Prospecto : information for the user

Kreon 5.000 U granulated gastro-resistant

Pancreatina (lipase, amylase, protease)

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect.See section 4.

1.What is Kreon and for what it is used

2.What you need to know before starting to take Kreon

3.How to take Kreon

4.Possible adverse effects

5.Storage of Kreon

6.Contents of the package and additional information

Kreon belongs to a group of medications known as pancreatic enzymes. Thanks to its activity on fats, carbohydrates, and proteins, pancreatic enzymes facilitate digestion and promote the absorption of food in individuals whose body is unable to produce sufficient amounts of these enzymes.

The pancreatin (lipase, amylase, protease) contained in this preparation is extracted from a pig pancreas.

Kreon 5,000 U is used for the treatment of exocrine pancreatic insufficiency in children, infants, and adults who cannot swallow capsules. It is used when low doses of pancreatin are required.

Do not take Kreon:

• if you are allergic to pancreatin (lipase, amylase, protease) or to any of the other components of this medication (listed in section 6).

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to take Kreon.

Be especially careful with Kreon:

• if you experience symptoms of an allergy.
• if you experience a rare intestinal disorder called "fibrosing colopathy," in which the intestine narrows, which has been described in patients with cystic fibrosis who take high doses of pancreatic enzymes.

However, if you have cystic fibrosis and take more than 10,000 units of lipase per kilogram of body weight per day and experience unusual abdominal symptoms or changes in abdominal symptoms, inform your doctor.

Taking Kreon with other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Taking Kreon with food, drinks, and alcohol:

This medication is taken during or immediately after meals. If necessary, it can be mixed with slightly acidic foods or acidic liquids. In this case, the mixture should be taken immediately to avoid damaging the enzymes.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There are no data in pregnant women or breastfeeding women, but animal studies do not show absorption or systemic exposure to pancreatic enzymes. Precautions should be taken when prescribing this medication to pregnant women, as well as to women who are breastfeeding.

If it is necessary to use Kreon during pregnancy or breastfeeding, it should be administered in doses sufficient to achieve adequate nutritional status.

Driving and operating machinery:

Given the characteristics of this medication, it is unlikely that its administration will affect your ability to drive and operate hazardous machinery.

Follow exactly the administration instructions for Kreon indicated by your doctor or pharmacist.

Always use the dosing spoon contained in the package. One spoonful contains 5,000 units of lipase.

The dose will be adjusted according to the severity of the disease, weight, diet, and fat content in stools. If you continue to have fatty stools or other gastrointestinal symptoms, consult your doctor, as you may need to adjust your dose.

Dosage in pediatric and adult patients with cystic fibrosis

In children up to 2 years old, the initial dose should be up to 5,000 units of lipase per meal (calculated for meals of approximately 120 ml of formula) and adjust it to a maximum dose of 2,500 units of lipase/kg/meal. The maximum dose should not exceed 10,000 units of lipase/kg of body weight per day.

The most frequent starting dose for children under 4 years old is 1,000 units of lipase/kg/meal.

The most frequent starting dose for children 4 years old or older, adolescents, or adults is 500 units of lipase/kg/meal.

Dosage in other conditions associated with exocrine pancreatic insufficiency

The dose should be adjusted individually according to symptoms and fat content in the diet. The dose needed per meal varies between approximately 25,000 to 80,000 units Ph. Eur. of lipase and half the individual dose in case of light meals.

Kreon should be taken during or after meals. This allows the enzymes to mix completely with food and digest as they pass through the intestine.

Microgranules can be mixed with small amounts of slightly acidic foods that do not require mastication or with acidic liquids. Slightly acidic foods could be apple sauce or yogurt. Liquids could be fruit juices, for example, apple, orange, or pineapple.

Alternatively, the granulated gastro-resistant (minimicrospheres) can be mixed with small amounts of milk and given immediately to the child. Do not add the minimicrospheres to the bottle.

Any mixture with food or drink should be taken immediately without crushing or chewing, followed by water or juice to ensure complete ingestion. This mixture should not be stored.

Crushing or chewing the minimicrospheres or mixing with foods or liquids that are not acidic may cause irritation in the mouth or change the way Kreon acts in the body.

Do not retain the medication in the mouth.

It is essential to ensure adequate hydration at all times while taking this medication to maintain an adequate state of hydration.

If you take more Kreon than you should

In case of overdose or accidental ingestion, it is recommended to suspend treatment and drink plenty of water.

Consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

High doses of pancreatin may cause, in some cases, an increase in uric acid in urine or blood.

If you forget to take Kreon

If you forget to take this medication, wait until the next meal and take the usual dose of enzymes. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Kreon

Your doctor will indicate the duration of your treatment with Kreon. Do not interrupt it without consulting him first.

Like all medications, Kreon can produce adverse effects, although not all people will experience them.

The following adverse effects were detected during the studies conducted in patients taking Kreon 5,000 U. These adverse effects may appear when using this medication:

Very Frequent(affect more than 1 in 10 people): stomach pain (abdomen).

Frequent(affect 1 in 10 people): nausea, vomiting, constipation, inflamed abdomen, diarrhea.

These effects may be due to the disease for which you are taking Kreon. During the studies conducted, the number of patients taking Kreon who presented stomach pain or diarrhea was similar or lower than patients not taking Kreon.

Rare(affect 1 in 100 people): skin rash.

Unknown Frequency(cannot be estimated from available data): pruritus (itching), urticaria.

Kreon may cause other severe allergic reactions (hypersensitivity) that include breathing problems or swelling of the lips.

Intestinal stenosis and colonopathy (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of preparations containing pancreatin.

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if it is an adverse effect not listed in this prospectus.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist or nurse, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly throughthe Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

After opening, do not store at a temperature above25°Cand use within the 3 months that follow.

Keep the container perfectly closed to protect it from moisture.

Do not use this medication after the expiration date that appears on the container after CAD.The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash.Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Composition ofKreon

- The active principle of Kreon is pancreatin (lipase, amylase, protease). Each spoonful contains 100mg of microspheres. This is equivalent to 60.12mg of pancreatin corresponding to (in Ph. Eur. units) 5,000 U of lipase, 3,600 U of amylase, and 200 U of protease.

- The other components are for the core of the granule: macrogol 4000 and for the coating are hypromellose phthalate, dimethicone 1000, triethyl citrate, cetyl alcohol.

Appearance of the product and contents of thepackage

Kreon 5,000 U is presented in the form of gastro-resistant microgranules (Minimicrospheres™), round and light brown in color.

Each package contains a glass vial of20g. The vial comes inside a cardboard box provided with a measuring spoon.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Abbott Laboratories GmbH

Justus von Liebig Strasse 33

31535 Neustadt

Germany

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This leaflet has been reviewed inMarch 2016

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/