Adverse reactions : תופעות לוואי

4.8     Undesirable effects
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 pruritis 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 reactions classification

Psychiatric disorders                   Uncommon                abnormal dreams Nervous system disorders                Uncommon                Headache, sinus headache,dysguesia
Eye disorders                            Common                  eye pain, ,eye pruritus,eye , 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                   Uncommon                rash tissue disorders


Reporting of suspected adverse reactions
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form

(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=Advers EffectMedic@moh.health.gov.il ) or by email (adr@MOH.HEALTH.GOV.IL ).