Creon Micro

New Zealand - English - Medsafe (Medicines Safety Authority)

Buy It Now

Active ingredient:
Pancreatin 60.12 mg (3,600 Ph. Eur. u/Amylase, 5,000 Ph. Eur. u/Lipase and 200 Ph. Eur. u/Protease)
Available from:
Mylan New Zealand Ltd
INN (International Name):
Pancreatin 60.12 mg (3,600 Ph. Eur. u/Amylase, 5,000 Ph. Eur. u/Lipase and 200 Ph. Eur. u/Protease)
Pharmaceutical form:
Modified release granules
Composition:
Active: Pancreatin 60.12 mg (3,600 Ph. Eur. u/Amylase, 5,000 Ph. Eur. u/Lipase and 200 Ph. Eur. u/Protease) Excipient: Cetyl alcohol Dimeticone Hypromellose phthalate Macrogol 4000 Triethyl citrate
Units in package:
Bottle, glass, with LDPE stopper and dosing scoop, 20 g
Class:
General sale
Prescription type:
General sale
Manufactured by:
Abbott Laboratories GmbH
Therapeutic indications:
For treatment of conditions associated with pancreatic exocrine insufficiency, such as: cystic fibrosis, chronic pancreatitis, post-pancreatectomy, post-gastrointestinal bypass surgery, e.g. Billroth II, gastroenterostomy; ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm).
Product summary:
Package - Contents - Shelf Life: Bottle, glass, with LDPE stopper and dosing scoop - 20 g - 36 months from date of manufacture stored at or below 25°C protect from moisture 3 months opened stored at or below 25°C protect from moisture
Authorization number:
TT50-4663/4
Authorization date:
2011-03-15

Page 1 of 4

NEW ZEALAND CONSUMER MEDICINE INFORMATION

CREON

®

MICRO

Pancreatin modified release granules

What is in this leaflet

Please read this leaflet carefully

before you start taking Creon Micro.

This leaflet answers some common

questions about Creon Micro.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor or pharmacist

has weighed the risks of you taking

Creon Micro against the benefits

they expect it will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the

medicine. You may need to read it

again.

What Creon Micro is

used for

Creon Micro is a pancreatic enzyme

used to treat conditions associated

with pancreatic exocrine

insufficiency, such as:

Cystic fibrosis

Chronic pancreatitis

Various upper

gastrointestinal surgery

People

with pancreatic exocrine

insufficiency often suffer with

symptoms of:

abdominal pain

diarrhoea

steatorrhoea (foul fatty

stools which float in the

toilet)

bloating

weight loss

These symptoms appear because

the body is unable to digest food

normally. When this happens, your

body's ability to absorb important

nutrients from food is impaired and

leads to malnutrition. If left

untreated these symptoms can

affect your quality of life and a poor

nutritional status could have long

term health implications.

Creon Micro contains digestive

enzymes (amylase, lipase and

protease) extracted from pancreas

of pigs.

It works by restoring normal

digestive action in your body to

relieve abdominal symptoms and

improve nutritional status.

Your doctor may have prescribed

this medicine for another reason.

Ask your doctor or pharmacist if

you have any questions about

why this medicine has been

advised for you.

There is no evidence that Creon

Micro granules are addictive.

This medicine is not expected to

affect your ability to drive a car or

operate machinery.

Before you take

Creon Micro

When you must not take

it

Do not take Creon Micro if you

have an allergy to:

any medicine containing

pancreatic enzymes

pork or other pig products

any of the ingredients listed

at the end of this leaflet.

Some symptoms of an allergic

reaction may include: shortness of

breath; wheezing or difficulty

breathing; swelling of the face, lips,

tongue or other parts of the body;

rash, itching or hives on the skin.

Do not take this medicine after

the expiry date printed on the

pack or if the packaging is torn or

shows signs of tampering.

If it has expired or is damaged,

return it to your pharmacist for

disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor or pharmacist.

Before you start to take

it

Tell your doctor or pharmacist if

you have allergies to any other

medicines, foods, preservatives

or dyes.

Tell your doctor or pharmacist if

you are pregnant or plan to

become pregnant or are breast-

feeding.

Your doctor can discuss with you

the risks and benefits involved.

If you have not told your doctor

or pharmacist about any of the

above, tell them before you start

taking Creon Micro.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including medicines

that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

You should also tell any health

professional who is prescribing a

new medication for you that you are

taking Creon Micro.

