Kreon Travix

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Kreon Travix (Kreon 10,000)

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

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.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a 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, 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 digestion 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 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 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

Warnings and precautions

A rare disease of the large intestine called fibrosing colonopathy, in which the large intestine narrows, has been reported in patients with cystic fibrosis who have taken large doses of pancreatin.
Therefore, in the case of cystic fibrosis and taking pancreatin in a dose greater than 10,000 Ph.Eur. lipase/kg body weight/day and the occurrence of any disturbing symptoms from the digestive system or changes in existing symptoms, a doctor should be consulted.

Pregnancy and breastfeeding

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

3. How to take Kreon Travix

This medicine should always be taken as advised by a doctor or pharmacist. In case of doubt, a 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 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 used,
• the amount of fat in the stool.
• If fatty stools or gastrointestinal symptoms persist, a doctor should be consulted, as the dose may need to be adjusted.

Cystic fibrosis

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

Other pancreatic disorders - adults

• Usually, the dose is between 25,000 and 80,000 units of lipase (2 to 8 capsules of Kreon Travix) per main meal (breakfast, lunch, dinner).
• For snacks, the dose is usually half the dose taken during the 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 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. An acidic drink 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 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 retained in the mouth.
• The mixture should not be stored.
• Large amounts of fluids should be drunk throughout 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 taking too much Kreon Travix, plenty of fluids should be drunk and a doctor or pharmacist should be consulted.
Very high doses of pancreatin can sometimes cause an increase in uric acid in the urine and blood.

Missing a dose of Kreon Travix

In case of missing a dose of Kreon Travix, the normal dose should be taken at the usual time with 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, a 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 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 immediately consult a doctor or the Emergency Department of the nearest hospital.
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 who experienced abdominal pain or diarrhea was similar to or lower than that of patients 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 urticaria,
• Kreon 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 product was marketed.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301; Fax: +48 22 49 21 309; Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the 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. After opening the bottle, do not use for more than 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. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Kreon Travix contains

• The active substance of Kreon Travix is 150 mg of pancreatin with an activity of: 10,000 Ph.Eur. lipase (BP units) 8,000 Ph.Eur. amylase (BP units) 600 Ph.Eur. protease.
• The other ingredients are: macrogol 4000, hypromellose phthalate, dimethicone 1000, cetyl alcohol, triethyl citrate. Capsule shell: 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 in the form of 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 packaging contains: 20, 50, 100 enteric-coated capsules, hard, in blister packs or 50 enteric-coated capsules, hard, in a bottle.

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

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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Hungary, the country of export: OGYI-T-4231/09
OGYI-T-4231/10

Parallel import authorization number: 55/12 Date of leaflet approval: 27.01.2022

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