CREON 400 Milligram Capsules Gastro-Resistant
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
21-04-2017
Summary of Product characteristics
(SPC)
21-04-2017
Active ingredient:
PANCREAS POWDER
Available from:
BGP Products Ltd
ATC code:
A09AA02
INN (International Name):
PANCREAS POWDER
Dosage:
400 Milligram
Pharmaceutical form:
Capsules Gastro-Resistant
Administration route:
Oral use
Units in package:
50 or 100 Gastro-resistant capsules
Prescription type:
Product subject to prescription which may be renewed (B)
Manufactured by:
Abbott Laboratories GmbH
Therapeutic group:
Multienzymes (amylase, lipase, protease)
Therapeutic area:
Enzyme preparations
Therapeutic indications:
For the treatment of pancreatic exocrine insufficiency
Authorization status:
Authorised
Authorization date:
2015-03-27
Patient Information leaflet
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PACKAGE LEAFLET: INFORMATION FOR THE
USER
Creon 10000
Gastro-resistant Capsules
Creon 25000
Gastro-resistant Capsules
Creon 40000
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:
1.
What Creon is and what it is used for
2.
Before you take Creon
3.
How to take Creon
4.
Possible side effects
5.
How to store Creon
6.
Further 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.
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
b
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Creon 40000 Gastro-resistant Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400 mg pancreatin equivalent to:
Lipase
40,000 Ph.Eur. units
Amylase 25,000 Ph. Eur. units
Protease
1,600 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
Brown/clear size 00 hard gelatin capsule containing light brown,
gastro-resistant 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:_
Creon 40000 should only be used if the patient requires equal to or
more than 40,000 lipase units per meal or snack.
Initially one or two capsules during or immediately after meals.
The capsules should be swallowed whole, without
crushing or chewing, with enough fluid during or after each meal or
snack.
Dose adjustments, if required, should be
done slowly, with careful monitoring of response and symptomatology.
When swallowing of capsules is difficult (e.g. small children or
elderly patients), the capsules may be carefully opened and
the minimicrospheres added to acidic soft food [pH < 5.5] that does
not require chewing, or the minimicrospheres will be
taken with acidic liquid [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.
This
mixture should not be stored.
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 taken that no product
is retained in the mouth.
It is important to ensure adequate hydration of patients at all times
whilst dosing Creon 40000.
Colonic damage has been reported in
Read the complete document
