Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxazepam
Kent Pharma (UK) Ltd
N05BA04
Oxazepam
15mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200
OXAZEPAM 15MG TABLETS PATIENT INFORMATION LEAFLET 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. Your medicine is called Oxazepam 15mg Tablets but will be referred to as Oxazepam Tablets throughout the leaflet. Please note that your medicine is available in another strength. WHAT IS IN THIS LEAFLET What Oxazepam Tablets are and what they are used for Before you take Oxazepam Tablets How to take Oxazepam Tablets Possible side-effects How to store Further Information 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. 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 Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxazepam 15mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg of oxazepam. Excipient with known effect: Lactose monohydrate – 95 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Pale yellow tablet marked “OM” break line “15” on one side and “G” on the other 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Oxazepam tablets are indicated for the short-term relief (2-4 weeks) only of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short term psychosomatic, organic or psychotic illness. The use of Oxazepam to treat short-term ‘mild’ anxiety is considered to be inappropriate and unsuitable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology All patients taking oxazepam should be carefully monitored and routine repeat prescriptions should be avoided. Patients who have taken benzodiazepines for a long time may require an extended withdrawal period during which doses are reduced. Long-term chronic use is not recommended. Adults Severe anxiety: The recommended dosage is 15-30mg three or four times daily. Insomnia associated with anxiety Most patients need a dose of 15-25mg but some patients may need up to 50mg. The dose should be taken one hour before retiring. Elderly patients and those who are particularly sensitive to benzodiazepines The recommended dosage is 10-20mg three or four times daily. Children Oxazepam is not recommended for the treatment of anxiety or insomnia in children. Treatment of anxiety should not be continued beyond 8-12 weeks including a tapering off period. Treatment of insomnia should be as short as possible. Generally, the duration of treatment varies from a few days to two weeks with a maximum, including tapering off process of four weeks. In all cases, the dosage of Oxazepam should be titrated according to the needs of the individual patient and the lowe Izlasiet visu dokumentu