Summary of Product Characteristics (SmPC) - Brolene 0.15% w/w eye ointment
1 NAME OF THE MEDICINAL PRODUCT
Brolene 0.15% w/w Eye Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dibrompropamidine isetionate 0.15% w/w.
3 PHARMACEUTICAL FORM
Ointment.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Dibrompropamidine isetionate is an aromatic diamidine 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
Adults, elderly persons and children: for the treatment of minor eye infections.
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 any 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 ointment is unsuitable for use with hard contact lenses.
The eye ointment should be discarded 4 weeks after first opening because of the risk of contamination.
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 instillation. Warn patients not to drive or operate hazardous machinery unless vision is clear.
4.8 Undesirable effects
Hypersensitivity may occur, in which case treatment should be discontinued immediately.
Immune system disorders:
Not known: Hypersensitivity
Eye disorders:
Not known: Eye pain or irritation, usually in the form of a stinging or burning sensation. 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. (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 5g tube is unlikely to cause any toxic effects.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Dibrompropamidine is a member of the aromatic diamidine group of compounds which possess bacteriostatic properties against a wide range of fungi and bacteria. These diamidines exert antibacterial action against pyrogenic 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
No relevant data.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Paraffin, white soft
Paraffin, liquid
Wool fat
Phenylethanol
Water, purified
6.2 Incompatibilities
None known.
6.3 Shelf life
24 months. Use within 4 weeks of first opening
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
Printed, internally lacquered aluminium collapsible tubes with screw capped nozzle fitted with a polythene cap containing 5g ointment.
6.6 Special precautions for disposal
No relevant instructions.
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd, trading as STADA
Linthwaite
Huddersfield
HD7 5QH
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL00240/0581
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22 July 2002
10 DATE OF REVISION OF THE TEXT
14/01/2022