Tadalafil 20 mg film-coated tablets

Each film-coated tablet contains 20 mg tadalafil.

Excipient(s) with known effect:

Lactose (as monohydrate)

Each 20 mg film-coated tablet contains 367.584 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Film-coated tablet.

Yellow, capsule shaped, approximately 14.3 mm in length and 7 mm in width, biconvex, bevelled edged, film coated tablet, debossed with “T 20” on one side and plain on other side.

Treatment of erectile dysfunction in adult males.

In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is require.

It is indicate in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).

Efficacy has been show in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

Posology

Erectile dysfunction in adult Men

In general, the recommend dose is 10 mg take 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 trie. It may be take at least 30 minutes prior to sexual activity.

The maximum dose frequency is once per day.

Tadalafil 10 mg and 20 mg is intend for use prior to anticipated sexual activity and it is not recommend for continuous daily use.

In patients who anticipate a frequent use of Tadalafil (i.e., at least twice weekly) a once daily regimen with the lowest doses of Tadalafil tablets might be consider suitable, based on patient choice and the physician’s judgement.

In these patients, the recommend dose is 5 mg take once a day at approximately the same time of day. The dose may be decrease to 2.5 mg once a day base on individual tolerability.

The appropriateness of continue use of the daily regimen should be reassesse periodically.

Pulmonary arterial hypertension

Treatment should only be initiate and monitore by a physician experience in the treatment of PAH.

Posology

The recommend dose is 40 mg (2 x 20 mg) take once daily with or without food.

Special Populations

Elderly patients

Dose adjustments are not require in elderly patients.

Renal Impairment

Adult men with erectile dysfunction: Dose adjustments are not require in patients with mild to moderate renal impairment. For patients with severe renal impairment, 10 mg is the maximum recommend dose for on-demand treatment.

Once-a-day dosing of tadalafil is not recommend in patients with severe renal impairment. (See sections 4.4 and 5.2.)

Pulmonary arterial hypertension: In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommend. The dose may be increase to 40 mg once per day, base on individual efficacy and tolerability. In patients with severe renal impairment the use of tadalafil is not recommend. (see sections 4.4 and 5.2).

Hepatic Impairment

Adult men with erectile dysfunction: For the treatment of erectile dysfunction using on-demand Tadalafil the recommend dose of tadalafil is 10 mg taken prior to anticipate sexual activity and with or without food. There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh class C); if prescribed, a careful individual benefit/risk evaluation should be undertake 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 tadalafil for the treatment of erectile dysfunction has not been evaluate in patients with hepatic impairment; therefore if prescribed, a careful individual benefit/risk evaluation must be undertake by the prescribing physician. (See sections 4.4 and 5.2.)

Pulmonary arterial hypertension: Due to limite clinical experience in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B), following single doses of 10 mg, a starting dose of 20 mg once per day may be considere. If tadalafil is prescribe, a careful individual benefit/risk evaluation should be undertake by the prescribing physician. Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil is not recommend. (see sections 4.4 and 5.2).

Men with Diabetes

Adult men with erectile dysfunction: Dose adjustments are not required in diabetic patients.

Paediatric population

There is no relevant use of Tadalafil in the paediatric population with regard to the treatment of erectile dysfunction.

The safety and efficacy of tadalafil in the paediatric population has not yet been established. Currently available data are described in section 5.1.

Method of administration

Tablets for oral use.