As there is a monograph of tadalafil in the European Pharmacopoeia, the manufacturer of the active substance has been granted a Certificate of Suitability of the European Pharmacopoeia (CEP) for tadalafil which has been provided within the current Marketing Authorisation Application. Manufacture, characterisation and process controls.

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Vasodilator; a selective phosphodiesterase (PDE) type 5 inhibitor. Uses for Tadalafil Erectile Dysfunction To facilitate attainment of a sexually functional erection in males with erectile dysfunction (ED, impotence). May be used as needed (on demand) or on a daily basis (without regard to timing of sexual activity).

Some experts recommend a selective PDE type 5 inhibitor as first-line therapy for ED unless contraindicated. Evidence currently insufficient to support superiority of one selective PDE type 5 inhibitor over another. Benign Prostatic Hyperplasia Symptomatic management (e.g., to improve lower urinary tract symptoms) of benign prostatic hyperplasia (BPH, benign prostatic hypertrophy). Not recommended for use in combination with an α-adrenergic blocking agent (e.g., doxazosin, terazosin); inadequate data and potential for additive hypotensive effects.

(See Concomitant Administration with α-Adrenergic Blocking Agents under Cautions.) Concomitant ED and BPH Treatment of both ED and symptomatic BPH in men with such coexisting conditions. Pulmonary Arterial Hypertension (PAH) Symptomatic management of PAH (WHO group 1 pulmonary hypertension) to improve exercise capacity. Efficacy established principally in patients with NYHA/WHO functional class II–III PAH (idiopathic, heritable, or associated with connective tissue diseases). Recommended as one of several treatment options for initial management of PAH in patients with NYHA/WHO functional class II, III, or IV symptoms who are not candidates for calcium-channel blocker therapy or in whom such therapy failed. Individualize choice of therapy; consider factors such as disease severity, route of administration, potential adverse effects and costs of treatment, clinician experience, and patient preference. In patients with inadequate response to initial monotherapy, may consider combination therapy with a prostanoid or endothelin-receptor antagonist (added sequentially).

By targeting different pathophysiologic pathways of the disease, such combination therapy may provide additive and/or synergistic benefits. Tadalafil Dosage and Administration Administration Oral Administration Administer orally without regard to meals. May be administered as-needed (just prior to [e.g., ≥0.5 hours before] anticipated sexual activity) or on a daily basis (at approximately the same time every day) for treatment of ED; take entire dose and do not split tablets. Because of prolonged duration of action (up to 36 hours), timing of administration relative to anticipated sexual activity is less important than with relatively short-acting drugs for ED. Administer as a once-daily dose at approximately the same time every day in patients with BPH with or without coexisting ED. When used for the treatment of PAH, administer as a once-daily dosage. Take entire dose at one time and not as divided doses throughout the day.