your doctor, an experienced nurse in asthma problems or your pharmacist before using the inhaler.

The doctor may decide to measure your potassium levels in the blood periodically, especially if your form of asthma is severe.Like many bronchodilators, INUVER can cause a sudden drop in serum potassium levels (hypokalemia). This happens because a reduction in oxygen in the blood associated with some other treatments taken together with INUVER can worsen the reduction in potassium levels.

If you have taken high doses of inhaled corticosteroids for long periods of time, you may need more corticosteroids in stressful situations. Stressful situations can include hospitalization following an accident, having suffered serious injuries, or the period before surgery. In such cases, the doctor will decide whether or not to increase your dose of corticosteroids and may prescribe steroids in tablets or steroids for injection.

If you need to be hospitalized, remember to bring all your medicines and inhalers with you, including INUVER and any over-the-counter medicines or tablets, in their original packaging, if possible.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
This medicine should not be administered to children and adolescents under 18 years of age.

Other medicines and INUVER
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is necessary because INUVER can alter the action of other medicines. Also, other medicines can have effects on the activity of INUVER.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Some medicines can increase the effects of INUVER and your doctor may want to keep you under close observation if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, high blood pressure or glaucoma (increased pressure in the eyes). If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or canceled.
• Beta-adrenergic drugs (drugs with activity similar to that of formoterol) can increase the effects of formoterol.
• Medicines for the treatment of heart rhythm abnormalities (quinidine, disopyramide, procainamide).
• Medicines for treating allergic reactions (antihistamines, such as terfenadine).
• Medicines for the treatment of depression or mental disorders such as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazide,) or tricyclic antidepressants (e.g., amitriptyline and imipramine) or phenothiazines.
• Medicines for the treatment of Parkinson's disease (L-dopa).
• Medicines for the treatment of an underactive thyroid gland (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines for the treatment of mental disorders such as Monoamine Oxidase Inhibitors (MAOIs), including drugs with properties similar to furazolidone and procarbazine.
• Medicines for the treatment of heart disease (digoxin).
• Other medicines for the treatment of asthma (theophylline, aminophylline or steroids)
• Diuretics (water pills).

Also inform your doctor or pharmacist if you intend to use a general anesthetic for an operation or dental procedure.

Pregnancy and breastfeeding
There are no clinical data on the use of INUVER during pregnancy.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before using this medicine. INUVER should only be used during pregnancy if your doctor advises you to do so. The doctor will decide whether you should stop taking INUVER during breastfeeding or whether you should take INUVER but refrain from breastfeeding. Always follow your doctor's advice carefully.

Driving and using machines
It is unlikely that INUVER will affect your ability to drive vehicles or use machines
However, if you experience side effects such as dizziness and/or tremor, your ability to drive vehicles or use machines may be altered.

INUVER contains lactose monohydrate
Lactose contains small amounts of milk proteins, which can cause reactions in patients with milk allergies. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

For those who play sports:

The use of the drug without therapeutic necessity constitutes doping and may determine positive results in anti-doping tests.

3. How to use INUVER

Use this medicine following the doctor's, nurse's, or pharmacist's instructions exactly. If you have any doubts, consult your doctor or pharmacist.
INUVER delivers an extrafine powder, which allows a greater amount of the drug contained in the dose to reach the lungs. The doctor may, therefore, prescribe a lower dose of this inhaler than those you were taking with other inhalers.

Asthma
The doctor will monitor you regularly to ensure you are taking the correct dose of INUVER. Once asthma is well controlled, the doctor may deem it appropriate to gradually reduce the dose of INUVER. Do not modify the dose under any circumstanceswithout first consulting the doctor.
Inuver can be prescribed by the doctor with two treatment modalities:
a) daily use of Inuver for the treatment of asthma together with a suitable "as needed" inhaler to treat sudden worsening of asthma symptoms, such as shortness of breath, wheezing, and cough
b) daily use of Inuver for the treatment of asthma and further use of Inuver to treat sudden worsening of asthma symptoms, such as shortness of breath, wheezing, and cough
a) Use of Inuver together with another "as needed" medicine:

Adults and the elderly:
The recommended dose is 1 or 2 inhalations twice a day.
The maximum daily dose is 4 inhalations.
Remember: You should always carry your fast-acting "as needed" inhaler with you to treat a worsening of asthma symptoms or a sudden asthma attack.
b) Use of Inuver as the only inhaler for asthma:

Adults and the elderly:
The recommended dose is one inhalation in the morning and one inhalation in the evening
You should also use Inuver as an "as needed" inhaler to treat sudden asthma symptoms.
If you experience asthma symptoms, take one inhalation and wait a few minutes.
If you do not feel better, take another inhalation.

No more than 6 "as needed" inhalations should be taken per day.
The maximum daily dose of Inuver is 8 inhalations.
If you feel you need a greater number of inhalations per day to control asthma symptoms, ask your doctor for advice. It may be necessary to change the therapy.

Do not increase the dose
If you feel that the medicine is not effective, always consult your doctor before increasing the dose.

Chronic Obstructive Pulmonary Disease (COPD)
Adults and the elderly:
The recommended dose is 2 inhalations in the morning and 2 inhalations in the evening

How to use INUVER:
INUVER is for inhalation use.
If possible, stand or sit in an upright position when taking the inhalation.

If you use more INUVER than you should

• Contact your doctor or the nearest hospital emergency room immediately for advice. Bring the medicine with you, so that healthcare personnel can understand which medicine you have taken;
• Adverse effects may occur. Inform your doctor if you notice any unusual symptoms, as further investigations or any necessary therapeutic measures may be required.

If you forget to use INUVER
Take the dose as soon as you remember. If it is almost time to take the next dose, skip the missed dose and take the next dose at the correct time. Do not take a double dose.
If you stop treatment with INUVER:
Even if you feel better, do not stop using INUVER or reduce the dosage. If you intend to do so, talk to your doctor. It is very important that INUVER is used every day, as prescribed by your doctor, even in the absence of symptoms.
If your breathing remains unchanged:
If your symptoms do not improve after inhaling INUVER, it is possible that you are using the device incorrectly. Therefore, check the instructions for proper use of the device below and/or contact your doctor or nurse to explain how to use it correctly.
If asthma worsens:
If your symptoms worsen or are difficult to control (for example, if you use another "as needed" inhaler or Inuver as a rescue inhaler more frequently), or if your "as needed" inhaler or Inuver does not improve your symptoms, you should continue to use INUVER but contact your doctor as soon as possible. The doctor may decide to change your dose of INUVER or prescribe you further or alternative treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

INSTRUCTIONS FOR USE OF THE NEXTHALER INHALER

• A.Package Contents

For information on the package contents, see section 6. If the package contents do not correspond to the above, return the inhaler to the person who provided it (e.g., the pharmacist or doctor) and obtain a new one.

• B.General Warnings and Precautions
• Donot remove the inhaler from its bag unless you intend to use it immediately.
• Use the inhaler only as directed.
• Keep the inhaler cap closed until you are ready to take your dose.
• When not in use, store the inhaler in a clean, dry place.
• Donot attempt to disassemble the Nexthaler inhaler for any reason.
• C.Main features of the Nexthaler inhaler

of air
Taking a dose from the Nexthaler inhaler requires only three simple steps: Opening, Inhalation, Closing.

• D.Before using a new Nexthaler inhaler
• 1. Open the bag and remove the inhaler.o Donot use the inhaler if the bag is not sealed or is damaged – return it to the supplier and obtain a new one. o Use the adhesive label on the package to write the date of first opening of the bag.
• 2. Check the inhaler.o If the inhaler appears broken or damaged, return it to the supplier and obtain a new one.
• 3. Check the dose counter window. If the inhaler is new, the number “120” appears in the dose counter window.o Donot use a new inhaler if the number indicated is less than “120” – return it to the supplier and obtain a new one.

• E.How to use the Nexthaler inhaler
• 1. If you are unsure of receiving the dose correctly, contact your pharmacist or doctor.
• 2. If you are unsure whether the number indicated by the dose counter has decreased by one unit after inhalation, wait until the next scheduled dose and take it normally. Do not take a double dose.

E.1Opening

1. Hold the inhaler firmly in a vertical position.

2. Check the number of doses remaining: any number between “1” and

“120” indicates that there are still doses.
o If the dose counter window indicates “0”, it means that there are no doses remaining – the inhaler must be disposed of and a new one obtained.

3. Open the cap completely.

4. Before inhalation, exhale as much as possible.

o Do notbreathe through the inhaler.

E.2Inhalation
When possible, remain standing or sit in an upright position during
inhalation.

1. Lift the inhaler, bring it to your mouth and close your lips around

the mouthpiece.
o Do notcover the air intake while holding the inhaler.
o Do notinhale through the air intake.

2. Breathe rapidly and deeply through your mouth.

o You may perceive a certain taste in your mouth while taking the dose.
o You may feel or hear a “click” while taking the dose.
o Do notbreathe through your nose.
o Do notmove your lips from the inhaler during inhalation.

3. Remove the inhaler from your mouth.

4. Hold your breath for 5 or 10 seconds, or for as long as is comfortable for you.

5. Exhale slowly.

o Do notexhale through the inhaler.

E.3Closing

1. Return the inhaler to an upright position and close the cap completely.

2. Check that the dose counter has advanced by one number.

3. If you need to take another dose, repeat the operations from point E.1 to

point E.3.

• F.Cleaning
• Normally, it is not necessary to clean the inhaler.
• If necessary, you can keep the inhaler clean after use by wiping the device with a dry cloth or paper towel.
• Do notclean the inhaler with water or other liquids. Always keep the device dry.
• G.Storage and disposal

For information on storage conditions and disposal instructions,
see section 5.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
As with other treatments via inhalation, there is a risk of worsening of breathlessness, cough and wheezing immediately after using INUVER, and this
occurrence is called paradoxical bronchospasm. If this occurs, you must

STOP using INUVER immediatelyand use your “as needed” fast-acting inhaler as soon as possibleto treat the symptoms. You should contact
your doctor immediately.
Immediately inform your doctor if allergic reactions have appeared, which
include skin allergies, skin itching, skin rash, skin redness,
swelling of the skin or mucous membranes, especially of the eyes, face, lips and throat.
Below are listed further possible side effects of INUVER listed in order of
frequency.

