Creon 25000 Gastro-resistant Capsules

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

LIPASE, AMYLASE, PROTEASE

Disponível em:

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

Código ATC:

A09AA02

DCI (Denominação Comum Internacional):

LIPASE 25000 U AMYLASE 18000 U PROTEASE 1000 U

Forma farmacêutica:

GASTRO-RESISTANT CAPSULE

Composição:

LIPASE 25000 U AMYLASE 18000 U PROTEASE 1000 U

Tipo de prescrição:

POM

Área terapêutica:

DIGESTIVES, INCL. ENZYMES

Status de autorização:

Authorised

Data de autorização:

2008-07-11

Folheto informativo - Bula

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

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Creon

25000 Gastro-resistant Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300 mg Pancreatin equivalent to:
Lipase
25,000 Ph. Eur. units
Amylase
18,000 Ph. Eur. units
Protease
1,000 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 0, hard gelatin capsules with opaque orange caps and colourless
transparent 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 with 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 particularly
applies to young children.
It is important to ensure adequate hydration of patients at all times
whilst dosing Creon
25000.
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. 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.
If the granules are mixed with flu