Beclometasone and formoterol Genetic

PACKAGE LEAFLET

Package leaflet: information for the user

BECLOMETASONE AND FORMOTEROL GENETIC 100 micrograms/6 micrograms per

dose, pressurized solution for inhalation
beclometasone dipropionate/formoterol fumarate dihydrate
equivalent medicine
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Keep this package leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if
their symptoms are the same as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your
doctor or pharmacist. See section 4.
Contents of this leaflet:

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

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

BECLOMETASONE AND FORMOTEROL GENETIC is a pressurised inhalation solution
containing two active substances which are inhaled through the mouth and delivered directly into the lungs.
The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids which have an
anti-inflammatory action, reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators which
relax the muscles of the airways and help you breathe more easily.
Together, these two active substances make breathing easier, providing relief from symptoms such as
shortness of breath, wheezing and cough in patients with asthma or COPD, and also help prevent asthma symptoms.

Asthma
BECLOMETASONE AND FORMOTEROL GENETIC is indicated for 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 may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a long-term disease of the airways in the lungs, mainly caused by cigarette smoking.
BECLOMETASONE AND FORMOTEROL GENETIC is for use in adults.

2. What you should know before using BECLOMETASONE AND FORMOTEROL GENETIC

Do not use BECLOMETASONE AND FORMOTEROL 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
Consult your doctor or pharmacist before using BECLOMETASONE AND FORMOTEROL
GENETIC:

• If you have heart problems, such as angina (chest pain), if you have recently had a 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 have high blood pressure, or if you know you have an aneurysm (an abnormal dilation of the blood vessel wall).
• If you have heart rhythm disorders such as rapid or irregular heartbeat, rapid pulse, or palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal.
• If you have an overactive thyroid gland.
• If you have low levels of potassium in the blood.
• If you have any liver or kidney disorders.
• If you have diabetes (if you inhale high doses of formoterol, your blood sugar may increase, and you may therefore need additional blood tests to monitor your blood glucose levels when you start using this inhaler and occasionally during treatment).
• If you have a tumour of the adrenal gland (known as phaeochromocytoma).
• If you are due to undergo anaesthesia. Depending on the type of anaesthesia, you may need to stop taking BECLOMETASONE AND FORMOTEROL GENETIC at least 12 hours before anaesthesia.
• If you are currently being treated, or have ever been treated, for tuberculosis (TB), or if you have a known viral or fungal infection in the chest.
• If you need to avoid alcohol for any reason.

If any of the above conditions apply to you, always inform your doctor before
using BECLOMETASONE AND FORMOTEROL GENETIC.
If you have or have had any medical conditions or allergies, or if you are unsure whether you can use BECLOMETASONE AND FORMOTEROL GENETIC, consult your doctor or pharmacist before using this medicine.

Treatment with a beta-agonist such as formoterol contained in BECLOMETASONE AND FORMOTEROL GENETIC may cause a sudden drop in serum potassium levels (hypokalaemia).
If you have severe asthma, you should take particular care. This is due to lack of oxygen in the blood, and other treatments you may be taking together with BECLOMETASONE AND FORMOTEROL GENETIC, such as medicines for heart conditions or high blood pressure known as diuretics, or other medicines used to treat asthma, may worsen the reduction in potassium levels. For this reason, your doctor may wish to monitor your blood potassium levels periodically.

If you are taking higher doses of inhaled corticosteroids for long periods, you may require additional corticosteroids during periods of stress. Stressful situations may include hospitalization following an accident, a serious injury, or surgery. In such cases, your treating doctor will decide whether you may need an increased dose of corticosteroids and may prescribe steroid tablets or injectable steroids.

If you need to go to hospital, remember to bring all your medicines and inhalers with you, including BECLOMETASONE AND FORMOTEROL GENETIC and any over-the-counter medicines or tablets you are taking, preferably in their original packaging.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
BECLOMETASONE AND FORMOTEROL GENETIC must not be used in children and adolescents under 18 years of age until further data are available.

