Creon 10000 Capsules
Important things you SHOULD know about Creon® 10000.
- Creon® 10000 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® 10000 with a meal or a snack and drink plenty of water.
- Do not take Creon® 10000 if you are allergic to pork or any pig product.
- If you experience severe abdominal pain while taking Creon® 10000, contact your doctor immediately.
- Most people do not have problems taking Creon® 10000 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.
|2) BEFORE YOU TAKE CREON® 100001
500971/PL1f ®
Creon 10000 Capsules
(pancreatin)
Patient Information Leaflet
The name of your medicine is Creon® 10000 Capsules, throughout this leaflet it will be referred to as Creon® 10000.
How to find the information you need:
1) About Creon® 10000
What Creon® 10000 is and how it works.
2) Before you take Creon® 10000
Who can take Creon® 10000?
Can you take Creon® 10000 if you are pregnant or breast-feeding?
Driving or operating machinery.
3) How to take Creon® 10000
How much Creon® 10000 you should take.
(r)
When you should take Creon® 10000.
(r)
How you should take Creon® 10000.
What to do if you take too much Creon® 10000.
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® 10000
How and where to keep your capsules.
6) Further information
The ingredients in Creon® 10000.
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® 10000
What is Creon® 10000
• Creon® 10000 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® 10000 capsules contain a mixture of the natural enzymes which are used to digest food.
• The enzymes are taken from pig pancreas glands.
How does Creon® 10000 work?
The enzymes in Creon® 10000 work by digesting food as it passes through the gut. So, you must take Creon® 10000 at the same time as eating a meal or a snack. This will allow the enzymes to mix thoroughly with the food.
Do not take Creon® 10000 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® 10000. 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.
Talk to your doctor if:
• you are pregnant or trying to get pregnant (Creon® 10000 can be used while breast-feeding)
Please tell your doctor, dietician or pharmacist if you think that you should not take Creon® 10000 for any other reason.
If you drive or use machines
It is unlikely that Creon® 10000 will affect your ability to drive or operate tools or machines.
3) HOW TO TAKE CREON® 10000
How much Creon 10000 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® 10000
• Always take Creon® 10000 at the same time as eating a meal or a snack and drink plenty of water (see section 1).
How to take Creon® 10000
• 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® 10000 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® 10000
If you take too much Creon® 10000 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.
Continued overleaf
4) POSSIBLE SIDE EFFECTS
Like all medicines, Creon® 10000 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® 10000 - 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 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.
What Creon looks like and the contents of the pack
Creon® 10000 Capsules are brown/clear capsules containing gastro-resistant granules.
Creon® 10000 is available in a pack size of 100 capsules. Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Abbott Laboratories GmbH, Justus-Von-Liebig Strasse 33, Neustadt Am Ruebenberge, D-31535, Germany.
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 B139FW.
The CF Trust and The Pancreatitis Supporters Network are not associated with Ginova Ltd or Ginova UK Ltd.
Creon® 10000 Capsules
PL No: 18067/0321 P
Creon® is a registered trademark of Abbott Products Operations AG.
This leaflet was last revised on 4th June 2015.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.
5) HOW TO STORE CREON® 10000
How and where to keep your capsules:
• Keep out of the sight and reach of children -
preferably locked in a cupboard or medicine cabinet.
• Do not store above 30°C and keep in the original container. Keep container tightly closed. The enzymes in Creon® 10000 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® 10000 capsules after the expiry date on the bottle
• Return all unused medicine to your pharmacist
• If you notice any sign of deterioration or discolouration of the capsules consult your pharmacist.
6) FURTHER INFORMATION
The ingredients in Creon 10000
Each capsule contains 150 mg of pancreatin equivalent to lipase 10,000 Ph Eur units, amylase 8,000 Ph Eur units and protease 600 Ph Eur units.
The capsules are coated with a mixture of the following ingredients: macrogol 4000, hypromellose phthalate, dimeticone 1000, triethyl citrate and cetyl alcohol.
The capsules contain: gelatin, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), titanium dioxide (E171) and sodium lauryl sulphate.
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