Страна: Мальта
Язык: английский
Источник: Medicines Authority
SODIUM PICOSULFATE, MAGNESIUM OXIDE, LIGHT, CITRIC ACID, ANHYDROUS
Casen Recordati, S.L. Autovia de Logrono, km 13,300, 50180 Utebo, Zaragoza, Spain
A06AB58
SODIUM PICOSULFATE 10 mg MAGNESIUM OXIDE, LIGHT 3.5 g CITRIC ACID ANHYDROUS 10.97 g
POWDER FOR ORAL SOLUTION
SODIUM PICOSULFATE 10 mg MAGNESIUM OXIDE, LIGHT 3.5 g CITRIC ACID ANHYDROUS 10.97 g
POM
DRUGS FOR CONSTIPATION
Authorised
2019-03-25
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CITRAFLEET, POWDER FOR ORAL SOLUTION IN SACHET 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 is and what it is used for 2. What you need to know before you take CitraFleet 3. How to take CitraFleet 4. Possible side effects 5. How to store CitraFleet 6. Contents of the pack and other information 1. WHAT CITRAFLEET IS AND WHAT IT IS USED FOR You are taking CitraFleet 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 a powder that smells and tastes of lemons. It contains two types of laxatives mixed in each sachet which, when dissolved in water and 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 is indicated in adults (including the elderly) aged 18 years and over. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITRAFLEET DO NOT TAKE CITRAFLEET 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 pump blood round the body). - have a condition called GASTRIC RETENTION (your sto Прочитать полный документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CitraFleet, Powder for oral solution in sachet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet (15.08 g) 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 sachet also contains 5 mmol (or 195 mg) potassium and sodium (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral solution in sachet. White crystalline powder with a lemon 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 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 sachet on the evening prior to the procedure and the second sachet in the morning of the day of the procedure. • Both sachets on the afternoon and evening prior to the procedure. This schedule is more suitable when the procedure is early in the morning. • Both sachets 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 sachets should be at least 5 hours. Method of administration _Route of administration: Oral use. _ For instructions on reconstitution of the medicinal product before administration, see section 6.6. _ _ 2 A low residue 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. Because the osmolarity of the product needs to be maintained in order to obtain the desired effect, each sachet should be reconstituted in a cup of water. Do not further dilute the product by drinking liq Прочитать полный документ