natgillin/translations-raw huggingface dataset:
In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 80/12.5 mg (60%) compared to hydrochlorothiazide 12.5 mg (25%) and hydrochlorothiazide 25 mg (27%). 
Poleg tega je do odziva na zdravljenje (znižanje diastoličnega krvnega tlaka <90 mmHg ali za ≥10 mmHg) prišlo pri pomembno večjem deležu bolnikov, ki so jemali valsartan/ hidroklorotiazid 80/12,5 mg (60 %) v primerjavi s tistimi, ki so jemali hidroklorotiazid 12,5 mg (25 %) ali hidroklorotiazid 25 mg (27 %).
Each film-coated tablet contains 320 mg valsartan and 25 mg hydrochlorothiazide. 
Ena filmsko obložena tableta vsebuje 320 mg valsartana in 25 mg hidroklorotiazida.
Co-Dalzad (160+25) mg 160 mg / 25 mg film-coated tablets oral 
Co-Dalzad (160+25) mg 160 mg / 25 mg filmsko obložene tablete
These doses in rat, respectively, represent 3.0 and 12 times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis. 
Pri podganah ti odmerki predstavljajo 3,0 oziroma 12-kratnik najvišjega priporočenega odmerka za človeka za valsartan oziroma hidroklorotiazid glede na enoto mg/m2.
Co- Novacard 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral 
Co- Novacard 80/12.5 mg 80 mg / 12,5 mg filmsko obložene tablete
In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 160/25 mg (68%) and 160/12.5 mg (62%) compared to valsartan 160 mg (49%). 
Poleg tega je do odziva na zdravljenje (znižanje diastoličnega krvnega tlaka <90 mmHg ali za ≥10 mmHg) prišlo pri pomembno večjem deležu bolnikov, ki so jemali valsartan/ hidroklorotiazid 160/25 mg (68 %) in 160/12,5 mg (62%) v primerjavi s tistimi, ki so jemali samo valsartan 160 mg
Co-Dalzad (160+12.5) mg 160 mg / 12,5 mg film-coated tablets oral 
Co-Dalzad (160+12.5) mg 160 mg / 12,5 mg filmsko obložene tablete
Each film-coated tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide. 
Ena filmsko obložena tableta vsebuje 160 mg valsartana in 25 mg hidroklorotiazida.
Co-Dalzad (80+12.5) mg 80 mg / 12,5 mg film-coated tablets oral 
Co-Dalzad (80+12.5) mg 80 mg / 12,5 mg filmsko obložene tablete
• facial rash associated with joint pain 
• izpuščaj na obrazu v povezavi z bolečinami v sklepih
Cordinate plus 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral 
Cordinate plus 320/12.5 mg 320 mg / 12,5 mg filmsko obložene tablete
Cordinate plus 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral 
Cordinate plus 160/12.5 mg 160 mg / 12,5 mg filmsko obložene tablete
There have been isolated reports of haemolytic anaemia in patients receiving concomitant treatment with methyldopa and hydrochlorothiazide. 
Pri bolnikih, ki so sočasno prejemali metildopo in hidroklorotiazid, so poročali o posameznih primerih hemolitične anemije.
Co- Novacard 160/25 mg 160 mg / 25 mg film-coated tablets oral 
Co- Novacard 160/25 mg 160 mg / 25 mg filmsko obložene tablete
Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide. 
Ena tableta vsebuje 320 mg valsartana in 25 mg hidroklorotiazida.
In addition, a significantly greater percentage of patients responded (diastolic BP <90 mmHg or reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 80/12.5 mg (64%) compared to placebo (29%) and hydrochlorothiazide (41%). 
Poleg tega je do odziva na zdravljenje (znižanje diastoličnega krvnega tlaka <90 mmHg ali za ≥10 mmHg) prišlo pri pomembno večjem deležu bolnikov, ki so jemali valsartan/ hidroklorotiazid 80/12,5 mg (64 %) v primerjavi s tistimi, ki so jemali placebo (29 %), in s tistimi, ki so jemali hidroklorotiazid (41 %).
Co-Dalzad (320+25) mg 320 mg / 25 mg film-coated tablets oral 
Co-Dalzad (320+25) mg 320 mg / 25 mg filmsko obložene tablete
Cotareg 160mg/25 mg 160 mg / 25 mg film-coated tablets oral 
Cotareg 160mg/25 mg 160 mg / 25 mg filmsko obložene tablete
Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. 
Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti, razen, če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
Co-Dalzad (320+12.5) mg 320 mg / 12,5 mg film-coated tablets oral 
Co-Dalzad (320+12.5) mg 320 mg / 12,5 mg filmsko obložene tablete
• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives 
• če ste alergični (preobčutljivi) na valsartan, hidroklorotiazid, druga sulfonamidna zdravila (snovi, ki imajo sorodno kemijsko strukturo kot hidroklorotiazd) ali katerokoli drugo sestavino zdravila Diovan Comp.
Absorption of thiazide diuretics, including hydrochlorothiazide, is impaired in the presence of anionic exchange resins. 
Izmenjevalni smoli holestiramin in holestipol Prisotnost anionskih izmenjevalnih smol ovira absorpcijo tiazidnih diuretikov, vključno s hidroklorotiazidom.
Each film-coated tablet contains 320 mg valsartan and 12.5 mg hydrochlorothiazide. 
Ena filmsko obložena tableta vsebuje 320 mg valsartana in 12,5 mg hidroklorotiazida.
These doses in marmoset, respectively, represent 0.3 and 1.2-times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis. 
Pri marmozetkah pa ti odmerki predstavljajo 0,3 oziroma 1,2-kratnik najvišjega priporočenega odmerka za človeka za valsartan oziroma hidroklorotiazid glede na enoto mg/m2.
Co- Novacard 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral 
Co- Novacard 160/12.5 mg 160 mg / 12,5 mg filmsko obložene tablete
Cotareg 160mg/12.5 mg 160 mg / 12.5 mg film-coated tablets oral 
Cotareg 160mg/12.5 mg 160 mg / 12,5 mg filmsko obložene tablete
Adverse reactions known to occur with each component given individually but which have not been seen in clinical trials may occur during treatment with valsartan/hydrochlorothiazide. 
Pri zdravljenju s kombinacijo valsartan/ hidroklorotiazid lahko pride tudi do neželenih dogodkov, ki so znani pri uporabi vsake posamezne učinkovine, a jih niso opažali v kliničnih študijah.
General disorders and administration site conditions Uncommon 
Splošne težave in spremembe na mestu aplikacije občasni utrujenost
Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide. 
Ena tableta vsebuje 160 mg valsartana in 25 mg hidroklorotiazida.
Diovan Comp 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral 
Diovan Comp 160/12.5 mg 160 mg / 12,5 mg filmsko obložene tablete
Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide. 
Ena tableta vsebuje 320 mg valsartana in 12,5 mg hidroklorotiazida.
Slovenia Novartis Pharma GmbH Roonstrasse 25 
Slovenija Novartis Pharma GmbH Roonstrasse 25
In a double-blind, randomised, placebo-controlled, factorial design trial comparing various dose combinations of valsartan/hydrochlorothiazide to their respective components, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 80/12.5 mg (16.5/11.8 mmHg) compared to placebo (1.9/4.1 mmHg) and both hydrochlorothiazide 12.5 mg (7.3/7.2 mmHg) and valsartan 80 mg (8.8/8.6 mmHg). 
V dvojno slepem, randomiziranem, s placebom kontroliranem preskušanju s faktorsko zasnovo, v katerem so primerjali uporabo različnih kombinacij odmerkov valsartana in hidroklorotiazida z uporabo posameznih učinkovin, so opažali pomembno večje znižanje povprečnega sistoličnega/diastoličnega krvnega tlaka pri uporabi kombinacije valsartan/ hidroklorotiazid 80/12,5 mg (16,5/11,8 mmHg) v primerjavi z jemanjem placeba (1,9/4,1 mmHg) ali z uporabo samo hidroklorotiazida 12,5 mg (7,3/7,2 mmHg) ali z uporabo samo valsartana 80 mg (8,8/8,6 mmHg).
Cotareg 80mg/12.5 mg 80 mg / 12.5 mg film-coated tablets oral 
Cotareg 80mg/12.5 mg 80 mg / 12,5 mg filmsko obložene tablete
Each film-coated tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide. 
Ena filmsko obložena tableta vsebuje 80 mg valsartana in 12,5 mg hidroklorotiazida.
Each film-coated tablet contains 160 mg valsartan and 12.5 mg hydrochlorothiazide. 
