Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Paroxetine hydrochloride hemihydrate
Lexon (UK) Ltd
N06AB; N06AB05
Paroxetine hydrochloride hemihydrate
20 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors; paroxetine
2011-08-05
SEROXAT 20MG FILM-COATED TABLETS PATIENT INFORMATION 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: What Seroxat is and what it is used for What you need to know before you take ‘Seroxat’ How to take Seroxat Possible side effects How to store Seroxat Contents of the pack and other information WHAT SEROXAT IS AND WHAT IT IS USED FOR SEROXAT IS A TREATMENT FOR ADULTS WITH DEPRESSION AND/OR ANXIETY DISORDERS. The anxiety disorders that Seroxat is used to treat are: obsessive compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviour), panic disorder (panic attacks, including those caused by agoraphobia, which is a fear of open spaces), social anxiety disorder (fear or avoidance of social situations), post-traumatic stress disorder (anxiety caused by a traumatic event) and generalised anxiety disorder (generally feeling very anxious or nervous). Seroxat is one of a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Seroxat and other SSRIs work but they may help by increasing the level of serotonin in the brain. Treating depression or anxiety disorders properly is important to help you get better. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ‘SEROXAT’ DO NOT TAKE SEROXAT... • IF YOU ARE TAKING MEDICINES CALLED MONOAMINE OXIDASE INHIBITORS (MAOIs, including moclobemide and methylthioninium ch Read the complete document
Health Products Regulatory Authority 23 October 2018 CRN008KCY Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Seroxat 20 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg paroxetine (as paroxetine hydrochloride hemihydrate). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from the UK:_ White, film-coated oval tablets, debossed with “SEROXAT 20” or “20” on one side and a break bar on the other. The 20mg film-coated tablet has a break-line and can be divided into equal halves if required. 4 CLINICAL PARTICULARS As per PA1077/097/002 5 PHARMACOLOGICAL PROPERTIES As per PA1077/097/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet core: Dibasic calcium phosphate dihydrate (E341) Magnesium sterate (E470b) Sodium starch glycolate (Type A) Tablet coating: Hypromellose (E464) Titanium dioxide (E171) Macgrogol 400 Polysorbate 80 (E433) Health Products Regulatory Authority 23 October 2018 CRN008KCY Page 2 of 3 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for 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 Do not store above 30ºC. Store in the original package in order to protect from light. 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs comprising opaque PVC/PVdC or opaque polyvinyl chloride (PVC) backed with aluminium foil. Pack size: 30 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 Lexon (UK) Ltd Unit 18 Oxleasow Road East Moons Moat Redditch Worcestershire B98 0RE United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1097/040/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 th August 20 Read the complete document