Your doctor and pharmacist have

more information on medicines to

be careful with or avoid while taking

this medicine.

Page 2 of 4

How to take Creon

Micro

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the information

contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

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.

Your doctor has prescribed a dose

of Creon Micro for you or your child

which is specifically tailored to the

severity of the condition.

For patients with cystic fibrosis, your

doctor will have determined a dose

specific to your body weight and

condition.

The starting dose for infants with

cystic fibrosis should start at a dose

of 2000 to 5000 lipase units for

each feeding (usually 120 mL) and

adjusted to a dose no greater than

2500 lipase units per kilogram per

feeding.

For children less than 4 years old,

dosing should begin with 1000

lipase units per kilogram per meal,

and 500 lipase units per kilogram

per meal for children over the age of

The maximum recommended dose

of lipase in infants and children with

cystic fibrosis is 10,000 lipase units

per kilogram body weight per day.

Dosing in other conditions

associated with exocrine pancreatic

insufficiency ranges from about

25,000 to 80,000 lipase units per

meal and half of the dose for

snacks.

Patients who use more than 10,000

units of lipase per kilogram per day,

will probably be monitored closely

by their doctor.

Your doctor may need to make a

number of adjustments before

determining the right dose which

suits you best.

It is normally not necessary to

restrict your diet of fat while you are

taking Creon Micro as your

symptoms will usually be under

control. In people with malnutrition,

getting enough fat in the diet will

help improve nutrition. If unsure,

you should consult your doctor or

dietitian regarding your diet whilst

on Creon Micro.

If the doctor advises you to increase

the dosage, you should increase it

slowly. A very rapid increase in

dosage may lead to constipation. If

you are unsure how to increase the

dose, ask your doctor or pharmacist

to explain it to you.

How to take it

The small measuring scoop that is

provided with the bottle is designed

to contain dose of 100 mg of

granules, equivalent to 5000 units of

lipase.

Creon Micro can be added to small

amounts of acidic soft food that do

not require chewing, such as apple

sauce, yogurt or fruit juice.

For infants, Creon Micro can be

mixed with a small amount of milk

on a weaning spoon immediately

before the feed. Do not add to

baby’s bottle.

Any mixture of Creon Micro with soft

food or fluid should be swallowed

immediately and not stored.

Do not crush or chew the granules,

swallow the granules whole

followed by juice or water, to ensure

complete ingestion. The granules

have a special coating to stop them

dissolving until they have gone

through the stomach and into the

intestines where they work.

Make sure to drink plenty of liquid

every day while taking Creon Micro.

When to take it

Take Creon Micro with every meal

and snack.

How long to take it?

Continue taking your medicine

for as long as your doctor tells

you.

This medicine helps to control your

condition but does not cure it. It is

important to keep taking your

medicine even if you feel well.

If you forget to take it

Wait until your next meal or

snack and take your usual

number of doses.

Do not take a double dose to

make up for the dose that you

missed.

This may increase the chance of

you getting an unwanted side effect.

If you are not sure what to do,

ask your doctor or pharmacist.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints.

While you are taking

Creon Micro

Things you must do

If you are about to be started on

any new medicine, tell your

doctor and pharmacist that you

are taking Creon Micro.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist

that you are taking this medicine.

It may affect other medicines used

during surgery.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Make sure you tell your doctor if

you are still having problems

with fatty stools or abdominal

pain while you are taking Creon

Micro.

Drink plenty of water every day

when you are taking Creon Micro.

Follow your doctor’s instructions

carefully and do not stop taking

Creon Micro unless told to do so

by a doctor.

Page 3 of 4

Things you must not do

Do not take Creon Micro to treat

any other complaints unless your

doctor tells you to.

Do not give Creon Micro to

anyone else, even if they have

the same condition as you.

Do not stop taking your medicine or

lower the dosage without checking

with your doctor.

Things that would be

helpful for your

condition

Diet should be considered as part of

your overall management plan. Talk

to your doctor or dietician for more

information and advice.

In case of overdose

If you take too much

(overdose)

Immediately telephone your

doctor or the National Poisons

Centre (telephone 0800 POISON

or 0800 764 766), or go to

accident and emergency at your

nearest hospital, if you think that

you or anyone else may have

taken too much Creon Micro. Do

this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

Extremely high doses of pancreatin

have been associated with

excessive amounts of uric acid in

the urine and the blood.

