Creon 25000 Gastro-resistant Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pancreas powder

Available from:

Mylan IRE Healthcare Limited

ATC code:

A09AA; A09AA02

INN (International Name):

Pancreas powder

Dosage:

300 milligram(s)

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:

Marketed

Authorization date:

1997-04-24

Patient Information leaflet

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”, w

Summary of Product characteristics

Health Products Regulatory Authority
07 December 2022
CRN00D8QD
Page 1 of 5
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.
Size 0, hard gelatin capsules with opaque orange caps and colourless
transparent bodies filled with gastro-resistant brown
granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of pancreatic exocrine insufficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly) and children:
Initially one or two capsules during or immediately after each meal.
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 result
in the early release of enzymes in the oral cavity and may
lead to reduced efficacy and irritation of the mucous membranes. Care
should be t