Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
COATED MIRTAZAPINE 62.5 mg EQV MIRTAZAPINE
ORGANON SINGAPORE PTE. LTD.
N06AX11
Mirtazapine 15mg eqv coated mirtazapine 62.50mg
TABLET
COATED MIRTAZAPINE 62.5 mg EQV MIRTAZAPINE 15 mg
ORAL
Prescription Only
Anesta LLC
ACTIVE
2004-03-25
S-CCDS-MK8246-ALL-122018 REMERON SolTab® 15, 30 and 45 mg Orodispersible Tablet 1. NAME OF THE MEDICINAL PRODUCT Remeron SolTab 15 mg orodispersible tablets Remeron SolTab 30 mg orodispersible tablets Remeron SolTab 45 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. Each Remeron SolTab 45 mg orodispersible tablet contains 45 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. Each Remeron SolTab 45 mg orodispersible tablet contains 13.95 mg aspartame and about 84 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. 45 mg orodispersible tablet: Round, white, standard beveled-edge, coded with “TZ4” 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). Each strip contains six tablet pockets, which are separated by perforations. Tear off one tablet pocket along the dotted lines (Figure 1). Carefully peel off the lidding foil, starting in the corner indicated by the arrow (Figures 2 and 3). Fig. A Fig. 1 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. 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 Đọc toàn bộ tài liệu
S-CCDS-MK8246-ALL-072020 REMERON SolTab® 15 and 30 mg Orodispersible Tablet 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). 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. 2 Fig. 3 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 dose should result in a positive response within 2-4 weeks. With an insufficient response, the dose can be increased up to the maximum dose. Đọc toàn bộ tài liệu