Creon 10000 Gastro-resistant Capsules

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

LIPASE, AMYLASE, PROTEASE

Disponibil de la:

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

Codul ATC:

A09AA02

INN (nume internaţional):

LIPASE 10000 U AMYLASE 8000 U PROTEASE 600 U

Forma farmaceutică:

GASTRO-RESISTANT CAPSULE

Compoziție:

LIPASE 10000 U AMYLASE 8000 U PROTEASE 600 U

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

DIGESTIVES, INCL. ENZYMES

Statutul autorizaţiei:

Authorised

Data de autorizare:

2008-07-11

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
CREON 10000 GASTRO-RESISTANT CAPSULES
CREON 25000 GASTRO-RESISTANT CAPSULES
pancreatin
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, 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
1.
WHAT CREON IS AND WHAT IT IS USED FOR
WHAT CREON IS
•
Creon contains an 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 the pancreatin in
your gut (gastro-resistant pellets, called Minimicrospheres™).
WHAT CREON IS USED FOR
•
Creon is used by children and 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
A rare bowel condition called “fibrosing colonopathy”, w

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Creon
®
10000 Gastro-resistant Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150 mg pancreatin, equivalent to:
Lipase
10,000 Ph. Eur. units
Amylase
8,000 Ph. Eur. units
Protease
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.
Size 2 hard gelatin capsules with brown caps and colourless bodies
filled with gastro-resistant
brown granules.
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:
Initially one or two capsules during or immediately after each meal.
Dose increases, if
required, should be
added slowly, with careful monitoring of response and
symptomatology.
The daily dose of pancreatic enzymes for most patients should remain
below 2500 units of lipase
per kilogram per meal (10,000 units per kilogram per day), and that
higher doses should be used
with caution and only if quantitative measures demonstrate
substantially improved absorption
with such treatment. This applies particularly to young children.
The capsules can be swallowed whole, or for ease of administration
they may be opened
and the granules taken with acidic fluid [pH<5.5]or acidic soft food
[pH<5.5]. This
could be apple sauce or yoghurt or any fruit juice with a pH less than
5.5, e.g. apple,
orange or pineapple juice
_. _
If the granules are mixed with fluid or food it is important
that
they are taken immediately and the mixture should not stored,
otherwise dissolution
of the
enteric coating may result. In order to protect the enteric coating,
it is important
that the granules are not crushed or chewed. 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 th