Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Alprazolam
Upjohn EESV
N05BA; N05BA12
Alprazolam
250 microgram(s)
Tablet
Benzodiazepine derivatives; alprazolam
Marketed
1982-11-01
Page 1 of 8 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 contains the active ingredient alprazolam. It belongs to a group of medicines called benzodiazepines (anxiety-relieving medicines). Xanax is used in adults for treatment of anxiety symptoms which are severe, disabling or causing the patient great distress. This medicine is for short-term use only. 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 bronchitis or emphysema). • If you have severe liver problems. • If you have ‘sleep apnoea’ - this is a condition where your breathing becomes irregular, even stopping for short periods, while you are asleep. Page 2 of 8 WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before Lugege kogu dokumenti
Health Products Regulatory Authority 20 April 2023 CRN00DF1X 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_ Xanax is indicated for short-term symptomatic treatment of anxiety in adults. Xanax is only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Duration of treatment_ Xanax should be used in the lowest possible effective dose, for the shortest possible time and for a maximum of 2-4 weeks. The need for continued treatment should be reassessed frequently. Long-term treatment is not recommended. The risk of dependence may increase with dose and duration of treatment (see section 4.4). 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. The dose must be gradually reduced to avoid withdrawal symptoms. _ _ _Elderly_ In the elderly or debilitated patient a regimen of 250 micrograms twice daily should be used initially with gradual increments if required and tolerance is assured. _Paediatric population_ Safety and efficacy of alprazolam have not been established in children and adolescents below the age of 18 years; therefore use of alprazolam is not recommended. Method of administration For oral use. Treatment should be started with the lower recommended dose. The maxim Lugege kogu dokumenti