País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxazepam
A A H Pharmaceuticals Ltd
N05BA04
Oxazepam
10mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200; GTIN: 5037563002375
Phama- code area PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Oxazepam 10mg and 15mg Tablets READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • • •Keep•this•leaflet.•You•may•want•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•Oxazepam•is•and•what•it•is•used•for 2 •What•you•need•to•know•before•you•take•Oxazepam 3 •How•to•take•Oxazepam 4 •Possible•side•effects 5 •How•to•store•Oxazepam 6 •Contents•of•the•pack•and•other•information What Oxazepam is and what it is used for 1 Oxazepam•belongs•to•a•group•of•medicines•known•as• benzodiazepines. Oxazepam•is•intended•for•short•term•use•(approximately• 2-4•weeks)•to•relieve•severe•anxiety. What you need to know before you take Oxazepam 2 DO NOT TAKE OXAZEPAM IF: • • •You•are•allergic•(hypersensitive)•to•Oxazepam,•other• benzodiazepines•or•any•of•the•other•ingredients•of•this• medicine•(listed•in•section•6) • • •You•have•a•phobia•(a•very•strong•fear•of•something),• obsessions•or•other•mental•disorders• • • •You•suffer•from•severe•liver•disorders• • • •You•suffer•from•breathing•difficulties • • •You•suffer•from•myasthenia•gravis•(muscle•weakness)• • • •You•suffer•from•sleep•apnoea•syndrome•(a Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxazepam Tablets 10mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oxazepam tablets containing oxazepam 10mg Oxazepam (INN, BAN) is chemically defined as 7-chloro-1,3-dihydro-3- hydroxy-5-phenyl-2H-1 ,4-benzodiazepine-2-one. 3 PHARMACEUTICAL FORM Oxazepam Tablets 10mg are white, round tablets, approx. 6.5mm in diameter, having flat faces with bevelled edges. A break bar on one face and “10” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oxazepam is indicated for the short term relief (2-4 weeks) of anxiety that is disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic and psychotic illness. The use of benzodiazepines to treat short-term anxiety is considered to be inappropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Dosage and duration of therapy should be individualised and all patients receiving oxazepam should be carefully monitored and re-evaluated before any extension of the treatment period. Long-term chronic use is not recommended. As an anxiolytic, the lowest effective dose should be employed for the shortest time possible. Dosage regimes should not exceed beyond 4 weeks and treatment should be withdrawn gradually to minimise possible withdrawal symptoms (See Special Warnings and Precautions for Use). Please note that in patients with renal or hepatic impairment, lower doses may be sufficient (see Special Warnings and Precautions for Use). _Adults: _ • Anxiety – one to two 15mg tablets three (or four) times daily • Insomnia associated with anxiety – In most cases, 15-25mg dose taken 1 hour before retiring. This may be increased to a maximum of 50mg where necessary _Elderly _ _or _ _patients _ _who _ _are _ _particularly _ _sensitive _ _to _ _the _ _effects _ _of _ _benzodiazepines: _ 10-20mg three or four times daily _Children: _ Oxazepam is not recommended for the treatment of children METHOD OF ADMINISTR Leer el documento completo