Zovirax Tablets BP 800mg

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

ACICLOVIR

Tersedia dari:

The Wellcome Foundation 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Kode ATC:

J05AB01

INN (Nama Internasional):

ACICLOVIR 800 mg

Bentuk farmasi:

DISPERSIBLE FILM-COATED TABLET

Komposisi:

ACICLOVIR 800 mg

Jenis Resep:

POM

Area terapi:

ANTIVIRALS FOR SYSTEMIC USE

Status otorisasi:

Withdrawn

Tanggal Otorisasi:

2006-11-20

Selebaran informasi

(GLAXOSMITHKLINE LOGO)
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX TABLETS 800 MG
ACICLOVIR
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.
IN THIS LEAFLET:
1
What Zovirax is and what it is used for
2
What you need to know before you take Zovirax
3
How to take Zovirax
4
Possible side effects
5
How to store Zovirax
6
Contents of the pack and other information
1 WHAT ZOVIRAX IS AND WHAT IT IS USED FOR
Zovirax Tablets 800 mg (called ‘Zovirax’ in this leaflet) contain
a medicine called aciclovir. This
belongs to a group of medicines called antivirals. It works by killing
or stopping the growth of viruses.
Zovirax can be used to:
•
treat chickenpox and shingles.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOVIRAX
DO NOT USE ZOVIRAX:
•
if you are allergic to aciclovir or valaciclovir or any of the other
ingredients of this medicine (listed in
Section 6).
Do not take Zovirax if the above applies to you. If you are not sure,
talk to your doctor or pharmacist
before taking Zovirax.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zovirax if:
•
you have kidney problems
•
you are over 65 years of age.
If you are not sure if the above apply to you, talk to your doctor or
pharmacist before taking Zovirax.
It is important that you drink plenty of water while taking Zovirax
OTHER MEDICINES AND ZOVIRAX
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines. This includes medicines obtained without a prescription,
including herbal medicines.
In partic

Karakteristik produk

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Zovirax Tablets BP 800mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aciclovir 800mg BP
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersible film coated tablet
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zovirax tablets 800 mg are indicated for the treatment of varicella
(chickenpox) and herpes
zoster (shingles) infections
(excluding neonatal HSV and severe HSV infections in
immunocompromised children).
Zovirax 800mg tablets is recommended in children over the age of 6.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage in adults:
Treatment of varicella and herpes zoster infections: 800 mg Zovirax
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 (e.g. 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.
Treatment of chickenpox in immunocompetent patients should begin
within 24 hours after
the onset of the rash.
Dosage in children:
Treatment of varicella infections:
6 years and over: 800 mg Zovirax four times daily.
Treatment should continue for five days.
No specific data are available on the treatment of herpes zoster
infections in
immunocompetent children.
Page 2 of 9
For treatment of neonatal herpes virus infections, intravenous
acyclovir is
recommended.
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).
Adequate hydration of elderly patients taking high oral doses of
aciclovir should be
maintained.
Dosage in renal impairment:
Caution is advised when administering aciclovir