FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be exercised in hypertensive patients with severe renal impairment and end stage renal disease as there is no experience of use of Edarbi in these patients (see sections 4.4 and 5.2).
Icelandic: Gæta skal varúðar hjá sjúklingum með háþrýsting og alvarlega skerðingu á nýrnastarfsemi og nýrnasjúkdóm á lokastigi þar sem engin reynsla er af notkun Edarbi hjá þessum sjúklingum (sjá kafla 4.4 og 5.2).
English: No data are available on the effect of azilsartan medoxomil on human fertility.
Icelandic: Engar upplýsingar liggja fyrir um áhrif azilsartanmedoxomils á frjósemi manna.
English: In active-comparator studies with either valsartan or ramipril, the blood-pressure-lowering effect with Edarbi was sustained during long-term treatment.
Icelandic: Í rannsóknum með virku samanburðarlyfi, annaðhvort valsartani eða ramipríli, héldust blóðþrýstingslækkandi áhrif Edarbi við langtímameðferð.
English: Adverse reactions were reported at a similar frequency for the Edarbi 20 mg dose as with the 40 and 80 mg doses in one placebo controlled study.
Icelandic: Greint var frá svipaðri tíðni aukaverkana vegna 20 mg skammts af Edarbi og vegna 40 mg og 80 mg skammta í einni rannsókn með samanburði við lyfleysu.
English: Following oral administration, azilsartan medoxomil is rapidly hydrolyzed to the active moiety azilsartan in the gastrointestinal tract and/or during absorption.
Icelandic: Eftir inntöku er azilsartanmedoxomil vatnsrofið hratt í virka efnið azilsartan í meltingarveginum og/eða við frásog.
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately and, if appropriate, alternative therapy should be started.
Icelandic: Þegar þungun hefur verið staðfest skal tafarlaust hætta meðferð með angíótensín II viðtakablokkum og hefja meðferð með öðrum blóðþrýstingslækkandi lyfjum ef það á við.
English: If you forget to take Edarbi Do not take a double dose to make up for a forgotten dose.
Icelandic: Ekki á að tvöfalda skammt til að bæta upp skammt sem gleymst hefur að taka.
English: Blood creatine phosphokinase increased
Icelandic: Hækkun kreatínkínasa í blóði
English: Furthermore, concomitant use of angiotensin II receptor antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Icelandic: Þar að auki getur samhliða notkun á angíótensín II viðtakablokkum og bólgueyðandi gigtarlyfjum valdið aukinni hættu á versnandi nýrnastarfsemi og hækkun á kalíum í sermi.
English: Edarbi has not been studied in patients with severe hepatic impairment and therefore its use is not recommended in this patient group (see sections 4.4 and 5.2).
Icelandic: Edarbi hefur ekki verið rannsakað hjá sjúklingum með alvarlega skerðingu á lifrarstarfsemi og því er notkun þess ekki ráðlögð hjá þessum hópi sjúklinga (sjá kafla 4.4 og 5.2).
English: ACE inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients with diabetic nephropathy.
Icelandic: Þess vegna skal ekki nota ACE hemla og angíótensín II viðtakablokka samhliða hjá sjúklingum með nýrnakvilla vegna sykursýki.
English: (angioedema) - Itching of the skin with raised lumps.
Icelandic: - Kláði í húð með upphleyptum hnútum.
English: Additionally, Edarbi 80 mg resulted in significantly greater reductions in SBP than the highest approved doses of olmesartan medoxomil and valsartan.
Icelandic: Þar að auki kom fram mun meiri lækkun á slagbilsþrýstingi við notkun 80 mg skammta af Edarbi en við notkun hæstu samþykktu skammta af olmesartanmedoxomili og valsartani.
English: Monitoring of serum potassium should be undertaken as appropriate (see section 4.4).
Icelandic: Mæla skal kalíum í sermi eftir því sem við á (sjá kafla 4.4).
English: Because no information is available regarding the use of azilsartan medoxomil during breastfeeding, Edarbi is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while breast-feeding a newborn or preterm infant.
Icelandic: Þar sem engar upplýsingar liggja fyrir um notkun azilsartanmedoxomils meðan á brjóstagjöf stendur er ekki mælt með notkun Edarbi hjá konum sem hafa barn á brjósti.
English: Edarbi contains an active substance called azilsartan medoxomil and belongs to a class of medicines called angiotensin II receptor antagonists (AIIRAs).
Icelandic: Edarbi inniheldur virkt efni sem kallast azilsartanmedoxomil og tilheyrir flokki lyfja sem kölluð eru angíótensín II viðtakablokkar.
English: Edarbi has not been studied in patients with severe hepatic impairment and therefore its use is not recommended in this patient group (see sections 4.2 and 5.2).
Icelandic: Edarbi hefur ekki verið rannsakað hjá sjúklingum með alvarlega skerðingu á lifrarstarfsemi og því er notkun lyfsins hjá þessum hópi sjúklinga ekki ráðlögð (sjá kafla 4.2 og 5.2)
English: If symptomatic hypotension should occur, supportive treatment should be instituted and vital signs monitored.
Icelandic: Meðferð Ef lágþrýstingur með einkennum kemur fram skal hefja stuðningsmeðferð og fylgjast með lífsmörkum.
English: Takeda Nederland bv Tel: +31 23 566 8777 nl.medical.info@takeda.com
Icelandic: +31 23 566 8777 nl.medical.info@takeda.com
English: There are no data from the use of azilsartan medoxomil in pregnant women.
Icelandic: Engar upplýsingar liggja fyrir um notkun azilsartanmedoxomils á meðgöngu.
English: How to store Edarbi
Icelandic: Hvernig geyma á Edarbi
English: When Edarbi was coadministered with chlortalidone, the frequencies of blood creatinine increased and hypotension were increased from uncommon to common.
Icelandic: Þegar Edarbi var gefið samhliða klórtalidóni jókst tíðni hækkunar á kreatíníni í blóði og lágþrýstings úr sjaldgæfum í algengar.
English: België/Belgique/Belgien Takeda Belgium Tél/Tel: +32 2 464 06 11 takeda-belgium@takeda.com
Icelandic: +32 2 464 06 11 takeda-belgium@takeda.com
English: Placebo at 0.05 level within the framework of the step-wise analysis † Significant difference vs. Comparator(s) at 0.05 level within the framework of the step-wise analysis # Maximum dose achieved in study 2.
Icelandic: Marktækur munur miðað við samanburðarlyf við mörk 0,05 innan ramma þrepagreiningarinnar #
English: Black population
Icelandic: Sjúklingar af svörtum kynstofni
English: - have low blood pressure or feel dizzy or lightheaded.
Icelandic: - hefur lágan blóðþrýsting eða finnur fyrir sundli eða svima.
English: Intravascular volume depletion
Icelandic: Tafla yfir aukaverkanir
English: White to nearly white round tablets, 7.6 mm in diameter, debossed “ASL” on one side and “40” on the other.
Icelandic: Hvítar eða nærri því hvítar kringlóttar töflur, 7,6 mm í þvermál, með áletruninni „ASL“ á annarri hliðinni og „40“ á hinni hliðinni.
English: In these clinical studies, adverse reactions associated with treatment with Edarbi were mostly mild or moderate, with an overall incidence similar to placebo.
Icelandic: Í þessum klínísku rannsóknum kom fram að aukaverkanir í tengslum við meðferð með Edarbi voru að mestu vægar eða miðlungi alvarlegar, og heildartíðni var svipuð og við meðferð með lyfleysu.
English: Clinical trial data has shown that dual blockade of the RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Icelandic: ACE hemlum, angíótensín II viðtakablokkum eða aliskireni tengist hærri tíðni aukaverkana eins og blóðþrýstingslækkun, blóðkalíumhækkun og skerðingu á nýrnastarfsemi (þ.m.t. bráðri nýrnabilun) samanborið við notkun á einu lyfi sem hamlar renín-angíótensín-aldósterónkerfinu (sjá kafla 4.3, 4.4 og 5.1).
English: Dose proportionality in exposure was established for azilsartan in the azilsartan medoxomil dose range of 20 mg to 320 mg after single or multiple dosing.
Icelandic: Útsetning í réttu hlutfalli við skammta var staðfest fyrir azilsartan þegar skammtar azilsartanmedoxomils, stakir eða endurteknir, voru á bilinu 20 mg til 320 mg.
English: The elevations in serum creatinine during coadminstiration of Edarbi with diuretics were associated with larger blood pressure reductions compared with a single medicinal product.
Icelandic: Hækkanir á kreatíníni í sermi við gjöf Edarbi samhliða þvagræsilyfjum var tengd meiri lækkunum á blóðþrýstingi en við gjöf eins lyfs.
English: How to take Edarbi
Icelandic: Hvernig nota á Edarbi
English: Placebo Edarbi 20 mg
Icelandic: Lyfleysa Edarbi 20 mg
English: Edarbi 20 mg tablets Edarbi 40 mg tablets Edarbi 80 mg tablets
Icelandic: Edarbi 20 mg töflur Edarbi 40 mg töflur
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Edarbi in one or more subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Icelandic: á Edarbi hjá einum eða fleiri undirhópum barna með háþrýsting (sjá upplýsingar í kafla 4.2 um notkun hjá börnum).
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists, plain, ATC Code: C09CA09
Icelandic: Lyf með verkun á renínangíótensín-kerfið, angíótensín II blokkar, einir sér, ATC flokkur:
English: White to nearly white round tablets, 6.0 mm in diameter, debossed “ASL” on one side and “20” on the other.
Icelandic: Hvítar til nærri því hvítar kringlóttar töflur, 6,0 mm í þvermál, með áletruninni „ASL“ á annarri hliðinni og „20“ á hinni hliðinni.
English: Edarbi 40 mg tablets
Icelandic: Edarbi 40 mg töflur
English: Dose dependent adverse events including dizziness, hypotension and serum creatinine elevations were more frequent with diuretic coadministration compared with Edarbi alone, while hypokalemia was less frequent compared with diuretic alone.
Icelandic: Skammtaháðar aukaverkanir eins og sundl, lágþrýstingur og hækkun á kreatíníni í sermi voru tíðari við samhliða notkun þvagræsilyfja samanborið við Edarbi eitt sér, á meðan blóðkalíumlækkun var sjaldgæfari samanborið við þvagræsilyf eitt sér.
English: Тел.
Icelandic: Lotunr.
English: Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Icelandic: Kalíumsparandi þvagræsilyf, kalíumuppbót, saltlíki sem inniheldur kalíum og önnur lyf sem geta hækkað kalíumþéttni í sermi
English: As with other angiotensin II receptor antagonists and angiotensin converting enzyme inhibitors the antihypertensive effect was lower in black patients (usually a low-renin population).
Icelandic: II viðtakablokka og ACE-hemla voru blóðþrýstingslækkandi áhrif minni hjá sjúklingum af svörtum kynstofni (þýði sem yfirleitt er með lág reníngildi).
English: In the reproduction toxicity studies, there were no effects on male or female fertility.
Icelandic: á æxlun komu ekki fram nein áhrif á frjósemi hjá karleða kvendýrum.
English: Infants whose mothers have taken Angiotensin II receptor antagonists should be closely observed for hypotension (see sections 4.3 and 4.4).
Icelandic: Fylgjast skal vel með hvort lágþrýstingur komi fram hjá ungbörnum mæðra sem notað hafa angíótensín II viðtakablokka (sjá kafla 4.3 og 4.4).
English: White to nearly white round tablets, 9.6 mm in diameter, debossed “ASL” on one side and “80” on the other.
Icelandic: Hvítar eða nærri því hvítar kringlóttar töflur, 9,6 mm í þvermál, með áletruninni „ASL“ á annarri hliðinni og „80“ á hinni hliðinni.
English: Takeda Pharma AB Tel: + 46 8 731 28 00 infosweden@takeda.com
Icelandic: + 46 8 731 28 00 infosweden@takeda.com
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Icelandic: Vitað er að notkun angíótensín II viðtakablokka á öðrum og þriðja þriðjungi meðgöngu hefur skaðleg áhrif á fóstur (skert starfsemi nýrna, legvatnsbrestur, skert beinmyndun höfuðkúpu) og skaðleg áhrif á nýbura (nýrnabilun, lágþrýstingur, blóðkalíumhækkun) (sjá kafla 5.3 Forklínískar upplýsingar).
English: Diarrhoea Nausea
Icelandic: Skert blóðrúmmál
English: Edarbi 80 mg tablets
Icelandic: Edarbi 80 mg töflur
English: Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid > 3 g/day), and non-selective NSAIDs When angiotensin II receptor antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Icelandic: Við samhliða notkun angíótensín II viðtakablokka og bólgueyðandi gigtarlyfja (t.d. sértækra COX-2 hemla, asetýlsalicýlsýru (> 3 g/dag) og ósértækra bólgueyðandi gigtarlyfja, geta blóðþrýstingslækkandi áhrif dvínað.
English: The possibility of similar effects cannot be excluded with Edarbi.
Icelandic: Ekki er hægt að útiloka að Edarbi geti hugsanlega valdið svipuðum áhrifum.
English: (medicines to relieve pain and inflammation) - Acetylsalicyclic acid if taking more than 3 g per day (medicine to relieve pain and inflammation) - Medicines that increase the amount of potassium in your blood; these include potassium supplements, potassium-sparing medicines (certain ‘water tablets') or salt substitutes containing potassium - Heparin (a medicine for thinning the blood) - Diuretics (water tablets) - Aliskiren or other medicines to lower your blood pressure (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker, such as enalapril, lisinopril, ramipril or valsartan,
Icelandic: - Aliskiren eða önnur lyf sem lækka blóðþrýstinginn (ACE-hemil eða angíótensín II viðtakablokka svo sem enalapríl, lísínópríl, ramípríl eða valsartan, telmísartan, írbesartan).
English: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 3 g/l and 1 volume percent, respectively) were observed in placebo-controlled monotherapy studies.
Icelandic: Væg lækkun á blóðrauða og blóðkornahlutfalli (meðallækkun um annars vegar u.þ.b. 3 g/l og hins vegar 1 rúmmálsprósentu) kom fram í rannsóknum á einlyfjameðferð með samanburði við lyfleysu.
English: Characteristics in specific groups of patients
Icelandic: Lyfjahvörf hjá sérstökum sjúklingahópum
English: Each tablet contains 40 mg azilsartan medoxomil (as potassium)
Icelandic: Hver tafla inniheldur 40 mg azilsartanmedoxomil (sem kalíum)
English: Edarbi 20 mg tablets
Icelandic: Edarbi 20 mg töflur
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of lithium and angiotensin-converting enzyme inhibitors.
Icelandic: Greint hefur verið frá afturkræfum hækkunum á litíumþéttni í sermi og eiturverkunum við samhliða notkun litíums og ACE-hemla.
English: The incidence of elevations in serum creatinine following treatment with Edarbi was similar to placebo in the randomised placebo-controlled monotherapy studies.
Icelandic: Tíðni hækkunar á kreatíníni í sermi í kjölfar meðferðar með Edarbi var svipuð og með lyfleysu í slembuðum rannsóknum á einlyfjameðferð með samanburði við lyfleysu.
English: The incidence of adverse reactions with this treatment was not affected by gender, age, or race.
Icelandic: Kyn, aldur eða kynstofn höfðu ekki áhrif á tíðni aukaverkana meðferðarinnar.
English: Renal impairment
Icelandic: - Sundl - Niðurgangur
English: Puh/Tel: +358 20 746 5000
Icelandic: Oy Leiras Takeda Pharmaceuticals Ab Puh/Tel: +358 20 746 5000
English: Suomi/Finland Takeda Oy
Icelandic: Takeda Latvia SIA
English: EU/1/11/734/001 14 tablets EU/1/11/734/002 28 tablets EU/1/11/734/012 30 tablets EU/1/11/734/003 56 tablets EU/1/11/734/013 90 tablets EU/1/11/734/004 98 tablets EU/1/11/734/005 14 tablets EU/1/11/734/006 28 tablets EU/1/11/734/014 30 tablets EU/1/11/734/007 56 tablets EU/1/11/734/015 90 tablets EU/1/11/734/008 98 tablets EU/1/11/734/016 14 tablets EU/1/11/734/009 28 tablets EU/1/11/734/017 30 tablets EU/1/11/734/010 56 tablets EU/1/11/734/018 90 tablets EU/1/11/734/011 98 tablets EU/1/11/734/019 14 tablets EU/1/11/734/020 28 tablets EU/1/11/734/021 56 tablets EU/1/11/734/022 98 tablets EU/1/11/734/023 14 tablets EU/1/11/734/024 28 tablets EU/1/11/734/025 56 tablets EU/1/11/734/026 98 tablets EU/1/11/734/027 14 tablets EU/1/11/734/028 28 tablets EU/1/11/734/029 56 tablets EU/1/11/734/030 98 tablets
Icelandic: EU/1/11/734/001 14 töflur EU/1/11/734/002 28 töflur EU/1/11/734/012 30 töflur EU/1/11/734/003 56 töflur EU/1/11/734/013 90 töflur EU/1/11/734/004 98 töflur EU/1/11/734/005 14 töflur EU/1/11/734/006 28 töflur EU/1/11/734/014 30 töflur EU/1/11/734/007 56 töflur EU/1/11/734/015 90 töflur EU/1/11/734/008 98 töflur EU/1/11/734/016 14 töflur EU/1/11/734/009 28 töflur EU/1/11/734/017 30 töflur EU/1/11/734/010 56 töflur EU/1/11/734/018 90 töflur EU/1/11/734/011 98 töflur EU/1/11/734/019 14 töflur EU/1/11/734/020 28 töflur EU/1/11/734/021 56 töflur EU/1/11/734/022 98 töflur EU/1/11/734/023 14 töflur
English: Each tablet contains 20 mg azilsartan medoxomil (as potassium)
Icelandic: Hver tafla inniheldur 20 mg azilsartanmedoxomil (sem kalíum)
English: Change from BL -0.3
Icelandic: C09CA09
English: - The active substance is azilsartan medoxomil (as potassium).
Icelandic: - Virka innihaldsefnið er azilsartanmedoxomil (sem kalíum)
English: Uncommon side effects (may affect up to 1 in 100 people): - Low blood pressure, which may make you feel faint or dizzy - Feeling tired - Swelling of the hands, ankles or feet (peripheral oedema) - Skin rash and itching - Nausea - Muscle spasms - Increased serum creatinine in the blood (an indicator of kidney function) - Increased uric acid in the blood.
Icelandic: - Lágþrýstingur, sem getur valdið yfirliði eða sundli - Þreyta - Þroti á höndum, ökklum eða fótum (bjúgur í útlimum)
English: ANNEX I
Icelandic: Rannsókn 1
English: There was no evidence of QT/QTc prolongation at a dose of 320 mg of azilsartan medoxomil.
Icelandic: á QT/QTc við 320 mg skammt af azilsartanmedoxomili.
English: Rare side effects (may affect up to 1 in 1,000 people): - Changes in blood test results including decreased levels of a protein in the red blood cells
Icelandic: - Breytingar á niðurstöðum blóðprófa, þ.m.t. lækkun próteins í rauðum blóðkornum
English: ANNEX II
Icelandic: Rannsókn 2
English: Elimination Following an oral dose of
Icelandic: Brotthvarf Eftir inntöku skammts af
English: What you need to know before you take Edarbi
Icelandic: Áður en byrjað er að nota Edarbi
English: Biotransformation
Icelandic: Vöðvakrampar
English: Hyperkalaemia
Icelandic: Taugakerfi
English: Each tablet contains 80 mg azilsartan medoxomil (as potassium)
Icelandic: Hver tafla inniheldur 80 mg azilsartanmedoxomil (sem kalíum)
English: This generally has been true for other angiotensin II receptor (AT1) antagonists and angiotensin-converting enzyme inhibitors.
Icelandic: II (AT1) viðtakablokka og ACE-hemla.
English: Aluminum blisters integrated with desiccant.
Icelandic: Algengasta aukaverkunin var sundl.
English: Date of first authorisation: 7 December 2011 Date of latest renewal:
Icelandic: Nýjasta dagsetning endurnýjunar markaðsleyfis:
English: Coadministration of Edarbi with diuretics, such as chlortalidone, resulted in a greater incidence of creatinine elevations, an observation consistent with that of other angiotensin II receptor antagonists and angiotensin converting enzyme inhibitors.
Icelandic: Þegar Edarbi var gefið samhliða þvagræsilyfjum, t.d. klórtalidóni, jókst tíðni hækkunar á kreatíníni, sem einnig á við um aðra angíótensín II viðtakablokka og ACE-hemla.
English: EU/1/11/734/016 14 tablets EU/1/11/734/009 28 tablets EU/1/11/734/017 30 tablets EU/1/11/734/010 56 tablets EU/1/11/734/018 90 tablets EU/1/11/734/011 98 tablets EU/1/11/734/027 14 tablets EU/1/11/734/028 28 tablets EU/1/11/734/029 56 tablets EU/1/11/734/030 98 tablets
Icelandic: EU/1/11/734/016 14 töflur EU/1/11/734/009 28 töflur EU/1/11/734/017 30 töflur EU/1/11/734/010 56 töflur EU/1/11/734/018 90 töflur EU/1/11/734/011 98 töflur EU/1/11/734/027 14 töflur EU/1/11/734/028 28 töflur EU/1/11/734/029 56 töflur EU/1/11/734/030 98 töflur
English: In the repeated-dose toxicity studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters, changes in the kidney and renal haemodynamics,
Icelandic: Í rannsóknum á eituráhrifum eftir endurtekna skammta orsökuðu skammtar sem leiddu til sambærilegrar útsetningar og ráðlagðir skammtar, lækkun á mælibreytum fyrir rauð blóðkorn, breytingar á nýrum og blóðaflfræði nýrna, sem og hækkun á kreatíníni í sermi hjá dýrum með eðlilegan blóðþrýsting.
English: Vascular disorders
Icelandic: LÁGMARKSUPPLÝSINGAR
English: EU/1/11/734/005 14 tablets EU/1/11/734/006 28 tablets EU/1/11/734/014 30 tablets EU/1/11/734/007 56 tablets EU/1/11/734/015 90 tablets EU/1/11/734/008 98 tablets EU/1/11/734/023 14 tablets EU/1/11/734/024 28 tablets EU/1/11/734/025 56 tablets EU/1/11/734/026 98 tablets
Icelandic: EU/1/11/734/005 14 töflur EU/1/11/734/006 28 töflur EU/1/11/734/014 30 töflur EU/1/11/734/007 56 töflur EU/1/11/734/015 90 töflur EU/1/11/734/008 98 töflur EU/1/11/734/023 14 töflur EU/1/11/734/024 28 töflur EU/1/11/734/025 56 töflur EU/1/11/734/026 98 töflur
English: ΒΙΑΝΕΞ Α.Ε.
Icelandic: VIÐAUKI I
English: EU/1/11/734/001 14 tablets EU/1/11/734/002 28 tablets EU/1/11/734/012 30 tablets EU/1/11/734/003 56 tablets EU/1/11/734/013 90 tablets EU/1/11/734/004 98 tablets EU/1/11/734/019 14 tablets EU/1/11/734/020 28 tablets EU/1/11/734/021 56 tablets EU/1/11/734/022 98 tablets
Icelandic: EU/1/11/734/001 14 töflur EU/1/11/734/002 28 töflur EU/1/11/734/012 30 töflur EU/1/11/734/003 56 töflur EU/1/11/734/013 90 töflur EU/1/11/734/004 98 töflur EU/1/11/734/019 14 töflur EU/1/11/734/020 28 töflur EU/1/11/734/021 56 töflur EU/1/11/734/022 98 töflur
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Icelandic: Sjúklingar sem ráðgera að verða barnshafandi skulu skipta yfir í aðra blóðþrýstingslækkandi meðferð þar sem sýnt hefur verið fram á öryggi á meðgöngu, nema nauðsynlegt sé talið að halda áfram meðferð með angíótensín II viðtakablokkum.
English: Rash, pruritus Angioedema
Icelandic: Blóðrauði og blóðkornahlutfall
English: including diuretics (such as chlortalidone and hydrochlorothiazide) and calcium channel blockers (see sections 4.3, 4.4, 4.5 and 5.1).
Icelandic: Ef ekki næst nægilega góð stjórn á blóðþrýstingi með Edarbi einu sér er hægt að ná frekari lækkun á blóðþrýstingi með því að gefa önnur blóðþrýstingslækkandi lyf í meðferðinni, þ.m.t. þvagræsilyf (eins og klórtalidón og hýdróklórtíazíð) og kalsíumgangaloka (sjá kafla 4.3, 4.4, 4.5 og 5.1).
English: Edarbi 20 mg: Each tablet contains 20 mg azilsartan medoxomil (as potassium) Edarbi 40 mg: Each tablet contains 40 mg azilsartan medoxomil (as potassium) Edarbi 80 mg: Each tablet contains 80 mg azilsartan medoxomil (as potassium)
Icelandic: Hver tafla inniheldur 40°mg af azilsartanmedoxomili (sem kalíum) Edarbi 80°mg:
English: Caution should be exercised in hypertensive patients with severe renal impairment, congestive heart failure or renal artery stenosis, as there is no experience of use of Edarbi in these patients (see sections 4.2 and 5.2).
Icelandic: Gæta skal varúðar hjá sjúklingum með háþrýsting og alvarlega skerðingu á nýrnastarfsemi, hjartabilun eða nýrnaslagaæðarþrengsli, þar sem engin reynsla er af notkun Edarbi hjá þessum sjúklingum.
English: Angiotensin II receptor antagonists should not be initiated during pregnancy.
Icelandic: Ekki skal hefja meðferð með angíótensín II viðtakablokkum á meðgöngu.
English: Common side effects (may affect up to 1 in 10 people): - Dizziness - Diarrhoea - Increased blood creatine phosphokinase (an indicator of muscle damage).
Icelandic: - Ógleði - Vöðvakrampar - Aukning á kreatíníni í blóði (mælikvarði fyrir nýrnastarfsemi)