Emadine · 4.4 Special warnings and precautions for use · 2

HOS-083870 · has-adverse-reaction-information · PDF-Seite 4

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. The most common adverse drug reactions were eye pain and eye pruritus occurring in 1% to 2.0% 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 Frequency Adverse reaction Classification 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

Auszug; vollständigen Abschnitt im Original lesen.

HOS-083876 · has-adverse-reaction-information · PDF-Seite 9

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. The most common adverse drug reactions were eye pain and eye pruritus, occurring in 1% to of 2.0% 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 9 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 Frequency Adverse reaction Classification 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,

Auszug; vollständigen Abschnitt im Original lesen.

HOS-083866 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-083872 · has-contraindication-information · PDF-Seite 9

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-083871 · has-indication-information · PDF-Seite 8

Symptomatic treatment of seasonal allergic conjunctivitis.

HOS-083865 · has-indication-information · PDF-Seite 2

Symptomatic treatment of seasonal allergic conjunctivitis.

HOS-083874 · has-interaction-information · PDF-Seite 9

No interaction studies have been performed.

HOS-083868 · has-interaction-information · PDF-Seite 3

No interaction studies have been performed.

HOS-083875 · has-pregnancy-information · PDF-Seite 9

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. Breast-feeding 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. Fertility Studies in animals have shown no evidence of impaired fertility (See Section 5.3). No human fertility data are available.

HOS-083869 · has-pregnancy-information · PDF-Seite 3

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. Breast-feeding 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. Fertility Studies in animals have shown no evidence of impaired fertility (See Section 5.3). No human fertility data are available.

HOS-083867 · has-warning-information · PDF-Seite 3

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.

HOS-083873 · has-warning-information · PDF-Seite 9

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.