Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE
Auden Mckenzie (Pharma Division) Ltd
A06AD65
MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE
13.8 Grams
Powder for Oral Solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives
Authorised
2009-12-18
PACKAGE LEAFLET PATIENT INFORMATION LEAFLET . _ _ The name of this medicine is LAXAGOL 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. LAXAGOL helps you to have a normal bowel movement even if you have been constipated for a long time. LAXAGOL also works when there is a build up of hard faeces in your bowel which may be a result of long-term constipation (called faecal impaction). LAXAGOL contains macrogol 3350 which makes your faeces softer and easier to pass, giving you relief from constipation. The electrolytes help to maintain your body’s normal levels of sodium, potassium and water while you are being treated for constipation. Do not take LAXAGOL 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 (hypersensitivity) to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride or any of the other ingredients of LAXAGOL _ _ _Take special care with LAXAGOL _ _BEFORE TAKING LAXAGOL TO TREAT FAECAL IMPACTION, YOU SHOULD HAVE THIS CONDITION _ _CONFIRMED BY YOUR DOCTOR. _ _ _ _Heart conditions _ Follow the special instructions in section 3 if you are taking LAXAGOL for faecal impaction. _ _ _Pregnancy and breast feeding _ If you are pregnant or breast feeding talk to your doctor before taking LAXAGOL. _ _ _Driving and using machines _ LAXAGOL does not affect your ability to dri Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT LAXAGOL powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of LAXAGOL contains the following active ingredients: Macrogol 3350 13.125 g Sodium chloride 350.7 mg Sodium bicarbonate (Sodium hydrogen carbonate) 178.5 mg Potassium chloride 46.6 mg 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 (Hydrogen carbonate) 17 mmol/l For a full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Powder for oral solution. Single-dose sachet containing a free flowing white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of chronic constipation. LAXAGOL 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 CHRONIC CONSTIPATION A course of treatment for constipation with LAXAGOL 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 THE ELDERLY: 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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 09/04/2013_ _CRN 2128346_ _page number: 1_ CHILDREN BELOW 12 YEARS OLD: Not re Прочитайте повний документ