Kreon travix

PACKAGE LEAFLET: 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. units lipase, gastro-resistant hard capsules
Pancreatinum
Kreon Travix and Kreon 10 000 are different trade names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

What Kreon Travix is

• Kreon Travix contains a mixture of digestive enzymes called "pancreatin".
• Pancreatin helps digest food. The enzymes are derived from porcine pancreas.
• Kreon Travix contains small granules that slowly release pancreatin in the intestine (acid-resistant granules known as Minimicrospheres).

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

• cystic fibrosis (a rare genetic disorder)
• obstruction of the pancreatic or biliary ducts
• acute pancreatitis attack. Kreon Travix may be started when the patient resumes oral feeding
• chronic pancreatitis
• pancreatic cancer
• partial or complete pancreatectomy
• partial or complete gastrectomy
• gastroenteroanastomosis
• Shwachman-Diamond syndrome (a very rare genetic disorder). Exocrine pancreatic insufficiency may also occur in other clinical conditions not listed above.

How Kreon Travix works
The enzymes in Kreon Travix aid digestion of food passing through the small intestine. Treatment with Kreon Travix significantly reduces the severity of symptoms of exocrine pancreatic insufficiency, including abdominal pain, bloating, and helps normalize bowel movement frequency and improve stool consistency, regardless of the underlying disease. Kreon Travix should be taken during or immediately after main meals or snacks to ensure thorough mixing of the enzymes with food.

2. Important information before taking Kreon Travix

When not to take Kreon Travix

• if the patient is allergic to porcine pancreatin or any of the other ingredients of this medicine (listed in section 6). If in doubt, consult a doctor or pharmacist.

Warnings and precautions
A rare bowel disorder called fibrosing colonopathy, in which the colon becomes narrowed, has been reported in patients with cystic fibrosis who were taking high doses of pancreatin.
Therefore, if you have cystic fibrosis and are taking pancreatin at a dose greater than 10,000 Ph.Eur. units of lipase/kg body weight/day, and experience any worrying gastrointestinal symptoms or a change in your usual symptoms, you should contact your doctor.

Pregnancy and breastfeeding

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

Driving and operating machinery
Kreon Travix has no effect or negligible effect on the ability to drive and operate machinery.

Kreon Travix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, this medicine is considered "sodium-free".

3. How to take Kreon Travix

This medicine should always be taken as directed by a doctor or pharmacist. In case of
doubt, consult a 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 determined by the doctor.
• The doctor will adjust the dose according to the patient's needs, depending on:
• type of disease
• body weight
• diet
• amount of fat present in the stool.
• If fatty stools or gastrointestinal symptoms persist, consult a doctor, as the dose may need to be adjusted.

Cystic fibrosis

• The usual initial dose for children under 4 years of age is 1000 lipase units/kg body weight/meal.
• The usual initial dose for children aged 4 years and older, adolescents and adults is 500 lipase units/kg body weight/meal.
• In most patients, the dose should be less than or not exceed 10,000 lipase units/kg body weight/day or 4,000 lipase units/g of fat ingested.

Other pancreatic disorders - adults

• The usual dose is 25,000 to 80,000 lipase units (2 to 8 capsules of Kreon Travix) with each main meal (breakfast, lunch, dinner).
• For snacks, the usual dose is half the dose taken with a 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 ensures thorough mixing of the enzymes with food and digestion as it passes
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 may be carefully opened and the granules mixed with soft, acidic food or an acidic drink. Acidic foods include, for example, apple sauce or yogurt. Acidic drinks include apple, orange or pineapple juice.
• The mixture should be swallowed immediately without chewing or crushing, and followed with water or juice.
• Mixing with non-acidic food or drink, or chewing or crushing the minimicrospheres, may cause irritation of the mouth or alter the action of Kreon Travix in the body.
• Do not retain Kreon Travix or capsule contents in the mouth.
• Do not store the medicine mixture.
• Drink plenty of fluids throughout the day.

How long to take Kreon Travix
Take this medicine for as long as your doctor advises. Many patients need to take Kreon Travix
for life.
Taking more than the recommended dose of Kreon Travix
If too much Kreon Travix has been taken, drink plenty of fluids and seek advice from a doctor or
pharmacist.
Very high doses of pancreatin may sometimes increase uric acid levels in urine and
blood.
Missing a dose of Kreon Travix
If a dose of Kreon Travix is missed, take the usual dose at the next meal. Do not take a double
dose to make up for a missed dose.
Stopping Kreon Travix
Do not stop taking Kreon Travix without consulting your doctor.
If in doubt, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported during studies in patients taking Kreon.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue and/or
throat, which may cause difficulty in breathing or swallowing, or other serious adverse reactions occur,
treatment with Kreon Travix must be discontinued immediately and medical advice must be sought
without delay from a doctor or at the nearest hospital Emergency Department.
Adverse reactions that may occur during treatment with Kreon Travix:
Very common (affects more than 1 in 10 people)

• abdominal pain

Common (affects less than 1 in 10 people)

• nausea
• vomiting
• constipation
• bloating
• diarrhoea
  These effects may be due to the underlying disease for which Kreon Travix is prescribed. During clinical studies, the number of patients taking Kreon who experienced abdominal pain or diarrhoea was similar to or lower than in patients not taking Kreon.

Uncommon (affects less than 1 in 100 people)

• rash

Frequency not known (cannot be estimated from the available data)

• itching and urticaria
• Kreon may cause hypersensitivity reactions, including anaphylactic reactions manifesting as breathing difficulties or swelling of the lips
• stricture of the ileocaecal region and large intestine (fibrosing colonopathy) has been reported in patients with cystic fibrosis of the pancreas receiving high doses of pancreatin-containing products. Hypersensitivity reactions, mainly affecting the skin but not limited to it, have been observed and reported following marketing of the product.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Kreon Travix

Keep this medicine 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 of 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 stated month.
Medicines must 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. Package contents and other information

What Kreon Travix contains

• The active substance is 150 mg of pancreatin with activity: 10,000 Ph.Eur. units (BP units) of lipase, 8,000 Ph.Eur. units (BP units) of amylase, 600 Ph.Eur. units (BP units) of protease.
• Other ingredients: macrogol 4000, hypromellose phthalate, dimethicone 1000, cetyl alcohol, triethyl citrate. Capsule coating: gelatin, yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate.

What Kreon Travix looks like and contents of the pack

• Kreon Travix is available as hard gastro-resistant gelatin capsules containing enteric-coated granules (mini-microspheres).
• The capsules are two-coloured: one part is an opaque brown, the other part is colourless and transparent.
• Pack sizes: 20 or 50 capsules.

For further detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Hungary, 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 in:
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
Hungary Marketing Authorisation Numbers: OGYI-T-4231/09
OGYI-T-4231/10
Parallel Import Authorisation Number: 5/19