CLENIL 0.8 MG + 1.6 MG Небулизируемая суспензия

Содержание инструкции

1. CLENIL COMPOSITUM 0.8 mg + 1.6 mg/ 2 ml suspension for nebulisation
   1. What is CLENIL COMPOSITUM and what is it used for
   2. What you need to know before taking CLENIL COMPOSITUM
   3. How to take CLENIL COMPOSITUM
   4. Possible side effects
   5. How to store CLENIL COMPOSITUM
   6. Package Contents and Other Information
2. CLENIL COMPOSITUM 250 mcg + 100 mcg pressurised suspension for inhalation
   1. What is CLENIL COMPOSITUM and what is it used for
   2. What you need to know before taking CLENIL COMPOSITUM
   3. How to take CLENIL COMPOSITUM
   4. Possible side effects
   5. How to store CLENIL COMPOSITUM
   6. Contents of the pack and other information
3. CLENIL COMPOSITUM 250 mcg + 100 mcg pressurised suspension for inhalation
   1. What is CLENIL COMPOSITUM and what is it used for
   2. What you need to know before taking CLENIL COMPOSITUM
   3. How to take CLENIL COMPOSITUM
   4. Possible side effects
   5. How to store CLENIL COMPOSITUM
   6. Contents of the pack and other information

CLENIL COMPOSITUM 0.8 mg + 1.6 mg/ 2 ml suspension for nebulisation

Beclometasone dipropionate; Salbutamol

Read this leaflet carefully before you start to take 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 their symptoms are the same as yours, as it could 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 CLENIL COMPOSITUM is and what it is used for
• 2. What you need to know before you take CLENIL COMPOSITUM
• 3. How to take CLENIL COMPOSITUM
• 4. Possible side effects
• 5. How to store CLENIL COMPOSITUM
• 6. Contents of the pack and other information

1. What is CLENIL COMPOSITUM and what is it used for

CLENIL COMPOSITUM is a medicine that contains 2 active ingredients:

• beclometasone dipropionate, belonging to the group of corticosteroids, which reduces swelling and inflammation of the airways;
• salbutamol, belonging to the group of bronchodilators, which relaxes the muscles of the walls of the small airways of the lungs.

CLENIL COMPOSITUM is used to prevent breathing difficulties due to asthma and other
conditions that involve a narrowing of the bronchi (chronic obstructive bronchopneumopathy with
asthmatic component).

2. What you need to know before taking CLENIL COMPOSITUM

Do not take CLENIL COMPOSITUM if:

• you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6);
• you have lung infections caused by viruses;
• you have or have had pulmonary tuberculosis;
• you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor before taking CLENIL COMPOSITUM if:

• you are taking corticosteroids;
• you have increased thyroid function (hyperthyroidism);
• you have heart problems such as: diseases of the heart vessels (coronary artery disease), irregular heartbeat (arrhythmias) or heart function (heart failure);
• you suffer from high blood pressure (arterial hypertension);
• you have an enlarged prostate (prostatic hypertrophy);
• you have increased pressure in the eye with possible worsening of vision (glaucoma);
• you have diabetes;
• you have a particular tumor of the adrenal gland called pheochromocytoma. Contact your doctor if you experience blurred vision or other visual disturbances.

Pay particular attention if

• during therapy with CLENIL COMPOSITUM asthma worsens or does not improve or you have increased difficulty breathing. This means that your bronchospasm is persistent;
• you are switching from treatment with corticosteroids for systemic therapy (e.g. tablets) to inhaled therapy. Initially, your doctor will tell you to take both therapies, then gradually reduce the systemic corticosteroid;
• you have heart disease and during therapy with CLENIL COMPOSITUM you experience chest pain or worsening of symptoms due to heart disease;
• you notice psychological and behavioral effects such as: psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disorders (predominantly in children). These effects rarely occur during therapy with inhaled corticosteroids.

IN ALL THESE CASES CONSULT YOUR DOCTOR WHO MAY PRESCRIBE APPROPRIATE THERAPY
For long-term therapy, like with all medicines, CLENIL COMPOSITUM can cause redness and
itching (sensitization phenomena). If this occurs, stop treatment and consult your
doctor.

Children and adolescents
In children using CLENIL COMPOSITUM, height should be measured regularly as
long-term treatment with inhaled corticosteroids may lead to a slowing of
growth. In this case, consult your doctor as it may be necessary to modify the therapy.

