CREON MICRO GRANULES

Active substance: PANCREATIN

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This product is known by the above name but will be referred to as Creon Micro in this leaflet.

How to find the information you need
1. About Creon Micro
What Creon Micro is and how it works.
2. Before you give Creon Micro
Who can take Creon Micro?
Can you take Creon Micro if you are pregnant or breast-feeding?
Driving or operating machinery.
3. How to give Creon Micro
How much Creon Micro you should give.
When you should give Creon Micro.
How you should give Creon Micro.
What to do if you give too much Creon Micro.
What to do if you forget a dose.

WARNING!

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

6. Further information
The ingredients in Creon Micro.
More information about cystic fibrosis and pancreatitis.
1. About Creon Micro
What is Creon Micro
• Creon Micro 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 Micro granules contain a mixture of the natural enzymes which are used to digest food.
• The enzymes are taken from pig pancreas glands.

DATE:

CUSTOMER
APPROVED:

5. How to store Creon Micro
How and where to keep this medicine.

02/05/14

If the above applies to the patient, do not give Creon Micro. Talk to the doctor or dietician again.

TVT CHECKED

When you need to take special care with Creon Micro
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.

UK PIL DATEDDECEMBER 2012

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.

MULTIPLE MANUFACTURERS

671-0057D 06464/2885D

DATE OF PROOF:

DATE:

2. Before you give Creon Micro
Do not give Creon Micro if:
• The patient is allergic (or hypersensitive) to pork, any pig product or any of the ingredients of Creon
Micro (listed in section 6).

CODE:

DT
ARTWORKER:
PRODUCT:

Creon Micro Granules

05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
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How does Creon Micro work?
The enzymes in Creon Micro work by digesting food as it passes through the gut. So you must give Creon
Micro with a meal or a snack. This will allow the enzymes to mix thoroughly with the food.

Additional information about pancreatic enzymes
The pancreas glands used to make Creon Micro and other pancreatic enzyme products come from pigs used
for food. These pigs may carry viruses. When Creon Micro 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 the doctor, if:
• you are pregnant or trying to get pregnant (Creon Micro can be used while breast feeding)
Please tell the doctor, dietician, or pharmacist if you think that the patient should not take Creon Micro for any
other reason.
If the patient drives or uses machinery
It is unlikely that Creon Micro will affect the patient’s ability to drive or operate tools or machines.
3. How to give Creon Micro
How much Creon Micro to give
• Always follow the doctor or dietician’s advice on how many granules to give.
• The usual starting dose is 100 mg (one measure). The maximum amount you may give should not
be greater than 10,000 units lipase/kg/day.
• If the doctor advises you to increase the dose you give, you should do so slowly. If the patient still
has fatty stools or abdominal pain, talk to the doctor or dietician.
When to give Creon Micro
• Always give Creon Micro with a meal or a snack and provide plenty of water (see section 1).
How to take Creon Micro
• 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 Micro works in your body.
• Do not hold Creon Micro in your mouth.
• Do not store the mixture.

Colour
Swatch

Black

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

Please read the rest of this leaflet carefully before you start giving these granules.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask a doctor or pharmacist.
• Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell a
doctor or pharmacist.

PROOF HISTORY:
v.1 - waymade - 02/05/14

Leaflet Flat Size = 148 x 400

Important things you SHOULD know about Creon Micro
• Creon Micro is a pancreatic enzyme supplement for people whose bodies do not make enough enzymes to
digest their food.
• Give the amount of granules prescribed by your doctor.
• Give Creon Micro with a meal or a snack and provide plenty of water.
• Do not give Creon Micro if the patient is allergic to pork, any pig product or any of the ingredients of Creon
Micro (listed in section 6).
• If the patient experiences severe abdominal pain while taking Creon Micro, contact a doctor immediately.
• Most people do not have problems taking Creon Micro but side effects can occur (see section 4).

