natgillin/translations-raw huggingface dataset:
As is the case with other medicinal products that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy. 
Kao što je to slučaj i s drugim lijekovima koji utječu na sustav renin-angiotenzin, osobe crne rase koje boluju od hipertenzije imaju znatno slabiji odgovor na monoterapiju irbesartanom.
If you get any of these symptoms or get short of breath, stop taking Irbesartan/Hydrochlorothiazide Teva and contact your doctor immediately. 
Ako dobijete neki od tih simptoma ili ako imate nedostatak zraka, prestanite uzimati Irbesartan/Hidroklorotiazid Teva i odmah se obratite svome liječniku.
Hydrochlorothiazide crosses the placental but not the blood-brain barrier, and is excreted in breast milk. 
Hidroklorotiazid prolazi placentalnu, ali ne i krvno-moždanu barijeru te se izlučuje u majčino mlijeko.
The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration. 
Selektivni antagonizam receptora angiotenzina II (AT1) dovodi do povećanja razine renina u plazmi i razine angiotenzina II te snižavanja koncentracije aldosterona u plazmi.
This limit is considered a sufficiently robust threshold for APIs that can technically be reached. 
Smatra se da je ta granična vrijednost dostatno pouzdan i tehnički ostvariv prag za aktivne farmaceutske sastojke.
Aluminium - Aluminium blisters: This medicinal product does not require any special storage conditions. 
Aluminij - aluminij blisteri: Lijek ne zahtjeva posebne uvjete čuvanja.
If Irbesartan/Hydrochlorothiazide Teva is used during breast feeding, doses should be kept as low as possible. 
Ako se Irbesartan/Hidroklorotiazid Teva primjenjuje tijekom dojenja, njegove doze trebaju biti što je moguće niže.
If the combination proves necessary, careful monitoring of serum lithium levels is recommended. 
Ako je kombinacija neophodna, preporučuje se pomna kontrola razine litija u serumu.
Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidneys. 
Hidroklorotiazid se ne metabolizira, ali se brzo izlučuje iz organizma putem bubrega.
Plasma protein binding of irbesartan is approximately 96%, with negligible binding to cellular blood components. 
Oko 96% irbesartana veže se za proteine u plazmi, sa zanemarivim vezanjem za krvne stanice.
Corticosteroids, ACTH Electrolyte depletion, particularly hypokalaemia, may be increased; 
Kortikosteroidi, ACTH Može se pojačati gubitak elektrolita, posebice hipokalijemija;
Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18 
Vrijednosti AUC i Cmax irbesartana također su bile nešto veće u starijih (≥ 65 godina) nego u mlađih bolesnika (18 do 40 godina).
There were no toxicological findings observed of relevance to human therapeutic use. 
Nije bilo toksikoloških nalaza značajnih za terapijsku primjenu u ljudi.
Calcium salts 
Kalcijeve soli
The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. 
Nisu procijenjeni učinci induktora CYP2C9 poput rifampicina na farmakokinetiku irbesartana.
Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. 
Irbesartan sprječava vezanje angiotenzina II na te receptore, uzrokujući opuštanje krvnih žila i sniženje krvnog tlaka.
Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure. 
Hidroklorotiazid pripada skupini lijekova (nazvani tiazidski diuretici) koji povećavaju izlučivanje mokraće i tako snižavaju krvni tlak.
Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials. 
Tablici 1. prikazane su nuspojave prikupljene spontanim prijavljivanjem te u placebom kontroliranim studijama.
There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester. 
Iskustvo s primjenom hidroklorotiazida u trudnoći, a posebno u prvom tromjesečju, je ograničeno.
if your doctor determines that you have persistently high calcium or low potassium levels in your blood. 
akoliječnik utvrdi da imate stalno povišenu razinu kalcija ili nisku razinu kalija u krvi.
Concomitant use of carbamazepine and hydrochlorothiazide has been associated with the risk of symptomatic hyponatraemia. 
Istovremena primjena karbamazepina i hidroklorotiazida povezana je s rizikom od simptomatske hiponatrijemije.
Anaphylactic reaction including anaphylactic shock 
anafilaktička reakcija uključujući anafilaktički šok
However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium). 