Common(may affect up to 1 in 10 people):

• tremor.
• pneumonia (lung infection), in patients with COPD

Inform your doctor if you have any of the following symptoms while taking INUVER, they could
be symptoms of a lung infection:

• fever or chills.
• increased mucus production, changes in mucus color.
• increased cough or greater difficulty breathing.

Uncommon(may affect up to 1 in 100 people):

• cold symptoms, sore throat
• fungal infections (of the mouth and throat). Rinsing your mouth or gargling with water and brushing your teeth immediately after inhalation can help prevent these side effects
• worsening of asthma symptoms, difficulty breathing
• hoarseness
• cough
• unusually fast heartbeat
• unusually slow heartbeat
• oppressive chest pain
• headache
• feeling unwell
• feeling tired or nervous
• alteration in electrocardiogram (ECG)
• low level of cortisol in urine or blood
• high level of potassium in the blood
• high level of glucose in the blood
• high level of fats in the blood.

Not known(frequency cannot be estimated based on available data)

• blurred vision

Side effects observed with similar inhaled medicinescontaining
beclometasone dipropionate and/or formoterol are:

• palpitations
• irregular heartbeat
• taste anomalies or alterations
• muscle pain and muscle cramps
• restlessness, dizziness
• feeling anxious
• sleep disturbances
• low level of potassium in the blood
• increase/decrease in blood pressure.

The use of inhaled corticosteroids at high doses and for long periods of time
can cause systemic effects, including:

• disorders of adrenal gland function (adrenal suppression)
• thinning of the bones
• growth retardation in children and adolescents
• increased pressure in the eye (glaucoma), cataracts
• rapid weight gain, especially in the face and torso
• sleep disturbances, depression or feeling worried, agitation, nervousness, overexcitement or irritability. These effects are more likely to occur in children.
• Abnormal behavior.

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
You can also report side effects directly through the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store INUVER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, on the sachet and
on the label after Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture. Remove
the inhaler from its protective sachet only immediately before its first use.
Before the first opening of the sachet:
This medicine does not require any particular storage temperature.
After the first opening of the sachet:
Do not store at a temperature above 25°C.
After the first opening of the sachet, the medicine must be used within 6 months.
Use the label on the package to write the date of opening the sachet.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What INUVER contains
The active ingredients are: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate.
Each pre-metered dose contains 100 micrograms of beclometasone dipropionate anhydrous
and 6 micrograms of formoterol fumarate dihydrate. This corresponds to an inhaled dose,
delivered through the mouthpiece, of 81.9 micrograms of beclometasone dipropionate anhydrous and 5
micrograms of formoterol fumarate dihydrate.
The other ingredients are: lactose monohydrate (which contains small amounts of milk
proteins) and magnesium stearate.

Description of the appearance of INUVER and package contents
This medicine is presented in the form of a white or almost
white inhalation powder contained in a plastic inhaler called Nexthaler.
Each pack contains one, two or three inhalers providing 120 inhalations each.
Each inhaler is packaged in a heat-sealed protective sachet (aluminium foil packaging).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
CHIESI FARMACEUTICI S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturers
Chiesi Farmaceutici S.p.A.
Via San Leonardo 96
43122 Parma - Italy
Chiesi S.A.S.
2 rue des Docteurs Alberto et Paolo Chiesi 41260 La Chaussée Saint Victor - France
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Vienna – Austria

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Belgium:Inuvair NEXThaler Greece:Inuvair NEXThaler

Bulgaria:Foster NEXThaler Ireland:Fostair Nexthaler 100 micrograms/6
micrograms per metered dose inhalation powder

Cyprus:Foster NEXThaler Italy:Inuver

Denmark:Innovair Nexthaler Latvia:Foster NEXThaler 100 mikrogrami/6
mikrogrami devā inhalācijas pulveris

Estonia:Foster NEXThaler Lithuania:Foster

Finland:Innovair nexthaler 100 mikrog/6
mikrog/annos inhalaatiojauhe

Luxembourg:Inuvair NEXThaler

France:Formodual NEXThaler Norway:Inuxair

Germany:KANTOS MASTER NEXThaler 100
Mikrogramm / 6 Mikrogramm pro Dosis Pulver
zur Inhalation

Romania:Foster NEXThaler 100 micrograme/6
micrograme pe doză pulbere de inhalat

Spain:Formodual NEXThaler

Sweden:Innovair nexthaler
Updated and detailed information on this product is available by scanning with an
external

The same information is also available at the following URL: https://qrco.de/Nexthaler100-6-
120 .

INUVER 100 micrograms/6 micrograms powder for inhalation

inhalation
For use in adults only
beclometasone dipropionate anhydrous/formoterol fumarate dihydrate

Read this leaflet carefully before you start to take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, talk to your doctor, pharmacist or nurse.

Contents of this leaflet:

• 1. What INUVER is and what it is used for
• 2. What you need to know before you use INUVER
• 3. How to use INUVER
• 4. Possible side effects
• 5. How to store INUVER
• 6. Contents of the pack and other information

1. What INUVER is and what it is used for

INUVER is a powder that is inhaled through the mouth and released directly into the
lungs. It contains two active ingredients: beclometasone dipropionate anhydrous and formoterol
fumarate dihydrate.

• Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which have an anti-inflammatory action, reducing swelling and irritation in the lungs
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which relax the muscles of the airways, widening them, and thus making it easier to inhale and exhale air from the lungs

These two active ingredients make breathing easier, providing relief from symptoms such as shortness of
breath, wheezing and cough in patients with asthma or COPD and also help to prevent the
symptoms of asthma.

Asthma
INUVER is used for the treatment of asthma in adults.
If INUVER has been prescribed to you, it is likely that:

• your asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators “as needed” or
• your asthma responds well to treatment with both corticosteroids and long-acting bronchodilators.

COPD

INUVER can also be used to treat the symptoms of severe chronic obstructive pulmonary disease

obstructive (COPD) in adult patients. COPD is a chronic airway disease in the lungs, mainly caused by cigarette smoking.

2. What you need to know before you use INUVER

Do not use INUVER
If you are allergic to beclometasone dipropionate anhydrous or formoterol fumarate dihydrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using INUVER if you have any of the following conditions:

• heart problems, including any type of known heart disease and/or heart function
• irregular heartbeats, such as increased or irregular heart rate, fast pulse or palpitations, or if you have been told that your heart tracing is abnormal
• high blood pressure
• narrowing of the arteries (also known as arteriosclerosis), or if you are aware of having an aneurysm (an abnormal dilation of the blood vessel walls)
• overactive thyroid gland
• low levels of potassium in the blood
• any liver or kidney disorders
• diabetes. If you inhale high doses of formoterol, blood glucose levels may increase and, as a result, you may need to undergo additional tests to monitor blood sugar levels both when you start using this inhaler and periodically throughout the duration of treatment.
• tumour of the adrenal gland (called pheochromocytoma)
• if you are to undergo anesthesia. Depending on the type of anesthesia, it may be necessary to stop treatment with INUVER at least 12 hours before anesthesia.
• If you are taking, or have taken, medicines to treat tuberculosis (TB), or if you suffer from known viral or fungal infections of the chest.

If you fall into any of the cases listed above, always inform your doctor before using
INUVER.
If you are not sure if you can use INUVER, consult your doctor, an experienced nurse in asthma problems or your pharmacist before using the inhaler.

The doctor may decide to measure your potassium levels periodically,
especially if your asthma is severe.Like many bronchodilators, INUVER can
cause a sudden drop in serum potassium levels (hypokalemia). This happens because a
reduction in oxygen in the blood associated with some other treatments taken together with INUVER
can worsen the reduction in potassium levels.

If you have taken high doses of inhaled corticosteroids for long periods of time,
you may have a greater need for corticosteroids in stressful situations. Stressful situations
may include hospitalization following an accident, having suffered serious injuries, or the
period prior to surgery. In such cases, the doctor will decide whether or not to increase your dose of corticosteroids and may prescribe steroids in tablets
or steroids for injection.

If you need to be hospitalized, remember to bring all your medicines
and inhalers with you, including INUVER and any over-the-counter medicines or tablets, if possible, in their original packaging.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age.

Other medicines and INUVER
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is necessary because INUVER can alter the action of
other medicines. Also, other medicines can have effects on the activity of INUVER.
In particular, tell your doctor or pharmacist if you are taking any of the following
medicines:

• Some medicines may increase the effects of INUVER and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, high blood pressure or glaucoma (increased pressure in the eyes). If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or cancelled.
• Beta-adrenergic drugs (drugs with activity similar to that of formoterol) may increase the effects of formoterol.
• Medicines for the treatment of heart rhythm abnormalities (quinidine, disopyramide, procainamide).
• Medicines for treating allergic reactions (antihistamines, such as terfenadine).
• Medicines for the treatment of depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide,) or tricyclic antidepressants (e.g. amitriptyline and imipramine) or phenothiazines.
• Medicines for the treatment of Parkinson's disease (L-dopa).
• Medicines for the treatment of an underactive thyroid (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines for the treatment of mental disorders such as Monoamine Oxidase Inhibitors (MAOIs), including drugs with properties similar to furazolidone and procarbazine.
• Medicines for the treatment of heart disease (digoxin).
• Other medicines for the treatment of asthma (theophylline, aminophylline or steroids)
• Diuretics (water pills).

Also tell your doctor or pharmacist if you intend to use a general anesthetic for
an operation or dental procedure.

