The incidence in placebo was taken into account. Adverse drug reactions identified through post-marketing surveillance were considered to be rare or very rare (including isolated reports). Blood and lymphatic system disorders: Very rare: Thrombocytopenia.
Metabolism and nutrition disorders: Very Rare: Anorexia.
Psychiatric disorders: Uncommon: Depression.
Very rare: Psychosis, apathy, confusion.
Nervous system disorders: Common: CNS disturbances, dizziness.
Very rare: Headache.
Eye disorders: Common: Visual disturbances (blurred or yellow vision).
Cardiac disorders: Common: Arrhythmia, conduction disturbances, bigeminy, trigeminy, PR prolongation, sinus bradycardia.
Very rare: Supraventricular tachyarrhythmia, atrial tachycardia (with or without block), junctional (nodal) tachycardia, ventricular arrhythmia, ventricular premature contraction, ST segment depression.
Gastrointestinal disorders: Common: Nausea, vomiting, diarrhoea.
Very rare: Intestinal ischemia, intestinal necrosis.
Skin disorders: Common: Skin rashes of urticarial or scarlatiniform character may be accompanied by pronounced eosinophilia.
Reproductive system and breast disorders: Very rare: Gynaecomastia can occur with long term administration.
General disorders and administration site conditions: Very rare: Fatigue, malaise, weakness.
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