Excipient(s) with known effect: Lactose. Indications. Treatment of erectile dysfunction in adult males. Treatment of the signs and symptoms of benign prostatic hyperplasia in adult men. Posology. Erectile disorders in adult men. 10 mg taken prior to anticipated sexual activity. In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use. In these patients the recommended dose is 5 mg once a day at approximately the same time of day. The dose may be decreased to 2.5 mg once a day based on individual tolerability. Benign prostatic hyperplasia in adult men. The recommended dose is 5 mg. For adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the recommended dose is also 5 mg taken at approximately the same time every day. Elderly. Dose adjustments are not required. Renal impairment. Dose adjustments are not required in patients with mild to moderate. Hepatic insufficiency. There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment. Dose adjustments are not required in diabetic patients. There is no relevant use of tadalafil in the paediatric population. Contraindications. Hypersensitivity to the active substance or to any of the excipients. Administration of tadalafil to patients who are using any form of organic nitrate is contraindicated. Must not be used in men with cardiac disease for whom sexual activity is inadvisable. 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 mm Hg), 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. Precautions for use. Consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Prior to initiating treatment with tadalafil for benign prostatic hyperplasia patients should be examined to rule out the presence of carcinoma of the prostate and carefully assessed for cardiovascular conditions. It is not known if tadalafil is effective in patients who have undergone pelvic surgery or radical non-nervesparing prostatectomy. Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials. In patients receiving concomitant antihypertensive medicinal products, tadalafil may induce a blood pressure decrease. In patients who are taking alpha1 blockers, concomitant administration of tadalafil may lead to symptomatic hypotension in some patients. Visual defects and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors. Cases of sudden hearing loss have been reported after the use of tadalafil. Once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment. There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency. Should be used with caution in patients with anatomical deformation of the penis. Caution should be exercised when prescribing tadalafil to patients using potent CYP3A4 inhibitors. The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. As a precautionary measure, it is preferable to avoid the use of tadalafil during pregnancy. Tadalafil should not be used during breast-feeding. Adverse Events. Headache. Flushin. Nasal Congestion. Dyspepsia. Back pain, myalgia, pain in extremity. CDS_v03, November 2017.