Beclometasone and formoterol EG

Package leaflet: Information for the user

Beclometasone and formoterol EG

100 micrograms/6 micrograms per dose, pressurised solution for inhalation
Generic medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

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

Beclometasone and Formoterol EG is a pressurised inhalation solution 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 that exert an anti-inflammatory action by reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which relax the muscles of the airways and help you breathe more easily.
Together, these two active substances make breathing easier, relieving 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 EG is indicated for regular treatment of asthma in adults when:

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

COPD
Beclometasone and Formoterol EG may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic disease of the lung airways mainly caused by cigarette smoking.
Beclometasone and Formoterol EG is intended for use in adults.

2. What you need to know before using Beclometasone and formoterolo EG

Do not use Beclometasone and formoterolo EG

• 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 or pharmacist before using Beclometasone and formoterolo EG:

• if you have heart problems, such as angina (chest pain), have recently had a heart attack (myocardial infarction), heart failure, narrowing of the arteries near the heart (coronary heart disease), heart valve disease, or any other known heart condition, or if you have a condition known as obstructive hypertrophic cardiomyopathy (also known as HOCM, a disorder characterized by abnormal heart muscle).
• if you have narrowing of the arteries (a condition also known as arteriosclerosis), if you have high blood pressure, or if you know you have an aneurysm (an abnormal bulging of the blood vessel wall).
• if you have heart rhythm disorders, such as increased or irregular heartbeat, rapid or irregular pulse, or if you have been diagnosed with an abnormal electrocardiogram.
• if you have an overactive thyroid gland.
• if you have low levels of potassium in the blood.
• if you have any liver or kidney disease.
• if you have diabetes (inhaling high doses of formoterol may increase blood glucose levels; therefore, you may need to have additional blood sugar tests periodically when you start using this medicine).
• if you have a tumour of the adrenal gland (known as phaeochromocytoma).
• if you are due to undergo anaesthesia. Depending on the type of anaesthetic, you may need to stop treatment with Beclometasone and formoterolo EG at least 12 hours before the anaesthesia.
• if you are 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 conditions listed above apply to you, always inform your doctor before using
Beclometasone and formoterolo EG.
If you have or have ever had any medical condition or allergy, or if you are unsure whether you can use
Beclometasone and formoterolo EG, talk to your doctor or pharmacist before using this medicine.
Treatment with a beta-agonist such as formoterol, contained in Beclometasone and formoterolo EG, may
cause a sudden drop in serum potassium levels (hypokalaemia).
Particular caution is recommended in case of severe asthma. This is due to low oxygen levels
in the blood, and some of the other treatments you may be taking together with Beclometasone and formoterolo
EG, such as medicines for heart problems or high blood pressure known as diuretics
or “water tablets”, or other medicines used in the treatment of asthma, may 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 long periods of time, you may require additional corticosteroids during periods of stress. Stressful situations may include hospitalisation following an accident, a serious injury, or before surgery. In such cases, your doctor will decide whether an increase in corticosteroid dose is necessary and may prescribe steroid tablets or injectable steroids.
If you need to go to hospital, remember to bring all your medicines and inhalers, including
Beclometasone and formoterolo EG, and any over-the-counter medicines or tablets, in their original packaging, if possible.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
Beclometasone and formoterolo EG must not be used in children and adolescents under 18
years of age until further data are available.
Other medicines and Beclometasone and formoterolo EG
Tell 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 EG may affect how other medicines work. Some other medicines may also affect the way Beclometasone and formoterolo EG works.
In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following
medicines:
Some medicines may increase the effects of Beclometasone and formoterolo EG, and your doctor
may wish to monitor you closely if you are taking these medicines (including some
medicines for the treatment of HIV: ritonavir, cobicistat).
Beta-blockers. Beta-blockers are medicines used to treat many 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 blocked.
Beta-adrenergic medicines (medicines that work similarly to formoterol) may enhance the effect 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 isocarbazide), tricyclic antidepressants (e.g. amitriptyline and imipramine), phenothiazines.
Medicines for the treatment of Parkinson’s disease (levodopa).
Medicines for the treatment of hypothyroidism (levothyroxine).
Medicines containing oxytocin (which cause uterine contractions).
Medicines for the treatment of mental disorders such as monoamine oxidase inhibitors (MAOIs), including medicines with similar properties such as furazolidone and procarbazine.
Medicines for the treatment of heart conditions (digoxin).
Other medicines used in the treatment of asthma (theophylline, aminophylline, or steroids).
Diuretics (water tablets).
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 EG in pregnant women.
Do not use Beclometasone and formoterolo EG if you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, unless advised by your doctor.
Driving and using machines
It is unlikely that Beclometasone and formoterolo EG will impair your ability to drive or operate machinery.
Beclometasone and formoterolo EG contains alcohol
This medicine contains 7 mg of alcohol (ethanol) per dose, which is equivalent to 0.20 mg/kg for a two-dose administration. The amount in this medicine is equivalent to less than 1 mL of wine or 1 mL of beer. The small amount of alcohol in this medicine will not produce significant effects.
For athletes:
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use Beclometasone and formoterol EG

