Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Yuvanci

Yuvanci 10 mg/20 mg film-coated tablets Yuvanci 10 mg/40 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10–11

HOS-143979 · Präparat HOS-099076

10  Ventricular arrhythmiae Not knownf Vascular disorders Flushinga,g Very common Hypotension Common Respiratory, thoracic and Nasopharyngitisa (including Very common mediastinal disorders nasal congestion, sinus congestion and rhinitis) Epistaxis Common Gastrointestinal disorders Nauseaa Very common Dyspepsiaa Very common Abdominal discomforta Very common Abdominal paina Very common Vomiting Common Gastroesophageal reflux Common disease Hepatobiliary disorders Transaminases increased Common Skin and subcutaneous tissue Rash Common disorders Urticariae Uncommon Hyperhidrosise Uncommon Stevens-Johnson syndromee Not knownf Exfoliative dermatitise Not knownf Musculoskeletal and Myalgiaa Very common connective tissue disorders Back paina Very common Pain in extremitya Very common Renal and urinary disorders Haematuriae Uncommon Reproductive system and Increased uterine bleedingh Common breast disorders Priapisme Uncommon Penile haemorrhagee Uncommon Haematospermiae Uncommon Prolonged erectionse Not knownf General disorders and Oedemai Very common administration site conditions Fluid retentioni Very common Swelling face Common Chest pain Common a When the same adverse reaction has been observed in more than one medicinal product (i.e., macitentan, tadalafil, and Yuvanci), the category representing the highest frequency is presented. b Not observed with Yuvanci in double-blind study data, but reported with macitentan monotherapy c Includes anaemia, iron deficiency anaemia, anaemia of chronic disease, haemoglobin decreased, normochromic anaemia, pancytopenia, blood loss anaemia, and myelofibrosis. d Pruritus was observed with macitentan with a frequency of uncommon. e Not observed with Yuvanci in double-blind study data, but reported with tadalafil monotherapy. f Events not reported in registration studies and cannot be estimated from the available data. The adverse reactions have been included in the table as a result of postmarketing or clinical study data from the use of tadalafil in the treatment of erectile dysfunction. g Includes flushing and hot flush. h Includes heavy menstrual bleeding, intermenstrual bleeding, polymenorrhagia, and vaginal haemorrhage. Frequency based on exposure in females. i Includes oedema peripheral, peripheral swelling, generalised oedema, swelling, bone marrow oedema, fluid retention, joint swelling, oedema, hypervolaemia, and pericardial effusion.

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