Beclometasone and formoterol Teva

Package leaflet: Information for the patient

Beclometasone and Formoterol Teva 100 micrograms/6 micrograms per dose solution

for pressurized inhalation
beclometasone dipropionate/formoterol fumarate dihydrate
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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Beclometasone and Formoterol Teva 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 have an anti-inflammatory action that reduces 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 by providing relief from symptoms such as shortness of breath, wheezing and cough in patients with asthma or chronic obstructive pulmonary disease (COPD), and also help prevent asthma symptoms.

Asthma
Beclometasone and Formoterol Teva is indicated for regular treatment of asthma in adult patients in whom:

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

COPD
Beclometasone and Formoterol Teva may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a long-term lung airway disease mainly caused by cigarette smoking.

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

Do not use Beclometasone and Formoterolo Teva

• if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate, or to any of the other ingredients of this medicine (listed in section 6).

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

• if you have heart problems, such as angina (chest pain), if you have recently had a heart attack (myocardial infarction), if you have heart failure, narrowing of the arteries around the heart (coronary artery disease), valvular heart disease, or any other known heart abnormalities, or if you have a condition called obstructive hypertrophic cardiomyopathy (HOCM, a condition characterized by an abnormality of the 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 dilation of the wall of a blood vessel);
• if you have heart rhythm disorders such as increased or irregular heart rate, rapid pulse, or palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal;
• if you have overactivity of the thyroid gland;
• if you have low levels of potassium in your blood;
• if you have a liver or kidney disease;
• if you have diabetes (inhaled high doses of formoterol may increase blood glucose levels and may require additional blood tests to monitor blood sugar levels when starting this inhaler and periodically during treatment);
• if you have a tumour of the adrenal gland (called phaeochromocytoma);
• if you are to be given an anaesthetic. Depending on the type of anaesthetic, you may need to stop treatment with Beclometasone and Formoterolo Teva at least 12 hours before anaesthesia;
• if you are being treated 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 apply to you, always inform your doctor before using
Beclometasone and Formoterolo Teva.
If you have or have had any medical conditions or allergies, or if you are unsure whether you can use Beclometasone and Formoterolo Teva, consult your doctor, a nurse experienced in asthma management, or pharmacist before using this medicine.
Treatment with a beta2-agonist, such as formoterol contained in Beclometasone and Formoterolo Teva, may cause a significant decrease in serum potassium levels (hypokalaemia).
If you have severe asthma, you must take particular care. This is due to low oxygen levels in the blood and other treatments you may be taking together with Beclometasone and Formoterolo Teva, such as medicines for heart conditions or high blood pressure called diuretics, or other medicines used to treat asthma, which can worsen the reduction in potassium levels. For this reason, your doctor may wish to monitor your blood potassium levels periodically.
If you are taking high doses of inhaled corticosteroids for prolonged periods, you may require additional corticosteroids during periods of stress. Stressful situations may include hospitalization following an accident, a serious injury, or before surgery. In such cases, your treating doctor will decide whether corticosteroid dosage needs to be increased and may prescribe steroid tablets or injections.
If you need to go to hospital, remember to bring all your medicines and inhalers with you, including Beclometasone and Formoterolo Teva and any non-prescription 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 Teva must not be used in children and adolescents under 18 years of age until further data are available.

Other medicines and Beclometasone and Formoterolo Teva
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Some medicines may increase the effects of Beclometasone and Formoterolo Teva, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV medicines: ritonavir, cobicistat).
Do not use beta-blockers with this medicine. If you need to use beta-blockers (including eye drops), the effect of formoterol may be reduced or blocked. The use of other beta-adrenergic drugs (medicines that act like formoterol) may instead increase the effects of formoterol.
The use of Beclometasone and Formoterolo Teva together 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), phenothiazines may cause changes in the electrocardiogram (ECG). These may also increase the risk of heart rhythm disorders (ventricular arrhythmias);
• medicines used to treat Parkinson's disease (L-dopa), medicines used to treat underactive thyroid (L-thyroxine), medicines containing oxytocin (which causes uterine contractions), and alcohol may reduce cardiac tolerance to beta2-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 potassium levels;
• certain 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 Teva during pregnancy.
Beclometasone and Formoterolo Teva must not be used if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, unless advised by your doctor.

