natgillin/translations-raw huggingface dataset:
No dosage adjustment is necessary in female patients. 
Nije potrebna prilagodba doziranja u bolesnica.
Ifirmacombi 150 mg/12.5 mg film-coated tablets EU/1/11/673/001-008 
Ifirmacombi 150 mg/12,5 mg filmom obložene tablete EU/1/11/673/001-008
Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. 
Tijekom trudnoće ne smiju se uvoditi antagonisti 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 dijelove 4.4 i 4.5).
EU/1/11/673/017 (14 film-coated tablets) EU/1/11/673/018 (28 film-coated tablets) EU/1/11/673/019 (30 film-coated tablets) EU/1/11/673/020 (56 film-coated tablets) EU/1/11/673/021 (56 x 1 film-coated tablets) EU/1/11/673/022 (84 film-coated tablets) EU/1/11/673/023 (90 film-coated tablets) EU/1/11/673/024 (98 film-coated tablets) 
EU/1/11/673/017 (14 filmom obloženih tableta) EU/1/11/673/018 (28 filmom obloženih tableta) EU/1/11/673/019 (30 filmom obloženih tableta) EU/1/11/673/020 (56 filmom obloženih tableta) EU/1/11/673/021 (56 x 1 filmom obloženih tableta) EU/1/11/673/022 (84 filmom obložene tablete) EU/1/11/673/023 (90 filmom obloženih tableta) EU/1/11/673/024 (98 filmom obloženih tableta)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) - Second and third trimesters of pregnancy (see sections 4.4 and 4.6) - Severe renal impairment (creatinine clearance < 30 ml/min) - Refractory hypokalaemia, hypercalcaemia - Severe hepatic impairment, biliary cirrhosis and cholestasis - The concomitant use of Ifirmacombi 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 
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na druge tvari koje su derivati sulfonamida (hidroklorotiazid je derivat sulfonamida) Drugo i treće tromjesečje trudnoće (vidjeti dijelove 4.4 i 4.6) Teško oštećenje funkcije bubrega (klirens kreatinina < 30 ml/min) Refraktorna hipokalijemija, hiperkalcijemija
The recommended dose of Ifirmacombi 150 mg/12.5 mg is one tablet a day. 
Preporučena doza lijeka Ifirmacombi 150 mg/12,5 mg je jedna tableta na dan.
EU/1/11/673/001 (14 film-coated tablets) EU/1/11/673/002 (28 film-coated tablets) EU/1/11/673/003 (30 film-coated tablets) EU/1/11/673/004 (56 film-coated tablets) EU/1/11/673/005 (56 x 1 film-coated tablets) EU/1/11/673/006 (84 film-coated tablets) EU/1/11/673/007 (90 film-coated tablets) EU/1/11/673/008 (98 film-coated tablets) 
EU/1/11/673/001 (14 filmom obloženih tableta) EU/1/11/673/002 (28 filmom obloženih tableta) EU/1/11/673/003 (30 filmom obloženih tableta) EU/1/11/673/004 (56 filmom obloženih tableta) EU/1/11/673/005 (56 x 1 filmom obloženih tableta) EU/1/11/673/006 (84 filmom obložene tablete) EU/1/11/673/007 (90 filmom obloženih tableta) EU/1/11/673/008 (98 filmom obloženih tableta)
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 te posljedična blokada sustava renin-angiotenzin-aldosteron utječe na sprječavanje gubitka kalija povezanog s primjenom tih diuretika.
The recommended dose of Ifirmacombi 300 mg/25 mg is one tablet a day. 
Preporučena doza lijeka Ifirmacombi 300 mg/25 mg je jedna tableta na dan.
EU/1/11/673/009 (14 film-coated tablets) EU/1/11/673/010 (28 film-coated tablets) EU/1/11/673/011 (30 film-coated tablets) EU/1/11/673/012 (56 film-coated tablets) EU/1/11/673/013 (56 x 1 film-coated tablets) EU/1/11/673/014 (84 film-coated tablets) EU/1/11/673/015 (90 film-coated tablets) EU/1/11/673/016 (98 film-coated tablets) 
EU/1/11/673/009 (14 filmom obloženih tableta) EU/1/11/673/010 (28 filmom obloženih tableta) EU/1/11/673/011 (30 filmom obloženih tableta) EU/1/11/673/012 (56 filmom obloženih tableta) EU/1/11/673/013 (56 x 1 filmom obloženih tableta) EU/1/11/673/014 (84 filmom obložene tablete) EU/1/11/673/015 (90 filmom obloženih tableta) EU/1/11/673/016 (98 filmom obloženih tableta)
Not known: vertigo, paraesthesia, light-headedness, restlessness 
Nije poznato: vrtoglavica, parestezija, ošamućenost, nemir
Irbesartan/hydrochlorothiazide 
Irbesartan/hidroklorotiazid:
Not known: cardiac arrhythmias 
Nije poznato: srčane aritmije
Warnings and precautions Talk to your doctor before taking Ifirmacombi and if any of the following apply to you: - if you get excessive vomiting or diarrhoea - if you suffer from kidney problems or have a kidney transplant - 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 you 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). 
- 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 ste imali rak kože ili ako Vam se pojavi neočekivana lezija (promjena) na koži tijekom liječenja.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started. 
Kada se utvrdi trudnoća, mora se odmah prekinuti liječenje antagonistima receptora angiotenzina II te treba, ako je to primjereno, uvesti drugu odgovarajuću terapiju.
Medicinal products affecting potassium: 
Lijekovi koji utječu na razinu kalija:
The recomended dose of Ifirmacombi 300 mg /12.5 mg is one tablet a day. 
Preporučena doza lijeka Ifirmacombi 300 mg/12,5 mg je jedna tableta na dan.
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. 
Farmakokinetika irbesartana je linearna i proporcionalna dozi u rasponu doza od 10 do 600 mg.
Hydrochlorothiazide 
Hidroklorotiazid:
Psychiatric disorders: 
Psihijatrijski poremećaji
Ifirmacombi 150 mg/12.5 mg film-coated tablets Pale pink, biconvex, oval, film-coated tablets. 
Ifirmacombi 150 mg/12,5 mg filmom obložene tablete Blijedo ružičaste, bikonveksne, ovalne, filmom obložene tablete.
Ifirmacombi 150 mg/12.5 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172) in the film-coating. 
Ifirmacombi 150 mg/12,5 mg: manitol, hidroksipropilceluloza, nisko supstituirana hidroksipropilceluloza, natrijev škroboglikolat, talk, makrogol 6000, hidrogenirano ricinusovo ulje u jezgri tablete i poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk, žuti željezov oksid (E172) i crveni željezov oksid (E172) u film ovojnici tablete.
Ifirmacombi 300 mg/25 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172) in the film-coating. 
Ifirmacombi 300 mg/25 mg: manitol, hidroksipropilceluloza, nisko supstituirana hidroksipropilceluloza, natrijev škroboglikolat, talk, makrogol 6000, hidrogenirano ricinusovo ulje u jezgri tablete i poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk, žuti željezov oksid (E172) i crveni željezov oksid (E172) u film ovojnici tablete.
Ifirmacombi 150 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. 
Liječnik će Vam obično propisati Ifirmacombi 150 mg/12,5 mg ako Vam dosadašnje liječenje povišenog krvnog tlaka nije osiguralo odgovarajući učinak.
Ifirmacombi 150 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/25 mg film-coated tablets 
Ifirmacombi 150 mg/12,5 mg filmom obložene tablete Ifirmacombi 300 mg/12,5 mg filmom obložene tablete Ifirmacombi 300 mg/25 mg filmom obložene tablete
Uncommon: chest pain 
Manje često: bol u prsima
Ifirmacombi 300 mg/12.5 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc in the film-coating. 
Ifirmacombi 300 mg/12,5 mg: manitol, hidroksipropilceluloza, nisko supstituirana hidroksipropilceluloza, natrijev škroboglikolat, talk, makrogol 6000, hidrogenirano ricinusovo ulje u jezgri tablete i poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk u film ovojnici tablete.