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 EG. The doctor will adjust your treatment to the lowest dose that best controls your symptoms.

Beclometasone and formoterol EG may be prescribed by your doctor in two different ways:

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

Adults and elderly:

The recommended dose of this medicine is one or two actuations twice daily. The maximum daily dose is 4 actuations.

Please remember: You must always carry your fast-acting "reliever" inhaler with you to treat worsening asthma symptoms or sudden asthma attacks.

b) Daily use of Beclometasone and formoterol EG for asthma treatment and additional use of Beclometasone and formoterol EG to treat sudden worsening of asthma symptoms such as shortness of breath, wheezing, and cough.

Adults and elderly:

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

You must also use Beclometasone and formoterol EG as a "reliever" inhaler to treat sudden asthma symptoms.

If you experience asthma symptoms, take one actuation and wait a few minutes.
If you do not feel better, take another actuation.

Do not take more than 6 "reliever" actuations of Beclometasone and formoterol EG per day.
The maximum daily dose of Beclometasone and formoterol EG as the sole asthma inhaler is 8 actuations.

If you feel you need more actuations per day to control your asthma symptoms, consult your doctor. Your treatment may need to be adjusted.

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 actuations in the morning and two actuations 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 EG in patients with liver or kidney problems.

Beclometasone and formoterolo EG is effective in the treatment of asthma at a beclometasone dipropionate dosage that may be lower than that of other inhaled products containing beclometasone dipropionate. If you previously used a different beclometasone dipropionate inhaler, your doctor will advise you on the exact dose of Beclometasone and formoterol EG 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 your breathing worsens:

If you experience worsening shortness of breath or wheezing (a clearly audible whistling sound when breathing) immediately after inhaling the medicine, stop using Beclometasone and formoterol EG immediately and use your fast-acting "reliever" inhaler right away. Contact your doctor immediately.
Your doctor will assess your symptoms and, if necessary, decide to start a different treatment.
See also section 4 – Possible side effects.

If asthma worsens:

If your symptoms worsen or are difficult to control (for example, if you are using another "reliever" inhaler or Beclometasone and formoterol EG as a "reliever" more frequently), or if your "reliever" inhaler or Beclometasone and formoterol EG does not improve your symptoms, contact your doctor immediately. Asthma may be worsening, and your doctor may decide to adjust the dose of Beclometasone and formoterol EG or prescribe an alternative treatment.

Instructions for use:

Beclometasone and formoterol EG is for inhalation use only.

This medicine is contained in a pressurized canister inside a plastic housing 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 show how many doses remain.

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

For the 180-dose pack, the indicator shows the approximate number of remaining actuations (sprays) in the canister. The dose indicator window displays the number of sprays remaining in multiples of twenty (e.g., 180, 120, 100, 80, etc.). When 20 actuations remain and the display shows "20", the canister is nearing the end of its life.
When 180 actuations have been delivered, the display will show "0".
The indicator will stop functioning after reaching "0".

Checking the inhaler's function

Before using the inhaler for the first time, or if you have not used it for 14 days or more, you must test the inhaler to ensure it is working properly.

• Remove the protective cap from the mouthpiece.
• Hold the inhaler upright with the mouthpiece pointing downward.
• Turn 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 dose.
• 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 counter should read 180.

