Beclometasone and formoterol Zentiva

Patient Information Leaflet: Information for the User

Beclometasone and Formoterol Zentiva 100 micrograms/6 micrograms per dose

Pressurised solution for inhalation
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because 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, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor,
pharmacist or nurse.
Contents of this leaflet:

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

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

Beclometasone and Formoterolo Zentiva 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 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 breathlessness, wheezing and cough in patients with asthma or COPD, and also help prevent asthma symptoms.

Asthma
Beclometasone and Formoterolo Zentiva is indicated for the regular treatment of asthma in adults when:

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

COPD
Beclometasone and Formoterolo Zentiva 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 taking Beclometasone and Formoterolo Zentiva

Do not take Beclometasone and Formoterolo Zentiva

• 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 taking Beclometasone and Formoterolo Zentiva:

• If you have heart problems, such as angina (chest pain or discomfort), if you recently had a heart attack (myocardial infarction), heart failure, narrowing of the heart arteries (coronary heart disease), heart valve disease, or other known heart abnormalities, or if you have a condition known as obstructive hypertrophic cardiomyopathy (also known as HOCM, a disease characterized by abnormal heart muscle).
• If you have narrowing of the arteries (also called arteriosclerosis), 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, 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 potassium levels in your blood.
• If you have any liver or kidney disorders.
• 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 (known as phaeochromocytoma).
• If you are due to undergo anaesthesia. Depending on the type of anaesthesia, you may need to stop treatment with Beclometasone and Formoterolo Zentiva at least 12 hours before the procedure.
• If you are or have previously been treated for tuberculosis (TB), or if you have a known viral or fungal infection of 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 Formoterolo Zentiva.
If you have or have had any medical problems or allergies, or if you are unsure whether you can use
Beclometasone and Formoterolo Zentiva, consult your doctor, a nurse experienced in asthma management, or a pharmacist before using the inhaler.
Treatment with beta-2 agonists, such as formoterol contained in Beclometasone and Formoterolo Zentiva, may cause a significant decrease in blood potassium levels (hypokalaemia).
If you have severe asthma, you should exercise particular caution. This is due to lack of oxygen in the blood and to other treatments that may be taken together with Beclometasone and Formoterolo Zentiva, such as medicines for heart disease or high blood pressure known as diuretics, or other asthma medicines, which may worsen the reduction in potassium levels. For this reason, your doctor may wish to periodically monitor your blood potassium levels.
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 may include hospitalization following an accident, a severe injury, or prior to surgery. In such cases, your treating doctor may decide whether you need an increased dose of corticosteroids and may prescribe oral steroids or injectable steroids.
If you need to go to hospital, remember to bring all your medicines and inhalation products, including Beclometasone and Formoterolo Zentiva, as well as any over-the-counter medicines or tablets, in their original packaging if possible.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Beclometasone and Formoterolo Zentiva must not be used in children and adolescents under 18 years of age until further data become available.

Other medicines and Beclometasone and Formoterolo Zentiva
Inform your doctor if you are currently taking, or have recently taken, any other medicines, including those for asthma or COPD, or medicines obtained without a prescription.
Some medicines may increase the effects of Beclometasone and Formoterolo Zentiva, 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 formoterol may not work at all. On the other hand, the use of other beta-adrenergic medicines (medicines that work similarly to formoterol) may increase the effect of formoterol.

Taking Beclometasone and Formoterolo Zentiva 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 (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 the treatment of 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 (MAOIs), including medicines 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 and breastfeeding
There are no clinical data on the use of Beclometasone and Formoterolo Zentiva during pregnancy.
Beclometasone and Formoterolo Zentiva must not be used if you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, unless specifically advised by your doctor.

Driving and using machines
It is unlikely that Beclometasone and Formoterolo Zentiva 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 machines may be impaired.

Beclometasone and Formoterolo Zentiva contains alcohol
This medicine 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 noticeable effects.

For athletes:
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Beclometasone and Formoterol Zentiva

Beclometasone and Formoterol Zentiva is for inhalation use. Beclometasone and Formoterol Zentiva must be inhaled through the mouth into the lungs.
Always use this medicine exactly as your doctor or pharmacist has instructed you. If you are unsure, consult your doctor or pharmacist.

