Creon Micro Pancreatin 60.12mg Gastro-Resistant Granules
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By rajeevkumarj at 12:54 pm, May 12,2015
Assessed against UK PIL dated March 2015
S1665 LEAFLET Creon 20150428
PACKAGE LEAFLET: INFORMATION FOR THE USER CREON MICRO PANCREATIN 60.12MG GASTRO-RESISTANT GRANULES
(pancreatin)
Your medicine is known as Creon Micro Pancreatin 60.12mg
Gastro-Resistant Granules but will be referred to as Creon Micro
throughout the following leaflet.
Important things you SHOULD know about Creon Micro
- Creon Micro 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 Micro with a meal or a snack and provide plenty of water.
- Do not give Creon Micro if the patient is allergic to pork, any pig product or any of the ingredients of Creon Micro (listed in section 6).
- If the patient experiences severe abdominal pain while taking Creon Micro, contact a doctor immediately.
- Most people do not have problems taking Creon Micro 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.
tAOCK-lAP
How does Creon Micro work?
The enzymes in Creon Micro work by digesting food as it passes through the gut. So you must give Creon Micro with a meal or a snack. This will allow the enzymes to mix thoroughly with the food.
2. BEFORE YOU GIVE CREON MICRO
Do not give Creon Micro if:
- The patient is allergic (or hypersensitive) to pork, any pig product or any of the ingredients of Creon Micro (listed in section 6).
If the above applies to the patient, do not give Creon Micro. Talk to the doctor or dietician again.
When you need to take special care with Creon Micro
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 Micro can be used while breast feeding)
Please tell the doctor, dietician, or pharmacist if you think that the patient should not take Creon Micro for any other reason.
If the patient drives or uses machinery
It is unlikely that Creon Micro will affect the patient's ability to drive or operate tools or machines.
3. HOW TO GIVE CREON MICRO
How to find the information you need
1. About Creon Micro
What Creon Micro is and how it works.
2. Before you give Creon Micro
Who can take Creon Micro?
Can you take Creon Micro if you are pregnant or breastfeeding?
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 Micro
How and where to keep this medicine.
6. Further information
The ingredients in Creon Micro.
More information about cystic fibrosis and pancreatitis.
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 100 mg (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 Micro works in your body.
- Do not hold Creon Micro in your mouth.
- Do not store the mixture.
1. ABOUT CREON MICRO
What is Creon Micro
- Creon Micro 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 Micro granules contain a mixture of the natural enzymes which are used to digest food.
- The enzymes are taken from pig pancreas glands.
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 Micro works in the body.
- Do not store the mixture.
5. HOW TO STORE CREON MICRO
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 Micro 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 the patient too much Creon Micro
If you give the 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 Micro 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 Micro - 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 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 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. Store in the original container.
• Keep the container tightly closed to protect from moisture.
The enzymes in Creon Micro 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 Creon Micro within 3 months of opening the container.
• Do not give Creon Micro capsules after the expiry date on the container.
• Return all unused medicine to your pharmacist.
6. FURTHER INFORMATION
What Creon Micro contains
• The active ingredient in Creon Micro is pancreatin.
One measure (100mg) of gastro-resistant granules contains pancreatin 60.12mg equivalent to the following enzymes:
- Lipase 5,000 PhEur Units;
- Amylase 3,600 PhEur Units;
- Protease 200 PhEur Units.
• The granules are coated with a mixture of the following ingredients: cetyl alcohol, triethyl citrate, dimeticone 1000, macrogol 4000, and hypromellose phthalate.
What Creon Micro looks like and contents of the pack
Creon Micro granules are round, light-brown gastro-resistant granules.
The bottle contains 20 grams of granules (about 200 measures). Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1Dx.
Manufacturer
This product is manufactured by Abbott Laboratories GmbH, Freundallee 9A, 30173 Hannover, Germany.
[P] PL No: 19488/1665
Leaflet revision date: 28 April 2015
Creon is a registered trade mark of Abbott Healthcare Products Ltd, UK.
S1665 LEAFLET Creon 20150428
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.