FrancophonIA/ELRC3.0 huggingface dataset:
English: Sabervel 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: Sabervel 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: In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function
Croatian: U tom će Vam slučaju Vaš liječnik možda raditi redovite pretrage krvi, posebno određivanje koncentracije kalija u krvi u slučaju oslabljene funkcije bubrega.
English: Peak plasma concentrations are attained at 1.5 - 2 hours after oral administration.
Croatian: Vršne koncentracije u plazmi postižu se 1,5 do 2 sata nakon oralne primjene.
English: • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Croatian: • ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje krvnog tlaka koji sadrži aliskiren
English: Children should not take Sabervel
Croatian: Djeca ne smiju uzimati Sabervel
English: Paediatric population: the safety and efficacy of Sabervel in children aged 0 to 18 has not been established.
Croatian: Pedijatrijska populacija: sigurnost primjene i djelotvornost Sabervela u djece u dobi do 18 godina nisu još ustanovljene.
English: In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Sabervel (see section 4.5).
Croatian: Konkretno, dodatak diuretika poput hidroklorotiazida je pokazao da ima aditivni učinak sa Sabervelom (vidjeti dio 4.5.).
English: Sabervel belongs to a group of medicines known as angiotensin-II receptor antagonists.
Croatian: Sabervel pripada skupini lijekova koja se naziva antagonisti receptora angiotenzina II.
English: Do not take Sabervel
Croatian: Nemojte uzimati Sabervel
English: Available pharmacodynamic/toxicological data in rats have shown excretion of irbesartan or its metabolites in milk (for details see 5.3).
Croatian: Dostupni farmakodinamski/toksikološki podaci u štakora pokazali su izlučivanje irbesartana ili njegovih metabolita u mlijeko (vidjeti dio 5.3).
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the irbesartan 300 mg group (34%) than in the placebo group (21%).
Croatian: Regresija do normoalbuminurije (< 30 mg/dan) bila je češća u skupini koja je primala irbesartan 300 mg (34%) nego u skupini koja je primala placebo (21%).
English: • if you receive Sabervel for diabetic kidney disease.
Croatian: • Ako uzimate Sabervel zbog dijabetičke bolesti bubrega.
English: 08184 - Palau-solità i Plegamans, Barcelona, Spain
Croatian: 08184 - Palau-solità i Plegamans, Barcelona, Španjolska
English: If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere (npr. laktozu), obratite se svom liječniku prije uzimanja ovog lijeka.
English: There is no experience regarding the administration of Sabervel in patients with a recent kidney transplantation.
Croatian: Nema iskustava s primjenom Sabervela u bolesnika kojima je nedavno transplantiran bubreg.
English: Sabervel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Croatian: Doza od 150 mg Sabervela jedanput na dan općenito osigurava bolju kontrolu krvnog tlaka nego doza od 75 mg u razdoblju od 24 sata.
English: dysgeusia
Croatian: Disgeuzija
English: If you get any of these symptoms or get short of breath, stop taking Sabervel and contact your doctor imme diate ly.
Croatian: Ako dobijete bilo koji od ovih simptoma ili nedostatak zraka, prestanite uzimati Sabervel i odmah se javite liječniku.
English: Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
Croatian: Manje često su prijavljeni i slučajevi žutice (žutilo kože i/ili bjeloočnica).
English: Taking Sabervel with food and drink Sabervel can be taken with or without food.
Croatian: Uzimanje hrane i pića sa Sabervelom Sabervel može se uzeti s hranom ili bez nje.
English: No dosage adjustment is necessary in elderly patients.
Croatian: Stoga, nije potrebna prilagodba doze za starije bolesnike.
English: Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Croatian: Drugo i treće tromjesečje trudnoće (vidjeti dijelove 4.4. i 4.6).
English: Renal impairment and kidney transplantation: when Sabervel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Croatian: Oštećena funkcija bubrega i transplantacija bubrega: kad Sabervel uzimaju bolesnici s oštećenom funkcijom bubrega, preporučuje se periodički kontrolirati serumske razine kalija i kreatinina.
English: Based on its pharmacodynamic properties, irbesartan is unlikely to affect this ability.
Croatian: Na temelju farmakodinamičkih svojstava, irbesartan ne bi trebao utjecati na te sposobnosti.
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 imao nikakvog utjecaja na plodnost tretiranih štakora i njihovih potomaka do doza koje induciraju prve znakove roditeljske toksičnosti (vidjeti dio 5.3).
English: Paediatric population: irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2).
