Consumer medicine information

Xorox (Aciclovir) 30 mg/g Eye Ointment Tube

Aciclovir

BRAND INFORMATION

Brand name

Xorox

Active ingredient

Aciclovir

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Xorox (Aciclovir) 30 mg/g Eye Ointment Tube.

What is in this leaflet

This leaflet answers some common questions about Xorox. 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 Xorox 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 Xorox eye ointment is used for

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

Xorox used to treat eye infections caused by the Herpes simplex virus. It works by killing or stopping the growth of viruses on the front of your eyeball (cornea).

Xorox is only suitable for use in the eye.

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

There is no evidence that Xorox is addictive.

This medicine is available only on doctor's prescription.

Before you use Xorox eye ointment

When you must not use it

Do not use Xorox ointment if:

  • You have or have had an allergy to aciclovir, valaciclovir or any of the ingredients listed at the end of this leaflet.
  • Do not use Xorox if the packaging is torn or shows signs of tampering.
  • Do not use Xorox 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.

Use within four weeks after first opening.

If you are not sure whether you should start using Xorox, 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 Xorox when pregnant.
  1. if you are breast-feeding or intend to breast-feed
Your doctor will discuss the risks and benefits of using Xorox when breastfeeding.
  1. If you wear contact lenses.

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

Using other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

When applied locally in the eye, no significant interactions were observed so far.

There is however insufficient information on the use of Xorox and simultaneous use with eye medicines containing corticosteroids. Your doctor will decide if this is appropriate for you.

How to use Xorox eye ointment

How much to use

Instructions for Use

For ocular use

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist, if you are not sure.

Unless otherwise prescribed by a doctor, the recommended dose is:

Place a 1 cm ribbon of ointment inside the lower conjunctival sac 5 times a day (every 4 hours). Suggested times are: 7:00, 11:00, 15:00, 19:00 and 23:00.

Pull down the lower lid and place the ointment strand inside the conjunctival sac. Close your eye lids, and rotate your eye ball so that the ointment gets better distributed.

It is essential that you apply Xorox during the day in regular intervals of 4 hours to ensure the success of treatment. After the inflammation of the cornea has healed up, Treatment should be continued for 14 days or at least 3 days after healing is completed, whichever is shorter.

How long to use it

Your doctor or pharmacist will tell you how long to use Xorox.

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

Do not use Xorox for longer than your doctor tells you.

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

If you forget to use it

If you forget to use Xorox, use it as soon as you remember.

However, if it is nearly time for your next application, skip the missed application. Do not use a double dose to make up for a forgotten dose.

Use in children and adolescents

The dose in children and adolescents is same as prescribed for adults.

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 Xorox.

Keep these telephone numbers handy.

If you stop using Xorox eye ointment

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

While you are using Xorox eye ointment

Things you must do

Tell all doctors and pharmacists who are treating you that you are using Xorox.

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

If you become pregnant while using Xorox, tell your doctor.

Things you must not do

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

Do not use Xorox to treat other complaints unless your doctor tells you to.

Things to be careful of

Do not use large amounts of Xorox for a long time.

Avoid wearing contact lenses when using Xorox.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Xorox.

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

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

If you have an allergic reaction or acute hypersensitivity reactions, stop using Xorox and see a doctor straight away.

The signs may include:

  • rash, itching or hives on your skin
  • swelling of your face, lips, tongue or other parts of your body
  • shortness of breath, wheezing or trouble breathing
  • Unexplained fever (high temperature) and feeling faint, especially when standing up.
  • Burning or irritation, photophobia/ light sensitivity or feeling as if there is something in your eye (superficial punctuate keratopathy)
  • 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 Xorox and tell your doctor immediately or go to casualty at your nearest hospital:

A very few people may be allergic/sensitive to Xorox. 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 Xorox.

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 Xorox eye ointment

Storage

Keep Xorox in a cool dry place where the temperature stays below 25°C.

Discard 28 days after opening.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton.

The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Disposal

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

Product description

What Xorox eye ointment looks like

Xorox is a White to whitish-grey sterile ointment available in a 4.5 g tube.

Ingredients

Each gram of ointment contains 30mg of aciclovir.

Xorox also contains the inactive ingredient white soft paraffin.

Xorox is supplied in Australia by:

AGEPHA Pharma Pty Ltd.
Level 36 Governor Phillip Tower,
1 Farrer place, Sydney
NSW 2000

This leaflet was last updated on September 2020

Australian Register Number:

Xorox 30 mg/g Eye Ointment
AUST R 319440

The information provided applies only to: Xorox 30 mg/g eye ointment

Published by MIMS March 2021

BRAND INFORMATION

Brand name

Xorox

Active ingredient

Aciclovir

Schedule

S4

 

1 Name of Medicine

Aciclovir.

2 Qualitative and Quantitative Composition

Each gram of Xorox Eye Ointment contains 30 mg of aciclovir.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye ointment.
White to whitish grey, homogeneous sterile eye ointment.

4 Clinical Particulars

4.1 Therapeutic Indications

Xorox eye ointment is indicated for the 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 4 hourly intervals). Treatment should be continued for 14 days or at least 3 days after healing is completed, whichever is shorter.

Paediatric population.

As for adults.

Use in elderly people (≥ 65 years).

No adjustment in dosage is required.

Use in people with impaired renal and liver function.

No adjustment in dosage is required.

Method of administration.

Ocular use.
For individual patient use only.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
Hypersensitivity to valaciclovir.

4.4 Special Warnings and Precautions for Use

For ocular use.

For ocular use only. Not for injection or oral intake.

Combined use with topical corticosteroids.

