FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili blisteru iza oznake„EXP“.
English: Antidiabetic medicinal products (oral agents and insulins): dosage adjustment of the antidiabetic medicinal product may be required (see section 4.4);
Croatian: Antidijabetici (oralni pripravci i inzulini): može biti potrebna prilagodba doze antidijabetika (vidjeti dio 4.4);
English: Excipients: also contains lactose monohydrate.
Croatian: Pomoćne tvari: također sadrži laktozu hidrat.
English: SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel 37100 Tours - France
Croatian: SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel 37100 Tours - Francuska
English: Therefore, the combination of lithium and CoAprovel is not recommended (see section 4.4).
Croatian: Stoga se kombinacija litija i lijeka CoAprovel ne preporučuje (vidjeti dio 4.4).
English: Ambarès & Lagrave F-33565 Carbon Blanc Cedex - France
Croatian: F-33565 Carbon Blanc Cedex - Francuska
English: In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/kg/day in rats and ≥ 100 mg/kg/day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Croatian: U pretkliničkim ispitivanjima sigurnosti primjene, visoke doze irbesartana (≥ 250 mg/kg/dan u štakora i ≥ 100 mg/kg/dan u makaki majmuna) uzrokovale su smanjenje vrijednosti crvenih krvnih stanica (eritrocita, hemoglobina, hematokrita).
English: AngiotensinII is a substance produced in the body that binds to receptors in blood vessels causing them to tighten.
Croatian: Angiotenzin II je tvar koju stvara tijelo i koja se veže na receptore u krvnim žilama te uzrokuje njihovo sužavanje.
English: Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnaesemia.
Croatian: Tiazidi povećavaju izlučivanje magnezija mokraćom, što može dovesti do hipomagnezijemije.
English: The mean plasma half-life of hydrochlorothiazide reportedly ranges from 5-15 hours.
Croatian: Srednja vrijednost poluvijeka hidroklorotiazida u plazmi je u rasponu od 5 do 15 sati.
English: impaired renal function including isolated cases of renal failure in patients at risk (see section 4.4)
Croatian: oslabljena bubrežna funkcija uključujući izolirane slučajeve bubrežnog zatajenja kod rizičnih bolesnika (vidjeti dio 4.4)
English: 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.
Croatian: Primarni cilj ispitivanja bio je usporediti omjer bolesnika čiji je dijastolički krvni tlak u sjedećem položaju bio kontroliran (< 90 mmHg) u 5. tjednu liječenja.
English: Other interactions: the hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Croatian: Druge interakcije: tiazidi mogu pojačati hiperglikemijski učinak beta-blokatora i diazoksida.
English: Renal impairment and kidney transplantation: when CoAprovel is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Croatian: Oštećena funkcija bubrega i transplantacija bubrega: kad CoAprovel uzimaju bolesnici s oštećenom funkcijom bubrega, preporučuje se periodički kontrolirati razine kalija, kreatinina i mokraćne kiseline u serumu.
English: Severe hepatic impairment, biliary cirrhosis and cholestasis The concomitant use of CoAprovel with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m²) (see sections 4.5 and 5.1).
Croatian: Teško oštećenje funkcije jetre, bilijarna ciroza i kolestaza Istodobna primjena lijeka CoAprovel s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
English: Colestyramine and Colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Croatian: Kolestiramin i smole kolestipola: apsorpcija hidroklorotiazida oslabljena je u prisutnosti smola anionskih izmjenjivača.
English: Efficacy and safety of CoAprovel as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomized, double-blind, active-controlled, 8-week, parallel-arm study.
Croatian: Djelotvornost i sigurnost lijeka CoAprovel kao inicijalne terapije za tešku hipertenziju (dijastolički tlak u sjedećem položaju ≥ 110 mmHg) ocijenjena je u multicentričnom, randomiziranom, dvostruko-slijepom ispitivanju s aktivnom kontrolom, u trajanju od 8 tjedana, s paralelnom skupinom.
