Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Escitalopram oxalate
Glenmark Pharmaceuticals s.r.o.
N06AB; N06AB10
Escitalopram oxalate
20 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors; escitalopram
Not marketed
2010-11-05
PACKAGE LEAFLET: INFORMATION FOR THE USER ESCITALOPRAM GLENMARK 10 MG FILM-COATED TABLETS ESCITALOPRAM GLENMARK 15 MG FILM-COATED TABLETS ESCITALOPRAM GLENMARK 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 symptoms 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 Glenmark is and what it is used for 2. What you need to know before you take Escitalopram Glenmark 3. How to take Escitalopram Glenmark 4. Possible side effects 5. How to store Escitalopram Glenmark 6. Contents of the pack and other information 1. WHAT ESCITALOPRAM GLENMARK IS AND WHAT IT IS USED FOR Escitalopram Glenmark contains the active substance escitalopram . 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 Glenmark 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, 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 < ESCITALOPRAM Read the complete document
Health Products Regulatory Authority 21 May 2021 CRN00C6F9 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Escitalopram Glenmark 20 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 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 '20' (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 daily. Social anxiety disorder is a disease with a chro Read the complete document