This medicinal product 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. Artelac 3.2 mg/ml Eye Drops Solution is indicated in adults and children.

Posology

Suitable for use in adults and children. Unless otherwise directed, instil 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.

Method of administration

For ocular use only.

Hypersensitivity to the active substance (hypromellose) or to any of the excipients. Listed in section 6.1.

Stop treatment and consult a physician if irritation persists or worsens or new eye signs or symptoms develop. Wearers of soft contact lenses should remove their lenses before Artelac 3.2 mg/ml Eye Drops Solution is administered and should wait for at least 15 minutes before they insert them again. Ensure the dropper tip does not touch any surface including the eye surface.

None.

Pregnancy

Artelac 3.2 mg/ml Eye Drops Solution can be used during pregnancy.

Breast-feeding

Artelac 3.2 mg/ml Eye Drops Solution can be used during and lactation.

Fertility

Artelac 3.2 mg/ml Eye Drops Solution is not expected to have any effect on fertility.

Artelac 3.2 mg/ml Eye Drops Solution 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.

The following adverse reactions have been reported following administration of Artelac 3.2 mg/ml Eye Drops Solution.

Eye disorder:

Very rare (<1/10,000):

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Not known: Brief blurred vision or a slight stinging sensation on instilling Artelac 3.2 mg/ml Eye Drops Solution.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation 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 via Yellow Card Scheme; Website: www.mhra.gov.uk/yellowcard.

No case of overdose has been reported.

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 the 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

Water for Injections in Bulk

Not applicable.

3 years. Discard within 28 days of first opening.

Protect from light. Store below 25° C. 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. Hypromellose SDU eye drops are sterile until first opened. For single use only. Each carton contains a patient insert with instructions for use.