Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Alprazolam
Pfizer Healthcare Ireland
N05BA; N05BA12
Alprazolam
250 microgram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Benzodiazepine derivatives; alprazolam
Marketed
1982-11-01
Page 1 of 8 2018-0040716 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XANAX ® 250 MICROGRAM TABLETS XANAX ® 500 MICROGRAM TABLETS XANAX ® 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 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 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. Page 2 of 8 2018-0040716 • Read the complete document
Health Products Regulatory Authority 18 December 2020 CRN009VGY Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xanax 250 microgram Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 micrograms alprazolam. Excipient(s) with known effect: Each tablet contains 96 mg lactose monohydrate. Each tablet contains 0.11 mg sodium benzoate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, oval, biconvex tablets scored on one side and marked ‘Upjohn 29’ on the other. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Anxiety _ Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Anxiety _ Treatment should be as short as possible. The overall duration of treatment generally should not be more than 8-12 weeks, including a tapering off process. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in case the patient is symptom free. It is usual to commence with a dose of 500 micrograms to 1 mg daily in divided doses, with increments (no greater than 1 mg every 3-4 days), to the level of optimal control usually 3 to 4 mg daily. To discontinue alprazolam treatment, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of alprazolam be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction. The risk of dependence may increase with dose and duration of treatment, therefore, the lowest possible effective dose and duration should be used and the need for continued treatment reassessed frequently (see section 4.4). _Elderly_ In the elderly or debilitated patient a regimen of 250 micrograms twice daily should be used initially with gradual increme Read the complete document