Beclometasone and formoterol Mylan

Package leaflet: Information for the user

Beclometasone and Formoterol Mylan 100/6 micrograms per dose

pressurised solution for inhalation
Beclometasone dipropionate/formoterol fumarate dihydrate
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

Contents of this leaflet:

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

1. What Beclometasone and Formoterolo Mylan is and what it is used for

Beclometasone and Formoterolo Mylan is a pressurised solution for inhalation 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 exert 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.
Together, these two active substances make breathing easier, providing relief from symptoms such as shortness of breath, wheezing and coughing in patients with asthma or COPD, and also help to prevent asthma symptoms.

Asthma
Beclometasone and Formoterolo Mylan 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 is well controlled with treatment using both inhaled corticosteroids and long-acting bronchodilators.

COPD
Beclometasone and Formoterolo Mylan may also be used for the treatment of symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic airway disease of the lungs, primarily caused by cigarette smoking.

2. What you should know before using Beclometasone and Formoterolo Mylan

Do not take Beclometasone and Formoterolo Mylan

• If you are allergic or think you may be allergic to either of the active substances in Beclometasone and Formoterolo Mylan, or if you are allergic to other medicines or inhaled preparations used to treat asthma, or to any of the excipients in Beclometasone and Formoterolo Mylan (listed in section 6: Contents of the pack and other information), contact your doctor for advice.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Beclometasone and Formoterolo Mylan:

• If you have heart problems such as angina (chest pain or discomfort), if you have recently had a heart attack (myocardial infarction), if you have heart failure, if you suffer from narrowing of the heart arteries (coronary artery disease), heart valve disorders or other known heart abnormalities, or if you have a condition called obstructive hypertrophic cardiomyopathy (also known as HOCM, a disease characterized by abnormal heart muscle).
• If you suffer from narrowing of the arteries (also known as atherosclerosis), if you have high blood pressure, or if you know you have an aneurysm (an abnormal dilation of blood vessel walls).
• If you have heart rhythm disorders such as rapid or irregular heartbeat, increased pulse rate, 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 (inhaled high doses of formoterol may increase blood glucose levels, so additional tests to monitor blood sugar levels may be needed when starting this inhaler and occasionally during treatment).
• If you have a tumour of the adrenal gland (called phaeochromocytoma).
• If you are due to undergo anaesthesia. Depending on the type of anaesthesia, you may need to stop treatment with Beclometasone and Formoterolo Mylan at least 12 hours before the procedure.
• If you are taking or have recently taken medicines to treat tuberculosis (TB), or if you have viral or fungal lung infections.
• If you need to avoid alcohol for any reason.

If you are in any of the situations listed above, always inform your doctor before using Beclometasone and Formoterolo Mylan. If you have or have had any medical conditions or allergies, or if you are unsure whether you can use Beclometasone and Formoterolo Mylan, contact your doctor, an asthma nurse, or pharmacist before using the inhaler.
Treatment with β2-agonist medicines such as formoterol contained in Beclometasone and Formoterolo Mylan may cause a serious decrease in blood potassium levels (hypokalaemia).
Particular caution is required in patients with severe asthma. This is because low oxygen levels in the blood and some other treatments taken together with Beclometasone and Formoterolo Mylan, such as medicines for heart problems 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 have taken high doses of inhaled corticosteroids for long periods of time, you may require higher doses of corticosteroids during periods of stress. Stressful situations include hospitalization following an accident, severe injury, or before surgery. In such cases, your doctor may decide whether or not to increase your corticosteroid dose and may prescribe steroid tablets or injectable steroids.
If you are admitted to hospital, remember to bring all your medicines and inhalation products, including Beclometasone and Formoterolo Mylan, as well as 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 Formoterolo Mylan must not be used in children and adolescents under 18 years of age until further data become available.

Other medicines and Beclometasone and Formoterolo Mylan
Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Beclometasone and Formoterolo Mylan, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV treatments: ritonavir, cobicistat).
Do not take this medicine together with beta-blockers.
Beta-blockers such as atenolol, propranolol, and sotalol are used to treat various conditions including high blood pressure and heart conditions such as abnormal heart rhythms and heart failure; timolol is used to treat glaucoma. If you need to use beta-blockers, including beta-blocker eye drops, the effect of formoterol may be reduced or blocked. On the other hand, concomitant use of other beta-adrenergic medicines (medicines that work similarly to formoterol) may increase the effect of formoterol.

Taking Beclometasone and Formoterolo Mylan with:

• 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 (MAO-I) (e.g. phenelzine and isocarboxazide), tricyclic antidepressants (e.g. amitriptyline and imipramine), and phenothiazines may cause changes in the electrocardiogram (ECG). They may also increase the risk of heart rhythm disorders (ventricular arrhythmias).
• Medicines used to treat Parkinson’s disease (L-dopa), for treating hypothyroidism (L-thyroxine), medicines containing oxytocin (which causes uterine contractions), and alcohol may reduce cardiac tolerance to beta-2-agonists such as formoterol.
• Monoamine oxidase inhibitors (MAO-I), including drugs with similar properties such as furazolidone and procarbazine used to treat mental disorders, may cause an increase in blood pressure.
• Medicines used to treat heart conditions (digoxin) may cause a decrease in blood potassium levels. This may increase the likelihood of heart rhythm abnormalities.
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids) and diuretics may cause a decrease in blood potassium levels.
• Some anaesthetics may increase the risk of heart rhythm abnormalities.

Pregnancy, breastfeeding, and fertility
There are no clinical data on the use of Beclometasone and Formoterolo Mylan during pregnancy.
Beclometasone and Formoterolo Mylan must not be used if you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, unless your doctor has specifically instructed you to use the medicine.

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

Beclometasone and Formoterolo Mylan contains alcohol
Beclometasone and Formoterolo Mylan contains 7 mg of alcohol (ethanol) per dose (inhalation). The amount of alcohol in this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
This small amount of alcohol in the medicine will not have any noticeable effects.
For athletes: Using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use Beclometasone and Formoterol Mylan

Beclometasone and Formoterol Mylan is for inhalation use only. Beclometasone and Formoterol Mylan
must be inhaled through the mouth into the lungs.
Always use this medicine exactly as your doctor or pharmacist has told you. If you are unsure,
consult your doctor or pharmacist. The pharmacist's label will tell you how many inhalations to take and how often.
Dosage
Asthma
Your doctor will monitor you regularly to ensure you are taking the optimal
dose of Beclometasone and Formoterol Mylan. Your doctor will prescribe the lowest dose that provides optimal
control of your symptoms.
Beclometasone and Formoterol Mylan may be prescribed by your doctor in two different treatment approaches:
a. Daily use of Beclometasone and Formoterol Mylan for asthma treatment together with another inhaler to be used “as needed” 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 dosage is 4 inhalations.
Remember: You must always carry your fast-acting inhaler with you to use “as needed” to treat worsening asthma symptoms or a sudden asthma attack.
b. Daily use of Beclometasone and Formoterol Mylan for asthma treatment and additional use of Beclometasone and Formoterol Mylan 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 in the evening.
You should also use Beclometasone and Formoterol Mylan as a “rescue” inhaler for 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 “as needed” inhalations of Beclometasone and Formoterol Mylan per day.
The maximum daily dosage of Beclometasone and Formoterol Mylan as the only inhaled medicine for asthma is 8 inhalations.
If you feel you need more inhalations per day to control your asthma symptoms, consult your doctor. Your treatment may need to be changed.
Use in children and adolescents under 18 years of age:
Children and adolescents under 18 years of age must NOT use 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:
Dosage adjustment is not required in elderly patients. There is no available information on the use of Beclometasone and Formoterol Mylan in patients with impaired liver or kidney function.
Beclometasone and Formoterol Mylan is effective in the treatment of asthma with a dosage of beclometasone dipropionate that may be lower than that of other inhaled products containing beclometasone dipropionate. If you previously used a different inhaled medicine containing beclometasone dipropionate, your doctor will prescribe the exact dose of Beclometasone and Formoterol Mylan needed to treat your asthma.
Do not increase the dose
If you feel the medicine is not very effective, always consult your doctor before increasing the dosage.
If your breathing worsens:
If you experience worsening shortness of breath or wheezing (with a clearly audible whistling sound during breathing) immediately after inhaling the medicine, stop using Beclometasone and Formoterol Mylan immediately and use your fast-acting “rescue” inhaler right away. Contact your doctor immediately. Your doctor will assess your symptoms and, if necessary, decide on 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 need to use your “rescue” inhaler or Beclometasone and Formoterol Mylan as a rescue inhaler more frequently), or if your symptoms do not improve when using your “rescue” inhaler or Beclometasone and Formoterol Mylan does not improve your symptoms, contact your doctor immediately. Your asthma may be worsening and your doctor may increase your dose of Beclometasone and Formoterol Mylan or prescribe an alternative treatment.
If you have further questions about using this product, ask your doctor or pharmacist.
Method of administration:
This medicine is contained in a pressurized canister inserted into a plastic inhaler with a mouthpiece. On the front of the inhaler is a dose indicator, which shows how many doses remain. Each time you press the canister, a dose of medicine is released. The inhaler is equipped with an integrated dose indicator that accurately counts each dose and displays every 20 doses.
The dose indicator shows the approximate number of doses (inhalations) remaining in the canister.
The dose indicator window displays the number of inhalations remaining in the inhaler in units of twenty (e.g., 120, 100, 80, etc.). When 20 doses remain, the display shows the number 20 on a half-red, half-white background, indicating that the canister is nearly empty.
After 120 doses, the display will show the number 0 on a red background. 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 function to ensure it works properly.

