MUCODYNE Capsule, hard Ref.[2616] Active ingredients: Carbocisteine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Therapeutic indications

Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.

Posology and method of administration

Posology

Adults including the elderly

Dosage is based upon an initial daily dosage of 2250 mg Carbocisteine in divided doses, reducing to 1500 mg daily in divided doses when a satisfactory response is obtained e.g. two capsules three times a day reducing to one capsule four times a day.

Paediatric population

This formulation is not recommended for children. The normal daily dosage is 20 mg/kg body weight in divided doses. It is recommended that this is achieved with Mucodyne Paediatric Syrup.

Method of administration

Mucodyne capsules are for oral use.

Overdose

Gastric lavage may be beneficial, followed by observation. Gastrointestinal disturbance is the most likely symptom of Mucodyne overdose.

Shelf life

36 months.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Grey HDPE tampertainer bottles with white LDPE cap or child resistant cap, or grey polypropylene securitainer bottles with white LDPE cap, containing 100 or 30 capsules. Blister packs of 120, 30, 18 or 6 capsules.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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