DUOBEXON 100 MIKROGRAMÓW/6 MIKROGRAMÓW Roztwór ciśnieniowy do inhalacji

Treść ulotki

1. DUOBEXON 100 micrograms /6 micrograms per actuation, pressurised solution for
   1. What is DUOBEXON and what is it used for
   2. What you need to know before using DUOBEXON
   3. How to use DUOBEXON
   4. Possible side effects
   5. How to store DUOBEXON
   6. Package Contents and Other Information
2. DUOBEXON 200 micrograms /6 micrograms per actuation, pressurised solution for
   1. What DUOBEXON is and what it is used for
   2. What you need to know before using DUOBEXON
   3. How to use DUOBEXON
   4. Possible side effects
   5. How to store DUOBEXON
   6. Package Contents and Other Information

DUOBEXON 100 micrograms /6 micrograms per actuation, pressurised solution for

inhalation
beclometasone dipropionate/formoterol fumarate dihydrate
equivalent medicinal product

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

1. What is DUOBEXON and what is it used for

DUOBEXON 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 that
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 the
symptoms of asthma.
Asthma
DUOBEXON 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
DUOBEXON 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.

DUOBEXON is for use in adults.

2. What you need to know before using DUOBEXON

Do not use DUOBEXON:
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 precautions
Talk to your doctor or pharmacist before using DUOBEXON:

• 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 blood vessel wall).
• If you suffer from heart rhythm disorders such as a fast or irregular heart rate, 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 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 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 DUOBEXON at least 12 hours before anesthesia.
• If you are undergoing, or have ever been, treated 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 tell your doctor before
using DUOBEXON.
If you have or have had any medical problems or allergies or if you are not sure you can use
DUOBEXON, talk to your doctor or pharmacist before using this medicine.
Treatment with a beta-agonist such as formoterol contained in DUOBEXON may cause a
sharp drop in serum potassium levels (hypokalemia).

If you suffer from severe asthma, you must pay particular attention.This is due to a lack of
oxygen in the blood and some other treatments you may be taking along with DUOBEXON, 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 potassium levels in your blood.

If you take higher doses of inhaled corticosteroids for long periods, you may need more
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 whether it may be necessary to increase the dose of corticosteroids and may
prescribe steroid tablets or steroid injections.

If you have to go to hospital, remember to bring with you all your medicines and inhalers, including
DUOBEXON and all 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
DUOBEXON should not be used in children and adolescents under 18 years of age,
until further data are available.

Other medicines and DUOBEXON
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
DUOBEXON can affect the way some other medicines work. Also, some
medicines can affect the way DUOBEXON 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 DUOBEXON 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 for a
dental procedure.

Pregnancy, breastfeeding and fertility
There is no clinical data on the use of DUOBEXON during pregnancy.
Do not take DUOBEXON 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 DUOBEXON will affect your ability to drive vehicles and use machines.

DUOBEXON contains alcohol
This medicine contains 7 mg of alcohol (ethanol) in each actuation, which is equivalent to 0.20 mg/kg for
a two-actuation dose. 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 sporting activity
The use of the medicine without therapeutic necessity constitutes doping and may still
result in a positive doping test.

3. How to use DUOBEXON

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 give you regular check-ups to make sure you are taking the optimal dose of
DUOBEXON. Your doctor will adjust the treatment to the lowest dose that best controls your
symptoms.

DUOBEXON can be prescribed by your doctor in two different ways:
a)Daily use of DUOBEXON to treat asthma together with a
“as needed” 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 “as needed” quick-relief inhaler with you to treat a
worsening of asthma symptoms or a sudden asthma attack.

b)Daily use of DUOBEXON to treat asthma and further use of
DUOBEXON 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 DUOBEXON 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.

Do not take more than 6 inhalations “as needed” per day.
The maximum daily dose of DUOBEXON as a sole inhaler for asthma is 8 inhalations.
If you think you need more than the 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. There is no information available on the use of
DUOBEXON in patients with hepatic or renal impairment.