Ena filmsko obložena tableta vsebuje 160 mg valsartana in 12,5 mg hidroklorotiazida.
At the recommended dose of Diovan Comp no dose adjustment is required for patients with a creatinine clearance of 30-70 ml/min. 
Bolnikom z očistkom kreatinina 30-70 ml/min, ki jemljejo zdravilo Diovan Comp v skladu s priporočenim odmerjanjem, ni treba prilagajati odmerkov.
In a double-blind, randomised, active-controlled trial in patients not adequately controlled on hydrochlorothiazide 12.5 mg, significantly greater mean systolic/diastolic BP reductions were observed with the combination of valsartan/hydrochlorothiazide 80/12.5 mg (14.9/11.3 mmHg) compared to hydrochlorothiazide 12.5 mg (5.2/2.9 mmHg) and hydrochlorothiazide 25 mg 
V dvojno slepem, randomiziranem, aktivno kontroliranem preskušanju pri bolnikih, pri katerih jemanje hidroklorotiazida 12,5 mg ni dovolj uravnalo visokega krvnega tlaka, so opažali pomembno večje znižanje povprečnega sistoličnega/diastoličnega krvnega tlaka pri uporabi kombinacije valsartan/hidroklorotiazid 80/12,5 mg (14,9/11,3 mmHg) v primerjavi z uporabo samo hidroklorotiazida 12,5 mg (5,2/2,9 mmHg) ali z uporabo hidroklorotiazida 25 mg (6,8/5,7 mmHg).
Diovan Comp 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral 
Diovan Comp 320/12.5 mg 320 mg / 12,5 mg filmsko obložene tablete
Nervous system disorders Rare 
Bolezni živčevja redki glavobol
• light-headedness 
• vrtoglavost
Co-Diovane 80/12,5 mg 160 mg / 12.5 mg film-coated tablets oral 
Co-Diovane 80/12,5 mg 160 mg / 12,5 mg filmsko obložene tablete
Metabolism and nutrition disorders Uncommon 
Presnovne in prehranske motnje občasni dehidracija
• itchy rash and other types of rash 
• srbeč izpuščaj ali druga vrsta izpuščaja
These doses in marmoset, respectively, represent 0.9 and 3.5 times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis. 
Pri marmozetkah ti odmerki predstavljajo 0,9 oziroma 3,5-kratnik najvišjega priporočenega odmerka za človeka za valsartan oziroma hidroklorotiazid glede na enoto mg/m2.
• skin rash with or without itching together with some of the following signs or symptoms: fever, 
• kožni izpuščaj s srbenjem ali brez njega s pridruženimi naslednjimi znaki ali simptomi: zvišana telesna temperatura, bolečine v sklepih, bolečine v mišicah, povečane bezgavke in/ali gripi podobni simptomi
80/12.5 mg film-coated tablets oral 
80/12,5 mg filmsko obložene tablete
Co-Diovan (320 + 25 mg) 320 mg / 25 mg film-coated tablets oral 
Co-Diovan (320 + 25 mg) 320 mg / 25 mg filmsko obložene tablete
Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. 
Ena tableta vsebuje 80 mg valsartana in 12,5 mg hidroklorotiazida.
Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide. 
Ena tableta vsebuje 160 mg valsartana in 12,5 mg hidroklorotiazida.
These doses in rat, respectively, represent 0.9 and 3.5-times the maximum recommended human dose (MRHD) of valsartan and hydrochlorothiazide on a mg/m2 basis. 
Pri podganah ti odmerki predstavljajo 0,9 oziroma 3,5-kratnik najvišjega priporočenega odmerka za človeka za valsartan oziroma hidroklorotiazid glede na enoto mg/m2.
