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We would like to inform you that Viatris, the marketing authorisation holder for Creon® has decided to increase the capsule length of Creon® 25000 from 21.7mm to 24.2mm. The diameter of the capsule will not change.

The new size of Creon® 25000 capsule does not affect the efficacy of the product and should not have an impact on the patient’s ability to swallow the capsules whole.

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Efficacy & Tolerability

The data demonstrates that Creon® treats the symptoms of PEI and improves the nutritional status of patients with PEI and:

  • chronic pancreatitis1
  • pancreatic cancer1
  • cystic fibrosis2
  • diabetes3
  • coeliac disease1

In all associated diseases, Creon® has been shown to:1-3

  • increase fat absorption and reduce steatorrhoea
  • reduce stool frequency
  • improve stool consistency
  • be well tolerated

Creon® can achieve such improvements in patients with PEI because it has been developed to mimic the physiological pattern of pancreatic exocrine secretion.4


TOLERABILITY

A review of data from 15,000 patients with PEI and cystic fibrosis, chronic pancreatitis or pancreatic cancer found that side effects were present in < 1% of patients. The most commonly reported adverse events were gastrointestinal disorders which are mainly associated with underlying disease. According to the Creon® SmPC, similar or lower incidences compared to placebo were reported for abdominal pain and diarrhoea.5-8

References

    1. Smith RC, Smith FS, Wilson J, Pearce C, Wray N, Vo R, et al. Australasian Pancreatic Club. Summary and recommendations from the Australasian guidelines for the management of pancreatic exocrine insufficiency. Pancreatology. October 2015 pp 1-1222
    2. Columbo C, et al. Efficacy and tolerability of Creon for Children in infants and toddlers with pancreatic exocrine insufficiency caused by cystic fibrosis: an open-label, single-arm, multicenter study. Pancreas. 2009 Aug;38(6):693-699
    3. Mohan V, et al. Oral pancreatic enzyme therapy in the control of diabetes mellitus in tropical calculous pancreatitis. Int J Pancreatol. 1998; 24(1):19-22
    4. Domínguez-Muñoz JE et al. Advances in medical sciences, Pancreatic enzyme replacement therapy for pancreatic exocrine insufficiency: when is it indicated, what is the goal and how to do it? Vol.56(1), 2011, pp1-5
    5. Creon® Micro Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/5564/smpc. Last accessed: December 2023
    6. Creon® 10000 Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/1167/smpc. Last accessed: December 2023
    7. Creon® 25000 Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/1168/smpc. Last accessed: December 2023
    8. Imrie CW, et al. Review article: enzyme supplementation in cystic fibrosis, chronic pancreatitis, pancreatic and periampullary cancer. Aliment Pharmacol Ther. 2010; 1:1-25.

Guideline Recommendation

… the cornerstone of therapy for PEI is replacement of pancreatic enzymes to allow for efficient digestion and nutrient absorption.4

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Please continue to report suspected adverse drug reactions and device failures with any medicine or vaccine to the MHRA through the Yellow Card Scheme. It is easiest and quickest to report adverse drug reactions and device failures online via the Yellow Card website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Alternatively, you can report via some clinical IT systems (EMIS/SystmOne/Vision/MiDatabank) or by calling the Commission on Human Medicines (CHM) free phone line: 0800-731-6789.
Adverse reactions/events and device failures should also be reported to MAH at e-mail address: pv.uk@viatris.com.

This website is intended for UK healthcare professionals. If you are a patient who has been prescribed Creon® please click here

Viatris UK Healthcare Limited (company registration number 09189103), an English company with a registered office address at 20 Station Close, Potters Bar, Hertfordshire, EN6 1TL (VAT - 421 623 781).

Creon® is indicated for the treatment of pancreatic exocrine insufficiency.

CRE-2021-0769 December 2023.

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