Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM HYDROGEN CARBONATE
Clonmel Healthcare Ltd
A06AD65
MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM HYDROGEN CARBONATE
13.7 Grams
Powder for Oral Solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives
Authorised
2012-01-06
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER MOVILIEF 13.7G POWDER FOR ORAL SOLUTION, SACHET 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 or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve after 14 days for chronic constipation, or after 3 days for faecal impaction. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Movilief is and what it is used for 2. What you need to know before you take Movilief 3. How to take Movilief 4. Possible side effects 5. How to store Movilief 6. Contents of the pack and other Information 1. WHAT MOVILIEF IS AND WHAT IT IS USED FOR The name of this medicine is Movilief 13.7g powder for oral solution. • It is a laxative for the treatment of chronic constipation in adults, children (aged 12 years and above) and the elderly. • It helps you to have a comfortable bowel movement even if you have been constipated for a long time. It also works in very bad constipation called faecal impaction (complete severe constipation). 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE MOVILIEF DO NOT TAKE MOVILIEF IF YOU: • are allergic to any of the ingredients of this medicine (listed in section 6). • have a perforated gut wall. • have a blockage in your intestine (gut obstruction, ileus) for example by paralysis Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Movilief 13.7g Powder For Oral Solution, Sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains the following active ingredients: Macrogol 3350 13.125 g Sodium chloride 350.7 mg 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 Hydrogen carbonate 17 mmol/l Potassium 5.4 mmol/l For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. A white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of chronic constipation. 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 serious chronic or resistant constipation secondary to multiple sclerosis (MS) or Parkinson’s disease, or induced by regular constipating medication, in particular opioids or 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. _Children below 12 years old: _Not recommended. Alternative products are available for children. _Faecal impaction_ A course of treatment for faecal impaction does not normally exceed 3 days. _Adults, adolescents and the elderly: _8 sachets daily, all of which should be consumed within a 6 hour period. HEAL Preberite celoten dokument