SUMMARY CMI

CREON^® 10,000, CREON^® 25,000, CREON^® 35,000

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using CREON?

CREON contains the active ingredient Pancreatic extract. CREON is used in a condition called pancreatic exocrine insufficiency where the body does not make enough enzymes to digest food.

For more information, see Section 1. Why am I using CREON? in the full CMI.

2. What should I know before I use CREON?

Do not use if you have ever had an allergic reaction to CREON or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use CREON? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CREON and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use CREON?

• Your doctor will tell you how many capsules to take to suit your particular needs. Do not increase the number of capsules yourself without informing your doctor.
• Swallow the capsules whole with a full glass of water or, if you prefer, open the capsules and mix the granules with soft food.

More instructions can be found in Section 4. How do I use CREON? in the full CMI.

5. What should I know while using CREON?

For more information, see Section 5. What should I know while using CREON? in the full CMI.

6. Are there any side effects?

Speak to your doctor if you experience stomach or bowel problems, including diarrhoea, constipation, abnormal stools, abdominal discomfort, nausea and skin reactions. Seek immediate medical attention if you experience severe or prolonged abdominal pain. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

CREON^® 10,000, CREON^® 25,000, CREON^® 35,000

Active ingredient(s): Pancreatic extract

Consumer Medicine Information (CMI)

This leaflet provides important information about using CREON 10,000, CREON 25,000 and CREON 35,000. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CREON. Please read this leaflet before you start taking CREON capsules. If you are helping someone else to take Creon capsules, please read this leaflet before you give the first dose.

Where to find information in this leaflet:

1. Why am I using CREON?
2. What should I know before I use CREON?
3. What if I am taking other medicines?
4. How do I use CREON?
5. What should I know while using CREON?
6. Are there any side effects?
7. Product details

1. Why am I using CREON?

CREON contains the active ingredient Pancreatic extract. CREON is a pancreatic enzyme supplement.

CREON is used in a condition called pancreatic exocrine insufficiency where the body does not make enough enzymes to digest food. This condition appears in a number of different patients including those with cystic fibrosis, chronic pancreatitis, or patients who have had upper gastrointestinal surgery. People with a deficiency of pancreatic enzymes often suffer with symptoms of diarrhoea, steatorrhoea (foul fatty stools which float in the toilet), bloating and weight loss. These symptoms appear because the body is unable to digest food normally.

When this happens your body's ability to absorb important nutrients from food is impaired and leads to malnutrition. If left untreated these symptoms can affect your quality of life and a poor nutritional status could have long term health implications. The supplementation of pancreatic enzymes using CREON helps restore the normal digestive action in your body to relieve abdominal symptoms and improve nutritional status.

The enzymes are extracted from pancreas of pigs.

CREON capsules are approved for the uses listed above. However, your doctor may prescribe this medicine for another use. If you would like more information, ask your doctor.

CREON 25,000 and CREON 35,000 cannot be obtained without a doctor's prescription.

There is no evidence that CREON capsules are addictive.

2. What should I know before I use CREON?

Warnings

Do not use CREON if:

• you are allergic to pork, other pig products, or any of the ingredients listed at the end of this leaflet.
• always check the ingredients to make sure you can use this medicine.
• the packaging is torn or shows signs of tampering, or if the capsules do not look quite right.
• the expiry date has passed, it may not work as well.

Check with your doctor if you:

• are allergic to any other medicines or any foods, dyes or preservatives.
• take any medicines for any other condition
• are pregnant, planning to become pregnant, are breast feeding or intend to breast feed.

Your doctor will discuss whether you should take these products.

If you have not told your doctor about any of the above, tell them before you take CREON capsules.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with CREON and affect how it works.

You should avoid taking antacids, which are medicines that are used to treat heartburn and indigestion, when taking CREON capsules. Antacids may affect how well CREON capsules work by breaking down the special coating used to protect the pancreatic enzymes. If it is necessary to take an antacid, then it should be taken at least one hour before you take your CREON capsules.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CREON.

