NIKP-Bisoprolol Adverse Reactions

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); not known (cannot be estimated from the available data).
Psychiatric disorders: Uncommon: sleep disorder, depression.
Rare: nightmare, hallucination.
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.
Cardiac disorders: Very common: bradycardia (in patients with chronic heart failure).
Common: worsening of pre-existing heart failure (in patients with chronic heart failure).
Uncommon: AV-conduction disturbances; worsening of pre-existing heart failure (in patients with hypertension or angina pectoris); bradycardia (in patients with hypertension or angina pectoris).
Vascular disorders: Common: feeling of coldness or numbness in the extremities, hypotension especially in patients with heart failure.
Uncommon: orthostatic hypotension.
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.
Hepatobiliary disorders: Rare: hepatitis.
Skin and subcutaneous tissue disorders: Rare: hypersensitivity reactions such as 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, muscle cramps.
Reproductive system and breast disorders: Rare: erectile dysfunction.
General disorders and administration site conditions: Common: asthenia (in patients with chronic heart failure), fatigue*.
Uncommon: asthenia (in patients with hypertension or angina pectoris).
Investigations: Rare: increased triglycerides, increased liver enzymes (ALAT, ASAT).
Paediatric population: No data are available.
Inform the physician if the patient finds any of the side effects listed as previously mentionedor any other unwanted or unexpected effects. Meet and inform a physician immediately in case of severe adverse effect occurs.
5 mg: Applies only to hypertension or angina pectoris: *These symptoms especially occur at the beginning of the therapy. They are generally mild and often disappear within 1 to 2 weeks.