Može se, međutim, očekivati da učinak hidroklorotiazida na razinu kalija u serumu bude potenciran drugim lijekovima koji su povezani s gubitkom kalija i hipokalijemijom (primjerice, drugi diuretici koji potiču kaliurezu, laksativi, amfotericin, karbenoksolon, penicilin G natrij).
• decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan. 
• smanjenje razine kalija u serumu koje izaziva hidroklorotiazid djelomično je smanjeno kad se hidroklorotiazid davao u kombinaciji s irbesartanom.
• Based on the analysis of potential root causes the CHMP considered that all the MAHs should perform risk assessment of the manufacturing processes used for the APIs in their finished products to evaluate the risk of N-nitrosamine formation and contamination. 
• Na temelju analize potencijalnih osnovnih uzroka CHMP smatra da svi nositelji odobrenja za stavljanje lijeka u promet trebaju provesti procjenu rizika proizvodnih procesa aktivnih farmaceutskih sastojaka u svojim krajnjim proizvodima kako bi se ocijenio rizik od nastanka N-nitrozamina i kontaminacije njime.
After the transitional period of 2 years, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented. 
Nakon prijelaznog razdoblja od dvije godine potrebno je primijeniti graničnu vrijednost za tvari NDMA i NDEA od najviše 0,03 ppm.
Irbesartan/Hydrochlorothiazide Teva is not recommended for use in children and adolescents because the safety and efficacy have not been established. 
Ne preporučuje se primjena lijeka Irbesartan/Hidroklorotiazid Teva u djece i adolescenata jer sigurnost primjene i djelotvornost nije utvrđena.
Your doctor will instruct you how to switch from the previous treatment to Irbesartan/Hydrochlorothiazide Teva. 
Liječnik će Vas uputiti kako prijeći s prethodnog liječenja na Irbesartan/Hidroklorotiazid Teva.
Film-coated tablets 
Filmom obložene tablete
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock) and decrease in the number of platelets (a blood cell essential for the clotting of the blood) have also been reported. 
Uz gore navedene nuspojave zabilježene su bol u prsnom košu, teške alergijske reakcije (anafilaktički šok) i smanjenje broja krvnih pločica (krvna stanica nužna za zgrušavanje krvi).
Digitalis glycosides 
Glikozidi digitalisa
Film-coated tablet. 
OBLIK Filmom obložena tableta.
The ICH M7(R1) guideline sets out principles for determining limits for mutagenic / DNA-reactive impurities. 
U Smjernicama ICH M7(R1) navedena su načela za utvrđivanje graničnih vrijednosti nečistoća koje su mutagene odnosno reagiraju s DNK.
No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a medicinal product metabolised by CYP2C9. 
Nisu zabilježene značajne farmakokinetičke ili farmakodinamičke interakcije kod istodobne primjene irbesartana i varfarina, lijeka koji se metabolizira pomoću CYP2C9.
Cases of hypersensitivity reactions such as angioedema, rash, urticaria 
Reakcije preosjetljivosti kao što su angioedem, osip, urtikarija
Irbesartan/Hydrochlorothiazide Teva can be taken once daily, with or without food. 
Doziranje Irbesartan/Hidroklorotiazid Teva može se uzimati jedanput na dan, s hranom ili bez nje.
Management depends on the time since ingestion and the severity of the symptoms. 
Zbrinjavanje ovisi o vremenu koje je prošlo od uzimanja lijeka i o težini simptoma.
Jaundice (intrahepatic cholestatic jaundice) 
Žutica (intrahepatička kolestatska žutica)
Irbesartan/Hydrochlorothiazide Teva should be taken at least one hour before or four hours after these medications; 
Teva se mora uzeti najmanje jedan sat prije ili 4 sata poslije tih lijekova;
Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. 
Tiazidi mogu smanjiti izlučivanje kalcija mokraćom i uzrokovati povremeno i blago povišenje razine kalcija u serumu ako nisu prisutni poznati poremećaji metabolizma kalcija.
While hydrochlorothiazide is a sulfonamide, only isolated cases of acute angle-closure glaucoma have been reported so far with hydrochlorothiazide. 
Iako je hidroklorotiazid sulfonamid, kod njegove su primjene dosad prijavljeni samo izolirani slučajevi akutnog glaukoma zatvorenog kuta.
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. 
ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje krvnog tlaka koji sadrži aliskiren.
Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended. 
Preporučljivo je titriranje doze pojedinačnih sastojaka (tj. irbesartana i hidroklorotiazida).
What Irbesartan/Hydrochlorothiazide Teva is and what it is used for What you need to know before you take Irbesartan/Hydrochlorothiazide Teva How to take Irbesartan/Hydrochlorothiazide Teva Possible side effects 
Što je Irbesartan/Hidroklorotiazid Teva i za što se koristi Što morate znati prije nego počnete uzimati Irbesartan/Hidroklorotiazid Teva Kako uzimati Irbesartan/Hidroklorotiazid Teva
Hypokalaemia may result in muscle spasms and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products. 
Hipokalijemija može izazvati spazam mišića i/ili pojačati srčane aritmije koje se mogu pojaviti uz istodobnu primjenu glikozida digitalisa ili nekih antiaritmika.
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. 
Irbesartan pripada skupini lijekova koji se zovu antagonisti receptora angiotenzina II.
Among 898 hypertensive patients who received various doses of irbesartan/hydrochlorothiazide (range: 37.5 mg/6.25 mg to 300 mg/25 mg) in placebo-controlled trials, 29.5% of the patients experienced adverse reactions. 
Od 898 hipertenzivnih bolesnika koji su primali različite doze irbesartana/hidroklorotiazida (raspon: od 37,5 mg/6,25 mg do 300 mg/25 mg) u placebom kontroliranim kliničkim studijama, u 29,5% bolesnika zabilježene su nuspojave.
Obligatory risk assessments to be performed for manufacturing processes of the drug substances in order to evaluate the theoretical risk of N-nitrosamine formation and contamination 
Obvezna procjena rizika za proizvodne procese djelatnih tvari lijekova kako bi se procijenio teoretski rizik od nastanka N-nitrozamina i kontaminacije njime.
Irbesartan/Hydrochlorothiazide Teva should not be given to children and adolescents (under 18 years). 
Teva se ne smije davati djeci i adolescentima (mlađima od 18 godina).
Because no information is available regarding the use of Irbesartan/Hydrochlorothiazide Teva during breast-feeding, Irbesartan/Hydrochlorothiazide Teva is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. 
Budući da nema dostupnih podataka o upotrebi lijeka Irbesartan/Hidroklorotiazid Teva tijekom dojenja, ne preporučuje se njegova primjena tijekom dojenja i prednost treba dati drugoj terapiji s bolje ustanovljenim profilom sigurnosti primjene, osobito kada se doji novorođenče ili nedonošče.
In case of identification of other nitrosamines, this should be forthwith reported to the competent authorities, together with a toxicology assessment of the impurity, a clinical assessment for the exposed patients, a root cause analysis and a corrective action plan (e.g. changes to the manufacturing process). 
Ako se utvrdi postojanje drugih nitrozamina, to odmah treba prijaviti nadležnim tijelima, zajedno s toksikološkom procjenom nečistoće, kliničkom procjenom za izložene bolesnike, analizom osnovnog uzroka i planom korektivnih mjera (npr. promjene proizvodnog procesa).
Diuretic agents such as the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiaizde Teva may have an effect on other medicines. 
Diuretičke tvari, kao što je hidroklorotiazid iz lijeka Irbesartan/Hidroklorotiazid Teva, mogu imati učinke na druge lijekove.
Thiazides should be used with caution in patients with impaired hepatic function. 
Tiazide treba s oprezom davati bolesnicima s oštećenom funkcijom jetre.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'. 
Ovaj lijek sadrži manje od 1 mol (23 mg) natrija po filmom obloženoj tableti, tj. zanemarive količine natrija.
Limited clinical data (7 out of 22 patients) suggest that patients not controlled with the 300 mg/12.5 mg combination may respond when uptitrated to 300 mg/25 mg. 
Ograničeni klinički podaci (7 od 22 bolesnika) upućuju na mogućnost da se bolesnicima čiji krvni tlak nije kontroliran kombinacijom doze od 300 mg/12,5 mg, tlak može kontrolirati povećanjem doze do 300 mg/25 mg.
Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia. 
Na osnovi farmakološkog mehanizma djelovanja hidroklorotiazida može se zaključiti da njegova primjena u drugom i trećem tromjesečju trudnoće može ugroziti feto-placentarnu perfuziju i uzrokovati nuspojave kod fetusa i novorođenčadi poput žutice, poremećaja ravnoteže elektrolita i trombocitopenije.
