natgillin/translations-raw huggingface dataset:
(95% CI: 1.23-1.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
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.
No dosage adjustment of Irbesartan/Hydrochlorothiazide Teva is necessary in older people.
Nije potrebno prilagođavati dozu lijeka Irbesartan/Hidroklorotiazid Teva za starije osobe.
Pack size of 50x1 film coated tablet in unit dose blisters.
Pakiranje od 50 x 1 filmom obloženom tabletom u perforiranim blisterima djeljivi na jedinične doze.
Non-steroidal anti-inflammatory drugs
Nesteroidni protuupalni lijekovi
Electrolytes should be monitored during concomitant use.
Tijekom istovremene primjene treba pratiti razine elektrolita.
Non-melanoma skin cancer
Nemelanomski rak kože
Irbesartan/Hydrochlorothiazide Teva with alcohol
Irbesartan/Hidroklorotiazid Teva s alkoholom
Side effects associated with irbesartan alone:
Nuspojave prijavljene kod uzimanja samo irbesartana:
Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Österreich ratiopharm Arzneimittel Vertriebs-GmbH
Exposure to AIIRAs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Poznato je da u ljudi terapija antagonistima receptora angiotenzina II tijekom drugog i trećeg tromjesečja izaziva fetotoksičnost (smanjena bubrežna funkcija, oligohidramnion, poremećaj okoštavanja lubanje) i neonatalnu toksičnost (zatajenje bubrega, hipotenzija, hiperkalijemija) (vidjeti dio 5.3.).
• During this period, NDMA and NDEA impurities in the API should be controlled for a transition period at limits calculated based on the principles of ICH M7(R1) using validated assays
• Tijekom tog razdoblja potrebno je primjenom validiranih testova kontrolirati jesu li NDMA i NDEA nečistoće u aktivnim farmaceutskim sastojcima u prijelaznom razdoblju u granicama izračunatima na temelju načela iz Smjernica ICH M7(R1).
Pharmacotherapeutic group: angiotensin-II antagonists, combinations ATC code: C09D A04
ATK oznaka: C09D A04
Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice seen as yellowing of the skin and/or whites of the eyes; inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout.
Gubitak apetita; nadraženost želuca; grčevi u želucu; zatvor; žutica (žućkasta boja kože i/ili bjeloočnica); upala gušterače koju karakterizira jaka bol u gornjem dijelu trbuha, često s mučninom i povraćanjem; poremećaji spavanja; depresija; zamagljen vid; smanjenje broja bijelih krvnih stanica, što može rezultirati čestim infekcijama i vrućicom; smanjenje broja trombocita (krvne stanice neophodne za zgrušavanje krvi); smanjenje broja crvenih krvnih stanica (anemija), praćeno umorom, glavoboljom, nedostatkom zraka prilikom vježbanja, omaglicom i blijedim izgledom; bolest bubrega; problemi s plućima, uključujući upalu pluća i nakupljanje tekućine u plućima; povećana osjetljivost kože na sunce; upala krvnih žila; kožna bolest koju karakterizira ljuštenje kože po cijelom tijelu; kožni eritemski lupus, koji se očituje kao osip koji se javlja na licu, vratu i vlasištu; alergijske reakcije; slabost i spazam mišića; promjene brzine otkucaja srca; pad krvnog tlaka nakon promjene položaja tijela; oticanje žlijezda slinovnica; visoka vrijednost šećera u krvi; šećer u mokraći, povećanje nekih vrsta masnoća u krvi; visoke koncentracije mokraćne kiseline u krvi, što može dovesti do gihta.
In patients not adequately controlled on 25 mg hydrochlorothiazide alone, the addition of irbesartan gave an added placebo-subtracted systolic/diastolic mean reduction of 11.1/7.2 mmHg.
Bolesnicima čiji se tlak ne može učinkovito kontrolirati samo sa 25 mg hidroklorotiazida, dodatak irbesartana omogućuje dodatno smanjenje sistoličkog/dijastoličkog tlaka (korigirano za placebo) za prosječno 11,1/7,2 mmHg.
