Land: Niederlande
Sprache: Niederländisch
Quelle: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
KALIUMCHLORIDE (E 508) 0,0233 g/stuk ; MACROGOL 3350 6,563 g/stuk ; NATRIUMCHLORIDE 0,1754 g/stuk ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) 0,0893 g/stuk
KALIUMCHLORIDE (E 508) 0,0233 g/stuk ; MACROGOL 3350 6,563 g/stuk ; NATRIUMCHLORIDE 0,1754 g/stuk ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) 0,0893 g/stuk
Poeder voor drank
ARABISCHE GOM (E 414) ; ASPARTAAM (E 951) ; BUTYLHYDROXYANISOL (E 320) ; CITROENSMAAKSTOF ; CITROENZUUR 0-WATER (E 330) ; MALTODEXTRINE ; SINAASAPPELSMAAKSTOF ; SUCRALOSE (E 955) ; TOCOFEROL, ALFA (OPTISCHE ROTATIE ONBEKEND), ARABISCHE GOM (E 414) ; ASPARTAAM (E 951) ; BUTYLHYDROXYANISOL (E 320) ; CITROENSMAAKSTOF ; CITROENZUUR 0-WATER (E 330) ; MALTODEXTRINE ; SINAASAPPELSMAAKSTOF ; SUCRALOSE (E 955) ; TOCOPHEROL, ALPHA (OPTICAL ROTATION UNKNOWN)
Oraal gebruik
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BENLAXID 6,9 g poeder voor drank macrogol 3350,sodium chloride,sodium hydrogen carbonate,potassium chloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 only. 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 Benlaxid is and what it is used for 2. What you need to know before you give Benlaxid 3. How to give Benlaxid 4. Possible side effects 5. How to store Benlaxid 6. Contents of the pack and other information 1. WHAT BENLAXID IS AND WHAT IT IS USED FOR The name of this medicine is Benlaxid 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. Benlaxid 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 BENLAXID DO NOT GIVE BENLAXID IF YOUR DOCTOR HAS TOLD YOU THAT YOUR CHILD HAS: - an allergy to the active substances of Benlaxid or any of the other ingredients of this medicine (listed in section 6).” - 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. If your child has a heart or kidney problem, an impaired gag reflex or reflux oesophagitis (heart-burn caused by back-flow of stomach contents into the oesophagus), you should talk to your doctor before giving Benlaxid . WARNINGS Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BENLAXID 6,9 g poeder voor drank 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Benlaxid contains the following active substances: Macrogol 3350 6.563 g Sodium Chloride 0.1754 g Sodium Hydrogen Carbonate 0.0893 g Potassium Chloride 0.0233 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 5.0 mmol/l Bicarbonate 17 mmol/l Excipients with known effect: Each sachet contains 12.5 mg of Aspartame (E951). For the full list of excipients, see section 6.1. 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 – 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). Treatment should be stopped gradually and resumed if constipation recurs. FAECAL IMPACTION A course of treatment for faecal impaction with Benlaxid is for up to 7 days as follows: DAILY DOSAGE REGIMEN: NUMBER OF BENLAXID SACHETS Age (years) Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 5 - 11 4 6 8 10 12 12 12 The daily number of sachets should be taken in divided doses, all consumed within a 12 hour Lesen Sie das vollständige Dokument