Pregnancy and breastfeeding
There are no clinical data on the use of INUVER during pregnancy.
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding
with breast milk, ask your doctor for advice before using this medicine. INUVER should
be used during pregnancy only if your doctor advises you to do so. The doctor will decide whether
you should stop taking INUVER during breastfeeding or whether you should take INUVER
but refrain from breastfeeding. Always follow your doctor's instructions carefully.

Driving and using machines
It is unlikely that INUVER will affect your ability to drive vehicles or use machinery
However, if you experience side effects such as dizziness and/or tremor, your ability to
drive vehicles or use machinery may be altered.

INUVER contains lactose monohydrate
Lactose contains small amounts of milk proteins, which can cause reactions in
patients with milk allergy. If your doctor has diagnosed you with intolerance to certain sugars, contact
him before taking this medicine.

For those who engage in sports:

The use of the drug without therapeutic need constitutes doping and may result in positive anti-doping tests.

3. How to use INUVER

Use this medicine following the instructions of your doctor, nurse
or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
INUVER delivers an extrafine powder, which allows a greater amount of drug
contained in the dose to reach the lungs. The doctor may, therefore, prescribe a lower dose
of this inhaler than those you were taking with other inhalers.

Asthma
The doctor will monitor you regularly to ensure that you are taking the correct dose
of INUVER. Once asthma is well controlled, the doctor may deem it
appropriate to gradually reduce the dose of INUVER. Do not change the dose in any case
without first consulting your doctor.
Inuver can be prescribed by the doctor with two treatment modalities:
a) daily use of Inuver for the treatment of asthma together with a specific inhaler
“as needed” to treat sudden worsening of asthma symptoms, such as shortness of
breath, wheezing and cough
b) daily use of Inuver for the treatment of asthma and further use of Inuver to treat
sudden worsening of asthma symptoms, such as shortness of breath, wheezing
and cough
a) Use of Inuver together with another “as needed” medication:

Adults and the elderly:
The recommended dose is 1 or 2 inhalations twice a day.
The maximum daily dose is 4 inhalations.
Remember: You should always carry your “as needed” fast-acting inhaler with you to treat
a worsening of asthma symptoms or a sudden asthma attack.
b) Use of Inuver as the only inhaler for asthma:

Adults and the elderly:
The recommended dose is one inhalation in the morning and one inhalation in the evening
You should also use Inuver as a “as needed” inhaler to treat sudden symptoms
of asthma.
If you experience asthma symptoms, take one inhalation and wait a few minutes.
If you do not feel better, take another inhalation.

No more than 6 “as needed” inhalations should be taken per day.
The maximum daily dose of Inuver is 8 inhalations.
If you feel you need a greater number of inhalations per day to control
asthma symptoms, ask your doctor for advice. It may be necessary to change the therapy.

Do not increase the dose
If you think the medicine is not effective, always consult your doctor before increasing
the dose.

Chronic Obstructive Pulmonary Disease (COPD)
Adults and the elderly:
The recommended dose is 2 inhalations in the morning and 2 inhalations in the evening

How to use INUVER:
INUVER is for inhalation use.
If possible, stand or sit upright when you take the inhalation.

If you use more INUVER than you should

• Contact your doctor or the emergency room of the nearest hospital immediately for advice. Bring the medicine with you, so that healthcare personnel can understand which medicine you have taken;
• Adverse effects may occur. Inform your doctor if you notice any unusual symptoms, as further investigations or any necessary therapeutic measures may be required.

If you forget to use INUVER
Take the dose as soon as you remember. If it is almost time to take the next dose, skip the
forgotten dose and take the next dose at the correct time. Do not take a double dose.
If you stop treatment with INUVER:
Even if you feel better, do not stop using INUVER or reduce the dosage. If you
intend to do so, talk to your doctor. It is very important that INUVER is used every day,
as prescribed by your doctor, even in the absence of symptoms.
If your breathing remains unchanged:
If your symptoms do not improve after inhaling INUVER, it is possible that you are using
the device incorrectly. Therefore, check the instructions for proper use
of the device below and/or contact your doctor or nurse to explain
how to use it correctly.
If asthma worsens:
If your symptoms worsen or are difficult to control (for example, if you use a
other “as needed” inhaler or Inuver as a “as needed” inhaler more frequently), or if your
“as needed” inhaler or Inuver do not improve your symptoms, you should continue to use INUVER
but contact your doctor as soon as possible. The doctor may decide to change your dose
of INUVER or prescribe further or alternative treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

INSTRUCTIONS FOR USE OF THE NEXTHALER INHALER

• A.Package Contents

For information on the package contents, see section 6. If the package contents do not correspond to what is stated above, return the inhaler to
the person who provided it (e.g. the pharmacist or doctor) and obtain a new one.

• B.General Warnings and Precautions
• Do notremove the inhaler from its bag unless you intend to use it immediately.
• Use the inhaler only as directed.
• Keep the inhaler cap closed until you are about to take your dose.
• When not using the inhaler, store it in a clean and dry place.
• Do notattempt to disassemble the Nexthaler inhaler for any reason.
• C.Main features of the Nexthaler inhaler

of air
Taking a dose from the Nexthaler inhaler requires only three simple steps: Opening, Inhalation, Closing.

• D.Before using a new Nexthaler inhaler
• 1. Open the bag and remove the inhaler.o Do notuse the inhaler if the bag is not sealed or is damaged – return it to the supplier and obtain a new one. o Use the adhesive label on the package to write the date of first opening of the bag.
• 2. Check the inhaler.o If the inhaler appears broken or damaged, return it to the supplier and obtain a new one.
• 3. Check the dose counter window. If the inhaler is new, the number “180” appears in the dose counter window.o Do notuse a new inhaler if the number indicated is less than “180” – return it to the supplier and obtain a new one.

• E.How to use the Nexthaler inhaler
• 1. If you are unsure of receiving the dose correctly, contact your pharmacist or doctor.

• 2. If you are unsure whether the number indicated by the dose counter has decreased by one unit after inhalation, wait until the next scheduled dose and take it normally. Do not take a double dose.

E.1Opening

1. Hold the inhaler firmly in a vertical position.

2. Check the number of doses remaining: any number between “1” and

“180” indicates that there are still doses.
o If the dose counter window shows “0”, it means that there are no doses remaining – the inhaler must be disposed of and a new one obtained.

3. Open the cap completely.

4. Before inhalation, exhale as much as possible.

o Do notbreathe through the inhaler.

E.2Inhalation
When possible, remain standing or sit in an upright position during
inhalation.

1. Lift the inhaler, bring it to your mouth and close your lips around

the mouthpiece.
o Do notcover the air inlet while holding the inhaler.
o Do notinhale through the air inlet.

2. Breathe rapidly and deeply through your mouth.

o You may perceive a certain taste in your mouth while taking the dose.
o You may feel or hear a “click” while taking the dose.
o Do notbreathe through your nose.
o Do notmove your lips from the inhaler during inhalation.

3. Remove the inhaler from your mouth.

4. Hold your breath for 5 or 10 seconds, or for as long as is comfortable for you.

5. Exhale slowly.

o Do notexhale through the inhaler.

E.3Closing

1. Return the inhaler to an upright position and completely close the cap.

2. Check that the dose counter has advanced by one number.

3. If you need to take another dose, repeat the operations from point E.1 to

point E.3.

• F.Cleaning
• Normally, it is not necessary to clean the inhaler.
• If necessary, you can keep the inhaler clean after use by wiping the device with a dry cloth or paper towel.
• Do notclean the inhaler with water or other liquids. Keep the device always dry.
• G.Storage and disposal

For information on storage conditions and disposal instructions,
see section 5.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
As with other treatments via inhalation, there is a risk of worsening of breathlessness, cough and
wheezing immediately after using INUVER, and this event is called paradoxical bronchospasm. If this occurs, you must

STOP using INUVER immediatelyand use your fast-acting “rescue” inhaler as soon as
possibleto treat the symptoms. You should contact your doctor immediately.
Immediately inform your doctor if allergic reactions have appeared, including skin allergies, skin
itching, skin rash, skin redness, swelling of the skin or mucous membranes, especially of the eyes,
face, lips and throat.
Below are listed further possible side effects of INUVER listed in order of frequency.

Common(may affect up to 1 in 10 people):

• tremor.
• pneumonia (lung infection), in patients with COPD

Inform your doctor if you have any of the following symptoms while taking INUVER, they could
be symptoms of a lung infection:

• fever or chills.
• increased mucus production, changes in mucus color.
• increased cough or greater difficulty breathing.

Uncommon(may affect up to 1 in 100 people):

• cold symptoms, sore throat
• fungal infections (of the mouth and throat). Rinsing your mouth or gargling with water and brushing
  your teeth immediately after inhalation may help prevent these side effects
• worsening of asthma symptoms, difficulty breathing
• hoarseness
• cough
• unusually fast heartbeat
• unusually slow heartbeat
• oppressive chest pain
• headache
• feeling unwell
• feeling tired or nervous
• alteration in electrocardiogram (ECG)
• low level of cortisol in urine or blood
• high level of potassium in the blood
• high level of glucose in the blood
• high level of fats in the blood.

Not known(frequency cannot be estimated based on available data)

• blurred vision

Side effects observed with similar inhaled medicinescontaining beclometasone dipropionate
and/or formoterol are:

• palpitations
• irregular heartbeat
• taste anomalies or alterations
• muscle pain and muscle cramps
• restlessness, dizziness
• feeling anxious
• sleep disturbances
• low potassium level in the blood
• increase/decrease in blood pressure.

