KREON 35,000 U HARD GASTRORESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Kreon 35,000 U Gastro-Resistant Capsules

Pancreatic Powder

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

1. What is Kreon and what is it used for

What is Kreon

• Kreon contains a combination of enzymes called “pancreatic powder”.
• Pancreatic powder is also called pancreatin. It helps to digest food. The enzymes are extracted from the pancreas glands of pigs.
• Kreon capsules contain small granules that release the pancreatic powder slowly in your intestine (gastro-resistant granules, called minimicropheres).

What Kreon is used for

Kreon is used to treat “pancreatic exocrine insufficiency”. This is a condition where the pancreas gland does not produce enough enzymes to digest food. It occurs frequently, for example, in people who:

• Suffer from cystic fibrosis, a rare genetic disorder.
• Have chronic inflammation of the pancreas (chronic pancreatitis).
• Have had all or part of their pancreas removed (total or partial pancreatectomy).
• Have pancreatic cancer.

Kreon 35,000 can be used in children, adolescents, and adults. The dosage by age group is explained in section 3 of this leaflet, “How to take Kreon”.

Treatment with Kreon improves the symptoms of pancreatic exocrine insufficiency, including the consistency of stools (e.g., fatty stools), abdominal pain, bloating, and frequency of bowel movements (diarrhea or constipation), regardless of the underlying disease.

How Kreon works

The enzymes in Kreon work by digesting food as it passes through the intestine. You should take Kreon during or immediately after a meal or snack. This will allow the enzymes to mix well with the food.

2. What you need to know before you take Kreon

Do not take Kreon

• If you are allergic to pancreatic powder or any of the other ingredients of Kreon (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Kreon.

Patients with cystic fibrosis

A rare bowel condition, called “fibrosing colonopathy”, has been detected in patients with cystic fibrosis who take high-dose pancreatic powder products. If you have cystic fibrosis and take more than 10,000 units of lipase per kilogram and day and experience unusual abdominal symptoms or changes in abdominal symptoms, tell your doctor.

The dosage of lipase units is explained in section 3 of this leaflet, “How to take Kreon”.

Severe allergic reaction

If an allergic reaction occurs, stop treatment and talk to your doctor. An allergic reaction can include itching, hives, or rash. Rarely, a more serious allergic reaction can include feeling hot, dizziness, and fainting, breathing problems; these are symptoms of a serious and potentially life-threatening condition called “anaphylactic shock”. If it occurs, seek immediate medical attention.

Talk to your doctor if you are allergic to pig proteins before taking Kreon.

Mouth irritation

Mouth pain, irritation (stomatitis), bleeding, and ulcer formation in the mouth can occur if the capsules are chewed or kept in the mouth for too long. Rinsing the mouth and drinking a glass of water may help if there are early signs of mouth irritation.

Kreon can only be sprinkled on certain foods (see section 3 of this leaflet, “How to take Kreon”).

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

Using Kreon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility

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

Your doctor will decide whether you can take Kreon during pregnancy.

Kreon can be used during breastfeeding.

Driving and using machines

Kreon does not affect your ability to drive or use tools or machinery.

3. How to take Kreon

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Your dose is measured in “lipase units”. Lipase is one of the enzymes in the pancreatic powder. The different concentrations of Kreon contain different amounts of lipase.

Always follow the medical advice about which dose of Kreon to take. Your doctor will adjust the dose to your needs.

This will depend on:

• the severity of your disease
• your weight
• your diet
• how much fat is in your stools

If you have fatty stools or other stomach or bowel problems (gastrointestinal symptoms), talk to your doctor, as it may be necessary to adjust the dose.

How much Kreon to take

For patients with cystic fibrosis

Children:

The concentration of this medicine may not be suitable for starting treatment in children, depending on their age and weight.

The doctor must determine the necessary dose for a child with dosage forms that contain fewer lipase units (e.g., 10,000 or 5,000 lipase units).

Once the dose per meal is established, this concentration of the medicine can be used in children.

• The initial dose for children under 4 years is 1,000 units of lipase per kilogram of body weight per meal.
• The initial dose for children from 4 years is 500 units of lipase per kilogram of body weight per meal.

Adolescents and adults:

The enzyme-based dosage should start with 500 units of lipase per kilogram of body weight per meal in adolescents and adults.

For all age groups:

The dose should not exceed 2,500 units of lipase per kilogram of body weight per meal or 10,000 units of lipase per kilogram of body weight per day or 4,000 units of lipase per gram of fat ingested.

