FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptomatic hypotension, especially after the first dose of Telmisartan Teva, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Croatian: Simptomatska hipotenzija, osobito nakon prve doze Telmisartana Teva, može se pojaviti u bolesnika koji imaju depleciju volumena i/ili natrija zbog snažne terapije diureticima, prehrane s ograničenim unosom soli, proljeva ili povraćanja.
English: 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 medicinal products that affect the renin-angiotensin-aldosterone system.
Croatian: Postoji povećan rizik od teške hipotenzije i insuficijencije bubrega kada se bolesnici s bilateralnom stenozom bubrežne arterije ili stenozom arterije jednog funkcionalnog bubrega liječe lijekovima koji utječu na sustav renin-angiotenzin-aldosteron.
English: Diuretics (thiazide or loop diuretics)
Croatian: Diuretici (tiazidni diuretici ili diuretici Henleove petlje)
English: If you are intolerant to some sugars, contact your doctor before taking Telmisartan Teva.
Croatian: Ako ne podnosite neke šećere, posavjetujte se sa svojim liječnikom prije uzimanja Telmisartana Teva.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva B.V.
English: The listing also takes into account serious adverse reactions and adverse reactions leading to discontinuation reported in three clinical long-term studies including 21642 patients treated with telmisartan for the reduction of cardiovascular morbidity for up to six years.
Croatian: Popis također uzima u obzir teške nuspojave i nuspojave koje dovode do prekida liječenja, zabilježene u tri dugotrajna klinička ispitivanja koja su uključivala 21642 bolesnika liječena telmisartanom radi smanjenja kardiovaskularnog morbiditeta, u trajanju do 6 godina.
English: What you need to know before you take Telmisartan Teva
Croatian: Što morate znati prije nego počnete uzimati Telmisartan Teva
English: Arthralgia, pain in extremetis, tendon pain (tendenitis like symptoms)
Croatian: Artralgija, bol u ekstremitetima, bol tetiva (simptomi poput tendinitisa)
English: • type 2 diabetes mellitus with documented target organ damage
Croatian: - dijabetes melitus tip 2 s dokazanim oštećenjem ciljnih organa.
English: Or:
Croatian: NN:
English: The adjusted DBP changes from baseline were -8.4 (1.5) mm Hg, -4.5 (1.6) mm Hg and -3.5 (2.1) mm Hg respectively.
Croatian: Prilagođene promjene DKT-a u odnosu na početnu vrijednsot bile su -8,4 (1,5) mm Hg, -4,5 (1,6) mm Hg te -3,5 (2,1) mm Hg, po istom redoslijedu.
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Croatian: Osim ako se produljena terapija antagonistima receptora angiotenzina II ne smatra nužnom, bolesnice koje planiraju trudnoću trebaju prijeći na alternativno antihipertenzivno liječenje s utvrđenim sigurnosnim profilom primjene u trudnoći.
English: The effect of Telmisartan Teva may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Croatian: Učinak Telmisartana Teva se može smanjiti kada uzimate NSAIL (nesteroidne protupalne lijekove, npr. aspirin ili ibuprofen) ili kortikosteroide.
English: Telmisartan is highly bound to plasma protein in renal-insufficient patients and cannot be removed by dialysis.
Croatian: Telmisartan se u visokoj mjeri veže za proteine plazme u bolesnika s insuficijencijom bubrega te se ne može ukloniti dijalizom.
English: • Narcotics (strong pain killers)
Croatian: • Narkotici (jaki lijekovi za ublažavanje boli)
English: Such conditions should be corrected before the administration of Telmisartan Teva.
Croatian: Takva stanja moraju se korigirati prije primjene Telmisartana
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Croatian: Ostala stanja sa stimulacijom sustava renin-angiotenzin-aldosteron
English: Sepsis
Croatian: Sepsa
English: Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss.
Croatian: Antagonisti receptora angiotenzina II, kao što je telmisartan, ublažavaju gubitak kalija induciranog diureticima.
English: There was no evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95 % CI 0.85 - 1.24).
Croatian: Nije dokazana korist u odnosu na kardiovaskularni mortalitet (omjer hazarda 1,03, 95 % CI 0,85 - 1,24).
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan.
Croatian: Zabilježena su reverzibilna povećanja koncentracija litija u serumu i toksičnost tijekom istodobne primjene litija s inhibitorima angiotenzin konvertirajućeg enzima te s antagonistima receptora angiotenzina II, uključujući telmisartan.
English: Hepatic function abnormal/liver disorder 3
Croatian: Abnormalna funkcija jetre/poremećaj rada jetre 3
English: Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Croatian: Ako dođe do izloženosti antagonistima receptora angiotenzina II od drugog tromjesečja trudnoće nadalje, preporučuju se ultrazvučno praćenje funkcije bubrega i razvoja lubanje.
