This information is intended for use by health professionals

1. Name of the medicinal product

Brolene Eye Drops.

2. Qualitative and quantitative composition

Propamidine isetionate 0.1% w/v.

3. Pharmaceutical form

Eye drops.

4. Clinical particulars
4.1 Therapeutic indications

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.

4.2 Posology and method of administration

One or two drops up to four times daily. Medical advice should be obtained if there has been no significant improvement after two days.

4.3 Contraindications

Hypersensitivity to propamidine or any other component of the preparation.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

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

4.7 Effects on ability to drive and use machines

May cause blurring of vision on instillation. Patients should not drive or operate hazardous machinery unless vision is clear.

4.8 Undesirable effects

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

4.9 Overdose

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

5. Pharmacological properties
5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

No data available.

5.3 Preclinical safety data

None stated.

6. Pharmaceutical particulars
6.1 List of excipients

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

6.2 Incompatibilities

None known.

6.3 Shelf life

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.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

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.

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

Aventis Pharma Limited

trading as or Rhône-Poulenc Rorer or Aventis Pharma

One Onslow Street

Guildford

Surrey

GU1 4YS

United Kingdom

or trading as

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

8. Marketing authorisation number(s)

PL 04425/0197

9. Date of first authorisation/renewal of the authorisation

07 November 2002

10. Date of revision of the text

18 November 2014

Legal classification

P