4. How do I use CREON?

How much to take

• Follow all directions given to you by your doctor carefully.
• Your doctor will tell you how many capsules to take to suit your particular needs. Do not increase the number of capsules yourself without informing your doctor.
• For children and adolescents with cystic fibrosis, your doctor will have determined a dose specific to the patient's body weight and condition.
• For adult patients starting CREON for the first time, the usual starting dose is 25 000 to 40 000 units of lipase with each meal and half this dose with snacks. Your doctor may need to make a number of adjustments before determining the right dose which suits you best. If needed, the dose can be increased up to 80,000 units of lipase with each meal.
• It is normally not necessary to restrict your diet of fat while you are taking CREON as your symptoms will usually be under control. In people with malnutrition, getting enough fat in the diet will help improve nutrition. If unsure, you should consult your doctor or dietitian regarding your diet whilst on CREON.
• If the doctor advises you to increase the dosage, you should increase the number of capsules gradually (for example, by one at a time). A very rapid increase in dosage may lead to constipation. If you are unsure how to increase the dose, ask your doctor or pharmacist to explain it to you.
• The maximum recommended dose of lipase in infants and children with cystic fibrosis is 10,000 units per kilogram body weight in 24 hours.
• Patients who use more than 10,000 units per kilogram per day, will probably be monitored closely by their doctor.
• Follow the instructions provided and use CREON until your doctor tells you to stop.

When to take

• Take CREON capsules with every meal and snack.

How to take CREON

• Swallow the capsules whole with a full glass of water or, if you prefer, open the capsules and mix the granules with soft food.
• If you mix the granules with food, it is important to swallow the mixture straight away, without chewing.
• Neither the capsules nor the granules inside should be chewed as they have a special coating to stop them dissolving until they have gone through the stomach and into the intestines where they work.
• When you are taking CREON capsules, it is important to make sure that you drink plenty of liquid every day.

If you forget to use CREON

CREON should be used regularly at the same time each day. If you miss your dose at the usual time, wait until your next meal or snack and take your usual number of capsules.

Do not take a double dose to make up for the dose you missed.

If you have trouble remembering when to take your medicine, ask your pharmacist for hints.

If you use too much CREON

If you think that you have used too much CREON, you may need urgent medical attention.

You should immediately:

• Drink plenty of water and
• phone the Poisons Information Centre
  (Australia telephone 13 11 26) for advice, or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using CREON?

Things you should do

Drink plenty of water every day when you are taking CREON capsules.

Follow your doctor's instructions carefully and do not stop taking the capsules unless told to do so by your doctor.

Call your doctor straight away if you:

• are still having problems with fatty stools or abdominal pain while you are taking CREON capsules.

Remind any doctor, dentist or pharmacist you visit that you are using CREON.

Things you should not do

• Do not give CREON capsules to anyone else, even if they have the same condition as you.
• Do not use this medicine for any purpose other than for the purpose it has been recommended for you.
• Do not use more than the recommended amount.
• Do not stop taking your medicine until your doctor tells you to do so.
• Do not let yourself run out of medicine unless told to do so by your doctor.

Things that may help your condition

• Diet should be considered as part of your overall management plan. Talk to your doctor for more information and advice.

Driving or using machines

CREON has no influence on the ability to drive and use machines.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• Keep your capsules in the bottle until it is time to take them.
• If you take the capsules out of the bottle they may not keep well.
• Keep your CREON capsules in a cool dry place where the temperature stays below 25°C. Please note that in warmer climates it may be necessary to store CREON capsules in the refrigerator. After opening use within 6 months.

Follow the instructions in the carton on how to take care of your medicine properly.

A locked cupboard at least one-and half metres above the ground is a good place to store medicines.

Heat and dampness can destroy some medicines.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine (as relevant)

After opening use within 6 months.