Other medicines and CLENIL COMPOSITUM
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained
without a prescription.
This is particularly important if you are using:

• drugs belonging to the same class as beclometasone (corticosteroids) for systemic use (e.g. tablets) or nasally, as this may increase the risk of altered adrenal function (adrenal suppression);
• drugs belonging to the same class as salbutamol (sympathomimetics), which stimulate the nervous system and have effects mainly on the heart and blood vessels;
• beta-blockers, used mainly for high blood pressure (hypertension) and heart disease.

Some medicines can increase the effects of CLENIL COMPOSITUM and your doctor may want to keep you
under close observation if you are taking these medicines (including some medicines for the
treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, do not take CLENIL COMPOSITUM

Driving and operating machinery
CLENIL COMPOSITUM does not impair the ability to drive or operate machinery.

CLENIL COMPOSITUM contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically ‘sodium-free’.
For those who engage in sports:
the use of the drug without therapeutic necessity constitutes doping and may still result in positive
anti-doping tests.

3. How to take CLENIL COMPOSITUM

Take this medicine following the instructions of your doctor exactly, if you have doubts, consult your
doctor or pharmacist.
The doctor will indicate the correct dose of this medicine, based on the severity of your condition.
CLENIL COMPOSITUM is used to treat the initial period of your illness, your doctor will
prescribe an alternative medicine after about 10 days.
The average dose is 1 vial 1-2 times a day in adults.

Use in children
half the content of a vial, 1-2 times a day.
The vial has a graduation corresponding to half a dose.

Method of administration
Shake the medicine vigorously before use
This medicine must be nebulized (transformed into very small droplets) by means of an “aerosol
device”, equipped with devices for administration through the mouth and/or nose.
Take CLENIL COMPOSITUM by inhalation, through the mouth; inhale deeply to
ensure the entry of the drug into the lungs.
To use this medicine correctly, consult the section “Instructions for use of CLENIL
Immediately after using CLENIL COMPOSITUM, rinse your mouth thoroughly with water; this will
reduce the risk of fungal infections. The rinsing liquid must not be swallowed.

If you take more CLENIL COMPOSITUM than you should
If you accidentally take excessive doses of CLENIL COMPOSITUM, you may notice an increase in heart
beats and muscle tremors that disappear after a few days or alterations in adrenal function;
however, immediately inform your doctor or go to the nearest hospital, as appropriate
measures may be necessary.

If you forget to take CLENIL COMPOSITUM
Continue regularly with the therapy, without doubling the next dose.

If you stop taking CLENIL COMPOSITUM
Do not stop treatment without consulting your doctor.
If you have any doubts 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 will experience them.
undesirable.
As with other medicines taken by inhalation, immediately after taking the dose, shortness of breath, cough, wheezing and gasping ( paradoxical bronchospasm) may occur. The frequency of this side
effect is not known. If this happens, stop taking CLENIL
COMPOSITUM immediatelyand contact your doctor.
Other side effects
If you use CLENIL COMPOSITUM, especially at high doses and/or for prolonged periods of time, you may
experience other side effects. Inform your doctor if you notice:

Common side effects(may affect up to 1 in 10 people)
pneumonia (lung infection), in patients with COPD.
Inform your doctor if you have any of the following symptoms while taking beclometasone dipropionate,
they may be symptoms of a lung infection:

• fever or chills.
• increased mucus production, changes in mucus color.
• increased cough or greater difficulty breathing.

Side effects with unknown frequency(frequency cannot be estimated based on available data)
Fungal infections (candidiasis) in the oral cavity (mouth and throat). In such cases, your doctor will prescribe you therapy
against fungi (with antifungal drugs or alkalizing agents).
Muscle tremors.
Increased heart rate.
Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioral disorders
(predominantly in children).
Blurred vision.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store CLENIL COMPOSITUM

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage temperature. Store the medicine in
an upright position as indicated on the packaging.
After opening the protective sachet, the single-dose vials can be stored for up to 3 months.
If half a dose is used, the resealed vial must be stored at a temperature between 2 
C and 8  C (in a refrigerator) and the remaining quantity must be used within 12 hours of first opening.
Do not use this medicine after the expiry date which is stated on the pack after the wording EXP. The
expiry date refers to the last day of that month. This date applies to the product in
intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What CLENIL COMPOSITUM contains
The active ingredients are: beclometasone dipropionate and salbutamol.
Each 2 ml vial contains: 0.8 mg of beclometasone dipropionate and 1.6 mg of salbutamol.
The other ingredients are: sodium chloride, polysorbate 20, sorbitan monolaurate, water for
injections.

Description of the appearance of CLENIL COMPOSITUM and package contents
This medicine is a suspension for nebulization, available in packs containing 10 or 20 single-dose
2 ml vials, each with a half-dose graduation, and resealable.