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

Beclometasone and Formoterolo Teva contains alcohol
Beclometasone and Formoterolo Teva contains 7 mg of alcohol (ethanol) per dose, equivalent to 0.20 mg/kg for a two-dose administration. The amount of this medicine in two doses is equivalent to less than 1 mL of wine or beer.
The small amount of alcohol present in this medicine will not have noticeable effects.
Caution for those engaged in sports: the product contains substances prohibited for doping. It is forbidden to use this medicine in a manner different from the therapeutic indications, dosage regimen, or route of administration stated.

3. How to use Beclometasone and Formoterol Teva

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Asthma

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

Beclometasone and Formoterol Teva may be prescribed by your doctor in two different ways:

a) daily use of Beclometasone and Formoterol Teva for asthma treatment, together with another "reliever" inhaler for managing sudden worsening of asthma symptoms, such as shortness of breath, wheezing, and coughing;

b) daily use of Beclometasone and Formoterol Teva for asthma treatment, plus additional use of Beclometasone and Formoterol Teva as needed for managing sudden worsening of asthma symptoms, such as shortness of breath, wheezing, and coughing.

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

Adults and elderly

The recommended dose is one or two inhalations twice daily.

The maximum daily dose is four inhalations.

Remember: you must always carry your fast-acting "reliever" inhaler to treat any sudden worsening of asthma symptoms or sudden asthma attacks.

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

Adults and elderly

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

You must also use Beclometasone and Formoterol Teva 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 as needed per day.

The maximum daily dose of Beclometasone and Formoterol Teva 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 take this medicine.

Chronic obstructive pulmonary disease (COPD)

Adults and elderly

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

Patients at risk

Dose adjustment is not required in elderly patients. There is no available information on the use of Beclometasone and Formoterol Teva in patients with liver or kidney problems.

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

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

• Taking too much formoterol may cause the following effects: nausea, vomiting, rapid heartbeat, palpitations, heart rhythm disturbances, certain changes in the electrocardiogram (ECG), headache, tremor, drowsiness, excess acid in the blood, low blood potassium levels, and high blood glucose levels. Your doctor may wish to perform blood tests to monitor your potassium and glucose levels.
• Taking too much beclometasone dipropionate may cause temporary problems with the adrenal glands. These will improve within a few days, but your doctor may need to check your serum cortisol levels.

Inform your doctor if you experience any of these symptoms.

If you forget to use Beclometasone and Formoterol Teva:

Take it 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. Do not take a double dose.

If you stop using Beclometasone and Formoterol Teva:

Do not reduce the dose or stop using the medicine.

Even if you feel better, do not stop using Beclometasone and Formoterol Teva or reduce the dose without first consulting your doctor. It is very important that you use Beclometasone and Formoterol Teva regularly, even when you have no symptoms.

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

If your breathing worsens:

If you develop worsening shortness of breath or wheezing (breathing with an audible whistling sound) immediately after inhaling the medicine, stop using the Beclometasone and Formoterol Teva inhaler immediately and use your fast-acting "reliever" inhaler right away. You must contact your doctor immediately. Your doctor will assess your symptoms and, if necessary, may start you 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 are using your "reliever" inhaler or Beclometasone and Formoterol Teva as a reliever more frequently), or if your "reliever" inhaler or Beclometasone and Formoterol Teva does not improve your symptoms, contact your doctor immediately. Your asthma may be getting worse, and your doctor may need to adjust your dose of Beclometasone and Formoterol Teva or prescribe an alternative treatment.

Method of administration

Beclometasone and Formoterol Teva is for inhalation use only.

This medicine is contained in a pressurized canister fitted into a plastic holder with a mouthpiece.

On the back of the inhaler there is a dose counter (or dose indicator) showing the number of doses (or inhalations) remaining. Each time the canister is pressed, one dose of medicine is released and the dose counter decreases by one (or the dose indicator rotates slightly; the number of remaining inhalations is displayed in intervals of 20). Be careful not to drop the inhaler, as this could accidentally activate the dose counter.

