Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Results from controlled clinical studies show undesirable effects with an overall frequency of 33% occuring during therapy. These are predominantly dose dependent and attributed to pharmacological effects of the medicament.
Undesirable reactions with supposed or possible interrelations with therapy are presented below considering system organ classes and overall frequencies.

The following incidences are used:
Very common (≥1/10)
Common          (≥1/100 to <1/10)
Uncommon        (≥1/1,000 to <1/100)
Rare            (≥1/10,000 to <1/1,000)
Very rare       (<1/10,000) not known       (cannot be estimated from the available data)

Eye disorders:
Very rare: increased lacrimation, blurred vision, changes in accommodation ability.
Cardiac disorders:
Common: bradycardia.
Not known: temporary periods with atrial fibrillation were noticed in patients suffering from thyroid dysfunction.

Vascular disorders:
Common: drop in blood pressure.
Rare: especially at the beginning of therapy feeling of dizziness or giddiness (orthostatic hypotension).

Respiratory, thoracic and mediastinal disorders:
Very rare: retrosternal pain, bronchospasm, dyspnoea, wheezing, especially in patients with tendency towards bronchial constriction.

Gastrointestinal disorders:
Common: diarrhoea.
Uncommon: nausea and vomiting, gastrointestinal disturbances.
Very rare: eructation, ulcer.

Skin and subcutaneous tissue disorders:
Very common: skin flushing.
Very rare: white heat rash (Miliaria cristallina).
Renal and urinary disorders:
Very common: urinary urgency.

General disorders and administration site conditions:
Very common: increased salivation and perspiration (as a result of the parasympathetic stimulation).
Common: hypothermia.
Very rare: heat sensation, feeling tense, headache.

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