BECLOMETASONE 100 MICROGRAMMI/6 MICROGRAMMI Roztwór ciśnieniowy do inhalacji

Treść ulotki

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

Beclometasone and formoterol EG

100 micrograms/6 micrograms/actuation, pressurised solution for inhalation
Generic medicine

Read 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same
symptoms as you, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 you use 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 is Beclometasone and formoterolo EG and what is it used for

Beclometasone and formoterolo EG is a pressurized inhalation solution containing two active ingredients
that are inhaled through the mouth and are released directly into the lungs.
The two active ingredients are beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids which 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.
These two active ingredients, together, make breathing easier, relieving symptoms such as shortness of breath,
wheezing and coughing in patients with asthma or COPD and also help to prevent asthma symptoms.
Asthma
Beclometasone and formoterolo EG is indicated for the regular treatment of asthma in adult patients in whom:

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

COPD
Beclometasone and formoterolo EG can also be used to treat the symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic disease of the airways
lungs mainly caused by cigarette smoking.

Beclometasone and formoterolo EG is intended for use in adults.

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

Do not use Beclometasone and formoterol 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 formoterol EG:

• if you have heart problems, such as angina (heart pain, chest pain), have recently had a heart attack (myocardial infarction), heart failure, narrowing of the arteries near the heart (coronary artery disease), heart valve disease or any other known heart condition, or if you suffer from a condition known as obstructive hypertrophic cardiomyopathy (also known as HOCM, a condition characterized by abnormal heart muscle).
• if you have a narrowing of the arteries (also known as arteriosclerosis), if you suffer from high blood pressure or if you know you have an aneurysm (an abnormal bulge in the wall of blood vessels).
• if you suffer from heart rhythm disorders, such as an increase or irregularity in heart rate, a fast or irregular heartbeat, or if an abnormal ECG has been detected.
• if you have an overactive thyroid.
• 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 can increase blood glucose levels; therefore, you may need to undergo periodic further tests to check your blood sugar when you start using this medicine).
• if you have a tumor of the adrenal gland (known as pheochromocytoma).
• if you are going to have an anaesthetic. Depending on the type of anaesthetic, you may need to stop treatment with Beclometasone and formoterol EG at least 12 hours before the anaesthetic.
• if you have or have previously been treated for tuberculosis (TB) or if you have a known viral or fungal infection in your chest.
• if you need to avoid drinking alcohol for any reason.

If any of the above conditions apply to you, always tell your doctor before using
Beclometasone and formoterol EG.
If you have or have had any medical problem or allergy, or if you are not sure you can use
Beclometasone and formoterol EG, ask your doctor or pharmacist before using this medicine.
Treatment with a beta-agonist like formoterol, contained in Beclometasone and formoterol EG, can
cause a sudden drop in serum potassium levels (hypokalaemia).

Particular caution is recommended in cases of severe asthma.This is due to a lack of oxygen
in the blood and some of the other treatments you may be taking together with Beclometasone and formoterol
EG, such as medicines for the treatment of heart problems or high blood pressure, known as diuretics
or “water tablets”, or other medicines used in the treatment of asthma can
worsen the reduction in potassium levels. For this reason, your doctor may want to monitor
potassium levels in your blood periodically.

If you are taking high doses of inhaled corticosteroids for long periods of time,you may
have a greater need for corticosteroids in stressful situations. Stressful situations can include
hospitalization following an accident, a serious injury, or before surgery. In such cases, the
doctor will decide whether it is necessary to increase the dose of corticosteroids and may prescribe steroids in
tablets or steroid injections.

If you have to go to hospital, remember to bring all your medicines and inhalers, including
Beclometasone and formoterol 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 formoterol EG should not be used in children and adolescents under 18
years of age, until further data are available.

Other medicines and Beclometasone and formoterol EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription. This is because Beclometasone and
formoterol EG can affect the way other medicines work. Also, some other medicines
can affect the way Beclometasone and formoterol EG works.
In particular, tell your doctor, pharmacist or nurse if you are taking any of the following
medicines:
Some medicines can increase the effects of Beclometasone and formoterol EG and your doctor
may want to monitor you closely if you are taking these medicines (including some
medicines for the treatment of HIV: ritonavir, cobicistat).
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 cancelled.
Beta-adrenergic medicines (medicines that work in the same way as formoterol) can
enhance the effect of formoterol.
Medicines for the treatment of heart rhythm abnormalities (quinidine, disopyramide,
procainamide).
Medicines used to treat allergic reactions (antihistamines).
Medicines for the treatment of 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 for the treatment of Parkinson's disease (levodopa).
Medicines for the treatment of hypothyroidism (levothyroxine).
Medicines containing oxytocin (which cause the uterus to contract).
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, tell your doctor if you are going to have a general anaesthetic for surgery or dental treatment.

