CREON 40000 CAPSULES

Active substance: PROTEASE

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<<< Pharmacode
FOR POSITION ONLY

Patient Information Leaflet

Pancreatin

Important things you SHOULD know about Creon 40000


Creon 40000 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 40000 with a meal or a snack and drink plenty of
water.
• Do not take Creon 40000 if you are allergic to pork or any pig
product.
• If you experience severe abdominal pain while taking Creon
40000, contact your doctor immediately.
• Most people do not have problems taking Creon 40000 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.

• Creon 40000 granules contain a mixture of the natural enzymes which
are used to digest food.

How to find the information you need
1. About Creon 40000
What Creon 40000 is and how it works.
2. Before you take Creon 40000
Who can take Creon 40000?
Can you take Creon 40000 if you are pregnant or breast-feeding?
Driving or operating machinery.
3. How to take Creon 40000
How much Creon 40000 you should take.
When you should take Creon 40000.
How you should take Creon 40000.
What to do if you take too much Creon 40000.
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 40000
How and where to keep your capsules.
6. Further Information
The ingredients in Creon 40000.
More information about cystic fibrosis and pancreatitis.

• The enzymes are taken from pig pancreas glands.
How does Creon 40000 work?
The enzymes in Creon 40000 work by digesting food as it passes
through the gut. So, you must take Creon 40000 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 40000
Do not take Creon 40000 if:
• You are allergic to pork or any pig product, or to any of the other
ingredients (see section 6).
If the above applies to you do not take Creon 40000. 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.

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 40000
What is Creon 40000

• Creon 40000 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.

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 40000 can be used
while breast-feeding)
Please tell your doctor, dietician, or pharmacist if you think that you
should not take Creon 40000 for any other reason.
If you drive or use machines
It is unlikely that Creon 40000 will affect your ability to drive or operate
tools or machines.

3. How to take Creon 40000
How much Creon 40000 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 40000
• Always take Creon 40000 at the same time as eating a meal or a
snack and drink plenty of water (see section 1).
How to take Creon 40000
• 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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How long to take Creon 40000 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 40000
If you take too much Creon 40000, 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 40000 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
40000 – 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.

P. 3025 - P. 1805 - Cutting Die

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.
If you notice any unwanted effect (even one not mentioned in
this leaflet), or if you feel unwell while taking Creon 40000: Tell your
doctor.

5. How to store Creon 40000
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 25 °C and keep in the original container. The
enzymes in Creon 40000 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 40000 capsules after the expiry date on the bottle.
Return all unused medicine to your pharmacist.

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 sulphate.
Creon 40000 is available in 100 capsule packs.
The Marketing Authorisation Holder is:
Abbott Healthcare Products Limited, Southampton,
SO18 3JD, 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

6. Further information
The ingredients in Creon 40000
The active ingredient in Creon 40000 is pancreatin.
Each capsule contains enteric coated brownish-coloured granules
(minimicrospheres) containing pancreatin 400 mg, equivalent to:
List of Enzymes: (PhEur units per capsule)
Lipase
40,000
Amylase
25,000
Protease
1,600

This leaflet was last revised in December 2012.

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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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