Creon 40000 Gastro-resistant Capsules

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Pancreas powder
Available from:
Mylan IRE Healthcare Limited
ATC code:
A09AA; A09AA02
INN (International Name):
Pancreas powder
Dosage:
400 milligram(s)
Pharmaceutical form:
Gastro-resistant capsule
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Enzyme preparations; multienzymes (lipase, protease etc.)
Authorization status:
Not marketed
Authorization number:
PA2010/008/003
Authorization date:
2006-09-08

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v3/July 2017

Creon 10000 and 25000 gastro-resistant capsules,

150 mg, 300 mg, 50, 100

07 JUN 2019

13:20

Leaflet (Insert)

1871729

400542282

400542311

N.A.

N.A.

Black

8 pt

8 pt

1871729

PA 2010/8/1

Ireland

ABT (Neustadt - DE)

N.A.

1122638

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PACKAGE LEAFLET: INFORMATION FOR THE

USER

Creon 10000

Gastro-resistant Capsules

Creon 25000

Gastro-resistant Capsules

Creon 40000

Gastro-resistant Capsules

pancreatin

Read

this

leaflet

carefully

before

start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

have

further

questions,

your

doctor, pharmacist or nurse.

This medicine has been prescribed for you only.

Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor,

pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

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

WHAT CREON IS AND WHAT IT IS USED FOR

What Creon is

Creon

contains

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

pancreatin

your

(gastro-resistant

pellets,

called

Minimicrospheres™).

What Creon is used for

Creon

used

children

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

rare

bowel

condition

called

“fibrosing

colonopathy”,

where

your

narrowed,

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. Creon can be used while breast-

feeding.

Driving and using machines

It is unlikely that Creon will affect your ability to drive

or operate tools or machines.

3. HOW TO TAKE CREON

Always take Creon exactly as your doctor has told

you. You should check with your doctor if you are

not sure.

How much Creon to take

Your dose is measured in ‘lipase units’. Lipase

is one of the enzymes in pancreatin. Different

strengths of Creon contain different amounts of

lipase.

Always follow your doctor’s advice on how much

Creon to take.

Your doctor will adjust your dose to suit you. It

will depend on:

your illness

your weight

your diet

how much fat is in your stools.

If you still have fatty stools or other stomach or

gut problems (gastrointestinal symptoms), talk

to your doctor as your dose may need to be

adjusted.

If your doctor advises you to increase the number

of capsules you take, you should do so slowly.

When to take Creon

Always take Creon during or immediately after a

meal or a snack. This will allow the enzymes to mix

thoroughly with the food and digest it as it passes

through the gut.

How to take Creon

Swallow the capsules whole.

Do not crush or chew the capsules.

If it is difficult to swallow the capsules, open them

carefully and add the pellets to a small amount

of soft acidic food. This could for example

applesauce. Swallow the mixture immediately,

without crushing or chewing and drink some

water or juice, e.g. apple, orange or pineapple

juice. Or, you can also just take the pellets with

liquid.

Care should be taken that no product is retained

in the mouth.

As a general rule, drink plenty of liquid every day.

How long to take Creon for

Take Creon until your doctor tells you to stop. Many

patients will need to take Creon for the rest of their

lives.

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BACK

Colours

Non-Print

Colours

Date:

Time:

Dimensions

Main Font

Body Text Size

Min Text Size used

Page Count

No. of colours

Pharma Code

SAP No.

Vendor Job No.

Trackwise Proof No.

Client Market

Keyline/Drawing No.

Barcode Info

3D Render ID

Description

Component Type

TrackWise PR No.

MA No.

Packing Site/Printer

Supplier Code

Sign-offs

Equivalent Pantone+

Color Bridge Coated

colours

v3/July 2017

Creon 10000 and 25000 gastro-resistant capsules,

150 mg, 300 mg, 50, 100

07 JUN 2019

13:20

Leaflet (Insert)

1871729

400542282

400542311

N.A.

N.A.

Black

8 pt

8 pt

1871729

PA 2010/8/1

Ireland

ABT (Neustadt - DE)

N.A.

1122638

N.A.

Helvetica Neue

N.A.

300*141mm

Cutting Die

P. 3025 C

1122638

1871729

If you take more Creon than you should

If you take more Creon than you should, drink plenty

of water and talk to a doctor or pharmacist.