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 it 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 you and press firmly on the canister to release one dose.
4. Check the dose counter (or dose indicator). If this is the first time you are checking the inhaler, the dose counter (or indicator) should show 120 or 180.

How to use the inhaler

Whenever possible, stand or sit upright when inhaling.

Before starting to inhale, check the dose counter (or indicator): any number between "1" and "120" or "180" means doses remain. If the dose counter (or 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 facing upwards and place the mouthpiece between your lips.

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 you need to take another inhalation, 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 counter (or dose indicator).

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 every time you use the inhaler.

Get a new inhaler when the dose counter (or indicator) shows 20. Stop using the inhaler when the dose counter shows 0, as the amount of medicine remaining in the device may not be sufficient to deliver a full dose. Start using your new inhaler.

If you see a "mist" escaping from the top of the inhaler or from the sides of your mouth, this means Beclometasone and Formoterol Teva is not reaching your lungs properly. Take another inhalation, following the instructions again from step 2.

If you think the effect of Beclometasone and Formoterol Teva is too strong or too weak, inform your doctor or pharmacist.

If you have difficulty activating 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 that you read the leaflet provided with the AeroChamber Plus™ spacer device and carefully follow the instructions for its use and cleaning.

Cleaning

You must clean your inhaler once a week.

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

To clean the inhaler:

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
As with other inhaled treatments, there is a risk of worsening breathlessness and wheezing immediately after using Beclometasone and Formoterolo Teva. This condition is known as paradoxical bronchospasm. In this case, you must IMMEDIATELY STOP
using Beclometasone and Formoterolo Teva and use your rapid-acting “rescue” inhaler immediately to treat symptoms of breathlessness and wheezing. You must contact your doctor immediately.
Inform your doctor immediately if you experience hypersensitivity reactions such as skin allergies, skin itching, rash, skin redness, 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 mouth and throat), headache, hoarseness, sore throat
• pneumonia in patients with COPD: inform your doctor if you experience any of the following symptoms during treatment with Beclometasone and Formoterolo Teva, as they may indicate a lung infection: fever or chills or increased mucus production, change in mucus colour, or increased cough or breathing difficulties

Uncommon: may affect up to 1 in 100 people

• palpitations
• abnormally fast heartbeat and heart rhythm disorders, some changes in the electrocardiogram (ECG)
• influenza-like symptoms
• vaginal fungal infections
• sinus inflammation
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• nausea
• taste disturbances or impaired sense of taste
• lip burning, dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhoea
• muscle pain and muscle cramps
• facial flushing
• increased blood flow in certain body tissues
• excessive sweating
• tremor
• restlessness
• dizziness
• urticaria
• changes in certain blood components: o decrease in white blood cell count o increase in platelet count o decrease in blood potassium levels o increase in blood sugar levels o increase in blood insulin, free fatty acids, and ketones

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 gland
• irregular heartbeat

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

• sensation of chest tightness, skipped heartbeat (caused by premature ventricular contractions), increase or decrease in blood pressure, kidney inflammation, persistent swelling of the skin and mucous membranes lasting several days

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

• breathlessness, worsening of asthma, decreased platelet count, swelling of hands and feet

Not known: frequency cannot be estimated from available data

• blurred vision

Prolonged use of high-dose inhaled corticosteroids may very rarely cause systemic effects:

• These include adrenal function problems (adrenal suppression), reduced bone mineral density (thinning of the bones), growth retardation in children and adolescents, increased intraocular pressure (glaucoma), cataract.
• Sleep disorders, depression or anxiety, restlessness, nervousness, hyperexcitability, or irritability: these events are more likely to occur in children, but the frequency is unknown.

