CREON 25 000 CAPSULES

Active substance: PROTEASE

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PATIENT INFORMATION LEAFLET

CREON® 25000 CAPSULES

(pancreatin)
This product is available as the above name but will be referred to as Creon 25000 throughout
the remainder of this leaflet.
IMPORTANT THINGS YOU SHOULD KNOW ABOUT CREON 25000
• Creon 25000 is a pancreatic enzyme supplement for people whose bodies do not make
enough enzymes to digest their food.
• Take the number of capsules as prescribed by your doctor or dietician.
• Take Creon 25000 with a meal or a snack and drink plenty of water.
• Do not take Creon 25000 if you are allergic to pork or any pig product.
• If you experience severe abdominal pain while taking Creon 25000, contact your doctor
immediately.
• Most people do not have problems taking Creon 25000 but side effects can occur (see section
4).
Please read the rest of this leaflet carefully before you start taking these capsules.
It includes other important information on the safe and effective use of this medicine that might
be especially important for you.
HOW TO FIND THE INFORMATION YOU NEED
1. About Creon 25000
What Creon 25000 is and how it works.
2. Before you take Creon 25000
Who can take Creon 25000?
Can you take Creon 25000 if you are pregnant or breast-feeding?
Driving or operating machinery.
3. How to take Creon 25000
How much Creon 25000 you should take.
When you should take Creon 25000.
How you should take Creon 25000.
What to do if you take too much Creon 25000.
What to do if you forget a dose.
4. Possible side effects
Abdominal symptoms (such as abdominal pain).
Side effects and what to do if you get them.
5. How to store Creon 25000
How and where to keep your capsules.
6. Further Information
The ingredients in Creon 25000.
More information about cystic fibrosis and pancreatitis.
This medicine has been prescribed for you personally. Don’t offer it to other people, even if their
symptoms seem to be the same as yours.
1. ABOUT CREON 25000
What is Creon 25000
• Creon 25000 is a high strength pancreatic enzyme supplement.
• Pancreatic enzyme supplements are used by people whose bodies do not make enough of
their own enzymes to digest their food.
• Creon 25000 granules contain a mixture of the natural enzymes which are used to digest
food.
• The enzymes are taken from pig pancreas glands.
How does Creon 25000 work?
The enzymes in Creon 25000 work by digesting food as it passes through the gut. So you must
take Creon 25000 at the same time as eating a meal or a snack. This will allow the enzymes to
mix thoroughly with the food.
2. BEFORE YOU TAKE CREON 25000
Do not take Creon 25000 if:
• You are allergic to pork, any pig product, or to any of the other ingredients (see section 6).
If the above applies to you, do not take Creon 25000. Talk to your doctor or dietician again.
Additional information about pancreatic enzymes
The pancreas glands used to make Creon and other pancreatic enzyme products come from
pigs used for food. These pigs may carry viruses. When Creon is made several steps are taken
to reduce the risk of viruses being spread, including their destruction and testing for specific
viruses. The risk of infections caused by these or other unknown or novel viruses cannot be
totally ruled out. However, there have not been any cases reported where infection of patients
has occurred.
Talk to your doctor, if:
• you are pregnant or trying to get pregnant (Creon 25000 can be used while breast-feeding)

Please tell your doctor, dietician or pharmacist if you think that you should not take Creon 25000
for any other reason.
If you drive or use machines
It is unlikely that Creon 25000 will affect your ability to drive or operate tools or machines.
3. HOW TO TAKE CREON 25000
How much Creon 25000 to take
• Always follow your doctor or dietician’s advice on how many capsules to take.
• If your doctor advises you to increase the number of capsules you take, you should do so
slowly. If you still have fatty stools or abdominal pain, talk to your doctor or dietician.
When to take Creon 25000
• Always take Creon 25000 at the same time as eating a meal or a snack and drink plenty of

water (see section 1).

How to take Creon 25000
• Swallow the capsules whole or
• Open the capsules and mix the granules (without crushing) with acidic liquid (e.g. apple,
orange or pineapple juice) or soft food (e.g. apple sauce or yoghurt). Swallow the mixture
straight away, without chewing.
• Drink plenty of liquid every day.
• Mixing with non-acidic food or liquid, crushing or chewing of the pellets may cause irritation in
your mouth or change the way Creon 25000 work in your body.
• Do not hold Creon 25000 or its content in your mouth.
• Do not store the mixture.
How long to take Creon 25000 for
You should take your medicine until your doctor tells you to stop. Many patients will need to take
pancreatic enzyme supplements for the rest of their lives.
If you take too much Creon 25000
If you take too much Creon 25000, you should drink plenty of water and see your doctor
immediately.
If you forget a dose
If you forget to take your medicine, wait until your next meal and take your usual number of
capsules. Do not try to make up for the number of capsules that you have missed. Just take
your next dose at the usual time.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Creon 25000 can cause side effects (unwanted effects or reactions), but not
everyone gets them.
If you have severe or long-lasting abdominal pain, contact your doctor immediately.
If you notice any unusual abdominal symptoms while taking Creon 25000 – contact your
doctor.
Very common side effects (affect more than 1 in 10 patients):
• stomach pains
Common side effects (affect 1–10 patients out of 100):
diarrhoea
constipation
feeling or being sick
bloating






Uncommon side effects (affect 1–10 patients out of 1000):
• Skin reactions, such as a rash.

During use, some patients have also experienced the following, the frequency of which is
unknown:
• itching with or without a rash
• allergic reactions (which may be severe).
At extremely high doses, some patients have had high levels of uric acid in their blood and urine.
If you notice any unwanted effect (even one not mentioned in this leaflet), or if you feel unwell
while taking Creon 25000: Tell your doctor.
5. HOW TO STORE CREON 25000
Do not store above 25°C.
Keep all medicines out of the sight and reach of children.
The enzymes in Creon 25000 are natural products and their ability to digest food decreases over
time. If the container is left in warm conditions (e.g. the glove compartment of a car), the
digestive activity decreases faster.
Do not use after the expiry date printed on the carton or bottle label.
If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for
safe disposal. Only keep the capsules if your doctor tells you to.
If the capsules become discoloured or show signs of any deterioration, you should ask your
pharmacist who will advise you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.
6. FURTHER INFORMATION
Your medicine is called Creon 25000. Each opaque brown, colourless capsule contains entericcoated spheres containing pancreatin equivalent to:
Lipase
25,000 Ph.Eur units
Amylase
18,000 Ph.Eur units
Protease
1000 Ph.Eur units
Other enzymes are also present in small quantities.
Creon 25000 also contains the following ingredients:
Hypromellose phthalate, macrogol 4000, dimeticone 1000, cetyl alcohol, triethyl citrate, gelatin,
titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
Creon 25000 is available in plastic bottle of 60 capsules.
PL No: 17805/0186

POM

This product is manufactured by Abbott Products GmbH, D-31535 Neustadt a. Rbge, Germany
and procured from within the EU by the Product Licence holder Delta Pharma (Europe) Ltd, 1
Colonial Way, P.O. Box 233, North Watford, Herts WD24 4EW and repackaged by O.P.D.
Laboratories Ltd, Watford, Herts WD2 4PR.
Leaflet revision and issue date (Ref.) 02.01.2013.
Creon is a registered Trade Mark of Abbot Products GmbH, Germany.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
More information about cystic fibrosis and pancreatitis
You can find out more about Cystic Fibrosis from the following organisation:
The CF Trust
11 London Road, Bromley BR1 1BY.
You can find out more about Pancreatitis from the following organisation:
Pancreatitis Supporters Network
PO Box 8938, Birmingham B13 9FW.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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