CORTIMENT

Posology Adults Ulcerative colitis and microscopic colitis:

The recommended daily dose for induction of remission is one 9 mg tablet in the morning, for up to 8 weeks. 4). Paediatric population The safety and efficacy of Cortiment tablets in children aged 0-18 years have not yet been established.

No data are available, therefore the use in paediatric population is not recommended until further data become available. Elderly No special dose adjustment is recommended. However, experience of the use of Cortiment in the elderly is limited.

Hepatic and renal impairment population Cortiment 9 mg was not studied in patients with hepatic and renal impairment, therefore caution should be exercised in the administration and monitoring of the product in these patients. Method of administration One tablet of Cortiment 9 mg is taken orally in the morning, with or without food.

The tablet should be swallowed with a glass of water and must not be broken, crushed or chewed as the film coating is intended to ensure a prolonged release.

Adverse drug reactions reported in clinical trials with Cortiment are presented in Table 1. Adverse drug reactions reported for the therapeutic class are presented in Table 2. In Phase II and III clinical trials, the incidence of adverse events for Cortiment tablets, at the recommended dose of 9 mg/day, was comparable to placebo.

Most adverse events were of mild to moderate intensity and of a non-serious nature.

Adverse reactions reported are listed according to the following frequency:

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). 2) 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. Paediatric population No data available. 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/yellowcard.

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. , 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.

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).

1.