Torfil 2.5/Torfil 5/Torfil 10/Torfil 20 Adverse Reactions

Torfil 2.5: The most commonly reported adverse events associated with the use of tadalafil were headache, upper abdominal pain, and myalgia. These adverse events were mild to moderate, transient and decreased with continued dosing. Other common adverse events were gastroesophageal reflux disease, nausea, vomiting, arthralgia, and muscle spasm. The table as follows shows other adverse events that were minor, those with no plausible relation to drug use, and reports were too imprecise to be meaningful. (See Table 1.)

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Torfil 5: The most commonly reported adverse reactions in patients taking Tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increases with increasing dose of Tadalafil. The adverse reactions reported were transient and generally mild to moderate. The majority of headaches reported with Tadalafil once-a-day dosing are experienced within the first 10 to 30 days of starting treatment.
Tabulated Summary of Adverse Drug Reactions: The tablet as follows lists the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials for on demand and a once-a-day treatment of erectile dysfunction an the once-a-day treatment for benign prostatic hyperplasia.
Frequency convention: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1,000) and 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 treatment of benign prostatic hyperplasia, are limited. In clinical trials with Tadalafil 5 mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhea were reported more frequently in patients over 75 years of age.
Torfil 10/Torfil 20: The most commonly reported adverse events associated with the use of tadalafil were headache and dyspepsia. These adverse events were mild to moderate, transient and decreased with continued dosing. Other common adverse events were myalgia, back pain, flushing and nasal congestion. Uncommon adverse events reported were swelling of eyelids, sensations described as eye pain, conjunctival hyperaemia, dyspnea, and dizziness. In post-marketing surveillance, the following adverse events were reported. (See Table 3.)

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