DOSE COUNTER
DOSE INDICATOR

How to use the inhaler

Whenever possible, stand 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. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust, dirt, or any foreign objects (Figure 1).
2. Breathe out as slowly and deeply as possible (Figure 2).
3. Hold the canister upright with the actuator pointing upward and place your lips around the mouthpiece. Do not bite the mouthpiece with your teeth (Figure 3).
4. Breathe in slowly and deeply through your mouth and, just as you begin 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 top of the inhaler and both thumbs underneath (Figure 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 you need to take a second dose, 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 (120-dose pack) or dose indicator (180-dose pack).
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.

When to replace the inhaler

You should 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 begin using the 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 EG is not reaching your lungs properly. Take another dose following the instructions from step 2.

If you think the effect of Beclometasone and formoterol EG 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 Patient Information Leaflet provided with the AeroChamber Plus spacer device and carefully follow the instructions for use and cleaning.

Cleaning

You must clean the inhaler once a week.
During cleaning, do not remove the canister from the actuator and do not use water or other liquids to clean the inhaler.

How 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 EG than you should:

• If you use more formoterol than you should, you may experience 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 check your potassium and glucose levels.
• Excessive use of beclometasone dipropionate may cause temporary adrenal gland problems. These will improve within a few days, but your doctor may need to perform blood tests to monitor your serum cortisol levels.

Inform your doctor if you experience any of these symptoms.

If you forget to use Beclometasone and formoterol EG:

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 usual time.
Do not take a double dose to make up for a forgotten dose.

If you stop treatment with Beclometasone and formoterol EG:

Even if you feel better, do not stop taking Beclometasone and formoterol EG and do not reduce the dose. If you wish to do so, consult your doctor. It is very important that you use Beclometasone and formoterol EG regularly, even when you have no 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 everyone gets them.

As with other inhaled treatments, there is a risk of worsening breathlessness and wheezing immediately after using Beclometasone and formoterolo EG. This effect is known as paradoxical bronchospasm. If this occurs, STOP treatment with Beclometasone and formoterolo EG IMMEDIATELY and use your fast-acting "rescue" inhaler right away to treat breathlessness and wheezing symptoms. Contact your doctor immediately.

Inform your doctor immediately if you experience any hypersensitivity reactions, such as skin allergies, skin itching, skin rash, skin redness, 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

Pneumonia in patients with COPD: Inform your doctor if you experience any of the following symptoms while taking Beclometasone and formoterolo EG, as they may indicate a lung infection:
fever or chills
increased mucus production, change in mucus colour
worsening cough or worsening breathing difficulties

Uncommon (may affect up to 1 in 100 people):
palpitations, unusually fast heartbeat, heart rhythm disorders
changes in electrocardiogram (ECG)
influenza-like symptoms
sinusitis
rhinitis
ear inflammation
throat irritation
cough and productive cough
asthma attack
vaginal fungal infections
nausea
abnormal or altered taste sensation
burning sensation of the lips
dry mouth
difficulty swallowing
indigestion
stomach disturbances
diarrhoea
muscle pain and muscle cramps
redness of the face and throat
increased blood flow to certain body tissues
excessive sweating
tremor
restlessness
dizziness
urticaria
changes in certain blood components:
reduction in the number of white blood cells in the blood
increase in the number of platelets in the blood
reduction in blood potassium concentrations
increase in blood sugar levels
increase in insulin, free fatty acids, or ketone levels in the blood

The following side effects have been reported as "uncommon" in patients with chronic obstructive pulmonary disease (COPD):
reduction in 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
absence of heartbeat (caused by premature ventricular contractions)
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

Long-term use of inhaled corticosteroids may, very rarely, cause systemic effects throughout the body. These include:
adrenal gland function disorders (adrenal suppression)
reduction in 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
feeling of hyperexcitability or irritability
These events are more likely to occur in children, but the frequency is unknown.
blurred vision

Reporting of side effects

If you experience any side effects, 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 EG

