Beclometasone and formoterol Teva Italia

Patient Information Leaflet: Information for the User

Beclometasone and Formoterol Teva Italia 100 micrograms/6 micrograms per dose,

pressurised inhalation solution
beclometasone dipropionate/formoterol fumarate dihydrate
Generic medicine
Please read this leaflet carefully before using 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Beclometasone and Formoterolo Teva Italia is and what it is used for

Beclometasone and Formoterolo Teva Italia is a pressurized inhalation solution 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 have an anti-inflammatory effect 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 cough in patients with asthma or COPD, and also help prevent asthma symptoms.

Asthma
Beclometasone and Formoterolo Teva Italia is indicated for regular treatment of asthma in adults when:

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

COPD
Beclometasone and Formoterolo Teva Italia may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease of the airways in the lungs, mainly caused by cigarette smoking.
Beclometasone and Formoterolo Teva Italia is for use in adults.

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

Do not use Beclometasone and Formoterolo Teva 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 Consult your doctor or pharmacist before using Beclometasone and Formoterolo Teva Italia:
• If you have heart problems, such as angina (chest pain), if you have recently had a myocardial infarction, heart failure, narrowing of the arteries around the heart (coronary heart disease), valvular heart disease or any other known heart abnormality, or if you suffer from a condition known as obstructive hypertrophic cardiomyopathy (also known as HOCM, a condition in which the heart muscle is abnormal).
• If you suffer from narrowing of the arteries (also known as arteriosclerosis), if you have high blood pressure or if you know you have an aneurysm (an abnormal dilation of the blood vessel wall).
• If you have heart rhythm disorders such as rapid or irregular heartbeat, rapid pulse or palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal.
• If you have an overactive thyroid gland.
• If you have low levels of potassium in the blood.
• If you have any liver or kidney disorders.
• If you have diabetes (if you inhale high doses of formoterol, your blood sugar may rise, so you may need additional blood tests to monitor your blood glucose levels when you start using this inhaler and occasionally during treatment).
• If you have a tumour of the adrenal gland (known as phaeochromocytoma).
• If you are undergoing anaesthesia. Depending on the type of anaesthesia, you may need to stop taking Beclometasone and Formoterolo Teva Italia at least 12 hours before the anaesthesia.
• If you are currently being treated, or have ever been treated, for tuberculosis (TB), or if you have a known viral or fungal infection of the chest.
• If you need to avoid alcohol for any reason.

If any of the above conditions apply to you, always inform your doctor before
using Beclometasone and Formoterolo Teva Italia.
If you have or have had any medical conditions or allergies, or if you are unsure whether you can use
Beclometasone and Formoterolo Teva Italia, consult your doctor or pharmacist before using this
medicine.
Treatment with a beta-agonist such as formoterol contained in Beclometasone and Formoterolo
Teva Italia may cause a sudden drop in serum potassium levels (hypokalaemia).
If you have severe asthma, you must take particular care. This is due to a lack of
oxygen in the blood and to other treatments you may be taking together with Beclometasone and
Formoterolo Teva Italia, such as medicines for heart disease or
hypertension known as 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 higher doses of inhaled corticosteroids for long periods,
you may require additional corticosteroids during periods of stress. Stressful situations may include hospitalisation after an accident, a serious injury or surgery. In such cases, your treating doctor will decide whether you may 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 inhalers with you, including
Beclometasone and Formoterolo Teva Italia and any over-the-counter medicines or tablets you are taking, preferably in their original packaging.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
Beclometasone and Formoterolo Teva 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 Teva Italia

• Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription. This is because Beclometasone and Formoterolo Teva Italia can affect how some other medicines work. In addition, some medicines can affect how Beclometasone and Formoterolo Teva 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 Beclometasone and Formoterolo Teva Italia, and your doctor may wish to monitor you closely if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat many conditions, including heart problems, hypertension 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 in the same way as 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 for treating symptoms of depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarbidazine), tricyclic antidepressants (e.g. amitriptyline and imipramine), phenothiazines.
• Medicines for treating Parkinson's disease (L-dopa).
• Medicines for treating hypothyroidism (L-thyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines for treating mental disorders such as monoamine oxidase inhibitors (MAOIs), including medicines with similar properties such as furazolidone and procarbazine.
• Medicines for treating heart disease (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline or steroids).
• Diuretics. Also inform your doctor if you are about 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 Italia during pregnancy.
Do not take Beclometasone and Formoterolo Teva Italia if you are pregnant, think 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 Italia will affect your ability to drive
or use machinery.
Beclometasone and Formoterolo Teva Italia contains alcohol
This medicine contains 7 mg of alcohol (ethanol) per dose, equivalent to 0.20 mg/kg for a two-dose administration. The amount in two doses of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
For athletes
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Beclometasone and Formoterol Teva Italia

