New Zealand - English - Medsafe (Medicines Safety Authority)
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NEW ZEALAND CONSUMER MEDICINE INFORMATION
Pancreatin modified release granules
What is in this leaflet
Please read this leaflet carefully
before you start taking Creon Micro.
This leaflet answers some common
questions about Creon Micro.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
Creon Micro against the benefits
they expect it will have for you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the
medicine. You may need to read it
What Creon Micro is
Creon Micro is a pancreatic enzyme
used to treat conditions associated
with pancreatic exocrine
insufficiency, such as:
with pancreatic exocrine
insufficiency often suffer with
steatorrhoea (foul fatty
stools which float in the
These symptoms appear because
the body is unable to digest food
normally. When this happens, your
body's ability to absorb important
nutrients from food is impaired and
leads to malnutrition. If left
untreated these symptoms can
affect your quality of life and a poor
nutritional status could have long
term health implications.
Creon Micro contains digestive
enzymes (amylase, lipase and
protease) extracted from pancreas
It works by restoring normal
digestive action in your body to
relieve abdominal symptoms and
improve nutritional status.
Your doctor may have prescribed
this medicine for another reason.
Ask your doctor or pharmacist if
you have any questions about
why this medicine has been
advised for you.
There is no evidence that Creon
Micro granules are addictive.
This medicine is not expected to
affect your ability to drive a car or
Before you take
When you must not take
Do not take Creon Micro if you
have an allergy to:
any medicine containing
pork or other pig products
any of the ingredients listed
at the end of this leaflet.
Some symptoms of an allergic
reaction may include: shortness of
breath; wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
Do not take this medicine after
the expiry date printed on the
pack or if the packaging is torn or
shows signs of tampering.
If it has expired or is damaged,
return it to your pharmacist for
If you are not sure whether you
should start taking this medicine,
talk to your doctor or pharmacist.
Before you start to take
Tell your doctor or pharmacist if
you have allergies to any other
medicines, foods, preservatives
Tell your doctor or pharmacist if
you are pregnant or plan to
become pregnant or are breast-
Your doctor can discuss with you
the risks and benefits involved.
If you have not told your doctor
or pharmacist about any of the
above, tell them before you start
taking Creon Micro.
Taking other medicines
Tell your doctor or pharmacist if
you are taking any other
medicines, including medicines
that you buy without a
prescription from your pharmacy,
supermarket or health food shop.
You should also tell any health
professional who is prescribing a
new medication for you that you are
taking Creon Micro.
Your doctor and pharmacist have
more information on medicines to
be careful with or avoid while taking
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How to take Creon
Follow all directions given to you
by your doctor or pharmacist
They may differ from the information
contained in this leaflet.
If you do not understand the
instructions on the box, ask your
doctor or pharmacist for help.
How much to take
Your doctor will tell you how
much Creon Micro to take or give
to your child. Do not increase the
number of doses yourself without
informing your doctor.
Your doctor has prescribed a dose
of Creon Micro for you or your child
which is specifically tailored to the
severity of the condition.
For patients with cystic fibrosis, your
doctor will have determined a dose
specific to your body weight and
The starting dose for infants with
cystic fibrosis should start at a dose
of 2000 to 5000 lipase units for
each feeding (usually 120 mL) and
adjusted to a dose no greater than
2500 lipase units per kilogram per
For children less than 4 years old,
dosing should begin with 1000
lipase units per kilogram per meal,
and 500 lipase units per kilogram
per meal for children over the age of
The maximum recommended dose
of lipase in infants and children with
cystic fibrosis is 10,000 lipase units
per kilogram body weight per day.
Dosing in other conditions
associated with exocrine pancreatic
insufficiency ranges from about
25,000 to 80,000 lipase units per
meal and half of the dose for
Patients who use more than 10,000
units of lipase per kilogram per day,
will probably be monitored closely
by their doctor.
Your doctor may need to make a
number of adjustments before
determining the right dose which
suits you best.
It is normally not necessary to
restrict your diet of fat while you are
taking Creon Micro as your
symptoms will usually be under
control. In people with malnutrition,
getting enough fat in the diet will
help improve nutrition. If unsure,
you should consult your doctor or
dietitian regarding your diet whilst
on Creon Micro.
If the doctor advises you to increase
the dosage, you should increase it
slowly. A very rapid increase in
dosage may lead to constipation. If
you are unsure how to increase the
dose, ask your doctor or pharmacist
to explain it to you.
How to take it
The small measuring scoop that is
provided with the bottle is designed
to contain dose of 100 mg of
granules, equivalent to 5000 units of
Creon Micro can be added to small
amounts of acidic soft food that do
not require chewing, such as apple
sauce, yogurt or fruit juice.
