Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Entacapone Orion

Entacapone Orion 200 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-215664 · Präparat HOS-155488

Psychiatric disorders Common: Insomnia, hallucinations, confusion, paroniria Very rare: Agitation Nervous system disorders Very common: Dyskinesia Common: Parkinsonism aggravated, dizziness, dystonia, hyperkinesia Cardiac disorders** Common: Ischaemic heart disease events other than myocardial infarction (e.g. angina pectoris) Uncommon: Myocardial infarction Gastrointestinal disorders Very common: Nausea Common: Diarrhoea, abdominal pain, dry mouth, constipation, vomiting Very rare: Anorexia Not known: Colitis Hepatobiliary disorders Rare: Hepatic function tests abnormal Not known: Hepatitis with mainly cholestatic features (see section 4.4.) Skin and subcutaneous tissue disorders Rare: Erythematous or maculopapular rash Very rare: Urticaria Not known: Skin, hair, beard and nail discolourations Renal and urinary disorders Very common: Urine discoloration General disorders and administration site conditions Common: Fatigue, sweating increased, fall Very rare: Weight decrease * Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: 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, since no valid estimate can be derived from clinical trials or epidemiological studies).

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