If you take too much Creon Micro

you may get irritation or

inflammation in the anal region.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel well while you are taking

Creon Micro.

This medicine helps most people

with insufficient enzymes to digest

their food, but it may have

unwanted side effects in a few

people.

All medicines can have side

effects. Sometimes they are

serious, most of the time they are

not. You may need medical

treatment if you get some of the

side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

stomach or bowel

problems, including:

diarrhoea

constipation

abnormal stools

abdominal discomfort

nausea

vomiting

skin reactions

If any of the following happen,

tell your doctor immediately or

go to Accident and Emergency at

your nearest hospital:

An allergic reaction, symptoms

include:

wheezing

difficulty breathing

swelling of face, lips, tongues

or other part of the body

shortness of breath

Tell your doctor immediately if

you have severe or prolonged

abdominal pain.

Patients with cystic fibrosis taking

high doses of pancreatic enzyme

supplements have suffered from

narrowing of the bowel and required

an operation.

Tell your doctor or pharmacist if

you notice anything that is

making you feel unwell.

In rare cases, people taking very

high doses may develop high levels

of uric acid in their blood and urine.

Other side effects not listed above

may also occur in some people. Tell

your doctor or pharmacist if you

notice any other effects.

Do not be alarmed by this list of

possible side effects. You may

not experience any of them.

After taking Creon

Micro

Storage

Keep your granules in the bottle

until it is time to take them.

If you take the granules out of the

bottle they may not keep well.

Keep your granules in a cool dry

place where the temperature

stays below 25°C. Protect from

moisture.

Once open, use within 3 months.

Do not store Creon Micro or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy

some medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

Creon Micro is a round light brown

minimicrosphere. Available in

bottles of 200 scoop measures, with

dosing scoop.

Ingredients

Active ingredient(s):

Each 100 mg (equivalent to one

measuring dosing spoon) of Creon

Micro contains 60.12 mg of

pancreatin as the active ingredient,

equivalent to Lipase 5000 Ph. Eur.

units, Amylase 3600 Ph. Eur. units

and Protease 200 Ph. Eur. units.

Inactive ingredient(s):

Creon Micro also contains:

Cetyl alcohol

Dimeticone

Page 4 of 4

Hypromellose phthalate

Macrogol 4000

Triethyl citrate

This medicine does not contain

lactose or gluten.

If you want to know

more

Should you have any questions

regarding this product, please

contact your pharmacist or doctor.

Who supplies this

medicine

Creon Micro is supplied in New

Zealand by:

Mylan New Zealand Ltd,

PO Box 11183,

Ellerslie,

Auckland

NEW ZEALAND

Telephone: (09) 579 2792

Date of Preparation

8 January 2020

(Based on datasheet dated 27

December 2019)

Page 1 of 6

NEW ZEALAND DATA SHEET

CREON

®

MICRO

1. Product Name

Creon Micro, 60.12 mg, modified release granules.

2. Qualitative and Quantitative Composition

Each 100 mg of minimicrospheres (equivalent to one measuring spoonful) contains 60.12 mg of

pancreatin, containing the following pancreatic enzymes: Lipase 5000 Ph.Eur. units, Amylase 3600

Ph.Eur. units and Protease 200 Ph.Eur. units.

3. Pharmaceutical Form

Creon Micro is a round, light brown minimicrospheres (gastro-resistant pellets).

4. Clinical Particulars

4.1

Therapeutic indications

For treatment of conditions associated with pancreatic exocrine insufficiency, such as:

cystic fibrosis

chronic pancreatitis

post-pancreatectomy

post-gastrointestinal bypass surgery (e.g. Billroth II, gastroenterostomy)

ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm)

4.2

Dose and method of 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.

Dose

Creon Micro is a specific dosage form with a small minimicrosphere size in particular for use in

infants and children unable to swallow capsules. Creon Micro allows improved individual dosing

when low lipase doses are needed for adequate treatment of young children.

Dosing in paediatric and adult patients with cystic fibrosis

Based upon a recommendation of the Cystic Fibrosis (CF) Consensus Conference, the US CF

Foundation case-control study, and the UK case-control study, the following general dosage

recommendation for pancreatic enzyme replacement therapy can be proposed:

In infants dosing should be initiated at a dose of 2000 to 5000 lipase units for each feeding

(usually 120 ml) and adjusted up to a dose no greater than 2500 lipase units per kilogram

per feeding with a maximum daily dose of 10,000 lipase units per kg per day.

