Posology : מינונים

3.1 Posology and method of administration
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.

Posology

The recommended dose is 40 mg (2 x 20 mg) taken once daily with or without food.
Elderly patients

Dose adjustments are not required in elderly patients.

Renal impairment
In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommended. The dose may be increased to 40 mg once per day, based on individual efficacy and tolerability. In patients with severe renal impairment the use of tadalafil is not recommended (see sections 3.3 and 4.2).

Hepatic impairment

Due to limited 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 considered. If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil is not recommended (see sections 3.3 and 4.2).

Paediatric population

The safety and efficacy of TADAIR in the paediatric population has not yet been established.
Currently available data are described in section 4.1.
Method of administration

TADAIR is for oral use.