English: 4.6 Fertility, pregnancy and lactation Pregnancy
Croatian: 4.6 Plodnost, trudnoća i dojenje Trudnoća
English: Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports
Croatian: Nuspojave prikupljene u placebom kontroliranim ispitivanjima i spontanim prijavljivanjem
English: There is no experience regarding the administration of CoAprovel in patients with a recent kidney transplantation.
Croatian: Nema iskustava s primjenom lijeka CoAprovel u bolesnika kojima je nedavno transplantiran bubreg.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Croatian: Ako se utvrdi trudnoća, treba odmah prekinuti liječenje antagonistima receptora angiotenzina II te treba, ako je to primjereno, započeti s alternativnom terapijom (vidjeti dio 4.3 i 4.6).
English: Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloremia, hyponatraemia) and dehydration resulting from excessive diuresis.
Croatian: Predoziranje hidroklorotiazidom povezano je s manjkom elektrolita (hipokalijemija, hipokloremija, hiponatrijemija) i dehidracijom zbog prekomjerne diureze.
English: CoAprovel will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Croatian: Liječnik će Vam obično propisati CoAprovel ako Vam dosadašnje liječenje povišenog krvnog tlaka nije osiguralo odgovarajući učinak.
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with CoAprovel (see section 4.5).
Croatian: Diuretici koji štede kalij, nadomjesci kalija ili nadomjesci soli koji sadrže kalij moraju se s oprezom istodobno primjenjivati s lijekom CoAprovel (vidjeti dio 4.5).
English: CoAprovel is a combination of two active substances, irbesartan and hydrochlorothiazide.
Croatian: CoAprovel je kombinacija dvije djelatne tvari, irbesartana i hidroklorotiazida.
English: Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Croatian: Istraživanja irbesartana na životinjama pokazala su prolazne toksične učinke (povećana kavitacija bubrežne nakapnice, hidroureter ili potkožni edem) u fetusa štakora, koji su se povukli nakon okota.
English: pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
Croatian: pankreatitis, anoreksija, proljev, konstipacija, iritacija želuca, sijaloadenitis, gubitak apetita
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Croatian: Dojenčad čije su majke uzimale antagoniste receptora angiotenzina II treba pažljivo pratiti zbog moguće hipotenzije (vidjeti dijelove 4.3 i 4.4).
English: The effects of the irbesartan/hydrochlorothiazide combination on fertility have not been evaluated in animal studies, as there is no evidence of adverse effect on fertility in animals or humans with either irbesartan or hydrochlorothiazide when administered alone.
Croatian: U istraživanjima na životinjama nije ocijenjen učinak kombinacije irbesartana i hidroklorotiazida na plodnost jer nema dokaza o neželjenim učincima na plodnost životinja ili ljudi ni irbesartana niti hidroklorotiazida kad se primjenjuju kao monoterapija.
English: Table 3: Adverse reactions reported with the use of hydrochlorothiazide alone
Croatian: Tablica 3. Nuspojave prijavljene pri primjeni samo hidroklorotiazida
English: 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.
Croatian: Pri vrlo visokim dozama (≥ 500 mg/kg/dan) irbesartan je izazvao degenerativne promjene na bubrezima (poput intersticijskog nefritisa, tubularne distenzije, bazofilnih tubula, povećane koncentracija ureje i kreatinina u plazmi) u štakora i makaki majmuna, što se smatra sekundarnim učinkom uz hipotenzivne učinke lijeka koji dovode do smanjenja perfuzije bubrega.
English: Table 2: Adverse reactions reported with the use of irbesartan alone
Croatian: Tablica 2. Nuspojave prijavljene pri primjeni samo irbesartana
English: Due to the hydrochlorothiazide component, CoAprovel is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min).
Croatian: Zbog hidroklorotiazida u sastavu lijeka, CoAprovel se ne preporučuje bolesnicima s teško oštećenom funkcijom bubrega (klirens kreatinina < 30 ml/min.).