Pregnancy, breastfeeding and fertility
There is no clinical data regarding the use of Beclometasone and formoterol EG in pregnant women.
Do not use Beclometasone and formoterol EG if you are pregnant, suspect you might be pregnant or are planning a
pregnancy, or if you are breastfeeding, unless your doctor has advised you to do so.

Driving and using machines
It is unlikely that Beclometasone and formoterol EG will affect your ability to drive or
use machines.

Beclometasone and formoterol EG contains alcohol
This medicine contains 7 mg of alcohol (ethanol) in each actuation, which is equivalent to 0.20 mg/kg per
dose of two actuations. 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:
The use of the drug without therapeutic necessity constitutes doping and may still result in positive
anti-doping tests.

3. How to use Beclometasone and formoterol EG

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.

Asthma
Your doctor will keep you under regular control to ensure that you are taking the optimal dose of
Beclometasone and formoterol EG. The doctor will adjust the treatment to the lowest dose that best controls
your symptoms.

Beclometasone and formoterol EG can be prescribed by the doctor in two different ways:
a)Daily use of Beclometasone and formoterol EG for the treatment of asthma
together with a specific inhaler "as needed" to treat sudden worsening of
asthma symptoms, such as shortness of breath, wheezing and cough.
Adults and the elderly:
The recommended dose of this medicine is one or two puffs twice a day. The maximum daily
dose is 4 puffs.
Remember: You should always carry your "as needed" fast-acting inhaler with you to treat a
worsening of asthma symptoms or a sudden asthma attack.

b)Daily use of Beclometasone and formoterol EG for the treatment of asthma and further
use of Beclometasone and formoterol EG to treat sudden worsening of
asthma symptoms, such as shortness of breath, wheezing and cough.
Adults and the elderly:
The recommended dose is one puff in the morning and one puff in the evening.
You should also use Beclometasone and formoterol EG as a "as needed" inhaler to treat sudden asthma symptoms.
If you experience asthma symptoms, take one puff and wait a few minutes.
If you do not feel better, take another puff.

Do not take more than 6 puffs of Beclometasone and formoterol EG "as needed" per day.
The maximum daily dose of Beclometasone and formoterol EG as a single inhaler for asthma is
8 puffs.
If you think you need a higher number of puffs per day to control your asthma symptoms,
ask your doctor for advice. It may be necessary to modify the therapy.

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

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

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.

Beclometasone and formoterol EG is effective in the treatment of asthma with a dosage of
beclometasone dipropionate which may be lower than that of other inhalable products containing beclometasone dipropionate. If you were previously using a different inhaler
based on beclometasone dipropionate, your doctor will advise you on the exact dose of Beclometasone and
formoterol EG to take to treat asthma.
Do not increase the dose
If you think the medicine is not very effective, always consult your doctor before increasing the
dosage.

If your breathing gets worse:
If you experience worsening shortness of breath or your breathing becomes wheezy(wheezing
clearly audible), immediately after inhaling the medicine, stop using Beclometasone and
formoterol EG immediately and use your fast-acting "as needed" inhalerright away. Contact your
doctor immediately.
The doctor will evaluate the symptoms and, if necessary, decide to start a different treatment.
See also section 4 - Possible side effects.

If your asthma gets worse:
If your symptoms worsen or are difficult to control (for example if you use another "as needed" inhaler
or Beclometasone and formoterol EG as a rescue inhaler more frequently), or if your
"as needed" inhaler or Beclometasone and formoterol EG does not improve your symptoms, contact your
doctor immediately. Asthma may worsen and the doctor may decide to change the dose of Beclometasone and
formoterol EG or prescribe alternative treatment.

