Nebenwirkungen · Talmanco (previously Tadalafil Generics)
Talmanco 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-137566 · Präparat HOS-098059
Placebo-controlled clinical trial in paediatric patients (H6D-MC-LVHV) In a randomised, placebo-controlled study in 35 patients aged 6.2 to 17.9 years (median age of 14.2 years) with PAH, a total of 17 patients were treated once daily with tadalafil 20 mg (middle-weight cohort, ≥ 25 kg to < 40 kg) or 40 mg (heavy-weight cohort, ≥ 40 kg), and 18 patients were treated with placebo, for 24 weeks. The most common AEs, occurring in ≥ 2 patients treated with tadalafil, were headache (29.4 %), upper respiratory tract infection and influenza (17.6 % each), and arthralgia and epistaxis (11.8 % each). No deaths or SAEs were reported. Of the 35 paediatric patients treated in the short-term, placebo-controlled study, 32 entered the 24 month long-term open-label extension and 26 patients completed the follow-up. No new safety signals were observed.
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