English: syncope, hypotension, tachycardia, oedema
Croatian: sinkopa, hipotenzija, tahikardija, edem
English: Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Croatian: Nakon peroralne ili intravenske primjene 14C irbesartana, 80-85% cirkulirajuće radioaktivnosti u plazmi odnosi se na nepromijenjeni irbesartan.
English: No dosage adjustment of CoAprovel is necessary in older people.
Croatian: Nije potrebno prilagođavati dozu lijeka CoAprovel za starije osobe.
English: These findings appear to have no relevance to the use of therapeutic doses of irbesartan/hydrochlorothiazide in humans.
Croatian: Čini se da ti nalazi nisu značajni za primjenu terapijskih doza irbesartana/hidroklorotiazida u ljudi.
English: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France
Croatian: sanofi-aventis groupe 54, rue La Boétie, F-75008 Paris - Francuska
English: aplastic anaemia, bone marrow depression, neutropenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
Croatian: aplastična anemija, depresija koštane srži, neutropenija/agranulocitoza, hemolitička anemija, leukopenija, trombocitopenija
English: Pregnancy: angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Croatian: Trudnoća: tijekom trudnoće ne smiju se uvoditi antagonisti receptora angiotenzina II.
English: Adequate monitoring of serum potassium in patients at risk is recommended (see section 4.4).
Croatian: Preporučuje se pratiti razinu kalija u serumu kod rizičnih bolesnika (vidjeti dio 4.4).
English: The frequency of the side effects listed below is defined using the following convention: Common: may affect up to 1 in 10 people
Croatian: Učestalost dolje navedenih nuspojava definirana je na sljedeći način: često: mogu se javiti u manje od 1 na 10 osoba manje često: mogu se javiti u manje od 1 na 100 osoba
English: Conversely, due to the irbesartan component of CoAprovel hyperkalaemia might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.
Croatian: Nasuprot tomu, zbog irbesartana u sastavu lijeka CoAprovel može se pojaviti hiperkalijemija, posebice ako istodobno postoji narušena funkcija bubrega i/ili srčano zatajenje i šećerna bolest.
English: Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine): the effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide;
Croatian: Nedepolarizirajući relaksansi koštanih mišića (primjerice tubokurarin): hidroklorotiazid može potencirati učinak nedepolarizirajućih relaksansa koštanih mišića;
English: Although not specifically studied with the CoAprovel, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Croatian: Iako nisu provedena posebna ispitivanja s lijekom CoAprovel, ni s irbesartanom niti s hidroklorotiazidom nije primijećen povratak hipertenzije (tzv. rebound hipertenzija).
English: 14 tablets 28 tablets 30 tablets 56 tablets 56 x 1 tablets 84 tablets 90 tablets 98 tablets
Croatian: 14 tableta 28 tableta 30 tableta 56 tableta 56x1 tableta 84 tableta 90 tableta 98 tableta
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan with or without thiazide diuretics unless the volume depletion is corrected first (see section 4.4).
Croatian: Prethodno liječenje visokim dozama diuretika može dovesti do hipovolemije i rizika od pojave hipotenzije prilikom uvođenja terapije irbesartanom u monoterapiji ili u kombinaciji s tiazidskim diureticima te stoga prije toga treba korigirati hipovolemiju (vidjeti dio 4.4).
English: 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.
Croatian: 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.
English: Irbesartan/hydrochlorothiazide
Croatian: Irbesartan/hidroklorotiazid
English: You should also tell your doctor: if you are on a low-salt diet if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in CoAprovel) if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal if you are going to have an operation (surgery) or be given anaesthetics if you have changes in your vision or pain in one or both of your eyes while taking CoAprovel.