1. Remove the protective cap from the mouthpiece.

2. Hold the inhaler upright with the mouthpiece pointing downwards.

3. Move the mouthpiece away from yourself.
   4.a. If using the inhaler for the first time, press firmly on the canister 3 times to release a dose each time the canister is pressed.
   4.b. If you have not used the inhaler for 14 days or more, press firmly on the canister once to release a dose.

4. Check the dose indicator. If using the inhaler for the first time, the number 120 should appear in the dose indicator window.

How to use the inhaler
Whenever possible, stand or sit upright during inhalation. Before starting inhalation, check the dose indicator:
any number between “1” and “120” indicates that doses remain. If the indicator shows “0”, no doses remain—dispose of the inhaler and get a new one.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust, dirt, or any foreign objects.
2. Breathe out as slowly and deeply as possible.
3. Hold the canister upright, with the body of the inhaler facing upwards, and place the mouthpiece between your lips, sealing your lips firmly around it. Do not bite the mouthpiece.
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 inhalation.
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.

If another inhalation is needed, keep the inhaler upright for about half a minute and 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 indicator.
When to replace the inhaler
Replace the inhaler when the dose indicator shows the number 20 and the color on the dose indicator changes from white to red.
Stop using the inhaler when the dose indicator shows the number 0, as the amount of medicine remaining in the device may not be sufficient to deliver a complete dose.
If you see a mist escaping from the inhaler or from the sides of your mouth after inhalation, this means Beclometasone and Formoterol Mylan did not reach your lungs as intended. Take another dose by repeating the steps from step 2.
If you have a weak grip, it may be easier to hold the inhaler with both hands: place your index fingers on the top of the inhaler and both thumbs on the base of the inhaler.
To reduce the risk of fungal infection in the mouth or throat, rinse your mouth or gargle with water or brush your teeth after each inhalation.
If you feel that the effect of Beclometasone and Formoterol Mylan is too strong or not strong enough, tell your doctor or pharmacist.
If you find it difficult to operate 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 instruction leaflet provided with the AeroChamber Plus spacer device and follow the instructions carefully regarding its use and cleaning.
Cleaning
The inhaler should be cleaned once a week. During cleaning, do not remove the canister from the inhaler and do not use water or other liquids to clean the inhaler.
To clean the inhaler:

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

If you use more Beclometasone and Formoterol Mylan than you should:

• An overdose of formoterol may cause the following effects: feeling unwell, nausea, rapid heartbeat, palpitations, heart rhythm disturbances, changes in the electrocardiogram (ECG), headache, tremors, drowsiness, excess acid in the blood, low potassium levels in the blood, high blood glucose levels. Your doctor may perform blood tests to monitor your potassium and blood glucose levels.
• An overdose of beclometasone dipropionate may cause temporary adrenal gland problems. These issues will resolve spontaneously within a few days, but your doctor may decide to monitor your blood cortisol levels.

Contact your doctor if you experience any of these symptoms.
If you forget to take Beclometasone and Formoterol Mylan:
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 double the dose.
If you stop treatment with Beclometasone and Formoterol Mylan:
Do not reduce the dose or stop taking the medicine.
Even if you feel better, do not stop taking Beclometasone and Formoterol Mylan or reduce the dose. If you intend to do so, discuss it with your doctor. It is very important that Beclometasone and Formoterol Mylan is used regularly, even when you have no symptoms.

