Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE
Teva Pharma B.V.
A06AD65
MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE
6.9 Grams
Powder for Oral Solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives
Authorised
2014-02-28
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LAXATEV PAEDIATRIC 6.9 G POWDER FOR ORAL SOLUTION 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What _Laxatev Paediatric_ is and what it is used for 2. What you need to know before you use _Laxatev Paediatric_ 3. How to use _Laxatev Paediatric_ 4. Possible side effects 5. How to store _Laxatev Paediatric_ 6. Contents of the pack and other information 1. WHAT LAXATEV PAEDIATRIC IS AND WHAT IT IS USED FOR The name of this medicine is _Laxatev Paediatric 6.9 g 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. It helps your child to have a comfortable bowel movement even if your child has been constipated for a long time. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE _LAXATEV PAEDIATRIC_ DO NOT GIVE _LAXATEV PAEDIATRIC_ TO YOUR CHILD,_ _ - if your child is allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients of this medicine (listed in section 6) - if your child has a perforated gut (bowel) wall - if your child has a blockage in the intestine (gut obstruction, ileus) - if your child has severe inflammatory bowel disease such as ulcerative colitis, Crohn’s disease or toxic megacolon. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before giving _Laxatev Paediatric_ to your child, if you Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Laxatev Paediatric 6.9g Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains the following active ingredients: Macrogol 3350 6.563 g Sodium chloride 175.4 mg Sodium hydrogen carbonate 89.3 mg Potassium chloride 23.3 mg 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 Hydrogen carbonate 17 mmol/l Potassium 5 mmol/l Excipient with known effect: sorbitol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution Single-dose sachet containing a free flowing white 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 5 to 11 years of age, 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 to be increased 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 to 12 months). However, safety and efficacy have only been proved for a period of up to three months. Treatment should be stopped gradually and resumed if constipation recurs. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Lire le document complet