Kreon 5,000 U gastro-resistant granules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Kreon 5,000 U gastro-resistant granules

Pancreatine (lipase, amylase, protease)

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Kreon is and what it is used for
2. What you need to know before taking Kreon
3. How to take Kreon
4. Possible side effects
5. How to store Kreon
6. Contents of the pack and other information

1. What Kreon is and what it is used for

Kreon belongs to a group of medicines known as pancreatic enzymes. Due to their activity on fats, carbohydrates, and proteins, pancreatic enzymes aid digestion and promote the absorption of food in individuals whose bodies are unable to produce sufficient amounts of these enzymes.

The pancreatin (lipase, amylase, protease) contained in this preparation is derived from the pancreas of pigs.

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.

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

Do not take Kreon:

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

Warnings and precautions:

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

Take special care with Kreon:

• if symptoms of allergy occur.
• if you experience a rare intestinal disorder called "fibrosing colonopathy," in which the intestine becomes narrowed. This has been reported in patients with cystic fibrosis taking high doses of pancreatic enzymes.

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

Taking Kreon with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Taking Kreon with food, drinks, and alcohol

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

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Pregnancy, breastfeeding and fertility

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

There are no data available in pregnant or breastfeeding women; however, animal studies have shown no absorption or systemic exposure to pancreatic enzymes. Precautions should be taken when prescribing this medication to pregnant women or those who are breastfeeding.

If Kreon needs to be used during pregnancy or breastfeeding, it should be administered at doses sufficient to achieve adequate nutritional status.

Driving and use of machines

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

3. How to take Kreon

Follow exactly the administration instructions for Kreon provided 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, body weight, diet, and fat content in stools. If you continue to have fatty stools or other gastrointestinal symptoms, consult your doctor, as your dose may need to be adjusted.

Dosage in pediatric and adult patients with cystic fibrosis

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

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

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

Dosage in other conditions associated with exocrine pancreatic insufficiency

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

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

The microspheres may be mixed with small amounts of slightly acidic foods that do not require chewing, or with acidic liquids. Slightly acidic foods could include apple puree or yogurt. Liquids could include fruit juice, for example apple, orange, or pineapple juice.

Alternatively, the gastro-resistant granules (mini-microspheres) may be mixed with small amounts of milk and administered immediately to the child. Do not add the mini-microspheres to a feeding bottle.

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

Crushing or chewing the mini-microspheres or mixing them with foods or liquids that are not acidic may cause irritation in the mouth or alter the way Kreon works in the body.

Do not retain the medication in the mouth.

It is important to ensure adequate hydration at all times while taking this medication to maintain proper hydration status.

If you take more Kreon than you should

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

Contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91.562.04.20, indicating the medication and the amount ingested.

High doses of pancreatin may in some cases lead to increased uric acid levels in urine or blood.

If you forget to take Kreon

If you forget to take this medication, wait until the next meal and take your usual enzyme dose. Do not take a double dose to make up for missed doses.

If you stop taking Kreon

Your doctor will advise you on the duration of your treatment with Kreon. Do not stop treatment without consulting your doctor first.

4. Possible adverse effects

Like all medicines, Kreon can cause adverse effects, although not everyone experiences them.

The following adverse effects were observed during studies conducted in patients taking Kreon 5,000 U. These adverse effects may occur when using this medicine:

Very common (affects more than 1 in 10 people): stomach (abdominal) pain.

Common (affects 1 in 10 people): nausea, vomiting, constipation, bloated abdomen, diarrhoea.

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

Uncommon (affects 1 in 100 people): skin rash.

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

Kreon may cause other serious allergic reactions (hypersensitivity), including breathing difficulties or swelling of the lips.

Cases of ileocecal stenosis and of large intestine (fibrosing colonopathy) have been reported in cystic fibrosis patients taking high doses of pancreatin-containing preparations.

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicinal Products: https://www.notificaram.es.

By reporting adverse 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.

After opening, store at a temperature not exceeding 25 °C and use within 3 months.

Keep the container tightly closed to protect it from moisture.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Kreon

• The active substance in Kreon is pancreatin (lipase, amylase, protease). Each spoonful contains 100 mg of minimicrospheres. This corresponds to 60.12 mg of pancreatin, equivalent 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 granule core: macrogol 4000; and for the coating: hypromellose phthalate, dimethicone 1000, triethyl citrate, cetyl alcohol.

Appearance of the product and contents of the pack

Kreon 5,000 U is available as gastro-resistant microgranules (Minimicrospheres™), round and light brown in colour.

Each pack contains a 20 g glass bottle. The bottle is contained within a cardboard carton which includes a measuring spoon.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Abbott Laboratories GmbH

Justus von Liebig Strasse 33

31535 Neustadt

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This leaflet was last revised in March 2016

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