Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alprazolam
Viatris UK Healthcare Ltd
N05BA12
Alprazolam
500microgram
Oral tablet
Oral
Schedule 4 (CD Benz)
Invalid to prescribe in NHS primary care
BNF: 04010200; GTIN: 5013457027433
Page 1 of 7 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 breathing difficulties (e.g. chronic b Læs hele dokumentet
OBJECT 1 XANAX TABLETS 500 MICROGRAMS Summary of Product Characteristics Updated 09-May-2018 | Pfizer Limited 1. Name of the medicinal product Xanax 500 microgram Tablets 2. Qualitative and quantitative composition Each tablet contains 500 micrograms alprazolam. Excipient(s) with known effect: Lactose, 91.1 mg per tablet. For the full list of excipients, see section 6.1 3. Pharmaceutical form Tablet Pink, oval, biconvex tablet scored on one side and marked "Upjohn 55" 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 _Anxiety_ 250 micrograms (0.25 mg) to 500 micrograms (0.5 mg) three times daily, increasing if required to a total of 3 mg daily. _The elderly or in the presence of debilitating disease_ 250 micrograms (0.25 mg) two to three times daily to be gradually increased if needed and tolerated. If side-effects occur, the dose should be lowered. It is advisable to review treatment regularly and to discontinue use as soon as possible. Should longer term treatment be necessary, then intermittent treatment may be considered to minimize the risk of dependence. _Paediatric population_ The safety and efficacy of alprazolam in children and adolescents below the age of 18 years have not been established. No data are available. Method of administration For oral use. Treatment should be as short as possible. It is recommended that the patient be reassessed at the end of no longer than 4 weeks of treatment and the need for continued treatment establi Læs hele dokumentet