FENISTIL COLD SORE Cream Ref.[6306] Active ingredients: Penciclovir

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Omega Pharma Ltd., 1st Floor, 32 Vauxhall Bridge Road, LONDON, SW1V 2SA, United Kingdom

Therapeutic indications

Fenistil Cold Sore Cream is indicated for the treatment of herpes simplex virus infections of the lips and face (herpes labialis) in adults (including older people) and children over 12 years of age.

Immunocompromised patients

Fenistil Cold Sore Cream is not recommended for use in immunocompromised patients; such patients should consult a physician concerning the treatment of any infection.

Posology and method of administration

Adults (including older people) and children over 12 years of age

Fenistil Cold Sore Cream should be applied at approximately two hourly intervals during waking hours, (approximately 8 times a day). Treatment should be continued for 4 days. If the condition gets worse or does not improve after 4 days treatment, seek medical advice.

Treatment should be started as early as possible after the first sign of an infection.

Paediatric population

Children (under 12 years)

The safety and efficacy of Fenistil Cold Sore Cream in children below 12 years of age have not been established.

No data are available.

Overdose

No untoward effects would be expected even if the entire contents of a container of Fenistil Cold Sore Cream were ingested orally; penciclovir is poorly absorbed following oral administration. However, some irritation in the mouth could occur. No specific treatment is necessary if accidental oral ingestion occurs.

Shelf life

2g aluminium tubes – 3 years.

Special precautions for storage

Store at temperatures not exceeding 30°C.

Do not freeze.

Nature and contents of container

2g aluminium tube.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

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