Kreon

KREON 10,000 hard caps with gastric juice coating pellets

Important notes (mandatory information)

Kreon 10000 capsules, hard capsules with enteric-coated pellets. Active ingredient: Pancreas powder from pigs with amylase/lipase/protease activity. Areas of application: for digestive disorders (maldigestion) due to insufficient or absent function of the pancreas (exocrine pancreatic insufficiency) and for cystic fibrosis to support insufficient function of the pancreas.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Kreon 10000 capsules, hard capsules with enteric-coated pellets, for use in children and adults
Active ingredient: Pancreas powder from pigs with amylase/lipase/protease activity

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Kreon 10000 capsules must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 5 days, you must consult a doctor.
• If any of the listed side effects affect you significantly or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet includes

1. WHAT ARE KREON 10000 CAPSULES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KREON 10000 CAPSULES?
3. HOW SHOULD KREON 10000 CAPSULES BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD KREON 10000 CAPSULES BE STORED?
6. FURTHER INFORMATION

1. WHAT ARE KREON 10000 CAPSULES AND WHAT ARE THEY USED FOR?

What are Kreon 10000 capsules?

• Kreon contains an enzyme mixture called "pancreas powder".
• Pancreas powder supports digestion. The enzymes are extracted from pig pancreases.
• Kreon capsules contain small enteric-coated pellets that slowly release the pancreas powder into the intestine.

Kreon 10000 capsules are used for:

• Digestive disorders (maldigestion) due to insufficient or absent function of the pancreas (exocrine pancreatic insufficiency).
• Cystic fibrosis to support insufficient function of the pancreas.

How Kreon 10000 capsules work

The enzymes in Kreon digest food as it passes through the gastrointestinal tract. You should take Kreon 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 10000 CAPSULES?

Kreon 10000 capsules must not be taken if you have a known hypersensitivity to pork (pork allergy) or any other ingredient of Kreon 10000 capsules.

Situations that require special caution when taking Kreon 10000 capsules:

• If you suffer from cystic fibrosis, a congenital metabolic disorder, and are therefore receiving high doses of pancreas powder from pigs, there is a possibility in individual cases that intestinal strictures may form in certain parts of the small and large intestine. These strictures can sometimes lead to intestinal obstruction. The following symptoms may indicate intestinal obstruction: nausea and vomiting, belching, flatulence with retention of stool and wind in connection with (severe) colicky pain. If you experience severe and possibly unusual symptoms in the digestive tract, you should consult a doctor immediately.
• If unusual gastrointestinal symptoms or changes in the symptoms occur, you should have them examined by your doctor as a precaution to rule out the possibility of damage to the intestine. This applies especially to patients who take more than 10000 Ph. Eur. units of lipase per kg of body weight per day.

When taking Kreon 10000 capsules with other medicines

No medicines are known that affect the action of Kreon or are themselves affected in their action.

Pregnancy and breastfeeding

There is insufficient experience with the use of Kreon in pregnant women. There are only insufficient data from animal studies with regard to pregnancy, development of the unborn child, delivery and development of the child after birth. The potential risk to humans is unknown. If you are pregnant or breastfeeding, you should not take Kreon unless your doctor considers it absolutely necessary.

Driving and operating machinery

No effects are to be expected with regard to impairment of the ability to drive and operate machinery.

3. HOW SHOULD KREON 10000 CAPSULES BE TAKEN?

Always take Kreon exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

How many Kreon 10000 capsules should be taken?

• The dosage is measured in "lipase units". Lipase is one of the pancreatic enzymes. Different strengths of Kreon contain different amounts of lipase.
• Always follow your doctor's instructions on how much Kreon to take.
• Your doctor will determine the appropriate dose for you. This depends on: your condition, your weight, your diet, the fat content in your stool.
• If you continue to have fatty stools or other stomach or intestinal problems (gastrointestinal symptoms), talk to your doctor as your dosage may need to be adjusted.
• The dosage is always based on the severity of the pancreatic insufficiency. The usual dose for a main meal is between 20,000 and 80,000 lipase units (corresponding to 2 to 8 capsules of Kreon 10000 capsules). However, the required dose may be considerably higher depending on the severity.

Dosage for children

In children under 4 years of age, the weight-based dosage should start with 1,000 Ph. Eur. units of lipase per kg of body weight per meal, in children 4 years of age and older with a dosage of 500 Ph. Eur. units of lipase per kg of body weight per meal.

When should Kreon 10000 capsules be taken?
Always take Kreon during or immediately after a meal or snack. This allows the enzymes to mix well with the food and digest it as it passes through the intestine.

How should Kreon 10000 capsules be taken?