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 Teva

Keep this medicine out of the sight and reach of children.
For the pharmacist:
Store in a refrigerator (2-8 °C) for up to 18 months.
For patients:
Do not use this medicine for more than 3 months after the date the inhaler was dispensed by the pharmacist, and never use it after the expiry date stated on the carton and label after "Exp.".
The expiry date refers to the last day of that month.
Store the inhaler at a temperature below 25 °C.
If the inhaler has been exposed to intense cold, warm it with your hands for a few minutes before use. Never heat it with artificial means.
Warning: The canister contains a pressurised liquid. Do not expose the canister to temperatures above 50 °C. Do not pierce the canister.
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 Teva contains
The active substances are beclometasone dipropionate and formoterol fumarate dihydrate.
Each metered dose delivered from the inhaler contains 100 micrograms of beclometasone
dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to an inhaled
dose from the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of
formoterol fumarate dihydrate.
The other components are norflurane (HFA-134a), anhydrous ethanol, hydrochloric acid.

Description of the appearance of Beclometasone and Formoterolo Teva and contents of the pack
Beclometasone and Formoterolo Teva is a pressurized solution contained in a 19 mL aluminum
pressurized canister sealed with a metering valve, fitted into a white plastic inhaler device incorporating a dose counter (pack size: 120 actuations) or a dose indicator (pack size: 180 actuations), and supplied with a blue plastic protective cap.
This medicine contains fluorinated greenhouse gases.
For 120 actuations: each inhaler contains 8.07 g of 1,1,1,2-tetrafluoroethane, equivalent to 0.0115
tonnes of CO₂ equivalents (global warming potential [GWP] = 1,430).
For 180 actuations: each inhaler contains 11.40 g of 1,1,1,2-tetrafluoroethane, equivalent to 0.0163
tonnes of CO₂ equivalents (global warming potential [GWP] = 1,430).

Each package contains:
1 pressurized canister (120 actuations);
2 pressurized canisters (120 actuations each);
3 pressurized canisters (120 actuations each);
1 pressurized canister (180 actuations).
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano

Manufacturer
ELPEN Pharmaceutical Co. Inc.
Zapani, Block 1048, Keratea, 19001, Greece
ELPEN Pharmaceutical Co. Inc.
Marathonos Avenue 95, Pikermi Attiki, 19009, Greece

This medicine is authorized in the European Economic Area member states under the following names:
Sweden Forobec
Austria Beclometason/Formoterol ratiopharm 100 Mikrogramm/6
Mikrogramm/Sprühstoß Druckgasinhalation, Lösung
Beclometason/Formoterol ratiopharm 200 Mikrogramm/6
Mikrogramm/Sprühstoß Druckgasinhalation, Lösung
Czech Republic Forobex
Germany Beclometason/Formoterol-ratiopharm 100 Mikrogramm/6 Mikrogramm pro
Sprühstoß Druckgasinhalation, Lösung
Beclometason/Formoterol-ratiopharm 200 Mikrogramm/6 Mikrogramm pro
Sprühstoß Druckgasinhalation, Lösung
Denmark Forobec
Estonia Brelivio
Finland Beclometasone/Formoterol ratiopharm 100 mikrog /6 mikrog /annos
inhalaatiosumute, liuos
Beclometasone/Formoterol ratiopharm 200 mikrog /6 mikrog /annos
inhalaatiosumute, liuos
France BECLOMETASONE/FORMOTEROL TEVA 100/6 microgrammes/dose,
solution pour inhalation en flacon pressurisé
BECLOMETASONE/FORMOTEROL TEVA 200/6 microgrammes/dose,
solution pour inhalation en flacon pressurisé
Croatia Breduo 100 mikrograma po potisku, stlačeni inhalat, otopina
Breduo 200 mikrograma po potisku, stlačeni inhalat, otopina
Hungary Forobex 100 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat
Forobex 200 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat
Italy Beclometasone e Formoterolo Teva
Latvia Brelivio 100 mikrogrami/6 mikrogrami izsmidzinājumā aerosols inhalācijām,
zem spiediena, šķīdums
Brelivio 200 mikrogrami/6 mikrogrami izsmidzinājumā aerosols inhalācijām,
zem spiediena, šķīdums
Netherlands Beclometasondipropionaat/Formoterolfumaraatdihydraat Teva 100/6
microgram/dosis, aërosol, oplossing
Beclometasondipropionaat/Formoterolfumaraatdihydraat Teva 200/6
microgram/dosis, aërosol, oplossing
Norway Forobec
Portugal FOROBEX

