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KREON 35,000 U HARD GASTRORESISTANT CAPSULES

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About the medicine

How to use KREON 35,000 U HARD GASTRORESISTANT CAPSULES

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Kreon 35,000 U Gastro-Resistant Capsules

Pancreatic Powder

Read all of this leaflet carefully before you start 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, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  1. What is Kreon and what is it used for
  2. What you need to know before you take Kreon
  3. How to take Kreon
  4. Possible side effects
  5. Storage of Kreon
  6. Contents of the pack and other information

1. What is Kreon and what is it used for

What is Kreon

  • Kreon contains a combination of enzymes called “pancreatic powder”.
  • Pancreatic powder is also called pancreatin. It helps to digest food. The enzymes are extracted from the pancreas glands of pigs.
  • Kreon capsules contain small granules that release the pancreatic powder slowly in your intestine (gastro-resistant granules, called minimicropheres).

What Kreon is used for

Kreon is used to treat “pancreatic exocrine insufficiency”. This is a condition where the pancreas gland does not produce enough enzymes to digest food. It occurs frequently, for example, in people who:

  • Suffer from cystic fibrosis, a rare genetic disorder.
  • Have chronic inflammation of the pancreas (chronic pancreatitis).
  • Have had all or part of their pancreas removed (total or partial pancreatectomy).
  • Have pancreatic cancer.

Kreon 35,000 can be used in children, adolescents, and adults. The dosage by age group is explained in section 3 of this leaflet, “How to take Kreon”.

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

How Kreon works

The enzymes in Kreon work by digesting food as it passes through the intestine. You should take Kreon during or immediately after a meal or snack. This will allow the enzymes to mix well with the food.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take Kreon

Do not take Kreon

  • If you are allergic to pancreatic powder or any of the other ingredients of Kreon (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Kreon.

Patients with cystic fibrosis

A rare bowel condition, called “fibrosing colonopathy”, has been detected in patients with cystic fibrosis who take high-dose pancreatic powder products. If you have cystic fibrosis and take more than 10,000 units of lipase per kilogram and day and experience unusual abdominal symptoms or changes in abdominal symptoms, tell your doctor.

The dosage of lipase units is explained in section 3 of this leaflet, “How to take Kreon”.

Severe allergic reaction

If an allergic reaction occurs, stop treatment and talk to your doctor. An allergic reaction can include itching, hives, or rash. Rarely, a more serious allergic reaction can include feeling hot, dizziness, and fainting, breathing problems; these are symptoms of a serious and potentially life-threatening condition called “anaphylactic shock”. If it occurs, seek immediate medical attention.

Talk to your doctor if you are allergic to pig proteins before taking Kreon.

Mouth irritation

Mouth pain, irritation (stomatitis), bleeding, and ulcer formation in the mouth can occur if the capsules are chewed or kept in the mouth for too long. Rinsing the mouth and drinking a glass of water may help if there are early signs of mouth irritation.

Kreon can only be sprinkled on certain foods (see section 3 of this leaflet, “How to take Kreon”).

This medicine contains less than 1 mmol of sodium (23 mg) per dose, so it is essentially sodium-free.

Using Kreon with 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, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will decide whether you can take Kreon during pregnancy.

Kreon can be used during breastfeeding.

Driving and using machines

Kreon does not affect your ability to drive or use tools or machinery.

3. How to take Kreon

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Your dose is measured in “lipase units”. Lipase is one of the enzymes in the pancreatic powder. The different concentrations of Kreon contain different amounts of lipase.

Always follow the medical advice about which dose of Kreon to take. Your doctor will adjust the dose to your needs.

This will depend on:

  • the severity of your disease
  • your weight
  • your diet
  • how much fat is in your stools

If you have fatty stools or other stomach or bowel problems (gastrointestinal symptoms), talk to your doctor, as it may be necessary to adjust the dose.

How much Kreon to take

For patients with cystic fibrosis

Children:

The concentration of this medicine may not be suitable for starting treatment in children, depending on their age and weight.

The doctor must determine the necessary dose for a child with dosage forms that contain fewer lipase units (e.g., 10,000 or 5,000 lipase units).

Once the dose per meal is established, this concentration of the medicine can be used in children.