• Swallow the capsules whole with sufficient liquid.
• Do not break or chew the capsules.
• If it is difficult to swallow the capsules, open them carefully and add the pellets to a small amount of a soft, acidic food (e.g. applesauce).
• Swallow the mixture immediately without crushing or chewing it and drink some water or juice afterwards.
• Crushing or chewing the pellets or mixing them into non-acidic food or liquids can damage the oral mucosa and reduce the effectiveness of the enzymes.
• Care should be taken to ensure that no product residues remain in the oral cavity.
• Consume the mixture immediately
• Ensure adequate fluid intake.

Duration of use

Take Kreon until your doctor tells you to stop. In many cases, the deficiency of your own pancreatic enzymes must be compensated for permanently.

If you have taken more Kreon 10000 capsules than you should

If you have taken more Kreon than you should, drink plenty of water and talk to your doctor or pharmacist. Extremely high doses of pancreas powder can lead to an increase in uric acid in the blood (hyperuricemia) and urine (hyperuricosuria), especially in patients with cystic fibrosis.

If you have taken too little Kreon 10000 capsules or have forgotten to take Kreon 10000 capsules

If you forget to take a dose, please continue the therapy as recommended without increasing the following dose on your own.

If you stop taking Kreon 10000 capsules or discontinue taking Kreon 10000 capsules

Do not stop taking Kreon without first talking to your doctor.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Kreon can have side effects, although not everybody gets them. The following frequency categories are used to evaluate side effects

The following frequency categories are used to describe the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Significant side effects or signs to watch out for, and what to do if you are affected

If you are affected by any of the following side effects, stop taking Kreon 10000 capsules and see your doctor as soon as possible. He will then decide on the type of further treatment.

Very common:

• Abdominal pain

Common:

• Constipation (obstipation), stool abnormalities, diarrhea and nausea/vomiting.

Uncommon:

• Rash

Not known:

• Immediate-type allergic reactions (such as rash, itching, sneezing, watery eyes, shortness of breath due to bronchial spasm, swollen lips)
• In patients with cystic fibrosis, a congenital metabolic disorder, the formation of strictures in the ileocecal region and ascending colon has been described in individual cases after administration of high doses of pancreatic enzymes. These strictures can sometimes lead to intestinal obstruction (ileus) (see 2. "Special caution when taking..."). These intestinal lesions have not been described with Kreon to date.

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 package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD KREON 10000 CAPSULES BE STORED?

Keep out of reach of children. Do not use this medicine after the expiry date which is stated on the carton/can after "Use by". The expiry date refers to the last day of the month. Storage condition: Do not store above 25°C. Keep the can tightly closed to protect the contents from moisture. Shelf life after opening the can: 3 months.

6. FURTHER INFORMATION

What Kreon 10000 capsules contain

The active ingredient is: Pancreas powder from pigs with amylase/lipase/protease activity. One hard capsule with enteric-coated pellets contains 150 mg of pancreas powder, made from pig pancreas tissue, corresponding to (activities in Ph. Eur. units): lipolytic activity: 10000 Ph.Eur.E, amylolytic activity: 8000 Ph.Eur.E, proteolytic activity: 600 Ph.Eur.E. The other ingredients are: Pellets: Cetyl alcohol, triethyl citrate, dimethicone 1000, macrogol 4000, hypromellose phthalate. Capsule shell: Gelatin, sodium dodecyl sulfate, titanium dioxide, iron(III) oxide, iron(III) hydroxide oxide x H20, iron(II,III) oxide. Note: Kreon does not contain any sugar and is therefore also suitable for diabetics.

What Kreon 10000 capsules look like and contents of the pack

Kreon 10000 capsules are hard capsules with a transparent and a brown capsule part. The hard capsules can also be opened, as the pellets they contain are enteric-coated. Kreon 10000 capsules are available in pack sizes of 50, 100 and 200 hard capsules with enteric-coated pellets.

Pharmaceutical entrepreneur and manufacturer

Abbott Laboratories GmbH
Freundallee 9A
30173 Hanover
Germany

Co-distributor

Mylan Healthcare GmbH
Freundallee 9A
30173 Hanover
Tel.: 0511 / 6750-2400
Fax: 0511 /6750-3120
E-mail: mylan.healthcare@mylan.com

This package leaflet was last revised in April 2015.

Source: Information from the package leaflet
Status: 01/2017
Active ingredient: Pancreas powder from pigs with amylase/lipase/protease activity. Areas of application: for digestive disorders (maldigestion) due to insufficient or absent function of the pancreas (exocrine pancreatic insufficiency) and for cystic fibrosis to support insufficient function of the pancreas.