国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ALPRAZOLAM
VIATRIS SDN. BHD.
ALPRAZOLAM
30Tablet Tablets; 10Tablet Tablets; 100Tablet Tablets
SANICO N.V.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ XANAX ® TABLETS Alprazolam (0.25 mg, 0.5 mg, 1 mg) 1 WHAT IS IN THIS LEAFLET 1. What XANAX is used for 2. How XANAX works 3. Before you use XANAX 4. How to use XANAX 5. While you are using it 6. Side Effects 7. Storage and Disposal of XANAX 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT XANAX IS USED FOR XANAX tablets are used to treat severe anxiety severe anxiety associated with depression depression where individuals show loss of interest or depression associated with other diseases panic related disorders neurotic or reactive 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’). HOW XANAX WORKS 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 and impacts central nervous system function like reduction in anxiety and worry. BEFORE YOU USE XANAX - _When you must not use it_ Do not take XANAX if you: - Are allergic to alprazolam or other similar benzodiazepine medicines, or to any of the other ingredients (see Section 10 ‘Product Description’ for more details) _Pregnancy and lactation_ XANAX may be harmful to the developing baby so you should not take XANAX if you are pregnant or planning to become pregnant. Tell your doctor immediately if you think you may be pregnant. Do not breastfeed while taking XANAX, as the drug may pass into breast milk. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it_ Talk to your doctor or pharmacist before taking XANAX if you: - Are pregnant, think you might be pregnant now, are planning to become pregnant or if you are breastfeeding (see also Section Before you us 阅读完整的文件
1 1. NAME OF THE MEDICINAL PRODUCT XANAX ® (ALPRAZOLAM TABLETS) 2. QUALITATIVE & QUANTITATIVE COMPOSITION Each immediate-release (IR) tablet contains 0.25 mg, 0.5 mg or 1 mg of alprazolam. 3. PHARMACEUTICAL FORM Immediate-release tablets. XANAX ® 0.25 mg Tablets – White, elliptical full oval scored tablets. XANAX ® 0.5 mg Tablets – Pink-coloured, elliptical full oval scored tablets. XANAX ® 1 mg Tablets – Lavender-coloured, elliptical full oval scored tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Alprazolam is indicated for the treatment of: ● ANXIETY STATES (ANXIETY NEUROSES) Symptoms which occur in such patients include anxiety, tension, agitation, insomnia, apprehension, irritability and/or autonomic hyperactivity resulting in a variety of somatic complaints. ● MIXED ANXIETY-DEPRESSION Symptoms of both anxiety and depression occur simultaneously in such patients. ● NEUROTIC OR REACTIVE DEPRESSION Such patients primarily exhibit a depressed mood or a pervasive loss of interest or pleasure. Symptoms of anxiety, psychomotor agitation and insomnia are usually present. Other characteristics include appetite disturbances, changes in weight, somatic complaints, cognitive disturbances, decreased energy, feeling of worthlessness or guilt, or thoughts of death or suicide. ● ANXIETY STATES, MIXED ANXIETY-DEPRESSION, OR DEPRESSION ASSOCIATED WITH OTHER DISEASES Such as the chronic phase of alcohol withdrawal and functional or organic disease, particularly certain gastrointestinal, cardiovascular or dermatological disorders. ● PANIC RELATED DISORDERS Alprazolam is indicated in the treatment of panic disorder with or without some phobic avoidance. Alprazolam is also indicated for the blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic 2 attacks. The effectiveness of alprazolam in the treatment of anxiety, anxiety associated with depression and neurotic (reactive) depression for long-term use exceeding six months has not been established by system 阅读完整的文件