BECLOMETASONE 100 MICROGRAMS/6 MICROGRAMS Pressurized solution for inhalation

Зміст інструкції

1. BECLOMETASONE E FORMOTEROLO GENETIC 100 micrograms /6 micrograms per
2. beclometasone dipropionate/formoterol fumarate dihydrate
   1. What is BECLOMETASONE AND FORMOTEROL GENETIC and what is it used for
   2. What you need to know before using BECLOMETASONE E FORMOTEROLO GENETIC
3. BECLOMETASONE E FORMOTEROLO GENETIC and all medicines or tablets purchased
   1. How to use BECLOMETASONE AND FORMOTEROL GENETIC
   2. Possible side effects
   3. How to store BECLOMETASONE E FORMOTEROLO GENETIC
   4. Package contents and other information
4. BECLOMETASONE E FORMOTEROLO GENETIC 200 micrograms /6 micrograms per
5. beclometasone dipropionate/formoterol fumarate dihydrate
   1. What is BECLOMETASONE E FORMOTEROLO GENETIC and what is it used for?
   2. What you need to know before using BECLOMETASONE E FORMOTEROLO GENETIC
   3. How to use BECLOMETASONE AND FORMOTEROL GENETIC
6. BECLOMETASONE AND FORMOTEROL GENETIC. Your doctor will adjust the treatment to the lowest
   1. Possible side effects
   2. How to store BECLOMETASONE E FORMOTEROLO GENETIC
   3. Package contents and other information

BECLOMETASONE E FORMOTEROLO GENETIC 100 micrograms /6 micrograms per

delivery, pressurized solution for inhalation

beclometasone dipropionate/formoterol fumarate dihydrate

equivalent medicine

Read this leaflet carefully before using this medicine as it contains
important information for you.
If you have any doubts, ask your doctor or pharmacist
This medicine has been prescribed only for you. Do not give it to other people, even if their
symptoms of the illness are the same as yours, as it could be dangerous.
If you experience any side effects, including those not listed in this leaflet, consult
your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is BECLOMETASONE AND FORMOTEROL GENETIC and what is it used for

BECLOMETASONE AND FORMOTEROL GENETIC 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
BECLOMETASONE AND FORMOTEROL GENETIC is indicated for the regular treatment of asthma
in adult patients in whom:

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

COPD
BECLOMETASONE AND FORMOTEROL GENETIC 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 FORMOTEROL GENETIC is for use in adults.

2. What you need to know before using BECLOMETASONE E FORMOTEROLO GENETIC

Do not use BECLOMETASONE E FORMOTEROLO GENETIC:
if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or any
other ingredient of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using BECLOMETASONE E FORMOTEROLO
GENETIC:

• If you suffer from heart problems, such as angina (heart pain, chest pain), if you have had a recent heart attack, heart failure, narrowing of the arteries around the heart (coronary artery disease), valve 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 heartbeat, a fast 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 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 going to have anesthesia. Depending on the type of anesthesia, you may need to stop taking BECLOMETASONE E FORMOTEROLO GENETIC 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 E FORMOTEROLO GENETIC.
If you have or have had any medical problem or allergies or if you are not sure you can use
BECLOMETASONE E FORMOTEROLO GENETIC, ask your doctor or pharmacist before
using this medicine.
Treatment with a beta-agonist like formoterol contained in BECLOMETASONE E
FORMOTEROLO GENETIC may cause a sudden drop in serum potassium levels (hypokalaemia).

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 BECLOMETASONE E
FORMOTEROLO GENETIC, 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 more
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 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 E FORMOTEROLO GENETIC 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
BECLOMETASONE E FORMOTEROLO GENETIC should not be used in children and adolescents under 18 years of age, until further data are available.

Other medicines and BECLOMETASONE E FORMOTEROLO GENETIC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription. This is because
BECLOMETASONE E FORMOTEROLO GENETIC can affect the way some other medicines work. Also, some medicines can affect the way
BECLOMETASONE E FORMOTEROLO GENETIC 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 E FORMOTEROLO
GENETIC and your doctor may want to monitor you closely 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 irregular heartbeats (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 are no clinical data on the use of BECLOMETASONE E FORMOTEROLO GENETIC during
pregnancy.
Do not take BECLOMETASONE E FORMOTEROLO GENETIC if you are pregnant, think you might be
pregnant or are planning a pregnancy, or if you are breastfeeding, unless your doctor has told you to.

Driving and using machines
It is unlikely that BECLOMETASONE E FORMOTEROLO GENETIC will affect your ability to
drive vehicles and use machines.

