Pharmacology: TALEGRIA Tablets

Film-Coated Tablets

• TALEGRIA 5: Yellow coloured, oval shape, biconvex with bevelled edge, film-coated tablets debossed “897” on one side and plain on the other side.
• TALEGRIA 20: Yellow coloured, oval shape, biconvex with bevelled edge, film-coated tablets debossed “899” on one side and plain on the other side.

Therapeutic Indications

• TALEGRIA is indicated for the treatment of erectile dysfunction.
• Sexual stimulation is required for TALEGRIA to be effective.

Posology and Method of Administration

• The recommended dose is 5 mg taken once a day at approximately the same time of day.
• The recommended maximum dose of TALEGRIA is 20 mg taken prior to anticipated sexual activity and without regard to food.
• TALEGRIA 20 mg can be taken up to 36 hours and as early as 16 minutes prior to sexual activity.
• Patients may initiate sexual activity at varying time points relative to dosing in order to determine their own optimal window of responsiveness.
• The maximum recommended dosing frequency of TALEGRIA is once per day.

Special Populations

• Dosage adjustments are not required in patients with mild or moderate renal impairment.
• Once-daily dosing of TALEGRIA is not recommended in patients with severe renal impairment.
• TALEGRIA is not indicated for children under 18 years.

Contraindications

• Hypersensitivity to the active substance, tadalafil, or to any of the excipients of TALEGRIA.
• Administration of TALEGRIA to patients who are using any form of organic nitrate.
• Patients with severe hepatic insufficiency (Child-Pugh Class C).
• Previous experience of loss of vision in one or both eyes because of non-arteritic anterior ischaemic optic neuropathy (NAION).
• Previous experience of unilateral or bilateral decrease or loss of hearing with or without associated vestibular symptoms.

Special Warnings and Precautions for Use

• A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes.
• Sexual activity carries a potential cardiac risk for patients with pre-existing cardiovascular disease.
• Prior to initiating any treatment for erectile dysfunction, medical practitioners should consider the cardiovascular status of their patients.
• Tadalifil has vasodilator properties, resulting in mild and transient decreases in blood pressure.
• TALEGRIA should not be used in men with cardiac disease for whom sexual activity is inadvisable.
• It is not known if tadalafil is effective in patients who have undergone pelvic surgery or radical non nerve-sparing prostatectomy.