Kreon

KREON 35,000 Ph.Eur.Lipase Units msr.Hard Capsules

Important notes (mandatory information)

Kreon 35000 units - capsules. Active ingredient: Pancreatin. Areas of application: for the treatment of exocrine pancreatic insufficiency.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Kreon 35000 units - capsules
Active ingredient: Pancreatin

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may need to read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if they have the same symptoms as you.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.

What this leaflet contains

1. WHAT ARE KREON 35000 - CAPSULES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KREON 35000 - CAPSULES?
3. HOW TO TAKE KREON 35000 - CAPSULES?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE KREON 35000 - CAPSULES?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE KREON 35000 - CAPSULES AND WHAT ARE THEY USED FOR?

What are Kreon 35000 - capsules?
Kreon 35000 - capsules contain an enzyme mixture called "pancreas powder". Pancreas powder is also called pancreatin. It aids digestion. The enzymes are extracted from pig pancreases. Kreon 35000 - capsules contain small enteric-coated pellets that slowly release the pancreas powder in the intestine (enteric-coated pellets, also called minimicrospheres).

What Kreon 35000 - capsules are used for

Kreon 35000 - capsules are used to treat a condition called exocrine pancreatic insufficiency. In this condition, the pancreas does not produce enough enzymes to digest food. This is often seen in patients:

• with cystic fibrosis, a rare inherited disorder.
• with chronic inflammation of the pancreas (chronic pancreatitis).
• in whom the pancreas has been partially or completely removed (partial or total pancreatectomy).
• with pancreatic cancer.

Kreon 35000 - capsules can be used in children, adolescents and adults. The dosage instructions for the age groups are explained in section 3 of this package leaflet "How to take Kreon 35000 - capsules?". Treatment with Kreon 35000 - capsules improves the symptoms of exocrine pancreatic insufficiency, including stool consistency (e.g. fatty stools), abdominal pain, flatulence and stool frequency (diarrhoea or constipation), regardless of the underlying disease. You should only use this medicine if your doctor has confirmed that you have one of these conditions and your doctor has specifically recommended treatment with this product. Infants and children should only use this product on the recommendation of a doctor and must be treated under medical supervision. If you do not feel better or even worse after 5 days, contact your doctor.

How Kreon 35000 - capsules work

The enzymes in Kreon 35000 - capsules digest food as it passes through the intestine. You should take Kreon 35000 - capsules during or immediately after a meal or snack. This allows the enzymes to mix thoroughly with the food.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KREON 35000 - CAPSULES?

Kreon 35000 - capsules must not be taken if you are allergic to the active substance or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Kreon 35000 - capsules.

Patients with cystic fibrosis

In patients with cystic fibrosis, a rare bowel disease called "fibrosing colonopathy", in which their bowel is narrowed, has been reported when taking high-dose pancreas powder products. Tell your doctor if you have cystic fibrosis and are taking more than 10,000 lipase units per kilogram of body weight per day and have unusual abdominal discomfort or changes in abdominal symptoms. The dosage of lipase units is explained in section 3 of this package leaflet "How to take Kreon 35000 - capsules?".

Severe allergic reaction

If an allergic reaction occurs, stop your treatment and talk to your doctor. An allergic reaction could include itching, hives or rash. In rare cases, a serious allergic reaction may occur with a feeling of warmth, dizziness and fainting and difficulty breathing. These are symptoms of a serious, potentially life-threatening condition called "anaphylactic shock". If this is the case, call for medical help immediately. Talk to your doctor before taking Kreon 35000 - capsules if you are allergic to pork proteins.

Mouth irritation

Soreness in the mouth, irritation (stomatitis), bleeding and ulceration in the mouth can occur if the capsules are chewed and/or kept in the mouth for too long. Rinsing the mouth and drinking a glass of water may help if the first signs of mouth irritation occur. Kreon can only be sprinkled on certain foods (see section 3 of this package leaflet "How to take Kreon 35000 - capsules?").

Taking Kreon 35000 - capsules with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Kreon 35000 - capsules during pregnancy. Kreon 35000 - capsules can be used during breast-feeding.

Driving and using machines

Kreon 35000 - capsules have no effect on the ability to drive and use machines.

Kreon 35000 - capsules contain sodium

This medicine contains less than 1 mmol (23 mg) sodium per dosage unit, i.e. it is virtually "sodium-free".

3. HOW TO TAKE KREON 35000 - CAPSULES?

Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Your dosage will be measured in "lipase units". Lipase is one of the enzymes in pancreas powder. Different strengths of Kreon contain different amounts of lipase. Always follow your doctor's instructions on how many Kreon 35000 - capsules to take. Your doctor will determine the appropriate dose for you. This depends on:

• the severity of your condition.
• your weight.
• your diet.
• the fat content in your stool.

If you continue to have fatty stools or other stomach or intestinal complaints (gastrointestinal symptoms), talk to your doctor as your dosage may need to be adjusted.

How many Kreon 35000 - capsules to take

For

Patients with cystic fibrosis

Children

The strength of this medicine may not be suitable for initiating therapy in children, depending on the age and weight of the child. The dose required for a child should be determined by the doctor using dosage forms containing fewer lipase units (e.g. 10,000 or 5,000 lipase units). Once the dose per meal has been established, this strength of the medicine can be used in children. The usual starting dose for children under 4 years of age is 1,000 lipase units per kilogram of body weight per meal. The usual starting dose for children 4 years of age and older is 500 lipase units per kilogram of body weight per meal.