Other medicines and BECLOMETASONE AND FORMOTEROL GENETIC
Inform 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 AND FORMOTEROL GENETIC may affect how some other medicines work. In addition, some medicines may affect how BECLOMETASONE AND FORMOTEROL GENETIC works.

In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medicines:

Some medicines may increase the effects of BECLOMETASONE AND FORMOTEROL GENETIC, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV medicines: ritonavir, cobicistat).

Beta-blockers. Beta-blockers are medicines used to treat many conditions, including heart problems, high blood pressure, and glaucoma (increased pressure in the eyes). If you need to use beta-blockers, including eye drops, the effect of formoterol may be reduced or formoterol may not work at all.

Beta-adrenergic medicines (medicines that work in the same way as formoterol) may increase the effects of formoterol.

Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide).

Medicines used to treat allergic reactions (antihistamines).

Medicines used to treat symptoms of depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarbazide), tricyclic antidepressants (e.g. amitriptyline and imipramine), phenothiazines.

Medicines used to treat Parkinson's disease (L-dopa).

Medicines used to treat hypothyroidism (L-thyroxine).

Medicines containing oxytocin (which causes uterine contractions).

Medicines used to treat mental disorders such as monoamine oxidase inhibitors (MAOIs), including medicines with similar properties such as furazolidone and procarbazine.

Medicines used to treat heart conditions (digoxin).

Other medicines used to treat asthma (theophylline, aminophylline, or steroids).

Diuretics.

Also inform your doctor if you are about to undergo general anaesthesia for surgery or a dental procedure.

Pregnancy, breastfeeding and fertility
There are no clinical data on the use of BECLOMETASONE AND FORMOTEROL GENETIC during pregnancy.

Do not take BECLOMETASONE AND FORMOTEROL GENETIC if you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, unless advised by your doctor.

Driving and using machines
It is unlikely that BECLOMETASONE AND FORMOTEROL GENETIC will affect your ability to drive or use machines.

BECLOMETASONE AND FORMOTEROL GENETIC contains alcohol
This medicine contains 7 mg of alcohol (ethanol) per dose, equivalent to 0.20 mg/kg for a two-dose administration. The amount in two doses 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 engaged in sports activities
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use BECLOMETASONE AND FORMOTEROL GENETIC

Always use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Asthma

Your doctor will regularly monitor you to ensure 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 may be prescribed by your doctor in two different ways:

a) Daily use of BECLOMETASONE AND FORMOTEROL GENETIC for the treatment of asthma, together with a "reliever" inhaler to treat sudden worsening of asthma symptoms, such as shortness of breath, wheezing, and cough

Adults and elderly:

The recommended dose of this medicine is one or two inhalations twice daily. The maximum daily dose is four inhalations.

Remember: You must always carry your "reliever" inhaler with rapid action to treat worsening asthma symptoms or sudden asthma attacks.

b) Daily use of BECLOMETASONE AND FORMOTEROL GENETIC for the treatment of asthma, and additional use of BECLOMETASONE AND FORMOTEROL GENETIC to treat sudden worsening of asthma symptoms, such as shortness of breath, wheezing, and cough

Adults and elderly:

The recommended dose is one inhalation in the morning and one inhalation in the evening.

You should use BECLOMETASONE AND FORMOTEROL GENETIC also 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 "reliever" inhalations per day.

The maximum daily dose of BECLOMETASONE AND FORMOTEROL GENETIC when used as the only asthma inhaler is 8 inhalations.

If you feel you need more inhalations per day to control your asthma symptoms, consult your doctor. A change in therapy may be necessary.

Use in children and adolescents under 18 years of age:

Children and adolescents under 18 years of age must not take this medicine.

Chronic Obstructive Pulmonary Disease (COPD)

Adults and elderly

The recommended dose is two inhalations in the morning and two inhalations in the evening.

Patients at risk

Dose adjustment is not required in elderly patients. There is no information available on the use of BECLOMETASONE AND FORMOTEROL GENETIC in patients with hepatic or renal impairment.

