Aciclovir Tablets BP 400mg
Actavis UK Ltd Contact details
1. Name of the medicinal product
ACICLOVIR TABLETS BP 400mg

2. Qualitative and quantitative composition
Each tablet contains 400mg Aciclovir PhEur.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
Pink uncoated tablets.

4. Clinical particulars
4.1 Therapeutic indications
1) Treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding severe HSV infections in immunocompromised children).

2) Suppression (prevention of recurrences) of recurrent herpes simplex infections in immunocompetent patients.

3) Prophylaxis of herpes simplex infections in immunocompromised patients.

4) Treatment of varicella (chickenpox) infection.

4.2 Posology and method of administration
Posology

Adults: Treatment of herpes simplex infections: 200mg aciclovir should be taken five times daily at approximately four hourly intervals omitting the night time dose. Treatment should continue for five days, but in severe initial infections this may have to be extended.

In severely immunocompromised patients (eg after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 400mg aciclovir or alternatively intravenous dosing could be considered.

Dosing should begin as early as possible after the start of an infection; for recurrent episodes this should preferably be during the prodromal period or when lesions first appear.

Suppression of herpes simplex infections in immunocompetent patients: 200mg aciclovir should be taken four times daily at approximately six-hourly intervals.

Many patients may be conveniently managed on a regime of 400mg aciclovir twice daily at approximately twelve-hourly intervals.

Dosage titration down to 200mg aciclovir taken three times daily at approximately eight-hourly intervals or even twice daily at approximately twelve-hourly intervals, may prove effective.

Some patients may experience break-through infections on total daily doses of 800mg aciclovir.

Therapy should be interrupted periodically at intervals of six to twelve months, in order to observe possible changes in the natural history of the disease.

Prophylaxis of herpes simplex infections in immunocompromised patients: 200mg aciclovir should be taken four times daily at approximately six hourly intervals.

In severely immunocompromised patients (eg after marrow transplant) or in patients with impaired absorption from the gut, the dose can be doubled to 400mg aciclovir or, alternatively, intravenous dosing could be considered.

The duration of prophylactic administration is determined by the duration of the period at risk.

Dosage in the paediatric population: Treatment of herpes simplex infections, and prophylaxis of herpes simplex infections in the immunocompromised: children aged two years and over should be given the adult doses and children below the age of two years should be given half the adult dose. Treatment of varicella infection: children under 2 years should be given 200mg four times daily. Children aged 2-5 years should be given 400mg four times daily. Children aged 6 years and over should be given 800mg four times daily. Treatment should continue for 5 days. Dosing may be more accurately calculated as 20mg/kg bodyweight (not to exceed 800mg four