Keep this medicine out of the sight and reach of children.
Single pack containing one 120-dose or one 180-dose inhaler
For the pharmacist
Store in the refrigerator (2–8 °C) for up to 18 months.
Apply the patient's dispensing date on the adhesive label provided on the packaging and affix the label to the inhaler. Ensure that there is a minimum period of 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 EG more than 3 months after the date the pharmacist dispensed the inhaler, and never use it after the expiry date stated on the box and on the label after "Exp". The expiry date refers to the last day of that month.
Double or triple pack containing two or three 120-dose or 180-dose inhalers
Before use: store the inhalers in the refrigerator (2–8 °C).
After first use:
Store the inhalers for a maximum of three months at a temperature not exceeding 25 °C.
Each time you start using an inhaler, write the date of first use on one of the adhesive labels provided on the packaging and affix this label to the inhaler in use. 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 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.
Warning: 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 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 EG contains:
The active substances are: beclometasone dipropionate, 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 amount 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-dose inhaler contains 8.15 g of HFA-134a, equivalent to 0.012 tonnes of CO₂
equivalent (global warming potential = 1,430).
Each 180-dose inhaler contains 11.2 g of HFA-134a, equivalent to 0.016 tonnes of CO₂
equivalent (global warming potential = 1,430).

Description of the appearance of Beclometasone and formoterolo EG and contents of the pack
Beclometasone and formoterolo EG is a pressurized solution for inhalation in an aluminium container
with a metering valve, fitted into a white plastic inhaler device with a dose counter (pack of 120
doses) or a dose indicator (pack of 180 doses), and a pink plastic protective cap.
Each pack contains:
1 pressurized container (delivering 120 doses) (sprays) or
2 pressurized containers (each delivering 120 doses) or
3 pressurized containers (each delivering 120 doses) or
1 pressurized container (delivering 180 doses) or
3 pressurized containers (each delivering 180 doses)
Not all pack sizes may be marketed.

Marketing Authorization Holder:
EG S.p.A., via Pavia 6, 20136 Milano
Manufacturer:
Genetic S.p.A., Contrada Canfora, 84084 Fisciano - Salerno, Italy

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
AT Beclometason/Formoterol STADA 100 Mikrogramm /6 Mikrogramm pro Sprühstoß
Druckgasinhalation, Lösung
BE Beclometasone/Formoterol EG 100/6 microgram/dosis aërosol, oplossing
CZ Oreto
DE Beclometason/Formoterol AL 100 Mikrogramm/6 Mikrogramm pro Inhalation Druckgasinhalation,
Lösung
DK Laberon
EE Bedufora
EL Beclometasone+Formoterol / STADA
FI Laberon
FR BECLOMETASONE / FORMOTEROL EG 100 / 6 microgrammes/dose, solution pour inhalation
en flacon pressurisé
HR Laberon 100/6 mikrograma po potisku, stlačeni inhalat, otopina
IS Laberon
IT BECLOMETASONE E FORMOTEROLO EG
LT Bedufora 100 mikrogramų/6 mikrogramai/spūsnyje suslėgtasis įkvepiamasis tirpalas
LV Bedufora 100 mikrogrami/6 mikrogrami izsmidzinājumā aerosols inhalācijām, zem spiediena,
šķīdums
NO Laberon
NL Beclometason/Formoterol CF 100/6 microgram/dosis, aërosol, oplossing
PL Bedufora
RO Beclometazonă /Formoterol Stada, 100/6 micrograme pe doză, soluţie de inhalat presurizată
SE Laberon
SK Beklometazón/Formoterol STADA 100/6 mikrogramov/dávka

Patient Information Leaflet: Information for the User

Beclometasone and formoterol EG

200 micrograms/6 micrograms/dose, pressurised inhalation solution
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, pharmacist or nurse.
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 effect, 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 EG is and what it is used for
2. What you need to know before using Beclometasone and formoterol EG
3. How to use Beclometasone and formoterol EG
4. Possible side effects
5. How to store Beclometasone and formoterol EG
6. Contents of the pack and other information

2. What Beclometasone and Formoterol EG is and what it is used for

Beclometasone and Formoterol EG is a pressurised inhalation solution containing two active substances
which are inhaled through the mouth and are 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, reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines known as 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 relieving symptoms such as shortness of breath,
wheezing and coughing in patients with asthma, and also help to prevent asthma symptoms.
Beclometasone and Formoterol EG is used for the treatment of asthma in adults.
If Beclometasone and Formoterol EG has been prescribed for you, it is likely that:
your asthma is not adequately controlled using inhaled corticosteroids and short-acting bronchodilators used “as needed”
or
your asthma is responding well to treatment with both corticosteroids and long-acting bronchodilators.

