البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
ZOLPIDEM TARTRATE
Meda Health Sales Ireland Limited
N05CF; N05CF02
ZOLPIDEM TARTRATE
5 milligram(s)
Sublingual tablet
Product subject to prescription which may not be renewed (A)
Benzodiazepine related drugs; zolpidem
Not marketed
2012-09-24
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EDLUAR 5 MG SUBLINGUAL TABLETS EDLUAR 10 MG SUBLINGUAL TABLETS zolpidem tartrate 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 Edluar is and what it is used for 2. What you need to know before you take Edluar 3. How to take Edluar 4. Possible side effects 5. How to store Edluar 6. Contents of the pack and other information 1. WHAT EDLUAR IS AND WHAT IT IS USED FOR Edluar Tablets are sleeping pills (hypnotics) which work by acting on the brain to cause sleepiness. It may be used for short-term treatment of insomnia in adults which is severe, disabling or causing great distress. Insomnia is a difficulty in falling asleep or sleeping properly. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EDLUAR DO NOT TAKE EDLUAR IF YOU: are allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in Section 6). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. have severe liver problems suffer from sleep apnoea (a condition where you stop breathing for very short periods whilst sleeping) suffer from severe muscle weakness (myasthenia gravis) have acute and severe breathing problems WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Edluar if you: are elderly or frail. If you get up at night, take care. Edluar may relax your muscles. This and the sedative effect increases your risk of falling and consequently of hip fractures. اقرأ الوثيقة كاملة
Health Products Regulatory Authority 18 January 2019 CRN008L5P Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Edluar 5 mg sublingual tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sublingual tablet contains 5 mg zolpidem tartrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Sublingual tablet. White, round, flat-faced, bevel-edged tablet approximately 7.5 mm in diameter with V debossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short term treatment of insomnia in adults. Hypnotic/ sedative drugs are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Duration of treatment Treatment should be as short as possible. Generally the duration of treatment varies from a few days to two weeks with a maximum, including the tapering off process, of four weeks. The tapering off process should be tailored to the individual. As with all hypnotics, long-term use is not recommended and a course of treatment should not exceed four weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient‘s status. Posology _Adults_ The treatment should be taken in a single intake and not be re-administered during the same night. Health Products Regulatory Authority 18 January 2019 CRN008L5P Page 2 of 15 The recommended daily dose for adults is 10 mg to be taken immediately at bedtime. The lowest effective daily dose of zolpidem should be used and must not exceed 10 mg. The total dose of Zolpidem should not exceed 10 mg in any patient. _Elderly (over 65 years) or debilitated patients_ Elderly or debilitated patients may be especially sensitive to the effects of Zolpidem therefore a 5 mg dose is recommended. These recommended doses should not be exceeded. _Hepatic impairment_ Patients with hepatic insufficiency do not clear the drug as rapidly as patients with normal h اقرأ الوثيقة كاملة