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

Logo 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
CROMABAK 2% eye drops are available in polyethylene pump bottles containing 10 mL solution.

STORAGE INSTRUCTIONS
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

REGISTRATION NUMBER
35/15.4/0408

NAME AND BUSINESS ADDRESS OF THE APPLICANT
MC Pharma (Pty) Ltd
62 Constantia Avenue
Mnandi
Pretoria

DATE OF PUBLICATION OF THIS PACKAGE INSERT
20 September 2002

Updated on this site: September 2009
Source: Pharmaceutical Industry

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