SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Golden Eye 0.15% w/w Eye Ointment

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Contains 0.15% w/w dibrompropamidine isetionate.

For the full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Eye ointment

A smooth uniform off-white translucent greasy ointment

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Indicated for the treatment of minor eye and eyelid infections such as conjunctivitis and blepharitis.

4.2    Posology and method of administration

For topical ophthalmic administration.

Adults (Elderly and Children): Apply topically once or twice daily.

Medical advice should be obtained if there has been no significant improvement after two days.

4.3 Contraindications

Hypersensitivity to dibrompropamidine or to any component of the preparation.

Contact lenses should not be worn during treatment with this product.

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 2 days therapy, discontinue use and consult a physician.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, 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

Eye ointment will cause blurring of vision on application. Patients should be warned not to drive or operate machinery unless vision is clear.

4.8 Undesirable effects

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

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 (www.mhra.gov.uk/yellowcard).

4.9 Overdose

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

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Dibrompropamidine is a member of the aromatic diamidine class of compounds which possess bacteriostatic properties against a wide range of fungi and bacteria.

These diamidines exert antibacterial action against pyogenic 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.

5.2 Pharmacokinetic properties

No data available.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Liquid paraffin

Dispersed polyethylene in mineral oil

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months unopened and 4 weeks after first opening.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

A white pigmented, collapsible multi-laminate tube (5 gram) incorporating an aluminium foil barrier with inner polyethylene coating with a polyethylene elongated nozzle with a screw cap.

6.6 Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Cambridge Healthcare Supplies Limited

Chestnut Drive

Wymondham

Norfolk

NR18 9SB

8    MARKETING AUTHORISATION NUMBER(S)

PL 16794/0011

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17 March 1992.

10 DATE OF REVISION OF THE TEXT

14/03/2014