Page 2 of 6

Weight-based enzyme dosing should begin with 1000 lipase units/kg/meal for children less

than 4 years of age and with 500 lipase units/kg/meal for those over age 4.

Dosage should be adjusted according to the severity of the disease, control of steatorrhea

and maintenance of good nutritional status.

Most patients should remain below or should not exceed 10,000 lipase units/kg body weight

per day or 4000 lipase units/gram fat intake.

Dosing in other conditions associated with exocrine pancreatic insufficiency

Dosage should be individualized by patients according to the degree of maldigestion and the fat

content of the meal. The required dose for meal ranges from about 25,000 to 80,000 Ph. Eur.units

of lipase and half of the individual dose for snacks.

Method of administration

The minimicrosphere can be added to small amounts of acidic soft food (pH < 5.5) that do not require

chewing or be taken with acidic 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.

Alternatively, Creon Micro can be mixed with a small amount of milk on a (weaning) spoon and

administered to the infant immediately. The minimicrospheres should not be added to the baby’s

bottle. Any mixture of Creon Micro with soft food or fluid 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 the oral

cavity and may lead to reduced efficacy and irritation of the mucous membranes. Care should be

taken to ensure that no product is retained in the mouth.

It is important to ensure hydration at all times, especially during periods of increased loss of fluids.

Inadequate hydration may aggravate constipation. Any mixture of the minimicrospheres with food or

liquid should be used immediately and should not be stored.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4

Special warnings and precautions for use

Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients

with cystic fibrosis taking high doses of pancreatin prepartions. As a precaution, unusual abdominal

symptoms or changes in the abdominal symptoms should be medically assessed to exclude the

possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000 units of

lipase/kg/day.

4.5

Interaction with other medicines and other forms of interaction

No interaction studies have been performed.

4.6

Fertility, pregnancy and lactation

Pregnancy and fertility

For pancreatic enzymes no clinical data on exposed pregnancies are available. Animal studies show

no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive of

developmental toxicity is to be expected. Caution should be exercised when prescribing to pregnant

women.

Page 3 of 6

Breast-feeding

No effects on the suckling child are anticipated since animal studies suggest no systemic exposure

of the breastfeeding woman to pancreatic enzymes. Pancreatic enzymes can be used during

breastfeeding. If required during pregnancy and lactation Creon Micro should be used in does

sufficient to provide adequate nutritional status.

4.7

Effects on ability to drive and use machines

Creon Micro has no or negligible influence on the ability to drive and use machines.

4.8

Undesirable effects

In clinical trials, more than 900 patients were exposed to pancreatin enzymes. The most commonly

reported adverse reactions were gastrointestinal disorders and were primarily mild or moderate in

severity. The following adverse reactions have been observed during clinical trials with the below

indicated frequencies.

Organ system

Very common

≥ 1/10

Common

≥ 1/100 to < 1/10

Uncommon

≥ 1/1000 to

< 1/100

Frequency

not

known

Gastrointestinal

disorders

abdominal pain*

nausea, vomiting,

constipation,

abdominal

distention,

diarrhea*

strictures of the

ileo-caecum and

large bowel

(fibrosing

colonopathy)

Skin and

subcutaneous

tissue disorders

rash

pruritus, urticaria

Immune system

disorders

hypersensitivity

(anaphylactic

reactions).

*Gastroinstestinal disorders are mainly associated with the underlying disease. Similar or lower incidences compared to placebo were

reported for abdominal pain and diarrhea.

Stricture of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients

with cystic fibrosis taking high doses of pancreatin preparations (see section 4.4).

Allergic reactions mainly but not exclusively limited to the skin have been observed and identified as

adverse reactions during postapproval use. Because these reactions were reported spontaneously

from a population of uncertain size, it is not possible to reliably estimate their frequency.

Paediatric population

No specific adverse reactions were identified in the paediatric population. Frequency, type and

severity of adverse reactions were similar in children with cystic fibrosis as compared to adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows

continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked

to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.

4.9

Overdose

Extremely high doses of pancreatin have been reported to be associated with hyperuricosuria and

hyperuricaemia.

For further advice on management of overdose please contact the National Poisons Information

Centre (0800 POISON or 0800 764 766).

