Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mirtazapine
Pfizer Ltd
N06AX11
Mirtazapine
15mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400; GTIN: 5013457015218
PACKAGE LEAFLET: INFORMATION FOR THE USER MIRTAZAPINE 15 MG ORODISPERSIBLE TABLETS MIRTAZAPINE 30 MG ORODISPERSIBLE TABLETS MIRTAZAPINE 45 MG ORODISPERSIBLE TABLETS Mirtazapine WHAT IS IN THIS LEAFLET: 1. What Mirtazapine Orodispersible tablets are and what they are used for 2. What you need to know before you take Mirtazapine Orodispersible tablets 3. How to take Mirtazapine Orodispersible tablets 4. Possible side effects 5. How to store Mirtazapine Orodispersible tablets 6. Contents of the pack and other Information 1. WHAT MIRTAZAPINE ORODISPERSIBLE TABLETS ARE AND WHAT THEY ARE USED FOR Mirtazapine is one of a group of medicines called ANTIDEPRESSANTS. Mirtazapine is used to treat depressive illness in adults. Mirtazapine Orodispersible tablets 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 ORODISPERSIBLE TABLETS DO NOT TAKE MIRTAZAPINE − If you are allergic to mirtazapine or any of the other ingredients of Mirtazapine Orodispersible tablets. If so, you must talk to your doctor as soon as you can before taking Mirtazapine Orodispersible tablets. − 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 mirtazapine orodispersible tablets. 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 pharm Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mirtazapine 15 mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 15 mg mirtazapine. Excipient: aspartame 3 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. 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 Mirtazapine orodisperisible tables 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 30mg. 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 mirtazapine tablets 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, particularly with sev Les hele dokumentet