Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
SERTRALINE HYDROCHLORIDE
IMED Healthcare Ltd.
N06AB06
SERTRALINE HYDROCHLORIDE
100 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors
Authorised
2009-11-13
PACKAGE LEAFLET: INFORMATION FOR THE USER Lustral 50 mg Film Coated Tablets Lustral 100 mg Film Coated Tablets Sertraline 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 Lustral is and what it is used for 2. What you need to know before you take Lustral 3. How to take Lustral 4. Possible side effects 5. How to store Lustral 6. Contents of the pack and other information 1. WHAT LUSTRAL IS AND WHAT IT IS USED FOR Lustral contains the active substance sertraline. Sertraline is one of a group of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders. LUSTRAL CAN BE USED TO TREAT: Depression and prevention of recurrence of depression (in adults). Social anxiety disorder (in adults). Post traumatic stress disorder (PTSD) (in adults). Panic disorder (in adults). Obsessive compulsive disorder (OCD) (in adults and children and adolescents aged 6-17 years old). Depression is a clinical illness with symptoms like feeling sad, unable to sleep properly or to enjoy life as you used to. OCD and Panic diso Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lustral 100mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains sertraline hydrochloride equivalent to 100mg sertraline. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet _Product imported from the UK:_ White, capsular-shaped, film-coated tablets coded “ZLT-100” or "LTL-100" or "SER-100" on one side and “PFIZER” on the other. 4 CLINICAL PARTICULARS As per PA0822/001/005 5 PHARMACOLOGICAL PROPERTIES As per PA0822/001/005 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet Core Calcium hydrogen phosphate dihydrate (E341) Microcrystalline cellulose (E460) Hydroxypropylcellulose (E463) Sodium starch glycolate Magnesium stearate (E572) Film Coating Opadry white containing: Hypromellose (E464) Macrogol Polysorbate-80 (E433) Titanium dioxide (E171) Opadry clear containing: Hypromellose (E464) Macrogol 6.2 INCOMPATIBILITIES Not applicable. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 16/06/2016_ _CRN 2179029_ _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 Do not store above 30 °C 6.5 NATURE AND CONTENTS OF CONTAINER Blister strips in an over-labelled cardboard 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 IMED Healthcare Ltd. Unit 625 Kilshane Avenue Northwest Business Park Ballycoolin Dub Citiți documentul complet