MUCOSOLVAN syrup (30 mg Ambroxol/5 ml Syrup) is an expectorant which is used to thin the mucus in acute and chronic bronchial and lung diseases where thick, tenacious mucus is a problem.

Do not take MUCOSOLVAN syrup  if you are hypersensitive (allergic) to the active substance (ambroxol hydrochloride) or to any of the other ingredients of MUCOSOLVAN syrup.

Special care must be taken with Mucosolvan

Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN): In a very small number of cases, there have been reports of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) occurring in temporal association with the use of expectorants such as ambroxol hydrochloride.

Most of these cases were attributable to the underlying disease and/or to other medication being taken concomitantly. In addition, during the early phase of Stevens-Johnson syndrome or TEN, patients may initially experience non-specific influenza-like symptoms such as fever, joint pain, rhinitis, cough and sore throat.

Because of these non-specific influenza-like initial symptoms, symptomatic treatment with cough and cold medications, which is inappropriate, may be started. If new skin or mucosal lesions appear, therefore, medical advice should be sought immediately and the use of ambroxol hydrochloride discontinued.

Patients with impaired kidney or liver function: If you have impaired kidney function or severe liver disease, you must not take MUCOSOLVAN cough syrup except on medical advice. With ambroxol, as with any medicine which is broken down in the liver and then eliminated via the kidneys, accumulation of the breakdown products which are formed in the liver can be expected to occur in patients with severely impaired kidney function.

Primary ciliary dyskinesia: In some rare bronchial diseases which are associated with excessive accumulation of secretions (such as primary ciliary dyskinesia), Mucosolvan syrup should only be used under medical supervision because of the risk that secretions may accumulate.

Use in children

MUCOSOLVAN syrup must not be used in children under 2 years of age except on medical advice.

Taking other medicines

Please tell your doctor or pharmacist if you are taking/ using or have recently taken/used any other medicines. including medicines obtained without a prescription.

Ambroxol and cough suppressants Simultaneous: use of MUCOSOLVAN syrup  and cough suppressaats may lead to the development of a dangerous accumulation of secretions owing to reduction of the cough reflex and should be undertaken only after careful risk-benefit assessment.

Pregnancy and breast-feeding

Pregnancy: Ambroxol passes through the placenta to the unborn child. You should not take this medicine while you are pregnant, especially during the first 3 months.

Breast-feeding: Ambroxol has been shown to pass into breast milk in animal studies. Use while breast-feeding is not recommended.

Driving and using machines

There is no evidence of any effect on the ability to drive or use machines. No relevant studies have been performed.

Other Ingredients

This medicine contains approximately 1.2 g sorbitol per 5 ml (equivalent to 4.9 g if the maximum recommended daily dose is taken). If you have been told that you have an intolerance to some sugars, please consult your doctor before taking MUCOSOLVAN syrup.

How to take MUCOSOLVAN syrup?

Always take MUCOSOLVAN syrup exactly as described in this package leaflet. You should check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by the doctor, the recommended doses are as follows:

Children from 2 to 5 years of age: 1.25 ml three times daily (equivalent to 22.5 mg ambroxol hydrochloride per day).

Children from 6 to 12 years of age: 2.5 ml two to three times daily (equivalent to 30 -45 mg ambroxol hydrochloride per day).

Adults and adolescents over 12 years of age: The usual dosage is 5 ml three times daily (equivalent to 90 mg ambroxol hydrochloride per day) for the first 2-3 days and 5 ml twice daily (equivalent to 60 mg ambroxol hydrochloride per day). For adults and adolescents over 12 years of age, the therapeutic effect may be enhanced by increasing the dosage to 10 ml twice daily (equivalent to 120 mg ambroxol hydrochloride per day).

Route and method of administration and duration of treatment

• MUCOSOLVAN syrup is for oral use.
• MUCOSOLVAN syrup can be taken with or without food and is dispensed with the aid of the measuring cup provided. Please clean the measuring cup after each use by rinsing with warm water.
• You should contact a doctor if your symptoms worsen or do not improve after 4-5 days.
• If you feel that the effect of MUCOSOLVAN syrup is too strong or too weak, talk to your doctor or pharmacist.

