Special Warning : אזהרת שימוש

4.4.        Special warnings and precautions for use
Cortiment tablets should be used with caution in patients with infections, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts or with a family history of diabetes or glaucoma or with any other condition where the use of glucocorticoids may have unwanted effects.
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.
Reduced liver function may affect the elimination of glucocorticoids including budesonide, causing higher systemic exposure. Be aware of possible systemic side effects. Potential systemic effects include glaucoma.
When treatment is to be discontinued, it may be useful to gradually reduce the dose at the discretion of the treating physician.
Treatment with Cortiment tablets results in lower systemic steroid levels than conventional oral glucocorticoid therapy. Transfer from other steroid therapy may result in symptoms relating to the change in systemic steroid levels. Some patients may feel unwell in a non-specific way during the withdrawal phase, e.g., pain in muscles and joints. A general insufficient corticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase in the dose of systemic corticosteroids is sometimes necessary.
As corticosteroids are known to have immunological effects the co-administration of Cortiment tablets is likely to reduce the immune response to vaccines.
Concomitant administration of ketoconazole or other potent CYP3A4 inhibitors should be avoided. If this is not possible, the period between treatments should be as long as possible and a reduction of the Cortiment dose could also be considered (see also section 4.5). Following significant intake of grapefruit juice (which inhibits CYP3A4 activity predominantly in the intestinal mucosa), the systemic exposure for oral budesonide increased by approximately twofold. As with other drugs primarily being metabolised through CYP3A4, regular ingestion of grapefruit or grapefruit juice simultaneously with budesonide administration should be avoided (other juices such as orange juice or apple juice do not inhibit CYP3A4 activity). See also section 4.5.
Cortiment tablets contains lecithin (soya oil). If a patient is hypersensitive to peanut or soya, this medicine should not be used.
Cortiment tablets contain lactose monohydrate and should not be taken by patients with rare hereditary problems such as galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
The following warnings and precautions have been generally identified for corticosteroids:
 systemic corticosteroid treatment with higher systemic effect.
 susceptibility to infections.
Corticosteroids may cause suppression of the HPA axis and reduce the stress response. Where patients are subject to surgery or other stresses, supplementary systemic corticosteroid treatment is recommended.
 rious course in patients on oral glucocorticoids. Particular care should be taken to avoid exposure in patients who have not previously had these diseases. If patients are infected or suspected of being infected, consider reduction or discontinuation of glucocortiocosteriod treatment at the discretion of the treating physician.
 doses and for prolonged periods. Such effects may include Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and very rarely a wide range of psychiatric/behavioral effects (see section 4.8).
 in patients with current or previous history of severe affective disorders in the patient or any first degree relatives.
 unmasks allergies, e.g. rhinitis and eczema that were previously controlled by the systemic drug.


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