If your doctor tells you to stop taking CREON capsules, or the capsules have passed their expiry date, ask your pharmacist what to do with any that are left over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

The active ingredient in CREON capsules is an extract of pancreatic powder of porcine origin (pigs), therefore the presence of porcine parvovirus or other porcine viruses cannot be totally excluded. However, there is no evidence of transmission of these viruses to humans or of porcine pancreatic powder extracts causing illness in humans.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What CREON contains

Do not take this medicine if you are allergic to any of these ingredients.

What CREON looks like

CREON 10,000 is a dark brown/colourless capsule containing small brownish coloured granules (minimicrospheres) that have a special coating. Available in bottles of 100 capsules (AUST R 158453).

CREON 25,000 is a light brown/colourless capsule containing small brownish coloured granules (minimicrospheres) that have a special coating. Available in bottles of 100 capsules (AUST R 158452).

CREON 35,000 is a red brown/colourless capsule containing small brownish coloured granules (minimicrospheres) that have a special coating. Available in bottles of 100 capsules (AUST R 313833).

Who distributes CREON

Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in February 2023.

CREON^® is a Viatris company trade mark

CREON_cmi\Feb23/00

Published by MIMS April 2023

1 Name of Medicine

Pancreatic extract.

2 Qualitative and Quantitative Composition

Creon 10,000, 20,000, 25,000, 35,000 and 40,000 are porcine pancreatic enzyme preparations containing pancreatic extract encapsulated in minimicrospheres with a pH-sensitive coating.
Each Creon 10,000 capsule contains pancreatic extract 150 mg equivalent to not less than 10,000 Ph.Eur. units lipase, 8,000 Ph.Eur. units amylase and 600 Ph.Eur. units protease.
Each Creon 20,000 capsule contains pancreatic extract 300 mg equivalent to not less than 20,000 Ph.Eur. units lipase, 16,000 Ph.Eur. units amylase and 1,200 Ph.Eur. units protease.
Each Creon 25,000 capsule contains pancreatic extract 300 mg equivalent to not less than 25,000 Ph.Eur. units lipase, 18,000 Ph.Eur. units amylase and 1,000 Ph.Eur. units protease.
Each Creon 35,000 capsule contains pancreatic extract 420 mg equivalent to not less than 35,000 Ph.Eur. units lipase, 25,200 Ph.Eur. units amylase and 1,400 Ph.Eur. units protease.
Each Creon 40,000 capsule contains pancreatic extract 400 mg equivalent to not less than 40,000 Ph.Eur. units lipase, 25,000 Ph.Eur. units amylase and 1,600 Ph.Eur. units protease.
See Table 1.

Excipients with known effect.

3 Pharmaceutical Form

Creon 10,000.

Creon 20,000.

Creon 25,000.

Creon 35,000.

Creon 40,000.

4 Clinical Particulars

4.1 Therapeutic Indications

Creon is indicated as pancreatic enzyme replacement in paediatric and adult patients with pancreatic exocrine insufficiency (PEI).
Pancreatic exocrine insufficiency is often associated with, but not limited to:
cystic fibrosis;
chronic pancreatitis;
pancreatic surgery;
gastrointestinal bypass surgery (e.g. Bilroth II gastroenterostomy);
ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm).

4.2 Dose and Method of Administration

The capsules should be swallowed without crushing or chewing, with enough fluid during or after each meal or snack. When swallowing of capsules is difficult (e.g. small children or elderly patients), the capsules may be carefully opened and the minimicrospheres added to acidic soft food such as apple sauce, mashed bananas, or yoghurt or fruit juice with a pH less than 5.5 that does not require chewing, or the minimicrospheres will be taken with liquid such as fruit juice with a pH less than 5.5 for example apple, orange or pineapple juice. Any mixture of the minimicrospheres with food or liquids should be used immediately and should not be stored.
Crushing and chewing of the minimicrospheres or mixing with food or fluid with a pH greater than 5.5 can disrupt the protective enteric coating. This can result in early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes.
Care should be taken to ensure no product is retained in the mouth.
Based upon Australasian Clinical Practice Guidelines for nutrition in Cystic Fibrosis 2006, the key goal of pancreatic enzyme replacement therapy is to improve the patient's nutritional status and growth as well as controlling the symptoms of maldigestion (e.g. steatorrhoea). This is achieved through optimal dietary intake using a diet without restriction of fat content (> 100 g fat per day if over five years of age), unless the patient is overweight. The dose of Creon required is adjusted according to the fat content of the meal and the severity of the disease.
See Tables 2 and 3.
Agents which increase gastric pH, such as H₂-antagonists and proton pump inhibitors, have been reported to increase the activity of administered pancreatic lipase and may be helpful in patients who do not achieve adequate response to pancreatic enzyme therapy.
This is not an approved indication for these agents. Prescribers should decide, on the basis of published evidence, whether or not to use them in this way.
It is important to ensure adequate hydration at all times, especially during periods of increased loss of fluids. Inadequate hydration may aggravate constipation.

