Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Symptomatic treatment of seasonal allergic conjunctivitis.
EMADINE has not been studied in clinical trials beyond six weeks.
The dose is one drop of EMADINE to be applied to the affected eye(s) twice daily.
When used with other ophthalmic medicines, an interval of ten minutes should be allowed between applications of each medicinal product. Eye ointments should be administered last.
EMADINE has not been studied in elderly patients older than 65 years, and therefore its use is not recommended in this population.
EMADINE may be used in paediatric patients (3 years of age and older) at the same posology as in adults.
EMADINE has not been studied in these patients and therefore, its use is not recommended in this population.
For ocular use.
To prevent contamination of the dropper tip and solution, care should be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
After cap is removed, if tamper evident snap collar is loose, remove before using product.
No specific reactions are to be expected with an ocular overdose of the product.
No data are available in humans regarding overdose by accidental or deliberate ingestion. In case of accidental ingestion of the content of a bottle of EMADINE, sedative effects may occur and the potential of emedastine to increase the QT interval should be borne in mind and appropriate monitoring and management should be implemented.
Shelf life: 30 months.
EMADINE should not be used for longer than 4 weeks after first opening.
Do not store above 25°C.
EMADINE is supplied in 5 ml and 10 ml opaque plastic DROP-TAINER bottles.
Not all pack sizes may be marketed.
No special requirements.
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