Creon 35000 Gastro-resistant Capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pancreas Powder Ph. Eur.

Available from:

Mylan IRE Healthcare Limited

ATC code:

A09AA02

INN (International Name):

Pancreas Powder Ph. Eur.

Dosage:

35000

Pharmaceutical form:

Gastro-resistant capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

multienzymes (lipase, protease etc.)

Authorization status:

Not marketed

Authorization date:

2019-02-01

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CREON 35 000 GASTRO-RESISTANT CAPSULES, HARD
Pancreas powder
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions ask your doctor or pharmacist
-
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 or pharmacist. 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
1.
WHAT CREON IS AND WHAT IT IS USED FOR
WHAT CREON IS
•
Creon contains an enzyme mixture called “pancreas powder”.
•
Pancreas powder is also called pancreatin. It helps you digest food.
The enzymes are taken
from pig pancreas glands.
•
Creon capsules contain small pellets which slowly release the pancreas
powder in your gut
(gastro-resistant pellets, called minimicrospheres).
WHAT CREON IS USED FOR
Creon is used for the treatment of “pancreatic exocrine
insufficiency”. This is when the pancreas gland
does not make enough enzymes to digest food. It is for example often
found in people who have:
•
cystic fibrosis, a rare genetic disorder
•
chronic inflammation of the pancreas (chronic pancreatitis)
•
had a part or the whole of their pancreas removed (partial or total
pancreatectomy)
•
cancer of the pancreas
Creon 35 000 can be used in children, adolescents and adults. The
dosing in age groups is explained in
section 3 of this leaflet, “How to take Creon”.
Treatment with Creon improves the symptoms of pancreatic exocrine
insufficiency including stool
consistency (e.g. fatty stools), abdominal pain, flatulence and sto

Summary of Product characteristics

Health Products Regulatory Authority
23 November 2020
CRN00C1LR
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Creon 35000 Gastro-resistant Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 420 mg pancreas powder* corresponding to
Lipase 35,000 Ph.Eur. units
Amylase 25,200 Ph. Eur. units
Protease 1,400 Ph.Eur. units
*produced from porcine pancreatic tissue
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
Bicoloured hard gelatin capsule (size 00 elongated) with red brown
opaque cap and transparent body filled with brownish
gastro-resistant pellets (minimicrospheres).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pancreatic enzyme replacement treatment in pancreatic excocrine
insufficiency due to cystic fibrosis or other conditions (e.g.
chronic pancreatitis, pancreatectomy or pancreatic cancer).
Creon gastro-resistant capsules are indicated in children, adolescents
and adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The posology aims at individual needs and depends on the severity of
the disease and the composition of food.
Therapy should be initiated at the lowest recommended dose and
gradually increased with careful monitoring of the patient's
response, symptoms and nutritional status. Patients should be
instructed not to increase the dosage on their own.
Changes in dosage may require an adjustment period of several days.
DOSING INCYSTIC FIBROSIS
Children:
The strengths of 20,000 and 35,000 Ph. Eur. lipase units may not be
suitable for the initiation of therapy in patients under a
certain body weight, depending on the age.
In the paediatric age group, dosing is recommended to be started with
1,000 Ph. Eur. units of lipase units per kilogram body
weight per meal in children less than four years of age, and with 500
Ph.Eur. units of lipase per kilogram bodyweight per meal
in children at the age of four and older.
The dose needed in this population may therefore need to be
established w