Always use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Asthma
Your doctor will regularly monitor you to ensure you are taking the optimal dose of
Beclometasone and Formoterol Teva Italia. Your doctor will adjust your treatment to the lowest dose that
best controls your symptoms.
Your doctor may prescribe Beclometasone and Formoterol Teva Italia in two different ways:
a) Daily use of Beclometasone and Formoterol Teva Italia for the treatment of asthma,
together with a “rescue” inhaler to treat sudden worsening of asthma symptoms such as
shortness of breath, wheezing and coughing
Adults and elderly:
The recommended dose of this medicine is one or two inhalations twice daily. The maximum
daily dose is 4 inhalations.
Remember: You must always carry your “rescue” fast-acting inhaler with you to treat worsening
asthma symptoms or sudden asthma attacks.
b) Daily use of Beclometasone and Formoterol Teva Italia for asthma treatment and
additional use of Beclometasone and Formoterol Teva Italia to treat sudden worsening
of asthma symptoms such as shortness of breath, wheezing and coughing
Adults and elderly:
The recommended dose is one inhalation in the morning and one inhalation in the evening.
You should also use Beclometasone and Formoterol Teva Italia as a “rescue” 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 “rescue” inhalations per day.
The maximum daily dose of Beclometasone and Formoterol Teva Italia when used as the
only asthma inhaler is 8 inhalations.
If you feel you need more than this number of inhalations per day to control your asthma symptoms, consult your doctor. Your therapy 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 information available on the use of
Beclometasone and Formoterol Teva Italia in patients with hepatic or renal impairment.
Beclometasone and Formoterol Teva Italia 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 previously used a different inhaler
containing beclometasone dipropionate, your doctor will advise you on the exact dose of
Beclometasone and Formoterol Teva Italia to take for asthma treatment.
Do not increase the dose
If you feel the medicine is not very effective, always consult your doctor before increasing the
dosage.
If your breathing worsens

• If you experience sudden worsening of shortness of breath or wheezing (a clearly audible whistling sound when breathing) immediately after inhaling the medicine, stop using Beclometasone and Formoterol Teva Italia immediately and use your fast-acting “rescue” inhaler immediately. You must contact your doctor immediately. Your doctor will assess your symptoms and, if necessary, may start a different type of 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 another
“rescue” inhaler or Beclometasone and Formoterol Teva Italia as a rescue inhaler more
frequently), or if your “rescue” inhaler or Beclometasone and Formoterol Teva Italia does not
improve your symptoms, contact your doctor immediately. Your asthma may be worsening and your doctor
may need to increase your dose of Beclometasone and Formoterol Teva Italia or prescribe an
alternative treatment.
Method of administration
Beclometasone and Formoterol Teva Italia is for inhalation use only.
This medicine is contained in a pressurized canister placed inside a plastic casing with a mouthpiece. At the back of the inhaler is a dose counter for 120 doses and a dose indicator for 180 actuations, which shows the number of doses remaining.
For the 120-dose pack, each time you press the canister, one dose of medicine is released and the counter decreases by one. Be careful not to drop the inhaler, as this may cause the dose counter to advance by one dose.
For the 180-actuation pack, the dose indicator shows the approximate number of actuations (sprays) remaining in the canister. The dose indicator window displays the number of sprays left in the inhaler in units of twenty (e.g., 180, 120, 100, 80, etc.). When 20 actuations remain, the display shows the number 20, indicating that the canister is nearing the end of its life.
When 180 actuations have been delivered, the display shows the number 0.
The indicator will stop moving at “0”.
Checking the inhaler function
Before using the inhaler for the first time, or if the inhaler has not been used for 14 days or more,
you must check the inhaler function to ensure it is working properly.

