ACETYLCYSTEINE Powder for oral solution Ref.[6059] Active ingredients: Acetylcysteine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Colonis Pharma Limited, Quantum House, Hobson Industrial Estate, Burnopfield County Durham, NE16 6EA, United Kingdom

Therapeutic indications

Mucolytic adjuvant in the therapy of respiratory disorders associated with thick, viscous, mucus hypersecretion.

Posology and method of administration

Posology

Adults and adolescents over the age of 12 years

200 mg (1 sachet) 3 times a day. Maximum recommended daily dose 600 mg/day.

The duration of therapy is dependent on the nature and severity of the illness, and should be decided by the doctor treating the patient for adults and adolescents.

Abundant fluid intake supports the mucolytic effect of acetylcysteine.

Method of administration

Dissolve the contents of one sachet completely in a glass containing a little water just before use, stirring as needed with a teaspoon.

Overdose

An acute overdose of acetylcysteine can cause gastrointestinal symptoms such as nausea, vomiting and diarrhoea.

Treatment of Overdose

Treatment of overdose is to be symptomatic and supportive treatment as indicated by the patient’s clinical condition.

Shelf life

3 years.

After reconstitution, the product must be administered immediately.

Special precautions for storage

Store in the original package to protect from moisture.

Nature and contents of container

Paper/aluminium/polyethylene sachet containing l g powder for oral solution, packaged in a cardboard box, in the following pack sizes: 10, 18, 20, 30 sachets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal. Any unused product should be disposed of in accordance with local requirements.

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