Kreon 10 000

Package leaflet: Information for the patient

Kreon 10 000, 10 000 Ph.Eur.U. lipolytic activity, enteric-coated hard capsules
Pancreatinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

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

Contents of the leaflet

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

What Kreon 10 000 is

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

What Kreon 10 000 is used for
Kreon 10 000 is used to treat exocrine pancreatic insufficiency. This is a condition in which the pancreas does not produce enough digestive enzymes. It commonly occurs in patients with:

• Cystic fibrosis (a rare genetic disorder)
• Chronic pancreatitis
• Pancreatectomy or partial removal of the pancreas
• Pancreatic cancer

Kreon 10 000 can be used in children, adolescents, and adults. Dosage recommendations for each age group are provided in section 3 of this leaflet, "How to take Kreon 10 000".

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

How Kreon 10 000 works
The enzymes 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 ensures thorough mixing of the enzymes with food.

2. Important information before taking Kreon 10 000

When not to take Kreon 10 000

• if the patient is 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 this with your doctor or pharmacist.
Patients with cystic fibrosis
A rare bowel condition 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.U. lipolytic activity/kg body weight/day, and you experience any new or worsening gastrointestinal symptoms, you should contact your doctor.
Dosing expressed in terms of lipase dosage is provided in section 3 of this leaflet, "How to take Kreon 10 000".

Severe allergic reactions
If an allergic reaction occurs, stop taking the medicine and contact your doctor.
An allergic reaction may include itching and rash. A less common, more serious allergic reaction may include: hot flushes, dizziness and fainting, breathing difficulties.
These are symptoms of a severe, potentially life-threatening condition called "anaphylactic shock". If this occurs, seek immediate medical help.

Before taking Kreon 10 000, inform your doctor if you are allergic to porcine (pork) protein.

Oral irritation
Chewing and/or holding the capsules in the mouth for too long may cause pain, irritation, bleeding, and ulceration of the oral mucosa. If early signs of oral irritation occur, rinsing the mouth with water and drinking a glass of water may help.

The contents of Kreon 10 000 capsules may be sprinkled onto 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, i.e. the medicine is considered "sodium-free".

Kreon 10 000 and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Your doctor will decide whether you can take Kreon 10 000 during pregnancy.
Kreon 10 000 may be taken during breastfeeding.

Driving and operating machinery
Kreon 10 000 has no influence on the ability to drive and use tools or machines.

3. How to take Kreon 10 000

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
The dose is measured in lipolytic activity units. 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 determined by the doctor. The doctor will adjust the dose according to the patient's needs.
The dose depends on:

• severity of the disease
• body weight
• diet being followed
• amount of fat present in the stool

If fatty stools or gastrointestinal symptoms persist, contact a doctor, as dose adjustment may be necessary.

Dosage of Kreon 10 000
Patients with cystic fibrosis
Children
The appropriate dose for a child should always be determined by a doctor.
After the dose per meal has been established, this strength of the medicine may be used in children.

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

Adolescents and adults
The usual initial dose in adolescents and adults, adjusted according to body weight, is
500 Ph.Eur.U. lipolytic activity/kg body weight/meal.
Patients of any age
The usual daily dose should not exceed 2500 Ph.Eur.U. lipolytic activity/kg body
weight/meal or 10 000 Ph.Eur.U. lipolytic activity/kg body weight/day or 4000 Ph.Eur.U.
lipolytic activity per gram of dietary fat ingested.
Patients with other pancreatic disorders
Adolescents and adults
The usual dose ranges from 25 000 to 80 000 Ph.Eur.U. lipolytic activity per main meal.
For snacks, the usual dose is half the dose taken with 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 ensures thorough mixing of the enzymes with food and proper digestion as it passes 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 with water or juice.
• Do not chew or crush the capsules or their contents, as this may cause irritation of the mouth or alter the medicine's action in the body.
• If swallowing the capsules is difficult, they may be carefully opened and the pellets mixed with a small amount of soft, acidic food or acidic drink. Suitable soft acidic foods include, for example, yoghurt or apple puree. Suitable acidic drinks include apple, orange or pineapple juice. Do not mix the pellets with water, milk (including flavoured milk), breast milk, infant formula, or hot food. The mixture should be swallowed immediately without chewing or crushing, and followed with water or juice.
• Mixing with non-acidic food or drink, or chewing or crushing the minimicrospheres, may cause irritation of the mouth or alter the action of Kreon 10 000 in the body.
• Do not retain Kreon 10 000 or the capsule contents in the mouth. Ensure that the medicine or medicine-food mixture has been completely swallowed and that no pellets remain in the mouth.
• Do not store the medicine mixture.

Taking more Kreon 10 000 than recommended
If too high a dose of Kreon 10 000 has been taken, drink plenty of water and consult a
doctor or pharmacist.
Very high doses of pancreatin may sometimes increase the level of uric acid in urine
and blood.
Missing a dose of Kreon 10 000
If a dose of Kreon 10 000 is missed, 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 a doctor. Many patients need to take Kreon 10 000 for life.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible side effects

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

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

Long-term use of high doses of medicines containing pancreatic enzymes may also cause scarring or thickening of the intestinal wall, which may lead to intestinal blockage. This condition is called fibrosing colonopathy. If you experience severe abdominal pain, problems with passing stools (constipation), nausea or vomiting, 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
• diarrhoea
  These effects may be due to the underlying disease for which Kreon 10 000 is prescribed.

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

• rash

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Kreon 10 000

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the immediate packaging and carton, marked as EXP. The expiry date refers to the last day of the specified month.
The batch number is indicated on the immediate packaging and carton, marked as 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. Keep bottles tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the package and other information

What Kreon 10 000 contains
The active substance is pancreatic powder (pancreatin).

• Each Kreon 10 000 capsule contains 150 mg of pancreatic powder (pancreatin) with activity:
  • lipolytic: 10,000 Ph.Eur.U.
  • amylolytic: 8,000 Ph.Eur.U.
  • proteolytic: 600 Ph.Eur.U.
• Other components are:
  • Macrogol 4000
  • Pellet coating: hypromellose phthalate, cetyl alcohol, triethyl citrate, dimethicone 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 acid-resistant pellets (mini-microspheres).
Kreon 10 000 is available in HDPE bottles with polypropylene screw caps containing 50, 100 and 200 capsules, and in aluminium/aluminium blisters containing 20 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Pancrin 10 000, magensaftresistente Hartkapseln
Poland: Kreon 10 000

For further information, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00