Atlantic Pharma Produções Farmacêuticas S.A. – Portugal

TV Pharmaceutical Trade Promotion and Investment Co., Ltd.

Tadalafil

10 mg

36 months

Film-coated tablets

Box of 1 blister x 4 tablets

560110067526

May 29, 2026

May 29, 2031

Selective phosphodiesterase type 5 (PDE5) inhibitors

- Treatment of erectile dysfunction in adult males. Sexual stimulation is required for tadalafil to be effective.
- Cidafil 10 is not indicated for use by women.

Erectile dysfunction in adult males:
- The recommended dose is 10 mg, taken prior to anticipated sexual activity, with or without food.
- In patients in whom tadalafil 10 mg does not produce an adequate effect, a 20 mg dose may be tried. It should be taken at least 30 minutes prior to sexual activity.
- The maximum dosing frequency is once daily.
- Tadalafil 10 mg and 20 mg are intended for use prior to anticipated sexual activity and are not recommended for continuous daily use.
- In patients who anticipate frequent use of tadalafil (i.e., at least twice weekly), a once-daily regimen with the lowest dose of tadalafil may be considered appropriate, depending on patient choice and the physician's evaluation. In these patients, the recommended dose is 5 mg taken once daily at approximately the same time each day. The dose may be decreased to 2.5 mg once daily based on individual tolerability.
- The appropriateness of continued use of the daily regimen should be reassessed periodically.
Special Populations:
- Elderly Patients: No dose adjustment is required in elderly patients.
- Renal Impairment: No dose adjustment is required in patients with mild to moderate renal impairment. For patients with severe renal impairment, 10 mg is the maximum recommended dose for on-demand treatment. Once-daily dosing of 2.5 mg or 5 mg tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended in patients with severe renal impairment (see Special Warnings and Precautions for Use and Pharmacokinetic Properties).
- Hepatic Impairment: For the on-demand treatment of erectile dysfunction, the recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity, with or without food. There are limited clinical safety data on tadalafil in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/risk assessment must be conducted by the treating physician. No data are available regarding the use of doses higher than 10 mg of tadalafil in patients with hepatic impairment.
A once-daily dosing regimen for both erectile dysfunction and benign prostatic hyperplasia has not been evaluated in patients with hepatic impairment; therefore, if prescribed, the treating physician must conduct a careful individual benefit/risk assessment (see Special Warnings and Precautions for Use and Pharmacokinetic Properties).
- Patients with Diabetes: No dose adjustment is required.
- Pediatric Population: The use of tadalafil is not relevant in the pediatric population for the treatment of erectile dysfunction.