4. Possible side effects

Like all medicines, Beclometasone and Formoterolo Mylan can cause side effects, although not everybody gets them.

Serious side effects

As with other inhaled treatments, there is a risk of worsening shortness of breath and wheezing immediately after using Beclometasone and Formoterolo Mylan. This condition is known as paradoxical bronchospasm. If this occurs, you must STOP using Beclometasone and Formoterolo Mylan IMMEDIATELY and use your "rescue" fast-acting inhaler to treat symptoms of shortness of breath and wheezing. Contact your doctor immediately.

Contact your doctor immediately if you experience any signs of hypersensitivity reactions such as skin allergy, itching, rash, skin redness, or swelling of the skin or mucous membranes, especially around the eyes, face, lips, and throat.

Other side effects

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 experience any of the following symptoms while taking Beclometasone and Formoterolo Mylan, as they may indicate a lung infection:
  • Fever or chills
  • Increased mucus production or change in mucus color
  • Worsening cough or increased breathing difficulties

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

• Increased heart rate
• Palpitations
• Cough and productive cough
• Irregular heart rhythm disorders (detected on electrocardiogram - ECG)
• Nausea
• Dry mouth
• Tremor
• Restlessness
• Dizziness
• Influenza-like symptoms
• Muscle pain and cramps
• Vaginal fungal infections
• Sinusitis
• Ear inflammation
• Throat irritation
• Altered taste
• Burning sensation of the lips
• Difficulty swallowing
• Indigestion
• Stomach discomfort
• Diarrhea
• Excessive sweating
• Facial redness
• Increased blood flow in certain body areas
• Urticaria (hives)
• Changes in white blood cell count
• Reduction in platelet count
• Increased platelet count
• Increased blood sugar levels
• Increased levels of insulin, free fatty acids, and ketones in the blood
• Reduction in blood potassium levels

The following side effects have been reported as "uncommon" in patients with Chronic Obstructive Pulmonary Disease (COPD):

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

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

• Chest tightness
• Sensation of breathlessness
• Persistent increase or decrease in blood pressure
• Inflammation of the kidney
• Swelling of the skin and mucous membranes
• Swelling of hands and feet lasting for several days.

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

• Worsening of asthma
• Shortness of breath
• Decrease in platelet count

Long-term use of high-dose inhaled corticosteroids may, in very rare cases, lead to systemic effects.

These may include:

• Adrenal gland function disorders (adrenal suppression)
• Delayed growth (growth retardation in children and adolescents)
• Decreased bone mineral density (osteoporosis - thinning of the bones)
• Increased intraocular pressure (glaucoma)
• Cataract

Not known (frequency cannot be estimated from the available data):

• Sleep disorders, depression, anxiety, restlessness, nervousness, hyperexcitability, or irritability: these effects occur mainly in children
• 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 Mylan

Keep this medicine out of the sight and reach of children.
Single pack containing a 120-dose container.
Do not use this medicine for more than 3 months after the date of purchase from the pharmacy, and never use it after the expiry date stated on the packaging and label following "Exp." The expiry date refers to the last day of that month.
Before use: store the inhaler in the refrigerator (2–8 °C) in an upright position for up to 18 months.
After first use: do not store the inhaler at temperatures above 25 °C for longer than 3 months.
Do not use this medicine after the expiry date printed on the box and label.
If the inhaler has been exposed to low temperatures, warm it with your hands for a few minutes before use.
Never warm the inhaler using artificial methods.
Warning: The container contains pressurised liquid. Do not expose it to temperatures above 50 °C.
Do not pierce the container.
Medicines must not be disposed of via wastewater or household waste. Return empty, partially used, or unused inhalers to the pharmacist for proper disposal. This will help protect the environment.

6. Package contents and other information

What Beclometasone and Formoterolo Mylan contains

• The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate. Each inhalation/dose
  delivered from the inhaler 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.

• This medicinal product contains fluorinated greenhouse gases. Each inhaler contains 8.12 g of norflurane (HFC-134a), equivalent to 0.012 tonnes of CO₂e (global warming potential GWP = 1,430).

• The excipients are: norflurane (HFC-134a), anhydrous ethanol, maleic acid and water for injections.

