Creon 10000 Capsule coated pellets 150mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

PANCREAS POWDER

Available from:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC code:

A09AA02

Dosage:

150MG

Pharmaceutical form:

CAPSULE, COATED PELLETS

Composition:

PANCREAS POWDER 150MG

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Abbott Laboratories GmbH, Plant Neustadt

Authorization status:

ACTIVE

Authorization date:

2011-04-01

Patient Information leaflet

SmPC version 07052012 
Updated 28-May-2014 
_ _
_HARD GELATINE CAPSULES FILLED WITH GASTRO- _
_RESISTANT GRANULES  _ 
_(= MINIMICROSPHERES™) _ 

INN 150 mg pancreas powder  

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 further questions, please ask your doctor 
or pharmacist. This medicine has been prescribed 
for you personally and you should not pass it on to 
others. It may harm them, even if their symptoms 
are the same as yours.  

Creon 10 000 is a bicoloured hard gelatine capsule 
with brown opaque cap and colourless transparent 
body filled with brownish gastro-resistant granules 
(= Minimicrospheres™) for oral administration. 
Creon 10 000 contains 150 mg pancreas powder 
corresponding to  
Amylase    8 000 Ph.Eur. units  

Lipase       10 000 Ph.Eur. units   

Protease    600 Ph.Eur. units   

Produced from porcine pancreatic tissue. 

INDICATIONS  
Creon 10 000 is indicated for the treatment of 
exocrine pancreatic insufficiency due to cystic 
fibrosis, chronic pancreatitis, pancreatectomy, or 
other conditions. 

DOSAGE AND ADMINISTRATION  
The posology aims at individual needs and depends 
on the severity of the disease and the composition 
of food.  

It is recommended to take the enzymes during or 
immediately after the meals.  
The capsules should be swallowed intact, without 
crushing or chewing, with enough fluid during 
or 
after each 
meal or snack. When swallowing of 
capsules is difficult (e.g. small children or elderly 
patients), the capsules may be carefully opened and 
the minimicrospheres may be added to acidic soft 
food [pH < 5.5] that does not require chewing, or 
the minimicrospheres can be taken with liquid [pH 
< 5.5]. This could be apple sauce or yogurt or fruit 
juice with a pH less than 5.5, e.g. apple

Summary of Product characteristics

Updated 14 Mar 2022
_HARD GELATINE CAPSULES FILLED WITH GASTRO- _
_RESISTANT GRANULES _
_ _
INN
150 mg pancreas powder
Creon 10 000 is a bicoloured hard gelatine capsule with brown
opaque
cap
and
colourless
transparent
body
filled
with
brownish
gastro-resistant
granules
for
oral
administration.
Creon 10 000 contains 150 mg pancreas powder corresponding
to
Amylase 8 000 Ph.Eur. units
Lipase
10 000 Ph.Eur. units
Protease 600 Ph.Eur. units
Produced from porcine pancreatic tissue.
INDICATIONS
Creon
10
000
is
indicated
for
the
treatment
of
exocrine
pancreatic
insufficiency
due
to
cystic
fibrosis,
chronic
pancreatitis, pancreatectomy, or other conditions.
DOSAGE AND ADMINISTRATION
The posology aims at individual needs and depends on the
severity of the disease and the composition of food.
It is recommended to take the enzymes during or immediately
after the meals.
The capsules should be swallowed intact, without crushing or
chewing, with enough fluid during or after each meal or snack.
When swallowing of capsules is difficult (e.g. small children or
elderly patients), the capsules may be carefully opened and the
pellets may be added to acidic soft food [pH < 5.5] that does
not require chewing, or the pellets can be taken with liquid [pH
< 5.5]. This could be apple sauce or yogurt 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 pellets or mixing with food or
fluid with a pH greater than 5.5 can disrupt the protective
enteric coating. This can result in 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
at
all
times,
especially during periods of increased loss of fluids. Inadequate
hydration
may
aggravate
constipation.
Any
mixture
of
the
pellets with food or liquids should be used immediately and
should not be stored.
POSOLOGY IN CYSTIC FIBROSIS
Dosage recom