How to administer:
Beclometasone and formoterol EG is for inhalation use.
This medicine is contained in a pressurized container inside a plastic casing with a
mouthpiece. On the back of the inhaler there is a counter for 120 doses and an indicator for 180 doses, which
indicate how many doses are remaining.
For the 120-dose pack, each time you press the container, a dose of
medicine is released, decreasing the counter by one unit. Be careful not to drop the inhaler, as
this may cause the dose counter to decrease by one dose.
For the 180-dose pack, the indicator will show the approximate number of doses (sprays)
remaining in the container. The dose indicator window shows the number of sprays remaining in the inhaler
in units of twenty (e.g. 180, 120, 100, 80, etc.). When 20 doses remain and the display
shows the number 20, it means that the container is nearing the end of its life cycle.
When 180 doses have been discharged, the display will show the number 0.
The indicator will stop working after reaching "0".

Checking the operation of the inhaler
Before using the inhaler for the first time or if you have not used it for 14 days or more, you must try the inhaler
to verify that it is working correctly.

• Remove the protective cap from the mouthpiece.
• Hold the inhaler in a vertical position, with the mouthpiece facing down.
• Point the mouthpiece away from you and press firmly on the container to deliver a dose.
• If you have not used the inhaler for 14 days or more, press firmly on the container once to release a dose.
• For the 120-dose pack: check the counter. If you are using the inhaler for the first time, the counter should indicate 120.
• For the 180-dose pack: check the dose indicator. If you are using the inhaler for the first time, the counter should indicate 180.

DOSE COUNTER
DOSE INDICATOR
How to use the inhaler
When possible, remain standing or sitting upright while inhaling.
Before starting inhalation, check the dose counter or indicator that shows how many doses are
remaining. If the dose counter or indicator shows "0", there are no doses remaining: dispose of the inhaler and
get 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 and dirt or any foreign object (Figure 1).
• 2. Exhale as slowly and deeply as possible (Figure 2).
• 3. Hold the container in a vertical position, with the body of the dispenser facing upwards and place your lips around the mouthpiece. Do not bite the mouthpiece with your teeth (Figure 3).
• 4. Take a slow, deep breath through your mouth and immediately after starting to inhale, pressfirmlyon the top of the inhaler to deliver a 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 (Figure 4).
• 5. Hold your breath as long as possible, and at the end, remove the inhaler from your mouth and exhale slowly. Do not exhale into the inhaler (Figure 5).

If you need to deliver a second dose, hold the inhaler in a vertical position for about half a minute, then repeat
steps 2 to 5.

Important:Do not perform steps 2 to 5 too quickly.
After use, close with the protective cap and check the counter of the 120-dose pack and the dose indicator of 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 each time you use the inhaler.

When to replace the inhaler
You should get a new inhaler when the dose counter shows the number 20. Stop using the inhaler
when the dose counter shows the number 0, the doses remaining in the device may not be sufficient to
provide you with 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,
it means that Beclometasone and formoterol EG will not reach your lungs as it should. Take another
dose following the instructions starting from step 2.
If you think the effect of Beclometasone and formoterol EG is excessive or insufficient, tell your doctor
or pharmacist.
If you have difficulty using the inhaler while starting to inhale, you can use the AeroChamber Plus spacer device. Ask your doctor, pharmacist or nurse for information about this device.
follow the instructions for use and cleaning carefully.

Cleaning
You should clean the inhaler once a week.

During cleaning, do not remove the container from the dispenser 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 handkerchief.
• 3. Reposition 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, fast heartbeat, palpitations, irregular heartbeat, some changes in the electrocardiogram (heart tracing), headache, tremor, drowsiness, excess acid in the blood, low levels of potassium in the blood, high levels of glucose in the blood. The doctor may want to perform some blood tests to check your potassium and glucose levels in the blood.
• Excessive intake of beclometasone dipropionate can cause temporary disturbances of the adrenal gland. These will improve within a few days, however your doctor may need to perform some blood tests to check 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 to take the next dose, do not take the missed
dose, but take the next dose at the scheduled time.

Do not take a double dose to make up for a missed 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 want to do so, consult your doctor. It is very important that you use Beclometasone and formoterol EG with
regularity even in the absence of symptoms.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other inhaled treatments, there is a risk of worsening of breathlessness and wheezing immediately after using Beclometasone and formoterolo EG. This effect is known as paradoxical bronchospasm. If this happens, IMMEDIATELY STOP treatment with Beclometasone and formoterolo EGand use your reliever inhaler straight away to treat your breathlessness and wheezing. Contact your doctor immediately.

