Pancreatin KREON 20,000 Ph.Eur. Lipase Units, Measurable Hard Capsules

Kreon 20,000 Ph. Eur. Lipase Units, gastro-resistant hard capsules. Active ingredient: pancreatin. Indications: For the treatment of exocrine pancreatic insufficiency.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Kreon 20,000 Ph. Eur. Lipase Units, gastro-resistant hard capsules
Active ingredient: pancreatin

Read the entire package leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist 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 20000 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KREON 20000?
3. HOW SHOULD YOU TAKE KREON 20000?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD KREON 20000 BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS KREON 20000 AND WHAT IS IT USED FOR?

What is Kreon 20000?
Kreon 20000 contains an enzyme mixture called pancreatic powder. Pancreatic powder is also called pancreatin. It supports digestion. The enzymes are extracted from pig pancreases. Kreon 20000 capsules contain small enteric-coated pellets that slowly release the pancreatic powder into the intestine (enteric-coated pellets, also called minimicrospheres).

What Kreon 20000 is used for:
Kreon 20000 is used to treat exocrine pancreatic insufficiency. In this condition, the pancreas does not produce enough enzymes to digest food. This is often observed in patients:

• with cystic fibrosis, a rare congenital disorder.
• with chronic inflammation of the pancreas (chronic pancreatitis).
• in which the pancreas was partially or completely removed (partial or total pancreatectomy).
• with pancreatic cancer.

Kreon 20000 can be used in children, adolescents, and adults. The dosage instructions for the different age groups are explained in section 3 of this package leaflet. Treatment with Kreon 20000 improves the symptoms of exocrine pancreatic insufficiency, including stool consistency (e.g., fatty stools), abdominal pain, flatulence, and stool frequency (diarrhea or constipation), regardless of the underlying condition. You should only use this medicine if your doctor has confirmed that you suffer from one of these conditions and your doctor has specifically recommended treatment with this product. Infants and children should only use this product on the recommendation of a doctor and must be treated under medical supervision. If you do not feel better, or if you feel worse, after 5 days, consult your doctor.

How Kreon 20000 works:
The enzymes in Kreon 20000 digest food as it passes through the intestines. You should take Kreon 20000 during or immediately after a meal or snack. This allows the enzymes to mix thoroughly with the food.

2. WHAT SHOULD YOU KNOW BEFORE TAKING KREON 20000?

Do not take Kreon 20000 if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:
Please talk to your doctor or pharmacist before taking Kreon 20000.

Patients with cystic fibrosis:
A rare bowel condition called fibrosing colonopathy, in which your bowel is narrowed, has been reported in patients with cystic fibrosis when taking high-dose pancreatic powder products. Tell your doctor if you have cystic fibrosis and are taking more than 10,000 lipase units per kilogram of body weight per day and have unusual abdominal discomfort or changes in abdominal symptoms. The dosage of lipase units is explained in section 3 of this package leaflet ###How to take Kreon 20000?###

Severe allergic reaction:
If an allergic reaction occurs, stop your treatment and talk to your doctor. An allergic reaction could include itching, hives, or a rash. In rare cases, a serious allergic reaction may occur with a feeling of warmth, dizziness and fainting, and difficulty breathing. These are symptoms of a serious, potentially life-threatening condition called ###anaphylactic shock###. If this happens, call for medical help immediately. Talk to your doctor before taking Kreon 20000 if you are allergic to pork proteins.

Mouth irritation:
Sore mouth, irritation (stomatitis), bleeding, and ulceration in the mouth may occur if the capsules are chewed and/or kept in the mouth for too long. Rinsing your mouth and drinking a glass of water may help when the first signs of mouth irritation appear. Kreon can only be sprinkled on certain foods (see section 3 of this leaflet ###How to take Kreon###).

This medicine contains less than 1 mmol (23 mg) sodium per dosage unit, that is, it is essentially ###sodium-free###.

Taking Kreon 20000 with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility:
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. Your doctor will decide whether you can take Kreon 20000 during pregnancy. Kreon 20000 can be used while breastfeeding.

Driving and using machines:
Kreon 20000 has no effect on your ability to drive and use machines.

3. HOW TO TAKE KREON 20000

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your dose will be measured in ###Lipase Units###. Lipase is one of the enzymes in pancreatic powder. Different strengths of Kreon contain different amounts of lipase. Always follow your doctor's instructions on how much Kreon 20000 to take. Your doctor will determine the right dose for you. This depends on:

• the severity of your illness.
• your weight.
• your diet.
• the fat content in your stool.

If you continue to have fatty stools or other stomach or bowel discomfort (gastrointestinal symptoms), talk to your doctor, as your dosage may need to be adjusted.

How much Kreon 20000 to take:
For patients with cystic fibrosis:
Children:
The strength of this medicine may not be suitable for initiating therapy in children, depending on the child's age and weight. The required dose for a child should be determined by the doctor using dosage forms containing fewer lipase units (e.g., 10,000 or 5,000 lipase units). Once the dose per meal has been established, that strength of medicine can be used in children. The usual starting dose for children under 4 years of age is 1,000 lipase units per kilogram of body weight per meal. The usual starting dose for children 4 years and older is 500 lipase units per kilogram of body weight per meal.

