Creon 10000 Gastro-resistant Capsules

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Lipase; Amylase; Protease

から入手可能:

Merit Pharmaceuticals Limited

ATCコード:

A09AA02

INN（国際名）:

Lipase; Amylase; Protease

投薬量:

150 milligram(s)

医薬品形態:

Gastro-resistant capsule, hard

治療領域:

multienzymes (lipase, protease etc.)

承認日:

2018-02-16

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CREON
 10000 GASTRO-RESISTANT CAPSULES
(pancreatin)
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
•
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.
WHAT YOU NEED TO KNOW 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.
WARNINGS AND PRECAUTIONS
A rare bowel condition called “fibrosing colonopathy”, where your
gut is
narrowed, has been reported in patients with cystic fibrosis taking
high
dose pancreatin products. However, this is not known to have happened
during studies in patients taking Creon.
However, if you have cystic fibrosis and take in excess of 10000
lipase
units per kilogram per day and have unusual abdominal symptoms or
changes in abdominal symptoms TELL YOUR DOCTOR.
PREGNANCY, BREAST-FEEDING AND FERTILITY
•
Talk to your doctor before taking this medicine if you are pregnant or
might become pregnant your doctor will decide if you should take
Creon and at which dose. Cr

製品の特徴

Health Products Regulatory Authority
21 May 2021
CRN00C2WR
Page 1 of 2
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.
_Product imported from the UK._
Capsules with brown caps and colourless, transparent bodies filled
with gastro-resistant brownish granules (minimicrospheres).
4 CLINICAL PARTICULARS
As per PA2010/008/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/008/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Granules:
Macrogol4000
Hypromellosephthalate
Triethylcitrate
Cetylalcohol
Dimethicone.
Capsuleshell:
Gelatin,
Iron oxides(E172)
Titanium dioxide(E171)
Sodium laurylsulphate
6.2 INCOMPATIBILITIES
Notapplicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Health Products Regulatory Authority
21 May 2021
CRN00C2WR
Page 2 of 2
Do not store above 25
°
C. Keep container tightly closed in order to protect frommoisture.
6.5 NATURE AND CONTENTS OF CONTAINER
HDPE container with polypropylene cap. Containers hold 100 capsules.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Merit Pharmaceuticals Limited
Unit C4 Metropoint Business Park
Kettles Lane
Swords
Co Dublin
K67 RH92
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23080/019/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16
th
February 2018
10 DATE OF REVISION OF THE TEXT
May 2021