Marketing Authorisation Holder
PROMEDICA S.r.l., Via Palermo 26/A - Parma

Manufacturer
CHIESI FARMACEUTICI S.p.A., Parma Plant, Via S. Leonardo 96.

INSTRUCTIONS FOR USE OF CLENIL COMPOSITUM FOR AEROSOL
CLENIL COMPOSITUM is easy to use. Before use, read the following instructions carefully, which
tell you what to do and what to pay attention to.
To use, perform the following operations:
Figure A Bend the single-dose vial in two directions.
Figure B Detach the single-dose vial from the strip first at the top and then in the middle.
Figure C Shake vigorously by shaking and inverting the vial several times, until the
suspension is homogeneous.
Figure D Open the single-dose vial by rotating the tab in the direction indicated by the arrow.
Figure E By applying moderate pressure on the walls of the single-dose vial, release the
medicine in the prescribed amount and introduce it into the nebulizer ampoule
(aerosol device).
Figure F If you are using a half dose, hold the single-dose container against the light and compare the level of
remaining medicine with the graduation on the vial (corresponding to half a
dose) to verify that you have used the correct dose. The vial must be resealed
by inverting and pressing the cap.
The resealed vial must be stored in the refrigerator, at a temperature between 2  C and
8  C, and the remaining amount must be used within 12 hours of first opening.

CLENIL COMPOSITUM 250 mcg + 100 mcg pressurised suspension for inhalation

Beclometasone dipropionate; Salbutamol

Read this leaflet carefully before you start to take 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 their symptoms are the same as yours, as it could 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 CLENIL COMPOSITUM is and what it is used for
• 2. What you need to know before you take CLENIL COMPOSITUM
• 3. How to take CLENIL COMPOSITUM
• 4. Possible side effects
• 5. How to store CLENIL COMPOSITUM
• 6. Contents of the pack and other information

1. What is CLENIL COMPOSITUM and what is it used for

CLENIL COMPOSITUM is a medicine that contains 2 active ingredients:

• beclometasone dipropionate, belonging to the group of corticosteroids, which reduces swelling and inflammation of the airways;
• salbutamol, belonging to the group of bronchodilators, which relaxes the muscles of the walls of the small airways of the lungs.

CLENIL COMPOSITUM is used to prevent breathing difficulties due to asthma and other
conditions that involve narrowing of the bronchi (chronic obstructive bronchopneumopathy with
asthmatic component).

2. What you need to know before taking CLENIL COMPOSITUM

Do not take CLENIL COMPOSITUM if:

• you are allergic (hypersensitive) to the active ingredients or to any of the other ingredients of this medicine (listed in section 6);
• you have lung infections caused by viruses;
• you have or have had pulmonary tuberculosis;
• you are pregnant or breastfeeding;
• you are under 18 years of age.

Warnings and precautions
Talk to your doctor before taking CLENIL COMPOSITUM if:

• you are undergoing therapy with corticosteroids;
• you have increased thyroid function (hyperthyroidism);
• you have heart problems such as: diseases of the heart vessels (coronary artery disease), irregular heartbeat (arrhythmias) or heart function (heart failure);
• you suffer from high blood pressure (arterial hypertension);
• you have an enlarged prostate (prostatic hypertrophy);
• you have increased pressure in the eye with possible worsening of vision (glaucoma);
• you have diabetes;
• you have a particular tumor of the adrenal gland called pheochromocytoma. Contact your doctor if you experience blurred vision or other visual disturbances.

Pay particular attention if

• during therapy with CLENIL COMPOSITUM your asthma worsens or does not improve or you have increased difficulty breathing. This means that your bronchospasm is persistent;
• you are switching from treatment with corticosteroids for systemic therapy (e.g. tablets) to inhalation therapy. Initially, your doctor will tell you to take both therapies, then gradually reduce the systemic corticosteroid;
• you are going through periods of stress (due to lung infections, serious illnesses, surgeries, traumas, etc.) or if you experience a severe asthma attack, because additional systemic corticosteroid treatment may be necessary; this is particularly important if you have stopped oral corticosteroid treatment or if you have impaired adrenal function;
• you have heart disease and during therapy with CLENIL COMPOSITUM you experience chest pain or worsening of heart disease symptoms;
• you notice psychological and behavioral effects such as: psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disorders (mainly in children). These effects occur rarely during therapy with inhaled corticosteroids.

IN ALL THESE CASES CONSULT YOUR DOCTOR WHO MAY PRESCRIBE APPROPRIATE
THERAPY.
As with other medicines in case of prolonged therapy, CLENIL COMPOSITUM can cause redness and
itching (sensitization phenomena). If this should occur, stop treatment and consult your
doctor.

