Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Intelence

INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets · Abschnitt 4.8 · PDF-Seite 15–16

HOS-119752 · Präparat HOS-095005

15  system disorders uncommon decreased white blood cell count Immune system common drug hypersensitivity disorders uncommon immune reconstitution syndrome Metabolism and common diabetes mellitus, hyperglycaemia, nutrition disorders hypercholesterolaemia, increased low density lipoprotein (LDL), hypertriglyceridaemia, hyperlipidaemia, dyslipidaemia, anorexia Psychiatric disorders common anxiety, insomnia, sleep disorders uncommon confusional state, disorientation, nightmares, nervousness, abnormal dreams Nervous system very common headache disorders common peripheral neuropathy, paraesthesia, hypoaesthesia, amnesia, somnolence uncommon convulsion, syncope, tremor, hypersomnia, disturbance in attention Eye disorders common blurred vision Ear and labyrinth uncommon vertigo disorders Cardiac disorders common myocardial infarction uncommon atrial fibrillation, angina pectoris Vascular disorders common hypertension rare haemorrhagic strokea Respiratory, thoracic common exertional dyspnoea and mediastinal uncommon bronchospasm disorders Gastrointestinal very common diarrhoea, nausea disorders common gastrooesophageal reflux disease, vomiting, abdominal pain, abdominal distension, flatulence, gastritis, constipation, dry mouth, stomatitis, lipase increased, blood amylase increased uncommon pancreatitis, haematemesis, retching Hepatobiliary disorders common increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST) uncommon hepatitis, hepatic steatosis, cytolytic hepatitis, hepatomegaly Skin and subcutaneous very common rash tissue disorders common night sweats, dry skin, prurigo uncommon angioneurotic oedemaa, swelling face, hyperhidrosis rare Stevens-Johnson Syndromea, erythema multiformea very rare toxic epidermal necrolysisa, DRESSb Renal and urinary common renal failure, blood creatinine increased disorders Reproductive system uncommon gynaecomastia and breast disorders General disorders and common fatigue administration site uncommon sluggishness conditions a These adverse reactions were observed in other clinical trials than DUET-1 and DUET-2. b These adverse reactions have been identified through postmarketing experience with etravirine.

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