INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo STOP-ALLERG Eye Drops
SCHEDULING STATUS:
Schedule 2

PROPRIETARY NAME
(and dosage form):

STOP-ALLERG Eye Drops

COMPOSITION:
STOP-ALLERG Eye Drops contain:
Sodium cromoglycate 20 mg/mL
Preservative:
Benzalkonium chloride 0,01% m/v

PHARMACOLOGICAL CLASSIFICATION
A 15.4 Ophthalmic preparations. Other.

PHARMACOLOGICAL ACTION
Sodium cromoglycate inhibits the release of certain pharmacological mediators from sensitised mast cells.

INDICATIONS
Allergic conjunctivitis.

CONTRA-INDICATIONS
Known hypersensitivity to sodium cromoglycate or any of the other constituents.

WARNINGS
STOP-ALLERG Eye Drops contain benzalkonium chloride as a preservative. 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
For adults (including the elderly) and children, the dose is 1 or 2 drops into each eye 4 times daily.

STOP-ALLERG Eye Drops should be used regularly to ensure optimal control of symptoms. It is recommended that treatment is continued during the period of exposure to allergen, even when free of symptoms.
Care should be taken to avoid contamination of the contents during use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Transient stinging and burning may occur after instillation of STOP-ALLERG Eye Drops. Other symptoms of local irritation have been reported rarely.
STOP-ALLERG Eye Drops should be used with caution during the first trimester of pregnancy as safety in pregnancy has not been established.
Patients should be advised not to wear soft contact lenses during treatment with STOP-ALLERG Eye Drops.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See side-effects. Treatment is symptomatic and supportive.

IDENTIFICATION
A clear, colourless to pale yellow liquid.

PRESENTATION
STOP-ALLERG Eye Drops are supplied in sterile dropper bottles containing 13,5 mL solution.

STORAGE INSTRUCTIONS
Store below 30°C. Protect from direct sunlight.
Discard any remaining contents 4 weeks after opening the bottle.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
W/15.4/430

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT
20 November 1989

Updated on this site: Aug 2007
Source: Pharmaceutical Industry

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