Electrolyte imbalance
Poremećaj elektrolita
Irbesartan/Hydrochlorothiazide Teva is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Teva je kombinacija irbesartana, antagonista receptora angiotenzina II i hidroklorotiazida, tiazidskog diuretika.
Immune system disorders:
Poremećaji imunološkog sustava:
Eye disorders:
Poremećaji oka:
Lithium The combination of lithium and Irbesartan/Hydrochlorothiazide Teva is not recommended (see section 4.5).
Litij Ne preporučuje se kombinacija litija i lijeka Irbesartan/Hidroklorotiazid Teva (vidjeti dio 4.5).
In patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
U bolesnika s blagom do umjerenom cirozom farmakokinetički parametri irbesartana nisu bitno promijenjeni.
White opaque PVC-PVdC - Aluminium blisters: Do not store above 30°C.
Bijeli neprozirni PVC-PVdC - aluminijski blisteri: Ne čuvati na temperaturi iznad 30°C.
Fever
Vrućica
Pressor amines (e.g. noradrenaline) The effect of pressor amines may be decreased, but not sufficiently to preclude their use;
Učinak presornih amina može biti smanjen, ali ne dovoljno da se isključi njihova primjena;
Severe hepatic impairment, biliary cirrhosis and cholestasis The concomitant use of Irbesartan/Hydrochlorothiazide Teva 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).
• Istodobna primjena lijeka Irbesartan/Hidroklorotiazid Teva 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)
The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mmHg.
Dodatak 12,5 mg hidroklorotiazida dozi od 300 mg irbesartana jedanput na dan bolesnicima koji nisu odgovarajuće kontrolirani sa 300 mg irbesartana u monoterapiji doveo je do daljnjeg smanjenja dijastoličkog krvnog tlaka (u usporedbi s placebom) za 6,1 mm Hg u vrijeme najniže koncentracije u krvi (24 sata nakon uzimanja doze).
The active ingredients are irbesartan and hydrochlorothiazide.
Djelatne tvari su irbesartan i hidroklorotiazid.
Hydrochlorothiazide
Hidroklorotiazid
Magyarország
Mađarska
When measured by ambulatory blood pressure monitoring, the trough to peak effects of irbesartan/hydrochlorothiazide 150 mg/12.5 mg were 100 %.
Na osnovi ambulantnih mjerenja krvnog tlaka, učinci najniže i najviše koncentracije pri primjeni irbesartana/hidroklorotiazida 150 mg/12,5 mg iznosili su 100%.
No dosage adjustment is necessary in patients with renal impairment whose creatinine clearance is ≥ 30 ml/min.
Nije potrebno prilagođavati dozu u bolesnika koji imaju oslabljenu funkciju bubrega, s klirensom kreatinina ≥ 30 ml/min.
There is no experience regarding the administration of Irbesartan/Hydrochlorothiazide Teva in patients with a recent kidney transplantation.
Nema iskustava s primjenom lijeka Irbesartan/Hidroklorotiazid Teva u bolesnika kojima je nedavno transplantiran bubreg.
Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed.
Nemelanomski rak kože: Na temelju dostupnih podataka iz epidemioloških ispitivanja, između HCTZa i NMSC-a primijećena je povezanost ovisna o kumulativnoj dozi.
Teva Italia S.r.l.
TEVA UK Ltd
Swelling extremity Arthralgia, myalgia
Artralgija, mijalgija
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP KALENDARSKO PAKIRANJE (BLISTER)
For Irbesartan/Hydrochlorothiazide Teva packaged in white opaque PVC-PVdC - aluminium blisters: Do not store above 30°C.
Irbesartan/Hidroklorotiazid Teva u bijelim, neprozirnim PVC-PVdC - aluminij blisterima: Ne čuvati na temperaturi iznad 30°C.
