Kreon Travix

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, the information on the immediate packaging in a foreign language!

Kreon Travix(Kreon 10000 V)
10,000 Ph. Eur. lipase units, enteric-coated capsules, hard
Pancreatinum
Kreon Travix and Kreon 10000 V 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
the doctor, pharmacist, or nurse.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. 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 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 is Kreon Travix used for
Kreon Travix is used in children, adolescents, and adults with digestion problems 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 have taken large 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 gastrointestinal symptoms or changes in existing symptoms, the doctor should be consulted.

Pregnancy and breastfeeding

• In case of pregnancy or suspected pregnancy, the doctor should be consulted before taking Kreon Travix. The doctor will decide whether Kreon Travix can be taken 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 considered "sodium-free".

3. How to take Kreon Travix

This medicine should always be taken exactly as advised by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.

Dosage of Kreon Travix

• The dose is measured in lipase units. Lipase is one of the enzymes in pancreatin. Different strengths of Kreon Travix contain different amounts of lipase.
• The number of capsules to be taken is decided by the doctor.
• The doctor will adjust the dose according to the patient's needs, which depends on:
• the type of disease
• body weight
• diet
• the amount of fat in the stool.
• If fatty stools or gastrointestinal symptoms persist, the doctor should be consulted, as the dose may need to be adjusted.

Cystic fibrosis

• Usual initial dose in children under 4 years of age is 1000 lipase units/kg body weight/meal.
• Usual initial dose in children over 4 years of age, 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 ingested.

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.
• The capsules should not be chewed or crushed.
• 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.
• Kreon Travix or the contents of the capsules should not be kept in the mouth.
• The mixture should not be stored.
• A lot of fluids should be drunk during the day.

How long to take Kreon Travix

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

Taking more than the recommended dose of Kreon Travix

In case of overdose, a lot of fluids should be drunk and the doctor or pharmacist should be consulted.
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

In case a dose is missed, the normal dose should be taken at the next meal. A double dose should not be taken to make up for the missed dose.

Stopping treatment with Kreon Travix

Treatment with Kreon Travix should not be stopped without consulting a doctor.
In case of doubt, the doctor or pharmacist should be consulted.

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 the patient experiences an allergic reaction, including rash, swelling of the face, lips, tongue, and/or
throat, which may cause difficulty breathing or swallowing, or other serious side effects, they should stop taking Kreon Travix and contact their doctor or the Emergency Department of the 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 that of 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 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 any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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
Reporting side effects will allow more information to be collected on the safety of the medicine.

5. How to store Kreon Travix

• The medicine should be stored out of sight and reach of children.
• Store in a temperature below 25°C. Store the bottle tightly closed. Protect from moisture.
• Shelf life after first opening the bottle: 6 months.
• This medicine should not be used 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. The pharmacist should be asked how to dispose of medicines that are no longer needed. 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 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. Cap 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 available as enteric-coated capsules, hard, 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: 50 enteric-coated capsules, hard.

For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in Latvia, the 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:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Latvia, the country of export: 99-0594
Parallel import authorization number: 324/24

Date of leaflet approval: 19.08.2024

[Information about the trademark]