BECLOMETASONE E FORMOTEROLO GENETIC 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 have any significant effects.

For athletes
The use of the medicine without therapeutic need constitutes doping and may still
result in positive doping tests.

3. How to use BECLOMETASONE AND FORMOTEROL GENETIC

Always use this medicine exactly as your doctor or pharmacist has told you. If you have
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 FORMOTEROL GENETIC. Your doctor will adjust the treatment to the lowest
dose that best controls your symptoms.

BECLOMETASONE AND FORMOTEROL GENETIC can be prescribed by your doctor in two
different ways:
a)Daily use of BECLOMETASONE AND FORMOTEROL GENETIC to treat asthma together with a reliever inhaler to treat sudden
worsenings of asthma symptoms, such as breathlessness, wheezing and coughing
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 reliever inhaler with you to treat a
worsening of asthma symptoms or a sudden asthma attack.

b)Daily use of BECLOMETASONE AND FORMOTEROL GENETIC for the
treatment of asthma and further use of BECLOMETASONE AND FORMOTEROL
GENETIC to treat sudden worsenings of asthma symptoms, such as breathlessness,
wheezing and coughing
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 FORMOTEROL GENETIC as a reliever inhaler to treat
sudden asthma symptoms.
If you experience asthma symptoms, take one inhalation and wait a few minutes.
If you do not feel better, take another inhalation.

Do not take more than 6 inhalations as a reliever per day.
The maximum daily dose of BECLOMETASONE AND FORMOTEROL GENETIC as
a single inhaler for asthma is 8 inhalations.
If you think you need more than this number of inhalations per day to control your asthma
symptoms, ask your doctor for advice. It may be necessary to change your therapy.

Use in children and adolescents under 18 years of age:
Children and adolescents under 18 years of age should NOT use 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
BECLOMETASONE AND FORMOTEROL GENETIC in patients with impaired liver or
kidney function.

BECLOMETASONE AND FORMOTEROL GENETIC is effective in the treatment of asthma with
a dose of beclometasone dipropionate that may be lower than that of other
inhalers containing beclometasone dipropionate. If you were previously using a different
beclometasone dipropionate-based inhaler, your doctor will advise you on the exact dose of
BECLOMETASONE AND FORMOTEROL GENETIC 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 breathlessness or your breathing becomes wheezy (a whistling sound when you breathe), immediately after inhaling the medicine, stop using BECLOMETASONE AND FORMOTEROL GENETIC immediately and use your fast-acting reliever inhalerimmediately. You should contact your doctor immediately. Your doctor will assess your symptoms and may start another type of treatment if necessary. See also section 4. Possible side effects.

If your asthma gets worse
If your symptoms worsen or are difficult to control (for example, if you use another
reliever inhaler or BECLOMETASONE AND FORMOTEROL GENETIC as a reliever inhaler
more frequently), or if your reliever inhaler or BECLOMETASONE AND
FORMOTEROL GENETIC does not improve your symptoms, contact your doctor immediately. Asthma
may be getting worse and your doctor may need to increase the dose of BECLOMETASONE AND
FORMOTEROL GENETIC or prescribe alternative treatment.

How to administer
BECLOMETASONE AND FORMOTEROL GENETIC is for inhalation use.
This medicine is contained in a pressurized container placed in 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 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 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 vertically with the mouthpiece facing down.
• Point the mouthpiece away from you and press down firmly on the container to release a dose
• If you have not used the inhaler for 14 days or more, press down 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 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 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. Breathe out as slowly and deeply as possible (Figure 2).
• 3. Hold the container vertically, with the actuator body upwards, and place your lips around the mouthpiece. Do not bite the mouthpiece (Figure 3).

• 4. Breathe in slowly and deeply through your mouth and immediately after starting to inhale, press down 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 vertically 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 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 see a “mist” escaping from the inhaler or from the sides of your mouth after inhalation, this
means that BECLOMETASONE AND FORMOTEROL GENETIC 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 FORMOTEROL GENETIC is too strong or not
sufficient, 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 actuator 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 GENETIC than you should:

• Taking more formoterol than you should may have the following effects: feeling unwell, discomfort, rapid 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 blood glucose levels. Your doctor may want to perform blood tests to check your potassium and blood 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 your serum cortisol levels. Tell your doctor if you have any of these symptoms.

