Zovirax 200 mg Dispersible Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Aciclovir

Διαθέσιμο από:

GlaxoSmithKline (Ireland) Limited

Φαρμακολογική κατηγορία (ATC):

J05AB; J05AB01

INN (Διεθνής Όνομα):

Aciclovir

Δοσολογία:

200 milligram(s)

Φαρμακοτεχνική μορφή:

Dispersible tablet

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1996-12-03

Φύλλο οδηγιών χρήσης

Reason for Update: Type II C.1.4 Update to GDS 30 and Minor labelling
findings
Market: IE
Agenc Approval date: TBA
Text date: 21/04/2020
Text Issue and Draft No.: Issue 3, Draft 1
(GSK LOGO)
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX 200 MG DISPERSIBLE TABLETS
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. Do not pass it on to
others. It may harm them, even if
their symptoms 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 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 200 mg Dispersible Tablets (called ‘Zovirax’ in this
leaflet) contains a medicine called aciclovir.
This belongs to a group of medicines called antivirals. It works by
stopping the growth of viruses.
Zovirax 200 mg Dispersible Tablets can be used to:

treat chickenpox

treat shingles, and when started right after the rash appears, it can
help reduce the nerve pain that
can exist after the shingles rash has cleared

treat cold sores, genital herpes and other herpes simplex infections
(but not to be used to treat
herpes simplex infections in newborn infants or severe herpes simplex
infections in children
whose immune systems work less well, which means their bodies are less
able to fight infections)

stop cold sores and genital herpes returning after you have had them

prevent cold sores and genital herpes in people whose immune systems
work less well.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOVIRAX
DO NOT USE ZOVIRAX IF:

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
21 May 2021
CRN00CD8H
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zovirax 200 mg Dispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg aciclovir
Excipient(s) with known effect:
This product contains sodium as Sodium starch glycollate, see section
4.4
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Dispersible Film-coated tablet.
Zovirax 200 mg tablets are white, round film-coated tablets branded
with 'GXCF3' on one side and plain on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zovirax Tablets 200 mg 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 200 mg are indicated for the suppression (prevention
of recurrences) of recurrent Herpes simplex infections in
immunocompetent patients.
Zovirax Tablets 200 mg are indicated for the prophylaxis of Herpes
simplex infections in immunocompromised patients.
Zovirax Tablets 200 mg are indicated for the treatment of Varicella
(chickenpox) and Herpes zoster (shingles) infections. Studies
have shown that early treatment of shingles with Zovirax has a
beneficial effect on pain and can reduce the incidence of
post-herpetic neuralgia (zoster- associated pain).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE FOR TREATMENT OF HERPES SIMPLEX IN ADULTS.
For 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 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 or, alternatively, intravenous
dosing could be considered.
Dosing should begin as early