  • The initial dose for children under 4 years is 1,000 units of lipase per kilogram of body weight per meal.
  • The initial dose for children from 4 years is 500 units of lipase per kilogram of body weight per meal.

Adolescents and adults:

The enzyme-based dosage should start with 500 units of lipase per kilogram of body weight per meal in adolescents and adults.

For all age groups:

The dose should not exceed 2,500 units of lipase per kilogram of body weight per meal or 10,000 units of lipase per kilogram of body weight per day or 4,000 units of lipase per gram of fat ingested.

For patients with other pancreatic problems

Adolescents and adults:

The usual dose for a meal is between 25,000 and 80,000 units of lipase.

The usual dose for a snack is half the dose for a meal.

When to take Kreon

Always take Kreon during or immediately after a meal or snack. This will allow the enzymes to mix well with the food and digest as it passes through the intestine.

How to take Kreon

  • Kreon must always be taken with a meal or snack.
  • The capsules should be swallowed whole with a glass of water or juice.
  • Do not break or chew the capsules or their contents, as this can cause irritation inside the mouth or change the way Kreon works in your body.
  • If you have difficulty swallowing the capsules, carefully open them and add the granules to a small amount of soft acidic food or acidic liquids. Soft acidic foods could be, for example, yogurt or apple sauce. Acidic liquids could be apple, orange, or pineapple juice. Do not mix the granules with water, milk, including flavored milk, breast milk, or formula, or hot food. Take the mixture immediately, without crushing or chewing, and drink water or juice.
  • Mixing with non-acidic food or liquids, crushing, or chewing the granules can cause irritation inside the mouth or change the way Kreon works in your body.
  • Do not keep the Kreon capsules or their contents in your mouth. Make sure the medicine and food mixture are swallowed completely and that no granules are left in the mouth.
  • Do not store the mixture.

If you take more Kreon than you should

If you take more Kreon than you should, drink plenty of water and talk to your doctor or pharmacist.

Occasionally, very high doses of pancreatic enzyme replacement medicines have caused too much uric acid in the urine (hyperuricosuria) and blood (hyperuricemia).

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91.562.04.20, stating the medicine and the amount ingested.

If you forget to take Kreon

If you forget a dose, take the next dose at the usual time, with your next meal. Do not take a double dose to make up for the forgotten dose.

If you stop taking Kreon

Do not stop taking Kreon without talking to your doctor first. Many patients will have to take Kreon for the rest of their lives.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, Kreon can cause side effects, although not everybody gets them.

The following side effects can occur with this medicine.

The most important side effects seen with pancreatic enzyme replacement medicines are “anaphylactic shock” and fibrosing colonopathy. These two side effects have occurred in a very small number of people, but their exact frequency is unknown.

Anaphylactic shock is a severe and potentially life-threatening allergic reaction that can develop rapidly.

If you experience any of the following symptoms, seek immediate medical attention:

  • Itching, hives, or rash.
  • Swelling of the face, eyes, lips, hands, or feet.
  • Weakness or fainting.
  • Difficulty breathing or swallowing.
  • Palpitations.
  • Dizziness, collapse, or loss of consciousness.

High doses of pancreatic enzyme replacement medicines can also cause scarring or thickening of the intestinal wall, which can cause blockage of the intestines, a condition called fibrosing colonopathy. If you have severe stomach pain, bowel problems (constipation), nausea, or vomiting, talk to your doctor immediately.

Very common side effects(may affect more than 1 in 10 people)

  • Stomach pain (abdomen).

Common side effects(may affect up to 1 in 10 people)

  • Feeling sick (nausea).
  • Being sick (vomiting).
  • Constipation.
  • Bloating (abdominal distension).
  • Diarrhea.

These may be due to the condition for which you are taking Kreon.

Uncommon side effects(may affect up to 1 in 100 people)

  • Rash.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Kreon

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of the month.

Do not store above 25°C.

Once opened, do not store above 25°C and use within 6 months. Keep the container tightly closed to protect from moisture.

Medicines should 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 pack and other information

What Kreon contains

The active ingredient in Kreon is pancreatic powder.

