MUCODYNE Syrup Ref.[27671] 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

4.1. 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.

4.2. Posology and method of administration

Posology

Adults including the elderly (300 ml presentation only)

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. for normal syrup 15 ml tds reducing to 10 ml tds.

Paediatric population (125 ml presentation only)

Children 2–5 years: The usual dose is 1.25–2.5 ml four times daily.

Children 5–12 years: The usual dose is 5 ml three times daily.

Method of administration

Mucodyne Syrup and Mucodyne Paediatric Syrup are for oral use.

Use of syringe for dosing (125 ml presentation only)

An oral dosing syringe is provided for use for dosing children.

How to use the oral dosing syringe for children

The syringe end should be placed into the neck of the bottle below the liquid fill line. To fill the syringe whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark on the syringe. The dose for children is given above based on age. Remove the syringe from the bottle neck carefully. Place the end of the syringe into the child’s mouth against the cheek and gently press the plunger down slowly to gently release the medicine. After use replace the bottle cap. Wash the syringe in warm water and allow to dry. Store out of the reach of children.

4.9. Overdose

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

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

*125 ml, 200 ml, 250 ml or 300 ml clear glass bottle (Type III glass) and a polypropylene childproof, tamper-evident screw cap with polyethylene liner together with a graduated polypropylene beaker for oral dose delivery to adults.

125 ml clear glass bottle (Type III glass) and a polypropylene childproof, tamper-evident cap with a polyethylene liner together with a 5 ml CE marked graduated syringe for oral dose delivery in children.

* The 125 ml pack size only will be provided with a syringe composed of a polyethylene barrel and a polystyrene piston with graduation markings each of 0.25 ml on the outside of the barrel.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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