Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mirtazapine
Teva UK Ltd
N06AX11
Mirtazapine
45mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400; GTIN: 5017007028727
ZINC Ref: EAS4539C LEA MIRTAZAPINE 15MG 45MG TAB TUK ULM 10 DECEMBER 2020 Version: 1 Colours Used: Length: Width: Depth: 600 MM 148 MM - TEMPLATE UK & Ireland Artwork Department BLACK MIRTAZAPINE 15 AND 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. 1. WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIRTAZAPINE 3. HOW TO TAKE MIRTAZAPINE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE MIRTAZAPINE 6. CONTENT OF THE PACK AND OTHER INFORMATION WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR • Mirtazapine is one of a group of medicines called ANTIDEPRESSANTS. • Mirtazapine is used to treat depressive illness in adults. 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 (MAO-Is). WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING MIRTAZAPINE DO NOT TAKE - OR - TELL YOUR DOCTOR BEFORE TAKING Mirtazapine: IF YOU HAVE EVER DEVELOPED A SEVERE SKIN RASH OR SKIN PEELING, BLISTERING AND/OR MOUTH SORES after taking Mirtazapine or other medicinal product(s). Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself. These may be increase Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mirtazapine 45 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 45 mg of mirtazapine Excipients with known effect: 45 mg: Each tablet contains 323.0 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. 45 mg: White to off-white, round tablets, debossed with the number “93” on one side of the tablet and debossed with the number “7208” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of episodes of major depression Mirtazapine is indicated 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. 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). Older people The recommended dose is the same as that for adults. In older people 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 it to this ca Prečítajte si celý dokument