CREON 10000 150 Milligram Capsules Gastro-Resistant
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
23-04-2024
Summary of Product characteristics
(SPC)
23-04-2024
Active ingredient:
PANCREAS POWDER
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
PANCREAS POWDER
Dosage:
150 Milligram
Pharmaceutical form:
Capsules Gastro-Resistant
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
CREON 10000 GASTRO-RESISTANT CAPSULES
CREON 25000 GASTRO-RESISTANT CAPSULES
CREON 40000 GASTRO-RESISTANT CAPSULES
pancreatin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
• 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. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the
side effects gets serious, or if you notice any side effects not
listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Creon is and what it is used for
2.
Before you take Creon
3.
How to take Creon
4.
Possible side effects
5.
How to store Creon
6.
Further 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 after a meal or a snack. This will
allow the enzymes to mix thoroughly with the
food.
2.
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 se
Read the complete document
Summary of Product characteristics
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 deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly) and children:
Initially one to two capsules with meals. 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 coati
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