CROMABAK 2% EYE DROPS
(and dosage form):
CROMABAK 2% EYE DROPS
Contains Sodium cromoglycate 2 g/100 mL (20 mg/mL)
Excipients: Sodium chloride and purified water.
A 15.4 Ophthalmic preparations, other.
Sodium cromoglycate inhibits the release of certain pharmacological mediators from sensitized mast cells.
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.
A clear, colourless solution.
CROMABAK 2% eye drops are available in polyethylene pump bottles containing 10 mL solution.
Store upright below 25ºC. Protect from light. Keep well closed. Do not refrigerate.
Discard any remaining contents 8 weeks after opening the bottle.
KEEP OUT OF REACH OF CHILDREN
NAME AND BUSINESS ADDRESS OF THE APPLICANT
MC Pharma (Pty) Ltd
62 Constantia Avenue
DATE OF PUBLICATION OF THIS PACKAGE INSERT
20 September 2002
Updated on this site: September 2009
Source: Pharmaceutical Industry
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