Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
PANCREAS POWDER
BGP Products Ltd
A09AA02
PANCREAS POWDER
400 Milligram
Capsules Gastro-Resistant
Oral use
50 or 100 Gastro-resistant capsules
Product subject to prescription which may be renewed (B)
Abbott Laboratories GmbH
Multienzymes (amylase, lipase, protease)
Enzyme preparations
For the treatment of pancreatic exocrine insufficiency
Authorised
2015-03-27
>>> Pharmacode reading direction (from left to right) Pharmacode reading direction (from right to left) <<< Black - P. 3025 C - Cutting Die MKP-00531-2017_d2 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 immediately 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 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 b Прочитать полный документ
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 during or immediately after 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 irritation of the mucous membranes. Care should be taken that no product is retained in the mouth. It is important to ensure adequate hydration of patients at all times whilst dosing Creon 40000. Colonic damage has been reported in Прочитать полный документ