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CROMABAK 2% EYE DROPS
SCHEDULING STATUS:
Schedule 2
PROPRIETARY NAME
(and dosage form):
CROMABAK 2% EYE DROPS
COMPOSITION:
Contains
Sodium cromoglycate
2 g/100 mL (20 mg/mL)
Excipients: Sodium chloride and purified water.
PHARMACOLOGICAL CLASSIFICATION
A 15.4 Ophthalmic preparations, other.
PHARMACOLOGICAL ACTION
Sodium cromoglycate inhibits the release of certain pharmacological mediators from sensitized mast cells.
INDICATIONS
Allergic conjunctivitis.
CONTRA-INDICATIONS
Known hypersensitivity to sodium cromoglycate or any of the other ingredients. Safe use during pregnancy and lactation
has not been established.
DOSAGE AND DIRECTIONS FOR USE
Adults and children: 1 drop into each eye 4 to 6 times daily.
CROMABAK 2% eye drops should be used regularly to ensure optimal control of symptoms.
Do not exceed the recommended dosage.
The lack of a preservative allows for the use of these eye drops while wearing contact lenses.
It is recommended that treatment be continued during the period of exposure to allergen even when free from any
symptoms. Avoid contact between the bottle tip and the eye or eye lids, to prevent possible contamination of the
contents during use.
In the absence of improvement, or in case of persistence of symptoms, seek medical advice. In case of concurrent
treatment with another eye drop, allow 15 minutes between each instillation.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Transient stinging and burning may occur after instillation of CROMABAK 2% eye drops. Other symptoms of local
irritation have been reported, but less frequently.
Safe use duringpregnancy has not been established.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See ‘Side-Effects’. Treatment is symptomatic and supportive.
IDENTIFICATION
A clear, colourless solution.
PRESENTATION
CROMA
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