Kreon travix

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Kreon Travix (Kreon)
10,000 Ph.Eur. units of lipase, enteric hard capsules
Pancreatinum
Kreon Travix and Kreon 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, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 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 purpose 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
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
• after an episode of acute pancreatitis. Kreon Travix may be started when the patient resumes oral intake
• chronic pancreatitis
• pancreatic cancer
• removal of the pancreas or part of it
• removal of the stomach or part of it
• gastroenteroanastomosis
• 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 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. 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 to 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 condition called fibrosing colonopathy, in which narrowing of the large intestine occurs, 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 unusual gastrointestinal symptoms or changes in existing 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 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
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning 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 your doctor or pharmacist.
Dosage of Kreon Travix

• The dose is measured in lipase units. Lipase is one of the enzymes contained 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 (gastrointestinal complaints) 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 less than or not exceed 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 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 liquid. Suitable acidic foods include, for example, apple sauce 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 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 take more Kreon Travix than prescribed, drink plenty of fluids and consult your doctor or pharmacist.
Very high doses of pancreatin may sometimes increase the level of uric acid in urine and blood.
Missed dose of Kreon Travix
If you miss a dose of Kreon Travix, take your normal 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, contact your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody 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,
discontinue use of Kreon Travix immediately and contact a doctor or the nearest hospital Emergency Department
without delay.
Adverse reactions that may occur during treatment with Kreon Travix:
Very common (affects more than 1 in 10 people)

• abdominal pain

Common (affects less than 1 in 10 people)

• nausea
• vomiting
• constipation
• bloating
• diarrhoea
  These effects may be due to the underlying disease for which Kreon Travix is prescribed. 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 (affects less than 1 in 100 people)

• rash

Frequency not known (cannot be estimated based on available data)

• itching and urticaria
• Kreon Travix may cause hypersensitivity reactions, including anaphylactic reactions manifesting as breathing difficulties or swelling of the lips
• narrowing of the ileocaecal region and of the large intestine (fibrosing colonopathy) 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 medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions at the 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 provide more information on the safety of the medicine.

5. How to store Kreon Travix

• Keep the medicine out of sight and reach of children.
• Do not store above 25°C. Store the bottle tightly closed.

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 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 package 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.
• Other ingredients 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 enteric-coated, hard gelatin capsules containing granules in an acid-resistant coating (mini-microspheres).
• The capsules are two-coloured: one part is opaque brown, the other part is transparent and colourless.
• Pack contents: 60 enteric-coated hard capsules in an HDPE bottle with PP screw cap.

For further information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Portugal, country of export:
BGP Products, Unipessoal Lda.
Av. D. João II, Edifício Atlantis, N.º 44C - 7.3 and 7.4
1990-095 Lisbon, Portugal
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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Portugal, country of export: 4893780
Parallel Import Authorisation Number: 309/23