ZENAVIL FILM COATED TABLETS 20MG

TABLET, FILM COATED

**4.2 Posology and method of administration** **Posology** **Erectile Dysfunction** **Zenavil 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 10mg and 20mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use. **Zenavil for Once Daily Use** In patients who anticipate a frequent use of Zenavil (i.e. at least twice weekly) a once daily regimen with the lowest doses of Zenavil 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 5mg 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 5mg, taken at approximately the same time every day. When therapy for BPH is initiated with Zenavil and finasteride, the recommended dose of Zenavil 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 5mg, taken at approximately the same time every day, without regard to timing of sexual activity. Special populations **Elderly men** Dose adjustments are not required in elderly patients. **Men with renal impairment** **Zenavil 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_). **Zenavil 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): Zenavil 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** **Zenavil for Use as Needed** The recommended dose is 10mg taken prior to anticipated sexual activity. There is limited clinical data on the safety of Zenavil 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. **Zenavil 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** Zenavil should not be used in individuals below 18 years of age. **Patients taking CYP3A4 Inhibitors** **Zenavil for Use as Needed** For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of Zenavil 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_). **Zenavil for Once Daily Use** For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of Zenavil 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. Zenavil can be taken with or without food.