Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Macrogol 3350; Sodium chloride; Sodium hydrogen carbonate; Potassium chloride
Mylan IRE Healthcare Limited
A06AD; A06AD65
Macrogol 3350; Sodium chloride; Sodium hydrogen carbonate; Potassium chloride
13.125/350 milligram(s)
Powder for oral solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives; macrogol, combinations
Marketed
2009-12-04
PACKAGE LEAFLET: INFORMATION FOR THE USER MOLAXOLE® POWDER FOR ORAL SOLUTION, Macrogol 3350 Sodium chloride Sodium hydrogen carbonate 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 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 or nurse. This includes any possible side effects not listed in this leaflet. – You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks of constipation. If you are treated for very bad constipation (called faecal impaction) you should follow your doctor’s instruction. WHAT IS IN THIS LEAFLET: 1. What Molaxole is and what it is used for 2. What you need to know before you take Molaxole 3. How to take Molaxole 4. Possible side effects 5. How to store Molaxole 6. Contents of the pack and other information 1. WHAT MOLAXOLE IS AND WHAT IT IS USED FOR Molaxole helps you to have a comfortable bowel movement even if you have been constipated for a long time. After consulting a doctor, Molaxole can also be used for treatment of very bad constipation (called faecal impaction). Macrogol 3350 increases the volume of faeces by binding water leading to a normalisation of motility in the colon. The physiological consequences are an increased movement of the softened stools and easing of defecation. The salts in the formulation help maintain the body´s normal salt and water balance. You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks of constipation. If you are treated for very bad constipation (called faecal impaction) you should follow your doctor’s instruction. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOLAXOLE Do not take Molaxole – if you ar Đọc toàn bộ tài liệu
Health Products Regulatory Authority 24 November 2020 CRN00C1SK Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Molaxole powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains following active substances Macrogol 3350 13.125 g Sodium chloride 350.7 mg Potassium chloride 46.6 mg Sodium hydrogen carbonate 178.5 mg The content of electrolyte ions per sachet when made up to 125 ml of solution Sodium 65 mmol/l Potassium 5.4 mmol/l Chloride 53 mmol/l Hydrogen carbonate 17 mmol/l For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for oral solution A white crystalline powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of chronic constipation. Resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by physical examination of the abdomen and rectum. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY_ _ _ _Chronic constipation:_ Adults: 1-3 sachets daily in divided doses. Normal dose for most patients is 1-2 sachets per day. Depending on the individual response 3 sachets per day might be needed. A course of treatment for constipation does not normally exceed two weeks, although this can be repeated if required. For extended use, the lowest effective dose should be used. _Faecal impaction:_ Adults: 8 sachets daily, all of which should be consumed within a 6 hour period. A course of treatment for faecal impaction does not normally exceed 3 days. _Patients with impaired cardiovascular function:_ For the treatment of faecal impaction, the dose should be divided so that no more than two sachets are taken in any one hour. _Patients with renal insufficiency:_ Health Products Regulatory Authority 24 November 2020 CRN00C1SK Page 2 of 5 No dosage change is necessary for treatment of either constipation or faecal impaction. Paediatric population: Not recommended for children below 12 years old. METHOD OF ADMINISTRATION Administration: Each sachet should b Đọc toàn bộ tài liệu