Creon 40000 Capsules
Creon® 40000 Capsules
(pancreatin)
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.
Your medicine is known by the above name but will be referred to as Creon
40000 throughout this:
Patient Information Leaflet
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 number 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)
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.
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 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
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).
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 40000 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 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.
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.
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.
• Do not store above 25°C.
• Keep the can tightly closed in order to protect from moisture.
• After opening use within 3 months.
• 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 use after the expiry date on the bottle.
• Return all unused medicine to your pharmacist.
• 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.
• If the capsules become discoloured or show signs of any deterioration, you should ask your pharmacist who will advise you what to do.
6) 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 400mg, equivalent to:
List of Enzymes: (PhEur units per capsule)
Lipase 40,000
Amylase 25,000
Protease 1,600
Creon 40000 capsules also contain the following inactive ingredients:
The granules 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.
The capsules are clear colourless and opaque brown hard gelatin capsules with no markings
Creon 40000 Capsules are available as 50, 100 and 200 capsules in a white plastic tub with a tamper evident seal.
PL 10383/1978 Creon 40000 Capsules |POM
Who makes and repackages your medicine:
Your medicine is manufactured by Abbott Laboratories GmbH, Freundallee 9A 30173 Hannover, Germany. Procured from within the EU and repackaged by the Product Licence holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 15.06.2016
Creon is a registered trademark of BGP Products Operations GmbH, Switzerland.
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.