CREON 40000 400 Milligram Capsules Gastro-Resistant
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
26-04-2024
Summary of Product characteristics
(SPC)
26-04-2024
Active ingredient:
PANCREAS POWDER
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
PANCREAS POWDER
Dosage:
400 Milligram
Pharmaceutical form:
Capsules Gastro-Resistant
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
CREON FOR CHILDREN 5000 GASTRO-RESISTANT GRANULES
Pancreatin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions,
ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Creon for Children is and what it is used for
2.
Before you take Creon for Children
3.
How to take Creon for Children
4.
Possible side effects
5.
How to store Creon for Children
6.
Further information
1.
WHAT CREON FOR CHILDREN IS AND WHAT IT IS USED FOR
WHAT CREON FOR CHILDREN IS
•
Creon for
Children contains an enzyme mixture called “pancreatin”.
•
Pancreatin helps you
digest food. The enzymes are taken from pig pancreas glands.
•
The small pellets of Creon for
Children slowly release the pancreatin in your gut (gastro-
resistant pellets, called Minimicrospheres™).
•
Creon for
Children is for children and infants who cannot swallow capsules. It is used when
low doses of pancreatin are needed.
WHAT CREON FOR CHILDREN IS USED FOR
•
Creon for
Children is intended for use in children and infants with “pancreatic exocrine
insufficiency”. This is when
their pancreas gland does not make enough enzymes to digest
food.
HOW CREON FOR CHILDREN WORKS
The enzymes in Creon for Children work by digesting food
as it passes through the gut. You
should take Creon for Children during or
after a me
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Creon 40000 Gastro-resistant Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400 mg pancreatin equivalent to:
Lipase 40,000 Ph.Eur. units
Amylase 25,000 Ph. Eur. units
Protease 1,600 Ph. Eur. units
Produced from porcine pancreatic tissue.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant Capsule, hard
Brown/clear size 00 hard gelatin capsule containing light brown, gastro-resistant granules
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of pancreatic exocrine insufficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults (including the elderly) and children:_
Creon 40000 should only be used if the patient requires equal to or more than 40,000 lipase units per meal or snack.
Initially one or two capsules with meals. The capsules should be swallowed whole, without crushing or chewing, with
enough fluid during or after each meal or snack. Dose adjustments, if required, should be done slowly, with careful
monitoring of response and symptomatology
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 [pH < 5.5] that does not require chewing, or the minimicrospheres will be
taken with acidic liquid [pH < 5.5].
This could be apple sauce or yoghurt or fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice. This
mixture 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 the early release of enzymes in the oral
cavity and may lead to reduced efficacy and irri
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