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CREON 40 000 CAPSULES

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(leaflet continued)
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.
Additional information about pancreatic
enzymes
The pancreas glands used to make Creon
40000 and other pancreatic enzyme products
come from pigs used for food. These pigs may
carry viruses. When Creon 40000 is made
several steps are taken to reduce the risk of
viruses being spread, including their
destruction and testing for specific viruses. The
risk of infections caused by these or other
unknown or novel viruses cannot be totally
ruled out. However, there have not been any
cases reported where infection of patients has
occurred.
Talk to your doctor if:
you are pregnant or trying to get pregnant
(Creon 40000 can be used while breast
feeding)
Please tell your doctor, dietician, or pharmacist
if you think that you should not take Creon
40000 for any other reason.
If you drive or use machines
It is unlikely that Creon 40000 will affect your
ability to drive or operate tools or machines.
3. How to take Creon 40000
How much Creon 40000 to take
Always follow your doctor or dietician’s
advice on how many capsules to take.
If your doctor advises you to increase the
number of capsules you take, you should
do so slowly. If you still have fatty stools or
abdominal pain, talk to your doctor or
dietician.
When to take Creon 40000
Always take Creon 40000 at the same time
as eating a meal or a snack and drink
plenty of water (see section 1).
How to take Creon 40000
Swallow the capsules whole or
Open the capsules and 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 capsules or its content in
your mouth
Do not store the mixture.
How long to take Creon 40000 for
You should take your medicines until your
doctor tells you to stop. Many patients will
need to take pancreatic enzymes supplements
for the rest of their lives.
If you take too much Creon 40000
If you take too much Creon 40000, you should
drink plenty of water and see your doctor
immediately.
If you forget a dose
If you forget to take your medicine, wait until
your next meal and take your usual number of
capsules.
Do not try to make up for the number of
capsules that you have missed. Just take
your next dose at the usual time.
4. Possible side effects
Like all medicines, Creon 40000 can cause
side effects (unwanted effects or reactions),
but not everyone gets them.
If you have severe or long-lasting
abdominal pain, contact your doctor
immediately.
If you notice any unusual abdominal
symptoms while taking Creon 40000 – contact
your doctor.
Very common side effects (affect 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

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.
If you notice any unwanted effect (even one
not mentioned in this leaflet), or if you feel
unwell while taking Creon 40000: Tell your
doctor.
5. How to store Creon 40000
Keep out of the sight and reach of children
The enzymes in Creon 40000 Capsules are a
natural product 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.
Do not store above 25ºC. Keep in the original
container.
Do not use after the expiry date shown on the
packaging, as the enzyme activity will be less
than 40000 lipase units per capsule.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines that
are no longer required. These measures will
help to protect the environment.
If the capsules show any signs of deterioration
or discoloration, seek the advice of your
pharmacist who will tell you what to do.
If the doctor decides to stop treatment return
any capsules you have left to the pharmacist
for safe disposal. Only keep them if the doctor
tells you to.
6. Further information
The name of your medicine is Creon 40000
Capsules.
Each soft gelatin capsule has a brown cap and
a clear colourless body containing light brown
enteric coated granules, containing pancreatin
400mg equivalent to:

Uncommon side effects (affect 1–10
patients out of 1000):
skin reactions, such as a rash.

List of Enzymes: Ph. Eur. Units per
Capsule
Lipase
40,000
Amylase
25,000
Protease
1,600
Other enzymes are also present in small
quantities.
The granules are coated with a mixture of the
following ingredients: macrogol 4000,
hypromellose phthalate, dimeticone, triethyl
citrate and cetyl alcohol.
The capsule contains gelatin, titanium dioxide,
sodium lauryl sulphate, iron oxide (E172),
black iron oxide (E172) and yellow iron oxide
(E172).
Creon 40000 Capsules is one of a group of
medicines called high strength pancreatic
enzyme supplement.
Creon 40000 Capsules are available in 2 x 50
capsules bottles in one carton.
Creon 40000 Capsules are manufactured by
Abbott Laboratories GmbH, Hans – Bockler
Alle 20, D – 30173 Hannover, Germany.
Procured from within the EU: Product Licence
Holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, Lynstock Way, Lostock,
Bolton BL6 4SA. Repackaged by Maxearn Ltd,
Bolton BL6 4SA.
Creon 40000 Capsules PL 20774/0904
POM
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.
Leaflet prepared 6th August 2014
Creon is a registered trademark of Solvay
Pharmaceuticals GmbH.

