CREON 10,000 E 20 capsules, KREON

CREON 10,000 E Purpose:

Creon contains a mixture of enzymes called "pancreatin".
Pancreatin helps digest food. The enzymes are of pancreatic glands of pigs.
Creon contains small pellet which slowly release the pancreatin in the intestine (enteric-coated pellets, called microspheres).


Creon using in children and adults with "pancreatic exocrine insufficiency". This is a condition in which the body does not produce enough enzymes to break down food. It is often found in people who have:

· Cystic fibrosis - a rare inherited disease;

· Obstructed ducts of the pancreas or bile (pancreatic duct or common bile duct);

· Acute inflammation of the pancreas (pancreatitis). You can take Creon when you start eating again;

· Chronic inflammation of the pancreas (pancreatitis);

· Pancreatic cancer;

· Partial or complete surgical removal of the pancreas (partial or total pancreatectomy);

· Partial or complete surgical removal of the stomach (partial or complete gastrectomy);

· Gastrointestinal bypass;

· Schwachmann-Diamond syndrome, a very rare genetic disease.

CREON 10,000 E Act:

The enzymes in Creon work by digesting food as it passes through the intestines. You should take Creon during or after a meal. This will allow the enzymes to mix.

Do not take Creon:

• If you are allergic (hypersensitive) to the active substance (s) or to any of the other ingredients of Creon.
• If you are not sure about anything, please ask your doctor!

Take special care with Creon
A rare condition called 'fibrosing colonopathy' has been reported in patients with high-dose pancreatin cystic fibrosis, in which the bowels become narrowed. However, if you have cystic fibrosis, take more than 10,000 units of lipase / kg per day and have unusual abdominal symptoms or changes in these symptoms, tell your doctor!

Additional information on pancreatic enzymes
The pancreatic glands from which Creon and other pancreatic enzymes are produced are from pigs used for food. These animals can carry viruses. In the production of Creon, several steps are taken to reduce the risk of spreading viruses, incl. destruction and testing for specific viruses. The risk of infections caused by these or other unknown or new viruses cannot be completely ruled out. However, no cases of infection have been reported in patients.

Fertility, pregnancy and breast-feeding
Please tell your doctor before taking this medicine if you are pregnant or planning to become pregnant! Your doctor will decide if you can take Creon and in what dose.
Creon can be taken during breastfeeding.

Taking other medications
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription:

Driving and using machines
Creon is unlikely to affect your ability to drive or use machines.

CREON 10,000 E Dosage:
Always take Creon exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

What dose to take CREON 10,000 E :

· Your dose is measured in "lipase units". Lipase is one of the enzymes pancreatin. Different doses of Creon contain different amounts of lipase.

· Always follow your doctor's advice on what dose of Creon to take.

· Your doctor will adjust your dose to your needs. It depends on:

o Your illness;

o Your weight;

o Your diet;

o How much fat is in your stool.

· If you still have greasy stools, other stomach or intestinal problems (gastrointestinal symptoms), tell your doctor, as your dose may need to be adjusted.

Cystic fibrosis

· The usual starting dose for children under 4 years of age is 1000 lipase units per kilogram of diet.

· The usual starting dose for children 4 years of age and older, adolescents and adults is 500 lipase units per kilogram of diet.

Other pancreatic problems

· The usual dietary dose is between 25,000 and 80,000 lipase units.

· The usual dose for meals between meals is half the dose of the main meal.

When to take Creon
Always take Creon during or after a meal or meal. This will allow the enzymes to mix completely with the food, digest it and pass it through the intestines.

How to take Creon
Swallow the capsules whole.
Do not break or chew the capsules.
If you find it difficult to swallow the capsules, open them carefully and add the pellets to a small amount of soft acidic food or mix them with acidic liquids. Acidic foods can be, for example, apple sauce or yogurt. Acidic liquids, for example, are apple, orange or pineapple juice.
Swallow the mixture immediately without breaking or chewing and drink some water or juice.
Mixing with non-acidic foods and liquids, breaking or chewing the pellets can cause irritation in your mouth or change the action of Creon in your body.
Do not keep Creon capsules or their contents in your mouth.
Do not store the mixture.
As a general rule, drink plenty of fluids every day.

How long to take Creon
Take Creon until your doctor tells you to stop. Many patients need Creon throughout their lives.

Possible side effects
Like all medicines, Creon can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Very common (affects more than 1 user in 10): stomach pain (stomach).

Common (affects less than 1 user in 10): nausea, vomiting, constipation, bloating, diarrhea.

These reactions can also be caused by conditions for which Creon is taken. In studies, the number of patients taking Creon who had stomach pain and diarrhea was similar to or less than patients who did not take Creon.

Uncommon (affects less than 1 in 100 patients): rash.

Not known (frequency cannot be determined from the available data): severe pruritus (itching) and urticaria (hives); other serious allergic reactions can be caused by Creon, including breathing problems and swollen lips; strictures (narrowing) of the ileo-caecum and colon (fibrosing colonopathy) have been reported in patients with cystic fibrosis receiving high doses of pancreatin.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist!

CREON 10,000 E Ingredients:
Each Creon 10,000 Ph.Eur.U capsule contains 150 mg of pancreatin (pancreatic powder) corresponding to:

• amylase 8,000 Ph. Eur. Units;
• lipase 10,000 Ph. Eur. Units;
• protease 600 Ph. Eur. Units.

The other ingredients are: macrogol 4000; hypromellose phthalate; dimethicone 1000; cetyl alcohol; triethyl citrate; gelatin; iron oxide (E172); titanium dioxide (E171); sodium lauryl sulfate.