Very

high

doses

pancreatin

have

sometimes

caused

much

uric

acid

urine

(hyperuricosuria) and in the blood (hyperuricaemia).

If you forget to take Creon

If you forget a dose, take your next dose at the usual

time, with your next meal. Do not try to make up for

the dose that you have missed.

If you stop taking Creon

Do not stop taking Creon without first talking to your

doctor.

If you have any further questions on the use of this

medicine, ask your doctor, pharmacist or nurse.

POSSIBLE SIDE EFFECTS

Like all medicines, Creon can cause side effects,

although not everybody gets them. The following

side effects were seen during studies in patients

taking Creon. These side effects may happen with

this medicine:

Very Common (may affect more than 1 in 10 people)

pain in your stomach (abdomen).

Common (may affect up to 1 in 10 people)

feeling sick (nausea)

being sick (vomiting)

constipation

bloating (abdominal distention)

diarrhoea.

These may be due to the condition you are taking

Creon for. During studies, the number of patients

taking Creon who had pain in their stomach or

diarrhoea was similar or lower than in patients not

taking Creon.

Uncommon (may affect up to 1 in 100 people)

rash.

Severe itching (pruritus) and hives (urticaria) have

also been reported.

Other serious allergic (hypersensitive) reactions may

be caused by Creon. These can include trouble with

breathing or swollen lips.

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible

side

effects

listed

this

leaflet.

also

report

side

effects

directly

HPRA

Pharmacovigilance, Earlsfort Terrace, IRL - Dublin

2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; e-mail: medsafety@hpra.ie

By reporting side effects you can help

provide more

information on the safety of this medicine.

HOW TO STORE CREON

Keep out of the sight and reach of children.

Do not store above 25°C. Keep container tightly

closed in order to protect from moisture.

After first opening do not store above 25°C and

use within 6 months.

Do not take Creon after the expiry date, which is

stated on the pack. The expiry date refers to the

last day of that month.

Do not throw away any medicines via wastewater

or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These

measures will help to protect the environment.

CONTENTS OF THE PACK AND OTHER

INFORMATION

What Creon contains

The active ingredient in Creon is pancreatin.

Each

Creon

10000

gastro-resistant

capsule

contains 150 mg pancreatin corresponding to

(Ph.Eur. units):

Amylase

8000

Lipase

10000

Protease

Each

Creon

25000

gastro-resistant

capsule

contains 300 mg pancreatin corresponding to

(Ph.Eur. units):

Amylase

18000

Lipase

25000

Protease

1000

Each

Creon

40000

gastro-resistant

capsule

contains 400 mg pancreatin corresponding to

(Ph.Eur. units):

Amylase

25000

Lipase

40000

Protease

1600

The other ingredients are:

Granules:

macrogol

4000,

hypromellose

phthalate, dimethicone, triethyl citrate, cetyl

alcohol

Capsule: iron oxides (E 172), titanium dioxide

(E 171), sodium lauryl sulphate, gelatin

What Creon looks like and the contents of the

pack

The Creon 10000 and 40000 gastro-resistant

capsules are brown and transparent. They contain

gastro-resistant pellets (Minimicrospheres™).

The Creon 25000 gastro-resistant capsules are

orange and transparent. They contain gastro-

resistant pellets (Minimicrospheres™).

Creon is available in bottles with 50 capsules,

100 capsules, 250 capsules, 300 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan IRE Healthcare Limited,

Unit 35/36,

Grange Parade,

Baldoyle Industrial Estate,

Dublin 13.

Manufacturer

Abbott Laboratories GmbH,

31535 Neustadt a. Rbge,

Germany.

This leaflet was last revised in

More

information

about

cystic

fibrosis

pancreatitis

You can find out more about Cystic Fibrosis from the

following organisation:

Cystic

Fibrosis

Association

Ireland,

House, 24 Lower Rathmines, Dublin 6.

You can find out more about Pancreatitis from the

following organisation:

Pancreatitis

Supporters

Network,

8938,

Birmingham B13 9FW, UK.

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Health Products Regulatory Authority

02 August 2019

CRN008LL2

Page 1 of 5

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Creon 40000 Gastro-resistant Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 400 mg pancreatin equivalent to:

Lipase 40,000 Ph.Eur. units

Amylase 25,000 Ph. Eur. units

Protease 1,600 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

Brown/clear size 00 hard gelatin capsule containing light brown, gastro-resistant granules

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

For the treatment of pancreatic exocrine insufficiency.