Description of the appearance of Beclometasone and Formoterolo Mylan and contents of the pack
Each pack contains one pressurized container with 120 doses (inhalations).
Beclometasone and Formoterolo Mylan is a pressurized solution contained in an aluminum container
treated with fluorocarbon polymerization (FCP), closed with a metering valve. The container is inserted
into a white plastic actuator with a pink dust-cap. The actuator is equipped with an integrated dose indicator,
which accurately counts each dose dispensed and displays the remaining doses every 20 actuations.

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

| Member State | Name of the medicinal product | |------------------|-----------------------------------| | Bulgaria | Aforbe | | Croatia | Aforbe 100/6 micrograma po potisku, stlačeni inhalat, otopina | | Denmark | Aforbe | | Estonia | Aforbe | | Finland | Aforbe | | France | Béclométasone / Formotérol Viatris 100/6 microgrammes/dose, solution pour inhalation en flacon pressurisé | | Germany | Aforbe 100 Mikrogramm /6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung | | Italy | Beclometasone e Formoterolo Mylan | | Latvia | Aforbe 100 mikrogrami /6 mikrogrami izsmidzinājumā aerosols inhalācijām, zem spiediena, šķīdums | | Lithuania | Aforbe 100 mikrogramų/6 mikrogramai spūsnyje suslėgtasis įkvepiamasis tirpalas | | Norway | Aforbe | | Sweden | Aforbe | | Netherlands | Beclometason/Formoterol Viatris 100/6 microgram/dosis, aërosol, oplossing |

Marketing Authorisation Holder and Manufacturer
Mylan Spa
Via Vittor Pisani 20
20124 Milano
Italy

Manufacturers
Mylan Germany GmbH,
Benzstrasse 1, Bad Homburg,
Germany
Eurofins BioPharma Product Testing Finland Oy
Volttikatu 5, Volttikatu 8,
Kuopio, 70700
Finland
McDermott Laboratories Limited
25 Baldoyle Industrial Estate
Grange Road, Dublin 13, D13N5X2
Ireland

Package leaflet: Information for the user

Beclometasone and Formoterol Mylan

200 micrograms/6 micrograms per dose
pressurised solution for inhalation
beclometasone dipropionate/formoterol fumarate dihydrate
Generic medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

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

Contents of this leaflet:

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

1. What Beclometasone and Formoterol Mylan is and what it is used for

Beclometasone and Formoterol Mylan is a pressurised solution for inhalation containing two active substances which are inhaled through the mouth and released directly into the lungs.
The two active substances are:

• beclometasone dipropionate, which 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, which 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 substances make breathing easier. They also help prevent asthma symptoms such as shortness of breath, wheezing and coughing.
Beclometasone and Formoterol Mylan is used in the treatment of asthma in adults.
If you have been prescribed Beclometasone and Formoterol Mylan, 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 inhaled corticosteroids and long-acting bronchodilators.

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

Do not use Beclometasone and Formoterolo Mylan
If you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate, or to any of the other
components of this medicine (listed in section 6).

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

• heart problems, such as angina (chest pain, heart pain), heart failure, narrowed arteries, heart valve disorders, or any other known heart condition
• high blood pressure or if you have an aneurysm (an abnormal widening of blood vessel walls)
• heart rhythm disorders such as rapid or irregular heartbeat, increased pulse rate, palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal
• overactive thyroid gland
• low levels of potassium in the blood
• any liver or kidney disorder
• diabetes (if you inhale high doses of formoterol, blood glucose levels may rise. When starting this medicine and periodically during treatment, additional blood tests may be needed to monitor blood sugar levels)
• a tumour of the adrenal gland (called phaeochromocytoma)
• if you are due to undergo anaesthesia. Depending on the type of anaesthetic, you may need to stop treatment with Beclometasone and Formoterolo Mylan at least 12 hours before anaesthesia
• if you have had or are currently being treated for tuberculosis (TB), or if you have viral or fungal chest infections
• if you need to avoid alcohol for any reason.