Tell your doctor immediatelyif you experience any hypersensitivity reactionsuch as skin allergies, itchy skin, skin rash, skin redness, swelling of the skin or mucous membranes and in
particular of the eyes, face, lips and throat.
Other possible side effects are listed below according to their frequency:

Common(may affect up to 1 in 10 people):
fungal infections (of the mouth and throat)
headache
hoarseness
sore throat
Pneumonia in patients with COPD: Tell your doctor if you have any of the following symptoms while
taking Beclometasone and formoterolo EG as they could be symptoms of a lung infection:
fever or chills
increased mucus production, change in mucus color
increased cough or increased difficulty breathing

Uncommon(may affect up to 1 in 100 people):
palpitations, unusually fast heartbeat and heart rhythm disorders
changes in the electrocardiogram (ECG)
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 discomfort
diarrhoea
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
alteration of some blood components:
reduction in the number of white blood cells in the blood
increase in the number of platelets in the blood
reduction in 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
bronchopneumonia:
reduction in cortisol levels in the blood; this is caused by the effect of corticosteroids on the
adrenal gland
irregular heartbeat

Rare(may affect up to 1 in 1000 people):
chest tightness
missed heartbeat (caused by premature ventricular contractions)
decreased blood pressure
increased blood pressure
kidney inflammation
swelling of skin and mucous membranes, persisting 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

The use of inhaled corticosteroids for prolonged periods can, in very rare cases, cause effects on the whole
body.These include:
disorders of adrenal gland function (adrenal suppression)
reduction in bone mineral density (thinning of the bones)
delayed growth in children and adolescents
increased pressure in the eye (glaucoma)
cataract

Not known (frequency cannot be estimated from the available data):
sleep disorders
depression or anxiety
nervousness
feeling of overstimulation or irritability
These events are more likely to occur in children, but the frequency is unknown.
blurred vision
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in
this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Beclometasone and formoterolo EG

Keep this medicine out of the sight and reach of children.

Single pack containing a 120-dose actuator or an 180-dose actuator
For the pharmacist
Store in a refrigerator (2-8 °C) for a maximum of 18 months.
Affix the dispensing date to the patient on the adhesive label on the packaging and apply
the label to the inhaler. Ensure that 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 a temperature above 25 °C.
Do not use Beclometasone and formoterolo EG after 3 months have elapsed from the date the inhaler was dispensed
by the pharmacist and never use it 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.

Double or triple pack containing two or three 120 or 180-dose actuators
Before use:store the inhalers in a 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, affix the date of first use to one of the adhesive labels
on the packaging and apply this label to the inhaler in use. The inhalers must not be
used after 3 months from 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 using it.
Never heat it with artificial means.

Warning:The container contains a pressurized liquid. Do not expose the container to temperatures
above 50 °C. Do not puncture the container.
Do not dispose of any medicine in drain water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Beclometasone and formoterolo EG contains:
The active ingredients are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each actuation/predefined dose released from the inhaler contains 100 micrograms of beclometasone
dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose, from the
mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate
dihydrate.
The other ingredients are anhydrous ethanol, concentrated hydrochloric acid and norflurane (HFA -134a).
This medicine contains fluorinated greenhouse gases.
Each inhaler with 120 actuations contains 8.15 g of HFA-134a which corresponds to 0.012 tonnes of CO
equivalent (global warming potential = 1,430).
Each inhaler with 180 actuations contains 11.2 g of HFA-134a which corresponds to 0.016 tonnes of CO
equivalent (global warming potential = 1,430).

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

Marketing Authorisation 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 authorised in the Member States of the European Economic Area (EEA) under the
following denominations:
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

Beclometasone and formoterol EG

200 micrograms/6 micrograms/actuation, pressurised solution for inhalation
Generic medicine

Read 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 questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms
are the same as yours, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. 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 you use 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 is Beclometasone and formoterolo EG and what is it used for

Beclometasone and formoterolo EG is a pressurized inhalation solution containing two active ingredients
which are inhaled through the mouth and are released directly into the lungs.
The two active ingredients are beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids which exert
an anti-inflammatory action by 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.
These two active ingredients, together, make breathing easier, relieving symptoms such as shortness of breath,
wheezing and cough in patients with asthma and also help to prevent asthma symptoms.

