SPEDRA Tablet

Active ingredients: Avanafil

Therapeutic indications

Treatment of erectile dysfunction in adult men.

In order for Spedra to be effective, sexual stimulation is required.

Posology and method of administration

Posology

Use in adult men

The recommended dose is 100 mg taken as needed approximately 15 to 30 minutes before sexual activity (see section 5.1). Based on individual efficacy and tolerability, the dose may be increased to a maximum dose of 200 mg or decreased to 50 mg. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment.

Special populations

Elderly (≥65 years old)

Dose adjustments are not required in elder patients. Limited data are available in elder patients aged 70 years or above.

Renal impairment

Dose adjustments are not required in patients with mild to moderate renal impairment (creatinine clearance ≥30 mL/min). Spedra is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min) (see sections 4.3 and 5.2). Patients with mild or moderate renal impairment (creatinine clearance ≥30 mL/min but <80 mL/min) who were enrolled in phase 3 studies showed decreased efficacy compared to those with normal renal function.

Hepatic impairment

Spedra is contraindicated in patients with severe hepatic impairment (Child Pugh class C) (see sections 4.3 and 5.2). Patients with mild to moderate hepatic impairment (Child-Pugh class A or B) should initiate treatment with the minimum efficacious dose and adjust posology based on tolerance.

Use in men with diabetes

Dose adjustments are not required in diabetic patients.

Paediatric population

There is no relevant use of Spedra in the paediatric population in the indication of erectile dysfunction.

Use in patients using other medicinal products

Concomitant use of CYP3A4 inhibitors

Co-administration of avanafil with potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) is contraindicated (see sections 4.3, 4.4 and 4.5).

In patients receiving concomitant treatment with moderate CYP3A4 inhibitors (including erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil), the maximum recommended dose of avanafil should not exceed 100 mg, with an interval of at least 48 hours between doses (see section 4.5).

Method of administration

For oral use. If Spedra is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).

Overdose

Single dose of up to 800 mg of avanafil have been given to healthy subjects and multiple daily doses up to 300 mg have been given to patients. Adverse reactions were similar to those seen at lower doses but incidence rates and severities were increased.

In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as avanafil is highly bound to plasma proteins and it is not eliminated in the urine.

Shelf life

5 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 4x1, 8x1 and 12x1 tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.