Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Mirtazapine
Bluefish Pharmaceuticals AB
N06AX; N06AX11
Mirtazapine
15 milligram(s)
Orodispersible tablet
Product subject to prescription which may not be renewed (A)
Other antidepressants; mirtazapine
Marketed
2008-04-25
PACKAGE LEAFLET: INFORMATION FOR THE USER MIRTAZAPINE BLUEFISH 15 MG ORODISPERSIBLE TABLETS MIRTAZAPINE BLUEFISH 30 MG ORODISPERSIBLE TABLETS MIRTAZAPINE BLUEFISH 45 MG ORODISPERSIBLE 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 or nurse. • 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 or nurse.This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET: 1. What Mirtazapine Bluefish is and what it is used for 2. What you need to know before you take Mirtazapine Bluefish 3. How to take Mirtazapine Bluefish 4. Possible side effects 5. How to store Mirtazapine Bluefish 6. Contents of the pack and other information 1. WHAT MIRTAZAPINE BLUEFISH IS AND WHAT IT IS USED FOR Mirtazapine Bluefish is one of a group of medicines called antidepressants . Mirtazapine Bluefish is used to treat depressive illness in adults. Mirtazapine Bluefish 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 BLUEFISH DO NOT TAKE MIRTAZAPINE BLUEFISH - if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). - if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAO-Is). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist or nurse before taking Mirtazapine Bluefish. DO NOT TAKE - OR - TELL YOUR DOCTOR BEFORE TAKING Pročitajte cijeli dokument
Health Products Regulatory Authority 13 April 2023 CRN00D7ML Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mirtazapine Bluefish 15 mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 15 mg mirtazapine. Excipientwith known effect: aspartame 3 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. Mirtazapine Bluefish 15 mg orodispersible tablets: White, round orodispersible tablets debossed with “36” on one side and ‘A’ on the other side with an embossed circular edge. 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 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 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). 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 account when prescribing Mirtazapine Bluefish to this category of patients (see also section 4.4). Hepatic impairment: The clearance of mirtazapine may be decreased in patients with hepatic impairment. This should be taken into account w Pročitajte cijeli dokument