Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Pancreatin
LTT Pharma Limited
A09AA; A09AA02
Pancreatin
10000 units/dose
Gastro-resistant capsule
Product subject to prescription which may be renewed (B)
Enzyme preparations; multienzymes (lipase, protease etc.)
Authorised
2015-02-13
PACKAGE LEAFLET: INFORMATION FOR THE USER CREON 10000 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: What Creon is and what it is used for Before you take Creon How to take Creon Possible side effects How to store Creon Further information 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. 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. WHEN YOU NEED TO TAKE SPECIAL CARE WITH CREON A rare bowel condition called “fibrosing colonopathy”, where your gut is narrowed, has been reported in patients with cystic fibrosis taking high dose pancreatin products. However, this is not known to have happened during studies in patients taking Creon. However, if Lire le document complet
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 capsules, hard. _Product imported from Italy._ Size 2 hard gelatin capsules with brown caps and colourless bodies filled with gastro-resistant brown granules. 4 CLINICAL PARTICULARS As per PA2010/008/001 5 PHARMACOLOGICAL PROPERTIES As per PA2010/008/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Macrogol 4000 Hypromellose phthalate Dimeticone 1000 Triethyl citrate Cetyl alcohol Gelatin Iron oxides (E172) Titanium dioxide (E171) Sodium lauril sulfate 6.2 INCOMPATIBILITIES Not applicable H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _2_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _9_ _9_ _7_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C and keep in the original container. Keep the container tightly closed. 6.5 NATURE AND CONTENTS OF CONTAINER HDPE container with polypropylene cap. Container holds 10 Lire le document complet