Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Escitalopram
PCO Manufacturing 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
Authorised
2011-07-08
_ _ _ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER LEXAPRO ® 10 MG FILM-COATED TABLETS LEXAPRO ® 15 MG FILM-COATED TABLETS LEXAPRO ® 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 Lexapro is and what it is used for 2. What you need to know before you take Lexapro 3. How to take Lexapro 4. Possible side effects 5. How to store Lexapro 6. Contents of the pack and other information 1. WHAT LEXAPRO IS AND WHAT IT IS USED FOR Lexapro contains the active substance escitalopram. Lexapro 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. Lexapro 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 Lexapro, 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 LEXAPRO DO NOT TAKE LEXAPRO if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6). if y Leggi il documento completo
Health Products Regulatory Authority 15 May 2020 CRN009Q7S Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lexapro 15 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg escitalopram (as oxalate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from Spain, France and The Netherlands:_ Oval, white, scored, film-coated tablet marked with E” and “M on each side of the score on one side of the tablet. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS As per PA0805/002/003 5 PHARMACOLOGICAL PROPERTIES As per PA0805/002/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet core: Microcrystalline cellulose Colloidal anhydrous silica Talc Croscarmellose sodium Magnesium stearate Coating: Hypromellose Macrogol 400 Titanium dioxide (E171) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. Health Products Regulatory Authority 15 May 2020 CRN009Q7S Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Aluminium blister strips in an outer carton. Pack size 28 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/129/004 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 8 th July 2011 10 DATE OF REVISION OF THE TEXT May 2020 Leggi il documento completo