Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Dexketoprofen trometamol
Rowex Ltd
M01AE; M01AE17
Dexketoprofen trometamol
25 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Propionic acid derivatives; dexketoprofen
Marketed
2013-10-11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DEXKETOPROFEN ROWEX 25MG FILM-COATED TABLETS dexketoprofen 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 1. What Dexketoprofen Rowex is and what it is used for 2. What you need to know before you take Dexketoprofen Rowex 3. How to take Dexketoprofen Rowex 4. Possible side effects 5. How to store Dexketoprofen Rowex 6. Contents of the pack and other information 1. WHAT DEXKETOPROFEN ROWEX IS AND WHAT IT IS USED FOR Dexketoprofen Rowex is a pain killer from the group of medicines called non-steroidal anti- inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscular pain, painful periods (dysmenorrhoea), toothache. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEXKETOPROFEN ROWEX DO NOT TAKE DEXKETOPROFEN ROWEX IF YOU are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6) are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory medicines have asthma or have suffered attacks of asthma, acute allergic rhinitis (a short period of inflamed lining of the nose), nasal polyps (lumps within the nose due to allergy), urticaria (skin rash), angioedema (swollen face, eyes, lips, or tongue, or respiratory distress) or wheezing in the chest after taking acetylsalicylic acid or other non-steroidal anti-inflammatory medicines have suffered from photoallergic or phototoxic reactions (a particular form of reddening and/or blistering of the skin exposed to sunlight) whi Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 02 November 2021 CRN009XSJ Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexketoprofen Rowex 25 mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 36.9 mg of dexketoprofen trometamol, corresponding to 25 mg dexketoprofen. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film coated tablets. White, biconvex cylindric shaped scored tablets debossed with 'DT2' in one side. The tablets can be divided into equal doses. Tablet dimensions are: 3,9 mm x 9,3 mm ± 0,3 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of pain of mild to moderate intensity, such as musculo-skeletal pain, dysmenorrhoea, dental pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ According to the nature and severity of pain, the recommended dose is generally 12.5 mg every 4-6 hours or 25 mg every 8 hours. The total daily dose should not exceed 75 mg. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Dexketoprofen Rowex is not intended for long term use and the treatment must be limited to the symptomatic period. _Paediatric population_ Dexketoprofen trometamol has not been studied in children and adolescents. Therefore, the safety and efficacy in children and adolescents have not been established and the product should not be used in children and adolescents. _Elderly _ In elderly patients it is recommended to start the therapy at the lower end of the dose range (50 mg total daily dose). The dose may be increased to that recommended for the general population only after good general tolerance has been ascertained. _Hepatic dysfunction_ Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. Dexketoprofen Rowex should not be used in patients with severe hepatic dysfunction. _Renal dysfunction_ The in Olvassa el a teljes dokumentumot