БЕКЛОМЕТАЗОН 100 МКГ/6 МКГ Прессованный раствор для ингаляции

Содержание инструкции

1. Beclometasone and Formoterolo Teva Italia 100 micrograms/6 micrograms per actuation,
2. beclometasone dipropionate/formoterolo fumarate dihydrate
   1. What is Beclometasone and Formoterolo Teva Italia and what is it used for
   2. What you need to know before using Beclometasone and Formoterolo Teva Italia
   3. How to use Beclometasone and Formoterolo Teva Italia
   4. Possible side effects
   5. How to store Beclometasone and Formoterolo Teva Italia
   6. Package contents and other information
3. Beclometasone and Formoterolo Teva Italia 200 micrograms /6 micrograms per actuation,
4. beclometasone dipropionate/formoterolo fumarate dihydrate
   1. What is Beclometasone and Formoterolo Teva Italia and what is it used for
   2. What you need to know before using Beclometasone and Formoterol Teva Italia
   3. How to use Beclometasone and Formoterol Teva Italia
   4. Possible side effects
   5. How to store Beclometasone and Formoterolo Teva Italia
   6. Package contents and other information

Beclometasone and Formoterolo Teva Italia 100 micrograms/6 micrograms per actuation,

pressurized solution for inhalation

beclometasone dipropionate/formoterolo fumarate dihydrate

Generic medicine

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

• If you have any questions, ask your doctor 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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Beclometasone and Formoterolo Teva Italia and what is it used for

Beclometasone and Formoterolo Teva Italia 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 coughing in patients with asthma or COPD and also help to prevent the
symptoms of asthma.
Asthma
Beclometasone and Formoterolo Teva Italia 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 corticosteroids and long-acting bronchodilators.

COPD
Beclometasone and Formoterolo Teva Italia can also be used to treat the symptoms of
severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a long-term disease of the
airways of the lungs mainly caused by cigarette smoking.

Beclometasone and Formoterolo Teva Italia is for use in adults.

2. What you need to know before using Beclometasone and Formoterolo Teva Italia

Do not use Beclometasone and Formoterolo Teva Italia:

• if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or to any of the excipients of this medicine (listed in section 6). Warnings and precautionsConsult your doctor or pharmacist before using Beclometasone and Formoterolo Teva Italia:
• If you suffer from heart problems, such as angina (heart pain, chest pain), if you have had a recent myocardial infarction, heart failure, narrowing of the arteries around the heart (coronary artery disease), valvular heart disease or any other known heart abnormality or if you suffer from a condition known as obstructive hypertrophic cardiomyopathy (also known as HOCM, a condition in which the heart muscle is abnormal).
• If you suffer from narrowing of the arteries (also known as arteriosclerosis), if you suffer from high blood pressure or if you know you have an aneurysm (an abnormal dilation of the wall of blood vessels).
• If you suffer from heart rhythm disorders such as rapid or irregular heartbeat, rapid pulse or palpitations or if you have been told that your heart tracing is abnormal.
• If you have an overactive thyroid gland.
• If you have low blood levels of potassium.
• If you suffer from any liver or kidney disorder.
• If you suffer from diabetes (if you inhale high doses of formoterol, blood sugar may increase and therefore you may need to undergo some additional blood tests to monitor blood sugar levels when you start using this inhaler and from time to time during treatment).
• If you have a tumor of the adrenal gland (known as pheochromocytoma).
• If you are to undergo anesthesia. Depending on the type of anesthesia, you may need to stop taking Beclometasone and Formoterolo Teva Italia at least 12 hours before anesthesia.
• If you are undergoing, or have ever been, treatment for tuberculosis (TB) or if you have a known viral or fungal infection in your chest.
• If you need to avoid alcohol for any reason.

If any of the above conditions apply to you, always inform your doctor before
using Beclometasone and Formoterolo Teva Italia.
If you have or have had any medical problem or allergies or if you are not sure you can use
Beclometasone and Formoterolo Teva Italia, consult your doctor or pharmacist before using this
medicine.
Treatment with a beta-agonist such as formoterol contained in Beclometasone and Formoterolo
Teva Italia can cause a sharp drop in serum potassium levels (hypokalemia).

