KREON 25,000 U HARD GASTRO-RESISTANT CAPSULES

2. What you need to know before you take Kreon

Do not take Kreon:

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

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before taking Kreon.

Be particularly careful with Kreon:

• if you experience symptoms of an allergy.
• if you have a rare intestinal disorder called "fibrosing colonopathy", where the intestine narrows, which has been described in patients with cystic fibrosis taking 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 medicinal products, the name and batch number of the administered medicinal product must be clearly recorded.

Other medicines and Kreon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Taking Kreon with food, drinks, and alcohol

This medicine is taken during or immediately after meals. If necessary, the contents of the capsules can be mixed with soft or liquid foods. In this case, the mixture should be taken immediately to avoid damaging the enzymes.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There are no data in pregnant or breast-feeding women, but animal studies do not show absorption or systemic exposure of pancreatic enzymes. Precautions should be taken when prescribing this medication to pregnant or breast-feeding women.

In case it is necessary to use Kreon during pregnancy or breast-feeding, it should be administered in doses that are sufficient to achieve an adequate nutritional status.

Driving and Using Machines

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

Kreon contains sodium

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

3. How to Take Kreon

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

Dosing inPediatric and Adult Patients with Cystic Fibrosis

The initial dose is established according to weight and age. The initial dose should 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.

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

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

Dosing in OtherConditions Associated with Pancreatic Exocrine Insufficiency

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

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

When there is difficulty swallowing the capsules, they can be opened and the contents 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 apple, orange, or pineapple juice.

Mixing with foods or liquids that are not acidic, crushing, or chewing the capsules can cause irritation in the mouth or change the way Kreon works in the body.

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

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

Do not store the mixture.

Drink plenty of fluids (2-3 liters) while taking this medicine to maintain adequate hydration.

If you take more Kreon than you should

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

Consult your doctor, pharmacist, or nurse immediately or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Kreon

If you forget to take this medicine, wait until the next meal and take the usual number of capsules. Do not take a double dose to make up for forgotten doses.

If you stop taking Kreon

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

4. Possible Side Effects

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

The following side effects were detected during studies in patients taking Kreon. These side effects may occur with this medicine:

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

Common (may affect up to 1 in 10 people): nausea, vomiting, constipation, abdominal bloating, 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 lower than those not taking Kreon.

Uncommon (may affect up to 1 in 100 people): skin rash.

Frequency not known (cannot be estimated from the available data): itching, hives.

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

Intestinal strictures and colonopathy (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatic enzyme preparations.

If you experience side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: 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 store above 25°C.

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

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

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 Further Information

Composition of Kreon

• The active substance is pancreatin (lipase, amylase, protease). Each capsule contains 300 mg of pancreatin, equivalent to 25,000 Ph. Eur. units of lipase, 18,000 Ph. Eur. units of amylase, and 1,000 Ph. Eur. units of protease.

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

Appearance of the Product and Contents of the Pack

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

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 Strasse 33

31535 Neustadt (Germany)

You can obtain further information on this medicine by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the last revision of this leaflet: July 2021

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