Kreon Travix Max

Package Leaflet: Information for the Patient

Kreon Travix Max, 20,000 Ph.Eur.U. of lipolytic activity, enteric-coated capsules, hard
Pancreatinum

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• The package 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 package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 5 days, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is Kreon Travix Max and what is it used for
• 2. Important information before taking Kreon Travix Max
• 3. How to take Kreon Travix Max
• 4. Possible side effects
• 5. How to store Kreon Travix Max
• 6. Contents of the pack and other information

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

What is Kreon Travix Max

• Kreon Travix Max contains a mixture of digestive enzymes called pancreatin (pancreas powder)
• Pancreatin helps digest food. The enzymes are obtained from pig pancreas.
• Kreon Travix Max contains small pellets that slowly release pancreatin in the intestine (pellets resistant to stomach acid, called minimicrospheres).

What is Kreon Travix Max used for

Kreon Travix Max is used to treat pancreatic exocrine insufficiency. This is a condition in which the pancreas does not produce enough digestive enzymes.
It often occurs in patients with:

• cystic fibrosis (a rare genetic disease)
• chronic pancreatitis
• removed pancreas or part of it
• pancreatic cancer Kreon Travix Max can be used in children, adolescents, and adults. The dosage in different age groups is presented in section 3 of this package leaflet "How to take Kreon Travix Max".

Treatment with Kreon Travix Max reduces the severity of symptoms of pancreatic exocrine insufficiency, including stool consistency (i.e., fatty stools), abdominal pain, bloating, and frequency of stool (diarrhea or constipation), regardless of the underlying disease.
The medicine should only be used when one of the above conditions has been previously confirmed by a doctor and the doctor has recommended taking this medicine.
Newborns and children may only take this medicine when it has been prescribed by a doctor and treatment is carried out under close medical supervision.
If there is no improvement or the patient feels worse after 5 days, they should contact their doctor.

How Kreon Travix Max works

The enzymes contained in Kreon Travix Max work by digesting food passing through the small intestine. Kreon Travix Max should be taken during or immediately after main meals or snacks. This will allow the enzymes to mix with the food and digest it as it passes through the small intestine.

2. Important information before taking Kreon Travix Max

When not to take Kreon Travix Max

• if the patient is allergic to pancreatin or any of the other ingredients of Kreon Travix Max (listed in section 6)

Warnings and precautions

Before starting treatment with Kreon Travix Max, the patient should discuss it with their doctor or pharmacist.
Patients with cystic fibrosis
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 took high doses of pancreatin. Therefore, in the case of cystic fibrosis and taking pancreatin in a dose higher than 10,000 Ph.Eur.U. of lipolytic activity/kg body weight/day and the occurrence of any worrying symptoms from the digestive system or changes in existing symptoms, the patient should contact their doctor.
The dosage in terms of lipase has been presented in section 3 of the package leaflet "How to take Kreon Travix Max".
Severe allergic reactions
If an allergic reaction occurs, the patient should stop taking the medicine and contact their doctor.
An allergic reaction may include itching and rash. Less common, more serious allergic reactions may include: hot flashes, dizziness, and fainting, breathing difficulties.
These are symptoms of a severe, potentially life-threatening condition called "anaphylactic shock".
In case of its occurrence, the patient should seek immediate medical attention.
Before taking Kreon Travix Max, the patient should inform their doctor about an allergy to pork protein.
Mouth irritation
Chewing and/or holding the capsules in the mouth for too long may cause mouth pain, irritation, bleeding, and ulcers in the mouth. If the first symptoms of mouth irritation occur, rinsing the mouth with water and drinking a glass of water may be helpful.
The contents of the Kreon Travix Max capsule can be sprinkled on certain foods (see section 3 of this package leaflet "How to take Kreon Travix Max").
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

Kreon Travix Max and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The doctor will decide whether the patient can take Kreon Travix Max during pregnancy.
Kreon Travix Max can be taken during breastfeeding.

Driving and using machines

Kreon Travix Max does not affect the ability to drive and use tools and machines.

3. How to take Kreon Travix Max

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The dose is measured in units of lipolytic activity. Lipase is one of the enzymes of pancreatin. Different strengths of Kreon Travix Max contain different amounts of lipase.
The number of capsules to be taken is decided by the doctor. The doctor will adjust the dose to the patient's needs.
This is dependent on:

• the severity of the disease
• body weight
• the diet used
• the amount of fat present in the stool If fatty stools persist or gastrointestinal symptoms (gastrointestinal symptoms) occur, the patient should contact their doctor, as the dose may need to be adjusted.

Dosage of Kreon Travix Max

Patients with cystic fibrosis

Children
This strength of the medicine may not be suitable for starting treatment in children, depending on the child's age and weight.
The dose suitable for the child should always be determined by the doctor using a medicine with a lower content of lipolytic activity units (i.e., 10,000 or 5,000 Ph.Eur.U. of lipolytic activity).
After determining the dose of the medicine for a meal, this strength of the medicine can be used in children.

• Usually, the initial dose in children under 4 years of age is 1,000 Ph.Eur.U. of lipolytic activity/kg body weight/meal.
• Usually, the initial dose in children aged 4 and over is 500 Ph.Eur.U. of lipolytic activity/kg body weight/meal.

Adolescents and adults
Usually, the initial dose in adolescents and adults, depending on the patient's weight, is 500 Ph.Eur.U. of lipolytic activity/kg body weight/meal.
Patients of any age
Usually, the daily dose should not exceed 2,500 Ph.Eur.U. of lipolytic activity/kg body weight/meal or 10,000 Ph.Eur.U. of lipolytic activity/kg body weight/day or 4,000 Ph.Eur.U. of lipolytic activity/kg body weight/g of fat consumed.

Patients with other pancreatic disorders

Adolescents and adults
Usually, the dose is between 25,000 and 80,000 Ph.Eur.U. of lipolytic activity per main meal.
For snacks, the dose is usually half the dose taken during the main meal.

When to take Kreon Travix Max

Kreon Travix Max should always be taken during or immediately after main meals and snacks. This will allow the enzymes to mix with the food and digest it as it passes through the small intestine.

How to take Kreon Travix Max

• Kreon Travix Max should always be taken with a main meal or snack.
• Swallow the capsules whole and wash them down with water or juice.
• The capsules or their contents should not be chewed or crushed, as this may cause mouth irritation or change the action of the medicine in the body.
• If swallowing capsules is difficult, they can be carefully opened and the pellets added to a small amount of soft, acidic food or acidic drink. Acidic food can be, for example, yogurt or apple puree. Acidic drink can be, for example, apple, orange, or pineapple juice. The pellets should not be mixed with water, milk (including flavored milk), breast milk, infant formula, or hot food. 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 mouth irritation or change the action of Kreon Travix Max in the body.
• Kreon Travix Max or the contents of the capsules should not be kept in the mouth. The patient should make sure that the medicine or the mixture of the medicine with food has been completely swallowed and that no pellets remain in the mouth.
• The mixture of the medicine should not be stored.

Overdose of Kreon Travix Max

In case of taking too much Kreon Travix Max, the patient should drink plenty of water and consult their doctor or pharmacist.
Very high doses of pancreatin may sometimes cause an increase in the amount of uric acid in the urine and blood.

Missed dose of Kreon Travix Max

In case of missing a dose of Kreon Travix Max, the patient should take the normal dose at the usual time with the next meal. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Kreon Travix Max

The patient should not stop taking Kreon Travix Max without consulting their doctor. Many patients need to take Kreon Travix Max for the rest of their lives.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Kreon Travix Max can cause side effects, although not everybody gets them.
The following side effects may occur in patients taking this medicine.
The most important, most serious side effects that have occurred during treatment with pancreatic enzyme products are "anaphylactic shock" and fibrosing colonopathy. These two side effects have occurred in a very small number of people, but their exact frequency is not known.
Anaphylactic shock is a severe, potentially life-threatening allergic reaction that can occur suddenly.
If any of the following symptoms occur, the patient should seek immediate medical attention:

• itching, hives, or rash
• swelling of the face, eyes, lips, hands, or feet
• feeling faint or fainting
• difficulty breathing or swallowing
• rapid heartbeat
• dizziness, falls, or loss of consciousness

Long-term use of high doses of pancreatic enzyme products may also cause scarring or thickening of the intestinal walls, which can lead to blockage of the intestine. This condition is called fibrosing colonopathy. If severe abdominal pain, problems with bowel movements (constipation), nausea, or vomiting occur, the patient should contact their doctor immediately.
Very common side effects(occurring in more than 1 in 10 patients)

• abdominal pain

Common side effects(occurring in less than 1 in 10 patients)

• nausea
• vomiting
• constipation
• bloating
• diarrhea These side effects may be due to the disease for which Kreon Travix Max is indicated.

Uncommon side effects(occurring in less than 1 in 100 patients)

• rash

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Kreon Travix Max

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the label and carton after: EXP.
The expiry date refers to the last day of the month stated. The batch number is stated on the label and carton after: Lot.
The medicine should not be stored above 25°C.
After first opening, the medicine should not be stored above 25°C. The shelf life after first opening the bottle: 6 months. The bottles should be stored tightly closed to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist 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 Max contains

The active substance of the medicine is pancreas powder (pancreatin).

• Each Kreon Travix Max capsule contains 300 mg of pancreas powder (pancreatin) with an activity of:
• lipolytic 20,000 Ph.Eur.U.
• amylolytic 16,000 Ph.Eur.U.
• proteolytic 1,200 Ph.Eur.U.
• The other ingredients are:
• Macrogol 4000
• Pellet coating: hypromellose phthalate, cetyl alcohol, triethyl citrate, dimethicone 1000
• Capsule shell: gelatin, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172), sodium lauryl sulfate

What Kreon Travix Max looks like and contents of the pack

Kreon Travix Max capsules, size 0, elongated, have one brown and one transparent part. They contain brownish pellets resistant to stomach acid (minimicrospheres).
Kreon Travix Max is available in HDPE bottles with a PP cap, containing 50, 60, 100, 120, 200, and 250 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Ireland

Manufacturer

Abbott Laboratories GmbH, Site Neustadt
Justus-von-Liebig-Straße 33
31535 Neustadt
Germany
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Höhe
Benzstraße 1
61352 Bad Homburg v.d. Höhe
Germany
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00
Date of last revision of the package leaflet:06/2024