natgillin/translations-raw huggingface dataset:
The antihypertensive effect of Irbesartan/Hydrochlorothiazide Teva may be increased with the concomitant use of other antihypertensive agents. 
Antihipertenzivni učinak lijeka Irbesartan/Hidroklorotiazid Teva može se pojačati istodobnim uzimanjem drugih antihipertenziva.
It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide. 
Poznato je da se nuspojave povezane s uzimanjem hidroklorotiazida mogu povećati kad se poveća doza hidroklorotiazida.
How to store Irbesartan/Hydrochlorothiazide Teva Contents of the pack and other information 
Kako čuvati Irbesartan/Hidroklorotiazid Teva Sadržaj pakiranja i druge informacije
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. 
U ispitivanjima na životinjama nije evaluiran učinak kombinacije irbesartana i hidroklorotiazida na fertilitet jer nema dokaza o neželjenim učincima na fertilitet životinja ili ljudi ni irbesartana niti hidroklorotiazida kad se primjenjuju kao monoterapija.
An interim limit based on daily intakes according to principles in ICH M7(R1) using toxicology data are set in order to control these impurities in the meantime at an acceptable level. 
U skladu s načelima Smjernica ICH M7(R1) i primjenom toksikoloških podataka utvrđene su privremene granične vrijednosti na temelju dnevnih unosa kako bi se te nečistoće u međuvremenu održale na prihvatljivoj razini.
As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals. 
Kao kod svih bolesnika koji uzimaju diuretike, potrebno je periodički i u primjerenim intervalima kontrolirati razinu serumskih elektrolita.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for products containing candesartan, irbesartan, losartan, olmesartan, valsartan. 
CHMP stoga preporučuje izmjene uvjeta za izdavanje odobrenja za stavljanje lijeka u promet za lijekove koji sadržavaju kandesartan, irbesartan, losartan, olmesartan i valsartan.
Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth. 
Ispitivanja 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.
What Irbesartan/Hydrochlorothiazide Teva is and what it is used for 
Što je Irbesartan/Hidroklorotiazid Teva i za što se koristi
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. 
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 betaadrenergičkih receptora.
Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker. 
ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) i VA NEPHRON-D (eng. The Veterans Affairs Nephropathy in Diabetes)) ispitivala su primjenu kombinacije ACE inhibitora s blokatorom angiotenzin II receptora.
See also information under the heading “Do not take Irbesartan/Hydrochlorothiazide Teva”. 
Vidjeti također informacije pod naslovom “Nemojte uzimati Irbesartan/Hidroklorotiazid Teva”
The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges. 
Kombinacija hidroklorotiazida i irbesartana dodatno smanjuje krvni tlak, ovisno o dozi, u njihovom terapijskom rasponu doza.
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). 
Ako se utvrdi trudnoća, treba odmah prekinuti liječenje antagonistima receptora angiotenzina II te treba, ako je to primjereno, započeti s alternativnom terapijom (vidjeti dijelove 4.3. i 4.6.).
Syncope, hypotension, tachycardia, oedema 
Sinkopa, hipotenzija, tahikardija, edem
Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group. 
Kardiovaskularna smrt i moždani udar oboje su numerički bili učestaliji u skupini koja je primala aliskiren nego u onoj koja je primala placebo, a štetni događaji i ozbiljni štetni događaji od značaja (hiperkalemija, hipotenzija i bubrežna disfunkcija) bili su učestalije zabilježeni u skupini koja je primala aliskiren nego u onoj koja je primala placebo.
In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5). 
U bolesnika čiji vaskularni tonus i funkcija bubrega ovise najviše o aktivnosti renin-angiotenzinaldosteronskog sustava (npr. bolesnici s teškim kongestivnim zatajenjem srca ili postojećom bolesti bubrega, uključujući stenozu bubrežne arterije), liječenje inhibitorima angiotenzin konvertirajućeg enzima ili antagonistima receptora angiotenzina II koji utječu na taj sustav, bilo je povezano s pojavom akutne hipotenzije, azotemije, oligurije i rijetko, akutnog zatajenja bubrega (vidjeti dio 4.5).
The mean plasma half-life of hydrochlorothiazide reportedly ranges from 5-15 hours. 
Srednja vrijednost poluvijeka hidroklorotiazida u plazmi je u rasponu je od 5 do 15 sati.
The total body and renal clearance are 157-176 and 3.0-3.5 ml/min, respectively. 
Sveukupni tjelesni klirens iznosi 157 -176, a bubrežni 3 - 3,5 ml/min.