If any of the above conditions apply to you, always inform your doctor before using
Beclometasone and Formoterolo Mylan.
If you have or have previously had any medical condition or allergies, or if you are unsure whether you can use Beclometasone and Formoterolo Mylan, consult your doctor, asthma nurse specialist, or pharmacist before using the inhaler.
Your doctor may decide to periodically check your blood potassium levels, especially if your asthma is severe. Like many bronchodilators, Beclometasone and Formoterolo Mylan may cause a sudden drop in blood potassium levels (hypokalaemia). This may result from low oxygen levels in the blood, and may be worsened by other treatments taken together with Beclometasone and Formoterolo Mylan, which can further reduce 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 following an accident, a serious injury, or before surgery. In such cases, your doctor will decide whether your corticosteroid dose should be increased and may prescribe steroid tablets or injectable steroids.
If you are admitted to hospital, remember to bring all your medicines and inhalers with you, including Beclometasone and Formoterolo Mylan, 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 Formoterolo Mylan must not be used in children and adolescents under 18 years of age.

Other medicines and Beclometasone and Formoterolo Mylan
Inform your doctor, pharmacist or nurse if you are currently taking, or have recently taken, any other medicines, including those obtained without a prescription. This is important because Beclometasone and Formoterolo Mylan may affect the action of other medicines. In addition, some medicines may affect the action of Beclometasone and Formoterolo Mylan.
In particular, talk to your doctor, pharmacist or nurse if you are taking any of the following medicines:

• Some medicines may increase the effects of Beclometasone and Formoterolo Mylan, and your doctor may wish to monitor you closely if you are taking these (including certain HIV treatments: ritonavir, cobicistat)
• Beta-blockers. Beta-blockers are medicines used to treat various 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 blocked
• Beta-adrenergic medicines (drugs with effects similar to 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 (MAO-Is) (e.g. phenelzine and isocarboxazide), 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 (MAO-Is), including drugs 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 (tablets that increase urine production)

Also inform your doctor or pharmacist if you are due 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 Formoterolo Mylan during pregnancy.
Beclometasone and Formoterolo Mylan must not be used during pregnancy, if you suspect you might be pregnant or are planning a pregnancy, or while breastfeeding, unless your doctor has specifically instructed you to do so.

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

Beclometasone and Formoterolo Mylan contains alcohol
Beclometasone and Formoterolo Mylan contains 9 mg of alcohol (ethanol) per dose (inhalation). The amount of alcohol in each dose is equivalent to less than 1 ml of beer or 1 ml of wine.
This small amount of alcohol in the medicine will not have any noticeable 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 Mylan

Use this medicine exactly as instructed 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 Mylan. The treatment will be adjusted to the lowest dose that provides adequate control of symptoms.

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

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

At-risk patients
Dosage adjustment is not required in elderly patients. There is no information available on the use of Beclometasone and Formoterol Mylan 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 Mylan is effective in the treatment of asthma with a dosage of beclometasone dipropionate that may be lower than that of other inhaled products containing this active substance. If you have previously used a different inhaled medicine containing beclometasone dipropionate, your doctor will prescribe the exact dose of Beclometasone and Formoterol Mylan needed to treat your asthma.

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

If asthma worsens
If your symptoms worsen or become difficult to control (for example, if you are using your “as needed” inhaler more frequently), or if your “as needed” inhaler fails to relieve symptoms, contact your doctor immediately. Asthma may be worsening, and your doctor may consider adjusting the dose of Beclometasone and Formoterol Mylan or prescribing an alternative treatment.

Method of administration
Beclometasone and Formoterol Mylan is for inhalation use only.
This medicine is contained in a pressurized canister fitted into a plastic inhaler device with a mouthpiece. On the front of the inhaler is a dose indicator showing how many doses remain. Each time the canister is pressed, one dose of medicine is released and the dose indicator decreases by one number. The indicator also emits a click with each dose, providing an audible signal that the indicator is functioning correctly. Be careful not to drop the inhaler, as this may cause the dose counter to advance unintentionally.

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

• Remove the protective cap from the mouthpiece.
• Hold the inhaler upright with the mouthpiece pointing downwards.
• Point the mouthpiece away from you and:
  • If using the inhaler for the first time, press firmly on the canister three times to release three doses.
  • If you have used the inhaler before but not for 14 days or more, press firmly on the canister once to release one dose.
• Check the dose indicator (counter). If checking for the first time, the counter should display the number “120”.

