Package Insert: Information for the Patient

Kreon 35,000 U Hard-Gastroresistant Capsules

Pancreatic Powder

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section4

1.What is Kreon and how is it 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

What is Kreon

• Kreon contains a combination of enzymes known as “pancreatic powder”.
• Pancreatic powder is also referred to as pancreatin. It helps digest food. The enzymes are extracted from the pig pancreas.
• Kreon capsules contain small granules that slowly release the pancreatic powder in the intestine (gastroresistant granules, known as minimicrospheres).

What is Kreon used for

Kreon is used for the treatment of “exocrine pancreatic insufficiency”. This is a disorder in which the pancreas does not produce enough enzymes to digest food.It often occurs in individuals who:

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

Kreon 35,000 can be used in children, adolescents, and adults. The dosage by age group is explained in section3 of this prospectus, “How to take Kreon”.

Treatment with Kreon improves the symptoms of exocrine pancreatic insufficiency, including stool consistency (e.g., fatty stools), abdominal pain, flatulence, and bowel frequency (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.

Do not take Kreon

• If you are allergic to pancreas powder or any of the other components of Kreon (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Kreon.

Patients with cystic fibrosis

A rare intestinal condition, known as "fibrous colopathy," in which the intestine narrows, has been detected in patients with cystic fibrosis who take products with high doses of pancreas powder. If you have cystic fibrosis and take more than 10,000units of lipase per kilogram and day and experience unusual abdominal symptoms or changes in abdominal symptoms,inform your doctor.

The dosage of lipase units is explained in section3 of this prospectus, "How to take Kreon".

Severe allergic reaction

If an allergic reaction occurs, stop treatment and consult your doctor. An allergic reaction may include itching, urticaria, or rashes. Rarely, a more serious allergic reaction may include a feeling of heat, dizziness, and fainting, breathing problems; these are symptoms of a serious and potentially fatal condition called "anaphylactic shock." If it occurs, seek urgent medical attention immediately.

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

Mouth irritation

Painful mouth, irritation (stomatitis), bleeding, and ulcer formation in the mouth may occur if the capsules are chewed or left 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 section3 of this prospectus, "How to take Kreon").

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

Use of Kreon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

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

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

Kreon can be used during breastfeeding.

Driving and operating machinery

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

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

Your dose is measured in "lipase units". Lipase is one of the enzymes in pancreas powder. Different concentrations of Kreon contain different amounts of lipase.

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

It 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 gastrointestinal problems (gastrointestinal symptoms), consult 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 medication may not be suitable for initiation of treatment in children, according to their age and weight.

Your doctor must determine the necessary dose for a child with formulations containing fewer lipase units (e.g., 10,000 or 5,000 lipase units).

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

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

Adolescents and adults:

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

For all age groups:

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

For patients with other pancreatic problems

Adolescents and adults:

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

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

When to take Kreon

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

How to take Kreon

• Kreon must be taken always 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 it may cause irritation in the mouth or change the way Kreon works in your body.
• If you have difficulty swallowing the capsules, open them carefully and add the granules to a small amount of mild acidic food or acidic liquids. Mild 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 milk, or with hot food. Consume the mixture immediately, without crushing or chewing and drink water or juice.
• Mixing with non-acidic food, crushing, or chewing the granules may cause irritation in the mouth or change the way Kreon works in your body.
• Do not keep the Kreon capsules or their contents in the mouth. Make sure the medication and food mixture are ingested completely and no granules remain 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 consult your doctor or pharmacist.

In some cases, very high doses of pancreas powder have caused too much uric acid in the urine (hyperuricosuria) and blood (hyperuricemia).

In case of overdose or accidental ingestion, 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 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 compensate for the missed dose.

If you interrupt treatment with Kreon

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

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

Like all medications, Kreon can produce adverse effects, although not everyone will experience them.

The following secondary effects can occur with this medication.

The most important secondary effects observed with pancreatic enzyme replacement medications are "anaphylactic shock" and fibrous colonopathy. These two secondary effects have occurred in a very small number of people, but their exact frequency is unknown.

Anaphylactic shock is a severe and potentially fatal allergic reaction that can develop rapidly.

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

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

Repeated high doses of pancreatic enzyme replacement medications can also cause intestinal wall scarring or thickening, which can lead to intestinal blockage, a condition known as fibrous colonopathy. If you have severe stomach pain, intestinal flow problems (constipation), nausea, or vomiting, consult your doctor immediately.

Very Common Adverse Effects(can affect more than 1 in 10 people)

• Abdominal pain (stomach pain).

Common Adverse Effects(can affect up to 1 in 10 people)

• Uncomfortable feeling (nausea).
• Discomfort (vomiting).
• Constipation.
• Swelling (abdominal distension).
• Diarrhea.

They may be related to the condition for which you are taking Kreon.

Rare Adverse Effects(can affect up to 1 in 100 people)

• Rash.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

It should not be stored at a temperature above 25°C.

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

Medications should not be thrown away through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Kreon

The active ingredient in Kreon is pancreas powder.

• Each Kreon 35,000 capsule contains 420 mg of pancreas powder corresponding to (European Pharmacopoeia units):

• The other components are:

Capule content:

• Phthalate hypromellose
• Macrogol 4000
• Triethyl citrate
• Dimethicone 1000
• Cetomacrogol

Capule coating:

• Gelatin
• Iron oxide red and yellow (E 172)
• Sodium lauryl sulfate

Appearance of the product and packaging content

Kreon 35,000 capsules are elongated size 00. They are orange and transparent. They contain brownish-colored gastro-resistant granules (minimicrospheres).

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

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

Abbott Laboratories GmbH

Justus-von-Liebig-Str. 33

31535 Neustadt

Germany

or

Mylan Germany GmbH

Lütticher Straße 5

53842 Troisdorf

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

This medication is authorized in the European Economic Area member states with the following names:

Last review date of this leaflet: September 2018

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.