BECLOMETASONE AND FORMOTEROL GENETIC is effective in the treatment of asthma with a dosage of beclometasone dipropionate that may be lower than that of other inhalers containing beclometasone dipropionate. If you were previously using a different beclometasone dipropionate inhaler, your doctor will advise you on the exact dose of BECLOMETASONE AND FORMOTEROL GENETIC to take for asthma treatment.

Do not increase the dose

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

If your breathing worsens

• If you experience worsening shortness of breath or wheezing (audible whistling sound while breathing) immediately after inhaling the medicine, stop using BECLOMETASONE AND FORMOTEROL GENETIC immediately and use your rapid-acting "reliever" inhaler immediately. You must contact your doctor immediately. Your doctor will assess your symptoms and, if necessary, may start a different treatment. See also section 4. Possible side effects.

If your asthma worsens

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

Method of administration

BECLOMETASONE AND FORMOTEROL GENETIC is for inhalation use only.

This medicine is contained in a pressurized canister inserted into a plastic holder with a mouthpiece. On the back of the inhaler there is a dose counter for 120 doses and a dose indicator for 180 actuations, which shows the number of doses remaining.

For the 120-dose pack, each time the canister is pressed, one dose of medicine is released and the counter decreases by one number. Be careful not to drop the inhaler, as this may cause the dose counter to decrease by one dose.

For the 180-actuation pack, the dose indicator shows the approximate number of actuations (sprays) remaining in the canister. The dose indicator window displays the number of sprays left 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 canister is nearing the end of its life.

When 180 actuations have been delivered, the display shows the number 0.

The indicator will stop moving at "0".

Checking the inhaler function

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's function to ensure it is working properly.

• Remove the protective cap from the mouthpiece.
• Hold the inhaler upright with the mouthpiece pointing down.
• Tilt the mouthpiece away and press firmly on the canister to release one dose.
• If you have not used the inhaler for 14 days or more, press firmly on the canister once to release one actuation.
• For the 120-dose pack, check the dose counter. If you are using the inhaler for the first time, the counter should read 120.
• For the 180-actuation pack, check the dose indicator. If you are using the inhaler for the first time, the indicator should read 180.

How to use the inhaler

Whenever possible, remain standing or sit upright while inhaling.

Before starting to inhale, check the dose counter or dose indicator to see how many doses remain. If the dose counter or dose indicator shows "0", no doses remain: 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, dirt, or any foreign object (Figure 1).
2. Breathe out as slowly and deeply as possible (Figure 2).
3. Hold the canister vertically, with the body of the inhaler upright, 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 firmly on the top of the inhaler to release one 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, then remove the inhaler from your mouth and breathe out slowly. Do not exhale into the inhaler (Figure 5).

If another actuation is needed, keep 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, replace the protective cap and check the dose counter for the 120-dose pack or 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 0, as the remaining doses in the device may not be sufficient to deliver a complete 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 has not reached your lungs as intended. Take another actuation by repeating steps 2 to 5.

If you feel the effect of BECLOMETASONE AND FORMOTEROL GENETIC is too strong or not strong enough, inform your doctor or pharmacist.

If you have difficulty using the inhaler while starting to inhale, you may use the AeroChamber Plus spacer device. Ask your doctor, pharmacist, or nurse for information about this device.

It is important to read the Patient Information Leaflet provided with the AeroChamber Plus spacer device and carefully follow the instructions on how to use and clean it.

Cleaning

The inhaler must be cleaned once a week.

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

To clean the inhaler:

1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
2. Wipe the inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
3. Replace the protective cap on the mouthpiece.

If you take more BECLOMETASONE AND FORMOTEROL GENETIC than you should:

• Taking more formoterol than you should may cause the following effects: feeling unwell, malaise, rapid heartbeat, palpitations, heart rhythm disturbances, certain changes in the electrocardiogram (ECG), 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 your potassium and glucose levels.
• Excessive intake of beclometasone dipropionate may cause temporary disturbances of the adrenal glands. These will improve within a few days, but your doctor may want to check your serum cortisol levels. Inform your doctor if you experience 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 forgotten dose.