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Croatian: Primjena antagonista receptora angiotenzina II je kontraindicirana tijekom drugog i trećeg tromjesečja trudnoće (vidjeti dijelove 4.3 i 4.4).
English: If you take more Telmisartan Teva than you should If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Croatian: Ako ste slučajno uzeli previše tableta, odmah se obratite svom liječniku, ljekarniku ili u hitnu službu najbliže bolnice.
English: This medicinal product contains sorbitol (E420).
Croatian: Ovaj lijek sadrži sorbitol (E420).
English: No statistically significant difference in the incidence of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure) was found [15.7 % in the telmisartan and 17.0 % in the placebo groups with a hazard ratio of 0.92 (95 % CI 0.81 - 1.05, p = 0.22)].
Croatian: Nije pronađena statistički značajna razlika u incidenciji primarnog složenog ishoda (kardiovaskularna smrt, nefatalni infarkt miokarda, nefatalni moždani udar ili hospitalizacija zbog kongestivnog zatajenja srca) [15,7 % u skupini na telmisartanu i 17,0 % u skupini na placebu s omjerom hazarda od 0,92 (95 % CI 0,81 - 1,05, p = 0,22)].
English: See also information under the heading “Do not Telmisartan Teva”.
Croatian: Vidjeti također informacije pod naslovom “Nemojte uzimati Telmisartan Teva”
English: - The other ingredients are microcrystalline cellulose (Avicel PH 102), sodium starch glycolate (Type
Croatian: - Pomoćne tvari su: mikrokristalična celuloza (Avicel PH 102), natrijev škroboglikolat (vrste A),
English: Your doctor has recommended a lower dose of one 20 mg tablet daily.
Croatian: Liječnik Vam može preporučiti nižu dozu odnosno jednu tabletu od 20 mg dnevno.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: Fertility In preclinical studies, no effects of telmisartan on male and female fertility were observed.
Croatian: U pretkliničkim ispitivanjima učinci telmisartana na plodnost muškaraca i žena nisu uočeni.
English: At the beginning of the preventive therapy with Telmisartan Teva 80 mg, blood pressure should be frequently monitored.
Croatian: Na početku preventivnog liječenja s Telmisartanom Teva od 80 mg, krvni tlak treba redovito pratiti.
English: Dyspnoea, cough
Croatian: Dispneja, kašalj
English: These changes, also a class effect of angiotensin converting enzyme inhibitors and other angiotensin II receptor antagonists, do not appear to have clinical significance.
Croatian: Ove promjene, koje su također učinak klase inhibitora angiotenzin konvertirajućeg enzima i ostalih antagonista receptora angiotenzina II, nemaju klinički značaj.
English: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased
Croatian: Sniženi hemoglobin, povišene vrijednosti mokraćne kiseline u krvi, povišeni jetreni enzimi, povišena kreatin fosfokinaza u krvi
English: Read the package leaflet for further information
Croatian: Pročitajte Uputu o lijeku za dodatne informacije.
English: How to take Telmisartan Teva
Croatian: Kako uzimati Telmisartan Teva
English: Or: TEVA Pharmaceutical Works Private Limited Company
Croatian: Mađarska ili: TEVA Pharmaceutical Works Private Limited Company
English: Slovenská republika Teva Pharmaceuticals Slovakia s.r.o.
Croatian: Česká republika Teva Pharmaceuticals CR, s.r.o.
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
Croatian: Kada se trudnoća dijagnosticira, liječenje antagonistima receptora angiotenzina II treba se odmah prekinuti te, ako je potrebno, započeti s primjenom drugog lijeka.
English: Aluminium-Aluminium peelable perforated unit dose blisters and aluminium-aluminium perforated unit-dose blisters.
Croatian: Aluminij-Aluminij perforirani blisteri s odvojivim slojem djeljivi na jedinične doze i aluminij-aluminij perforirani blisteri djeljivi na jedinične doze.
English: Therefore, the use of telmisartan is not recommended.
Croatian: Stoga se ne preporučuje primjena telmisartana.
English: Symptoms
Croatian: Simptomi:
English: Urinary tract infection including cystitis, upper respiratory tract infection including pharyngitis and sinusitis
Croatian: Infekcije mokraćnog sustava uključujući cistitis, infekcije gornjeg dišnog sustava uključujući faringitis i sinusitis
English: Telmisartan Teva is contraindicated in patients with severe hepatic impairment (see section 4.3).
Croatian: Telmisartan Teva je kontraindiciran u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
English: Telmisartan showed a similar effect to ramipril in reducing the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure.