Beclometasone and formoterolo EG is used for the treatment of asthma in adults.
If Beclometasone and formoterolo EG has been prescribed to 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 ingredients 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, chest discomfort), 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 the
blood vessels).
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 heart tracing is abnormal.
if you have an overactive thyroid.
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 can increase blood glucose levels.
Therefore, you may need to have periodic further tests to check
your blood sugar when you start using this medicine).
if you have a tumor of the adrenal gland (known as pheochromocytoma).
if you are going to have an anesthetic. Depending on the type of anesthetic, you may need to stop
treatment with Beclometasone and formoterolo EG at least 12 hours before the anesthetic.
if you have or have been treated for tuberculosis (TB) or if you have a known viral or fungal infection in the
chest.
if you need to avoid drinking alcohol for any reason.
If any of the above conditions apply to you, always tell your doctor before using
Beclometasone and formoterolo EG.
If you have or have had any medical problem or allergy, or if you are not sure you can use
Beclometasone and formoterolo EG, talk to your doctor, an asthma nurse or your pharmacist
before using this medicine.

Your doctor may want to measure 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 a lack of oxygen in the blood and some
of the other treatments you may be taking with Beclometasone and formoterolo EG can worsen
the reduction in potassium levels.

If you are taking high doses of inhaled corticosteroids for long periods of time,you may
have a greater need for corticosteroids in stressful situations. Stressful situations can include
hospitalization following an accident, a serious injury, or before surgery. In such cases, the
doctor will decide whether it is necessary to increase the dose of corticosteroids and may prescribe steroids in
tablets or steroid injections.

If you have to go to hospital,remember to take your medicines and inhalers, including Beclometasone and
formoterolo EG and any over-the-counter medicines or tablets, with you 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 should 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 available without a prescription. This is because Beclometasone and
formoterolo EG can affect the way other medicines work. Also, some other medicines can affect the way Beclometasone and
formoterolo EG works.
In particular, tell 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 want 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 cancelled.
Beta-adrenergic medicines (medicines that have the same effect as formoterol) can
enhance the effect of formoterol.
Medicines for the treatment of heart rhythm abnormalities (quinidine, disopyramide,
procainamide).
Medicines used to treat allergic reactions (antihistamines).
Medicines for the treatment of depression or mental disorders such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide), 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 the uterus to contract).
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 (tablets that promote diuresis).
Also, tell your doctor if you are going to have a general anesthetic for surgery or dental treatment.

Pregnancy, breastfeeding and fertility
There is no clinical data regarding the use of Beclometasone and formoterolo EG in pregnant women.
Do not use Beclometasone and formoterolo EG if you are pregnant, suspect you are pregnant or are planning a
pregnancy or if you are breastfeeding, unless your doctor has told you to do so.

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

Beclometasone and formoterolo EG contains alcohol
This medicine contains 9 mg of alcohol (ethanol) in each actuation, which is equivalent to 0.25 mg/kg per
dose of two actuations. The amount in two actuations 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 have any significant effects.

For athletes:
The use of the drug without therapeutic necessity constitutes doping and may still result in positive
anti-doping tests.

3. How to use Beclometasone and formoterol EG

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have doubts
consult your doctor or pharmacist.
Your doctor will keep you under regular control to make sure you are taking the optimal dose of
Beclometasone and formoterol EG. The doctor will adjust the treatment to the lowest dose that best controls
your symptoms.

Dosage:
Adults and elderly:
The recommended dose is two puffs twice a day.
The maximum daily dose is 4 puffs.

Remember: You should always carry your "as needed" fast-acting inhaler with you to treat a
worsening of asthma symptoms or a sudden asthma attack.
Patients at risk:
No dose adjustment is necessary if you are elderly. 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 should 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 inhaler products containing this active ingredient. If you were previously using a different inhaler based on beclometasone dipropionate, your doctor will advise on the exact dose of Beclometasone and
formoterol EG to take to treat asthma.
Do not increase the dose
If you think the medicine is not very effective, always consult your doctor before increasing the
dosage.

If asthma worsens:
If your symptoms worsen or are difficult to control (for example, if you use another "as needed" inhaler
more frequently), or if your "as needed" inhaler does not improve 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 alternative treatment.

