Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mirtazapine
Accord-UK Ltd
N06AX11
Mirtazapine
45mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400; GTIN: 5012617015648
READ ALL OF THIS LEA F LET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this lea f let. 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 LEA F LET 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. 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 this medicine (listed in section 6). • if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAO-Is). 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). WARNINGS AND PRECAUTIONS CHILDREN AND ADOLESCENTS Mirtazapine should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may pres Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mirtazapine 45 mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 45 mg of mirtazapine. Excipient(s): 18 mg of Aspartame (E951) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Orodispersible tablet The tablets are white or almost white, 12 mm round, biconvex, uncoated tablets and marked M4. 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 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 Mirtazapine 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 severe hepatic impairment, as patients with severe hepatic impairment have not been investigated (see section 4.4). Paediatric population M Läs hela dokumentet