Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride
PCO Manufacturing Ltd.
A06AD; A06AD65
Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride
13.8 gram(s)
Powder for oral solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives; macrogol, combinations
Authorised
2005-12-22
_ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MOVICOL ® 13.8 G SACHET, POWDER FOR ORAL SOLUTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get 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 is and what it is used for 2. What you need to know before you take Movicol 3. How to take Movicol 4. Possible side effects 5. How to store Movicol 6. Contents of the pack and other information 1. WHAT MOVICOL IS AND WHAT IT IS USED FOR The name of this medicine is Movicol 13.8g sachet, powder for oral solution. It is a laxative for the treatment of constipation in adults, adolescents and elderly. It is not recommended for children below 12 years of age. Movicol helps you to have a comfortable bowel movement even if you have been constipated for a long time. Movicol also works in very bad constipation called faecal impaction. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVICOL DO NOT TAKE MOVICOL IF YOUR DOCTOR HAS TOLD YOU THAT YOU HAVE: – a blockage in your 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 (listed in section 6). WARNINGS AND PRECAUTIONS When taking Movicol you should continue to take plenty of fluids. The fluid content of Movicol should not replace your regular liquid intake. HEART CONDITIONS Follow the special instructions in section 3 if you are taking Movicol for faecal impaction. OTHER MEDICINES AND Soma hati kamili
Health Products Regulatory Authority 05 February 2020 CRN009K2P Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Movicol 13.8 g sachet, powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Movicol contains the following active ingredients: Macrogol 3350 13.125 g Sodium chloride 350.70 mg Sodium bicarbonate 178.50 mg Potassium chloride 46.60 mg The content of electrolyte ions per sachet when made up to 125ml of solution is as follows: Sodium 65.00 mmol/l Chloride 53.00 mmol/l Potassium 5.40 mmol/l Bicarbonate 17.00 mmol/l For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. _Product imported from France and United Kingdom:_ Free flowing, white powder. 4 CLINICAL PARTICULARS As per PA1336/006/005 5 PHARMACOLOGICAL PROPERTIES As per PA1336/006/005 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Product imported from France_ Lemon flavour Acesulfame potassium (E950) _Product imported form the UK:_ Lemon and lime flavour (containing acacia solids, maltodextrin, lime oil, lemon oil, citral, citric acid and water). Acesulfame potassium (E950) 6.2 INCOMPATIBILITIES Not applicable. Health Products Regulatory Authority 05 February 2020 CRN009K2P Page 2 of 2 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. Reconstituted solution: 6 hours. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Sachet: Do not store above 25°C. Store in the original package in order to protect from moisture. Reconstituted solution: Store at 2ºC – 8ºC (in a refrigerator and covered). 6.5 NATURE AND CONTENTS OF CONTAINER 20 or 30 overlabelled sachets contained in an outer cardboard carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL Any unused solution should be discarded within 6 hours. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISAT Soma hati kamili