Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Amisulpride
PCO Manufacturing Ltd.
N05AL; N05AL05
Amisulpride
200 milligram(s)
Tablet
Oral use
Blister packs containing 60 tablets
Product subject to prescription which may be renewed (B)
Sanofi-Winthrop Industrie, Fawdon Manufacturing Centre
Antipsychotics, psychopharmaca, neuroleptics
Benzamides; amisulpride
It is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.
Authorised
2015-05-08
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER SOLIAN ® 50MG TABLETS SOLIAN ® 100MG TABLETS SOLIAN ® 200MG TABLETS SOLIAN ® 400MG FILM-COATED TABLETS Amisulpride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE 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. IN THIS LEAFLET: 1. What Solian is and what it is used for 2. What you need to know before you take Solian 3. How to take Solian 4. Possible side effects 5. How to store Solian 6. Contents of the pack and other information 1. WHAT SOLIAN IS AND WHAT IT IS USED FOR Solian contains a medicine called amisulpride. This belongs to a group of medicines called 'anti-psychotics'. It is used to treat an illness called schizophrenia. Schizophrenia can make you feel, see or hear things which do not exist, have strange and frightening thoughts, change how you act, and make you feel alone. Sometimes people with these symptoms may also feel tense, anxious or depressed. Solian works by improving disturbed thoughts, feelings and behaviour. It is used to treat schizophrenia when it starts and also over the long term. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLIAN Do not take this medicine, and tell your doctor if: – You are allergic (hypersensitive) to amisulpride or any of the other ingredients of Solian (listed in Section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. – You are pregnant, might become pregnant or are breast-feeding (see ‘Pregnancy and breast-feeding’ section) – You have breast cancer or something called 'a prolactin dependent tumour' – You have a pituitary tumour – You ha Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solian 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amisulpride 200 mg per tablet. Also contains lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from the UK:_ White to off-white round flat faced breakable tablet engraved ‘AMI 200’ on one face and with a breakable bar on the other face. The scoreline / breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS As per PA 0540/158/003 5 PHARMACOLOGICAL PROPERTIES As per PA 0540/158/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sodium Starch Glycolate Lactose Monohydrate Microcrystalline Cellulose Hypromellose Magnesium Stearate 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 carton of the product as marketed in the country of origin 6.4 SPECIAL PRECAUTIONS FOR STORAGE No special precautions for storage. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _5_ _/_ _1_ _0_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _4_ _4_ _6_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs containing 60 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 spe Baca dokumen lengkap