Children and adolescents
CLENIL COMPOSITUM 250 mcg + 100 mcg is not suitable for children and adolescents. If necessary,
ask your doctor or pharmacist for advice, as there are dosages (lower) of CLENIL
COMPOSITUM specifically for these patients.

Other medicines and CLENIL COMPOSITUM
Tell your doctor if you are taking, have recently taken or might take other medicines, including
medicines obtained without a prescription. This is particularly important if you are using:

• drugs belonging to the same class as beclomethasone (corticosteroids) by systemic route (e.g. tablets) or nasal route, as this may increase the risk of impaired adrenal function (adrenal suppression);
• drugs belonging to the same class as salbutamol (sympathomimetics), which stimulate the nervous system and have effects mainly on the heart and blood vessels;
• beta-blockers, used mainly for high blood pressure (hypertension) and heart disease.

In addition, since CLENIL COMPOSITUM contains small amounts of alcohol, it is particularly
important that you inform your doctor if you are taking:

• disulfiram (used in alcoholism);
• metronidazole (used in infections).

Some medicines can increase the effects of CLENIL COMPOSITUM and your doctor may want to keep you
under close observation if you are taking these medicines (including some medicines for the
treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, do not take CLENIL COMPOSITUM.

Driving and operating machinery
CLENIL COMPOSITUM does not impair the ability to drive or operate machinery.

CLENIL COMPOSITUM contains ethanol
This medicine contains 8.3 mg of alcohol (ethanol) in each actuation, which is equivalent to 0.24 mg / kg per
dose of two actuations. The amount in two actuations of this medicine is equivalent to that contained
in less than 1 mL of wine or beer. The small amount of alcohol in this medicine will not produce
significant effects.
For athletes:
the use of the drug without therapeutic need constitutes doping and may still result in positive
doping tests.

3. How to take CLENIL COMPOSITUM

Take this medicine following exactly the instructions of your doctor, who will indicate the correct dose
based on the severity of your condition. CLENIL COMPOSITUM is used to treat the initial period of your
condition; your doctor will prescribe an alternative medicine after about 10 days.
If you have any doubts, consult your doctor or pharmacist.
The average dose is 2 inhalations, 2 times a day in adults.
In severe cases, the doctor may increase the number of inhalations, 2 inhalations 3-4 times a day.
The effect of one inhalation of CLENIL COMPOSITUM lasts for at least 4 hours.
Perform a maximum of 2 inhalations at a time and do not repeat the treatment before 4 hours.

Method of administration
CLENIL COMPOSITUM is easy to use. Before use, carefully read the following instructions, which tell you
what to do and what to pay attention to.
A positive treatment outcome depends on correct use of the inhaler.
Inhaler function test: before using the inhaler for the first time, or if you have not used
the inhaler for seven or more days, remove the protective cap from the mouthpiece by pressing it gently
on the sides and perform two test sprays to ensure your inhaler is working correctly.

Opening the package
When you open the box, the device is closed with the protective cap.

Taking a dose of CLENIL COMPOSITUM
Figure 1-2 Remove the protective cap.
Hold the device between your thumb and index finger, with the mouthpiece at the bottom.
Figure 3 Shake vigorously without pressing.
Figure 4 a-b Perform a complete exhalation (4a) and then place the mouthpiece between your lips
closed tightly (4b).
Figure 5 Inhale slowly and deeply with your mouth only and press simultaneously
with your index finger on the device once. Avoid partial sprays. Once
the inhalation is complete, hold your breath for as long as possible. Once you have completed the
prescribed number of inhalations, close the mouthpiece with the protective cap.

Cleaning
The mouthpiece must always be kept clean, to avoid blockage due to obstruction. If cleaning is not
performed regularly as indicated, the device may become blocked or not function
correctly.The device must be cleaned at least every 3 days from the start of use.
To clean the device, follow the instructions below:

• 1. Remove the plastic protective cap.

• 2. Remove the metal canister from the plastic mouthpiece.

• 3. Wash for one minute with warm running water on the underside of the plastic mouthpiece body, positioning it under the running water flow.

• 4. Rotate the mouthpiece and wash for another minute with warm running water on the top of the mouthpiece, positioning it under the water flow.

• 5. Carefully remove any water remaining inside the plastic mouthpiece by repeatedly tapping it gently against a hard surface. Check that no water remains in the central cavity of the plastic mouthpiece where the metal canister stem is inserted.
• 6. Carefully dry the plastic mouthpiece body internally and externally, for example

by leaving it to air dry overnight without the metal canister and protective cap, or
using a warm air jet. Make sure the mouthpiece is completely dry before
use.

