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.
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Pancrex V contains the active substance 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 may also be used when the stomach has been removed, as an aid to digestion. These capsules may be used when small amounts of pancreatin are required, such as in younger children. The capsules may also be used in patients who cannot easily dissolve the special coating of other pancreatin preparations. The pancreatin in Pancrex V is derived from pancreases of pigs. 2.
e Pancrex V
Do not take Pancrex V If you are allergic to pancreatin or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Pancrex V. Some irritation of the skin of the mouth may occur if the capsules are chewed or the contents kept in the mouth. Irritation of the anus may also occur, which may be prevented by use of a barrier cream. Pan340mgCap-LBL-UK-6
It is possible that some people may be allergic to Pancrex V. Allergic/asthmatic reactions have occasionally occurred on handling the capsule contents. 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, do not take any more. Tell a doctor straight away and take the packaging and this leaflet with you. Other medicines and Pancrex V Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine as dose adjustments may be necessary. Driving and using machines Pancrex V does not interfere with your ability to drive or operate machinery. 3.
Pancrex V
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 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. If loose pale stools (faeces) occur you may need to increase the dose. The following should provide a good starting point for adjustment of the dose: • For infants, the contents of 1-2 capsules mixed with feeds. • For older children and adults, 2-6 capsules (or their contents) with each meal or snack. If the capsule contents are mixed with liquids or feeds, use within one hour. If you take more Pancrex V than you should There are no special precautions to take. If you forget to take Pancrex V Simply skip that dose and take the next dose with your next meal or snack. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Rarely, high levels of uric acid in the blood and urine have been reported when extremely high doses of pancreatin have been taken. Narrowing of parts of the bowel, and inflammation of the colon, have been reported in children with cystic fibrosis taking high doses of pancreatic enzyme supplements. Pan340mgCap-LBL-UK-6
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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. 5.
Pancrex V
Store in a refrigerator (2°C – 8°C). Keep this medicine out of the sight and reach of children. Do not use 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 protect the environment. 6.
What Pancrex V contains The active substance is pancreatin. Each capsule contains at least: 430 BP units of free protease, an enzyme that digests protein 8000 BP units of lipase, an enzyme that digests fat 9000 BP units of amylase, an enzyme that digests starch and sugars BP is a British standard measure of potency (expected biological effect) of a pharmaceutical product. The other excipients are aluminium oxide, magnesium stearate, microcrystalline cellulose, titanium dioxide (E171), yellow iron oxide (E172) and quinoline yellow (E104). The capsule is made of gelatin, which is of bovine origin. What Pancrex V looks like and contents of the pack Pancrex V consists of white or buff-coloured powder in an ivory-coloured hard gelatin capsule imprinted with ʻPancrex Vʼ and a company logo. Each plastic container holds 100, 300 or 500 capsules. However, not all pack sizes may be marketed. 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.. Other sources of information 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. Pan340mgCap-LBL-UK-6
Pancrex V 340 mg hard capsules comes as capsule containing 340mg. 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 340 mg hard capsules is pancreatin.
This leaflet reproduces the patient information leaflet approved for Pancrex V 340 mg hard 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.
Pancrex V 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 following dosage ranges provide a suitable basis for adjustment.
Infants: The contents of 1 - 2 capsules mixed with feeds.
Older Children and Adults: the contents of 2 - 6 capsules with each snack or meal. The capsules may be swallowed.
The capsules may provide a suitable alternative to the enteric coated presentations in cases where the pH of the duodenum is not sufficiently alkaline to dissolve the enteric coat.
Paediatric population
Capsules provide a simple and convenient method of dose measurement of pancreatin for administration to younger children requiring a low dose.
Method of administration
Oral use.
The capsules should be taken with each feed or meal or snack.
If the capsule contents are mixed with liquids or feeds the resulting mixture should not be allowed to stand for more than one hour prior to use.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
It is possible that some irritation of the skin of the mouth may occur if capsules are chewed or the contents 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 capsule contents.
None known.
Pancrex V should not be used in pregnancy and lactation unless clearly necessary but if required should be used in doses sufficient to provide adequate nutritional status.
Pancrex V 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.
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. 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 340 mg hard 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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