Lipancrea 16 000

Package leaflet: information for the patient

LIPANCREA 16 000
16 000 Ph. Eur. units of lipase, capsules
Pancreatinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Lipancrea 16 000 is and what it is 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 Lipancrea 16 000 is and what it is 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 derived from porcine pancreas.
• Lipancrea 16 000 contains small granules that slowly release pancreatin in the intestine (acid-resistant granules, known as pellets).

What Lipancrea 16 000 is used for
Lipancrea 16 000 is used in children, adolescents and adults with exocrine
pancreatic insufficiency. This is a condition in which the pancreas does not produce enough
digestive enzymes. This condition commonly occurs in patients with the following
diseases:

• cystic fibrosis (a rare genetic disease)
• obstruction of the pancreatic or biliary ducts
• following an episode of acute pancreatitis. Lipancrea 16 000 may 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
• gastroenteroanastomosis
• Shwachman-Diamond syndrome (a very rare genetic disease).

Exocrine pancreatic insufficiency may also be diagnosed in other
clinical conditions not listed above.
How Lipancrea 16 000 works
The enzymes contained in Lipancrea 16 000 act 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 thoroughly with food.

2. Important information before using Lipancrea 16 000

When not to use Lipancrea 16 000:

• if the patient is allergic to pancreatin, pork protein, or any of the other ingredients of this medicine (listed in section 6).

If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with Lipancrea 16 000, discuss it with your doctor.
A rare intestinal disorder called fibrosing colonopathy, which may lead to narrowing of the large intestine, has been reported in patients with cystic fibrosis who were receiving high doses of pancreatin.
Therefore, if you have cystic fibrosis and are taking pancreatin at a dose exceeding 10,000 Ph. Eur. units of lipase per kg body weight per day, and experience any new or worsening gastrointestinal symptoms, contact your doctor immediately.
Lipancrea 16 000 with food and drink
Lipancrea 16 000 should be taken during or immediately after a meal or snack, with each capsule swallowed with liquid.
For detailed instructions, see section 3 of the leaflet, "How to take Lipancrea 16 000".
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
In case of pregnancy or suspected pregnancy, contact a doctor before taking Lipancrea 16 000. The doctor will decide whether Lipancrea 16 000 can be used and at what dosage.
Lipancrea 16 000 may be used during breastfeeding.
Driving and operating machinery
Lipancrea 16 000 has no effect or has a negligible effect on the ability to drive or operate machinery.

3. How to use Lipancrea 16 000

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult your doctor or pharmacist.
The dose is measured in lipase units. Lipase is one of the pancreatic enzymes contained in pancreatin.
The number of capsules to be taken is determined by the physician.
The physician will adjust the dose according to the patient's individual needs, based on:

• the type of disease
• body weight
• dietary intake
• amount of fat present in the stool.

If fatty stools or gastrointestinal symptoms (gastrointestinal complaints) persist, contact your doctor, as dose adjustment may be necessary.
Dosage
Dosage is individually determined by the physician, depending on the patient's requirement for pancreatic enzymes.
Cystic fibrosis
The usual initial dose in children under 4 years of age is 1,000 lipase units/kg body weight/meal.
The usual initial dose in children aged 4 years and older, adolescents, and adults is 500 lipase units/kg body weight/meal.
In most patients, the dose should be lower than or not exceed 10,000 lipase units/kg body weight/day or 4,000 lipase units per gram of dietary fat intake.
Other pancreatic disorders
The usual dose is 25,000 to 80,000 lipase units with each main meal (breakfast, lunch, dinner).
For snacks, the usual dose is half the dose taken with a main meal.
Instructions for use

• Lipancrea 16 000 should be taken orally during or immediately after a meal or snack, with each capsule swallowed whole with liquid. The capsule must be swallowed whole and must not be chewed or crushed.
• If difficulty swallowing the capsule occurs, or if a lower enzyme dose is required, the capsule may be carefully opened. The contents should be sprinkled onto a teaspoon, mixed with a small amount of acidic soft food that does not require chewing (such as apple puree or yoghurt), or mixed with an acidic liquid, e.g. apple, orange or pineapple juice (do not mix with milk or milk-based formulae). The mixture of pellets should be swallowed immediately without chewing or biting, and followed with water or juice. The mixture must not be stored.
• Do not retain the medicine or capsule contents in the mouth.
• Drink plenty of fluids throughout the day.
• It is not necessary to administer the medicine with light meals consisting of fruits, vegetables, fruit juices, and other fat-free foods.
• Administration of the medicine with food having a neutral or alkaline pH (pH higher than 5.5, e.g. eggs, chicken, veal, green peas) may reduce its effectiveness. Under such conditions, premature release of the active substance from the pellets (before reaching the duodenum) may occur, leading to enzyme inactivation in the stomach and potential irritation of the oral mucosa.

Overdose of Lipancrea 16 000
In case of accidental overdose of Lipancrea 16 000, drink plenty of fluids and consult your doctor or pharmacist.
Very high doses of pancreatin may occasionally increase uric acid levels in blood and urine.
Missed dose of Lipancrea 16 000
If a dose of Lipancrea 16 000 is missed, take the next dose at the usual time with the next meal. Do not take a double dose to make up for a missed dose.
Stopping treatment with Lipancrea 16 000
Do not discontinue taking Lipancrea 16 000 without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue and (or)
throat, which may cause difficulty in breathing or swallowing, or if other serious adverse effects occur,
treatment with Lipancrea 16 000 must be discontinued immediately and the patient should
contact a doctor or the nearest hospital Emergency Department without delay.

Adverse effects that may occur during treatment with this 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
• diarrhoea

These effects may be due to the underlying disease for which Lipancrea 16 000 is prescribed. During clinical studies, the number of patients taking pancreatin who experienced abdominal pain or diarrhoea was similar to or lower than in 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 manifesting as difficulty in breathing or swelling of the lips
• narrowing of the ileocaecal region and large intestine (fibrosing colonopathy) has been reported in patients with cystic fibrosis of the pancreas who were receiving high doses of pancreatin-containing medicines. If severe abdominal pain and problems with bowel movements (constipation), nausea or vomiting occur, contact a 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 of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of 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 effects can also be reported to the Marketing Authorisation Holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Lipancrea 16 000

Store 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 stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot.
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 Lipancrea 16 000 contains

• The active substance is pancreatin. Each capsule contains pancreatin with the following enzymatic 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-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 or in aluminium/PVC/PVdC blisters containing 30 or 60 capsules. The container or blister pack of capsules is placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba