BECLOMETASONE 100 MICROGRAMS/6 MICROGRAMS Pressurized solution for inhalation

Зміст інструкції

1. Beclometasone and Formoterol Zentiva 100 micrograms /6 micrograms per actuation
   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 use Beclometasone and Formoterol Zentiva
   4. Possible side effects
   5. How to store Beclometasone and Formoterolo Zentiva
   6. Package contents and other information

Beclometasone and Formoterol Zentiva 100 micrograms /6 micrograms per actuation

pressurized solution for inhalation
Generic medicine

Read this leaflet carefully before you start to take 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 others, even if
their symptoms are the same as yours, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse.

Contents of this leaflet:

• 1. What is Beclometasone and Formoterol Zentiva and what it is used for
• 2. What you need to know before you take 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 Formoterol Zentiva is and what it is used for

Beclometasone and Formoterol Zentiva is a pressurized inhalation solution containing two
active ingredients that are inhaled through the mouth and are released directly into the lungs.
The two active ingredients are beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called
corticosteroids, which have an anti-inflammatory action by reducing swelling and irritation
in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called
long-acting bronchodilators, which relax the muscles of the airways and
help you breathe more easily.
These two active ingredients, together, make breathing easier, providing relief from symptoms such as
shortness of breath, wheezing and cough in patients with asthma or COPD and also help to
prevent asthma symptoms.
Asthma
Beclometasone and Formoterol Zentiva is indicated for the regular treatment of asthma in adult
patients in whom:
asthma is not adequately controlled using inhaled corticosteroids and
short-acting bronchodilators “as needed”
or
asthma responds well to treatment with both inhaled corticosteroids and
long-acting bronchodilators.
COPD
Beclometasone and Formoterol Zentiva can also be used for the treatment of symptoms of
severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic
disease of the airways in the lungs that is mainly caused by cigarette smoking.

2. What you need to know before taking Beclometasone and Formoterol Zentiva

Do not take Beclometasone and Formoterol 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 precautionsTalk to your doctor, pharmacist or nurse before taking Beclometasone and Formoterol Zentiva :
• If you have heart problems, such as angina (chest pain or discomfort), if you have recently had a heart attack (myocardial infarction), heart failure, narrowing of the arteries of the heart (coronary artery disease), heart valve disease or other known heart abnormalities, or if you suffer from a condition known as obstructive hypertrophic cardiomyopathy (also known as HOCM, a disease characterized by abnormal heart muscle).
• If you suffer from narrowing of the arteries (also called arteriosclerosis), if you have high blood pressure or if you know you have an aneurysm (an abnormal dilation of the blood vessel walls).
• If you suffer from heart rhythm disorders such as a fast or irregular heartbeat, a rapid pulse or palpitations, or if you have been told that your heart tracing is abnormal.
• If you have an overactive thyroid gland.
• If you have a low level of potassium in your blood.
• If you suffer from any liver or kidney disorder.
• If you suffer from diabetes (inhaling high doses of formoterol can cause an increase in blood glucose levels and, as a result, additional tests may be needed to monitor blood sugar levels when you start using this inhaler and from time to time during the course of treatment).
• If you suffer from a tumor of the adrenal gland (known as pheochromocytoma).
• If you are to undergo anesthesia. Depending on the type of anesthesia, it may be necessary to stop treatment with Beclometasone and Formoterol Zentiva at least 12 hours before anesthesia.
• If you are or have ever been treated for tuberculosis (TB), or if you have a known viral or fungal infection in your chest.
• If you need to avoid drinking alcohol for any reason.

If any of the above applies to you, always tell your doctor before
using Beclometasone and Formoterol Zentiva.
If you have or have had any medical problems or allergies, or if you are not sure if you can use
Beclometasone and Formoterol Zentiva, contact your doctor, or a nurse who specializes in asthma
or a pharmacist before using the inhaler.
Therapy with beta-2-agonists, such as formoterol contained in Beclometasone and
Formoterol Zentiva, can cause a serious decrease in plasma potassium levels
(hypokalemia).

If you suffer from severe asthma, you should take particular care. This is due to a lack of
oxygen in the blood and some of the other treatments that may be taken together with
Beclometasone and Formoterol Zentiva, such as medicines for the treatment of heart disease or
high blood pressure, known as diuretics, or other medicines used in the treatment
of asthma, which can worsen the reduction of potassium levels. For this reason, your doctor
may want to periodically monitor potassium levels in your blood.