4.2 Posology and method of administration

Adults (including the elderly) and children:

Creon 40000 should only be used if the patient requires equal to or more than 40,000 lipase units per meal or snack.

Initially one or two capsules during or immediately after meals. The capsules should be swallowed whole, without crushing or

chewing, with enough fluid during or after each meal or snack. Dose adjustments, if required, should be done slowly, with

careful monitoring of response and symptomatology.

When swallowing of capsules is difficult (e.g. small children or elderly patients), the capsules may be carefully opened and the

minimicrospheres added to acidic soft food [pH < 5.5] that does not require chewing, or the minimicrospheres will be taken

with acidic liquid [pH < 5.5].

This could be apple sauce or yoghurt 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 minimicrospheres or mixing with food or fluid with a pH greater than 5.5

can disrupt the protective enteric coating. This can result in the 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 of patients at all times whilst dosing Creon 40000.

Colonic damage has been reported in patients with cystic fibrosis taking in excess of 10,000 units of lipase/kg/day (see section

4.8).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

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 preparations. As a precaution, unusual abdominal symptoms or changes in abdominal symptoms

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02 August 2019

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Page 2 of 5

should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of

10000 units of lipase/kg/day.

4.5 Interaction with other medicinal products and other forms of interactions

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

Fertility and pregnancy

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 or

developmental toxicity is to be expected.

Caution should be exercised when prescribing to pregnant women.

Lactation

No effects on the breast-fed new-borns/infants are anticipated since animal studies suggest no systemic exposure of the

breast-feeding woman to pancreatic enzymes. Pancreatic enzymes can be used during breast-feeding.

If required during pregnancy or lactation Creon should be used in doses sufficient to provide adequate nutritional status.

4.7 Effects on ability to drive and use machines

Creon 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 Creon.

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, diarrhoea*

strictures of the

ileo-caecum and

large bowel

(fibrosing

colonopathy)

Skin and

subcutaneous

tissue disorders

rash

pruritus, urticaria

Immune system

disorders

hypersensitivity

(anaphylactic

reactions).

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

were reported for abdominal pain and diarrhoea.

Strictures 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 Special warnings and precautions for use.

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

post approval use.

Because these reactions were reported spontaneously from a population of uncertain size, it is not possible to reliably estimate

their frequency.

Paediatric population

Health Products Regulatory Authority

02 August 2019

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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 medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected

adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971 ; Fax: +353 1 6762517 .

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

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

Supportive measures including stopping enzyme therapy and ensuring adequate rehydration are recommended.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

Creon contains porcine pancreatin formulated as enteric-coated (acid-resistant) minimicrospheres within gelatin capsules.

The capsules dissolve rapidly in the stomach releasing plentyof 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:

Overall 30studies investigating the efficacy of Creon (Creon capsules with 10000, 25000 or 40000 Ph. Eur units of lipase and

Creon 5000) in patients with pancreatic exocrine insufficiency have been conducted. Tenof 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 fecal 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 improves the symptoms of pancreatic exocrine insufficiency including stool consistency, abdominal pain,

flatulence and stool frequency, independent of the underlying disease.

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02 August 2019

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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% on Creon comparably in all paediatric age

groups.

5.2 Pharmacokinetic properties

Pharmacokinetic data are not available as the enzymes act locally in the gastro-intestinal tract. After exerting their action, the

enzymes are digested themselves in the intestine.

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

Granules:

Macrogol 4000

Cetyl alcohol

Triethyl citrate

Hypromellose phthalate

Dimethicone

Capsule:

Gelatin

Iron oxide (E172)

Titanium dioxide (E171)

Sodium lauryl sulphate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Unopened: 2 years.

After first opening: 6 months.

6.4 Special precautions for storage

Do not store above 25°C.

Keep container tightly closed in order to protect from moisture.

6.5 Nature and contents of container

HDPE tablet container with polypropylene closure, containing 50 or 100 Gastro-resistant capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Health Products Regulatory Authority

02 August 2019

CRN008LL2

Page 5 of 5

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Mylan IRE Healthcare Limited

Unit 35/36

Grange Parade

Baldoyle Industrial Estate

Dublin 13

Ireland

8 MARKETING AUTHORISATION NUMBER

PA2010/008/003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 8th September 2006

Date of last renewal: 8th September 2011

10 DATE OF REVISION OF THE TEXT

July 2019

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