Croatian: Svog liječnika također trebate obavijestiti: ako ste na dijeti s malim unosom soli ako imate simptome kao što su neuobičajena žeđ, suha usta, opća slabost, omamljenost, grčevi ili bol u mišićima, mučnina, povraćanje ili neuobičajeno brzi otkucaji srca jer oni mogu upućivati na pretjerani učinak hidroklorotiazida (sastojak lijeka CoAprovel) ako iskusite povećanu osjetljivost kože na sunce s pojavom simptoma sunčanih opeklina (kao što su crvenilo kože, svrbež, oticanje, nastanak mjehurića), a pojavljuju se brže nego što je normalno ako trebate ići na operaciju (kirurški zahvat) ili trebate primiti anestetike ako tijekom uzimanja lijeka CoAprovel primijetite promjene vida ili bol u jednom ili oba oka.
English: Following oral administration of CoAprovel, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Croatian: Nakon peroralne primjene lijeka CoAprovel apsolutna oralna bioraspoloživost je 60-80% za irbesartan, odnosno 50-80% za hidroklorotiazid.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) Second and third trimesters of pregnancy (see sections 4.4 and 4.6) Severe renal impairment (creatinine clearance < 30 ml/min) Refractory hypokalaemia, hypercalcaemia
Croatian: Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na druge tvari koje su derivati sulfonamida (hidroklorotiazid je derivat sulfonamida) Drugo i treće tromjesečje trudnoće (vidjeti dijelove 4.4 i 4.6).
English: When irbesartan is administered concomitantly with a low dose of hydrochlorothiazide (e.g. 12.5 mg daily), the antihypertensive response in black patients approaches that of non-black patients.
Croatian: Kad se irbesartan primijeni zajedno s malom dozom hidroklorotiazida (primjerice 12,5 mg na dan), antihipertenzivni učinak u bolesnika crne rase približava se učinku kod drugih rasa.
English: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed.
Croatian: Na temelju dostupnih podataka iz epidemioloških ispitivanja, između HCTZ-a i NMSC-a primijećena je povezanost ovisna o kumulativnoj dozi.
English: No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenom funkcijom bubrega čiji je klirens kreatinina ≥ 30 ml/min (vidjeti dijelove 4.3 i 4.4).
English: Medicinal products affecting potassium: the potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of irbesartan.
Croatian: Lijekovi koji utječu na razinu kalija: učinak hidroklorotiazida na sniženje razine kalija umanjen je učinkom irbesartana koji štedi izlučivanje kalija.
English: transient blurred vision, xanthopsia, acute myopia and secondary acute angle-closure glaucoma
Croatian: prolazno zamagljeni vid, ksantopsija, akutna miopija i sekundarni akutni glaukom zatvorenog kuta
English: hyperkalaemia
Croatian: hiperkalijemija
English: There is no clinical experience with CoAprovel in patients with hepatic impairment.
Croatian: Nema kliničkog iskustva s primjenom lijeka CoAprovel u bolesnika s oštećenom funkcijom jetre.
English: Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting.
Croatian: Znaci koji upozoravaju na neravnotežu tekućine i elektrolita su suhoća u ustima, žeđ, slabost, letargija, omamljenost, nemir, bol ili grčevi u mišićima, mišićna slabost, hipotenzija, oligurija, tahikardija i gastrointestinalni poremećaji poput mučnine i povraćanja.
English: There were 0.6% and 0% of patients with hypotension and 2.8% and 3.1% of patients with dizziness as adverse reactions reported in the combination and monotherapy groups, respectively.
Croatian: U skupini podvrgnutoj kombiniranoj terapiji bilo je 0,6% bolesnika s hipotenzijom i 2,8% bolesnika s omaglicom kao nuspojavama, dok je taj postotak u skupini na monoterapiji iznosio 0% za hipotenziju i 3,1% za omaglicu.
