Aciclovir 800mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Aciclovir

Commercializzato da:

Accord-UK Ltd

Codice ATC:

J05AB01

INN (Nome Internazionale):

Aciclovir

Dosaggio:

800mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 05030201; GTIN: 5012617004277

Foglio illustrativo

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

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ACICLOVIR TABLETS BP 800mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800mg Aciclovir PhEur.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White uncoated tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
1) Treatment of varicella (chickenpox) and herpes zoster (shingles)
infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY_ _
_ _
_ADULTS: TREATMENT OF HERPES ZOSTER INFECTIONS_: 800mg aciclovir
should be
taken five times daily at approximately four-hourly intervals,
omitting the
night time dose. Treatment should continue for seven days.
In severely immunocompromised patients (_eg_ after marrow transplant)
or in
patients with impaired absorption from the gut, consideration should
be given
to intravenous dosing.
Dosing should begin as early as possible after the start of an
infection.
Treatment of herpes zoster yields better results if initiated as soon
as possible
after the onset of the rash.
_ _
_DOSAGE IN THE PAEDIATRIC POPULATION: _Treatment of varicella
infection:
Children aged 6 years and over should be given 800mg four times daily.
Treatment should continue for 5 days. Dosing may be more accurately
calculated as 20mg/kg bodyweight (not to exceed 800mg four times
daily).
No specific data are available on the _suppression of herpes simplex_
infections
or the _treatment of herpes zoster_ infections in immunocompetent
children.
When treatment of herpes zoster infections is required in
immunocompromised children, intravenous dosing should be considered.
_ _
_DOSAGE IN THE ELDERLY_: The possibility of renal impairment in the
elderly must
be considered and the dosage should be adjusted accordingly (see
Dosage in
renal impairment below).
In the elderly, total aciclovir body clearance declines along with
creatinine
clearance. Adequate hydration of elderly patients taking high oral
doses of
aciclovir should be maintained. Special attention should be given to
dosage
reduction in elderl