How to use the inhaler
Whenever possible, stand or sit upright during inhalation.
Before starting, check the dose indicator:
any number between “1” and “120” means doses are still available.
The inhaler is equipped with an integrated dose indicator that accurately counts each dose and displays the approximate number of doses (inhalations) remaining in the canister. The dose indicator window shows the number of inhalations remaining in multiples of twenty (e.g., 120, 100, 80, etc.).

When 20 doses remain, the display shows the number 20 on a half-red, half-white background, indicating the canister is nearly empty. After 120 doses have been delivered, the display shows 0 on a red background. The indicator will stop moving and clicking once it reaches “0”.
If the indicator shows “0”, no doses remain – dispose of the inhaler and obtain a new one.

6. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust, debris, or any foreign objects.
7. Breathe out as slowly and deeply as possible.
8. Hold the canister upright with the inhaler body facing upwards, and place your lips around the mouthpiece. Do not bite the mouthpiece.
9. 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.
10. 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.

If a second dose is required, keep the inhaler upright for about half a minute and 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 indicator.
To reduce the risk of developing a fungal infection in the mouth or throat, rinse your mouth with water, gargle, or brush your teeth after each inhalation.

When to replace the inhaler
Replace the inhaler when the dose indicator shows the number 20 and the background color changes from white to half red and half white, as this indicates the canister is nearly empty.
Stop using the inhaler when the dose indicator shows 0 on a red background, as the remaining medicine may not be sufficient to deliver a full dose. Begin using a new inhaler.

If you see a mist escaping from the inhaler or from the sides of your mouth, this means Beclometasone and Formoterol Mylan did not reach your lungs as intended. Take another dose by repeating the instructions starting from step 2.

If you have weak hand strength, it may be easier to hold the inhaler with both hands: place your index fingers on top of the inhaler and both thumbs on the base.

If you think the effect of Beclometasone and Formoterol Mylan is too strong or not strong enough, consult 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
You must clean the inhaler 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:

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

If you use more Beclometasone and Formoterol Mylan than you should

• An overdose of formoterol 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 blood potassium levels, high blood glucose levels. Your doctor may wish to perform blood tests to monitor your blood potassium and glucose levels.
• An overdose of beclometasone dipropionate may cause temporary adrenal gland problems. These issues will resolve spontaneously within a few days, but your doctor may need to perform blood tests to monitor your blood cortisol levels.

Inform your doctor if you experience any of these symptoms.

If you forget to take Beclometasone and Formoterol Mylan
Take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose; instead, take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

If you stop using Beclometasone and Formoterol Mylan
Even if you feel better, do not stop taking Beclometasone and Formoterol Mylan or reduce the dose. If you intend to do so, discuss it with your doctor. It is very important that Beclometasone and Formoterol Mylan is used regularly, even in the absence of symptoms.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Beclometasone and Formoterolo Mylan can cause side effects, although not everyone experiences them.
As with other inhaled treatments, there is a risk of worsening breathlessness and wheezing immediately after using Beclometasone and Formoterolo Mylan. This condition is known as paradoxical bronchospasm. If this occurs, STOP using Beclometasone and Formoterolo Mylan immediately and use your fast-acting "rescue" inhaler right away to treat symptoms of breathlessness and wheezing. Contact your doctor immediately.
Contact your doctor immediately if you experience any hypersensitivity reactions, such as skin allergies, itching, rash, skin redness, or swelling of the skin or mucous membranes, especially 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 infection (of the mouth and throat)
• headache
• hoarseness
• sore throat

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

• palpitations, abnormally 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
• taste disturbances or altered taste
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhoea
• muscle pain and cramps
• redness of the face and throat
• increased blood flow to certain body tissues
• excessive sweating
• tremor
• restlessness
• dizziness
• urticaria (hives)
• changes in certain blood components:
  • reduction in the number of white blood cells or increase in the number of blood platelets
  • reduction in potassium levels in the blood
  • increase in blood sugar levels
  • increase in insulin, free fatty acids, and ketone levels in the blood

The following side effects have been reported as "uncommon" in patients with Chronic Obstructive Pulmonary Disease (COPD):

• pneumonia; inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum colour, fever, increased coughing, worsening breathing problems
• reduction in cortisol levels in the blood; this is caused by the effect of corticosteroids on the adrenal glands
• irregular heartbeat

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

• chest tightness
• absence of heartbeat (caused by premature ventricular contractions)
• reduction 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
• reduction in the number of platelets in the blood
• swelling of the hands and feet

