Kreon Travix

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

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

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

You should carefully read the contents of the leaflet 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
your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should 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 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 (granules resistant to stomach acid, called Minimicrospheres).

What Kreon Travix is used for
Kreon Travix is used in children, adolescents, and adults with digestive disorders due to pancreatic exocrine 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 exocrine insufficiency may also be diagnosed in other clinical conditions not listed 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 exocrine 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

• 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 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 symptoms, you should contact your doctor.

Pregnancy and breastfeeding

• If you are pregnant or think you may be pregnant, you should 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 advised 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 according to your needs, which depends on:
• the type of disease
• body weight
• diet used
• the amount of fat in the stool.
• If you continue to have fatty stools or 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 of age is 1000 lipase units/kg body weight/meal.
• Usual starting 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 Ph.Eur. lipase units/kg body weight/day or 4000 lipase units/g of fat ingested.

Other pancreatic disorders - adults

• Usual dose is between 25,000 and 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 with water or juice.
• Mixing with non-acidic food or drink, chewing, or crushing the Minimicrospheres may cause irritation of the mouth or alter 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.
• You should 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 more Kreon Travix than prescribed, you should 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, you should take the normal dose at the next usual time with a meal. Do not take a double dose to make up for the missed dose.

Stopping Kreon Travix

You should 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 an allergic reaction, including rash, swelling of the face, lips, tongue, and/or
throat, which may cause difficulty breathing or swallowing, or experience other serious
side effects, you should 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. 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 may cause hypersensitivity reactions, including anaphylactic reactions with difficulty breathing or swelling of the mouth
• narrowing of the ileocecal region 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 product was marketed.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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

The medicine should be stored out of sight and reach of children.
Blister packs: Do not store above 25°C.
Bottle: Do not store above 25°C. Store the bottle tightly closed to 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 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 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. Coating:gelatin, iron oxide yellow (E 172), iron oxide black (E 172), iron oxide red (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 in 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: 20 or 50 capsules.

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

Marketing authorization holder in Hungary, the country of export:

Mylan EPD Kft.
Váci út 150.
1138 Budapest
Hungary

Manufacturer:

Abbott Laboratories GmbH
Justus-von-Liebig Str. 33
D-31535 Neustadt
Germany

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o. o.
ul. Jagiellońska 76
03-301 Warsaw
Marketing authorization number in Hungary, the country of export: OGYI-T-4231/09
OGYI-T-4231/10
Parallel import authorization number: 5/19

Date of leaflet approval: 09.01.2024

[Information about the trademark]