Aciclovir 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aciclovir

Available from:

Waymade Healthcare Plc

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 400 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 400 mg tablet contains 400 mg aciclovir.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White to off-white, round (diameter: 11.8 mm), biconvex, uncoated
tablets
debossed with ‘AR and 400’ separated with breakline on one side
and plain on
the other side. The tablet can be divided into equal doses
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aciclovir Tablets are 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 Tablets are indicated for the suppression (prevention of
recurrences)
of recurrent herpes simplex infections in immunocompetent patients.
Aciclovir Tablets are indicated for the prophylaxis of herpes simplex
infections in immunocompromised patients.
Aciclovir Tablets are indicated for the treatment of varicella
(chickenpox) and
herpes zoster (shingles) infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Dosage in adults _
_ _
Treatment of herpes simplex infections: 200 mg Aciclovir 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 400
mg 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:
200
mg Aciclovir should be taken four times daily at approximately
six-hourly
intervals.