Muciclar

Patient Information Leaflet

MUCICLAR 15 mg/2 ml nebulising solution

Ambroxol hydrochloride
Equivalent medicine
Please read all of this leaflet carefully before you take this medicine, as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement, or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What MUCICLAR is and what it is used for

This medicinal product contains the active substance ambroxol hydrochloride, which belongs to a group of medicines called mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
MUCICLAR is indicated for the treatment of secretions in acute and chronic diseases of the bronchi and lungs (in the presence of cough and phlegm).
Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before taking MUCICLAR

Do not take MUCICLAR

• if you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking MUCICLAR.

Take this medicine with caution and inform your doctor:

• if you suffer from a stomach or intestinal condition called peptic ulcer;
• if you have kidney problems (renal insufficiency).

Serious skin reactions have been reported with ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking MUCICLAR and contact your doctor immediately.
In particular, during the early stages of such conditions, you may experience influenza-like symptoms such as fever, pain, cold symptoms (rhinitis), cough, and sore throat.
If you develop skin or mucosal lesions, consult your doctor and stop treatment with MUCICLAR.
Cough due to irritation may occur during administration of the nebulized solution; it is recommended to breathe normally during inhalation. If you are particularly sensitive to this effect, it is advisable to warm the solution to body temperature (37°C) before inhalation.
If you have asthma, it is advisable to take asthma medications (bronchodilators) before using this medicine by inhalation.

Other medicines and MUCICLAR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking antibiotics such as amoxicillin, cefuroxime, and erythromycin.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The use of MUCICLAR is not recommended during pregnancy, especially during the first three months.
If you are pregnant, take MUCICLAR only when strictly necessary and under direct medical supervision.

Breastfeeding
The use of MUCICLAR is not recommended during breastfeeding.

Driving and using machines
There are no data available to assess the effects on the ability to drive vehicles or operate machinery.

3. How to take MUCICLAR

Take this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine can be diluted with an equal volume of distilled water to achieve optimal
humidification of the inhaled air.
The recommended dose for adults is 2–3 single-dose containers per day.
Use in children
The recommended dose is 1–2 single-dose containers per day.
Each single-dose container contains 2 ml, corresponding to 15 mg of ambroxol.
If you take more MUCICLAR than you should
No cases of overdose have been reported. Symptoms of overdose may correspond to the
adverse effects that may occur at the recommended doses (See section 4).
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take MUCICLAR
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

• disturbances in taste sensation (dysgeusia);
• loss of sensitivity (hypoaesthesia) in the oral cavity and pharynx;
• nausea.

Uncommon (may affect up to 1 in 100 people)

• vomiting, diarrhoea, digestive difficulties (dyspepsia), and abdominal pain;
• dry mouth.

Rare (may affect up to 1 in 1,000 people)

• headache (cephalalgia);
• increased mucus production, runny nose (rhinorrhoea);
• heartburn and oesophageal burning (pyrosis);
• constipation (stipsis);
• skin irritation (rash, urticaria);
• difficulty in urination (dysuria);
• fatigue.
• Hypersensitivity reactions

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

• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa, and submucosal tissues), and pruritus;
• Serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis);
• bronchial occlusion (bronchial obstruction);
• dry throat.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MUCICLAR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Once the aluminium pouch containing the single-dose containers has been opened, the medicine must be used within three months. After this period, any unused medicine must be discarded.
When half a dose is used, the container can be reclosed by pressing the cap back on and must be stored in the refrigerator (2-8°C) for no longer than 12 hours. Any remaining medicine must be discarded.
Do not dispose of any medicine via 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 MUCICLAR contains

• The active substance is ambroxol hydrochloride. One single-dose vial (2 ml) contains 15 mg of ambroxol hydrochloride.
• The other components are: sodium chloride, water for injections.

Description of the appearance of MUCICLAR and contents of the pack
Pack containing 30 single-dose containers of 2 ml, each marked with a notch at the 1 ml volume (half dose). The single-dose containers are divided into strips of 5 containers; each strip is enclosed in an aluminum pouch.

Marketing Authorization Holder
PIAM FARMACEUTICI S.P.A. - Via Fieschi, 8 - 16121 Genoa
Manufacturer
Genetic S.p.A., Contrada Canfora, Fisciano (SA)

Patient information leaflet

MUCICLAR 15 mg/5 ml syrup, 75 mg prolonged-release capsule, 30 mg granules for oral solution

Ambroxol hydrochloride
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after a few days.

Contents of this leaflet:

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

1. What MUCICLAR is and what it is used for

This medicinal product contains the active substance ambroxol hydrochloride, which belongs to a group of medicines called mucolytics, used to facilitate the elimination of mucus from the respiratory tract.
MUCICLAR is indicated for the treatment of secretions in acute and chronic diseases of the bronchi and lungs (in the presence of cough and phlegm).
If you do not feel better or if you feel worse, talk to your doctor.

2. What you should know before taking MUCICLAR

Do not take MUCICLAR

• if you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver or kidney problems.

MUCICLAR must not be taken in children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking MUCICLAR.
Take this medicine with caution and inform your doctor:

• if you suffer from a stomach or intestinal condition called peptic ulcer;
• if you have kidney problems (renal insufficiency).

