
Description of selected adverse reactions: A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo. Most of these ECG abnormalities were not associated with adverse reactions.
Other special populations: Based on available data, patients over 65 years of age receiving tadalafil either for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia are limited. Based on data available, tadalafil taken on demand for the treatment of erectile dysfunction, diarrhoea was reported more frequently in patients over 65 years of age. According to available data, tadalafil 5 mg taken once a day for treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.