Patient information leaflet

Beclometasone and Formoterol Teva 200 micrograms/6 micrograms per dose inhalation solution

pressurized inhalation
beclometasone dipropionate/formoterol fumarate dihydrate
Generic medicine
Please read this leaflet carefully before 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 others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Beclometasone and Formoterol Teva 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 that reduces 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 substances make breathing easier. They also help prevent asthma symptoms such as shortness of breath, wheezing and coughing.
Beclometasone and Formoterol Teva is used to treat asthma in adults.
If Beclometasone and Formoterol Teva has been prescribed for you, it is likely that:

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

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

Do not use Beclometasone and Formoterolo Teva

• if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate, or to any of the other ingredients of this medicine (listed in section 6).

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

• if you have heart problems, such as angina (chest pain), heart failure, narrowed arteries, valvular heart disease, or other known heart conditions;
• if you have high blood pressure or if you know you have an aneurysm (an abnormal widening of a blood vessel wall);
• if you have heart rhythm disorders such as increased or irregular heartbeat, rapid pulse, or palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal;
• if you have hyperactivity of the thyroid gland (hyperthyroidism);
• if you have low levels of potassium in your blood;
• if you have liver or kidney disease;
• if you have diabetes (inhaling high doses of formoterol may increase blood glucose levels. When starting this medicine and periodically during treatment, additional blood tests may be needed to monitor blood sugar levels);
• if you have a tumour of the adrenal gland (called phaeochromocytoma);
• if you are due to receive an anaesthetic. Depending on the type of anaesthetic, you may need to stop treatment with Beclometasone and Formoterolo Teva for at least 12 hours before anaesthesia;
• if you are being treated or have previously been treated for tuberculosis (TB), or if you have a known viral or fungal chest infection;
• if you need to avoid alcohol for any reason.

If any of the above apply to you, always inform your doctor before using
Beclometasone and Formoterolo Teva.
If you have or have had any medical conditions or allergies, or if you are unsure whether you can use Beclometasone and Formoterolo Teva, talk to your doctor, an asthma nurse, or pharmacist before using this medicine.
Your doctor may want to check your blood potassium levels periodically, especially if you have severe asthma. Like many bronchodilators, Beclometasone and Formoterolo Teva can cause a significant decrease in serum potassium levels (hypokalaemia). Low oxygen levels in the blood, combined with other treatments you may be taking alongside Beclometasone and Formoterolo Teva, can worsen this drop in potassium levels.
If you are using high doses of inhaled corticosteroids for long periods, you may require additional corticosteroids during times of stress. Stressful situations may include hospital admission following an accident, a serious injury, or before surgery. In such cases, your treating doctor will decide whether you need an increased dose of corticosteroids and may prescribe steroid tablets or injections.
If you need to go to hospital, remember to bring all your medicines and inhalers with you, including Beclometasone and Formoterolo Teva 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 Teva must not be used in children and adolescents under 18 years of age.

Other medicines and Beclometasone and Formoterolo Teva
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. Beclometasone and Formoterolo Teva may affect how some other medicines work. Likewise, some medicines may affect how Beclometasone and Formoterolo Teva works.
In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• certain medicines may increase the effects of Beclometasone and Formoterolo Teva, and your doctor may wish to monitor you closely if you are taking these (including some HIV medicines: ritonavir, cobicistat);
• beta-blockers. Beta-blockers are medicines used to treat various conditions, including heart problems, high blood pressure, and glaucoma (increased intraocular pressure). If you need to use beta-blockers (including eye drops), the effect of formoterol may be reduced or blocked;
• beta-adrenergic medicines (drugs that act 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 isocarboxazide), tricyclic antidepressants (e.g. amitriptiline and imipramine), phenothiazines;
• medicines used to treat Parkinson’s disease (L-dopa);
• medicines used to treat underactive thyroid (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 a dental procedure.