Croatian: Pedijatrijska populacija: irbesartan je ispitivan na pedijatrijskoj populaciji u dobi od 6 do 16 godina, ali trenutni podaci nisu dostatni da bi podržali proširenje primjene na djecu dok ne budu i daljnji podaci dostupni (vidjeti dijelove 4.8., 5.1. i 5.2.).
English: Therefore, this combination is not recommended (see section 4.4).
Croatian: Ta se kombinacija stoga ne preporučuje (vidjeti dio 4.4).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Molimo Vas da obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali neke druge lijekove, uključujući lijekove nabavljene bez recepta.
English: In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.
Croatian: U otvorenom razdoblju ove studije, u trajanju od 26 tjedana, najčešće opažene laboratorijske abnormalnosti bile su povećana koncentracija kreatinina (6,5%) i povišene vrijednosti CK u 2% djece.
English: You can take Sabervel with or without food.
Croatian: Sabervel se može uzimati s hranom ili bez nje.
English: Sabervel is indicated in adults for the treatment of essential hypertension.
Croatian: 4.1 Terapijske indikacije Sabervel je indiciran u odraslih za liječenje esencijalne hipertenzije.
English: • if you are going to have an operation (surgery) or be given anaesthetics.
Croatian: • Ako trebate ići na bilo kakav kirurški zahvat ili trebate primiti anestetike.
English: Approximately 33% of patients in the irbesartan group reached the primary renal composite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20% relative risk reduction versus placebo (p = 0.024) and 23% relative risk reduction compared to amlodipine (p = 0.006)].
Croatian: Oko 33% bolesnika u irbesartan skupini dostiglo je primarni složeni studijski ishod za bubrežnu bolest, u usporedbi sa 39% u placebo i 41% u amlodipin skupini [20% smanjenje relativnog rizika u odnosu na placebo (p=0,024) i 23% smanjenje relativnog rizika u usporedbi s amplodipinom (p=0,006)].
English: Studies in animals indicate that the radiolabeled irbesartan is detected in rat and rabbit fetuses.
Croatian: Ispitivanja na životinjama pokazuju da je radioaktivno označeni ibesartan otkriven u štakora i fetusa kunića.
English: In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.
Croatian: U bolesnika s povišenim krvnim tlakom, šećernom bolesti tipa 2 i bubrežnom bolešću također su prijavljeni omaglica i nizak krvni tlak nakon podizanja iz sjedećeg ili ležećeg položaja, bol u zglobovima i mišićima i smanjene razine proteina u crvenim krvnim stanicama (hemoglobina).
English: Because no information is available regarding the use of Sabervel during breast-feeding, Sabervel 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 Sabervela tijekom dojenja, ne preporučuje se njegova primjena tijekom dojenja i prednost treba dati drugoj terapiji s boljim profilom sigurnosti primjene, osobito kada se doji novorođenče ili nedonošče.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja o utjecaju na sposobnost upravljanja vozilima i rada na strojevima.
English: • if you get excessive vomiting or diarrhoea
Croatian: • Ako Vas muči prekomjerno povraćanje ili proljev.
English: In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%).
Croatian: U placebom kontroliranim ispitivanjima, koja su provedena na bolesnicima s hipertenzijom, ukupna incidencija štetnih događaja nije se razlikovala između skupine koja je uzimala irbesartan (56,2%) i placebo skupine (56,5%).
English: Sabervel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Croatian: Sabervel sprječava vezanje angiotenzina II na te receptore, uzrokujući opuštanje krvnih žila i sniženje krvnog tlaka.
English: The total body and renal clearance are 157 - 176 and 3 - 3.5 ml/min, respectively.
Croatian: Ukupni tjelesni klirens iznosi 157-176, a bubrežni klirens 3-3,5 ml/min.
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 bilo utjecaja na plodnost i reprodukcijsku sposobnost u ispitivanjima na mužjacima i ženkama štakora, čak i pri oralnim dozama irbesartana koje katkad uzrokuju roditeljsku toksičnost (od 50 do 650 mg/kg/dan), uključujući i smrtnost pri najvišoj dozi.
English: Hypersensitivity to the active substance, or to any of the excipients (see section 6.1).
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari (vidjeti dio 6.1).
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 (tj. selektivnim inhibitorima COX2, acetilsalicilnom kiselinom (> 3 g/dan) i neselektivnim NSAIL) moguć je oslabljeni antihipertenzivni učinak.
English: Irbesartan is excreted in the milk of lactating rats.
