国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Macrogol 35000; Sodium bicarbonate; Sodium chloride; Potassium chloride
Imbat Limited
A06AD; A06AD65
Macrogol 35000; Sodium bicarbonate; Sodium chloride; Potassium chloride
13.8 gram(s)
Powder for oral solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives; macrogol, combinations
Authorised
2009-05-08
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MOVICOL ® 13.8G SACHET, POWDER FOR ORAL SOLUTION Your medicine is available using the above name, but will be referred to as ‘Movicol’ throughout this leaflet. 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 Movicol is and what it is used for 2. What you need to know before you take Movicol 3. How to take Movicol 4. Possible side effects 5. How to store Movicol 6. Contents of the pack and other information 1. WHAT MOVICOL IS AND WHAT IT IS USED FOR The name of this medicine is Movicol 13.8g sachet, powder for oral solution. It is a laxative for the treatment of constipation in adults, adolescents and elderly. It is not recommended for children below 12 years of age. Movicol helps you to have a comfortable bowel movement even if you have been constipated for a long time. Movicol also works in very bad constipation called faecal impaction. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVICOL DO NOT TAKE MOVICOL IF YOUR DOCTOR HAS TOLD YOU THAT YOU HAVE: a blockage in your intestine (gut obstruction, ileus) a perforated gut wall severe inflammatory bowel disease like ulcerative colitis, Crohn's disease or toxic megacolon an allergy to the active substances or any of the other ingredients of Movicol (listed in section 6). WARNINGS AND PRECAUTIONS When taking Movicol you should continue to take plenty of fluids. The fluid content of Movicol should not replace your regular liquid intake. HEART CONDITIONS F 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Movicol 13.8g sachet, powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Movicol contains the following active ingredients: The content of electrolyte ions per sachet when made up to 125 ml of solution is as follows: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM _UK:_ Free flowing white powder for oral solution. _France:_ Powder for oral solution _Product imported from France and the UK_ 4 CLINICAL PARTICULARS As per PA0102/023/002 5 PHARMACOLOGICAL PROPERTIES As per PA0102/023/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _UK:_ Acesulfame potassium (E950) as a sweetener Lime and lemon flavour* * (Lime and lemon flavour contains the following constituents: acacia solids, maltodextrin, lime oil, lemon oil, citral, citric acid and water). _France:_ Acesulfame potassium (E950) and lemon flavour 6.2 INCOMPATIBILITIES Not applicable. Macrogol 3350 13.125 g Sodium Chloride 350.7 mg Sodium Bicarbonate 178.5 mg Potassium Chloride 46.6 mg Sodium 65 mmol/l Chloride 53 mmol/l Potassium 5.4 mmol/l Bicarbonate 17 mmol/l 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_ _ _ _1_ _5_ _/_ _0_ _9_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _2_ _6_ _9_ _1_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.3 SHELF LIFE The shelf-life expiry date of the product shall be the date shown on the container and outer package of the product on the market in the country of 阅读完整的文件