• 7. Replace the metal canister in the device and the protective cap on the mouthpiece.

Do not use the mouthpiece while it is still wet, make sure it is completely dry before using it.
Using a wet mouthpiece can promote obstruction and blockage of the device.
If the device becomes blocked: perform steps 1 to 7 of the cleaning procedure.
Spray a test dose to verify the removal of the obstruction before proceeding with normal use.
Immediately after using CLENIL COMPOSITUM, rinse your mouth thoroughly with water; this
will reduce the risk of fungal infections. The rinsing liquid must not be swallowed.

If you take more CLENIL COMPOSITUM than you should
If you accidentally take excessive doses of CLENIL COMPOSITUM, you may notice an increase in your
heart rate and tremors that disappear after a few days or alterations in adrenal function; however, immediately inform your doctor or go to the nearest hospital, as appropriate measures may need to be
taken.

If you forget to take CLENIL COMPOSITUM
Continue therapy regularly, without doubling the next dose.

If you stop taking CLENIL COMPOSITUM
Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Like other medicines taken by inhalation, immediately after taking the dose, shortness of breath, cough, wheezing and
difficulty breathing ( paradoxical bronchospasm) may occur. The frequency of this side effect is not known. If this happens, stop taking CLENIL
COMPOSITUM immediatelyand contact your doctor.
Other side effects
If you use CLENIL COMPOSITUM, especially in high doses and/or for prolonged periods of time, you may experience other
side effects. Tell your doctor if you notice:

Common side effects(may affect up to 1 in 10 people)
pneumonia (lung infection), in patients with COPD.
Tell your doctor if you have any of the following symptoms while taking beclometasone dipropionate, they may be
symptoms of a lung infection:

• fever or chills.
• increased mucus production, changes in mucus color.
• increased cough or greater difficulty breathing.

Very rare side effects(may affect up to 1 in 10,000 people)
Adrenal suppression (with symptoms such as loss of appetite, low blood pressure, abdominal pain, weight loss, fatigue,
headache, nausea, vomiting).
Cataracts, increased pressure in the eye with possible worsening of vision (glaucoma).
Changes in heart rhythm (arrhythmias such as atrial fibrillation, supraventricular tachycardia, extrasystoles), decreased
blood flow to the heart tissue (myocardial ischemia).
Decreased bone mineral density.

Side effects with unknown frequency(frequency cannot be estimated based on available data)
Fungal infections (candidiasis) in the oral cavity (mouth and throat). In such cases, your doctor will prescribe you
therapy against fungi (with antifungal drugs or alkalizing agents).
Tremor, ulcer of the stomach or duodenum (peptic).
Hoarseness (dysphonia), redness and pain (irritation) of the throat, cough, difficulty breathing (dyspnea).
Weakening of the bones (osteoporosis).
Increased heart rate.
Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioral disorders (predominantly in
children).
Blurred vision.
In children and adolescents taking inhaled corticosteroids, delayed growth has also been reported (a very rare side effect).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report
side effects directly through the national reporting system at 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 CLENIL COMPOSITUM

Keep this medicine out of sight and reach of children.
Store at a temperature not exceeding 30° C.
The pressurized container must not be punctured, must not be brought near sources of heat, even if empty, must
not be frozen and must not be exposed to direct sunlight.
Do not use this medicine after the expiry date which is reported on the pack after the words EXP. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CLENIL COMPOSITUM contains
The active ingredients are: beclometasone dipropionate and salbutamol.
Each container contains: 50 mg of beclometasone dipropionate and 20 mg of salbutamol (each actuation
contains 250 micrograms of beclometasone dipropionate and 100 micrograms of salbutamol).
The other ingredients are: HFC 134a (norflurane), anhydrous ethyl alcohol, oleic acid.
This medicine contains fluorinated greenhouse gases. Each inhaler contains 11.129 g of norflurane
(HFC-134a) which corresponds to 0.016 tonnes of CO2 equivalent (global warming potential =
1430).

Description of the appearance of CLENIL COMPOSITUM and contents of the pack
This medicine is a pressurized suspension for inhalation, available in a pressurized aluminum container, equipped with a metering valve, traditional actuator button, - and a snap-on protective closure.
CLENIL COMPOSITUM is sufficient for 200 inhalations of 250 micrograms of beclometasone and 100
micrograms of salbutamol.

