Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Macrogol 3350; Sodium sulfate anhydrous; Sodium chloride; Potassium chloride; Macrogol 3350; Sodium chloride; Potassium chloride; Sodium ascorbate; Ascorbic acid
Norgine B.V.
A06AD; A06AD65
Macrogol 3350; Sodium sulfate anhydrous; Sodium chloride; Potassium chloride; Macrogol 3350; Sodium chloride; Potassium chloride; Sodium ascorbate; Ascorbic acid
0 gram(s)
Powder for oral solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives; macrogol, combinations
Marketed
2017-12-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PLENVU POWDER FOR ORAL SOLUTION Macrogol 3350, sodium ascorbate, sodium sulfate anhydrous, ascorbic acid, sodium chloride and potassium chloride. 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 Plenvu is and what it is used for 2. What you need to know before you take Plenvu 3. How to take Plenvu 4. Possible side effects 5. How to store Plenvu 6. Contents of the pack and other information 1. WHAT PLENVU IS AND WHAT IT IS USED FOR Plenvu contains the combination of active substances macrogol 3350, sodium ascorbate, sodium sulfate anhydrous, ascorbic acid, sodium chloride and potassium chloride. Plenvu is a laxative. Plenvu is intended for adults 18 years of age and older prior to any clinical procedure requiring a clean bowel. Plenvu cleans your bowel by causing you to have diarrhoea. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PLENVU DO NOT TAKE PLENVU: • if you are allergic (hypersensitive) to the active substances or any of the other ingredients of Plenvu (listed in section 6) • if you have a blockage in your bowel (bowel obstruction) • if you have an opening in the wall of your stomach or bowel (bowel perforation) • if you have paralysis of the gut (ileus) 2 • if you experience problems with food and fluid emptying from your stomach (e.g. gastric paresis, gastric retention) • if you suffer from phenylketonuria. This is a hereditary inability of the body to use a particular amino acid. Plenvu contains a source of phe Lestu allt skjalið
Health Products Regulatory Authority 19 June 2023 CRN00D393 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Plenvu powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The ingredients of Plenvu are contained in three separate sachets. The first dose is supplied in one sachet and the second dose is supplied in two sachets, A and B. DOSE 1 SACHET contains the following active substances: Macrogol 3350 100 g Sodium sulfate anhydrous 9 g Sodium chloride 2 g Potassium chloride 1 g The concentration of electrolyte ions when the first dose is made up to 500 ml of solution is as follows: Sodium 160.9 mmol/500 ml Sulfate Chloride Potassium 63.4 mmol/500 ml 47.6 mmol/500 ml 13.3 mmol/500 ml Dose 1 also contains 0.79 g of sucralose (E955). DOSE 2 (SACHETS A AND B) contains the following active substances: SACHET A: Macrogol 3350 40 g Sodium chloride 3.2 g Potassium chloride 1.2 g SACHET B: Sodium ascorbate 48.11 g Ascorbic acid 7.54 g The concentration of electrolyte ions when the second dose (Sachets A and B) is made up to 500 ml of solution is as follows: Sodium 297.6 mmol/500 ml Ascorbate Chloride 285.7 mmol/500 ml 70.9 mmol/500 ml Potassium 16.1 mmol/500 ml Excipients with known effect Dose 2 (Sachet A) also contains 0.88 g of aspartame (E951). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. Health Products Regulatory Authority 19 June 2023 CRN00D393 Page 2 of 8 White to yellow powders. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Plenvu is indicated in adults for bowel cleansing prior to any procedure requiring a clean bowel. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ADULTS AND ELDERLY_ _ _ A course of treatment consists of two separate non-identical 500 ml doses of Plenvu. At least 500 ml of additional clear fluid, which may include water, clear soup, fruit juice without pulp, soft drinks, tea and/or coffee without milk must be taken with each dose. This course of treatment can be taken according to a two-da Lestu allt skjalið