Kreon travix

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is 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 so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, 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).

What Kreon Travix is used for
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
• 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
• gastroenterostomy
• Shwachman-Diamond syndrome (a very rare genetic disorder).

Exocrine pancreatic insufficiency may also occur 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 severity of symptoms of exocrine pancreatic insufficiency, such as abdominal pain, bloating, and helps regulate bowel 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, which causes narrowing of the large intestine, 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 greater than 10,000 Ph.Eur. units of lipase per kg 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 Kreon Travix can be taken and what dose is appropriate.
• 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 according to the instructions given by your doctor or pharmacist. If in doubt, 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 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 needs, depending on:
  • type of disease
  • body weight
  • diet
  • amount of fat present in the stool.
• If fatty stools or gastrointestinal symptoms persist, consult 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 equal to or less than 10,000 lipase units/kg body weight/day or 4000 lipase units per gram of ingested fat.

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 a main meal (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 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. Acidic foods include, for example, apple sauce or yoghurt. 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

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

Taking more Kreon Travix than recommended

If you have taken too much Kreon Travix, 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 urine and blood.

Missing a dose of Kreon Travix

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

Stopping Kreon Travix

Do not stop taking Kreon Travix without consulting your doctor.
If in doubt, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported during clinical trials 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 effects occur, treatment with Kreon Travix must be discontinued and immediate contact must be made with a doctor or the nearest hospital Emergency Department.
Adverse effects 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 the available data)

• itching and urticaria
• Kreon Travix may cause hypersensitivity reactions, including anaphylactic reactions manifesting as difficulty in breathing or swelling of the lips
• fibrosing colonopathy, including stricture of the ileocaecal region and colon, 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 the introduction of the medicine into the market.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, patients should inform their doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects allows additional information on the safety of the medicine to be collected.

5. How to store Kreon Travix

• Keep this 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 stated month.
• Medicines must not be disposed of via household waste or sewage. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the package and other information

What Kreon Travix contains

• The active substance is 150 mg of pancreatin with activity: 10,000 Ph.Eur. units lipase (BP units), 8,000 Ph.Eur. units amylase (BP units), 600 Ph.Eur. units protease.
• The other ingredients are: macrogol 4000, hypromellose phthalate, simethicone 1000, cetostearyl 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 enteric-coated, hard gelatin capsules containing granules protected by a gastric-resistant coating (mini-microspheres).
• The capsules are two-coloured: one part is opaque brown, the other part is transparent and colourless.
• Pack contents: 50 enteric-coated hard capsules in an HDPE bottle with a PP cap, contained in a cardboard box.

For more detailed information, please contact the responsible entity 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Latvia, country of export: 99-0594
Parallel Import Licence Number: 183/24