Creon Micro Granules
Important things you SHOULD know about Creon
Patient Information Leaflet
Creon® micro granules
(pancreatin)
The name of your medicine is Creon micro granules but will be referred as Creon or Creon micro throughout this leaflet.
Creon is a pancreatic enzyme supplement for people whose bodies do not make enough enzymes to digest their food.
Give the amount of granules prescribed by your doctor.
Give Creon with a meal or a snack and provide plenty of water. Do not give Creon if the patient is allergic to pork, any pig product or any of the ingredients of Creon (listed in section 6).
If the patient experience severe abdominal pain while taking Creon, contact a doctor immediately.
Most people do not have problems taking Creon but side effects can occur (see section 4).
Please read the rest of this leaflet carefully before you start giving these granules.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask a doctor or pharmacist.
- Do not pass it on to others. It may harm them, even if their symptoms are the same.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell a doctor or pharmacist.
How to find the information you need
1. About Creon
What Creon is and how it works.
2. Before you give Creon
Who can take Creon?
Can you take Creon if you are pregnant or breast-feeding? Driving or operating machinery.
3. How to give Creon Micro
How much Creon Micro you should give.
When you should give Creon Micro.
How you should give Creon Micro.
What to do if you give too much Creon Micro.
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 the patient gets them.
5. How to store Creon
How and where to keep this medicine.
6. Further Information The ingredients in Creon.
More information about cystic fibrosis and pancreatitis.
1. About Creon
What is Creon
Creon is a pancreatic enzyme supplement.
Pancreatic enzyme supplements are used by people whose bodies t not make enough of their own enzymes to digest their food.
2. Before you give Creon
3. How to give Creon Micro
Creon micro contain a mixture of the natural enzymes which are used to digest food.
The enzymes are taken from pig pancreas glands.
How does Creon work?
The enzymes in Creon work by digesting food as it passes through the gut. So you must give Creon with a meal or a snack. This will allow the enzymes to mix thoroughly with the food.
Do not give Creon if:
The patient is allergic (or hypersensitive) to pork, any pig product or any of the ingredients of Creon (listed in section 6).
If the above applies to the patient, do not give Creon. Talk to the 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 the doctor, if:
you are pregnant or trying to get pregnant (Creon can be used while breast-feeding)
Please tell the doctor, dietician, or pharmacist if you think that the patient should not take Creon for any other reason.
If the patient drives or uses machinery
It is unlikely that Creon will affect the patient’s ability to drive or operate tools or machines.
How much Creon Micro to give
Always follow the doctor or dietician’s advice on how many granules to give.
The usual starting dose is 100mg (one measure). The maximum amount you may give should not be greater than 10,000 units lipase/kg/day.
If the doctor advises you to increase the dose you give, you should do so slowly. If the patient still has fatty stools or abdominal pain, talk to the doctor or dietician.
When to give Creon Micro
Always give Creon Micro with a meal or a snack and provide plenty of water (see section 1).
How to take Creon Micro
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 in your mouth.
Do not store the mixture.
How to give Creon Micro to babies and infants
Mix the granules (without crushing) with a small amount of apple juice and give from a spoon directly before the feed.
Alternatively mix the granules on a spoon (without crushing) with a small amount of baby’s usual milk and give to the infant immediately.
Do not add the granules to the baby’s bottle.
Make sure the infant swallows all the granules immediately and none are left in the mouth.
Provide plenty of liquid every day.
Mixing with non-acidic food or liquid, crushing or chewing of the pellets may cause mouth irritation or change the way Creon works in the body. Do not store the mixture.
Weaned infants
Mix the granules (without crushing) with acidic liquid (e.g. apple, orange or pineapple juice) or soft food (e.g. apple sauce or yoghurt). Alternatively mix the granules on a spoon (without crushing) with a small amount of baby’s usual milk and give to the infant immediately.
Do not add the granules to the baby’s bottle.
Make sure the infant swallows all the granules immediately, without chewing and none are left in the mouth.
Provide plenty of liquid every day.
Mixing with non-acidic food or liquid, crushing or chewing of the pellets may cause mouth irritation or change the way Creon works in the body. Do not store the mixture.
How long to give Creon Micro
You should keep giving the medicine until the doctor tells you to stop. Many patients will need to take pancreatic enzyme supplements for the rest of their lives.
If you give patient too much Creon Micro
If you give patient too much Creon Micro, he/she should drink plenty of water and see the doctor immediately.