- if you are taking any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems - Aliskiren 
Zaštitite svoju kožu od izlaganja suncu i UV zrakama za vrijeme uzimanja lijeka Ifirmacombi. - ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog krvnog tlaka: - ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću. - aliskiren.
Common side effects (may affect up to 1 in 10 people): - nausea/vomiting - abnormal urination - fatigue - dizziness (including when getting up from a lying or sitting position) - blood tests may show raised levels of an enzyme that measures the muscle and heart function 
- omaglica (uključujući onu koja se javlja nakon dizanja iz ležećeg ili sjedećeg položaja) - krvnim pretragama dokazane povišene vrijednosti enzima koji određuje funkciju srca i mišića
Hydroxypropylcellulose Hydroxypropylcellulose, low-substituted Sodium starch glycolate Talc 
Jezgra tablete: manitol hidroksipropilceluloza hidroksipropilceluloza, nisko supstituirana natrijev škroboglikolat talk makrogol 6000 ricinusovo ulje, hidrogenirano
Ifirmacombi 150 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/25 mg film-coated tablets Irbesartan/Hydrochlorothiazide 
Ifirmacombi 150 mg/12,5 mg filmom obložene tablete Ifirmacombi 300 mg/12,5 mg filmom obložene tablete Ifirmacombi 300 mg/25 mg filmom obložene tablete irbesartan/hidroklorotiazid
Ifirmacombi 300 mg/25 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. 
Liječnik će Vam obično propisati Ifirmacombi 300 mg/25 mg ako Vam dosadašnje liječenje povišenog krvnog tlaka nije osiguralo odgovarajući učinak.
- Ifirmacombi 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; - Ifirmacombi 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Ifirmacombi 150 mg/12.5 mg. - Ifirmacombi 300 mg/25 mg may be administered in patients insufficiently controlled by Ifirmacombi 300 mg/12.5 mg. 
Ifirmacombi 300 mg/12,5 mg može se propisati bolesnicima čiji se krvni tlak ne može na odgovarajući način kontrolirati irbesartanom u dozi od 300 mg ili lijekom Ifirmacombi 150 mg/12,5 mg.
Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mmHg in patients with mild-to-moderate hypertension. 
U bolesnika s blagom do srednje teškom hipertenzijom doza od 150 mg irbesartana i 12,5 mg hidroklorotiazida jedanput na dan dovela je do srednjeg sniženja sistoličkog/dijastoličkog krvnog tlaka od 12,9/6,9 mm Hg (korigirano za rezultate placebo skupine) u vrijeme najniže koncentracije u krvi (24 sata nakon uzimanja doze).
However, another angiotensin-II antagonist affected fertility parameters in animal studies when given alone. 
Rezultati ispitivanja na životinjskim modelima pokazali su, međutim, da je jedan drugi antagonist receptora angiotenzina II primijenjen sam utjecao na parametre fertilnosti.
Ifirmacombi 300 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. 
Liječnik će Vam obično propisati Ifirmacombi 300 mg/12,5 mg ako Vam dosadašnje liječenje povišenog krvnog tlaka nije osiguralo odgovarajući učinak.
A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically force titrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively. 
Nakon jednog tjedna doze su sustavno forsirano titrirane (prije procjene odgovora na nisku dozu) na irbesartan/hidroklorotiazid 300 mg/25 mg, odnosno irbesartan 300 mg.
No dosage adjustment of Ifirmacombi is necessary in patients with mild to moderate hepatic impairment (see section 4.3). 
Za bolesnike s blago ili umjereno oštećenom funkcijom jetre nije potrebna prilagodba doze lijeka Ifirmacombi (vidjeti dio 4.3).
However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min but < 60 ml/min) this fixed dose combination should be administered with caution. 
Međutim, kombinaciju fiksne doze treba oprezno primjenjivati u bolesnika koji imaju blago do umjereno oštećenom funkciju bubrega (klirens kreatinina ≥ 30 ml/min, ali < 60 ml/min).