If you suffer from severe asthma, you should pay particular attention.This is due to a lack of
oxygen in the blood and some other treatments you may be taking along with Beclometasone and
Formoterolo Teva Italia, such as medicines for the treatment of heart disease or
hypertension, known as diuretics, or other drugs used to treat asthma, may worsen the
reduction in potassium levels. For this reason, your doctor may want to periodically monitor
blood potassium levels.

If you take higher doses of inhaled corticosteroids for long periods, you may have a greater
need for corticosteroids in stressful situations. Stressful situations can include hospitalization
after an accident, a serious injury or surgery. In this case, the doctor who is treating you may decide
that you may need to increase the dose of corticosteroids and may prescribe steroids in tablets or
steroids for injection.

If you have to go to hospital, remember to bring all your medicines and inhalers with you, including
Beclometasone and Formoterolo Teva Italia and all medicines or tablets purchased without
prescription, in their original packaging, if possible.

Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
Beclometasone and Formoterolo Teva Italia should not be used in children and adolescents
under the age of 18 years, until further data are available.

Other medicines and Beclometasone and Formoterolo Teva Italia

• Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including those without a prescription. This is because Beclometasone and Formoterolo Teva Italia can affect the way some other medicines work. Also, some medicines can affect the way Beclometasone and Formoterolo Teva Italia works. In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
• Some medicines may increase the effects of Beclometasone and Formoterolo Teva Italia and your doctor may want to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat many conditions including heart problems, high blood pressure and glaucoma (increased pressure in the eyes). If you need to use beta-blockers, including eye drops, the effect of formoterol may be reduced or formoterol may not work at all.
• Beta-adrenergic medicines (medicines that work in the same way as 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 for the treatment of 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 hypothyroidism (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contraction).
• Medicines for the treatment of mental disorders such as monoamine oxidase inhibitors (MAO-I), including medicines 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. Also tell your doctor if you are about to undergo general anesthesia for surgery or dental treatment.

Pregnancy, breastfeeding and fertility
There are no clinical data on the use of Beclometasone and Formoterolo Teva Italia during pregnancy.
Do not take Beclometasone and Formoterolo Teva Italia if you are pregnant, think you may be pregnant or are
planning a pregnancy, or if you are breastfeeding, unless advised by your
doctor.

Driving and using machines
It is unlikely that Beclometasone and Formoterolo Teva Italia will affect your ability to drive vehicles
and use machines.

Beclometasone and Formoterolo Teva Italia contains alcohol
This medicine 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 less than 1
ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce
significant effects.

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

3. How to use Beclometasone and Formoterolo Teva Italia

Always use this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

Asthma
Your doctor will check you regularly to make sure you are taking the optimal dose of
Beclometasone and Formoterolo Teva Italia. Your doctor will adjust the treatment to the lowest dose that
best controls your symptoms.

Beclometasone and Formoterolo Teva Italia can be prescribed by your doctor in two different ways:
a)Daily use of Beclometasone and Formoterolo Teva Italia to treat asthma treatment
together with a “rescue” inhaler to treat sudden worsening of asthma symptoms, such as shortness of
breath, wheezing and cough
Adults and the elderly:
The recommended dose of this medicine is one or two inhalations twice a day. The maximum
daily dose is 4 inhalations.
Remember: You should always carry your “rescue” quick-relief inhaler with you to treat a
worsening of asthma symptoms or a sudden asthma attack.

b)Daily use of Beclometasone and Formoterolo Teva Italia for the treatment of asthma and
further use of Beclometasone and Formoterolo Teva Italia to treat sudden
worsening of asthma symptoms, such as shortness of breath, wheezing and cough
Adults and the elderly:
The recommended dose is one inhalation in the morning and one inhalation in the evening.
You should also use Beclometasone and Formoterolo Teva Italia as a “rescue” 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.

Do not take more than 6 inhalations “as needed” per day.
The maximum daily dose of Beclometasone and Formoterolo Teva Italia as a single inhaler
for asthma is 8 inhalations.
If you think you need more inhalations per day to control your asthma symptoms, ask your doctor for advice. You may need 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 required in elderly patients. There is no information available on the use of
Beclometasone and Formoterolo Teva Italia in patients with hepatic or renal impairment.

Beclometasone and Formoterolo Teva Italia is effective in the treatment of asthma with a dosage of
beclometasone dipropionate that may be lower than that of other inhalers
containing beclometasone dipropionate. If you were previously using a different inhaler based on
beclometasone dipropionate, your doctor will advise you on the exact dose of Beclometasone
and Formoterolo Teva Italia to take to treat asthma.
Do not increase the dose
If you think the medicine is not very effective, always consult your doctor before increasing the
dosage.

