Creon 40000 Capsules
Ref: LTT0025/150216/1 /F
Creon 40000 Capsules
(pancreatin)
Patient Information Leaflet
Your medicine is called Creon 40000 capsules but will be referred to as Creon 40000 throughout this 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)
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 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.
[a Before 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 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 enzyme supplements for the rest of
their lives.
|
Creon 40000 Capsules (pancreatin) Patient Information Leaflet (continued) If you take too much Creon 40000 |
Ref: LTT0025/150216/1 /B H6) Further information |
|
If you take too much Creon 40000, you should drink plenty of water and see |
The ingredients in Creon 40000 |
|
your doctor immediately. |
* The active substance in Creon 40000 is pancreatin. |
|
Each capsule contains gastro-resistant granules of pancreatin | |
|
If you forget a dose |
400mg, equivalent to 40,000 PhEur units of lipase, 25,000 PhEur |
|
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 |
units of amylase and 1,600 PhEur units of protease. |
|
that you have missed. Just take your next dose at the usual time. |
* The other ingredients are: cetyl alcohol, triethyl citrate, dimeticone |
|
1000, macrogol 4000, hypromellose phthalate, gelatin, sodium | |
|
Possible side effects |
lauryl sulphate, titanium dioxide (E171), red iron oxides (E172), black iron oxides (E172), yellow iron oxides (E172). |
|
What Creon 40000 looks like and contents of the pack | |
|
Like all medicines, Creon 40000 can cause side effects (unwanted effects or |
Creon 40000 Capsules are unmarked with a brown cap and a clear |
|
reactions), but not everyone gets them. |
body containing light brown gastro-resistant granules. |
|
If you have severe or long-lasting abdominal pain, contact your doctor |
Creon 40000 Capsules are available in plastic tubs of 50, 100 or 200 |
|
immediately. |
capsules. |
|
If you notice any unusual abdominal symptoms while taking Creon 40000 |
Manufacturer and Licence Holder |
|
- contact your doctor. |
This medicine is manufactured by Abbott Products GmbH, Hans-Bockler-Allee 20, D-30173 Hannover, Germany and is |
|
Very common side effects (affect more than 1 in 10 patients): |
procured from within the EU. Product Licence Holder: LTT |
|
* stomach pains |
Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 ORE. Repackaged by Lexon (UK) |
|
Common side effects (affect 1-10 patients out of 100): * diarrhoea |
Limited, Redditch, B98 ORE. |
|
* constipation * feeling or being sick |
POM PL 33723/0025 Creon 40000 Capsules |
|
* bloating |
Revision date: 15/02/16 |
|
Uncommon side effects (affect 1-10 patients out of 1000): * skin reactions, such as a rash |
Creon is a registered trademark of Solvay Pharmaceutical GmbH. |
|
During use, some patients have also experienced the following, the |
Blind or partially sighted? |
|
frequency of which is unknown: * itching with or without a rash * allergic reactions (which may be severe). |
Is this leaflet hard to see or read? Phone LTT Pharma Limited, Tel: 01527 |
|
* severe or long-lasting abdominal pain (Fibrosing colonopathy). |
505414 for help. |
|
At extremely high doses, some patients have had high levels of uric acid in their blood and urine. |
More information about cystic fibrosis and pancreatitis You can find out more about Cystic Fibrosis from the following |
|
Reporting of side effects |
organisation: |
|
If you get any side effects, talk to your doctor, pharmacist or nurse. This |
The CF Trust |
|
includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at |
11 London Road, Bromley BR1 1 BY. |
|
You can find out more about Pancreatitis from the following | |
|
By reporting side effects, you can help provide more information on the |
organisation: |
|
safety of this medicine. |
Pancreatitis Supporters Network PO Box 8938, Birmingham B13 9FW. |
|
How to store Creon 40000 | |
|
How and where to keep your capsules * Keep out of the sight and reach of children. * Do not store above 25°C * Keep container tightly closed. 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. * If the medicine becomes discoloured or shows any other signs of | |
|
deterioration, you should seek the advice of your pharmacist who will tell you what to do. | |
|
* 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. |