Method of administration:
Beclometasone and formoterol EG is for inhalation use.
This medicine is contained in a pressurized container inside a plastic casing with a
mouthpiece. On the back of the inhaler there is a counter for 120 doses and a dose indicator for 180
doses, which indicate how many doses are remaining.
For the 120-dose pack, each time you press the container, one dose of
medicine is released, decreasing the counter by one unit. Be careful not to drop the inhaler, as
this may cause the dose counter to decrease by one dose.
For the 180-dose pack, the indicator will show the approximate number of doses (sprays)
remaining in the container. The dose indicator window shows the number of sprays remaining in the inhaler
in units of twenty (e.g. 180, 120, 100, 80, etc.). When 20 doses remain and the display
shows the number 20, it means that the container is nearing the end of its life cycle.
When 180 doses have been discharged, the display will show the number 0.
The indicator will stop working after reaching "0".

Checking the inhaler's operation
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 verify that it is working correctly.
Remove the protective cap from the mouthpiece.
Hold the inhaler in a vertical position, with the mouthpiece facing down.
Move the mouthpiece away from you and press firmly on the container to deliver a dose.
If you have not used the inhaler for 14 days or more, press firmly on the container once to
release a dose.
If you are using the inhaler for the first time, press firmly on the container 1 time to release a dose and
press the container.
For the 120-dose pack: check the counter. If you are using the inhaler for the first time,
the counter should indicate 120.
For the 180-dose pack: check the dose indicator. If you are using the inhaler for the
first time, the counter should indicate 180.

COUNTERI DOSE
INDICATOR
How to use the inhaler
When possible, remain standing or sitting in an upright position while performing the inhalation.
Before starting the inhalation, check the counter or dose indicator showing how many doses are
remaining. If the counter or dose indicator shows "0", there are no doses remaining: dispose of the inhaler and
obtain a new one.

• 2) 3) 4) 5)
• 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust and dirt or any foreign body (Figure 1).
• 2. Exhale as slowly and deeply as possible (Figure 2).
• 3. Hold the container in a vertical position, with the body of the dispenser facing upwards and place your lips around the mouthpiece. Do not bite the mouthpiece with your teeth (Figure 3).
• 4. Take a slow and deep breath through your mouth and immediately after starting to inhale, pressfirmlyon the top of the inhaler to deliver a 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 (Figure 4).
• 5. Hold your breath as long as possible, and at the end remove the inhaler from your mouth and exhale slowly. Do not exhale into the inhaler (Figure 5).

If you need to deliver a second dose, hold the inhaler in a vertical position for about half a minute and then
repeat steps 2 to 5.

Important:Do not perform steps 2 to 5 too quickly.
After use, close with the protective cap and check the counter of the 120-dose pack and the dose indicator of 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 each time you use the inhaler.

When to replace the inhaler
You should obtain a new inhaler when the counter shows the number 20. Stop using the inhaler
when the counter shows the number 0, the doses remaining in the device may not be sufficient to
provide you with 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,
it means that Beclometasone and formoterol EG will not reach your lungs as it should. Take another
dose following the instructions starting from step 2.
If you think the effect of Beclometasone and formoterol EG is too much or not enough, tell your doctor
or pharmacist.
If you have difficulty using the inhaler while starting to inhale, you can use the AeroChamber Plus spacer device. Ask your doctor, pharmacist or nurse for information about this device.
follow the instructions for use and cleaning carefully.

Cleaning
You should clean the inhaler once a week.

During cleaning, do not remove the container from the dispenser 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 handkerchief.
• 3. Reposition 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,
fast heartbeat, palpitations, heart rhythm disturbances, some changes in the electrocardiogram
(heart tracing), headache, tremor, drowsiness, excess acid in the blood, low levels of potassium
in the blood, high levels of glucose in the blood. The doctor may want to perform some blood tests to check your potassium and glucose levels in the blood.
Excessive intake of beclometasone dipropionate can cause temporary disorders of the
adrenal gland. These will improve within a few days, however, your doctor may
need to perform some blood tests to check your serum cortisol levels.

