REVATIO FILM-COATED TABLETS 20MG [SIN13244P]

Product Info

REVATIO FILM-COATED TABLETS 20MG

[SIN13244P]

4.1 Therapeutic indications

Revatio tablets are indicated for the treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.

4.2 Posology and method of administration

For oral use.

Adults
The recommended dose is 20 mg three times a day. Tablets should be taken approximately 6 to 8 hours apart with or without food.

Elderly (≥65 years)
Dose adjustments are not required in elderly patients.

Renal impairment
Dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance <30 mL/min).

Hepatic impairment
Dose adjustments are not required in patients with mild to moderate hepatic impairment (Child-Pugh class A and B). Revatio has not been studied in patients with severe hepatic impairment (Child-Pugh class C).

Use in children
Revatio is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.

Patients using other medicinal products
Co-administration of most potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) with sildenafil is not recommended (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dose adjustments for sildenafil may be required when co-administered with CYP3A4 inducers (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). However, there are no data to support increasing the dose of sildenafil in combination with bosentan (see sections 4.4, 4.5, and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

Co-administration with nitric oxide donors or nitrates in any form (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension.

Hypersensitivity to the active substance or to any of the excipients.

Sildenafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous phosphodiesterase 5 (PDE5) inhibitor exposure.