Posology: Erectile dysfunction in adult men: In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food. In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It may be taken at least 30 minutes prior to sexual activity.
The maximum dose frequency is once per day.
Tadalafil 10 mg and 20 mg is 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 HappiLong (i.e., at least twice weekly) a once daily regimen with the lowest doses of HappiLong might be considered suitable, based on patient choice and the physician's judgement.
In these patient, the recommended dose is 5 mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5 mg* once a day on individual tolerability.
The appropriateness of continued use of the daily regimen should be reassessed periodically.
Special Populations: Elderly Men: Dose adjustments are not required in elderly patients.
Men with Renal Impairment: Dose adjustments are not 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-a-day dosing of 2.5 mg* or 5 mg tadalafil for the treatment of erectile dysfunction is not recommended in patients with severe renal impairment.
Men with Hepatic Impairment: For the treatment of erectile dysfunction using on-demand HappiLong the recommended dose of HappiLong is 10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on the safety of HappiLong in patients with severe hepatic impairment (Child-Pugh class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment. Once-a-day dosing of HappiLong for the treatment of erectile dysfunction has not been evaluated in patients with hepatic impairment; therefore if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Men with Diabetes: Dose adjustments are not required in diabetic patients.
Paediatric population: There is no relevant use of HappiLong in the paediatric population with regard to the treatment of erectile dysfunction.
Method of administration: HappiLong is available as 20 mg film-coated tablet for oral use.
* HappiLong 2.5 mg Tablet is not available.