Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Escitalopram
Clonmel Healthcare Ltd
N06AB; N06AB10
Escitalopram
15 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors; escitalopram
Marketed
2009-12-04
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER ETALOPRO 5MG FILM-COATED TABLETS ETALOPRO 10MG FILM-COATED TABLETS ETALOPRO 15MG FILM-COATED TABLETS ETALOPRO 20MG FILM-COATED TABLETS Escitalopram 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 Etalopro is and what it is used for 2. What you need to know before you take Etalopro 3. How to take Etalopro 4. Possible side effects 5. How to store Etalopro 6. Contents of the pack and other information 1. WHAT ETALOPRO IS AND WHAT IT IS USED FOR Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin-system in the brain by increasing the serotonin level. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases. Etalopro contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalised anxiety disorder and obsessive-compulsive disorder). It may take a couple of weeks before you start to feel better. Continue to take ETALOPRO , even if it takes some time before you feel any improvement in your condition. 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 ETALOPRO DO NOT TAKE ETALOPRO • if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6). • i Đọc toàn bộ tài liệu
Health Products Regulatory Authority 26 January 2021 CRN00C44N Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Etalopro 15 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Etalopro 15 mg: Each tablet contains 15 mg escitalopram (as oxalate) Excipient with known effect One film-coated contains 1.27 mg sodium. 3 PHARMACEUTICAL FORM Film-coated tablet. Oval shaped (ca. 10.4 x 5.6 mm), white, film-coated tablet with break line on one side. _The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses._ 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 Posology Safety of daily doses above 20 mg has not been demonstrated. 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 individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily. Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response. L Đọc toàn bộ tài liệu