If you stop using BECLOMETASONE AND FORMOTEROL GENETIC:

Even if you feel better, do not stop taking BECLOMETASONE AND FORMOTEROL GENETIC or reduce the dose. If you wish to do so, speak to your doctor. It is very important that you use BECLOMETASONE AND FORMOTEROL GENETIC regularly, even in the absence of symptoms.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
As with other inhaled treatments, there is a risk of worsening breathlessness and wheezing immediately after using BECLOMETASONE AND FORMOTEROL GENETIC, a condition known as paradoxical bronchospasm. If this occurs, you must STOP using BECLOMETASONE AND FORMOTEROL GENETIC immediately and use your "reliever" inhaler with fast action to treat breathlessness and wheezing symptoms right away. You must contact your doctor immediately.
Inform your doctor immediately if you experience hypersensitivity reactions such as skin allergy, itching, rash, skin redness, swelling of the skin or mucous membranes, particularly of the eyes, face, lips, and throat.

Other possible side effects are listed below by frequency.

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

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

Pneumonia in patients with COPD: Inform your doctor if you experience any of the following symptoms while taking BECLOMETASONE AND FORMOTEROL GENETIC, as they may be signs of a lung infection:

• fever or chills
• increased mucus production, change in mucus colour
• increased cough or worsening breathing difficulties

Uncommon (may affect up to 1 in 100 people):
palpitations, abnormally rapid heartbeat, and heart rhythm disorders
some changes in the electrocardiogram (ECG)
influenza-like symptoms
sinusitis
rhinitis
ear inflammation
throat irritation
cough and productive cough
asthma attack
fungal vaginal infections
nausea
abnormal or altered taste sensation
burning of the lips
dry mouth
difficulty swallowing
indigestion
stomach discomfort
diarrhoea
muscle pains and cramps
redness of the face and throat
increased blood flow to certain body tissues
excessive sweating
tremor
restlessness
dizziness
rash or hives
changes in certain blood components:
reduction in the number of white blood cells
increase in the number of platelets in the blood
decrease in blood potassium levels
increase in blood sugar levels
increase in blood levels of insulin, free fatty acids, and ketones

The following side effects have been reported as "uncommon" in patients with chronic obstructive pulmonary disease (COPD):
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 premature contraction of the heart's ventricles)
decrease in blood pressure
increase in blood pressure
kidney inflammation
swelling of the skin and mucous membranes persisting 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 may very rarely cause systemic effects. These include:
adrenal gland function disorders (adrenal suppression)
decrease in bone mineral density (thinning of the bones)
growth retardation 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
hyperexcitability or irritability.
These events are more likely in children, but the frequency is not known.
Blurred vision

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

5. How to store BECLOMETASONE AND FORMOTEROL GENETIC

Keep this medicine out of the sight and reach of children.
Single pack containing one 120-dose or 180-dose inhaler
For the pharmacist
Store in a refrigerator (2-8 °C) for up to 18 months.
Enter the date of dispensing to the patient on the adhesive label on the packaging and affix the label to the inhaler. Ensure that there is a period of at least 3 months between the date of dispensing and the expiry date printed on the packaging.
For patients
Do not store the inhaler at temperatures above 25 °C.
Do not use BECLOMETASONE AND FORMOTEROL GENETIC more than 3 months after the date you received the inhaler from the pharmacist, and never use it after the expiry date stated on the box and on the label following "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 (2-8 °C).
After first use: Store the inhalers for a maximum of three months 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 affix the label to the inhaler. The inhalers must not be used more than 3 months after first use, and must never be used after the expiry date printed on the box and on the label following "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 several minutes before use.
Never heat it using artificial means.
Caution: The container contains a pressurised liquid. Do not expose the container to temperatures above 50 °C. Do not pierce the container.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What BECLOMETASONE AND FORMOTEROL GENETIC contains
The active substances 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 corresponds 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 components are: anhydrous ethanol, concentrated hydrochloric acid and norflurane (HFA-134a).
This medicinal product contains fluorinated gases with a greenhouse effect.
Each 120-dose inhaler contains 8.15 g of HFA-134a, equivalent to 0.012 tonnes of CO₂ (global warming potential GWP = 1,430).
Each 180-dose inhaler contains 11.2 g of HFA-134a, equivalent to 0.016 tonnes of CO₂ (global warming potential GWP = 1,430).

