KREON TRAVIX

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Kreon Travix (Kreon 10000 V)
10,000 Ph. Eur. units of lipase, enteric hard capsules
Pancreatinum
Kreon Travix and Kreon 10000 V are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Kreon Travix is and what it is used for

What is Kreon Travix

• Kreon Travix contains a mixture of digestive enzymes called "pancreatin".
• Pancreatin helps digest food. The enzymes are derived from porcine pancreas.
• Kreon Travix contains small granules that slowly release pancreatin in the intestine (acid-resistant granules known as minimicrospheres).

For what purpose is Kreon Travix used
Kreon Travix is used in children, adolescents, and adults with digestive disorders due to
exocrine pancreatic insufficiency. This is a condition in which the pancreas does not produce
sufficient digestive enzymes. This condition commonly occurs in patients with the following
diseases:

• cystic fibrosis (a rare genetic disorder)
• obstruction of the pancreatic or biliary ducts
• following an episode of acute pancreatitis. Kreon Travix may be started when the patient resumes oral feeding
• chronic pancreatitis
• pancreatic cancer
• partial or complete removal of the pancreas
• partial or complete gastrectomy
• gastroenteroanastomosis
• Shwachman-Diamond syndrome (a very rare genetic disorder).

Exocrine pancreatic insufficiency may also be diagnosed in other clinical conditions not listed above.
How Kreon Travix works
The enzymes in Kreon Travix act by digesting food passing through the small intestine. Treatment with Kreon Travix significantly reduces the symptoms of exocrine pancreatic insufficiency, such as abdominal pain, bloating, frequency of bowel movements, and improves stool consistency, regardless of the underlying disease. Kreon Travix should be taken during or immediately after main meals or snacks to ensure thorough mixing of enzymes with food.

2. Important information before taking Kreon Travix

When not to take Kreon Travix

• if the patient is allergic to porcine pancreatin or any of the other ingredients of this medicine (listed in section 6). If in doubt, consult a doctor or pharmacist.

Warnings and precautions
A rare bowel disorder called fibrosing colonopathy, in which the colon becomes narrowed, has been reported in patients with cystic fibrosis who were taking high doses of pancreatin.
Therefore, if you have cystic fibrosis and are taking pancreatin at a dose exceeding 10,000 Ph.Eur. units of lipase per kg body weight per day, and experience any concerning gastrointestinal symptoms or changes in previous symptoms, contact your doctor.

Pregnancy and breastfeeding

• If you are pregnant or suspect you may be pregnant, consult your doctor before taking Kreon Travix. Your doctor will decide whether you may take Kreon Travix and at what dose.
• Kreon Travix may be used during breastfeeding.

Driving and operating machinery
Kreon Travix has no effect or negligible effect on the ability to drive and operate machinery.

Kreon Travix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, this medicine is considered "sodium-free".

3. How to take Kreon Travix

This medicine should always be taken exactly as recommended by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Dosage of Kreon Travix

• The dose is measured in lipase units. Lipase is one of the enzymes in pancreatin. Different strengths of Kreon Travix contain different amounts of lipase.
• The number of capsules to be taken is determined by the doctor.
• The doctor will adjust the dose according to the patient's individual needs, depending on:
  • the type of disease
  • body weight
  • diet
  • amount of fat present in the stool.
• If fatty stools or gastrointestinal symptoms persist, contact your doctor, as the dose may need to be adjusted.

Cystic fibrosis

• The usual initial dose for children under 4 years of age is 1000 lipase units/kg body weight/meal.
• The usual initial dose for children aged 4 years and older, adolescents, and adults is 500 lipase units/kg body weight/meal.
• In most patients, the dose should be less than or not exceed 10,000 lipase units/kg body weight/day or 4,000 lipase units/g of dietary fat intake.

Other pancreatic disorders – adults

• The usual dose is 25,000 to 80,000 lipase units (2 to 8 Kreon Travix capsules) per main meal (breakfast, lunch, dinner).
• For snacks, the usual dose is half the dose taken with a main meal (1 to 4 Kreon Travix capsules).

When to take Kreon Travix
Kreon Travix should always be taken during or immediately after main meals and snacks. This ensures proper mixing of the enzymes with food and effective digestion as the food passes through the small intestine.

