Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Amisulpride
LTT Pharma Limited
N05AL; N05AL05
Amisulpride
100 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Benzamides; amisulpride
Authorised
2014-09-19
IN PARTICULAR, DO NOT TAKE THIS MEDICINE, AND TELL YOUR DOCTOR IF YOU ARE TAKING ANY OF THE FOLLOWING MEDICINES: * Medicines used to control your heart beat such as quinidine, disopyramide, procainamide, amiodarone and sotalol * Bepridil, used to treat heart disease * Cisapride, used to treat heartburn * Thioridazine or sultopride, used to treat mental illness * Methadone, used to treat pain and opiate addiction * Antibiotics such as erythromycin (given by injection) or sparfloxacin * Vincamine (given by injection), used for brain circulation problems * Halofantrine, used for malaria * Pentamidine used for pneumonia * Levodopa, a medicine to treat parkinson's disease * Clozapine, used to treat schizophrenia TELL YOUR DOCTOR IF YOU ARE TAKING ANY OF THE FOLLOWING MEDICINES: * Medicines for depression or to calm emotional and mental illness such as pimozide, haloperidol, imipramine, and lithium * Medicines for severe pain called opiates such as morphine or pethidine * Medicines for high blood pressure and migraine such as clonidine, diltiazem and verapamil, guanfacine and digitalis * Medicines which may lower potassium levels. This includes water tablets such as bendrofluazide or hydrochlorothiazide, some laxatives, glucocorticoids (used to treat severe asthma and other inflammatory disorders), tetracosactides and amphotericin (used to treat fungal infections) * Medicines which help you sleep such as barbiturates and benzodiazepines * Pain-killers such as tramadol and indometacin * Anaesthetics * Antihistamines such as promethazine which make you sleepy If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Solian. TAKING SOLIAN WITH FOOD AND DRINK * Swallow Solian tablets with plenty of water before a meal * Do not drink alcohol while you are taking Solian. This is because it can affect the way the medicine works PREGNANCY AND BREAST-FEEDING Do not take this medicine if: * You are breast-feeding or planning to breast-feed The following symptoms may occur in newborn ba Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solian 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amisulpride 100mg per tablet. Excipient(s) with known effect Lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet _Product imported from the United Kingdom_ White to off white, round flat-faced, breakable tablet engraved ‘AMI 100’ 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 PA0540/158/002 5 PHARMACOLOGICAL PROPERTIES As per PA0540/158/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate 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 package of the product on the market in the country of origin. 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_ _6_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _5_ _6_ _5_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE No special precautions for storage. 6.5 NATURE AND CONTENTS OF CONTAINER PVC/aluminium foil blister packs containing 60 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICI Lees het volledige document