Cortiment 9mg prolonged release tablets

  • Name:

    Cortiment 9mg prolonged release tablets

  • Company:
    info
  • Active Ingredients:

    Budesonide

  • Legal Category:

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

Summary of Product Characteristics last updated on medicines.ie: 12/7/2019

Click on this link to Download PDF directly

Ferring Ireland Limited

Ferring Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Cortiment 9mg prolonged release tablets Active Ingredients Budesonide
Medicine Name DDAVP Desmopressin 100 micrograms/ml Nasal drops,solution Active Ingredients Desmopressin Acetate
Medicine Name DDAVP/Desmopressin 4 micrograms/ml Solution for Injection Active Ingredients Desmopressin Acetate
Medicine Name Desmospray, Desmopressin Nasal Spray Active Ingredients Desmopressin Acetate
Medicine Name Desmotabs Melt 120 micrograms oral lyophilisate Active Ingredients Desmopressin Acetate
Medicine Name Desmotabs Melt 240 micrograms oral lyophilisate Active Ingredients Desmopressin Acetate
Medicine Name Desmotabs Melt 60 micrograms oral lyophilisate Active Ingredients Desmopressin Acetate
Medicine Name FIRMAGON 120 mg powder and solvent for solution for injection Active Ingredients degarelix acetate
Medicine Name FIRMAGON 80 mg powder and solvent for solution for injection Active Ingredients degarelix acetate
Medicine Name Glypressin 1 mg Powder and Solvent for Solution for Injection Active Ingredients Terlipressin acetate
Medicine Name Glypressin 1 mg/ 8.5 ml solution for injection Active Ingredients Terlipressin acetate
Medicine Name Gonapeptyl Depot 3.75 mg powder and solvent for suspension for injection Active Ingredients triptorelin acetate
Medicine Name Lutinus 100 mg Vaginal Tablets Active Ingredients Progesterone
Medicine Name Menopur 1200IU powder and solvent for solution for injection Active Ingredients Menotrophin
Medicine Name Menopur 600IU powder and solvent for solution for injection Active Ingredients Menotrophin
Medicine Name Menopur 75IU Powder and Solvent for Solution for Injection. Menotrophin (HMG) Active Ingredients Menotrophin
Medicine Name Noqturina 25 microgram oral lyophilisate Active Ingredients Desmopressin Acetate
Medicine Name Noqturina 50 microgram oral lyophilisate Active Ingredients Desmopressin
Medicine Name Nordurine 0.1 mg Tablets Active Ingredients Desmopressin Acetate
Medicine Name Nordurine 0.2mg Tablets Active Ingredients Desmopressin Acetate
Medicine Name Pabal 100 micrograms/ml solution for injection Active Ingredients Carbetocin
Medicine Name Pentasa 1 g Prolonged-release Tablets Active Ingredients Mesalazine
Medicine Name Pentasa 1 g Suppositories Active Ingredients Mesalazine
Medicine Name Pentasa 10 mg/ml Rectal Suspension Active Ingredients Mesalazine
Medicine Name Pentasa 500 mg Prolonged Release Tablets Active Ingredients Mesalazine
1 - 0 of 35 items.Total: Infinity pages

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 12 July 2019 SmPC

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 SmPC

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 PIL

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 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 26 June 2017 PIL

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 SmPC

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 1 May 2015 PIL

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided

Updated on 1 May 2015 SmPC

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