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CREON MICRO GRANULES

Active substance(s): 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 or Creon micro throughout this leaflet.

Important things you SHOULD know about Creon
Creon 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 with a meal or a snack and provide plenty of water.
Do not give Creon if the patient is allergic to pork, any pig
product or any of the ingredients of Creon (listed in section 6).
If the patient experience severe abdominal pain while taking
Creon, contact a doctor immediately.
Most people do not have problems taking Creon 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
What Creon is and how it works.
2. Before you give Creon
Who can take Creon?
Can you take Creon 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
How and where to keep this medicine.
6. Further Information
The ingredients in Creon.
More information about cystic fibrosis and pancreatitis.

1. About Creon
What is Creon
Creon 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 contain a mixture of the natural enzymes which are used
to digest food.
The enzymes are taken from pig pancreas glands.
How does Creon work?
The enzymes in Creon work by digesting food as it passes through the gut.
So you must give Creon with a meal or a snack. This will allow the
enzymes to mix thoroughly with the food.

2. Before you give Creon
Do not give Creon if:
The patient is allergic (or hypersensitive) to pork, any pig product or
any of the ingredients of Creon (listed in section 6).
If the above applies to the patient, do not give Creon. Talk to the doctor or
dietician again.
When you need to take special care with Creon
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 can be used while
breast-feeding)
Please tell the doctor, dietician, or pharmacist if you think that the patient
should not take Creon for any other reason.

If the patient drives or uses machinery
It is unlikely that Creon 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 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 works in
your body.
Do not hold Creon 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 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 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 patient too much Creon Micro
If you give 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 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 Creoncontact 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 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
How and where to keep the medicine
Keep out of the sight and reach of children- preferably locked in a
cupboard or medicine cabinet.
Do not store above 25°C.
Keep the container tightly closed to protect from moisture.
Store in the original container.
The enzymes in Creon 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 within 12 weeks of opening the container.
Do not take your medicine after the expiry date which is stated on the
carton or bottle label after ‘Exp’. The expiry date refers to the last day
of that month.
If your medicine becomes 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.

6. Further information
What Creon contains
The active ingredient in Creon is pancreatin.
Each scoop measure contains 100mg.
One measure of 100mg contains gastro-resistant 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 looks like and the contents of the pack
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).
Manufactured by: Abbott Products GmbH, Hans-Böckler-Allee 20, 30173
Hannover, Germany.
AND/OR
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
P
Leaflet date: 17.08.2015

Patient Information Leaflet

Pancreatin 60.12mg gastro-resistant granules
The name of your medicine is Pancreatin 60.12mg gastro-resistant
granules but will be referred to as Pancreatin or Pancreatin granules
throughout this leaflet.

Important things you SHOULD know about Pancreatin
Pancreatin 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 Pancreatin with a meal or a snack and provide plenty of
water.
Do not give Pancreatin if the patient is allergic to pork, any pig
product or any of the ingredients of Pancreatin (listed in section
6).
If the patient experience severe abdominal pain while taking
Pancreatin, contact a doctor immediately.
Most people do not have problems taking Pancreatin 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 Pancreatin
What Pancreatin is and how it works.
2. Before you give Pancreatin
Who can take Pancreatin?
Can you take Pancreatin if you are pregnant or breast-feeding?
Driving or operating machinery.
3. How to give Pancreatin
How much Pancreatin you should give.
When you should give Pancreatin.
How you should give Pancreatin.
What to do if you give too much Pancreatin.
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 Pancreatin
How and where to keep this medicine.
6. Further Information
The ingredients in Pancreatin.
More information about cystic fibrosis and pancreatitis.

1. About Pancreatin
What is Pancreatin
Pancreatin 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.

Pancreatin contain a mixture of the natural enzymes which are used to
digest food.
The enzymes are taken from pig pancreas glands.
How does Pancreatin work?
The enzymes in Pancreatin work by digesting food as it passes through the
gut. So you must give Pancreatin with a meal or a snack. This will allow the
enzymes to mix thoroughly with the food.

2. Before you give Pancreatin
Do not give Pancreatin if:
The patient is allergic (or hypersensitive) to pork, any pig product or
any of the ngredients of Pancreatin (listed in section 6).
If the above applies to the patient, do not give Pancreatin. Talk to the
doctor or dietician again.
When you need to take special care with Pancreatin
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 (Pancreatin can be used
while breast-feeding)
Please tell the doctor, dietician, or pharmacist if you think that the patient
should not take Pancreatin for any other reason.
If the patient drives or uses machinery
It is unlikely that Pancreatin will affect the patient’s ability to drive or
operate tools or machines.

3. How to give Pancreatin
How much Pancreatin 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 Pancreatin
Always give Pancreatin with a meal or a snack and provide plenty of
water (see section 1).
How to take Pancreatin
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 Pancreatin works
in your body.
Do not hold Pancreatin in your mouth.
Do not store the mixture.
How to give Pancreatin 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 Pancreatin 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 Pancreatin works in the
body.
Do not store the mixture.
How long to give Pancreatin
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 patient too much Pancreatin
If you give patient too much Pancreatin , 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 take 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, Pancreatin 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 Pancreatincontact 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 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 Pancreatin
How and where to keep the medicine
Keep out of the sight and reach of children- preferably locked in a
cupboard or medicine cabinet.
Do not store above 25°C.
Keep the container tightly closed to protect from moisture.
Store in the original container.
The enzymes in Pancreatin 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 Pancreatin within 12 weeks of opening the container.
Do not take your medicine after the expiry date which is stated on the
carton or bottle label after ‘Exp’. The expiry date refers to the last day
of that month.
If your medicine becomes 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.

6. Further information
What Pancreatin contains
The active ingredient in Pancreatin granules is pancreatin.
Each scoop measure contains 100mg.
One measure of 100mg contains gastro-resistant 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 Pancreatin looks like and the contents of the pack
Pancreatin granules 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).
Manufactured by: Abbott Products GmbH, Hans-Böckler-Allee 20, 30173
Hannover, Germany.
AND/OR
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.
Pancreatin 60.12mg gastro-resistant granules
P
PL 18799/2788
Leaflet date: 17.08.2015

Expand view ⇕

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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