The use of inhaled corticosteroids at high doses and for long periods of time
can cause systemic effects, including:

• disorders of adrenal gland function (adrenal suppression)
• thinning of the bones
• delayed growth in children and adolescents
• increased pressure in the eye (glaucoma), cataracts
• rapid weight gain, especially in the face and torso
• sleep disturbances, depression or feeling worried, agitation, nervousness, overexcitement or
  irritability. These effects are more likely to occur in children.
• Abnormal behavior.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store INUVER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, on the sachet and
on the label after Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture. Remove
the inhaler from its protective sachet only immediately before its first use.
Before the first opening of the sachet:
This medicine does not require any particular storage temperature.
After the first opening of the sachet:
Do not store at a temperature above 25°C.
After the first opening of the sachet, the medicine must be used within 6 months.
Use the label on the package to write the date of opening the sachet.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What INUVER contains
The active ingredients are: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate.
Each pre-metered dose contains 100 micrograms of beclometasone dipropionate anhydrous
and 6 micrograms of formoterol fumarate dihydrate. This corresponds to an inhaled dose,
delivered through the mouthpiece, of 81.9 micrograms of beclometasone dipropionate anhydrous and 5
micrograms of formoterol fumarate dihydrate.
The other ingredients are: lactose monohydrate (which contains small amounts of milk proteins) and magnesium stearate.

Description of the appearance of INUVER and contents of the pack
This medicine is presented in the form of a white or almost white inhalation powder contained in a plastic inhaler called Nexthaler.
Each pack contains one, two or three inhalers providing 180 inhalations each.
Each inhaler is packaged in a heat-sealed protective sachet (aluminium foil packaging).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
CHIESI FARMACEUTICI S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturers
Chiesi Farmaceutici S.p.A.
Via San Leonardo 96
43122 Parma - Italy
Chiesi S.A.S.
2 rue des Docteurs Alberto et Paolo Chiesi
41260 La Chaussée Saint Victor - France
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Vienna – Austria

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Belgium:Inuvair NEXThaler Greece:Inuvair NEXThaler

Bulgaria:Foster NEXThaler Ireland:Fostair Nexthaler 100 micrograms/6
micrograms per metered dose inhalation powder

Cyprus:Foster NEXThaler Italy:Inuver

Denmark:Innovair Nexthaler Latvia:Foster NEXThaler 100 mikrogrami/6
mikrogrami devā inhalācijas pulveris

Estonia:Foster NEXThaler Lithuania:Foster

Finland:Innovair nexthaler 100 mikrog/6
mikrog/annos inhalaatiojauhe

Luxembourg:Inuvair NEXThaler

France:Formodual NEXThaler Norway:Inuxair

Germany:KANTOS MASTER NEXThaler 100
Mikrogramm / 6 Mikrogramm pro Dosis Pulver
zur Inhalation

Romania:Foster NEXThaler 100 micrograme/6
micrograme pe doză pulbere de inhalat

Spain:Formodual NEXThaler

Sweden:Innovair nexthaler
Updated and detailed information on this product is available by scanning with an
external

The same information is also available at the following URL:
https://qrco.de/Nexthaler100-6-180.

INUVER 200/6 micrograms per actuation pressurized solution

for inhalation
For use in adults only
beclometasone dipropionate/formoterol fumarate dihydrate

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What INUVER is and what it is used for
• 2. What you need to know before you use INUVER
• 3. How to use INUVER
• 4. Possible side effects
• 5. How to store INUVER
• 6. Contents of the pack and other information

1. What is INUVER and what is it used for

INUVER is a pressurized inhalation solution containing two active ingredients that are inhaled
through the mouth and released directly into the lungs.
The two active ingredients are:
Beclometasone dipropionate, which belongs to a group of medicines called corticosteroids, which
have an anti-inflammatory action capable of reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate, which belongs to a group of medicines called long-acting bronchodilators,
relaxes the muscles of the airways, thus making breathing easier.
These two active ingredients, together, facilitate breathing; they also help to prevent the symptoms
of asthma, such as shortness of breath, wheezing and cough.

INUVER is used for the treatment of asthma in adults.
If INUVER has been prescribed to you, it is likely that:

• your asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators “as needed” or
• your asthma responds well to treatment with both corticosteroids and long-acting bronchodilators

2. What you need to know before using INUVER

Do not use INUVER:

• if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using INUVER if you have any of the
following conditions:

• heart problems, such as angina (heart pain, chest pain), heart failure, narrowing of the arteries, problems with heart valves or other known heart abnormalities
• high blood pressure or if you know you have an aneurysm (an abnormal dilation of the blood vessel walls)
• heart rhythm disorders such as a fast or irregular heartbeat, rapid pulse or palpitations, or if you have been told that your heart tracing is abnormal
• excessive activity of the thyroid gland
• low levels of potassium in the blood
• any liver or kidney problems
• diabetes (if you inhale high doses of formoterol, blood glucose levels may increase. It may therefore be necessary to perform further blood tests to check your blood sugar levels when you start using this medicine and periodically during the entire duration of treatment)
• tumour of the adrenal gland (called pheochromocytoma)
• if you are going to have anaesthesia. Depending on the type of anaesthetic, it may be necessary to stop treatment with INUVER at least 12 hours before the anaesthetic
• if you are taking, or have taken, medicines to treat tuberculosis (TB), or if you suffer from known viral or fungal infections of the chest
• if you need to avoid drinking alcohol for any reason

If you fall into any of the cases listed above, always inform your doctor before using INU-
VER.
If you have or have had any medical problem or allergies or if you are not sure you can use INUVER
talk to your doctor, experienced asthma nurse or pharmacist before using this
medicine.

The doctor may decide to measure your blood potassium levels periodically,
especially if your asthma is severe.Like many bronchodilators, INUVER can cause a
sudden drop in serum potassium levels (hypokalaemia). This is because a reduction in oxygen in the
blood associated with some other treatments taken together with INUVER can worsen the reduction in
potassium levels.

If you take high doses of inhaled corticosteroids for long periods of time, you may
have a greater need for corticosteroids in stressful situations. Stressful situations can include
hospitalisation following an accident, having suffered serious injuries or the period before
surgery. In such cases, the doctor may decide whether or not to increase your
dose of corticosteroids and to prescribe steroid tablets or steroid injections.

If you need to be hospitalised, remember to bring all your medicines and
inhalers with you, including INUVER and any medicines or tablets purchased without a prescription,
in their original packaging, if possible.

Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
INUVER should not be used in children and adolescents under the age of 18 years.

Other medicines and INUVER
Tell your doctor, pharmacist or nurse if you are taking, have recently taken any other
medicines including medicines obtained without a prescription. This is necessary because INUVER
can alter the action of other medicines. Also, other medicines can have effects on the activity
of INUVER.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Some medicines may increase the effects of INUVER and your doctor may want to keep you under close observation if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, high blood pressure or glaucoma (increased pressure in the eyes). If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or cancelled.
• Beta-adrenergic drugs (drugs with activity similar to that of formoterol) may increase the effects of formoterol.
• Medicines for the treatment of heart rhythm abnormalities (quinidine, disopyramide, procainamide).
• Medicines used to treat allergic reactions (antihistamines).
• Medicines used to treat symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide), tricyclic antidepressants (e.g. amitriptyline and imipramine), phenothiazines.
• Medicines for the treatment of Parkinson's disease (L-dopa).
• Medicines for the treatment of an underactive thyroid (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines for the treatment of mental disorders such as monoamine oxidase inhibitors (MAOIs), including drugs with similar properties such as furazolidone and procarbazine.
• Medicines for the treatment of heart disease (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline or steroids).
• Diuretics (water tablets).

Also tell your doctor or pharmacist if you intend to use a general anaesthetic for an
operation or for dental treatment.

Pregnancy, breastfeeding and fertility
There are no clinical data on the use of INUVER during pregnancy.
INUVER should not be used if you are pregnant, suspect you are pregnant or are planning a
pregnancy, or if you are breastfeeding, unless your doctor has told you that you can do so.

Driving and using machines
It is unlikely that INUVER will affect your ability to drive vehicles or use machines.

INUVER contains alcohol
INUVER contains 9 mg of alcohol (ethanol) in each actuation, which is equivalent to 0.25 mg/kg per dose
of two actuations. The amount of alcohol in two actuations of this medicine is equivalent to less than 1
ml of wine or beer. The small amount of alcohol in this medicine will not have noticeable effects.

For athletes:
The use of the drug without therapeutic need constitutes doping and may still result in positive
anti-doping tests.

3. How to use INUVER

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts consult your doctor or pharmacist.
The doctor will monitor you regularly to ensure that you are taking the optimal dose of
INUVER. The doctor will prescribe the lowest dose that provides optimal control of your symp- toms.

Dose:
Adults and elderly
The recommended dose is 2 inhalations twice a day.
The maximum daily dose is 4 inhalations.

Remember: You should always carry your “as needed” fast-acting inhaler with you to treat a
worsening of asthma symptoms or a sudden asthma attack.
Patients at risk:
No dose adjustment is necessary if you are elderly. No information is available on the use of
INUVER in patients with liver or kidney problems.

Use in children and adolescents under 18 years of age
Children and adolescents under 18 years of age should NOT take this medicine.

INUVER is effective in the treatment of asthma with a beclometasone dipropionate dosage that
may be lower than that of other inhaler products containing this substance.
If you have previously used a different inhaler medicine based on beclometasone
dipropionate, your doctor will prescribe the exact dose of INUVER to take to treat
asthma.
Do not increase the dose
If you feel that the medicine is not very effective, always ask your doctor before increas- ing the dosage.

If asthma worsens
If your symptoms worsen or are difficult to control (for example if you use your “as needed” inha- ler more frequently), or if your “as needed” inhaler does not improve your symptoms, contact
your doctor immediately. Asthma may be worsening and your doctor may decide
to change your dose of INUVER 200/6 micrograms per actuation pressurized solution for
inhalation or prescribe you alternative treatment.

Method of administration
INUVER is for inhalation use
This medicine is contained in a pressurized canister inserted into a plastic inhaler with a
mouthpiece. On the back of the inhaler there is a dose counter, which indicates the number of doses
remaining. Each time the canister is pressed, a dose of medicine is delivered and the counter
decreases by one number. Be careful not to drop the inhaler, as this may decrease
the number of doses reported by the counter.

