Creon 40000 Gastro-resistant Capsules

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Pancreas powder

Dostupné s:

Mylan IRE Healthcare Limited

ATC kód:

A09AA; A09AA02

INN (Mezinárodní Name):

Pancreas powder

Dávkování:

400 milligram(s)

Léková forma:

Gastro-resistant capsule

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Enzyme preparations; multienzymes (lipase, protease etc.)

Stav Autorizace:

Not marketed

Datum autorizace:

2006-09-08

Informace pro uživatele

FRONT
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Barcode Info
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Description
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Equivalent Pantone+
Color Bridge Coated
colours
v3/July 2017
Creon 10000 and 25000 gastro-resistant capsules,
150 mg, 300 mg, 50, 100
07 JUN 2019
13:20
Leaflet (Insert)
389
1871729
400542282
400542311
N.A.
N.A.
2
Black
1
8 pt
8 pt
1871729
1
PA 2010/8/1
Ireland
ABT (Neustadt - DE)
N.A.
1122638
N.A.
Helvetica Neue
N.A.
300*141mm
Cutting Die
P. 3025 C
1122638
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 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
•
Cr

Charakteristika produktu

Health Products Regulatory Authority
02 August 2019
CRN008LL2
Page 1 of 5
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 a