Summary of Product Characteristics Updated 13-Mar-2020 | SANOFI
Brolene Eye Drops.
Propamidine isetionate 0.1% w/v.
Propamidine isetionate is an aromatic diamidine disinfectant which is active against Gram-positive non-spore forming organisms, but less active against Gram-negative bacteria and spore forming organisms. It also has antifungal properties. It may be used topically for the treatment of minor eye infections such as conjunctivitis and blepharitis.
One or two drops up to four times daily. Medical advice should be obtained if there has been no significant improvement after two days.
Hypersensitivity to propamidine or any other component of the preparation.
If vision is disturbed or symptoms become worse during therapy, discontinue use and consult a physician.
If there is no significant improvement after two days' therapy, discontinue use and consult a physician.
The eye drops are unsuitable for use with hard or soft contact lenses.
The drops should be discarded 28 days after first opening for domiciliary use or, when used under hospital conditions, seven days after first opening.
Safety of use in pregnancy and lactation has not been established. Use during pregnancy and lactation only if considered essential by a physician.
May cause blurring of vision on instillation. Patients should not drive or operate hazardous machinery unless vision is clear.
Hypersensitivity may occur.
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.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Topical overdosage 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 being retained in the presence of organic matter such as tissue fluids, pus and serum.
No data available.
Ammonium chloride, Sodium chloride, Benzalkonium chloride, Sodium hydroxide, Water for injections.
Once opened the drops should be discarded 28 days after first opening for domiciliary use or, when used under hospital conditions, 7 days after first opening.
Store below 25°C.
10 ml plastic dropper bottle and tamper-proof cap, or 10 ml plastic dropper bottle and tamper-proof cap together with an autodrop device as a separate item.
Aventis Pharma Limited, trading as Sanofi
410 Thames Valley Park Drive,
07 November 2002
11 March 2020
Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
+44 (0)845 372 7101
+44 (0)845 023 0441