国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
ESCITALOPRAM OXALATE
LTT Pharma Limited
ESCITALOPRAM OXALATE
10 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
• Flow of milk in men and in women that are not nursing • Mania • An increased risk of bone fractures has been observed in patients taking this type of medicines • Alteration of the heart rhythm (called “prolongation of QT interval”, seen on ECG, electrical activity of the heart). In addition, a number of side effects are known to occur with drugs that work in a similar way to escitalopram (the active ingredient of Lexapro). These are: • Motor restlessness (akathisia) • Loss of appetite Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Reports may be made by following the links to the online reporting option accessible from the IMB homepage, or by completing the downloadable report form also accessible from the IMB website, which may be completed manually and submitted to the IMB via freepost, to the following address: FREEPOST Pharmacovigilance Section Irish Medicines Board Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2 Tel: +353 1 676 4971 Fax: +353 1 676 2517 Website: www.imb.ie e-mail: imbpharmacovigilance@imb.ie 5. HOW TO STORE LEXAPRO Keep out of the sight and reach of children. Do not use Lexapro after the expiry date, which is stated on the label or carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT LEXAPRO CONTAINS The active substance is escitalopram. Each Lexapro tablet contains 10 mg escitalopram (as oxalate). The other ingredients are: Core: microcrysta 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lexapro 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg escitalopram (as oxalate) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Romania_ Oval, white, scored, film-coated tablet marked with "E” and “L" on each side of the score on one side of the tablet. The 10 mg tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. Treatment of panic disorder with or without agoraphobia. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Safety of daily doses above 20 mg has not been demonstrated. Lexapro is administered as a single daily dose and may be taken with or without food. Major depressive episodes Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually 2-4 weeks are necessary to obtain antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response. Panic disorder with or without agoraphobia An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months. Social anxiety disorder Usual dosage is 10 mg once daily. Usually 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on 完全なドキュメントを読む