Croatian: Irbesartan se izlučuje u mlijeku kod štakorica.
English: In patients insufficiently controlled with 150 mg once daily, the dose of Sabervel can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1).
Croatian: U bolesnika u kojih se bolest ne može dostatno kontrolirati dozom od 150 mg jedanput na dan, doza Sabervela može se povećati na 300 mg ili se mogu dodati drugi antihipertenzivi (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANA UZ SIGURNU I UČINKOVITU PRIMJENU
English: 28 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Croatian: 28 filmom obloženih tableta 56 filmom obloženih tableta 90 filmom obloženih tableta 98 filmom obloženih tableta
English: • medicines containing lithium
Croatian: • lijekove koji sadrže litij
English: Sabervel 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: Sabervel se ne preporučuje u ranoj trudnoći te se ne smije uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi
English: Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).
Croatian: Tijekom sljedeća dva tjedna kada su bolesnici ponovo randomizirani ili na lijek ili na placebo, bolesnici na placebu imali su porast od 2,4 i 2,0 mmHg za sjSKT i sjDKT, u usporedbi s promjenom od +0,1 i -0,3 mmHg za bolesnike na svim dozama irbesartana (vidjeti dio 4.2.).
English: Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however irbesartan has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Croatian: Diuretici i drugi antihipertenzivni lijekovi: drugi antihipertenzivi mogu pojačati hipotenzivni učinak irbesartana; irbesartan se, međutim, pokazao sigurnim za primjenu s ostalim antihipertenzivnim lijekovima poput beta blokatora, dugodjelujućih blokatora kalcijevih kanala i tiazida.
English: • salt substitutes containing potassium
Croatian: • nadomjeske soli koji sadrže kalij
English: Lithium: the combination of lithium and Sabervel is not recommended (see section 4.5).
Croatian: Litij: ne preporučuje se kombinacija litija i Sabervela (vidjeti dio 4.5).
English: 6, Dervenakion str., 15351 Pallini Attiki, Greece Tel.: +30 210 66 65 067
Croatian: 6, Dervenakion str., 15351 Pallini Attiki, Grčka Tel.: +30 210 66 65 067
English: hypersensitivity reactions such as angioedema, rash, urticaria
Croatian: Reakcije preosjetljivosti kao što su angioedem, osip, urtikarija
English: While this is not documented with Sabervel, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Croatian: Iako to još nije potvrđeno za Sabervel, sličan učinak može se očekivati s antagonistima receptora angiotenzina II.
English: C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Croatian: irbesartana, oko 20% radioaktivnosti pojavilo se u mokraći, a ostatak u stolici.
English: Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
Croatian: Pojmovi označeni zvjezdicom (*) odnose se na nuspojave koje su dodatno prijavljene u više od 2% dijabetičkih hipertenzivnih bolesnika s kroničnom insuficijencijom bubrega i manifestnom proteinurijom i to s većom učestalosti nego kod placeba.
English: The concomitant use of Sabervel with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Croatian: Istodobna primjena Sabervel 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: Sabervel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Croatian: Sabervel usporava slabljenje bubrežne funkcije u bolesnika koji imaju povišen krvni tlak i boluju od šećerne bolesti tipa 2.
English: In 1,715
Croatian: Doze od 150
English: HOW TO TAKE SABERVEL
Croatian: Kako uzimati Sabervel
English: See leaflet for further information
Croatian: Dodatne informacije
English: Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Croatian: Ograničena akumulacija irbesartana (< 20%) zabilježena je u plazmi nakon primjene opetovanih doza jedanput na dan.
English: If you forget to take Sabervel:
Croatian: Ako ste zaboravili uzeti Sabervel
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Sabervel (see section 4.4).
Croatian: Prethodno liječenje visokim dozama diuretika može dovesti do smanjenja volumena i rizika od pojave hipotenzije prilikom uvođenja terapije Sabervelom (vidjeti dio 4.4).
English: • Very common : if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
Croatian: • Vrlo često: ako imate povišen krvni tlak i šećernu bolest tipa 2 te bolest bubrega, krvne pretrage mogu pokazati povišene vrijednosti kalija.
English: (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Croatian: do < 1/10); manje često (≥ 1/1.000 do < 1/100); rijetko (≥ 1/10.000 do < 1/1.000); vrlo rijetko (< 1/10.000).
English: 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.
Croatian: 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 već postojećom slabom funkcijom bubrega.
