Emadine 0.05% w/v, Eye drops, Solution (2011)
Active ingredients: Emadine
Symptomatic treatment of seasonal allergic conjunctivitis.
Posology and method of administration
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.
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.
Hepatic and Renal impairment Use
EMADINE has not been studied in these patients and therefore, its use is not recommended in this population.
Method of administration
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.
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, the potential of emedastine to increase the QT interval should be borne in mind and appropriate monitoring and management should be implemented.
EMADINE should not be used for longer than 4 weeks after first opening.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
EMADINE is supplied in 5 ml and 10 ml opaque plastic DROP-TAINER bottles.
Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.