Kreon 10 000

Package Leaflet: Information for the Patient

Kreon 10,000, 10,000 Ph.Eur.U. of lipolytic activity, enteric-coated capsules, hard
Pancreatinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Kreon 10,000 and what is it used for
• 2. Important information before taking Kreon 10,000
• 3. How to take Kreon 10,000
• 4. Possible side effects
• 5. How to store Kreon 10,000
• 6. Contents of the pack and other information

1. What is Kreon 10,000 and what is it used for

What is Kreon 10,000

• Kreon 10,000 contains a mixture of digestive enzymes called pancreatin (pancreas powder).
• Pancreatin helps digest food. The enzymes are obtained from pig pancreas.
• Kreon 10,000 contains small pellets that slowly release pancreatin in the intestine (acid-resistant pellets, called minimicrospheres).

What is Kreon 10,000 used for

Kreon 10,000 is used to treat pancreatic exocrine insufficiency. This is a condition in which the pancreas does not produce enough digestive enzymes to digest food properly.
It often occurs in patients with:

• cystic fibrosis (a rare genetic disease)
• chronic pancreatitis
• pancreas removal or partial removal
• pancreatic cancer Kreon 10,000 can be used in children, adolescents, and adults. The dosage for different age groups is presented in section 3 of this leaflet "How to take Kreon 10,000".

Treatment with Kreon 10,000 reduces the severity of symptoms of pancreatic exocrine insufficiency, including stool consistency (i.e., fatty stools), abdominal pain, bloating, and frequency of stool (diarrhea or constipation), regardless of the underlying disease.

How Kreon 10,000 works

The enzymes contained in Kreon 10,000 work by digesting food passing through the small intestine.
Kreon 10,000 should be taken during or immediately after main meals or snacks.
This will allow the enzymes to mix with food and digest during passage through the small intestine.

2. Important information before taking Kreon 10,000

When not to take Kreon 10,000

• if you are allergic to pancreatin or any of the other ingredients of Kreon 10,000 (listed in section 6)

Warnings and precautions

Before starting treatment with Kreon 10,000, discuss it with your doctor or pharmacist.
Patients with cystic fibrosis
A rare disease of the large intestine called fibrosing colonopathy, in which the large intestine narrows, has been reported in patients with cystic fibrosis who took high doses of pancreatin.
Therefore, in the case of cystic fibrosis and taking pancreatin in a dose higher than 10,000 Ph.Eur.U. of lipolytic activity/kg body weight/day and the occurrence of any disturbing symptoms from the digestive system or changes in existing symptoms, you should contact your doctor.
The dosage in terms of lipase dose is presented in section 3 of the leaflet "How to take Kreon 10,000".
Severe allergic reactions
If an allergic reaction occurs, discontinue taking the medicine and contact your doctor.
An allergic reaction may include itching and rash. Less common, more serious allergic reactions may include: flushing, dizziness, and fainting, breathing difficulties.
These are symptoms of a severe, potentially life-threatening condition called "anaphylactic shock". In case of its occurrence, seek immediate medical attention.
Before taking Kreon 10,000, inform your doctor about an allergy to pork protein.
Mouth irritation
Chewing and/or holding the capsules in the mouth for too long may cause mouth pain, irritation, bleeding, and ulcers of the mouth mucosa.
If the first symptoms of mouth irritation occur, it may be helpful to rinse the mouth with water and drink a glass of water.
The contents of the Kreon 10,000 capsule can be sprinkled on certain foods (see section 3 of this leaflet "How to take Kreon 10,000").
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

Kreon 10,000 and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Your doctor will decide whether you can take Kreon 10,000 during pregnancy.
Kreon 10,000 can be taken during breastfeeding.

Driving and using machines

Kreon 10,000 does not affect the ability to drive and use tools and machines.

3. How to take Kreon 10,000

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
The dose is measured in units of lipolytic activity. Lipase is one of the enzymes of pancreatin.
Different strengths of Kreon contain different amounts of lipase.
The number of capsules to be taken is determined by your doctor. Your doctor will adjust the dose to your needs.
This depends on:

• the severity of the disease
• body weight
• the diet used
• the amount of fat present in the stool If fatty stools persist or gastrointestinal symptoms (gastrointestinal symptoms) occur, contact your doctor, as there may be a need to adjust the dose.

Dosage of Kreon 10,000

Patients with cystic fibrosis

Children
The appropriate dose for a child should always be determined by a doctor.
After determining the dose of the medicine for a meal, this strength of the medicine can be used in children.

• Usually, the initial dose in children under 4 years of age is 1000 Ph.Eur.U. of lipolytic activity/kg body weight/meal.
• Usually, the initial dose in children 4 years of age and older is 500 Ph.Eur.U. of lipolytic activity/kg body weight/meal.

Adolescents and adults
Usually, the initial dose in adolescents and adults, depending on the patient's body weight, is 500 Ph.Eur.U. of lipolytic activity/kg body weight/meal.
Patients of all ages
Usually, the daily dose should not exceed 2500 Ph.Eur.U. of lipolytic activity/kg body weight/meal or 10,000 Ph.Eur.U. of lipolytic activity/kg body weight/day or 4000 Ph.Eur.U. of lipolytic activity/g of fat consumed.