DUOBEXON is effective in the treatment of asthma with a beclometasone
dipropionate dosage 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 DUOBEXON 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 a worsening of shortness of breath or your breathing becomes wheezy (wheezing
  breath with a clearly audible whistle), immediately after inhaling the medicine, stop using DUOBEXON
  immediately and use your quick-relief “as needed” inhalerimmediately. You should contact your
  doctor immediately. The doctor will evaluate 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
“as needed” inhaler or DUOBEXON as a “as needed” inhaler more frequently), or if your
“as needed” inhaler or DUOBEXON does not improve your symptoms, contact your doctor
immediately.
Asthma may be worsening and your doctor may need to increase the dose of DUOBEXON or
prescribe alternative treatment.

How to administer
DUOBEXON 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 the container is pressed, a 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 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.
When 180 actuations have been discharged, the display shows the number 0.
The indicator will stop moving at "0".

Checking the inhaler is working
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 inhaler is working 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 upright while taking the inhalation.
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 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 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 needed, 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 after inhalation you observe a “mist” escaping from the inhaler or from the sides of your mouth, this
means that DUOBEXON 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 DUOBEXON 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 about
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 handkerchief.
• 3. Reposition the protective cap on the mouthpiece.

If you take more DUOBEXON 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 potassium levels in the blood, high blood
  glucose levels. Your doctor may want to perform blood tests to check potassium and glucose levels in
  the blood.
• Taking too much beclometasone dipropionate can cause temporary disorders 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 DUOBEXON:
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 DUOBEXON:
Even if you feel better, do not stop taking DUOBEXON or reduce the dose. If you want to do so,
talk to your doctor. It is very important that you use DUOBEXON regularly even in the absence of
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 DUOBEXON, and this condition is known as paradoxical
bronchospasm. If this happens, you must IMMEDIATELY STOP using DUOBEXONand 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 reactions such 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 DUOBEXON as they could 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):
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 blood potassium level
increased blood sugar level
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 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):
chest tightness
missed heartbeat (caused by a premature contraction of the ventricles of the heart)
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):
breathlessness
worsening of asthma
decrease in the number of platelets in the blood
swelling of the hands and feet

Prolonged use of high-dose inhaled corticosteroids can, in very rare cases, 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 from the 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 DUOBEXON

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

Single pack containing a 120-dose or 180-dose actuator
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 DUOBEXON more than 3 months from the date you receive the inhaler from the pharmacist and do not
use it after the expiry date that is stated on the box and label after "Exp.". The expiry
date refers to the last day of that month.

Double or triple packs containing two or three 120-dose actuators
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 to the inhaler. The inhalers must not be used after 3
months from first use and must never be used after the expiry date that is stated on the
box 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 DUOBEXON 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 DUOBEXON and package contents
DUOBEXON 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
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 Authorisation 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 authorised in the Member States of the European Economic Area with the
following denominations:
Austria Duobexon
Italy Duobexon

DUOBEXON 200 micrograms /6 micrograms per actuation, pressurised solution for

inhalation
beclometasone dipropionate/formoterol fumarate dihydrate
equivalent 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 DUOBEXON is and what it is used for
• 2. What you need to know before you use DUOBEXON
• 3. How to use DUOBEXON
• 4. Possible side effects
• 5. How to store DUOBEXON
• 6. Contents of the pack and other information

1. What DUOBEXON is and what it is used for

DUOBEXON 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 and also help to prevent asthma symptoms.

DUOBEXON is indicated for the treatment of asthma in adult patients.
If DUOBEXON 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 DUOBEXON

Do not use DUOBEXON:
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 precautions
Talk to your doctor, pharmacist or nurse before using DUOBEXON:

• 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 a fast or irregular heart rate, 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 blood sugar levels).
• If you have a tumor of the adrenal gland (known as pheochromocytoma).
• If you are going to have anesthesia. Depending on the type of anesthesia, you may need to stop taking DUOBEXON 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 DUOBEXON.
If you have or have had any medical problem or allergies or if you are not sure you can use
DUOBEXON, contact your doctor, or a nurse who is knowledgeable about asthma or a pharmacist before
using the inhaler.

