Patient leaflet - Pancrex granules
1. WHAT PANCREX GRANULES ARE AND WHAT THEY ARE USED FOR
The active ingredient in Pancrex Granules 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 Granules may also be used when the stomach has been removed, as an aid to digestion.
The pancreatin in Pancrex Granules is derived from pancreases of pigs.
2. BEFORE YOU TAKE PANCREX GRANULES
Do not take Pancrex Granules if you − are allergic (hypersensitive) to pancreatin or any of the other ingredients of
Pancrex Granules (see list in section 6 ʻFurther Informationʼ)
cannot easily digest or absorb milk sugars (lactose, galactose, glucose).
Contact your doctor or pharmacist before taking Pancrex Granules if you think this might be the case.
Taking other medicines
Pancrex Granules are 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 Granules.
Pregnancy and breast-feeding
If you are pregnant, thinking of becoming pregnant or breast-feeding, discuss this with your doctor before taking your medicine as dose adjustments may be necessary.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Pancrex Granules do not interfere with your ability to drive or operate machinery.
Important information about some of the ingredients of Pancrex Granules
This product contains lactose. If you are lactose intolerant, contact your doctor or pharmacist before taking this product.
3. HOW TO TAKE PANCREX GRANULES
Dosage
Your doctor or pharmacist will advise you on the amount of Pancrex Granules 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. Always check with your pharmacist if you are not sure.
For adults, elderly, and children, 5g-10g of granules swallowed dry or mixed with a little water or milk just before meals should provide a good starting point for adjustment of the dose.
If the granules are mixed with liquids or food, use within one hour.
If you take more Pancrex Granules 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 Granules
Simply skip that dose and take the next dose with your next meal.
If you have any further questions on the use of this product, ask your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pancrex Granules can cause side effects, although not everybody gets them.
It is possible that some people may be allergic (hypersensitive) to Pancrex Granules. 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 Granules, don’t take any more. Tell a doctor straight away and take the packaging and this leaflet with you.
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.
Some irritation of the skin of the mouth may occur if the capsules are chewed or kept in the mouth. Irritation of the anus may also occur, which may be prevented by use of a barrier cream.
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
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PANCREX GRANULES
Store at, or below, 15˚C. This is best achieved by storing the container in the refrigerator.
Keep out of the reach and sight of children.
Do not use Pancrex Granules after the expiry date which is stated on the pack after Expiry Date. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Pancrex Granules contain
The active substance is Pancreatin BP. BP is a British standard measure of potency (expected biological effect) of a pharmaceutical product.
Each gram of granules contains at least:
- 300 BP units of free protease, an enzyme that digests protein
- 5000 BP units of lipase, an enzyme that digests fat
- 4000 BP units of amylase, an enzyme that digests starch and sugars
The other ingredients are lactose, acacia (E414), Opaseal P17-0200 containing IMS, polyvinyl acetate phthalate and stearic acid (E570). Pancrex Granules contain approximately 70g of lactose per 100g. When taken as recommended (see section 3 “How to take Pancrex Granules”) each dose supplies up to 7g of lactose. What Pancrex Granules look like and contents of the pack Pancrex Granules are light to dark buff-coloured coated granules. Each plastic container holds 300g of granules. Internet sites for patients with your condition 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 The Marketing Authorisation for Pancrex Granules is held by Essential Pharmaceuticals Ltd, 8a Crabtree Road, Egham, Surrey, TW20 8RN, UK. The granules are manufactured by Penn Pharmaceuticals Ltd., Tredegar, Gwent, NP2 3AA, South Wales, UK