Beclometasone and formoterol Zentiva Italia

Package leaflet: Information for the user

Beclometasone and Formoterol Zentiva Italia

200 micrograms/6 micrograms per dose pressurised solution for inhalation
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 if used by someone else, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Contents of this leaflet:

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

1. What Beclometasone and Formoterol Zentiva Italia is and what it is used for

Beclometasone and Formoterol Zentiva Italia is a pressurized 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.
Beclometasone and Formoterol Zentiva Italia is indicated for the treatment of asthma in adult patients.
If Beclometasone and Formoterol Zentiva Italia has been prescribed for you, it is likely that:
your asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators “as needed”, or
your asthma does not respond well to treatment with both inhaled corticosteroids and long-acting bronchodilators.

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

Do not take Beclometasone and Formoterolo Zentiva Italia

• 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 Italia if:

• you have heart problems, such as angina (chest pain or discomfort), a heart attack, narrowed heart arteries, heart valve disease, or other known heart abnormalities.
• you have high blood pressure or if you know you have an aneurysm (an abnormal bulging of blood vessel walls).
• you have heart rhythm disorders such as rapid or irregular heartbeat, increased pulse rate, palpitations, or if you have been told that your heart tracing is abnormal.
• you have an overactive thyroid gland.
• you have low levels of potassium in your blood.
• you have any liver or kidney problems.
• you have diabetes (inhaling high doses of formoterol may increase blood glucose levels, so additional tests may be needed to monitor blood sugar levels when you start using this inhaler and occasionally during treatment).
• you have a tumour of the adrenal gland (known as phaeochromocytoma).
• you are due to undergo anaesthesia. Depending on the type of anaesthesia, you may need to stop treatment with Beclometasone and Formoterolo Zentiva Italia at least 12 hours before the anaesthesia.
• if you are or have ever been treated for tuberculosis (TB), or if you have a known viral or fungal infection in the chest.
• you must avoid alcohol for any reason.

If any of the above conditions apply to you, always inform your doctor before using
Beclometasone and Formoterolo Zentiva Italia.
If you have or have had any medical conditions or allergies, or if you are unsure whether you can use
Beclometasone and Formoterolo Zentiva Italia, consult your doctor, a nurse experienced in asthma, or a pharmacist before using the inhaler.
Your doctor may want to check your blood potassium levels from time to time, especially if your asthma
is severe. Like many bronchodilators, Beclometasone and Formoterolo Zentiva Italia can cause a
sudden drop in serum potassium levels (hypokalaemia). This is because lack of oxygen in the blood, combined with other treatments you may be taking alongside this medicine, can worsen the drop in potassium levels.
If you have used high doses of inhaled corticosteroids for long periods of time, you may need higher doses of corticosteroids during periods of stress. Stressful situations may include hospitalisation following an accident, suffering a severe injury, or before surgery. In such cases, your treating doctor may decide whether you need an increased dose of corticosteroids and may prescribe steroid tablets or injectable steroids.
If you need to go to hospital, remember to bring all your medicines and inhalation products, including Beclometasone and Formoterolo Zentiva Italia, 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 Formoterolo Zentiva Italia must not be used in children and adolescents under 18 years of age until further data are available.

Other medicines and Beclometasone and Formoterolo Zentiva Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is because this medicine may affect how other medicines work. In addition, some medicines may affect how Beclometasone and Formoterolo Zentiva Italia works.
In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• Some medicines can increase the effects of this medicine, 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 formoterol may not work at all.
• Beta-adrenergic medicines (medicines that work similarly 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 (e.g. phenelzine and isocarbazide), tricyclic antidepressants (e.g. amitriptyline and imipramine), phenothiazines.
• Medicines used to treat Parkinson’s disease (L-dopa).
• Medicines used to treat hypothyroidism (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines used to treat mental disorders such as monoamine oxidase inhibitors (MAOIs), including medicines with similar properties such as furazolidone and procarbazine.
• Medicines used to treat heart conditions (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids).
• Diuretics.

Also inform your doctor if you are due to undergo general anaesthesia for surgery or dental procedures.

Pregnancy, breastfeeding, and fertility
There are no clinical data on the use of Beclometasone and Formoterolo Zentiva Italia during pregnancy.
Beclometasone and Formoterolo Zentiva Italia 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 Italia will affect your ability to drive or use machines. 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 Italia contains alcohol
This medicine contains 9 mg of alcohol (ethanol) per dose. The amount in one dose of this medicine is equivalent to less than 1 mL of wine or beer. The small amount of alcohol in this medicine will not have noticeable effects.

For athletes
Using this medicine without a therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to use Beclometasone and Formoterol Zentiva Italia

Beclometasone and Formoterol Zentiva Italia is for inhalation use. Beclometasone and Formoterol Zentiva Italia must be inhaled through the mouth into the lungs.
Use this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Your doctor will monitor you regularly to ensure you are taking the optimal
dose of Beclometasone and Formoterol Zentiva Italia. Your doctor will adjust your treatment to the lowest dose that provides optimal control of your symptoms.
Dosage:
Adults and elderly:
The recommended dose is 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 sudden asthma attacks.
Patients at risk:
No dose adjustment is required if you are elderly. There is no information available on the use of this medicine 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 Zentiva Italia is effective in the treatment of asthma with a dosage of beclometasone dipropionate that may be lower than that of other inhalers containing beclometasone dipropionate. If you previously used a different beclometasone dipropionate inhaler, your doctor will advise you on the exact dose of Beclometasone and Formoterol Zentiva Italia to take for your asthma.
Do not increase the dose
If you feel the medicine is not working well enough, always consult your doctor before increasing the dosage.
If asthma worsens:
If your symptoms worsen or are difficult to control (for example, if you are using your “as needed” inhaler more frequently), or if your “as needed” inhaler does not improve your symptoms, contact your doctor immediately. Asthma may be worsening, and your doctor may decide to change the dose of Beclometasone and Formoterol Zentiva Italia or prescribe an alternative treatment.
Method of administration
Beclometasone and Formoterol Zentiva Italia is for inhalation use.
This medicine is contained in a pressurized canister housed in a plastic casing fitted with a mouthpiece. On the back of the inhaler there is a dose counter indicating how many doses remain. Each time you press down on the canister, a dose of medicine 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
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 properly.