Pregnancy, breastfeeding, and fertility
There are no clinical data on the use of Beclometasone and Formoterolo Teva during pregnancy.
Beclometasone and Formoterolo Teva must not be used if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, unless advised by your doctor.

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

Beclometasone and Formoterolo Teva contains alcohol
Beclometasone and Formoterolo Teva contains 9 mg of alcohol (ethanol) per actuation, equivalent to 0.25 mg/kg per two actuations. The amount of this medicine in two actuations is equivalent to less than 1 mL of wine or beer.
The small amount of alcohol in this medicine will not have any noticeable effects.

3. How to use Beclometasone and Formoterol Teva

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will regularly monitor you to ensure you are taking the optimal dose of
Beclometasone and Formoterol Teva. Your doctor will adjust your treatment to the lowest dose that
provides the best control of your symptoms.
Dosage:
Adults and elderly
The recommended dose is two actuations twice daily.
The maximum daily dose is 4 actuations.
Remember: you should always carry your rapid-acting inhaler with you to treat any possible
worsening of asthma symptoms or sudden asthma attacks.
Patients at risk:
Dose adjustments are not required in elderly patients. There is no available information
on the use of Beclometasone and Formoterol Teva in patients with hepatic or renal impairment.
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 Teva is effective for the treatment of asthma with a dose of
beclometasone dipropionate that may be lower than that of some other inhalers containing
beclometasone dipropionate. If you previously used a different inhaler containing
beclometasone dipropionate, your doctor will advise you on the exact dose of Beclometasone and
Formoterol Teva to take for your asthma.
Do not increase the dose
If you feel the medicine is not very effective, always consult your doctor before increasing the
dose.
If your asthma worsens:
If your symptoms worsen or become difficult to control (e.g. if you use your "reliever" inhaler more
frequently), or if your "reliever" inhaler or Beclometasone and Formoterol Teva does not improve your
symptoms, contact your doctor immediately. Your asthma may be worsening, and your doctor may need to adjust the dose of Beclometasone and Formoterol Teva or prescribe an alternative
treatment.
Method of administration:
Beclometasone and Formoterol Teva is for inhalation use only.
This medicine is contained in a pressurized canister inserted into a plastic holder equipped with a mouthpiece.
On the back of the inhaler there is a dose counter (or dose indicator) showing the number of doses (or inhalations) remaining. Each time you press the canister, one dose of medicine is released and the dose counter decreases by one number (or the dose indicator rotates slightly; the number of remaining inhalations is displayed in intervals of 20). Be careful not to drop the inhaler, as this may accidentally activate the dose counter (or dose indicator).
Checking the inhaler is working
Before using the inhaler for the first time, or if you have not used it for 14 days or more, you must
check that it is working properly.

1. Remove the protective cap from the mouthpiece.
2. Hold the inhaler upright with the mouthpiece pointing downwards.
3. Turn away from the mouthpiece and press firmly on the canister to release one dose.
4. Check the dose counter (or dose indicator). If checking for the first time, the dose counter (or dose indicator) should display the number 120 or 180.

How to use the inhaler
Whenever possible, stand or sit upright when inhaling.
Before starting to inhale, check the dose counter (or dose indicator): any number between "1"
and "120" or "180" indicates that doses remain. If the dose counter (or dose indicator) 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 of dust, dirt, or any foreign objects.
2. Breathe out as slowly and deeply as possible.
3. Hold the canister vertically, with the body facing upwards, and place the mouthpiece between your lips. 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 actuation. 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 you need to perform another inhalation, hold 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 counter (or dose indicator).
To reduce the risk of developing a fungal infection in the mouth and throat, rinse your mouth, gargle with water, or brush your teeth each time you use the inhaler.
You should obtain a new inhaler when the dose counter (or dose indicator) shows the number 20. Stop using the inhaler when the dose counter shows 0, as the amount of medicine remaining in the device may not be sufficient to deliver a complete dose, and start using the new inhaler.
If you notice a "mist" escaping from the top of the inhaler or from the sides of your mouth, this means Beclometasone and Formoterol Teva is not reaching your lungs properly. Perform another inhalation, following the instructions again starting from step 2.
If you think the effect of Beclometasone and Formoterol Teva is too strong or too weak, inform your doctor or pharmacist.
If you have difficulty operating 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 that you read the instruction leaflet provided with the AeroChamber Plus™ spacer device and carefully follow the instructions for its use and cleaning.
Cleaning
You must clean your 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:

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

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

• Taking more formoterol than you should may cause the following effects: nausea, vomiting, rapid heartbeat, palpitations, heart rhythm disturbances, certain changes in the electrocardiogram (ECG), headache, tremor, drowsiness, excess acid in the blood, low levels of potassium in the blood, high levels of glucose in the blood. Your doctor may wish to perform blood tests to monitor your potassium and glucose levels.
• Taking too much beclometasone dipropionate may cause temporary problems with the adrenal glands. These will improve within a few days, but your doctor may need to check your serum cortisol levels.

Inform your doctor if you experience any of these symptoms.
If you forget to use Beclometasone and Formoterol Teva:
Take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose, but take the next dose at the correct time. Do not take a double dose to make up for the forgotten dose.
If you stop using Beclometasone and Formoterol Teva
Even if you feel better, do not stop using Beclometasone and Formoterol Teva or reduce your
dose. If you intend to do so, consult your doctor. It is very important that you use Beclometasone
and Formoterol Teva regularly, even
in the absence of symptoms.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other inhaled treatments, there is a risk of worsening breathlessness and wheezing immediately after using Beclometasone and Formoterolo Teva. This condition is known as paradoxical bronchospasm. If this occurs, you must IMMEDIATELY STOP using Beclometasone and Formoterolo Teva and use your "reliever" inhaler immediately to treat symptoms of breathlessness and wheezing. You must contact your doctor immediately.
Inform your doctor immediately if you experience hypersensitivity reactions such as skin allergies, skin itching, rash, skin redness, 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 mouth and throat)
• headache
• hoarseness
• sore throat

Uncommon: may affect up to 1 in 100 people

• palpitations, unusually fast heartbeat, and heart rhythm disturbances
• some changes in the electrocardiogram (ECG)
• increased blood pressure
• influenza-like symptoms
• sinus inflammation
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• vaginal fungal infections
• nausea
• taste disturbances or impaired sense of taste
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhoea
• muscle pain and muscle cramps
• facial and throat flushing
• increased blood flow in certain body tissues
• excessive sweating
• tremor
• restlessness
• dizziness
• urticaria
• changes in certain blood components: either decreased number of white blood cells or increased number of platelets or decreased blood potassium levels or increased blood sugar levels or increased insulin, free fatty acids, and ketones 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 cough, worsening of breathing problems
• reduced blood cortisol levels; this is caused by the effect of corticosteroids on the adrenal gland
• irregular heartbeat

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

• chest tightness
• skipped heartbeat (caused by premature ventricular contractions)
• reduced blood pressure
• kidney inflammation
• persistent swelling of the skin and mucous membranes lasting several days

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

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

Prolonged use of inhaled corticosteroids at high doses may, very rarely, lead to systemic effects. These include:

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

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

• sleep disorders
• depression or anxiety
• nervousness
• hyperexcitability or irritability: these events are more likely to occur in children, but frequency is unknown
• blurred vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website
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 Teva

Keep this medicine out of the sight and reach of children.
Single packs of 120 or 180 doses
For the pharmacist:
Must be stored upright in the refrigerator (2-8 °C) for up to 18 months.
For patients:
Do not use this medicine for more than 3 months after the date the inhaler was dispensed by the pharmacist, and never use it after the expiry date stated on the carton and label after "Exp.".
The expiry date refers to the last day of that month.
Store the inhaler at a temperature below 25 °C.

Multiple packs of 120 doses
For the pharmacist:
Must be stored upright in the refrigerator (2-8 °C) for up to 18 months.
For patients:
All containers must be stored upright in the refrigerator (2-8 °C) until ready for use.
Once a container has been removed from the refrigerator and opened for treatment, it must not be stored at temperatures above 25 °C.
Do not use this medicine for more than 3 months and never use it after the expiry date stated on the carton and label after "Exp.".
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 using artificial means.

