SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Golden Eye 0.1% w/v Eye Drops Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Contain 0.1% w/v propamidine isethionate.

3 PHARMACEUTICAL FORM

A clear colourless solution practically free from particles.

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 opthahnic administration.

Adults (Elderly and Children):

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

i.    Hypersensitivity to propamadine or any component of the preparation.

ii.    Soft or gas permeable contact lenses.

4.4 Special warnings and precautions for use

i    If vision is disturbed or symptoms become worse during therapy, discontinue use and consult a physician.

ii    If there is no significant improvement after two days therapy, discontinue use and consult a physician.

Benzalkonium chloride may cause eye irritation and is known to discolour soft contact lenses.

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

May cause transient blurring of vision on instillation. 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 10 ml bottle is unlikely to cause any toxic effects.

5.1 Pharmacodynamic properties

Propamidine is a member of the aromatic diamidine class of compounds, which possess bacteriostatic properties against a wide range of organisms.

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 tissue fluids, pus and serum.

5.2 Pharmacokinetic properties

No data available.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sodium chloride, benzalkonium chloride solution, purified water, sodium hydroxide and hydrochloric acid.

6.2 Incompatibilities

None known.

6.3    Shelf life

48 months unopened and 28 days after opening.

6.4    Special precautions for storage

Store below 25°C.

Nature and contents of container

Polypropylene dropper bottle (10 ml) fitted with a low density polyethylene nozzle and a high density polyethylene tamper evident 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 16794/0010

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

12 March 1992 / 19 February 2008

10 DATE OF REVISION OF THE TEXT

15/06/2015