Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Most adverse effects are mild and tend to diminish with continued therapy.

Adverse events have been ranked under headings of frequency using the following convention:
Very common ≥ 1/10
Common          ≥ 1/100, <1/10
Uncommon        ≥1/1000, <1/100
Rare            ≥1/10000, <1/1000
Very rare       <1/10000
Not known       Cannot be estimated from the available data 

Endocrine disorders:
Gynaecomastia            rare
Psychiatric disorders:
Confusional state        not known

Delusional perception uncommon
Depression               common
Hallucination            uncommon
Libido decreased         not known
Nightmare                uncommon
Sleep disorder           common
Nervous system disorders:
Dizziness                very common
Headache                 common
Paraesthesia             uncommon
Sedation                 very common
Eye disorders:
Accommodation            not known disorder
Lacrimation decreased rare
Cardiac disorders:
Atrioventricular block rare
Bradyarrhythmia          not known
Sinus bradycardia        uncommon
Vascular disorders:
Orthostatic              very common hypotension
Raynaud's                uncommon phenomenon
Respiratory, thoracic and mediastinal disorders:
Nasal dryness            rare
Gastrointestinal disorders:
Colonic pseudo-          rare obstruction
Constipation             common
Dry mouth                very common
Nausea                   common
Salivary gland pain      common
Vomiting                 common
Skin and subcutaneous tissue disorders:
Alopecia              rare
Pruritus              uncommon
Rash                  uncommon
Urticaria             uncommon
Reproductive system and breast disorders:
Erectile dysfunction  common

General disorders and administration site conditions:
Fatigue                common
Malaise                uncommon
Investigations:
Blood glucose          rare increased

There are occasional reports of fluid retention during initial stages of oral treatment. This is usually transitory and can be corrected by the addition of a diuretic.

Occasional reports of abnormal liver function tests and two cases of hepatitis have also been reported.

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/