• Remove the protective cap from the mouthpiece.
• Hold the inhaler upright with the mouthpiece pointing downwards.
• Point the mouthpiece away from you and press firmly on the canister to release one dose.
• If you have not used the inhaler for 14 days or more, press firmly on the canister once to release one actuation.
• For the 120-dose pack, check the dose counter. If you are using the inhaler for the first time, the counter should read 120.
• For the 180-actuation pack, check the dose indicator. If you are using the inhaler for the first time, the indicator should read 180.

How to use the inhaler
Whenever possible, remain standing or sit upright while inhaling.
Before starting to inhale, check the dose counter or dose indicator to see how many doses remain. If the dose counter or dose indicator shows “0”, no doses remain: dispose of the inhaler and obtain a new one.

1 2 3 4 5

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust, dirt or any foreign object (Figure 1).
2. Breathe out as slowly and deeply as possible (Figure 2).
3. Hold the canister vertically with the body of the inhaler upright, and place your lips around the mouthpiece. Do not bite the mouthpiece (Figure 3).
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 your index fingers on the top of the inhaler and both thumbs on the bottom of the inhaler (Image 4).
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 (Figure 5).

If another actuation is needed, hold the inhaler upright for about half a minute, then 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 for the 120-dose pack or the dose indicator for the 180-actuation pack.
To reduce the risk of a fungal infection in the mouth and throat, rinse your mouth, gargle with water or brush your teeth each time you use the inhaler.
When to replace the inhaler
You should obtain a new inhaler when the dose counter reads 20. Stop using the inhaler when the dose counter reads 0, as the remaining doses in the device may not be sufficient to deliver a full dose, and start using a new inhaler.
If you see a “mist” escaping from the inhaler or from the sides of your mouth after inhalation,
this means that Beclometasone and Formoterol Teva Italia has not reached your lungs as intended.
Take another actuation by following the instructions, repeating steps 2 to 5.
If you think the effect of Beclometasone and Formoterol Teva Italia is too strong or not strong enough,
inform your doctor or pharmacist.
If you have difficulty using the inhaler when starting to inhale, you may use the AeroChamber Plus spacer device. Ask your doctor, pharmacist or nurse for information about this device.
It is important to read the leaflet provided with the AeroChamber Plus spacer device and follow carefully the instructions on how to use and clean it.
Cleaning
The inhaler should be cleaned once a week.
During cleaning, do not remove the canister from the inhaler and do not use water or other liquids
to clean the inhaler.
To clean the inhaler

1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
2. 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 take more Beclometasone and Formoterol Teva Italia than you should

• Taking more formoterol than you should may cause the following effects: feeling unwell, malaise, rapid heartbeat, palpitations, heart rhythm disturbances, certain changes in the electrocardiogram (ECG), headache, tremor, drowsiness, excess acid in the blood, low potassium levels in the blood, high blood glucose levels. Your doctor may wish to perform blood tests to monitor your potassium and glucose levels.
• Excessive intake of beclometasone dipropionate may cause temporary disturbances of the adrenal glands. These will improve within a few days, but your doctor may wish to monitor your serum cortisol levels. Inform your doctor if you experience any of these symptoms.

If you forget to take Beclometasone and Formoterol Teva Italia:
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 a forgotten dose.
If you stop treatment with Beclometasone and Formoterol Teva Italia:
Even if you feel better, do not stop taking Beclometasone and Formoterol Teva Italia or reduce the dose. If you wish to do so, speak to your doctor. It is very important that you use Beclometasone and Formoterol Teva Italia regularly, even when you have no symptoms.
If you have any doubts about using this product, 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 Italia, and this condition is known as paradoxical bronchospasm. If this occurs, you must STOP using Beclometasone and Formoterolo Teva Italia IMMEDIATELY and use your "rescue" fast-acting inhaler right away to treat breathlessness and wheezing symptoms. You must contact your doctor immediately.
Inform your doctor IMMEDIATELY if you experience hypersensitivity reactions such as skin allergy, itching, rash, skin redness, or swelling of the skin or mucous membranes, particularly affecting 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 experience any of the following symptoms while taking Beclometasone and Formoterolo Teva Italia, as they could be signs of a lung infection:

• fever or chills
• increased mucus production, change in mucus color
• worsening cough or increased breathing difficulties

