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

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

CROMOHEXAL^® Eye Drops

COMPOSITION:
Each mL contains:

	sodium cromoglycate dihydrate equivalent to
	sodium cromoglycate 20 mg
	benzalkonium chloride 0,01% m/v.

PHARMACOLOGICAL CLASSIFICATION:
A/15.4 Ophthalmic preparations (other).

PHARMACOLOGICAL ACTION:
Sodium cromoglycate is an anti-allergic agent that acts mainly by inhibiting release of inflammatory mediators.

INDICATIONS:
Allergic conjunctivitis.

CONTRA-INDICATIONS:
Hypersensitivity to sodium cromoglycate or benzalkonium chloride.
Safety in pregnancy and lactation has not been established.

WARNINGS:

1.	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.
2.	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:
Adults and children:         Instill 1 or 2 drops into each eye 4 times daily.
It is important that the regular administration of Cromohexal Eye Drops is maintained in the prevention and treatment of allergic conjunctivitis as therapy is essentially prophylactic.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Soft contact lenses should not be worn during the treatment period.
Burning or stinging may occur following instillation of the drops.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear, colourless aqueous solution, free from foreign particles.

PRESENTATION:
White polyethylene dropper bottles containing in each 10 mL.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light. Discard any unused contents 4 weeks after opening.

REGISTRATION NUMBER:
29/15.4/0382

NAME AND BUSINESS ADDRESS OF APPLICANT:
Hexal Pharma (SA) (Pty) Ltd
10 Fangio Road
Mahogany Ridge
Westmead
Pinetown

DATE OF PUBLICATION OF THIS PACKAGE INSERT
July 1996

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Updated on this site: October 2000
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