Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Escitalopram
Accord Healthcare Ireland Ltd.
N06AB; N06AB10
Escitalopram
20 milligram(s)
Film-coated tablet
Selective serotonin reuptake inhibitors; escitalopram
Not marketed
2010-04-16
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ESCITALOPRAM 5 MG FILM-COATED TABLETS ESCITALOPRAM 10 MG FILM-COATED TABLETS ESCITALOPRAM 15 MG FILM-COATED TABLETS ESCITALOPRAM 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Escitalopram is and what it is used for 2. What you need to know before you take Escitalopram 3. How to take Escitalopram 4. Possible side effects 5. How to store Escitalopram 6. Contents of the pack and other information 1. WHAT ESCITALOPRAM IS AND WHAT IT IS USED FOR Escitalopram is an antidepressant which belongs to the ‘SSRI’ group (selective serotonin reuptake inhibitors). 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 is used to treat: – Depressive disorders (episodes of a major depression) – Panic disorder with or without agoraphobia (e.g. fear of leaving the house, entering shops, being in crowds and in public places) – Social anxiety disorder (social phobia) – Generalised anxiety disorder – Obsessive-compulsive disorder 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESCITALOPRAM DO NOT TAKE ESCITALOPRAM - if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6) - if you take other medicines which belongs to a group called MAO inhibitors, including selegiline (used in the treatmen Прочитајте комплетан документ
Health Products Regulatory Authority 05 March 2021 CRN009ZD9 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Escitalopram 20 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg escitalopram (as oxalate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Oval, biconvex, white film-coated tablet (diameter 8 x 11.7 mm) with score on one side, sidescores and marked with ‘E’ on the other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of - Major depressive episodes - Panic disorder with or without agoraphobia - Social anxiety disorder (social phobia) - Obsessive-compulsive disorder 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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. POSOLOGY _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. Health Products Regulatory Authority 05 March 2021 CRN009ZD9 Page 2 of 14 Social anxiety disorder is a disease with Прочитајте комплетан документ