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

• palpitations, unusually fast heartbeat, and heart rhythm disorders
• certain changes in the electrocardiogram (ECG)
• flu-like symptoms
• sinusitis
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• fungal infection of the vagina
• nausea
• altered or abnormal taste sensation
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhea
• muscle pain and cramps
• redness of the face and throat
• increased blood flow to certain body tissues
• excessive sweating
• tremor
• restlessness
• dizziness
• skin rash or hives
• changes in certain blood components:
  • decrease in the number of white blood cells
  • increase in the number of platelets in the blood
  • decrease in blood potassium levels
  • increase in blood sugar levels
  • 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 amount of cortisol 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):

• chest tightness
• missed heartbeat (caused by premature contraction of the heart's ventricles)
• decrease in blood pressure
• increase in blood pressure
• kidney inflammation
• persistent swelling of the skin and mucous membranes lasting for several days

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

• breathlessness
• worsening of asthma
• decrease in the number of platelets in the blood
• swelling of the hands and feet

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

• adrenal gland function disorders (adrenal suppression)
• decreased bone mineral density (bone thinning)
• growth retardation in children and adolescents
• increased pressure in the eyes (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 in children, but the frequency is unknown.
• blurred vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 Italia

Keep this medicine out of the sight and reach of children.
Single pack containing a 120-dose or 180-dose inhaler
For the pharmacist
Store in the refrigerator (2-8 °C) for up to 18 months.
Enter the patient's dispensing date on the adhesive label on the packaging and affix the label to the inhaler. Ensure there is a period of at least 3 months between the dispensing date and the expiry date printed on the packaging.
For patients
Do not store the inhaler at temperatures above 25 °C.
Do not use Beclometasone and Formoterol Teva Italia more than 3 months after the date you received the inhaler from the pharmacist, and never use it after the expiry date shown on the box and on the label after "Exp.". The expiry date refers to the last day of that month.
Double or triple packs containing two or three 120-dose inhalers
Before use: store the inhalers in the refrigerator (at 2-8°C).
After first use: store the inhalers for a maximum of three months at temperatures not exceeding 25 °C.
Each time you start using an inhaler, enter the date of first use on the adhesive label on the packaging and affix the label to the inhaler. The inhalers must not be used more than 3 months after first use and must never be used after the expiry date shown on the box and on the label after "Exp.".
The expiry date refers to the last day of that month.
Do not freeze.
If the inhaler has been exposed to intense cold, warm it with your hands for a few minutes before use. Never warm it using artificial means.
Caution: The container contains a pressurised liquid. Do not expose the container to temperatures above 50 °C. Do not pierce the container.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Beclometasone and Formoterolo Teva Italia contains
The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each metering valve actuation contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate.
This corresponds to an inhaled dose delivered from the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
The other components are: anhydrous ethanol, concentrated hydrochloric acid and norflurane (HFA-134a).
This medicinal product contains fluorinated greenhouse gases.
Each 120-actuation inhaler contains 8.15 g of HFA-134a, equivalent to 0.012 tonnes of CO₂ (global warming potential GWP = 1,430).
Each 180-actuation inhaler contains 11.2 g of HFA-134a, equivalent to 0.016 tonnes of CO₂ (global warming potential GWP = 1,430).

Description of the appearance of Beclometasone and Formoterolo Teva Italia and contents of the package
Beclometasone and Formoterolo Teva Italia is a pressurized solution for inhalation contained in an aluminum canister fitted with a metering valve, inserted into a white plastic inhaler incorporating either a dose counter (120-actuation pack) or a dose indicator (180-actuation pack), with a pink protective cap.
Each package contains:
1 pressurized canister (providing 120 actuations) (sprays) or
2 pressurized canisters (each providing 120 actuations) or
3 pressurized canisters (each providing 120 actuations) or
1 pressurized canister (providing 180 actuations).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Genetic S.p.A.
Via G. Della Monica 26
84083 Castel San Giorgio (SA)
Italy

Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano
Italy

This medicinal product is authorized in the European Economic Area member states under the following names:
Austria Beclometason/Formoterol Pavese
Italy Beclometasone e Formoterolo Teva Italia

Package leaflet: Information for the user

Beclometasone and Formoterol Teva Italia 200 micrograms/6 micrograms per dose,

pressurized solution for inhalation
beclometasone dipropionate/formoterol fumarate dihydrate
equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.

