Creon 10000 Gastro-resistant Capsules

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Pancreatin

थमां उपलब्ध:

LTT Pharma Limited

ए.टी.सी कोड:

A09AA; A09AA02

INN (इंटरनेशनल नाम):

Pancreatin

डोज़:

10000 units/dose

फार्मास्यूटिकल फॉर्म:

Gastro-resistant capsule

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

Enzyme preparations; multienzymes (lipase, protease etc.)

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2015-02-13

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
CREON 10000 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:
What Creon is and what it is used for
Before you take Creon
How to take Creon
Possible side effects
How to store Creon
Further information
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.
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 patients with cystic fibrosis taking
high dose
pancreatin products. However, this is not known to have happened
during
studies in patients taking Creon.
However, if

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Creon 10000 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
Produced from porcine pancreatic tissue.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsules, hard.
_Product imported from Italy._
Size 2 hard gelatin capsules with brown caps and colourless bodies
filled with gastro-resistant brown granules.
4 CLINICAL PARTICULARS
As per PA2010/008/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/008/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Macrogol 4000
Hypromellose phthalate
Dimeticone 1000
Triethyl citrate
Cetyl alcohol
Gelatin
Iron oxides (E172)
Titanium dioxide (E171)
Sodium lauril sulfate
6.2 INCOMPATIBILITIES
Not applicable
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6.3 SHELF LIFE
The shelf life expiry date for 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
Do not store above 25°C and keep in the original container.
Keep the container tightly closed.
6.5 NATURE AND CONTENTS OF CONTAINER
HDPE container with polypropylene cap. Container holds 10