PP8/0904/V1

(leaflet continued overleaf)
4. Possible side effects
Abdominal symptoms (such as abdominal
pain). Side effects and what to do if you get
them.
3. How to take Creon 40000
How much Creon 40000 you should take.
When you should take Creon 40000.
How you should take Creon 40000.
What to do if you take too much Creon 40000.
What to do if you forget a dose.
2. Before you take Creon 40000
Who can take Creon 40000?
Can you take Creon 40000 if you are pregnant
or breast feeding?
Driving or operating machinery.
How to find the information you need
1. About Creon 40000
What Creon 40000 is and how it works.
Please read the rest of this leaflet carefully
before you start taking these capsules.
It includes other important information on the
safe and effective use of this medicine that
might be especially important for you.

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 the above applies to you do not take Creon
40000. Talk to your doctor or dietician again.
2. Before you take Creon 40000
Do not take Creon 40000 if:
You are allergic to pork or any pig product,
or to any of the other ingredients (see
section 6).
How does Creon 40000 work?
The enzymes in Creon 40000 work by
digesting food as it passes through the gut. So,
you must take Creon 40000 at the same time
as eating a meal or a snack. This will allow the
enzymes to mix thoroughly with the food.
1. About Creon 40000
What is Creon 40000
Creon 40000 is a high strength 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 40000 granules contain a mixture of
the natural enzymes which are used to
digest food.
The enzymes are taken from pig pancreas
glands.

This medicine will be referred to as Creon
40000 throughout the remainder of this leaflet.

5. How to store Creon 40000
How and where to keep your capsules.

Important things you SHOULD know about
Creon 40000
Creon 40000 is a pancreatic enzyme
supplement for people whose bodies do not
make enough enzymes to digest their food.
Take the number of capsules as prescribed
by your doctor or dietician.
Take Creon 40000 with a meal or a snack
and drink plenty of water.
Do not take Creon 40000 if you are allergic
to pork or any pig product.
If you experience severe abdominal pain
while taking Creon 40000, contact your
doctor immediately.
Most people do not have problems taking
Creon 40000 but side effects can occur.
(see section 4)

6. Further Information
The ingredients in Creon 40000.
More information about cystic fibrosis and
pancreatitis.

This medicine has been prescribed for you
personally. Don’t offer it to other people, even
if their symptoms seem to be the same as
yours.

Creon® 40000 Capsules
(Pancreatin)
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP8/0904/V1

(leaflet continued)
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.
Additional information about pancreatic
enzymes
The pancreas glands used to make Creon
40000 and other pancreatic enzyme products
come from pigs used for food. These pigs may
carry viruses. When Creon 40000 is made
several steps are taken to reduce the risk of
viruses being spread, including their
destruction and testing for specific viruses. The
risk of infections caused by these or other
unknown or novel viruses cannot be totally
ruled out. However, there have not been any
cases reported where infection of patients has
occurred.
Talk to your doctor if:
you are pregnant or trying to get pregnant
(Creon 40000 can be used while breast
feeding)
Please tell your doctor, dietician, or pharmacist
if you think that you should not take Creon
40000 for any other reason.
If you drive or use machines
It is unlikely that Creon 40000 will affect your
ability to drive or operate tools or machines.
3. How to take Creon 40000
How much Creon 40000 to take
Always follow your doctor or dietician’s
advice on how many capsules to take.
If your doctor advises you to increase the
number of capsules you take, you should
do so slowly. If you still have fatty stools or
abdominal pain, talk to your doctor or
dietician.
When to take Creon 40000
Always take Creon 40000 at the same time
as eating a meal or a snack and drink
plenty of water (see section 1).
How to take Creon 40000
Swallow the capsules whole or
Open the capsules and 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 capsules or its content in
your mouth
Do not store the mixture.
How long to take Creon 40000 for
You should take your medicines until your
doctor tells you to stop. Many patients will
need to take pancreatic enzymes supplements
for the rest of their lives.
If you take too much Creon 40000
If you take too much Creon 40000, you should
drink plenty of water and see your doctor
immediately.
If you forget a dose
If you forget to take your medicine, wait until
your next meal and take your usual number of
capsules.
Do not try to make up for the number of
capsules that you have missed. Just take
your next dose at the usual time.
4. Possible side effects
Like all medicines, Creon 40000 can cause
side effects (unwanted effects or reactions),
but not everyone gets them.
If you have severe or long-lasting
abdominal pain, contact your doctor
immediately.
If you notice any unusual abdominal
symptoms while taking Creon 40000 – contact
your doctor.
Very common side effects (affect 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.
If you notice any unwanted effect (even one
not mentioned in this leaflet), or if you feel
unwell while taking Creon 40000: Tell your
doctor.
5. How to store Creon 40000
Keep out of the sight and reach of children
The enzymes in Creon 40000 Capsules are a
natural product 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.
Do not store above 25ºC. Keep in the original
container.
Do not use after the expiry date shown on the
packaging, as the enzyme activity will be less
than 40000 lipase units per capsule.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines that
are no longer required. These measures will
help to protect the environment.
If the capsules show any signs of deterioration
or discoloration, seek the advice of your
pharmacist who will tell you what to do.
If the doctor decides to stop treatment return
any capsules you have left to the pharmacist
for safe disposal. Only keep them if the doctor
tells you to.
6. Further information
The name of your medicine is Creon 40000
Capsules.
Each soft gelatin capsule has a brown cap and
a clear colourless body containing light brown
enteric coated granules, containing pancreatin
400mg equivalent to:

