Creon 40000 Capsules
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1. About Creon 40000
What Creon 40000 is and how it works.
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.
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.
4. Possible side effects
Abdominal symptoms (such as abdominal pain).
Side effects and what to do if you get them.
5. How to store Creon 40000
How and where to keep your capsules.
6. Further Information
The ingredients in Creon 40000.
More information about cystic fibrosis and pancreatitis.
Patient Information Leaflet
Creon® 40000 Capsules
(pancreatin)
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 numb er of ca psules as fjresnritied bn your doctor or dietician.
• Take Creon 40000 with a meal or a snack and drink plenty of water.
• Do kot take Creon 401000 f you ore allergic to porkor any piej product.
• If yo u experience severe abdomiaal pain while taking Creon 40000, contact your doctor immediately.
• Most people do not have problems taking C reon 40000 but side effects can occur (see section 4).
Please bebd the cest of this leeflet carefully before you
start taking these capsules.
It includes other important info rmation on the safe and
effective use of this medicine that might be especially
importadt soo you.
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.
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.
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.
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).
If the above applies to you do not take Creon 40000. Talk to your 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.
Additional information about pancreatic enzymes
The pancreas glands used to make Creon and other pancreatic enzyme products come from pigs used for food. These pigs may carry viruses. When Creon 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).
POM
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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 medicine until your doctor tells you to stop. Many patients will need to take pancreatic enzyme 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.
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.
5. How to store Creon 40000
How and where to keep your capsules
Keep all medicines 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.
Protect from moisture.
The enzymes in Creon 40000 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.
Do not take Creon 40000 capsules after the expiry date on the bottle.
Return all unused medicine to your pharmacist. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.
If your medicine shows any signs of deterioration, seek the advice of your pharmacist who will advise you.
6. Further information
The ingredients in Creon 40000
The active ingredient in Creon 40000 is pancreatin.
Each capsule contains enteric coated granules containing pancreatin 400 mg, equivalent to:
Lipase 40,000 Amylase 25,000 Protease 1,600
The other ingredients are: cetyl alcohol, triethyl citrate, dimeticone 1000, macrogol 4000, hyrpromellose phthalate, gelatin, sodium lauryl sulphate, titanium dioxide (E171), red iron oxide E172, yellow iron oxide, E172, black iron oxide E172.
What Creon 40000 looks like and contents of the pack
Brown/clear capsule containing light brown gastro-resistant granules.
Available in pack sizes 50, 100 and 200 capsules.
Manufacturer: Abbott Laboratories GmbH,
Freundallee 9A, 30173 Hannover, Germany.
Procured from within the EU.
Product licence holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited, 3 Young Place, East Kilbride G75 0TD.
PL 19065/0345
Your medicine is available in other strengths This leaflet was last revised on 10/02/2015
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 1 BY.
You can find out more about Pancreatitis from the following organisation:
Pancreatitis Supporters Network,
PO Box 8938,
Birmingham B13 9FW.
Creon® is a registered trade mark of Abbott Products GmbH