ZOVIRAX CREAM

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

GlaxoSmithKline South Africa (Pty) Limited

Dosage:

See ingredients

Pharmaceutical form:

CREAM

Composition:

EACH GRAM CONTAINS ACICLOVIR 50 MG

Authorization status:

Registered

Authorization date:

1985-07-12

Patient Information leaflet

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ZOVIRAX
 CREAM
1
SCHEDULING STATUS:
2
S4
3
4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
5
ZOVIRAX CREAM
6
ACYCLOVIR
7
8
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING ZOVIRAX
CREAM.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your
pharmacist.
ZOVIRAX CREAM has been prescribed for you personally and you should
not share
your medicine with other people. It may harm them, even if their
symptoms are the
same as yours.
9
WHAT ZOVIRAX CREAM CONTAINS:
10
1 gram of cream contains 0,05 grams of acyclovir.
11
The inactive ingredients include poloxamer 407, cetostearyl alcohol,
sodium lauryl
12
sulphate, white soft paraffin, liquid paraffin, propylene glycol and
purified water.
13
14
WHAT ZOVIRAX CREAM IS USED FOR:
15
ZOVIRAX contains the active ingredient acyclovir. Acyclovir belongs to
a group of
16
medicines called antivirals, used for treating infections caused by
the herpes simplex
17
virus.
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ZOVIRAX CREAM is used to treat cold sores, genital herpes and other
skin infections
20
caused by the herpes simplex virus. It is not for use in your eyes, or
inside your mouth
21
or vagina.
22
23
BEFORE YOU USE ZOVIRAX CREAM:
24
DO NOT USE ZOVIRAX CREAM:
25

if you are hypersensitive (allergic) to acyclovir, valacyclovir,
propylene glycol, or any
26
of the ingredients of ZOVIRAX CREAM
27

for herpes infections of the eyes or genital area.
28
29
TAKE SPECIAL CARE WITH ZOVIRAX CREAM:
30

if you are pregnant or intend to become pregnant
31

if you are breastfeeding or planning to breastfeed
32

if you are under the care of a doctor because of a weak immune system
(i.e. your
33
ability to fight infection is reduced) e.g. HIV infection, a bone
marrow transplant or
34
cancer treatment. If so, a skin infection could be more serious for
you than with other
35
people.
36
37
Tell your doctor each time you get a cold sore or herpes blister. Do
not treat it yourself
38
with ZOVIRAX CREAM, unless your doctor tells y

Summary of Product characteristics

1
ZOVIRAX
 CREAM
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND DOSAGE FORM:
ZOVIRAX CREAM
COMPOSITION:
1 gram of cream contains 0,05 grams of acyclovir
PHARMACOLOGICAL CLASSIFICATION:
A 20.2.8 Antiviral agent
PHARMACOLOGICAL ACTION:
Acyclovir is an antiviral agent which is active _in vitro_ against
herpes simplex (HSV) type I and
II. Toxicity to mammalian host cells is low. Acyclovir is
phosphorylated after entry into
herpes infected cells to the active compound acyclovir triphosphate.
The first step in this
process is dependant on the presence of the HSV coded thymidine
kinase. Acyclovir
triphosphate acts as an inhibitor of and substrate for the herpes
specific DNA polymerase
preventing further viral DNA synthesis without affecting normal
cellular processes.
Pharmacology studies have shown only minimal systemic absorption of
acyclovir following
repeated topical administration of acyclovir cream.
2
INDICATIONS:
ZOVIRAX CREAM is indicated for the treatment of herpes simplex virus
infections of the
skin, lips or genitalia in the initial and recurrent situation.
CONTRA-INDICATIONS:
ZOVIRAX CREAM is contra-indicated in patients known to be
hypersensitive to acyclovir,
valacyclovir or propylene glycol, or any of the excipients of ZOVIRAX
CREAM.
WARNINGS AND SPECIAL PRECAUTIONS:
In severely immune compromised patients (e.g. AIDS patients or bone
marrow transplant
recipients) topical ZOVIRAX may be inappropriate. Such patients should
be encouraged to
consult a physician concerning treatment of any infection.
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
accidental introduction into the
eye.
INTERACTIONS:
Probenecid increases the acyclovir mean half life and area under the
plasma concentration
curve.
Other
drugs
affecting
renal
physiology
could
potentially
influence
the
pharmacokinetics of acyclovir. However, clinical experience has not
identified other drug
interactions with acyclovir.
No clinical