KREON 35 000

Patient Information Leaflet

Kreon 35 000, 35 000 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 side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Kreon 35 000 is and what it is 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 Kreon 35 000 is and what it is 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 derived from porcine pancreas.
• Kreon 35 000 contains small pellets that slowly release pancreatin in the intestine (acid-resistant pellets known as minimicrospheres).

What Kreon 35 000 is used for
Kreon 35 000 is used in the treatment of 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
• Surgical removal of the pancreas or part of it
• Pancreatic cancer

Kreon 35 000 can be used in infants, children, adolescents, and adults. Dosage recommendations for different age groups are provided in section 3 of this leaflet, "How to take Kreon 35 000". Treatment with Kreon 35 000 helps reduce 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.

This medicine should only be used if one of the above-mentioned conditions has been previously diagnosed by a doctor and the doctor has recommended taking this medicine.
Newborns and children may take this medicine only if prescribed by a doctor and under strict medical supervision.
If there is no improvement after 5 days of treatment, or if the patient feels worse, please contact your doctor.

How Kreon 35 000 works
The enzymes in Kreon 35 000 work by digesting food as it passes through the small intestine. Kreon 35 000 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 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, discuss this with your doctor or pharmacist.
Patients with cystic fibrosis
A rare bowel condition called fibrosing colonopathy, which causes 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 greater than 10,000 Ph.Eur.U. lipolytic activity/kg body weight/day, and you develop any new or worsening gastrointestinal symptoms, you should contact your doctor.
Dosing expressed as lipase dose is provided in section 3 of this leaflet, "How to take Kreon 35 000".
Severe allergic reactions
If you experience an allergic reaction, stop taking the medicine and contact your doctor immediately.
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 urgent medical help immediately.
Before taking Kreon 35 000, inform your doctor if you are allergic to pork protein.
Irritation of the mouth
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 35 000 capsules may be sprinkled onto 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, i.e. the medicine is considered "sodium-free".
Kreon 35 000 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 35 000 during pregnancy.
Kreon 35 000 can be taken during breastfeeding.
Driving and operating machinery
Kreon 35 000 has no influence on the ability to drive and use tools or machinery.

3. How to take Kreon 35 000

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 units of lipolytic activity. 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, who will adjust the dose according to the patient's needs, based on:

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

If fatty stools or gastrointestinal symptoms persist, contact a doctor, as the dose may need to be adjusted.

Dosage of Kreon 35 000
Patients with cystic fibrosis
Children
This strength of the medicine may not be appropriate for initiating treatment in children, depending on the child's age and body weight. The appropriate dose for a child should always be determined by a doctor using a lower-strength formulation (i.e. 10,000 or 5,000 Ph.Eur.U. of lipolytic activity). Once the meal dose has been established, this strength may be used in children.

• The usual initial dose in children under 4 years of age is 1,000 Ph.Eur.U. of lipolytic activity/kg body weight/meal.
• The usual initial dose in children aged 4 years and older is 500 Ph.Eur.U. of lipolytic activity/kg body weight/meal.

Adolescents and adults
The usual initial dose in adolescents and adults, based on body weight, is 500 Ph.Eur.U. of lipolytic activity/kg body weight/meal.

Patients of all ages
The usual 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 dietary fat intake.

Patients with other pancreatic disorders
Adolescents and adults
The usual dose is 25,000 to 80,000 Ph.Eur.U. of lipolytic activity per main meal. For snacks, the usual dose is half the dose taken with 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 ensures proper mixing of the enzymes with food and effective digestion 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 with water or juice.
• Do not chew or crush the capsules or their contents, as this may irritate the mouth or alter the medicine's action in the body.
• If swallowing capsules is difficult, the capsule may be carefully opened and the pellets mixed with a small amount of soft, acidic food or acidic drink. Acidic foods include, for example, yoghurt or apple puree. Acidic drinks include apple, orange, or pineapple juice. Do not mix the pellets with water, milk (including flavoured milk, breast milk, or 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 irritate the mouth or alter the action of Kreon 35 000 in the body.
• Do not retain Kreon 35 000 or the capsule contents in the mouth. Ensure that the medicine or the mixture of medicine with food is completely swallowed and that no pellets remain in the mouth.
• Do not store the medicine mixture.

Taking more than the recommended dose of Kreon 35 000
If too high a dose of Kreon 35 000 is taken, drink plenty of water and consult a doctor or pharmacist. Very high doses of pancreatin may sometimes increase uric acid levels in urine and blood.

Missing a dose of Kreon 35 000
If a dose of Kreon 35 000 is missed, take the normal dose at the usual time with the next meal. Do not take a double dose to make up for a missed dose.

Stopping treatment with Kreon 35 000
Do not stop taking Kreon 35 000 without consulting a doctor. Many patients need to take Kreon 35 000 for life.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Kreon 35 000 can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur in patients taking this medicine.
The most important and serious adverse reactions reported during treatment with medicines containing pancreatic enzymes are "anaphylactic shock" and fibrosing colonopathy. These two adverse reactions have occurred in a very small number of individuals, 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, or rash
• swelling of the face, eyes, lips, hands, or feet
• pre-syncope or fainting
• difficulty breathing or swallowing
• palpitations
• dizziness, falls, 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 obstruction. This condition is called fibrosing colonopathy. If you experience severe abdominal pain, problems with bowel movements (constipation), nausea, or vomiting, contact your doctor immediately.

Very common adverse reactions (occurring in more than 1 in 10 patients):

• abdominal pain

Common adverse reactions (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 35 000 is prescribed.

Uncommon adverse reactions (occurring in less than 1 in 100 patients):

• rash

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Kreon 35 000

Keep the medicine out of the 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 stated month. The batch number is indicated on the label
and carton after: Lot.
Do not store above 25°C.
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 will help protect the environment.

6. Contents of the packaging and other information

What Kreon 35 000 contains
The active substance in Kreon 35 000 is pancreatic powder (pancreatin).

• Each Kreon 35 000 capsule contains 420 mg of pancreatic powder (pancreatin) with the following activity:
  • Lipolytic: 35 000 Ph.Eur.U.
  • Amylolytic: 25 200 Ph.Eur.U.
  • Proteolytic: 1 400 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), sodium lauryl sulfate

What Kreon 35 000 looks like and contents of the pack
Kreon 35 000 capsules are elongated size 00, with one dark orange and one transparent part. They contain brownish acid-resistant pellets (minimicrospheres).
Kreon 35 000 is available in HDPE bottles with PP screw caps containing 50, 60, 100, 120, and 200 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, Site Neustadt
Justus-von-Liebig-Straße 33
31535 Neustadt
Germany
Mylan Germany GmbH
Branch office Bad Homburg v. d. Höhe
Benzstraße 1
61352 Bad Homburg v.d. Höhe
Germany

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