Aciclovir Tablets BP 800mg
Actavis UK Ltd Contact details
1. Name of the medicinal product
ACICLOVIR TABLETS BP 800mg

2. Qualitative and quantitative composition
Each tablet contains 800mg Aciclovir PhEur.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
White uncoated tablets.

4. Clinical particulars
4.1 Therapeutic indications
1) Treatment of varicella (chickenpox) and herpes zoster (shingles) infections.

4.2 Posology and method of administration
Posology

Adults: Treatment of herpes zoster infections: 800mg aciclovir should be taken five times daily at approximately four-hourly intervals, omitting the night time dose. Treatment should continue for seven days.

In severely immunocompromised patients (eg after marrow transplant) or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing.

Dosing should begin as early as possible after the start of an infection. Treatment of herpes zoster yields better results if initiated as soon as possible after the onset of the rash.

Dosage in the paediatric population: Treatment of varicella infection: 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 times daily).

No specific data are available on the suppression of herpes simplex infections or the treatment of herpes zoster infections in immunocompetent children. When treatment of herpes zoster infections is required in immunocompromised children, intravenous dosing should be considered.

Dosage in the elderly: The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly (see Dosage in renal impairment below).

In the elderly, total aciclovir body clearance declines along with creatinine clearance. Adequate hydration of elderly patients taking high oral doses of aciclovir should be maintained. Special attention should be given to dosage reduction in elderly patients with impaired renal function.

Dosage in renal impairment: Caution is advised when administering aciclovir to patients with impaired renal function. Adequate hydration should be maintained.

In the management of herpes simplex infections in patients with severe renal impairment (creatinine clearance less than 10 ml/minute) an adjustment of dosage to 200 mg aciclovir twice daily at approximately twelve-hourly intervals is recommended.

In the treatment of herpes zoster infections it is recommended to adjust the dosage to 800mg aciclovir twice daily at approximately twelve-hourly intervals for patients with severe renal impairment (creatinine clearance less than 10ml/minute), and to 800mg aciclovir three times daily at intervals of approximately six to eight hours for patients with moderate renal impairment (creatinine clearance in the range 10-25ml/minute).

In the treatment of herpes zoster infections it is recommended to adjust the dosage to 800mg aciclovir twice daily at approximately twelve-hourly intervals for patients with renal impairment (creatinine clearance less than 10ml/minute), and to 800mg aciclovir three times daily at intervals of approximately six to eight hours for patients with moderate renal impairment (creatinine clearance in the range 10-25ml/minute).

Method of Administratio