In these patients, an incremental blood pressure lowering effect was observed for both systolic blood pressure (SBP) and diastolic blood pressure (DBP) (13.3 and 8.3 mmHg, respectively). 
U tih je bolesnika pojačan učinak na snižavanje krvnog tlaka zabilježen za sistolički i za dijastolički krvni tlak (13,3 odnosno 8,3 mm Hg).
At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidneys (such as interstitial nephritis, tubular distention, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion. 
Pri vrlo visokim dozama (≥ 500 mg/kg/dan) irbesartan je izazvao degenerativne promjene na bubrezima (poput intersticijskog nefritisa, tubularne distenzije, bazofilnih tubula, povećane koncetracija uree i kreatinina u plazmi) u štakora i makaki majmuna, što se smatra sekundarnim učinkom hipotenzivnog učinka lijeka koji dovodi do smanjenja perfuzije bubrega.
In addition to NDMA and NDEA, other N-nitrosamines have been detected in a few sartan-containing medicinal products. 
Osim tvari NDMA i NDEA, u nekoliko lijekova koji sadržavaju sartan otkriveni su i drugi Nnitrozamini.
Hydrochlorothiazide is a thiazide diuretic. 
Hidroklorotiazid je tiazidski diuretik.
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. 
Oštećena funkcija jetre Tiazide treba primjenjivati s oprezom kod bolesnika s oštećenom funkcijom jetre ili progresivnom bolešću jetre jer male promjene ravnoteže tjelesnih tekućina i elektrolita mogu izazvati hepatičku komu.
VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy. 
VA NEPHRON-D je bilo ispitivanje u bolesnika sa šećernom bolešću tipa 2 i dijabetičkom nefropatijom.
The CHMP, as a consequence, considers that the benefit-risk balance of products containing candesartan, irbesartan, losartan, olmesartan, valsartan remains favourable subject to the conditions described above. 
Slijedom toga, CHMP smatra da je omjer koristi i rizika lijekova koji sadržavaju kandesartan, irbesartan, losartan, olmesartan i valsartan i dalje povoljan, što je podložno prethodno opisanim uvjetima.
Pack size of 28 film-coated tablets in non-perforated calendar blisters. 
Pakiranje od 28 filmom obloženih tableta u neperforiranim blisterima u kalendarskom pakiranju.
Studies have not been performed in patients with severe hepatic impairment. 
Nisu provođena ispitivanja na bolesnicima s teško oštećenom funkcijom jetre.
Following oral administration of irbesartan/hydrochlorothiazide, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively. 
Nakon peroralne primjene irbesartana/hidroklorotiazida apsolutna oralna bioraspoloživost je 60- 80% za irbesartan, odnosno 50-80% za hidroklorotiazid.
The risk of hypokalaemia is greatest in patients with cirrhosis of the liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or ACTH. 
Rizik od razvoja hipokalijemije najveći je u bolesnika s cirozom jetre, u bolesnika s pojačanom diurezom, u bolesnika koji oralno uzimaju premalo elektrolita i u bolesnika koji istodobno uzimaju kortikosteroide ili adrenokortikotropne hormone (ACTH).
In a study, somewhat higher plasma concentrations of irbesartan were observed in female hypertensive patients. 
U jednom su ispitivanju zabilježene nešto više koncentracije irbesartana u plazmi u bolesnica s hipertenzijom.
Conversely, due to the irbesartan component of Irbesartan/Hydrochlorothiazide Teva hyperkalaemia might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus. 
Nasuprot tomu, zbog irbesartana u sastavu lijeka Irbesartan/Hidroklorotiazid Teva može se pojaviti hiperkalijemija, posebice ako istodobno postoji narušena funkcija bubrega i/ili srčano zatajenje i diabetes mellitus.
As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function. 
Kao i s ACE inhibitorima, istodobna primjena antagonista angiotenzina II i nesteroidnih protuupalnih lijekova može povećati rizik od pogoršanja bubrežne funkcije, uključujući moguće akutno zatajenje bubrega i porast serumskog kalija, posebice u bolesnika s postojećom slabom funkcijom bubrega.
Carbamazepine 
Karbamazepin
The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at Week 5 of treatment. 
