Components:
Tadalafil
Method of action:
Improves Erectile Function, Urologicals
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 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 Afilta (i.e., at least twice weekly) a once daily regimen with the lowest doses of Afilta might be considered suitable, based on patient choice and the physician's judgement.
In these patients, the recommended dose is 5mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5mg once a day based on individual tolerability.
The appropriateness of continued use of the daily regimen should be reassessed periodically.
Benign prostatic hyperplasia in adult men (tadalafil 5 mg only)
The recommended dose is 5 mg, taken at approximately the same time every day with or without food. For adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the recommended dose is also 5 mg taken at approximately the same time every day. Patients who are unable to tolerate tadalafil 5 mg for the treatment of benign prostatic hyperplasia should consider an alternative therapy as the efficacy of tadalafil 2.5 mg for the treatment of benign prostatic hyperplasia has not been demonstrated.
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.
Once-a-day dosing of 2.5 or 5 mg tadalafil both for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended in patients with severe renal impairment.
Men with Hepatic Impairment
For the treatment of erectile dysfunction using on-demand Afilta the recommended dose of Afilta is 10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on the safety of Afilta 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 10mg of tadalafil to patients with hepatic impairment.
Once-a-day dosing both for the treatment of erectile dysfunction and benign prostatic hyperplasia 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 Afilta in the paediatric population with regard to the treatment of erectile dysfunction.
Method of administration
Afilta is available as 2.5, 5, 10, and 20 mg film-coated tablets for oral use.
Posology
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 Afilta 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.
Afilta 10 mg and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.
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 Afilta is not recommended in patients with severe renal impairment.
Men with Hepatic Impairment
For the treatment of erectile dysfunction using on-demand Afilta the recommended dose of Afilta is 10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on the safety of Afilta 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 Afilta to patients with hepatic impairment.
Once-a-day dosing of Afilta for the treatment of erectile dysfunction has not been evaluated in patients with hepatic impairment; therefore if prescribed, a careful individual benefit/risk evaluation must 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 Afilta in the paediatric population with regard to the treatment of erectile dysfunction.
Method of administration
Tablets for oral use.