If you have taken high doses of inhaled corticosteroids for long periods of time, you may
need higher doses of corticosteroids in stressful situations. Stressful situations
may include hospitalization following an accident, having sustained a serious injury, or before surgery. In such cases, the doctor who is treating you may decide if you need to increase the dose of corticosteroids and may prescribe steroids in tablets or steroids for
injection.
If you have to go to hospital, remember to bring all your medicines and inhalable products with you, including Beclometasone and Formoterol Zentiva and 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 Formoterol Zentiva should not be used in children and adolescents under the age of
18 years, until further data are available.

Other medicines and Beclometasone and Formoterol Zentiva
Tell your doctor if you are taking, have recently taken other medicines, including medicines for
asthma or COPD, or over-the-counter medicines.
Some medicines can increase the effects of Beclometasone and Formoterol Zentiva and your doctor
may want to monitor you closely if you are taking these medicines (including some
medicines for the treatment of HIV: ritonavir, cobicistat).

Do not take this medicine together with beta-blockers
Beta-blockers such as atenolol, propranolol and sotalol are used to treat a number of 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-blockers in 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 have the
same effect as formoterol) can increase the effect of formoterol.

Taking Beclometasone and Formoterol Zentiva with:

• medicines for the treatment of heart rhythm abnormalities (quinidine, disopyramide, procainamide), medicines used in the treatment of 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), phenothiazines can cause some changes in the electrocardiogram (ECG, heart tracing). They can also increase the risk of heart rhythm disorders (ventricular arrhythmias).
• medicines for the treatment of Parkinson's disease (L-dopa), for the treatment of hypothyroidism (L-thyroxine), medicines containing oxytocin (which causes uterine contractions) and alcohol can decrease cardiac tolerance to beta2-agonists, such as formoterol.
• monoamine oxidase inhibitors (MAOIs), including medicines with similar characteristics such as furazolidone and procarbazine, used in the treatment of mental disorders, can cause an increase in blood pressure.
• medicines for the treatment of heart disorders (digoxin) can cause a decrease in the level of potassium in the blood. This can increase the possibility of heart rhythm abnormalities.
• other medicines used in the treatment of asthma (theophylline, aminophylline or steroids) and diuretics can cause a decrease in the level of potassium in the blood.
• Some anesthetics can cause an increased risk of heart rhythm abnormalities.

Pregnancy and breastfeeding
There are no clinical data regarding the use of Beclometasone and Formoterol Zentiva in pregnancy.
Beclometasone and Formoterol Zentiva should not be used if you are pregnant, think you may be
pregnant or are planning a pregnancy, or if you are breastfeeding, unless advised by your doctor.

Driving and operating machinery
It is unlikely that Beclometasone and Formoterol 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 vehicles or use machinery may be impaired.

Beclometasone and Formoterol Zentiva contains alcohol
This medicine contains 7 mg of alcohol (ethanol) in each actuation (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:

The use of the drug without therapeutic need constitutes doping and may still
result in a positive 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.
Use this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

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

Beclometasone and Formoterol Zentiva can be prescribed by your doctor with two treatment methods:
a) Daily use of Beclometasone and Formoterol Zentiva for the treatment of asthma, together
with a separate reliever inhaler to treat sudden worsening of asthma symptoms,
such as shortness of breath, wheezing and coughing.
b) Daily use of Beclometasone and Formoterol Zentiva for the treatment of asthma and
further use of Beclometasone and Formoterol Zentiva to treat a sudden worsening of
asthma symptoms, such as shortness of breath, wheezing and coughing.

a)Use of Beclometasone and Formoterol Zentiva together with another “as needed” inhaler:
Adults and the elderly:
The recommended dose is one or two inhalations twice a day. The maximum daily
dose is 4 inhalations.

Remember:You should always carry your fast-acting reliever inhaler with you to treat
a worsening of asthma symptoms or a sudden asthma attack.

b)Use of Beclometasone and Formoterol Zentiva as the only inhaler for asthma:
Adults and the elderly:
The recommended dose is one inhalation in the morning and one inhalation in the evening.
You should also use this medicine as a “as needed” 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 “as needed” per day.
The maximum daily dose of Beclometasone and Formoterol Zentiva as the only inhaler
for asthma is 8 inhalations.
If you feel you need more inhalations per day to control your asthma symptoms, ask your doctor for advice. You may need to change your therapy.

