Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Pancreatin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
Creon 25000
1142609
Please turn over FRONT
Date: 19-SEPT-2025
Description Creon, 25000 IU, 100 Component Type Leaflet (Insert) Affiliate Item Code 3920830 Superseded Affiliate Item Code ART-337-05 TrackWise Job No. 3920830 MA No. PL 46302/0029
Site Barcode/ DataMatrix
1187
Viatris SAP No. 400541493 Vendor Job No. N/A Artwork Proof No. 2
Client Market United Kingdom
Supplier SAP No. N/A
Market Barcode Info N/A
New Supplier Code 1142609
3D Render ID N/A
Superseded Supplier Code 1137504 Packing Site/Printer ABT (Neustadt – DE)
Pharmacode >>>
GTIN/PC N/A
Time: 12:17
No. of colours 3 Colours Non-Print Colours
Page Count Black
P. 3025 U
1 of 2
P. 7413 U
Cutting Die
Equate CMYK with Main Font Helvetica Neue LT Pro Dimensions
Leaflet 400mm x 170mm, folded to 200mm x 170mm
Body Text Size 9.5 pt Min Text Size used 9.5 pt
Keyline/Drawing No. N/A
Notes N/A N/A Sign-offs V6 APR 2025
Like all medicines, Creon 25000 can cause side effects (unwanted effects or reactions), but not everyone gets them. If you have severe or long-lasting abdominal pain, contact your doctor immediately. If you notice any unusual abdominal symptoms while taking Creon 25000 – contact your doctor. Very common side effects (affect more than 1 in 10 patients):
Common side effects (affect 1- 10 patients out of 100):
By reporting side effects you can help provide more information on the safety of this medicine.
Creon 25000 How and where to keep your capsules Keep this medicine out of the sight and reach of children. Do not store above 25°C and keep in the original container. After opening do not store above 25 °C and use within 6 months. Keep the container tightly closed. The enzymes in Creon 25000 are natural products and their ability to digest food decreases over time. If the container is left in warm conditions (e.g. the glove compartment of a car), the digestive activity decreases faster. Do not take Creon 25000 capsules after the expiry date on the bottle. Return all unused medicine to your pharmacist.
6. Further information The ingredients in Creon 25000 The active ingredient in Creon 25000 is pancreatin. Each capsule contains enteric coated brownish-coloured granules (minimicrospheres) containing pancreatin 300 mg, equivalent to: List of Enzymes: (PhEur units per capsule) Lipase 25,000 Amylase 18,000 Protease 1,000
The granules are coated with a mixture of the following ingredients: macrogol 4000, hypromellose phthalate, dimeticone, triethyl citrate and cetyl alcohol. The capsules contain: gelatin, iron oxides (E172) and sodium lauryl sulfate. Creon 25000 is available in 100 capsule packs. The Marketing Authorisation Holder is: Viatris Products Limited, Station Close, Potters Bar, EN6 1TL, United Kingdom. The Manufacturer is: Abbott Laboratories GmbH, 31535 Neustadt a. Rbge, Germany. ® Registered trademark If you wish to receive this PIL in Braille, large font or audio format please contact 023 8046 7000. This leaflet was last revised in October 2025
3920830 1142609
BACK
Date: 19-SEPT-2025
Description Creon, 25000 IU, 100 Component Type Leaflet (Insert) Affiliate Item Code 3920830 Superseded Affiliate Item Code ART-337-05 TrackWise Job No. 3920830 MA No. PL 46302/0029
Site Barcode/ DataMatrix
1187
Viatris SAP No. 400541493 Vendor Job No. N/A Artwork Proof No. 2
Client Market United Kingdom
Supplier SAP No. N/A
Market Barcode Info N/A
New Supplier Code 1142609
3D Render ID N/A
Superseded Supplier Code 1137504 Packing Site/Printer ABT (Neustadt – DE)
GTIN/PC N/A
Time: 12:17
No. of colours 3 Colours Non-Print Colours
Page Count Black
P. 3025 U
2 of 2
P. 7413 U
Cutting Die
Equate CMYK with Main Font Helvetica Neue LT Pro Dimensions
Leaflet 400mm x 170mm, folded to 200mm x 170mm
Body Text Size 9.5 pt Min Text Size used 9.5 pt
Keyline/Drawing No. N/A
Notes N/A N/A Sign-offs V6 APR 2025
Creon 25000 Capsules comes as capsule. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Creon 25000 Capsules is pancreatin.
Medicines with the same active substance, strength and form include: Creon 10000 Capsules. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Creon 25000 Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the treatment of pancreatic exocrine insufficiency.
Adults (including the elderly) and children:
Initially one or two capsules during or immediately after each meal. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology.
The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with acidic fluid or soft food, but without chewing.
This could be apple sauce or yoghurt or any fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice. If the granules are mixed with fluid or food, it is important that they are taken immediately and the mixture not stored, otherwise dissolution of the enteric coating may result. In order to protect the enteric coating, it is important that the granules are not crushed or chewed. Crushing and chewing of the minimicrospheres or mixing with food or fluid with a pH greater than 5.5 can disrupt the protective enteric coating. This can result in early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes. Care should be taken to ensure that no product is retained in the mouth.
It is important to ensure adequate hydration of patients at all times whilst dosing Creon 25000.
Fibrosing colonopathy has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day (see section 4.4).
Hypersensitivity to pancreatin of porcine origin or to any of the excipients.
Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000 units of lipase/kg/day.
Creon is essentially 'sodium free' as it contains less than 1 mmol sodium (23 mg) per dose (2 mg).
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
No interaction studies have been performed.
Pregnancy
For pancreatic enzymes no clinical data on exposed pregnancies are available.
Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected.
Caution should be exercised when prescribing to pregnant women.
Lactation
No effects on the suckling child are anticipated since animal studies suggest no systemic exposure of the breast-feeding woman to pancreatic enzymes. Pancreatic enzymes can be used during breast-feeding.
If required during pregnancy or lactation Creon should be used in doses sufficient to provide adequate nutritional status.
Creon has no or negligible influence on the ability to drive or use machines.
In clinical trials, more than 900 patients were exposed to Creon. The most commonly reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in severity.
The following adverse reactions have been observed during clinical trials with the below indicated frequencies;
Organ system
Very common
≥ 1/10
Common
≥ 1/100 to < 1/10
Uncommon
≥ 1/1000 to < 1/100
Frequency not known
Gastrointestinal disorders
abdominal pain*
nausea, vomiting, constipation, abdominal distention, diarrhoea*
strictures of the ileo-caecum and large bowel
(fibrosing colonopathy)
Skin and subcutaneous tissue disorders
rash
pruritus, urticaria
Immune system disorders
hypersensitivity
(anaphylactic reactions).
*Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower incidences compared to placebo were reported for abdominal pain and diarrhoea.
Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations, see section 4.4 Special warnings and precautions for use.
Allergic reactions mainly but not exclusively limited to the skin have been observed and identified as adverse reactions during post-approval use. Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate their frequency.
Paediatric population
No specific adverse reactions were identified in the paediatric population. Frequency, type and severity of adverse reactions were similar in children with cystic fibrosis as compared to adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricaemia.
Supportive measures including stopping enzyme therapy and ensuring adequate rehydration are recommended.
Ask anything about Creon 25000 Capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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