देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
ZOLPIDEM TARTRATE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
N05CF02
ZOLPIDEM TARTRATE 10 mg
FILM-COATED TABLET
ZOLPIDEM TARTRATE 10 mg
POM
PSYCHOLEPTICS
Authorised
2013-09-12
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOLPIDEM AUROBINDO 5 MG FILM-COATED TABLETS ZOLPIDEM AUROBINDO 10 MG FILM-COATED TABLETS zolpidem tartarate 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 Zolpidem Aurobindo is and what it is used for 2. What you need to know before you take Zolpidem Aurobindo 3. How to take Zolpidem Aurobindo 4. Possible side effects 5. How to store Zolpidem Aurobindo 6. Contents of the pack and other information 1. WHAT ZOLPIDEM AUROBINDO IS AND WHAT IT IS USED FOR Zolpidem belongs to agroup of medicines known as benzodiazepine-like agents. Zolpidem Aurobindo 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 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 ZOLPIDEM AUROBINDO DO NOT TAKE ZOLPIDEM AUROBINDO: • 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. • if you have severe liver problems • if you suffer from sleep apnoea (a condition where you stop breathing for very short periods whilst sleeping) • if you suffer from severe muscle weakness (myasthenia gravis) • if you have acute and severe breathing problems • if you are under the age of 18 years • If y पूरा दस्तावेज़ पढ़ें
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zolpidem Aurobindo 5 mg film-coated tablets Zolpidem Aurobindo 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Zolpidem Aurobindo 5 mg film-coated tablets _ Each film-coated tablet contains 5 mg of zolpidem, tartarate. Excipient with known effect: Each 5mg film-coated tablet contains 43.8 mg lactose monohydrate. _Zolpidem Aurobindo 10 mg film-coated tablets _ Each film-coated tablet contains 10 mg of zolpidem, tartarate. Excipient with known effect: Each 10 mg film-coated tablet contains 87.6 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _Zolpidem Aurobindo 5 mg film-coated tablets _ White to off-white, circular, biconvex, film- coated tablets, debossed with “E” on one side and “78” on the other side. _Zolpidem Aurobindo 10 mg film-coated tablets _ White to off-white, oval shaped, biconvex film- coated tablets, debossed with “E” on one side and debossed with “80” with a score line between “8” and “0” on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term treatment of insomnia. Benzodiazepines or benzodiazepine-like agents 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. Page 2 of 16 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 _ Zolpidem acts पूरा दस्तावेज़ पढ़ें