ประเทศ: สหราชอาณาจักร
ภาษา: อังกฤษ
แหล่งที่มา: MHRA (Medicines & Healthcare Products Regulatory Agency)
Temazepam
Genus Pharmaceuticals Ltd
N05CD07
Temazepam
20mg
Oral tablet
Oral
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04010100
TEMAZEPAM 10MG AND 20MG TABLETS _Continued over page_ _Continued top of next column _ BBBA7399 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 TEMAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMAZEPAM TABLETS 3 HOW TO TAKE TEMAZEPAM TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE TEMAZEPAM TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT TEMAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR Temazepam tablets are sedatives which may be used: • for the short-term treatment of insomnia (difficulty sleeping), which is severe, disabling or distressing • as a pre-medication before minor surgery or investigative procedures, especially when hospital admission is not required. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMAZEPAM TABLETS DO NOT TAKE TEMAZEPAM TABLETS IF YOU: • are ALLERGIC to temazepam or any of the ingredients of this medicine (listed in section 6). An allergic reaction may include a rash, itching, difficulty breathing or swallowing or swelling of the face, lips, throat or tongue (see section 6 for list of ingredients) • are UNDER 18 YEARS OF AGE • have any LONG-TERM MENTAL ILLNESS including obsessions or phobias (irrational fears) • suffer from ANXIETY with depression or as the only treatment for depression (as treatment with temazepam may unmask depression or worsen existing depression, or suicidal thoughts) • suffer from sudden or severe BREATHING PROBLEMS • have SEVERE LIVER อ่านเอกสารฉบับเต็ม
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Temazepam Tablets 20mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20mg Temazepam PhEur Excipient with known effect Each 20mg tablet contains 282.20mg lactose PhEur. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White to off-white uncoated tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated for: 1) The short-term treatment of insomnia only when it is severe, disabling, or subjecting the individual to extreme stress, especially for those patients in whom the persistence of a hypnotic effect would be undesirable. 2) The premedication before minor surgical and investigative procedures particularly when hospital admission is not essential. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology Treatment to be given • under close medical supervision • at the lowest effective dose • for the shortest possible duration (not exceeding 4 weeks). Treatment should be tapered off gradually (see section 4.4). 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 the possibility of rebound phenomena. Patients who have received benzodiazepines for a long time may require an extended withdrawal period. The recommended doses are as follows: _Insomnia_ _Adults_ 10-20mg at bedtime. A dose of 20mg will be found satisfactory for most patients. In extreme cases this may be increased to 30-40mg in patients who do not respond to the lower dose. _Elderly or debilitated or those with cerebrovascular disease or hepatic or renal _ _impairment _ 5mg at bedtime. This may be increased to 10mg or to 20mg in extreme cases. _Premedication_ _Adults _ The normal dose is 20-40mg, half an hour to one hour befor อ่านเอกสารฉบับเต็ม