Description of the appearance of BECLOMETASONE AND FORMOTEROL GENETIC and contents of the package
BECLOMETASONE AND FORMOTEROL GENETIC is a pressurized solution for inhalation contained in an aluminum canister fitted with a metering valve, inserted into a white plastic actuator incorporating a dose counter (120-dose pack) or a dose indicator (180-dose pack), with a pink plastic protective cap.
Each package contains:
1 pressurized canister (providing 120 actuations) or
2 pressurized canisters (each providing 120 actuations) or
3 pressurized canisters (each providing 120 actuations) or
1 pressurized canister (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 European Economic Area countries under the following names:
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

Package leaflet: information for the user

BECLOMETASONE AND FORMOTEROL GENETIC 200 micrograms/6 micrograms per

dose, pressurized inhalation solution
beclometasone dipropionate/formoterol fumarate dihydrate
equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.
Keep this patient information leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet

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

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

BECLOMETASONE AND FORMOTEROL GENETIC is a pressurised inhalation solution
containing two active substances which are inhaled through the mouth and delivered directly into the lungs.
The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids which have an anti-inflammatory effect, 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.
Together, these two active substances 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 AND FORMOTEROL GENETIC is indicated for the treatment of asthma in adult patients.
If you have been prescribed BECLOMETASONE AND FORMOTEROL GENETIC, it is likely that:

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

2. What you need to know before using BECLOMETASONE AND FORMOTEROL GENETIC

Do not use BECLOMETASONE AND FORMOTEROL 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 AND
FORMOTEROL GENETIC:

• If you have heart problems, such as angina (chest pain, heart pain), heart failure, narrowed arteries, valvular heart disease, or any other known heart condition.
• If you have high blood pressure or if you know you have an aneurysm (an abnormal bulging of blood vessel walls).
• If you have heart rhythm disorders such as rapid or irregular heartbeat, fast pulse, or palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal.
• If you have an overactive thyroid gland.
• If you have low levels of potassium in your blood.
• If you have any liver or kidney problems.
• If you have diabetes (if you inhale high doses of formoterol, your blood sugar may increase. When you start using this medicine and occasionally during treatment, you may need additional blood tests to monitor your blood sugar levels).
• If you have a tumour of the adrenal gland (known as phaeochromocytoma).
• If you are due to undergo anaesthesia. Depending on the type of anaesthesia, you may need to stop taking BECLOMETASONE AND FORMOTEROL GENETIC at least 12 hours before the anaesthesia.
• If you are currently being treated, or have previously been treated, for tuberculosis (TB), or if you have a known viral or fungal infection in the chest.
• If you need to avoid alcohol for any reason.

If any of the conditions listed above apply to you, always inform your doctor before
using BECLOMETASONE AND FORMOTEROL GENETIC.
If you have or have had any medical problems or allergies, or if you are unsure whether you can use
BECLOMETASONE AND FORMOTEROL GENETIC, consult your doctor, a nurse experienced in asthma, or a pharmacist before using the inhaler.
Your doctor may want to check your blood potassium levels from time to time, especially if
your asthma is severe. Like many bronchodilators, BECLOMETASONE AND FORMOTEROL GENETIC
can cause a sudden drop in serum potassium levels (hypokalaemia). This is because lack of
oxygen in the blood, combined with certain other treatments you may be taking alongside
BECLOMETASONE AND FORMOTEROL GENETIC, can worsen the reduction in potassium levels.
If you are taking high doses of inhaled corticosteroids for long periods, you may require additional
corticosteroids during times of stress. Stressful situations may include hospitalisation after an accident, a serious injury, or surgery. In such cases, your treating doctor will decide whether you may need an increased dose of corticosteroids and may prescribe steroid tablets or injectable steroids.
If you need to go to hospital, remember to bring all your medicines and inhalers with you, including
BECLOMETASONE AND FORMOTEROL GENETIC, and any over-the-counter medicines or tablets, preferably in their original packaging.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
BECLOMETASONE AND FORMOTEROL GENETIC must not be used in children and adolescents under 18 years of age.

