Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mirtazapine
Genesis Pharmaceuticals Ltd
N06AX11
Mirtazapine
30mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400; GTIN: 5060014442536
NO GOOD FOR COLOR PROOF TEXT BODY: _Font _- Helvetica _Min. size_ - 9 pt Notes Black Keylines Pantone: Colours 240x400mm Size MIRTAZAPINE OLS 30mg FILM-COATED TABLETS (Package leaflet EN) Description Customer 2018-04-11 Date Grasshopper Sistemas de Informação geral@gsiportugal.com www.gsiportugal.com AW.CRC.164.03.V08 Code IN THIS LEAFLET 1. What Mirtazapine Tablets is and what it is used for 2. What you need to know before you take Mirtazapine Tablets 3. How to take Mirtazapine Tablets 4. Possible side effects 5. How to store Mirtazapine Tablets 6. Contents of the pack and other information 1. WHAT MIRTAZAPINE TABLETS IS AND WHAT IT IS USED FOR Mirtazapine 30mg Tablets contain the active substance, mirtazapine. Mirtazapine is one of a group of medicines called antidepressants. Depression is linked to a shortage of substances which carry messages in the brain (including serotonin and noradrenaline). Mirtazapine helps to relieve the shortage of these 'brain messages'. Common signs of depression include feelings of worthlessness or deep sadness; difficulty with everyday tasks; sleeping too much or not being able to sleep; feeling anxious; and changes in appetite. It may take 2 to 4 weeks before you start to feel better and sleep better. It is important to take your medicine every day and not to stop taking it unless your doctor tells you to. If you do, your symptoms may come back. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIRTAZAPINE TABLETS DO NOT TAKE MIRTAZAPINE 30MG TABLETS: Ÿ if you are allergic to mirtazapine or any of the other ingredients of Mirtazapine 30mg Tablets Ÿ if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs) WARNINGS AND PRECAUTIONS CHILDREN AND ADOLESCENTS Mirtazapine 30mg Tablets should normally not be used for children and adolescents under 18 years because efficacy was not demonstrated. Patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggres Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mirtazapine 30mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Mirtazapine 30mg film-coated tablet contains 30mg of mirtazapine. Excipient with known effect: Each Mirtazapine 30mg film-coated tablet contains 203.6mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet, film coated. Brownish, scored on both sides, oval, biconvex, film-coated tablets. Marked with “I” on one side. The tablet can be divided into equal doses. 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 15mg and 45mg; the starting dose is 15mg 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. _Paediatric population _ Mirtazapine tablets should not be used in children and adolescents under the age of 18 years (see section 4.4) 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 a Lees het volledige document