If your breathing gets worse

• If you experience worsening shortness of breath or your breathing becomes wheezy (wheezing with a clearly audible whistle), immediately after inhaling the medicine, stop using Beclometasone and Formoterolo Teva Italia immediately and use immediately your quick-relief “rescue” inhaler. You should contact your doctor immediately. The doctor will assess your symptoms and, if necessary, may start another type of 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
“rescue” inhaler or Beclometasone and Formoterolo Teva Italia as a rescue inhaler more
frequently), or if your “rescue” inhaler or Beclometasone and Formoterolo Teva Italia does not
improve your symptoms, contact your doctor immediately. Asthma may have worsened and the doctor
may need to increase the dose of Beclometasone and Formoterolo Teva Italia or prescribe a
alternative treatment.

How to administer
Beclometasone and Formoterolo Teva Italia is for inhalation use.
This medicine is contained in a pressurized container inserted into a plastic casing with
a mouthpiece. On the back of the inhaler there is a counter for 120 doses and a dose indicator for
180 actuations, which indicates the number of doses remaining.
For the 120-actuation pack, each time you press the container, one dose of
medicine is released and the counter decreases by one number. Be careful not to drop the inhaler as this
may cause the dose counter to decrease by one dose.
For the 180-actuation pack, the dose indicator will show the approximate number of
actuations (sprays) remaining in the container. The dose indicator window shows the number of
sprays remaining in the inhaler in units of twenty (e.g., 180, 120, 100, 80, etc.). When
20 actuations remain, the display shows the number 20 indicating that the container is nearing the end
of its life cycle.
When 180 actuations have been discharged, the display shows the number 0.
The indicator will stop moving at “0”.

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 make sure 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 container to release a dose
• If you have not used the inhaler for 14 days or more, press firmly on the container once to release an actuation.
• For the 120-inhalation pack, check the dose counter. If you are using the inhaler for the first time, the counter should indicate 120.
• For the 180-inhalation pack, check the dose indicator. If you are using the inhaler for the first time, the indicator should indicate 180.

How to use the inhaler
When possible, remain standing or sitting in an upright position while inhaling.
Before starting to inhale, check the dose counter or dose indicator showing how many doses are
remaining. If the dose counter or dose indicator shows “0” there are no doses remaining: dispose of
the inhaler and get a new one.

1 2 3 4 5

• 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 (Figure 1).
• 2. Exhale as slowly and deeply as possible (Figure 2).
• 3. Hold the container vertically, with the dispenser body facing upwards, and place your lips around the mouthpiece. Do not bite the mouthpiece (Figure 3).
• 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 bottom of the inhaler (Image 4).
• 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. (Figure 5).

If another actuation is necessary, hold the inhaler in a vertical position for about
half a minute, then 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 for the 120-dose pack and the dose indicator for the 180-dose pack.
To reduce the risk of a fungal infection in the mouth and throat, rinse your mouth, gargle with water or brush your teeth each time you use the inhaler.

When to replace the inhaler
You should get a new inhaler when the dose counter indicates the number 20. Stop using
the inhaler when the dose counter shows the number 0, as the doses remaining in the device may
not be sufficient to provide you with a full dose, and start using a new inhaler.

If you observe a “mist” escaping from the inhaler or from the sides of your mouth after inhalation, this
means that Beclometasone and Formoterolo Teva Italia will not reach your lungs as it should.
Perform another actuation following the instructions by repeating the operations from point 2.
If you think the effect of Beclometasone and Formoterolo Teva Italia is too much or not enough,
tell your doctor or pharmacist.
If you have difficulty using the inhaler while starting to inhale, you can use the AeroChamber Plus spacer device. Ask your doctor, pharmacist or nurse for information on
this device.
carefully follow the instructions on how to use it and how to clean it.

Cleaning
The inhaler should be cleaned once a week.

During cleaning, do not remove the container from the dispenser 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 take more Beclometasone and Formoterolo Teva Italia than you should

• Taking more formoterol than you should may have the following effects: feeling unwell, malaise, fast heartbeat, palpitations, heart rhythm disturbances, some changes in the electrocardiogram (heart tracing), headache, tremor, drowsiness, excess acid in the blood, low levels of potassium in the blood, high glucose levels in the blood. Your doctor may want to perform blood tests to check your potassium and glucose levels.
• Taking too much beclometasone dipropionate may cause temporary disturbances of the adrenal glands. These will improve within a few days, however your doctor may want to check serum cortisol levels. Tell your doctor if you have any of these symptoms.