2. What you need to know before using Beclometasone and formoterolo EG

Do not use Beclometasone and formoterolo EG
if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or to any of the other
components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Beclometasone and formoterolo EG:
if you have heart problems, such as angina (chest pain), heart failure,
narrowing of the arteries, heart valve disease, or any other known heart condition.
if you have high blood pressure or if you know you have an aneurysm (an abnormal bulge in the wall of a blood vessel).
if you have heart rhythm disorders such as a fast or irregular heartbeat, rapid heart rate, 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 your blood.
if you have any liver or kidney disease.
if you have diabetes (inhaling high doses of formoterol may increase blood glucose levels. Therefore, you may need to have additional periodic tests to monitor your blood sugar levels, especially when starting this medicine).
if you have a tumour of the adrenal gland (known as phaeochromocytoma).
if you are due to undergo anaesthesia. Depending on the type of anaesthetic, you may need to stop treatment with Beclometasone and formoterolo EG at least 12 hours before the anaesthesia.
if you are 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 conditions apply to you, always inform your doctor before using
Beclometasone and formoterolo EG.
If you have or have ever had any medical condition or allergy, or if you are unsure whether you can use
Beclometasone and formoterolo EG, talk to your doctor, an asthma nurse, or pharmacist before using this medicine.
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 EG can cause a sudden drop in serum potassium levels (hypokalaemia). This is due to lack of oxygen in the blood, and some of the other treatments you may be taking together with Beclometasone and formoterolo EG can worsen this reduction in potassium levels.
If you are taking high doses of inhaled corticosteroids for long periods, you may require additional corticosteroids during stressful situations. Stressful situations may include hospitalisation following an accident, a serious injury, or before surgery. In such cases, your doctor will decide whether your corticosteroid dose needs to be increased and may prescribe steroid tablets or injectable steroids.
If you need to go to hospital, remember to bring your medicines and inhalers, including Beclometasone and formoterolo EG, and any over-the-counter medicines or tablets, in their original packaging if possible.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
Beclometasone and formoterolo EG must not be used in children and adolescents under 18 years of age.
Other medicines and Beclometasone and formoterolo EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. This is because Beclometasone and formoterolo EG may affect how other medicines work. Some other medicines may also affect how Beclometasone and formoterolo EG 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 EG, and your doctor may wish to monitor you closely if you are taking these (including certain HIV treatments: ritonavir, cobicistat).
Beta-blockers. Beta-blockers are medicines used to treat various conditions including heart problems, high blood pressure, and glaucoma (increased pressure in the eyes). If you need to use beta-blockers, including eye drops, the effect of formoterol may be reduced or blocked.
Beta-adrenergic medicines (medicines that work similarly to formoterol) may enhance the effect 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 (levodopa).
Medicines used to treat hypothyroidism (levotiroxine).
Medicines containing oxytocin (which cause 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 in the treatment of asthma (theophylline, aminophylline, or steroids).
Diuretics (tablets that increase urine production).
Also inform your doctor if you are due to undergo general anaesthesia for a surgical or dental procedure.
Pregnancy, breastfeeding, and fertility
There are no clinical data on the use of Beclometasone and formoterolo EG in pregnant women.
Do not use Beclometasone and formoterolo EG 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 EG will impair your ability to drive or operate machinery.
Beclometasone and formoterolo EG contains alcohol
This medicine contains 9 mg of alcohol (ethanol) per dose, equivalent 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 wine or 1 mL of beer. The small amount of alcohol in this medicine will not produce significant effects.
For those engaged in sports:
Using the medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Beclometasone and formoterol EG

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 receiving the optimal dose of Beclometasone and formoterol EG. Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.

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

Remember: You must 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 necessary in elderly patients. There is no information available on the use of Beclometasone and formoterol EG in patients with liver or kidney problems.

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

Beclometasone and formoterol EG is effective in the treatment of asthma with a dosage of beclometasone dipropionate that may be lower than that of other inhaled products containing this active substance. If you previously used a different beclometasone dipropionate-based inhaler, your doctor will advise you on the exact dose of Beclometasone and formoterol EG 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 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 no longer improves your symptoms, contact your doctor immediately.
Asthma may worsen, and your doctor may decide to change the dose of Beclometasone and formoterol EG or prescribe an alternative treatment.

Method of administration:
Beclometasone and formoterol EG is for inhalation use only.
This medicine is contained in a pressurized canister inside a plastic housing 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 show how many doses remain.

