Sunday 29 July 2012

Creon 40000







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 amount 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)


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.


This leaflet was last approved in September 2009.




How to find the information you need



  • 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.


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.




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.





Before you take Creon 40000



Do not take Creon 40000 if:


  • Your doctor has told you that you are in the early stages of inflammation of the pancreas (acute pancreatitis)

  • You are allergic to pork or any pig product, or to any of the other ingredients (see section 6).

If any of the above applies to you do not take Creon 40000. Talk to your doctor or dietician again.




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.





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.

  • Drink plenty of liquid every day.



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 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.





Creon 40000 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):


Inform your doctor if you have:


  • diarrhoea

  • constipation

  • feeling or being sick



Uncommon side effects (affect 1–10 patients out of 1000):


  • skin reactions, such as a rash or itching


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.




How to store Creon 40000



How and where to keep your capsules



Keep all medicines out of the reach and sight of children – preferably locked in a cupboard or medicine cabinet.


Do not store above 25 °C and keep in the original container. 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.





Further information



The ingredients in Creon 40000


The active ingredient in Creon 40000 is pancreatin.


Each capsule contains enteric coated brownish-coloured granules (minimicrospheres) containing pancreatin 400 mg, equivalent to:


List of Enzymes: (PhEur units per capsule)


Lipase 40,000


Amylase 25,000


Protease 1,600


The granules are coated with a mixture of the following ingredients: macrogol 4000, hypromellose phthalate, dimeticone, triethyl citrate and cetyl alcohol.


The capsules contain: gelatin, iron oxides (E172), titanium dioxide (E171) and lauryl sulphate.


Creon 40000 is available in 100 capsule packs.




The Marketing Authorisation Holder is:



Solvay Healthcare Ltd

Southampton

SO18 3JD

UK




The Manufacturer is:



Solvay Pharmaceuticals GmbH

31535 Neustadt a. Rbge

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

B13 9FW




Registered trademark


1069334





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