Pancreatic Extract enteric coated minimicrospheres .

Each capsules contains
Lipase 10000 BP units
Amylase 8000 BP Units
Protease 600 Ph Eur Units
Consumer Medicine Information

What is in this leaflet
This leaflet answers some of the common questions about CREON 5000, CREON 10000 and CREON FORTE. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

Please read this leaflet before you start taking CREON 5000, CREON 10000 or CREON FORTE.

If you are helping someone else take CREON 5000, CREON or CREON FORTE, please read this leaflet before you give the first dose.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking CREON 5000, CREON 10000 or CREON FORTE against the benefits expected for you.

If you have any concerns about taking CREON 5000, CREON 10000 or CREON FORTE, ask your doctor or pharmacist.

Your doctor and pharmacist have more information.

Keep this leaflet with your CREON 5000, CREON 10000 or CREON FORTE.

You may need to read it again.

What CREON 5000, CREON 10000 and CREON FORTE are used for
CREON 5000, CREON 10000 and CREON FORTE are pancreatic enzyme supplements that are used by people whose bodies do not make enough enzymes to digest their food such as patients with cystic fibrosis or chronic pancreatitis; or patients who have had their pancreas removed or who have had gastrointestinal bypass surgery or suffer from ductal obstruction. The enzymes are extracted from pig pancreas.

CREON 5000, CREON 10000 and CREON FORTE 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 FORTE cannot be obtained without a doctor's prescription.

There is no evidence that CREON 5000, CREON 10000 or CREON FORTE is addictive.

Before you take CREON 5000, CREON 10000 or CREON FORTE
When you must not take it
Do not take CREON 5000, CREON 10000 or CREON FORTE if your doctor has told you that you have acute pancreatitis.

Do not take CREON 5000, CREON 10000 or CREON FORTE if you are allergic to pork, other pig products or any of the ingredients listed at the end of this leaflet.

Do not use CREON 5000, CREON 10000 or CREON FORTE after the expiry date (EXP) printed on the pack.

If you take this medicine after the expiry date has passed, it may not work as well.

Do not use CREON 5000, CREON 10000 or CREON FORTE if the packaging is torn or shows signs of tampering, or if the capsules do not look quite right.

Before you start to take it
You must tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives.

You must tell your doctor if you 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 use CREON 5000, CREON 10000 or CREON FORTE.

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

You should avoid taking antacids, which are medicines that are used to treat heartburn and indigestion, when taking CREON 5000, CREON 10000 or CREON FORTE. Antacids may affect how well CREON 5000, CREON 10000 and CREON FORTE 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 5000, CREON 10000 or CREON FORTE.

How to take CREON 5000, CREON 10000 or CREON FORTE
Follow all directions given to you by your doctor carefully.

These directions may differ from the information in this leaflet.
How much to take
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.

The usual starting dose for CREON 5000, CREON 10000 and CREON FORTE in adults (including the elderly) and children is one capsule with every meal and snack. Your doctor will probably adjust the number of capsules you are taking until the medicine is effective.

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 you doctor or pharmacist to explain it to you.

The maximum recommended dose of lipase in infants and children with cystic fibrosis is 20,000 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.

When to take it
Take CREON 5000, CREON 10000 or CREON FORTE with every meal or snack.

How to take it
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 5000, CREON 10000 or CREON FORTE, it is important to make sure that you drink plenty of liquid every day.

If you forget to take it
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 that you missed.

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

If you take too much (overdose)
If you, or anybody else, have taken too much CREON 5000, CREON 10000 or CREON FORTE, drink plenty of water and contact your doctor, pharmacist or the Poisons Information Centre (13 11 26), or go to the casualty department of the hospital nearest to you. Do this even if there are no signs of discomfort or poisoning.

While you are taking CREON 5000, CREON 10000 or CREON FORTE
Things you must do
Make sure you tell your doctor if you are still having problems with fatty stools or abdominal pain while you are taking CREON 5000, CREON 10000 or CREON FORTE.

