Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Mirtazapine
Accord Healthcare Ireland Ltd.
N06AX; N06AX11
Mirtazapine
15 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Other antidepressants; mirtazapine
Marketed
2006-02-17
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MIRTAZAPINE 15 MG, 30 MG & 45 MG FILM-COATED TABLETS Mirtazapine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 is and what it is used for 2. 2 What you need to know before you take Mirtazapine 3. 3 How to take Mirtazapine 4. 4 Possible side effects 5. 5 How to store Mirtazapine 6. 6 Contents of the pack and other information 1. WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR Mirtazapine contains the active ingredient mirtazapine. Mirtazapine is one of a group of medicines called ANTIDEPRESSANTS . Mirtazapine is used to treat depressive illness in adults. Mirtazapine will take 1 to 2 weeks before it starts working. After 2 to 4 weeks you may start feeling better. You must talk to your doctor if you do not feel better or if you feel worse after 2 to 4 weeks. More information is in section 3 heading "When can you expect to start feeling better". 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIRTAZAPINE DO NOT TAKE MIRTAZAPINE • 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. • if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Mirtazapine. TELL YOUR DOCTOR BEFORE TAKING MIRTAZAPINE: If you have ever developed a severe skin rash or skin peeling, blisteri Lees het volledige document
Health Products Regulatory Authority 25 January 2022 CRN00CPZK Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mirtazapine 15 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Mirtazapine 15 mg film-coated tablet contains 15 mg of mirtazapine. Excipients with known effect: Each Mirtazapine 15 mg film-coated tablet contains 101.8 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Yellow, scored on both sides, 10 x 5.2mm oval, biconvex film-coated tablets, marked I. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mirtazapine is indicated in adults for the 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). _ _ _Elderly_ The recommended dose is the same as that for adults. In elderly patients 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 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 se Lees het volledige document