  • Each Kreon 35,000 capsule contains 420 mg of pancreatic powder which corresponds to (European Pharmacopoeia units):
  • Lipase

35,000

  • Amylase

25,200

  • Protease

1,400

  • The other ingredients are:

Contents of the capsule:

  • Hypromellose phthalate
  • Macrogol 4000
  • Triethyl citrate
  • Dimeticone 1000
  • Cetyl alcohol

Capsule shell:

  • Gelatin
  • Red and yellow iron oxides (E 172)
  • Sodium lauryl sulfate

Appearance and packaging

Kreon 35,000 capsules are elongated, size 00. They are orange and transparent. They contain gastro-resistant granules of brown color (minimicropheres).

Kreon 35,000 is available in HDPE bottles with screw caps of polypropylene 50 capsules, 60 capsules, 100 capsules, 120 capsules, and 200 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Abbott Laboratories GmbH

Justus-von-Liebig-Str. 33

31535 Neustadt

Germany

or

Mylan Germany GmbH

Lütticher Straße 5

53842 Troisdorf

Germany

You can obtain further information about this medicine from the representative of the marketing authorization holder in your country:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria

KREON 35,000 Einheiten - Kapseln

Belgium

Creon 35,000, 300 mg, maagsapresistente capsules, hard

Bulgaria

Kreon 35,000 gastro-resistant capsules, hard

Croatia

KREON 35,000 želucanootporne kapsule, tvrde

Cyprus

Creon 35,000

Czech Republic

KREON

Denmark

Creon 35,000

Estonia

Kreon 35,000 U

Finland

Creon 35,000 enterokapseli, kova

France

CREON 35,000 U, gélule gastro-résistante

Greece

Creon-P 35,000 gastro-resistant capsule, hard

Hungary

Kreon 35,000 egység gyomornedv-ellenálló kemény kapszula

Iceland

Creon 35,000 sýruþolin hylki, hörð

Ireland

Creon 35,000 Gastro-resistant Capsules

Italy

CreonIPE 35,000

Latvia

Kreon 35,000 V zarnas škistošas cietas kapsulas

Lithuania

Kreon 35,000 V skrandyje neirios kietosios kapsules

Luxembourg

Creon 35,000, 300 mg, gélules gastro-résistantes

Malta

Creon 35,000 Capsules

Netherlands

Creon 35,000, maagsapresistente capsules

Norway

Creon 35,000

Poland

Kreon 35,000

Portugal

KREON 35,000, Cápsula gastro-resistente

Romania

KREON 35,000 capsule gastrorezistente

Slovakia

Kreon 35,000, tvrdé gastrorezistentné kapsuly

Slovenia

Uprašeni pankreas Mylan 35,000 Ph.Eur.e. trde gastrorezistentne kapsule

Spain

Kreon 35,000 U cápsulas duras gastrorresistentes

Sweden

Creon 35,000 enterokapslar, hårda

United Kingdom

Creon 35,000 Capsules

Date of last revision of this leaflet: September 2018

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

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Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

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Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

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Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

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Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

Over the years, he has gained solid experience in interpreting MRI studies in various areas, including:

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You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

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Frequently Asked Questions

Is a prescription required for KREON 35,000 U HARD GASTRORESISTANT CAPSULES?
KREON 35,000 U HARD GASTRORESISTANT CAPSULES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in KREON 35,000 U HARD GASTRORESISTANT CAPSULES?
The active ingredient in KREON 35,000 U HARD GASTRORESISTANT CAPSULES is multienzymes (lipase, protease etc.). This information helps identify medicines with the same composition but different brand names.
Who manufactures KREON 35,000 U HARD GASTRORESISTANT CAPSULES?
KREON 35,000 U HARD GASTRORESISTANT CAPSULES is manufactured by Viatris Healthcare Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of KREON 35,000 U HARD GASTRORESISTANT CAPSULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether KREON 35,000 U HARD GASTRORESISTANT CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to KREON 35,000 U HARD GASTRORESISTANT CAPSULES?
Other medicines with the same active substance (multienzymes (lipase, protease etc.)) include KREON 10,000 U HARD GASTRORESISTANT CAPSULES, KREON 25,000 U HARD GASTRO-RESISTANT CAPSULES, KREON 5,000 U GASTRO-RESISTANT GRANULES. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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