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

Chronic Obstructive Pulmonary Disease (COPD)
Adults and the elderly:
The recommended dose is two inhalations in the morning and two inhalations in the evening.

Patients at risk:
Elderly patients do not need to modify the dose. No information is available 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 with a beclometasone dipropionate dosage
that may be lower than that of other inhalers
containing beclometasone dipropionate. If you were previously using a different beclometasone dipropionate-based inhaler, your doctor will advise you on the exact dose of
Beclometasone and Formoterol Zentiva to take for asthma.
Do not increase the dose:
If you feel that the medicine is not very effective, always ask your doctor before
increasing the dosage.

How to administer
Beclometasone and Formoterol Zentiva is for inhalation use.
This medicine is contained in a pressurized canister inserted into a plastic casing
with a mouthpiece. On the back of the inhaler there is a dose counter, which indicates
how many doses are remaining. Each time you press the canister, a dose of
medicine is released and the dose counter decreases by one number. Be careful not to drop the inhaler,
as this may cause the dose counter to decrease by one dose.

Checking the operation of the inhaler
Before using the inhaler for the first time or if you have not used the inhaler 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 in a vertical position with the mouthpiece facing down
• 3. Point the mouthpiece away from yourself and firmly press the canister to release a spray
• 4. Check the dose counter. If you are using the inhaler for the first time, the counter window should show the number 120.

How to use the inhaler
When possible, remain standing or sit upright while taking the inhalation.
Before starting the inhalation, check the dose counter: any number between “1” and “120” indicates that
doses remain. If the dose counter indicates “0”, there are no doses remaining: 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 and dirt or any other foreign object.
• 2. Exhale as slowly and deeply as possible.
• 3. Hold the canister vertically, with the body of the device upwards, and place your lips around the. Do not bite the mouthpiece.
• 4. Inhale slowly and deeply through your mouth and immediately after starting to inhale, press firmly on the top of the inhaler to release a dose. If you have a weak grip, it may be easier to hold the inhaler with both hands: hold the top of the inhaler with both index fingers and the bottom with both thumbs.
• 5. Hold your breath for as long as possible and at the end remove the inhaler from your mouth and exhale slowly. Do not exhale into the inhaler.

If another actuation is necessary, keep the inhaler in a vertical position
for about half a minute and repeat steps 2 to 5.

Important: Do not perform steps 2 to 5 too quickly.
After use, close with the protective cap and check the dose indicator.
Replace the inhaler when the dose counter indicates the number 20. Stop using the inhaler
when the dose counter shows the number 0, as the amount of actuations remaining in the device
may not be sufficient to deliver a full dose.

If you see a “mist” escaping from the inhaler or from the sides of your mouth, this means that
Beclometasone and Formoterol Zentiva will not reach your lungs as it should. Perform
another actuation following the instructions by repeating the operations from point 2.
To reduce the risk of a fungal infection in your mouth or throat, after you use the inhaler rinse
your mouth or gargle with water or brush your teeth.
If you think that 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 can use the AeroChamber Plus™ spacer device. Ask your doctor, pharmacist or
nurse for information about this device.
Plus™ and carefully follow the instructions regarding the use and cleaning of the AeroChamber Plus™ spacer.

Cleaning
The inhaler should be cleaned once a week.
During cleaning, do not remove the canister from the device 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 out of the inhaler.
• 2. Clean the inside and outside of the mouthpiece and the device with a clean, dry cloth or handkerchief.
• 3. Reposition the mouthpiece protective cap.

If you take more Beclometasone and Formoterol Zentiva than you should

• Taking more formoterol than you should may have the following effects: feeling unwell, malaise, rapid heartbeat, palpitations, irregular heartbeat, some changes in the electrocardiogram (heart tracing), headache, tremor, drowsiness, excess acid in the blood, low potassium levels in the blood, high glucose levels in the blood. Your doctor may want to perform some blood tests to check your potassium and glucose levels.
• Excessive intake of beclometasone dipropionate may cause temporary disorders of the adrenal glands. These will improve within a few days, however, your doctor may need to perform some blood tests to check your 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 missed dose. Take the dose as soon as you remember. If it is almost time for the next dose, do not take the missed dose, but simply take the next dose at the correct time.

