Artelac 3.2 mg/ml Eye Drops, Solution

Hypromellose 3.2 mg/ml

For full list of excipients, see section 6.1.

Eye drops, solution.

Sterile clear solution.

Acts as a lubricant and artificial tear in the symptomatic treatment of dehydration of the cornea and conjunctiva due to impaired lacrimal secretion and functional disorders as a result of topical or systemic diseases, or caused by deficient or incomplete eyelid closure.

Dosage

Suitable for use in adults and children.

Unless otherwise directed, instill 1 drop into the conjunctival sac (corner of the eye, nearest the nose) 3 to 5 times per day or as required, to provide sufficient lubrication.

Therapy of dry eye syndrome requires an individual dosage regimen.

Administration

For ocular use only.

There are no known contra-indications except use in patients hypersensitive to the ingredients of the preparation.

Wearers of soft contact lenses should remove their lenses before Artelac is administered and should wait for at least 15 minutes before they insert them again.

Stop treatment and consult a physician if irritation persists or worsens or new eye signs or symptoms develop.

None.

Artelac can be used during pregnancy and lactation.

Artelac on instillation may cause a short term blurring of vision when first used. If affected wait until vision has cleared before driving or operating machinery.

Brief blurred vision or a slight stinging sensation on instilling Artelac.

None.

Pharmacotherapeutic group:

Ophthalmologicals: other ophthalmologicals

ATC code: S01X A20

Hypromellose prolongs adhesion, enhances moistening of the cornea and conjunctiva and allows for a smoother movement of the conjunctiva over the cornea.

Hypromellose does not permeate the cornea or reach the systemic circulation via ophthalmic vessels.

Hypromellose has proved to be very well tolerated in local toxicity studies.

Cetrimide

Disodium Phosphate Dodecahydrate

Sodium Dihydrogen Phosphate Dihydrate

Disodium Edetate

Sorbitol E420

Water for Injections in Bulk

Not applicable.

3 years. Discard within 28 days of first opening.

Keep bottle in the outer carton. Do not store above 25ºC.

Sterile until opened. Avoid contamination during use.

10 ml round transparent white bottle (LDPE) with white dropper plug (LDPE) and white cap (HDPE).

Avoid contamination during use. Artelac eye drops are sterile until first opened. Ensure that the dropper tip does not touch any surface including the eye surface. Each carton contains a patient insert with instructions for use.

Pharma Global Limited

Hudson Road

Sandycove

Co. Dublin

Ireland

PL 11185/0001

03 July 1997

July 1996

November 2007

May 2007