Forty-seven percent (47.2 %) of patients on the combination achieved trough SeDBP < 90 mmHg compared to 33.2 % of patients on irbesartan (p = 0.0005).
Pri najnižoj koncentraciji lijeka u krvi, 47,2% bolesnika koji su primali kombinaciju irbesartan/hidroklorotiazid postiglo je dijastolički tlak < 90 mmHg, u usporedbi sa 33,2% bolesnika koji su primali irbesartan (p<0,0005).
Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with Irbesartan/Hydrochlorothiazide Teva (see section 4.5).
Diuretici koje štede kalij, nadomjesci kalija ili nadomjesci soli koji sadrže kalij moraju se s oprezom istodobno primjenjivati s lijekom Irbesartan/Hidroklorotiazid Teva (vidjeti dio 4.5.).
One side of the tablet debossed with the number "93".
Na jednoj strani tablete je utisnut broj “93”.
België/Belgique/Belgien
België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG
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).
Nije potrebna prilagodba doze u bolesnika s oštećenom funkcijom bubrega čiji je klirens kreatinina ≥ 30 ml/min (vidjeti dijelove 4.3. i
When assessed by ambulatory blood pressure monitoring, the combination 150 mg irbesartan and 12.5 mg hydrochlorothiazide once daily produced consistent reduction in blood pressure over the 24 hours period with mean 24-hour placebosubtracted systolic/diastolic reductions of 15.8/10.0 mmHg.
Na osnovi ambulantnih mjerenja krvnog tlaka, utvrđeno je da kombinacija od 150 mg irbesartana i 12,5 mg hidroklorotiazida jednom na dan uzrokuje konzistentno smanjenje krvnog tlaka u periodu od 24 sata, s prosječnim24-satnim smanjenjem sistoličkog/dijastoličkog krvnog tlaka (korigiranim za rezultate placebo skupine) od 15,8/10,0 mm Hg.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Ako se antagonisti receptora angiotenzina II uzimaju od drugog tromjesečja trudnoće na dalje, preporučuje se ultrazvučni pregled funkcije bubrega i lubanje.
Adverse reactions reported with the use of hydrochorothiazide alone Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tablica 3. Nuspojave (bez obzira na povezanost s lijekom) prijavljene pri primjeni samo hidroklorotiazida Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe):
Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with irbesartan and hydrochlorothiazide combinations.
Nadalje, tiazidi smanjuju renalni klirens litija pa uzimanje kombinacija irbesartana i hidroklorotiazida može povećati rizik od toksičnosti litija.
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 Irbesartan/Hydrochlorothiazide Teva).
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 Irbesartan/Hidroklorotiazid Teva).
Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg was observed; the mechanism for this is unknown.
Manje nego proporcionalan porast oralne apsorpcije uočen je pri dozama većima od 600 mg; mehanizam tog porasta nije poznat.
Weakness, muscle spasm
Slabost, mišićni spazam
The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.
Nije utvrđeno u kojoj se mjeri hidroklorotiazid uklanja hemodijalizom.
Teva Denmark A/S Tlf: +45 44985511
Tlf: +45 44985511
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Osim ako se nastavak terapije antagonistima receptora angiotenzina II ne smatra neophodnim, bolesnice koje planiraju trudnoću trebaju prijeći na alternativnu antihipertenzivnu terapiju s potvrđenom sigurnošću primjene u trudnoći.
Talk to your doctor before taking Irbesartan/Hydrochlorothiazide Teva and if any of the following apply to you:
Obratite se svom liječniku prije nego uzmete Irbesartan/Hidroklorotiazid Teva i ako se bilo što od sljedećeg odnosi na Vas: ako značajno povraćate ili imate jaki proljev.
Musculoskeletal and connective tissue disorders:
Poremećaji mišićno-koštanog sustava i vezivnog tkiva:
Cardiac arrhythmias
Srčane aritmije
The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
• Drugo i treće tromjesečje trudnoće (vidjeti dijelove 4.4. i 4.6).
