Kreon travix max

Package leaflet: Information for the patient

Kreon Travix Max, 20,000 Ph.Eur.U. lipolytic activity, enteric-coated hard capsules
Pancreatinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• 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 reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement within 5 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

What Kreon Travix Max is

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

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

• cystic fibrosis (a rare genetic disease)
• chronic pancreatitis
• absence of the pancreas or part of it
• pancreatic cancer

Kreon Travix Max may be used in children, adolescents, and adults. Dosage recommendations for each age group are provided in section 3 of this leaflet, "How to take Kreon Travix Max".

Treatment with Kreon Travix Max reduces the severity of symptoms of exocrine pancreatic insufficiency, including stool consistency (i.e. fatty stools), abdominal pain, bloating, and stool frequency (diarrhea or constipation), regardless of the underlying disease.
This medicine should only be used when one of the above conditions has been previously diagnosed by a doctor and when the doctor has recommended taking this medicine.
Newborns and children may take this medicine only if prescribed by a doctor and under strict medical supervision.
If there is no improvement after 5 days, or if you feel worse, you should contact your doctor.

How Kreon Travix Max works
The enzymes in Kreon Travix Max work by digesting food as it passes through the small intestine. Kreon Travix Max should be taken during or immediately after main meals or snacks. This ensures thorough mixing of the enzymes with food.

2. 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 to take Kreon Travix Max, discuss this with your doctor or pharmacist.
Patients with cystic fibrosis
A rare bowel condition called fibrosing colonopathy, which causes narrowing of the colon, 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.U. lipolytic activity/kg body weight/day, and experience any new or worsening gastrointestinal symptoms, you should contact your doctor.
Dosing expressed in terms of lipase dosage is provided in section 3 of this leaflet, “How to take Kreon Travix Max”.
Severe allergic reactions
If an allergic reaction occurs, stop taking the medicine and contact your doctor.
An allergic reaction may include itching and rash. A less common, more serious allergic reaction may include: hot flushes, dizziness and fainting, breathing difficulties.
These are symptoms of a severe, potentially life-threatening condition called “anaphylactic shock”.
If this occurs, seek immediate medical help.
Before taking Kreon Travix Max, inform your doctor if you are allergic to porcine protein.
Oral cavity irritation
Chewing and/or holding the capsules in the mouth for too long may cause pain, irritation, bleeding, and ulceration of the oral mucosa. If early signs of oral irritation occur, rinsing the mouth with water and drinking a glass of water may be helpful.
The contents of Kreon Travix Max capsules may be sprinkled onto certain foods (see section 3 of this leaflet, “How to take Kreon Travix Max”).
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered “sodium-free”.
Kreon Travix Max and other medicines
Tell your doctor or pharmacist if you are currently taking, have recently taken, or plan to take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Your doctor will decide whether you may take Kreon Travix Max during pregnancy.
Kreon Travix Max may be taken during breastfeeding.
Driving and using machines
Kreon Travix Max has no influence on the ability to drive and use tools or machines.

3. How to take Kreon Travix Max

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The dose is measured in units of lipolytic activity. 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, who will adjust the dose according to the patient's individual needs, based on:

• severity of the disease
• body weight
• diet
• amount of fat present in the stool

If fatty stools or gastrointestinal symptoms persist, contact your 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 initiating treatment in children, depending on the child's age and body weight.
The appropriate dose for a child should always be determined by a doctor using a lower-strength formulation (i.e. 10,000 or 5,000 Ph.Eur.U. lipolytic activity).
Once the dose has been established, this strength may be used in children.

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

Adolescents and adults
The usual initial dose in adolescents and adults, based on body weight, is 500 Ph.Eur.U. lipolytic activity/kg body weight/meal.

Patients of all ages
The usual daily dose should generally not exceed 2,500 Ph.Eur.U. lipolytic activity/kg body weight/meal, or 10,000 Ph.Eur.U. lipolytic activity/kg body weight/day, or 4,000 Ph.Eur.U. lipolytic activity/kg body weight/g of dietary fat intake.