List of Enzymes:

Ph. Eur. Units per
Capsule
Lipase
40,000
Amylase
25,000
Protease
1,600
Other enzymes are also present in small
quantities.
The granules are coated with a mixture of the
following ingredients: macrogol 4000,
hypromellose phthalate, dimeticone, triethyl
citrate and cetyl alcohol.
The capsule contains gelatin, titanium dioxide,
sodium lauryl sulphate, iron oxide (E172),
black iron oxide (E172) and yellow iron oxide
(E172).
Creon 40000 Capsules is one of a group of
medicines called high strength pancreatic
enzyme supplement.
Creon 40000 Capsules are available in 2 x 50
capsules bottles in one carton.
Creon 40000 Capsules are manufactured by
Abbott Laboratories GmbH, Hans – Bockler
Alle 20, D – 30173 Hannover, Germany.
Procured from within the EU: Product Licence
Holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, Lynstock Way, Lostock,
Bolton BL6 4SA. Repackaged by Maxearn Ltd,
Bolton BL6 4SA.
Creon 40000 Capsules PL 20774/0904
POM
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.
Leaflet prepared 6th August 2014
Creon is a registered trademark of Solvay
Pharmaceuticals GmbH.

PP8/0904/V1

(leaflet continued overleaf)
4. Possible side effects
Abdominal symptoms (such as abdominal
pain). Side effects and what to do if you get
them.
3. How to take Creon 40000
How much Creon 40000 you should take.
When you should take Creon 40000.
How you should take Creon 40000.
What to do if you take too much Creon 40000.
What to do if you forget a dose.
2. Before you take Creon 40000
Who can take Creon 40000?
Can you take Creon 40000 if you are pregnant
or breast feeding?
Driving or operating machinery.
How to find the information you need
1. About Creon 40000
What Creon 40000 is and how it works.
Please read the rest of this leaflet carefully
before you start taking these capsules.
It includes other important information on the
safe and effective use of this medicine that
might be especially important for you.

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 the above applies to you do not take Creon
40000. Talk to your doctor or dietician again.
2. Before you take Creon 40000
Do not take Creon 40000 if:
You are allergic to pork or any pig product,
or to any of the other ingredients (see
section 6).
How does Creon 40000 work?
The enzymes in Creon 40000 work by
digesting food as it passes through the gut. So,
you must take Creon 40000 at the same time
as eating a meal or a snack. This will allow the
enzymes to mix thoroughly with the food.
1. About Creon 40000
What is Creon 40000
Creon 40000 is a high strength 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 40000 granules contain a mixture of
the natural enzymes which are used to
digest food.
The enzymes are taken from pig pancreas
glands.
6. Further Information
The ingredients in Creon 40000.
More information about cystic fibrosis and
pancreatitis.

Important things you SHOULD know about
Creon 40000
Creon 40000 is a pancreatic enzyme
supplement for people whose bodies do not
make enough enzymes to digest their food.
Take the number of capsules as prescribed
by your doctor or dietician.
Take Creon 40000 with a meal or a snack
and drink plenty of water.
Do not take Creon 40000 if you are allergic
to pork or any pig product.
If you experience severe abdominal pain
while taking Creon 40000, contact your
doctor immediately.
Most people do not have problems taking
Creon 40000 but side effects can occur.
(see section 4)

5. How to store Creon 40000
How and where to keep your capsules.

This medicine will be referred to as Creon
40000 throughout the remainder of this leaflet.

This medicine has been prescribed for you
personally. Don’t offer it to other people, even
if their symptoms seem to be the same as
yours.

Creon® 40000 Capsules
(Pancreatin)
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP8/0904/V1

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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