Lipancrea 16 000

Package Leaflet: Information for the Patient

LIPANCREA 16 000

16 000 Ph. Eur. lipase units, capsules
Pancreatinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Lipancrea 16 000 and what is it used for
• 2. Important information before taking Lipancrea 16 000
• 3. How to take Lipancrea 16 000
• 4. Possible side effects
• 5. How to store Lipancrea 16 000
• 6. Contents of the pack and other information

1. What is Lipancrea 16 000 and what is it used for

What is Lipancrea 16 000

• Lipancrea 16 000 contains a mixture of digestive enzymes called "pancreatin".
• Pancreatin helps digest food. The enzymes are obtained from pig pancreas.
• Lipancrea 16 000 contains small granules that slowly release pancreatin in the intestine (acid-resistant granules, called pellets).

What is Lipancrea 16 000 used for
Lipancrea 16 000 is used in children, adolescents, and adults with 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 16 000 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 mentioned above.
How does Lipancrea 16 000 work
The enzymes in Lipancrea 16 000 work by digesting food passing through the small intestine. Lipancrea 16 000 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 16 000

When not to take Lipancrea 16 000:

• 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, consult your doctor or pharmacist.

Warnings and precautions

Before taking Lipancrea 16 000, discuss it with your doctor.
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 gastrointestinal tract or changes in existing symptoms, you should contact your doctor.

Lipancrea 16 000 with food and drink

Lipancrea 16 000 should be taken during meals or immediately after meals or snacks, drinking each capsule with a liquid.
For more information, see section 3 of the leaflet "How to take Lipancrea 16 000".

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
In case of pregnancy or suspected pregnancy, consult your doctor before taking Lipancrea 16 000. The doctor will decide whether you can take Lipancrea 16 000 and in what dose.
Lipancrea 16 000 can be used during breastfeeding.

Driving and using machines

Lipancrea 16 000 has no or negligible influence on the ability to drive and use machines.

3. How to take Lipancrea 16 000

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The dose is measured in lipase units. Lipase is one of the enzymes in pancreatin.
The number of capsules to be taken is determined by the doctor.
The doctor will adjust the dose to the patient's needs, depending on:

• the type of disease
• body weight
• the diet used
• the amount of fat present in the stool.

If fatty stools or gastrointestinal symptoms (gastrointestinal symptoms) persist, you should contact your doctor, as it may be necessary to adjust the dose.

Dosage

The dosage is determined individually by the doctor, 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 per main meal (breakfast, lunch, dinner).
For snacks, the dose is usually half of the dose taken during the main meal.

Method of administration

• Lipancrea 16 000 should be taken orally during meals or immediately after meals or snacks, drinking each capsule with a liquid. The capsule should be swallowed whole, without chewing or crushing.
• In case of difficulty 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 (e.g., apple sauce or yogurt), or mixed with an acidic liquid, e.g., 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.
• 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 such conditions, there is a possibility of premature release of the active substances from the pellets (before the medicine reaches the duodenum), which may lead to inactivation of the enzymes in the stomach and also cause irritation of the oral mucosa.

Overdose of Lipancrea 16 000

In case of taking too much of the medicine, drink plenty of fluids and consult your 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 Lipancrea 16 000

In case of missing a dose of Lipancrea 16 000, 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.

Stopping treatment with Lipancrea 16 000

Do not stop taking Lipancrea 16 000 without consulting your doctor.
If you have any further questions about the use of this medicine, ask 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, stop taking
Lipancrea 16 000 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 16 000 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 hives
• pancreatin may cause hypersensitivity reactions, including anaphylactic reactions with difficulty breathing or swelling of the mouth
• narrowing of the colon and large intestine (fibrosing colonopathy) has been reported in patients with cystic fibrosis taking high doses of pancreatin. If you experience severe abdominal pain and problems with bowel movements (constipation), nausea, or vomiting, contact your doctor immediately.

Hypersensitivity reactions, mainly affecting the skin but not limited to it, have been observed and reported after the product was placed on the market.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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
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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lipancrea 16 000

Store in a temperature below 25°C. Protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
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 Lipancrea 16 000 contains

• The active substance is pancreatin. Each capsule contains pancreatin with the activity: lipase 16,000 Ph. Eur. units, amylase 11,500 Ph. Eur. units, protease 900 Ph. Eur. units (1 Ph. Eur. unit = 1 FIP unit).
• The other ingredients are: methacrylic acid and ethyl acrylate copolymer (1:1); simethicone emulsion 30%; triethyl citrate; talc; gelatin; iron oxide red (E172); iron oxide black (E172); titanium dioxide (E171).

What Lipancrea 16 000 looks like and contents of the pack

Lipancrea 16 000 is a capsule filled with pellets.
The medicine is available in polyethylene containers containing 30 or 60 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 last revision of the leaflet:December 2024