Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Macrogol 3350
Laboratoires Mayoly Spindler
A06AD; A06AD15
Macrogol 3350
8.50 gram(s)
Powder for oral solution in sachet
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives; macrogol
Not marketed
2016-09-16
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRANSISOFT 8.5 G POWDER FOR ORAL SOLUTION IN SACHET Macrogol 3350 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. 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. You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What TRANSISOFT 8.5 g is and what it is used for 2. What you need to know before you take use TRANSISOFT 8.5 g 3. How to take TRANSISOFT 8.5 g 4. Possible side effects 5. How to store TRANSISOFT 8.5 g 6. Contents of the pack and other information 1. WHAT TRANSISOFT 8.5 G IS AND WHAT IT IS USED FOR HOW IT WORKS It belongs to a group of medicines called osmotic laxatives.This medicine carries water to your stool, which loosens and increases stool volume, helping to overcome sluggish bowels. It is not absorbed into the bloodstream or broken down in the body. WHAT IT IS USED FOR This medicine is used for the treatment of chronic constipation in adults. It is not recommended for children below 17 years of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRANSISOFT 8.5 G INFORMATION ON CONSTIPATION TREATMENT The treatment of chronic constipation with any medicine should only be in addition to a healthy lifestyle and diet, for example: increase the proportion of vegetal source products in the diet (vegetables, bread, fruits), increase water and fruit juice intake, increase physical activity (sports, walking…), rehabilitation of defecation reflex. DO NOT TAKE TRANSISOFT 8.5 G If you are allergic (hypersensitive) to the active substance (macrogol = P.E.G. = polyethylene glycol). If you have s Прочитајте комплетан документ
Health Products Regulatory Authority 15 February 2022 CRN00CP47 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Transisoft 8.5 g powder for oral solution in sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 8.5 g of macrogol 3350. 3 PHARMACEUTICAL FORM Powder for oral solution in sachet. White or almost white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Transisoft 8.5 g powder for oral solution in sachet is indicated for the symptomatic treatment of chronic constipation in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and the elderly: 2 sachets daily. Do not take more than 2 sachets per day. _Paediatric population: _Not recommended in children below 17 years of age. _Elderly_ No dosage change is necessary for the treatment of chronic constipation in elderly. _In patients with renal impairment_ No dosage adjustment is required for the treatment of chronic constipation in patients with renal impairment. (see section 5.2) _Method of administration _ Each sachet should be dissolved in a ½ glass of water (100 mL) just before use. The dissolved solution remains as clear as water. Should be taken as a single dose, preferably in the morning. The effect of Transisoft8.5 g powder for oral solution in sachet usually becomes apparent within 24 to 48 hours after its administration. An organic disorder should have been ruled out before initiation of treatment. Transisoft8.5 g powder for oral solution in sachet should remain a temporary adjuvant treatment to appropriate lifestyle and dietary management of constipation. A course of treatment for chronic constipation with Transisoft 8.5 g does not normally exceed 2 weeks, although this can be repeated if required. As for all laxatives, prolonged use is not usually recommended. If symptoms persist despite associated dietary measures, an underlying cause should be considered. 4.3 CONTRAINDICATIONS Severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon, I Прочитајте комплетан документ