- Treatment of erectile dysfunction in adult males. Tadalafil is effective only in the presence of adequate sexual stimulation.
- Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.
Erectile dysfunction in adult males
- The usual daily dose is 10 mg at least 30 minutes before sexual intercourse, may be increased to 20 mg. The maximum dose is frequency is once per day.
- Doses of 10 mg and 20 mg are intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.
- In patients who anticipate a frequent use of tadalafil (at least twice weekly), a once daily regimen with the lowest doses might be considered suitable. The recommended dose is 5 mg taken once a day, may be decreased to 2.5 mg once a day.
- The appropriateness of continued use of daily regimen should be reassessed periodically.
Benign prostatic hyperplasia in adult males
- The recommended dose is 5 mg, taken at approximately the same time every day.
Elderly patients, patients with mild to moderate renal impairment, patients with diabetes
- Dose adjustment is not required.
Patients with severe renal impairment
- 10 mg is the maximum recommended dose. Once-a-day dosing of 2.5 or 5 mg is not recommended.
Patients with hepatic impairment
- The recommended dose is 10 mg taken prior to anticipated sexual activity.
- There is no relevant use in paediatric population.
Tadalafil STELLA 5 mg is administered orally without regard to meals.