Cortiment 9mg prolonged release tablets

Section 4.1 - Update to add indication for indiction of remission in patients with active microscopic colitis (MC)

Section 4.2 - Update to add sub-heading 'ulcerative colitis and microscopic colitis'

Section 5.1 - Update to add evidence for new indication

Side effects reordered. No new information.

Section 4.4: New paragraph: “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 condition diseases such as Central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.”

Section 4.5: New text: “Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).”

Section 4.6: Section on breast-feeding updated, updated to the following text: 

“Budesonide is excreted in breast milk.

Maintenance treatment with inhaled budesonide (200 or 400 micrograms twice daily) in asthmatic nursing women results in negligible systemic exposure to budesonide in breast-fed infants.

In a pharmacokinetic study the estimated daily infant dose was 0.3% of the daily maternal dose for both dose levels, and the average plasma concentration in infants was estimated to be 1/600th of the concentrations observed in maternal plasma, assuming complete infant oral bioavailability.

Budesonide concentrations in infant plasma samples were all less than the limit of quantification.

Based on data from inhaled budesonide and the fact that budesonide exhibits linear PK properties within the therapeutic dosage intervals after inhaled, oral and rectal administrations, at therapeutic doses of budesonide, exposure to the suckling child is anticipated to be low. These data support continued use of budesonide, oral and rectal administrations, during breast-feeding.”

Section 4.8: Full update of this section.  This section now contains two tables, Table 1 lists Adverse drug reactions reported in clinical trials with Cortiment and Table 2 lists Adverse drug reactions reported for the therapeutic class. New adverse reactions are included in this update in all categories.

Section 4.4: New paragraph: “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 condition diseases such as Central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.”

Section 4.5: New text: “Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).”

Section 4.6: Section on breast-feeding updated, updated to the following text: 

“Budesonide is excreted in breast milk.

Maintenance treatment with inhaled budesonide (200 or 400 micrograms twice daily) in asthmatic nursing women results in negligible systemic exposure to budesonide in breast-fed infants.

In a pharmacokinetic study the estimated daily infant dose was 0.3% of the daily maternal dose for both dose levels, and the average plasma concentration in infants was estimated to be 1/600th of the concentrations observed in maternal plasma, assuming complete infant oral bioavailability.

Budesonide concentrations in infant plasma samples were all less than the limit of quantification.

Based on data from inhaled budesonide and the fact that budesonide exhibits linear PK properties within the therapeutic dosage intervals after inhaled, oral and rectal administrations, at therapeutic doses of budesonide, exposure to the suckling child is anticipated to be low. These data support continued use of budesonide, oral and rectal administrations, during breast-feeding.”

Section 4.8: Full update of this section.  This section now contains two tables, Table 1 lists Adverse drug reactions reported in clinical trials with Cortiment and Table 2 lists Adverse drug reactions reported for the therapeutic class. New adverse reactions are included in this update in all categories.