Posology : מינונים

4.2 Posology and method of administration
Posology

Crohn’s disease and collagenous colitis

Adults aged > 18 years
The recommended daily dose is one sachet (containing gastro-resistant granules with 9mg budesonide) once daily in the morning about a half hour before breakfast.
Paediatric population
Budeson should not be taken by children and adolescents due to insufficient experience in this age group.

Patients with renal impairment
There are no specific dosage recommendations for patients with renal insufficiency (see section 5.2).

Patients with hepatic impairment
Since the information is limited in this patient-population a specific dose recommendation cannot be made (see sections 4.3, 4.4 and 5.2).
Method of administration

Oral use

The content of one sachet should be taken before breakfast. The granules should be placed on the tongue and swallowed whole, with plenty of liquid (e.g. a glass of water). The granules should not be chewed or crushed to avoid destruction of the gastro-resistant coating of the granules. Premature disintegration will affect drug disposition in an unpredictable fashion.

Duration of treatment
The duration of treatment should be limited to 8 weeks.

Termination of treatment
The treatment with Budeson 9 mg Granules should not be stopped abruptly. At the end of the treatment, Budeson 9 mg Granules should be given in prolonged dosing intervals, i.e. every other day for up to two weeks. Afterwards treatment can be stopped.