CREON 25000 Milligram Capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PANCREATIN

Available from:

LTT Pharma Limited

INN (International Name):

PANCREATIN

Dosage:

25000 Milligram

Pharmaceutical form:

Capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

CREON  25000 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 25000 gastro-resistant capsules, but
will be
refered to as Creon 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

Summary of Product characteristics

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 capsules, hard.
_Product imported from the United Kingdom_
Size 0, hard gelatin capsules with orange caps and colourless transparent bodies with brownish granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of pancreatic exocrine deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly) and children:
Initially one capsule 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 particularly applies to young
children.
It is important to ensure adequate hydration of patients at all times whilst dosing Creon 25000.
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. Crushing and chewing of the minimicrospheres or mixing with food or
fluid with a pH greater than 5.5 can disrupt the protective enteric coating. This can res