Friday, September 16, 2016

Creon Micro







Creon Micro




Pancreatin 60.12 mg
Gastro-resistant Granules




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 the granules as prescribed by the 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 or 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 the 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.



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 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 Micro

How and where to keep this medicine.



  • 6. Further information

The ingredients in Creon Micro.


More information about cystic fibrosis and pancreatitis.





About Creon Micro



What is Creon Micro


  • Creon Micro is a high strength 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 contains a mixture of the natural enzymes which are used to digest food.

  • The enzymes are taken from pig pancreas glands.



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.





Before you give Creon Micro



Do not give Creon Micro if:


  • The doctor has told you that the patient is in the early stages of inflammation of the pancreas (acute pancreatitis).

  • The patient is allergic (or hypersensitive) to pork or any pig product or any of the ingredients of Creon Micro (listed in section 6).

If any of the above applies to the patient, do not give Creon Micro. Talk to the doctor or dietician again.




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 use machines


It is unlikely that Creon Micro will affect the patient’s ability to drive or operate tools or machines.





How to give Creon Micro



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. 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 give Creon Micro to babies and infants


  • Mix the granules with a small amount of undiluted apple juice

  • Provide plenty of liquid every day.



Weaned infants


  • Mix the granules with soft food (e.g. apple puree).

  • Make sure the infant swallows all the granules immediately, without chewing.

  • Provide plenty of liquid every day.



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.





Creon Micro 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



Uncommon side effects (affect 1–10 patients out of 1000):


  • Skin reactions, such as a rash or itching.

At extremely high doses, some patients have had high levels of uric acid in their blood and urine.



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 store Creon Micro



How and where to keep the medicine


Keep all medicines where children cannot reach or see them, preferably locked in a cupboard or medicine cabinet.


Do not store above 30 °C and keep in the original container. 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 12 weeks of opening the container.


Do not give Creon Micro capsules after the expiry date on the container.


Return all unused medicine to your pharmacist.





Further information



The ingredients in Creon Micro


The active ingredient in Creon Micro is pancreatin.


Each scoop measure contains 100 mg. One measure of 100 mg contains gastro-resistant granules of pancreatin is equivalent to the following list of enzymes:


(Ph. Eur. Units per Capsule)




Lipase: 5,000

Amylase: 3,600

Protease: 200



The granules are coated with a mixture of the following ingredients: macrogol 4000, hypromellose phthalate, dimeticone, triethyl citrate and cetyl alcohol.


Each container contains about 200 measures.




The Marketing Authorisation holder is:



Solvay Healthcare Ltd

Southampton

SO18 3JD

UK




The Manufacturer is:



Solvay Pharmaceuticals GmbH

31535 Neustadt a. Rbge

Germany




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




registered trade mark


This leaflet was last amended in September 2009.





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