Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108, Freiburg, Germany
The recommended daily dose is three capsules once daily in the morning or one capsule (containing 3 mg budesonide) three times daily (morning, midday and evening; corresponding to a total daily dose of 9 mg budesonide) if this is more convenient to the patient.
The recommended dose is three capsules once daily in the morning (corresponding to a daily dose of 9 mg budesonide).
For the induction of remission (i.e. normalisation of elevated laboratory parameters) the recommended daily dose is one capsule (containing 3 mg budesonide) three times daily (morning, midday and evening; corresponding to a total daily dose of 9 mg budesonide).
After achievement of remission the recommended daily dose is one capsule (containing 3 mg budesonide) twice daily (one capsule in the morning and one capsule in the evening; corresponding to a total daily dose of 6 mg budesonide).
If the transaminases ALAT and/or ASAT increase during maintenance treatment, the dose should be increased to 3 capsules per day (corresponding to a total daily dose of 9 mg budesonide) as described for induction of remission.
In patients tolerant to azathioprine, treatment for induction and maintenance of remission with budesonide should be combined with azathioprine.
Budenofalk 3mg should not be taken by children younger than 12 years due to insufficient experience and possibly increased risk of adrenal suppression in this age group.
The safety and efficacy of Budenofalk 3mg in children aged 12 to 18 years have not yet been established. Currently available data in adolescent patients (12–18 years) with Crohn’s disease or autoimmune hepatitis are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
The capsules containing the gastro-resistant granules should be taken about half an hour before meals, swallowed whole with plenty of fluid (e.g. a glass of water).
The duration of treatment in active Crohn’s Disease and in collagenous colitis should be limited to 8 weeks.
For the induction of remission, a total daily dose of 9 mg should be given until remission is achieved. Thereafter, for maintenance of remission a total daily dose of 6 mg budesonide should be given. Treatment for maintenance of remission in autoimmune hepatitis should be continued at least for 24 months. It might beterminated only if biochemical remission is constantly maintained and if no signs of inflammation are present in a liver biopsy.
The treatment with Budenofalk 3mg should not be stopped abruptly, but withdrawn gradually (tapering doses). In the first week, the dosage should be reduced to two capsules daily, one in the morning, one in the evening. In the second week, only one capsule should be taken in the morning. Afterwards treatment can be stopped.
To date, no cases of overdose with budesonide are known.
3 years.
This medicinal product does not require any special storage conditions.
Al/PVC/PVDC blister strips.
Pack sizes: 10, 50, 90, 100 or 120 capsules.
Not all pack sizes may be marketed.
No special requirements.
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