Zovirax 5% w/w Cream

Land: Malta

Tungumál: enska

Heimild: Malta Medicines Authority

Virkt innihaldsefni:

ACICLOVIR

Fáanlegur frá:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC númer:

D06BB03

INN (Alþjóðlegt nafn):

ACICLOVIR 5 % (W/W)

Lyfjaform:

CREAM

Samsetning:

ACICLOVIR 5 % (W/W)

Gerð lyfseðils:

POM

Lækningarsvæði:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Leyfisstaða:

Authorised

Leyfisdagur:

2005-11-10

Upplýsingar fylgiseðill

(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 you are not sure, talk to your doctor or pharmacist before using
Zovirax.
OTHER MEDICINES AND ZOVIRAX
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any ot

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zovirax 5% w/w Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cream containing 5% w/w aciclovir.
Excipients with known effect:
Propylene glycol 40% w/w
Cetostearyl alcohol 6/75% w/w.
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 contraindicated 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.
2
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.
The excipient propylene glycol may cause skin irritation and the
excipient cetyl alcohol can
cause local skin reactions (e.g. contact dermatitis).
Zovirax Cream contains 400 mg of propy