If you forget a dose
If you forget to give the medicine, wait until the next meal and give the usual dose. Do not try to make up for the dose that you have missed. Just give the next dose at the usual time.
4. Possible side effects
Like all medicines, Creon can cause side effects (unwanted effects or reactions), but not everyone gets them.
If the patient has severe or long-lasting abdominal pain, contact the doctor immediately.
If you notice any unusual abdominal symptoms while taking Creon-contact the doctor.
Very common side effects (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 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.aov.uk/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Creon
How and where to keep the medicine
- Keep out of the sight and reach of children- preferably locked in a cupboard or medicine cabinet.
- Do not store above 25°C.
- Keep the container tightly closed to protect from moisture.
- Store in the original container.
The enzymes in Creon are natural products and their ability to digest food decreases overtime. If the container is left in warm conditions (e.g. the glove compartment of a car), the digestive activity decreases faster.
- Use Creon within 12 weeks of opening the container.
- Do not take your medicine after the expiry date which is stated on the carton or bottle label after ‘Exp’. The expiry date refers to the last day of that month.
- If your medicine becomes discoloured or show any signs of deterioration, seek the advice of your pharmacist.
- Remember if your doctor tells you to stop taking this medicine, return any unused granules to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
6. Further information
What Creon contains
The active ingredient in Creon is pancreatin.
Each scoop measure contains 100mg.
One measure of 100mg contains gastro-resistant granules of pancreatin, equivalent to the following list of enzymes:
(Ph.Eur. Units per 100mg)
The other ingredients are macrogol 4000, hypromellose phthalate, cetyl alcohol, triethyl citrate and dimeticone 1000.
What Creon looks like and the contents of the pack
Creon micro are round, light-brown gastro-resistant granules in a glass bottle with a scoop measure and are available as bottles of 20g (containing about 200 measures).
Manufactured by: Abbott Products GmbH, Hans-Bockler-Allee 20, 30173 Hannover, Germany. AND/OR
Abbott Laboratories GmbH, Freundallee 9A, 30173 Hannover, Germany Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
Creon® micro granules PL 18799/2788 p
Important things you SHOULD know about Pancreatin
Patient Information Leaflet
Pancreatin 60.12mg gastro-resistant granules
The name of your medicine is Pancreatin 60.12mg gastro-resistant granules but will be referred to as Pancreatin or Pancreatin granules throughout this leaflet._
Pancreatin is a pancreatic enzyme supplement for people whose bodies do not make enough enzymes to digest their food.
Give the amount of granules prescribed by your doctor.
Give Pancreatin with a meal or a snack and provide plenty of water.
Do not give Pancreatin if the patient is allergic to pork, any pig product or any of the ingredients of Pancreatin (listed in section 6).
If the patient experience severe abdominal pain while taking Pancreatin, contact a doctor immediately.
Most people do not have problems taking Pancreatin but side effects can occur (see section 4).
Please read the rest of this leaflet carefully before you start giving these granules.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask a doctor or pharmacist.
- Do not pass it on to others. It may harm them, even if their symptoms are the same.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell a doctor or pharmacist.
How to find the information you need
1. About Pancreatin
What Pancreatin is and how it works.
2. Before you give Pancreatin
Who can take Pancreatin?
Can you take Pancreatin if you are pregnant or breast-feeding? Driving or operating machinery.
3. How to give Pancreatin
How much Pancreatin you should give.
When you should give Pancreatin.
How you should give Pancreatin.
What to do if you give too much Pancreatin.
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 the patient gets them.
5. How to store Pancreatin
How and where to keep this medicine.
6. Further Information
The ingredients in Pancreatin.
More information about cystic fibrosis and pancreatitis._
1. About Pancreatin
What is Pancreatin
Pancreatin is a pancreatic enzyme supplement.
Pancreatic enzyme supplements are used by people whose bodies t not make enough of their own enzymes to digest their food.
2. Before you give Pancreatin
3. How to give Pancreatin
Pancreatin contain a mixture of the natural enzymes which are used to digest food.
The enzymes are taken from pig pancreas glands.
How does Pancreatin work?
The enzymes in Pancreatin work by digesting food as it passes through the gut. So you must give Pancreatin with a meal or a snack. This will allow the enzymes to mix thoroughly with the food.
Do not give Pancreatin if:
The patient is allergic (or hypersensitive) to pork, any pig product or any of the ngredients of Pancreatin (listed in section 6).
If the above applies to the patient, do not give Pancreatin. Talk to the doctor or dietician again.
When you need to take special care with Pancreatin
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 the doctor, if:
you are pregnant or trying to get pregnant (Pancreatin can be used while breast-feeding)
Please tell the doctor, dietician, or pharmacist if you think that the patient should not take Pancreatin for any other reason.
If the patient drives or uses machinery
It is unlikely that Pancreatin will affect the patient’s ability to drive or operate tools or machines.
How much Pancreatin to give
Always follow the doctor or dietician’s advice on how many granules to give.
The usual starting dose is 100mg (one measure). The maximum amount you may give should not be greater than 10,000 units lipase/kg/day.
If the doctor advises you to increase the dose you give, you should do so slowly. If the patient still has fatty stools or abdominal pain, talk to the doctor or dietician.
When to give Pancreatin
Always give Pancreatin with a meal or a snack and provide plenty of water (see section 1).
How to take Pancreatin
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 Pancreatin works in your body.
Do not hold Pancreatin in your mouth.
Do not store the mixture.
How to give Pancreatin to babies and infants
Mix the granules (without crushing) with a small amount of apple juice and give from a spoon directly before the feed.
Alternatively mix the granules on a spoon (without crushing) with a small amount of baby’s usual milk and give to the infant immediately.
Do not add the granules to the baby’s bottle.
Make sure the infant swallows all the granules immediately and none are left in the mouth.
Provide plenty of liquid every day.
Mixing with non-acidic food or liquid, crushing or chewing of the pellets may cause mouth irritation or change the way Pancreatin works in the body.
Do not store the mixture.
Weaned infants
Mix the granules (without crushing) with acidic liquid (e.g. apple, orange or pineapple juice) or soft food (e.g. apple sauce or yoghurt). Alternatively mix the granules on a spoon (without crushing) with a small amount of baby’s usual milk and give to the infant immediately.
Do not add the granules to the baby’s bottle.
Make sure the infant swallows all the granules immediately, without chewing and none are left in the mouth.
Provide plenty of liquid every day.
Mixing with non-acidic food or liquid, crushing or chewing of the pellets may cause mouth irritation or change the way Pancreatin works in the body.
Do not store the mixture.
How long to give Pancreatin
You should keep giving the medicine until the doctor tells you to stop. Many patients will need to take pancreatic enzyme supplements for the rest of their lives.
If you give patient too much Pancreatin
If you give patient too much Pancreatin , he/she should drink plenty of water and see the doctor immediately.
If you forget a dose
If you forget to give the medicine, wait until the next meal and take the usual dose. Do not try to make up for the dose that you have missed. Just give the next dose at the usual time.
4. Possible side effects
Like all medicines, Pancreatin can cause side effects (unwanted effects or reactions), but not everyone gets them.
If the patient has severe or long-lasting abdominal pain, contact the doctor immediately.
If you notice any unusual abdominal symptoms while taking Pancreatin-contact the doctor.
Very common side effects (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 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.aov.uk/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Pancreatin
How and where to keep the medicine
- Keep out of the sight and reach of children- preferably locked in a cupboard or medicine cabinet.
- Do not store above 25°C.
- Keep the container tightly closed to protect from moisture.
- Store in the original container.
The enzymes in Pancreatin 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.
- Use Pancreatin within 12 weeks of opening the container.
- Do not take your medicine after the expiry date which is stated on the carton or bottle label after ‘Exp’. The expiry date refers to the last day of that month.
- If your medicine becomes discoloured or show any signs of deterioration, seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this medicine, return any unused granules to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
6. Further information
What Pancreatin contains
The active ingredient in Pancreatin granules is pancreatin.
Each scoop measure contains 100mg.
One measure of 100mg contains gastro-resistant granules of pancreatin, equivalent to the following list of enzymes:
(Ph.Eur. Units per 100mg)
The other ingredients are macrogol 4000, hypromellose phthalate, cetyl alcohol, triethyl citrate and dimeticone 1000.
What Pancreatin looks like and the contents of the pack
Pancreatin granules are round, light-brown gastro-resistant granules in a glass bottle with a scoop measure and are available as bottles of 20g (containing about 200 measures).
Manufactured by: Abbott Products GmbH, Hans-Bockler-Allee 20, 30173 Hannover, Germany. AND/OR
Abbott Laboratories GmbH, Freundallee 9A, 30173 Hannover, Germany Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex,HA4 0NU, UK.
Pancreatin 60.12mg gastro-resistant granules fpl
PL 18799/2788 L—J
Leaflet date: 17.08.2015