1. Name of the medicinal product
Aciclovir 200mg/5ml Oral Suspension
2. Qualitative and quantitative composition
The active substance is aciclovir.

Each 5ml of oral suspension contains 200mg aciclovir.

Excipient(s) with known effect:

Each 5ml of suspension contains 2.25g sorbitol liquid (non-crystallising) (E420) and 10mg of methyl parahydroxybenzoate (E218).

For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral Suspension

White to off-white uniform oral suspension with orange and vanilla odour
4. Clinical particulars
4.1 Therapeutic indications
Aciclovir Suspension is indicated for the treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children).

Aciclovir Suspension is indicated for the suppression (prevention of recurrences) of recurrent herpes simplex infections in immunocompetent patients.

Aciclovir Suspension is indicated for the prophylaxis of herpes simplex infections in immunocompromised patients.

Aciclovir Suspension is indicated for the treatment of varicella (chickenpox) and herpes zoster (shingles) infections.
4.2 Posology and method of administration
Dosage in Adults

Treatment of herpes simplex infections:

200mg Aciclovir suspension should be taken five times daily at approximately four hourly intervals omitting the night time dose. Treatment should continue for 5 days, but in severe initial infections this may have to be extended.

In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 400mg Aciclovir suspension 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 suspension should be taken four times daily at approximately six-hourly intervals.

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

Dosage titration down to 200mg Aciclovir suspension taken thrice daily at approximately eight-hourly intervals or even twice daily at approximately twelve-hourly intervals, may prove effective.

Some patients may experience break-through infection on total daily doses of 800mg Aciclovir suspension.

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 suspension should be taken four times daily at approximately six hourly intervals.

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

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

Treatment of