JOVAN T 20 FILM-COATED TABLET 20MG

TABLET, FILM COATED

**4.2 Posology and method of administration** _Posology_ _Use in Adult Men_ In general, the recommended dose is 10mg taken prior to anticipated sexual activity and with or without food. In those patients in whom tadalafil 10mg does not produce an adequate effect, 20mg might be tried. It may be taken at least 30 minutes prior to sexual activity. The maximum dose frequency is once per day. Tadalafil 10mg and 20mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous 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 dose is 2.5mg taken once a day at approximately the same time of day. The dose may be increased to 5mg once a day based on individual efficacy and tolerability. The appropriateness of continued use of the daily regimen should be reassessed periodically. _Use in Elderly Men_ Dose adjustments are not required in elderly patients. _Use in Men with Impaired Renal Function_ 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 5mg 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 5mg 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): Cialis 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_). _Use in Men with Impaired Hepatic Function_ 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 Cialis 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_). _Use in 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_)