Caliberi Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions in patients taking Tadalafil for the treatment of ED or BPH were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of Tadalafil. The adverse reactions reported were transient, and generally mild or moderate.
Tabulated summary of adverse reactions: The table as follows lists the adverse reactions observed from spontaneous reporting and in placebo‐controlled clinical trials (comprising a total of 7116 patients on Tadalafil and 3718 patients on placebo) for on‐demand and once‐a‐day treatment of ED and the once‐a‐day treatment of BPH.
Frequency convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very rare (<1/10,000) and Not known (cannot be estimated from the available data). (See Table 2.)

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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: Data in patients over 65 years of age receiving Tadalafil in clinical trials, either for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia, are limited. In clinical trials with Tadalafil 5mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.