FrancophonIA/ELRC3.0 huggingface dataset:
English: CoAprovel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Croatian: CoAprovel se ne preporučuje majkama koje doje, a Vaš liječnik može izabrati drugu terapiju ako želite dojiti, osobito ako se radi o dojenju novorođenčeta ili nedonoščeta.
English: CoAprovel is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Croatian: CoAprovel se ne preporučuje uzimati u ranoj trudnoći te se ne smije uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi Vašem djetetu uzimate li ga nakon trećeg mjeseca trudnoće.
English: Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Laktoza: bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: If a child swallows some tablets, contact your doctor immediately.
Croatian: Ako dijete proguta tablete, odmah se obratite svome liječniku.
English: It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines, or colestyramine and colestipol resins for lowering blood cholesterol.
Croatian: Također je važno da obavijestite svog liječnika ako uzimate druge lijekove za sniženje krvnog tlaka, steroide, lijekove za liječenje raka, lijekove protiv bolova, lijekove za liječenje artritisa ili kolestiramin i smole kolestipola za snižavanje razine kolesterola u krvi.
English: Tables 2 and 3 below detail the adverse reactions reported with the individual components of CoAprovel.
Croatian: Tablice 2. i 3. prikazuju nuspojave prijavljene za pojedinačne komponente lijeka CoAprovel.
English: The recommended dose of CoAprovel is one or two tablets a day.
Croatian: Uobičajena doza lijeka CoAprovel je jedna ili dvije tablete na dan.
English: Due to the hydrochlorothiazide contained in CoAprovel, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position.
Croatian: Ako pijete alkohol za vrijeme terapije ovim lijekom, zbog hidroklorotiazida u lijeku CoAprovel možete imati pojačan osjećaj omaglice prilikom ustajanja, posebno kod ustajanja iz sjedećeg položaja.
English: Irbesartan had no effect upon fertility of treated rats and their offspring up to the dose levels inducing the first signs of parental toxicity (see section 5.3).
Croatian: Irbesartan nije utjecao na plodnost liječenih štakora ili njihovog potomstva sve do onih doza koje izazivaju prve znakove toksičnosti u roditelja (vidjeti dio 5.3).
English: CoAprovel contains lactose.
Croatian: CoAprovel sadrži laktozu.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Hypotension - Volume-depleted patients: CoAprovel has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Croatian: Hipotenzija - bolesnici s hipovolemijom: CoAprovel je rijetko povezan sa simptomatskom hipotenzijom u hipertenzivnih bolesnika koji nemaju druge rizične faktore koji bi uzrokovali hipotenziju.
English: Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in CoAprovel, minimal or no effects were reported.
Croatian: Povišenje razine kolesterola i triglicerida bilo je povezano s terapijom tiazidima; međutim, pri dozi od 12,5 mg koliko sadrži CoAprovel, zabilježeni su minimalni učinci ili ih uopće nije bilo.
English: Carbamazepine: concomitant use of carbamazepine and hydrochlorothiazide has been associated with the risk of symptomatic hyponatraemia.
Croatian: Karbamazepin: istodobna primjena karbamazepina i hidroklorotiazida povezana je s rizikom od simptomatske hiponatrijemije.
English: NDEA Limit in ng/day
Croatian: NDEA Granična vrijednost u ng/dan
English: Olmesartan 40 Irbesartan 300 Candesartan 32
Croatian: valsartan 320 losartan 150 olmesartan 40 irbesartan 300 kandesartan 32
English: Twelve percent (12%) of patients were diabetic, 34% were hyperlipidemic and the most frequent cardiovascular condition was stable angina pectoris in 3.5% of the participants.
Croatian: Od šećerne bolesti bolovalo je 12% bolesnika, 34% ih je imalo hiperlipidemiju, a najčešće kardiovaskularno stanje bila je stabilna angina pektoris i to u 3,5% sudionika.