If you forget to take BECLOMETASONE AND FORMOTEROL GENETIC:
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 GENETIC:
Even if you feel better, do not stop taking BECLOMETASONE AND FORMOTEROL
GENETIC or reduce the dose. If you want to do so, talk to your doctor. It is very important that you use
BECLOMETASONE AND FORMOTEROL GENETIC 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 E FORMOTEROLO
GENETIC, and this condition is known as paradoxical bronchospasm. If this occurs, it must

IMMEDIATELY STOP using BECLOMETASONE E FORMOTEROLO
GENETICand immediately use your “as needed” fast-acting inhaler to treat 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 E FORMOTEROLO GENETIC 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):
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 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):
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 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 E FORMOTEROLO GENETIC

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

Single pack containing a 120-dose or 180-dose inhaler
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 E FORMOTEROLO GENETIC beyond 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 box and
on the label after "Exp.". The expiry date refers to the last day of that month.

Double or triple packs containing two or three 120-dose inhalers
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
box and on 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 E FORMOTEROLO GENETIC 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 a metered 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 E FORMOTEROLO GENETIC and contents
of the pack
BECLOMETASONE E FORMOTEROLO GENETIC 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 under
the following denominations:
Austria Beclometason/Formoterol Genetic
Belgium Beclometasone/Formoterol Genetic
Luxembourg Beclometasone/Formoterol Genetic
Germany Beclometason/Formoterol Genetic
Netherlands Beclometason/Formoterol Allgen
Estonia Beclametasone/Formoterol Genetic
France Béclométasone/Formotérol Biogaran
Lithuania Beclometasone/Formoterol Genetic
Latvia Beclometasone/Formoterol Genetic
Romania Beclometazonă/Formoterol Genetic
Slovakia Beklometasón-formoterol Genetic
Italy Beclometasone e Formoterolo Genetic
Portugal Beclometasona Formoterol Genetic
Spain Beclometasona Formoterol Genetic
Greece Breair
Poland Aerox
Hungary Beclometasone formoterol
Bulgaria Беклометазон формотерол Genetic
Czech Republic Beklometason/Formoterol Genetic
Slovenia Beklometazon/formoterol Genetic
Ireland Beclometasone/formoterol
Croatia Beklometazondipropionat/formoterolfumarat dihidrat Genetic
Malta Beclometasone formoterol Genetic
Cyprus Beclometasone formoterol Genetic

BECLOMETASONE E FORMOTEROLO GENETIC 200 micrograms /6 micrograms per

delivery, pressurized solution for inhalation

beclometasone dipropionate/formoterol fumarate dihydrate

equivalent medicine

Read this leaflet carefully before 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 only for you. Do not give it to other people, even if their symptoms
are the same as yours, as it could be dangerous.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is BECLOMETASONE E FORMOTEROLO GENETIC and what is it used for?

BECLOMETASONE E FORMOTEROLO GENETIC 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.

BECLOMETASONE E FORMOTEROLO GENETIC is indicated for the treatment of asthma in
adult patients.
If BECLOMETASONE E FORMOTEROLO GENETIC 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 E FORMOTEROLO GENETIC

Do not use BECLOMETASONE E FORMOTEROLO GENETIC:
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 BECLOMETASONE E
FORMOTEROLO GENETIC:

• If you suffer from heart problems, such as angina (chest pain, chest discomfort), 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 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 E FORMOTEROLO GENETIC 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 E FORMOTEROLO GENETIC.
If you have or have had any medical problem or allergies or if you are not sure you can use
BECLOMETASONE E FORMOTEROLO GENETIC contact your doctor, or a nurse who
understands 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 BECLOMETASONE E FORMOTEROLO GENETIC
can cause a sudden drop in serum potassium levels (hypokalaemia). This is because a lack of
oxygen in the blood combined with some other treatments you may be taking together with
BECLOMETASONE E FORMOTEROLO GENETIC can worsen the reduction in 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 hospitalisation
after an accident, a serious injury or surgery. In this case, the doctor treating you will decide if you
may need to increase the dose of corticosteroids and may prescribe steroid tablets or steroid injections.

If you have to go to hospital, remember to take all your medicines and inhalers with you, including
BECLOMETASONE E FORMOTEROLO GENETIC 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
BECLOMETASONE E FORMOTEROLO GENETIC should not be used in children and
adolescents under the age of 18 years.

Other medicines and BECLOMETASONE E FORMOTEROLO GENETIC
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
may take any other medicines, including those without a prescription.
This is because BECLOMETASONE E FORMOTEROLO GENETIC can affect the way
some other medicines work. Also, some medicines can affect the
way BECLOMETASONE E FORMOTEROLO GENETIC 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 E FORMOTEROLO
GENETIC and your doctor may want to monitor you closely 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 a general anaesthetic for an operation or dental
procedure.

