Betaloc ZOK is well tolerated and adverse reactions have generally been mild and reversible. The following events have been reported as adverse events in clinical trials or reported from routine use, mostly with conventional Betaloc (metoprolol tartrate). In many cases a relationship to treatment with Betaloc has not been established.
The following definitions of frequencies are used: Very common (≥1:10), common (≥1:100 - <1:10), uncommon (≥1:1000 - <1:100), rare (≥1:10000 - <1:1000), and very rare (<1:10000).
Cardiovascular system: Common: Bradycardia, postural disorders (very rarely with syncope), cold hands and feet, palpitations.
Uncommon: Transient deterioration of heart failure symptoms, cardiogenic shock in patients with acute myocardial infarction*, AV-block I, oedema, precordial pain.
Rare: Disturbances of cardiac conduction, cardiac arrhythmias.
Very rare: Gangrene in patients with pre-existing severe peripheral circulatory disorders.
* Excess frequency of 0.4% compared with placebo in a study of 46000 patients with acute myocardial infarction where the frequency of cardiogenic shock was 2.3% in the metoprolol group and 1.9% in the placebo group in the subset of patients with low shock risk index. The shock risk index was based on the absolute risk of shock in each individual patient derived from age, sex, time delay, Killip class, blood pressure, heart rate, ECG abnormality, and prior history of hypertension. The patient group with low shock risk index corresponds to the patients in which metoprolol is recommended for use in acute myocardial infarction.
Central nervous system: Very common: Fatigue.
Common: Dizziness, headache.
Uncommon: Paraesthesiae, muscle cramps.
Gastrointestinal: Common: Nausea, abdominal pain, diarrhoea, constipation.
Rare: Dry mouth.
Haematologic: Very rare: Thrombocytopenia.
Hepatic: Rare: Liver function test abnormalities.
Very Rare: Hepatitis.
Musculoskeletal: Very rare: Arthralgia.
Metabolism: Uncommon: Weight gain.
Psychiatric: Uncommon: Depression, concentration impaired, somnolence or insomnia, nightmares.
Rare: Nervousness, anxiety, impotence/sexual dysfunction.
Very rare: Amnesia/memory impairment, confusion, hallucinations.
Respiratory: Common: Dyspnoea on exertion.
Sense organs: Rare: Disturbances of vision, dry and/or irritated eyes, conjunctivitis.
Very rare: Tinnitus, taste disturbances.
Skin: Uncommon: Rash (in the form of urticaria psoriasiform and dystrophic skin lesions), increased sweating.
Rare: Loss of hair.
Very rare: Photosensitivity reactions, aggravated psoriasis