English: increases in blood urea nitrogen (BUN), creatinine and creatine kinase
Croatian: porast koncentracije dušika iz ureje u krvi (BUN), kreatinina i kreatinin kinaze
English: The recommended dose of CoAprovel is one tablet a day.
Croatian: Uobičajena doza lijeka CoAprovel je jedna tableta na dan.
English: If a readministration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Croatian: Ako se ocijeni da je ponovna primjena diuretika neophodna, preporučuje se da se izložena područja kože zaštite od Sunca ili umjetnog UVA zračenja.
English: Hydrochlorothiazide is excreted in human milk in small amounts.
Croatian: Hidroklorotiazid se izlučuje u majčinom mlijeku u manjim količinama.
English: Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidneys.
Croatian: Hidroklorotiazid se ne metabolizira, ali se brzo eliminira iz organizma putem bubrega.
English: With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6-12 hours.
Croatian: S hidroklorotiazidom početak diureze nastupa nakon 2 sata, vršni učinak postiže se nakon 4 sata, dok djelovanje traje 6-12 sati.
English: 30 - 56 x 1 - 90 tablets
Croatian: 30 - 56 x 1 - 90 tableta
English: Because no information is available regarding the use of CoAprovel during breast-feeding, CoAprovel is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Croatian: Budući da nema dostupnih podataka o upotrebi lijeka CoAprovel 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.
English: Additional information on hydrochlorothiazide interactions: when administered concurrently, the following medicinal products may interact with thiazide diuretics:
Croatian: Dodatne informacije o interakcijama hidroklorotiazida: pri istodobnom liječenju, sljedeći lijekovi mogu ući u interakciju s tiazidskim diureticima:
English: CoAprovel is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
Croatian: CoAprovel se primjenjuje za liječenje visokog krvnog tlaka kad liječenje samo irbesartanom ili samo hidroklorotiazidom ne osigurava odgovarajuću kontrolu krvnog tlaka.
English: Hydrochlorothiazide crosses the placenta.
Croatian: Hidroklorotiazid prolazi kroz placentu.
English: Diuretic agents such as the hydrochlorothiazide contained in CoAprovel may have an effect on other medicines.
Croatian: Diuretičke tvari, kao što je hidroklorotiazid iz lijeka CoAprovel, mogu imati učinke na druge lijekove.
English: In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
Croatian: Ispitivanja in vitro upućuju da se irbesartan primarno oksidira pomoću enzima CYP2C9 citokroma P450; izoenzim CYP3A4 ima neznatan učinak.
English: Preparations containing lithium should not be taken with CoAprovel without close supervision by your doctor.
Croatian: Pripravci koji sadrže litij ne smiju se uzimati s lijekom CoAprovel bez pomnog liječničkog nadzora.
English: If calcium supplements or calcium sparing medicinal products (e.g. vitamin D therapy) must be prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly;
Croatian: Ako se moraju propisati nadomjesci kalcija ili lijekovi koji čuvaju kalcij (primjerice terapija vitaminom D), potrebno je nadzirati razinu kalcija u serumu i sukladno tomu prilagoditi dozu kalcija;
English: Not known (frequency cannot be estimated from the available data): skin and lip cancer (nonmelanoma skin cancer)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): rak kože i usana (nemelanomski rak kože)
English: The potential toxicity of the irbesartan/hydrochlorothiazide combination after oral administration was evaluated in rats and macaques in studies lasting up to 6 months.
Croatian: Potencijalna toksičnost kombinacije irbesartan/hidroklorotiazid nakon peroralne primjene ocijenjena je na štakorima i makaki majmunima, u istraživanjima koja su trajala do 6 mjeseci.
English: Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex France
Croatian: Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex Francuska
English: NDMA Limit in ng/day
Croatian: NDMA Granična vrijednost u ng/dan
English: As with any antihypertensive agent, excessive blood pressure decrease in patients with ischemic cardiopathy or ischemic cardiovascular disease could result in a myocardial infarction or stroke.
