Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mirtazapine
A A H Pharmaceuticals Ltd
N06AX11
Mirtazapine
15mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400; GTIN: 5025903006213
Black BLUEFISH PHARMACEUTICALS Product name Dimension Artwork made to No. of colours Braille Artwork code Pantone Shades M/MIR/UK/P01 01 MIRTAZAPINE ORODISPERSIBLE TABLETS Strength Packs 15/30/45 MG NA 200 X 600 MM 100% Country UK Component LEAFLET Manufacturer CENTAUR Reason of change Revision no. Reviewed & Approved by Revision History PDC QA RA Remarks Folding size: 200 x 37.5 mm FONT SIZE: HEADING - 15, 13 PTS. REST ALL 9 PTS. Blister Layout No.: NA Date: 28.02.2017 02 REVISED TEXT RECEIVED ON 28.02.17 R1 - Initial Mock-up Artwork (AM-17-011), text dated (21.02.17) - 28.02.17 NA PACKAGE LEAFLET: INFORMATION FOR THE USER MIRTAZAPINE 15 MG ORODISPERSIBLE TABLETS MIRTAZAPINE 30 MG ORODISPERSIBLE TABLETS MIRTAZAPINE 45 MG ORODISPERSIBLE TABLETS Mirtazapine United kingdom 200 mm 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 or nurse. • 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET: 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. Contents of the pack and other information 1. 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIRTAZAPINE DO NOT TAKE MIRTAZAPINE - if you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of Mirtazapine. If so, you must talk to your doctor as soon as you can before taking Mirtazapine. - if you are taking or have recently taken Lue koko asiakirja
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 Lue koko asiakirja