For infants, Creon Micro can be
mixed with a small amount of milk
on a weaning spoon immediately
before the feed. Do not add to
Any mixture of Creon Micro with soft
food or fluid should be swallowed
immediately and not stored.
Do not crush or chew the granules,
swallow the granules whole
followed by juice or water, to ensure
complete ingestion. The granules
have a special coating to stop them
dissolving until they have gone
through the stomach and into the
intestines where they work.
Make sure to drink plenty of liquid
every day while taking Creon Micro.
When to take it
Take Creon Micro with every meal
How long to take it?
Continue taking your medicine
for as long as your doctor tells
This medicine helps to control your
condition but does not cure it. It is
important to keep taking your
medicine even if you feel well.
If you forget to take it
Wait until your next meal or
snack and take your usual
number of doses.
Do not take a double dose to
make up for the dose that you
This may increase the chance of
you getting an unwanted side effect.
If you are not sure what to do,
ask your doctor or pharmacist.
If you have trouble remembering to
take your medicine, ask your
pharmacist for some hints.
While you are taking
Things you must do
If you are about to be started on
any new medicine, tell your
doctor and pharmacist that you
are taking Creon Micro.
Tell any other doctors, dentists,
and pharmacists who treat you
that you are taking this medicine.
If you are going to have surgery,
tell the surgeon or anaesthetist
that you are taking this medicine.
It may affect other medicines used
If you become pregnant while
taking this medicine, tell your
Make sure you tell your doctor if
you are still having problems
with fatty stools or abdominal
pain while you are taking Creon
Drink plenty of water every day
when you are taking Creon Micro.
Follow your doctor’s instructions
carefully and do not stop taking
Creon Micro unless told to do so
by a doctor.
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Things you must not do
Do not take Creon Micro to treat
any other complaints unless your
doctor tells you to.
Do not give Creon Micro to
anyone else, even if they have
the same condition as you.
Do not stop taking your medicine or
lower the dosage without checking
with your doctor.
Things that would be
helpful for your
Diet should be considered as part of
your overall management plan. Talk
to your doctor or dietician for more
information and advice.
In case of overdose
If you take too much
Immediately telephone your
doctor or the National Poisons
Centre (telephone 0800 POISON
or 0800 764 766), or go to
accident and emergency at your
nearest hospital, if you think that
you or anyone else may have
taken too much Creon Micro. Do
this even if there are no signs of
discomfort or poisoning. You may
need urgent medical attention.
Extremely high doses of pancreatin
have been associated with
excessive amounts of uric acid in
the urine and the blood.
If you take too much Creon Micro
you may get irritation or
inflammation in the anal region.
Tell your doctor or pharmacist as
soon as possible if you do not
feel well while you are taking
This medicine helps most people
with insufficient enzymes to digest
their food, but it may have
unwanted side effects in a few
All medicines can have side
effects. Sometimes they are
serious, most of the time they are
not. You may need medical
treatment if you get some of the
Ask your doctor or pharmacist to
answer any questions you may
Tell your doctor or pharmacist if
you notice any of the following
and they worry you:
stomach or bowel
If any of the following happen,
tell your doctor immediately or
go to Accident and Emergency at
your nearest hospital:
An allergic reaction, symptoms
swelling of face, lips, tongues
or other part of the body
shortness of breath
Tell your doctor immediately if
you have severe or prolonged
Patients with cystic fibrosis taking
high doses of pancreatic enzyme
supplements have suffered from
narrowing of the bowel and required
Tell your doctor or pharmacist if
you notice anything that is
making you feel unwell.
In rare cases, people taking very
high doses may develop high levels
of uric acid in their blood and urine.
Other side effects not listed above
may also occur in some people. Tell
your doctor or pharmacist if you
notice any other effects.
Do not be alarmed by this list of
possible side effects. You may
not experience any of them.
After taking Creon
Keep your granules in the bottle
until it is time to take them.
If you take the granules out of the
bottle they may not keep well.
Keep your granules in a cool dry
place where the temperature
stays below 25°C. Protect from
Once open, use within 3 months.
Do not store Creon Micro or any
other medicine in the bathroom or
near a sink. Do not leave it on a
window sill or in the car.
Heat and dampness can destroy
Keep it where children cannot
A locked cupboard at least one-and-
a half metres above the ground is a
good place to store medicines.
If your doctor tells you to stop
taking this medicine or the expiry
date has passed, ask your
pharmacist what to do with any
medicine that is left over.
What it looks like
Creon Micro is a round light brown
minimicrosphere. Available in
bottles of 200 scoop measures, with
Each 100 mg (equivalent to one
measuring dosing spoon) of Creon
Micro contains 60.12 mg of
pancreatin as the active ingredient,
equivalent to Lipase 5000 Ph. Eur.
units, Amylase 3600 Ph. Eur. units
and Protease 200 Ph. Eur. units.
