Emadine

EMADINE has not been studied in clinical trials beyond six weeks. Posology 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. Elderly population EMADINE has not been studied in elderly patients older than 65 years, and therefore its use is not recommended in this population. Paediatric 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. 3 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.

Summary of safety profile In 13 clinical studies involving 696 patients, Emadine was administered one to four times daily in both eyes for up to 42 days. In clinical trials, approximately 7% of patients experienced an adverse drug reaction associated with the use of Emadine; however, less than 1% of these patients discontinued therapy due to these adverse drug reactions.

No serious ophthalmic or systemic adverse drug reactions were reported in the clinical trials. 0% of patients. Tabulated list of adverse reactions The following adverse reactions listed below were observed in clinical studies or with post marketing experience.

They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness. System Organ Classification Frequency Adverse reaction Psychiatric disorders Uncommon abnormal dreams Nervous system disorders Uncommon headache, sinus headache, dysgeusia Eye disorders Common eye pain, eye pruritus, conjunctival hyperaemia Uncommon corneal infiltrates, corneal staining, blurred vision, eye irritation, dry eye, foreign body sensation in eyes, lacrimation increased, asthenopia, ocular hyperaemia Cardiac disorders Not known tachycardia Skin and subcutaneous tissue disorders Uncommon rash Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Ocular corneal infiltrates Ocular corneal infiltrates were reported in conjunction with the use of EMADINE. In case of corneal infiltrates, the product should be discontinued and appropriate management should be implemented. Excipients Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.

Since EMADINE contains benzalkonium chloride, close monitoring is required with frequent or prolonged use. In addition benzalkonium chloride may cause eye irritation and is known to discolour soft contact lenses. Contact with soft contact lenses is to be avoided.

Patients must be instructed to remove contact lenses prior to the application of EMADINE and wait 15 minutes after instillation of the dose before reinsertion.

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