Long-term, high-dose inhaled corticosteroid therapy may very rarely cause systemic effects.
These include:

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

Not known (frequency cannot be estimated from the available data):

• blurred vision

These events are more likely to occur in children, although their frequency is unknown:

• sleep disorders
• depression or anxiety
• nervousness
• feeling of hyperexcitability or irritability

Reporting of side effects
If you experience any side effects, 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 Mylan

Keep this medicine out of the sight and reach of children.
Single pack containing one container with 120 doses.
Do not use this medicine for more than 3 months after the date of purchase from the pharmacy and never use it after the expiry date stated on the packaging and label following "Exp.". The expiry date refers to the last day of that month.
Double pack containing two inhalers, each with 120 doses.
Store the inhalers in a refrigerator (2-8 °C) in an upright position until use.
Once the container is removed from the refrigerator and opened for treatment, it may be kept at room temperature (not above 25°C) during use. Use for up to three months, but never beyond the expiry date indicated on the packaging or label. The expiry date refers to the last day of that month.
If the inhaler has been exposed to intense cold, warm it with your hands for a few minutes before use. Never heat it by artificial means.
Warning: The container contains pressurised liquid. Do not expose it to temperatures above 50°C.
Do not pierce the container.
Do not dispose of any medicine via household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Beclometasone and Formoterolo Mylan contains

• The active substances are: beclometasone dipropionate and formoterol fumarate dihydrate. Each inhalation/dose delivered from the inhaler 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: anhydrous ethanol, water for injections, maleic acid and norflurane (HFC134a). See section 2, "Beclometasone and Formoterolo Mylan contains alcohol".
• This medicinal product contains fluorinated greenhouse gases. Each inhaler contains 10.3 g of norflurane (HFC134a), equivalent to 0.015 tonnes of CO₂ (global warming potential GWP = 1,430).

Description of the appearance of Beclometasone and Formoterolo Mylan and contents of the pack
Each pack contains:
One pressurized container with 120 doses (inhalations) or two pressurized containers with 120 doses (inhalations) each.
Not all pack sizes may be marketed.
Beclometasone and Formoterolo Mylan is a pressurized solution contained in an aluminium container lined with fluorocarbon polymer (FCP) and closed with a metering valve. The container is inserted into a white plastic actuator with a green dust cap. The actuator is equipped with an integrated dose indicator that accurately counts each dose dispensed and displays the remaining doses every 20 actuations.

Marketing Authorisation Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan
Italy

Manufacturers
Eurofins BioPharma Product Testing Finland Oy
Volttikatu 5, Volttikatu 8,
Kuopio, 70700
Finland
McDermott Laboratories Limited
25 Baldoyle Industrial Estate
Grange Road, Dublin 13, D13N5X2
Ireland

This medicinal product is authorised in the European Economic Area countries under the following names:

| Member State | Name of the medicinal product | |------------------|-----------------------------------| | Bulgaria | Aforbe | | Croatia | Aforbe 100/6 microgram per puff, pressurised inhalation, solution | | Denmark | Aforbe | | Estonia | Aforbe | | Finland | Aforbe | | France | Béclométasone / Formotérol Viatris 100/6 microgrammes/dose, solution pour inhalation en flacon pressurisé
Béclométasone / Formotérol Viatris 200/6 microgrammes/dose, solution pour inhalation en flacon pressurisé | | Germany | Aforbe 100 Mikrogramm /6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung
Aforbe 200 Mikrogramm /6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung | | Italy | Beclometasone e Formoterolo Mylan | | Latvia | Aforbe 100 mikrogrami /6 mikrogrami izsmidzinājumā aerosols inhalācijām, zem spiediena, šķīdums
Aforbe 200 mikrogrami /6 mikrogrami izsmidzinājumā aerosols inhalācijām, zem spiediena, šķīdums | | Lithuania | Aforbe 100 mikrogramų/6 mikrogramai spūsnyje suslėgtasis įkvepiamasis tirpalas
Aforbe 200 mikrogramų/6 mikrogramai spūsnyje suslėgtasis įkvepiamasis tirpalas | | Norway | Aforbe | | Sweden | Aforbe | | Netherlands | Beclometason/Formoterol Viatris 100/6 microgram/dosis, aërosol, oplossing
Beclometason/Formoterol Viatris 200/6 microgram/dosis, aërosol, oplossing |