Compositon/Ingredients: Tadalafil

Used in the management of erectile dysfunction. Tadalafil is effective only in the presence of adequate sexual stimulation.

• Concomitant use of organic nitrates or nitrites, either regularly and/or intermittently.
• Known hypersensitivity to tadalafil or to any of the ingredients.

Usual dose: 10 mg at least 30 minutes before sexual intercourse. The daily dose may be increased to 20 mg or decreased to 5 mg, if necessary. Efficacy may persist for up to 36 hours after dosing. The maximum recommended dosing frequency is once daily and discourage continuous daily use.

Elderly patients: Dosage adjustments are not necessary.

Hepatic impairment mild to moderate: Maximum dose is 10 mg once daily; severe: Not recommended.

Renal impairment:

• ClCr = 31 – 50 ml/minute: Initial with 5 mg, once daily, and maximum dosage is 10 mg no more than once every 48 hours.
• ClCr < 30 ml/minute, including those undergoing hemodialysis: Maximum dosage is 5 mg, once daily.

In patients stabilized on alpha blocker therapy, a starting dose 5 mg may be used.

In patients taking potent inhibitors of the CYP3A4, the dose should not exceed 10 mg once every 72 hours.

• It is necessary to assess the cardiovascular status of the patient prior to initiating tadalafil therapy. Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported.
• Use of tadalafil currently is not recommended in patients with hereditary degenerative retinal disorders, including retinitis pigmentosa.
• Use with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie’s disease) and with conditions that may predispose to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).
• Combined use of tadalafil and other therapies for erectile dysfunction currently is not recommended.
• The drug is not indicated for use in children, neonates and women.
• Patients should be aware of how they react to tadalafil before driving or operating machinery.

Store at temperature below 30°C, protect from light.