Croatian: Telmisartan je pokazao sličan učinak ramiprilu u smanjenju primarnog složenog ishoda kojeg čine kardiovaskularna smrt, nefatalni infarkta miokarda, nefatalni moždani udar ili hospitalizacija zbog kongestivnog zatajenja srca.
English: • Biliary obstructive disorders
Croatian: - Bilijarni opstruktivni poremećaji.
English: Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion, and in a risk of hypotension when initiating therapy with telmisartan.
Croatian: Prethodno liječenje visokim dozama diuretika, kao što su furosemid (diuretik Henleove petlje) i hidroklorotiazid (tiazidni diuretik) može rezultirati deplecijom volumena kao i povećanim rizikom od hipotenzije pri započinjanju terapije telmisartanom.
English: If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Teva.
Croatian: Ako se nešto od prethodno navedenog odnosi na Vas, obavijestite liječnika ili ljekarnika prije početka uzimanja Telmisartan Teva.
English: Chest pain, asthenia (weakness)
Croatian: Bol u prsima, astenija (slabost)
English: Potassium sparing diuretics or potassium supplements
Croatian: Diuretici koji štede kalij ili dodaci kalija
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Croatian: Obavijestite liječnika ako dojite ili trebate početi dojiti.
English: Patients were randomized to one of the three following treatment groups: telmisartan 80 mg (n = 8542), ramipril 10 mg (n = 8576), or the combination of telmisartan 80 mg plus ramipril 10 mg (n = 8502), and followed for a mean observation time of 4.5 years.
Croatian: ramipril 10 mg (n = 8576) ili kombinacija telmisartana 80 mg i ramiprila 10 mg (n = 8502) uz prosječno trajanje praćenja od 4,5 godina.
English: The incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups.
Croatian: (16,7 %) i ramiprilu (16,5 %).
English: The elimination half-life is not changed in patients with hepatic impairment.
Croatian: Poluvrijeme eliminacije nije promijenjeno u bolesnika s oštećenjem jetrene funkcije.
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Croatian: U pojedinih bolesnika s narušenom funkcijom bubrega (npr. dehidrirani bolesnici ili stariji bolesnici s narušenom funkcijom bubrega), istodobna primjena antagonista receptora angiotenzina II i inhibitora ciklooksigenaze može rezultirati daljnjim pogoršanjem bubrežne funkcije, uključujući moguće akutno zatajenje bubrega koje je obično reverzibilno.
English: Muscoloskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: Pharmachemie B.V. Swensweg 5, 2031 GA, Haarlem, The Netherlands
Croatian: Swensweg 5, 2031 GA, Haarlem, Nizozemska
English: In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
Croatian: U jednom ispitivanju istodobna primjena telmisartana i ramiprila dovela je do porasta do 2,5 puta u
English: The concomitant use of Telmisartan 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).
Croatian: Istodobna primjena Telmisartana Teva s lijekovima koji sadrže aliskiren kontrainidicrana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dijelove
English: Blood and the lymphatic system disorders Uncommon
Croatian: Poremećaji krvi i limfnog sustava Manje često:
English: - Intercurrent events, in particular dehydratation, acute cardiac decompensation, metabolic acidosis, worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extend trauma).
Croatian: - Interkurentni događaji, osobito dehidracija, akutna kardijalna dekompenzacija, metabolička acidoza, pogoršanje funkcije bubrega, iznenadno pogoršanje stanja bubrega (npr. infektivne bolesti), liza stanica (npr. akutna ishemija uda, rabdomioliza, produljena trauma).
English: If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Croatian: Ako je primjena kombinacije dokazano potrebna, preporučuje se pažljivo pratiti razine litija u serumu.
English: When initiating telmisartan therapy for the reduction of cardiovascular morbidity, close monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary.
Croatian: Kada se započinje terapija telmisartanom zbog smanjenja kardiovaskularnog morbiditeta, potrebne su redovne kontrole krvnog tlaka te, ako je potrebno, prilagodba doze drugih antihipertenziva.
English: Telmisartan Teva 40 mg Tablets Telmisartan
Croatian: Telmisartan Teva 40 mg tablete telmisartan
English: The blood pressure lowering effect of telmisartan can be increased by concomitant use of other antihypertensive medicinal products.
Croatian: Antihipertenzivni učinak telmisartana se može povećati istodobnom primjenom drugih antihipertenziva.
English: Hepatic function abnormal / liver disorder
Croatian: Abnormalna funkcija jetre/poremećaj rada jetre
English: In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo.
Croatian: U ispitivanju PRoFESS, uočena je povećana incidencija sepse s telmisartanom u usporedbi s placebom.
English: These pharmacologically-mediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
Croatian: Ove farmakološki posredovane nuspojave, poznate iz pretkliničkih ispitivanja s inhibitorima angiotenzin konvertirajućeg enzima i antagonistima receptora angiotenzina II, bile su spriječene oralnim nadomjeskom soli.
