देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Olmesartan medoxomil; Hydrochlorothiazide
Stada Arzneimittel AG
C09DA; C09DA08
Olmesartan medoxomil; Hydrochlorothiazide
20 mg/25 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics; olmesartan medoxomil and diuretics
Not marketed
2017-03-10
Olmesartan/HCT, PIL-IE Var. 006 - EMA/PRAC/595691/2018 2018-11-21 Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER OLMESARTAN/HYDROCHLOROTHIAZIDE STADA ARZNEIMITTEL AG 20 MG/12.5 MG FILM-COATED TABLETS OLMESARTAN/HYDROCHLOROTHIAZIDE STADA ARZNEIMITTEL AG 20 MG/25 MG FILM-COATED TABLETS Olmesartan medoxomil/Hydrochlorothiazide 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 Olmesartan/Hydrochlorothiazide STADA Arzneimittel AG is and what it is used for 2. What you need to know before you take Olmesartan/Hydrochlorothiazide STADA Arzneimittel AG 3. How to take Olmesartan/Hydrochlorothiazide STADA Arzneimittel AG 4. Possible side effects 5. How to store Olmesartan/Hydrochlorothiazide STADA Arzneimittel AG 6. Contents of the pack and other information 1. WHAT OLMESARTAN/HYDROCHLOROTHIAZIDE STADA ARZNEIMITTEL AG IS AND WHAT IT IS USED FOR Olmesartan/Hydrochlorothiazide STADA Arzneimittel AG contains two active substances, olmesartan medoxomil and hydrochlorothiazide, that are used to treat high blood pressure (hypertension): Olmesartan medoxomil is one of a group of medicines called angiotensin II-receptor antagonists. It lowers blood pressure by relaxing the blood vessels. Hydrochlorothiazide is one of a group of medicines called thiazide diuretics (“water tablets”). It lowers blood pressure by helping the body to get rid of extra fluid by making your kidneys produce more urine. You will only be given Olmesartan/Hydrochlorothiazide STADA Arzneimittel AG if olmesartan medoxomil alone पूरा दस्तावेज़ पढ़ें
HealthProductsRegulatoryAuthority 21May2019 CRN008RFK Page1of20 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olmesartan/HydrochlorothiazideSTADAArzneimittelAG20mg/25mgfilm-coatedtablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachfilm-coatedtabletcontains20 mgolmesartanmedoxomiland25 mghydrochlorothiazide. Excipient(s)withknowneffect Eachfilm-coatedtabletcontains92.84 mglactosemonohydrate. Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Film-coatedtablet. Olmesartan/HydrochlorothiazideSTADAArzneimittelAG20mg/25mgfilm-coatedtabletsaresalmon,round,biconvex film-coatedtabletswithadiameterof8mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatmentofessentialhypertension. Olmesartan/HydrochlorothiazideSTADAArzneimittelAG20mg/12.5mgand20mg/25mgfixeddosecombinationis indicatedinadultpatientswhosebloodpressureisnotadequatelycontrolledonolmesartanmedoxomilalone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS Olmesartan/HydrochlorothiazideSTADAArzneimittelAGisnotforuseasinitialtherapy,butinpatientswhosebloodpressure isnotadequatelycontrolledby20mgolmesartanmedoxomilalone.Olmesartan/HydrochlorothiazideSTADAArzneimittelAG isadministeredoncedaily,withorwithoutfood. Whenclinicallyappropriate,directchangefrommonotherapywith20mgolmesartanmedoxomiltothefixedcombinationmay beconsidered,takingintoaccountthattheantihypertensiveeffectofolmesartanmedoxomilismaximalbyabout8weeksafter initiatingtherapy(seesection5.1).Dosetitrationoftheindividualcomponent पूरा दस्तावेज़ पढ़ें