CREON 10000 Capsules Gastro-Resistant

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

PANCREATIN

थमां उपलब्ध:

LTT Pharma Limited

INN (इंटरनेशनल नाम):

PANCREATIN

डोज़:

10000

फार्मास्यूटिकल फॉर्म:

Capsules Gastro-Resistant

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

0000-00-00

सूचना पत्रक

CREON  10000 GASTRO-RESISTANT CAPSULES 
(pancreatin)
PATIENT INFORMATION 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.
Your medicine is called Creon 10000 gastro-resistant capsules, but
will be
refered to as Creon 10000 throughout this leaflet.
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 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.
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
hig

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 the UK:_
Gastro-resistant capsule, hard.
Size 2 hard gelatin capsules with brown caps and colourless bodies filled with gastro-resistant brown granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pancreatic exocrine deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly) and children:
Initially one to two capsules with meals. Dose increases, if required, should be added slowly, with careful monitoring
of response and symptomatology. The daily dose of pancreatic enzymes for most patients should remain below 2500
units of lipase per kilogram per meal (10,000 units per kilogram per day), and that higher doses should be used with
caution and only if quantitative measures demonstrate substantially improved absorption with such treatment. This
applies particularly to young children.
It is important to ensure adequate hydration of patients at all times whilst dosing Creon.
The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with
acidic fluid [pH<5.5] or acidic soft food [pH<5.5]. This could be apple sauce or yoghurt or fruit juice with a pH less
than 5.5, e.g. apple, orange or pineapple juice.. If the granules are mixed with food, it is important that they are taken
immediately and the mixture should not be stored, otherwise dissolution of the