Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ESCITALOPRAM OXALATE
BioOrganics BV
N06AB10
ESCITALOPRAM OXALATE
10 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
escitalopram
Not Marketed
2010-10-15
Date: 03-03-14 Pg 1 of 10 M13.1_03.ECM.hox.tab.002.09.IE.201.01 PACKAGE LEAFLET: INFORMATION FOR THE USER ESCITALOPRAM BIOORGANICS 10 MG FILM-COATED TABLETS ESCITALOPRAM BIOORGANICS 15 MG FILM-COATED TABLETS ESCITALOPRAM BIOORGANICS 20 MG 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 Escitalopram BioOrganics is and what it is used for 2. What you need to know before you take Escitalopram BioOrganics 3. How to take Escitalopram BioOrganics 4. Possible side effects 5. How to store Escitalopram BioOrganics 6. Contents of the package and other information 1. WHAT ESCITALOPRAM BIOORGANICS 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. Escitalopram BioOrganics contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders such as repeated panic attacks (panic disorder) with or without fear of experiencing a panic attack in a place or situation from which escape is difficult or embarrassing e.g. in public or open spaces (agoraphobia), fear of being judged by others and/or publicly behaving in a way that could lead to embarrassment (social anxiety disorder), chronic anxiety (generalised anxiety disorder) and obsessions or comp Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Escitalopram BioOrganics 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg escitalopram (as oxalate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) White, oval, film-coated tablets, debossed with 'E9CM' on one side and on the other side scored and debossed with '10' (one number on each side of the scoring line). The tablets can be divided 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 Safety of daily doses above 20 mg has not been demonstrated. Escitalopram 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 individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Read the complete document