Patients with other pancreatic disorders
Adolescents and adults
The usual dose ranges from 25,000 to 80,000 Ph.Eur.U. lipolytic activity per main meal.
For snacks, the usual dose is half the amount taken with a main meal.

When to take Kreon Travix Max
Kreon Travix Max should always be taken during or immediately after main meals and snacks. This ensures proper mixing of the enzymes with food and effective digestion 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 with water or juice.
• Do not chew or crush the capsules or their contents, as this may cause irritation of the mouth or alter the medicine's action in the body.
• If swallowing the capsules is difficult, they may be carefully opened and the pellets mixed with a small amount of soft, acidic food or acidic drink. Acidic foods include, for example, yoghurt or apple puree. Acidic drinks include apple, orange, or pineapple juice. Do not mix the pellets with water, milk (including flavoured milk), breast milk, infant formula, or hot food. The mixture should be swallowed immediately without chewing or crushing, and followed by 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 Max in the body.
• Do not retain Kreon Travix Max or the capsule contents in the mouth. Ensure that the medicine or mixture of medicine with food is completely swallowed and that no pellets remain in the mouth.
• Do not store the medicine mixture.

Taking more Kreon Travix Max than prescribed
If you take more Kreon Travix Max than you should, drink plenty of water and seek advice from your doctor or pharmacist immediately.
Very high doses of pancreatin may occasionally increase the level of uric acid in the blood and urine.

If you forget to take Kreon Travix Max
If you miss a dose of Kreon Travix Max, take your usual dose at the next scheduled meal. Do not take a double dose to make up for the missed dose.

Stopping Kreon Travix Max
Do not stop taking Kreon Travix Max without consulting your doctor. Many patients need to take Kreon Travix Max for the rest of their lives.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Kreon Travix Max can cause adverse reactions, although not everyone experiences
them.
The following adverse reactions may occur in patients taking this medicine.
The most important and serious adverse reactions reported during treatment with medicines
containing pancreatic enzymes are "anaphylactic shock" and fibrosing colonopathy. These two
adverse reactions have occurred in a very small number of people; however, the exact incidence is
unknown.
Anaphylactic shock is a severe, potentially life-threatening allergic reaction that may occur suddenly.
If any of the following symptoms occur, seek immediate medical help:

• itching, urticaria or rash
• swelling of the face, eyes, lips, hands or feet
• pre-syncope or fainting
• difficulty breathing or swallowing
• palpitations
• dizziness, falls or loss of consciousness

Long-term use of high doses of medicines containing pancreatic enzymes may also cause scarring or thickening of the intestinal wall, which may lead to intestinal obstruction. This condition is known as fibrosing colonopathy. If you experience severe abdominal pain, problems with passing stools (constipation), nausea or vomiting, contact your doctor immediately.
Very common adverse reactions (occurring in more than 1 in 10 patients)

• abdominal pain

Common adverse reactions (occurring in less than 1 in 10 patients)

• nausea
• vomiting
• constipation
• bloating
• diarrhoea
  These reactions may be caused by the underlying disease for which Kreon Travix Max is prescribed.

Uncommon adverse reactions (occurring in less than 1 in 100 patients)

• rash

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Kreon Travix Max

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following: EXP.
The expiry date refers to the last day of the stated month. The batch number is indicated on the label
and carton following: Lot.
Do not store above 25°C.
After first opening, do not store above 25°C. Shelf-life after first opening of the bottle: 6 months. Keep bottles tightly closed to protect from moisture.
Medicines must 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 Max contains
The active substance is pancreatic powder (pancreatin).

• Each capsule of Kreon Travix Max contains 300 mg of pancreatic powder (pancreatin) with activity:

  • lipolytic: 20,000 Ph.Eur.U.
  • amylolytic: 16,000 Ph.Eur.U.
  • proteolytic: 1,200 Ph.Eur.U.

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

Marketing Authorisation 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
Branch office Bad Homburg v. d. Höhe
Benzstraße 1
61352 Bad Homburg v.d. Höhe
Germany

For further information, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel. 22 546 64 00