CREON MICRO pancreatic extract 20 g enteric coated granules bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Pancreatic extract, Quantity: 601.2 mg/g (Equivalent: protease, Qty 2000 PH Eur unit; Equivalent: Amylase, Qty 36000 PH Eur unit; Equivalent: lipase, Qty 50000 PH Eur unit)

Available from:

Viatris Pty Ltd

INN (International Name):

Pancreatic extract

Pharmaceutical form:

Granules, enteric-coated

Composition:

Excipient Ingredients: hypromellose phthalate; cetyl alcohol; dimeticone 1000; macrogol 4000; triethyl citrate

Administration route:

Oral

Units in package:

1x 20g bottle

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Creon Micro is indicated as pancreatic enzyme replacement in paediatric and adult patients with pancreatic exocrine insufficiency (PEI). Pancreatic exocrine insufficiency is often associated with, but not limited to: cystic fibrosis, chronic pancreatitis, pancreatic surgery, gastrointestinal bypass surgery (eg. Bilroth II gastroenterostomy), ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm).

Product summary:

Visual Identification: round, light brown granules; Container Type: Bottle; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2010-09-29

Patient Information leaflet

CREON
® MICRO
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CREON MICRO?
CREON MICRO contains the active ingredient Pancreatic Extract. CREON
MICRO is used in a condition called pancreatic exocrine
insufficiency where the body does not make enough enzymes to digest
food.
For more information, see Section 1. Why am I using CREON MICRO? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CREON MICRO?
Do not use if you have ever had an allergic reaction to CREON MICRO or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
CREON MICRO? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CREON MICRO and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CREON MICRO?
•
Your doctor has prescribed a dose of CREON MICRO for you or your child
which is specifically tailored to the severity of the
condition. Your doctor will tell you how much CREON MICRO to take or
give to your child. Do not increase the number of doses
yourself without informing your doctor.
•
The small measuring scoop that is provided with the bottle is designed
to contain a dose of 100 mg of granules. This amount
provides 5,000 units of lipase.
More instructions can be found in Section 4. How do I use CREON MICRO?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CREON MICRO?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CREON MICRO.
•
Drink plenty of water every day when you are taking CREON MICRO.
•
Call your doctor straight away if you are still having problems with
fatty stools or abdomina

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CREON
® MICRO
_Pancreatic extract enteric-coated granules _
1
NAME OF THE MEDICINE
Pancreatic extract
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CREON MICRO is a porcine pancreatic enzyme preparation containing
pancreatic extract encapsulated in
enteric-coated granules with a pH-sensitive coating.
Each dosing unit of 100 mg of CREON MICRO contains pancreatic extract
60.12 mg equivalent to not less
than 5,000 Ph.Eur. units lipase, 3,600 Ph.Eur. units amylase and 200
Ph. Eur. units protease.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CREON MICRO: Round, light brown enteric-coated granules. One dosage
unit is measured with a measuring
scoop as dosing device.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CREON MICRO is indicated as pancreatic enzyme replacement in
paediatric and adult patients with
pancreatic exocrine insufficiency (PEI).
Pancreatic exocrine insufficiency is often associated with, but not
limited to:
•
cystic fibrosis
•
chronic pancreatitis
•
pancreatic surgery
•
gastrointestinal bypass surgery (e.g. Bilroth II gastroenterostomy)
•
ductal obstruction of the pancreas or common bile duct (e.g. from
neoplasm)
4.2
DOSE AND METHOD OF ADMINISTRATION
The granules can be added to small amounts of acidic soft food [pH <
5.5] that do not require chewing, such
as apple sauce, mashed bananas or yoghurt, or be taken with liquid
such as fruit juice with a pH less than 5.5
for example apple, orange or pineapple juice. The small measuring
scoop that is provided with the bottle is
designed to contain a dose of 100 mg of granules. This amount provides
5,000 units of lipase.
The mixture of CREON MICRO and soft food should be swallowed
immediately without crushing or chewing,
and followed with water or juice to ensure complete ingestion.
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 early release of enzymes in