ADIR

What it is

ADIR Tadalafil is available as 2.5 mg, 5 mg, 10 mg or 20 mg tadalafil tablets for oral administration. Tadalafil is a reversible inhibitor of cyclic guanosine monophosphate (cGMP)–specific phosphodiesterase type 5 (PDE5) in the smooth muscle of the corpus cavernosum, the prostate, the bladder and their vascular supply.

Approved indications

— Erectile dysfunction (ED) in adult males. — Moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult males.

Dosing overview

ADIR Tadalafil can be taken with or without food.

Key safety warnings

**Cardiovascular effects.** ADIR Tadalafil has systemic vasodilatory properties that may result in mild and transient decreases in blood pressure. Physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by vasodilatory effects. Physicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and should report the episode to their physician. **Hearing and vision.** Physicians should advise patients to stop taking ADIR Tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing. This may be accompanied by tinnitus, which has been reported in association with the use of PDE5 inhibitors, including tadalafil. Visual defects including central serous chorioretinopathy (CSCR) have been reported in connection with the intake of tadalafil and other PDE5 inhibitors. Most cases of CSCR resolved spontaneously after stopping tadalafil. **Priapism.** Priapism has been reported with PDE5 inhibitors, including tadalafil. Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. **Elderly patients.** In clinical trials with tadalafil 5 mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age. Hypotensive events are a potential risk in patients aged ≥75 years treated with tadalafil 5 mg.

Contraindications

Nitrates and tadalafil must not be used concomitantly. Co-administration of tadalafil with nitric oxide donors, organic nitrates or organic nitrites in any form either regularly or intermittently is contraindicated. ADIR Tadalafil is contraindicated in men for whom sexual intercourse is inadvisable due to unstable cardiovascular disease (for example, patients with unstable angina and severe congestive heart failure). ADIR 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 following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated: patients with a 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. ADIR Tadalafil should not be used in patients with a known hypersensitivity to tadalafil or to any ingredient of the tablet. The combination of tadalafil and guanylate cyclase stimulators, such as riociguat, is contraindicated because it may lead to symptomatic hypotension.

Regulatory history

ADIR Tadalafil 10 mg and 20 mg tablets were first registered on the ARTG on 12 May 2020.