Zovirax Tablets 200mg

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

ACICLOVIR

Dostupno od:

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

ATC koda:

J05AB01

INN (International ime):

ACICLOVIR 200 mg

Farmaceutski oblik:

DISPERSIBLE FILM-COATED TABLET

Sastav:

ACICLOVIR 200 mg

Tip recepta:

POM

Područje terapije:

ANTIVIRALS FOR SYSTEMIC USE

Status autorizacije:

Withdrawn

Datum autorizacije:

2006-11-20

Uputa o lijeku

(GLAXOSMITHKLINE LOGO)
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX TABLETS 200 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 200 mg (called ‘Zovirax’ in this leaflet) contains
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
•
treat cold sores, genital herpes and other herpes simplex infections
•
stop these problems returning after you have had them
•
stop these problems in people whose immune systems work less well,
which means their bodies
are less able to fight infections.
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 pl

Svojstava lijeka

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Zovirax Tablets 200 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aciclovir BP 200 mg
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 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).
Zovirax Tablets are indicated for the suppression (prevention of
recurrences) of recurrent
herpes simplex infections in immunocompetent patients.
Zovirax Tablets are indicated for the prophylaxis of herpes simplex
infections in
immunocompromised patients.
Zovirax Tablets are indicated for the treatment of varicella
(chickenpox) and herpes zoster
(shingles) infections.
Route of administration: Oral.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Zovirax tablets may be dispersed in a minimum of 50 ml of water or
swallowed whole with
a little water. Ensure that patients on high doses of aciclovir are
adequately hydrated.
Dosage in adults
Treatment of herpes simplex infections: 200 mg Zovirax 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
Zovirax or
alternatively intravenous dosing could be considered.
Page 2 of 10
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 Zovirax
should be taken four times daily at approximately six-hourly
intervals.
Man