Summary of Product Characteristics (SmPC) - Golden eye 0.1% w/v eye drops solution
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Topical overdose not applicable. Oral ingestion of a full 10 ml bottle is unlikely to cause any toxic effects.
5 PHARMACOLOGICAL PROPERTIES
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.
6.5 Nature and contents of container
Polypropylene dropper bottle (10ml) fitted with a polypropylene nozzle or a polyethylene (LDPE) dropper bottle (10ml) 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
10/10/2022