English: Children and adolescents The use of Telmisartan Teva in children and adolescents up to the age of 18 years is not recommended.
Croatian: Djeca i adolescenti Primjena Telmisartana Teva u djece i adolescenata do dobi od 18 godina se ne preporučuje.
English: Limited experience is available in patients with severe renal impairment or haemodialysis.
Croatian: Postoji ograničeno iskustvo u bolesnika s teškim oštećenjem funkcije bubrega ili na hemodijalizi.
English: For treatment of high blood pressure, the usual dose of Telmisartan Teva for most patients is 40 mg once a day to control your blood pressure over the 24-hour period.
Croatian: Za terapiju povišenog krvnog tlaka uobičajena doza Telmisartana Teva za većinu bolesnika je jedna tableta od 40 mg jedanput na dan za kontrolu krvnog tlaka tijekom 24 sata.
English: Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters.
Croatian: Upute kako izvaditi tabletu iz blistera su naznačene na kutiji blistera s odvojivim slojem.
English: Interstinal lung disease4
Croatian: Bolest plućnog intersticija4
English: Eosinophilia, thrombocytopenia
Croatian: Eozinofilija, trombocitopenija
English: Non-steroidal anti-inflammatory medicinal products
Croatian: Nesteroidni protuupalni lijekovi
English: Very rare side effects (may affect up to 1 in 10,000 people):
Croatian: Vrlo rijetke nuspojave (mogu se javiti u manje od 1 na 10 000 osoba):
English: At the beginning of the preventive therapy with Micardis 80 mg, blood pressure should be frequently monitored.
Croatian: Na početku preventivnog liječenja s Telmisartana Teva od 80 mg, krvni tlak treba redovito pratiti.
English: 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).
Croatian: Dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS) 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).
English: Angiotensin II is a substance occurring in the body, which causes your blood vessels to narrow, thus increasing your blood pressure.
Croatian: Angiotenzin II je tvar koja nastaje u tijelu i dovodi do sužavanja krvnih žila, čime se povisuje krvni tlak.
English: (TPW) Tel.: +36 1 288 64 00
Croatian: Teva Gyógyszergyár Zrt. (TPW) Tel.: +36 1 288 64 00
English: Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem, The Netherlands
Croatian: Swensweg 5, 2031 GA Haarlem, Nizozemska
English: Angiotensin II receptor antagonists should not be initiated during pregnancy.
Croatian: Trudnoća Primjena antagonista receptora angiotenzina II ne smije započeti tijekom trudnoće.
English: Other conditions with stimulation of the renin-angiotensin-aldosterone system In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as telmisartan has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Croatian: U bolesnika čiji vaskularni tonus i funkcija bubrega ovise prvenstveno o djelovanju sustava reninangiotenzin-aldosteron (npr. bolesnici s teškim kongestivnim zatajenjem srca ili osnovnom bolešću bubrega, uključujući stenozu bubrežne arterije), liječenje lijekovima koji utječu na ovaj sustav, kao što je telmisartan, je povezano s akutnom hipotenzijom, hiperazotemijom, oligurijom ili rijetko, akutnim zatajenjem bubrega (vidjeti dio 4.8).
English: Renal impairment and kidney transplantation
Croatian: Oštećenje funkcije bubrega i transplantacija bubrega
English: Telmisartan Teva blocks this effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Croatian: Telmisartan Teva blokira učinak angiotenzina II, tako da se krvne žile šire, a krvni tlak snižava.
English: There was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.87 (95 % CI 0.76 - 1.00, p = 0.048)].
Croatian: Dokazana je korist liječenja telmisartanom u usporedbi s placebom u prethodno određenom sekundarnom složenom ishodu od kardiovaskularne smrti, nefatalnog infarkta miokarda i nefatalnog moždanog udara [0,87 (95 % CI 0,76 - 1,00, p = 0,048)].
English: Telmisartan Teva is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Croatian: Telmisartan Teva se ne preporučuje u ranoj trudnoći te se ne smije uzimati ako ste trudni dulje od 3 mjeseca, jer može izazvati teška oštećenja kod Vašeg djeteta ako se primjenjuje nakon trećeg mjeseca trudnoće.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of blisters
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kutija za blistere
English: ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Croatian: ACE inhibitori i blokatori angiotenzin II receptora ne smiju se primjenjivati istodobno u bolesnika s dijabetičkom nefropatijom.
English: If your liver is not working properly, the usual dose should not exceed 40 mg once a day.
Croatian: U bolesnika s oštećenom jetrom, uobičajena doza ne smije prelaziti 40 mg jedanput na dan.