Other medicines and BECLOMETASONE AND FORMOTEROL GENETIC
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
This is because BECLOMETASONE AND FORMOTEROL GENETIC may affect how some other medicines work. In addition, some medicines may affect how BECLOMETASONE AND FORMOTEROL GENETIC works.
In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medicines:
Some medicines can increase the effects of BECLOMETASONE AND FORMOTEROL
GENETIC, and your doctor may wish to monitor you closely if you are taking these
medicines (including some HIV medicines: ritonavir, cobicistat).
Beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, hypertension, and glaucoma (increased pressure in the eyes). If you need to use beta-blockers, including eye drops, the effect of formoterol may be reduced or formoterol may not work at all.
Beta-adrenergic medicines (medicines that work in the same way as formoterol) may increase the effects of formoterol.
Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide).
Medicines used to treat allergic reactions (antihistamines).
Medicines for treating symptoms of depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarbazide), 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 contractions).
Medicines for the treatment of mental disorders such as monoamine oxidase inhibitors (MAOIs), 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.
You should also inform your doctor if you are about to undergo general anaesthesia for surgery or a dental procedure.

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

Driving and using machines
It is unlikely that BECLOMETASONE AND FORMOTEROL GENETIC will affect your ability to
drive or operate machinery.

BECLOMETASONE AND FORMOTEROL GENETIC contains alcohol
This medicine contains 9 mg of alcohol (ethanol) per dose, equivalent to 0.25 mg/kg per two-dose administration. The amount in two doses 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
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use BECLOMETASONE AND FORMOTEROL GENETIC

Always use this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will regularly monitor you to ensure you are taking the optimal dose of
BECLOMETASONE AND FORMOTEROL GENETIC. Your doctor will adjust your treatment to the
lowest dose that best controls your symptoms.

Dosage
Adults and elderly
The recommended dose is two inhalations twice daily.
The maximum daily dose is 4 inhalations.

Remember: Always carry your “reliever” fast-acting inhaler with you to treat worsening asthma symptoms or sudden asthma attacks.

Patients at risk
Dose adjustment is not necessary in elderly patients. There is no available information on the use of BECLOMETASONE AND FORMOTEROL GENETIC in patients with liver or kidney problems.

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

BECLOMETASONE AND FORMOTEROL GENETIC is effective in the treatment of asthma at a beclometasone dipropionate dosage that may be lower than that of other inhalers containing this active ingredient. If you previously used a different beclometasone dipropionate inhaler, your doctor will advise you on the exact dose of BECLOMETASONE AND FORMOTEROL GENETIC to take for asthma treatment.

Do not increase the dose
If you feel the medicine is not working well enough, always consult your doctor before increasing the dose.

If your asthma worsens
If your symptoms worsen or become difficult to control (for example, if you are using your
“reliever” inhaler more frequently), or if your “reliever” inhaler does not improve your
symptoms, contact your doctor immediately. Your asthma may be worsening, and your doctor may need to adjust your dose of BECLOMETASONE AND FORMOTEROL GENETIC or prescribe an alternative treatment.

Method of administration
BECLOMETASONE AND FORMOTEROL GENETIC is for inhalation use only.

This medicine is contained in a pressurized canister inserted into a plastic housing with a mouthpiece. On the back of the inhaler, there is a dose counter for 120 doses and a dose indicator for 180 actuations, which shows the number of doses remaining.

For the 120-dose pack, each time you press the canister, one dose of medicine is released and the counter decreases by one. Be careful not to drop the inhaler, as this may cause the dose counter to decrement by one.