How to take Kreon Travix

• Swallow the capsules whole.
• Do not chew or crush the capsules.
• If swallowing the capsules is difficult, they may be carefully opened and the granules mixed with soft, acidic food or an acidic drink. Suitable acidic foods include, for example, apple puree or yoghurt. Suitable acidic drinks include apple juice, orange juice, or pineapple juice.
• The mixture should be swallowed immediately without chewing or crushing, and followed with water or juice.
• Mixing with non-acidic food or drink, or chewing or crushing the minimicrospheres, may cause irritation of the mouth or alter the way Kreon Travix works in the body.
• Do not retain Kreon Travix or capsule contents in the mouth.
• Do not store the medicine mixture.
• Drink plenty of fluids throughout the day.

How long to take Kreon Travix
Take this medicine for as long as your doctor recommends. Many patients need to take Kreon Travix for life.

Taking more than the recommended dose of Kreon Travix
If you take more Kreon Travix than you should, drink plenty of fluids and consult your doctor or pharmacist immediately.
Very high doses of pancreatin may sometimes increase the level of uric acid in the urine and blood.

Missing a dose of Kreon Travix
If you miss a dose of Kreon Travix, take your usual dose at the next meal. Do not take a double dose to make up for a missed dose.

Stopping Kreon Travix treatment
Do not stop taking Kreon Travix without consulting your doctor.
If you have any doubts, contact your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported in clinical trials in patients taking Kreon Travix.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue and/or
throat, causing difficulty in breathing or swallowing, or other serious adverse reactions occur,
discontinue use of Kreon Travix immediately and contact a doctor or the nearest hospital Emergency Department.

Adverse reactions that may occur during treatment with Kreon Travix:

Very common (occurring in more than 1 in 10 patients):

• abdominal pain

Common (occurring in less than 1 in 10 patients):

• nausea
• vomiting
• constipation
• bloating
• diarrhoea

These effects may be due to the underlying disease for which Kreon Travix is prescribed. During clinical trials, the number of patients taking Kreon Travix who experienced abdominal pain or diarrhoea was similar to or lower than in patients not taking Kreon Travix.

Uncommon (occurring in less than 1 in 100 patients):

• rash

Frequency not known (cannot be estimated from available data):

• itching and urticaria
• Kreon Travix may cause hypersensitivity reactions, including anaphylactic reactions manifesting as breathing difficulties or swelling of the mouth
• fibrosing colonopathy, including stricture of the ileocaecal region and large intestine, has been reported in patients with cystic fibrosis of the pancreas receiving high doses of pancreatin-containing products. Hypersensitivity reactions, mainly affecting the skin but not limited to it, have been observed and reported following marketing of the product.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to:
Department for Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, Poland
Tel: +48 22 49 21 301; Fax: +48 22 49 21 309; Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to improve the safety information available for this medicine.

5. How to store Kreon Travix

• Keep the medicine out of the sight and reach of children.
• Store below 25°C. Keep the bottle tightly closed. Protect from moisture.
• Shelf life after first opening the bottle: 6 months.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Kreon Travix contains

• The active substance is 150 mg of pancreatin with activity: 10,000 Ph.Eur. units (BP units) of lipase, 8,000 Ph.Eur. units (BP units) of amylase, 600 Ph.Eur. units (BP units) of protease.
• The other components are: macrogol 4000, hypromellose phthalate, dimethicone 1000, cetyl alcohol, triethyl citrate. Capsule shell composition: gelatin, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172), titanium dioxide (E 171), sodium lauryl sulfate.

What Kreon Travix looks like and contents of the pack

• Kreon Travix is available as gastro-resistant, hard gelatin capsules containing granules (mini-microspheres) protected by an enteric coating resistant to gastric juice.
• The capsules are two-coloured: one part is an opaque brown, the other part is transparent and colourless.
• Pack contents: 50 gastro-resistant hard capsules.

For further detailed information, please contact the responsible entity or parallel importer.
Responsible entity in Latvia, country of export:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15, Dublin
Ireland
Manufacturer:
Abbott Laboratories GmbH
Justus-von-Liebig-Str. 33
31535 Neustadt
Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Latvia, country of export: 99-0594
Parallel Import Licence Number: 324/24