4.3 Contraindications

Creon capsules are contraindicated in patients who are known to be hypersensitive to porcine protein or any of the ingredients.

4.4 Special Warnings and Precautions for Use

Fibrosing colonopathy.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Antacids should not be taken concomitantly with Creon as the alkaline pH may break down the enteric coating. Should antacid administration be considered necessary, it is recommended that at least one hour elapse between the intake of antacids and any Creon.
No interaction studies have been performed.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Creon has no influence on the ability to drive and use machinery.

4.8 Adverse Effects (Undesirable Effects)

In clinical trials, more than 1000 patients with pancreatic exocrine insufficiency due to cystic fibrosis, chronic pancreatitis, and pancreatic surgery were exposed to Creon.

Adverse events reported from clinical trials.

Adverse reactions.

Post-marketing.

Other patient populations.

Paediatric population.

Reporting suspected adverse effects.

4.9 Overdose

Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and hyperuricaemia.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Efficacy studies.

Studies in other diseases.

5.2 Pharmacokinetic Properties

Animal studies showed no evidence for absorption of intact enzymes and therefore classical pharmacokinetic studies have not been performed. Pancreatic enzyme supplements do not require absorption to exert their effects. On the contrary, their full therapeutic activity is exerted from within the lumen of the gastrointestinal tract. Furthermore, they are proteins, and as such undergo proteolytic digestion while passing along the gastrointestinal tract before being absorbed as peptides and amino acids.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Creon 10,000: macrogol 4000, hypromellose phthalate, dimeticone 1000, cetyl alcohol, triethyl citrate, gelatin, iron oxide red, iron oxide black, iron oxide yellow, titanium dioxide and sodium lauryl sulfate.
Creon 20,000: macrogol 4000, hypromellose phthalate, dimeticone 1000, cetyl alcohol, triethyl citrate, gelatin, iron oxide red, iron oxide black, iron oxide yellow, titanium dioxide and sodium lauryl sulfate.
Creon 25,000: macrogol 4000, hypromellose phthalate, cetyl alcohol, triethyl citrate, dimeticone 1000, gelatin, iron oxide red, iron oxide yellow and sodium lauryl sulfate.
Creon 35,000: macrogol 4000, hypromellose phthalate, dimeticone 1000, cetyl alcohol, triethyl citrate, gelatin, iron oxide red, iron oxide black, iron oxide yellow, titanium dioxide and sodium lauryl sulfate.
Creon 40,000: macrogol 4000, hypromellose phthalate, cetyl alcohol, triethyl citrate, dimeticone 1000, gelatin, iron oxide, titanium dioxide and sodium lauryl sulfate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.
In warmer climates, it may be necessary to store the product in the refrigerator.
Use within 6 months after opening.
Keep out of reach of children.

6.5 Nature and Contents of Container

Container Type: HDPE bottles.
Pack Sizes: 20 (Creon 40,000 only), 50 (Creon 40,000 only) or 100 capsules.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian register of therapeutic goods (ARTG).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Creon 25,000, Creon 35,000 and Creon 40,000: Schedule 4.
Creon 10,000 and Creon 20,000: Not Scheduled.

Summary Table of Changes