If you forget to take Beclometasone and Formoterolo Teva Italia:
Take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose, but
take the next dose at the correct time.

Do not take a double dose to make up for a missed dose.
If you stop taking Beclometasone and Formoterolo Teva Italia:
Even if you feel better, do not stop taking Beclometasone and Formoterolo Teva Italia or
reduce the dose. If you want to do so, talk to your doctor. It is very important that you use Beclometasone and Formoterolo Teva Italia regularly even if you have no symptoms.
If you have any doubts about using this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other treatments via inhalation, there is a risk of worsening of breathlessness and
wheezing immediately after using Beclometasone and Formoterolo Teva Italia, and
this condition is known as paradoxical bronchospasm. If this occurs, it must

IMMEDIATELY STOP using Beclometasone and Formoterolo Teva Italiaand use
immediately your “as needed” fast-acting inhaler to treat the symptoms of breathlessness and
wheezing. You should contact your doctor immediately.

Immediately inform your doctorif you experience hypersensitivity reactionssuch as skin allergy,
itching, rash, redness of the skin, swelling of the skin or mucous membranes in
particular of the eyes, face, lips and throat.
Other possible side effects are listed below according to their frequency.

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

• fungal infections (of the mouth and throat)
• headache
• hoarseness
• sore throat Pneumonia in patients with COPD: Inform your doctor if you have any of the following symptoms while taking Beclometasone and Formoterolo Teva Italia as they may be symptoms of a lung infection:
• fever or chills
• increased mucus production, change in mucus color
• increased cough or greater difficulty breathing

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

• palpitations, unusually fast heartbeat and heart rhythm disorders
• some changes in the electrocardiogram (ECG)
• flu-like symptoms
• sinusitis
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• vaginal fungal infections
• nausea
• abnormal or altered sense of taste
• 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
• rash or hives
• changes in some blood components: reduction in the number of white blood cells increase in the number of platelets in the blood reduction in potassium levels in the blood increase in blood sugar levels increase in 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 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):
• chest tightness
• missed heartbeat (caused by a premature contraction of the heart ventricles)
• decreased blood pressure
• increased blood pressure
• kidney inflammation
• swelling of the skin and mucous membranes that persists for several days Very rare(may affect up to 1 in 10,000 people):
• breathlessness
• worsening of asthma
• decrease in the number of platelets in the blood
• swelling of the hands and feet Prolonged use of inhaled corticosteroids at high doses can, in very rare cases, causesystemic effects.These include:
• disorders of adrenal gland function (adrenal suppression)
• decreased bone mineral density (thinning of the bones)
• delayed growth in children and adolescents
• increased pressure in the eyes (glaucoma)
• cataract Not known (frequency cannot be estimated based on available data):
• sleep disturbances
• depression or anxiety
• nervousness
• hyperactivity or irritability. These events are more likely in children, but the frequency is unknown.
• blurred vision

Reporting of side effects
If you get any side effects, even 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:
https://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 Beclometasone and Formoterolo Teva Italia

Keep this medicine out of the sight and reach of children.

Single pack containing a device delivering 120 doses or 180 doses
For the pharmacist
Store in a refrigerator (2-8 °C) for a maximum of 18 months.
Enter the dispensing date to the patient on the adhesive label on the pack and stick
the label on the inhaler. Ensure that there is a period of at least 3 months between the
dispensing date and the expiry date printed on the pack.

For patients
Do not store the inhaler at a temperature above 25 °C.
Do not use Beclometasone and Formoterolo Teva Italia more than 3 months from the date you receive the inhaler
from the pharmacist and never use it after the expiry date which is stated on the carton and the label
after “Exp.”. The expiry date refers to the last day of that month.

Double or triple packs containing two or three devices delivering 120 doses
Before use:store the inhalers in a refrigerator (at 2-8°C).

After first use:store the inhalers for a maximum of three months and at a temperature not
exceeding 25 °C.
Each time you start using an inhaler, enter the date of first use on the adhesive label
on the pack and apply the label on the inhaler. The inhalers must not be used after 3
months from first use and must never be used after the expiry date which is stated on the
carton and the label after “Exp.”.
The expiry date refers to the last day of that month.
Do not freeze.
If the inhaler has been exposed to intense cold, warm it with your hands for a few minutes before use.
Never warm it with artificial means.

