FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Croatian: Farmakokinetika telmisartana se ne razlikuje između starijih i onih mlađih od 65 godina.
English: Reduction of the antihypertensive effect.
Croatian: Smanjenje antihipertenzivnog učinka.
English: What Tolura contains - The active substance is telmisartan.
Croatian: Što Tolura sadrži - Djelatna tvar je telmisartan.
English: If you forget to take Tolura
Croatian: Ako ste zaboravili uzeti Toluru
English: Tolura tablets contain lactose.
Croatian: Tolura tablete sadrže laktozu.
English: These clinical data do not allow to make conclusions on the efficacy and safety of telmisartan in hypertensive paediatric population.
Croatian: Na temelju ovih kliničkih podataka ne mogu se donositi zaključci o djelotvornosti i sigurnosti primjene telmisartana u pedijatrijskoj populaciji s hipertenzijom.
English: The mean steady state apparent volume of distribution (Vdss) is approximately 500 l.
Croatian: Prosječni prividni volumen distribucije u stanju dinamičke ravnoteže (Vdss) je oko 500 l.
English: Only on blisters containing 7 tablets MON
Croatian: Samo na blisterima koji sadrže 7 tableta PON
English: What Tolura is and what it is used for What you need to know before you take Tolura How to take Tolura
Croatian: Što je Tolura i za što se koristi Što morate znati prije nego počnete uzimati Toluru Kako uzimati Toluru
English: Precautions to be taken before handling or administering the medicinal product
Croatian: Mjere opreza koje treba poduzeti prije rukovanja ili primjene lijeka
English: In case of surgery or anaesthesia, you should tell your doctor that you are taking Tolura.
Croatian: U slučaju kirurškog zahvata ili anestezije, trebate obavijestiti svog liječnika da uzimate Toluru.
English: You should consult with your doctor if you need to adjust the dose of your other medicine while taking Tolura.
Croatian: Savjetujte se sa svojim liječnikom ako je potrebno prilagoditi dozu Vašeg drugog lijeka dok koristite Toluru.
English: What you need to know before you take Tolura
Croatian: Što morate znati prije nego počnete uzimati Toluru
English: Insomnia, depression Anxiety
Croatian: Nesanica, depresija Anksioznost
English: After oral (and intravenous) administration telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged compound.
Croatian: Nakon peroralne (i intravenske) primjene, telmisartan se gotovo isključivo izlučuje fecesom, uglavnom u nepromijenjenom obliku.
English: If you have the impression that the effect of Tolura is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako mislite da je učinak Tolure prejak ili preslab, razgovarajte sa svojim liječnikom ili ljekarnikom.
English: To be taken into account with concomitant use
Croatian: Potrebno je uzeti u obzir kod istodobne primjene
English: This applies especially to the medicines listed below taken at the same time with Tolura:
Croatian: Ovo se osobito odnosi na lijekove koji su navedeni u nastavku, a uzimaju se istovremeno s Tolurom:
English: Although the study was too small for a meaningful assessment of the pharmacokinetics of children under 12 years of age, the results are generally consistent with the findings in adults and confirm the non-linearity of telmisartan, particularly for Cmax.
Croatian: Iako je ispitivanje bilo premalo za smislenu procjenu farmakokinetike u djece mlađe od 12 godina, rezultati su općenito bili u skladu s nalazima u odraslih i potvrdili nelinearnost telmisartana, osobito za Cmax.
English: Tablets should be taken out of the blister shortly before administration (see section 6.6).
Croatian: Tablete se trebaju izvaditi iz blistera neposredno prije primjene (vidjeti dio 6.6).
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %.
Croatian: Farmakokinetička ispitivanja u bolesnika s oštećenjem jetre pokazala su porast apsolutne bioraspoloživosti do gotovo 100 %.
English: Corticosteroids (systemic route)
Croatian: Kortikosteroidi (sistemska primjena)
English: In some of the investigated patients the doses used were higher than those recommended in the treatment of hypertension in the adult population, reaching a daily dose comparable to160 mg, which was tested in adults.
