Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Escitalopram oxalate
McDermott Laboratories Ltd., T/A Gerard Laboratories
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
Marketed
2009-12-22
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ESCITALPRO 5 MG FILM-COATED TABLETS ESCITALPRO 10 MG FILM-COATED TABLETS ESCITALPRO 15 MG FILM-COATED TABLETS ESCITALPRO 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 Escitalpro is and what it is used for 2. What you need to know before you take Escitalpro 3. How to take Escitalpro 4. Possible side effects 5. How to store Escitalpro 6. Contents of the pack and other information. 1. WHAT ESCITALPRO IS AND WHAT IT IS USED FOR Escitalpro belongs to a group of medicines called Selective Serotonin Re-uptake Inhibitor (SSRI) antidepressants. These medicines act on the serotonin-system in the brain by increasing the serotonin level. Escitalpro can be given to treat the following conditions: • depression (major depressive episodes) • panic disorder which may or may not be associated with agoraphobia (fear of open spaces) • Social anxiety disorder • Generalised anxiety disorder • Obsessive-compulsive disorder. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESCITALPRO DO NOT TAKE ESCITALPRO • if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6) • if you take other medicines that belong to a group called MAO inhibitors, including selegiline (used in the treatment of Parkinson’s disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic) • if you are born with or have had an episode of abnormal heart rh Read the complete document
Health Products Regulatory Authority 04 May 2021 CRN00C4H3 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Escitalpro 20mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Escitalpro 20 mg film-coated tablets: each tablet contains 20 mg escitalopram (as oxalate) Excipient with known effect: 20 mg film-coated tablets contain 1.6 mg lactose (as lactose monohydrate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Escitalpro 20mg film-coated tablets: white, scored, film-coated tablet marked with EC|20 on one side and “G” on the other. The tablets are oblong with dimensions of 12.5 mm x 7 mm. The tablet 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 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 o Read the complete document