Page 4 of 6

5. Pharmacological Properties

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Multienzymes (amylase, lipase, protease), ATC code: A09A A02

Mechanism of action

Creon

Micro

contains

porcine

pancreatin

formulated

enteric-coated

(acid-resistant)

minimicrospheres, a multi-dose principle which is designed to achieve good mixing with the chyme,

emptying from the stomach together with the chyme and after release, good distribution of enzymes

within the chyme.

When the minimicrospheres reach the small intestine the coating rapidly disintegrates (at pH > 5.5)

to release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats,

starches and proteins. The products of pancreatic digestion are then either absorbed directly, or

following further hydrolysis by intestinal enzymes.

Clinical efficacy and safety

Overall 30 studies investigating the efficacy of Creon (including Creon Micro) in patients with

pancreatic exocrine insufficiency have been conducted. Ten of these were placebo controlled studies

performed in patients with cystic fibrosis, chronic pancreatitis or post-surgical conditions.

In all randomized, placebo-controlled, efficacy studies, the pre-defined primary objective was to show

superiority of Creon over placebo on the primary efficacy parameter, the coefficient of fat absorption

(CFA).

The coefficient of fat absorption determines the percentage of fat that is absorbed into the body

taking into account fat intake and faecal fat excretion. In the placebo-controlled PEI studies, the

mean CFA (%) was higher with Creon treatment (83.0%) as compared to placebo (62.6%). in all

studies, irrespective of the design, the mean CFA (%) at the end of the treatment period with Creon

was similar to the mean CFA values for Creon in the placebo-controlled studies.

Treatment with Creon markedly improves the symptoms of pancreatic exocrine insufficiency

including stool consistency, abdominal pain, flatulence and stool frequency, independent of the

underlying disease.

Paediatric population

In cystic fibrosis (CF) the efficacy of Creon was demonstrated in 288 paediatric patients covering an

age range from newborns to adolescents. In all studies, the mean end-of-treatment CFA values

exceeded 80% of Creon comparably in all paediatric age groups.

Creon Micro has been specifically developed to offer a dosage from for infants and children. One

baseline-adjusted specific study performed over 8 weeks in infants demonstrated that Creon Micro

was effective regarding the improvement of CFA and stool fat excretion as well as faecal energy loss

after two weeks of treatment.

The study was designed mainly to evaluate the efficacy of Creon Micro in 12 infants, aged

1-23 months. The analysis of the results showed that the primary efficacy parameter, CFA,

significantly increased from a baseline mean of 58.0% to a mean of 84.7% (mean increase 26.7%,

p = 0.0013, paired t-test). Height and weight increased, but the weight for height percentile remained

nearly constant and close to 100%.

5.2

Pharmacokinetic properties

Animal studies showed no evidence for absorption of intact enzymes and therefore classical

pharmacokinetic studies have not been performed. Pancreatic enzyme supplements do not require

absorption to exert their effects. On the contrary, their full therapeutic activity is exerted from within

Page 5 of 6

the lumen of the gastrointestinal tract. Furthermore, they are proteins, and as such undergo

proteolytic digestion while passing along the gastrointestinal tract before being absorbed as peptides

and amino acids.

5.3

Preclinical safety data

Preclinical data show no relevant acute, subchronic or chronic toxicity. Studies on genotoxicity,

carcinogenicity or toxicity to reproduction have not been performed.

6. Pharmaceutical Particulars

6.1

List of excipients

Creon Micro modified release granules also contain:

Cetyl alcohol

Dimeticone

Hypromellose phthalate

Macrogol 4000

Triethyl citrate

Creon Micro is gluten free and lactose free.

Pancreatin extract derived from porcine pancreas gland.

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

3 years.

6.4

Special precautions for storage

Store at or below 25°C, protect from moisture.

After opening, do not store above 25°C, protect from moisture and use within 3 months.

6.5

Nature and contents of container

Glass bottle with LDPE stopper and dosing scoop. Pack size of 200 scoop measures (equivalent to

20 grams).

6.6

Special precautions for disposal

Not applicable.

7. Medicines Schedule

General Sale Medicine

8. Sponsor Details

Mylan New Zealand Ltd

PO Box 11183

Ellerslie

Page 6 of 6

AUCKLAND

Telephone 09-579-2792

9. Date of First Approval

2 August 2012

10. Date of Revision of the Text

27 December 2019 New data sheet.

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