Croatian: U nekih od ispitivanih bolesnika korištene doze bile su veće od onih preporučenih u liječenju hipertenzije u odrasloj populaciji, dosežući dnevnu dozu usporedivu sa 160 mg, koja je ispitana u odraslih.
English: At the beginning of the preventive therapy with Tolura 80 mg, blood pressure should be frequently monitored.
Croatian: Na početku preventivnog liječenja s Tolurom od 80 mg, krvni tlak treba redovito pratiti.
English: There are no adequate data from the use of Tolura in pregnant women.
Croatian: Ne postoje odgovarajući podaci o primjeni Tolure u trudnica.
English: 14 tablets 28 tablets 30 tablets 56 tablets 84 tablets 90 tablets 98 tablets 100 tablets
Croatian: 14 tableta 28 tableta 30 tableta 56 tableta 84 tableta 90 tableta 98 tableta 100 tableta
English: Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC code: C09CA07.
Croatian: Farmakoterapijska skupina: Antagonisti angiotenzina II, čisti, ATK oznaka: C09CA07.
English: Possible side effects of Tolura:
Croatian: Moguće nuspojave Tolure:
English: Such conditions should be corrected before the administration of Tolura.
Croatian: Takva stanja moraju se korigirati prije primjene Tolure.
English: Cardiovascular prevention:
Croatian: Kardiovaskularna prevencija:
English: The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo (41.4 % vs 43.9 %) in controlled trials in patients treated for hypertension.
Croatian: Ukupna incidencija nuspojava zabilježenih s telmisartanom bila je uobičajeno usporediva s placebom (41,4 % u odnosu na 43,9 %), u kontroliranim ispitivanjima u bolesnika liječenih zbog hipertenzije.
English: Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Croatian: Nuspojave su poredane po kategorijama učestalosti prema sljedećem pravilu: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko
English: Volume and/or sodium depletion should be corrected prior to administration of Tolura.
Croatian: Deplecija volumena i/ili natrija se mora korigirati prije primjene Tolure.
English: Some people feel dizzy or tired when taking Tolura.
Croatian: Neki ljudi osjećaju omaglicu ili umor kada uzimaju Toluru.
English: - Elevated potassium levels in your blood.
Croatian: - Povišene razine kalija u krvi.
English: Manufacturers
Croatian: Proizvođači
English: In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily.
Croatian: U slučajevima gdje nije postignuta ciljna vrijednost krvnog tlaka, doza telmisartana može se povisiti na maksimalno 80 mg jednom dnevno.
English: The recommended dose of Tolura is one tablet a day.
Croatian: Preporučena doza Tolure je jedna tableta dnevno.
English: Tolura is used to treat essential hypertension (high blood pressure) in adults.
Croatian: Tolura se primjenjuje u liječenju esencijalne hipertenzije (visoki krvni tlak) u odraslih osoba.
English: - Heart trouble.
Croatian: - Probleme sa srcem.
English: Bradycardia Tachycardia
Croatian: Bradikardija Tahikardija
English: Tolura is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Croatian: Tolura se ne preporučuje dojiljama te Vaš liječnik može odabrati drugo liječenje za Vas ako želite dojiti, osobito ako je Vaše dijete novorođenče ili je prerano rođeno.
English: Tolura may be less effective in lowering the blood pressure in black patients.
Croatian: Tolura može biti manje učinkovita u snižavanju krvnog tlaka u bolesnika crne rase.
English: Telmisartan does not inhibit human plasma renin or block ion channels.
Croatian: Telmisartan ne inhibira renin u ljudskoj plazmi, niti blokira ionske kanale.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
English: High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness.
Croatian: Visoki krvni tlak, ako se ne liječi, može oštetiti krvne žile u različitim organima, što ponekad može dovesti do srčanog udara, zatajenja srca ili bubrega, moždanog udara ili sljepoće.
English: For reduction of cardiovascular events, the usual dose of Tolura is one 80 mg tablet once a day.
Croatian: Za smanjivanje kardiovaskularnih događaja, uobičajena doza Tolure je jedna tableta od 80 mg, jednom dnevno.
English: Telmisartan does not show affinity for other receptors, including AT2and other less characterised AT receptors.