Croatian: Kao i kod bilo kojeg drugog antihipertenziva, prekomjerni pad krvnog tlaka u bolesnika s ishemijskom kardiopatijom ili ishemijskom kardiovaskularnom bolešću može dovesti do infarkta miokarda ili moždanog udara.
English: Based on its pharmacodynamic properties, CoAprovel is unlikely to affect the ability to drive and use machines.
Croatian: Na temelju farmakodinamičkih svojstava, CoAprovel ne bi trebao utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: For N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance:
Croatian: Za N-nitrozodimetilamin (NDMA) i N-nitrozodietilamin (NDEA) nositelj odobrenja za stavljanje lijeka u promet mora uvesti sljedeće specifikacije za djelatnu tvar lijeka: 1)
English: Anti-doping test: hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test.
Croatian: Anti-doping test: hidroklorotiazid u sastavu lijeka može proizvesti pozitivan analitički rezultat antidoping testa.
English: The two active ingredients in CoAprovel work together to lower blood pressure further than if either was given alone.
Croatian: Dvije djelatne tvari lijeka CoAprovel zajedno snažnije djeluju na sniženje krvnog tlaka nego kad se daju pojedinačno.
English: Irbesartan and hydrochlorothiazide (at doses up to 300 mg irbesartan/25 mg hydrochlorothiazide) have been safely administered with other antihypertensive agents including calcium channel blockers and beta-adrenergic blockers.
Croatian: Irbesartan i hidroklorotiazid (u dozama do 300 mg irbesartana/25 mg hidroklorotiazida) primjenjivani su sa sigurnošću u kombinaciji s drugim antihipertenzivima uključujući blokatore kalcijevih kanala i blokatore beta-adrenergičkih receptora.
English: In rabbits, abortion or early resorption was noted at doses causing significant maternal toxicity, including mortality.
Croatian: Abortus ili rana resorpcija opaženi su u kunića pri dozama koje su izazvale značajnu toksičnost za majku, uključujući smrtnost.
English: 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.
Croatian: Uz gore navedene nuspojave zabilježene su i bol u prsnom košu, teške alergijske reakcije (anafilaktički šok) i smanjenje broja krvnih pločica (krvna stanica nužna za zgrušavanje krvi).
English: Latent diabetes mellitus may become manifest during thiazide therapy.
Croatian: Latentna šećerna bolest može postati izražena za vrijeme terapije tiazidima.
English: Cases of photosensitivity reactions have been reported with thiazides diuretics (see section 4.8).
Croatian: Prijavljeni su slučajevi reakcija fotoosjetljivosti prilikom primjene tiazidskih diuretika (vidjeti dio 4.8).
English: Side effects reported in clinical studies for patients treated with CoAprovel were:
Croatian: Nuspojave prijavljene u kliničkih ispitivanjima kod bolesnika liječenih lijekom CoAprovel:
English: Pharmacotherapeutic group: angiotensin-II antagonists, combinations ATC code: C09DA04.
Croatian: Farmakoterapijska skupina: antagonisti angiotenzina II, kombinacije ATK oznaka: C09DA04.
English: How to take CoAprovel
Croatian: Kako uzimati CoAprovel
English: High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.231.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
Croatian: Velika primjena hidroklorotiazida (≥50,000 mg kumulativno) bila je povezana s prilagođenim OR od 1,29 (95% CI: 1,23-1,35) za BCC i 3,98 (95% CI: 3,68-4,31) za SCC.
English: Less than 2% of the dose is excreted in the urine as unchanged irbesartan.
Croatian: 2% doze izlučuje se u obliku nepromijenjenog irbesartana.
English: Danmark Sanofi A/S Tlf: +45 45 16 70 00
Croatian: Sanofi A/S Tlf: +45 45 16 70 00
English: CoAprovel is unlikely to affect your ability to drive or use machines.
