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<<< Pharmacode

Patient Information Leaflet

How to find the information you need

• Creon 25000 granules contain a mixture of the natural enzymes which
are used to digest food.

1. About Creon 25000
What Creon 25000 is and how it works.

• 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
Who can take Creon 25000?
Can you take Creon 25000 if you are pregnant or breast-feeding?
Driving or operating machinery.

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
Take Creon 25000 with a meal or a snack and drink plenty of
Do not take Creon 25000 if you are allergic to pork or any pig
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.

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.

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).

4. Possible side effects
Abdominal symptoms (such as abdominal pain).
Side effects and what to do if you get them.

If the above applies to you, do not take Creon 25000. 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.

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.

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 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
works in your body.
• Do not hold Creon capsules or its content in your mouth.
• Do not store the mixture.


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Pharmacode >>>


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.

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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.

Do not store above 30 °C and keep in the original container. 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
Do not take Creon 25000 capsules after the expiry date on the bottle.
Return all unused medicine to your pharmacist.

6. Further information
The ingredients in Creon 25000
The active ingredient in Creon 25000 is pancreatin.
Each capsule contains enteric coated brownish-coloured granules
(minimicrospheres) containing pancreatin 300 mg, equivalent to:

In the UK:
The Yellow Card Scheme at:
In Malta:
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
By reporting side effects you can help provide more information
on the safety of this medicine.

List of Enzymes: (PhEur units per capsule)
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 25000 is available in 100 capsule packs.

5. How to store Creon 25000
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.

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
The CF Trust
11 London Road, Bromley BR1 1BY.
You can find out more about Pancreatitis from the following
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.

The Marketing Authorisation Holder is:
Abbott Healthcare Products Limited,
Abbott House, Vanwall Business Park, Vanwall Road,
Maidenhead, SL6 4XE, UK.


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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.