KREON 35000 Ph.Eur.U. Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Kreon 35,000 and what is it used for
   1. What is Kreon 35,000
   2. What is Kreon 35,000 used for
   3. How Kreon 35,000 works
3. Important information before taking Kreon 35,000
   1. When not to take Kreon 35,000
   2. Warnings and precautions
   3. Kreon 35,000 and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
4. How to take Kreon 35,000
   1. Dosage of Kreon 35,000
   2. Patients with cystic fibrosis
   3. Patients with other pancreatic disorders
   4. When to take Kreon 35,000
   5. How to take Kreon 35,000
   6. Taking a higher dose of Kreon 35,000 than recommended
   7. Missing a dose of Kreon 35,000
   8. Stopping treatment with Kreon 35,000
5. Possible side effects
   1. Reporting side effects
6. How to store Kreon 35,000
7. Contents of the pack and other information
   1. What Kreon 35,000 contains
   2. What Kreon 35,000 looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Kreon 35,000, 35,000 Ph.Eur.U. of lipolytic activity, enteric-coated capsules, hard
Pancreatinum

Read the 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 or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Kreon 35,000 and what is it used for
• 2. Important information before taking Kreon 35,000
• 3. How to take Kreon 35,000
• 4. Possible side effects
• 5. How to store Kreon 35,000
• 6. Contents of the pack and other information

1. What is Kreon 35,000 and what is it used for

What is Kreon 35,000

• Kreon 35,000 contains a mixture of digestive enzymes called pancreatin (pancreatic powder).
• Pancreatin helps digest food. The enzymes are obtained from pig pancreas.
• Kreon 35,000 contains small pellets that slowly release pancreatin in the intestine (pellets resistant to stomach acid, called minimicrospheres).

What is Kreon 35,000 used for

Kreon 35,000 is used to treat pancreatic exocrine insufficiency. This is a condition in which the pancreas does not produce enough digestive enzymes to digest food.
It often occurs in patients with:

• cystic fibrosis (a rare genetic disease)
• chronic pancreatitis
• pancreas removal or partial removal
• pancreatic cancer Kreon 35,000 can be used in children, adolescents, and adults. The dosage in different age groups is presented in section 3 of this leaflet "How to take Kreon 35,000". Treatment with Kreon 35,000 reduces the severity of symptoms of pancreatic exocrine insufficiency, including stool consistency (i.e., fatty stools), abdominal pain, bloating, and frequency of stool passage (diarrhea or constipation), regardless of the underlying disease.

The medicine can only be used if one of the above conditions has been previously confirmed by a doctor and the doctor has recommended taking this medicine.
Newborns and children can take this medicine only if it has been prescribed by a doctor and treatment is carried out under close medical supervision.
If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

How Kreon 35,000 works

The enzymes contained in Kreon 35,000 work by digesting food passing through the small intestine. Kreon 35,000 should be taken during or immediately after main meals or 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 35,000

When not to take Kreon 35,000

• if the patient is allergic to pancreatin or any of the other ingredients of Kreon 35,000 (listed in section 6)

Warnings and precautions

Before starting treatment with Kreon 35,000, the patient should discuss it with their 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 gastrointestinal tract or changes in existing symptoms, the patient should contact their doctor.
The dosage in terms of lipase has been presented in section 3 of the leaflet "How to take Kreon 35,000".
Severe allergic reactions
If an allergic reaction occurs, the patient should stop taking the medicine and contact their 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, the patient should seek immediate medical attention.
Before taking Kreon 35,000, the patient should inform their doctor about an allergy to pork protein.
Mouth irritation
Chewing 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, rinsing the mouth with water and drinking a glass of water may be helpful.
The contents of the Kreon 35,000 capsule can be sprinkled on certain foods (see section 3 of this leaflet "How to take Kreon 35,000").
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

Kreon 35,000 and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The doctor will decide whether the patient can take Kreon 35,000 during pregnancy.
Kreon 35,000 can be taken during breastfeeding.

