ZOVIRAX OPHTHALMIC ointment

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

GLAXOSMITHKLINE SOUTH AFRICA (PTY) LIMITED

Pharmaceutical form:

Ointment

Composition:

Each 1 g ophthalmic ointment contains ACICLOVIR 30 mg

Authorization date:

1983-04-07

Patient Information leaflet

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ZOVIRAX OPHTHALMIC OINTMENT
APPROVED PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING ZOVIRAX
OPHTHALMIC OINTMENT.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your
pharmacist.
ZOVIRAX Ophthalmic Ointment has been prescribed for you personally and
you should not
pass it on to others. It may harm them, even if their symptoms are the
same as yours.
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND DOSAGE FORM:
ZOVIRAX Ophthalmic Ointment
WHAT ZOVIRAX OPHTHALMIC OINTMENT CONTAINS:
Each gram contains 30 mg acyclovir in white, soft paraffin.
WHAT ZOVIRAX OPHTHALMIC OINTMENT IS USED FOR:
ZOVIRAX Ophthalmic Ointment is an antiviral used to treat an eye
infection called herpes
simplex keratitis. This is a viral infection in the eye. It is NOT
used in other infections in the
eye such as conjunctivitis.
ZOVIRAX Ophthalmic Ointment is available only with a doctor's
prescription.
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BEFORE YOU USE ZOVIRAX OPHTHALMIC OINTMENT:
DO NOT USE ZOVIRAX OPHTHALMIC OINTMENT IF:

you have an allergy to this medicine, acyclovir, valaciclovir or to
the inactive ingredient,
white soft paraffin

it is more than a month after you first opened the tube of ointment.
BEFORE YOU START USING ZOVIRAX OPHTHALMIC OINTMENT, TELL YOUR DOCTOR
IF:

you have any allergies to any other medicines or any other substances,
such as foods,
preservatives or dyes.
If you have blurred vision after applying ZOVIRAX Ophthalmic Ointment,
do not drive or
operate machinery.
If you wear contact lenses, you should avoid wearing lenses while
using ZOVIRAX
Ophthalmic Ointment.
Always tell your health care professional if you are taking/using any
other medicine.
If you are pregnant or breast feeding your baby please consult your
doctor, pharmacist or
other health care professional for advice before using this medicine.
HOW TO USE ZOVIRAX OPHTHALMIC OINTMENT:
Do not share medicines prescribed for you with any other person.
Follow your doctor's instructi

Summary of Product characteristics

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ZOVIRAX OPHTHALMIC OINTMENT
APPROVED PACKAGE INSERT
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND DOSAGE FORM:
ZOVIRAX Ophthalmic Ointment
COMPOSITION:
Each gram contains 30 mg acyclovir in white, soft paraffin.
PHARMACOLOGICAL CLASSIFICATION:
A 15.4 Ophthalmic preparations. Other
PHARMACOLOGICAL ACTION:
Acyclovir is an antiviral agent which is highly active _in vitro_
against herpes simplex (HSV)
type I and II viruses, but its toxicity to the infected mammalian
cells is low. Acyclovir is
phosphorylated to the active compound acyclovir triphosphate after
entry into a herpes-
infected cell. The first step in this process requires the presence of
the HSV coded
thymidine kinase. Acyclovir triphosphate acts as an inhibitor of and
substrate for the herpes
specified DNA polymerase preventing further viral DNA synthesis
without affecting normal
cellular processes.
INDICATIONS:
ZOVIRAX Ophthalmic Ointment is indicated for the treatment of herpes
simplex keratitis.
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CONTRA-INDICATIONS:
ZOVIRAX Ophthalmic Ointment is contra-indicated in patients known to
be previously
hypersensitive to acyclovir or valaciclovir.
WARNINGS AND SPECIAL PRECAUTIONS:
Patients should be informed that transient mild stinging immediately
following application of
ZOVIRAX Ophthalmic Ointment may occur.
Patients should avoid wearing contact lenses when using ZOVIRAX
Ophthalmic Ointment.
INTERACTIONS:
Probenecid increases the acyclovir mean half-life and area under the
plasma concentration
curve. Other medicines affecting renal physiology could potentially
influence the
pharmacokinetics of acyclovir. However, clinical experience has not
identified other drug
interactions with acyclovir.
PREGNANCY AND LACTATION:
Safety in pregnancy and lactation has not been established.
PREGNANCY: A post-marketing acyclovir pregnancy registry has
documented pregnancy
outcomes in women exposed to any formulation of ZOVIRAX. The registry
findings have not
shown an increase in the number of birth defects amongst
ZOVIRAX-exposed subjects
compared with