BROLENE Eye ointment Ref.[27605] Active ingredients: Dibrompropamidine

If there is no significant improvement within 2 days medical advice should be sought.

There is always the possibility, although rare, of a sensitisation reaction resulting from the use of Brolene preparations. In such an event treatment should be discontinued immediately. Should erythema or other evidence of increased inflammation occur application should cease immediately and medical opinion should be sought.

If problems of visual acuity occur or its symptoms are detected, the doctor should be consulted immediately.

Brolene Ointment contains wool fat, which may cause local skin reactions (e.g. contact dermatitis).

None stated.

Safety of use in pregnancy and lactation has not been established. Use during pregnancy and lactation only if considered essential by the physician.

Brolene Eye Ointment may cause transient blurring of vision on instillation. Patients should be warned not to drive or operate machinery unless vision is clear.

Eye disorders

Not known: Eye pain or irritation, usually in the form of a stinging or burning sensation. In such cases use should be discontinued immediately. If symptoms persist medical advice should be sought.

Immune system disorders

Not known: Hypersensitivity may occur, in which case treatment should be discontinued immediately.

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.