Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride
Norgine Healthcare B.V.
A06AD; A06AD65
Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride
Powder for oral solution
Osmotically acting laxatives; macrogol, combinations
Marketed
2006-01-27
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MOVICOL ® PAEDIATRIC PLAIN 6.9G SACHET, POWDER FOR ORAL SOLUTION (Macrogol 3350, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium Chloride) 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 Plain is and what it is used for 2. What you need to know before you give Movicol Paediatric Plain 3. How to give Movicol Paediatric Plain 4. Possible side effects 5. How to store Movicol Paediatric Plain 6. Contents of the pack and other information 1. WHAT MOVICOL PAEDIATRIC PLAIN IS AND WHAT IT IS USED FOR The name of this medicine is Movicol Paediatric Plain 6.9g sachet, powder for oral solution. It is a laxative for the treatment of chronic constipation in children aged 1 to 11 years and for the treatment of very bad constipation (called faecal impaction) in children aged 5 to 11 years. Movicol Paediatric Plain 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 PLAIN DO NOT GIVE MOVICOL PAEDIATRIC PLAIN 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 of Movicol Paediatric Plain (listed in section 6). _ _ If your child has a heart or kidney problem, Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 27 April 2023 CRN00DFS6 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Movicol Paediatric Plain 6.9 g sachet powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Movicol Paediatric Plain contains the following active substances: Macrogol 3350 6.563 g Sodium Chloride 0.1754 g Sodium Hydrogen Carbonate 0.0893 g Potassium Chloride 0.0251 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 53 mmol/l Potassium 5.4 mmol/l Bicarbonate 17 mmol/l 3 PHARMACEUTICAL FORM Powder for oral solution. Free flowing white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of chronic constipation in children 1 to 11 years of age. For the treatment of faecal impaction in children from the age of 5 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 1 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. For children below 2 years of age, the maximum recommended dose should not exceed 2 sachets a day. For children aged 2 to 11 years, the maximum recommended 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 Plain 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 Plain is for up to 7 days as follows: DAILY DOSAGE REGIMEN: Number of MOVICOL Paediatric Plain sachets AGE (Y Διαβάστε το πλήρες έγγραφο