Warning:The container contains a pressurized liquid. Do not expose the container to temperatures
above 50 °C. Do not puncture the container.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Beclometasone and Formoterol Teva Italia 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 inhaled dose delivered from the mouthpiece of 84.6 micrograms of beclometasone
dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
The other ingredients are: anhydrous ethanol, concentrated hydrochloric acid and norflurane (HFA-134a).
This medicine contains fluorinated greenhouse gases.
Each inhaler with 120 actuations contains 8.15 g of HFA-134a corresponding to 0.012 tonnes of
CO equivalent (global warming potential GWP = 1,430).
Each inhaler with 180 actuations contains 11.2 g of HFA-134a corresponding to 0.016 tonnes of
CO equivalent (global warming potential GWP = 1,430).

Description of the appearance of Beclometasone and Formoterol Teva Italia and package contents
Beclometasone and Formoterol Teva Italia is a pressurized solution for inhalation contained in an
aluminum container with a metering valve, inserted into a white plastic actuator incorporating a dose
counter (pack of 120 actuations) or a dose indicator (pack of 180 actuations) with a pink plastic
protective cap.
Each pack contains:
1 pressurized container (providing 120 actuations) (sprays) or
2 pressurized containers (providing 120 actuations) each or
3 pressurized containers (providing 120 actuations) each or
1 pressurized container (providing 180 actuations)
Not all pack sizes may be marketed.

Marketing authorization holder
Genetic S.p.A.
Via G. Della Monica 26
84083 Castel San Giorgio (SA)
Italy

Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano
Italy

This medicinal product is authorized in the Member States of the European Economic Area with the
following denominations:
Austria Beclometason/Formoterol Pavese
Italy Beclometasone e Formoterolo Teva Italia

Beclometasone and Formoterolo Teva Italia 200 micrograms /6 micrograms per actuation,

pressurized solution for inhalation

beclometasone dipropionate/formoterolo fumarate dihydrate

generic medicine

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

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

1. What is Beclometasone and Formoterolo Teva Italia and what is it used for

Beclometasone and Formoterolo Teva Italia 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 that 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 that relax the muscles of the airways and help you breathe more easily.
These two active ingredients, together, facilitate breathing, providing relief from symptoms such as
shortness of breath, wheezing and cough in patients with asthma and also help to prevent the symptoms
of asthma.

Beclometasone and Formoterolo Teva Italia is indicated for the treatment of asthma in adult patients.
If Beclometasone and Formoterolo Teva Italia 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 Beclometasone and Formoterol Teva Italia

Do not use Beclometasone and Formoterol Teva Italia:

• if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or to any of the excipients of this medicine (listed in section 6). Warnings and precautionsTalk to your doctor, pharmacist or nurse before using Beclometasone and Formoterol Teva Italia:
• If you suffer from heart problems, such as angina (heart pain, chest pain), heart failure, narrowing of the arteries, valvular heart disease or any other known heart abnormality.
• If you suffer from high blood pressure or if you know you have an aneurysm (an abnormal dilation of the blood vessel wall).
• If you suffer from 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.
• If you have an overactive thyroid gland.
• If you have low blood levels of potassium.
• If you suffer from any liver or kidney disorder.
• If you suffer from diabetes (if you inhale high doses of formoterol, blood sugar levels may increase. When you start using this medicine and from time to time during treatment, you may need to undergo some additional blood tests to monitor your blood sugar levels).
• If you have a tumor of the adrenal gland (known as pheochromocytoma).
• If you are to undergo anesthesia. Depending on the type of anesthesia, you may need to stop taking Beclometasone and Formoterol Teva Italia at least 12 hours before anesthesia.
• If you are undergoing, or have ever been, treatment for tuberculosis (TB) or if you have a known viral or fungal infection in your chest.
• If you need to avoid alcohol for any reason.

If any of the above conditions apply to you, always inform your doctor before
using Beclometasone and Formoterol Teva Italia.
If you have or have had any medical problem or allergies or if you are not sure you can use
Beclometasone and Formoterol Teva Italia contact your doctor, or a nurse who is knowledgeable about
asthma or a pharmacist before using the inhaler.

