VECTAVIR Cream Ref.[50416] Active ingredients: Penciclovir

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland

4.1. Therapeutic indications

Vectavir Cold Sore Cream is indicated for the treatment of cold sores (herpes labialis) in adults (including older people) and children over 12 years of age.

4.2. Posology and method of administration

Posology

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

Vectavir Cold Sore Cream should be applied at approximately two hourly intervals during waking hours.

Paediatric population

Children (under 12 years)

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

No data are available.

Method of administration

Vectavir Cold Sore Cream may be applied with a clean finger, or with a single-use applicator (for packages which contain applicators), in the amount required for the size of the affected area of skin. Treatment should becontinued for 4 days.

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

4.9. Overdose

No untoward effects would be expected even if the entire contents of a container of Vectavir 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.

6.3. Shelf life

2g and 5g aluminium tubes – 3 years.

2g plastic airless pump dispenser – 2 years.

6.4. Special precautions for storage

Store at temperatures not exceeding 30°C.

Do not freeze.

6.5. Nature and contents of container

2g and 5g aluminium tube. May be supplied with 20 single-use Low Density Polyethylene(LDPE) applicators.

2g plastic airless pump dispenser.

Not all pack sizes may be marketed.

6.6. 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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