Creon 2000 Capsules Gastro-Resistant 300mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PANCREATIN

Available from:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

A09AA02

INN (International Name):

PANCREATIN 300 mg

Pharmaceutical form:

GASTRO-RESISTANT CAPSULE

Composition:

PANCREATIN 300 mg

Prescription type:

POM

Therapeutic area:

DIGESTIVES, INCL. ENZYMES

Authorization status:

Authorised

Authorization date:

2018-11-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CREON 20 000 GASTRO-RESISTANT CASPULES, 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 20 000 can be used by 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 stool
frequency (di

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Creon 20 000 gastro-resistant capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
*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 0 elongated) with 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 IN CYSTIC 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.
Creon 20000:
One capsule contains 300 mg pancreas powder* corresponding to
Lipase
20,000 Ph.Eur. units
Amylase
16,000 Ph. Eur. units
Protease
1,200 Ph.Eur. units
Page 2 of 6
The dose needed in this population may therefore need to be
established with dosage forms containing
less lip