The doctor may want to measure your blood potassium levels from time to time, especially if
your asthma is severe.Like many bronchodilators Beclometasone and Formoterol Teva Italia can cause a
sudden drop in serum potassium levels (hypokalemia). This is because the lack of oxygen in the
blood combined with some other treatments you may be taking together with Beclometasone and
Formoterol Teva Italia can worsen the reduction of potassium levels.

If you are taking high doses of inhaled corticosteroids for long periods, you may have a greater
need for corticosteroids in stressful situations. Stressful situations can include hospitalization
after an accident, a serious injury or surgery. In this case, the doctor who is treating you will decide if it
may be necessary to increase the dose of corticosteroids and may
prescribe steroid tablets or steroid injections.

If you have to go to the hospital, remember to bring all your medicines and inhalers with you, including
Beclometasone and Formoterol Teva Italia and all medicines or tablets purchased without
prescription, in their original packaging if possible.

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

Other medicines and Beclometasone and Formoterol Teva Italia

• Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including those without a prescription. This is because Beclometasone and Formoterol Teva Italia can affect how some other medicines work. Also, some medicines can affect how Beclometasone and Formoterol Teva Italia works. In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
• Some medicines can increase the effects of Beclometasone and Formoterol Teva Italia and your doctor may want to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat many conditions including heart problems, high blood pressure and glaucoma (increased pressure in the eyes). If you need to use beta-blockers, including eye drops, the effect of formoterol may be reduced or formoterol may not work at all.
• Beta-adrenergic medicines (medicines that work in the same way as 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 for the treatment of 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 hypothyroidism (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contraction).
• Medicines for the treatment of mental disorders such as monoamine oxidase inhibitors (MAO-I), including medicines 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. Also tell your doctor if you are about to undergo general anesthesia for an operation or dental procedure. Pregnancy, breastfeeding and fertilityThere are no clinical data on the use of Beclometasone and Formoterol Teva Italia during pregnancy. Do not take Beclometasone and Formoterol Teva Italia if you are pregnant, think you may be pregnant or are planning a pregnancy, or if you are breastfeeding, unless advised by your doctor.

Driving and using machines
It is unlikely that Beclometasone and Formoterol Teva Italia will affect your ability to drive vehicles
and use machines.

Beclometasone and Formoterol Teva Italia contains alcohol
This medicine contains 9 mg of alcohol (ethanol) in each actuation, which is equivalent to 0.25 mg/kg per
dose of two actuations. The amount in two actuations of this medicine is equivalent to less than 1
ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant
effects.

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

3. How to use Beclometasone and Formoterol Teva Italia

Always use this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
Your doctor will check you regularly to make sure you are taking the optimal dose of
Beclometasone and Formoterol Teva Italia. Your doctor will adjust the treatment to the lowest dose that
best controls your symptoms.

Dosage
Adults and the elderly
The recommended dose is two 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 Beclometasone and Formoterol Teva Italia in people 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 use this medicine.

Beclometasone and Formoterol Teva Italia is effective in the treatment of asthma with a dosage of
beclometasone dipropionate that may be lower than that of other inhalers
containing this active ingredient. If you were previously using a different inhaler based on
beclometasone dipropionate, your doctor will advise you on the exact dose of Beclometasone and
Formoterol Teva Italia to take to treat asthma.
Do not increase the dose
If you think the medicine is not very effective, always consult your doctor before increasing the
dosage.

If your asthma gets worse
If your symptoms worsen or are difficult to control (for example, if you use a
different “as needed” inhaler more frequently), or if your “as needed” inhaler does not improve your
symptoms, contact your doctor immediately. Your asthma may be getting worse and your doctor may
need to adjust the dose of Beclometasone and Formoterol Teva Italia or prescribe alternative
treatment.

How to administer
Beclometasone and Formoterol Teva Italia is for inhalation use.
This medicine is contained in a pressurized container inserted into a plastic casing with
a mouthpiece. On the back of the inhaler there is a counter for 120 doses and a dose indicator for
180 actuations, which indicates the number of doses remaining.
For the 120-actuation pack, each time you press the container, a dose of
medicine is released and the counter decreases by one number. Be careful not to drop the inhaler as
it may cause the dose counter to decrease by one dose.
For the 180-actuation pack, the dose indicator will show the approximate number of
actuations (sprays) remaining in the container. The dose indicator window shows the number of
sprays remaining in the inhaler in units of twenty (e.g., 180, 120, 100, 80, etc.). When
20 actuations remain, the display shows the number 20 indicating that the container is nearing the end
of its life cycle.
When 180 actuations have been discharged, the display shows the number 0.
The indicator will stop moving at “0”.

