Kreon 25 000

Package Leaflet: Information for the Patient

Kreon 25,000

25,000 Ph.Eur. lipase, enteric-coated capsules 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.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Kreon 25,000 and what is it used for
• 2. Important information before taking Kreon 25,000
• 3. How to take Kreon 25,000
• 4. Possible side effects
• 5. How to store Kreon 25,000
• 6. Contents of the pack and other information

1. What is Kreon 25,000 and what is it used for

What is Kreon 25,000

• Kreon 25,000 contains a mixture of digestive enzymes called "pancreatin".
• Pancreatin helps digest food. The enzymes are obtained from pig pancreas.
• Kreon 25,000 contains small granules that slowly release pancreatin in the intestine (acid-resistant granules, called Minimicrospheres).

What Kreon 25,000 is used for
Kreon 25,000 is used in children, adolescents, and adults with pancreatic exocrine insufficiency. This is a disease in which the pancreas does not produce enough digestive enzymes. This disease often occurs in patients with the following conditions:

• cystic fibrosis (a rare genetic disease)
• blockage of the pancreatic or bile ducts
• acute pancreatitis. Kreon 25,000 can be started when the patient resumes oral feeding
• chronic pancreatitis
• pancreatic cancer
• removal of the pancreas or part of it
• removal of the stomach or part of it
• gastrointestinal anastomosis
• Shwachman-Diamond syndrome (a very rare genetic disease).

Pancreatic exocrine insufficiency may also be diagnosed in other clinical conditions not listed above.
How Kreon 25,000 works
The enzymes in Kreon 25,000 work by digesting food passing through the small intestine. Kreon 25,000 should be taken during or immediately after main meals and snacks. This will allow the enzymes to mix with the food and digest it as it passes through the small intestine.

2. Important information before taking Kreon 25,000

When not to take Kreon 25,000

• if you are allergic to pork pancreatin or any of the other ingredients of this medicine (listed in section 6). In case of doubt, consult a doctor or pharmacist.

Warnings and precautions

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 have taken large doses of pancreatin.
Therefore, in the case of cystic fibrosis and taking pancreatin in a dose greater than 10,000 Ph.Eur. lipase/kg body weight/day and the occurrence of any disturbing symptoms from the gastrointestinal tract or changes in existing symptoms, you should contact your doctor.

Pregnancy and breastfeeding

• In case of pregnancy or suspected pregnancy, consult a doctor before taking Kreon 25,000. The doctor will decide whether and in what dose Kreon 25,000 can be taken.
• Kreon 25,000 can be used during breastfeeding.

Driving and using machines

Kreon 25,000 has no or negligible influence on the ability to drive and use machines.

Kreon 25,000 contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Kreon 25,000

This medicine should always be taken exactly as advised by your doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

Dosage of Kreon 25,000

• The dose is measured in units of lipase. Lipase is one of the enzymes in pancreatin. Different strengths of Kreon contain different amounts of lipase.
• The number of capsules to be taken is decided by the doctor.
• The doctor will adjust the dose according to the patient's needs. It depends on:
• the type of disease
• body weight
• the diet used
• the amount of fat in the stool.
• If fatty stools or gastrointestinal symptoms (gastrointestinal symptoms) persist, you should contact your doctor, as the dose may need to be adjusted.

Cystic Fibrosis

• Usually, the initial dose in children under 4 years of age is 1000 units of lipase/kg body weight/meal.
• Usually, the initial dose in children over 4 years of age, adolescents, and adults is 500 units of lipase/kg body weight/meal.
• In most patients, the dose should be lower or not exceed 10,000 units of lipase/kg body weight/day or 4000 units of lipase/g of fat consumed.

Other pancreatic disorders - adults

• Usually, the dose is between 25,000 and 80,000 units of lipase per main meal (breakfast, lunch, dinner).
• For snacks, the dose is usually half the dose taken during a main meal.

