Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Sertraline hydrochloride
Imbat Limited
N06AB; N06AB06
Sertraline hydrochloride
50 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors; sertraline
Not marketed
2005-01-07
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER LUSTRAL ® 50 MG FILM-COATED TABLETS sertraline Your medicine is available using the above name but will be referred to as Lustral throughout this leaflet. 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 disorders are illnesses linked to anxiety with symptoms like being constantly troubled by persistent ideas (obsessions) that make you carry out repetitive rituals (compulsions). PTSD is a condition that can occur after a very emotionally traumatic experience, and has some symptoms that are similar to depression and an Lugege kogu dokumenti
Health Products Regulatory Authority 29 January 2020 CRN009L6R Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lustral 50mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg sertraline (as hydrochloride). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from the UK_ White, capsule shaped, film coated, scored tablets coded 'ZLT 50' on one side and 'PFIZER' on the other. _Product imported from Spain_ White, capsule shaped, film-coated, scored tablets coded 'ZLT-50' on one side and 'PFIZER' on the other. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS As per PA0822/001/004 5 PHARMACOLOGICAL PROPERTIES As per PA0822/001/004 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Product imported from the UK_ Tablet Core: Calcium hydrogen phosphate Microcrystalline cellulose Hydroxypropylcellulose Sodium starch glycolate (Type A) Magnesium stearate Macrogol Film Coating: Titanium dioxide (E171) Hypromellose Macrogol Polysorbate 80 _Product imported from Spain_ Calcium hydrogen phosphate dihydrate (E341) Microcrystalline cellulose (E460) Hydroxypropylcellulose (E463) Sodium starch glycolate Magnesium stearate (E572) Hypromellose (E464) Macrogol Polysorbate-80 (E433) Health Products Regulatory Authority 29 January 2020 CRN009L6R Page 2 of 3 Titanium dioxide (E171) 6.2 INCOMPATIBILITIES Not applicable. 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 Overlabelled carton or carton containing blister strips Pack size: 28 tablets _(product imported from the UK)_, 30 tablets _(product imported from Spain)_ Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 MARKETING AUTHORISATION HOLDER Imbat Limited Unit Lugege kogu dokumenti