Kreon Travix
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How to use 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.
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 your doctor, pharmacist, or nurse.
- Keep this leaflet, you may need to read it again.
- If you need advice or more information, ask your pharmacist.
- If you experience any side effects, including those not listed in the leaflet, 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 (acid-resistant granules, called Minimicrospheres).
What Kreon Travix is 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 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 patients with cystic fibrosis taking pancreatin at a dose greater than 10,000 Ph.Eur. lipase units/kg body weight/day and experiencing any disturbing gastrointestinal symptoms or changes in existing symptoms, consult your doctor.
Pregnancy and breastfeeding
- If you are pregnant or think you may be pregnant, consult your doctor before taking Kreon Travix. Your doctor will decide whether you can take Kreon Travix and at 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
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".
3. How to take Kreon Travix
This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, 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 Travix contain different amounts of lipase.
- The number of capsules to be taken is determined by your doctor.
- Your doctor will adjust the dose to your individual needs, which depends on:
- the type of disease,
- body weight,
- the diet used,
- the amount of fat in the stool.
- If you continue to have fatty stools or gastrointestinal symptoms (gastrointestinal symptoms), consult your doctor, as the dose may need to be adjusted.
Cystic fibrosis
- Usual starting dose in children under 4 years of age is 1000 lipase units/kg body weight/meal.
- Usual starting 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
- Usual dose is 25,000 to 80,000 lipase units (2 to 8 Kreon Travix capsules) per main meal (breakfast, lunch, dinner).
- For snacks, the usual dose is half the dose taken during main meals (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.
- Do not chew or crush the capsules.
- 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. Acidic drinks can be apple, orange, or pineapple juice.
- The mixture should be swallowed immediately without chewing and followed 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.
- 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
If you have taken more than the recommended dose of Kreon Travix, drink plenty of fluids and consult your doctor or pharmacist.
Very high doses of pancreatin may sometimes cause an increase in uric acid levels in the urine and blood.
Missing a dose of Kreon Travix
If you miss a dose of Kreon Travix, take the normal dose at the next mealtime. Do not take a double dose to make up for the missed dose.
Stopping treatment with Kreon Travix
Do not stop taking Kreon Travix without consulting your doctor.
In case of doubt, consult your doctor or pharmacist.
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 Travix during clinical trials.
If you experience allergic reactions, including rash, swelling of the face, lips, tongue, and/or
throat, which may cause difficulty breathing or swallowing, or other serious side effects, stop taking
Kreon Travix and contact your doctor or the Emergency Department of your nearest hospital immediately.
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 Travix who experienced abdominal pain or diarrhea was similar to or lower than those not taking Kreon Travix.
Uncommon (occurring in less than 1 in 100 patients)
- rash.
Frequency not known (cannot be estimated from the available data)
- itching and hives,
- Kreon Travix 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 you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301; Fax: +48 22 49 21 309; Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Kreon Travix
- Keep the medicine out of the sight and reach of children.
- Store in a temperature below 25°C. Keep the bottle tightly closed. 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. 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 contains
- The active substance is 150 mg of pancreatin with an activity of: 10,000 Ph.Eur. lipase units (BP units) 8,000 Ph.Eur. amylase units (BP units) 600 Ph.Eur. protease units.
- The other ingredients are: macrogol 4000, hypromellose phthalate, dimeticone 1000, cetyl alcohol, triethyl citrate. 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 enteric-coated capsules, hard, containing granules in an acid-resistant coating (Minimicrospheres).
- The capsules are two-colored: one part is opaque brown, the other part is transparent and colorless.
- The pack contains: 50 enteric-coated capsules, hard, in an HDPE bottle with a PP cap in a cardboard box.
For more detailed information, please contact the marketing authorization holder or parallel importer.
Marketing authorization holder in Latvia, the country of export:
Viatris Healthcare Limited
Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland
Manufacturer:
Abbott Laboratories GmbH
Justus-von-Liebig-Str.33
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
Marketing authorization number in Latvia, the country of export: 99-0594
Parallel import authorization number: 184/24
Date of leaflet approval: 06.05.2024
[Information about the trademark]
- Country of registration
- Active substance
- Prescription requiredNo
- Marketing authorisation holder (MAH)Viatris Healthcare Limited
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to Kreon TravixDosage form: Capsules, 10,000 Ph.Eur.U. of lipolytic activityActive substance: multienzymes (lipase, protease etc.)Prescription not requiredDosage form: Capsules, 25,000 Ph. Eur. lipase unitsActive substance: multienzymes (lipase, protease etc.)Manufacturer: Abbott Laboratories GmbH, Werk NeustadtPrescription requiredDosage form: Capsules, 35000 Ph.Eur.U. of lipolytic activityActive substance: multienzymes (lipase, protease etc.)Prescription required
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