Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
MACROGOL, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, POTASSIUM CHLORIDE
Stirling Anglian Pharmaceuticals Ireland Limited 3 Burlington Road, Dublin 4, D04RD68, , Ireland
A06AD65
MACROGOL 3350 6.563 g SODIUM CHLORIDE 0.1754 g SODIUM HYDROGEN CARBONATE 0.0893 g POTASSIUM CHLORIDE 0.0233 g
POWDER FOR ORAL SOLUTION
MACROGOL 3350 6.563 g SODIUM CHLORIDE 0.1754 g SODIUM HYDROGEN CARBONATE 0.0893 g POTASSIUM CHLORIDE 0.0233 g
POM
DRUGS FOR CONSTIPATION
Authorised
2015-06-02
Stirling Anglian Pharmaceuticals CosmoCol Paediatric Module 1.3.1 V019 PACKAGE LEAFLET: INFORMATION FOR THE USER COSMOCOL PAEDIATRIC 6.9 G, POWDER FOR ORAL SOLUTION 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 or pharmacist. - This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child‘s. - If you or your child notice 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 CosmoCol Paediatric is and what it is used for 2. What you need to know before you give CosmoCol Paediatric 3. How to use CosmoCol Paediatric 4. Possible side effects 5. How to store CosmoCol Paediatric 6. Contents of the pack and other information 1. WHAT COSMOCOL PAEDIATRIC IS AND WHAT IT IS USED FOR CosmoCol Paediatric is a laxative. This medicine is used to treat: - chronic constipation in children aged 2-11 years. - impaction in children from 5 years. Impaction is persistent constipation, where a large volume of stools cause a blockage of the rectum and / or colon. A medicine with a higher dose is recommended for children over the age of 12. 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE COSMOCOL PAEDIATRIC _ _ DO NOT GIVE COSMOCOL PAEDIATRIC TO YOUR CHILD IF YOUR DOCTOR HAS TOLD YOU THAT YOUR CHILD: - is allergic to Macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients in this medicine (listed in section 6). - has a blockage in their intestine. - has a perforated gut wall. - has a severe inflammatory bowel disease like ulcerative colitis, Crohn's disease or toxic megacolon. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmac Baca dokumen lengkap
V019 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CosmoCol Paediatric 6.9 g, powder for oral solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One sachet of CosmoCol Paediatric contains the following active ingredients: Macrogol 3350, 6.563 g Sodium chloride, 0.1754 g Sodium hydrogen carbonate, 0.0893 g Potassium chloride, 0.0233 g Content of electrolyte ions when one sachet is dissolved in 62.5 mL water: Sodium 65 mmol/l Chloride 53 mmol/l Bicarbonate 17 mmol/l Potassium 5.0 mmol/l Excipients with known effect Each sachet contains: - 12.22 mg (0.31 mmol) potassium - 93.86 mg sodium - 0.38 mg sorbitol (E420) 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 aged 2 to 11 years. For the treatment of faecal impaction in children aged 5 years or above. Faecal impaction is defined as refractory constipation with faecal loading in the rectum and/or colon. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology CHRONIC CONSTIPATION _Children aged 2 to 6 years: _ starting dose of 1 sachet daily. _Children aged 7 to 11 years: _ starting dose of 2 sachets daily. V019 Adjust dose as required to produce regular, soft stools. Introduce dose increases every other day. Normal maximum dose is 4 sachets daily. Doses may be reduced or temporarily omitted in cases of loose stools. Treatment of children with chronic constipation needs to be for a prolonged period (at least 6 - 12 months). However, safety and efficacy of CosmoCol Paediatric has only been proved for a period of up to 3 months. Treatment should be stopped gradually andresume if constipation recurs. FAECAL IMPACTION A course of treatment with CosmoCol Paediatric takes up to 7 days, as follows: DAILY DOSE REGIMEN Number of CosmoCol Paediatric sachets Age Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 5 – 11 years 4 6 8 10 12 12 12 Take the daily number of sachets as divided doses Baca dokumen lengkap