For patients with other pancreatic problems

Adolescents and adults:

The usual dose for a meal is between 25,000 and 80,000 units of lipase.

The usual dose for a snack is half the dose for a meal.

When to take Kreon

Always take Kreon during or immediately after a meal or snack. This will allow the enzymes to mix well with the food and digest as it passes through the intestine.

How to take Kreon

• Kreon must always be taken with a meal or snack.
• The capsules should be swallowed whole with a glass of water or juice.
• Do not break or chew the capsules or their contents, as this can cause irritation inside the mouth or change the way Kreon works in your body.
• If you have difficulty swallowing the capsules, carefully open them and add the granules to a small amount of soft acidic food or acidic liquids. Soft acidic foods could be, for example, yogurt or apple sauce. Acidic liquids could be apple, orange, or pineapple juice. Do not mix the granules with water, milk, including flavored milk, breast milk, or formula, or hot food. Take the mixture immediately, without crushing or chewing, and drink water or juice.
• Mixing with non-acidic food or liquids, crushing, or chewing the granules can cause irritation inside the mouth or change the way Kreon works in your body.
• Do not keep the Kreon capsules or their contents in your mouth. Make sure the medicine and food mixture are swallowed completely and that no granules are left in the mouth.
• Do not store the mixture.

If you take more Kreon than you should

If you take more Kreon than you should, drink plenty of water and talk to your doctor or pharmacist.

Occasionally, very high doses of pancreatic enzyme replacement medicines have caused too much uric acid in the urine (hyperuricosuria) and blood (hyperuricemia).

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91.562.04.20, stating the medicine and the amount ingested.

If you forget to take Kreon

If you forget a dose, take the next dose at the usual time, with your next meal. Do not take a double dose to make up for the forgotten dose.

If you stop taking Kreon

Do not stop taking Kreon without talking to your doctor first. Many patients will have to take Kreon for the rest of their lives.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects can occur with this medicine.

The most important side effects seen with pancreatic enzyme replacement medicines are “anaphylactic shock” and fibrosing colonopathy. These two side effects have occurred in a very small number of people, but their exact frequency is unknown.

Anaphylactic shock is a severe and potentially life-threatening allergic reaction that can develop rapidly.

If you experience any of the following symptoms, seek immediate medical attention:

• Itching, hives, or rash.
• Swelling of the face, eyes, lips, hands, or feet.
• Weakness or fainting.
• Difficulty breathing or swallowing.
• Palpitations.
• Dizziness, collapse, or loss of consciousness.

High doses of pancreatic enzyme replacement medicines can also cause scarring or thickening of the intestinal wall, which can cause blockage of the intestines, a condition called fibrosing colonopathy. If you have severe stomach pain, bowel problems (constipation), nausea, or vomiting, talk to your doctor immediately.

Very common side effects(may affect more than 1 in 10 people)

• Stomach pain (abdomen).

Common side effects(may affect up to 1 in 10 people)

• Feeling sick (nausea).
• Being sick (vomiting).
• Constipation.
• Bloating (abdominal distension).
• Diarrhea.

These may be due to the condition for which you are taking Kreon.

Uncommon side effects(may affect up to 1 in 100 people)

• Rash.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: 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 use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of the month.

Do not store above 25°C.

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

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 other information

What Kreon contains

The active ingredient in Kreon is pancreatic powder.

• Each Kreon 35,000 capsule contains 420 mg of pancreatic powder which corresponds to (European Pharmacopoeia units):

• The other ingredients are:

Contents of the capsule:

• Hypromellose phthalate
• Macrogol 4000
• Triethyl citrate
• Dimeticone 1000
• Cetyl alcohol

Capsule shell:

• Gelatin
• Red and yellow iron oxides (E 172)
• Sodium lauryl sulfate

Appearance and packaging

Kreon 35,000 capsules are elongated, size 00. They are orange and transparent. They contain gastro-resistant granules of brown color (minimicropheres).

Kreon 35,000 is available in HDPE bottles with screw caps of polypropylene 50 capsules, 60 capsules, 100 capsules, 120 capsules, and 200 capsules.

Not all pack sizes may be marketed.

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-Str. 33

31535 Neustadt

Germany

or

Mylan Germany GmbH

Lütticher Straße 5

53842 Troisdorf

Germany

You can obtain further information about this medicine from the representative of the marketing authorization holder in your country:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: September 2018

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