国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Sodium picosulfate; Magnesium oxide, light ; Citric acid
Casen-Recordati S.L.
A06AB58
Sodium picosulfate; Magnesium oxide, light ; Citric acid
Oral solution
sodium picosulfate, combinations
Not marketed
2023-03-03
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CITRAFLEET ORAL SOLUTION SODIUM PICOSULFATE / LIGHT MAGNESIUM OXIDE / CITRIC ACID 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 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 CitraFleet oral solution is and what it is used for 2. What you need to know before you take CitraFleet oral solution 3. How to take CitraFleet oral solution 4. Possible side effects 5. How to store CitraFleet oral solution 6. Contents of the pack and other information 1. WHAT CITRAFLEET ORAL SOLUTION IS AND WHAT IT IS USED FOR You are taking CitraFleet oral solution to clean your bowels (also known as intestines and colon) before having any diagnostic procedure that requires a clean bowel, for example a colonoscopy (procedure that looks inside your bowel using a long, flexible instrument that the doctor inserts through your anus) or x-ray examination. CitraFleet is an oral solution that smells and tastes of grenadine. It contains two types of laxatives mixed in each bottle which, when drunk, wash-out and clean the bowels. It is important to have an empty, clean bowel so that your doctor or surgeon can see it clearly. CitraFleet oral solution is indicated in adults (including the elderly) aged 18 years and over. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITRAFLEET ORAL SOLUTION DO NOT TAKE CITRAFLEET ORAL SOLUTION IF YOU: - are ALLERGIC to sodium picosulfate, magnesium oxide, citric acid or any of the other ingredients of this medicine (listed in section 6). - have CONGESTIVE HEART FAILURE (your heart is unable to properly 完全なドキュメントを読む
Health Products Regulatory Authority 03 March 2023 CRN00CP9P Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CitraFleet oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle (160ml) contains the following active ingredients: Sodium picosulfate 10.0 mg Light magnesium oxide 3.5 g Citric acid 10.97 g Excipients with known effect: Each bottle contains 3.4 g sodium, 0.83g sodium metabisulfite (E 223), 0.17 g sodium methyl p-hydroxybenzoate (E 219), 0.066 g ethanol, 0.02 g sodium propyl p-hydroxybenzoate (E 217) and 0.013 g propylene glycol (E 1520). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. Transparent solution, colourless or slightly yellowish with grenadine flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For bowel cleansing prior to any diagnostic procedures requiring a clean bowel e.g. colonoscopy or x-ray examination. CitraFleet oral solution is indicated in adults (including the elderly) aged 18 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly) aged 18 years and over._ The treatment can be administered in one of the following ways: Usually, one bottle on the evening prior to the procedure and the second bottle in the morning of the day of the procedure. Both bottles on the afternoon and evening prior to the procedure. This schedule is more suitable when the procedure is early in the morning. Both bottles in the morning of the day of the procedure. This regimen is only suitable when the procedure is planned in the afternoon/evening. The time elapsed between the two bottles should be at least 5 hours. Method of administration _Route of administration: Oral use._ A special (low fibre food) diet or only clear liquids on the day before the procedure is recommended. No solid food should be taken from the start of the course of treatment until after the procedure. CitraFleet oral solution should not be mixed or diluted. It is ready to be drunk right from the 完全なドキュメントを読む