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.
for This medicine is given to patients who have a disorder of their pancreas. The pancreas is an organ situated in your abdomen near to your stomach. The pancreas releases substances called enzymes into the small intestine (small bowel) to digest food. If you have a disorder such as cystic fibrosis or pancreatitis and your pancreas is not working properly you may need to take extra enzymes, so that your food is fully digested. Nutrizym 22 contains the active ingredient pancreatin, which includes the enzymes that you need.
e Nutrizym 22 Do not take Nutrizym 22:
Nutrizym 22 Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Swallow the capsules whole with water with meals and snacks which are soft foods. If you find that swallowing the capsules is difficult, remove the minitablets from their capsule and swallow them quickly with a small amount of acidic fluid or soft food. This could be apple sauce, yoghurt or any fruit juice with acidic pH (e.g., apple, orange or pineapple juice). You should not chew the minitablets because this damages the special coating on them. It is important that you drink plenty of fluid while you are on Nutrizym 22.
Recommended dose Your doctor or dietician will tell you how many capsules you should take. The number taken will depend on your symptoms and on how well you respond to Nutrizym 22. If your doctor tells you to increase the number of capsules you are taking, make sure you do it gradually. Do not take more capsules than he has told you to. If you take more Nutrizym 22 than you should You may have an uncomfortable stomach, irritation/inflammation just outside of the anus, feel sick or vomit. If you do take a large overdose and feel unwell contact your doctor. Stop taking the capsules and keep well hydrated. If you forget to take Nutrizym 22 It is important to take your capsules with snacks or meals. If you forget to do this, make sure you take your next dose with your next snack or meal. Do not take any capsules other than at meal or snack time. If you stop taking Nutrizym 22 If you stop taking this medicine your condition may worsen. Do not do this unless your doctor has told you to. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects with Nutrizym 22, STOP taking the capsules and contact your doctor immediately: A severe allergic reaction (frequency not known), such as itching, swelling of the face, lips, tongue, mouth, or throat, which may cause shortness of breath, wheezing, or difficulty breathing. Other side effects include: Very common:
Nutrizym 22 Keep this medicine out of the sight and reach of children. Do not store above 25°C. It should be kept in the original container given to you by the pharmacist. You should keep the container tightly closed. Do not use this medicine after the expiry date which is stated on the carton and bottle after 'EXP'. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Nutrizym 22 contains The active substance is pancreatin. Each capsule contains 313 mg of pancreatin as the active ingredient. This is equivalent to at least 22,000 units of lipase, 19,800 units of amylase and 1,100 units of protease. The other ingredients are: castor oil, silicon dioxide, magnesium stearate, sodium carboxymethylcellulose, microcrystalline cellulose, simethicone emulsion, a methacrylic copolymer, talc and triethyl citrate. The capsules are made from gelatin and are coloured with titanium dioxide (E171), as well as iron oxide red and iron oxide yellow (E172). What Nutrizym 22 looks like and contents of the pack The active ingredient, pancreatin, is made into minitablets* which have been put inside hard, red and yellow gelatine capsules. The capsules are available in packs of 50, 100, 200 or 500 capsules. Not all pack sizes may be marketed. *EURAND MINITABS-Trademark of Adare Pharmaceuticals S.r.I Marketing Authorisation Holder Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom. Manufacturer Zentiva Pharma UK Limited, First Floor, Andrews House, College Road, Guildford, GU1 4QB, United Kingdom This leaflet was last revised in March 2026
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The active substance in Nutrizym 22 is pancreatin.
This leaflet reproduces the patient information leaflet approved for Nutrizym 22, 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 symptomatic relief of pancreatic exocrine insufficiency such as in fibrocystic disease of the pancreas and chronic pancreatitis.
Posology
Adults (including elderly) and Paediatric population
1-2 capsules with meals and 1 capsule with snacks.
Since the individual response to pancreatin supplements is variable, the number of capsules taken may need to be titrated to the individual according to symptoms and at the discretion of the physician. Dose increase, if required should be added slowly with careful monitoring of response and symptomatology.
Colonic damage has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day. The dose of Nutrizym 22 should usually not exceed this dose.
Where a patient is already receiving a lower unit dose enteric coated pancreatic supplement, then Nutrizym 22 may be substituted at 1/2 of the number of capsules normally consumed with the previous preparation.
Method of administration
Capsules should be swallowed whole with water. Where swallowing of capsules proves to be difficult, the minitablets may be removed and taken with water or with a small amount of acidic fluid or soft food, but without chewing. This could be apple sauce or yoghurt or any fruit juice with acidic pH (a pH less than 5.5), e.g. apple, orange or pineapple juice. If the minitablets 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 minitablets are not crushed or chewed. Crushing and chewing of the minitablets or mixing with food or fluid with alkaline pH 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.
Adequate patient hydration should be ensured at all times whilst treating with Nutrizym 22.
In children aged 15 years and under with cystic fibrosis. Hypersensitivity to the active substance (porcine pancreatin) or to any of the excipients listed in section 6.1.
In several patients with cystic fibrosis (including children), high doses of pancreatin caused fibrosing colonopathy (narrowing of the colon and ileocecal part of the intestine). If symptoms of ileus occur in patients taking pancreatin, fibrosing colonopathy should be considered as potential cause.
Hyperuricaemia and hyperuricosuria have been reported to occur in cystic fibrosis patients; pancreatin extracts contain a small amount of purine which might, in high doses, contribute to this condition.
Important information about the ingredients of Nutrizym 22
Nutrizym 22 contains castor oil which may cause stomach upset and diarrhoea.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
When given concomitantly:
- Pancreatin may reduce the effect of acarbose and should, therefore, not be taken concomitantly.
- Calcium carbonate and/or magnesium hydroxide may reduce the effect of pancreatin.
- Cimetidine may potentiate the effect of pancreatin.
- Pancreatin may diminish folic acid absorption.
- Long term intake of pancreatin may diminish iron absorption.
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, pancreatin should be used in doses sufficient to provide adequate nutritional status.
Not known.
In clinical trials, more than 900 patients were exposed to pancreatin. 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) including children with cystic fibrosis**, oral mucosa irritation
Skin and subcutaneous tissue disorders
rash
pruritus, urticaria
Immune system disorders
hypersensitivity (anaphylactic reactions including urticaria and angioedema)
Metabolism and nutrition disorders
Hyperuricemia
Renal and urinary disorders
Hyperuricosuria***
*Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower incidences compared to placebo were reported for abdominal pain and diarrhoea.
** See section 4.4 - Special warnings and precautions for use
*** Hyperuricosuria has been reported when high doses of pancreatin have been taken
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.
As with any pancreatin extract, high doses may cause buccal and perianal irritation, in some cases resulting in inflammation.
Stricture of the ileo-caecum and large bowel, and colitis have been reported in children with cystic fibrosis taking Nutrizym 22 (see section 4.4). Abdominal symptoms (those not usually experienced by the patient) or changes in abdominal symptoms should be reviewed to exclude the possibility of colonic damage - especially if the patient is taking in excess of 10,000 units of lipase/kg/day.
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Inappropriately large doses could result in abdominal discomfort, nausea, vomiting and perianal irritation or inflammation. Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricaemia. Refer to section 4.8 for the potential side-effects of high doses of pancreatic enzymes in patients with cystic fibrosis.
Supportive measures including stopping enzyme therapy and ensuring adequate rehydration are recommended.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Nutrizym 22. 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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