Driving and using machines

Kreon 35,000 does not affect the ability to drive and use tools and machines.

3. How to take Kreon 35,000

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their 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 decided by the doctor. The doctor will adjust the dose to the patient's 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 or gastrointestinal symptoms (gastrointestinal symptoms) persist, the patient should contact their doctor, as there may be a need to adjust the dose.

Dosage of Kreon 35,000

Patients with cystic fibrosis

Children
This strength of the medicine may not be suitable for starting treatment in children, depending on the child's age and weight.
The dose suitable for the child should always be determined by the doctor using a medicine with a lower content of lipolytic activity units (i.e., 10,000 or 5,000 Ph.Eur.U. of lipolytic activity).
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 1,000 Ph.Eur.U. of lipolytic activity/kg body weight/meal.
• Usually, the initial dose in children over 4 years of age 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 weight, is 500 Ph.Eur.U. of lipolytic activity/kg body weight/meal.
Patients of all ages
Usually, the daily dose should not exceed 2,500 Ph.Eur.U. of lipolytic activity/kg body weight/meal or 10,000 Ph.Eur.U. of lipolytic activity/kg body weight/day or 4,000 Ph.Eur.U. of lipolytic activity/kg body weight/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 35,000

Kreon 35,000 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 35,000

• Kreon 35,000 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 food can be, for example, yogurt or apple puree. Acidic drinks can be apple, orange, or pineapple juice. The pellets should not be mixed with water, milk (including flavored milk), breast milk, or infant formula, or hot food. The mixture should be swallowed immediately without chewing or crushing 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 35,000 in the body.
• Kreon 35,000 or the contents of the capsules should not be kept in the mouth. The patient should make sure that the medicine or the mixture of the medicine with food has been completely swallowed and no pellets remain in the mouth.
• The mixture of the medicine should not be stored.

Taking a higher dose of Kreon 35,000 than recommended

In case of taking too much Kreon 35,000, the patient should drink plenty of water and consult their 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 35,000

In case of missing a dose of Kreon 35,000, the patient should take the normal dose at the usual time with the next meal. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Kreon 35,000

The patient should not stop taking Kreon 35,000 without consulting their doctor. Many patients need to take Kreon 35,000 for the rest of their lives.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Kreon 35,000 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 any of the following symptoms occur, the patient should 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 bowel obstruction. This condition is called fibrosing colonopathy. If severe abdominal pain, problems with passing stools (constipation), nausea, or vomiting occur, the patient should contact their 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 side effects may be a result of the disease for which Kreon 35,000 is indicated.

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

• rash

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 will help to gather more information on the safety of the medicine.

5. How to store Kreon 35,000

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after: EXP.
The expiry date refers to the last day of the month. The batch number is stated on the label and carton after: Lot.
Do not store above 25°C.
After first opening, do not store above 25°C. The shelf life after first opening the bottle: 6 months. Store the bottles tightly closed to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Kreon 35,000 contains

The active substance of the medicine is pancreatic powder (pancreatin).

• Each Kreon 35,000 capsule contains 420 mg of pancreatic powder (pancreatin) with an activity of:
• lipolytic 35,000 Ph.Eur.U.
• amylolytic 25,200 Ph.Eur.U.
• proteolytic 1,400 Ph.Eur.U.
• Other ingredients 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)
• sodium lauryl sulfate

What Kreon 35,000 looks like and contents of the pack

Kreon 35,000 capsules, size 00 elongated, have one part dark orange and the other transparent. They contain brownish pellets resistant to stomach acid (minimicrospheres).
Kreon 35,000 is available in HDPE bottles with a PP cap, containing 50, 60, 100, 120, or 200 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, Site Neustadt
Justus-von-Liebig-Straße 33
31535 Neustadt
Germany
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Höhe
Benzstraße 1
61352 Bad Homburg v.d. Höhe
Germany
To obtain more detailed information, the patient should contact the 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: