Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Macrogol 3350; Sodium bicarbonate; Sodium chloride ; Potassium chloride
Norgine B.V.
A06AD; A06AD65
Macrogol 3350; Sodium bicarbonate; Sodium chloride ; Potassium chloride
6.9 gram(s)
Powder for oral solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives; macrogol, combinations
Not marketed
2004-11-05
1 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MOVICOL ® PAEDIATRIC CHOCOLATE FLAVOUR 6.9G SACHET, POWDER FOR ORAL SOLUTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO GIVE THIS MEDICINE TO YOUR CHILD 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 your child. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s. If your child gets 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 Paediatric Chocolate flavour is and what it is used for 2. What you need to know before you give Movicol Paediatric Chocolate flavour 3. How to give Movicol Paediatric Chocolate flavour 4. Possible side effects 5. How to store Movicol Paediatric Chocolate flavour 6. Contents of the pack and other information 1. WHAT MOVICOL PAEDIATRIC CHOCOLATE FLAVOUR IS AND WHAT IT IS USED FOR The name of this medicine is Movicol Paediatric Chocolate flavour 6.9g sachet, powder for oral solution. It is a laxative for the treatment of chronic constipation in children aged 2 to 11 years and for the treatment of very bad constipation (called faecal impaction) in children aged 5 to 11 years. Movicol Paediatric Chocolate flavour helps your child to have a comfortable bowel movement even if they have been constipated for a long time. 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE MOVICOL PAEDIATRIC CHOCOLATE FLAVOUR DO NOT GIVE MOVICOL PAEDIATRIC CHOCOLATE FLAVOUR IF YOUR DOCTOR HAS TOLD YOU THAT YOUR CHILD HAS: - a blockage in their 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 Movicol P Přečtěte si celý dokument
Health Products Regulatory Authority 17 May 2021 CRN009VJN Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Movicol Paediatric Chocolate Flavour 6.9 g sachet powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Movicol Paediatric Chocolate flavour contains the following active substances: Macrogol 3350 6.563 g Sodium Chloride 0.1754 g Sodium Hydrogen Carbonate 0.0893 g Potassium Chloride 0.0159 g The content of electrolyte ions per sachet when made up to 62.5 ml of solution is as follows: Sodium 65 mmol/l Chloride 51 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 to light brown powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of chronic constipation in children 2 to 11 years of age. For the treatment of faecal impaction in children from the age of five years, defined as refractory constipation with faecal loading of the rectum and /or colon. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _CHRONIC CONSTIPATION _ The usual starting dose is 1 sachet daily for children aged 2 to 6 years, and 2 sachets daily for children aged 7 to 11 years. The dose should be adjusted up or down as required to produce regular soft stools. If the dose needs increasing this is best done every second day. The maximum dose needed does not normally exceed 4 sachets a day. Treatment of children with chronic constipation needs to be for a prolonged period (at least 6-12 months). However safety and efficacy of Movicol Paediatric Chocolate flavour has only been proved for a period of up to three months. Treatment should be stopped gradually and resumed if constipation recurs. _FAECAL IMPACTION_ A course of treatment for faecal impaction with Movicol Paediatric Chocolate flavour is for up to 7 days as follows: DAILY DOSAGE REGIMEN: NUMBER OF MOVICOL PAEDIATRIC CHOCOLATE FLAVOUR SACHETS AGE (YEARS) DAY 1 DAY 2 DAY 3 DAY 4 DAY 5 DAY 6 DAY Přečtěte si celý dokument