国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MIRTAZAPINE
ORGANON MALAYSIA SDN. BHD.
MIRTAZAPINE
6tablet Tablets; 18tablet Tablets; 30tablet Tablets
Anesta LLC
REMERON SOLTAB ® Mirtazapine (15mg, 30mg) _Consumer Medication Information Leaflet (RiMUP) _ 1 Copyright 2021 Organon group of companies. All rights reserved. WHAT IS IN THIS LEAFLET 1. What REMERON SolTab is used for 2. How REMERON SolTab works 3. Before you take REMERON SolTab 4. How to take REMERON SolTab 5. While you are using REMERON SolTab 6. Side effects 7. Storage and disposal of REMERON SolTab 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT REMERON SOLTAB IS USED FOR REMERON SolTab is one of a group of medicines called ANTIDEPRESSANTS . REMERON SolTab is used to treat depressive illness. HOW REMERON SOLTAB WORKS REMERON SolTab belongs to the group of medicines known as antidepressants that alleviate depressed mood, a characteristic of depression. Depression is a disturbance in emotional life. During depression changes in the brain take place. Nerve cells in the brain communicate with each other by means of chemical substances. In cases of depression the normal supply of these substances is reduced. Antidepressants can restore these deficiencies and re-establish the normal function of the brain. In general it may take two to four weeks of oral treatment before you experience an improvement. BEFORE YOU TAKE REMERON SOLTAB - _When you must not take it _ DO NOT TAKE REMERON SOLTAB: • if you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of REMERON SolTab. If so, you must talk to your doctor as soon as you can before taking REMERON SolTab. • if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAO-Is). - _Before you start to take it _ USE IN CHILDREN AND ADOLESCENTS UNDER 18 YEARS OF AGE REMERON SolTab should normally not be used for children and adolescents under 18 years as efficacy was not demonstrated in two short-term clinical trials and because of safety concerns. Also, you should know that patients under 18 have an increased risk of side-effects such as suic 阅读完整的文件
Remeron Soltab (mirtazapine) 15 & 30mg S-LPC-OG8246-ALL-072020 1 05MYPJ 1. NAME OF THE MEDICINAL PRODUCT Remeron SolTab 15 mg orodispersible tablets Remeron SolTab 30 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Remeron SolTab 15 mg orodispersible tablet contains 15 mg of mirtazapine. Each Remeron SolTab 30 mg orodispersible tablet contains 30 mg of mirtazapine. Excipients: Each Remeron SolTab 15 mg orodispersible tablet contains 4.65 mg aspartame and about 28 mg sucrose. Each Remeron SolTab 30 mg orodispersible tablet contains 9.30 mg aspartame and about 56 mg sucrose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet. 15 mg orodispersible tablet: Round, white, standard beveled-edge, coded with “TZ1” on one side. 30 mg orodispersible tablet: Round, white, standard beveled-edge, coded with “TZ2” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Episode of major depression. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION In order to prevent crushing the tablet, do not push against the tablet pocket (Figure A). Remeron Soltab (mirtazapine) 15 & 30mg S-LPC-OG8246-ALL-072020 2 05MYPJ Fig. 2 Fig. A Each strip contains six tablet pockets, which are separated by perforations. Tear off one tablet pocket along the dotted lines (Figure 1). Fig. 1 Carefully peel off the lidding foil, starting in the corner indicated by the arrow (Figures 2 and 3). Fig. 3 Remeron Soltab (mirtazapine) 15 & 30mg S-LPC-OG8246-ALL-072020 3 05MYPJ The tablet should be taken out of the strip with dry hands and should be placed on the tongue (Figure 4). The tablet will rapidly disintegrate and can be swallowed without water. Fig. 4 Adults Treatment should begin with 15 mg daily. The dosage generally needs to be increased to obtain an optimal clinical response. The effective daily dose is usually between 15 and 45 mg. (the dose should be taken at night). Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment. Treatment with an adequate d 阅读完整的文件