Kreon 25 000

Package leaflet: Information for the patient

Kreon 25 000
25 000 Ph.Eur. units of lipase, enteric capsules
Pancreatinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Contents of the leaflet

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

What Kreon 25 000 is

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

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

• Cystic fibrosis (a rare genetic disease)
• Blockage of the pancreatic or bile ducts
• Following an episode of acute pancreatitis. Kreon 25 000 may 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 disorder)

Exocrine pancreatic insufficiency may also occur 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 or snacks. This ensures thorough mixing of the enzymes with food.

2. Important information before taking Kreon 25 000

When not to take Kreon 25 000

• if the patient is allergic to porcine pancreatin or any of the other ingredients of this medicine (listed in section 6). If in doubt, consult a doctor or pharmacist.

Warnings and precautions
A rare bowel disorder called fibrosing colonopathy, characterized by narrowing of the large intestine, has been reported in patients with cystic fibrosis who were taking high doses of pancreatin.
Therefore, if you have cystic fibrosis and are taking pancreatin at a dose exceeding 10,000 Ph.Eur. units of lipase per kg body weight per day, and experience any new or worsening gastrointestinal symptoms, contact your doctor.
Pregnancy and breastfeeding

• If you are pregnant or suspect you might be pregnant, consult your doctor before taking Kreon 25 000. Your doctor will decide whether Kreon 25 000 can be taken and, if so, at what dose.
• Kreon 25 000 may be used during breastfeeding.

Driving and operating machinery
Kreon 25 000 has no effect or negligible effect on the ability to drive and operate machinery.
Kreon 25 000 contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, the medicine is considered "sodium-free".

3. How to take Kreon 25 000

This medicine should always be taken as directed by a doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
Dosage of Kreon 25 000

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

Cystic fibrosis

• The usual initial dose in children under 4 years of age is 1000 lipase units/kg body weight per meal.
• The usual initial dose in children aged 4 years and older, adolescents, and adults is 500 lipase units/kg body weight per meal.
• In most patients, the dose should be less than or not exceed 10,000 lipase units/kg body weight per day or 4000 lipase units per gram of dietary fat consumed.
  Other pancreatic disorders – adults
• The usual dose is between 25,000 and 80,000 lipase units for each main meal (breakfast, lunch, dinner).
• For snacks, the usual dose is half of the dose taken with 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 ensures proper mixing of the enzymes with food and effective digestion 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 the capsules is difficult, they may be carefully opened and the granules mixed with soft, acidic food or an acidic drink. Suitable acidic foods include apple puree or yoghurt. Suitable acidic drinks include apple, orange, or pineapple juice.
• The mixture should be swallowed immediately, without chewing or crushing, and followed with water or juice.
• Mixing with non-acidic food or drink, chewing or crushing the minimicrospheres may cause irritation of the mouth or alter the action of Kreon 25 000 in the body.
• Do not retain Kreon 25 000 or capsule contents in the mouth.
• Do not store the prepared mixture.
• Drink plenty of fluids throughout the day.

How long to take Kreon 25 000
This medicine should be taken for as long as your doctor recommends. Many patients need to take Kreon
25 000 for life.
Taking more Kreon 25 000 than prescribed
If you take more Kreon 25 000 than recommended, drink plenty of fluids and consult your doctor or pharmacist immediately.
Very high doses of pancreatin may occasionally increase uric acid levels in urine and blood.
Missing a dose of Kreon 25 000
If you miss a dose of Kreon 25 000, take your usual dose at the next scheduled time with the next meal. Do not take a double dose to make up for a missed dose.
Stopping Kreon 25 000 treatment
Do not stop taking Kreon 25 000 without consulting your doctor.
If in doubt, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been reported during clinical studies in patients taking Kreon.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue
and/or throat, which may cause difficulty in breathing or swallowing, or if other
serious adverse reactions occur, treatment with Kreon 25 000 must be discontinued immediately and
the doctor or the nearest hospital Emergency Department must be contacted immediately.
Adverse reactions that may occur during treatment with 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
• diarrhoea
  These effects may be due to the underlying disease for which Kreon 25 000 is prescribed. During clinical studies, the number of patients taking Kreon who experienced abdominal pain or diarrhoea was similar to or lower than in patients not taking Kreon.

Uncommon (occurring in less than 1 in 100 patients)

• rash

Frequency not known (cannot be estimated from available data)

• pruritus and urticaria
• Kreon may cause hypersensitivity reactions, including anaphylactic reactions manifested by breathing difficulties or swelling of the mouth
• narrowing of the ileocaecal region and large intestine (fibrosing colonopathy) has been reported in patients with cystic fibrosis of the pancreas who were receiving high doses of pancreatin-containing products. Hypersensitivity reactions, mainly affecting the skin but not limited to it, have been observed and reported following marketing of the product.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported
directly to: Department for Monitoring of Adverse Drug Reactions,
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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions contributes to the provision of more information on the safety of the medicine.

5. How to store Kreon 25 000

• Keep this medicine out of sight and reach of children.
• Store below 25°C. HDPE bottles: After first opening, do not store at temperatures above 25°C. Shelf life after first opening of the bottle: 6 months. Keep bottles tightly closed.
• Do not use this medicine after the expiry date stated on the packaging following: Expiry date (EXP). The expiry date refers to the last day of the stated month.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 activity: 25,000 Ph.Eur. units lipase (BP units), 18,000 Ph.Eur. units amylase (BP units), 1,000 Ph.Eur. units protease.
• The other ingredients are: macrogol 4000, hypromellose phthalate, dimethicone 1000, cetyl alcohol, triethyl citrate.
  Capsule shell composition: gelatin, anhydrous iron(III) oxide (E 172), hydrated iron(III) oxide (E 172), sodium lauryl sulfate.

What Kreon 25 000 looks like and contents of the pack

• Kreon 25 000 is available as hard gelatin enteric capsules containing granules with an acid-resistant coating (mini-microspheres).
• The capsules are two-coloured: one part is opaque orange, the other part is transparent and colourless.
• Pack contents: 20, 50 or 100 capsules. Not all pack sizes may be available on the market.

Marketing Authorisation Holder
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Manufacturer
Abbott Laboratories GmbH, Werk Neustadt
Justus-von-Liebig-Str. 33
31535 Neustadt, Germany

For further information, please contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
tel. 22 546 64 00