Asthma
Your doctor will monitor you regularly to ensure you are taking the optimal dose of Beclometasone and Formoterol Zentiva. Your doctor will adjust your treatment to the lowest dose that provides adequate control of your symptoms.

Your doctor may prescribe Beclometasone and Formoterol Zentiva in two different ways:

a) Daily use of Beclometasone and Formoterol Zentiva for asthma treatment, together with a separate "reliever" inhaler to treat sudden worsening of asthma symptoms such as shortness of breath, wheezing, and cough.

b) Daily use of Beclometasone and Formoterol Zentiva for asthma treatment, with additional use of Beclometasone and Formoterol Zentiva itself as needed to treat sudden worsening of asthma symptoms such as shortness of breath, wheezing, and cough.

a) Use of Beclometasone and Formoterol Zentiva together with another "reliever" inhaler:

Adults and elderly patients:
The recommended dose is one or two inhalations twice daily. The maximum daily dose is four inhalations.

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

b) Use of Beclometasone and Formoterol Zentiva as the only inhaler for asthma:

Adults and elderly patients:
The recommended dose is one inhalation in the morning and one inhalation in the evening.
You must also use this medicine as a "reliever" inhaler to treat sudden asthma symptoms.

If you experience asthma symptoms, take one inhalation and wait a few minutes.
If you do not feel better, take another inhalation.
Do not take more than 6 inhalations of Beclometasone and Formoterol Zentiva per day as needed.
The maximum daily dose of Beclometasone and Formoterol Zentiva 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. 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 patients:
The recommended dose is two inhalations in the morning and two inhalations in the evening.

Patients at risk:
Elderly patients do not need to adjust the dose. There is no available information on the use of Beclometasone and Formoterol Zentiva in patients with liver or kidney problems.

Beclometasone and Formoterol Zentiva is effective in the treatment of asthma at a dosage of beclometasone dipropionate that may be lower than that of other inhalers containing beclometasone dipropionate. If you previously used a different beclometasone dipropionate inhaler, your doctor will advise you on the exact dose of Beclometasone and Formoterol Zentiva to take for asthma.

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

Method of administration
Beclometasone and Formoterol Zentiva is for inhalation use.
This medicine is contained in a pressurized canister housed in a plastic device with a mouthpiece. On the back of the inhaler is a dose counter indicating how many doses remain. Each time you press the canister, one dose is released and the dose counter decreases by one. Be careful not to drop the inhaler, as this may cause the dose counter to decrease by one dose.

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

1. Remove the protective cap from the mouthpiece.
2. Hold the inhaler upright with the mouthpiece pointing down.
3. Point the mouthpiece away from yourself and firmly press the canister to release one puff.
4. Check the dose counter. If this is the first time you are using the inhaler, the dose counter should show 120 in the window.

How to use the inhaler
Whenever possible, stand or sit upright when taking your inhalation.
Before starting, check the dose counter: any number between "1" and "120" means doses remain. If the dose counter 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 vertically with the body of the inhaler upright, and place your lips around the mouthpiece. 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 dose. If you have a weak grip, it may be easier to hold the inhaler with both hands: place both index fingers on the top of the inhaler and both thumbs on the bottom.
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 dose 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.
Replace the inhaler when the dose counter shows 20. Stop using the inhaler when the dose counter shows 0, as the remaining medication in the device may not be sufficient to deliver a complete dose.

If you see a "mist" coming out of the inhaler or from the sides of your mouth, this means Beclometasone and Formoterol Zentiva is not reaching your lungs as it should. Take another dose by repeating the steps from step 2.

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 using the inhaler.

If you think the effect of Beclometasone and Formoterol Zentiva 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 leaflet provided with the AeroChamber Plus™ spacer device and to 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 any other liquid to clean the inhaler.

To clean the inhaler:

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

If you use more Beclometasone and Formoterol Zentiva than you should

• Taking more formoterol than you should 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 use of beclometasone dipropionate may cause temporary disturbances of the adrenal glands. These will resolve within a few days, but your doctor may need to perform blood tests to monitor serum cortisol levels.

Contact your doctor if you experience any of these symptoms.

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

If you stop using Beclometasone and Formoterol Zentiva
Do not reduce the dose or stop using this medicine. Even if you feel better, do not stop or reduce the dose of Beclometasone and Formoterol Zentiva without talking to your doctor. It is very important that you use this medicine regularly, even if you have no symptoms.

