Creon 10000 Gastro-resistant Capsules

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Pancreas powder; Amylase; Lipase; Protease

Предлага се от:

Viatris Healthcare Limited

АТС код:

A09AA; A09AA02

INN (Международно Name):

Pancreas powder; Amylase; Lipase; Protease

Лекарствена форма:

Gastro-resistant capsule, hard

Терапевтична област:

Enzyme preparations; multienzymes (lipase, protease etc.)

Статус Оторизация:

Marketed

Дата Оторизация:

1997-03-21

Листовка

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

Данни за продукта

Health Products Regulatory Authority
30 June 2023
CRN00DFMJ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 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.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pancreatic exocrine insufficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly) and children:
Initially one to 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.
It is important to ensure adequate hydration of patients at all times
whilst dosing Creon.
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 fruit juice with a pH less than 5.5, e.g. apple,
orange or pineapple juice. If the granules are mixed with food, it is
important that they are taken immediately and the mixture
should not be 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 (see 4.8
Undesirable Effects). Crushing and chewing of the
minimicrospheres