Posology : מינונים

4.2   Posology and method of administration

Posology
The recommended dose is one tablet of 500 micrograms roflumilast once daily.
Daliresp may need to be taken for several weeks to achieve its full effect (see section 5.1 and 5.2).
Daliresp has been studied in clinical trials for up to one year, and is intended for maintenance treatment.

Special populations

Elderly (65 years and older)
No dose adjustment is necessary.
Renal impairment
No dose adjustment is necessary.

Hepatic impairment
The clinical data with Daliresp in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Daliresp should be used with caution in these patients.
Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Daliresp (see section 4.3).

Paediatric population
There is no relevant use of Daliresp in the paediatric population (under 18 years) in the indication of COPD.

Method of administration
For oral use.
The tablet should be swallowed with water and taken at the same time every day. The tablet can be taken with or without food.