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PATIENT INFORMATION LEAFLET

Creon® 10000 Capsules

(pancreatin)

Your medicine is known by the above name, but will be referred to as Creon 10000 throughout this leaflet.

This medicine is available in other strengths.

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.

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.

2. Before you take Creon 10000

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.

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.

How to store Creon 10000

How and where to keep your capsules

Keep all medicines out of the sight and reach of children.

Do not store above 30°C. Keep the 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.

If the capsules show signs of deterioration or discolouration you should seek the advice of your pharmacist who will tell you what to do.

Return all unused medicine to your pharmacist.

6. Further information

The ingredients in Creon 10000

The active ingredient in Creon 10000 is pancreatin. Each capsule contains enteric coated brownish coloured granules (minimicrospheres) containing pancreatin 150 mg, equivalent to:

List of Enzymes: (PhEur units per capsule)

Lipase 10,000 Amylase 8,000 Protease 600

Each capsule also contains: macrogol 4000, hypromellose phthalate, dimethicone 1000, cetyl alcohol, triethyl citrate, gelatin, iron (III) oxide anhydrous (E172), iron (III) oxide hydrate (E172), iron (II, III) oxide (E172), titanium dioxide (E171) and sodium lauryl sulphate.

What Creon 10000 looks like and the contents of the pack

Each hard gelatin capsule has a clear, colourless, body and a brown opaque cap with no markings.

Creon 10000 are available in a plastic container of 100 Capsules.

Who manufactured your medicine

Manufactured by Abbott Laboratories GmbH, Neustadt, Germany. Procured from within the EU and repackaged by Product Licence Holder Ennogen Healthcare Limited, Unit G4 Riverside Industrial Estate, Riverside Way, Dartford, Kent DA1 5BS.

PL 40739/0022

Leaflet date: 5 June 2015 [U Ref: Creo10/v2

Creon is a registered trademark of Abbott Products GmbH.

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.

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