CREON FOR CHILDREN 5000 60.12 Milligram Granules Gastro-Resistant
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
PANCREAS POWDER
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
PANCREAS POWDER
Dosage:
60.12 Milligram
Pharmaceutical form:
Granules 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 10000 GASTRO-RESISTANT CAPSULES
CREON 25000 GASTRO-RESISTANT CAPSULES
CREON 40000 GASTRO-RESISTANT CAPSULES
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 is and what it is used for
2.
Before you take Creon
3.
How to take Creon
4.
Possible side effects
5.
How to store Creon
6.
Further information
1.
WHAT CREON IS AND WHAT IT IS USED FOR
WHAT CREON IS
•
Creon contains an enzyme mixture called “pancreatin”.
•
Pancreatin helps you digest food. The enzymes are taken
from pig pancreas glands.
•
Creon gastro-resistant capsules contain small pellets which slowly release the
pancreatin in
your gut (gastro-resistant pellets, called Minimicrospheres™).
WHAT CREON IS USED FOR
•
Creon is used by children and adults with “pancreatic exocrine
insufficiency”. This is when
their pancreas gland does not make enough enzymes to
digest food.
HOW CREON WORKS
The enzymes in Creon work
by digesting food as it passes through the gut. You should
take
Creon during or after a meal or a snack. This will
allow the enzymes to mix thoroughly with the
food.
2.
BEFORE YOU TAKE CREON
DO NOT TAKE CREON IF:
•
you are allergic (hypersensitive) to pig pancreatin or to
any of the other ingredients of Creon
(listed in se
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Creon for Children 5000 Gastro-resistant Granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg of gastro-resistant granules (equivalent to one measuring spoonful) contains 60.12mg Pancreatin,
containing the following pancreatic enzymes:
Lipase
5,000 Ph. Eur. units
Amylase
3,600 Ph. Eur. units
Protease
200 Ph. Eur. units
Produced from porcine pancreatic tissue.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro resistant granules
Round, 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
Initially 100 mg (5000 lipase units) of gastro-resistant granules (one measure) should be taken with each feed or meal.
Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology. The
maximum daily dosage should not exceed 10,000 units lipase/kg/day. The required quantity of gastro-resistant granules
should be dispensed using the measuring spoon contained in the pack which holds 100 mg.
In young infants, Creon for Children 5000 granules should be mixed with a small amount of infant formula, expressed
breast milk or fruit puree and given from a spoon directly before the feed. In weaned infants, granules should be taken
with acidic liquids or acidic soft foods but without chewing, directly before the meal. Suitable foodstuffs for use with
the granules include apple sauce or yoghurt or fruit juice with a pH less than 5.5(e.g. apple, orange or pineapple juice).
It is important to ensure adequate hydration of patients at all times whilst dosing with Creon.
The daily dose of pancreatic enzymes for most patients should re
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