Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mianserin hydrochloride
Teva UK Ltd
N06AX03
Mianserin hydrochloride
30mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100; GTIN: 5016192612216
1211122 TBC 1211122 TBC PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MIANSERIN 10 MG FILM-COATED TABLETS MIANSERIN 30 MG FILM-COATED TABLETS (mianserin hydrochloride) 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. WHAT IS IN THIS LEAFLET: 1. What Mianserin is and what it is used for 2. What you need to know before you take Mianserin 3. How to take Mianserin 4. Possible side effects 5. How to store Mianserin 6. Contents of the pack and other information 1. WHAT MIANSERIN IS AND WHAT IT IS USED FOR Mianserin belongs to a group of medicines called tetra-cyclic antidepressants. Mianserin is believed to work by increasing the levels of two naturally occurring chemicals within the brain, noradrenaline and 5 hydroxytryptamine (also called serotonin). Your doctor will prescribe Mianserin to help relieve the symptoms of depression. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIANSERIN DO NOT TAKE MIANSERIN IF YOU: • are allergic to mianserin or any of the other ingredients of this medicine (listed in section 6) • suffer from severe liver disease • have been or are being treated for mania (feeling over-excited with unusual behaviour) • are breast-feeding (refer to the 'Pregnancy and breast-feeding' section of this leaflet) • are also taking the following medicines used to treat depression: * a monoamine oxidase inhibitor (MAOI). You should not take mianserin at the same time or within 2 weeks of taking an MAOI. If you have taken mianserin, you should wait 1-2 weeks before you take a MAOI * a selective reversible monoamin Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mianserin 30 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30 mg mianserin hydrochloride. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Round, white film-coated convex tablet marked “MI 30” on one side and “G” on reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mianserin Tablets are indicated for symptoms of depressive illness. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The daily dose can be taken either in divided doses or as a single dose at night (due to the favourable effect on sleep). It is often advantageous to maintain antidepressant treatment for several months after clinical improvement has occurred. In order to ensure an optimal antidepressant effect the dosage of mianserin should not be reduced. _Adults_ Treatment should usually commence with 30 mg or 40 mg mianserin per day increasing gradually as necessary. The effective dosage usually lies between 30 mg and 90 mg. Divided doses of up to 200 mg are well tolerated. _Older people_ The use of mianserin is restricted to patients over 65 who: • do not respond to other antidepressant drugs • have glaucoma • have prostatic hypertrophy Not more than 30 mg a day initially. A lower than normal maintenance dose may be sufficient to produce a satisfactory clinical response. Pharmacokinetic studies of mianserin in the elderly patient suggest a longer half-life and slower metabolic clearance. This information implies that a single night time dose of mianserin should be preferable to the divided dose in older people; in addition a lower than normal maintenance dose may be sufficient to produce a satisfactory clinical response. _Paediatric population_ Mianserin should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.4). Method of administration For oral use. The tablets should be swallowed whole without chewing. 4.3 CONTRAI Læs hele dokumentet