Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Evaluation of adverse events is based on the following incidence reports: „Very common“ (≥1/10), „common“ (<1/10, ≥1/100), „uncommon“ (<1/100,    ≥1/1000),   „rare“   (<1/1000,   ≥1/10‘000),    „very      rare“ (<1/10‘000).
Nervous system disorders:
Common: headache

Uncommon: dizziness

Psychiatric disorders:
Uncommon: restlessness
General disorders:
Common: asthenia

Uncommon: fatigue

Gastrointestinal disorders:
Common: gastrointestinal disturbance
Skin and subcutaneous tissue disorders:
Common: hyperhidrosis

Uncommon: allergic skin reactions

Rare: photosensitivity reaction
In cases of undesirable reactions of the skin, the film coated tablets are to be discontinued and the symptoms should be examined by a physician.

Eye disorders:
In literature, undesired reactions of the eyes were linked to the intake of St. John’s wort preparations and concomitant sunlight exposure. In cases of undesirable reactions of the eyes, the film coated tablets are to be discontinued and the symptoms examined by a physician.

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. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il/