If you take more MUCOSOLVAN syrup than you should: No specific symptoms of overdose have been reported to date. The symptoms observed in cases of accidental overdose or medication error are consistent with the side effects which may occur at recommended doses (see side effects section). In case of overdose, please consult a doctor as symptomatic treatment may be required.

If you forget to take MUCOSOLVAN syrup: If you forget to take MUCOSOLVAN syrupor take too small a dose. wait until it is time to take your next dose and then continue taking MUCOSOLVAN syrup as described in the dosage instructions above.

If you stop taking MUCOSOLVAN syrup: If you stop treatment early, your symptoms may get worse.

Possible side effects

Like all medicines, MUCOSOLVAN syrup can have side effects although not everybody gets them. The following categories are normally used when reporting the frequencies of side effects:

Immune system disorders/ Skin and subcutaneous tissue disorders:

• Rare: Skin rash. urticaria (nettle rash).
• Not known: Swelling of the skin and mucous membranes, itching; anaphylactic reactions (severe allergic reactions) including shock, other hypersensitivity reactions.

Nervous system disorders

Common: Taste disturbances.

Gastrointestinal disorders

• Common: Nausea, feeling of numbness in the mouth.
• Uncommon: Vomiting, diarrhoea, indigestion, abdominal pain, dry mouth.
• Rare: Dry throat.
• Very rare: Constipation, increased salivation.

Respiratory, thoracic and mediastinal disorders

• Common: Feeling of numbness in the throat.
• Very rare: Increased nasal discharge.
• Not known: Shortness of breath (as symptom of a hypersensitivity reaction).

Renal and urinary disorders

Very rare: Difficulty urinating.

General disorders and administration site conditions

Uncommon: Fever, mucous membrane reaction.

Action to be taken in the event of side effects: At the first signs of a hypersensitivity reaction, stop taking MUCOSOLVAN syrup . If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

How to store MUCOSOLVAN syrup

• Keep out of the reach and sight of children.
• Do not use MUCOSOLVAN syrup after the expiry date which is stated on the carton and the label.
• Storage conditions: Do not store above 25°C.
• Shelf life after first opening the bottle: Use MUCOSOLVAN syrup within 6 months of first opening the bottle.
• Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

• What MUCOSOLVAN syrup 30 mg/5 ml contains: The active substance is ambroxol hydrochloride.( 5 ml of the syrup contains 30 mg ambroxol hydrochloride).
• The other ingredients are: Benzoic acid, liquid sorbitol (non-crystallising). hydroxyethylcellulose, glycerol 85%, acesulfame potassium, flavouring agents, purified water.
• Notes: MUCOSOLVAN syrup  is suitable for diabetics; 5 ml contains 1.2 g of carbohydrates. MUCOSOLVAN syrup does not contain alcohol.
• What MUCOSOLVAN syrup looks like and contents of the pack: MUCOSOLVAN syrup is a colourless liquid with a fruity odour.
• MUCOSOLVAN syrup  is available in original packs containing 100 ml and 250 ml. Not all pack sizes may be marketed.
• Medicament is a product which affects your health. and its consumption contrary to instructions is dangerous for you.
• Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sales the medicament.
• The doctor and the pharmacist are experts in medicine. it’s benefits and risks.
• Do not by yourself interrupt the period of treatment prescribed for you.
• Do not repeat the same prescription without consulting your doctor.
• Keep medicament out of children reach.

Marketing Authorisation Holder

Boehringer IngeIheim international GmbH

Binger StraBe 173

55216 Ingelheim am Rhein, Germany

Manufacturer

Delpharm Reims

10, Rue Colonel Charbonneaux

51100 Reims

France.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Boehringer Ingelheim Middle East & North Africa (Scientific Office) FZ-LLC

• P.O. Box 505123 .
• Dubai Healthcare City Dubai, UAE.
• Tel: +971 (4) 423 0400.
• Fax: +971 (4) 423 3637.

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