FrancophonIA/ELRC3.0 huggingface dataset:
English: No adjustment of the initial dose of aliskiren is required in patients with mild to moderate renal impairment (see sections 4.2 and 4.4).
Icelandic: Ekki þarf að aðlaga upphafsskammt aliskirens hjá sjúklingum með vægt til í meðallagi alvarlega skerta nýrnastarfsemi (sjá kafla 4.2 og 4.4).
English: No adjustment of the initial dose is required in patients with mild to moderate renal impairment (see sections 4.4 and 4.2).
Icelandic: Ekki þarf að aðlaga upphafsskammt hjá sjúklingum með vægt til í meðallagi skerta nýrnastarfsemi (sjá kafla 4.2 og 4.4).
English: - Amantadine
Icelandic: • kviðverkir
English: - medicines that may induce “torsades de pointes” (irregular heart beat), such as antiarrhythmics
Icelandic: - lyf sem geta valdið “torsades de pointes” (óreglulegum hjartslætti), svo sem lyf við hjartsláttaróreglu (lyf við hjartasjúkdómum) og sum geðrofslyf. - ketoconazol, lyf sem notað er við sveppasýkingum.
English: What Rasitrio is
Icelandic: Rasitrio inniheldur
English: Concomitant use of Rasitrio with ARBs or ACEIs is contraindicated in patients with diabetes mellitus (see section 4.3).
Icelandic: Rasitrio samhliða angíótensín II viðtakablokkum eða ACE hemlum hjá sjúklingum með sykursýki (sjá kafla 4.3).
English: Hyperglycaemia
Icelandic: - gigtarlyf.
English: Blood and lymphatic system disorders Very rare
Icelandic: Blóð og eitlar Mjög sjaldgæfar
English: The following, possibly serious, side effects have been reported with medicines containing aliskiren, amlodipine or hydrochlorothiazide alone.
Icelandic: Greint hefur verið frá eftirtöldum aukaverkunum, sem geta verið alvarlegar, vegna lyfja sem innihalda aliskiren, amlodipin eða hýdróklórtíazíð eitt sér.
English: - diltiazem, a medicine used to treat heart problems.
Icelandic: - diltiazem, lyf sem notað er við hjartasjúkdómum.
English: Hepatic impairment Rasitrio is contraindicated in patients with severe hepatic impairment (see section 4.3).
Icelandic: Skert lifrarstarfsemi Ekki má nota Rasitrio handa sjúklingum með verulega skerta lifrarstarfsemi (sjá kafla 4.3).
English: • severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin,
Icelandic: veruleg viðbrögð í húð (eitrunardreplos húðþekju og/eða áhrif á slímhúð í munni - húðroði,
English: Nervous system disorders Common
Icelandic: Ónæmiskerfi Koma örsjaldan fyrir
English: Caution should be exercised when administering Rasitrio to patients with mild to moderate hepatic impairment or progressive liver disease (see sections 4.2 and 5.2).
Icelandic: Rasitrio hjá sjúklingum með vægt til í meðallagi mikið skerta lifrarstarfsemi eða versnandi lifrarsjúkdóm (sjá kafla 4.2 og 5.2).
English: Agranulocytosis, bone marrow depression, haemolytic anaemia, leucopenia
Icelandic: Þvagsýruhækkun, blóðmagnesíumlækkun, blóðnatríumlækkun
English: Hydrochlorothiazide is eliminated predominantly as unchanged compound.
Icelandic: Hýdróklórtíazíð skilst aðallega út á óbreyttu formi.
English: The recommended starting dose of aliskiren in this group of patients is 150 mg. No clinically meaningful additional blood pressure reduction is observed by increasing the dose to 300 mg in the majority of elderly patients.
Icelandic: Hjá meirihluta aldraðra sjúklinga hafa ekki komið fram aukin blóðþrýstingslækkandi áhrif, sem eru klínískt mikilvæg, við það að auka skammtinn í 300 mg.
English: - if you have problems to produce urine (anuria).
Icelandic: - ef þú getur ekki myndað þvag (þvagþurrð).
English: The most common adverse reaction is diarrhoea.
Icelandic: Algengasta aukaverkunin er niðurgangur.
English: The combination of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) and is not recommended in other patients (see sections 4.3, 4.4 and 5.1).
Icelandic: Ekki má nota aliskiren samhliða angíótensín II viðtakablokkum eða ACE hemlum hjá sjúklingum með sykursýki eða skerta nýrnastarfsemi (GFR <60 ml/mín./1,73 m2) og slík samhliða notkun er ekki ráðlögð hjá öðrum sjúklingum (sjá kafla 4.3, 4.4 og 5.1).
English: In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalaemia after administration of verapamil and intravenous dantrolene.
Icelandic: Vart hefur orðið við banvænt sleglatif og lost vegna hjartaáfalls í tengslum við hækkun kalíums í blóði eftir gjöf verapamils og dantrolens í æð hjá dýrum.
English: General disorders and administration site conditions Not known
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Tíðni ekki þekkt
English: In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.
Icelandic: Í klínískum rannsóknum þar sem sjúklingum með annað hvort háþrýsting eða hjartaöng var gefið amlodipin ásamt betablokkum komu ekki fram nein áhrif á mæligildi hjartalínurits.
English: - St. John's wort (hypericum perforatum), a herbal medicine used to elevate mood.
Icelandic: - jóhannesarjurt (jónsmessurunni, hypericum perforatum), náttúrulyf sem notað er við vægu þunglyndi.
English: - Medicinal products affecting serum potassium levels Concomitant use of other agents affecting the RAAS, of NSAIDs or of agents that increase serum potassium levels (e.g. potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, heparin) may lead to increases in serum potassium.
Icelandic: Samhliða notkun annarra lyfja sem hafa áhrif á renín-angíótensín-aldósterónkerfið, bólgueyðandi gigtarlyfja eða efna sem auka þéttni kalíums í sermi (t.d. kalíumsparandi þvagræsilyfja, kalíumuppbótar, saltauppbótar sem inniheldur kalíum, heparíns), getur orsakað aukningu kalíums í sermi.
English: Hepatobiliary disorders Very rare
Icelandic: Taugakerfi Mjög sjaldgæfar
English: If hypokalaemia develops during hydrochlorothiazide therapy Rasitrio should be discontinued until stable correction of the potassium balance.
Icelandic: Ef blóðkalíumlækkun kemur fram meðan á meðferð með hýdróklórtíazíði stendur skal stöðva meðferð með Rasitrio þar til kalíumþéttni hefur verið leiðrétt og hún helst stöðug.
English: - Digoxin and verapamil bioavailability may be slightly decreased by aliskiren.
Icelandic: - Aliskiren getur dregið lítillega úr aðgengi digoxins og verapamils.
English: • increased muscle stiffness and inability to stretch
Icelandic: • aukinn vöðvastífleiki og stirðleiki
English: Rasitrio 300 mg/10 mg/25 mg film-coated tablets
Icelandic: Rasitrio 300 mg/10 mg/25 mg filmuhúðaðar töflur
English: Therefore caution should be exercised in patients with hepatic impairment.
Icelandic: Því skal gæta varúðar við notkun lyfsins hjá sjúklingum með skerta lifrarstarfsemi.
English: Lowering the amount of angiotensin II allows the blood vessels to relax; this lowers blood pressure.
Icelandic: Þegar magn angíótensíns II minnkar slaknar á æðunum, sem lækkar blóðþrýsting.
English: The fixed dose combination should only be used after a stable effect on the monocomponents, given concurrently, has been established after dose titration.
Icelandic: Einungis skal nota stöðluðu samsetninguna þegar sýnt hefur verið fram á stöðuga verkun lyfjanna eftir að skammtar hafa verið stilltir, þegar þau eru tekin sitt í hverju lagi, en samtímis.
English: • Severe allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue,
Icelandic: Alvarleg ofnæmisviðbrögð með einkennum svo sem útbrotum, kláða, þrota í andliti, vörum eða tungu, öndunarerfiðleikum, sundli.
English: NSAIDs may also weaken the diuretic and antihypertensive activity of hydrochlorothiazide.
Icelandic: Bólgueyðandi gigtarlyf geta einnig dregið úr þvagræsandi og blóðþrýstingslækkandi áhrifum hýdróklórtíazíðs.
English: In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine.
Icelandic: eftir inntöku amlodipins 10 mg, dregur úr frásogshraða amlodipins.
English: Aliskiren is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m2).
Icelandic: Ekki er ráðlagt að nota aliskiren hjá sjúklingum með alvarlega skerta nýrnastarfsemi (gaukulsíunarhraði (GFR) <30 ml/mín.
English: Talk to your doctor before taking Rasitrio: - if you are suffering from vomiting or diarrhoea or if you are taking a diuretic (a medicine to increase the amount of urine you produce).
Icelandic: - ef þú ert með uppköst eða niðurgang eða ef þú ert að nota þvagræsilyf (lyf sem notuð eru til að auka þvagmyndun).
English: Very common Increases in cholesterol and triglycerides Rare
Icelandic: Mjög sjaldgæfar Stoðkerfi og stoðvefur Algengar
English: Thiazide-induced hypokalaemia or hypomagnesaemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4).
Icelandic: - Digoxín og aðrir digitalisglýkósíðar Blóðkalíumlækkun eða blóðmagnesíumlækkun af völdum tíazíða geta aukið hættu á hjartsláttartruflunum af völdum digitalis (sjá kafla 4.4).
English: What Rasitrio contains - Each Rasitrio 150 mg/5 mg/12.5 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide.
Icelandic: - Hver Rasitrio 150 mg/5 mg/12,5 mg filmuhúðuð tafla inniheldur 150 mg aliskiren (sem hemifumarat), 5 mg amlodipin (sem besylat) og 12,5 mg hýdróklórtíazíð.
English: Shock (including cardiogenic shock).
Icelandic: Lost (þar með talið hjartalost).
English: Investigations: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of aliskiren.
Icelandic: Í klínískum samanburðarrannsóknum voru sjaldan orsakatengsl milli klínískt mikilvægra breytinga á stöðluðum rannsóknaviðmiðum og notkunar aliskirens.
English: Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets
Icelandic: Rasitrio 150 mg/5 mg/12,5 mg filmuhúðaðar töflur
English: What Rasitrio looks like and contents of the pack - Rasitrio 300 mg/10 mg/25 mg film-coated tablets are brown, oval tablets, with “VIV” debossed on one side and “NVR” on the other.
Icelandic: - Rasitrio 300 mg/10 mg/25 mg filmuhúðaðar töflur eru brúnar, sporöskjulaga töflur, með „VIV“
English: Posology The recommended dose of Rasitrio is one tablet per day.
Icelandic: Skammtar Ráðlagður skammtur af Rasitrio er ein tafla á sólarhring.
English: - Ion exchange resins
Icelandic: breytingar á bragðskyni
English: Violet white, ovaloid convex film-coated tablet with bevelled edges, with “YIY” debossed on one side and “NVR” on the other.
Icelandic: Fjólublá hvít, sporöskjulaga, kúpt filmuhúðuð tafla með sniðbrúnum, með „YIY“ grafið í aðra hliðina og „NVR“ í hina hliðina.
English: • inflammation of the gastric lining
Icelandic: • purpuralitir húðblettir
English: Rasitrio 300 mg/5 mg/25 mg film-coated tablets
Icelandic: Rasitrio 300 mg/5 mg/25 mg filmuhúðaðar töflur
English: The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
Icelandic: Fæðuneysla hefur ekki áhrif á aðgengi amlodipins.
English: Store in the original package in order to protect from moisture and light.
Icelandic: Geymið ekki við hærri hita en 30°C. Geymið í upprunalegum umbúðum til varnar gegn raka og ljósi.
English: In a randomised, double blind, active controlled, 36-week study in elderly patients whose blood pressure was not controlled with aliskiren/HCTZ 300/25 mg (SBP ≥140 mmHg), clinically meaningful further BP reduction was seen at week 36 endpoint for patients who received Rasitrio at a dose of 300/10/25 mg (from reductions in msSBP/msDBP of 15.0/8.6 mmHg at week 22 to reductions of 30.8/14.1 mmHg at week 36 endpoint).
Icelandic: Í slembaðri, tvíblindri 36 vikna samanburðarrannsókn með virkum samanburði, á öldruðum sjúklingum þar sem ekki hafði náðst stjórn á blóðþrýstingi með aliskireni/hýdróklórtíazíði 300/25 mg (slagbilsþrýstingur ≥140 mmHg), sást frekari klínískt marktæk lækkun á blóðþrýstingi við endapunkt í viku
English: Rasitrio 300 mg/10 mg/12.5 mg film-coated tablets
Icelandic: Rasitrio 300 mg/10 mg/12,5 mg filmuhúðaðar töflur
English: • muscle spasm
Icelandic: • nefrennsli
English: Brown, ovaloid convex film-coated tablet with bevelled edges, with “VIV” debossed on one side and “NVR” on the other.
Icelandic: Brún, sporöskjulaga, kúpt filmuhúðuð tafla með sniðbrúnum, með „VIV“ grafið í aðra hliðina og „NVR“ í hina hliðina.
English: Acute renal failure, renal impairment
Icelandic: Skert nýrnastarfsemi, bráð nýrnabilun
English: • inflammation of blood vessels
Icelandic: Truflun á blóðsaltajafnvægi
English: This effect is also seen with other medicinal products acting on the RAAS, such as ACEIs and ARBs.
Icelandic: Þessi áhrif koma einnig fram við notkun annarra lyfja sem verka á renín-angíótensín-aldósterónkerfið, t.d. ACE hemlar og angíótensín viðtakablokkar.
English: - Medicinal products affecting serum sodium level The hyponatraemic effect of diuretics may be intensified by concomitant administration of medicinal products such as antidepressants, antipsychotics, antiepileptics, etc.
Icelandic: Áhrif þvagræsilyfja til blóðnatríumlækkunar geta aukist við samhliða gjöf lyfja svo sem þunglyndislyfja, geðrofslyfja, flogaveikilyfja o.s.frv.
English: • dizziness.
Icelandic: Þvagþurrð.
English: Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilatation resulting in a reduction of supine and standing blood pressures.
Icelandic: Eftir gjöf ráðlagðra skammta handa sjúklingum með háþrýsting veldur amlodipin æðavíkkun sem hefur í för með sér lækkun blóðþrýstings í útafliggjandi og uppréttri stöðu.
English: Light pink, ovaloid convex film-coated tablet with bevelled edges, with “LIL” debossed on one side and “NVR” on the other.
Icelandic: Ljósbleik, sporöskjulaga, kúpt filmuhúðuð tafla með sniðbrúnum, með „LIL“ grafið í aðra hliðina og „NVR“ í hina hliðina.
English: • swelling
Icelandic: • sundl.
English: What Rasitrio contains - Each Rasitrio 300 mg/10 mg/25 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate), 10 mg amlodipine (as besylate) and 25 mg hydrochlorothiazide.
Icelandic: - Hver Rasitrio 300 mg/10 mg/25 mg filmuhúðuð tafla inniheldur 300 mg aliskiren (sem hemifumarat), 10 mg amlodipin (sem besylat) og 25 mg hýdróklórtíazíð.
English: dizziness
Icelandic: máttleysi
English: • fever.
Icelandic: • húðroði.
English: Tell your doctor immediately if you experience the following at the beginning of your treatment: Fainting and/or light-headedness linked to low blood pressure could occur at the beginning of treatment with Rasitrio.
Icelandic: Yfirlið og/eða svimi sem tengist lágum blóðþrýstingi getur komið fram í upphafi meðferðar með Rasitrio.
English: or an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc. - if you are 65 years of age or older (see section Elderly (age 65 years or older) below).
Icelandic: - ef þú ert 65 ára eða eldri (sjá kaflann „Aldraðir“ (65 ára og eldri) hér fyrir neðan).
English: What Rasitrio contains - Each Rasitrio 300 mg/5 mg/25 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 25 mg hydrochlorothiazide.
Icelandic: - Hver Rasitrio 300 mg/5 mg/25 mg filmuhúðuð tafla inniheldur 300 mg aliskiren (sem hemifumarat), 5 mg amlodipin (sem besylat) og 25 mg hýdróklórtíazíð.
English: • nausea
Icelandic: • verkur
English: What Rasitrio looks like and contents of the pack - Rasitrio 300 mg/10 mg/12.5 mg film-coated tablets are light red, oval tablets, with “UIU”
Icelandic: - Rasitrio 300 mg/10 mg/12,5 mg filmuhúðaðar töflur eru ljósrauðar, sporöskjulaga töflur, með
English: What Rasitrio contains - Each Rasitrio 300 mg/10 mg/12.5 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate), 10 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide.
Icelandic: - Hver Rasitrio 300 mg/10 mg/12,5 mg filmuhúðuð tafla inniheldur 300 mg aliskiren (sem hemifumarat), 10 mg amlodipin (sem besylat) og 12,5 mg hýdróklórtíazíð.
English: Rasitrio is contraindicated in hypertensive patients with severe hepatic impairment (see sections 4.3 and 5.2).
Icelandic: Ekki má nota Rasitrio hjá sjúklingum með háþrýsting og verulega skerta lifrarstarfsemi (sjá kafla 4.3 og 5.2).
English: Rasitrio 300 mg/5 mg/12.5 mg film-coated tablets
Icelandic: Rasitrio 300 mg/5 mg/12,5 mg filmuhúðaðar töflur
English: Liver disorder*, jaundice, hepatitis, liver failure** Skin and subcutaneous tissue disorders Uncommon
Icelandic: Lifrarsjúkdómar*, gula, lifrarbólga, lifrarbilun**
English: Rasitrio is contraindicated in patients with hypercalcaemia and should only be used after correction of any pre-existing hypercalcaemia.
Icelandic: Sjúklingar með blóðkalsíumhækkun mega ekki nota Rasitrio og einungis skal nota það eftir að blóðkalsíumhækkun sem er til staðar hefur verið leiðrétt.
English: Arthralgia, myalgia, muscle cramps, back pain
Icelandic: Liðverkir, vöðvaverkir, vöðvakrampar, bakverkur
English: OUTER CARTON OF MULTIPACK OF 98 (2 packs of 49 film-coated tablets) - WITH BLUE BOX
Icelandic: MEÐ 98 (2 pakkningar með 49 filmuhúðuðum töflum)
English: Tabulated list of adverse reactions:
Icelandic: Leggja skal fram uppfærða áætlun um áhættustjórnun:
English: Coadministration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.
Icelandic: Samhliða notkun með þvagræsilyfjum af flokki tíazíða, þ.m.t. hýdróklórtíazíði, getur aukið tíðni ofnæmis fyrir allopurinoli.
English: Hyperuricaemia, hypomagnesaemia, hyponatraemia
Icelandic: Sundl, höfuðverkur, dofi/náladofi
English: - if you have a narrowing of the aortic heart valve (aortic stenosis).
Icelandic: - ef þú ert með þrengingu í ósæðarloku í hjarta (ósæðarþröng).
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur 150 mg aliskiren (sem hemifumarat), 5 mg amlodipin (sem besylat) og 12,5 mg hýdróklórtíazíð.
English: Light red, ovaloid convex film-coated tablet with bevelled edges, with “UIU” debossed on one side and “NVR” on the other.
Icelandic: Ljósrauð, sporöskjulaga, kúpt filmuhúðuð tafla með sniðbrúnum, með „UIU“ grafið í aðra hliðina og „NVR“ í hina hliðina.
English: • headache
Icelandic: • hiti.
English: Renal dysfunction, acute renal failure
Icelandic: slæmur verkur í efri hluta kviðar
English: Ear and labyrinth disorders Uncommon
Icelandic: Eyru og völundarhús Sjaldgæfar
English: What Rasitrio contains - Each Rasitrio 300 mg/5 mg/12.5 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide.
Icelandic: - Hver Rasitrio 300 mg/5 mg/12,5 mg filmuhúðuð tafla inniheldur 300 mg aliskiren (sem hemifumarat), 5 mg amlodipin (sem besylat) og 12,5 mg hýdróklórtíazíð.
English: • dizziness
Icelandic: • vanlíðan
English: The concomitant use of aliskiren and ACEIs or ARBs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2).
Icelandic: Ekki má nota aliskiren samhliða ACE hemlum eða angíótensín II viðtakablokkum hjá sjúklingum með skerta nýrnastarfsemi (GFR <60 ml/mín./1,73 m2).
English: Tremor, dysgeusia, syncope, hypoesthesia, paraesthesia
Icelandic: Hárlos, purpuri, upplitun húðar, ofsviti, kláði, útbrot, útþot
English: - Anticholinergic agents and other medicinal products affecting gastric motility The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Icelandic: Andkólínvirk lyf (t.d. atropin, biperiden) geta aukið aðgengi þvagræsilyfja af flokki tíazíða, vegna minni hreyfinga meltingarvegar og hægari magatæmingar.
English: Intrahepatic cholestasis, jaundice Skin and subcutaneous tissue disorders Common
Icelandic: blæðingar frá tannholdi, særindi eða ofvöxtur tannholds
English: Thiazides, including hydrochlorothiazide, may increase the risk of adverse reactions caused by amantadine.