Creon Micro also contains:
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This medicine does not contain
lactose or gluten.
If you want to know
Should you have any questions
regarding this product, please
contact your pharmacist or doctor.
Who supplies this
Creon Micro is supplied in New
Mylan New Zealand Ltd,
PO Box 11183,
Telephone: (09) 579 2792
Date of Preparation
8 January 2020
(Based on datasheet dated 27
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NEW ZEALAND DATA SHEET
1. Product Name
Creon Micro, 60.12 mg, modified release granules.
2. Qualitative and Quantitative Composition
Each 100 mg of minimicrospheres (equivalent to one measuring spoonful) contains 60.12 mg of
pancreatin, containing the following pancreatic enzymes: Lipase 5000 Ph.Eur. units, Amylase 3600
Ph.Eur. units and Protease 200 Ph.Eur. units.
3. Pharmaceutical Form
Creon Micro is a round, light brown minimicrospheres (gastro-resistant pellets).
4. Clinical Particulars
For treatment of conditions associated with pancreatic exocrine insufficiency, such as:
post-gastrointestinal bypass surgery (e.g. Billroth II, gastroenterostomy)
ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm)
Dose and method of administration
The posology aims at individual needs and depends on the severity of the disease and the
composition of food. It is recommended to take the enzymes during or immediately after the meals.
Creon Micro is a specific dosage form with a small minimicrosphere size in particular for use in
infants and children unable to swallow capsules. Creon Micro allows improved individual dosing
when low lipase doses are needed for adequate treatment of young children.
Dosing in paediatric and adult patients with cystic fibrosis
Based upon a recommendation of the Cystic Fibrosis (CF) Consensus Conference, the US CF
Foundation case-control study, and the UK case-control study, the following general dosage
recommendation for pancreatic enzyme replacement therapy can be proposed:
In infants dosing should be initiated at a dose of 2000 to 5000 lipase units for each feeding
(usually 120 ml) and adjusted up to a dose no greater than 2500 lipase units per kilogram
per feeding with a maximum daily dose of 10,000 lipase units per kg per day.
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Weight-based enzyme dosing should begin with 1000 lipase units/kg/meal for children less
than 4 years of age and with 500 lipase units/kg/meal for those over age 4.
Dosage should be adjusted according to the severity of the disease, control of steatorrhea
and maintenance of good nutritional status.
Most patients should remain below or should not exceed 10,000 lipase units/kg body weight
per day or 4000 lipase units/gram fat intake.
Dosing in other conditions associated with exocrine pancreatic insufficiency
Dosage should be individualized by patients according to the degree of maldigestion and the fat
content of the meal. The required dose for meal ranges from about 25,000 to 80,000 Ph. Eur.units
of lipase and half of the individual dose for snacks.
Method of administration
The minimicrosphere can be added to small amounts of acidic soft food (pH < 5.5) that do not require
chewing or be taken with acidic liquid (pH < 5.5). This could be apple sauce or yogurt or fruit juice
with a pH less than 5.5, e.g. apple, orange or pineapple juice. This mixture should not be stored.
Alternatively, Creon Micro can be mixed with a small amount of milk on a (weaning) spoon and
administered to the infant immediately. The minimicrospheres should not be added to the baby’s
bottle. Any mixture of Creon Micro with soft food or fluid should be swallowed immediately without
crushing or chewing, and followed with water or juice to ensure complete ingestion.
Crushing and chewing of the minimicrospheres or mixing with food or fluid with a pH greater than
5.5 can disrupt the protective enteric coating. This can result in early release of enzymes in the oral
cavity and may lead to reduced efficacy and irritation of the mucous membranes. Care should be
taken to ensure that no product is retained in the mouth.
It is important to ensure hydration at all times, especially during periods of increased loss of fluids.
Inadequate hydration may aggravate constipation. Any mixture of the minimicrospheres with food or
liquid should be used immediately and should not be stored.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients
with cystic fibrosis taking high doses of pancreatin prepartions. As a precaution, unusual abdominal
symptoms or changes in the abdominal symptoms should be medically assessed to exclude the
possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000 units of
Interaction with other medicines and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Pregnancy and fertility
For pancreatic enzymes no clinical data on exposed pregnancies are available. Animal studies show
no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive of
developmental toxicity is to be expected. Caution should be exercised when prescribing to pregnant
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No effects on the suckling child are anticipated since animal studies suggest no systemic exposure
of the breastfeeding woman to pancreatic enzymes. Pancreatic enzymes can be used during
breastfeeding. If required during pregnancy and lactation Creon Micro should be used in does
sufficient to provide adequate nutritional status.
Effects on ability to drive and use machines
Creon Micro has no or negligible influence on the ability to drive and use machines.
