SYNERRV SILDENAFIL FILM-COATED TABLETS 50MG [SIN16066P]

Product Info

SYNERRV SILDENAFIL FILM-COATED TABLETS 50MG

[SIN16066P]

THERAPEUTIC INDICATIONS:
Sildenafil Tablet is indicated for use in adult men with erectile dysfunction, which is the inability to achieve or maintain an erection sufficient for satisfactory sexual performance.
In order for Sildenafil Tablet to be effective, sexual stimulation is required.

POSOLOGY AND METHOD OF ADMINISTRATION
Sildenafil tablets are for oral administration.

Use in adults
Film-coated tablets
For most patients, the recommended dose is 50 mg taken as needed, approximately 1 hour before sexual activity.

Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended daily dose is 100 mg. The maximum recommended dosing frequency is once per day.

Use in patients with impaired renal function
Dosage adjustments are not required in patients with mild to moderate renal impairment (creatinine clearance = 30 – 80 mL/min).

Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 mL/min), a 25 mg dose should be considered.

Use in patients with impaired hepatic function
Since sildenafil clearance is reduced in patients with hepatic impairment (e.g., cirrhosis), a 25 mg dose should be considered.

Use in patients using other medications
Given the extent of the interaction with patients receiving concomitant therapy with ritonavir (see section Interaction With Other Medicinal Products – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), co-administration with ritonavir is not advised. If ritonavir is co-administered with sildenafil, it is recommended not to exceed a maximum single dose of 25 mg of sildenafil in a 48-hour period.

A starting dose of 25 mg should be considered in patients receiving concomitant treatment with the CYP3A4 inhibitors (e.g., erythromycin, saquinavir, ketoconazole, itraconazole). See section Interaction With Other Medicinal Products – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

In order to minimize the potential for developing postural hypotension, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment. In addition, initiation of sildenafil at lower doses should be considered (see section Warning and Precautions & section Interaction With Other Medicinal Products – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in children
Sildenafil is not indicated for use in children (<18 years old).

Use in elderly men
Since sildenafil clearance is reduced in elderly patients, a first dose of 25 mg should be considered.

CONTRAINDICATIONS:
Hypersensitivity to the active substance or to any of the excipients.
Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway, sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.
The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension.
Medicines for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure).
Sildenafil Tablet is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure < 90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).