Checking the inhaler’s operation
Before using the inhaler for the first time or if the inhaler has not been used for 14 days or more,
you should check the operation of the inhaler to ensure it is working correctly.

• Remove the protective cap from the mouthpiece
• Hold the inhaler in a vertical position with the mouthpiece facing down
• Point the mouthpiece away and press the canister firmly to deliver a dose
• Check the dose counter. If you are using the inhaler for the first time, the number 120 should appear in the counter window.

How to use the inhaler
When possible, remain standing or sit in an upright position while inhaling.
Before inhalation, check the dose counter window: any number between “1” and “120”
indicates that there are still doses. If the dose counter window indicates “0”, it means that there are
no doses remaining - the inhaler must be disposed of and a new one obtained.

• 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust and dirt or any other foreign object.
• 2. Exhale as slowly and deeply as possible.
• 3. Hold the canister vertically, with the body of the device upwards, and then place the mouthpiece between your closed lips. Do not bite the mouthpiece.
• 4. Inhale slowly and deeply through your mouth and immediately after starting to inhale press firmly on the top of the inhaler to release a dose. If you have a weak grip, it may be easier to hold the inhaler with both hands: position your index fingers on the top of the inhaler and both thumbs on the base of the inhaler.
• 5. Hold your breath as long as possible and at the end remove the inhaler from your mouth and exhale slowly. Do not exhale into the inhaler.

If another actuation is necessary, keep the inhaler in a vertical position for
about half a minute and repeat steps 2 to 5.

Important: Do not perform steps 2 to 5 too quickly.
After use, close with the protective cap and check the dose counter.

To reduce the risk of a fungal infection in the mouth or throat, after each inhalation rinse
your mouth or gargle with water or brush your teeth.
You need to get a new package of medicine when the dose counter indicates the number
20. Stop using the inhaler when the dose counter shows the number 0, as the amount
of medicine remaining in the device may not be sufficient to deliver a complete dose.
If you observe “mist” escaping from the inhaler or from the sides of your mouth, it means that Inuver has not
reached your lungs as it should. Deliver another dose following the instructions repeating the
operations from point 2.
If you think that the effect of INUVER is too strong or not sufficient, contact your doctor or phar- macist.
If you find it difficult to operate the inhaler while starting to inhale, you can use the spacer device
AeroChamber Plus. Ask your doctor, pharmacist or nurse for information about this device.
roChamber Plus and follow the instructions on how to use and clean it carefully.

Cleaning
The inhaler should be cleaned once a week.

During cleaning, do not remove the canister from the inhaler and do not use water or other liquids
to clean the inhaler.
To clean the inhaler:

• 1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
• 2. Clean the inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or handkerchief.
• 3. Reposition the protective cap on the mouthpiece.

If you use more INUVER than you should

• Taking more formoterol than you should may cause the following effects: feeling of nausea, nausea, fast heartbeat, palpitations, irregular heartbeat, changes in the electrocardiogram (heart tracing), headache, tremor, drowsiness, excess acid in the blood, low levels of potassium in the blood, high blood glucose levels. The doctor may perform blood tests to check the level of potassium and glucose
• Taking an excessive amount of beclometasone dipropionate may result in temporary disorders of the adrenal glands. These problems will resolve spontaneously within a few days, and in any case the doctor may decide to check the serum cortisol levels.

Contact your doctor if you experience any of these symptoms.
If you forget to use INUVER
Take it as soon as you remember. If it is almost time for the next dose, do not take the dose you have
forgotten, but take the next dose at the correct time. Do not take a double dose to make up for the missed dose.

If you stop taking INUVER
Even if you feel better, do not stop taking INUVER or reduce the dose. If you intend to
do so, talk to your doctor. It is very important that INUVER is used regularly, even in the absence of symptoms.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
As with other treatments via inhalation, there is a risk of worsening of breathlessness and
wheezing immediately after use of INUVER and this event is called

paradoxical bronchospasm. If this occurs, you must IMMEDIATELY STOP using
INUVERand use your reliever inhaler as soon as possible to treat the symptoms of
breathlessness and wheezing. You should contact your doctor immediately.

Immediately inform your doctorif hypersensitivity reactionsappear, such
as skin allergies, itching, rash, redness of the skin, swelling of the skin or mucous
membranes, especially of the eyes, face, lips and throat.
Below are listed other possible side effects listed in order of frequency.

Common(may affect up to 1 in 10 people):

• fungal infections (of the mouth and throat)
• headache
• hoarseness
• sore throat

Uncommon(may affect up to 1 in 100 people):

• palpitations, unusually fast heartbeat and heart rhythm disturbances
• changes in the electrocardiogram (ECG)
• increased blood pressure
• flu-like symptoms
• inflammation of the sinuses
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• vaginal fungal infections
• nausea
• taste abnormalities or alteration
• burning of the lips
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhea
• muscle pain and cramps
• redness of the face and throat
• increased blood flow to some tissues of the body
• excessive sweating
• tremor
• restlessness
• dizziness
• urticaria
• changes in some blood components: either a reduction in the number of white blood cells or an increase in the number of platelets in the blood or a reduction in potassium levels in the blood or an increase in blood sugar levels or increased levels of insulin, free fatty acids and ketones in the blood

The following side effects have been reported with “uncommon” frequency in patients with chronic
obstructive bronchopneumonia:

• lung infection; inform your doctor if you notice any of the following symptoms: increased sputum (phlegm) production, change in sputum color, fever, increased cough, increased breathing problems
• reduction in the amount of cortisol in the blood: this is caused by the effect of corticosteroids on the adrenal gland
• irregular heartbeat

Rare(may affect up to 1 in 1,000 people):

• feeling of tightness in the chest
• loss of heartbeat (caused by premature ventricular contractions)
• decreased blood pressure
• inflammation of the kidneys
• swelling of the skin and mucous membranes lasting for several days

Very rare(may affect up to 1 in 10,000 people):

• shortness of breath
• worsening of asthma
• decreased number of platelets in the blood
• swelling of the hands and feet

The use of high doses of corticosteroids via inhalation for long periods of time can cause
in very rare cases systemic effects, including:

• disorders of adrenal gland function (adrenal suppression)
• reduction in bone mineral density (thinning of the bones)
• growth retardation in children and adolescents
• increased pressure inside the eyes (glaucoma)
• cataract

Not known (frequency cannot be estimated based on available data):

• sleep disturbances
• depression or anxiety
• nervousness
• feeling of overstimulation or irritability.
• Blurred vision These events are more likely in children, but their frequency is unknown.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store INUVER

Keep this medicine out of the sight and reach of children.
For pharmacists:
Store in a refrigerator (2 °C – 8 °C) for a maximum of 18 months.
For patients:
Do not use this medicine for more than 3 months after the date of purchase from the pharmacy and never use it after
the expiry date which is reported on the box and label after EXP. The expiry date refers to the last day of that month.
Do not store the inhaler at a temperature above 25°C.
If the inhaler has been exposed to low temperatures, warm it with your hands for a few minutes before
use. Never heat it with artificial methods.
Caution: The container contains liquid under pressure. Do not expose it to temperatures above
50°C. Do not puncture the container.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What INUVER contains:
The active ingredients are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each actuation from the metering valve contains 200 micrograms of beclometasone dipropionate and 6
micrograms of formoterol fumarate dihydrate. This is equivalent to an inhaled dose from the mouthpiece of
177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate di-
hydrate.
The other ingredients are: norflurane (HFC 134-a), anhydrous ethanol, hydrochloric acid.
This medicine contains fluorinated greenhouse gases. Each inhaler contains 10.356 g of norflura-
ne (HFC-134a) which corresponds to 0.015 tonnes of CO2 equivalent (global warming potential
= 1430).

Description of the appearance of INUVER and contents of the pack
INUVER is a pressurized solution for inhalation contained in an aluminum-coated canister with a metering
valve, inserted into a plastic actuator incorporating a dose counter (120 actuations) or a dose indicator (180
actuations) with a plastic protective cap.
Each pack contains:
1 pressure container (allowing 120 inhalations)
2 pressure containers (allowing 120 inhalations each)
1 pressure container (allowing 180 inhalations)
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma - Italy

Manufacturer responsible for batch release
Chiesi Farmaceutici S.p.A.
Via San Leonardo 96
43122 Parma - Italy

Alternative manufacturers responsible for batch release
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Vienna - Austria
Chiesi S.A.S
2 rue des Docteurs Alberto et Paolo Chiesi
41260 La Chaussée Saint Victor - France

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:

INUVER 200/6 micrograms per actuation pressurized solution

for inhalation
For use in adults only
beclometasone dipropionate/formoterol fumarate dihydrate

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What INUVER is and what it is used for
• 2. What you need to know before you use INUVER
• 3. How to use INUVER
• 4. Possible side effects
• 5. How to store INUVER
• 6. Contents of the pack and other information

1. What is INUVER and what is it used for

INUVER is a pressurized inhalation solution containing two active ingredients that are inhaled
through the mouth and released directly into the lungs.
The two active ingredients are:
Beclometasone dipropionate, which belongs to a group of medicines called corticosteroids, which
have an anti-inflammatory action capable of reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate, which belongs to a group of medicines called long-acting bronchodilators,
relaxes the muscles of the airways, thus making breathing easier.
These two active ingredients, together, facilitate breathing; they also help to prevent the symptoms
of asthma, such as shortness of breath, wheezing and cough.