Croatian: CoAprovel ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: jaundice (intrahepatic cholestatic jaundice)
Croatian: žutica (intrahepatička kolestatska žutica)
English: The blood pressure lowering effect of irbesartan in combination with hydrochlorothiazide is apparent after the first dose and substantially present within 1-2 weeks, with the maximal effect occurring by 68 weeks.
Croatian: Učinak irbesartana u kombinaciji s hidroklorotiazidom na sniženje krvnog tlaka vidljiv je nakon prve doze, značajno prisutan tijekom 1-2 tjedna, a maksimalan učinak nastupa nakon 6-8 tjedana.
English: A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Croatian: Povezanost odgovora i kumulativne doze dokazan je s prilagođenim OR 2,1 (95% CI: 1,7-2,6) s povećanjem na OR 3,9 (3,0-4,9) za veliku primjenu hidroklorotiazida (~25 000 mg) i OR 7,7 (5,7-10,5) za najvišu kumulativnu dozu (~100 000 mg) (vidjeti i dio 4.4).
English: Although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Croatian: Iako su iz nekih eksperimentalnih modela proizašli dvosmisleni dokazi o genotoksičnom i karcinogenom učinku, ekstenzivno iskustvo s primjenom u ljudi nije pokazalo vezu između primjene hidroklorotiazida i porasta pojave novotvorina.
English: Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.
Croatian: Hidroklorotiazid pripada skupini lijekova (nazvanoj tiazidski diuretici) koji povećavaju izlučivanje mokraće i tako snižavaju krvni tlak.
English: This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).
Croatian: Ova fiksna kombinacija doze indicirana je za liječenje odraslih bolesnika čiji se krvni tlak ne može na odgovarajući način kontrolirati samo irbesartanom ili samo hidroklorotiazidom (vidjeti dio 5.1).
English: Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
Croatian: Prijavljeni su i manje česti slučajevi žutice (žućkasta boja kože i/ili bjeloočnica).
English: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
Croatian: poremećaj ravnoteže elektrolita (uključujući hipokalijemiju i hiponatrijemiju, vidjeti dio 4.4), hiperuricemija, glikozurija, hiperglikemija, porast koncentracije kolesterola i triglicerida
English: Hepatic impairment: 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.
Croatian: 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 precipitirati hepatičku komu.
English: 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.
Croatian: 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 ispitivanjima, u 29,5% bolesnika zabilježene su nuspojave.
English: Acute Myopia and Secondary Acute Angle-Closure Glaucoma: sulfonamide drugs or sulfonamide derivative drugs can cause an idiosyncratic reaction, resulting in transient myopia and acute angleclosure glaucoma.
Croatian: Akutna miopija i sekundarni akutni glaukom zatvorenog kuta: lijekovi koji sadrže sulfonamide ili derivate sulfonamida mogu izazvati idiosinkratsku reakciju koja može dovesti do prolazne miopije i akutnog glaukoma zatvorenog kuta.
English: Most of the above mentioned effects appear to be due to the pharmacological activity of irbesartan (blockade of angiotensin-II-induced inhibition of renin release, with stimulation of the renin-producing cells) and occur also with angiotensin converting enzyme inhibitors.
Croatian: Čini se da je većina gore spomenutih učinaka povezana s farmakološkim učinkom irbesartana (blokada angiotenzin-II-inducirane inhibicije otpuštanja renina, uz stimulaciju stanica koje proizvode renin) te da se pojavljuju i pri primjeni inhibitora angiotenzin konvertirajućeg enzima.
English: Metabolic and endocrine effects: thiazide therapy may impair glucose tolerance.
Croatian: Metabolički i endokrini učinci: terapija tiazidima može oslabiti toleranciju glukoze.
English: Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with CoAprovel.
Croatian: Dodatne informacije o pojedinačnim komponentama lijeka: uz navedene nuspojave kombiniranog lijeka, moguće nuspojave lijeka CoAprovel mogu biti i one prethodno prijavljene za pojedinačne komponente lijeka.