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

If you are taking high doses of inhaled corticosteroids for long periods, you may need more
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
DUOBEXON and all 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
DUOBEXON should not be used in children and adolescents under the age of 18 years.

Other medicines and DUOBEXON
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
may take any other medicines, including those available without a prescription.
This is because DUOBEXON can affect how some other
medicines work. Also, some medicines can affect how DUOBEXON 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 DUOBEXON 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 isocarboxazid), 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 have general anesthesia for an operation or for a
dental procedure.

Pregnancy, breastfeeding and fertility
There is no clinical data on the use of DUOBEXON during pregnancy.
Do not take DUOBEXON if you are pregnant, think you may be pregnant or are planning a pregnancy, or if
you are breastfeeding, unless your doctor has advised you to do so.

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

DUOBEXON 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 athletes
The use of the medicine without therapeutic need constitutes doping and may still
result in a positive doping test.

3. How to use DUOBEXON

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 give you regular check-ups to make sure you are taking the optimal dose of
DUOBEXON. 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 DUOBEXON 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.

DUOBEXON is effective in the treatment of asthma with a beclometasone
dipropionate dosage that may be lower than that of other inhalers containing this
active ingredient. If you were previously using a different beclometasone
dipropionate inhaler, your doctor will advise you on the exact dose of DUOBEXON 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
“rescue” inhaler more frequently), or if your “rescue” inhaler does not improve your
symptoms, contact your doctor immediately. Your asthma may be getting worse and your doctor may
need to adjust your dose of DUOBEXON or prescribe alternative treatment.

How to administer
DUOBEXON 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
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 dispensed, the display shows the number 0.
The indicator will stop moving at "0".

Checking the inhaler is working
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 inhaler is working to make sure it is functioning correctly.

• Remove the protective cap from the mouthpiece.
• Hold the inhaler in an upright 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 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 inhaling.
Before starting to inhale, check the dose counter or dose indicator to see 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 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 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: position 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 you need to take another inhalation, hold the inhaler in an upright 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 inhaler
You 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, this
means that DUOBEXON will not reach the lungs as it should. Perform another
actuation following the instructions by repeating the operations from point 2.
If you think the effect of DUOBEXON 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 about
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 tissue.
• 3. Reposition the protective cap on the mouthpiece.

If you take more DUOBEXON 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 can lead to temporary disturbances in 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 DUOBEXON
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 DUOBEXON
Even if you feel better, do not stop taking DUOBEXON or reduce the dose. If you want to do so,
talk to your doctor. It is very important that you use DUOBEXON 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 DUOBEXON, and this condition is known as paradoxical
bronchospasm. If this happens, you must STOP using DUOBEXON immediatelyand use your
reliever inhaler straight away to treat the symptoms of breathlessness and wheezing. You should
contact your doctor immediately.

Tell your doctor immediatelyif 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
diarrhoea
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:
decreased number of white blood cells
increased number of platelets in the blood
decreased level of potassium in the blood
increased level of sugar in the blood
increased level 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:
pneumonia; tell your doctor if you notice any of the following symptoms: increased
sputum production, change in sputum color, fever, increased
cough, increased breathing problems
decreased 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):
chest tightness
missed heartbeat (caused by a premature contraction of the heart ventricles)
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):
breathlessness
worsening of asthma
decreased 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, 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 from the available data):
sleep disorders
depression or anxiety
nervousness
hyperactivity or irritability
These events are more likely in children, but the frequency is not known.
Blurred vision

Reporting of side effects
If you get any side effects, talk to 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 DUOBEXON

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

Single pack containing a 120-dose or 180-dose actuator
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 DUOBEXON more than 3 months from the date you receive the inhaler from the pharmacist and do not 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 120-dose actuators
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 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 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 DUOBEXON 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 delivered 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 DUOBEXON and contents of the pack:
DUOBEXON 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
protective green plastic 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 Authorisation 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 authorised in the Member States of the European Economic Area with the
following denominations:
Austria Duobexon
Italy Duobexon