sanofi-aventis

Brolene 0.15%w/w Eye Ointment.

Dibrompropamidine Isetionate 0.15% w/w.

Excipients: contains Wool fat 9.7%w/w.

For a full list of excipients, see section 6.1.

Eye ointment

A deep yellow, smooth, sterile ointment.

As an anti-infective for use in local infections of the superficial structures of the eye due to microorganisms sensitive to its action.

For ocular use.

Adults, elderly persons, and children: Cleanse the affected area and apply the ointment topically to the eyelid or conjunctival sac once or twice daily, for not more than 2 days.

Hypersensitivity to any component of the preparation.

Use of contact lenses.

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.

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.

Hypersensitivity may occur, in which case treatment should be discontinued immediately.

Topical overdose is not applicable. Oral ingestion of a full 5g tube is unlikely to cause any toxic effects.

Dibromopropamidine is a member of the aromatic diamidine group of compounds which possess bacteriostatic properties against a wide range of fungi and bacteria. These diamidines exert antibacterial action against pyrogenic cocci, antibiotic resistant staphylococci and some gram-negative bacilli. The activity of the diamidines is retained in the presence of organic matter such as pus and blood.

None stated.

There is no other information available which could be of relevance to the prescriber in recognising the safety profile of Brolene and which is not included in the relevant sections of this SPC.

Paraffin, yellow soft

Paraffin liquid.

Wool fat.

Phenyl ethanol.

Water for Injections.

Not applicable.

Unopened: 3 years.

Opened: 4 weeks.

Do not store above 25°C.

Printed, internally lacquered aluminium tube with screw capped nozzle fitted with a polythene cap, containing 5g of ointment.

No special requirements.

sanofi-aventis Ireland Ltd.

Citywest Business Campus,

Dublin 24.

PA 540/94/2

01 April 1983/ 01 April 2008

August 2008.