INUVER is used for the treatment of asthma in adults.
If INUVER has been prescribed to you, it is likely that:

• your asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators “as needed” or
• your asthma responds well to treatment with both corticosteroids and long-acting bronchodilators

2. What you need to know before using INUVER

Do not use INUVER:

• if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using INUVER if you have any of the following conditions:

• heart problems, such as angina (heart pain, chest pain), heart failure, narrowing of the arteries, problems with heart valves or other known heart abnormalities
• high blood pressure or if you know you have an aneurysm (an abnormal dilation of the blood vessel walls)
• heart rhythm disorders such as fast or irregular heartbeat, rapid pulse or palpitations, or if you have been told that your heart tracing is abnormal
• excessive activity of the thyroid gland
• low levels of potassium in the blood
• any liver or kidney problems
• diabetes (if you inhale high doses of formoterol, blood glucose levels may increase. It may therefore be necessary to perform further blood tests to check your blood sugar levels when you start using this medicine and periodically during the entire duration of treatment)
• tumor of the adrenal gland (called pheochromocytoma)
• if you are going to have anesthesia. Depending on the type of anesthetic, it may be necessary to stop treatment with INUVER at least 12 hours before anesthesia
• if you are taking, or have taken, medicines to treat tuberculosis (TB), or if you suffer from known viral or fungal infections of the chest
• if you need to avoid alcohol for any reason

If you fall into any of the cases listed above, always inform your doctor before using INU-
VER.
If you have or have had any medical problem or allergies or if you are not sure you can use INUVER
talk to your doctor, experienced asthma nurse or pharmacist before using this
medicine.

The doctor may decide to measure your blood potassium levels periodically,
especially if your asthma is severe.Like many bronchodilators, INUVER can cause a
sudden drop in serum potassium levels (hypokalemia). This is because a reduction in oxygen in the
blood associated with some other treatments taken together with INUVER can worsen the reduction in
potassium levels.

If you take high doses of inhaled corticosteroids for long periods of time, you may have
greater need for corticosteroids in stressful situations. Stressful situations can include
hospitalization following an accident, sustaining serious injuries, or the period before
surgery. In such cases, the doctor may decide whether or not to increase your
dose of corticosteroids and to prescribe steroid tablets or steroid injections.

If you need to be hospitalized, remember to bring all your medicines and
inhalers with you, including INUVER and any over-the-counter medicines or tablets,
in their original packaging, if possible.

Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
INUVER should not be used in children and adolescents under 18 years of age.

Other medicines and INUVER
Tell your doctor, pharmacist or nurse if you are taking, have recently taken any other
medicines, including over-the-counter medicines. This is necessary because INUVER
can alter the action of other medicines. Also, other medicines can have effects on the activity
of INUVER.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Some medicines can increase the effects of INUVER and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, high blood pressure or glaucoma (increased pressure in the eyes). If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or canceled.
• Beta-adrenergic medicines (medicines with similar activity to that of formoterol) can increase the effects of formoterol.
• Medicines for the treatment of heart rhythm abnormalities (quinidine, disopyramide, procainamide).
• Medicines used to treat allergic reactions (antihistamines).
• Medicines used to treat symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide), tricyclic antidepressants (e.g. amitriptyline and imipramine), phenothiazines.
• Medicines for the treatment of Parkinson's disease (L-dopa).
• Medicines for the treatment of an underactive thyroid (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines for the treatment of mental disorders such as monoamine oxidase inhibitors (MAOIs), including drugs with similar properties such as furazolidone and procarbazine.
• Medicines for the treatment of heart disease (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline or steroids).
• Diuretics (water pills).

Also tell your doctor or pharmacist if you intend to use a general anesthetic for an
operation or dental procedure.

Pregnancy, breastfeeding and fertility
There are no clinical data on the use of INUVER during pregnancy.
INUVER should not be used if you are pregnant, suspect or are planning a
pregnancy or if you are breastfeeding, unless your doctor has told you that you can do so.

Driving and operating machinery
It is unlikely that INUVER will affect your ability to drive or operate machinery.

INUVER contains alcohol
INUVER contains 9 mg of alcohol (ethanol) per actuation, which is equivalent to 0.25 mg/kg per dose
of two actuations. The amount of alcohol in two actuations of this medicine is equivalent to less than 1
ml of wine or beer. The small amount of alcohol in this medicine will not have noticeable effects.

For those who play sports:
The use of the drug without therapeutic need constitutes doping and may still result in
positive anti-doping tests.

3. How to use INUVER

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts consult your doctor or pharmacist.
Your doctor will monitor you regularly to ensure that you are taking the optimal dose of
INUVER. Your doctor will prescribe the lowest dose that provides optimal control of your symp- toms.

Dose:
Adults and the elderly
The recommended dose is 2 inhalations twice a day.
The maximum daily dose is 4 inhalations.

Remember: You should always carry your “as needed” fast-acting inhaler with you to treat a
worsening of asthma symptoms or a sudden asthma attack.
Patients at risk:
No dose adjustment is necessary if you are elderly. There is no information available on the use of
INUVER in patients with liver or kidney problems.

Use in children and adolescents under 18 years of age
Children and adolescents under 18 years of age should NOT take this medicine.

INUVER is effective in the treatment of asthma with a beclometasone dipropionate dosage that
may be lower than that of other inhaler products containing this substance.
If you have previously used a different inhaler medicine based on beclome- tasone
dipropionate, your doctor will prescribe the exact dose of INUVER to take to treat
asthma.
Do not increase the dose
If you feel that the medicine is not very effective, always ask your doctor before increas- ing the dosage.

If asthma worsens
If your symptoms worsen or are difficult to control (for example, if you use your “as needed” inha- ler more frequently), or if your “as needed” inhaler does not improve your symptoms, contact
your doctor immediately. Asthma may be worsening and your doctor may decide
to change your dose of INUVER 200/6 micrograms per actuation pressurized solution for
inhalation or prescribe you alternative treatment.

Method of administration
INUVER is for inhalation use
This medicine is contained in a pressurized canister inserted into a plastic inhaler with a
mouthpiece. On the back of the inhaler there is a dose indicator, which indicates the number of
doses remaining. Each time you press on the canister, the dose indicator decreases by a small quanti-
ty. The number of doses remaining is displayed in intervals of 20.
Be careful not to drop the inhaler, as this may decrease the number of doses reported by the
counter.

Checking the operation of the inhaler
Before using the inhaler for the first time or if the inhaler has not been used for 14 days or more,
you must check the operation of the inhaler to ensure that it is working correctly.

• Remove the protective cap from the mouthpiece
• Hold the inhaler in a vertical position with the mouthpiece facing down
• Point the mouthpiece away and press firmly on the canister to deliver a dose
• Check the dose indicator. If you are using the inhaler for the first time, the number 180 should appear in the window of the dose indicator.

How to use the inhaler
When possible, remain standing or sitting in an upright position while performing the inhalation.
Before inhalation, check the dose window: any number between “1” and “180”
indicates that there are still doses. If the dose window indicates “0”, it means that there are no
doses remaining – the inhaler must be disposed of and a new one obtained.

• 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust and dirt or any other foreign object.
• 2. Exhale as slowly and deeply as possible.
• 3. Hold the canister vertically, with the actuator body facing up, and then place the mouthpiece between your closed lips. Do not bite the mouthpiece.
• 4. Inhale slowly and deeply through your mouth and immediately after starting to inhale press firmly on the top of the inhaler to release a dose. If you have a weak grip, it may be easier to hold the inhaler with both hands: position your index fingers on the top of the inhaler and both thumbs on the base of the inhaler.
• 5. Hold your breath for as long as possible and at the end remove the inhaler from your mouth and exhale slowly. Do not exhale into the inhaler.

If another actuation is necessary, keep the inhaler in a vertical position for
about half a minute and repeat steps 2 to 5.

Important: Do not perform steps 2 to 5 too quickly.
After use, close with the protective cap and check the dose indicator.

To reduce the risk of a fungal infection in the mouth or throat, after each inhalation rinse
your mouth or gargle with water or brush your teeth after each use of the inhaler.
You need to get a new package of medicine when the dose indicator shows the
number 20. Stop using the inhaler when the dose indicator shows the number 0, bec-
cause the amount of medicine remaining in the device may not be sufficient to deliver
a full dose. If after inhalation you observe “mist” escaping from the inhaler or from the sides of your mouth, it means
that Inuver has not reached your lungs as it should. Deliver another dose following the instru-
ctions by repeating the operations from point 2.
If you think that the effect of INUVER is too strong or not sufficient, consult your doctor or phar-
macist.
If you find it difficult to operate the inhaler while starting to inhale, you can use the spacer device
AeroChamber Plus. Ask your doctor, pharmacist or nurse for information about this device.
roChamber Plus and follow the instructions on how to use and clean it carefully.

Cleaning
The inhaler should be cleaned once a week.

During cleaning, do not remove the canister from the inhaler and do not use water or other liquids
to clean the inhaler.
To clean the inhaler:

• 1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
• 2. Clean the inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or handkerchief.
• 3. Reposition the protective cap on the mouthpiece.

If you use more INUVER than you should

• Taking more formoterol than you should can cause the following effects: feeling of nausea, nausea, rapid heartbeat, palpitations, irregular heartbeat, changes in the electrocardiogram (heart tracing), headache, tremor, drowsiness, excess acid in the blood, low potassium levels in the blood, high glucose levels in the blood. The doctor may perform blood tests to check the level of potassium and glucose
• Taking an excessive amount of beclometasone dipropionate can lead to temporary disorders of the adrenal glands. These problems will resolve spontaneously within a few days, and in any case the doctor may decide to check the serum cortisol levels.

Contact your doctor if you experience any of these symptoms.
If you forget to use INUVER
Take it as soon as you remember. If it is almost time for the next dose, do not take the dose you have
forgotten, but take the next dose at the correct time. Do not take a double dose to make up for the
forgotten dose.

If you stop taking INUVER
Even if you feel better, do not stop taking INUVER or reduce the dose. If you intend to
do so, talk to your doctor. It is very important that INUVER is used regularly, even in the absence of symptoms.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
As with other treatments via inhalation, there is a risk of worsening of breathlessness and
wheezing immediately after use of INUVER and this event is called

paradoxical bronchospasm. If this occurs, you must IMMEDIATELY STOP using
INUVERand use your reliever inhaler as soon as possible to treat the symptoms of
breathlessness and wheezing. You should contact your doctor immediately.

