CREON 10000 CAPSULE

Ülke: Malezya

Dil: İngilizce

Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktif bileşen:

Pancreatin

Mevcut itibaren:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (International Adı):

Pancreatin

Paketteki üniteler:

50 Capsule Capsules; 20 Capsule Capsules; 100 Capsule Capsules; 100Capsule Capsules

Tarafından üretildi:

Abbott Laboratories GmbH.

Bilgilendirme broşürü

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
CREON® 10000 CAPSULES
_ _
Pancreatin (150mg)
Page no.1
WHAT IS IN THIS LEAFLET
1. What Creon® is used for
2. How Creon® works
3. Before you use Creon®
4. How to use Creon®
5. While you are using it
6. Side effects
7. Storage and disposal of Creon®
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT CREON®
IS USED FOR
Creon® is a pancreatic enzyme that is
used for people whose bodies do not
make enough of their own enzymes to
digest their food.
The enzymes are taken from pig
pancreas glands.
HOW CREON® WORKS
Creon® works by digesting food as it
passes through the gut. So, you must
take Creon® at the same time as
eating a meal. This will allow the
enzymes to mix thoroughly with
food.
BEFORE YOU USE CREON®
_- When you must not use it _
•
If you are allergic to pork,
any pig product or any of the
ingredients listed at the end
of this leaflet
Do not use Creon® if any of the
above apply to you. If you are not
sure, talk to your doctor or
pharmacist before taking Creon®.
_- Before you start to use it _
Discuss with your doctor or
pharmacist before taking your
medicine if:
-
you have a rare bowel
condition called “fibrosing
colonopathy”
_- Taking other medicines _
There is no known interaction with
other medication.
HOW TO USE CREON®
_- How much to use _
Always take Creon® exactly as your
doctor has told you. You should
check with your doctor or pharmacist
if you are not sure.
Dosage are individualized according
to the degree of maldigestion and
severity of the disease.
_- When to use it _
Always take Creon® during or
immediately after eating a meal and
drink plenty of water.
Swallow the capsule in whole or open
the capsule and mix the granule
(without crushing) with acidic liquid
such as apple, orange or pineapple
juice. Swallow the mixture straight
away without chewing.
Do not hold Creon® or its content in
your mouth.
_- How long to use it _
You should take your medicine until
your doctor tells you

Ürün özellikleri

CREON
®
10 000
150 mg Pancreatin
(pancreas powder)
HARD GELATINE CAPSULE FILLED WITH GASTRO-RESISTANT GRANULES
Creon
®
10,000 is bicoloured capsule with brown opaque cap and transparent
body of hard gelatin
capsules filled with gastro-resistant granules (Creon
Minimicrospheres™) for oral administration. 1
capsule of Creon
®
10,000 contains 150 mg Pancreatin (pancreas powder) corresponding to
Amylase
8 000 Ph.Eur. units (=BP units)
Lipase
10 000 Ph.Eur. units (=BP units)
Proteas
600 Ph.Eur. units (=BP units)
Produced from porcine pancreatic tissue.
Excipients: macrogol 4000, hypromellose phthalate, dimethicone 1000,
triethyl citrate, cetyl alcohol, iron
oxide (E172), titanium dioxide (E171), sodium lauryl sulphate,
gelatin.
INDICATIONS
Treatment of pancreatic exocrine insufficiency in paediatric and adult
patients often associated with, but
not limited to:
▪
cystic fibrosis
▪
chronic pancreatitis
▪
pancreatic surgery
▪
gastrectomy
▪
pancreatic cancer
▪
gastrointestinal bypass surgery (e.g.Billroth II gastroenterostomy)
▪
ductal obstruction of the pancreas or common bile duct (e.g. from
neoplasm)
▪
Shwachman-Diamond Syndrome
▪
Creon
®
10,000 only: For the improvement of digestion and relief of
maldigestion symptoms after
consumption of a (fatty) meal; like sensation of heaviness, bloating,
abdominal distension,
abdominal pain/cramping and/or diarrhoea.
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 meals or
snacks.
When swallowing of capsules is difficult (e.g. small children or
elderly patients), the capsules may be
carefully opened and the pellets added to acidic soft food [pH < 5.5]
that does not require chewing, or the
pellets will be taken with acidic liquid with [pH < 5.5]. This could
be apple sauce or yogurt or fruit juice
with