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

Contents of this leaflet

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

1. What Beclometasone and Formoterolo Teva Italia is and what it is used for

Beclometasone and Formoterolo Teva Italia is a pressurised inhalation solution 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 have an anti-inflammatory action, 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, and also help to prevent asthma symptoms.
Beclometasone and Formoterolo Teva Italia is indicated for the treatment of asthma in adult patients.
If you have been prescribed Beclometasone and Formoterolo Teva Italia, it is likely that:

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

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

Do not use Beclometasone and Formoterolo Teva 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 using Beclometasone and Formoterolo Teva Italia:
• If you have heart problems, such as angina (chest pain), heart failure, narrowed arteries, valvular heart disease, or any other known heart condition.
• If you have high blood pressure or if you know you have an aneurysm (an abnormal bulging of blood vessel walls).
• If you have heart rhythm disorders such as rapid or irregular heartbeat, increased pulse rate, palpitations, or if you have been told that your electrocardiogram (ECG) is abnormal.
• If you have an overactive thyroid gland.
• If you have low levels of potassium in your blood.
• If you have any liver or kidney problems.
• If you have diabetes (if you inhale high doses of formoterol, your blood sugar may increase. When you start using this medicine and occasionally during treatment, you may need additional blood tests to monitor your blood sugar levels).
• If you have a tumor of the adrenal gland (known as phaeochromocytoma).
• If you are due to undergo anaesthesia. Depending on the type of anaesthesia, you may need to stop taking Beclometasone and Formoterolo Teva Italia at least 12 hours before the anaesthesia.
• If you are currently being treated, or have ever been treated, for tuberculosis (TB) or if you have a known viral or fungal infection in the chest.
• If you need to avoid alcohol for any reason.

If any of the conditions listed above apply to you, always inform your doctor before
using Beclometasone and Formoterolo Teva Italia.
If you have or have had any medical problems or allergies, or if you are unsure whether you can use
Beclometasone and Formoterolo Teva Italia, contact 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 Teva Italia can cause a sudden drop in serum potassium levels (hypokalaemia). This is because lack of oxygen in the blood, combined with certain other treatments you may be taking together with Beclometasone and Formoterolo Teva Italia, can worsen the reduction in potassium levels.
If you are taking high doses of inhaled corticosteroids for long periods, you may require additional corticosteroids during periods of stress. Stressful situations may include hospitalisation following an accident, serious injury, or surgery. In such cases, your treating doctor will decide whether you may 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 inhalers with you, including Beclometasone and Formoterolo Teva Italia, and any over-the-counter medicines or tablets you are taking, preferably in their original packaging.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
Beclometasone and Formoterolo Teva Italia must not be used in children and adolescents under 18 years of age.
Other medicines and Beclometasone and Formoterolo Teva Italia

• Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is because Beclometasone and Formoterolo Teva Italia may affect how some other medicines work. In addition, some medicines may affect how Beclometasone and Formoterolo Teva 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 Beclometasone and Formoterolo Teva Italia, and your doctor may wish to monitor you closely if you are taking these medicines (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 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 in the same way as 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 isocarboxazid), 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 disease (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids).
• Diuretics. Also inform your doctor if you are about 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 Italia during pregnancy. Do not take Beclometasone and Formoterolo Teva Italia if you are pregnant, think 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 Italia will affect your ability to drive
or use machines.
Beclometasone and Formoterolo Teva Italia contains alcohol
This medicine contains 9 mg of alcohol (ethanol) per dose, which corresponds to 0.25 mg/kg for a two-dose administration. The amount in two doses of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
For those engaged in sports activities
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use Beclometasone and Formoterol Teva Italia

Always use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will regularly monitor you to ensure you are taking the optimal dose of
Beclometasone and Formoterol Teva Italia. Your doctor will adjust your treatment to the lowest dose that
adequately controls your symptoms.

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

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

Patients at risk
No dose adjustment is required if you are elderly. There is no available information on the use of Beclometasone and Formoterol Teva Italia 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 use this medicine.

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

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

If your asthma worsens
If your symptoms worsen or become difficult to control (for example, if you are using your
“rescue” inhaler more frequently), or if your “rescue” inhaler does not improve your
symptoms, contact your doctor immediately. Your asthma may be worsening, and your doctor may
need to adjust your dose of Beclometasone and Formoterol Teva Italia or prescribe an alternative treatment.

