Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using CREON MICRO?
CREON MICRO contains the active ingredient Pancreatic Extract. CREON MICRO is used
in a condition called pancreatic exocrine insufficiency where the body does not make
enough enzymes to digest food.
2. What should I know before I use CREON MICRO?
Do not use if you have ever had an allergic reaction to CREON MICRO or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with CREON MICRO and affect how it works.
4. How do I use CREON MICRO?
Your doctor has prescribed a dose of CREON MICRO for you or your child which is specifically
tailored to the severity of the condition. 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.
The small measuring scoop that is provided with the bottle is designed to contain
a dose of 100 mg of granules. This amount provides 5,000 units of lipase.
5. What should I know while using CREON MICRO?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using CREON MICRO.
Drink plenty of water every day when you are taking CREON MICRO.
Call your doctor straight away if you are still having problems with fatty stools
or abdominal pain while you are taking CREON MICRO.
|
|
Things you should not do
|
Do not stop taking CREON MICRO unless told to do so by your doctor.
Do not use this medicine for any purpose other than for the purpose it has been recommended
for you.
|
|
Driving or using machines
|
CREON MICRO has no influence on the ability to drive and use machinery.
|
|
Drinking alcohol
|
Tell your doctor if you drink alcohol.
|
|
Looking after your medicine
|
Keep your CREON MICRO in a cool dry place where the temperature stays below 25°C.
Please note that in warmer climates it may be necessary to store CREON MICRO in the
refrigerator.
After opening use within 3 months.
|
6. Are there any side effects?
Speak to your doctor if you experience stomach or bowel problems, including diarrhoea,
constipation, abnormal stools, abdominal discomfort, nausea and skin reactions. Seek
immediate medical attention if you experience severe or prolonged abdominal pain.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
Pancreatic Extract
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using CREON MICRO. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using CREON MICRO. Please read this
leaflet before you start taking CREON MICRO. If you are helping someone else to take CREON MICRO, please read this leaflet before
you give the first dose.
Where to find information in this leaflet:
1. Why am I using CREON MICRO?
CREON MICRO contains the active ingredient Pancreatic Extract. CREON MICRO is a pancreatic enzyme
supplement.
CREON MICRO is used in a condition called pancreatic exocrine insufficiency where
the body does not make enough enzymes to digest food. This condition appears in a
number of different patients including those with cystic fibrosis, chronic pancreatitis,
or patients who have had upper gastrointestinal surgery. People with a deficiency
of pancreatic enzymes often suffer with symptoms of diarrhoea, steatorrhoea (foul
fatty stools which float in the toilet), bloating and weight loss. 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. The
supplementation of pancreatic enzymes using CREON helps restore the normal digestive
action in your body to relieve abdominal symptoms and improve nutritional status.
The enzymes are extracted from pancreas of pigs.
CREON MICRO is approved for the uses listed above. However, your doctor may prescribe
this medicine for
another use. If you would like more information, ask your doctor.
There is no evidence that CREON MICRO is addictive.
2. What should I know before I use CREON MICRO?
Warnings
Do not use CREON MICRO if:
you are allergic to pork, other pig products, or any of the ingredients listed at
the end of this leaflet.
always check the ingredients to make sure you can use this medicine.
the packaging is torn or shows signs of tampering.
the expiry date has passed, it may not work as well.
Check with your doctor if you:
are allergic to any other medicines or any foods, dyes or preservatives.
take any medicines for any other condition
are pregnant, planning to become pregnant, are breast feeding or intend to breast
feed.
Your doctor will discuss whether you should take this product.
If you have not told your doctor about any of the above, tell them before you take
CREON MICRO.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with
CREON MICRO
and affect how it works.
You should avoid taking antacids, which are medicines that are used to treat heartburn
and indigestion, at the same time as when taking CREON MICRO. Antacids may affect
how well CREON MICRO work by breaking down the special coating used to protect the
pancreatic enzymes. If it is necessary to take an antacid, then it should be taken
at least one hour before you take your CREON MICRO.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect CREON MICRO.
4. How do I use CREON MICRO?
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.
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.
The maximum recommended dose of lipase in infants and children with cystic fibrosis
is 10,000 units per kilogram body weight in 24 hours.
Patients who use more than 10,000 units per kilogram per day, will probably be monitored
closely by their doctor.
Follow the instructions provided by your doctor and use CREON MICRO until your doctor
tells you to stop. These directions may differ from the information in this leaflet.
When to take CREON MICRO
CREON MICRO should be taken with every meal and snack.
How to take CREON MICRO
The small measuring scoop that is provided with the bottle is designed to contain
a dose of 100 mg of granules. This amount provides 5,000 units of lipase.
CREON MICRO can be added to small amounts of acidic soft food that do not require
chewing such as apple juice or mashed bananas. The mixture of CREON MICRO and soft
food should be swallowed immediately without crushing or chewing and followed with
water or juice to ensure complete ingestion. Care should be taken to ensure that no
drug is retained in the mouth.
In young infants, CREON MICRO should be mixed with a small amount of apple juice and
given from a spoon directly before the feed. In young infants, granules should be
taken with acidic liquids or soft foods (e.g. mixed with apple juice or apple puree),
but without chewing, directly before the meal. When giving CREON MICRO to young infants
the apple juice should not be diluted.
When you are taking CREON MICRO, it is important to make sure that you drink plenty
of liquid every day.
If you forget to use CREON MICRO
CREON MICRO should be used regularly at the same time each day. If you miss your dose
at the usual time, wait until your next meal or snack and take your usual number of
doses.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering when to take your medicine, ask your pharmacist for
hints.
If you use too much CREON MICRO
If you think that you have used too much CREON MICRO, you may need urgent medical
attention.
You should immediately:
Drink plenty of water and
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using CREON MICRO?
Things you should do
Follow your doctor's instructions carefully and do not stop taking CREON MICRO unless
told to do so by your doctor.
Drink plenty of water every day when you are taking CREON MICRO.
Call your doctor straight away if you:
are still having problems with fatty stools or abdominal pain while you are taking
CREON MICRO.
are about to start taking any new medicines, tell your doctor and pharmacist that
you are taking CREON MICRO.
Remind any doctor, dentist or pharmacist you visit that you are using CREON MICRO.
Things you should not do
Do not give CREON MICRO to anyone else, even if they have the same condition as you.
Do not use this medicine for any purpose other than for the purpose it has been recommended
for you.
Do not use more than the recommended amount.
Do not stop taking your medicine until your doctor tells you to do so.
Do not let yourself run out of medicine unless told to do so by your doctor.
Things that may help your condition
Diet should be considered as part of your overall management plan. Talk to your doctor
for more information and advice.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how CREON
MICRO affects you.
CREON MICRO has no influence on the ability to drive and use machinery.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep the container tightly closed in order to protect from moisture.
Keep your CREON MICRO in a cool dry place where the temperature stays below 25°C.
Please note that in warmer climates it may be necessary to store CREON MICRO in the
refrigerator.
After opening use within 3 months.
A locked cupboard at least one-and half metres above the ground is a good place to
store medicines.
Follow the instructions in the carton on how to take care of your medicine properly.
Heat and dampness can destroy some medicines.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
When to discard your medicine
After opening use within 3 months.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
The active ingredient in CREON MICRO is an extract of pancreatic powder of porcine
origin (pigs), therefore the presence of porcine parvovirus or other porcine viruses
cannot be totally excluded. However, there is no evidence of transmission of these
viruses to humans or of porcine pancreatic powder extracts causing illness in humans.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What CREON MICRO contains
|
Active ingredient
(main ingredient)
|
Each dosing unit of 100 mg of CREON MICRO contains Pancreatic Extract 60.12 mg equivalent
to not less than 5,000 Ph.Eur. units lipase, 3,600 Ph.Eur. units amylase and 200 Ph.
Eur. units protease.
|
|
Other ingredients
(inactive ingredients)
|
macrogol 4000
hypromellose phthalate
cetyl alcohol
triethyl citrate
dimeticone 1000
|
|
Potential allergens
|
None
|
One dosage unit is measured with a measuring scoop as dosing device.
Do not take this medicine if you are allergic to any of these ingredients.
What CREON MICRO looks like
CREON MICRO is a round, light brown enteric-coated granules in glass bottles. Each
glass bottle contains 20g of enteric-coated granules. Measuring scoop supplied (AUST
R 166118).
Who distributes CREON MICRO
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
This leaflet was prepared in February 2022.
CREON® is a Viatris company trade mark
CREON MICRO_cmi\Feb22/00