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 must 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 from you and press down firmly on the container to deliver a dose
• If you have not used the inhaler for 14 days or more, press down firmly on the container once to release a puff.
• For the 120-inhalation pack, check the dose counter. If you are using the inhaler for the first time, the counter should indicate 120.
• For the 180-inhalation pack, check the dose indicator. If you are using the inhaler for the first time, the counter should indicate 180.

How to use the inhaler
When possible, remain standing or sit upright while taking the inhalation.
Before starting to inhale, check the dose counter or dose indicator to show how many doses are
remaining. If the dose counter or dose indicator shows “0” there are no doses remaining: dispose of
the inhaler and obtain a new one.

1 2 3 4 5

• 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 (Figure 1).
• 2. Exhale as slowly and deeply as possible (Figure 2).
• 3. Hold the container vertically, with the body of the dispenser upwards, and place your lips around the mouthpiece. Do not bite the mouthpiece (Figure 3).
• 4. Inhale slowly and deeply through your mouth and immediately after starting to inhale press down firmlyon 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 bottom of the inhaler (Image 4).
• 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. (Figure 5). If you need to take another inhalation, hold the inhaler in a vertical position for about half a minute, then 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 for the 120-dose pack and the dose indicator for the 180-actuation pack. To reduce the risk of a fungal infection in the mouth and throat, rinse your mouth, gargle with water or brush your teeth each time you use the inhaler. When to replace the inhalerYou should obtain a new inhaler when the dose counter indicates the number 20. Stop using the inhaler when the dose counter shows the number 0, as the doses remaining in the device may not be sufficient to provide you with a full dose, and start using the new inhaler. If a “mist” is observed escaping from the inhaler or from the sides of the mouth after inhalation, thismeans that Beclometasone and Formoterol Teva Italia will not reach the lungs as it shouldhave. Perform another actuation following the instructions by repeating the operations from point 2.If you think the effect of Beclometasone and Formoterol Teva Italia is too strong or not strong enough, tell your doctor or pharmacist.

If you have difficulty using the inhaler while starting to inhale, you can use the
AeroChamber Plus spacer device. Ask your doctor, pharmacist or nurse for information on
this device.
follow the instructions on how to use it and how to clean it carefully.

Cleaning
The inhaler should be cleaned once a week.

During cleaning, do not remove the container from the dispenser 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 tissue.
• 3. Reposition the protective cap on the mouthpiece.

If you take more Beclometasone and Formoterol Teva Italia than you should

• Taking more formoterol than you should may have the following effects: feeling unwell, malaise, fast heartbeat, palpitations, irregular heartbeat, some changes in the electrocardiogram (heart tracing), headache, tremor, drowsiness, excess acid in the blood, low levels of potassium in the blood, high glucose levels in the blood. Your doctor may want to perform blood tests to check your potassium and glucose levels.
• Taking too much beclometasone dipropionate may cause temporary disorders of the adrenal glands. These will improve within a few days, however your doctor may want to check your serum cortisol levels. Tell your doctor if you have any of these symptoms.

If you forget to take Beclometasone and Formoterol Teva Italia
Take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose, but
take the next dose at the correct time.

Do not take a double dose to make up for a missed dose.
If you stop taking Beclometasone and Formoterol Teva Italia
Even if you feel better, do not stop taking Beclometasone and Formoterol Teva Italia or
reduce the dose. If you want to do so, talk to your doctor. It is very important that you use Beclometasone and Formoterol Teva Italia regularly even if you have no symptoms.
If you have any questions about using this product, 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 using Beclometasone and Formoterolo Teva Italia, and
this condition is known as paradoxical bronchospasm. If this occurs, it must

IMMEDIATELY STOP using Beclometasone and Formoterolo Teva Italiaand immediately use
your fast-acting “rescue” inhaler to treat the symptoms of breathlessness and
wheezing. You should contact your doctor immediately.

