SPASMONAL Hard capsule Ref.[49655] Active ingredients: Alverine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

4.1. Therapeutic indications

The relief of smooth muscle spasm, in conditions such as irritable bowel syndrome, painful diverticular disease of the colon and primary dysmenorrhoea.

4.2. Posology and method of administration

Posology

Adults and the elderly

1or 2 capsules one to three times daily.

Children below the age of 12 years

Not recommended.

Method of administration

For oral use.

4.9. Overdose

Symptoms

Can produce hypotension and atropine-like toxic effects.

Management is as for atropine poisoning with supportive therapy for hypotension.

Fatality has occurred following overdose with very high doses.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store in a dry place. Do not store above 25°C.

6.5. Nature and contents of container

Plastic containers of 20 or 100 capsules; foil/UPVC blister packs containing 3, 10, 12, 20, 90 or 100 capsules.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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