Drink plenty of water every day when you are taking CREON 5000, CREON 10000 or CREON FORTE.

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

If you are about to start taking any new medicines, tell your doctor and pharmacist that you are taking CREON 5000, CREON 10000 or CREON FORTE.

Things you must not do
Do not give CREON 5000, CREON 10000 or CREON FORTE 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. Your doctor may advise you to watch the amount of fat in your diet.

Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking CREON 5000, CREON 10000 or CREON FORTE.

CREON 5000, CREON 10000 and CREON FORTE help most people whose bodies do not make enough enzymes to digest their food, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

stomach or bowel problems, including:
diarrhoea
constipation
abnormal stools
abdominal discomfort
nausea
skin reactions
Tell your doctor immediately if you have severe or prolonged abdominal pain.

Several children with cystic fibrosis who were taking high doses of pancreatic enzyme supplements have suffered from narrowing of the bowel and required an operation.

Tell your doctor if you notice any other symptom while you are taking CREON 5000, CREON 10000 or CREON FORTE.

In rare cases, people taking very high doses have had a tendency to develop high levels of uric acid in their blood and urine.

If you take too much CREON 5000, CREON 10000 or CREON FORTE you may get irritation or inflammation in the anal region.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

The active ingredient in Creon and Creon Forte 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.

After taking CREON 5000, CREON 10000 or CREON FORTE
Storage
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 5000, CREON 10000 and CREON FORTE in a cool dry place where the temperature stays below 25 degrees C. Please note that in warmer climates it may be necessary to store CREON 5000, CREON 10000 and CREON FORTE in the refrigerator.

Do not store it, or any other medicine, in the bathroom or near a sink.

Do not leave it in the car or on a window sill on hot days.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

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

Disposal
If your doctor tells you to stop taking CREON 5000, CREON 10000 or CREON FORTE, or the capsules have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description
What it looks like
CREON 5000 is a light brown/colourless capsule containing small brownish coloured granules (minimicrospheres) that have a special coating. Available in bottles of 100 capsules.

CREON 10000 is a dark brown/colourless capsule containing small brownish coloured granules (minimicrospheres) that have a special coating. Available in bottles of 100 capsules.

CREON FORTE is a light brown/colourless capsules containing small brownish coloured granules (minimicrospheres) that have a special coating. Available in bottles of 100 capsules.

Ingredients
Each CREON 5,000 capsule contains Pancreatin Extract 75 mg equivalent to not less than lipase 5,000 BP units, amylase 4,000 BP units and protease 300 Ph. Eur. units.

Each CREON 10000 capsule contains Pancreatin Extract 150mg equivalent to not less than lipase 10,000 BP units, amylase 8,000 BP units and protease 600 Ph. Eur. units.

Inactive ingredients in CREON 5000 & CREON 10000 capsules are: macrogol 4000, light liquid paraffin, hypromellose phthalate, dimethicone 1000, dibutyl phthalate, gelatin, iron oxide red (CI 77491), iron oxide black (CI 77499) [only in Creon 10,000] iron oxide yellow (CI 77492) and titanium dioxide.

Each CREON FORTE capsule contains Pancreatic Extract 300mg equivalent to not less than lipase 25,000 BP units, amylase 18,000 BP units and protease 1,000 Ph. Eur. units.

Inactive ingredients in CREON FORTE capsules are: macrogol 4000, light liquid paraffin, hypromellose phthalate, dimethicone 1000, dibutyl phthalate, gelatin, iron oxide red (CI 77491), iron oxide yellow (CI 77492) and titanium dioxide.

Sponsor
CREON 5000, CREON 10000 and CREON FORTE are manufactured in Germany for:

Solvay Pharmaceuticals
Level 1, Building 2, 20 Bridge Street
Pymble NSW 2073
A division of Solvay Biosciences Pty. Ltd.
Telephone: (02) 944 00 977
This leaflet was prepared in February 1999
Last Updated: 19 August 2003
Australian Registration Numbers:
CREON 5000: AUST R 80973
CREON 10000 AUST R 67949
CREON FORTE: AUST R 67248