Patients with other pancreatic disorders

Adolescents and adults
Usually, the dose is between 25,000 and 80,000 Ph.Eur.U. of lipolytic activity per main meal.
For snacks, the dose is usually half the dose taken during the main meal.

When to take Kreon 10,000

Kreon 10,000 should always be taken during or immediately after main meals and snacks.
This will allow the enzymes to mix with food and digest during passage through the small intestine.

How to take Kreon 10,000

• Kreon 10,000 should always be taken with a main meal or snack.
• Swallow the capsules whole and wash them down with water or juice.
• The capsules or their contents should not be chewed or crushed, as this may cause mouth irritation or change the action of the medicine in the body.
• If swallowing capsules is difficult, they can be carefully opened and the pellets added to a small amount of soft, acidic food or acidic drink. Acidic, soft food can be, for example, yogurt or apple sauce. Acidic drink can be, for example, apple, orange, or pineapple juice. Do not mix the pellets with water, milk (including flavored milk), breast milk, or formula, or hot food. The mixture should be swallowed immediately without chewing and washed down with water or juice.
• Mixing with non-acidic food or drink, chewing, or crushing the minimicrospheres may cause mouth irritation or change the action of Kreon 10,000 in the body.
• Do not hold Kreon 10,000 or the contents of the capsules in the mouth. Make sure the medicine or the mixture of the medicine with food has been completely swallowed and no pellets remain in the mouth.
• Do not store the mixture.

Taking a higher dose of Kreon 10,000 than recommended

In case of taking too much Kreon 10,000, drink plenty of water and consult your doctor or pharmacist.
Very high doses of pancreatin may sometimes cause an increase in the amount of uric acid in the urine and blood.

Missing a dose of Kreon 10,000

In case of missing a dose of Kreon 10,000, take the normal dose at the usual time with the next meal. Do not take a double dose to make up for the missed dose.

Stopping treatment with Kreon 10,000

Do not stop taking Kreon 10,000 without consulting your doctor. Many patients need to take Kreon 10,000 for the rest of their lives.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Kreon 10,000 can cause side effects, although not everybody gets them.
The following side effects may occur in patients taking this medicine.
The most important, most serious side effects that have occurred during treatment with pancreatic enzyme products are "anaphylactic shock" and fibrosing colonopathy. These two side effects have occurred in a very small number of people, but their exact frequency is not known.
Anaphylactic shock is a severe, potentially life-threatening allergic reaction that can occur suddenly.
If you experience any of the following symptoms, seek immediate medical attention:

• itching, hives, or rash
• swelling of the face, eyes, lips, hands, or feet
• feeling faint or fainting
• difficulty breathing or swallowing
• rapid heartbeat
• dizziness, falls, or loss of consciousness

Long-term use of high doses of pancreatic enzyme products may also cause scarring or thickening of the intestinal walls, which can lead to intestinal obstruction. This condition is called fibrosing colonopathy. If severe abdominal pain, problems with bowel movements (constipation), nausea, or vomiting occur, contact your doctor immediately.
Very common side effects(occurring in more than 1 in 10 patients)

• abdominal pain

Common side effects(occurring in less than 1 in 10 patients)

• nausea
• vomiting
• constipation
• bloating
• diarrhea These effects may be due to the disease for which Kreon 10,000 is indicated.

Uncommon side effects(occurring in less than 1 in 100 patients)

• rash

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicines Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kreon 10,000

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP.
The expiry date refers to the last day of that month. The batch number is stated on the carton and blister pack after Lot.
Do not store above 25°C.
HDPE bottles: After first opening, do not store above 25°C. Shelf-life after first opening of the bottle: 6 months. Store the bottles tightly closed to protect from moisture.
Medicines should not be disposed of 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 10,000 contains

The active substance is pancreas powder (pancreatin).

• Each Kreon 10,000 capsule contains 150 mg of pancreas powder (pancreatin) with an activity of:
• lipolytic 10,000 Ph.Eur.U.
• amylolytic 8,000 Ph.Eur.U.
• proteolytic 600 Ph.Eur.U.
• The other ingredients are:
• Macrogol 4000
• Pellet coating: hypromellose phthalate, cetyl alcohol, triethyl citrate, dimeticone 1000
• Capsule shell: gelatin, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172), sodium lauryl sulfate

What Kreon 10,000 looks like and contents of the pack

Kreon 10,000 capsules, size 2, have one brown and one transparent part.
They contain brownish pellets that are resistant to stomach acid (minimicrospheres).
Kreon 10,000 is available in HDPE bottles with a polypropylene cap, containing 50, 100, and 200 capsules, and in aluminum/aluminum blisters, containing 20 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Ireland

Manufacturer

Abbott Laboratories GmbH
Justus-von-Liebig-Straße 33
31535 Neustadt Am Rübenberge
Germany
Mylan Germany GmbH
Benzstraße 1
61352 Bad Homburg
Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Pancrin 10,000, magensaftresistente Hartkapseln
Poland: Kreon 10,000
To obtain more detailed information, contact your local representative of the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00

Date of last revision of the leaflet: