Please visit the SMC website and search for Cortiment® for more information
UC flare-up?
5-ASA not sufficient? Systemic steroid inappropriate?
Need something more targeted? IT’S TIME FOR CORTIMENT CORTIMENT® is a topically acting steroid and the only licensed oral
budesonide formulation for active mild to moderate ulcerative colitis, for use when 5-ASA treatment is not sufficient.2 (MMX®) technology delivers CORTIMENT®
Please consult the full Summary of Product Characteristics before prescribing. Name of Product(s): Cortiment®
9 mg, prolonged release tablets. 9 mg, prolonged release
Innovative Multimatrix throughout the entire colon,
providing the efficacy of a corticosteroid with targeted topical release.2-6 Prescribing Information: Cortiment®
tablets. Composition: One tablet contains 9 mg of budesonide. Indication: Induction of remission in patients with mild to moderate active ulcerative colitis where 5-ASA treatment is not sufficient. Dosage: Adults: The recommended daily dose for induction of remission is one 9 mg tablet in the morning, for up to 8 weeks. When treatment is discontinued, it may be useful to gradually reduce the dose. Children: No data are available, therefore the use in paediatric population is not recommended until further data become available. Contraindications: Hypersensitivity to the active substance, soya oil, peanut oil or to any of the excipients of the product. Special Warnings and Precautions: Caution is recommended 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. Reduced liver function may affect the elimination of glucocorticoids including budesonide, causing higher systemic exposure. Treatment with Cortiment tablets results in lower systemic steroid
For effective, targeted control
levels than conventional oral glucocorticoid therapy. 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. Pregnancy: Cortiment should only be used during pregnancy if the potential benefit justifies the potential risk to the foetus. Side effects: For the full list of side effects please consult the Summary of Product Characteristics. Common: headache, nausea, abdominal pain, insomnia, altered mood, blood cortisol decrease, influenza, upper respiratory tract infection, viral infection. Uncommon: abdominal distension, diarrhoea, dyspepsia, somnolence, acne, cushingoid syndrome, anaemia. Rare: pruritus, fatigue, peripheral oedema. Nature and Contents of Container: The tablets are packaged in blister packs with aluminium push through foil, contained in a cardboard carton. Marketing Authorisation Number: Tablets 9 mg: 03194/0113. Marketing Authorisation Holder: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom. Legal Category: POM. Basic NHS Price: £75.00 for 30 x 9 mg tablets. Date of Preparation of Prescribing Information: February 2015. Cortiment is a registered trademark. PI Job Code: COR/270/2015/UK
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Ferring Pharmaceuticals Ltd. Tel: 0844 931 0050. Email:
medical@ferring.com
References: 1. Scottish Medial Consortium, (2016) Budesonide 9mg prolonged release tablet (Cortiment) SMC 1093/15. 2. SmPC Cortiment. 3. Fiorino G et al. Curr Med Chem. 2010;17:1851-1857. 4. Brunner M et al. Br J Clin Pharmacol. 2006;61:31-38. 5. Sandborn WJ et al. Gastroenterology. 2012;143:1218-26.e1-2. 6. Travis SPL, et al. Gut 2014;63:433–441. doi:10.1136/gutjnl-2012-304258.
*Budesonide (Cortiment®) is accepted for restricted use within NHS Scotland.
SMC restriction: for use in patients with UC who present with active left-sided disease and/or proctosigmoiditis who are not suitable for oral prednisolone, as an alternative to budesonide rectal formulations or off-label oral budesonide.1
MAKING A Positive UC action. Positive UC outcomes. Date of preparation: October 2016. COR/2615/2016/UK P Positive UC a ositive UC action DIFFERENCE ®
SMC
APPROVED1*
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48