Creon 10000 150mg Gastro-Resistant Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pancreas powder

Available from:

Imbat Limited

ATC code:

A09AA; A09AA02

INN (International Name):

Pancreas powder

Dosage:

150 milligram(s)

Pharmaceutical form:

Gastro-resistant capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Enzyme preparations; multienzymes (lipase, protease etc.)

Authorization status:

Authorised

Authorization date:

2008-02-22

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CREON
®
10000
150MG GASTRO-RESISTANT CAPSULES
(pancreatin)
Your medicine is available using the above name, but will be
referred to as ‘Creon’ throughout this leaflet.
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.
Contents of the pack and other 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 contains 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 section 6).
If you are not sure, talk to your doctor or pharmacist before
taking Creon.
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 pat

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Creon 10000 150mg Gastro-Resistant Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150 mg pancreatin, equivalent to:
-
Lipase 10,000 Ph. Eur. units
-
Amylase 8,000 Ph. Eur. units
-
Protease 600 Ph. Eur. units
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
_Product imported from the United Kingdom, Hungary and Italy:_
Hard gelatin capsules with brown caps and colourless bodies filled
with gastro-resistant brown granules.
4 CLINICAL PARTICULARS
As per PA2007/003/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2007/003/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Macrogol 4000
Hypromellose phthalate
Triethyl citrate
Cetyl alcohol
Dimethicone
_CAPSULE SHELL:_
Gelatin
Red, yellow and black iron oxides (E172)
Titanium dioxide (E171)
Sodium laurilsulfate
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
_UK:_ Do not store above 25°C. Store in the original container.
_Hungary:_ Do not store above 25°C. Store in the original container.
Keep the container tightly