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

How to use the inhaler
Whenever possible, remain standing or sit upright while inhaling.
Before starting to inhale, check the dose counter: any number between “1” and “120” indicates that doses remain. If the dose counter shows “0”, no doses remain: dispose of the inhaler and obtain a new one.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from 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 for 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 required, keep the inhaler in an upright position 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 displays the number 20. Stop using the inhaler when the dose counter shows 0, as the number of doses 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, this means that Beclometasone and Formoterol Zentiva Italia is not reaching your lungs as it should. Perform another inhalation by repeating the steps from point 2.
To reduce the risk of developing a fungal infection in the mouth or throat, rinse your mouth or gargle with water or brush your teeth after using the inhaler.
If you think the effect of Beclometasone and Formoterol Zentiva Italia 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 to carefully follow the instructions for 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 off the inhaler.
2. Wipe the inside and outside of the mouthpiece and inhaler with a clean, dry cloth or tissue. Replace the protective cap on the mouthpiece.

If you use more Beclometasone and Formoterol Zentiva Italia than you should

• Taking more formoterol than you should may cause the following effects: feeling unwell, tachycardia, 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 lead to temporary disturbances of the adrenal glands. These will improve 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 Italia
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, but simply take the next dose at the correct time.
If you stop using Beclometasone and Formoterol Zentiva Italia
Do not reduce the dose or stop using the medicine. Even if you feel better, do not stop using Beclometasone and Formoterol Zentiva Italia or reduce the dose without first talking to your doctor. It is very important that you use this medicine regularly, even if you do not have symptoms.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other inhaled treatments, there is a risk of worsening shortness of breath and wheezing immediately after using Beclometasone and Formoterolo Zentiva Italia, and this condition is known as paradoxical bronchospasm. If this occurs, you must STOP using Beclometasone and Formoterolo Zentiva Italia IMMEDIATELY and use your "rescue" fast-acting inhaler right away to treat symptoms of shortness of breath and wheezing. You must contact your doctor immediately.
Inform your doctor immediately if you experience any signs of hypersensitivity 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 possible side effects are listed below according to their frequency.
Common (may affect up to 1 in 10 people):

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

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

• palpitations
• unusually fast heartbeat and irregular heart rhythm
• some changes in the electrocardiogram (ECG)
• increased blood pressure
• flu-like symptoms
• sinusitis
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• fungal infection of the vagina
• nausea
• taste disturbances or altered taste
• burning of the lips
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhoea
• muscle pain and cramps
• facial and throat redness
• increased blood flow in certain areas of the body
• tremor
• restlessness
• dizziness
• urticaria or skin rash
• Changes in certain blood components:
  • reduction in the number of white blood cells
  • increase in the number of blood platelets
  • increased blood sugar levels
  • increased levels of insulin, free fatty acids, and ketones in the blood

The following side effects have been reported with "uncommon" frequency in patients with chronic obstructive pulmonary disease (COPD):

• pneumonia; inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum colour, fever, increased cough, worsening breathing problems
• reduced levels of cortisol in the blood: caused by the effect of corticosteroids on the adrenal gland
• 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
• laboured breathing
• decreased number of blood platelets
• swelling of hands and feet

Long-term, high-dose inhaled corticosteroid therapy may very rarely cause 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 (thinning of the bones)

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

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

These effects occur mainly in children.

• Blurred vision

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. 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 Zentiva Italia

• Keep this medicine out of the sight and reach of children.
• Before dispensing: store the inhaler in the refrigerator (2-8°C).
• After dispensing (after receiving this medicine from the pharmacist):
  • 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 printed on the packaging and label following "Exp." The expiry date refers to the last day of that month.
  • Do not store the inhaler at temperatures above 25°C.
  • Do not freeze.
  • 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.
    Caution: 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 wastewater 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 Formoterolo Zentiva Italia contains

• The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate. Each actuation/dose delivered by the metering valve contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a dose delivered from the mouthpiece of 169.2 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
• The excipients are anhydrous ethanol, hydrochloric acid and a CFC-free propellant – norflurane.

Description of the appearance of Beclometasone and Formoterolo Zentiva Italia and contents of the
package
Beclometasone and Formoterolo Zentiva Italia is contained in a 19 mL aluminium pressurised canister
closed with a metering valve and inserted into a polypropylene actuator incorporating a dose counter
and a mouthpiece, and equipped 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
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 200 Mikrogramm/6 Mikrogramm pro Sprühstoß, Druckgasinhalation, Lösung
France: BECLOMETASONE/FORMOTEROL ZENTIVA 200/6 microgrammes/dose, solution pour
inhalation en flacon pressurisé
Italy: Beclometasone e Formoterolo Zentiva Italia
Croatia: Befodair 200/6 mikrograma po potisku, stlačeni inhalat, otopina
Norway: Befodair

This leaflet was last revised on