Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Sodium phosphate monobasic; Sodium phosphate dibasic, anhydrous
Laboratoires Mayoly Spindler
A06AD; A06AD17
Sodium phosphate monobasic; Sodium phosphate dibasic, anhydrous
1500 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Osmotically acting laxatives; sodium phosphate
Not marketed
2017-09-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER COLOPREP 1500 MG TABLETS Sodium dihydrogen phosphate monohydrate Disodium phosphate anhydrous READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist. ⁻ 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, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Coloprep is and what it is used for 2. What you need to know before you take Coloprep 3. How to take Coloprep 4. Possible side effects 5. How to store Coloprep 6. Contents of the pack and other information 1. WHAT COLOPREP IS AND WHAT IT IS USED FOR Coloprep contains the active substances sodium dihydrogen phosphate monohydrate and disodium phosphate anhydrous which belong to a group of medicines that are described as purgatives (very strong laxatives). They are used to clean the bowel by causing large amounts of water to be drawn into the bowel resulting in diarrhoea. Coloprep is used for cleansing the bowel before certain diagnostic procedures such as colonoscopy. Coloprep is indicated in adults over the age of 18 years. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLOPREP DO NOT TAKE COLOPREP IF YOU HAVE: an allergy (hypersensitivity) to sodium phosphate salts or to any of the other ingredients of this medicine (listed in section 6). been told that you have kidney failure or that your kidneys have been damaged by the formation of phosphate crystals (phosphate nephropathy). a problem with your parathyroid gland known as primary hyperparathyroidism. problems with your heart, heart failure or severe chest pains. an accumulation of fluid in your abdomen (ascites). bowel problems such Read the complete document
Health Products Regulatory Authority 01 November 2021 CRN009XWF Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coloprep 1500 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1102 mg of sodium dihydrogen phosphate monohydrate and 398 mg of disodium phosphate anhydrous For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white oval compressed 18.7 mm x 10 mm tablets. The upper half bisected with a monogram “SLX” on the left and “102” on the right, and the lower half plain. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicine is indicated for cleansing of the bowel when required as a preparation for certain diagnostic procedures such as colonoscopy. Coloprep is indicated in adults over 18 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS (OVER 18 YEARS OF AGE): The usual adult dosage of this medicine is 32 tablets. The total dose of phosphate is 32.79 g. The intake of this medicine should begin the day before the colonoscopy. The day before the colonoscopy, patients may have a light, low-fibre breakfast (coffee or tea with or without sugar, toast, butter or equivalent, fruit jelly or honey). After noon, taking only “clear liquids” is permitted. “Clear liquid” may be water, light soup, diluted fruit juice without pulp, weak tea or black coffee, light soda with or without bicarbonate. Recommended administration regimen: The evening before the colonoscopy procedure: · Take 4 tablets with 250 ml of water (or another clear liquid) · Then repeat 4 times in the same conditions, every 15 minutes, for a total of 20 tablets to swallow. The day of the colonoscopy procedure, (starting 3-5 hours before the procedure): · Take 4 tablets with 250 ml of water (or another clear liquid) · Then repeat 2 times in the same conditions, every 15 minutes for a total of 12 tablets to swallow. Health Read the complete document