Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Talmanco (previously Tadalafil Generics)

Talmanco 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 9–10

HOS-137563 · Präparat HOS-098059

9  Very common Common Uncommon Rare Not known1 Renal and urinary disorders Haematuria Reproductive system and breast disorders Increased uterine Priapism5, Penile Prolonged erections bleeding4 haemorrhage, Haematospermia General disorders and administration site conditions Facial oedema, Chest pain2 1 Events not reported in registration trials and cannot be estimated from the available data. The adverse reactions have been included in the table as a result of postmarketing or clinical trial data from the use of tadalafil in the treatment of erectile dysfunction. 2 Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. 3 Actual MedDRA terms included are abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and stomach discomfort. 4 Clinical non-MedDRA term to include reports of abnormal/excessive menstrual bleeding conditions such as menorrhagia, metrorrhagia, menometrorrhagia, or vaginal haemorrhage. 5 The adverse reactions have been included in the table as a result of post-marketing or clinical trial data from the use of tadalafil in the treatment of erectile dysfunction; and in addition, the frequency estimates are based on only 1 or 2 patients experiencing the adverse reaction in the pivotal placebo-controlled study of tadalafil. 6 Headache was the most commonly reported adverse reaction. Headache may occur at the beginning of therapy; and decreases over time even if treatment is continued.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.