Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Mirtazapine
Organon Pharma (Ireland) Limited
N06AX; N06AX11
Mirtazapine
15 milligram(s)
Orodispersible tablet
Other antidepressants; mirtazapine
Not marketed
2003-02-21
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZISPIN® SOLTAB® 15 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 Zispin is and what it is used for 2. What you need to know before you take Zispin 3. How to take Zispin 4. Possible side effects 5. How to store Zispin 6. Contents of the pack and other information 1. WHAT ZISPIN IS AND WHAT IT IS USED FOR Zispin is one of a group of medicines called ANTIDEPRESSANTS . Zispin is used to treat depressive illness in adults. Zispin 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 ZISPIN DO NOT TAKE ZISPIN: 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 Zispin. 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 before taking Zispin. TELL YOUR DOCTOR BEFORE TAKING ZISPIN: If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Zispin. CHILDREN AND ADOLESCENTS Zispin should normally not be used for children and adolescents under Leggi il documento completo
Health Products Regulatory Authority 24 August 2021 CRN00C84K Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zispin SolTab 15 mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Zispin SolTab 15 mg orodispersible tablet contains 15mg of mirtazapine. Excipient(s) with known effect: Each Zispin SolTab 15 mg orodispersible tablet contains 4.65 mg aspartame and 28 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. Round, white, standard bevelled-edge, coded with ‘TZ1’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zispin 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. _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 Zispin to this category of patients (see section 4.4). Health Products Regulatory Authority 24 August 2021 CRN00C84K Page 2 of 10 _Hepatic impairment_ The clearance of mirtazapine may b Leggi il documento completo