Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Lorazepam
Pfizer Healthcare Ireland
N05BA; N05BA06
Lorazepam
1 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Benzodiazepine derivatives; lorazepam
Marketed
1997-01-10
Page 1 of 8 2022-0075703 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATIVAN ® 1MG TABLETS lorazepam 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 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 Ativan Tablets are and what they are used for 2. What you need to know before you take Ativan Tablets 3. How to take Ativan Tablets 4. Possible side effects 5. How to store Ativan Tablets 6. Contents of the pack and other information 1. WHAT ATIVAN TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Ativan Tablets. Ativan Tablets contain the active substance lorazepam. Ativan Tablets are a member of a group of medicines called benzodiazepines. It can help to relieve anxiety. Ativan Tablets may be prescribed as short-term therapy for anxiety or sleeping difficulties due to anxiety which is significantly affecting normal daily life. It may also be used as a sedative before surgery or operative dental treatment. 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 ATIVAN TABLETS DO NOT TAKE ATIVAN TABLETS • If you are allergic to lorazepam, other benzodiazepines or any of the other ingredients of this medicine (listed in section 6) • If you have severe breathing or chest problems • If you have ‘myasthenia gravis’ (very weak or tired muscles) • If you have serious liver problems • If you suffer from ‘sleep apnoea’ (breathing problems when you are asleep) If any of the above apply to you, do not take Ativan Tablets. WARNINGS AND PRECAUTIONS Talk to your docto Đọc toàn bộ tài liệu
Health Products Regulatory Authority 20 March 2023 CRN00D4DN Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ativan 1 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains lorazepam 1 mg. Excipient with known effect This medicine contains 67.65 mg lactose monohydrate in each 1 mg tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Round, flat, white, bevelled-edged tablets, impressed with ‘1.0’ on one side and a breakbar on the other. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ativan is indicated for the short term treatment of unacceptable disabling or distressful anxiety states including anxiety associated with psychosomatic, organic and psychotic illness, and the short term treatment of insomnia associated with anxiety. Ativanmay also be used as premedication before operative dentistry and general surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage and duration of therapy has to be individualised depending on symptoms and underlying condition. The risk of dependence may increase with dose and duration of treatment; therefore, the lowest effective dose should be prescribed for the shortest duration and the need for continued treatment reassessed frequently (see section 4.4). Abrupt discontinuation or rapid dosage reduction of lorazepam after continued use may precipitate withdrawal reactions which can be life-threatening, and/or rebound phenomena; therefore, the drug should be discontinued gradually or reduce the dosage (see section 4.4). Duration of Treatment Generally, the duration of treatment varies from a few days to 4 weeks including the tapering off process. Extension of the treatment period should not take place without re-evaluation of the need for continued therapy. Posology Increases in the dosage of lorazepam should be made gradually to help avoid adverse effects. The evening dose should be increased before the daytime doses. ADULTS: Moderate and seve Đọc toàn bộ tài liệu