Basic Information
TADAFIL 20 TADALAFIL TABLETS USP 20 MG
TABLET, FILM COATED
Regulatory Information
SIN16131P
March 23, 2021
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XG04BE08
Company Information
Active Ingredients
Strength: 20.000mg
Detailed Information
Contraindications
**4.3. Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. In clinical studies, 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/cyclic guanosine monophosphate (cGMP) pathway. Therefore, administration of Tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated: - 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 phosphodiesterase type 5 (PDE5) inhibitor exposure (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 (see Section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Indication Information
**4.1. Therapeutic indications** Treatment of erectile dysfunction (ED) in adult males. In order for tadalafil to be effective for the treatment of ED, sexual stimulation is required. Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). If Tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks. Treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED/BPH). Tadalafil is not indicated for use by women.