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CREON 10000 CAPSULES - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - CREON 10000 CAPSULES

Creon® 10000 Capsules

(pancreatin)

Patient Information Leaflet

Your medicine is called Creon 10000 Capsules but will be referred to as Creon 10000 throughout this Patient Information Leaflet.

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 during or immediately after 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.

How to find the information you need

0 About Creon 10000

What Creon 10000 is and how it works.

0 Before you take Creon 10000

Who can take Creon 10000?

Can you take Creon 10000 if you are pregnant or breast feeding?

Driving or operating machinery.

0

How to take Creon 10000

How much Creon 10000 you should take.

When you should take Creon 10000.

How you should take Creon 10000.

What to do if you take too much Creon 10000.

What to do if you forget a dose.

Q

Possible side effects

Abdominal symptoms (such as abdominal pain).

Side effects and what to do if you get them.

0

How to store Creon 10000

How and where to keep your capsules.

A Further Information

The ingredients in Creon 10000.

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.

O About Creon 10000

What is Creon 10000

  • Creon 10000 is a 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 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.

0 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.

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’

0

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 during or immediately after eating a meal or a snack and drink plenty of water (see section 1).

How to take Creon 10000

Creon® 10000 Capsules

(pancreatin)

Patient Information Leaflet (continued)

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.

O 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).

What this medicine looks like and contents of the pack

They are brown and clear capsules containing gastro-resistant granules.

Available in bottles of 100 capsules.

Manufacturer and Licence Holder

The capsules are manufactured by Abbott Laboratories GmbH, 31535 Neustadt A. Rbge, Germany and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

[P] 15184/0534

Creon is a registered trademark of Abbott Products GmbH.

Revision date: 13/04/21

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you

O How to store Creon 10000

How and where to keep your capsules

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

Do not store above 30°C.

Keep in the original container. Keep 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 packaging.

If your doctor tells you to stop taking this medicine, return any unused capsules to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.

If your capsules become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

A ALIMENTARY TRACT AND METABOLISM DRUGS

A09 DIGESTIVES, INCL. ENZYMES

A09A DIGESTIVES, INCL. ENZYMES

A09AA Enzyme preparations, digestives

A09AA02 multienzymes (lipase, protease etc.)

Frequently Asked Questions

What is CREON 10000 and how does it work?

CREON 10000 is a prescription medication that contains digestive enzymes like lipase, protease, and amylase. It helps people with pancreatic insufficiency digest food properly.

Who should take CREON 10000 capsules?

CREON 10000 is typically prescribed for patients with conditions that affect the pancreas, such as cystic fibrosis, chronic pancreatitis, or pancreatic cancer.

What are the common side effects of CREON 10000?

Some common side effects may include abdominal discomfort, bloating, gas, or diarrhea. If you experience severe symptoms, consult your doctor immediately.

How should I take CREON 10000 capsules?

Take CREON 10000 capsules with meals to help digest food effectively. Swallow the capsules whole; do not crush or chew them.

Can I open CREON 10000 capsules and mix them with food?

Yes, you can open the capsules and sprinkle the contents on soft food or applesauce, but avoid mixing it with hot foods.

Is CREON 10000 safe for children?

CREON 10000 is sometimes prescribed for children but always under the guidance of a healthcare provider. Dosing will depend on the child's needs.

How do I know if CREON 10000 is working for me?

You should notice improved digestion, reduced bloating, and less discomfort after eating when taking CREON 10000 as prescribed.

What should I do if I miss a dose of CREON 10000?

If you miss a dose of CREON 10000, take it as soon as you remember during your meal. If it's almost time for your next dose, skip the missed one and continue as usual.

Can I take CREON 10000 if I am pregnant or breastfeeding?

Discuss with your doctor if you are pregnant or breastfeeding before taking CREON 10000 to ensure it's safe for you and your baby.

Are there any foods I should avoid while taking CREON 10000?

There are no specific foods to avoid while taking CREON 10000, but it's essential to maintain a balanced diet. Your healthcare provider may give personalized dietary advice.

How should I store CREON 10000 capsules?

Store CREON 10000 capsules at room temperature in a dry place away from light. Keep them out of reach of children.

Can I take other medications while on CREON 10000?

Some medications may interact with CREON 10000. Always inform your doctor about all medications and supplements you are taking.

What happens if I take too much CREON 10000?

Taking too much CREON can lead to an overdose which may cause severe digestive issues. Seek medical attention if you suspect an overdose.

Is it normal to have changes in bowel movements while taking CREON 10000?

Yes, changes in bowel movements can occur while adjusting to treatment with CREON. Monitoring these changes is crucial; consult your doctor if they persist.

Can I drink alcohol while taking CREON 10000?

Moderate alcohol consumption may be acceptable for some patients on CREON; however, consult your physician for personalized advice based on your health status.

Are there any lifestyle changes I need to make while using CREON 10000?

Adopting a healthy diet that includes a balance of nutrients may improve treatment outcomes while using CREON. Your healthcare provider can offer tailored recommendations.

How long will I need to take CREON 10000?

The duration of treatment with CREON varies per individual needs; some may require long-term use based on their underlying condition.

What should I do if my symptoms don’t improve with CREON 10000?

If symptoms persist or worsen despite taking CREON as directed, contact your healthcare provider for further evaluation and possible adjustments in treatment.

Is there a difference between different strengths of CREON (like CREON 5000 vs. Creon 10,000)?

Yes, the difference lies in the enzyme content per capsule. Your doctor will prescribe the appropriate strength based on your specific needs for effective digestion.