Consumer medicine information

Duratears Lubricating Eye Ointment

Paraffin, liquid; Paraffin, white soft; Wool fat

BRAND INFORMATION

Brand name

Duratears Lubricating Eye Ointment

Active ingredient

Paraffin, liquid; Paraffin, white soft; Wool fat

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Duratears Lubricating Eye Ointment.

What is in this leaflet

Please read this leaflet carefully before you start using DURATEARS® Lubricating Eye Ointment.

This leaflet answers some common questions about DURATEARS® Lubricating Eye 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.

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 DURATEARS® Eye Ointment is used for

DURATEARS® Lubricating Eye Ointment is a multi-use preservative free ointment that has been specially formulated for the symptomatic treatment of dry eye conditions. The ointment forms a smooth, comfortable protective film when applied to the eyes. It is particularly effective for use while sleeping and in patients who are sensitive to preservatives or where the use of preservatives is considered inappropriate.

Before you use DURATEARS® Eye Ointment

When you must not use it

Do not use DURATEARS® Lubricating Eye Ointment if:

  • You have an allergy to any of the ingredients in DURATEARS® Lubricating Eye Ointment listed in this leaflet

If you are not sure whether you should start using DURATEARS® Lubricating Eye Ointment, talk to your doctor or pharmacist.

Before you start to use it

Tell your doctor if:

  • You experience headache, eye pain, vision changes, irritation of the eyes, persistent redness or if the condition worsens or persists for more than 72 hours.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

Remove contact lenses before using DURATEARS® Eye Ointment. This product is not to be used with contact lenses.

If you have not told your doctor about any of the above, tell them before you start using DURATEARS® Lubricating Eye Ointment.

How to use DURATEARS® Eye Ointment

How much to use

A ribbon of ointment (1-1.5 cm)

How to use

  1. Remove cap from tube. Gently pull lower eyelid down.
  2. Squeeze a ribbon of ointment (1-1.5 cm) into the lower portion of the eye.
  3. Slowly close the eye without blinking.
  4. Keep eye closed for 1 to 2 minutes.

Do not touch tube tip to any surface as this may contaminate the ointment.

When to use

Prior to going to sleep, or as directed by a doctor.

While you are using Eye Ointment Eye Ointment

Things you must do

If you are about to be started on any new medicine tell your doctor and pharmacist that you are using DURATEARS®Eye Ointment Lubricating Eye Ointment.

If you become pregnant or decide to breastfeed while using DURATEARS® Lubricating Eye Ointment, let your doctor know.

Things to be careful of

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines after application of the ointment. If blurred vision occurs after application, wait until the vision clears before driving or using machinery.

In case of overdose

If you take too much (overdose)

Due to the characteristics of this preparation, no toxic effects are to be expected with an overdose to the eye(s) of this product, nor in the event of accidental ingestion of the contents of one tube.

In any instance, in Australia contact the Poisons Information Centre on 13 11 26 and in New Zealand phone 0800 POISON or 0800 764 766, for advice on management.

Do this even if there are no signs of discomfort or poisoning.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using DURATEARS® Lubricating Eye Ointment.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse effects.

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

Tell your doctor if you notice any of the following effects in the eye(s) and the eye area, and they worry you:

  • Eye pain
  • Swelling
  • Itchiness and/or irritation
  • Feeling like something is in the eye
  • Red eye
  • Blurry vision

Occasionally some people notice unwanted effects in the rest of their body as a result of using the ointment. These effects may include:

  • Headache

Other adverse effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

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

After using DURATEARS® Eye Ointment

Storage

Store the tube below 25°C.

Disposal

Discard the tube 4 weeks after opening.

Product description

What it looks like

3.5g ophthalmic ointment tube.

Ingredients

Active ingredient(s):

  • Liquid paraffin
  • White soft paraffin
  • Wool fat

Sponsor Details

DURATEARS® Lubricating Eye Ointmentis supplied in Australia by:
ALCON LABORATORIES (Australia) Pty Ltd
25 Frenchs Forest Road East
Frenchs Forest NSW 2086
Phone Toll Free: 1800 025 032

Date of Preparation
This leaflet was prepared on 25 February 2013.

BRAND INFORMATION

Brand name

Duratears Lubricating Eye Ointment

Active ingredient

Paraffin, liquid; Paraffin, white soft; Wool fat

Schedule

Unscheduled

 

Name of the medicine

Paraffin, wool fat.

Excipients.

Preservative free.

Description

Duratears Lubricating Eye Ointment is a multiuse preservative free ointment that has been specially formulated for the symptomatic treatment of dry eye conditions. The ointment forms a smooth, comfortable protective film when applied to the eyes. It is particularly effective for use while sleeping and in patients who are sensitive to preservatives or where the use of preservatives is considered inappropriate.

Indications

For soothing relief of symptoms associated with dry eye conditions. Particularly useful for protection and lubrication during sleep.

Contraindications

Hypersensitivity to any component of the product.

Precautions

Ophthalmic use only.
If patients experience headache, eye pain, vision changes, irritation of the eyes, persistent redness or if the condition worsens or persists for more than 72 hours, they are to discontinue use and consult a doctor.
Do not touch tube tip to any surface as this may contaminate the ointment.

Effects on fertility.

There is no data indicating an adverse effect of Duratears Eye Ointment on male or female fertility.

Use in pregnancy.

There is no data from the use of Duratears Eye Ointment in pregnant women. This product contains wool fat, liquid paraffin and white soft paraffin. However, all three components are pharmaceutical excipients that exert a surface protective effect and are considered to be pharmacologically inert, nonirritating and nontoxic. No effects during pregnancy are anticipated, since these components are not expected to be absorbed systemically. There are also no preclinical animal data reporting reproductive toxicity or teratogenicity of wool fat, liquid paraffin or white soft paraffin individually, or of Duratears Eye Ointment.

Use in lactation.

It is unknown whether wool fat, liquid paraffin or white soft paraffin from Duratears Eye Ointment are excreted in human milk. However, no effects on the breastfed newborn/ infant are anticipated since the systemic exposure of the breastfeeding woman to the product is expected to be negligible. All three compounds are pharmaceutical excipients and are pharmacologically inert, nonirritating and nontoxic.

Use with contact lenses.

Remove contact lenses before using Duratears Eye Ointment. This product is not to be used with contact lenses.

Effects on ability to drive and use machines.

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines after application of the ointment. If blurred vision occurs after application, the patient must wait until the vision clears before driving or using machinery.

Interactions

No clinically relevant interactions have been described.

Adverse Effects

The following adverse reactions have been reported following administration of Duratears Eye Ointment. Frequency cannot be estimated from the available data.

Eye disorders.

Eye pain, eye swelling, eye pruritus, eye irritation, foreign body sensation in eyes, ocular hyperaemia, vision blurred.

Nervous system disorders.

Headache.

Dosage and Administration

Squeeze a ribbon of ointment (1-1.5 cm) into the affected eye(s) prior to going to sleep, or as directed by a doctor.
Discard tube 4 weeks after opening.

Overdosage

Due to the characteristics of this preparation, no toxic effects are to be expected with a topical ophthalmic overdose of this product, nor in the event of accidental ingestion of the contents of one tube.

Presentation

Ophthalmic ointment: 3.5 g (tube).

Storage

Store below 25°C.

Poison Schedule

Unscheduled.