البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Macrogol 3350; Potassium chloride; Sodium chloride; Sodium hydrogen carbonate
Galen Pharma Ireland Limited
A06AD; A06AD65
Macrogol 3350; Potassium chloride; Sodium chloride; Sodium hydrogen carbonate
13.7 gram(s)
Powder for oral solution in sachet
Osmotically acting laxatives; macrogol, combinations
Not marketed
2013-02-01
1.3.1 Package Leaflet 1 PACKAGE LEAFLET: INFORMATION FOR THE USER ELAXIGOL _13.7g sachet, powder for oral solution _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. • _Keep this leaflet. You may need to read it again. _ _•_ _ _ _If you have further questions, ask your doctor, pharmacist or nurse. _ _•_ _ _ _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 you get any of the 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 Elaxigol is and what it is used for 2. What you need to know before you take Elaxigol 3. How to take Elaxigol 4. Possible side effects 5. How to store Elaxigol 6. Contents of the pack and other information The name of this medicine is Elaxigol 13.7g sachet, powder for oral solution. It is a laxative for the treatment of constipation in adults, adolescents and the elderly. This product is not recommended for children below 12 years of age. It helps you to have a comfortable bowel movement even if you have been constipated for a long time. Elaxigol 13.7g sachet also works in very bad constipation called faecal impaction. DO NOT TAKE ELAXIGOL 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 Elaxigol (listed in section 6). WARNINGS AND PRECAUTIONS When taking Elaxigol 13.7g sachet, you should continue to take plenty of fluids. The fluid content of Elaxigol 13.7g sachet should not replace your regular liquid intake. Talk to your d اقرأ الوثيقة كاملة
Health Products Regulatory Authority 04 August 2020 CRN009QZZ Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elaxigol 13.7g sachet powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains the following active ingredients: Macrogol 3350 13.125 g Sodium chloride 0.3507 g Sodium hydrogen carbonate 0.1785g Potassium chloride 0.0466g 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 Hydrogen carbonate 17 mmol/l Potassium 5.4 mmol/l For a 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. It 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 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. _Paediatric population_ Children (below 12 years old)_:_ Not recommended. Alternative products are available for children. Health Products Regulatory Authority 04 August 2020 CRN009QZZ Page 2 of 5 FAECAL IMPACTION A course of treatment for faecal impaction 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. _Paediatric population_ (Children b اقرأ الوثيقة كاملة