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CREON® MICRO GRANULES
Pancreatin 60.12mg Gastro-resistant Granules
(Pancreatin)
Patient Information Leaflet

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

How to give Creon Micro to babies and infants
• Mix the granules (without crushing) with a small amount of apple juice and give from a spoon directly
before the feed.
• Make sure the infant swallows all the granules immediately and none are left in the mouth.
• Provide plenty of liquid every day.
• Mixing with non-acidic food or liquid, crushing or chewing of the pellets may cause mouth irritation or
change the way Creon Micro works in the body.
• Do not store the mixture.

If you give the patient too much Creon Micro
If you give the patient too much Creon Micro, he/she should drink plenty of water and see the doctor
immediately.
If you forget a dose
If you forget to give the medicine, wait until the next meal and give the usual dose. Do not try to make up for
the dose that you have missed. Just give the next dose at the usual time.
4. Possible side effects
Like all medicines, Creon Micro can cause side effects (unwanted effects or reactions), but not everyone gets
them.
If the patient has severe or long-lasting abdominal pain, contact the doctor immediately.
If you notice any unusual abdominal symptoms while taking Creon Micro - contact the doctor.
Very common side effects (more than 1 in 10 patients):
• Stomach pains

WARNING!

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.

02/05/14

DATE:

5. How to store Creon Micro
How and where to keep the medicine
• Keep all medicines out of sight and reach of children – preferably locked in a cupboard or medicine
cabinet.
• Creon Micro should not be stored above 25°C.
• Keep the container tightly closed to protect from moisture.
• Store in the original container.
The enzymes in Creon Micro 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.
• Use Creon Micro within 12 weeks of opening the container.
• Do not give Creon Micro granules after the expiry date printed on the carton or bottle label.
• If the granules become discoloured or show any other signs of deterioration, you should consult
your pharmacist who will tell you what to do.
• Return all unused medicine to your pharmacist.

TVT CHECKED

UK PIL DATEDDECEMBER 2012

6. Further Information
The ingredients in Creon Micro
Your medicine is called Creon Micro granules. The active ingredient in Creon Micro is pancreatin.
MULTIPLE MANUFACTURERS

671-0057D 06464/2885D

DATE OF PROOF:

CODE:

DT
ARTWORKER:
Creon Micro Granules
PRODUCT:

05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell a
doctor or pharmacist.

Each scoop measure contains 100mg.
One measure of 100mg contains gastro-resistant granules of pancreatin, equivalent to the following list of
enzymes:
Lipase
Amylase
Protease

(Ph.Eur. Units per 100mg)
5,000
3,600
200

Creon Micro granules are coated with a mixture of the following ingredients: macrogol 4000, hypromellose
phthalate, cetyl alcohol, triethyl citrate and dimeticone 1000.
Creon Micro are round, light-brown gastro-resistant granules in a glass bottle with a scoop measure and are
available as bottles of 20g (containing about 200 measures).
P

PL No: 06464/2885

This product is manufactured by Abbott Products GmbH, Hans-Böckler-Allee 20, 30173 Hannover, Germany
and/or Abbott Laboratories GmbH, Freundallee 9A, 30173 Hannover, Germany and procured from within the
EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 01.05.2014
Creon is a registered trademark of Abbott Products GmbH.
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.

Colour
Swatch

Black

WARNING!

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

CUSTOMER
APPROVED:

Common side effects (affect 1 - 10 patients out of 100):
• Diarrhoea
• Constipation
• Feeling or being sick
• Bloating

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

How long to give Creon Micro
You should keep giving the medicine until the doctor tells you to stop. Many patients will need to take
pancreatic enzyme supplements for the rest of their lives.

PROOF HISTORY:
v.1 - waymade - 02/05/14

Notes:

Leaflet Flat Size = 148 x 400
December 2012

Weaned infants
• Mix the granules (without crushing) with acidic liquid (e.g. apple, orange or pineapple juice) or soft
food (e.g. apple sauce or yoghurt).
• Make sure the infant swallows all the granules immediately, without chewing and none are left in the
mouth.
• Provide plenty of liquid every day.
• Mixing with non-acidic food or liquid, crushing or chewing of the pellets may cause mouth irritation or
change the way Creon Micro works in the body.
• Do not store the mixture.

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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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