Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PANCREAS POWDER
Abbott Healthcare Products Ltd
PANCREAS POWDER
400 Milligram
Capsules Gastro-Resistant
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
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 after a me Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Creon 40000 Gastro-resistant Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 400 mg pancreatin equivalent to: Lipase 40,000 Ph.Eur. units Amylase 25,000 Ph. Eur. units Protease 1,600 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 Brown/clear size 00 hard gelatin capsule containing 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 _Adults (including the elderly) and children:_ Creon 40000 should only be used if the patient requires equal to or more than 40,000 lipase units per meal or snack. Initially one or two capsules with meals. The capsules should be swallowed whole, without crushing or chewing, with enough fluid during or after each meal or snack. Dose adjustments, if required, should be done slowly, with careful monitoring of response and symptomatology When swallowing of capsules is difficult (e.g. small children or elderly patients), the capsules may be carefully opened and the minimicrospheres added to acidic soft food [pH < 5.5] that does not require chewing, or the minimicrospheres will be taken with acidic liquid [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. This mixture should not be stored. 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 the early release of enzymes in the oral cavity and may lead to reduced efficacy and irri Read the complete document