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 The active ingredient in Pancrex V Powder is pancreatin. Pancreatin is a combination of enzymes normally produced by the pancreas which help to digest protein, fat, starch and sugars in the food that you eat. Pancreatin is given to people who do not produce enough enzymes to digest their food properly, in conditions such as cystic fibrosis, persistent inflammation of the pancreas, and when the pancreas has been removed. Pancrex V Powder may also be used when the stomach has been removed, as an aid to digestion. The pancreatin in Pancrex V Powder is derived from pancreases of pigs.
e Pancrex V Powder Do not take Pancrex V Powder
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A rare bowel condition called "fibrosing colonopathy", where your gut is narrowed, has been reported in patients with cystic fibrosis taking high dose pancreatin products. If you have cystic fibrosis and take in excess of 10,000 lipase units per kilogram per day and have unusual abdominal symptoms or changes in abdominal symptoms tell your doctor. Other medicines and Pancrex V Powder Talk to your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pancrex V Powder is not known to interfere with any other medicines that you may be taking. However, if you are prescribed another medicine, inform the doctor you are taking Pancrex V Powder. Pregnancy and breast-feeding If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine as dose adjustments may be necessary. Pancrex V Powder should be used with caution in pregnancy. Driving and using machines Pancrex V Powder does not interfere with your ability to drive or operate machinery. Pancrex V Powder contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Pancrex V Powder Dosage Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. Your doctor or pharmacist will advise you on the amount of Pancrex V Powder to take before each meal, although you may find with experience that you need to adjust the dose according to the size and type of meal that you eat and also the clinical outcome. If loose pale stools (faeces) occur you may need to increase the dose. Always check with your pharmacist if you are not sure. The following should provide a good starting point for adjustment of the dose:
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If the powder is mixed with liquids or feeds, use within one hour. Pancrex V Powder is taken by mouth. Pancrex V Powder may be given via a tube direct into the stomach. If you take more Pancrex V Powder than you should There are no special precautions to take, although the use of a barrier cream may help prevent possible irritation of the anus. If you forget to take Pancrex V Powder Simply skip that dose and take the next dose before your next meal or snack. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. It is possible that some people may be allergic (hypersensitive) to Pancrex V Powder. Allergic/asthmatic reactions have occasionally occurred on handling the powder. Signs of an allergy to something include rash, wheezing, breathlessness, swollen eyelids, face or lips, and in extreme cases collapse. In the unlikely event that you should get any of these symptoms soon after taking Pancrex V Powder, don't take any more. Tell a doctor straight away and take the packaging and this leaflet with you. Very common side effects (affect more than 1 in 10 patients):
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Some irritation of the skin of the mouth may occur if the powder is kept in the mouth. Irritation of the anus may also occur, which may be prevented by use of the barrier cream. If you notice any different or unusual pain or discomfort in the abdomen (stomach area), if any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine.
Pancrex V Powder Do not store above 25°C. Keep this medicine out of the sight and reach of children. Do not take this medicine after the expiry date which is stated on the label 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 to protect the environment.
What Pancrex V Powder contains
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There are a number of websites available on your condition and its treatment, which may provide you with further useful information. Contact the Pancreatic Society of Great Britain and Ireland for assistance. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Essential Pharmaceuticals Ltd, 8a Crabtree Road, Egham, Surrey, TW20 8RN, UK. Manufacturer Lelypharma B.V., Zuiveringweg 42, 8243 PZ Lelystad, the Netherlands. This leaflet was last revised in 06/2024..
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Pancrex V Powder comes as powder. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Pancrex V Powder is pancreatin.
This leaflet reproduces the patient information leaflet approved for Pancrex V Powder, 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.
Pancrex is used to compensate for reduced intestinal enzyme activity in pancreatic deficiency states.
It is indicated for the treatment of fibrocystic disease of the pancreas (cystic fibrosis), chronic pancreatitis and pancreatic steatorrhoea following pancreatectomy. It may also be indicated following gastrectomy as an aid to digestion.
Posology
Dosage should be adjusted according to the needs of the individual patient and the amount and type of food consumed. The dosing may also require to be adjusted, as necessary, on the basis of the clinical outcome. The following dosage ranges provide a suitable basis for adjustment.
Adults, the Elderly, and Paediatric population
0.5- 2 grams swallowed dry or mixed with a little water or milk before each snack or meal.
New-born infants
0.25 - 0.5 grams with each feed.
1 gram of Pancrex V Powder corresponds approximately to the volume of a 1.25 ml spoonful. 2 grams of Pancrex V Powder correspond approximately to the volume of a 2.5 ml spoonful.
Method of administration
(1) Oral use
(2) Pancrex V Powder may be administered via a nasogastric tube or a gastrostomy tube. Refer to relevant local and national official guidelines (see section 4.4).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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.
It is possible that some irritation of the skin of the mouth may occur if the powder is retained in the mouth. Irritation of the anus may also occur. A barrier cream may prevent this local irritation.
Allergic/asthmatic reactions have occasionally occurred on handling the powder.
If the powder is mixed with liquids or feeds the resulting mixture should not be allowed to stand for more than one hour prior to use.
When Pancrex V Powder is administered via a nasogastric tube or a gastrostomy tube then the internal diameter of the tube must be adequate and patency of the tube must be ensured. Refer to relevant local and national official guidelines.
Excipients
This medicine contains lactose monohydrate. Patients with rare hereditary problems of, galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
No interaction studies have been performed.
Pregnancy
There are no or limited amount of data from the use of pancreatic enzymes in pregnant women. Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected. Pancrex V Powder should be used with caution in pregnancy.
Lactation
No effects on the breastfed newborn/infant are anticipated since animal studies suggest no systemic exposure of the breast-feeding woman to pancreatic enzymes.
If use during pregnancy and lactation is considered necessary, Pancrex V Powder should be used in doses sufficient to provide adequate nutritional status.
Pancrex V Powder has no or negligible influence on the ability to drive and use machines.
Rare cases of hyperuricosuria and hyperuricaemia have been reported when extremely high doses of pancreatin have been taken.
The following adverse reactions have been observed during clinical trials with the below indicated
Organ system
Very common
≥ 1/10
Common
≥ 1/100 to < 1/10
Uncommon
≥ 1/1,000 to < 1/100
Frequency not known (cannot be estimated from the available data)
Immune system disorders
hypersensitivity (anaphylactic reactions)
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
*Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower frequencies: incidences compared to placebo were reported for abdominal pain and diarrhoea.
Strictures of the ileo-caecum and large bowel, and colitis, have been reported in children with cystic fibrosis taking high doses of pancreatic enzyme supplements. To date Pancrex and Pancrex V presentations have not been implicated in the development of colonic damage. However unusual abdominal symptoms 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/kg/day of lipase.
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.
None stated.
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 Pancrex V Powder. 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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