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The recommended dose is one tablet of 500 micrograms roflumilast once daily.
Daxas may need to be taken for several weeks to achieve its effect. Daxas has been studied in clinical trials for up to one year.
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 Daxas in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment and therefore Daxas should be used with caution in these patients.
Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C should not take Daxas.
Paediatric population: There is no relevant use of Daxas in the paediatric population (under 18 years).
Mode 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.
