国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Macrogol 3350; Sodium bicarbonate; Sodium chloride ; Potassium chloride
Norgine B.V.
A06AD; A06AD65
Macrogol 3350; Sodium bicarbonate; Sodium chloride ; Potassium chloride
13.9 gram(s)
Powder for oral solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives; macrogol, combinations
Not marketed
2008-11-13
1 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MOVICOL ® CHOCOLATE 13.9G, SACHET POWDER FOR ORAL SOLUTION 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 Chocolate is and what it is used for 2. What you need to know before you take Movicol Chocolate 3. How to take Movicol Chocolate 4. Possible side effects 5. How to store Movicol Chocolate 6. Contents of the pack and other information 1. WHAT MOVICOL CHOCOLATE IS AND WHAT IT IS USED FOR The name of this product is Movicol Chocolate 13.9 g 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 Chocolate helps you to have a comfortable bowel movement even if you have been constipated for a long time. Movicol Chocolate also works in very bad constipation known as faecal impaction. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVICOL CHOCOLATE DO NOT TAKE MOVICOL CHOCOLATE 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 Chocolate (listed in section 6). WARNINGS AND PRECAUTIONS When taking Movicol Chocolate you should continue to take plenty of fluids. The fluid content of Movicol should not replace your regular liquid intake. 2 阅读完整的文件
Health Products Regulatory Authority 17 May 2021 CRN009VJN Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Movicol Chocolate 13.9 g sachet powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Movicol Chocolate contains the following active substances: Macrogol 3350 13.1250g Sodium Chloride 0.3507g Sodium Hydrogen Carbonate 0.1785g Potassium Chloride 0.0317g The content of electrolyte ions per sachet when made up to 125 ml of solution is as follows: Sodium 65 mmol/l Chloride 51 mmol/l Potassium 5.4 mmol/l Hydrogen Carbonate 17 mmol/l Excipient(s) with known effect Movicol Chocolate contains benzyl alcohol 14.1 mg per sachet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. White to light brown free flowing powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of chronic constipation in adults and children above the age of 12. Movicol Chocolate is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology CHRONIC CONSTIPATION A course of treatment for constipation with Movicol Chocolate does not normally exceed two weeks, although this can be repeated if required. As for all laxatives, prolonged use is not usually recommended. Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced by regular constipating medication, in particular opioids and antimuscarinics. ADULTS, ADOLESCENTS AND OLDER PEOPLE: 1-3 sachets daily in divided doses, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 sachets daily. CHILDREN UNDER 12 YEARS OF AGE: Not recommended. Alternative Movicol products are available for children. FAECAL IMPACTION A course of treatment for faecal impaction with Movicol Chocolate does not normally exceed 3 days. 阅读完整的文件