• In case of detection of other N-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. 
• Ako se utvrdi postojanje drugih N-nitrozamina, to odmah treba prijaviti nadležnim tijelima, zajedno s toksikološkom procjenom nečistoće, kliničkom procjenom za izložene bolesnike, analizom osnovnog uzroka i planom korektivnih mjera.
If any of these side effects causes you problems, talk to your doctor. 
Ako Vam neka od navedenih nuspojava uzrokuje tegobe, obratite se svome liječniku.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
U slučaju bilo kakvih pitanja u vezi s primjenom ovoga lijeka, obratite se svom liječniku ili ljekarniku.
Angiotensin II Receptor Antagonists (AIIRAs) 
Antagonisti receptora angiotenzina II
Thiazide therapy may impair glucose tolerance. 
Terapija tiazidima može oslabiti toleranciju glukoze.
Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. 
Ne preporučuju se doze veće od 300 mg irbesartana/25 mg hidroklorotiazida jedanput na dan.
Contents of the pack and other information What Irbesartan/Hydrochlorothiazide Teva contains 
Sadržaj pakiranja i druge informacije Što Irbesartan/Hidroklorotiazid Teva sadrži
Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with irbesartan may reduce diuretic-induced hypokalaemia. 
Iako se pri primjeni tiazida može razviti hipokalijemija, istodobna primjena irbesartana može smanjiti hipokalijemiju uzrokovanu diureticima.
STATEMENT OF ACTIVE SUBSTANCE(S) 
Granična vrijednost u aktivnim farmaceutskim sastojcima (ppm)
Hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test. 
Hidroklorotiazid u sastavu lijeka može proizvesti pozitivan analitički rezultat antidoping testa.
Untreated acute angle-closure glaucoma can lead to permanent vision loss. 
Akutni glaukom zatvorenog kuta koji se ne liječi može prouzročiti trajan gubitak vida.
Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine) The effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide; 
Nedepolarizirajući relaksansi koštanih mišića (primjerice tubokurarin) Hidroklorotiazid može potencirati učinak nedepolarizirajućih relaksansa koštanih mišića;
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. 
Kad se irbesartan primjeni zajedno s malom dozom hidroklorotiazida (primjerice 12,5 mg na dan), antihipertenzivni učinak u crnaca približava se učinku kod drugih rasa.
Abnormal urination Impaired renal function including isolated cases of renal failure in patients at risk (see section 4.4) 
Oslabljena bubrežna funkcija uključujući izolirane slučajeve bubrežnog zatajenja kod rizičnih bolesnika (vidjeti dio 4.4.)
Food does not affect the bioavailability of irbesartan/hydrochlorothiazide. 
Hrana ne utječe na bioraspoloživost irbesartana/hidroklorotiazida.
The two active ingredients in Irbesartan/Hydrochlorothiazide Teva work together to lower blood pressure further than if either was given alone. 
Dvije djelatne tvari lijeka Irbesartan/Hidroklorotiazid Teva zajedno snažnije djeluju na sniženje krvnog tlaka nego kad se daju pojedinačno.
Do not use this medicine after the expiry date that is stated on the carton and on the blister after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP“.
Tables 2 and 3 below detail the adverse reactions reported with the individual components of Irbesartan/Hydrochlorothiazide Teva. 
Tablice 2. i 3. prikazuju nuspojave prijavljene za pojedinačne komponente lijeka Irbesartan/Hidroklorotiazid Teva.
The use of HCTZ may also need to be reconsidered in patients who have experienced previous NMSC (see also section 4.8). 
Također, u bolesnika koji su prethodno imali NMSC može biti potrebno razmotriti opravdanost primjene hidroklorotiazida (vidjeti također dio 4.8).
Although not specifically studied with irbesartan/hydrochlorothiazide, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide. 
Iako nisu provedene specifične studije s irbesartanom/hidroklorotiazidom, ni s irbesartanom niti s hidroklorotiazidom nije primijećen povratak veće hipertenzije (tzv. rebound hipertenzija).
Another study showed a possible association between lip cancer (SCC) and exposure to HCTZ: 633 cases of lip-cancer were matched with 63,067 population controls, using a risk-set sampling strategy. 
633 slučaja raka usana usklađeno je s 63 067 kontrola u populaciji, primjenom strategije uzorkovanja iz rizične skupine (engl. risk-set sampling).
No specific information is available on the treatment of overdose with irbesartan and hydrochlorothiazide combinations. 
