Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Isosorbide-5-mononitrate
McDermott Laboratories Ltd., T/A Gerard Laboratories
C01DA; C01DA14
Isosorbide-5-mononitrate
60 milligram(s)
Prolonged-release tablet
Organic nitrates; isosorbide mononitrate
Marketed
1999-08-23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ISOSORBIDMONONITRAT MYLAN 60 MG PROLONGED-RELEASE TABLETS (isosorbide mononitrate) 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 Isosorbidmononitrat Mylan is and what it is used for 2. What you need to know before you take Isosorbidmononitrat Mylan 3. How to take Isosorbidmononitrat Mylan 4. Possible side effects 5. How to store Isosorbidmononitrat Mylan 6. Contents of the pack and other information 1. WHAT ISOSORBIDMONONITRAT MYLAN IS AND WHAT IT IS USED FOR Isosorbidmononitrat Mylan contains isosorbide mononitrate which belongs to a family of medicines known as nitrates. These medicines allow the blood vessels around the heart to relax and widen, allowing more blood to flow to the heart and around the body. Your medicine is in the form of a ‘prolonged- release’ tablet, which slowly releases the medicine into your body. Isosorbidmononitrat Mylan can be used to help prevent angina (a muscle cramp of the heart). However, Isosorbidmononitrat Mylan is NOT a suitable treatment for the relief of acute angina. If you suffer from an acute attack of angina, a more suitable medicine should be taken. Do not stop taking Isosorbidmononitrat Mylan without first consulting your doctor or pharmacist. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOSORBIDMONONITRAT MYLAN DO NOT TAKE ISOSORBIDMONONITRAT MYLAN: - if you are allergic to isosorbide mononitrate, other nitrates, or any of the other ingredients of this medicine (listed in section 6). - if you have heart c Preberite celoten dokument
HealthProductsRegulatoryAuthority 18April2019 CRN008ZSJ Page1of6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sormon60mgProlonged-releaseTablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachprolonged-releasetabletcontains60mgisosorbidemononitrate. Excipient with known effect: Eachtabletcontains0.8mglactosemonohydrate. Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Prolonged-releasetablet(tablet). Paleyellow,elliptical,film-coatedtablets(13.1x7.1mm),embossedwith‘IM’breakline‘60’ononesideandbreaklineonthe reverse. Thetabletcanbedividedintoequaldoses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylactictreatmentofanginapectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ _Sormon_areintendedforprophylactictherapy. Dosageshouldbeadjustedindividuallyandmonitoredaccordingtoclinical response. ADULTS _When initiating therapy in new patients,_thedosecanbetitratedtoreducethefrequencyofheadachebyadministering30mg (halfatablet)forthefirst2-4days. _The usual dosage_is60mgtobetakeninthemorning. Whennecessary,thedosemaybeincreasedto120mgdailytobe takeninthemorning. Thereisariskoftolerancedevelopingwhennitratetherapyisgiven. Forthisreason,itisimportantthat_Sormon_aretaken onceadaytoachieveanintervalwithlownitrateconcentration,therebyreducingtheriskoftolerancedevelopment. Whennecessarytheproductmaybeusedincombinationwithbeta-adrenoceptorblockersandcalciumantagonists. _PAEDIATRIC POPULATION_ Thesafetyandeffica Preberite celoten dokument