Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lorazepam
Teva UK Ltd
N05BA06
Lorazepam
1mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200; GTIN: 5017007112051
TEMESTA ® 1MG TABLETS/LORAZEPAM 1MG TABLETS (lorazepam) Your medicine is known by the above names, but will be referred to as Lorazepam Tablets throughout this: PATIENT INFORMATION LEAFLET IN THIS LEAFLET: 1) What Lorazepam Tablets are and what they are used for 2) Before you take Lorazepam Tablets 3) How to take Lorazepam Tablets 4) Possible side-effects 5) How to store Lorazepam Tablets 6) Further information 1) WHAT LORAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Lorazepam Tablets. Lorazepam is a member of a group of medicines called benzodiazepines. It can help to relieve anxiety. Lorazepam is prescribed as short-term therapy for anxiety (2 -4 weeks), or sleeping difficulties due to anxiety. It may also be used as a sedative before surgery or operative dental treatment. Lorazepam Tablets are not to be used for longer than 4 weeks, to treat mild or moderate anxiety in adults or for anxiety/insomnia in children. 2) BEFORE YOU TAKE LORAZEPAM TABLETS DO NOT TAKE LORAZEPAM TABLETS: • if you have severe breathing or chest problems • if you are allergic to benzodiazepines or any of the other ingredients in Lorazepam Tablets (see list under ‘What Lorazepam Tablets contain’) • if you have myasthenia gravis (very weak or tired muscles) • if you have serious liver problems • if you suffer from sleep apnoea (breathing problems when you are asleep) • if you are breast-feeding, since the drug may pass into breast milk. • if you are planning a pregnancy or are pregnant. If you have been only prescribed Lorazepam Tablets for anxiety and no other medications, please consult with your doctor whether other medications should also be prescribed. WARNINGS AND PRECAUTIONS Talk to your doctor before using Lorazepam Tablets: • if you abuse or have in the past abused drugs or alcohol • if you have a personality disorder. If so, you have a greater chance of becoming dependent on lorazepam • if you have any kidney or liver problems • if you are suffering from depression, since lo Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lorazepam 1mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lorazepam 1mg Tablets contain 1mg of the active ingredient lorazepam. Lorazepam (INN, BAN) is chemically defined as 7-chloro-5-(0-chlorphenyl)- 1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. 3 PHARMACEUTICAL FORM Lorazepam 1mg Tablets are blue, capsule-shaped tablets, measuring approximately 4 x 8mm, plain on one face and ‘gp’ breakbar ‘19’ on the other. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS FOR SHORT TERM (2-4 weeks only) USE (adults only) • 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 (adults and children 5 years and above) Before operative dentistry and general surgery NOT FOR USE • Long term (i.e. longer than 4 weeks) • For mild/moderate anxiety • For insomnia or anxiety 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: 1-4mg daily in divided doses. Insomnia: 1-2mg before retiring Premedication before operative dentistry or general surgery: 2-3mg the night before operation 2-4mg one to two hours before the procedure _Elderly and debilitated patients:_ For elderly and debilitated patients reduce the initial dose by approxima Lue koko asiakirja