Zovirax 5 % w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Acyclovir

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

D06BB; D06BB03

INN (International Name):

Acyclovir

Dosage:

5 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

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

Therapeutic area:

Antivirals; aciclovir

Authorization status:

Marketed

Authorization date:

1984-05-02

Patient Information leaflet

Reason for Update: Type IAIN Project PINE site transfer from GSK
Poznan to Delpharm
Market: Ireland
Agency Approval Date:
Text Date: 23/ Jun 2022
Text Issue and Draft No.: Issue 7, Draft 1 ,
(GSK LOGO)
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX 5% W/W CREAM
ACICLOVIR
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
WHATS IN THIS LEAFLET:
1
What Zovirax is and what it is used for
2
What you need to know before you use Zovirax
3
How to use 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 5% w/w Cream (called ‘Zovirax’ in this leaflet) contains a
medicine called aciclovir. This
belongs to a group of medicines called antivirals. It is used to treat
cold sores, genital herpes and
other skin infections caused by the Herpes simplex virus. It works by
stopping the growth of viruses
that cause cold sores or genital herpes.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE ZOVIRAX
DO NOT USE ZOVIRAX IF:

you are allergic to aciclovir, valaciclovir, propylene glycol or any
of the other ingredients (listed in
Section 6).
If you are not sure, talk to your doctor or pharmacist before using
Zovirax.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Zovirax:

if you have a condition where your immune system works less well and
your body is less able to
fight infections (e.g. if you have HIV or AIDS or if you have had a
bone marrow transplant).
Zovirax Cream is not for use in the mouth, eyes or the vagina.
If y

Summary of Product characteristics

Health Products Regulatory Authority
15 June 2021
CRN009ZF5
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zovirax 5 % w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 50mg of aciclovir (equivalent to 5% w/w).
Excipients with known effect:
Propylene glycol 400mg/g
Cetostearyl alcohol 67.5mg/g
Sodium laurilsulfate 7.5mg/g
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A smooth white to off-white cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zovirax Cream is indicated for the treatment of Herpes simplex virus
infections of the skin including initial and recurrent genital
herpes and herpes labialis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Zovirax Cream should be applied five times daily at approximately four
hourly intervals omitting the night time application.
Zovirax Cream should be applied to the lesions or impending lesions as
soon as possible preferably during the earliest stages
(prodrome or erythema). Treatment can also be started during the later
(papule or blister) stages.
Treatment should be continued for at least four days for herpes
labialis and for five days for genital herpes. If healing has not
occurred, treatment may be continued for up to ten days.
4.3 CONTRAINDICATIONS
Zovirax Cream is contra-indicated in patients known to be
hypersensitive to aciclovir, valaciclovir,propylene glycol or any of
the
excipients of Zovirax Cream as listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Zovirax Cream is not recommended for application to mucous membranes,
such as in the mouth, eye or vagina as it may be
irritant. Particular care should be taken to avoid contact with the
eye.
In severely immunocompromised patients (e.g. AIDS patients or bone
marrow transplant recipients) oral dosing should be
considered. Such patients should be encouraged to consult a physician
concerning the treatment of any infection.
_Excipients_
This medicine contains 67.5mg of cetostearyl