Package Insert: Information for the User

Kreon 25,000 U Capsules, Hard, Gastric-Resistant

pancreatin (lipase, amylase, protease)

Package Insert Content:

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 is used for the treatment of exocrine pancreatic insufficiency.

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.

Traceability

In order to improve the traceability of biological medicines, the name and batch number of the administered medication must be clearly recorded.

Other medications and Kreon

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication, including those purchased without a prescription.

Taking Kreon with food, drinks, and alcohol

This medication is taken during or immediately after meals. If necessary, the contents of the capsules can be mixed with liquid or soft foods. In this case, the mixture must 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 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 the ability to drive and operate hazardous machinery.

Kreon contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose unit; that is, it is essentially "sodium-free."

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage in pediatric and adult patients with cystic fibrosis

The initial dose is set according to weight and age. The initial dose must be 1,000 units of lipase/kg/meal in children under 4 years and 500 units of lipase/kg/meal in children over 4 years.

Your doctor will decide the maintenance dose based on symptom control.

The administered dose must not exceed 10,000 units of lipase/kg body weight and day or 4,000 units of lipase/g of ingested fat

Dosage in other conditions associated with exocrine pancreatic insufficiency

The dose must be adjusted individually according to symptoms and the fat content of the diet. The dose required per meal varies between approximately25,000 to80,000 units Ph. Eur. of lipase and half the individual dose in case of light meals.

The capsules must be swallowed whole, without chewing or crushing, with sufficient liquid during or after main and minor meals.

In case of difficulty swallowing the capsules, they can be opened and the content can be mixed with a small amount of slightly acidic food or acidic liquids. Slightly acidic foods could be, for example, apple sauce or yogurt. Acidic liquids could be orange or pineapple juice.

Mixing with non-acidic foods, crushing, or chewing the capsules may cause irritation in the mouth or change the way Kreon acts in the body.

Do not retain the Kreon capsules or their content in the mouth.

This mixture must be taken immediately to avoid damaging the coating of the granules.

Do not store the mixture.

Drink abundantly (2-3 liters of liquid) 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 advisable 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.

If you forgot to take Kreon

If you forget to take this medication, wait until the next meal and take the usual number of capsules.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, this medicationcan produce adverse effects, although not all people will experience them.

The following adverse effects were detected during studies in patients taking Kreon. These adverse effects may appear with this medication:

Very common (may affect more than 1 in 10 people): abdominal pain.

Common (may affect up to 1 in 10 people): nausea, vomiting, constipation, inflamed abdomen, diarrhea.

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

Uncommon (may affect up to 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 they are adverse effects that do not appear 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 that does not appear 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 about the safety of this medication.

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

Do not store at a temperature above 25 °C.

Once opened, it should not be stored above 25 °C and should be used before 6 months have passed.Keep the container perfectly closed

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

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

Kreon Composition

-The active principle is pancreatin (lipase, amylase, protease). Each capsule contains 300 mg of pancreatin, which is equivalent to 25,000 U of lipase, 18,000 U of amylase, and 1,000 U of protease.

- The other components are macrogol 4000, hypromellose phthalate, cetyl alcohol, triethyl citrate, and dimethicone. The capsule components are: gelatin, iron oxide red and yellow (E-172), and sodium lauryl sulfate.

Appearance of the product and contents of the packaging

Kreon 25,000is presented in the form of hard gelatin capsules with an orange opaque head and a transparent body in plastic containers. CEach container contains 50 or 100 capsules.

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 marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Last reviewed date of this leaflet: July 2021

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