Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Sprycel

SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13–14

HOS-116698 · Präparat HOS-094467

13 Rare diabetes mellitus Psychiatric disorders Common depression, insomnia Uncommon anxiety, confusional state, affect lability, libido decreased Nervous system disorders Very common headache Common neuropathy (including peripheral neuropathy), dizziness, dysgeusia, somnolence Uncommon CNS bleeding*b, syncope, tremor, amnesia, balance disorder Rare cerebrovascular accident, transient ischaemic attack, convulsion, optic neuritis, VIIth nerve paralysis, dementia, ataxia Eye disorders Common visual disorder (including visual disturbance, vision blurred, and visual acuity reduced), dry eye Uncommon visual impairment, conjunctivitis, photophobia, lacrimation increased Ear and labyrinth disorders Common tinnitus Uncommon hearing loss, vertigo Cardiac disorders Common congestive heart failure/cardiac dysfunction*c, pericardial effusion*, arrhythmia (including tachycardia), palpitations Uncommon myocardial infarction (including fatal outcome)*, electrocardiogram QT prolonged*, pericarditis, ventricular arrhythmia (including ventricular tachycardia), angina pectoris, cardiomegaly, electrocardiogram T wave abnormal, troponin increased Rare cor pulmonale, myocarditis, acute coronary syndrome, cardiac arrest, electrocardiogram PR prolongation, coronary artery disease, pleuropericarditis Not known atrial fibrillation/atrial flutter Vascular disorders Very common haemorrhage*d Common hypertension, flushing Uncommon hypotension, thrombophlebitis, thrombosis Rare deep vein thrombosis, embolism, livedo reticularis Not known thrombotic microangiopathy Respiratory, thoracic and mediastinal disorders Very common pleural effusion*, dyspnoea Common pulmonary oedema*, pulmonary hypertension*, lung infiltration, pneumonitis, cough Uncommon pulmonary arterial hypertension, bronchospasm, asthma, chylothorax* Rare pulmonary embolism, acute respiratory distress syndrome Not known interstitial lung disease Gastrointestinal disorders Very common diarrhoea, vomiting, nausea, abdominal pain Common gastrointestinal bleeding*, colitis (including neutropaenic colitis), gastritis, mucosal inflammation (including mucositis/stomatitis), dyspepsia, abdominal distension, constipation, oral soft tissue disorder Uncommon pancreatitis (including acute pancreatitis), upper gastrointestinal ulcer, oesophagitis, ascites*, anal fissure, dysphagia, gastroesophageal reflux disease Rare protein-losing gastroenteropathy, ileus, anal fistula Not known fatal gastrointestinal haemorrhage* Hepatobiliary disorders Uncommon hepatitis, cholecystitis, cholestasis

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