ARTELAC Eye drops, solution Ref.[27653] Active ingredients: Hypromellose

If irritation persists or worsens or new eye signs or symptoms develop, discontinue use and consult a doctor. 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.

Ensure the dropper tip does not touch any surface including the eye surface. Wearers of soft contact lenses should remove their lenses before Artelac 3.2mg/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 3.2mg/ml Eye Drops Solution can be used in pregnancy.

Breast-feeding

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

Fertility

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

Artelac 3.2mg/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.

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: HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2, Tel: +353 1 6764971; Fax: +353 1 6762517, Website: www.hpra.ie, E-mail: medsafety@hpra.ie.

Not applicable.