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Hypersensitivity to the active substance or to any of the excipients.
Tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated.
Tadalafil must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.
The use of tadalafil is therefore contraindicated in the following: Patients with myocardial infarction within the last 90 days; Patients with unstable angina or angina occurring during sexual intercourse; Patients with New York Heart Association Class 2 or greater heart failure in the last 6 months; Patients with uncontrolled arrhythmias, hypotension (<90/50 mmHg), or uncontrolled hypertension; Patients with a stroke within the last 6 months.
Tadalafil 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 co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension.
