Torfil 2.5: It is contraindicated in patients with known hypersensitivity to Tadalafil and to any of its excipients. Administration of Tadalafil is also contraindicated in patients who are taking any form of organic nitrates as it is known to increase the hypotensive effects of the nitrate.
Tadalafil is not recommended for concomitant use with guanylate cyclase (GC) stimulator due to potentiation of the hypotensive effects of GC stimulator.
Torfil 5: Administration of tadalafil to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates. Tadalafil is contraindicated in patients with a known serious hypersensitivity to tadalafil. Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis. Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including tadalafil tablets, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for tadalafil tablets, and therefore until further information is available, tadalafil tablets are not recommended for the following groups of patients: myocardial infarction within the last 90 days; unstable angina or angina occurring during sexual intercourse; New York Heart Association Class 2 or greater heart failure in the last 6 months uncontrolled arrhythmias, hypotension (<90/50 mmHg), or uncontrolled hypertension; stroke within the last 6 months.
Tadalafil is contraindicated in patients who have loss of vison in one eye because of non-arteritic ischemic neuropathy (NAION), regardless whether this episode was in connection or not with previous PDE5 inhibitor exposure.
Torfil 10/Torfil 20: It is contraindicated in patients with known hypersensitivity to Tadalafil and to any of its excipients. Administration of Tadalafil is also contraindicated in patients who are taking any form of organic nitrates as it is known to increase the hypotensive effects of the nitrate.
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