Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Macrogol 3350; Sodium chloride; Sodium hydrogen carbonate; Potassium chloride
Norgine B.V.
A06AD; A06AD65
Macrogol 3350; Sodium chloride; Sodium hydrogen carbonate; Potassium chloride
13.9 g/25 millilitre(s)
Oral solution in sachet
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives; macrogol, combinations
Not marketed
2016-09-02
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MOVICOL READY TO TAKE ORAL SOLUTION IN SACHET Macrogol 3350, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium Chloride 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 Ready to Take is and what it is used for 2. What you need to know before you take Movicol Ready to Take 3. How to take Movicol Ready to Take 4. Possible side effects 5. How to store Movicol Ready to Take 6. Contents of the pack and other information 1. WHAT MOVICOL READY TO TAKE IS AND WHAT IT IS USED FOR The name of this medicine is Movicol Ready to Take oral solution in sachet. It is a laxative for the treatment of constipation in adolescents, adults and older people. It is not recommended for children below 12 years of age. Movicol Ready to Take helps you to have a comfortable bowel movement even if you have been constipated for a long time. Movicol Ready to Take also works in very bad constipation called faecal impaction. You must talk to a doctor if you do not feel better within 2 weeks or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVICOL READY TO TAKE DO NOT TAKE MOVICOL READY TO TAKE IF YOUR DOCTOR HAS TOLD YOU THAT YOU HAVE: - a blockage in your intestine (gut obstruction, ileus) - a perforated gut (a hole in the gut wall) - severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon 2 - an allergy to the active substances or any of the other ingredients of Movicol Ready to Take (listed in Aqra d-dokument sħiħ
Health Products Regulatory Authority 05 July 2021 CRN009W3G Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Movicol Ready to Take 13.9 g/25 ml oral solution in sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 25 mL sachet of Movicol Ready to Take contains the following active substances: Macrogol 3350 13.125 g Sodium chloride 0.3508 g Sodium hydrogen carbonate 0.1786 g Potassium chloride 0.0502 g The concentration of electrolyte ions present in each 25 mL sachet is as follows: Sodium 325 mmol/L Chloride 267 mmol/L Potassium 27 mmol/L Hydrogen carbonate 85 mmol/L This corresponds to the following amount of each electrolyte in each 25 mL dose: Sodium 8.125 mmol Chloride 6.675 mmol Potassium 0.675 mmol Hydrogen carbonate 2.125 mmol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution in sachet Clear, colourless to light yellow, free flowing liquid 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of constipation in adults and adolescents (12 years and above). Movicol Ready to Take 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 Movicol Ready to Take should be used directly from the sachet. This product does not need to be diluted with water. CHRONIC CONSTIPATION A course of treatment for constipation with Movicol Ready to Take 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. Health Products Regulatory Authority 05 July 2021 CRN009W3G Page 2 of 5 For extended use, th Aqra d-dokument sħiħ