CILATIL

What it is

CILATIL contains tadalafil in strengths of 2.5 mg, 5 mg, 10 mg or 20 mg per tablet. The tablets are yellow or light yellow film-coated, oval-shaped, biconvex tablets for oral administration.

Approved indications CILATIL is indicated for the treatment of:

— Erectile dysfunction in adult males — Moderate to severe lower urinary tract symptoms associated with benign prostatic hyperplasia in adult males

Dosing overview

CILATIL can be taken with or without food. The medicine has been shown to be effective up to 36 hours after dosing and in some patients as early as 16 minutes after dosing.

Key safety warnings

CILATIL must not be used concomitantly with nitrates or nitric oxide donors. Drugs which must not be used include glyceryl trinitrate (injection, tablets, sprays or patches), isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates in any form. If nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours in most patients and 4–5 days in elderly patients should have elapsed after the last dose of CILATIL before nitrate administration is considered. Nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring. CILATIL has systemic vasodilatory properties that may result in mild and transient decreases in blood pressure. Physicians should carefully consider whether patients with underlying cardiovascular disease could be affected adversely by these vasodilatory effects. Caution should be exercised when prescribing CILATIL to patients taking alpha-blockers such as doxazosin, as simultaneous administration may lead to symptomatic hypotension in some patients. Physicians should advise patients to stop taking CILATIL and seek prompt medical attention in the event of sudden decrease or loss of hearing, which may be accompanied by tinnitus. Visual defects including central serous chorioretinopathy have been reported in connection with CILATIL use; most cases resolved spontaneously after stopping the medicine. Patients should seek medical attention in the event of sudden visual defect, visual acuity impairment, visual distortion and/or loss of vision in one or both eyes. Priapism has been reported with CILATIL. Patients who experience erections lasting 4 hours or more should seek immediate medical assistance, as untreated priapism may result in penile tissue damage and permanent loss of potency.

Contraindications

CILATIL must not be used concomitantly with nitrates or nitric oxide donors. CILATIL is contraindicated in men for whom sexual intercourse is inadvisable due to unstable cardiovascular disease, such as patients with unstable angina and severe congestive heart failure. CILATIL is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy, regardless of whether this episode was in connection with previous phosphodiesterase type 5 inhibitor exposure. CILATIL is contraindicated in patients with: myocardial infarction within the last 90 days; unstable angina or angina occurring during sexual intercourse; New York Heart Association Class 2 or greater heart failure in the last 6 months; uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension; or stroke within the last 6 months. CILATIL should not be used in patients with a known hypersensitivity to tadalafil or to any ingredient of the tablet. CILATIL is contraindicated in combination with guanylate cyclase stimulators such as riociguat.

PBS listing

No PBS listing information is available in the provided source documents.

Regulatory history

CILATIL tadalafil tablets were registered on the ARTG on 3 February 2021, with six registered variants at strengths of 2.5 mg, 5 mg, 10 mg and 20 mg in both blister pack and bottle presentations.