Co-Diovan (160 + 25 mg) 160 mg / 25 mg film-coated tablets oral 
Co-Diovan (160 + 25 mg) 160 mg / 25 mg filmsko obložene tablete
Romania Novartis Pharma GmbH Roonstrasse 25 
Romunija Novartis Pharma GmbH Roonstrasse 25
The following adverse reactions have been reported in patients treated with monotherapy of thiazide diuretics, including hydrochlorothiazide: Blood and lymphatic system disorders 
Pri bolnikih, ki so se zdravili samo s tiazidnimi diuretiki, vključno s hidroklorotiazidom, so poročali o naslednjih neželenih učinkih:
Co-Diovan (160 + 12.5 mg) 160 mg / 12.5 mg film-coated tablets oral 
Co-Diovan (160 + 12.5 mg) 160 mg / 12,5 mg filmsko obložene tablete
CORIXIL 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral 
CORIXIL 160/12.5 mg 160 mg / 12,5 mg filmsko obložene tablete
Co-Diovan (80 + 12.5 mg) 80 mg / 12.5 mg film-coated tablets oral 
Co-Diovan (80 + 12.5 mg) 80 mg / 12,5 mg filmsko obložene tablete
Agranulocytosis, leucopenia, haemolytic anaemia, bone marrow depression 
Bolezni kože in podkožja pogostnost neznana angioedem, izpuščaj, srbenje
Co-Diovan (320 + 12.5 mg) 320 mg / 12.5 mg film-coated tablets oral 
Co-Diovan (320 + 12.5 mg) 320 mg / 12,5 mg filmsko obložene tablete
Co-Diovan (160+25) mg 160 mg / 25 mg film-coated tablets oral 
Co-Diovan (160+25) mg 160 mg / 25 mg filmsko obložene tablete
Co-Diovan (160+12,5) mg 160 mg / 12,5 mg film-coated tablets oral 
Co-Diovan (160+12,5) mg 160 mg / 12,5 mg filmsko obložene tablete
Co-Diovan (80+12,5) mg 80 mg / 12,5 mg film-coated tablets oral 
Co-Diovan (80+12,5) mg 80 mg / 12,5 mg filmsko obložene tablete
Co-Diovan (320+25) mg 320 mg / 25 mg film-coated tablets oral 
Co-Diovan (320+25) mg 320 mg / 25 mg filmsko obložene tablete
Cardiac arrhythmias 
Stenoza ledvične arterije
convulsions) 
• vrtoglavica
In addition, a significantly greater percentage of patients responded (BP <140/90 mmHg or SBP reduction ≥20 mmHg or DBP reduction ≥10 mmHg) with valsartan/hydrochlorothiazide 160/12.5 mg (50%) compared to hydrochlorothiazide 25 mg (25%). 
Poleg tega je do odziva na zdravljenje (krvni tlak <140/90 mmHg ali znižanje sistoličnega krvnega tlaka za ≥20 mmHg ali znižanje diastoličnega krvnega tlaka za ≥10 mmHg) prišlo pri pomembno večjem deležu bolnikov, ki so jemali valsartan/ hidroklorotiazid 160/12,5 mg (50 %) v primerjavi s tistimi, ki so jemali hidroklorotiazid 25 mg
Co-Diovan (320+12,5) mg 320 mg / 12,5 mg film-coated tablets oral 
Co-Diovan (320+12,5) mg 320 mg / 12,5 mg filmsko obložene tablete
Co-Diovan forte 160/25 mg 160 mg / 25 mg film-coated tablets oral 
Co-Diovan forte 160/25 mg 160 mg / 25 mg filmsko obložene tablete
Co-Diovan forte 320/25 mg 320 mg / 25 mg film-coated tablets oral 
Co-Diovan forte 320/25 mg 320 mg / 25 mg filmsko obložene tablete
Co-Diovane 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral 
Co-Diovane 160/12.5 mg 160 mg / 12,5 mg filmsko obložene tablete
Dose-dependent decreases in serum potassium occurred in controlled clinical studies with valsartan + hydrochlorothiazide. 
V kontroliranih kliničnih študijah s kombinacijo valsartana in hidroklorotiazida je prišlo do od odmerka odvisnih znižanj koncentracij kalija v serumu.
In patients with severe renal impairment (creatinine clearance <30 ml/min) and patients undergoing dialysis no data are available for Diovan Comp. Valsartan is highly bound to plasma protein and is not to be removed by dialysis, whereas clearance of hydrochlorothiazide will be achieved by dialysis. 
O uporabi zdravila Diovan Comp pri bolnikih s hudo ledvično okvaro (z očistkom kreatinina <30 ml/min) in pri bolnikih na dializi ni podatkov.
