Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxazepam
Genus Pharmaceuticals Holdings Ltd
N05BA04
Oxazepam
15mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200; GTIN: 5030451001252
PATIENT INFORMATION LEAFLET OXAZEPAM 10MG AND 15MG 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. WHAT IS IN THIS LEAFLET 1. What Oxazepam Tablets are and what they are used for 2. Before you take Oxazepam Tablets 3. How to take Oxazepam Tablets 4. Possible side-effects 5. How to store 6. Further Information 1. WHAT OXAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Oxazepam Tablets. Oxazepam is a member of a group of medicines called ‘benzodiazepines’. Oxazepam is prescribed for the short term (maximum of 2-4 weeks) treatment of anxiety, which is disabling or distressing and may be associated with sleeplessness or other illnesses. This medicine should be used for as short a time as possible and should not be used for more than four weeks. If used for too long without a break, there is a risk of becoming dependant or of having problems when you stop taking it. When taking this medicine there is a risk of dependence (a need to keep taking the medicine). The risk increases with the dose and length of treatment period. The risk is greater if you have ever had a history of alcohol or drug abuse. 2. BEFORE YOU TAKE OXAZEPAM TABLETS DO NOT TAKE OXAZEPAM TABLETS AND TELL YOUR DOCTOR: � if you are allergic (hypersensitive) to Oxazepam or to other benzodiazepine medicines or any of the ingredients in your tablets (see section 6) � have a phobia (a fear of a particular object or situation), obsessions or other mental illness � if you have severe breathing or chest problems � if you suffer from sl Preberite celoten dokument
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 Preberite celoten dokument