CREON 10000 CAPSULES

Active substance: PROTEASE

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<<< Pharmacode

Patient Information Leaflet

pancreatin

Important things you SHOULD know
about Creon 10000


Creon 10000 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 10000 with a meal or a snack
and drink plenty of water.
• Do not take Creon 10000 if you are allergic
to pork or any pig product.
• If you experience severe abdominal pain
while taking Creon 10000, contact your
doctor immediately.
• Most people do not have problems taking
Creon 10000 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 10000
What Creon 10000 is and how it works.
2. Before you take Creon 10000
Who can take Creon 10000?
Can you take Creon 10000 if you are pregnant
or breast-feeding?
Driving or operating machinery.
3. How to take Creon 10000
How much Creon 10000 you should take.
When you should take Creon 10000.
How you should take Creon 10000.
What to do if you take too much Creon 10000.
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 10000
How and where to keep your capsules.
6. Further Information
The ingredients in Creon 10000.
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 10000
What is Creon 10000
• Creon 10000 is a 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 10000 capsules contain a mixture of the
natural enzymes which are used to digest food.
• The enzymes are taken from pig pancreas glands.
How does Creon 10000 work?
The enzymes in Creon 10000 work by digesting
food as it passes through the gut. So, you must
take Creon 10000 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 10000
Do not take Creon 10000 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 10000.
Talk to your doctor or dietician again.
When you need to take special care with Creon
A rare bowel condition called “fibrosing
colonopathy”, where your gut is narrowed, has been
reported in patients with cystic fibrosis taking high
dose pancreatin products.
If you have cystic fibrosis and take in excess of
10,000 lipase units per kilogram per day and have
unusual abdominal symptoms or changes in
abdominal symptoms tell your doctor.
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

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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
10000 can be used while breast-feeding)
Please tell your doctor, dietician or pharmacist if
you think that you should not take Creon 10000 for
any other reason.
If you drive or use machines
It is unlikely that Creon 10000 will affect your ability
to drive or operate tools or machines.

3. How to take Creon 10000
How much Creon 10000 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 10000
• Always take Creon 10000 at the same time as
eating a meal or a snack and drink plenty of water
(see section 1).
How to take Creon 10000
• 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.
Please
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• 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 works in your
body.
• Do not hold Creon capsules or its content in your
mouth.
• Do not store the mixture.
How long to take Creon 10000 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 10000
If you take too much Creon 10000 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 10000 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 10000 – contact your doctor.

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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)
• severe or long-lasting abdominal pain (Fibrosing
colonopathy).
At extremely high doses, some patients have had
high levels of uric acid in their blood and urine.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the national reporting system
listed below.
In the UK:
The Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

In Malta:
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Creon 10000
How and where to keep your capsules
Keep all medicines out of the reach and sight
of children – preferably locked in a cupboard or
medicine cabinet.
Do not store above 30 °C and keep in the original
container. The enzymes in Creon 10000 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 take Creon 10000 capsules after the expiry
date on the bottle.
Return all unused medicine to your pharmacist.

6. Further information
The ingredients in Creon 10000
The active ingredient in Creon 10000 is pancreatin.
Each capsule contains enteric coated brownishcoloured granules (minimicrospheres) containing
pancreatin 150 mg, equivalent to:

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List of Enzymes: (PhEur units per capsule)
Lipase
10,000
Amylase
8,000
Protease
600
The granules are coated with a mixture of the following
ingredients: macrogol 4000, hypromellose phthalate,
dimeticone, triethyl citrate and cetyl alcohol.
The capsules contain: gelatin, iron oxides (E172),
titanium dioxide (E171) and sodium lauryl sulfate.
Creon 10000 is available in 100, 250 or 300 capsule
packs. Not all pack sizes may be marketed.
The Marketing Authorisation Holder is:
Abbott Healthcare Products Limited,
Abbott House, Vanwall Business Park,
Vanwall Road, Maidenhead, SL6 4XE, UK.
The Manufacturer is:
Abbott Laboratories GmbH,
31535 Neustadt a. Rbge, Germany.
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.
® Registered trademark
If you wish to receive this PIL in Braille, large font
or audio format please contact 023 8046 7000.
This leaflet was last revised in July 2014.

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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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