Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as Very common (≥1/10); common (≥1/100 to 1/10); uncommon (≥1/1000 to 1/100); rare (≥1/10,000 to 1/1000); and very rare (1/10,000). The data from clinical trials are estimates. Post-marketing data refer to reporting rate rather than true frequency.

Clinical Trial Data

Gastrointestinal Disorders
Very Common:          Tongue coated
Common:               Dry mouth
Nervous system disorders

Common:               Aguesia/ dysguesia
Glossodynia
Oral paraesthesia/ hypoaesthesia
Post Marketing Data

Gastrointestinal Disorders
Isolated reports:     Discoloration of the teeth and tongue (see section 4.4) Irritation of the mouth (see section 4.4)
Desquamation/ swelling of oral mucosa (see section 4.4)
Parotid gland swelling
Immune System Disorders

Isolated reports:     Hypersensitivity and anaphylaxis (see section 4.3 and 4.4) Undesirable effects are generally minor and local in nature.
Reporting suspected adverse reactions after authorization 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://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.
gov.il