Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
ESCITALOPRAM OXALATE
WPR Healthcare Limited
N06AB10
ESCITALOPRAM OXALATE
10 Milligram
Film Coated Tablet
Oral use
Blister pack of 28 tablets
Product subject to prescription which may not be renewed (A)
Gerard Laboratories
Antidepressants, selective serotonin reuptake inhibitors
Selective serotonin reuptake inhibitors
Treatment of: major depressive episodes, panic disorder with or without agoraphobia, social anxiety disorder (social phobia), generalised anxiety disorder, obsessive-compulsive disorder
Authorised
2015-05-01
PACKAGE LEAFLET: INFORMATION FOR THE USER ESCITALPRO 5 MG FILM-COATED TABLETS ESCITALPRO 10 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. 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 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. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases. 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 (hypersensitive) to escitalopr Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Escitalpro 10mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Escitalpro 10 mg film-coated tablets: each tablet contains 10 mg escitalopram (as oxalate) Excipient with known effect: 10 mg film-coated tablets contain lactose (as lactose monohydrate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from the UK :_ Escitalpro 10 mg film-coated tablets: oblong, white, scored film-coated tablet marked with "EC|10" on one side and “G” on the other. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS As per PA0577/108/002 5 PHARMACOLOGICAL PROPERTIES As per PA0577/108/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Tablet core:_ Microcrystalline cellulose Colloidal anhydrous silica Talc Croscarmellose sodium Magnesium stearate _Coating:_ Lactose monohydrate Macrogol 4000 Titanium dioxide (E171) Hypromellose 6.2 INCOMPATIBILITIES Not applicable. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 05/05/2015_ _CRN 2159294_ _page number: 1_ 6.3 SHELF LIFE The shelf-life expiry date of this product is 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 Store below 25°C. Store in the original package. 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs of 28 tablets contained in a cardboard carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER WPR Healthcare Limited Unit 10 Ashbourne Business Park Rath Ashbourne Co. Meath 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0565/055/002 9 DATE OF FIRST AUTHORISATION/RENEWAL Läs hela dokumentet