Adolescents and adults

The weight-based enzyme dosage should start at 500 lipase units per kilogram of body weight per meal in adolescents and adults.

For all age groups

Your total daily dose should not exceed 2,500 lipase units per kilogram of body weight per meal or 10,000 lipase units per kilogram of body weight per day or 4,000 lipase units per gram of fat intake.

For patients with other pancreatic problems

Adolescents and adults

The usual dose for a meal is between 25,000 and 80,000 lipase units. The usual dose for a snack is half the dose for a meal.

When to take Kreon 35000 - capsules

Always take Kreon 35000 - capsules during or immediately after a meal or snack. This allows the enzymes to mix thoroughly with the food and digest it as it passes through the intestine.

How to take Kreon 35000 - capsules?
Kreon 35000 - capsules are enteric-coated hard capsules for oral use and should always be taken with a meal or snack. The capsules should be swallowed whole with some water or juice. Do not crush or chew the capsules or their contents, as this may cause irritation in the mouth or alter the way they work in your body. If it is difficult to swallow the capsules, open them carefully and add the pellets to a small amount of a soft, acidic food or acidic liquid. Acidic soft foods can be e.g. yoghurt or applesauce. Acidic liquids can be apple, orange or pineapple juice. Do not mix the pellets with water, milk, flavoured milk, breast milk and infant formula or with warm food. Swallow the mixture immediately without crushing or chewing it, and drink some water or juice afterwards. Mixing in non-acidic food or liquid, crushing or chewing the pellets may cause irritation in the mouth or alter the way they work in your body. Do not keep the capsules or their contents in your mouth. Make sure that the medicine and food mixture is swallowed completely and that no pellets remain in your mouth. Do not store the mixture.

If you have taken more Kreon 35000 - capsules than you should

If you have taken more Kreon 35000 - capsules than you should, drink plenty of water afterwards and talk to your doctor or pharmacist. Very high doses of pancreas powder have sometimes caused an increase in uric acid in the blood (hyperuricaemia) and urine (hyperuricosuria).

If you forget to take Kreon 35000 - capsules

If you forget a dose, take the next dose as usual with the next meal. Do not try to make up for the missed dose.

If you stop taking Kreon 35000 - capsules

Do not stop taking Kreon 35000 - capsules without first talking to your doctor. Many patients need to take Kreon 35000 - capsules for the rest of their lives.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine

The most important serious side effects that occur with pancreatic enzyme replacement medicines are anaphylactic shock and fibrosing colonopathy. Both of these side effects have occurred in a very small number of people, but their exact frequency is unknown. Anaphylactic shock is a severe, potentially life-threatening allergic reaction that can develop rapidly. Seek medical help immediately if you notice the following:

• Itching, hives or rash.
• Swollen face, eyes, lips, hands or feet.
• Feeling faint or weak.
• Difficulty breathing or swallowing.
• Palpitations.
• Dizziness, collapse or unconsciousness.

Repeated high doses of pancreatic enzyme replacement medicines can also cause scarring or thickening of the intestinal wall, which can lead to blockage of the intestine, a condition called fibrosing colonopathy. Tell your doctor immediately if you have severe abdominal pain, difficulty passing stools (constipation), nausea or vomiting.

Very common side effects (may affect more than 1 in 10 people):

• Abdominal pain.

Common side effects (may affect up to 1 in 10 people):

• Nausea.
• Vomiting.
• Constipation.
• Flatulence.
• Diarrhoea.

This may be due to the conditions for which you are taking Kreon 35000 - capsules.

Uncommon side effects (may affect up to 1 in 100 people):

• Rash.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kreon 35000 - capsules?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton/container after "Use by:". The expiry date refers to the last day of the specified month. Do not store above 25°C. After opening the can, do not store above 25°C and use within 6 months. Keep the can tightly closed in order to protect the contents from moisture. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Kreon 35000 - capsules contain

The active substance in Kreon 35000 - capsules is pancreatin. One Kreon 35000 - capsule contains 420 mg pancreatin, corresponding to (Ph. Eur. units). Lipolytic activity 35000, amylolytic activity 25200 and proteolytic activity 1400. The other ingredients are:

• Capsule contents: Hypromellose phthalate, macrogol 4000, triethyl citrate, dimethicone 1000, cetyl alcohol.
• Capsule shell: Gelatin, iron(III) oxide red (E172), iron(III) hydroxide yellow (E172), iron(II,III) oxide black (E172), sodium dodecyl sulphate, titanium dioxide (E171).

What Kreon 35000 - capsules look like and contents of the pack

Kreon 35000 - capsules are hard capsules (size 00, extended) with a transparent and a red-brown capsule part. They contain enteric-coated pellets (minimicrospheres). Kreon 35000 - capsules are available in HDPE bottles with PP screw caps containing 50 (10 x 50), 60, 100, 120 and 200 capsules. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Mylan Healthcare GmbH
Lütticher Straße 5
53842 Troisdorf
E-mail: mylan.healthcare@mylan.com

Manufacturer

Abbott Laboratories GmbH
Freundallee 9A
30173 Hannover
Germany

or

Mylan Germany GmbH
Lütticher Straße 5
53842 Troisdorf

This leaflet was last revised in October 2019.

Source: Package leaflet information
Status: 05/2022
Active ingredient: Pancreatin. Areas of application: