Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Treatment with Budeson results in lower systemic steroid levels than conventional oral glucocorticosteroid therapy. Transfer from other glucocorticosteroid therapy may result in symptoms relating to the change in systemic steroid levels.

Caution is required in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes, family history of glaucoma, or any other condition in which glucocorticosteroids may have undesirable effects.

This medicine is not appropriate for patients suffering from Crohn's disease of the upper gastrointestinal tract.

Due to the preferential local mode of action of the compound beneficial effects for patients suffering from extraintestinal symptoms (e.g. of the eyes, skin, joints) cannot be expected.

Systemic effects of glucocorticosteroids may occur, particularly when prescribed at high doses and for prolonged periods. Such effects may include Cushing’s syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and a wide range of psychiatric/behavioural effects (see section 4.8).

Infection
Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The risk of deterioration of bacterial, fungal, amoebic and viral infections during glucocorticosteroid treatment should be carefully considered. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked, and therefore may reach an advanced stage before being recognised.


Chickenpox
Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention. If the patient is a child, parents must be given the above advice. Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic glucocorticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment.
Glucocorticosteroids should not be stopped and the dose may need to be increased.

Measles
Patients with compromised immunity who have come into contact with measles should, wherever possible, receive normal immunoglobulin as soon as possible after exposure.

Vaccines
Live vaccines should not be given to individuals with chronic glucocorticosteroid use.
The antibody response to other vaccines may be diminished.

Patients with liver function disorders

Based on the experience with patients suffering from late stage primary biliary cirrhosis (PBC) with hepatic cirrhosis, an increased systemic availability of budesonide in all patients with severely impaired hepatic function is to be expected.

However, in patients with liver disease without hepatic cirrhosis, budesonide in daily doses of 9 mg was safe and well tolerated. There is no evidence that a specific dose recommendation for patients with non-cirrhotic liver diseases or only slightly impaired liver function is necessary.

Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Others
Glucocorticosteroids may cause suppression of the hypothalamic-pituitary-adrenal (HPA) axis and reduce the stress response. When patients are subject to surgery or other stresses, supplementary systemic glucocorticosteroid treatment is recommended.

Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided (see section 4.5).

Budeson capsules contain lactose and sucrose. Patients with rare hereditary problems of galactose or fructose intolerance, glucose-galactose malabsorption, sucrase - isomaltase insufficiency, the Lapp lactase deficiency or the congenital lactase deficiency should not take this medicine.

In patients with autoimmune hepatitis, serum levels of transaminases (ALAT, ASAT) should be evaluated at regular intervals to adapt the dose of budesonide adequately.
During the first month of treatment, transaminase levels should be evaluated every two weeks, thereafter at least every 3 months.

Effects on Driving

4.7   Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.