Creon for Children 5000 Gastro-resistant Granules

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Pancreas powder

Disponible depuis:

Mylan IRE Healthcare Limited

Code ATC:

A09AA; A09AA02

DCI (Dénomination commune internationale):

Pancreas powder

Dosage:

60.12 milligram(s)

forme pharmaceutique:

Gastro-resistant granules

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Enzyme preparations; multienzymes (lipase, protease etc.)

Statut de autorisation:

Marketed

Date de l'autorisation:

2006-06-23

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
CREON FOR CHILDREN 5000 GASTRO-RESISTANT GRANULES
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 for Children is and what it is used for
2.
Before you take Creon for Children
3.
How to take Creon for Children
4.
Possible side effects
5.
How to store Creon for Children
6.
Further information
1.
WHAT CREON FOR CHILDREN IS AND WHAT IT IS USED FOR
WHAT CREON FOR CHILDREN IS

Creon for Children contains an enzyme mixture called “pancreatin”.

Pancreatin helps you digest food. The enzymes are taken from pig
pancreas glands.

The small pellets of Creon for Children slowly release the pancreatin
in your gut (gastro-
resistant pellets, called Minimicrospheres™).

Creon for Children is for children and infants who cannot swallow
capsules. It is used when
low doses of pancreatin are needed.
WHAT CREON FOR CHILDREN IS USED FOR

Creon for Children is intended for use in children and infants with
“pancreatic exocrine
insufficiency”. This is when their pancreas gland does not make
enough enzymes to digest
food.
HOW CREON FOR CHILDREN WORKS
The enzymes in Creon for Children work by digesting food as it passes
through the gut. You
should take Creon for Children during or immediately after a meal or a
snack. This will allow the
enzymes to mix thoroughly with the food.
2.
BEFORE YOU TAKE CREON FOR CHILDREN
DO NOT TAKE CREON FOR CHILDREN IF:

you are allergic (hypersensitive) to pig pancreatin or to any of the
other ingredients of Creon
for Children (listed in section 6).
If you are not sure, t

Résumé des caractéristiques du produit

Health Products Regulatory Authority
30 March 2022
CRN00CT8F
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Creon for Children 5000 Gastro-resistant Granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg of gastro-resistant granules (equivalent to one measuring
spoonful) contains 60.12mg Pancreatin, containing the
following pancreatic enzymes:
Lipase 5,000 Ph. Eur. units
Amylase 3,600 Ph. Eur. units
Protease 200 Ph. Eur. units
Produced from porcine pancreatic tissue.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro resistant granules
Round, light brown gastro-resistant granules
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of pancreatic exocrine insufficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Initially 100 mg (5000 lipase units) of gastro-resistant granules (one
measure) should be taken with each feed or meal or
immediately after. Dose increases, if required, should be added
slowly, with careful monitoring of response and
symptomatology. The maximum daily dosage should not exceed 10,000
units lipase/kg/day. The required quantity of
gastro-resistant granules should be dispensed using the measuring
spoon contained in the pack which holds 100 mg.
In young infants, Creon for Children 5000 granules should be mixed
with a small amount of infant formula, expressed breast
milk or fruit puree and given immediately from a spoon, directly
before the feed. The granules should not be added to the
baby’s bottle.
In weaned infants, granules should be taken with acidic liquids or
acidic soft foods but without chewing, directly before the
meal. Suitable foodstuffs for use with the granules include apple
sauce or yoghurt or fruit juice with a pH less than 5.5(e.g.
apple, orange or pineapple juice. Alternatively, the granules can be
mixed with a small amount of milk on a spoon and
administered to the infant immediately. The granules should not be
added to the baby’s bottle.
It is important to ensure adequate hydration of patients