If your breathing gets worse
If you experience worsening shortness of breath or wheezing (breathing with an audible whistling sound) immediately after inhaling the medicine, stop using the Beclometasone and Formoterol Zentiva inhaler immediately and use your fast-acting "reliever" inhaler right away. Contact your doctor immediately. Your doctor will assess your symptoms and, if necessary, may start you on a different treatment regimen.

See also section 4. Possible side effects.

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

4. Possible side effects

Like all medicines, this medicine 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 Zentiva, a condition known as paradoxical bronchospasm. If this occurs, you must STOP using Beclometasone and Formoterolo Zentiva immediately and use your "rescue" fast-acting inhaler right away to treat symptoms of breathlessness and wheezing. You must contact your doctor immediately.
Inform your doctor immediately if you experience any signs of 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 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 Zentiva, as they may indicate a lung infection:

• fever or chills
• increased mucus production, changes in mucus color
• worsening cough or increased breathing difficulty

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

• unusually fast heartbeat and heart rhythm disturbances
• certain changes in the electrocardiogram (ECG)
• asthma attack
• tremor
• restlessness
• dizziness
• palpitations
• flu-like symptoms
• vaginal fungal infections
• sinusitis
• ear inflammation
• throat irritation
• cough and productive cough
• nausea
• taste disturbances or altered taste
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhea
• muscle pain and cramps
• facial redness
• excessive sweating
• increased blood flow in certain body areas
• rhinitis

Alterations in certain blood components:

• decreased number of white blood cells
• increased number of blood platelets
• decreased potassium levels in the blood
• increased blood sugar levels
• increased levels of insulin, free fatty acids, and ketones in the blood
• urticaria or skin rash

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

• Decreased 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 missed heartbeat
• increase or 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):

• worsening of asthma
• breathlessness
• decreased number of blood platelets
• swelling of hands and feet

Long-term use of high-dose inhaled corticosteroids may very rarely lead to systemic effects. These include:

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

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

• sleep disorders
• depression or anxiety
• restlessness
• nervousness
• hyperexcitability or irritability

These effects occur predominantly 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 or pharmacist. You may 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 Zentiva

• Keep this medicine out of the sight and reach of children.
• Before dispensing: store the inhaler in a refrigerator (2-8°C).
• After dispensing (after receiving this medicine from the pharmacist):
  o Do not use this medicine for more than 3 months after the date of purchase at the pharmacy, and never use it after the expiry date printed on the packaging and label following "Exp.". The expiry date refers to the last day of that month.
  o Do not store the inhaler at temperatures above 25°C.
  o Do not freeze.
  o If the inhaler has been exposed to low temperatures, warm it with your hands for a few minutes before use. Never warm it using artificial methods.
  o Warning: The container is under pressure and contains liquid. Do not expose the canister to temperatures above 50°C. Do not pierce the canister.
  o Do not dispose of any medicine via wastewater or 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 Zentiva contains

• The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate. Each actuation/delivered dose from the inhaler contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a dose delivered at the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
• The excipients are anhydrous ethanol, hydrochloric acid and norflurane.

Description of the appearance of Beclometasone and Formoterolo Zentiva and contents of the pack
Beclometasone and Formoterolo Zentiva is contained in a 19 mL aluminium pressurised canister closed with a metering valve and inserted into a polypropylene inhaler device with a dose counter incorporating a mouthpiece and fitted with a plastic protective cap.
Pack sizes:
1 pressurised container containing 120 actuations or
2 pressurised containers containing 120 actuations each
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano, Italy

Manufacturer
Cipla Europe NV
De Keyserlei 58-60 bus 19,
Antwerp, 2018 Belgium

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: BEFODAIR 100 Mikrogramm/6 Mikrogramm pro Sprühstoß, Druckgasinhalation, Lösung
France: BECLOMETASONE/FORMOTEROL ZENTIVA 100/6 microgrammes/dose, solution pour inhalation en flacon pressurisé
Italy: Beclometasone e Formoterolo Zentiva
Croatia: Befodair 100/6 mikrograma po potisku, stlačeni inhalat, otopina
Norway: Befodair

This leaflet was last revised on