Basic Information
SILCAP® 25 CAPSULE 25MG
CAPSULE
Regulatory Information
SIN16025P
October 9, 2020
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 4, 2025
XG04BE03
Company Information
Active Ingredients
Strength: 25 mg
Detailed Information
Contraindications
**CONTRAINDICATIONS** Use of sildenafil is contraindicated in patients with known hypersensitivity to any component of the capsule. **Nitrates and sildenafil must not be used concomitantly. Sildenafil was shown to potentiate the hypotensive effects of both acute and chronic nitrate administration and therefore, its co-administration with NO donors, organic nitrates or organic nitrites in any form, either regularly or intermittently is contraindicated. Drugs which must not be used concomitantly include glyceryl trinitrate (injection, tablets, sprays, or patches), isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates in any form.** 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. 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) (see PRECAUTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The possibility of undiagnosed cardiovascular disorders in men with erectile dysfunction should be considered before prescribing sildenafil. Sildenafil is not recommended in patients with male erectile dysfunction with a previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION) (see PRECAUTIONS and ADVERSE EFFECTS, Post Marketing Experience – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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), hypertension (blood pressure >170/110 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 PDEs).
Indication Information
**THERAPEUTIC INDICATIONS** 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.