Creon 25000 Gastro-resistant capsules

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Pancreatin

Commercializzato da:

IMED Healthcare Ltd.

Codice ATC:

A09AA; A09AA02

INN (Nome Internazionale):

Pancreatin

Dosaggio:

300 milligram(s)

Forma farmaceutica:

Gastro-resistant capsule, hard

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Enzyme preparations; multienzymes (lipase, protease etc.)

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2013-01-10

Foglio illustrativo

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 “fibrosing colonopathy

Scheda tecnica

Health Products Regulatory Authority
07 February 2024
CRN00F2D6
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 a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
_Product imported from Czech Republic and Slovakia:_
Hard gelatin capsules with opaque brick-red caps and colourless
transparent bodies filled with gastro-resistant brown granules.
4 CLINICAL PARTICULARS
As per PA23355/006/002
5 PHARMACOLOGICAL PROPERTIES
As per PA23355/006/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product as sourced from Czech Republic_
Granules:
Macrogol 4000
Hypromellose Phthalate
Cetyl alcohol
Triethyl citrate
Dimethicone
Capsules:
Gelatin
Red and Yellow Iron Oxides (E172)
Titanium dioxide (E171)
Sodium lauryl sulphate
_Product as sourced from Slovakia_
Granules:
Macrogol 4000
Hypromellose Phthalate
Cetyl alcohol
Triethyl citrate
Dimethicone
Health Products Regulatory Authority
07 February 2024
CRN00F2D6
Page 2 of 2
Capsules:
Gelatin
Red and Yellow Iron Oxides (E172)
Sodium lauryl sulphate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer carton of the product on the market in
the country of origin.
After first opening: 6 months
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Keep the container tightly closed in order
to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Plastic container containing 50 capsules.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane