CIDALA

What it is

CIDALA contains tadalafil 2.5 mg, 5 mg, 10 mg or 20 mg per tablet. The tablets are yellow film-coated, oval-shaped, biconvex tablets for oral administration. The tablets contain lactose as an ingredient with known effects.

Approved indications

CIDALA 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

For erectile dysfunction on-demand dosing, the recommended dose 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. CIDALA 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 CIDALA (at least twice weekly), the recommended dose is 5 mg taken once a day at approximately the same time of day, with a maximum of 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 patients with both 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

Nitrates and CIDALA must not be used concomitantly, including glyceryl trinitrate, isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates in any form. Patients should stop taking CIDALA 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 the intake of CIDALA and other PDE5 inhibitors, with most cases resolving spontaneously after stopping the medicine. Patients should stop use of CIDALA 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 such an event may be a sign of non-arteritic anterior ischaemic optic neuropathy, which has been reported rarely postmarketing. Priapism has been reported with CIDALA, and 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

CIDALA 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. CIDALA 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 or not with previous PDE5 inhibitor exposure. CIDALA is contraindicated in the following groups of patients with cardiovascular disease: 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 (less than 90/50 mm Hg), or uncontrolled hypertension; and patients with a stroke within the last 6 months. CIDALA should not be used in patients with a known hypersensitivity to tadalafil or to any ingredient of the tablet. The combination of CIDALA and guanylate cyclase stimulators, such as riociguat, is contraindicated because it may lead to symptomatic hypotension.

Regulatory history

CIDALA tadalafil tablets in strengths of 2.5 mg, 5 mg, 10 mg and 20 mg were first listed on the ARTG on 26 May 2017.