English: 15351 Pallini, Attiki, Greece
Croatian: 15351 Pallini, Attiki, Grčka
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: nedostatkom Lapp-laktaze ili malapsorpcijom glukoze-galaktoze ne smiju uzimati ovaj lijek.
English: irbesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/kg/day, in macaques at ≥ 10 mg/kg/day).
Croatian: Nadalje, irbesartan je izazivao hiperplaziju/hipertrofiju jukstaglomerularnih stanica (u štakora pri dozi od ≥ 90 mg/kg/dan, u makaki majmuna pri dozi od ≥ 10 mg/kg/dan).
English: What Sabervel contains
Croatian: DODATNE INFORMACIJE Što Sabervel sadrži
English: The blood pressure lowering effect of irbesartan is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Croatian: Učinak irbesartana na snižavanje krvnog tlaka vidljiv je unutar 1-2 tjedna, s maksimalnim učinkom za 46 tjedana od početka terapije.
English: A limited accumulation of irbesartan (18%) in plasma was observed upon repeated once daily dosing.
Croatian: Ograničeno nakupljanje irbesartana u plazmi (18%) opaženo je nakon ponovljenog jednodnevnog doziranja.
English: IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/day) and normal renal function (serum creatinine ≤ 1.5 mg/dl in males and < 1.1 mg/dl in females).
Croatian: IRMA 2 bila je placebom kontrolirana, dvostruko-slijepa studija morbiditeta u 590 bolesnika sa šećernom bolesti tipa 2, mikroalbuminurijom (30-300 mg/dan) i normalnom bubrežnom funkcijom (serumski kreatinin ≤ 1,5 mg/dl u muškaraca i < 1,1 mg/dl u žena).
English: In a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse reactions occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
Croatian: 318 djece i adolescenata s hipertenzijom u dobi od 6 do 16 godina pojavile su se sljedeći štetni događaji povezani s primjenom lijeka: glavobolja (7,9%), hipotenzija (2,2%), omaglica (1,9%), kašalj (0,9%).
English: There is no clinical experience in patients with severe hepatic impairment.
Croatian: Nema kliničkih iskustava u bolesnika s teškim oštećenjem funkcije jetre.
English: Unite d Kingdom Aspire Pharma Limited Tel: +44(0)1730 234527
Croatian: United Kingdom Aspire Pharma Limited Tel: +44(0)1730 234527
English: • Common : dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme).
Croatian: • Često: omaglica, mučnina/povraćanje, umor a krvne pretrage mogu pokazati povišenu razinu enzima specifičnog za mišićnu i srčanu funkciju (enzim kreatinin kinaza).
English: Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Sabervel, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Croatian: Hiperkalijemija: kao i kod ostalih lijekova koji djeluju na renin-angiotenzin-aldosteronski sustav, tijekom liječenja Sabervelom može se pojaviti hiperkalijemija, posebice ako je prisutna i oštećena bubrežna funkcija, izražena proteinurija zbog dijabetičke bubrežne bolesti i/ili zatajenje srca.
English: Ös te rreich Pharmathen S.A.
Croatian: Ös te rre ich Pharmathen S.A.
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: For oral use.
Croatian: Za peroralnu primjenu
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 (također vidjeti dijelove 4.3 i 4.4).
English: Reduction of blood pressure with 0.5 mg/kg (low), 1.5 mg/kg (medium) and 4.5 mg/kg (high) target titrated doses of irbesartan was evaluated in 318 hypertensive or at risk (diabetic, family history of hypertension) children and adolescents aged 6 to 16 years over a three week period.
Croatian: Smanjenje krvnog tlaka ispitivano je tijekom tri tjedna pri primjeni ciljanih titriranih doza od 0,5 mg/kg (niska doza), 1,5 mg/kg (srednja doza) i 4,5 mg/kg (visoka doza) irbesartana u 318 djece i adolescenata s hipertenzijom ili s rizikom od hipertenzije (šećerna bolest, hipertenzija u povijesti bolesti obitelji) u dobi od 6 do 16 godina.
English: Some side effects have been reported since marketing of Irbesartan Side effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Croatian: Prijavljene su sljedeće nuspojave: glavobolja, poremećaji okusa, zvonjenje u ušima, grčevi u mišićima, bol u zglobovima i mišićima, poremećaj funkcije jetre, povišena razina kalija u krvi, oslabljena funkcija bubrega te upala malih krvnih žila koja uglavnom zahvaća kožu (stanje poznato kao leukocitoklastični vaskulitis).
English: Pregnancy and breast-feeding
Croatian: Trudnoća i dojenje Trudnoća