Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
MACROGOL 3350, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE
Norgine Limited
A06AD65
MACROGOL 3350, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE
13.8 Grams
Powder for Oral Solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives
Authorised
1996-12-03
FONTS USED: Frutiger LT Std-65 Bold Frutiger LT Std-75 Black Helvetica-Regular AVERAGE TEXT SIZE (BODY TEXT): 8.0 pt Frutiger LT Std-55 Roman Frutiger LT Std-66 Bold Italic 10025906 1 CR/15/0257 MOVICOL L&L 07/12/15 Ireland PIL Hengeod NOR-LFT1-V1 157 x 230mm 691 N/A N/A 500756A02 Black Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MOVICOL ® _ _ 13.8G 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 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 Lire le document complet
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 substance: Macrogol 3350 13.125 g Sodium chloride 0.3507 g Sodium bicarbonate 0.1785 g Potassium chloride 0.0466 g The content of electrolyte ions per sachet when made up to 125 ml of solution is as follows: Sodium 65 mmol/l Chloride 53 mmol/l Potassium 5.4 mmol/l Bicarbonate 17 mmol/l For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. Free flowing white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of chronic constipation. Movicol 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 does not normally exceed 2 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 (BELOW 12 YEARS OLD): Not recommended. Alternative MOVICOL products are available for children. FAECAL IMPACTION A course of treatment for faecal impaction with MOVICOL does not normally exceed 3 days. ADULTS, ADOLESCENTS AND OLDER PEOPLE: 8 sachets daily, all of which should be consumed within a 6 hour period. CHILDREN (BELOW 12 YEARS OLD): Not recommended. Alternative MOVICOL products are available for children. 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 _ Lire le document complet