English: Periodic Safety Update Reports
Croatian: • Periodička izvješća o neškodljivosti
English: cases of hypersensitivity reactions such as angioedema, rash, urticaria
Croatian: reakcije preosjetljivosti kao što su angioedem, osip, urtikarija
English: Non-melanoma skin cancer:
Croatian: Nemelanomski rak kože:
English: Ear and labyrinth disorders:
Croatian: Poremećaji uha i labirinta:
English: The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
Croatian: Nuspojave hidroklorotiazida ovisne o dozi (poglavito poremećaj elektrolita) mogu postati izraženije prilikom titriranja doze hidroklorotiazida.
English: In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required.
Croatian: U bolesnika sa šećernom bolešću može biti potrebna prilagodba doze inzulina ili oralnih hipoglikemika.
English: anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria
Croatian: anafilaktičke reakcije, toksična epidermalna nekroliza, nekrotizirajući angitis (vaskulitis, kožni vaskulitis), kožne reakcije slične eritemskom lupusu, reaktivacija kožnog eritemskog lupusa, reakcije fotoosjetljivosti, osip, urtikarija
English: The use of CoAprovel during breast feeding is not recommended.
Croatian: Ne preporučuje se upotreba lijeka CoAprovel tijekom dojenja.
English: Fertility and reproductive performance were not affected in studies of male and female rats even at oral doses of irbesartan causing some parental toxicity (from 50 to 650 mg/kg/day), including mortality at the highest dose.
Croatian: Nije zabilježen utjecaj na plodnost i reproduktivnu učinkovitost u istraživanjima na mužjacima i ženkama štakora, čak ni pri peroralnim dozama irbesartana koje su uzrokovale određenu toksičnost za životinje (doze od 50 do 650 mg/kg/dnevno), uključujući mortalitet pri najvišim dozama.
English: 14 - 28 - 56 - 84 - 98 tablets: Mon
Croatian: 14 - 28 - 56 - 84 - 98 tableta: Pon
English: Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with CoAprovel.
Croatian: Nadalje, tiazidi smanjuju renalni klirens litija pa uzimanje lijeka CoAprovel može povećati rizik od toksičnosti litija.
English: Renal artery stenosis - Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists.
Croatian: Stenoza renalne arterije - renovaskularna hipertenzija: povećan je rizik od teške hipotenzije i insuficijencije bubrega u bolesnika s obostranom stenozom bubrežnih arterija ili stenozom arterije u jedinom funkcionalnom bubregu koji su liječeni inhibitorima angiotenzin konvertirajućeg enzima ili antagonistima receptora angiotenzina II.
English: In addition, increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials.
Croatian: BUN; 2,3%), kreatin kinaze (1,7%) i kreatinina (1,1%).
English: 14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets
Croatian: 14 tableta 28 tableta 56 tableta 56x1 tableta 98 tableta
English: CoAprovel is for oral use.
Croatian: CoAprovel je namijenjen za primjenu kroz usta.
English: Special Populations
Croatian: Posebne populacije bolesnika
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS): there is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Croatian: Dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS): postoje dokazi da istodobna primjena ACE inhibitora, blokatora angiotenzin II receptora ili aliskirena povećava rizik od hipotenzije, hiperkalemije i smanjene bubrežne funkcije (uključujući akutno zatajenje bubrega).
English: Electrolytes should be monitored during concomitant use.
Croatian: Tijekom istodobne primjene treba pratiti razine elektrolita.
English: CoAprovel is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Croatian: CoAprovel je kombinacija irbesartana, antagonista receptora angiotenzina II, i hidroklorotiazida, tiazidskog diuretika.
English: Electrolyte imbalance: as for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Croatian: Poremećaj elektrolita: kao kod svih bolesnika koji uzimaju diuretike, potrebno je periodički i u primjerenim intervalima kontrolirati razinu serumskih elektrolita.
English: The active substances are irbesartan and hydrochlorothiazide.
Croatian: Djelatne tvari su irbesartan i hidroklorotiazid.
English: CoAprovel should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.3).
Croatian: CoAprovel ne smiju uzimati bolesnici s teško oštećenom funkcijom bubrega (klirens kreatinina <30 ml/min) (vidjeti dio 4.3).