CALIBERI ORODISPERSIBLE FILM 20MG

FILM, SOLUBLE

**4.2. Posology and method of administration** For oral use. CALIBERI ODF should be taken without food. CALIBERI ODF must be immediately used once taken out of the pouch and it can be dissolved on the tongue, with or without any water. **Erectile Dysfunction in adult men** _CALIBERI ODF for Use as Needed_ The recommended dose is 10mg (2x 5mg CALIBERI ODF) taken prior to anticipated sexual activity. In those patients in whom CALIBERI ODF 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. CALIBERI ODF 10mg and 20mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use. _CALIBERI ODF for Once Daily Use_ In patients who anticipate a frequent use of CALIBERI ODF (i.e. at least twice weekly) a once daily regimen with the lowest doses of CALIBERI ODF might be considered suitable, based on patient choice and the physician’s judgement. The maximum recommended dose is 5mg (one 5mg CALIBERI ODF) once a day, taken at approximately the same time every day, without regard to timing of sexual activity. 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. **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. **Use in elderly men** Dose adjustments are not required in elderly patients. **Use in men with renal impairment** _CALIBERI ODF for Use as Needed_ - Mild (creatinine clearance 51 to 80mL/min): No dose adjustment is required. - Moderate (creatinine clearance 31 to 50mL/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 <30mL/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_). _CALIBERI ODF for Once Daily Use_ - Mild (creatinine clearance 51 to 80mL/min): No dose adjustment is required. - Moderate (creatinine clearance 31 to 50mL/min): No dose adjustment is required. - Severe (creatinine clearance <30mL/min or on hemodialysis): CALIBERI ODF 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 hepatic impairment** _CALIBERI ODF for Use as Needed_ The recommended dose is 10mg taken prior to anticipated sexual activity. There is limited clinical data on the safety of CALIBERI ODF 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 CALIBERI ODF to patients with hepatic impairment. _CALIBERI ODF 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** CALIBERI ODF should not be used in individuals below 18 years of age. **Use in patients taking CYP3A4 Inhibitors** _CALIBERI ODF for Use as Needed_ For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of CALIBERI ODF 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_). _CALIBERI ODF for Once Daily Use_ For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of CALIBERI ODF 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_). Caliberi ODF should not be used in these patients since the 2.5mg film dosage is unavailable.