Consumer medicine information

Zovirax Ophthalmic Ointment

Aciclovir

BRAND INFORMATION

Brand name

Zovirax Ophthalmic Ointment

Active ingredient

Aciclovir

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Zovirax Ophthalmic Ointment.

What is in this leaflet

This leaflet answers some common questions about Zovirax ophthalmic ointment. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Zovirax ophthalmic ointment against the benefits they expect it will have for you.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What Zovirax ophthalmic ointment is used for

Zovirax ophthalmic ointment is used for the treatment of herpes simplex virus infections of the eye.

Aciclovir (the active ingredient in Zovirax ophthalmic ointment) belongs to a group of medicines called "anti-virals".

Zovirax ophthalmic ointment works by stopping the production of the herpes simplex virus. Zovirax ophthalmic ointment does not get rid of the virus from your body.

Zovirax ophthalmic ointment is only suitable for use in the eye.

Your doctor may have prescribed Zovirax ophthalmic ointment for another purpose. Ask your doctor or pharmacist if you have any questions about why Zovirax ophthalmic ointment has been prescribed for you.

There is no evidence that Zovirax ophthalmic ointment is addictive

This medicine is available only with a doctor's prescription.

Before you use Zovirax ophthalmic ointment

When you must not use it

Do not use Zovirax ophthalmic ointment if:

  • you have or have had an allergy to Zovirax, aciclovir, valaciclovir or any of the ingredients listed at the end of this leaflet

Do not use Zovirax ophthalmic ointment if the packaging is torn or shows signs of tampering.

Do not use Zovirax ophthalmic ointment if the expiry date (EXP) printed on the pack has passed.

If you use this medicine after the expiry date has passed, it may not work as well.

Do not use Zovirax ophthalmic ointment 28 days after first opening the tube.

If you are not sure whether you should start using Zovirax ophthalmic ointment, ask your doctor or pharmacist.

Before you start to use it

Tell your doctor if:

  1. if you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
  2. if you are pregnant or intend to become pregnant
    Your doctor will discuss the risks and benefits of using Zovirax ophthalmic ointment when pregnant.
  3. if you are breast-feeding or intend to breast-feed
    Your doctor will discuss the risks and benefits of using Zovirax ophthalmic ointment when breast-feeding.
  4. If you wear contact lenses.

If you have not told your doctor about any of the above, tell them before you use any Zovirax ophthalmic ointment.

Using other medicines

Tell your doctor or pharmacist if you are using other creams or ointments or taking any other medicine. This includes any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when using Zovirax ophthalmic ointment with other medicines.

How to use Zovirax ophthalmic ointment

How much to use

The usual dose is a 1 cm ribbon of ointment five times a day at approximately 4 hour intervals.

Follow all directions given to you by your doctor and pharmacist carefully.

These directions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How to use it

It is important to use Zovirax ophthalmic ointment exactly as your doctor told you.

  • Wash your hands before and after applying the eye ointment.
  • Apply 1cm of the ointment to the inside of the lower eyelid on the affected side.
  • If you find this difficult, it may be easier if a mirror is used or for someone else to do this for you.
  • Try to avoid letting the tip of the tube touch any part of the eye.
  • After application, close your eye for 30 seconds. Repeat the application five times a day at approximately four-hourly intervals, omitting the night time application.
  • Your vision may be blurred for a short time (5-10 minutes), and you should wait until you can see clearly again before driving or operating machinery
  • It is important to follow the instructions on this leaflet. If, on a few occasions by mistake you apply more than the recommended amount do not worry.

Use Zovirax ophthalmic ointment at the same time every day.

How long to use it

Your doctor or pharmacist will tell you how long to use Zovirax ophthalmic ointment.

Treatment should usually be continued for 14 days or at least 3 days after healing is completed, whichever is shorter.

Do not use Zovirax ophthalmic ointment for longer than your doctor tells you.