Primarni cilj studije bio je usporediti omjer bolesnika čiji je dijastolički krvni tlak u sjedećem položaju bio kontroliran (< 90 mmHg) u 5. tjednu liječenja.
Other antihypertensive agents 
Ostali antihipertenzivni lijekovi
These findings appear to have no relevance to the use of therapeutic doses of irbesartan/hydrochlorothiazide in humans. 
Čini se da ti nalazi nisu značajni za primjenu terapijskih doza irbesartana/ hidroklorotiazida u ljudi.
Conversely, based on the experience with the use of other medicinal products that blunt the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin sodium) may lead to increases in serum potassium. 
Suprotno tomu, temeljem iskustva s drugim lijekovima koji ometaju funkciju renin-angiotenzinskog sustava, istodobna primjena diuretika koji štede kalij, nadomjestaka kalija, nadomjestaka soli koje sadrže kalij ili drugih lijekova koji mogu povećati razinu kalija u serumu (primjerice heparinnatrij), može uzrokovati povećanje razine kalija u serumu.
Irbesartan/Hydrochlorothiazide Teva is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure. 
Irbesartan/Hidroklorotiazid Teva primjenjuje se za liječenje visokog krvnog tlaka kad liječenje samo irbesartanom ili samo hidroklorotiazidom ne osigurava odgovarajuću kontrolu krvnog tlaka.
The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of Nnitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible. 
Nositelj odobrenja za stavljanje lijeka u promet mora osigurati da se pregledaju proizvodni procesi djelatnih tvari njegovih lijekova kako bi se utvrdio potencijalni rizik od nastanka N-nitrozamina te da se prema potrebi promijene kako bi se kontaminacija nitrozaminom svela na najmanju moguću mjeru.
Thiazides may increase the risk of adverse effects caused by amantadine. 
Tiazidi mogu povećati rizik od razvoja nuspojava uzrokovanih amantadinom.
Irbesartan and its metabolites are eliminated by both biliary and renal pathways. 
Irbesartan i njegovi metaboliti eliminiraju se putem žuči i bubrega.
White opaque PVC-PVdC - Aluminium blisters or Aluminium - Aluminium blisters. 
Bijeli, neprozirni PVC-PVdC - aluminijski blisteri ili aluminij - aluminij blisteri.
Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites. 
Irbesartan ne inhibira ACE (kininazu II), enzim koji generira angiotenzin II, te degradira bradikinin u neaktivne metabolite.
7 film-coated tablets 14 film-coated tablets 15 film-coated tablets 20 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets 100 film-coated tablets 50x1 film-coated tablets 
7 filmom obloženih tableta 14 filmom obloženih tableta 15 filmom obloženih tableta 20 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 56 filmom obloženih tableta 60 filmom obloženih tableta 84 filmom obloženih tableta 90 filmom obloženih tableta 98 filmom obloženih tableta 100 filmom obloženih tableta
The effect of the combination of irbesartan and hydrochlorothiazide on morbidity and mortality has not been studied. 
Nije proučavan učinak kombinacije irbesartana i hidroklorotiazida na morbiditet i mortalitet.
You should discontinue Irbesartan/Hydrochlorothiazide Teva treatment and seek medical attention. 
Prestanite uzimati Irbesartan/Hidroklorotiazid Teva i zatražite liječničku pomoć.
If you accidentally miss a daily dose, just take the next dose as normal. 
Ako ste zaboravili uzeti Irbesartan/Hidroklorotiazid Teva Ako slučajno zaboravite uzeti dnevnu dozu, samo uzmite sljedeću dozu kao što to obično i činite.
The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin activity, increases aldosterone secretion, with consequent increases in urinary potassium and bicarbonate loss, and decreases in serum potassium. 
Diuretsko djelovanje hidroklorotiazida smanjuje volumen plazme, pojačava aktivnost renina u plazmi, pojačava sekreciju aldosterona, s posljedičnim pojačanim gubitkom kalija i bikarbonata mokraćom te sniženjem koncentracije kalija u serumu.
The MAH shall complete, within the stated timeframe, the below measures: 
Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere: Uvjeti odobrenja za stavljanje u promet
No dosage adjustment is necessary in female patients. 
Nije potrebna prilagodba doziranja u žena.