Cortiment 9mg prolonged release tablets *

  • Company:

    Ferring Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 06 November 2020

File name

Cortiment_SPC_in line with license dated 06 11 2020_1604662185.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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

Updated on 12 July 2019

File name

Cortiment SPC_in line with license dated 25 5 2018_1562915357.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 14 June 2018

File name

Cortiment SPC_in line with license dated 25 5 2018.docx

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Side effects reordered. No new information.

Updated on 30 August 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

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.

Updated on 30 August 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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.

Updated on 30 August 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 26 June 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Free text change information supplied by the pharmaceutical company

Section 4.5, paragraph update:

Budesonide is primarily metabolized by cytochrome P450 3A4 (CYP3A4). Inhibitors of this enzyme are e.g. ketoconazole, itraconazole, HIV protease inhibitors (including cobicistat-containing products) and grapefruit juice can thereforeCo-treatment with CYP3A inhibitors is expected to increase systemic exposure to budesonide several times and the risk of systemic side effects (see section 4.4). Since there is no data to support a dosage recommendation, t 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. If treatments are combined this is not possible, the period between dosing of the combined treatments should be as long as possible and a reduction of the budesonide dose could also be considered. Budesonide is unlikely to inhibit other drugs metabolized via CYP3A4, since budesonide has low affinity to the enzyme.

Updated on 26 June 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.5, paragraph update:

Budesonide is primarily metabolized by cytochrome P450 3A4 (CYP3A4). Inhibitors of this enzyme are e.g. ketoconazole, itraconazole, HIV protease inhibitors (including cobicistat-containing products) and grapefruit juice can thereforeCo-treatment with CYP3A inhibitors is expected to increase systemic exposure to budesonide several times and the risk of systemic side effects (see section 4.4). Since there is no data to support a dosage recommendation, t 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. If treatments are combined this is not possible, the period between dosing of the combined treatments should be as long as possible and a reduction of the budesonide dose could also be considered. Budesonide is unlikely to inhibit other drugs metabolized via CYP3A4, since budesonide has low affinity to the enzyme.

Updated on 01 May 2015

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided

Updated on 01 May 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided