Kreon travix

Patient Information Leaflet

Warning! Keep this leaflet. The packaging information is in a foreign language.
Kreon Travix (Kreon 10 000 V)
10,000 Ph.Eur. units of lipase, enteric-coated hard capsules
Pancreatinum
Kreon Travix and Kreon 10 000 V are different brand names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as prescribed by your doctor, pharmacist, or nurse.

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

Table of contents

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 Kreon Travix is

• 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 Kreon Travix is 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 enough 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,
• acute pancreatitis attack. Kreon Travix may be started once the patient resumes oral feeding,
• chronic pancreatitis,
• pancreatic cancer,
• partial or complete pancreatectomy,
• 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 symptoms of exocrine pancreatic insufficiency, such as abdominal pain, bloating, and helps regulate bowel movement frequency and improve stool consistency, regardless of the underlying disease. Kreon Travix should be taken during or immediately after main meals or snacks. This ensures proper mixing of the 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 of body weight per day, and experience any new or worsening gastrointestinal symptoms, you should 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, if so, 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
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning that the medicine is considered "sodium-free".

3. How to take Kreon Travix

This medicine should always be taken exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
Dosage of Kreon Travix

• The dose is measured in lipase units. Lipase is one of the pancreatic 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,
  • the amount of fat present in the stool.
• If fatty stools or gastrointestinal symptoms persist, consult the 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 lower 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 capsules of Kreon Travix) with each main meal (breakfast, lunch, dinner).
• For snacks, the usual dose is half the dose taken with main meals (1 to 4 capsules of Kreon Travix).

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 it 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, applesauce or yoghurt. Suitable acidic drinks include apple, orange, 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 action of Kreon Travix 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
Continue taking Kreon Travix for as long as your doctor recommends. Many patients need to take Kreon
Travix for life.
Taking more Kreon Travix than prescribed
If you take more Kreon Travix than recommended, drink plenty of fluids and consult your doctor or
pharmacist immediately.
Very high doses of pancreatin may sometimes increase uric acid levels in the blood and urine.
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 the missed dose.
Stopping Kreon Travix treatment
Do not stop taking Kreon Travix without consulting your doctor.
If in doubt, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported during clinical studies in patients taking Kreon Travix.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue and/or
throat, which may cause difficulty in breathing or swallowing, or if other serious adverse reactions
occur, treatment with Kreon Travix should be discontinued immediately and the patient should
contact a doctor or the nearest hospital Emergency Department without delay.

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 requiring treatment with Kreon Travix. During clinical studies, the number of patients experiencing abdominal pain or diarrhoea while taking Kreon Travix 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 difficulty in breathing or swelling of the lips,
• narrowing of the ileocecal valve and large intestine (fibrosing colonopathy) has been reported in patients with cystic fibrosis of the pancreas who were receiving high doses of pancreatin-containing products. Hypersensitivity reactions, mainly affecting the skin but not limited to it, have been observed and reported following the product's market introduction.

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

5. How to store Kreon Travix

• Keep this medicine out of sight and reach of children.
• Store below 25°C. Keep the bottle tightly closed. Protect from moisture. After first opening of the bottle, do not use for longer than 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 month indicated.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This 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, and 600 Ph.Eur. units (BP units) of protease.
• The other ingredients are: macrogol 4000, hypromellose phthalate, dimethicone 1000, cetyl alcohol, triethyl citrate. Capsule shell: gelatin, yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (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 in an enteric-coated form (mini-microspheres).
• The capsules are two-coloured: one part is an opaque brown, the other part is transparent and colourless.
  • Pack contains: 50 gastro-resistant hard capsules in an HDPE bottle with a PP screw cap, in a cardboard box.

For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Marketing Authorisation number in Latvia, country of export: 99-0594
Parallel import licence number: 184/24