Nema dostupnih specifičnih podataka o liječenju predoziranja kombinacijama irbesartana i hidroklorotiazida.
Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol; 
Istodobna primjena tiazida može povećati incidenciju reakcija preosjetljivosti na alopurinol;
Symptomatic hypotension may be expected to occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. 
Simptomatska hipotenzija može se očekivati u bolesnika s hipovolemijom i/ili hiponatrijemijom zbog stroge terapije diureticima, smanjenog unosa soli, proljeva ili povraćanja.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported. 
Prijavljene su i manje česti slučajevi žutice (žućkasta boja kože i/ili bjeloočnica).
Skin and subcutaneous tissue disorders: 
Poremećaji kože i potkožnog tkiva:
No teratogenic effects were seen in rats given irbesartan and hydrochlorothiazide in combination at doses that produced maternal toxicity. 
Nije uočen teratogeni učinak na štakorima kojima je davana kombinacija irbesartana i hidroklorotiazida u dozama koje su bile toksične za majku.
Concomitant administration of hydrochlorothiazide and irbesartan has no effect on the pharmacokinetics of either medicinal product. 
Istodobna primjena hidroklorotiazida i irbesartana ne utječe na farmakokinetiku bilo kojeg od njih.
TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK 
Eastbourne East Sussex BN22 9AG
The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides. 
Tiazidi mogu pojačati hiperglikemijski učinak beta-blokatora i diazoksida.
Blood and lymphatic system disorders: 
Poremećaji krvi i limfnog sustava:
The combination of irbesartan and hydrochlorothiazide has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension. 
Hipotenzija - Bolesnici s hipovolemijom Kombinacija irbesartana i hidroklorotiazida rijetko je povezana sa simptomatskom hipotenzijom u hipertenzivnih bolesnika koji nemaju druge rizične faktore koji bi uzrokovali hipotenziju.
Due to the hydrochlorothiazide component, Irbesartan/Hydrochlorothiazide Teva is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min). 
Zbog hidroklorotiazida u sastavu lijeka, Irbesartan/Hidroklorotiazid Teva ne preporučuje se bolesnicima s teško oštećenom funkcijom bubrega (klirens kreatinina < 30 ml/min.).
In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required. 
U dijabetičara može biti potrebna prilagodba doze inzulina ili oralnih hipoglikemika.
Irbesartan/Hydrochlorothiazide Teva is not recommended during 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. 
Irbesartan/Hidroklorotiazid Teva ne preporučuje se 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.
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. 
Znaci koji upozoravaju na neravnotežu tekućine i elektrolita su suhoća u ustima, žeđ, slabost, letargija, pospanost, nemir, bol ili grčevi u mišićima, mišićna slabost, hipotenzija, oligurija, tahikardija i gastrointestinalni poremećaji poput mučnine i povraćanja.
Such conditions should be corrected before initiating therapy with Irbesartan/Hydrochlorothiazide Teva. 
Takva stanja treba korigirati prije započinjanja terapije lijekom Irbesartan/Hidroklorotiazid Teva.
Side effects reported in clinical studies for patients treated with the combination of irbesartan and hydrochlorothiazide were: 
Nuspojave prijavljene u kliničkim ispitivanjima kod bolesnika liječenih kombinacijom irbesartana i hidroklorotijazida:
Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen. 
Dinamička ravnoteža koncentracije u plazmi postiže se 3 dana nakon uvođenja doziranja jedanput na dan.
Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1). 
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).
The mean baseline blood pressure was approximately 172/113 mmHg in each treatment group and decreases of SeSBP/SeDBP at five weeks were 30.8/24.0 mmHg and 21.1/19.3 mmHg for irbesartan/hydrochlorothiazide and irbesartan, respectively (p < 0.0001). 
Prosječna početna vrijednost krvnog tlaka bila je približno 172/113 mmHg u svakoj skupini, a smanjivanje sistoličkog/dijastoličkog tlaka u sjedećem položaju u pet tjedana iznosilo je 30,8/24,0 mmHg za irbesartan/hidroklorotiazid te 21,1/19,3 mmHg za irbesartan (p < 0,0001).
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). 
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.).
Irbesartan/Hydrochlorothiazide Teva is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section). 
Irbesartan/Hidroklorotiazid Teva ne preporučuje se uzimati u ranoj trudnoći, a ne smije se uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi Vašem djetetu primjenjujete li ga u tom razdoblju (vidjeti dio o trudnoći).
