Patient leaflet - Pancrex V capsules 125 mg
1. What Pancrex V is and what it is used for
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 low-dose capsules may be used when small amounts of pancreatin are required, such as in newborns.
The pancreatin in Pancrex V is derived from pancreases of pigs.
2. What you need to know before you take Pancrex V
Do not take Pancrex V
If you are allergic to pancreatin or any of the other ingredients of this medicine (listed in
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.
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. How to take 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. For newborns, the contents of 1-2 capsules mixed with feeds should provide a good starting point for adjustment of the dose.
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. Possible side effects
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.
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. How to store 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. Contents of the pack and other information
What Pancrex V contains
The active substance is pancreatin. Each capsule contains at least:
- 160 BP units of free protease, an enzyme that digests protein
- 2950 BP units of lipase, an enzyme that digests fat
- 3300 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 and microcrystalline cellulose. 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 a clear hard gelatin capsule. Each plastic container holds 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.
Keep out of the sight and reach of
children.
Each capsule contains 125 mg pancreatin to
provide enzymatic activity per capsule not less
than:
Free protease 160 BP Units
Lipase 2950 BP Units
Amylase 3300 BP Units
Pancreatic enzymes for digestive support.
Oral use. Read the package leaflet before use.
DOSE: Infants: The contents of 1-2 capsules
mixed thoroughly with feeds.
When mixed with liquids use within one hour.
Store in a refrigerator.
Pancrex V
125 mg
hard capsules
300 Capsules
Essential Pharmaceuticals Ltd Egham, Surrey, TW20 8RN, UK. Essential Pharmaceuticals Ltd
Egham, Surrey TW20 8RN, UK.
UK Only
PL 41094/0005
UK Only
PL 41094/0005
Each capsule contains 125 mg pancreatin to provide enzymatic activity per capsule not less than:
Free protease 160 BP Units Lipase 2950 BP Units Amylase 3300 BP Units Pancreatic enzymes for digestive support. Oral use. Read the package leaflet before use. DOSE: Infants: The contents of 1-2 capsules mixed thoroughly with feeds.
When mixed with liquids use within one hour. Store in a refrigerator.
300 Capsules
Pancrex V
125 mg
hard capsules
pancreatin
^Pancrex b ^V
#125 mg hard ^Capsu
^Pancrex b ^V
#125 mg hard ^Capsules
Keep out of the sight and reach of children.
pancreatin