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

For the 180-actuation pack: the indicator will show the approximate number of actuations (sprays) remaining in the canister. The dose indicator window displays the number of sprays left in multiples of twenty (e.g., 180, 120, 100, 80, etc.). When 20 actuations remain and the display shows "20", this means the canister is nearing the end of its life.
When 180 actuations have been delivered, the display will show "0".
The indicator will stop functioning after reaching "0".

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 test the inhaler to ensure it works properly.
Remove the protective cap from the mouthpiece.
Hold the inhaler upright, with the mouthpiece pointing downward.
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 dose.
If you are using the inhaler for the first time, press firmly on the canister once to release one dose.
For the 120-actuation pack: check the dose counter. If using the inhaler for the first time, the counter should read 120.
For the 180-actuation pack: check the dose indicator. If using the inhaler for the first time, the counter should read 180.

DOSE COUNTER DOSE INDICATOR

How to use the inhaler
Whenever possible, stand or sit upright while inhaling.
Before starting, 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. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust, dirt, or any foreign objects (Figure 1).
2. Breathe out as slowly and deeply as possible (Figure 2).
3. Hold the canister upright, with the body of the inhaler pointing upward, and place your lips around the mouthpiece. Do not bite the mouthpiece with your teeth (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 top of the inhaler and both thumbs on the bottom (Figure 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 you need to administer a second dose, 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 a fungal infection in the mouth and throat, rinse your mouth, gargle with water, or brush your teeth every time you use the inhaler.

When to replace the inhaler
You should 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 top of the inhaler or from the sides of your mouth,
this means Beclometasone and formoterol EG is not reaching your lungs properly. Take another dose following the instructions from step 2.

If you think the effect of Beclometasone and formoterol EG 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 spacer device AeroChamber Plus. 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 for use and cleaning.

Cleaning
You must clean the 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.

How to clean the inhaler:

1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
2. Clean 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 EG than you should:
If you use more formoterol than you should, you may experience 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 check your potassium and blood glucose levels.
Excessive intake of beclometasone dipropionate may cause temporary adrenal gland problems. These will improve within a few days, but your doctor may need to perform blood tests to monitor your serum cortisol levels.
Inform your doctor if you experience any of these symptoms.

If you forget to use Beclometasone and formoterol EG:
Take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose; instead, take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

If you stop treatment with Beclometasone and formoterol EG:
Even if you feel better, do not stop taking Beclometasone and formoterol EG or reduce the dose. If you wish to do so, consult your doctor. It is very important that you use Beclometasone and formoterol EG regularly, even in the absence of symptoms.

If you have any questions about the use of this medicine, 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 EG. This effect is known as paradoxical bronchospasm. If this occurs, STOP treatment with Beclometasone and formoterolo EG IMMEDIATELY and use your "reliever" inhaler with rapid action to treat breathlessness and wheezing symptoms right away. Contact your doctor immediately.
Contact your doctor immediately if you experience any hypersensitivity reactions, such as skin allergies, skin itching, skin rash, skin redness, swelling of the skin or mucous membranes, particularly of the eyes, face, lips, and throat.

Other possible side effects are listed below by frequency:

Common (may affect up to 1 in 10 people):
fungal infections (of mouth and throat)
headache
hoarseness
sore throat

Uncommon (may affect up to 1 in 100 people):
palpitations, unusually fast heartbeat, and heart rhythm disorders
changes in electrocardiogram (ECG)
increased blood pressure
flu-like symptoms
sinusitis
rhinitis
ear inflammation
throat irritation
cough and productive cough
asthma attack
vaginal fungal infections
nausea
abnormal or altered sense of taste
burning of the lips
dry mouth
difficulty swallowing
indigestion
stomach disturbances
diarrhea
muscle pain and muscle cramps
redness of the face and throat
increased blood flow to certain tissues in the body
excessive sweating
tremor
restlessness
dizziness
urticaria (hives)
changes in certain blood components:
reduced number of white blood cells in the blood
increased number of platelets in the blood
reduced potassium concentrations in the blood
increased blood sugar levels
increased levels of insulin, free fatty acids, or 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 coughing, worsening breathing problems
reduced blood cortisol levels; caused by the effect of corticosteroids on the adrenal gland
irregular heartbeat

Rare (may affect up to 1 in 1,000 people):
chest tightness
absence of heartbeat (due to premature ventricular contractions)
decreased blood pressure
kidney inflammation
persistent swelling of skin and mucous membranes lasting several days

