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Creon® 25000 capsules
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.
Who can take Creon 25000?
Can you take Creon 25000 if you are pregnant or breast feeding? Driving or operating machinery
How much Creon 25000 you should take. When you should take Creon 25000.
How you should take Creon 25000.
What to do if you take too much Creon 25000. What to do if you forget a dose.
Abdominal symptoms (such as abdominal pain). Side effects and what to do if you get them.
How and where to keep your capsules.
The ingredients in Creon 25000.
More inforamtion 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.
The enzymes in Creon 25000 work by digesting food as it passes through the gut. So you must take Creon 25000 at the same time as eating a meal or a snack. This will allow the enzymes to mix thoroughly with the food.
- 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 25000. Talk to your doctor or dietician again.
A rare bowel condition called “fibrosing colonopathy”, where 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 syptoms tell you doctor.
- you are pregnant or trying to get pregnant (Creon 25000 can be used while breast feeding)
Please tell your doctor dietician or pharmacist if you think that you should not take Creon 25000 for any other reason.
It is unlikely that Creon 25000 will affect your ability to drive or operate tools or machines.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’
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 25000 you should drink plenty of water and see your doctor immediately.
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.
Like all medicines, Creon 25000 can cause side effects (unwanted effects or reactions), but not everyone gets them.
If you notice any unusual abdominal symptoms while taking Creon 25000 – contact your doctor.
At extremely high doses, some patients have had high levels of uric acid in their blood and urine.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below.
How and where to keep your capsules
Keep this medicine out of the sight and reach of children.
Do not store above 25°C and keep in the orignal container. Keep the container tightly closed. The enzymes in Creon 25000 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 descreases faster.
Do not take Creon 25000 capsules after the expiry date on the bottle. Once opened, use within 3 months.
Return all unused medicine to your pharmacist.
The active ingredient in Creon 25000 is pancreatin.
Each capsule contains enteric coated brownish-coloured granules (minimicrospheres) containing pancreatin 300 mg, equivalent to:
List of Enzymes (PhEur units per capsule) Lipase 25,000
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 sodium lauryl sulfate. Creon 25000 is available in 100 capsule packs.
The Marketing Authorisation Holder is:
Mylan Products Ltd,
20 Station Close, Potters Bar, Herts, EN6 1TL, UK.
The Manufacturer is:
Abbott Laboratories GmbH,
31535 Neustadt a. Rbge, Germany.