In clinical trials, more than 900 patients were exposed to pancreatin enzymes. The most commonly
reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in
severity. The following adverse reactions have been observed during clinical trials with the below
≥ 1/100 to < 1/10
≥ 1/1000 to
strictures of the
*Gastroinstestinal disorders are mainly associated with the underlying disease. Similar or lower incidences compared to placebo were
reported for abdominal pain and diarrhea.
Stricture of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients
with cystic fibrosis taking high doses of pancreatin preparations (see section 4.4).
Allergic reactions mainly but not exclusively limited to the skin have been observed and identified as
adverse reactions during postapproval use. Because these reactions were reported spontaneously
from a population of uncertain size, it is not possible to reliably estimate their frequency.
No specific adverse reactions were identified in the paediatric population. Frequency, type and
severity of adverse reactions were similar in children with cystic fibrosis as compared to adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows
continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked
to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.
Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and
For further advice on management of overdose please contact the National Poisons Information
Centre (0800 POISON or 0800 764 766).
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5. Pharmacological Properties
Pharmacotherapeutic group: Multienzymes (amylase, lipase, protease), ATC code: A09A A02
Mechanism of action
minimicrospheres, a multi-dose principle which is designed to achieve good mixing with the chyme,
emptying from the stomach together with the chyme and after release, good distribution of enzymes
within the chyme.
When the minimicrospheres reach the small intestine the coating rapidly disintegrates (at pH > 5.5)
to release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats,
starches and proteins. The products of pancreatic digestion are then either absorbed directly, or
following further hydrolysis by intestinal enzymes.
Clinical efficacy and safety
Overall 30 studies investigating the efficacy of Creon (including Creon Micro) in patients with
pancreatic exocrine insufficiency have been conducted. Ten of these were placebo controlled studies
performed in patients with cystic fibrosis, chronic pancreatitis or post-surgical conditions.
In all randomized, placebo-controlled, efficacy studies, the pre-defined primary objective was to show
superiority of Creon over placebo on the primary efficacy parameter, the coefficient of fat absorption
The coefficient of fat absorption determines the percentage of fat that is absorbed into the body
taking into account fat intake and faecal fat excretion. In the placebo-controlled PEI studies, the
mean CFA (%) was higher with Creon treatment (83.0%) as compared to placebo (62.6%). in all
studies, irrespective of the design, the mean CFA (%) at the end of the treatment period with Creon
was similar to the mean CFA values for Creon in the placebo-controlled studies.
Treatment with Creon markedly improves the symptoms of pancreatic exocrine insufficiency
including stool consistency, abdominal pain, flatulence and stool frequency, independent of the
In cystic fibrosis (CF) the efficacy of Creon was demonstrated in 288 paediatric patients covering an
age range from newborns to adolescents. In all studies, the mean end-of-treatment CFA values
exceeded 80% of Creon comparably in all paediatric age groups.
Creon Micro has been specifically developed to offer a dosage from for infants and children. One
baseline-adjusted specific study performed over 8 weeks in infants demonstrated that Creon Micro
was effective regarding the improvement of CFA and stool fat excretion as well as faecal energy loss
after two weeks of treatment.
The study was designed mainly to evaluate the efficacy of Creon Micro in 12 infants, aged
1-23 months. The analysis of the results showed that the primary efficacy parameter, CFA,
significantly increased from a baseline mean of 58.0% to a mean of 84.7% (mean increase 26.7%,
p = 0.0013, paired t-test). Height and weight increased, but the weight for height percentile remained
nearly constant and close to 100%.
Animal studies showed no evidence for absorption of intact enzymes and therefore classical
pharmacokinetic studies have not been performed. Pancreatic enzyme supplements do not require
absorption to exert their effects. On the contrary, their full therapeutic activity is exerted from within
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the lumen of the gastrointestinal tract. Furthermore, they are proteins, and as such undergo
proteolytic digestion while passing along the gastrointestinal tract before being absorbed as peptides
and amino acids.
Preclinical safety data
Preclinical data show no relevant acute, subchronic or chronic toxicity. Studies on genotoxicity,
carcinogenicity or toxicity to reproduction have not been performed.
6. Pharmaceutical Particulars
List of excipients
Creon Micro modified release granules also contain:
Creon Micro is gluten free and lactose free.
Pancreatin extract derived from porcine pancreas gland.
Special precautions for storage
Store at or below 25°C, protect from moisture.
After opening, do not store above 25°C, protect from moisture and use within 3 months.
Nature and contents of container
Glass bottle with LDPE stopper and dosing scoop. Pack size of 200 scoop measures (equivalent to
Special precautions for disposal
7. Medicines Schedule
General Sale Medicine
8. Sponsor Details
Mylan New Zealand Ltd
PO Box 11183
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9. Date of First Approval
2 August 2012
10. Date of Revision of the Text
27 December 2019 New data sheet.