Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride
Novalus Healthcare Limited
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)
macrogol, combinations
Authorised
2017-03-01
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 Movicol Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Movicol 13.8g sachet, powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of MOVICOL contains the following active substance: Macrogol 3350 13.1250 g Sodium chloride 0.3507 g Sodium bicarbonate 0.1785 g Potassium chloride 0.0466 g The content of electrolyte ions per sachet when made up to 125ml of solution is as follows: Sodium 65 mmol/l Chloride 53 mmol/l Potassium 5.4 mmol/l Bicarbonate 17 mmol/l For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. _Product imported from France:_ _Powder_ in a sachet. 4 CLINICAL PARTICULARS As per PA0101/023/002 5 PHARMACOLOGICAL PROPERTIES As per PA0101/023/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lemon Flavour, Acesulfame Potassium 6.2 INCOMPATIBILITIES None are known. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the container and outer carton of the product as marketed in the country of origin. Reconstituted solution: maximum of 6 hours. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _8_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _6_ _2_ _2_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store in the original package in order to protect from moisture Sachet: Do not store above 25°C. Reconstituted solution: Store at 2 - 8°C (in a refrigerator and covered). 6.5 NATURE AND CONTENTS OF CONT Read the complete document