Kreon Travix

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Kreon Travix (Kreon 10,000 V), 10,000 Ph.Eur. lipase units, enteric-coated capsules, hard
Pancreatinum
Kreon Travix and Kreon 10,000 V 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 that you can read it again if you need to.
• If you need advice or additional information, you should consult a 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 is Kreon Travix 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

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 units/kg body weight/day and the occurrence of any disturbing symptoms from the digestive system or changes in existing symptoms, you should contact your doctor.

Pregnancy and breastfeeding

• 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 exactly as advised by your doctor or pharmacist. If in doubt, 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 the doctor.
• The doctor will adjust the dose according to the patient's needs, which depends on:
• the type of disease
• body weight
• the diet used
• the amount of fat in the stool.

Cystic fibrosis

• Usually, the initial dose in children under 4 years of age is 1000 lipase units/kg body weight/meal.
• Usually, the 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 consumed.

Other pancreatic disorders - adults

• Usually, the 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 dose is usually half the dose taken during the main meal (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.
• 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.
• 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 than the recommended dose of Kreon Travix