Severe skin reactions have been reported with ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking MUCICLAR and contact your doctor immediately.
In particular, during the early stages of such conditions, you may experience influenza-like symptoms such as fever, pain, cold (rhinitis), cough and sore throat.
If you develop skin or mucous membrane lesions, consult your doctor and discontinue treatment with MUCICLAR.
Children
MUCICLAR 15 mg/5 ml syrup, MUCICLAR 75 mg prolonged-release capsules and MUCICLAR 30 mg granules for oral solution must not be administered to children under 2 years of age, as they may cause bronchial obstruction and impair normal breathing due to the limited ability of young children to clear secretions.
Other medicines and MUCICLAR
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking antibiotics such as amoxicillin, cefuroxime and erythromycin.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of MUCICLAR is not recommended during pregnancy, especially during the first three months. If you are pregnant, take MUCICLAR only when strictly necessary and under direct medical supervision.
Breastfeeding
The use of MUCICLAR is not recommended during breastfeeding.
Driving and using machines
There are no available data to determine the effects on the ability to drive vehicles or operate machinery.
MUCICLAR 15 mg/5 ml syrup contains sorbitol, glycerol, parahydroxybenzoates and alcohol.
This medicine contains sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.
This medicine contains glycerol, which may cause headache, gastrointestinal disturbances and diarrhoea.
This medicine contains parahydroxybenzoates (methyl parahydroxybenzoate, propyl parahydroxybenzoate) which may cause allergic reactions (including delayed reactions).
This medicine contains 3 vol% ethanol (alcohol), e.g. up to 300 mg per dose, equivalent to 6 ml of beer or 2.5 ml of wine per dose. It may be harmful for alcoholics. This should be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.
MUCICLAR 75 mg prolonged-release capsules and MUCICLAR 30 mg granules for oral solution contain sucrose.
These medicines contain sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking these medicines.

3. How to take MUCICLAR

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Muciclar 15 mg/5 ml syrup
The recommended dose for adults is 5–10 ml (5 ml of syrup corresponds to 15 mg of ambroxol), 3 times daily.

Use in children over 2 years of age
The recommended dose is 5 ml, 2–3 times daily.

Muciclar 75 mg prolonged-release capsules
The recommended dose for adults is 2 capsules taken once daily after breakfast for the first 8 days, followed by 1 capsule once daily until the end of treatment.

Muciclar 30 mg oral granules for oral solution
The recommended dose for adults is 1 sachet 2–3 times daily.

If you take more MUCICLAR than you should
Cases of overdose have not been reported. Symptoms of overdose may be consistent with the adverse reactions observed at the recommended doses (See section 4).
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take MUCICLAR
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

• altered taste sensation (dysgeusia);
• loss of sensitivity (hypoaesthesia) in the oral cavity and pharynx;
• nausea.

Uncommon (may affect up to 1 in 100 people)

• vomiting, diarrhoea, digestive difficulties (dyspepsia), and abdominal pain;
• dry mouth.

Rare (may affect up to 1 in 1000 people)

• headache (cephalalgia);
• increased mucus production, runny nose (rhinorrhoea);
• heartburn and oesophageal burning (pyrosis);
• constipation (stipsis);
• skin irritation (rash, urticaria);
• difficulty in urination (dysuria);
• fatigue.
• Hypersensitivity reactions

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

• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa, and submucosal tissues), and pruritus;
• severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalised exanthematous pustulosis);
• bronchial obstruction;
• dry throat.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MUCICLAR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Store the syrup, capsules, and granules for oral solution at a temperature not exceeding 25°C.
Do not dispose of any medicine via 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 MUCICLAR 15 mg/5 ml syrup contains

• The active substance is hydrochloride ambroxol. Each 100 ml of syrup contains 300 mg of hydrochloride ambroxol.
• The other components are: sorbitol solution, glycerin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, hydroxyethylcellulose, alcohol, saccharin, raspberry flavour, purified water.

What MUCICLAR 75 mg prolonged-release capsules contain

• The active substance is hydrochloride ambroxol. Each capsule contains 75 mg of hydrochloride ambroxol.
• The other components are: sucrose, starch, natural and artificial resins, talc, polyvinylpyrrolidone.

What MUCICLAR 30 mg oral solution granules contain

• The active substance is hydrochloride ambroxol. Each sachet contains 30 mg of hydrochloride ambroxol.
• The other components are: sucrose, orange flavour, pineapple flavour.

Description of MUCICLAR appearance and package contents
MUCICLAR 15 mg/5 ml syrup: package containing 1 bottle of 200 ml. A dosing cup is supplied with the package, marked at volumes of 2.5 ml, 5 ml and 10 ml.
MUCICLAR 75 mg prolonged-release capsules: package containing 20 capsules.
MUCICLAR 30 mg oral solution granules: package containing 30 sachets.
Marketing Authorization Holder
PIAM FARMACEUTICI S.P.A. - Via Fieschi, 8 - 16121 Genova
Manufacturers
Genetic S.p.A., Contrada Canfora, Fisciano (SA) (15 mg/5 ml syrup)
Fine Foods NTM S.p.A., Via dell’Artigianato 8/10 - Brembate (BG) (30 mg oral solution granules)
I.B.N. SAVIO S.r.l. – Ronco Scrivia - Genova (75 mg prolonged-release capsules)