TADAFIL 20 TADALAFIL TABLETS USP 20 MG

TABLET, FILM COATED

**4.2. Posology and method of administration** Posology _Erectile Dysfunction_ _Tadalafil for Use as Needed_ The recommended dose is 10mg taken prior to anticipated sexual activity. In those patients in whom tadalafil 10mg does not produce an adequate effect, the maximum dose is 20mg and the maximum dosing frequency is once per day. It may be taken from 30 minutes to 36 hours prior to sexual activity. Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use. _Tadalafil for Once Daily Use_ In patients who anticipate a frequent use of Tadalafil (i.e. at least twice weekly) a once daily regimen with the lowest doses of Tadalafil might be considered suitable, based on patient choice and the physician's judgement. In these patients the recommended starting dose is 2.5mg once a day, taken at approximately the same time every day, without regard to timing of sexual activity. The dose may be increased to 5 mg once a day, based on individual efficacy and tolerability. The appropriateness of continued use of the daily regimen should be reassessed periodically. _Benign Prostatic Hyperplasia_ The recommended dose is 5 mg, taken at approximately the same time every day. When therapy for BPH is initiated with Tadalafil and finasteride, the recommended dose of Tadalafil is 5mg, taken at approximately the same time every day for up to 26 weeks. _Erectile Dysfunction and Benign Prostatic Hyperplasia_ The recommended dose is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. Elderly men Dose adjustments are not required in elderly patients. Men with renal impairment _Tadalafil for Use as Needed_ - Mild (creatinine clearance 51 to 80 ml/min): No dose adjustment is required. - Moderate (creatinine clearance 31 to 50 ml/min): A starting dose of 5 mg not more than once per day is recommended and the maximum dose is 10mg not more than once in every 48 hours. - Severe (creatinine clearance < 30 ml/min or on hemodialysis): The maximum dose is 5 mg not more than once in every 72 hours (see section 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Tadalafil for Once Daily Use_ - Mild (creatinine clearance 51 to 80 ml/min): No dose adjustment is required. - Moderate (creatinine clearance 31 to 50 ml/min): No dose adjustment is required. - Severe (creatinine clearance < 30 ml/min or on hemodialysis): Tadalafil for once daily use is not recommended (see section 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Men with hepatic impairment _Tadalafil for Use as Needed_ The recommended dose is 10mg taken prior to anticipated sexual activity. There is limited clinical data on the safety of Tadalafil in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of doses higher than 10mg of tadalafil to patients with hepatic impairment. _Tadalafil for Once Daily Use_ Once-a-day dosing has not been extensively evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician (see section 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Men with diabetes Dose adjustments are not required in diabetic patients. Paediatric population Tadalafil should not be used in individuals below 18 years of age. Patients taking CYP3A4 Inhibitors _Tadalafil for Use as Needed_ For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of Tadalafil is 10mg, not to exceed once every 72 hours (see section 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Tadalafil for Once Daily Use_ For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of Tadalafil is 2.5mg (see section 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Method of administration For oral use. Tadalafil can be taken with or without food.