Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Alprazolam
Rowex Ltd
N05BA; N05BA12
Alprazolam
0.50 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Benzodiazepine derivatives; alprazolam
Marketed
2008-10-17
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ALPRAZOLAM 0.25 MG TABLETS ALPRAZOLAM 0.5 MG TABLETS ALPRAZOLAM 1 MG 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 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 illnes 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 Alprazolam is and what it is used for 2. What you need to know before you take Alprazolam 3. How to take Alprazolam 4. Possible side effects 5. How to store Alprazolam 6. Content of the pack and other information 1. WHAT ALPRAZOLAM IS AND WHAT IT IS USED FOR Alprazolam is a tranquilliser containing the active substance 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. Alprazolam is used to TREAT ANXIETY that is severe, disabling or causing the sufferer great distress. Alprazolam 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’). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALPRAZOLAM DO NOT TAKE ALPRAZOLAM IF YOU are allergic to alprazolam or any of the other ingredients of this medicine (listed in section 6), or previously had an allergic reaction to another benzodiazepine. suffer from myasthenia gravis (severe muscle weakness) have a severe lung disease e.g. bronchitis, emphysema have "sleep apnoea", where breathing temporarily stops during sleep have a severe liver disease. WARNINGS A Preberite celoten dokument
Health Products Regulatory Authority 14 July 2020 CRN009MQ5 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alprazolam 0.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5 mg of alprazolam. Excipient(s) with known effect: Each tablet contains 92.2 mg of lactose (as monohydrate) and 0.12 mg of sodium benzoate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet.Pink, oblong tablet with a score line and debossed APZM 0.5The tablets can be divided into equal doses 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of anxiety. Alprazolam should only be used if the disorder is severe or is causing invalidity, or if the patient is experiencing inordinate suffering as a result of the disorder. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The treatment period should be as short as possible. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in case the patient is symptom free. The total length of treatment should not exceed 8-12 weeks, including the period of gradual dose reduction. Prolonged treatment may be necessary in certain circumstances, but this should not be done until the patient's condition has been reassessed. As with all benzodiazepines, physicians should be aware that long-term use might lead to dependence in certain patients. The optimal dose of alprazolam should be individually determined in accordance with the severity of the symptoms and the patient's response. The lowest dose which can control symptoms should be used. Dose should be reassessed at intervals of no more than 4 weeks. The usual dose is stated below. In the few patients who require higher doses, the dose should be increased cautiously to avoid adverse reactions. When higher dose is required, the evening dose should be increased before the daytime doses. Patients who have never previously taken psychotropic medicinal products generally require lower doses than patien Preberite celoten dokument