sanofi-aventis

Brolene 0.1%w/v Eye Drops Solution.

Propamidine isetionate 0.1% w/v.

For a full list of excipients, see section 6.1.

Eye drops solution (eye drops).

A clear, colourless, sterile, aqueous solution.

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.

The usual dosage is 1-2 drops into the affected eye up to four times daily.

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 known.

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 Drops 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.

Eye pain or irritation, usually in the form of a stinging or burning sensation, may also occur. In such cases, use should be discontinued immediately and a physician should be consulted.

Topical overdose is not applicable. Oral ingestion of a full 10ml bottle is unlikely to cause any toxic effects.

Propamidine is a member of the aromatic diamidine group of compounds which possess bacteriostatic properties against a wide range of organisms. 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 tissue fluids, pus, and semen.

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.

Ammonium chloride

Sodium chloride

Benzalkonium chloride solution

Water for injections

Sodium hydroxide (for pH adjustment)

Not applicable.

Unopened: 2 years.

Opened: The drops should be discarded 28 days after first opening for domiciliary use or after 7 days when used under hospital conditions.

Do not store above 25°C.

Low density polyethylene bottle and plug with high density polyethylene tamperproof cap containing 10ml of solution, packaged in a cardboard carton.

No special requirements.

sanofi-aventis Ireland Ltd .

Citywest Business Campus,

Dublin 24.

PA 540/94/1

1 April 1983 / 1 April 2008

February 2010