If you stop using Beclometasone and Formoterol Zentiva
Do not decrease the dose or stop using the medicine. Even if you feel better, do not
stop using Beclometasone and Formoterol Zentiva or reduce the dose. If you want to do so, talk
to your doctor. It is very important that you use this medicine regularly even if you may not
have symptoms.

If your breathing gets worse
If you experience worsening shortness of breath or wheezing (breathing with an audible whistle
sound), immediately after inhaling the medicine, stop using the Beclometasone and Formoterol Zentiva inhaler
immediately and use your fast-acting reliever inhaler immediately.
Contact your doctor immediately. Your doctor will assess your symptoms and, if necessary, may
start a different course of treatment.
See also section 4. Possible side effects.
If you have any further questions about using this medicine, ask your doctor or pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
As with other treatments via inhalation, there is a risk of worsening of breathlessness and
wheezing immediately after using Beclometasone and Formoterolo Zentiva, and
this condition is known as paradoxical bronchospasm. If this occurs, you must
IMMEDIATELY stop using Beclometasone and Formoterolo Zentiva and immediately use your “as needed” fast-acting inhaler to treat the symptoms of breathlessness and wheezing. You should contact your doctor immediately.
Immediately inform your doctor if you experience any hypersensitivity reaction such as skin allergies,
itching, rash, redness of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat.
Other possible side effects are listed below according to their frequency.

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

• Fungal infections (of the mouth and throat)
• headache
• hoarseness
• sore throat.

Pneumonia in patients with COPD: Inform your doctor if you have any of the following symptoms while
taking Beclometasone and Formoterolo Zentiva, they may be symptoms of a lung
infection:

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

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

• unusually fast heartbeat and irregular heartbeat
• some 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 abnormalities or alterations
• burning of the lips
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhea
• muscle pain and cramps
• facial flushing
• excessive sweating
• increased blood flow to certain areas of the body
• rhinitis

Alteration of some blood components:

• reduction in the number of white blood cells
• increase in the number of blood platelets
• reduction in potassium levels in the blood
• increase in blood sugar level
• increase in insulin, free fatty acids and ketone levels in the blood
• urticaria or skin rash

The following side effects have been reported as “uncommon” in patients with
Chronic Obstructive Bronchopneumonia:

• Reduction in blood cortisol level; 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
• Feeling of a missed heartbeat
• increase or decrease in blood pressure
• kidney inflammation
• 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
• decrease in the number of blood platelets
• swelling of hands and feet.

The use of high doses of inhaled corticosteroids for long periods of time can
rarely cause systemic effects.These include:

• disorders of adrenal gland function (adrenal suppression)
• increased eye pressure (glaucoma)
• cataract.
• delayed growth (slowing of growth in children and adolescents)
• reduction in bone mineral density (thinning of the bones)

Not known(frequency cannot be estimated on the basis of available data):

• sleep disturbances
• depression or anxiety
• restlessness
• nervousness
• hyperactivity or irritability

These effects occur predominantly in children.

• Blurred vision.

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

5. How to store Beclometasone and Formoterolo 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 from the pharmacy and do not use it after the expiry date printed on the packaging and label after Exp. The expiry date refers to the last day of that month. o Do not store the inhaler at a temperature 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. Do not heat it with artificial methods. o Warning: The container contains liquid under pressure. Do not expose the canister to temperatures above 50°C. Do not puncture the canister. o Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Beclometasone and Formoterol Zentiva contains

• The active ingredients are: beclometasone dipropionate, formoterol fumarate dihydrate. Each actuation/dose delivered by the inhaler contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose from 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 Formoterol Zentiva and package contents
Beclometasone and Formoterol Zentiva is contained in a pressurized aluminum canister of 19
mL closed with a metering valve and inserted into a polypropylene actuator with a dose counter that incorporates a mouthpiece and is equipped with a plastic protective cap.
Pack sizes:
1 pressurized container with 120 actuations or
2 pressurized containers with 120 actuations each
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Marketing authorization holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano

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

This medicinal product is authorized in the Member States of the European Economic Area with the
following denominations:
Austria: BEFODAIR 100 Micrograms/6 Micrograms per actuation, pressurized inhalation, solution
France: BECLOMETASONE/FORMOTEROL ZENTIVA 100/6 micrograms/dose, solution for
inhalation
in pressurized container
Italy: Beclometasone e Formoterolo Zentiva
Croatia: Befodair 100/6 micrograms per puff, pressurized inhaler, solution
Norway: Befodair