Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Eviplera

Eviplera 200 mg/25 mg/245 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 22

HOS-214433 · Präparat HOS-155326

Frequency Adverse reaction Blood and lymphatic system disorders neutropenia1, decreased white blood cell count2, decreased haemoglobin2, decreased Common: platelet count2 Uncommon: anaemia1, 4 Immune system disorders Common: allergic reaction1 Uncommon: immune reactivation syndrome Metabolism and nutrition disorders increased total cholesterol (fasted)2, increased LDL-cholesterol (fasted)2, Very common: hypophosphataemia3, 5 Common: hypertriglyceridaemia1, 2, hyperglycaemia1, decreased appetite2 Uncommon: hypokalaemia3, 5 Rare: lactic acidosis3 Psychiatric disorders Very common: insomnia1, 2 Common: depression2, depressed mood2, sleep disorders2, abnormal dreams1, 2 Nervous system disorders Very common: headache1, 2, 3, dizziness1, 2, 3 Common: somnolence2 Gastrointestinal disorders Very common: increased pancreatic amylase2, vomiting1, 2, 3, diarrhoea1, 3, nausea1, 2, 3 elevated amylase including elevated pancreatic amylase1, elevated serum lipase1, 2, Common: abdominal pain1, 2, 3, abdominal discomfort2, abdominal distension3, dyspepsia1, flatulence3, dry mouth2 Uncommon: pancreatitis3 Hepatobiliary disorders Very common: increased transaminases (AST and/or ALT)1, 2, 3 Common: increased bilirubin1, 2 Rare: hepatitis3, hepatic steatosis3 Skin and subcutaneous tissue disorders Very common: rash1, 2, 3 vesiculobullous rash1, pustular rash1, urticaria1, skin discolouration (increased Common: pigmentation)1, 4, maculopapular rash1, pruritus1 Uncommon: angioedema1, 3, 6, severe skin reactions with systemic symptoms7 Musculoskeletal and connective tissue disorders Very common: elevated creatine kinase1 Common: bone mineral density decreased3 Uncommon: rhabdomyolysis3, 5, muscular weakness3, 5 osteomalacia (manifested as bone pain and infrequently contributing to fractures)3, 5, 8, Rare: myopathy3, 5 Renal and urinary disorders proximal renal tubulopathy including Fanconi syndrome3, increased creatinine3, Uncommon: proteinuria3 renal failure (acute and chronic)3, acute tubular necrosis3, nephritis (including acute Rare: interstitial nephritis)3, 8, nephrogenic diabetes insipidus3 General disorders and administration site conditions Very common: asthenia1, 3 Common: pain1, fatigue2 1 Adverse reaction identified for emtricitabine. 2 Adverse reaction identified for rilpivirine hydrochloride. 3 Adverse reaction identified for tenofovir disoproxil. 4 Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients (see section 4.8, Paediatric population).

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