Consumer medicine information

POLY GEL LUBRICATING EYE GEL

Carbomer

BRAND INFORMATION

Brand name

Poly Gel Lubricating Eye Gel

Active ingredient

Carbomer

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using POLY GEL LUBRICATING EYE GEL.

DESCRIPTION

Poly Gel® Lubricating Eye Gel is a sterile gel formulation containing carbomer 3mg/g, sorbitol and purified water.

Poly Gel®Lubricating Eye Gel is preservative free, making it particularly suitable for regular use for those who experience sensitivities to preservatives.

USES (Indications)

Poly Gel®Lubricating Eye Gel has been specially formulated to provide long lasting relief from the symptoms associated with dry, irritated eyes.

CONTRAINDICATIONS

People allergic to any ingredient in Poly Gel® Lubricating Eye Gel should not use this product.

DIRECTIONS

Twist off the top of the single use vial; instill 1 or 2 drops in the affected eye(s) as needed or as directed by your eye care professional. Place drops on the eye and blink.

WARNINGS

OPHTHALMIC USE ONLY.

It is essential that you follow your eye care practitioner’s directions and all labelling instructions for proper use of the product. If you experience eye pain, vision changes, redness, irritation of the eye or if the condition worsens or persists for more than 72 hours, discontinue use and consult your eye care practitioner.

Be careful driving or operating machinery until you know how Poly Gel® Lubricating Eye Gel affects you and your vision. As with any eye medicine, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, wait until your vision is clear before driving or using machinery.

ADVERSE EFFECTS

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

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

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

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

Most of the effects from Poly Gel® Lubricating Eye Gel occur in, or around, the eye. These may include:

  • Blurred vision
  • Eye irritation, discomfort or feeling of having something in the eye
  • Itchy eye(s)
  • Swollen eyelid(s) or swelling around the eyes
  • Red eyes
  • Eye pain
  • Increased tearing eyes
  • Crusty eyelids
  • Gel residue

Occasionally some people notice unwanted effects in the rest of their body as a result of using Poly Gel®Lubricating Eye Gel. These may include:

  • Itchy skin

If any of the following happen, stop using Poly Gel® Lubricating Eye Gel and tell your doctor immediately or go to Accident & Emergency at your nearest hospital:

  • Skin rash
  • Swelling of the face, hands or feet
  • Wheezing, difficulty in breathing
  • Severe and sudden onset of pinkish, itchy swellings on the skin, also called hives or nettlerash
  • Shortness of breath (dyspnoea, heart failure)

These hypersensitivity reactions can be very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

PRECAUTIONS

  • To avoid contamination, never touch the dropper tip of the container to any surface.
  • Store below 25°C
  • Use before the expiration date marked on the product.
  • Keep out of reach of children.
  • Do not swallow the gel.

HOW SUPPLIED

Poly Gel® Lubricating Eye Gel is supplied in 30 x 0.5g sterile single use plastic vials

Made in France for
Ioquin (A division of Alcon Laboratories (Australia) Pty Ltd)
25 Frenchs Forest Rd East
Frenchs Forest NSW 2086
Free Phone: 1800 025 032

Distributed in New Zealand by
Alcon New Zealand Limited
c/o Pharmaco (NZ) Limited
Auckland, New Zealand
Free Phone: 0800 101 106

This leaflet was prepared on 28 June 2013

®Registered trademark

BRAND INFORMATION

Brand name

Poly Gel Lubricating Eye Gel

Active ingredient

Carbomer

Schedule

Unscheduled

 

Name of the medicine

Carbomer 3 mg/g with sorbitol and purified water. Preservative free.

Description

Poly Gel Lubricating Eye Gel has been specially formulated to provide long lasting relief from the symptoms associated with dry, irritated eyes.
Poly Gel Lubricating Eye Gel is preservative free, making it particularly suitable for regular use for those who experience sensitivities to preservatives.

Indications

Long lasting relief for dry, irritated eyes.

Contraindications

Hypersensitivity to any component of the product.

Precautions

Ophthalmic use only.
If you experience eye pain, vision changes, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.
The contents of each individual container are sterile until opened. To avoid contamination, do not touch tip of container to eye or any other surface.
Keep this and all medicines out of the reach of children.

Effects on fertility.

There is no available data on the use of this medicine affecting male or female fertility.

Use in pregnancy.

There is no data from the use of Poly Gel Lubricating Eye Gel in pregnant women. However no effects during pregnancy are anticipated, since the systemic exposure to carbomer is expected to be negligible. Additionally, carbomer is an inactive ingredient that exerts a surface protective effect.

Use in lactation.

It is unknown whether Poly Gel Lubricating Eye Gel is excreted in human milk. However no effects on the breastfed newborn/ infant are anticipated since the systemic exposure of the breastfeeding woman to carbomer is expected to be negligible. Additionally, carbomer is an inactive ingredient that exerts a surface protective effect.

Effects on ability to drive and use machines.

Following instillation, there can be blurred vision or other visual disturbances and a tingling feeling for a short period of time. If these occur, avoid driving or using any machinery until the vision is clear again.
If irritation persists, discontinue use and consult a doctor.

Interactions

No clinically relevant interactions have been described.

Adverse Effects

The following adverse reactions are classified according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions have been observed during clinical trials and/or postmarketing experience for Poly Gel Lubricating Eye Gel.

Eye disorders.

Very common: vision blurred.
Common: ocular discomfort, eyelid margin crusting, eye irritation.
Uncommon: periorbital oedema, conjunctival oedema, eye pain, eye pruritus, ocular hyperaemia, lacrimation increased.

Skin and subcutaneous tissue disorders.

Uncommon: dermatitis contact.
Additional adverse reactions identified from postmarketing surveillance include the following. Frequencies cannot be estimated from the available data.

Immune system disorders.

Hypersensitivity.

Dosage and Administration

Instil 1 or 2 drops in the affected eye(s) as needed or as directed by your doctor.
Once opened, do not reuse individual containers.

Overdosage

Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, nor in the event of accidental ingestion of the contents of one bottle or tube.

Presentation

Eye gel, 0.5 g (sterile single use containers): 30's.

Storage

Store below 25°C.

Poison Schedule

Unscheduled.