Consumer medicine information

ViruPOS

Aciclovir

BRAND INFORMATION

Brand name

ViruPOS

Active ingredient

Aciclovir

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using ViruPOS.

What is in this leaflet

This leaflet answers some common questions about ViruPOS eye ointment. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

Please read this leaflet before you start using ViruPOS eye ointment. If you are helping someone else use ViruPOS eye ointment, please read this leaflet before using it for the first time.

All medicines have risks and benefits. Your doctor has weighed the expected benefits against possible risks of you using ViruPOS eye ointment. If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What ViruPOS eye ointment is used for

ViruPOS eye ointment contains 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. This medicine is available only on prescription.

Before you use ViruPOS eye ointment

Do not use ViruPOS eye ointment if:

  • you have an allergy to ViruPOS eye ointment, acyclovir, valaciclovir or any of the ingredients listed at the end of this leaflet.
  • the packaging is torn or shows signs of tampering, or the ointment has changed colour
  • it is past the expiry date printed on the pack.
  • If you use this medicine after the expiry date has passed, it may not work.
  • it is more than one month after you first opened the tube of ointment.

If you are not sure whether you should start using ViruPOS eye ointment, contact your doctor.

Do not give this medicine to anyone else. Your doctor has prescribed it specifically for you and your condition only.

Before you start to use ViruPOS eye ointment

Tell your doctor if:

  • you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
  • you are pregnant or intend to become pregnant.
  • you are breastfeeding or planning to breastfeed.

There is no information on whether ViruPOS eye ointment affects the ability to drive or operate machinery. If you have blurred vision after applying the ointment, do not drive or operate machinery.

How to use ViruPOS eye ointment

Follow your doctor’s instructions about how and when to use ViruPOS eye ointment.

ViruPOS eye ointment is usually applied five times a day – about every four hours while you are awake. See below for how to apply.

Do not touch the nozzle of the eye ointment or the eye ointment as it comes out of the tube. Wash your hands well with soap and dry them thoroughly before you apply the eye ointment.

With your finger under the bottom eye lid, pull the skin down gently so that the bottom eye lid comes down creating a little pocket between the eye and the eye lid. Put 10mm (1cm, just under half an inch) of ointment into this pocket. Release the eye lid and blink a couple of times to spread the ointment across the eye.

How long to use ViruPOS eye ointment

Keep using ViruPOS for at least three days after the eye infection has cleared up.

If you forget a dose of ViruPOS eye ointment

If you forget a dose of ViruPOS eye ointment use it as soon as you remember, then continue to use approximately every four hours.

It is important not to miss multiple doses of ViruPOS – it needs to be used regularly to work properly.

In case of an overdose

Overdosing with ViruPOS eye ointment when it is applied to the skin is unlikely. If you think that someone has accidentally swallowed the ointment, contact your doctor or the National Poisons Information Centre (03-474 7000), or go to your nearest accident and emergency centre. Do this even if there are no signs of poisoning or discomfort.

While you are using ViruPOS eye ointment

Things you must do

  • If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
  • If you develop itching with swelling of the face, a skin rash or difficulty breathing while you are using ViruPOS eye ointment do not use any more and contact your doctor immediately.
  • If you become pregnant while you are using ViruPOS eye ointment tell your doctor or pharmacist.

Things to be careful of

  • Do not give ViruPOS eye ointment to anyone else, even if they have the same condition as you. Do not use ViruPOS eye ointment to treat any other complaints including any other eye infections.
  • Throw ViruPOS eye ointment away 4 weeks after opening.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Viru-POS eye ointment.

Like other medicines, ViruPOS eye ointment can cause some side effects. If they occur, they are most likely to be minor and temporary. However, rarely some may be serious and need medical attention.

Ask your doctor or pharmacist if you have any questions.

Mild Effects

Tell your doctor if you notice any of the following that are troublesome or ongoing:

  • Mild stinging of the eye straight after applying the ointment. This usually only lasts a short time.
  • Itchy, watery eyes, (conjunctivitis)

More Serious Effects

Tell your doctor immediately if you notice any of the following:

If you think that ViruPOS eye ointment is causing you to have an allergic (hypersensitivity) reaction, TELL YOUR DOCTOR IMMEDIATELY. Symptoms include:

  • Severe skin rash, itching or hives
  • Swelling of the face, lips, mouth or throat
  • Difficulty breathing or swallowing
  • Low blood pressure (feeling faint or dizzy).