Marketing Authorization Holder
PROMEDICA S.r.l., Via Palermo 26/A - Parma

Manufacturer
CHIESI FARMACEUTICI S.p.A., Officina di Parma, Via S. Leonardo 96.
CHIESI SA, 2 rue des Docteurs Alberto et Paolo Chiesi, La Chaussée Saint-Victor - France

CLENIL COMPOSITUM 250 mcg + 100 mcg pressurised suspension for inhalation

Beclometasone dipropionate; Salbutamol

Read this leaflet carefully before taking 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What CLENIL COMPOSITUM is and what it is used for
• 2. What you need to know before you take CLENIL COMPOSITUM
• 3. How to take CLENIL COMPOSITUM
• 4. Possible side effects
• 5. How to store CLENIL COMPOSITUM
• 6. Contents of the pack and other information

1. What is CLENIL COMPOSITUM and what is it used for

CLENIL COMPOSITUM is a medicine that contains 2 active ingredients:

• beclometasone dipropionate, belonging to the group of corticosteroids, which reduces swelling and inflammation of the airways;
• salbutamol, belonging to the group of bronchodilators, which relaxes the muscles of the walls of the small airways of the lungs.

CLENIL COMPOSITUM is used to prevent breathing difficulties due to asthma and other
conditions that involve narrowing of the bronchi (chronic obstructive bronchopneumopathy with
asthmatic component).

2. What you need to know before taking CLENIL COMPOSITUM

Do not take CLENIL COMPOSITUM if:

• you are allergic (hypersensitive) to the active ingredients or to any of the other ingredients of this medicine (listed in section 6);
• you have lung infections caused by viruses;
• you have or have had pulmonary tuberculosis;
• you are pregnant or breastfeeding;
• you are under 18 years of age.

Warnings and precautions
Talk to your doctor before taking CLENIL COMPOSITUM if:

• you are undergoing therapy with corticosteroids;
• you have increased thyroid function (hyperthyroidism);
• you have heart problems such as: diseases of the heart vessels (coronary artery disease), irregular heartbeat (arrhythmias) or heart function (heart failure);
• you suffer from high blood pressure (arterial hypertension);
• you have an enlarged prostate (prostatic hypertrophy);
• you have increased pressure in the eye with possible worsening of vision (glaucoma);
• you have diabetes;
• you have a particular tumor of the adrenal gland called pheochromocytoma. Contact your doctor if you experience blurred vision or other visual disturbances.

Pay particular attention if

• during therapy with CLENIL COMPOSITUM your asthma worsens or does not improve or you have increased difficulty breathing. This means that your bronchospasm is persistent;
• you are switching from treatment with corticosteroids for systemic therapy (e.g. tablets) to inhalation therapy. Initially, your doctor will tell you to carry out both therapies, then gradually reduce the systemic corticosteroid;
• you are going through periods of stress (due to lung infections, serious illnesses, surgeries, traumas, etc.) or if you experience a severe asthma attack, because supplementary systemic corticosteroid treatment may be necessary; this is particularly important if you have stopped treatment with oral corticosteroids or if you have impaired adrenal function;
• you have heart disease and during therapy with CLENIL COMPOSITUM you experience chest pain or worsening of symptoms due to heart disease;
• you notice psychological and behavioral effects such as: psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disorders (predominantly in children). These effects occur rarely during therapy with inhaled corticosteroids.

IN ALL THESE CASES CONSULT YOUR DOCTOR WHO MAY PRESCRIBE APPROPRIATE THERAPY
. As with other medicines in case of prolonged therapy, CLENIL COMPOSITUM can cause redness and
itching (sensitization phenomena). If this should occur, stop treatment and consult your
doctor.

Children and adolescents
CLENIL COMPOSITUM 250 mcg + 100 mcg is not suitable for children and adolescents. If necessary,
ask your doctor or pharmacist for advice, as dosages (lower) of CLENIL
COMPOSITUM specific for these patients are available.

Other medicines and CLENIL COMPOSITUM
Tell your doctor if you are taking, have recently taken or might take other medicines, including
medicines obtained without a prescription. This is particularly important if you use:

• drugs belonging to the same class as beclometasone (corticosteroids) by systemic route (e.g. tablets) or by nasal route, as this may increase the risk of impaired adrenal function (adrenal suppression);
• drugs belonging to the same class as salbutamol (sympathomimetics), which stimulate the nervous system and have effects mainly on the heart and blood vessels;
• beta-blockers, used mainly for high blood pressure (hypertension) and heart disease.

Furthermore, since CLENIL COMPOSITUM contains small amounts of alcohol, it is particularly
important that you inform your doctor if you are taking:

• disulfiram (used in alcoholism);
• metronidazole (used in infections).

Some medicines can increase the effects of CLENIL COMPOSITUM and your doctor may want to keep you
under close observation if you are taking these medicines (including some medicines for the
treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, do not take CLENIL COMPOSITUM.