What Irbesartan/Hydrochlorothiazide Teva looks like and contents of the pack 
Kako Irbesartan/Hidroklorotiazid Teva izgleda i sadržaj pakiranja
Transient blurred vision, xanthopsia, acute myopia and secondary acute angle-closure glaucoma 
Prolazno zamagljeni vid, ksantopsija, akutna miopija i sekundarni akutni glaukom zatvorenog kuta
Pregelatinized starch (maize) Poloxamer 188 
Jezgra tablete: povidon kukuruzni škrob, prethodno geliran poloksamer 188
Name and address of the manufacturer(s) responsible for batch release 
Nazivi i adrese proizvođača odgovornog(ih) za puštanje serije lijeka u promet
Nervous system disorders: 
Poremećaji živčanog sustava:
Antidiabetic medicinal products (oral agents and insulins) Dosage adjustment of the antidiabetic medicinal product may be required (see section 4.4); 
Antidijabetici (oralni pripravci i inzulini) Može biti potrebna prilagodba doze antidijabetika (vidjeti dio 4.4.);
Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate. 
Jezgra tablete: povidon, prethodno geliran kukuruzni škrob, poloksamer 188, mikrokristalična celuloza, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid i magnezijev stearat.
Investigations: 
Pretrage:
Pharmachemie B.V. Swensweg 5 
Velika Britanija Pharmachemie B.V.
The potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of irbesartan. 
Učinak hidroklorotiazida na sniženje razine kalija umanjen je učinkom irbesartana koji štedi izlučivanje kalija.
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. 
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.
The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test. 
Hidroklorotiazid iz ovoga lijeka može dati pozitivne rezultate anti-doping testa.
Suggested measures include induction of emesis and/or gastric lavage. 
Preporučene mjere uključuju poticanje povraćanja i/ili ispiranje želuca.
Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation. 
Irbesartan se metabolizira u jetri glukuronidacijom i oksidacijom.
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. 
BUN; 2,3%), kreatin kinaze (1,7%) i kreatinina (1,1%).
The administration of a non-steroidal anti-inflammatory drug may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients; 
U nekih bolesnika primjena nesteroidnih protuupalnih lijekova može smanjiti diuretski, natriuretski i antihipertenzivni učinak tiazida;
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1). 
Podaci iz kliničkih ispitivanja pokazali su da je dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS) kombiniranom primjenom ACE inhibitora, blokatora angiotenzin II receptora ili aliskirena povezana s većom učestalošću štetnih događaja kao što su hipotenzija, hiperkalemija i smanjena bubrežna funkcija (uključujući akutno zatajenje bubrega) u usporedbi s primjenom samo jednog lijeka koji djeluje na RAAS (vidjeti dijelove 4.3, 4.4 i 5.1).
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 
Dojenčad čije su majke uzimale antagoniste receptora angiotenzina II treba pažljivo pratiti zbog moguće hipotenzije (također vidjeti dijelove 4.3. i 4.4.).
In patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered. 
U bolesnika s oštećenom bubrežnom funkcijom ili u bolesnika na hemodijalizi farmakokinetički parametri irbesartana nisu bitno promijenjeni.
No dosage adjustment is necessary in older people. 
U starijih bolesnika nije potrebno prilagođavati dozu.
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 Irbesartan/Hydrochlorothiazide Teva. 
Dodatne informacije o pojedinačnim komponentama lijeka: uz navedene nuspojave kombiniranog lijeka, moguće nuspojave lijeka Irbesartan/Hidroklorotiazid Teva mogu biti i one prethodno prijavljene za pojedinačne komponente lijeka.
Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma) 
Nemelanomski rak kože (karcinom bazalnih stanica i karcinom skvamoznih stanica)
There is no difference in response to irbesartan/hydrochlorothiazide, regardless of age or gender. 
Ne postoji razlika u terapijskom odgovoru bolesnika na irbesartan/hidroklorotiazid s obzirom na spol i dob.
Thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4); 
Tiazidima izazvana hipokalijemija ili hipomagnezijemija potiču pojavu srčanih aritmija uzrokovanih digitalisom (vidjeti dio 4.4.);
Irbesartan/Hydrochlorothiazide Teva 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. 
Teva ne preporučuje se majkama koje doje, a Vaš liječnik može izabrati drugu terapiju ako želite dojiti, osobito ako se radi o dojenju novorođenčeta ili nedonoščeta.
Since Irbesartan/Hydrochlorothiazide Teva contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy. 
Teva sadrži hidroklorotiazid, ne preporučuje se tijekom prvog tromjesečja trudnoće.