Adolescents and adults:
Weight-based enzyme dosing for adolescents and adults should start at 500 lipase units per kilogram of body weight per meal.

For all age groups:
Your total daily dose should not exceed 2,500 lipase units per kilogram of body weight per meal, or 10,000 lipase units per kilogram of body weight per day, or 4,000 lipase units per gram of fat intake.

For patients with other pancreatic problems:
Adolescents and adults:
The usual mealtime dose is between 25,000 and 80,000 lipase units. The usual snack dose is half the mealtime dose.

When to take Kreon 20000:
Always take Kreon 20000 during or immediately after a meal or snack. This allows the enzymes to thoroughly mix with and digest the food as it passes through the intestines.

How to take Kreon 20000
Kreon 20000 should always be taken with a meal or snack. The capsules should be swallowed whole with some water or juice. Do not crush or chew the capsules or their contents, as this may cause mouth irritation or alter how they work in your body. If you find it difficult to swallow the capsules, open them carefully and add the pellets to a small amount of a soft, acidic food or liquid. Acidic soft foods can include yogurt or applesauce. Acidic liquids can include apple, orange, or pineapple juice. Do not mix the pellets with water, milk, flavored milk, breast milk, infant formula, or hot foods. Swallow the mixture immediately without crushing or chewing and follow with some water or juice. Mixing the pellets with non-acidic food or liquid, crushing, or chewing the pellets may cause mouth irritation or alter how they work in your body. Do not keep the capsules or their contents in your mouth. Make sure that the medicine and food mix are swallowed completely and that no pellets are left in your mouth. Do not store the mixture.

If you take more Kreon 20000 than you should:
If you take more Kreon 20000 than you should, drink plenty of water and talk to your doctor or pharmacist. Very high doses of pancreatic powder have sometimes caused an increase in uric acid in the blood (hyperuricemia) and urine (hyperuricosuria).

If you forget to take Kreon 20000:
If you miss a dose, take the next dose with the next meal as usual. Do not try to make up for the forgotten dose.

If you stop taking Kreon 20000:
Do not stop taking Kreon 20000 without first talking to your doctor. Many patients must take Kreon 20000 for the rest of their lives.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine. The most important serious side effects associated with pancreatic enzyme replacement therapy are anaphylactic shock and fibrosing colonopathy. These two side effects have occurred in a very small number of people, but their exact frequency is unknown. Anaphylactic shock is a severe, potentially life-threatening allergic reaction that can develop rapidly. Seek immediate medical attention if you experience:

• Itching, hives or rash.
• Swollen face, eyes, lips, hands or feet.
• Feeling dizzy or faint.
• Difficulty breathing or swallowing.
• Heart palpitations.
• Dizziness, collapse or loss of consciousness.

Repeated high doses of pancreatic enzyme replacement medications can also cause scarring or thickening of the intestinal wall, which can lead to a blockage of the intestine, a condition called fibrosing colonopathy. Tell your doctor immediately if you experience severe abdominal pain, difficulty passing stools (constipation), nausea, or vomiting.

Very common side effects (may affect more than 1 in 10 people):

• stomach ache.

Common side effects (may affect up to 1 in 10 people):

• Nausea.
• Vomit.
• Constipation.
• Flatulence.
• Diarrhea.

This may be due to the conditions you are taking Kreon 20000.

Uncommon side effects (may affect up to 1 in 100 people):

• rash.

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 20000 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 ###use by:###. The expiry date refers to the last day of that month. Do not store above 25°C. Once the bottle has been opened, do not store above 25°C and use within 6 months. Keep the bottle tightly closed to protect the contents from moisture. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Kreon 20000 contains:
The active ingredient in Kreon 20000 is pancreatin. One Kreon 20000 capsule contains 300 mg pancreatin, equivalent to (Ph. Eur. units). Lipolytic activity: 20,000, amylolytic activity: 16,000, and proteolytic activity: 1,200. The other ingredients are:

• Capsule contents: Hypromellose phthalate, Macrogol 4000, triethyl citrate, Dimeticon 1000, cetyl alcohol.
• Capsule shell: gelatin, iron(III) oxide (E 172), iron(III) hydroxide oxide x H2O (E 172), iron(II,III) oxide (E 172), sodium laurilsulfate, titanium dioxide (E 171).

What Kreon 20000 looks like and contents of the pack:
Kreon 20000 are hard capsules (size 0, elongated) with a transparent body and a brown cap. They contain gastro-resistant pellets (minimicrospheres). Kreon 20000 is available in HDPE bottles with PP screw caps containing 50, 60, 100, 120, 200, and 250 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan Healthcare GmbH
Lütticher Straße 5
53842 Troisdorf
Email: mylan.healthcare@mylan.com

Manufacturer:
Abbott Laboratories GmbH
Freundallee 9A
30173 Hannover
Germany

or

Mylan Germany GmbH
Lütticher Straße 5
53842 Troisdorf

This package leaflet was last revised in November 2024.

Source: Information from the package leaflet
as of: 05/2025

Active ingredient: pancreatin. Indications: for the treatment of exocrine pancreatic insufficiency.