Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Invega

INVEGA 3 mg prolonged-release tablets INVEGA 6 mg prolonged-release tablets INVEGA 9 mg prolonged-release tablets INVEGA 12 mg prolonged-release tablets · Abschnitt 4.8 · PDF-Seite 10–11

HOS-208690 · Präparat HOS-154161

10 Hepatobiliary transaminases gamma-glutamyltran jaundice disorders increased sferase increased, hepatic enzyme increased Skin and pruritus, rash urticaria, alopecia, angioedema, drug subcutaneous eczema, acne eruptionc, tissue hyperkeratosis, dry disorders skin, erythema, skin discolouration, seborrhoeic dermatitis, dandruff Musculoskelet musculoskeletal blood creatine rhabdomyolysisc, al and pain, back pain, phosphokinase posture abnormalc connective arthralgia increased, muscle tissue spasms, joint stiffness, joint disorders swelling, muscular weakness, neck pain Renal and urinary incontinence, urinary pollakiuria, urinary disorders retention, dysuria Pregnancy, drug withdrawal puerperium syndrome neonatal and perinatal (see section 4.6)c conditions Reproductive amenorrhoea erectile dysfunction, priapismc, system and ejaculation disorder, menstruation breast menstrual disordere, delayedc, disorders galactorrhoea, sexual gynaecomastia, dysfunction, breast breast engorgement, pain, breast breast enlargementc, discomfort breast discharge, vaginal discharge General pyrexia, asthenia, face oedema, hypothermiac, body disorders fatigue oedemae, chills, temperature body temperature decreasedc, drug increased, gait withdrawal abnormal, thirst, syndromec, chest pain, chest indurationc discomfort, malaise Injury, fall poisoning and procedural complications a Refer to ‘Hyperprolactinaemia’ below. b Refer to ‘Extrapyramidal symptoms’ below. c Not observed in INVEGA clinical studies but observed in post-marketing environment with paliperidone. d In placebo-controlled pivotal trials, diabetes mellitus was reported in 0.05% in INVEGA-treated subjects compared to a rate of 0% in placebo group. Overall incidence from all clinical trials was 0.14% in all INVEGA-treated subjects. e Insomnia includes: initial insomnia, middle insomnia; Convulsion includes: grand mal convulsion; Oedema includes: generalised oedema, oedema peripheral, pitting oedema; Menstrual disorder includes: menstruation irregular, oligomenorrhoea.

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