PRILIGY TABLET 60MG [SIN13881P]

Product Info

PRILIGY TABLET 60MG

[SIN13881P]

4.1 Therapeutic indication

Priligy is indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age.

The following conditions were fulfilled in the clinical studies of PE:

• An intravaginal ejaculatory latency time (IELT) of less than two minutes; and

• Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes; and

• Marked personal distress or interpersonal difficulty as a consequence of PE; and

• Poor control over ejaculation.

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).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Significant pathological cardiac conditions such as:

• Heart failure (NYHA class II–IV)

• Conduction abnormalities (second- or third-degree AV block or sick sinus syndrome) not treated with a permanent pacemaker

• Significant ischemic heart disease

• Significant valvular disease.

Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI. Similarly, an MAOI should not be administered within 7 days after Priligy has been discontinued (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Concomitant treatment with thioridazine, or within 14 days of discontinuing treatment with thioridazine. Similarly, thioridazine should not be administered within 7 days after Priligy has been discontinued (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Concomitant treatment with serotonin reuptake inhibitors [selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)] or other medicinal/herbal products with serotonergic effects [e.g., L-tryptophan, triptans, tramadol, linezolid, lithium, St. John’s Wort (Hypericum perforatum)] or within 14 days of discontinuing treatment with these medicinal/herbal products. Similarly, these medicinal/herbal products should not be administered within 7 days after Priligy has been discontinued (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc. (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Moderate and severe hepatic impairment.