Method of administration
Beclometasone and Formoterol Teva Italia is for inhalation use only.
This medicine is contained in a pressurized canister inserted into a plastic holder with a mouthpiece. On the back of the inhaler is a dose counter for the 120-dose pack and a dose indicator for the 180-dose pack, which shows the number of doses remaining.

For the 120-dose pack, each time you press the canister, one dose of medicine is released and the counter decreases by one. Be careful not to drop the inhaler, as this may cause the dose counter to advance unintentionally.

For the 180-dose pack, the dose indicator shows the approximate number of remaining sprays (puffs). The dose indicator window displays the number of sprays left in increments of twenty (e.g., 180, 120, 100, 80, etc.). When 20 sprays remain, the display will show "20", indicating that the canister is nearing the end of its life.
When 180 sprays have been delivered, the display will show "0".
The indicator will stop moving at "0".

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

• Remove the protective cap from the mouthpiece.
• Hold the inhaler upright with the mouthpiece pointing downward.
• Tilt the mouthpiece away and press firmly on the canister to release one dose.
• If you have not used the inhaler for 14 days or more, press firmly on the canister once to release one puff.
• For the 120-dose pack, check the dose counter. If using the inhaler for the first time, the counter should read 120.
• For the 180-dose pack, check the dose indicator. If using the inhaler for the first time, the indicator should read 180.

How to use the inhaler
Whenever possible, remain standing or sit upright while inhaling.
Before starting to inhale, check the dose counter or dose indicator to see how many doses remain. If the dose counter or dose indicator shows “0”, no doses remain: dispose of the inhaler and obtain a new one.

1 2 3 4 5

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust, dirt, or any foreign object (Figure 1).
2. Breathe out as slowly and deeply as possible (Figure 2).
3. Hold the canister vertically with the body of the inhaler upright, and place your lips around the mouthpiece. Do not bite the mouthpiece (Figure 3).
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 a dose. If you have a weak grip, it may be easier to hold the inhaler with both hands: place your index fingers on top of the inhaler and both thumbs on the bottom (Image 4).
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 (Figure 5). If a second inhalation is needed, keep the inhaler upright for about half a minute, then 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 (for the 120-dose pack) or dose indicator (for the 180-dose pack). To reduce the risk of developing a fungal infection in the mouth or throat, rinse your mouth, gargle with water, or brush your teeth each time you use the inhaler.

When to replace the inhaler
Obtain a new inhaler when the dose counter shows "20". Stop using the inhaler when the dose counter shows "0", as the remaining doses in the device may not be sufficient to deliver a full dose, and start using the new inhaler.

If you see a “mist” escaping from the inhaler or from the sides of your mouth after inhalation, this means Beclometasone and Formoterol Teva Italia did not reach your lungs as intended. Perform another inhalation by repeating the steps from step 2.
If you think the effect of Beclometasone and Formoterol Teva Italia is too strong or not strong enough, inform your doctor or pharmacist.

If you have difficulty using the inhaler while starting to inhale, you may use the AeroChamber Plus spacer device. Ask your doctor, pharmacist, or nurse for information about this device.
It is important to read the Patient Information Leaflet provided with the AeroChamber Plus spacer device and carefully follow the instructions on how to use and clean it.

Cleaning
The inhaler should be cleaned once a week.
During cleaning, do not remove the canister from the inhaler and do not use water or other liquids to clean the inhaler.

To clean the inhaler

1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
2. 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 Italia than you should

• Taking more formoterol than prescribed may cause the following effects: feeling unwell, malaise, rapid heartbeat, palpitations, heart rhythm disturbances, certain changes in the electrocardiogram (ECG), headache, tremor, drowsiness, excess acid in the blood, low potassium levels in the blood, and high blood glucose levels. Your doctor may wish to perform blood tests to monitor your potassium and glucose levels.
• Excessive use of beclometasone dipropionate may cause temporary disturbances of the adrenal glands. These will resolve within a few days, but your doctor may wish to monitor your serum cortisol levels. Inform your doctor if you experience any of these symptoms.

If you forget to take Beclometasone and Formoterol Teva Italia
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 a forgotten dose.

If you stop treatment with Beclometasone and Formoterol Teva Italia
Even if you feel better, do not stop taking Beclometasone and Formoterol Teva Italia or reduce the dose. If you wish to do so, speak to your doctor. It is very important that you use Beclometasone and Formoterol Teva Italia regularly, even when you have no symptoms.

