Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
MIRTAZAPINE
MSD PHARMA (SINGAPORE) PTE. LTD.
N06AX11
30 mg
TABLET, FILM COATED
ORAL
Prescription Only
N V ORGANON
1997-06-02
1 S-CCDS-MK8246-ALL-022014 REMERON® Tablets (mirtazapine) 15, 30 and 45mg 1. NAME OF THE MEDICINAL PRODUCT Remeron 15 mg film-coated tablets Remeron 30 mg film-coated tablets Remeron 45 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Remeron 15 mg film-coated tablet contains 15 mg of mirtazapine. Each Remeron 30 mg film-coated tablet contains 30 mg of mirtazapine. Each Remeron 45 mg film-coated tablet contains 45 mg of mirtazapine. Excipients: Each Remeron 15 mg film-coated tablet contains not more than 114 mg lactose (as monohydrate). Each Remeron 30 mg film-coated tablet contains not more than 228 mg lactose (as monohydrate). Each Remeron 45 mg film-coated tablet contains not more than 342 mg lactose (as monohydrate). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 15 mg film-coated tablet: Oval, biconvex, yellow, scored and marked with ‘Organon’ on one side and a code on the other side (TZ over 3) on both sides of the score. The tablet can be divided into equal halves. 30 mg film-coated tablet: 2 Oval, biconvex, red-brown, scored and marked with ‘Organon’ on one side and a code on the other side (TZ over 5) on both sides of the score. The tablet can be divided into equal halves. 45 mg film-coated tablet: Oval, biconvex, white and marked with ‘Organon’ on one side and a code on the other side (TZ over 7). 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Episode of major depression. 4.2 Posology and method of administration 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 Baca dokumen lengkap