Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Quetiapine
Imbat Limited
N05AH04
Quetiapine
25 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
quetiapine
Authorised
2008-02-01
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER SEROQUEL ® 25MG FILM-COATED TABLETS (quetiapine) 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 Seroquel is and what it is used for 2. What you need to know before you take Seroquel 3. How to take Seroquel 4. Possible side effects 5. How to store Seroquel 6. Contents of the pack and other information 1. WHAT SEROQUEL IS AND WHAT IT IS USED FOR Seroquel contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Seroquel can be used to treat several illnesses such as: Bipolar depression: where you feel sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite or can’t sleep. Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgement including being aggressive or disruptive. Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed. Your doctor may continue to prescribe Seroquel even when you are feeling better. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SEROQUEL DO NOT TAKE SEROQUEL: if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6). if you are taking any of the following medicines: some medicines for HIV azole medicines (for fungal infections) erythromycin or clarithromycin (for infections) nefazodone (for d Przeczytaj cały dokument
Health Products Regulatory Authority 14 November 2019 CRN0094Q0 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Seroquel 25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Seroquel 25 mg contains 25 mg quetiapine (as quetiapine fumarate) Excipients: lactose monohydrate For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from Italy and Austria_ Peach coloured, round tablets engraved with ‘SEROQUEL 25’ on one side and plain on the other. 4 CLINICAL PARTICULARS As per PA1019/019/001 5 PHARMACOLOGICAL PROPERTIES As per PA1019/019/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS TABLET CORE : Povidone Calcium Hydrogen Phosphate Dihydrate Microcrystalline Cellulose Sodium Starch Glycollate Type A Lactose Monohydrate Magnesium Stearate FILM-COATING : Hypromellose Macrogol 400 Titanium Dioxide (E171) Ferric Oxide Yellow (E172) Ferric Oxide Red (E172) 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 Health Products Regulatory Authority 14 November 2019 CRN0094Q0 Page 2 of 2 Do not store above 30°C. Store in the original package. 6.5 NATURE AND CONTENTS OF CONTAINER Cardboard outer containing blister strips. Pack size : 30 or 60 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements 7 PARALLEL PRODUCT AUTHORISATION HOLDER Imbat Limited Unit L2 North Ring Business Park Santry Dublin 9 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1151/036/002 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1st February 2008 10 DATE OF REVISION OF THE TEXT November 2019 Przeczytaj cały dokument