When to take Kreon 25,000

Kreon 25,000 should always be taken during or immediately after main meals and snacks.
This will allow the enzymes to mix with the food and digest it as it passes through the small intestine.

How to take Kreon 25,000

• Swallow the capsules whole.
• Do not chew or crush the capsules.
• If swallowing capsules is difficult, they can be carefully opened and the granules added to soft, acidic food or mixed with an acidic drink. Acidic food can be, for example, apple puree or yogurt. Acidic drink can be, for example, apple, orange, or pineapple juice.
• 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 irritation of the mouth or change the action of Kreon 25,000 in the body.
• Do not keep Kreon 25,000 or the contents of the capsules in the mouth.
• Do not store the mixture.
• Drink plenty of fluids throughout the day.

How long to take Kreon 25,000

The medicine should be taken for as long as decided by the doctor. Many patients need to take Kreon 25,000 for the rest of their lives.

Taking more than the recommended dose of Kreon 25,000

In case of taking too much Kreon 25,000, drink plenty of fluids and consult a 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 25,000

In case of missing a dose of Kreon 25,000, 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 25,000

Do not stop taking Kreon 25,000 without consulting a doctor.
In case of doubt, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Kreon 25,000 can cause side effects, although not everybody gets them.
The following side effects have been reported in patients taking Kreon during clinical trials.
If you experience allergic reactions, including rash, swelling of the face, lips, tongue
and/or throat, which may cause difficulty breathing or swallowing, or other serious side effects, stop taking Kreon 25,000 and contact your doctor or the Emergency Department of the nearest hospital immediately.
Side effects that may occur when taking Kreon 25,000:
Very common (occurring in more than 1 in 10 patients)

• abdominal pain

Common (occurring in less than 1 in 10 patients)

• nausea
• vomiting
• constipation
• bloating
• diarrhea These symptoms may be due to the disease for which Kreon 25,000 is indicated. During clinical trials, the number of patients taking Kreon who experienced abdominal pain or diarrhea was similar to or lower than that of patients not taking Kreon.

Uncommon (occurring in less than 1 in 100 patients)

• rash

Frequency not known (cannot be estimated from the available data)

• itching and hives
• Kreon may cause hypersensitivity reactions, including anaphylactic reactions with difficulty breathing or swelling of the mouth
• Narrowing of the ileocecal junction and large intestine (fibrosing colonopathy) has been reported in patients with cystic fibrosis taking high doses of pancreatin products. Hypersensitivity reactions, mainly affecting the skin but not limited to it, have been observed and reported after the product was placed on the market.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to: Department for Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Kreon 25,000

• Keep the medicine out of the sight and reach of children.
• Store in a temperature below 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.
• Do not use this medicine after the expiry date stated on the packaging after: Expiry date (EXP). The expiry date refers to the last day of the month stated.
• 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 25,000 contains

• The active substance is 300 mg of pancreatin with an activity of: 25,000 Ph.Eur. lipase (BP units) 18,000 Ph.Eur. amylase (BP units) 1,000 Ph.Eur. protease.
• The other ingredients are: macrogol 4000, hypromellose phthalate, dimeticone 1000, cetyl alcohol, triethyl citrate. Ingredients of the capsule shell: gelatin, iron (III) oxide (E 172), iron (III) oxide hydrate (E 172), sodium lauryl sulfate.

What Kreon 25,000 looks like and contents of the pack

• Kreon 25,000 is available as enteric-coated, hard gelatin capsules containing granules with an acid-resistant coating (Minimicrospheres).
• The capsules are two-colored: one part is opaque orange, the other part is transparent and colorless.
• The pack contains: 20, 50, or 100 capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Sp. z o.o.
Postępu 21B
02-676 Warsaw

Manufacturer

Abbott Laboratories GmbH, Werk Neustadt
Justus-von-Liebig-Str. 33
31535 Neustadt, Germany
To obtain more detailed information, please contact the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
Postępu 21B
02-676 Warsaw
tel. 22 546 64 00
Date of last revision of the leaflet:02/2024