Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Capecitabine Accord

Capecitabine Accord 150 mg film-coated tablets Capecitabine Accord 300 mg film-coated tablets Capecitabine Accord 500 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14–15

HOS-125525 · Präparat HOS-096081

14 Body System Very Common Common Uncommon Rare/Very Rare All grades All grades Severe and/or Life- (Post-Marketing threatening (grade 3-4) Experience) or considered medically relevant Gastrointestinal Diarrhoea, Gastrointestinal Intestinal obstruction, disorders Vomiting, Nausea, haemorrhage, Ascites, Enteritis, Stomatitis, Constipation, Upper Gastritis, Dysphagia, Abdominal pain abdominal pain, Abdominal pain lower, Dyspepsia, Oesophagitis, Abdominal Flatulence, Dry discomfort, mouth Gastrooesophageal reflux disease, Colitis, Blood in stool Hepatobiliary - Hyperbilirubinemia, Jaundice Hepatic failure (rare), disorders Liver function test Cholestatic hepatitis abnormalities (rare) Skin and Palmar-plantar Rash, Alopecia, Blister, Skin ulcer, Rash, Cutaneous lupus subcutaneous erythrodysaesthesia Erythema, Dry skin, Urticaria, Photosensitivity erythematosus (rare), tissue disorders syndrome** Pruritus, Skin reaction, Palmar Severe skin reactions hyper-pigmentation, erythema, Swelling face, such as Stevens- Rash macular, Skin Purpura, Radiation recall Johnson Syndrome and desquamation, syndrome toxic Epidermal Dermatitis, Necrolysis (very rare) Pigmentation (see section 4.4.) disorder, Nail disorder Muskuloskeletal - Pain in extremity, Joint swelling, Bone pain, and connective Back pain, Facial pain, tissue disorders Arthralgia Musculoskeletal stiffness, Muscular weakness Renal and - - Hydronephrosis, Urinary urinary incontinence, Haematuria, disorders Nocturia, Blood creatinine increased Reproductive - - Vaginal haemorrhage system and breast disorders General Fatigue, Asthenia Pyrexia, Oedema Oedema, Chills, Influenza disorders and peripheral, Malaise, like illness, Rigors, Body administration Chest pain temperature increased site conditions ** Based on the post-marketing experience, persistent or severe palmar-plantar erythrodysaesthesia syndrome can eventually lead to loss of fingerprints (see section 4.4)

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