Creon 10000 Capsules
Creon® 10000 Capsules
(pancreatin)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Creon 10000 Capsules, but it will be referred to as Creon Capsules throughout this leaflet.
Important things you SHOULD know about Creon Capsules
■ Creon Capsules are a pancreatic enzyme supplement for people whose bodies do not make enough enzymes to digest their food.
■ Take the number of Creon Capsules as prescribed by your doctor or dietician.
■ Take Creon Capsules with a meal or a snack and drink plenty of water.
■ Do not take Creon Capsules if you are allergic to pork or any pig product.
■ If you experience severe abdominal pain while taking Creon Capsules, contact your doctor immediately.
■ Most people do not have problems taking Creon Capsules but side effects can occur (see section 4).
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.
How to find the information you need
1. About Creon Capsules
What Creon Capsules are and how they work.
2. Before you take Creon Capsules
Who can take Creon Capsules?
Can you take Creon Capsules if you are pregnant or breast-feeding?
Driving or operating machinery.
3. How to take Creon Capsules
How many Creon Capsules you should take.
When you should take Creon Capsules.
How you should take Creon Capsules.
What to do if you take too many Creon Capsules.
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 Capsules
How and where to keep your Creon Capsules.
6. Further Information
The ingredients in Creon Capsules.
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.
1. About Creon Capsules What are Creon Capsules
■ Creon Capsules are 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 Capsules contain a mixture of the natural enzymes which are used to digest food.
■ The enzymes are taken from pig pancreas glands.
How do Creon Capsules work?
The enzymes in Creon Capsules work by digesting food as it passes through the gut. So, you must take Creon Capsules 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 Capsules Do not take Creon Capsules if:
■ You are allergic to pork, any pig product, or to any of the other ingredients (see section 6).
If the above applies to you do not take Creon Capsules. Talk to your doctor or dietician again.
When you need to take special care with Creon Capsules
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 your doctor if:
■ you are pregnant or trying to get pregnant (Creon Capsules can be used while breast-feeding)
Please tell your doctor, dietician or pharmacist if you think that you should not take Creon Capsules for any other reason.
If you drive or use machines
It is unlikely that Creon Capsules will affect your ability to drive or operate tools or machines.
3. How to take Creon Capsules
How many Creon Capsules 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 Capsules
■ Always take Creon Capsules at the same time as eating a meal or a snack and drink plenty of water
(see section 1).
How to take Creon Capsules
■ 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 Capsules work in your body.
■ Do not hold Creon Capsules or its contents in your mouth.
■ Do not store the mixture.
How long to take Creon Capsules 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 many Creon Capsules
If you take too many Creon Capsules 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 Capsules 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 Capsules - 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.
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 national reporting system listed below.
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 Capsules
■ Keep all medicines out of the sight and reach of children.
■ Do not store above 30°C. The enzymes in Creon Capsules are a natural product and their ability to digest food decreases over time. If the container is left in warm conditions, the digestive activity decreases faster.
For this reason do not store Creon Capsules above 30°C.
■ Keep the container tightly closed.
■ Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to the last day of the month.
■ If your capsules appear to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you further.
■ If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for safe disposal. Only keep the capsules if your doctor tells you to.
■ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Creon Capsules contain:
Creon Capsules belong to a group of medicines called pancreatic enzyme supplements. Each capsule contains enteric coated minimicrospheres of pancreatin 150mg equivalent to:
Lipase 10,000 Ph. Eur. units Amylase 8,000 Ph. Eur. units Protease 600 Ph. Eur. Units Other enzymes are also present in small quantities.
Creon Capsules also contain the following ingredients: Macrogol 4000, hypromellose phthalate, dimethicone 1000, cetyl alcohol, triethyl citrate, gelatin, iron (III) oxide anhydrous E172, iron (III) oxide hydrate E172, iron (II, III) Oxide E172, titanium dioxide E171 and sodium lauryl sulphate.
What Creon Capsules look like and contents of the pack
Creon Capsules are hard gelatin capsules with a colourless translucent body and dark brown opaque cap, containing brownish pellets (minimicrospheres).
Creon Capsules are available in containers holding 100 capsules.
Manufacturer
Manufactured by:
Abbott Laboratories GmbH, Neustadt A. Rbge, Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder:
BR Lewis Pharmaceuticals Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
PL No: 08929/0098 0
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.
If you wish to receive this PIL in Braille, large font or audio format please contact 01302 365000 and ask for the Regulatory Department.
Leaflet revision and issue date (Ref.) 07.08.15
Creon® is a registered trademark of Abbott Products GmbH.
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