Страна: Малта
Език: английски
Източник: Medicines Authority
ALPRAZOLAM
Pfizer Hellas S.A.
N05BA12
ALPRAZOLAM
TABLET
ALPRAZOLAM 250 microgram(s)
POM
PSYCHOLEPTICS
Authorised
2005-10-26
Page 1 of 7 2015-0013890 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XANAX ® 250 MICROGRAM AND 500 MICROGRAM TABLETS ALPRAZOLAM 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 further questions, ask your doctor or your pharmacist. This medicine has been prescribed for you only. Do not pass it onto 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 Xanax is and what it is used for 2. What you need to know before you take Xanax 3. How to take Xanax 4. Possible side effects 5. How to store Xanax 6. Contents of the pack and other information 1. WHAT XANAX IS AND WHAT IT IS USED FOR Xanax is a tranquilliser containing the active ingredient alprazolam. Alprazolam belongs to one of a group of medicines called benzodiazepines. Benzodiazepines affect chemical activity in the brain to promote sleep and to reduce anxiety and worry. Xanax tablets are only used to treat severe anxiety and severe anxiety associated with depression. Xanax is not recommended for the treatment of depression. Xanax tablets should only be used for short-term treatment of anxiety. The overall duration of treatment should not be more than 12 weeks including a period where the dose is gradually reduced (this is called dose ‘tapering’). You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XANAX DO NOT TAKE XANAX: If you are allergic to alprazolam or other similar benzodiazepine medicines, or to any of the other ingredients of this medicine (listed in section 6). If you suffer from a disease called ‘myasthenia gravis’ where you suffer from very weak and tired muscles. If you have severe chest problems or Прочетете целия документ
Ref XX 12_0 Page 1 of 10 2015-0013890 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Xanax 250 microgram Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Alprazolam 250 micrograms. Excipient(s) with known effect: Each tablet also contains 96 mg lactose monohydrate. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet White, oval, biconvex tablet scored on one side and marked "Upjohn 29" on the other. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Xanax is indicated for the short-term treatment of moderate or severe anxiety states and anxiety associated with depression. It is only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. Xanax should not be used to treat short-term mild anxiety, such as anxiety or tension associated with the stress of everyday life. As the efficacy of Xanax in depression and in phobic or obsessional states has yet to be established, specific treatment may have to be considered. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY _ Treatment should be as short as possible. It is recommended that the patient be reassessed at the end of no longer than 4 weeks’ treatment and the need for continued treatment established, especially in case the patient is symptom free. The overall duration of treatment should not be more than 8-12 weeks, including a tapering off process. 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 with special expertise. As with all benzodiazepines, physicians should be aware that long-term use might lead to dependence in certain patients. The optimum dosage of Xanax should be based upon the severity of the symptoms and individual patient response. The lowest dose which can control symptoms should be used. Dosage should be reassessed at intervals of no more than 4 weeks. The usual dosage is stated below; in the few patients who require higher doses, the dos Прочетете целия документ