Kreon Travix

Package Leaflet: Information for the Patient

Kreon Travix

10,000 Ph.Eur. lipase units, enteric-coated capsules Pancreatinum

Read the package 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 package leaflet or as directed by your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again later.
• If you need advice or more information, you should speak to your pharmacist.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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 pack 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 Kreon Travix is used for
Kreon Travix is used in children, adolescents, and adults with digestion problems due to pancreatic insufficiency. This is a disease in which the pancreas does not produce enough digestive enzymes. This disease often occurs in patients with the following conditions:

• 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 mentioned above.
How Kreon Travix works
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 and 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

• if you are allergic to pork pancreatin or any of the other ingredients of this medicine (listed in section 6). If in doubt, consult your doctor or pharmacist.

Warnings and precautions

A rare disease of the colon called fibrosing colonopathy, which causes narrowing of the colon, has been reported in patients with cystic fibrosis who have taken 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 gastrointestinal tract or changes in existing symptoms, you should contact 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

This 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 directed by your doctor or pharmacist. If you are unsure, 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 to your needs, which depends on:
• the type of disease
• body weight
• the diet used
• the amount of fat in the stool.
• If you continue to have fatty stools or gastrointestinal symptoms (gastrointestinal symptoms), you should contact your doctor, as the dose may need to be adjusted.

Cystic fibrosis

• Usual starting dose in children under 4 years is 1,000 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 4,000 lipase units/g of fat consumed.

Other pancreatic disorders - adults

• Usual dose is 25,000 to 80,000 lipase units (2 to 8 capsules of Kreon Travix) per main meal (breakfast, lunch, dinner).
• For snacks, the usual dose is half the dose taken during 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 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 puree or yogurt. Acidic drinks can be apple, orange, or pineapple juice.
• The mixture should be swallowed immediately without chewing and washed down with 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 Kreon Travix than prescribed

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

Missing a dose of Kreon Travix

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

Stopping Kreon Travix

Do not stop taking Kreon Travix without consulting your doctor.
If you are unsure, 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 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:

• abdominal pain

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

• nausea
• vomiting
• constipation
• bloating
• diarrhea These symptoms may be due to the disease for which Kreon Travix is prescribed. In clinical trials, the number of patients taking Kreon who experienced abdominal pain or diarrhea was similar to or lower than those not taking Kreon.

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 colon (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 product was placed on the market.

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to: Department for Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kreon Travix

• Keep this medicine out of the sight and reach of children.
• Store in a temperature below 25°C. HDPE bottles: After first opening, do not store above 25°C. Shelf life after first opening of the bottle: 6 months. Store the bottles tightly closed.
• Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These 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 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. Ingredients of the capsule shell: gelatin, iron (III) oxide (E 172), iron (III) oxide hydrate (E 172), iron (II, III) oxide (E172), sodium lauryl sulfate.

What Kreon Travix looks like and contents of the pack

• Kreon Travix is available as enteric-coated capsules, hard, containing granules in an acid-resistant coating (Minimicrospheres).
• The capsules are two-colored: one part is opaque brown, the other is transparent and colorless.
• The pack contains: 20, 50, or 100 capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Sp. z o.o.
Postępu 21B
02-676 Warsaw

Manufacturer

Abbott Laboratories GmbH, Werk Neustadt
Justus-von-Liebig-Str. 33
31535 Neustadt, Germany
To obtain more detailed information, please contact the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
Postępu 21B
02-676 Warsaw
tel. 22 546 64 00
Date of last revision of the package leaflet:02/2025