Pregnancy, breastfeeding and fertility
There are no clinical data on the use of BECLOMETASONE E FORMOTEROLO GENETIC during
pregnancy.
Do not take BECLOMETASONE E FORMOTEROLO GENETIC if you are pregnant, think you are
pregnant or are planning a pregnancy, or if you are breastfeeding, unless your doctor has
advised you to.

Driving and using machines
It is unlikely that BECLOMETASONE E FORMOTEROLO GENETIC will affect your ability
to drive and use machines.

BECLOMETASONE E FORMOTEROLO GENETIC 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 BECLOMETASONE AND FORMOTEROL GENETIC

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 GENETIC. 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 GENETIC 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 GENETIC is effective in the treatment of asthma with
a dose 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 GENETIC 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 the dose of BECLOMETASONE AND FORMOTEROL GENETIC or prescribe a
alternative treatment.

How to administer
BECLOMETASONE AND FORMOTEROL GENETIC 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 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 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 from you 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 sitting in an upright position while inhaling.
Before starting to inhale, check the dose counter or dose indicator that shows 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 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 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 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 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 inhalerYou should get a new inhaler when the 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 GENETIC will not reach the lungsas it should. Perform another actuation following the instructions by repeating the operationsfrom point 2.If you think the effect of BECLOMETASONE AND FORMOTEROL GENETIC 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 BECLOMETASONE AND FORMOTEROL GENETIC than you should

• Taking more formoterol than you should may have the following effects: feeling unwell, discomfort, rapid 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 blood glucose levels. Your doctor

may want to perform blood tests to check potassium and glucose levels in the
blood.

• Excessive intake of beclometasone dipropionate may cause temporary disturbances in 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 FORMOTEROL GENETIC
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 FORMOTEROL GENETIC
Even if you feel better, do not stop taking BECLOMETASONE AND FORMOTEROL
GENETIC or reduce the dose. If you want to do so, talk to your doctor. It is very important that you use
BECLOMETASONE AND FORMOTEROL GENETIC 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 everybody gets them.
As with other treatments via inhalation, there is a risk of worsening of breathlessness and
wheezing immediately after using BECLOMETASONE E FORMOTEROLO
GENETIC, and this condition is known as paradoxical bronchospasm. If this occurs, it must

IMMEDIATELY STOP using BECLOMETASONE E FORMOTEROLO
GENETICand immediately use 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

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 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 levels
increased blood sugar levels
increased levels of insulin, free fatty acids and ketones in the blood
The following side effects have been reported as "uncommon" in patients with
chronic obstructive pulmonary disease:
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 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 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, 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 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 E FORMOTEROLO GENETIC

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 E FORMOTEROLO GENETIC beyond 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 box and
on 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 packaging and apply the label to the inhaler. The inhalers should not be used after 3
months from first use and should never be used after the expiry date which is stated on the
box and on 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 E FORMOTEROLO GENETIC 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 metered 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 BECLOMETASONE E FORMOTEROLO GENETIC and contents
of the pack:
BECLOMETASONE E FORMOTEROLO GENETIC is a pressurized solution for inhalation
contained in an aluminum container with a metering valve, inserted into a white plastic actuator
incorporating a 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 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 Beclometason/Formoterol Genetic
Belgium Beclometasone/Formoterol Genetic
Luxembourg Beclometasone/Formoterol Genetic
Germany Beclometason/Formoterol Genetic
Netherlands Beclometason/Formoterol Allgen
Estonia Beclametasone/Formoterol Genetic
France Béclométasone/Formotérol Biogaran
Lithuania Beclometasone/Formoterol Genetic
Latvia Beclometasone/Formoterol Genetic
Romania Beclometazonă/Formoterol Genetic
Slovakia Beklometasón-formoterol Genetic
Italy Beclometasone e Formoterolo Genetic
Portugal Beclometasona Formoterol Genetic
Spain Beclometasona Formoterol Genetic
Greece Breair
Poland Aerox
Hungary Beclometasone formoterol
Bulgaria Беклометазон формотерол Genetic
Czech Republic Beklometason/Formoterol Genetic
Slovenia Beklometazon/formoterol Genetic
Ireland Beclometasone/formoterol
Croatia Beklometazondipropionat/formoterolfumarat dihidrat Genetic
Malta Beclometasone formoterol Genetic
Cyprus Beclometasone formoterol Genetic