Amylase, lipase and protease KREON 25,000 hard caps with gastric juice coating pellets

Kreon 25000, hard capsules. Active ingredient: Porcine pancreas powder with amylase/lipase and protease activity. Indications: Digestive disorders (maldigestion) due to insufficient or lacking pancreatic function (exocrine pancreatic insufficiency) and in cystic fibrosis to support insufficient pancreatic function.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Kreon 25000, hard capsules with gastro-resistant pellets for use in children and adults
. Active ingredient: Porcine pancreas powder with amylase/lipase and protease activity.

Please read the entire package leaflet carefully before you start taking this medicine because it contains important information. This medicine is available without a prescription. However, to achieve the best possible results, Kreon 25000 must be used as directed. Always take this medicine exactly as described in this leaflet or as your doctor has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need further information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 5 days, consult your doctor.

What is in this leaflet:

1. WHAT IS KREON 25000 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KREON 25000?
3. HOW SHOULD YOU TAKE KREON 25000?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD KREON 25000 BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS KREON 25000 AND WHAT IS IT USED FOR?

What is Kreon 25000?
Kreon contains an enzyme mixture called pancreatic powder. Pancreatic powder supports digestion. The enzymes are extracted from pig pancreases. Kreon capsules contain small, enteric-coated pellets that slowly release the pancreatic powder into the intestine.

Kreon 25000 is used for:

• Digestive disorders (maldigestion) due to insufficient or lacking function of the pancreas (exocrine pancreatic insufficiency).
• Cystic fibrosis to support insufficient pancreatic function.

How Kreon 25000 works:
The enzymes in Kreon digest food as it passes through the gastrointestinal tract. You should take Kreon during or immediately after a meal or snack. This allows the enzymes to mix thoroughly with the food.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KREON 25000?

Kreon 25000 should not be taken if you have a proven hypersensitivity to pork (pork allergy) or any of the other ingredients of this medicine listed in section 6.

Warnings and special precautions:
Please talk to your doctor or pharmacist before taking this medicine.

Special care is required when taking Kreon:

• If you suffer from cystic fibrosis, a congenital metabolic disorder, and therefore receive high doses of pork pancreas powder, there is a risk that intestinal strictures may develop in certain parts of the small and large intestine. These strictures can potentially lead to intestinal obstruction. The following symptoms may indicate intestinal obstruction: nausea and vomiting, belching, flatulence with stool, and gas retention associated with (severe) colicky pain. If you experience severe and unusual symptoms in the digestive tract, consult a doctor immediately.
• If you experience any unusual gastrointestinal symptoms or changes in symptoms, you should have these examined by your doctor as a precautionary measure to rule out the possibility of intestinal damage. This particularly applies to patients taking more than 10,000 Ph. Eur. units of lipase per kg of body weight daily.

Taking Kreon 25000 with other medicines:
There are no known medicines that influence the effect of this medicine or that are themselves influenced in their effect.

Pregnancy, breastfeeding and fertility:
There is insufficient experience with the use of this medicine in pregnant women. There is only insufficient data from animal studies regarding pregnancy, development of the unborn child, delivery and development of the child after birth. The potential risk to humans is unknown. If you are pregnant or breastfeeding, you should not take this medicine unless your doctor considers it absolutely necessary.

Driving and using machines:
No effects on the ability to drive or use machines are expected.

3. HOW TO TAKE KREON 25000

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

How much Kreon 25000 should you take?
The dosage is measured in ###Lipase Units###. Lipase is one of the pancreatic enzymes. Different strengths of Kreon contain different amounts of lipase. Always follow your doctor's instructions on how much Kreon to take. Your doctor will determine the right dose for you. This will depend on: your condition, your weight, your diet, the fat content in your stool. If you continue to have fatty stools or other stomach or intestinal upset (gastrointestinal symptoms), talk to your doctor, as your dosage may need to be adjusted. In any case, the dosage depends on the severity of the pancreatic indigestion. The usual dose for a main meal is between 20,000 and 80,000 lipase units (equivalent to 1 to 3 Kreon 25000 capsules). However, the required dose may be considerably higher depending on the severity.

Dosage for children:
For children under 4 years of age, the weight-based dosage should start with 1,000 Ph. Eur. units of lipase per kg of body weight per meal. For children 4 years and older, the dosage should be 500 Ph. Eur. units of lipase per kg of body weight per meal.