English: The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Croatian: Hidroklorotiazid iz ovog lijeka može dati pozitivne rezultate anti-doping testa.
English: You can take CoAprovel with or without food.
Croatian: CoAprovel se može uzimati s hranom ili bez nje.
English: Additional information on irbesartan interactions: in clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Croatian: Dodatne informacije o interakcijama irbesartana: prema rezultatima kliničkih ispitivanja hidroklorotiazid ne utječe na farmakokinetiku irbesartana.
English: arthralgia, myalgia
Croatian: artralgija, mialgija
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials.
Croatian: U tablici 1. prikazane su nuspojave prikupljene spontanim prijavljivanjem te u placebom kontroliranim ispitivanjima.
English: 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 mm Hg, respectively).
Croatian: 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).
English: You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium sparing medicines or other diuretics (water tablets) some laxatives medicines for the treatment of gout therapeutic vitamin D supplements medicines to control heart rhythm medicines for diabetes (oral agents or insulins) carbamazepine (a medicine for the treatment of epilepsy).
Croatian: Možda ćete trebati provesti pretrage krvi ako uzimate: nadomjeske kalija nadomjeske soli koji sadrže kalij lijekove koji štede kalij ili druge diuretike (tablete za mokrenje) neke laksative lijekove za liječenje gihta terapijske nadomjeske vitamina D lijekove za kontrolu srčanog ritma lijekove za šećernu bolest (oralni pripravci ili inzulin) karbamazepin (lijek za liječenje epilepsije)
English: nausea/vomiting
Croatian: mučnina/povraćanje
English: Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalaemia, hyponatraemia, and hypochloremic alkalosis).
Croatian: Tiazidi, uključujući hidroklorotiazid, mogu uzrokovati neravnotežu tekućine i elektrolita (hipokalijemiju, hiponatrijemiju i hipokloremijsku alkalozu).
English: Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Croatian: Nesteroidni protuupalni lijekovi: kad se antagonisti angiotenzina II primjenjuju istodobno s nesteroidnim protuupalnim lijekovima (npr. selektivnim inhibitorima COX-2, acetilsalicilatnom kiselinom (> 3 g/dan) i neselektivnim nesteroidnim protuupalnim lijekovima), može doći do slabljenja antihipertenzivnog učinka.
English: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose dependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).
Croatian: Nemelanomski rak kože: Na temelju dostupnih podataka iz epidemioloških ispitivanja, između hidroklorotiazida i NMSC-a primijećena je povezanost ovisna o kumulativnoj dozi (vidjeti također dijelove 4.4 i 5.1).
English: While hydrochlorothiazide is a sulfonamide, only isolated cases of acute angleclosure glaucoma have been reported so far with hydrochlorothiazide.
Croatian: Iako je hidroklorotiazid sulfonamid, kod njegove su primjene dosad prijavljeni samo izolirani slučajevi akutnog glaukoma zatvorenog kuta.
English: Other antihypertensive agents: the antihypertensive effect of CoAprovel may be increased with the concomitant use of other antihypertensive agents.
Croatian: Ostali antihipertenzivni lijekovi: antihipertenzivni učinak lijeka CoAprovel može se pojačati istodobnim uzimanjem drugih antihipertenziva.
English: Therefore, the use of CoAprovel is not recommended.
Croatian: Primjena lijeka CoAprovel se stoga ne preporučuje.
English: Sanofi Winthrop Industrie 30-36, avenue Gustave Eiffel, BP 7166 F-37071, 37100 Tours France
Croatian: Sanofi Winthrop Industrie 30-36, avenue Gustave Eiffel, BP 7166 F-37071, 37100 Tours Francuska
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Croatian: Stenoza aortnog i mitralnog zaliska, opstruktivna hipertrofična kardiomiopatija: kao što je to slučaj i s ostalim vazodilatatorima, poseban oprez indiciran je u bolesnika s aortnom ili mitralnom stenozom ili opstruktivnom hipertrofičnom kardiomiopatijom.