If you are not sure how long to use Zovirax ophthalmic ointment, talk to your doctor or pharmacist.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use it as soon as you remember, and then go back to using your medicine as you would normally.

Do not use a double dose to make up for the dose that you missed.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

If you swallow it

There is not expected to be any untoward effects from swallowing the entire contents of the tube. However if you have any concerns you should still telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to casualty at your nearest hospital, if you think that you or anyone else may have swallowed Zovirax ophthalmic ointment.

Keep these telephone numbers handy.

While you are using Zovirax ophthalmic ointment

Things you must do

Tell all doctors and pharmacists who are treating you that you are using Zovirax ophthalmic ointment.

If you feel that your condition is getting worse rather than better, tell your doctor or pharmacist.

Tell your doctor if, for any reason, you have not used Zovirax ophthalmic ointment exactly as prescribed.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

If you become pregnant while using Zovirax ophthalmic ointment, tell your doctor.

Things you must not do

Do not give Zovirax ophthalmic ointment to anyone else, even if they have the same symptoms as yours.

Do not use Zovirax ophthalmic ointment to treat other complaints unless your doctor tells you to.

Things to be careful of

Do not use large amounts of Zovirax ophthalmic ointment for a long time.

Avoid wearing contact lenses when using Zovirax ophthalmic ointment.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Zovirax ophthalmic ointment.

Check with your doctor or pharmacist as soon as possible if you have any problems while using Zovirax ophthalmic ointment, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like other medicines, Zovirax ophthalmic ointment can cause some side effects. If they occur, most are likely to be minor and temporary.

  • You may feel a mild stinging immediately after applying the ointment to your eye(s) but this passes quickly.
  • Irritation or inflammation of the eye lids (blepharitis) or surface of the eye (eg conjunctivitis)

Ask your doctor or pharmacist to answer any questions you may have.

Some may be serious and need medical attention.

If any of the following happen, stop using Zovirax ophthalmic ointment and tell your doctor immediately or go to casualty at your nearest hospital:

A very few people may be allergic/sensitive to Zovirax. There have been rare reports of allergic reactions including swelling, especially of the lips, face and/or eyelids; skin rashes or weals.

Some people may get other side effects while using Zovirax ophthalmic ointment.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Zovirax ophthalmic ointment

Storage

Keep Zovirax ophthalmic ointment in a cool dry place where the temperature stays below 25°C.

Discard 28 days after opening.

Do not store Zovirax ophthalmic ointment or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep Zovirax ophthalmic ointment where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using Zovirax ophthalmic ointment or it has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

What Zovirax ophthalmic ointment looks like

Zovirax ophthalmic ointment is a white to pale yellow sterile ointment available in a 4.5 g tube.

Ingredients

Each gram of ointment contains 30mg of aciclovir.

Zovirax ophthalmic ointment also contains the inactive ingredient white soft paraffin.

Zovirax Ophthalmic ointment is supplied in Australia by:
GlaxoSmithKline Australia Pty Ltd
1061 Mountain Highway
BORONIA VIC 3155

This leaflet was prepared on
17 June 2005

AUST R 11013

The information provided applies only to: Zovirax Ophthalmic ointment.

™ Zovirax is a trade mark of the GlaxoSmithKline group of companies.

© 2003 GlaxoSmithKline

Version 1.0

Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your illness and its treatment from other sources, for example from books in public libraries.

BRAND INFORMATION

Brand name

Zovirax Ophthalmic Ointment

Active ingredient

Aciclovir

Schedule

S4

 

Name of the medicine

Aciclovir.

Excipients

White soft paraffin base.

Description

Chemical name: 9-((2-hydroxyethoxy) methyl)guanine. Synthetic acyclic purine nucleoside analogue. It is a white crystalline powder.

Pharmacology

Microbiology.

