Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxazepam
DE Pharmaceuticals
N05BA04
Oxazepam
15mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200
PAGE 1 OF 7 PACKAGE LEAFLET PAGE 2 OF 7 PACKAGE LEAFLET: INFORMATION FOR THE USER OXAZEPAM 10 MG AND 15 MG TABLETS (oxazepam) 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 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 1. WHAT OXAZEPAM IS AND WHAT IT IS USED FOR Oxazepam belongs to a group of medicines called benzodiazepines. Oxazepam increases the actions of a naturally occurring substance called GABA, in the brain. Oxazepam is used for the short-term (2 - 4 weeks) treatment of anxiety, which is severe, disabling, distressing and which may be associated with sleeplessness or with other illnesses. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXAZEPAM DO NOT TAKE OXAZEPAM if you are allergic to oxazepam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6) if you have severe breathlessness or breathing difficulties if you suffer from Myasthenia Gravis (a condition which causes muscles to weaken and tire easily) if you have a phobia or obsession, or you are being treated for a mental illness if you suffer from sleep apnoea (a condition where you stop breathing when asleep) if you have severe problems with your liver if you are pregnant, might become pregnant or are breast-feeding WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Oxazepam if you hav Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxazepam Tablets 15mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oxazepam tablets containing oxazepam 15mg. 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 15mg are white round tablets, 6.5mm in diameter, having flat faces with bevelled edges. A breakbar on one face and “15” 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 ADMINISTRATION Oral Läs hela dokumentet