देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mirtazapine
Viatris UK Healthcare Ltd
N06AX11
Mirtazapine
30mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400; GTIN: 5016695000671
1.3.1 SPC, LABELLING AND PACKAGE LEAFLET PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 1. NAME OF THE MEDICINAL PRODUCT Mirtazapine 15 mg orodispersible tablets Mirtazapine Mirtazapine 30 mg orodispersible tablets Mirtazapine Mirtazapine 45 mg orodispersible tablets Mirtazapine 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 15 mg mirtazapine. Each orodispersible tablet contains 30 mg mirtazapine. Each orodispersible tablet contains 45 mg mirtazapine. 3. LIST OF EXCIPIENTS Contains aspartame (E951), see leaflet for further information. 4. PHARMACEUTICAL FORM AND CONTENTS Orodispersible tablet _6 orodispersible tablets _ _18 orodispersible tablets _ _30 orodispersible tablets _ _48 orodispersible tablets _ _90 orodispersible tablets _ _96 orodispersible tablets _ 5. METHOD AND ROUTE(S) OF ADMINISTRATION _ _ Oral use. Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET 7. OTHER SPECIAL WARNING(S), IF NECESSARY ------- 8. EXPIRY DATE EXP _ _ 9. SPECIAL STORAGE CONDITIONS ------- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE ------- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bluefish Pharmceuticals AB, Stockholm, Sweden. 12. MARKETING AUTHORISATION NUMBER(S) Mirtazapine 15 mg Orodispersible Tablets: PL 31774/0013 Mirtazapine 30 mg Orodispersible Tablets: PL 31774/0014 Mirtazapine 45 mg Orodispersible Tablets: PL 31774/0015 13. BATCH NUMBER Lot 14. GENERAL CLASSIFICATION FOR SUPPLY 15. INSTRUCTIONS ON USE ------- 16. INFORMATION IN BRAILLE Mirtazapine 15 mg Mirtazapine 30 mg Mirtazapine 45 mg POM 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET 17. UNIQUE IDENTIFIER – 2D BARCODE_ _ <2D barcode carrying the unique identifier included.> 18. UNIQUE IDENTIFIER - HUMAN READABLE DATA_ _ PC: {number} SN: {number} NN: {number} 1 पूरा दस्तावेज़ पढ़ें
OBJECT 1 MIRTAZAPINE 30 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 19-Dec-2017 | Generics UK T/A Mylan 1. Name of the medicinal product Mirtazapine 30 mg Film-coated Tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 30 mg of mirtazapine. Excipients with known effect: Each tablet contains 226.5 mg lactose anhydrous and 1.8 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet A normal convex, circular buff film coated tablet debossed “MR scoreline 30” on one side and “G” on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. Clinical particulars 4.1 Therapeutic indications Treatment of episodes of major depression 4.2 Posology and method of administration Posology _Adults_ The effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30 mg. 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. If there is no response within a further 2-4 weeks, then treatment should be stopped. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. It is recommended to discontinue treatment with mirtazapine gradually to avoid withdrawal symptoms (see section 4.4). _Older people_ The recommended dose is the same as that for adults. In older people, an increase in dosing should be done under close supervision to elicit a satisfactory and safe response. _Paediatric population_ Mirtazapine should not be used in children and adolescents under the age of 18 years as efficacy was not demonstrated in two short-term clinical trials (see section 5.1) and because of safety concerns (see sections 4.4, 4.8 and 5.1) _Patients with renal impairment_ The clearance of पूरा दस्तावेज़ पढ़ें