Tablet core: 
Oštećena funkcija bubrega:
Ifirmacombi 300 mg/12.5 mg White, biconvex, capsule shaped, film-coated tablets (tablets). 
Ifirmacombi 300 mg/12,5 mg Bijele, bikonveksne, filmom obložene tablete u obliku kapsule (tablete).
Periodic monitoring of serum potassium is recommended when Ifirmacombi is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics). 
Pri istodobnoj primjeni lijeka Ifirmacombi i drugih lijekova na čije djelovanje utječu poremećaji kalija (primjerice glikozidi digitalisa, antiaritmici) preporučuje se periodičko praćenje razine kalija u serumu.
Ifirmacombi 300 mg/25 mg film-coated tablets Pale pink, biconvex, capsule shaped, film-coated tablets. 
Ifirmacombi 300 mg/25 mg filmom obložene tablete Blijedo ružičaste, bikonveksne, filmom obložene tablete u obliku kapsule.
(It is also better to avoid Ifirmacombi in early pregnancy - see pregnancy section) - if you have severe liver or kidney problems - if you have difficulty in producing urine - if your doctor determines that you have persistently high calcium or low potassium levels in your blood - if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren 
Nemojte uzimati Ifirmacombi - ako ste alergični na irbesartan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako ste alergični na hidroklorotiazid ili lijekove kemijski srodne sulfonamidima - ako ste trudni više od 3 mjeseca (preporučuje se, također, izbjegavati Ifirmacombi i u ranoj trudnoći - vidjeti dio o trudnoći) - ako imate teških problema s jetrom ili bubrezima - ako imate poteškoća sa stvaranjem urina - ako Vaš liječnik utvrdi da imate poremećaj koji je povezan sa stalno povišenom razinom kalcija ili niskom razinom kalija u krvi - ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje krvnog tlaka koji sadrži aliskiren
Ifirmacombi 300 mg/12.5 mg film-coated tablets White, biconvex, capsule shaped, film-coated tablets. 
Ifirmacombi 300 mg/12,5 mg filmom obložene tablete Bijele, bikonveksne, filmom obložene tablete u obliku kapsule.
Ifirmacombi 300 mg/25 mg tablets Irbesartan/Hydrochlorothiazide 
Ifirmacombi 300 mg/25 mg tablete irbesartan/hidroklorotiazid
Ifirmacombi 300 mg/25 mg Pale pink, biconvex, capsule shaped, film-coated tablets (tablets). 
Ifirmacombi 300 mg/25 mg Blijedo ružičaste, bikonveksne, filmom obložene tablete u obliku kapsule (tablete).
Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide. 
Jedna filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida) i 25 mg hidroklorotiazida.
Table 2: Adverse reactions reported with the use of irbesartan alone Blood and lymphatic system disorders 
Tablica 2: Nuspojave prijavljene samo za irbesartan
Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide. 
Jedna filmom obložena tableta sadrži 150 mg irbesartana (u obliku irbesartanklorida) i 12,5 mg hidroklorotiazida.
Ifirmacombi 300 mg/25 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide. 
Ifirmacombi 300 mg/25 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida) i 25 mg hidroklorotiazida.
Ifirmacombi 150 mg/12.5 mg film-coated tablets Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide. 
Ifirmacombi 150 mg/12,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg irbesartana (u obliku irbesartanklorida) i 12,5 mg hidroklorotiazida.
The trough to peak effects measured by cuff during office visits were 68% and 76% for Ifirmacombi 150 mg/12.5 mg and Ifirmacombi 300 mg/12.5 mg, respectively. 
Učinci najniže i najviše koncentracije na sniženje krvnog tlaka nakon primjene lijeka Ifirmacombi u dozama od 150 mg/12,5 mg, odnosno 300 mg/12,5 mg, prema mjerenjima manžetom za vrijeme kontrolnog pregleda, iznosili su 68%, odnosno 76%.
Each Ifirmacombi 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide. 
Jedna Ifirmacombi 150 mg/12,5 mg filmom obložena tableta sadrži 150 mg irbesartana (u obliku irbesartanklorida) i 12,5 mg hidroklorotiazida.