Co-Diovane 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral 
Co-Diovane 320/12.5 mg 320 mg / 12,5 mg filmsko obložene tablete
Co-Diovan 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral 
Co-Diovan 80/12.5 mg 80 mg / 12,5 mg filmsko obložene tablete
Diovan Comp 160mg/25 160 mg / 25 mg film-coated tablets oral 
Diovan Comp 160mg/25 160 mg / 25 mg filmsko obložene tablete
Diovan Comp 80mg/12.5 mg80 mg / 12.5 mg film-coated tablets oral 
Diovan Comp 80mg/12.5 mg80 mg / 12,5 mg filmsko obložene tablete
Co-Diovane 160/25 mg 160 mg / 25 mg film-coated tablets oral 
Co-Diovane 160/25 mg 160 mg / 25 mg filmsko obložene tablete
Diovan Comp 320mg/25 mg 320 mg / 25 mg film-coated tablets oral 
Diovan Comp 320mg/25 mg 320 mg / 25 mg filmsko obložene tablete
Co-Diovan 160/12.5 mg 160 mg / 12.5 mg film-coated tablets oral 
Co-Diovan 160/12.5 mg 160 mg / 12,5 mg filmsko obložene tablete
Diovan Comp 320 mg/25 mg320 mg / 25 mg film-coated tablets oral 
Diovan Comp 320 mg/25 mg320 mg / 25 mg filmsko obložene tablete
Diovan Comp 160 mg/25 mg160 mg / 25 mg film-coated tablets oral 
Diovan Comp 160 mg/25 mg160 mg / 25 mg filmsko obložene tablete
Diovan Comp 80 mg/12.5 mg80 mg / 12.5 mg film-coated tablets oral 
Diovan Comp 80 mg/12.5 mg80 mg / 12,5 mg filmsko obložene tablete
Concomitant use requiring caution 
Sočasna uporaba, pri kateri je potrebna previdnost Drugi antihipertenzivi
Diovan Comp 160/25 mg 160 mg / 25 mg film-coated tablets oral 
Diovan Comp 160/25 mg 160 mg / 25 mg filmsko obložene tablete
Diovan Comp 80/12.5 mg 80 mg / 12.5 mg film-coated tablets oral 
Diovan Comp 80/12.5 mg 80 mg / 12,5 mg filmsko obložene tablete
Diovan Comp 160mg/25 mg 160 mg / 25 mg film-coated tablets oral 
Diovan Comp 160mg/25 mg 160 mg / 25 mg filmsko obložene tablete
Co-Diovan 320/12.5 mg 320 mg / 12.5 mg film-coated tablets oral 
Co-Diovan 320/12.5 mg 320 mg / 12,5 mg filmsko obložene tablete
Co-Diovane 320/25 mg 320 mg / 25 mg film-coated tablets oral 
Co-Diovane 320/25 mg 320 mg / 25 mg filmsko obložene tablete
[To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally] 6.6 Special precautions for disposal No special requirements. 
6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
Nervous system disorders Very rare 
Bolezni prebavil zelo redki diareja
Diovan Comp 320/25 mg 320 mg / 25 mg film-coated tablets oral 
Diovan Comp 320/25 mg 320 mg / 25 mg filmsko obložene tablete
Co-Diovan 160/25 mg 160 mg / 25 mg film-coated tablets oral 
Co-Diovan 160/25 mg 160 mg / 25 mg filmsko obložene tablete
Hypotension Respiratory, thoracic and mediastinal disorders 
Žilne bolezni pogosti ortostatska hipotenzija
Co-Diovan 320/25 mg 320 mg / 25 mg film-coated tablets oral 
Co-Diovan 320/25 mg 320 mg / 25 mg filmsko obložene tablete
Impaired renal function 
• odpoved ledvic
Date of first authorisation: 19 January 2007 Date of latest renewal: 19 January 2012 
Datum pridobitve dovoljenja za promet: 19. januar 2007 Datum zadnjega podaljšanja: 19. januar 2012
Your doctor may need to change your dose and/or to take other precautions: 
Zdravnik vam bo morda moral spremeniti odmerek in/ali uporabiti druge previdnostne ukrepe:
The safety and efficacy of Irbesartan Zentiva in children aged 0 to 18 has not been established. 
Varnost in učinkovitost zdravila Irbesartan Zentiva pri otrocih, starih od 0 do 18 let, nista bili dokazani.
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality. 
Irbesartan je pomembno znižal tveganje za primarno povezan izid podvojitve serumskega kreatinina, zadnje faze ledvične bolezni (ESRD) in celokupne smrtnosti.