You may need urgent medical attention. Serious side effects are very rare.

Other side effects reported with ViruPOS eye ointment include:

  • Marks on the surface of the eye that look like points or dots. You don’t need to stop using ViruPOS and the marks will disappear again.

Some people may get other side effects while using ViruPOS eye 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 ViruPOS eye ointment

Storage

Store in a cool dry place where the temperature stays below 25 °C. Heat and dampness can destroy some medicines. Do not keep medicines in the bathroom or near a sink. Do not leave it in the car or on window sills.

Discard tube 4 weeks after opening it.

Store all medicines out of the reach of children such as in a locked cupboard.

Disposal

If your doctor advises you to stop using ViruPOS eye ointment, the medicine has passed its expiry date, or it is more than 4 weeks after opening, ask your pharmacist what to do with any ointment that is left over.

Product Description

What it looks like

ViruPOS eye ointment is a near-white, translucent (allows light through) eye ointment in a 4.5 g white aluminium tube with nozzle and cap.

Ingredients

Aciclovir, white soft paraffin.

Further Information

ViruPOS eye ointment is only available if prescribed by a doctor.

Distributor

Distributed in Australia by:

AFT Pharmaceuticals Pty Ltd
113 Wicks Road
North Ryde
NSW 2113

AUST R 324902

This leaflet was prepared in February 2021

Published by MIMS May 2021

BRAND INFORMATION

Brand name

ViruPOS

Active ingredient

Aciclovir

Schedule

S4

 

1 Name of Medicine

Aciclovir.

2 Qualitative and Quantitative Composition

White to pale yellow sterile ointment containing 3 per cent w/w aciclovir in a white soft paraffin base.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye ointment.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of Herpes simplex keratitis.

4.2 Dose and Method of 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 be continued for 14 days or at least 3 days after healing is completed, whichever is shorter.

Children.

As for adults.
For individual patient use only.

4.3 Contraindications

Patients with known hypersensitivity to aciclovir or valaciclovir.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Patients should be informed that transient mild stinging immediately following application may occur.
Patients should avoid wearing contact lenses when using ViruPOS eye ointment.
Resistant strains have been isolated in vitro and in animals following treatment with aciclovir. HSV strains resistant in vitro to aciclovir have also been isolated from immunocompromised as well as immuno-competent 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 herpes viruses to aciclovir and clinical response to therapy has yet to be established.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There is no information on the effect of ViruPOS 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.
(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 3 sc doses of 100 mg/kg aciclovir on gestation day 10, fetal abnormalities, such as 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 foetus.
 Limited human data show that aciclovir does pass into breast milk. Aciclovir should only be administered to nursing mothers if the benefits to the mother outweigh the potential risks to the baby.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable 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 ViruPOS eye 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.

Post-marketing.

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

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

No untoward effects are likely to occur if the entire contents of a tube containing 135 mg of aciclovir were ingested orally.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Aciclovir is a synthetic acyclic purine nucleoside analogue. Its chemical name is 9-((2-hydroxyethoxy) methyl) guanine. It is a white crystalline powder. Each gram of ViruPOS eye ointment contains 30 mg of aciclovir in white soft paraffin base (aciclovir 3 per cent).

Mechanism of action.

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 herpes viruses 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.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Aciclovir is absorbed through the corneal epithelium and superficial ocular tissues, and achieves significant concentrations in aqueous humour. Small quantities (2-16% 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.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Aciclovir and white soft paraffin base.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
Once opened, this medicine should not be used after 4 weeks.

6.4 Special Precautions for Storage

Store below 25 °C.

6.5 Nature and Contents of Container

ViruPOS eye ointment is provided in a white aluminium tube with internal epoxy phenol lacquer and white HDPE nozzle with white HDPE cap.
Each tube contains 4.5 g eye ointment.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

59277-89-3.

7 Medicine Schedule (Poisons Standard)

Schedule 4.