Apollo (Sildenafil)

Sildenafil

Each tablet contains sildenafil citrate equivalent to sildenafil 50 mg or 100 mg. Excipients with known effect: lactose monohydrate and sodium.

Indication: Apollo is indicated for adult men with erectile dysfunction (the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance); sexual stimulation is required for it to be effective.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Consistent with the known effects of sildenafil on the nitric oxide/cGMP pathway (see section 5.1), sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its concomitant administration with nitric oxide donors (such as amyl nitrite) or any form of nitrates is therefore contraindicated. Concomitant use of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated because it may cause symptomatic hypotension (see section 4.5). Medicinal products for the treatment of erectile dysfunction, including sildenafil, should not be given to men for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as unstable angina or severe heart failure). Apollo is contraindicated in patients who have experienced loss of vision in one eye due to non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was or was not related to previous PDE5 inhibitor exposure. The safety of sildenafil treatment has not been studied in the following patient subgroups and its use is therefore contraindicated in these cases: - severe hepatic impairment, - hypotension (blood pressure < 90/50 mmHg), - recent personal history of stroke or myocardial infarction, - known hereditary degenerative retinal disorders such as retinitis pigmentosa (a small percentage of these patients have genetic disorders of retinal phosphodiesterases).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
Before recommending treatment, a personal medical history should be taken and a physical examination performed to diagnose erectile dysfunction and identify potential causative factors.
Cardiovascular risk factors
Before initiating any treatment for erectile dysfunction, the physician should assess the cardiovascular status of the patient, since there is a degree of cardiac risk associated with sexual activity. Sildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure (see section 5.1). Before prescribing sildenafil, physicians should carefully consider whether patients with certain underlying conditions could experience adverse effects due to the vasodilatory effects, particularly in association with sexual activity. Patients with increased sensitivity to vasodilators include those with […]