Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Dexketoprofen
Laboratorios Menarini S.A.
M01AE; M01AE17
Dexketoprofen
25 milligram(s)
Granules for oral solution
Product subject to prescription which may be renewed (B)
Propionic acid derivatives; dexketoprofen
Not marketed
2011-07-08
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ENANTYUM 25 MG GRANULES FOR ORAL SOLUTION _ _ 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 Enantyum is and what it is used for 2. What you need to know before you take Enantyum 3. How to take Enantyum 4. Possible side effects 5. How to store Enantyum 6. Contents of the pack and other information 1. WHAT ENANTYUM IS AND WHAT IT IS USED FOR Enantyum is a pain killer from the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used for short term symptomatic treatment of mild to moderate acute pain, such as acute muscular pain or joint pain, painful periods (dysmenorrhoea), toothache. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENANTYUM DO NOT TAKE ENANTYUM: If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6); If you are allergic to the acetylsalicylic acid or to other non-steroidal anti-inflammatory medicines; If you 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; If you have suffered from photoallergic or phototoxic reactions (a particular form of reddening and/or blistering of the skin exposed to sunlight Přečtěte si celý dokument
HealthProductsRegulatoryAuthority 10June2019 CRN008SSM Page1of8 SUMMARYOFPRODUCTCHARACTERISTICS 1NAMEOFTHEMEDICINALPRODUCT Enantyum25mggranulesfororalsolution 2QUALITATIVEANDQUANTITATIVECOMPOSITION Eachsachetofgranulesfororalsolutioncontainsdexketoprofen12.5mgor25mg,asdexketoprofentrometamol. Excipientswithknowneffect: Sucrose:2.418g. Forthefulllistofexcipients,seesection6.1. 3PHARMACEUTICALFORM Granulesfororalsolution, lemon yellowcolouredgranules. 4CLINICALPARTICULARS 4.1THERAPEUTICINDICATIONS Shorttermsymptomatictreatmentofacutepainofmildtomoderateintensity,suchasacutemusculo-skeletalpain, dysmenorrhoeaanddentalpain. 4.2POSOLOGYANDMETHODOFADMINISTRATION _Posology_ Adults Accordingtothenatureandseverityofpain,therecommendeddosageis12.5mgevery4-6hoursor25mgevery8hours. Thetotaldailydoseshouldnotexceed75mg. Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol symptoms(seesection4.4.). Enantyumisonlyintendedforshorttermuseandthetreatmentmustbelimitedtothesymptomaticperiod. Elderly Inelderlypatientsitisrecommendedtostartthetherapyatthelowerendofthedosagerange(50mgtotaldailydose).The dosagemaybeincreasedtothatrecommendedfortheadultonlyaftergoodgeneraltolerancehasbeenascertained.Dueto thepossibleadverseeffectprofile(seesection4.4),elderlyindividualsshouldreceiveparticularlyclosemonitoring. Hepatic impairment Patientswithm Přečtěte si celý dokument