When should Kreon 25000 be taken?
Always take this medicine during or immediately after a meal or snack. This allows the enzymes to mix well with the food and digest it as it moves through the intestines.

How should Kreon 25000 be taken?
Swallow the capsules whole with sufficient liquid. Do not break or chew the capsules. If the capsules are difficult to swallow, open them carefully and add the pellets to a small amount of soft, acidic food (e.g., applesauce). Swallow the mixture immediately without crushing or chewing them, and follow with some water or juice. Crushing or chewing the pellets, or mixing them with non-acidic foods or liquids, can damage the oral mucosa and reduce the effectiveness of the enzymes. Care should be taken to ensure that no product residue remains in the oral cavity. Consume the mixture immediately. Ensure adequate fluid intake.

Duration of use:
Take this medicine until your doctor tells you to stop. In many cases, the deficiency of your own pancreatic enzymes must be permanently replaced.

If you take more Kreon 25000 than you should:
If you take more Kreon than you should, drink plenty of water and talk to your doctor or pharmacist. Extremely high doses of pancreas powder can lead to an increase in uric acid in the blood (hyperuricemia) and urine (hyperuricosuria), particularly in cystic fibrosis patients.

If you take too little Kreon 25000 or forget to take Kreon 25000:
If you forget to take a dose, please continue treatment as recommended without increasing the next dose yourself.

If you stop taking Kreon 25000:
Do not stop taking Kreon without first talking to your doctor.

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.

Important side effects or signs to look out for and what to do if you are affected:
If you experience any of the side effects listed below, stop taking this medicine and consult your doctor as soon as possible. They will then decide on the type of further treatment.

Very common:

• abdominal pain

Frequently:

• Constipation, stool abnormalities, diarrhea and nausea/vomiting.

Occasionally:

• rash

Not known:

• Immediate allergic reactions (such as skin rash, itching, sneezing, watery eyes, shortness of breath due to bronchial spasm, swollen lips).
• In patients with cystic fibrosis, a congenital metabolic disorder, the formation of narrowing of the ileum/cecum region and the ascending colon has been described in isolated cases after administration of high doses of pancreatic enzymes. These narrowings can potentially lead to intestinal obstruction (ileus) (see section 2. "Take special care with this medicine..."). These intestinal lesions have not yet been described with Kreon.

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD KREON 25000 BE STORE?

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 carton/container after ###Exp.###. The expiry date refers to the last day of that month.

Storage condition:
Do not store above 25°C. Keep the can tightly closed to protect from moisture.

Shelf life after opening the can:
3 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Kreon 25000 contains:
The active ingredient is: Porcine pancreas powder with amylase/lipase/protease activity. One hard capsule with gastro-resistant pellets contains 300 mg of pancreas powder made from porcine pancreas tissue, equivalent to (activities in Ph. Eur. Units) lipolytic activity: 25,000 Ph. Eur.U, amylolytic activity: 18,000 Ph. Eur.U, proteolytic activity: 1,000 Ph. Eur.U. The other ingredients are: Pellets: cetyl alcohol, triethyl citrate, dimethicone 1000, macrogol 4000, hypromellose phthalate. Capsule shell: gelatin, sodium laurilsulfate, titanium dioxide, iron oxide (iron), iron oxide yellow. Note: This medicine contains no sugar and is therefore also suitable for diabetics.

What Kreon 25000 looks like and contents of the pack:
Kreon 25000 is a hard capsule with one transparent and one dark orange capsule part. The hard capsules can also be opened because the pellets inside are gastro-resistant. This medicine is available in pack sizes of 50, 100, and 200 hard capsules with gastro-resistant pellets. Not all pack sizes may be marketed.

Pharmaceutical Entrepreneur and Manufacturer:
Abbott Laboratories GmbH
Freundallee 9A
30173 Hannover
Germany

Co-Distributor:
Mylan Healthcare GmbH
Freundallee 9A
30173 Hannover


This package leaflet was last revised in February 2025.

Source: Information from the package leaflet
as of: 06/2025

Active ingredient: Porcine pancreas powder with amylase/lipase and protease activity. Indications: Digestive disorders (maldigestion) due to insufficient or lacking pancreatic function (exocrine pancreatic insufficiency) and in cystic fibrosis to support insufficient pancreatic function.

Amylase, lipase and protease KREON 25,000 hard caps