TADALAFIL SANDOZ PHARMA

What it is

TADALAFIL — REDDY'S is available in strengths of 2.5 mg, 5 mg, 10 mg or 20 mg tadalafil per tablet. The tablets are yellow or light yellow to yellow coloured, film coated, oval shaped, biconvex tablets for oral administration. TADALAFIL — REDDY'S is for oral use and can be taken with or without food.

Approved indications TADALAFIL — REDDY'S is indicated for the treatment of:

— 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

For erectile dysfunction with on-demand dosing, the recommended dose of tadalafil is either 10 mg or 20 mg, taken prior to anticipated sexual activity, with a maximum recommended dose of 20 mg and maximum dosing frequency of once per day. Tadalafil has been proven effective up to 36 hours after dosing and, in some patients, as early as 16 minutes after dosing. For patients anticipating frequent use of tadalafil (at least twice weekly), the recommended dose is 5 mg taken once a day at approximately the same time of day, and the dose must not exceed 5 mg daily. The dose may be decreased to 2.5 mg once a day based on individual tolerability. For lower urinary tract symptoms associated with benign prostatic hyperplasia, the recommended dose is 5 mg, taken at approximately the same time every day. For adult men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia, the recommended dose is 5 mg taken at approximately the same time every day.

Key safety warnings

As with other PDE5 inhibitors, tadalafil has systemic vasodilatory properties that may result in mild and transient decreases in blood pressure, and physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by these vasodilatory effects. Caution should be exercised when prescribing tadalafil to patients who are taking alpha blockers, such as doxazosin, as simultaneous administration may lead to symptomatic hypotension in some patients. Physicians should advise patients to stop taking PDE5 inhibitors, including tadalafil, and seek prompt medical attention in the event of sudden decrease or loss of hearing, which may be accompanied by tinnitus. Physicians should advise patients to stop use of all PDE5 inhibitors, including tadalafil, and seek medical attention in the event of a sudden visual defect, visual acuity impairment, visual distortion and/or loss of vision in one or both eyes, as this may be a sign of non-arteritic anterior ischaemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision. 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, as if priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

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. 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). 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 are 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; and patients with a stroke within the last 6 months. 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

TADALAFIL — REDDY'S was first registered on the Australian Register of Therapeutic Goods on 7 June 2018, with variant registrations for 2.5 mg, 5 mg, 10 mg and 20 mg strengths.