Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
MIANSERIN HYDROCHLORIDE
Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
N06AX03
MIANSERIN HYDROCHLORIDE 10 mg
FILM-COATED TABLET
MIANSERIN HYDROCHLORIDE 10 mg
POM
PSYCHOANALEPTICS
Withdrawn
2006-11-02
PATIENT INFORMATION LEAFLET MIANSERIN TABLETS BP KEEP ALL MEDICATION OUT OF THE REACH AND SIGHT OF CHILDREN BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET CAREFULLY This leaflet contains a summary of the information about your medicine, Mianserin Tablets BP. YOUR MEDICINE Your medicine is in the form of a tablet. There are three different strengths of Mianserin Tablets BP available. Each tablet contains either 10 mg marked MI10, 20 mg marked MI20, or 30 mg marked MI30 of the active ingredient Mianserin Hydrochloride. Each tablet also contains maize starch, silicon dioxide, calcium hydrogen phosphate, microcrystalline cellulose, magnesium stearate, hydroxypropylmethyl-cellulose, ethylcellulose (20 mg and 30 mg strengths only), diethyl phthalate, hydroxypropyl cellulose, titanium dioxide and carnauba wax. Mianserin Tablets BP are available in blister packs of 28. Your pharmacist will dispense the number of tablets prescribed by your doctor. Product Licence Holder: Mylan Ireland Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland Manufacturer: Generics [UK] Limited, Station Close, Potters Bar, Hertforsdshire, United Kingdom. WHY DO YOU NEED TO TAKE YOUR MEDICINE? Your tablets contain Mianserin, which belongs to a group of medicines called the tetracyclic ANTIDEPRESSANTS. Your doctor will prescribe Mianserin to help relieve the symptoms of depression. The exact way in which Mianserin works to relieve the symptoms of depression is not known. WHAT SHOULD YOU DO BEFORE TAKING YOUR MEDICINE? YOU MUST TELL YOUR DOCTOR BEFORE TAKING YOUR MEDICINE IF: • you are pregnant, intend to become pregnant or are breast feeding • you have been or are being treated for any mental illness including mania • you suffer from liver disease • you are taking or have recently stopped taking another medicine to treat depression particularly if it is a monoamine oxidase inhibitor (MAOI) • you are recovering from a recent heart attack or a condition called 'heart block' • you suffer from epileps Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Mianserin Tablets BP 10 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg Mianserin Hydrochloride. 3. PHARMACEUTICAL FORM Film coated tablet. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Mianserin Tablets are indicated for symptoms of depressive illness. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The tablets should be swallowed whole without chewing. 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. _Adults_ : Treatment should usually commence with 30 mg or 40 mg mianserin per day for the first few days. The effective dosage usually lies between 30 mg and 90 mg. _Elderly_ : Not more than 30 mg a day initially. The dose should be slowly increased under close supervision. 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 the elderly patient; in addition a lower than normal maintenance dose may be sufficient to produce a satisfactory clinical response. Page 2 of 7 _Children_ : Mianserin should not be used in the treatment of children and adolescents under the age of 18 years (See section 4.4 Special warnings and precautions for use). 4.3 CONTRA-INDICATIONS Mania. Severe liver disease. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Use in children & adolescents under 18 years of age: Mianserin should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed i Soma hati kamili