Aciclovir is an antiviral agent which is active in vitro against herpes simplex virus (HSV) types I and II. However, the relationship between in vitro sensitivity of herpesviruses to aciclovir and clinical response to therapy has yet to be established. Aciclovir needs to be phosphorylated to the active compound, aciclovir triphosphate in order to become active against the virus. Such conversion is very limited in normal cells and in addition cellular DNA polymerase is not very sensitive to the active compound. However, in infected cells HSV or VZV coded thymidine kinase facilitates the conversion of aciclovir to aciclovir monophosphate which is then converted to aciclovir triphosphate by cellular enzymes. Aciclovir triphosphate acts as an inhibitor of, and substrate for, the herpes specified DNA polymerase, preventing further viral DNA synthesis.

Pharmacokinetics.

Aciclovir is absorbed through the corneal epithelium and superficial ocular tissues, and achieves significant concentrations in aqueous humour. Small quantities (2 to 16% of the applied dose) appear in the urine. In animal studies low levels of aciclovir could be detected in blood after topical application to the eye.

Indications

Treatment of herpes simplex keratitis.

Contraindications

Known hypersensitivity to aciclovir or valaciclovir.

Precautions

Patients should be informed that transient mild stinging immediately following application may occur.
Patients should avoid wearing contact lenses when using Zovirax Ophthalmic Ointment.
Resistant strains have been isolated in vitro and in animals following treatment with aciclovir. Herpes simplex virus (HSV) strains resistant in vitro to aciclovir have also been isolated from immune compromised as well as immunocompetent patients receiving aciclovir for herpes simplex infections. Therefore the potential for the development of resistant HSV strains in patients treated with aciclovir should be borne in mind. The relationship between in vitro sensitivity of the herpesviruses to aciclovir and clinical response to therapy has yet to be established.

Use in pregnancy.

(Category B3)
Animal studies show that aciclovir crosses the placenta readily. Aciclovir was not teratogenic in the mouse (450 mg/kg/day po), rabbit (50 mg/kg/day sc and iv) or rat (50 mg/kg/day sc) when dosed throughout the period of major organogenesis. In additional studies in which rats were given three sc doses of aciclovir 100 mg/kg on gestation day 10, fetal abnormalities, e.g. head and tail anomalies, were reported.
There have been no adequate and well controlled studies concerning the safety of aciclovir in pregnant women. Only small amounts are absorbed following application to the eye. It should not be used during pregnancy unless the benefits to the patient clearly outweigh the potential risks to the fetus.

Use in lactation.

Limited human data show that aciclovir does pass into breast milk. Aciclovir should only be administered to breastfeeding mothers if the benefits to the mother outweigh the potential risks to the baby.

Effects on fertility.

There is no information on the effect of Zovirax on human female fertility. In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1 g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.

Adverse Effects

Transient mild stinging immediately following administration occurs in a proportion of patients. Superficial punctate keratopathy occurs somewhat more frequently but healing has occurred, without apparent sequelae, following the completion of a course of treatment of dendritic ulcers. Blepharitis has been reported in patients on Zovirax Ophthalmic Ointment.
Sensitivity reactions have been reported but are uncommon.
The following have also been reported but may be disease related: mild hyperaemia, discharge, lid oedema and erythema, epithelial microcysts and conjunctivitis.

Postmarketing.

There have been very rare reports of immediate hypersensitivity reactions, including angioedema, with topical aciclovir.

Dosage and Administration

Adults.

1 cm ribbon of ointment should be placed inside the lower conjunctival sac five times a day at approximately four hourly intervals. Treatment should continue for 14 days or at least three days after healing is complete, whichever is shorter.

Children.

As for adults.

Overdosage

No untoward effects are likely to occur if the entire contents of the tube containing aciclovir 135 mg were ingested orally.

Presentation

Ointment, 30 mg/g (3% w/w) (sterile white to pale yellow): 4.5 g.

Storage

Store below 25°C. Discard one month after opening.

Poison Schedule

S4.