Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Mirtazapine
McDermott Laboratories Ltd., T/A Gerard Laboratories
N06AX; N06AX11
Mirtazapine
30 milligram(s)
Orodispersible tablet
Product subject to prescription which may not be renewed (A)
Other antidepressants; mirtazapine
Not marketed
2008-01-25
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZISMIRT OROTAB 15 MG ORODISPERSIBLE TABLETS ZISMIRT OROTAB 30 MG ORODISPERSIBLE TABLETS ZISMIRT OROTAB 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. - 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. What Zismirt orotab is and what it is used for 2. What you need to know before you take Zismirt orotab 3. How to take Zismirt orotab 4. Possible side effects 5. How to store Zismirt orotab 6. Contents of the pack and other information 1. WHAT ZISMIRT OROTAB IS AND WHAT IT IS USED FOR Zismirt orotab is one of a group of medicines called ANTIDEPRESSANTS . Zismirt orotab is used to treat depressive illness in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZISMIRT OROTAB DO NOT TAKE ZISMIRT OROTAB: - 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 inhibitors). WARNINGS AND PRECAUTIONS DO NOT TAKE OR TELL YOUR DOCTOR BEFORE TAKING ZISMIRT OROTAB: If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Zismirt orotab or other medicines. Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of Zismirt orotab. Stop using and seek medical attention immediately if you notice any of the symptoms read_full_document
Health Products Regulatory Authority 18 November 2022 CRN00CK5G Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zismirt orotab 30 mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 30 mg mirtazapine. Excipient with known effects: Each orodispersible tablet contains 6 mg aspartame. For the full list of the excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. Round and white, marked with the code ‘37’ on one side and ‘A’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of episodes of major depression in adults. 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. Zismirt orotab 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. _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 to this category of patients (see section 4.4). _Hepatic impairment_ The clearance of mirtazapine may be decreased in patients with hepatic impairment. This should be taken into account when prescribing mirtazapine to this category of patients, read_full_document