Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Tramadol hydrochloride; Paracetamol
LTT Pharma Limited
N02AJ; N02AJ13
Tramadol hydrochloride; Paracetamol
37.5/325 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Opioids in combination with non-opioid analgesics; opiods in combination with non-opiod analgesics
Authorised
2014-07-18
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 Прочитајте комплетан документ
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: One film coated tablet contains 1.878 mg lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Pale yellow film-coated tablet, marked with the manufacturers 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 Powdered cellulose Pregelatinised starch (potato, corn and rice) Sodium starch glycolate (potato) (type A) Maize starch Magnesium stearate Hypromellose Lactose monohydrate Titanium dioxide (E171) Macrogol 6000 Yellow iron oxide (E172) Propylene glycol Talc 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_ _1_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _5_ _5_ _7_ _3_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 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 are packed in paper/PET/aluminium-PVC blist Прочитајте комплетан документ