1. Name of the medicinal product
Aciclovir 800mg Tablets
2. Qualitative and quantitative composition
Aciclovir PhEur 800mg
3. Pharmaceutical form
Oral – tablets
4. Clinical particulars
4.1 Therapeutic indications
Treatment of herpes simplex virus (HSV) infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children).

Suppression of recurrent herpes simplex virus infections.

Prevention of herpes simplex virus infections in immunocompromised patients.

Treatment of herpes zoster infections.
4.2 Posology and method of administration
Treatment of herpes simplex infections of the skin and mucous membranes including initial and recurrent genital herpes

Adults: 200mg five times daily (usually every four hours while awake), for five days. In severe infections, duration of treatment may be extended. Aciclovir is effective only if started at the onset of symptoms.

Renal impairment: For patients with a creatinine clearance of less than 10ml per minute, reduce dosage to 200mg every 12 hours.

Elderly: dosage reduction may be required.

Children aged two to fourteen years: adult dose.

Children under two years: half the adult dose.

Suppression of recurrent herpes simplex infections

Adults: 200mg four times daily or 400mg twice daily which can be reduced to 200mg two or three times daily. Therapy should be interrupted every six to twelve months for reassessment of the condition.

Renal impairment: For patients with a creatinine clearance of less than 10ml per minute, reduce dosage to 200mg every 12 hours.

Elderly: dosage reduction may be required.

Children aged two to fourteen years: adult dose.

Children under two years: half the adult dose.

Prevention of herpes simplex infections in immunocompromised patients

Adults: 200mg four times daily for the duration of the period of risk. In severely immunocompromised patients or patients with impaired absorption from the gut, the dose may be increased to 400mg four times daily.

Renal impairment: For patients with a creatinine clearance of less than 10ml per minute, reduce dosage to 200mg every 12 hours.

Elderly: dosage reduction may be required.

Children aged two to fourteen years: adult dose.

Children under two years: half the adult dose.

Treatment of herpes zoster infections

Adults: 800mg five times daily (usually every four hours while awake) for seven days. Treatment should begin as early as possible and not later than three days after the first sign of outbreak.

Renal impairment: For patients with a creatinine clearance of 10 to 25ml per minute, reduce dosage to 800mg three to four times daily. For patients with a creatinine clearance of less than 10ml per minute, reduce dosage to 800mg twice daily.

Elderly: dosage reduction may be required.
4.3 Contraindications
Aciclovir tablets are contraindicated in patients known to be hypersensitive to aciclovir, valaciclovir or to any of the excipients.
4.4 Special warnings and precautions for use
Hydration status:

Care should be taken to maintain adequate hydration in patients receiving high oral doses of aciclovir.

Use in patients with renal impairment and in elderly patients:

Aciclovir is eliminated by renal clear