Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Tramadol hydrochloride; Paracetamol
Lexon (UK) Ltd
N02AX; N02AX52
Tramadol hydrochloride; Paracetamol
37.5/325 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Other opioids; tramadol, combinations
Authorised
2017-03-31
IXPRIM 37.5 MG/325 MG FILM-COATED TABLETS (tramadol hydrochloride/paracetamol) 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, please 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 Ixprim is and what it is used for What you need to know before you take Ixprim How to take Ixprim Possible side effects How to store Ixprim Contents of the pack and other information WHAT IXPRIM IS AND WHAT IT IS USED FOR Ixprim is a combination of two analgesics, tramadol and paracetamol, which act together to relieve your pain. Ixprim is intended for use in the treatment of moderate to severe pain when your doctor recommends that a combination of tramadol and paracetamol is needed. Ixprim should only be taken by adults and adolescents over 12 years. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IXPRIM DO NOT TAKE IXPRIM * if you are allergic to tramadol hydrochloride, paracetamol or any of the other ingredients of this medicine (listed in section 6); * in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions); * if you are also taking MAO inhibitors (certain medicines used for treatment of depression or Parkinson’s disease) or have taken them in the last 14 days before treatment with Ixprim; * if you suffer from a severe liver disorder; * if you have epilepsy that is not adequately controlled on your current medicine. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE TAKING IXPRIM: * if you take other medicines containing paracetamol or tramadol; * if you have liver problems or liver dise Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ixprim 37.5 mg/325 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol. Excipients with known effect : contains lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from The United Kingdom_ Pale yellow film-coated tablet, marked with the manufacturer’s logo on one side and ‘T5’ on the other side. 4 CLINICAL PARTICULARS As per PA1189/005/001 5 PHARMACOLOGICAL PROPERTIES As per PA1189/005/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet core: powdered cellulose, pregelatinised starch, sodium starch glycolate (type A), maize starch, magnesium stearate. Film-coating: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 6000, yellow iron oxide (E172), propylene glycol, talc. 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_ _ _ _3_ _1_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _8_ _0_ _9_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Ixprim tablets a Läs hela dokumentet