KREON 5,000 U GASTRO-RESISTANT GRANULES

2. What you need to know before you take Kreon

Do not take Kreon:

• if you are allergic to pancreatin (lipase, amylase, protease) or to any of the other ingredients 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.

Taking Kreon with other medicines

Tell your doctor or pharmacist if you are using or have recently used 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, 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, 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 breastfeeding, it should be administered in doses sufficient to achieve 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.

3. How to take Kreon

Follow exactly the administration instructions of Kreon given by your doctor or pharmacist.

Always use the measuring spoon contained in the pack. 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 of age, the initial dose should be up to 5,000 units of lipase per meal (calculated for meal intakes of approximately one 120 ml bottle) and adjusted up to a maximum dose of 2,500 units of lipase/kg/meal. The maximum dose should not exceed 10,000 units of lipase/kg body weight and day.

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

The most common initial dose for children 4 years of age or older, adolescents, or adults is 500 units of lipase/kg/meal.

Dosage in Other Conditions 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 units Ph. Eur. of lipase and half of the individual dose in the case of light meals.

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

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

Alternatively, the gastro-resistant granules (minimicrospheres) can be mixed with small amounts of milk and given to the child immediately. 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 intake. This mixture should not be stored.

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

Do not retain the medicine in the mouth.

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

If you take more Kreon than you should

In case of overdose or accidental ingestion, it is recommended to discontinue 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.

High doses of pancreatin may cause increased uric acid in urine or blood in some cases.

If you forget to take Kreon

If you forget to take this medicine, wait until the next meal and take the usual dose of enzymes. 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, Kreon can cause side effects, although not everybody gets them.

The following side effects were detected during studies carried out in patients taking Kreon 5,000 U. These side effects may appear when using this medicine:

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

Common(affect up to 1 in 10 people): nausea, vomiting, constipation, abdominal bloating, diarrhea.

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

Uncommon(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 serious allergic reactions (hypersensitivity) that include breathing problems or lip swelling.

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 Monitoring System: 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.

After opening, do not store above 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 which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Kreon

• The active substance of Kreon is pancreatin (lipase, amylase, protease). Each spoonful contains 100 mg of minimicrospheres. This is equivalent to 60.12 mg of pancreatin, which corresponds to (in Ph. Eur. units) 5,000 units of lipase, 3,600 units of amylase, and 200 units of protease.

• The other ingredients 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 the pack

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

Each pack contains a 20 g glass bottle. The bottle comes in a cardboard box with a measuring spoon.

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

This leaflet was last revised inMarch 2016

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