Driving and using machines
CLENIL COMPOSITUM does not impair the ability to drive or operate machinery.

CLENIL COMPOSITUM contains ethanol
This medicine contains 8.3 mg of alcohol (ethanol) in each actuation, which is equivalent to 0.24 mg / kg per
dose of two actuations. The amount in two actuations of this medicine is equivalent to that contained
in less than 1 mL of wine or 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 can still result in positive
doping tests.

3. How to take CLENIL COMPOSITUM

Take this medicine following the doctor's instructions exactly, who will indicate the correct dose, based on the severity of your condition. CLENIL COMPOSITUM is used to treat the initial period of your illness; your doctor will prescribe an alternative medicine after about 10 days. If you have any doubts, consult your doctor or pharmacist. The average dose is 2 inhalations, 2 times a day in adults. In severe cases, the doctor may increase the number of inhalations, 2 inhalations 3-4 times a day. The effect of one inhalation of CLENIL COMPOSITUM lasts for at least 4 hours. Perform a maximum of 2 inhalations at a time and do not repeat the treatment before 4 hours.

Method of administration
In the package you will find a pressurized container with a traditional dispenser and a JET spacer-dispenser, which can only be used with the metal canister supplied in the package. If you have difficulty coordinating between the inspiratory act and delivery, use the JET dispenser, otherwise use the traditional dispenser. CLENIL COMPOSITUM is easy to use. Before use, read the following instructions carefully, which indicate what to do and what to pay attention to. A positive outcome of the treatment depends on the correct use of the inhaler. Inhaler function test: before using the inhaler for the first time, or if you have not used the inhaler for seven or more days, remove the protective cap of the mouthpiece by pressing it gently on the sides and perform two empty deliveries to ensure that your inhaler is working correctly.

Opening the package
When you open the box, the dispenser is closed with the protective cap.

Taking a dose of CLENIL COMPOSITUM
TRADITIONAL DISPENSER
Figure 1-2 Remove the protective cap. Hold the dispenser between your thumb and index finger, with the mouthpiece at the bottom. Figure 3 Shake vigorously without pressing. Figure 4 a-b Perform a complete exhalation (4a) and then place the mouthpiece between your tightly closed lips (4b). Figure 5 Inhale deeply and slowly with your mouth only and press the index finger on the dispenser once at the same time. Avoid partial deliveries. Once the inhalation is finished, hold your breath for as long as possible. Once you have completed the prescribed number of inhalations, close the mouthpiece with the protective cap.

JET – SPACER DISPENSER
The JET device has been designed to improve the efficiency of a normal spray dispenser and to facilitate adherence to therapy for patients (especially the elderly) with poor familiarity with inhalation technique, avoiding the forced synchronization between the delivery and inspiration phase. The JET device reduces the amount of active ingredient that remains in the mouth and throat, allowing good local tolerance. Figure 1 Remove the pressurized container from the traditional dispenser and insert it into the JET device. Figure 2 Remove the protective cap from the JET spacer-dispenser by holding it as shown in the figure. Figure 3 Shake vigorously without pressing. Figure 4 a-b Exhale deeply (4a) and place the mouthpiece between your tightly closed lips (4b). Figure 5 Press the index finger on the pressurized container and inhale deeply even after a few moments. (You can also perform several breathing acts through the JET). Figure 6 a-b Once the inhalation is finished, hold your breath for as long as possible (6a) and close the JET with the appropriate protective cap (6b).

Cleaning

The mouthpiece must always be kept clean, to avoid blockage due to obstruction. If cleaning is not performed regularly as indicated, the dispenser may become blocked or not work correctly.The dispenser must be cleaned at least every 3 days from the start of use. To clean the traditional dispenser, follow the instructions below:

• 8. Remove the plastic protective cap.

• 9. Remove the metal canister from the plastic mouthpiece.

• 10. Wash for one minute with warm running water the body of the plastic mouthpiece from the bottom, positioning it under the flow of running water.

• 11. Rotate the mouthpiece and wash for another minute with warm running water the top of the mouthpiece, positioning it under the flow of water.
• 12. Carefully remove the water that remains inside the plastic mouthpiece by tapping it

repeatedly with moderation against a hard surface. Check that no water remains in the central cavity of the plastic mouthpiece into which the stem of the metal canister is inserted.

• 13. Carefully dry the body of the plastic mouthpiece internally and externally, for example

leaving it to air for a night without a metal canister and protective cap, or using a blast of warm air. Make sure the mouthpiece is completely dry before use.

• 14. Put the metal canister back into the dispenser and the protective cap on the mouthpiece.

To clean the JET dispenser, perform the same steps as the cleaning procedure for the traditional dispenser from 1 to 7.

