Kreon Travix

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Kreon Travix (Kreon)

10,000 Ph.Eur. lipase units, enteric-coated capsules, hard
Pancreatinum
Kreon Travix and Kreon are different trade names for the same medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor, pharmacist, or nurse.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Kreon Travix and what is it 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 packaging and other information

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

What is Kreon Travix

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

What is Kreon Travix used for
Kreon Travix is used in children, adolescents, and adults with digestive disorders due to pancreatic insufficiency. This is a condition where the pancreas does not produce enough digestive enzymes. This condition often occurs in patients with the following diseases:

• cystic fibrosis (a rare genetic disease)
• blockage of the pancreatic or bile ducts
• acute pancreatitis. Kreon Travix can be started when the patient resumes oral feeding
• chronic pancreatitis
• pancreatic cancer
• removal of the pancreas or part of it
• removal of the stomach or part of it
• gastrointestinal anastomosis
• Shwachman-Diamond syndrome (a very rare genetic disease).

Pancreatic insufficiency may also be diagnosed in other clinical conditions not listed above.
How does Kreon Travix work
The enzymes in Kreon Travix work by digesting food passing through the small intestine. Treatment with Kreon Travix significantly reduces the severity of symptoms of pancreatic insufficiency, including abdominal pain, bloating, regulates bowel movements, and improves stool consistency, regardless of the underlying disease. Kreon Travix should be taken during or after main meals or snacks. This will allow the enzymes to mix with food and digest during passage through the small intestine.

2. Important information before taking Kreon Travix

When not to take Kreon Travix

Warnings and precautions

A rare disease of the large intestine called fibrosing colonopathy, which causes narrowing of the large intestine, has been reported in patients with cystic fibrosis who took high doses of pancreatin.
Therefore, in patients with cystic fibrosis taking pancreatin at a dose greater than 10,000 Ph.Eur. lipase units/kg body weight/day and experiencing any worrying symptoms from the digestive system or changes in existing symptoms, consult your doctor.

Pregnancy and breastfeeding

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

Driving and using machines

Kreon Travix has no or negligible influence on the ability to drive and use machines.

Kreon Travix contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Kreon Travix

This medicine should always be taken exactly as advised 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 decided by your doctor.
• Your doctor will adjust the dose according to your needs, which depends on:
• the type of disease
• body weight
• the diet used
• the amount of fat in the stool.
• If you experience fatty stools or gastrointestinal symptoms (gastrointestinal symptoms), consult your doctor, as the dose may need to be adjusted.

Cystic fibrosis

• Usual starting dose in children under 4 years is 1000 lipase units/kg body weight/meal.
• Usual starting dose in children over 4 years, adolescents, and adults is 500 lipase units/kg body weight/meal.
• In most patients, the dose should be lower or not exceed 10,000 lipase units/kg body weight/day or 4000 lipase units/g of fat consumed.

Other pancreatic disorders - adults

• 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 during main meals (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 will allow the enzymes to mix with food and digest during passage through the small intestine.

How to take Kreon Travix

• Swallow the capsules whole.
• Do not chew or crush the capsules.
• If swallowing capsules is difficult, they can be carefully opened and the granules added to soft, acidic food or mixed with an acidic drink. Acidic food can be, for example, apple sauce or yogurt. Acidic drinks can be apple, orange, or pineapple juice.
• The mixture should be swallowed immediately without chewing, and followed by water or juice.
• Mixing with non-acidic food or drink, chewing, or crushing the minimicrospheres may cause irritation of the mouth or change the action of Kreon Travix in the body.
• Do not keep Kreon Travix or the contents of the capsules in your mouth.
• Do not store the mixture.
• Drink plenty of fluids throughout the day.

How long to take Kreon Travix

The medicine should be taken for as long as your doctor decides. Many patients need to take Kreon Travix for the rest of their lives.

Taking more than the recommended dose of Kreon Travix

If you take too much Kreon Travix, drink plenty of fluids and consult your doctor or pharmacist.
Very high doses of pancreatin can sometimes cause an increase in uric acid in the urine and blood.

Missing a dose of Kreon Travix

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

Stopping treatment with Kreon Travix

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

4. Possible side effects

Like all medicines, Kreon Travix can cause side effects, although not everybody gets them.
The following side effects have been reported in patients taking Kreon Travix during clinical trials.
If you experience allergic reactions, including rash, swelling of the face, lips, tongue, and/or
throat, which may cause difficulty breathing or swallowing, or other serious side effects, stop taking Kreon Travix and contact your doctor or the Emergency Department of your nearest hospital immediately.
Side effects that may occur when taking 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
• diarrhea These symptoms may be due to the disease for which Kreon Travix is indicated. During clinical trials, the number of patients taking Kreon Travix who experienced abdominal pain or diarrhea was similar to or lower than those 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 hives
• Kreon Travix may cause hypersensitivity reactions, including anaphylactic reactions with difficulty breathing or swelling of the mouth
• narrowing of the ileocecal junction and large intestine (fibrosing colonopathy) has been reported in patients with cystic fibrosis taking high doses of pancreatin products. Hypersensitivity reactions, mainly affecting the skin but not limited to it, have been observed and reported after the marketing of the medicine.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kreon Travix

• Keep the medicine out of the sight and reach of children.
• Do not store above 25°C. Keep 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 month stated.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Kreon Travix contains

• The active substance is 150 mg of pancreatin with an activity of: 10,000 Ph.Eur. lipase units (BP units) 8,000 Ph.Eur. amylase units (BP units) 600 Ph.Eur. protease units.
• The other ingredients are: macrogol 4000, hypromellose phthalate, dimeticone 1000, cetyl alcohol, triethyl citrate. Capsule shell: 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 a hard, enteric-coated capsule containing granules with an acid-resistant coating (minimicrospheres).
• The capsules are two-colored: one part is opaque brown, the other part is transparent and colorless.
• The pack contains: 60 enteric-coated capsules, hard, in an HDPE bottle with a PP cap.

For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

BGP Products, Unipessoal Lda.
Av. D. João II, Edifício Atlantis, N.º 44C - 7.3 e 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Portuguese marketing authorization number, country of export:4893780

Parallel import authorization number: 309/23

Date of leaflet approval: 27.12.2023

[Information about the trademark]