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

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 Italia, a condition known as paradoxical bronchospasm. If this occurs, you must STOP using Beclometasone and Formoterolo Teva Italia IMMEDIATELY and use your "reliever" inhaler with fast-acting medication right away to treat breathlessness and wheezing symptoms. You must contact your doctor immediately.

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

Other possible side effects are listed below by frequency.

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

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

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

• palpitations, unusually fast heartbeat, and heart rhythm disorders
• certain changes in the electrocardiogram (ECG)
• increased blood pressure
• flu-like symptoms
• sinusitis
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• fungal infections of the vagina
• nausea
• abnormal or altered taste sensation
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhoea
• muscle pain and cramps
• redness of the face and throat
• increased blood flow to certain body tissues
• excessive sweating
• tremor
• restlessness
• dizziness
• skin rash or urticaria
• changes in certain blood components:
  • reduced number of white blood cells
  • increased number of platelets in the blood
  • reduced potassium levels in the blood
  • increased blood sugar levels
  • increased levels of 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 breathing problems
• reduced levels of cortisol 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):

• chest tightness
• missed heartbeat (caused by premature contraction of the heart's ventricles)
• decreased 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):

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

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

• disorders of adrenal gland function (adrenal suppression)
• decreased bone mineral density (bone thinning)
• growth retardation in children and adolescents
• increased pressure in the eyes (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 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: 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 Teva Italia

Keep this medicine out of sight and reach of children.
Single pack containing a 120-dose or 180-dose inhaler
For the pharmacist
Store in the refrigerator (2–8 °C) for up to 18 months.
Enter the date of dispensing to the patient on the adhesive label on the packaging and affix the label to the inhaler. Ensure there is a period of at least 3 months between the date of dispensing and the expiry date printed on the packaging.
For patients
Do not store the inhaler at temperatures above 25 °C.
Do not use Beclometasone and Formoterolo Teva Italia for more than 3 months from the date you receive the inhaler from the pharmacist, and never use it after the expiry date stated on the box and label after “Exp.”. The expiry date refers to the last day of that month.
Double or triple packs containing two or three 120-dose inhalers
Before use: Store the inhalers in the refrigerator (at 2–8 °C).
After first use: Store the inhalers for a maximum of three months and at a temperature not exceeding 25 °C.
Each time you start using an inhaler, enter the date of first use on the adhesive label on the packaging and apply the label to the inhaler. The inhalers must not be used more than 3 months after first use and must never be used after the expiry date printed on the box and label after “Exp.”.
The expiry date refers to the last day of that month.
Do not freeze.
If the inhaler has been exposed to extreme cold, warm it with your hands for several minutes before use. Never warm it with artificial means.
Caution: The container contains a pressurised liquid. Do not expose the container to temperatures above 50 °C. Do not pierce the container.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package contents and other information

What Beclometasone and Formoterol Teva Italia contains:
The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each metered valve actuation contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate.
This corresponds to an inhaled dose delivered from the mouthpiece of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
The other components are: norflurane (HFA-134a), anhydrous ethanol, concentrated hydrochloric acid.
This medicinal product contains fluorinated greenhouse gases.
Each 120-dose inhaler contains 10.35 g of HFA-134a, equivalent to 0.015 tonnes of CO₂ (global warming potential GWP = 1,430).
Each 180-dose inhaler contains 14.24 g of HFA-134a, equivalent to 0.020 tonnes of CO₂ (global warming potential GWP = 1,430).

Description of the appearance of Beclometasone and Formoterol Teva Italia and contents of the pack:
Beclometasone and Formoterol Teva Italia is a pressurised solution for inhalation contained in an aluminium container fitted with a metering valve, placed in a white plastic inhaler device incorporating a dose counter (120-dose pack) or a dose indicator (180-dose pack), with a green plastic protective cap.
Each pack contains:
1 pressurised container (delivering 120 actuations), or
2 pressurised containers (each delivering 120 actuations), or
3 pressurised containers (each delivering 120 actuations), or
1 pressurised container (delivering 180 actuations).
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Genetic S.p.A.
Via G. Della Monica 26
84083 Castel San Giorgio (SA)
Italy

Manufacturer:
Genetic S.p.A.
Contrada Canhor
84084 Fisciano
Italy

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria Beclometasone/Formoterol Pavese
Italy Beclometasone and Formoterol Teva Italia