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CREON MICRO PANCREATIN 60.12MG GASTRO-RESISTANT GRANULES

Active substance(s): PANCREATIN

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By rajeevkumarj at 12:54 pm, May 12, 2015

Assessed against UK PIL dated March 2015

S1665 LEAFLET Creon 20150428

PACKAGE LEAFLET: INFORMATION FOR THE USER

CREON MICRO PANCREATIN 60.12MG
GASTRO-RESISTANT GRANULES
(pancreatin)
Your medicine is known as Creon Micro Pancreatin 60.12mg
Gastro-Resistant Granules but will be referred to as Creon Micro
throughout the following leaflet.

How does Creon Micro work?

MOCK-UP

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:


Important things you SHOULD know about Creon Micro

The patient is allergic (or hypersensitive) to pork, any pig
product or any of the ingredients of Creon Micro (listed in
section 6).



Creon Micro is a pancreatic enzyme supplement for people
whose bodies do not make enough enzymes to digest their
food.

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



Give the amount of granules prescribed by your doctor.

When you need to take special care with Creon Micro



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).

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 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.

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

How to find the information you need



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.

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 breastfeeding?
Driving or operating machinery.
3. How to give Creon Micro
How much Creon Micro you should give.

When to give Creon Micro


When you should give Creon Micro.

Always give Creon Micro with a meal or a snack and provide
plenty of water (see section 1).

How you should give Creon Micro.
What to do if you give too much Creon Micro.

How to take Creon Micro

What to do if you forget a dose.



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.

The ingredients in Creon Micro.



Do not hold Creon Micro in your mouth.

More information about cystic fibrosis and pancreatitis.



Do not store the mixture.

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

1. ABOUT CREON MICRO

How to give Creon Micro to babies and infants

What is Creon Micro



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.



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.

Weaned infants

5. HOW TO STORE 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).

How and where to keep the medicine


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.

Keep out of the sight and reach of children, preferably locked in
a cupboard or medicine cabinet.



Do not store above 25°C. Store in the original container.



Keep the container tightly closed to protect from moisture.
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.





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.



Use Creon Micro within 3 months of opening the container.



Do not store the mixture.

Do not give Creon Micro capsules after the expiry date on the
container.



Return all unused medicine to your pharmacist.



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.

6. FURTHER INFORMATION
What Creon Micro contains


One measure (100mg) of gastro-resistant granules contains
pancreatin 60.12mg equivalent to the following enzymes:

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

The active ingredient in Creon Micro is pancreatin.



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.

-

Lipase 5,000 PhEur Units;

-

Amylase 3,600 PhEur Units;

-

Protease 200 PhEur Units.

The granules are coated with a mixture of the following
ingredients: cetyl alcohol, triethyl citrate, dimeticone 1000,
macrogol 4000, and hypromellose phthalate.

What Creon Micro looks like and contents of the pack
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.

Creon Micro granules are round, light-brown gastro-resistant
granules.
The bottle contains 20 grams of granules (about 200 measures).
Product Licence holder

If you notice any unusual abdominal symptoms while taking
Creon Micro – contact the doctor.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Very common side effects (more than 1 in 10 patients):

Manufacturer



This product is manufactured by Abbott Laboratories GmbH,
Freundallee 9A, 30173 Hannover, Germany.

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:

P

PL No: 19488/1665

Leaflet revision date: 28 April 2015
Creon is a registered trade mark of Abbott Healthcare Products Ltd,
UK.
S1665 LEAFLET Creon 20150428

More information about cystic fibrosis and pancreatitis
You can find out more about Cystic Fibrosis from the following
organisation:
The CF Trust



itching with or without a rash

11 London Road, Bromley BR1 1BY.



allergic reactions (which may be severe).



severe or long-lasting abdominal pain (Fibrosing colonopathy).

You can find out more about Pancreatitis from the following
organisation:

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.

Pancreatitis Supporters Network
PO Box 8938, Birmingham B13 9FW.

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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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