Country: Malta
Tungumál: enska
Heimild: Medicines Authority
LIPASE, AMYLASE, PROTEASE
Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
A09AA02
LIPASE 25000 U AMYLASE 18000 U PROTEASE 1000 U
GASTRO-RESISTANT CAPSULE
LIPASE 25000 U AMYLASE 18000 U PROTEASE 1000 U
POM
DIGESTIVES, INCL. ENZYMES
Authorised
2008-07-11
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 Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Creon 25000 Gastro-resistant Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 300 mg Pancreatin equivalent to: Lipase 25,000 Ph. Eur. units Amylase 18,000 Ph. Eur. units Protease 1,000 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 0, hard gelatin capsules with opaque orange caps and colourless transparent bodies filled with gastro-resistant brown granules. 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: Initially one or two capsules with 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 particularly applies to young children. It is important to ensure adequate hydration of patients at all times whilst dosing Creon 25000. 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 any fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice. 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 early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes. Care should be taken to ensure that no product is retained in the mouth. If the granules are mixed with flu Lestu allt skjalið