For the 180-actuation pack, the dose indicator shows the approximate number of actuations (sprays) remaining in the canister. The dose indicator window displays the number of sprays left in multiples of twenty (e.g., 180, 120, 100, 80, etc.). When 20 actuations remain, the display will show the number 20, indicating that the canister is nearing the end of its life.
When 180 actuations have been delivered, the display will show the number 0.
The indicator will stop moving at "0".

Checking the inhaler function
Before using the inhaler for the first time, or if the inhaler has not been used for 14 days or more, you must check that the inhaler is working properly.

• Remove the protective cap from the mouthpiece.
• Hold the inhaler upright with the mouthpiece pointing downward.
• Point the mouthpiece away from you and press firmly on the canister to release one dose.
• If you have not used the inhaler for 14 days or more, press firmly on the canister once to release one puff.
• For the 120-dose pack, check the dose counter. If using the inhaler for the first time, the counter should read 120.
• For the 180-actuation pack, check the dose indicator. If using the inhaler for the first time, the indicator should read 180.

How to use the inhaler
Whenever possible, stand or sit upright while inhaling.
Before starting to inhale, check the dose counter or dose indicator to see how many doses remain. If the dose counter or dose indicator shows "0", no doses remain: 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, dirt, or any foreign objects (Figure 1).
2. Breathe out as slowly and deeply as possible (Figure 2).
3. Hold the canister upright, with the body of the inhaler facing upward, 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 firmly on the top of the inhaler to release one 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 (Image 4).
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler (Figure 5). If a second inhalation is required, keep the inhaler upright for about half a minute, then repeat steps 2 to 5.
   Important: Do not perform steps 2 to 5 too quickly. After use, replace the protective cap and check the dose counter (for the 120-dose pack) or dose indicator (for the 180-actuation pack). To reduce the risk of developing a fungal infection in the mouth and throat, rinse your mouth, gargle with water, or brush your teeth every time you use the inhaler.

When to replace the inhaler
You should obtain a new inhaler when the dose counter reads 20. Stop using the inhaler when the dose counter shows 0, as the remaining doses in the device may not be sufficient to deliver a full dose, and begin using the new inhaler.

If you see a “mist” escaping from the inhaler or from the sides of your mouth after inhalation, this means BECLOMETASONE AND FORMOTEROL GENETIC did not reach your lungs as intended. Perform another actuation by repeating the steps from point 2.

If you think the effect of BECLOMETASONE AND FORMOTEROL GENETIC is too strong or not strong enough, inform your doctor or pharmacist.
If you have difficulty using the inhaler while starting to inhale, you may use the AeroChamber Plus spacer device. Ask your doctor, pharmacist, or nurse for information about this device. It is important to read the Patient Information Leaflet provided with the AeroChamber Plus spacer device and carefully follow the instructions on how to use and clean it.

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

To clean the inhaler

1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
2. Wipe the inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
3. Replace the protective cap on the mouthpiece.

If you take more BECLOMETASONE AND FORMOTEROL GENETIC than you should

• Taking more formoterol than prescribed may cause the following effects: feeling unwell, nausea, rapid heartbeat, palpitations, heart rhythm disturbances, certain changes in the electrocardiogram (ECG), headache, tremor, drowsiness, excess acid in the blood, low potassium levels in the blood, high blood glucose levels. Your doctor may wish to perform blood tests to monitor your potassium and glucose levels.

• Excessive intake of beclometasone dipropionate may cause temporary disturbances of the adrenal glands. These will resolve within a few days, but your doctor may wish to monitor your serum cortisol levels.
  Inform your doctor if you experience 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 usual time.
Do not take a double dose to make up for a forgotten dose.

If you stop using BECLOMETASONE AND FORMOTEROL GENETIC
Even if you feel better, do not stop taking BECLOMETASONE AND FORMOTEROL GENETIC or reduce the dose. If you wish to do so, speak to your doctor. It is very important that you use BECLOMETASONE AND FORMOTEROL GENETIC regularly, even when you have no symptoms.