Immediately inform your doctorif you experience hypersensitivity reactionssuch as skin allergy,
itching, rash, redness of the skin, swelling of the skin or mucous membranes in
particular of the eyes, face, lips and throat.
Other possible side effects are listed below according to their 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 disorders
• some changes in the electrocardiogram (ECG)
• increased blood pressure
• flu-like symptoms
• sinusitis
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• vaginal fungal infections
• nausea
• abnormal or altered sense of taste
• 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
• rash or urticaria
• changes in some blood components: reduction in the number of white blood cells, increase in the number of platelets in the blood, reduction in potassium levels in the blood, increase in blood sugar levels, increase in insulin, free fatty acids and ketone levels in the blood

The following side effects have been reported as “uncommon” in patients with
chronic obstructive pulmonary disease:

• pneumonia; inform your doctor if you notice any of the following symptoms: increased sputum 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):

• chest tightness
• missed heartbeat (caused by a premature contraction of the ventricles of the heart)
• decreased blood pressure
• kidney inflammation
• swelling of the skin and mucous membranes that persists for several days

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

• breathlessness
• worsening of asthma
• decrease in the number of platelets in the blood
• swelling of the hands and feet

Prolonged use of inhaled corticosteroids at high doses can very rarely cause
systemic effects.These include:

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

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

• sleep disturbances
• depression or anxiety
• nervousness
• hyperactivity or irritability These events are more likely in children, but the frequency is unknown.
• Blurred vision

Reporting of side effects
If you get any side effects, even 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: https://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 Beclometasone and Formoterolo Teva Italia

Keep this medicine out of the sight and reach of children.

Single pack containing a device delivering 120 doses or 180 doses
For the pharmacist
Store in a refrigerator (2-8 °C) for a maximum of 18 months.
Enter the dispensing date to the patient on the adhesive label on the packaging and stick
the label on the inhaler. Ensure there is a period of at least 3 months between the dispensing date and the
expiry date printed on the packaging.

For patients
Do not store the inhaler at a temperature above 25 °C.
Do not use Beclometasone and Formoterolo Teva Italia more than 3 months from the date you receive the inhaler from the
pharmacist and never use it after the expiry date which is stated on the carton and label after
“Exp.”. The expiry date refers to the last day of that month.

Double or triple packs containing two or three devices delivering 120 doses
Before use:store the inhalers in a refrigerator (at 2-8°C).

After first use:store the inhalers for a maximum of three months and at a temperature not
exceeding 25 °C.
Each time you start using an inhaler, enter the date of first use on the adhesive label
on the packaging and apply the label to the inhaler. The inhalers must not be used after 3
months from first use and must never be used after the expiry date which is stated on the
carton and label after “Exp.”.
The expiry date refers to the last day of that month.
Do not freeze.
If the inhaler has been exposed to intense cold, warm it with your hands for a few minutes before use.
Never heat it with artificial means.

Warning:The container contains a pressurized liquid. Do not expose the container to temperatures
above 50 °C. Do not puncture the container.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Beclometasone and Formoterolo Teva Italia 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 a delivered inhaled dose from the mouthpiece of 177.7 micrograms of beclometasone
dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
The other ingredients are: norflurane (HFA-134a), anhydrous ethanol, concentrated hydrochloric acid.
This medicine contains fluorinated greenhouse gases.
Each inhaler with 120 actuations contains 10.35 g of HFA-134a corresponding to 0.015 tonnes of
CO equivalent (global warming potential GWP = 1.430).
Each inhaler with 180 actuations contains 14.24 g of HFA-134a corresponding to 0.020 tonnes of
CO equivalent (global warming potential GWP = 1.430).

Description of the appearance of Beclometasone and Formoterolo Teva Italia and package contents:
Beclometasone and Formoterolo Teva Italia is a pressurized solution for inhalation contained in an
aluminum container with a metering valve, inserted into a white plastic actuator incorporating a dose
counter (120 actuations pack) or a dose indicator (180 actuations pack) with a green plastic protective
cap.
Each pack contains:
1 pressurized container (providing 120 actuations) or
2 pressurized containers (providing 120 actuations each) or
3 pressurized containers (providing 120 actuations each) or
1 pressurized container (providing 180 actuations)
Not all pack sizes may be marketed.

Marketing authorization holder
Genetic S.p.A.
Via G. Della Monica 26
84083 Castel San Giorgio (SA)
Italy

Manufacturer:
Genetic S.p.A.
Contrada Canhor
84084 Fisciano
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria Beclometason/Formoterol Pavese
Italy Beclometasone e Formoterolo Teva Italia