Emadine 0.05% w/v, Eye drops, Solution Ref.[2780] Active ingredients: Emadine

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.

No interaction studies have been performed.

Pregnancy

There are no adequate data from the use of emedastine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Nevertheless, considering the absence of effects of emedastine on adrenergic, dopaminergic and serotonin receptors, EMADINE can be used during pregnancy if the dosage recommendation in section 4.2 is respected.

Lactation

Emedastine has been identified in the milk of rats following oral administration. It is not known whether topical administration to humans could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised if EMADINE is administered during breast-feeding.

As with any ocular medication, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.

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. The most frequent adverse drug reaction was eye pain, reported at an overall incidence of 2.0%.

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.

Cardiac disorders

Not known: tachycardia

Nervous system disorders

Common: headache

Uncommon: sinus headache, dysgeusia

Eye disorders

Common: eye pain, eye irritation, blurred vision, eye pruritus, dry eye, corneal staining, conjunctival hyperaemia

Uncommon: corneal infiltrates, foreign body sensation in eyes, lacrimation increased, asthenopia, ocular hyperaemia

Skin and subcutaneous tissue disorders

Uncommon: rash

Psychiatric disorders

Uncommon: abnormal dreams

Not applicable.