Summary of Product Characteristics (SmPC) - Golden eye 0.15%w/w eye ointment
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 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 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
24/02/2020