Creon 25000 Gastro-resistant Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pancreatin

Available from:

PCO Manufacturing Ltd.

ATC code:

A09AA; A09AA02

INN (International Name):

Pancreatin

Dosage:

25000

Pharmaceutical form:

Gastro-resistant capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Enzyme preparations; multienzymes (lipase, protease etc.)

Authorization status:

Authorised

Authorization date:

2004-06-25

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CREON
® 10000 GASTRO-RESISTANT CAPSULES
CREON
® 25000 GASTRO-RESISTANT CAPSULES
pancreatin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor,
pharmacist or nurse.
•
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
•
If you get any side effects talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET :
1.
What Creon is and what it is used for
2.
What you need to know 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 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 immediately
after a meal or a snack. This will allow the enzymes to mix
thoroughly with the food.
2.
WHAT YOU NEED TO KNOW 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.
WARNINGS AND PRECAUTIONS
A rare bowel condition called “fibr

Summary of Product characteristics

Health Products Regulatory Authority
22 February 2021
CRN009ZZQ
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Creon 25000 Gastro-resistant Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300 mg pancreatin equivalent to:
Lipase 25,000 Ph.Eur. units
Amylase 18,000 Ph.Eur. units
Protease 1,000 Ph.Eur. units
Produced from porcine pancreatic tissue.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
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_Product imported from Greece, Hungary and Poland:_
Hard gelatin capsules with opaque brick-red caps and colourless,
transparent bodies filled with gastro-resistant brown granules.
4 CLINICAL PARTICULARS
As per PA2007/003/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2007/003/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Macrogol 4000
Hypromellose phthalate
Cetyl alcohol
Triethyl citrate
Dimethicone
Gelatin
Red, yellow and black iron oxides (E172)
Titanium dioxide (E171)
Sodium lauryl sulphate
6.2 INCOMPATIBILITIES
Not applicable.
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.
After first opening: use within 6 months
Health Products Regulatory Authority
22 February 2021
CRN009ZZQ
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
Keep in the original container and keep it tightly closed.
6.5 NATURE AND CONTENTS OF CONTAINER
Plastic bottle with plastic closure.
Pack size: 50 capsules
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/125/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25th June 2004
Date of last renewal : 24th June 2009
10 DATE OF REVISION OF THE TEXT
February 2021