How does it work?

Creon micro gastro-resistant granules contain the activeingredient pancreatin, which is a mixture of digestive enzymes normallyreleased by the pancreas to digest food.

Pancreatin contains the pancreatic enzymes lipase, amylase andprotease. These assist the digestion of fat, carbohydrates and proteins. Theenzymes in Creon micro are extracted from pig pancreas glands.

Pancreatin supplements are given by mouth in conditions wherethe natural secretion of these enzymes by the pancreas is reduced or absent.These conditions include chronic inflammation of the pancreas (pancreatitis)and cystic fibrosis. Pancreatin may also be necessary if a tumour (egpancreatic cancer) obstructs the outflow of enzymes from the pancreas. Thesupplements are also needed following surgical removal of the pancreas orstomach.

The enzymes in pancreatin work by digesting food as it passesthrough the intestines. The medicine must be taken at the same time as a mealor snack to allow the enzymes to mix with the food.

Creon micro granules have a special coating that helps protectthe pancreatin from stomach acid. This allows more of the medicine to pass intothe intestines with the food, which is where the enzymes would normally bereleased as part of digestion. The granules should be swallowed without chewingto avoid damaging the protective coating.

For young infants, Creon micro granules should be mixed with asmall amount of undiluted apple juice and given from a spoon directly before afeed. For weaned infants, the granules should be mixed with acidic liquids orsoft foods (eg undiluted apple juice or apple puree) and given directly beforea meal. If you mix the granules with soft food, it is important that themixture is swallowed straight away, without chewing.

What is it used for?

• Aiding digestion of food in conditions where there is reduced or absent production of digestive enzymes by the pancreas, for example in chronic pancreatitis, cystic fibrosis, pancreatic cancer or following surgical removal of the pancreas (pancreatectomy) or stomach (gastrectomy).

Warning!

• This medicine should be taken with or after food. Follow the instructions given by your doctor or dietician.
• Do not exceed the recommended dose. If you think a higher dose is needed because fatty stools or abdominal pain are still present you should consult your doctor or dietician.
• People taking this medicine should make sure they drink plenty of fluids each day.
• Several children with cystic fibrosis taking high doses of pancreatin have experienced narrowing of the bowel that has required surgery. For this reason, the total dose of pancreatic enzyme supplements used in patients with cystic fibrosis should not usually exceed 10 000 units of lipase per kg body-weight daily. As a precaution, all people taking this medicine should consult their doctor immediately if they develop any new abdominal symptoms, or any change in their existing abdominal symptoms, so that any possible colonic problems can be ruled out.
• The ability of the enzymes in Creon micro to digest food decreases over time. If the container is left in very warm conditions, the digestive activity decreases faster. You should store Creon micro below 25 °C and the container should be tightly closed in order to protect from moisture. Any remaining medicine should be carefully disposed of 12 weeks after the container is first opened.

Not to be used in

• Allergy to pork proteins.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• Pancreatin is not known to be harmful when used during pregnancy or breastfeeding. However, as with all medicines, it should only be used if clearly necessary. You should seek medical advice from your doctor before using this medicine if you are pregnant or breastfeeding.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Because a side effect is statedhere, it does not mean that all people using this medicine will experience thator any side effect.

• Abdominal pain
• Diarrhoea
• Constipation
• Nausea and vomiting
• Abnormal stools
• Allergic skin reactions
• High level of uric acid in the blood or urine in people taking high doses

The side effects listed above may not include all of the sideeffects reported by the drug'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

Pancreatin is expected to reduce the blood glucose loweringeffect of the antidiabetic medicine acarbose.

It is not known to affect any other medicines.

Other medicines containing the same active ingredient