See also information under the heading “Do not take Irbesartan Zentiva”. 
Glejte tudi informacije pod naslovom “Ne jemljite zdravila Irbesartan Zentiva”.
You can take Irbesartan Zentiva with or without food. 
Zdravilo Irbesartan Zentiva lahko jemljete s hrano ali brez nje.
Please see section 2 “Irbesartan Zentiva contains lactose”. 
Prosimo glejte poglavje 2 »Zdravilo Irbesartan Zentiva vsebuje laktozo«.
Irbesartan Zentiva is indicated in adults for the treatment of essential hypertension. 
Zdravilo Irbesartan Zentiva je indicirano pri odraslih za zdravljenje esencialne hipertenzije.
It is important that you continue to take Irbesartan Zentiva until your doctor tells you otherwise. 
Pomembno je, da zdravilo Irbesartan Zentiva jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
If you get any of these symptoms or get short of breath, stop taking Irbesartan Zentiva and contact your doctor immediately. 
Če opazite kateregakoli od teh simptomov ali se pojavi občutek težkega dihanja, zdravilo Irbesartan Zentiva takoj prenehajte uporabljati in nemudoma poiščite zdravniško pomoč.
Irbesartan Zentiva belongs to a group of medicines known as angiotensin-II receptor antagonists. 
Zdravilo Irbesartan Zentiva spada v skupino zdravil, ki so znana kot antagonisti angiotenzina-II.
The study examined the long-term effects (2 years) of Irbesartan Zentiva on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline). 
V raziskavi so proučevali dolgotrajne učinke (2 leti) zdravila Irbesartan Zentiva na napredovanje v klinično proteinurijo (hitrost izločanja albuminov z urinom -“urinary albumin excretion rate”-UAER >300 mg/dan in povečanje UAER-a najmanj za 30% začetne vrednosti).
What Irbesartan Zentiva is and what it is used for 
Kaj je zdravilo Irbesartan Zentiva in za kaj ga uporabljamo
Irbesartan Zentiva at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. 
Na splošno zagotavlja odmerek 150 mg zdravila Irbesartan Zentiva enkrat na dan boljši 24 urni nadzor krvnega tlaka kot 75 mg.
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). 
Pediatrična populacija: irbesartan so raziskovali pri pediatričnih bolnikih, starih od 6 do 16 let, vendar trenutni podatki ne zadoščajo za podporo podaljšane uporabe pri otrocih, dokler ne bo na voljo dodatnih podatkov (glejte poglavja 4.8, 5.1 in 5.2).
Lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
Laktoza: Bolniki z redko dedno intoleranco za galaktozo, popolnim pomanjkanjem laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJE
What Irbesartan Zentiva is and what it is used for What you need to know before you take Irbesartan Zentiva How to take Irbesartan Zentiva Possible side effects 
Kaj je zdravilo Irbesartan Zentiva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Irbesartan Zentiva Kako jemati zdravilo Irbesartan Zentiva
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan Zentiva (see section 4.4). 
Predhodno zdravljenje z visokimi odmerki diuretikov lahko povzroči zmanjšanje volumna in tveganje za hipotenzijo ob uvedbi zdravljenja z zdravilom Irbesartan Zentiva (glejte poglavje 4.4).
No specific information is available on the treatment of overdose with Irbesartan Zentiva. 
Specifični podatki o zdravljenju prevelikega odmerjanja z zdravilom Irbesartan Zentiva niso na voljo.
Renal impairment and kidney transplantation: when Irbesartan Zentiva is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. 
Ledvična okvara in presaditev ledvic: pri dajanju zdravila Irbesartan Zentiva bolnikom s prizadeto ledvično funkcijo se priporoča redno nadzorovanje ravni kalija in kreatinina v serumu.
While this is not documented with Irbesartan Zentiva, a similar effect should be anticipated with angiotensin-II receptor antagonists. 
Čeprav to za zdravilo Irbesartan Zentiva ni dokazano, je treba podobne učinke pričakovati pri antagonistih receptorjev za angiotenzin II.
The blood pressure lowering effect of Irbesartan Zentiva is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy. 
Učinek zdravila Irbesartan Zentiva na znižanje krvnega tlaka je viden po 1-2 tednih, največji učinek pa nastopi 4-6 tednov po začetku zdravljenja.