Aciclovir 400mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Aciclovir

Disponível em:

Accord-UK Ltd

Código ATC:

J05AB01

DCI (Denominação Comum Internacional):

Aciclovir

Dosagem:

400mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 05030201; GTIN: 5012617004260

Folheto informativo - Bula

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Aciclovir Tablets
400, 800mg x 35, 56 (UK)
148x210 (Reel Fed)
51010698
Leaflet for Blisters
1536
T. Hull
01/02/22
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[e-mail]
ACICLOVIR ALL STRENGTHS TABLETS PIL - UNITED KINGDOM
Black
Profile
BBBB4169
R.Paul
10.03.2022
148 x 210 (Reel Fed)
7pt
Accord Barnstaple
n/a
n/a
1
Version 7
12.02.2020
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
WHAT ACICLOVIR IS AND WHAT IT IS
USED FOR
2
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ACICLOVIR TABLETS
3
HOW TO TAKE ACICLOVIR TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE ACICLOVIR TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT ACICLOVIR IS AND WHAT IT IS USED FOR
Aciclovir is an antiviral medicine, which acts on infected
cells by stopping the virus growing.
Aciclovir 400mg tablets are used to:
• treat or prevent herpes simplex infections of the skin
and mucous

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ACICLOVIR TABLETS BP 400mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400mg Aciclovir PhEur.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pink uncoated tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
1) Treatment of herpes simplex virus infections of the skin and mucous
membranes including initial and recurrent genital herpes (excluding
severe HSV infections in immunocompromised children).
2) Suppression (prevention of recurrences) of recurrent herpes simplex
infections in immunocompetent patients.
3) Prophylaxis of herpes simplex infections in immunocompromised
patients.
4) Treatment of varicella (chickenpox) infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULTS: TREATMENT OF HERPES SIMPLEX INFECTIONS:_ 200mg aciclovir
should be taken
five times daily at approximately four hourly intervals omitting the
night time dose.
Treatment should continue for five days, but in severe initial
infections this may have
to be extended.
In severely immunocompromised patients (_eg_ after marrow transplant)
or in patients
with impaired absorption from the gut the dose can be doubled to 400mg
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_: 200mg
aciclovir should be taken four times daily at approximately six-hourly
intervals.
Many patients may be conveniently managed on a regime of 400mg
aciclovir twice
daily at approximately twelve-hourly intervals.
Dosage titration down to 200mg aciclovir taken three times daily at
approximately
eight-hourly intervals or even twice daily at approximately
twelve-hourly intervals,
may prove effective.
Some patients may experience break-through infections on total daily
doses of 800mg