Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
MIRTAZAPINE
Actavis Group PTC ehf
N06AX11
MIRTAZAPINE
45 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Other antidepressants
Authorised
2007-12-14
V027 CRN 2159262 April 2015 PACKAGE LEAFLET: INFORMATION FOR THE USER MIRTAZAPINE ACTAVIS 15 MG, 30 MG & 45 MG FILM-COATED TABLETS Mirtazapine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU STARTTAKING 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. 1 What Mirtazapine Actavis is and what it is used for 2. 2 Before you take Mirtazapine Actavis 3. 3 How to take Mirtazapine Actavis 4. 4 Possible side effects 5. 5 How to store Mirtazapine Actavis 6. 6 Contents of the pack and other information 1. WHAT MIRTAZAPINE ACTAVIS IS AND WHAT IT ISUSED FOR Mirtazapine Actavis contains the active ingredient mirtazapine. Mirtazapine Actavis is one of a group of medicines called ANTIDEPRESSANTS. Mirtazapine Actavis is used to treat depressive illness. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIRTAZAPINE ACTAVIS DO NOT TAKE MIRTAZAPINE ACTAVIS • if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). If so, you must talk to your doctor as soon as you can before taking Mirtazapine Actavis. • if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs). WARNINGS AND PRECAUTIONS USE IN CHILDREN AND ADOLESCENTS UNDER 18 YEARS OF AGE Mirtazapine Actavis should normally not be used for Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mirtazapine Actavis 45 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Mirtazapine Actavis 45 mg film-coated tablet contains 45 mg of mirtazapine. Excipients with known effect: Each Mirtazapine Actavis 45 mg film-coated tablet contains 305.4 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, 14.5 x 7.5mm oval biconvex film-coated tablets, marked I. 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. _Elderly_ The recommended dose is the same as that for adults. In the elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response. _Paediatric population_ _Children and adolescents under the age of 18 years_ Mirtazapine Actavis should not be used in children and adolescents under the age of 18 (see section 4.4) as efficacy was not demonstrated in two short-term clinical trials (see section 5.1) and because of safety concerns (see section 4.4, 4.8 and 5.1). _Renal impairment_ The clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 ml/min). This should be taken into Прочитајте комплетан документ