Priligy Tablet 60mg

TABLET, FILM COATED

**4.2 Posology and method of administration** For oral use. Tablets should be swallowed whole to avoid the bitter taste. It is recommended that tablets be taken with at least one full glass of water. Patients should be cautioned to avoid situations where injury could result, including driving or operating hazardous machinery, should syncope or its prodromal symptoms such as dizziness or lightheadedness occur (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Adult men (aged 18 to 64 years) Before treatment is initiated, the physician should obtain a careful medical history focusing on past orthostatic events and also perform an orthostatic test (blood pressure and pulse rate, supine and standing). If the patient discloses a history suggestive of orthostatic reactions or an orthostatic test shows this kind of reaction, treatment with Priligy should be avoided. The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. The maximum recommended dosing frequency is once every 24 hours. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. If the patient experienced orthostatic reactions on the starting dose, no dose escalation to 60 mg should be performed. Priligy may be taken with or without food (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The physician who elects to use Priligy for the treatment of premature ejaculation should evaluate the risks and patient-reported benefits of the medicinal product after the first four weeks of treatment or after 6 doses to assess the patient risk-benefit balance and to determine whether continuing treatment with Priligy is appropriate. Elderly (age 65 years and over) Safety and efficacy of Priligy have not been established in patients age 65 years and over as limited data are available in this population (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Children and adolescents Priligy should not be used in individuals below 18 years of age. Patients with renal impairment Caution is advised in patients with mild or moderate renal impairment. Priligy is not recommended for use in patients with severe renal impairment (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients with hepatic impairment Priligy is contraindicated in patients with moderate and severe hepatic impairment (Child-Pugh Class B and C) (see sections 4.3 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Known CYP2D6 poor metabolizers or patients treated with potent CYP2D6 inhibitors Caution is advised if increasing the dose to 60 mg in patients known to be of CYP2D6 poor metabolizer genotype or in patients concomitantly treated with potent CYP2D6 inhibitors (see sections 4.4, 4.5 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients treated with moderate or potent inhibitors of CYP3A4 Concomitant use of potent CYP3A4 inhibitors is contraindicated. The dose is restricted to 30 mg in patients concomitantly treated with moderate CYP3A4 inhibitors and caution is advised (see sections 4.3, 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).