INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
BROLENE Eye Drops

SCHEDULING STATUS:
Schedule 0

PROPRIETARY NAME
(and dosage form):

BROLENE Eye Drops

COMPOSITION:
BROLENE Eye Drops contain:
Propamidine isethionate 1 mg/mL
Preservative:
Benzalkonium chloride solution 0,01% v/v.

PHARMACOLOGICAL CLASSIFICATION
15.5 Ophthalmic preparations. Other.

PHARMACOLOGICAL ACTION
Propamidine isethionate has antibacterial and anti-fungal properties. It is active against pyogenic cocci and some of the Gram negative bacilli, including those frequently involved in superficial infection. Moreover, it is often effective against staphylococci resistant to penicillin and other antibiotics and is less prone than the latter to promote the emergence of resistant strains of organisms. It is well tolerated, unlikely to give rise to sensitisation reactions and its action is not reduced by tissue fluids, serum or pus.

INDICATIONS
For the treatment of eye infections and for the prevention of infection resulting from minor injuries to the eye.

CONTRA-INDICATIONS
In the unlikely event of a sensitisation reaction resulting from the use of BROLENE Eye Drops, treatment should be discontinued immediately.

WARNINGS
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required.
Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.

DOSAGE AND DIRECTIONS FOR USE
One or two drops should be placed in the affected eye four times a day for not more than a week.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
If used as directed, no adverse reactions are to be expected. In some susceptible individuals, however, a slight smarting which passes off quickly and is of no significance may occur.
Avoid contamination of drops during use.
If there is no improvement in the condition after seven days treatment, medical advice should be obtained.

IDENTIFICATION
A clear, bright, colourless solution.

PRESENTATION
BROLENE Eye Drops are supplied in sterile dropper bottles containing 10 mL solution.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light. Do not use more than 30 days after opening.
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBER
H 1212 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT
Genop Healthcare (Pty) Ltd
Mount Royal Office Park
James Crescent
Halfway House
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT
January 1975

New addition to this site: December 2006
Source: Pharmaceutical Industry

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