- Contraindications
- Do not use in case of hypersensitivity to the active substance or any of the excipients.
- Due to the effect of sildenafil on metabolic changes involving nitric oxide and cyclic guanosine monophosphate (cGMP), it enhances the hypotensive effects of nitrates. Therefore, the concomitant use of sildenafil with nitric oxide donors (such as amyl nitrite) or nitrates in any form is contraindicated.
- Concomitant use of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may lead to symptomatic hypotension.
- Medicinal products 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 conditions such as unstable angina or severe heart failure).
- The medicinal product is contraindicated in patients who have loss of vision in one eye because of nonarteritic 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 patients with: severe hepatic impairment, hypotension (blood pressure < 90/50 mm Hg), recent stroke or heart attack, diagnosed with hereditary degenerative changes in the retina, such as retinitis pigmentosa (a small proportion of these patients have genetically determined abnormalities of retinal phosphodiesterase). Sildenafil is contraindicated in these patients.
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