País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lorazepam
Thame Laboratories Ltd
N05BA06
Lorazepam
1mg/1ml
Oral solution
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200; GTIN: 05055935100832
PIL/UK/MFG024/05/v8 TURN OVER L PACKAGE EAFLET: INFORMATION FOR THE USER LORAZEPAM 1MG/ML ORAL SOLUTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS 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 your leaflet. See section 4. The name of your medicine is Lorazepam 1mg/ml Oral Solution but it will be referred to as 'Lorazepam' throughout this leaflet. WHAT IS IN THIS LEAFLET 1. WHAT LORAZEPAM IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORAZEPAM 3. HOW TO TAKE LORAZEPAM 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE LORAZEPAM 1MG/ML ORAL SOLUTION 6. CONTENTS OF THE PACK AND OTHER INFORMATION Lorazepam is not to be used for longer than 4 weeks or to treat mild or moderate anxiety in adults. if you have severe breathing or chest problems if you are allergic to benzodiazepines or any of the other ingredients in Lorazepam (see list under ‘What Lorazepam contains’) if you have myasthenia gravis (very weak or tired muscles) if you have serious liver problems if you are planning a pregnancy or are pregnant. If you have been only prescribed Lorazepam for anxiety and no other medications, please consult with your doctor whether other medications should also be prescribed. 1. WHAT LORAZEPAM IS AND WHAT IT IS USED FOR WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORAZEPAM You should avoid alcohol while you are taking lorazepam, since this you very drowsy and seriously affect your ability to drive or use machines. The medicine can affect your ability to drive as it may make you feel sleepy or dizzy. DRIVING AND USING MACHINES Lorazepam may make you feel dizzy, sleepy or forgetful during the day, or may Llegiu el document complet
OBJECT 1 LORAZEPAM 1MG/ML ORAL SOLUTION Summary of Product Characteristics Updated 06-Jun-2018 | Thame Laboratories 1. Name of the medicinal product Lorazepam 1mg/ml Oral Solution 2. Qualitative and quantitative composition Each ml of oral solution contains 1mg lorazepam. _Excipients with known effect: _ Each ml of oral solution contains 20.21mg ethanol (alcohol). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral Solution A clear, colourless to pale yellow colour oral solution 4. Clinical particulars 4.1 Therapeutic indications FOR SHORT TERM (2-4 weeks only) USE • Symptomatic relief of anxiety that is severe, disabling or subjecting the individual to unacceptable distress occurring alone or in association with insomnia or short-term psychometric, organic or psychotic illness. AS PREMEDICATION • Before operative dentistry and general surgery NOT FOR USE • Long term (i.e. longer than 4 weeks) • For mild/moderate anxiety Lorazepam Oral Solution is not recommended for use in children. 4.2 Posology and method of administration Route of administration: oral Treatment to be given: • Under close medical supervision • At the lowest effective dose • For the shortest possible duration (not exceeding 4 weeks) Doses should be individualised Extension of use should not take place without further clinical evaluation Chronic use not recommended (little is known of the long term safety and efficacy; potential for dependence) (see section 4.4) When treatment is started the patient should be informed that • Treatment will be of limited duration • The dosage will be progressively decreased • There is a possibility of rebound phenomena Dosage: _Adults:_ • Anxiety: 1 - 4ml (1 - 4mg) daily in divided doses. • Insomnia: 1 - 2ml (1 - 2mg) before retiring • Premedication before operative dentistry or general surgery: 2 - 3ml (2 - 3mg) the night before operation 2 - 4ml (2 - 4mg) one to two hours before the procedure _Elderly:_ The elderly may respond to lower doses (half normal adult Llegiu el document complet