Basic Information
SIFE 50 SILDENAFIL CITRATE FILM COATED TABLETS 50 MG
TABLET, FILM COATED
Regulatory Information
SIN15676P
May 2, 2019
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XG04BE03
Company Information
Active Ingredients
Strength: 50.0 mg
Detailed Information
Contraindications
**CONTRAINDICATIONS** Use of sildenafil is contraindicated in patients with a known hypersensitivity to any component of the tablet. Sildenafil was shown to potentiate the hypotensive effects of acute and chronic nitrates, and its administration to patients who are concurrently using nitric oxide donors, organic nitrates or organic nitrites in any form either regularly or intermittently is therefore contraindicated (see Drug Interactions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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. The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: 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). Sildenafil is contraindicated in men for whom sexual intercourse is inadvisable due to cardiovascular risk factors (e.g., patients with severe cardiovascular disease such as established cardiac failure and unstable angina pectoris). 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.
Indication Information
**INDICATION AND USAGE** Sildenafil is indicated for the treatment of erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for sildenafil to be effective, sexual stimulation is required.