Brolene Eye Drops.

Propamidine isetionate 0.1% w/v.

Excipient with known effect

• Benzalkonium chloride: 0,05 mg/ml (see section 4.4)

Eye drops.

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.

Benzalkonium chloride

Brolene contains 0,0025 mg benzalkonium chloride in each drop (0.05 ml), which is equivalent to 0.05 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. The patient should be advised to remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Brolene should be used with caution in dry eye patients and in patients where the cornea may be compromised.

Patients should be monitored in case of prolonged use.

None known.

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.

None stated.

Ammonium chloride, Sodium chloride, Benzalkonium chloride, Sodium hydroxide, Water for injections.

None known.

24 months.

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.

None stated.

Thornton & Ross Ltd, trading as STADA

Linthwaite

Huddersfield

HD7 5QH

United Kingdom

PL 00240/0579

12/10/1990 / 05/02/2002

01/11/2021