Very rare (may affect up to 1 in 10,000 people):
shortness of breath
worsening of asthma
decreased number of platelets in the blood
swelling of hands and feet

Long-term use of inhaled corticosteroids may, very rarely, cause effects throughout the body. These include:
adrenal gland function disorders (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 available data):
sleep disorders
depression or anxiety
nervousness
feeling of hyperexcitation or irritability.
These events are more likely to occur 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, 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 EG

Keep this medicine out of the sight and reach of children.
Single pack containing one 120-dose or one 180-dose inhaler
For the pharmacist
Store in the refrigerator (2-8 °C) for up to 18 months.
Label the adhesive label provided on the packaging with the date of dispensing to the patient and affix the label to the inhaler. Ensure that 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 EG more than 3 months after the date the pharmacist dispensed the inhaler, and never use it after the expiry date printed on the packaging after "Exp". The expiry date refers to the last day of that month.
Double or triple pack containing two or three 120-dose or 180-dose inhalers
Before use: store the inhalers in the refrigerator (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, write the date of first use on one of the adhesive labels provided on the packaging and affix this label to the inhaler in use. 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 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 several minutes before use.
Never heat the inhaler using artificial means.
Warning: 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 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 EG contains:
The active substances are: beclometasone diproprionate, formoterol fumarate dihydrate.
Each metered dose delivered from the inhaler contains 200 micrograms of beclometasone
dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to the amount delivered via
the mouthpiece, which is 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate
dihydrate.
The other components are anhydrous ethanol, concentrated hydrochloric acid and norflurane (HFA 134-a).
This medicinal product contains fluorinated greenhouse gases.
Each inhaler providing 120 actuations contains 10.35 g of HFA-134a, equivalent to 0.015 tonnes of CO₂
equivalent (global warming potential = 1,430).
Each inhaler providing 180 actuations contains 14.24 g of HFA-134a, equivalent to 0.020 tonnes of CO₂
equivalent (global warming potential = 1,430).

Description of the appearance of Beclometasone and Formoterolo EG and contents of the pack
Beclometasone and Formoterolo EG is a pressurized solution for inhalation contained in an aluminum canister with a metering valve, inserted into a white plastic inhaler device with a dose counter (pack of 120 actuations) or a dose indicator (pack of 180 actuations), and a green plastic protective cap.

Each pack contains:
1 pressurized canister (delivering 120 actuations) or
2 pressurized canisters (each delivering 120 actuations) or
3 pressurized canisters (each delivering 120 actuations) or
1 pressurized canister (delivering 180 actuations) or
3 pressurized canisters (each delivering 180 actuations)

Not all pack sizes may be marketed.

Marketing Authorization Holder:
EG S.p.A., via Pavia 6, 20136 Milano, Italy

Manufacturer:
Genetic S.p.A., Contrada Canfora, 84084 Fisciano - Salerno, Italy

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
AT Beclometason/Formoterol STADA 200 Mikrogramm /6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung
BE Beclometasone/Formoterol EG 200/6 microgram/dosis aërosol, oplossing
CZ Oreto
DE Beclometason/Formoterol AL 200 Mikrogramm/6 Mikrogramm pro Inhalation Druckgasinhalation, Lösung
DK Laberon
EE Bedufora
EL Beclometasone+Formoterol / STADA
FI Laberon
FR BECLOMETASONE / FORMOTEROL EG 200 / 6 microgrammes/dose, solution pour inhalation en flacon pressurisé
HR Laberon 200/6 mikrograma po potisku, stlačeni inhalat, otopina
IS Laberon
IT BECLOMETASONE E FORMOTEROLO EG
LT Bedufora 200 mikrogramų/6 mikrogramai/spūsnyje suslėgtasis įkvepiamasis tirpalas
LV Bedufora 200 mikrogrami/6 mikrogrami izsmidzinājumā aerosols inhalācijām, zem spiediena, šķīdums
NO Laberon
NL Beclometason/Formoterol CF 200/6 microgram/dosis, aërosol, oplossing
PL Bedufora
RO Beclometazonă /Formoterol Stada, 200/6 micrograme pe doză, soluţie de inhalat presurizată
SE Laberon
SK Beklometazón/Formoterol STADA 200/6 mikrogramov/dávka