BUDESONIDE CR

Posology Adults Active Crohn’s disease:

The recommended daily dose for induction of remission is 9 mg once daily in the morning, for up to eight weeks. The full effect is usually achieved within 2–4 weeks. When treatment is to be discontinued, the dose should normally be reduced for the last 2 to 4 weeks of therapy.

Active Microscopic colitis:

The recommended dose is 9 mg once daily in the morning (corresponding to 3 capsules).

Maintenance of Microscopic colitis:

The recommended dose is 6 mg once daily in the morning (corresponding to 2 capsules), or the lowest effective dose. 2). The available data are insufficient to support safety and efficacy in the paediatric population, therefore such use cannot be recommended until further data become available.

Older people No special dose adjustment is recommended. However, experience with Budesonide CR Capsules in older people is limited. Method of administration The capsules should be swallowed whole with water. The capsules must not be chewed.

Tabulated list of adverse events The following definitions apply to the incidence of undesirable effects: Very Common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very Rare (< 1/10,000); Not Known (cannot estimate from the available data).

4) Cardiac disorders Common Palpitations Gastrointestinal disorders Common Dyspepsia Skin and subcutaneous tissue disorders Common Skin reactions (urticaria, exanthema) Rare Ecchymosis SOC Frequency Reaction Musculoskeletal and connective tissue disorders Common Muscle cramps Reproductive system and breast disorders Common Menstrual disorders Most of the adverse events mentioned in this SmPC can also be expected for other treatments with glucocorticoids.

g. cushingoid features and growth retardation) may occur. These side effects are dependent on dose, treatment time, concomitant and previous corticosteroid intake, and individual sensitivity. In clinical studies, at recommended doses, the incidence of adverse events was comparable to placebo.

Clinical studies showed the frequency of steroid associated side effects for Budesonide CR Capsules to be approximately half that of conventional prednisolone treatment, at equipotent doses. In studies of patients with active disease, receiving Budesonide 9 mg daily, the incidence of adverse events was comparable to placebo.

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk or search for MHRA Yellow Card in the Google Play or Apple App Store.

Side effects typical of systemic corticosteroids may occur. Potential systemic effects include glaucoma. 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.

Use 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 glucocorticosteroids may have unwanted effects.

Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.

Systemic effects of steroids may occur, particularly when prescribed at high doses and for prolonged periods. 8). Treatment with Budesonide CR Capsules results in lower systemic steroid levels than conventional oral glucocorticosteroid therapy.

When patients are transferred from systemic glucocorticosteroid treatment with higher systemic effect to Budesonide CR Capsules, they may have adrenocortical suppression. Therefore, monitoring of adrenocortical function may be considered in these patients and their dose of systemic steroid should be reduced cautiously.

g. rhinitis and eczema, which were previously controlled by the systemic drug. Chicken pox and measles can have a more serious course in patients on oral glucocorticosteroids. 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 glucocortiocosteriods treatment and immediately consult a physician. Glucocorticosteroids may cause suppression of the hypothalamus-pituitary-adrenal (HPA) axis and reduce the stress response.

Where patients are subject to surgery or other stress situations, supplementary systemic glucocorticoid treatment is recommended. Reduced liver function may affect the elimination of glucocorticosteroids, causing lower elimination rate and higher systemic exposure.

Be aware of possible systemic side effects. The pharmacokinetics after oral ingestion of budesonide was affected by compromised liver function as evidenced by increased systemic availability in patients with moderately severe hepatic cirrhosis.

When treatment is to be discontinued, the dose should normally be reduced for the last 2 to 4 weeks of therapy. g. pain in muscles and joints. A general insufficient glucocorticosteroid 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 glucocorticosteroids is sometimes necessary. Co-treatment with CYP3A inhibitors, including ketoconazole and cobicistat- containing products, is expected to increase the risk of systemic side-effects.

The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. 5). After extensive intake of grapefruit juice (which inhibits CYP3A4 activity predominantly in the intestinal mucosa), the systemic exposure for oral budesonide increased about two times.

As with other drugs primarily metabolised through CYP3A4, regular ingestion of grapefruit or its juice, should be avoided in connection with Budesonide CR Capsules administration (other juices such as orange juice or apple juice do not inhibit CYP3A4).

See also Section

1.