Aciclovir 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aciclovir

Available from:

Tillomed Laboratories Ltd

ATC code:

J05AB01

INN (International Name):

Aciclovir

Dosage:

400mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05030201

Patient Information leaflet

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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aciclovir 400mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Aciclovir 400 mg
Excipient with known effect: Each tablet contains 64mg lactose (as
lactose
monohydrate)
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
A white or almost white, oblong, biconvex scored tablet of 8mm x 16mm,
coded: ACY 400 on one side
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of herpes simplex 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 infections. Prevention of herpes simplex infections in
immunocompromised
patients. Treatment of herpes zoster infections. Treatment of
varicella (chickenpox)
infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment of herpes simplex infections of the skin and mucous
membranes
including initial and recurrent genital herpes.
Adults:
200mg five times daily for five days; in severe infections, the
duration of
treatment may have to be extended beyond 5 days, but in severe initial
infections this may have to be extended. Treatment should begin as
early as
possible after the first sign of outbreak. In severely
immunocompromised
patients: (e.g. after bone marrow transplant or in patients with
impaired
absorption from the gut), the dosage can be doubled to 400mg five
times daily
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 for
when lesions first appear.
Dosage reduction in renal impairment: At creatinine clearance <10
ml/minute
200mg twice daily for five days.
Children:
CHILDREN OVER THE AGE OF 2 YEARS: Adult dosage.
CHILDREN UNDER THE AGE