Lipancrea 8000

Package Leaflet: Information for the Patient

LIPANCREA 8 000

8 000 Ph. Eur. lipase units, capsules
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 or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Lipancrea 8 000 and what is it used for
• 2. Important information before taking Lipancrea 8 000
• 3. How to take Lipancrea 8 000
• 4. Possible side effects
• 5. How to store Lipancrea 8 000
• 6. Contents of the pack and other information

1. What is Lipancrea 8 000 and what is it used for

What is Lipancrea 8 000

• Lipancrea 8 000 contains a mixture of digestive enzymes called "pancreatin".
• Pancreatin helps digest food. The enzymes are obtained from pig pancreas.
• Lipancrea 8 000 contains small granules that slowly release pancreatin in the intestine (granules resistant to stomach acid, called pellets).

What is Lipancrea 8 000 used for
Lipancrea 8 000 is used in children, adolescents, and adults with digestive disorders due to pancreatic exocrine 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. Lipancrea 8 000 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 exocrine insufficiency may also be diagnosed in other clinical conditions not listed above.
How does Lipancrea 8 000 work
The enzymes in Lipancrea 8 000 work by digesting food passing through the small intestine. The treatment significantly reduces the severity of symptoms of pancreatic exocrine insufficiency, including abdominal pain, bloating, regulates bowel movements, and improves stool consistency, regardless of the underlying disease. Lipancrea 8 000 should be taken during or immediately after main meals or snacks. This will allow the enzymes to mix with the food.

2. Important information before taking Lipancrea 8 000

When not to take Lipancrea 8 000

• If you are allergic to pancreatin, pork protein, or any of the other ingredients of this medicine (listed in section 6).

In case of doubt, you should consult your doctor or pharmacist.

Warnings and precautions

Before taking Lipancrea 8 000, you should discuss it with your doctor or pharmacist.
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, you should contact your doctor.

Lipancrea 8 000 with food and drink

Lipancrea 8 000 should be taken during meals or immediately after meals or snacks, drinking a liquid with each capsule.
For more information, see section 3 of the leaflet "How to take Lipancrea 8 000".

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
In case of pregnancy or suspected pregnancy, you should contact your doctor before taking Lipancrea 8 000. The doctor will decide whether you can take the medicine and in what dose.
Lipancrea 8 000 can be used during breastfeeding.

Driving and using machines

Lipancrea 8 000 has no influence or negligible influence on the ability to drive and use machines.

3. How to take Lipancrea 8 000

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
The dose is measured in lipase units. Lipase is one of the enzymes in pancreatin.
The dose should be adjusted to the individual needs of the patient. It depends on:

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

Dosage

The dosage of the medicine should be determined individually, depending on the patient's need for pancreatic enzymes.
Cystic fibrosis
Usually, the initial dose in children under 4 years of age is 1,000 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 4,000 lipase units/g of fat consumed.
Other pancreatic disorders
Usually, the dose is between 25,000 and 80,000 lipase units (3 to 10 capsules of Lipancrea 8 000) per main meal (breakfast, lunch, dinner).
For snacks, the dose is usually half of the dose taken during the main meal (1 to 5 capsules of Lipancrea 8 000).

Method of administration

• Lipancrea 8 000 should be taken orally during meals or immediately after meals or snacks, drinking a liquid with each capsule. The capsule should be swallowed whole, not chewed or crushed.
• In case of problems with swallowing the capsule or the need to administer a smaller amount of enzymes, the capsule can be carefully opened. The contents of the capsule should be poured onto a spoon, added to an acidic, soft food that does not require chewing (it can be apple sauce or yogurt) or mixed with an acidic liquid, such as apple, orange, or pineapple juice (do not add to milk and milk mixtures). The pellet mixture should be swallowed immediately without chewing and washed down with water or juice. The mixture should not be stored.
• Do not keep the medicine or the contents of the capsules in the mouth.
• You should drink plenty of fluids throughout the day.
• It is not necessary to take the medicine with light meals consisting of fruits, vegetables, fruit juices, and other fat-free products.
• Taking the medicine with food with a pH close to neutral or alkaline (pH higher than 5.5 - e.g., eggs, chicken, veal, green peas) may reduce its effectiveness. In these conditions, there is a possibility of premature release of the active substances from the pellets (before the medicine reaches the duodenum), which may cause inactivation of the enzymes in the stomach and also lead to irritation of the oral mucosa.

Taking a higher dose of Lipancrea 8 000 than recommended

In case of taking too much Lipancrea 8 000, you should drink plenty of fluids and consult your doctor or pharmacist.
Very high doses of pancreatin can sometimes cause an increase in uric acid in the urine and blood.

Missing a dose of Lipancrea 8 000

In case of missing a dose of Lipancrea 8 000, you should take the normal dose at the usual time with the next meal. Do not take a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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, you should stop taking Lipancrea 8 000 and contact your doctor or the Emergency Department of the nearest hospital immediately.
Side effects that may occur when taking the medicine:

• 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 side effects may be due to the disease for which Lipancrea 8 000 is indicated. During studies, the number of patients taking pancreatin who experienced abdominal pain or diarrhea was similar to or lower than that of patients not taking pancreatin.
Uncommon(occurring in less than 1 in 100 patients)

• rash

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

• itching and urticaria
• pancreatin may cause hypersensitivity reactions, including anaphylactic reactions with difficulty breathing or swelling of the mouth
• narrowing of the ileocecal junction and the large intestine (fibrosing colonopathy) has been reported in patients with cystic fibrosis taking large doses of pancreatin. If you experience severe abdominal pain and problems with bowel movements (constipation), nausea, or vomiting, you should contact your doctor immediately.

Hypersensitivity reactions, mainly affecting the skin but not limited to it, have been observed and reported after the medicine was marketed.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lipancrea 8 000

Store in a temperature below 25°C. Protect from moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Lipancrea 8 000 contains

• The active substance of the medicine is pancreatin. Each capsule contains pancreatin with the activity: lipase 8,000 Ph. Eur., amylase 5,750 Ph. Eur., protease 450 Ph. Eur. (1 Ph. Eur. = 1 FIP)
• The other ingredients are: methacrylic acid and ethyl acrylate copolymer (1:1); simethicone emulsion 30%; triethyl citrate; talc; iron oxide red (E172); titanium dioxide (E171).

What Lipancrea 8 000 looks like and what the pack contains

Lipancrea 8 000 is in the form of capsules filled with pellets.
The medicine is available in polyethylene containers containing 20 or 50 capsules. The container with capsules is placed in a cardboard box.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Production Plant in Nowa Dęba
Metalowca 2, 39-460 Nowa Dęba
Date of the last revision of the leaflet:December 2024