If you have any questions about how to use this medicine, consult 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 inhaled treatments, there is a risk of worsening breathlessness and wheezing immediately after using BECLOMETASONE AND FORMOTEROL GENETIC, a condition known as paradoxical bronchospasm. If this occurs, you must STOP using BECLOMETASONE AND FORMOTEROL GENETIC IMMEDIATELY and use your "rescue" fast-acting inhaler right away to treat breathlessness and wheezing symptoms. You must contact your doctor immediately.
Inform your doctor immediately if you experience hypersensitivity reactions such as skin allergy, itching, rash, skin redness, or swelling of the skin or mucous membranes, particularly of the eyes, face, lips, and throat.

Other possible side effects are listed below by frequency.

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

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

Uncommon (may affect up to 1 in 100 people):
palpitations, abnormally rapid heartbeat, and heart rhythm disorders
some changes in the electrocardiogram (ECG)
increased blood pressure
influenza-like symptoms
sinusitis
rhinitis
ear inflammation
throat irritation
cough and productive cough
asthma attack
vaginal fungal infections
nausea
abnormal or altered taste sensation
lip burning
dry mouth
difficulty swallowing
indigestion
stomach disturbances
diarrhoea
muscle pain and cramps
redness of the face and throat
increased blood flow to certain body tissues
excessive sweating
tremor
restlessness
dizziness
rash or urticaria
changes in certain blood components:
reduction in the number of white blood cells
increase in the number of platelets in the blood
reduction in blood potassium levels
increase in blood sugar levels
increase in blood levels of insulin, free fatty acids, and ketones

The following side effects have been reported as "uncommon" in patients with chronic obstructive pulmonary disease (COPD):
pneumonia; inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum colour, fever, increased cough, worsening of 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 premature contraction of the heart's ventricles)
decrease in blood pressure
kidney inflammation
persistent swelling of the skin and mucous membranes lasting 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 may very rarely cause systemic effects. These include:
adrenal gland function disorders (adrenal suppression)
reduction in bone mineral density (bone thinning)
growth retardation 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
hyperexcitability or irritability
These events are more likely in children, but the frequency is unknown.
Blurred vision

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

5. How to store BECLOMETASONE AND FORMOTEROL 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 the refrigerator (2–8 °C) for up to 18 months.
Enter the date of dispensing to the patient on the adhesive label on the packaging and affix the label to the inhaler. Ensure there is a period of at least 3 months between the date of dispensing and the expiry date printed on the packaging.
For patients
Do not store the inhaler at temperatures above 25 °C.
Do not use BECLOMETASONE AND FORMOTEROL GENETIC more than 3 months after the date you received the inhaler from the pharmacist, and never use it after the expiry date stated on the box and on the label following "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 the 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 affix the label to the inhaler. The inhalers must not be used more than 3 months after first use and must never be used after the expiry date printed on the box and on the label following "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 using artificial means.
Caution: The container contains a pressurised liquid. Do not expose the container to temperatures above 50 °C. Do not pierce the container.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What BECLOMETASONE AND FORMOTEROL GENETIC contains:
The active substances 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 corresponds 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 components are: norflurane (HFA-134a), anhydrous ethanol, concentrated hydrochloric acid.
This medicinal product contains fluorinated greenhouse gases.
Each 120-dose inhaler contains 10.35 g of HFA-134a, equivalent to 0.015 tonnes of CO₂ (global warming potential GWP = 1,430).
Each 180-dose inhaler contains 14.24 g of HFA-134a, equivalent to 0.020 tonnes of CO₂ (global warming potential GWP = 1,430).

Description of the appearance of BECLOMETASONE AND FORMOTEROL GENETIC and contents of the pack:
BECLOMETASONE AND FORMOTEROL GENETIC is a pressurized solution for inhalation contained in an aluminium container with a metering valve, inserted into a white plastic actuator incorporating either a dose counter (120-dose pack) or a dose indicator (180-dose pack), with a green plastic protective cap.
Each pack contains:
1 pressurized container (delivering 120 doses) or
2 pressurized containers (each delivering 120 doses) or
3 pressurized containers (each delivering 120 doses) or
1 pressurized container (delivering 180 doses).
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 names:
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