CREON 150 Milligram Capsules Gastro-Resistant

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

PANCREAS POWDER

Fáanlegur frá:

BGP Products Ltd

ATC númer:

A09AA02

INN (Alþjóðlegt nafn):

PANCREAS POWDER

Skammtar:

150 Milligram

Lyfjaform:

Capsules Gastro-Resistant

Stjórnsýsluleið:

Oral use

Einingar í pakka:

100, 250 or 300 capsules

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Framleitt af:

Abbott Laboratories GmbH

Meðferðarhópur:

Multienzymes (amylase, lipase, protease)

Lækningarsvæði:

Enzyme preparations

Ábendingar:

Pancreatic exocrine deficiency

Leyfisstaða:

Authorised

Leyfisdagur:

2015-03-27

Upplýsingar fylgiseðill

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Black - P. 3025 C - Cutting Die
MKP-00531-2017_d2
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

Vara einkenni

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 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 insufficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly) and children:
Initially one to 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 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 enteric coating may result. In order to
protect the enteric coating, it is important that the granules are not
crushed or chewed (see 4.8 Undesirable Effects).
Crushing and chewing of the minimicrospheres or mixing with food or
fluid with a pH greater than 5.5 can disrupt the