Icelandic: - Amantadin Tíazíð, þ.m.t hýdróklórtíazíð, geta aukið hættu á aukaverkunum af völdum amantadins.
English: Serum potassium: Increases in serum potassium have been observed with aliskiren and these may be exacerbated by concomitant use of other agents acting on the RAAS or by NSAIDs.
Icelandic: Aukning á þéttni kalíums í sermi hefur komið fram við meðferð með aliskireni og getur aukist enn frekar við samhliða notkun annarra lyfja sem verka á renín-angíótensínaldósterónkerfið eða bólgueyðandi gigtarlyfja.
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate), 10 mg amlodipine (as besylate) and 25 mg hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur 300 mg aliskiren (sem hemifumarat), 10 mg amlodipin (sem besylat) og 25 mg hýdróklórtíazíð.
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 25 mg hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur 300 mg aliskiren (sem hemifumarat), 5 mg amlodipin (sem besylat) og 25 mg hýdróklórtíazíð.
English: Abdominal discomfort, constipation, diarrhoea
Icelandic: Þunglyndi, svefntruflanir
English: • allergic reaction with symptoms such as rash, itching, hives, difficulty breathing or swallowing,
Icelandic: ofnæmisviðbrögð með einkennum svo sem útbrotum, kláða, ofsakláða, öndunarerfiðleikum eða kyngingarerfiðleikum, sundli
English: Each tablet contains 150 mg aliskiren (as aliskiren hemifumarate), 5 mg amlodipine (as amlodipine besylate) and 12.5 mg hydrochlorothiazide.
Icelandic: Hver tafla inniheldur 150 mg aliskiren (sem aliskiren hemifumarat), 5 mg amlodipin (sem amlodipin besylat) og 12,5 mg hýdróklórtíazíð.
English: • increased level of creatinine in the blood
Icelandic: • aukið magn kreatíníns í blóði
English: Magnesium stearate Silica colloidal anhydrous
Icelandic: Magnesíumsterat Vatnsfrí kísilkvoða
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate), 10 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur 300 mg aliskiren (sem hemifumarat), 10 mg amlodipin (sem besylat) og 12,5 mg hýdróklórtíazíð.
English: • weight decrease.
Icelandic: • þyngdartap.
English: The use of aliskiren in combination with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see section 4.3).
Icelandic: Ekki má nota aliskiren samhliða angíótensín II viðtakablokkum eða ACE hemlum hjá sjúklingum með sykursýki eða skerta nýrnastarfsemi (GFR <60 ml/mín./1,73 m2) (sjá kafla 4.3).
English: The concomitant use of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5 and
Icelandic: Ekki má nota Rasitrio samhliða angíótensín II viðtakablokkum eða ACE hemlum hjá sjúklingum með skerta nýrnastarfsemi (GFR <60 ml/mín./1,73 m2) (sjá kafla 4.3, 4.4 og
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate), 5 mg amlodipine (as besylate) and 12.5 mg hydrochlorothiazide.
Icelandic: Hver filmuhúðuð tafla inniheldur 300 mg aliskiren (sem hemifumarat), 5 mg amlodipin (sem besylat) og 12,5 mg hýdróklórtíazíð.
English: What Rasitrio looks like and contents of the pack - Rasitrio 300 mg/5 mg/12.5 mg film-coated tablets are light pink, oval tablets, with “LIL”
Icelandic: - Rasitrio 300 mg/5 mg/12,5 mg filmuhúðaðar töflur eru ljósbleikar, sporöskjulaga töflur, með
English: Vomiting, dyspepsia, altered bowel habits (including diarrhoea and
Icelandic: Uppköst, meltingartruflun, breyttar hægðavenjur (þar með talið niðurgangur og hægðatregða), munnþurrkur
English: What Rasitrio looks like and contents of the pack - Rasitrio 150 mg/5 mg/12.5 mg film-coated tablets are violet white, oval tablets, with “YIY”
Icelandic: - Rasitrio 150 mg/5 mg/12,5 mg filmuhúðaðar töflur eru hvítar með fjólubláum undirtóni,
English: Rasitrio is contraindicated in patients with severe hepatic impairment.
Icelandic: Ekki má nota Rasitrio handa sjúklingum með verulega skerta lifrarstarfsemi.