Tell 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 to take the next dose, do not take the forgotten dose, but take the next dose at the scheduled time. Do not take a double dose to make up
for the missed 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 want to do so, consult your doctor. It is very important that you use Beclometasone and formoterol EG with
regularity even in the absence of symptoms.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other treatments via inhalation, there is a risk of worsening of breathlessness and wheezing immediately after using Beclometasone and formoterol EG. This effect is known as paradoxical bronchospasm. If this happens, IMMEDIATELY STOP treatment with Beclometasone and formoterol EGand immediately use your reliever inhaler to treat the symptoms of breathlessness and wheezing. Consult your doctor immediately.

Tell your doctor immediatelyif you experience any hypersensitivity reactionsuch as skin allergies, skin itching, skin rash, skin redness, swelling of the skin or mucous membranes and in particular of the eyes, face, lips and throat.
Other possible side effects are listed below according to their frequency:

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

Uncommon(may affect up to 1 in 100 people):
palpitations, unusually fast heartbeat and heart rhythm disorders
changes in the 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 lips
dry mouth
difficulty swallowing
indigestion
stomach discomfort
diarrhoea
muscle pain and muscle cramps
redness of the face and throat
increased blood flow to certain tissues of the body
excessive sweating
tremor
restlessness
dizziness
urticaria
alteration of some blood components:
reduction in the number of white blood cells in the blood
increase in the number of platelets in the blood
reduction in 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:
pneumonia; tell your doctor if you notice any of the following symptoms: increased sputum production, change in sputum colour, fever, increased cough, increased breathing problems
reduction in cortisol levels in the blood; this is caused by the effect of corticosteroids on the adrenal gland
irregular heartbeat

Rare(may affect up to 1 in 1000 people):
chest tightness
missed heartbeat (caused by premature ventricular contractions)
decreased blood pressure
kidney inflammation
swelling of skin and mucous membranes persisting 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 can, in very rare cases, cause effects on the whole
body.These include:
disorders of adrenal gland function (adrenal suppression)
reduction in bone mineral density (thinning of the bones)
delayed growth in children and adolescents
increased pressure in the eye (glaucoma)
cataract

Not known (frequency cannot be estimated from the available data):
sleep disturbances
depression or anxiety
nervousness
feeling of hyperactivity or irritability.
These events are more likely to occur in children, but the frequency is not known.
blurred vision
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Beclometasone and formoterolo EG

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 a refrigerator (2-8 °C) for a maximum of 18 months.
Affix the date of dispensing to the patient on the adhesive label on the packaging and apply
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 a temperature above 25 °C.
Do not use Beclometasone and formoterolo EG after 3 months have passed from the date the inhaler was delivered
by the pharmacist and never use it after the expiry date stated on the packaging
after "Expiry". 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 a 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, affix the date of first use to one of the adhesive labels
on the packaging and apply this label to the inhaler in use. The inhalers must not be
used after 3 months from first use and must never be used after the expiry date stated
on the box and label after “Expiry”.
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 using it.
Never heat it with artificial means.

Warning:The container contains a pressurized liquid. Do not expose the container to temperatures
above 50 °C. Do not puncture the container.
Do not dispose of any medicine in drains or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Beclometasone and formoterolo EG contains:
The active ingredients are: beclometasone dipropionate, formoterol fumarate dihydrate.
Each metered dose released from the inhaler contains 200 micrograms of beclometasone
dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a dose delivered by the
mouthpiece, of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate
dihydrate.
The other ingredients are anhydrous ethanol, concentrated hydrochloric acid and norflurane (HFA 134-a).
This medicine contains fluorinated greenhouse gases.
Each inhaler with 120 actuations contains 10.35 g of HFA-134a, which corresponds to 0.015 tonnes of CO
equivalent (global warming potential = 1,430).
Each inhaler with 180 actuations contains 14.24 g of HFA-134a, which corresponds to 0.020 tonnes of CO
equivalent (global warming potential = 1,430).

Description of the appearance of Beclometasone and formoterolo EG and package contents
Beclometasone and formoterolo EG is a pressurized solution for inhalation contained in an aluminum container with a
metering valve, inserted into a white plastic actuator with a counter (120 actuations pack) or a dose
indicator (180 actuations pack) with a green protective cap.
Each pack contains:
1 pressurized container (providing 120 actuations) or
2 pressurized containers (each providing 120 actuations) or
3 pressurized containers (each providing 120 actuations) or
1 pressurized container (providing 180 actuations) or
3 pressurized containers (each providing 180 actuations)
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area (EEA) under the
following denominations:
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