Side effects reported since the launch of the combination of Irbesartan and Hydrochlorothiazide Some undesirable effects have been reported since marketing of Ifirmacombi. 
Nuspojave prijavljene nakon stavljanja kombinacije irbesartana i hidroklorotiazida na tržište
Common: fatigue 
Često: umor
Ifirmacombi 300 mg/25 mg film-coated tablets Irbesartan/Hydrochlorothiazide 
Ifirmacombi 300 mg/25 mg filmom obložene tablete irbesartan/hidroklorotiazid
Each Ifirmacombi 300 mg/25 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide. 
Jedna Ifirmacombi 300 mg/25 mg filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida) i 25 mg hidroklorotiazida.
Ifirmacombi 150 mg/12.5 mg and 300 mg/25 mg film-coated tablets Film coating: 
Ifirmacombi 150 mg/12,5 mg i 300 mg/25 mg filmom obložene tablete Film ovojnica: poli(vinilni alkohol)
Ifirmacombi 300 mg/12.5 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide. 
Ifirmacombi 300 mg/12,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida) i 12,5 mg hidroklorotiazida.
Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide. 
Jedna filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida) i 12,5 mg hidroklorotiazida.
Each Ifirmacombi 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide. 
Jedna Ifirmacombi 300 mg/12,5 mg filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida) i 12,5 mg hidroklorotiazida.
Ifirmacombi 150 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide 
Ifirmacombi 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
Ifirmacombi 300 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide 
Ifirmacombi 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
Ifirmacombi 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide 
Ifirmacombi 150 mg/12,5 mg filmom obložene tablete irbesartan/hidroklorotiazid
Dosage of Ifirmacombi 300 mg/25 mg 
Doziranje lijeka Ifirmacombi 300 mg/25 mg
Ifirmacombi 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide 
Ifirmacombi 300 mg/12,5 mg filmom obložene tablete irbesartan/hidroklorotiazid
Hepatic impairment: 
Nemelanomski rak kože:
Hepatobiliary disorders 
Nepoznato: trombocitopenija
It is available as tablets (20 mg; 40 and 80 mg). 
Dostupan je u tabletama (20 mg; 40 mg i 80 mg).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Telmisartan Actavis. 
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Telmisartan Actavis.
This means that Telmisartan Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis. 
To znači da je Telmisartan Actavis sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Micardis.
The European Commission granted a marketing authorisation valid throughout the European Union for Telmisartan Actavis on 30 September 2010. 
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Telmisartan Actavis na snazi u Europskoj uniji od 30. rujna 2010.
This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke. 
To omogućuje snižavanje krvnog tlaka, čime se smanjuju rizici povezani s visokim krvnim tlakom, poput moždanog udara.
Telmisartan Actavis is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes. 
Telmisartan Actavis se također koristi za sprječavanje kardiovaskularnih problema (problema sa srcem i krvnim žilama) poput srčanog zastoja ili moždanog udara).
This is a summary of the European public assessment report (EPAR) for Telmisartan Actavis. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Telmisartan Actavis.
For the treatment of essential hypertension, the usual recommended dose of Telmisartan Actavis is 40 mg once a day, but some patients may benefit from using 20 mg once a day. 
Za terapiju esencijalne hipertenzije, uobičajena preporučena doza lijeka Telmisartan Actavis iznosi 40 mg jednom na dan, no pojedini bolesnici mogu imati koristi od doze od 20 mg.
pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide. 
može dostatno kontrolirati, doza se može povećati na 80 mg jedanput na dan ili se mogu dodati drugi antihipertenzivi, poput hidroklorotiazida.
The active substance in Telmisartan Actavis, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. 
Telmisartan, djelatna tvar u lijeku Telmisartan Actavis je „antagonist receptora angiotenzina II”, što znači da ova tvar blokira djelovanje hormona u tijelu naziva angiotenzin II.
If the target blood 
Ako se krvni tlak ne
Telmisartan Actavis is a ‘generic medicine'. 
Telmisartan Actavis je „generički lijek”.