Warning: The canister contains a pressurised liquid. Do not expose the canister to temperatures above 50 °C. Do not pierce the canister.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Beclometasone and Formoterolo Teva contains
The active substances are beclometasone dipropionate and formoterol fumarate dihydrate.
Each actuation/predosed dose from the inhaler contains 200 micrograms of beclometasone
dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to an inhaled
dose from the mouthpiece of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of
formoterol fumarate dihydrate.
The other components are norflurane (HFA-134a), anhydrous ethanol, hydrochloric acid.

Description of the appearance of Beclometasone and Formoterolo Teva and contents of the pack
Beclometasone and Formoterolo Teva is a pressurized solution contained in a 19 mL aluminum
pressurized container sealed with a metering valve and inserted into a white plastic inhaler device
equipped with either a dose counter (pack of 120 actuations) or a dose indicator (pack of 180 actuations), and provided with a dark blue plastic protective cap.
This medicinal product contains fluorinated greenhouse gases.
For 120 actuations: each inhaler contains 10.23 g of 1,1,1,2-tetrafluoroethane, equivalent to 0.0148
tonnes of CO₂ equivalents (global warming potential [GWP] = 1,430).
For 180 actuations: each inhaler contains 13.99 g of 1,1,1,2-tetrafluoroethane, equivalent to 0.0204
tonnes of CO₂ equivalents (global warming potential [GWP] = 1,430).

Each pack contains:
1 pressurized container (120 actuations);
2 pressurized containers (120 actuations each);
3 pressurized containers (120 actuations each);
1 pressurized container (180 actuations).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano

Manufacturer
ELPEN Pharmaceutical Co. Inc.
Zapani, Block 1048, Keratea, 19001, Greece
ELPEN Pharmaceutical Co. Inc.
Marathonos Avenue 95, Pikermi Attiki, 19009, Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Sweden Forobec
Austria Beclometason/Formoterol ratiopharm 100 Mikrogramm/6
Mikrogramm/Sprühstoß Druckgasinhalation, Lösung
Beclometason/Formoterol ratiopharm 200 Mikrogramm/6
Mikrogramm/Sprühstoß Druckgasinhalation, Lösung
Czech Republic Forobex
Germany Beclometason/Formoterol-ratiopharm 100 Mikrogramm/6 Mikrogramm pro
Sprühstoß Druckgasinhalation, Lösung
Beclometason/Formoterol-ratiopharm 200 Mikrogramm/6 Mikrogramm pro
Sprühstoß Druckgasinhalation, Lösung
Denmark Forobec
Estonia Brelivio
Finland Beclometasone/Formoterol ratiopharm 100 mikrog /6 mikrog /annos
inhalaatiosumute, liuos
Beclometasone/Formoterol ratiopharm 200 mikrog /6 mikrog /annos
inhalaatiosumute, liuos
France BECLOMETASONE/FORMOTEROL TEVA 100/6 microgrammes/dose,
solution pour inhalation en flacon pressurisé
BECLOMETASONE/FORMOTEROL TEVA 200/6 microgrammes/dose,
solution pour inhalation en flacon pressurisé
Croatia Breduo 100 mikrograma po potisku, stlačeni inhalat, otopina
Breduo 200 mikrograma po potisku, stlačeni inhalat, otopina
Hungary Forobex 100 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat
Forobex 200 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat
Italy Beclometasone e Formoterolo Teva
Latvia Brelivio 100 mikrogrami/6 mikrogrami izsmidzinājumā aerosols inhalācijām,
zem spiediena, šķīdums
Brelivio 200 mikrogrami/6 mikrogrami izsmidzinājumā aerosols inhalācijām,
zem spiediena, šķīdums
Netherlands Beclometasondipropionaat/Formoterolfumaraatdihydraat Teva 100/6
microgram/dosis, aërosol, oplossing
Beclometasondipropionaat/Formoterolfumaraatdihydraat Teva 200/6
microgram/dosis, aërosol, oplossing
Norway Forobec
Portugal FOROBEX