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CREON MICRO GRANULES

Active substance(s): PANCREATIN / PANCREATIN / PANCREATIN

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Patient Information Leaflet
®

Creon Micro granules
(pancreatin)
The name of your medicine is Creon Micro
granules but will be referred to as Creon
Micro throughout this leaflet.
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 during or
immediately after 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).
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.

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.
4. Possible side effects
Abdominal symptoms (such as
abdominal pain).
Side effects and what to do if the
patient gets them.
5. How to store Creon Micro
How and where to keep this
medicine.
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 contains a mixture of the
natural enzymes which are used to
digest food.

The enzymes are taken from pig
pancreas glands.
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.

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).
If the above applies to the patient, do not
give Creon Micro. Talk to the doctor or
dietician again.
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.
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.
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 100mg (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 during or
immediately after 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.
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.

Alternatively mix the granules on a
spoon (without crushing) with a small
amount of baby’s usual milk and give to
the infant immediately. Do not add the
granules to the baby’s bottle.

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.
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).

Alternatively mix the granules on a
spoon (without crushing) with a small
amount of baby’s usual milk and give to
the infant immediately. Do not add the
granules to the baby’s bottle.

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.

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.
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 Microcontact the doctor.
Very common side effects (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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help
provide more information on the safety of
this medicine.
5. How to store Creon Micro
 Keep out of the sight and reach of
children
 Do not store above 25°C.
 Keep the container tightly closed in
order 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.
 Take Creon Micro within 12 weeks of
opening the container.
 Do not take the granules after the expiry
date which is stated on the carton and
bottle labels after ‘Exp’. The expiry date
refers to the last day of that month.
 If the granules become discoloured or
show any signs of deterioration, seek
the advice of your pharmacist.
 Remember if your doctor tells you to
stop taking this medicine, return any
unused granules to your pharmacist for
safe disposal. Only keep this medicine if
your doctor tells you to.



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
What Creon Micro contains
The active ingredient in Creon Micro is
pancreatin.
Each scoop measure contains 100mg.
One measure of 100mg contains gastroresistant granules of pancreatin, equivalent
to the following list of enzymes:
(Ph.Eur. Units per 100mg)
Lipase
5,000
Amylase
3,600
Protease
200
The other ingredients are macrogol 4000,
hypromellose phthalate, cetyl alcohol,
triethyl citrate and dimeticone 1000.
What Creon Micro looks like and the
contents of the pack
Creon Micro are round, light-brown gastroresistant granules in a glass bottle with a
scoop measure and are available as bottles
of 20g (containing about 200 measures).
Manufactured by: Abbott Laboratories
GmbH, Freundallee 9A, 30173 Hannover,
Germany.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Creon® Micro granules; PL 18799/2788
Leaflet date: 30.08.2017

P

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.

Blind or partially
sighted?
Is this leaflet hard to see
or read?
Call 0208 515 3763 to
obtain the leaflet in a
format suitable for you.

Expand Transcript

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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