There is insufficient clinical data on the use of Xorox eye ointment for deep corneal defects and the combined use of Xorox eye ointment with topical corticosteroids.

Bacterial infection.

In case of a bacterial co infection, an additional antibiotic therapy must be carried out.

Transient mild stinging.

Patients should be informed that transient mild stinging immediately following application may occur.

Avoid wearing contact lenses.

Patients should avoid wearing contact lenses when using Xorox eye ointment.

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 clinically significant interactions have been identified when applied topically.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No studies have been performed to investigate the effect of topically eye use of aciclovir on fertility.
There is no information on the effect of aciclovir 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. With the recommended use of Xorox, the systemic exposure of aciclovir is expected to be negligible and no risk is anticipated.
(Category B3)
A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to aciclovir. The registry findings have not shown an increase in the number of birth defects described amongst aciclovir exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause.
Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice.
With the recommended use of Xorox no effects during pregnancy are anticipated since systemic exposure of aciclovir is expected to be negligible. When necessary, Xorox eye ointment can be used during pregnancy.
 Limited data show that the drug does pass into breast milk following systemic administration.
However, the dosage received by the nursing infant following maternal use of Xorox eye ointment would be insignificant. The use of Xorox eye ointment can be considered during breastfeeding.

4.7 Effects on Ability to Drive and Use Machines

Xorox eye ointment can affect visual ability and therefore caution is advised when driving or using machines.

4.8 Adverse Effects (Undesirable Effects)

Immediately after the application of the eye ointment, a temporary slight pricking or burning may occur but this may not interfere with the treatment.
Serious side effects after the use of systemically applied aciclovir are rare and most of the symptoms are reversible.
Adverse reactions are listed below by MedDRA body system organ class and by frequency.
The frequency categories used are: very common: (≥ 1/10); common: (≥ 1/100 and < 1/10); uncommon: (≥ 1/1000 and < 1/100); rare: (≥ 1/10,000 and < 1/1000); very rare: (< 1/10,000); not known: frequency cannot be estimated from the available data.
Due to the nature of the side effects, it is not possible to clearly determine whether these reactions were caused by the disease or the administration of the drug. Post-marketing spontaneous reports served as the basis for assigning frequencies of side effects.

Immune system disorders.

Very rare: immediate hypersensitivity reactions, including angioedema (Quincke's oedema, pale swelling of the skin especially in the face) and urticaria (hives).

Eye disorders.

Very common: superficial punctate keratopathy. This did not necessitate an early termination of therapy and healed without sequelae.
Uncommon: transient mild stinging or burning occurring immediately following application, conjunctivitis.
Rare: blepharitis.

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 case of overdose has been reported. Even if the entire content of a 4.5 g tube of Xorox eye ointment, containing 135 mg aciclovir, is swallowed, no undesirable effects would be expected.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Aciclovir is a purine nucleoside analogue and shows in vitro high activity against herpes simplex virus type 1 and 2, as well as against the Varicella-Zoster virus.
In the Herpes infected cells, aciclovir is phosphorylated to monophosphate by viral thymidine kinase in a first step. In further steps, it is converted to di- and triphosphate with participation of the cell's own enzyme. On the one hand, Acyclovir triphosphate inhibits the viral DNA polymerase and on the other hand it gets integrated into the viral DNA instead of deoxyguanosine triphosphate which results in a disruption of the viral DNA synthesis.
Due to the fact that aciclovir is preferentially taken up by herpes infected cells and the selective conversion to the active triphosphate form, there is low toxicity to human cells that are not affected by the virus.

Clinical trials.

A double-blinded randomised phase III therapeutic equivalence study was carried out to test Xorox 3% aciclovir eye ointment with innovator product Zovirax 3% aciclovir eye ointment. The study examined the efficacy and tolerability of two 3% aciclovir eye ointments with two parallel groups of 35 patients diagnosed with keratitis herpetica. The study used the same formulation as the currently marketed Xorox product. Results showed that the test product Xorox 3% aciclovir eye ointment was equivalent to Zovirax 3% aciclovir eye ointment in terms of efficacy and tolerability.

5.2 Pharmacokinetic Properties

Absorption.

Aciclovir is rapidly absorbed by the corneal epithelium and the superficial ocular tissues, penetrates into the aqueous humor and reaches there a therapeutic level of about 7.5 micromol/L.

Distribution.

It has not been possible to detect aciclovir in the blood by existing methods after topical application to the eye. However, trace quantities may be measured in the urine. These levels are not clinically significant.

Metabolism.

Aciclovir is metabolized by the enzyme aldehyde dehydrogenase to 9-Carboxymethoxymethylguanin.

Excretion.

Aciclovir is excreted via the kidneys, both by glomerular filtration and tubular secretion.

5.3 Preclinical Safety Data

Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at doses of aciclovir greatly in excess of those employed therapeutically. Two-generation studies in mice did not reveal any effect of orally administered aciclovir on fertility.
Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice.

Genotoxicity.

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that aciclovir does not pose a genetic risk to man.

Carcinogenicity.

Aciclovir was not found to be carcinogenic in long-term studies in the rat and the mouse.

6 Pharmaceutical Particulars

6.1 List of Excipients

White soft paraffin.

6.2 Incompatibilities

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

6.3 Shelf Life

5 years.
Use within four weeks after first opening.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

White aluminium tube with internal epoxy phenol lacquer and white, HDPE cannula and cap containing 4.5 g ointment.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Aciclovir is a synthetic acyclic purine nucleoside analogue. Its chemical name is 9-[(2-hydroxyethoxy)methyl]guanine. It is a white crystalline powder.

Chemical structure.


CAS number.

[59277-89-3].

7 Medicine Schedule (Poisons Standard)

S4.