Do not use the mouthpiece while still wet, make sure it is completely dry before using it. Using a wet mouthpiece can promote obstruction and blockage of the dispenser. If necessary, if the traditional dispenser is not dry, use the JET dispenser present in the package, and vice versa. If the dispenser should become blocked: perform the steps of the cleaning procedure from 1 to 7. Deliver a dose to empty to verify the removal of the obstruction before proceeding to normal use. Immediately after using CLENIL COMPOSITUM, rinse your mouth thoroughly with water; this will reduce the risk of fungal infections. The rinsing liquid must not be swallowed.

If you take more CLENIL COMPOSITUM than you should
If you accidentally take excessive doses of CLENIL COMPOSITUM, you may notice an increase in heartbeats and tremors that disappear after a few days or alterations in adrenal function; however, immediately inform your doctor or go to the nearest hospital, as appropriate measures may need to be taken.

If you forget to take CLENIL COMPOSITUM
Continue the therapy regularly, without doubling the next dose.

If you stop taking CLENIL COMPOSITUM
Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Like with other medicines taken by inhalation, immediately after taking the dose, shortness of breath, cough, wheezing and
breathlessness ( paradoxical bronchospasm) may occur. The frequency of this side effect is not known. If this
happens, stop taking CLENIL COMPOSITUM immediatelyand contact your doctor.
Other side effects
If you use CLENIL COMPOSITUM, especially in high doses and/or for prolonged periods of time, you may
experience other side effects. Inform your doctor if you notice:

Common side effects(may affect up to 1 in 10 people)
pneumonia (lung infection), in patients with COPD.
Inform your doctor if you have any of the following symptoms while taking beclometasone dipropionate,
they may be symptoms of a lung infection:

• fever or chills.
• increased mucus production, changes in mucus color.
• increased cough or greater difficulty breathing.

Very rare side effects(may affect up to 1 in 10,000 people)
Adrenal suppression (with symptoms such as loss of appetite, low blood pressure, abdominal pain, weight loss,
fatigue, headache, nausea, vomiting).
Cataracts, increased pressure in the eye with possible worsening of vision (glaucoma).
Changes in heart rhythm (arrhythmias such as atrial fibrillation, supraventricular tachycardia, extrasystoles),
decreased blood flow to the heart tissue (myocardial ischemia).
Decreased bone mineral density.

Side effects with unknown frequency(frequency cannot be estimated based on available data)
Fungal infections (candidiasis) in the oral cavity (mouth and throat). In such cases, your doctor will prescribe you
therapy against fungi (with antifungal drugs or alkalizing agents).
Tremor, stomach or duodenal ulcer (peptic).
Lowering of the voice (dysphonia), redness and pain (irritation) of the throat, cough, difficulty
breathing (dyspnea).
Weakening of the bones (osteoporosis).
Increased heart rate.
Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioral disorders
(mainly in children).
Blurred vision.
In children and adolescents taking inhaled corticosteroids, delayed growth has also been reported (a very rare side effect).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at 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 CLENIL COMPOSITUM

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30° C.
The pressurized container must not be punctured, must not be brought near, even if empty, to sources of heat, must
not be frozen and must not be exposed to direct sunlight.
Do not use this medicine after the expiry date which is reported on the pack after the wording EXP. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CLENIL COMPOSITUM contains
The active ingredients are: beclometasone dipropionate and salbutamol.
Each container contains: 50 mg of beclometasone dipropionate and 20 mg of salbutamol (each actuation
contains 250 micrograms of beclometasone dipropionate and 100 micrograms of salbutamol).
The other ingredients are: HFC 134a (norflurane), anhydrous ethyl alcohol, oleic acid.
This medicine contains fluorinated greenhouse gases. Each inhaler contains 11.129 g of norflurane
(HFC-134a) which corresponds to 0.016 tonnes of CO2 equivalent (global warming potential =
1430).

Description of the appearance of CLENIL COMPOSITUM and contents of the pack
This medicine is a pressurised suspension for inhalation, available in a pressurised aluminium container,
equipped with a metering valve, a traditional actuator button, a JET spacer and a snap-on protective cap.
CLENIL COMPOSITUM is sufficient for 200 inhalations of 250 micrograms of beclometasone and 100
micrograms of salbutamol.

Marketing Authorisation Holder
PROMEDICA S.r.l., Via Palermo 26/A - Parma

Manufacturer
CHIESI FARMACEUTICI S.p.A., Parma Manufacturing Plant, Via S. Leonardo 96.
CHIESI SA, 2 rue des Docteurs Alberto et Paolo Chiesi, La Chaussée Saint-Victor - France