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.
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.
Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses in patients without risk of electrolyte imbalance (see sections 4.4 and 4.5).
Pri preporučenim dozama, u bolesnika bez rizika od poremećaja ravnoteže elektrolita, irbesartan u monoterapiji ne utječe značajno na razinu serumskog kalija (vidjeti dio 4.4. i 4.5).
if you get excessive vomiting or diarrhoea if you suffer from kidney problems or have a kidney transplantation if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) if your suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure) if you are taking any of the following medicines used to treat high blood pressure:
Obratite se svom liječniku prije nego uzmete Irbesartan/Hidroklorotiazid Teva i ako se bilo što od sljedećeg odnosi na Vas: ako značajno povraćate ili imate jaki proljev ako imate problema s bubrezima ili ste imali transplantaciju bubrega ako imate srčanih problema ako imate problema s jetrom ako bolujete od šećerne bolesti ako bolujete od eritemskog lupusa (poznat i kao lupus ili SLE) ako bolujete od primarnog aldosteronizma (stanje povezano s visokom proizvodnjom hormona aldosterona, koji uzrokuje zadržavanje natrija u tijelu i, posljedično, povećanje krvnog tlaka) ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog krvnog tlaka:
The other side of the tablet debossed with the number "7469".
Na drugoj strani tablete je utisnut broj "7469".
A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.
Ako se planira trudnoća, potrebno je unaprijed prijeći na prikladnu alternativnu terapiju.
Additional information on hydrochlorothiazide interactions When administered concurrently, the following medicinal products may interact with thiazide diuretics:
Pri istodobnom liječenju, sljedeći lijekovi mogu ući u interakciju s tiazidskim diureticima:
Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of irbesartan tends to reverse the potassium loss associated with these diuretics.
Pretpostavka je da istodobna primjena irbesartana, blokadom sustava renin-angiotenzin-aldosteron, utječe na sprječavanje gubitka kalija povezanog s primjenom tih diuretika.
Irbesartan is not removed by haemodialysis.
Irbesartan se ne uklanja hemodijalizom.
In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Prema rezultatima kliničkih ispitivanja hidroklorotiazid ne utječe na farmakokinetiku irbesartana.
Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
20%) zabilježena je u plazmi nakon primjene ponovljenih doza jedanput na dan.
Anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria
nekrotizirajući angitis (vaskulitis, kožni vaskulitis), kožne reakcije slične eritemskom lupusu,
There was no evidence of mutagenicity or clastogenicity with the irbesartan/hydrochlorothiazide combination.
Nema dokaza o mutagenom ili klastogenom učinku kombinacije irbesartana i hidroklorotiazida.
For therapeutic doses of irbesartan in humans, the hyperplasia/hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Ne čini se da je, pri terapijskim dozama irbesartana, hiperplazija/hipertrofija bubrežnih jukstaglomerularnih stanica od bilo kakve važnosti u ljudi.
The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
Depresija, poremećaji spavanja Nuspojave hidroklorotiazida ovisne o dozi (poglavito poremećaj elektrolita) mogu postati izraženije prilikom titriranja doze hidroklorotiazida.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Ako se utvrdi trudnoća, mora se odmah prekinuti terapija antagonistima receptora angiotenzina II te treba, ako je to primjereno, uvesti alternativnu terapiju.
There is no clinical experience with Irbesartan/Hydrochlorothiazide Teva in patients with hepatic impairment.
Nema kliničkog iskustva s primjenom lijeka Irbesartan/Hidroklorotiazid Teva u bolesnika s oštećenom funkcijom jetre.
Teva Sweden AB Tel: +46 42121100
Tel: +46 42121100
Side effects associated with hydrochlorothiazide alone are:
Nuspojave prijavljene kod uzimanja samo hidroklorotiazida:
Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg
Irbesartan/Hidroklorotiazid Teva 300 mg/25 mg
When Irbesartan/Hydrochlorothiazide Teva is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Oštećena funkcija bubrega i transplantacija bubrega Kad Irbesartan/Hidroklorotiazid Teva uzimaju bolesnici s oštećenom funkcijom bubrega, preporučuje se periodički kontrolirati razine kalija, kreatinina i mokraćne kiseline u serumu.
Tablet coating for 300 mg/25 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, Indigotine (Indigo carmine aluminium lake FD&C blue #2) and iron oxide black.
Film ovojnica tablete od 300 mg/25 mg: hipromeloza titanijev dikoksid polietilenglikol 6000 (makrogol) polietilen glikol 400 (makrogol) željezov oksid, crveni indigotin (Indigo carmine aluminium lake FD&C plava #2) željezov oksid, crni
Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics.
U primjeni tiazidskih diuretika zabilježena je egzacerbacija ili aktivacija sistemskog eritemskog lupusa.
You can take Irbesartan/Hydrochlorothiazide Teva with or without food.
Irbesartan/Hidroklorotiazid Teva može se uzimati s hranom ili bez nje.
Efficacy and safety of irbesartan/hydrochlorothiazide as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomised, double-blind, active-controlled, 8-week, parallel-arm study.
Učinkovitost i sigurnost primjene irbesartana/hidroklorotiazida kao inicijalne terapije za tešku hipertenziju (dijastolički tlak u sjedećem položaju ≥ 110 mmHg) ocijenjena je u multicentričnom,
Some undesirable effects have been reported since the marketing of the combination of irbesartan and hydrochlorothiazide.
Neke su nuspojave prijavljene nakon stavljanja kombinacije irbesartana i hidroklorotiazida na tržište.
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).
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).
Increases in blood urea nitrogen (BUN), creatinine and creatine kinase Decreases in serum potassium and sodium
Porast koncentracije BUN-a (dušik iz ureje u krvi), kreatinina i kreatinin kinaze
Interstitial nephritis, renal dysfunction
Intersticijski nefritis, bubrežna disfunkcija
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalaemia, hyponatraemia, and hypochloremic alkalosis).
Tiazidi, uključujući hidroklorotiazid, mogu uzrokovati neravnotežu tekućine i elektrolita
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Kolestiramin i smole kolestipola Apsorpcija hidroklorotiazida oslabljena je u prisutnosti smola anionskih izmjenjivača.
The use of Irbesartan/Hydrochlorothiazide Teva during breast feeding is not recommended.
Ne preporučuje se upotreba lijeka Irbesartan/Hidroklorotiazid Teva tijekom dojenja.
Tinnitus
Tinitus
Irbesartan/Hydrochlorothiazide Teva is not indicated in patients with severe hepatic impairment.
Irbesartan/Hidroklorotiazid Teva nije indiciran u bolesnika s teško oštećenom funkcijom jetre.
One side of the tablet is debossed with the number “93" and the other side of the tablet is debossed with the number "7238".
Na jednoj strani tablete je utisnut broj “93”, a na drugoj strani tablete je utisnut broj "7238".
What you need to know before you take Irbesartan/Hydrochlorothiazide Teva Do not take Irbesartan/Hydrochlorothiazide Teva if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) if you are allergic to hydrochlorothiazole or to any other sulfonamide-derived medicines if you are more than 3 months pregnant (it is also better to avoid Irbesartan/Hydrochlorothiazide Teva in early pregnancy - see pregnancy section).
Teva ako ste alergični na irbesartan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) ako ste alergični na hidroklorotiazid ili neki drugi lijek koji je derivat sulfonamida ako ste trudni više od 3 mjeseca (preporučuje se, također, izbjegavati Irbesartan/Hidroklorotiazid Teva i u ranoj trudnoći - vidjeti dio o trudnoći)
The other side of the tablet debossed with the number "7238".
Na drugoj strani tablete je utisnut broj "7238".