Immediately inform your doctorif hypersensitivity reactionsappear, such
as skin allergies, itching, rash, skin redness, swelling of the skin or mucous
membranes, especially of the eyes, face, lips and throat.
Below are listed other possible side effects listed in order of frequency.

Common(may affect up to 1 in 10 people):

• fungal infections (of the mouth and throat)
• headache
• hoarseness
• sore throat

Uncommon(may affect up to 1 in 100 people):

• palpitations, unusually fast heartbeat and heart rhythm disturbances
• alteration of the electrocardiogram (ECG)
• increased blood pressure
• flu-like symptoms
• inflammation of the sinuses
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• vaginal fungal infections
• nausea
• taste abnormalities or alteration
• burning of the lips
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhea
• muscle pain and cramps
• redness of the face and throat
• increased blood flow to some tissues of the body
• excessive sweating
• tremor
• restlessness
• dizziness
• urticaria
• alteration of some blood components: either a reduction in the number of white blood cells or an increase in the number of platelets in the blood or a reduction in blood potassium levels or an increase in blood sugar levels or increased levels of insulin, free fatty acids and ketones in the blood

The following side effects have been reported with “uncommon” frequency in patients with chronic
obstructive bronchopneumonia:

• lung infection; inform your doctor if you notice any of the following symptoms: increased sputum (phlegm) production, change in sputum color, fever, increased cough, increased breathing problems
• reduction in the amount of cortisol in the blood: this is caused by the effect of corticosteroids on the adrenal gland
• irregular heartbeat

Rare(may affect up to 1 in 1,000 people):

• feeling of tightness in the chest
• loss of heartbeat (caused by premature ventricular contractions)
• decreased blood pressure
• kidney inflammation
• swelling of the skin and mucous membranes lasting for several days

Very rare(may affect up to 1 in 10,000 people):

• shortness of breath
• worsening of asthma
• decreased number of platelets in the blood
• swelling of the hands and feet

The use of high-dose inhaled corticosteroids for long periods of time can, in very rare cases, cause
systemic effects, including:

• disorders of adrenal gland function (adrenal suppression)
• reduction in bone mineral density (thinning of the bones)
• growth retardation in children and adolescents
• increased pressure inside the eyes (glaucoma)
• cataract

Not known (frequency cannot be estimated based on available data):

• sleep disturbances
• depression or anxiety
• nervousness
• feeling of overstimulation or irritability.
• Blurred vision These events are more likely in children, but their frequency is unknown.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store INUVER

Keep this medicine out of the sight and reach of children.
For pharmacists:
Store in a refrigerator (2 °C – 8 °C) for a maximum of 18 months.
For patients:
Do not use this medicine for more than 3 months after the date of purchase from the pharmacy and do not use it after
the expiry date which is stated on the box and label after EXP. The expiry date refers to the last day of that month.
Do not store the inhaler at a temperature above 25°C.
If the inhaler has been exposed to low temperatures, warm it with your hands for a few minutes before
use. Never heat it with artificial methods.
Caution: The container contains liquid under pressure. Do not expose it to temperatures above
50°C. Do not puncture the container.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What INUVER contains:
The active ingredients are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each actuation from the metering valve contains 200 micrograms of beclometasone dipropionate and 6
micrograms of formoterol fumarate dihydrate. This is equivalent to an inhaled dose from the mouthpiece of
177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate di-
hydrate.
The other ingredients are: norflurane (HFC 134-a), anhydrous ethanol, hydrochloric acid.
This medicine contains fluorinated greenhouse gases. Each inhaler contains 14.239 g of norflura-
ne (HFC-134a) which corresponds to 0.020 tonnes of CO2 equivalent (global warming potential = 1430).

Description of the appearance of INUVER and package contents
INUVER is a pressurized solution for inhalation contained in an aluminum-coated canister with a metering valve, inserted into a plastic actuator incorporating a dose counter (120 actuations) or a dose indicator (180 actuations) with a plastic protective cap.
Each pack contains:
1 pressurized container (allowing 120 inhalations)
2 pressurized containers (allowing 120 inhalations each)
1 pressurized container (allowing 180 inhalations)
Not all pack sizes may be marketed.

Marketing authorization holder
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma - Italy

Manufacturer responsible for batch release
Chiesi Farmaceutici S.p.A.
Via San Leonardo 96
43122 Parma - Italy

Alternative manufacturers responsible for batch release
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Vienna - Austria
Chiesi S.A.S
2 rue des Docteurs Alberto et Paolo Chiesi
41260 La Chaussée Saint Victor - France

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:

INUVER 200 micrograms/6 micrograms for inhalation powder for inhalation

For use in adults only
beclometasone dipropionate anhydrous/formoterol fumarate dihydrate

Read this leaflet carefully before you start to use this medicine as it containsimportant
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet

• 1. What INUVER is and what it is used for
• 2. What you need to know before you use INUVER
• 3. How to use INUVER
• 4. Possible side effects
• 5. How to store INUVER
• 6. Contents of the pack and other information

1. What is INUVER and what is it used for

INUVER is a powder that is inhaled through the mouth and released directly into the lungs.
It contains two active ingredients: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate.

• Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which have an anti-inflammatory action, reducing swelling and irritation in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators. These drugs relax the muscles of the airways, widening them and making it easier to inhale and exhale air from the lungs .

These two active ingredients, together, make breathing easier and also help to prevent the symptoms
of asthma, such as shortness of breath, wheezing and cough.
INUVER is used for the treatment of asthma in adults.
If INUVER has been prescribed to you, it is likely that:

• your asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators “as needed” or

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• your asthma responds well to treatment with both corticosteroids and long-acting bronchodilators

2. What you need to know before using INUVER

Do not use INUVER
If you are allergic to beclometasone dipropionate anhydrous or formoterol fumarate dihydrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Do not take this medicine if you experience acute asthma symptoms, such as shortness of breath, wheezing and cough, or if your asthma is getting worse or in the treatment of acute asthma attacks. To treat your symptoms you should use your fast-acting “as needed” inhaler which you should always carry with you.
Consult your doctor before using INUVER if you experience any of the following conditions:

• heart problems, including any type of known heart disease and/or heart function
• irregular heartbeat, such as increased or irregular heart rate, rapid pulse or palpitations, or if you have been told that your heart tracing is abnormal
• high blood pressure
• narrowing of the arteries (also known as arteriosclerosis), or if you are aware of having an aneurysm (an abnormal dilation of the blood vessel walls)
• overactive thyroid gland
• low levels of potassium in the blood
• any liver or kidney disorders
• diabetes. If you inhale high doses of formoterol, blood glucose levels may increase and, as a result, you may need to undergo further blood tests to monitor blood sugar levels both when you start using this medicine and periodically throughout the duration of treatment.
• adrenal gland tumor (called pheochromocytoma)
• if you are to undergo anesthesia. Depending on the type of anesthetic, it may be necessary to stop treatment with INUVER at least 12 hours before anesthesia.
• if you are taking, or have taken, medicines to treat tuberculosis (TB), or if you suffer from known viral or fungal infections of the chest.

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If you fall into any of the above cases, always inform your doctor before using INUVER.
If you are unsure if you can use INUVER, consult your doctor, an experienced nurse in asthma problems or your pharmacist before using this medicine.

Your doctor may decide to measure your blood potassium levels periodically,
especially if your form of asthma is severe.Like many bronchodilators, INUVER can cause a
sudden drop in serum potassium levels (hypokalemia). This happens because a reduction in oxygen in the
blood associated with some other treatments taken together with INUVER can worsen the reduction in
potassium levels.

If you take high doses of inhaled corticosteroids for long periods of time, you may
need more corticosteroids in stressful situations. Stressful situations can include
hospitalization following an accident, having suffered serious injuries or the period prior to
surgery. In such cases, the doctor will decide whether or not to increase your
dose of corticosteroids and may prescribe steroid tablets or steroid injections.

If you need to be hospitalized, remember to bring all your medicines and
inhalers with you, including INUVER, and any over-the-counter medicines or tablets, if possible in their original packaging.

Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
This medicine should not be administered to children and adolescents under 18 years of age.

Other medicines and INUVER
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine. This is necessary because INUVER can alter the action of other medicines.
Also, other medicines can have effects on the activity of INUVER.
In particular, consult your doctor or pharmacist if you are taking any of the following
medicines:

• Some medicines can increase the effects of INUVER and your doctor may want to keep you under close observation if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
• Beta-blockers. Do not use this medicine together with beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, high blood pressure or glaucoma (increased pressure in the eyes). If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or canceled.
• Beta-adrenergic drugs (drugs with similar activity to that of formoterol) can increase the effects of formoterol.
• Medicines for the treatment of cardiac arrhythmias (quinidine, disopyramide, procainamide).
• Medicines for treating allergic reactions (antihistamines, such as terfenadine).

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• Medicines for the treatment of depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide,) or tricyclic antidepressants (e.g. amitriptyline and imipramine) or phenothiazines.
• Medicines for the treatment of Parkinson's disease (L-dopa).
• Medicines for the treatment of an underactive thyroid (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines for the treatment of mental disorders such as Monoamine Oxidase Inhibitors (MAOIs), including drugs with properties similar to furazolidone and procarbazine.
• Medicines for the treatment of heart disease (digoxin).
• Other medicines for the treatment of asthma (theophylline, aminophylline or steroids)
• Diuretics (water pills).

Also inform your doctor or pharmacist if you intend to use a general anesthetic for an
operation or for dental work.

Pregnancy, breastfeeding and fertility
There is no clinical data on the use of INUVER during pregnancy.
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding, ask your doctor for advice before using this medicine. INUVER should only be used
during pregnancy if your doctor advises you to do so. The doctor will decide whether you should stop
taking INUVER during breastfeeding or whether you should take INUVER but refrain
from breastfeeding. Always follow your doctor's instructions carefully.

Driving and operating machinery
It is unlikely that INUVER will affect your ability to drive vehicles or operate machinery .However, if
you experience side effects such as dizziness and/or tremor, your ability to drive vehicles or
operate machinery may be altered.

