Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Zolpidem tartrate
Alliance Healthcare (Distribution) Ltd
N05CF02
Zolpidem tartrate
5mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010100
PATIENT INFORMATION LEAFLET ZOLPIDEM 5MG OR 10MG TABLETS 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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect. WHAT IS IN THIS LEAFLET: 1. What zolpidem is and what it is used for 2. What you need to know before you take zolpidem 3. How to take zolpidem 4. Possible side effects 5. How to store zolpidem 6. Contents of the pack and other information 1. WHAT ZOLPIDEM IS AND WHAT IT IS USED FOR The name of your medicine is Zolpidem 5mg or 10mg Tablets (called zolpidem throughout this leaflet). Zolpidem contains a medicine called zolpidem tartrate. This belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep. Zolpidem is used for temporary sleep problems in adults that are causing you severe distress or that are affecting your everyday life. This includes sleep problems in adults such as: • Difficulty falling asleep • Waking in the middle of the night • Waking too early Your doctor will identify your sleep problem wherever possible and the underlying factors before prescribing this medicine for you. The failure of your sleep problems to stop after a 7- 14 day course of treatment may indicate you have an underlying disorder, your doctor will assess you at regular intervals. Zolpidem is used for short-term treatment of insomnia in adults. Do not use long-term. Treatment should be as short as possible, because th Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zolpidem Tartrate 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg zolpidem tartrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Round, white, film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zolpidem is indicated for the short-term treatment of insomnia in adults in situations where the insomnia is debilitating or is causing severe distress for the patient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The treatment should be taken in a single intake and not be re-administered during the same night. 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. Treatment should be as short as possible. It should not exceed four weeks including the period of tapering off. In certain cases extension beyond the maximum treatment period may be necessary; if so, extension beyond the maximum treatment period should not take place without re-evaluation of the patient’s status, since the risk of abuse and dependence increases with the duration of treatment (see section 4.4). Special populations _Paediatric population _ Zolpidem is not recommended for use in children and adolescents below 18 years of age, due to a lack of data to support use in this age group. The available evidence from placebo-controlled clinical trials is presented in section 5.1. _Elderly _ 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 _ As clearance and metabolism of zolpidem is reduced in hepatic impairment, dosage should begin at 5 mg in these patients with particular caution being exercised in elderly patients. In adults (under 65 years) dosage may be increased to 10 mg only where the clinical response is inadequate and t Lue koko asiakirja