Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The following definitions apply to the frequency terminology used hereafter: 
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)
Frequency not known (cannot be estimated from available data)

Cardiac disorders:
Very common:           bradycardia.
Common:                worsening of heart failure.
Uncommon:              AV-conduction disturbances.
Investigations:
Rare:                  increased triglycerides, increased liver enzymes (ALAT, ASAT).

Nervous system disorders:
Common:              dizziness, headache.
Rare:                syncope.

Eye disorders:
Rare:                  reduced tear flow (to be considered if the patient uses lenses).
Very rare:             conjunctivitis.
Ear and labyrinth disorders:
Rare:                  hearing disorders.


Respiratory, thoracic and mediastinal disorders:
Uncommon:               bronchospasm in patients with bronchial asthma or a history of obstructive airways disease.
Rare:                   allergic rhinitis.

Gastrointestinal disorders:
Common:                gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation.

Skin and subcutaneous tissue disorders:
Rare:                 hypersensitivity reactions (pruritus, flush, rash and angioedema).
Very rare:            alopecia. Beta-blockers may provoke or worsen psoriasis or induce psoriasis-like rash.

Musculoskeletal and connective tissue disorders:
Uncommon:             muscular weakness and cramps.

Vascular disorders:
Common:                feeling of coldness or numbness in the extremities, hypotension.
Uncommon:              orthostatic hypotension.
General disorders:
Common:                asthenia, fatigue.

Hepatobiliary disorders:
Rare:                  hepatitis.

Reproductive system and breast disorders:
Rare:                erectile dysfunction.
Psychiatric disorders:
Uncommon:              sleep disorder, depression.
Rare:                  nightmare, hallucination.

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/