INUVER contains lactose
Lactose contains small amounts of milk proteins, which can cause reactions in patients
allergic to milk. If your doctor has diagnosed you with intolerance to certain sugars, contact him before
taking this medicine.

For those who engage in sports:

The use of the drug without therapeutic necessity constitutes doping and may still result in positive
anti-doping tests.

3. How to use INUVER

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor, pharmacist or nurse.
INUVER delivers an extrafine powder, which allows a greater amount of the drug contained in the
dose to reach the lungs. The doctor may, therefore, prescribe a lower dose of this inhaler than those you were taking with other inhalers.

4
The doctor will monitor you regularly to ensure that you are taking the correct dose of
INUVER. Once asthma is well controlled, the doctor may consider it appropriate to gradually reduce
the dose of INUVER. Do not change the dose in any casewithout first consulting your
doctor.

How much INUVER to use:
Adults and the elderly:
The recommended dose of this medicine is 2 inhalations twice a day.
The maximum daily dose is 4 inhalations.

Do not increase the dose.
If you feel that the medicine is not effective, always consult your doctor before increasing the dose.

Remember: you should always carry your fast-acting "rescue" inhaler with you to
treat a worsening of symptoms or a sudden asthma attack.
How to use INUVER:
INUVER is for inhalation use.
If possible, stand or sit upright when you inhale.

If you use more INUVER than you should:

• contact your doctor or the nearest hospital emergency room immediately for advice. Bring the medicine with you, so that healthcare personnel can understand which medicine you have taken;
• adverse effects may occur. Inform your doctor if you notice any unusual symptoms, as further investigations or any necessary therapeutic measures may be required.

If you forget to use INUVER:
Take the dose as soon as you remember. If it is almost time to take the next dose, skip the missed dose
and take the next dose at the correct time. Do not take a double dose to make up for the
missed dose.
If you stop treatment with INUVER:
Even if you feel better, do not stop using INUVER or reduce the dosage. If you intend
to do so, talk to your doctor. It is very important that you use INUVER every day, as prescribed by
your doctor, even if you have no symptoms.

If your breathing remains unchanged
If your symptoms do not improve after inhaling INUVER, it is possible that you are using
the device incorrectly. Therefore, check the instructions for proper use
of the device below and/or contact your doctor, nurse or pharmacist to explain how to use it correctly.

If your asthma gets worse
If your symptoms worsen or are difficult to control (for example if you use your
"rescue" inhaler more frequently), or if your "rescue" inhaler does not improve your symptoms,

5
you must continue to use INUVER but contact your doctor as soon as possible. The doctor may decide
to change your dose of INUVER or prescribe further or alternative treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

INSTRUCTIONS FOR USE OF THE NEXTHALER INHALER

• A.Package ContentsFor information on the package contents, see section 6. If the contents of the pack-age do not correspond to what is stated above, return the inhaler to the person who provided it to you (e.g. the pharmacist or doctor) and obtain a new one.
• B.General Warnings and Precautions
• Do notremove the inhaler from its bag unless you intend to use it immediately.
• Use the inhaler only as directed.
• Keep the inhaler cap closed until you are about to take your dose.
• When not using the inhaler, store it in a clean, dry place.
• Do notattempt to disassemble the Nexthaler inhaler for any reason.
• C.Main features of the Nexthaler inhaler

of air
Taking a dose from the Nexthaler inhaler requires only three simple steps: Opening, Inhala-
tion, Closing

• D.Before using a new Nexthaler inhaler
• 1. Open the bag and remove the inhaler.o Do notuse the inhaler if the bag is not sealed or is damaged – return it to the supplier and obtain a new one. o Use the adhesive label on the package to write the date of first opening of the bag
• 2. Check the inhaler.o If the inhaler appears broken or damaged, return it to the supplier and obtain a new one.
• 3. Check the dose counter window. If the inhaler is new, the number “120” will appear in the dose counter window.

6
o Do notuse a new inhaler if the number indicated is less than “120” – return it to the
supplier and obtain a new one.

• E.How to use the Nexthaler inhaler
• 1. If you are not sure you are receiving the dose correctly, contact your pharmacist or doctor.
• 2. If you are not sure that the number indicated by the dose counter has decreased by one unit after inhalation, wait until the next scheduled dose and take it normally. Do not take a double dose.

E.1Opening

1. Hold the inhaler firmly in a vertical position.

2. Check the number of doses remaining: any number between “1” and “120” indi-

cates that there are still doses.
o If the dose counter window shows “0”, it means that there are no doses left –
the inhaler must be discarded and a new one obtained.

3. Open the cap completely.

4. Before inhalation, exhale as much as possible.

o Do notbreathe through the inhaler.

E.2Inhalation
When possible, remain standing or sit in an upright position during inhalation.

• 1.Raise the inhaler, bring it to your mouth and close your lips around the mouth-piece.o Do notcover the air intake while holding the inhaler. o Do notinhale through the air intake.

2. Breathe in quickly and deeply through your mouth.

o You may perceive a certain taste in your mouth while taking the dose.
o You may feel or hear a “click” while taking the dose.
o Do notbreathe in through your nose.

7
o Do notmove your lips from the inhaler during inhalation.

3. Remove the inhaler from your mouth.

4. Hold your breath for 5 or 10 seconds, or for as long as is comfortable for you.

5. Exhale slowly.

o Do notexhale through the inhaler.

E.3Closing

1. Return the inhaler to an upright position and close the cap completely.

2. Check that the dose counter has advanced by one number.

3. If you need to take another dose, repeat the operations from point E.1 to point

E.3.

• F.Cleaning
• Normally, it is not necessary to clean the inhaler.
• If necessary, you can keep the inhaler clean after use by wiping the device with a dry cloth or paper towel.
• Do notclean the inhaler with water or other liquids. Keep the device always dry.
• G.Storage and disposalFor information on storage conditions and disposal instructions, see section 5.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
As with other treatments via inhalation, there is a risk of worsening of breathlessness,
cough and wheezing immediately after using INUVER, and this occurrence is
known as paradoxical bronchospasm. If this happens, you must IMMEDIATELY STOP
8
using INUVERand use your fast-acting ‘rescue’ inhaler as soon as possibleto
treat the symptoms. You should contact your doctor immediately.
Immediately inform your doctor if allergic reactions appear, including
skin allergies, skin itching, rash, skin redness, swelling of the skin or mucous membranes,
especially of the eyes, face, lips and throat.
Below are listed other possible side effects of INUVER, listed in order of frequency.

Common(may affect up to 1 in 10 people):

• tremor

Uncommon(may affect up to 1 in 100 people):

• cold symptoms, sore throat
• fungal infections (of the mouth and throat). Rinsing your mouth or gargling with water and brushing your teeth immediately after inhalation may help prevent these side effects
• worsening of asthma symptoms, difficulty breathing
• hoarseness
• cough
• unusually fast heartbeat
• unusually slow heartbeat
• oppressive chest pain
• headache
• feeling unwell
• feeling tired or nervous
• alteration in electrocardiogram (ECG)
• low level of cortisol in urine or blood
• high level of potassium in the blood
• high level of glucose in the blood
• high level of fats in the blood

Not known(frequency cannot be estimated based on available data)

• blurred vision

Side effects observed with similar inhaled medicinescontaining beclometasone
dipropionate and/or formoterol are as follows:

• palpitations
• irregular heartbeat
• taste anomalies or alterations
• muscle pain and muscle cramps
• restlessness, dizziness
• feeling anxious
• sleep disturbances
• decrease in blood potassium level
• increase/decrease in blood pressure

9
The use of inhaled corticosteroids at high doses and for long periods of time can
cause systemic effects, including:

• disorders of adrenal gland function (adrenal suppression)
• thinning of the bones
• growth retardation in children and adolescents
• increased eye pressure (glaucoma), cataract
• rapid weight gain, especially in the face and torso
• sleep disturbances, depression or feeling worried, agitation, nervousness, hyperactivity or irritability. These effects are more likely to occur in children
• abnormal behavior

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects, you can help provide more information
on the safety of this medicine.

5. How to store INUVER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, on the sachet and
on the label after Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture. Remove the inhaler
from its protective sachet only immediately before its first use.
Before the first opening of the sachet:
This medicine does not require any particular storage temperature.
After the first opening of the sachet:
Do not store at a temperature above 25°C.
After the first opening of the sachet, the medicine must be used within 6 months.
Use the label on the package to write the date of opening the sachet.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What INUVER contains
The active ingredients are: beclometasone dipropionate anhydrous and formoterol fumarate dihydrate.
Each metered dose contains 200 micrograms of beclometasone dipropionate anhydrous and 6
micrograms of formoterol fumarate dihydrate. This corresponds to an inhaled dose, delivered

10
through the mouthpiece, of 158.8 micrograms of beclometasone dipropionate anhydrous and 4.9
micrograms of formoterol fumarate dihydrate.
The other ingredients are: lactose monohydrate and magnesium stearate.

Description of the appearance of INUVER and package contents
INUVERis presented as a white or almost white inhalation powder contained in
a plastic inhaler called Nexthaler.
Each pack contains one, two or three inhalers providing 120 inhalations each.
Each inhaler is packaged in a heat-sealed protective pouch.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
CHIESI FARMACEUTICI S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer responsible for batch release:
Chiesi Farmaceutici S.p.A.
Via San Leonardo 96
43122 Parma - Italy

Alternative manufacturer responsible for batch release:
Chiesi S.A.S.
2 rue des Docteurs Alberto et Paolo Chiesi
41260 La Chaussée Saint Victor - France

Alternative manufacturer responsible for batch release:
Chiesi Pharmaceuticals GmbH
Gonzagagasse 16/16
1010 Vienna – Austria

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:

11

Updated and detailed information on this product is available by scanning with a
external

The same information is also available at the following URL:
https://qrco.de/Nexthaler200-6-120.

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