Croatian: Telmisartan ne pokazuje afinitet za druge receptore, uključujući AT2 i druge manje karakteristične AT receptore.
English: Patients with rare hereditary problems of fructose intolerance should not take Tolura.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne bi trebali uzimati Toluru.
English: Therefore, in these patients an approptiate blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.
Croatian: Stoga, u ovih bolesnika treba adekvatno kontrolirati glukozu u krvi; može biti potrebno podesiti dozu inzulina ili antidijabetika, kada je to indicirano.
English: In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations was observed.
Croatian: U bolesnika s blagim do umjerenim i teškim oštećenjem bubrega, uočeno je udvostručavanje koncentracija u plazmi.
English: By inclusion the presence of secondary hypertension was not investigated.
Croatian: Prisutnost sekundarne hipertenzije nije istražena uključivanjem.
English: There is no experience regarding the administration of Tolura in patients with recent kidney transplantation.
Croatian: Ne postoji iskustvo u vezi primjene Tolure u bolesnika kojima je nedavno transplantiran bubreg.
English: The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years).
Croatian: Glavni faktori rizika za hiperkalijemiju koji se moraju razmotriti su: - Dijabetes melitus, poremećaj rada bubrega, dob (>70 godina).
English: When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 6 % (40 mg dose) to approximately 19 % (160 mg dose).
Croatian: Kada se telmisartan uzima s hranom, smanjenje površine ispod krivulje koncentracije telmisartana u plazmi-vrijeme (AUC0-∞) varira od oko 6 % (doza 40 mg) do oko 19 % (doza 160 mg).
English: Pack sizes: 14, 28, 30, 56, 84, 90, 98 and 100 tablets in a box.
Croatian: Veličine pakiranja: 14, 28, 30, 56, 84, 90, 98 i 100 tableta u kutiji.
English: The mean absolute bioavailability for telmisartan is about 50 %.
Croatian: Prosječna apsolutna bioraspoloživost telmisartana je oko 50 %.
English: Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants.
Croatian: Nadalje, niski krvni tlak može se pogoršati alkoholom, barbituratima, narkoticima ili antidepresivima.
English: Therefore it is not expected to potentiate bradykininmediated adverse effects.
Croatian: Stoga se ne očekuje potenciranje nuspojava posredovanih bradikininom.
English: Tolura is available in blister packs containing 14, 28, 30, 56, 84, 90, 98 and 100 tablets.
Croatian: Tolura je dostupna u blister pakiranjima od 14, 28, 30, 56, 84, 90, 98 i 100 tableta.
English: The recommended dose is 80 mg once daily.
Croatian: Preporučena doza je 80 mg jednom dnevno.
English: Do not take Tolura - if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
Croatian: - Ako ste alergični na telmisartan ili neke druge sastojke ovog lijeka (navedene u dijelu 6).
English: - Combination with one or more other medicinal products that affect the renin-angiotensinaldosterone system and/or potassium supplements.
Croatian: - Kombinacija s jednim ili više drugih lijekova koji utječu na sustav renin-angiotenzin-aldosteron i/ili dodacima kalija.
English: This is confirmed by trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies.
Croatian: Ovo je potvrđeno omjerima minimalnih do maksimalnih vrijednosti koje su konstantno bile iznad 80 % nakon doza od 40 i 80 mg telmisartana u placebom kontroliranim kliničkim ispitivanjima.
English: Pharmacokinetic objectives included the determination of the steady-state of telmisartan in children and adolescents, and investigation of age-related differences.
Croatian: Farmakokinetički ciljevi obuhvaćali su određivanje stanja dinamičke ravnoteže telmisartana u djece i adolescenata te istraživanje razlika vezanih uz dob.
English: Tolura belongs to a class of medicines known as angiotensin II receptor antagonists.
Croatian: Tolura pripada grupi lijekova poznatih kao antagonisti receptora angiotenzina II.
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 AUC0-24 i Cmax ramiprila i ramiprilata.
English: - if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Croatian: - ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje krvnog tlaka koji sadrži aliskiren.
English: Because no information is available regarding the use of Tolura during breast-feeding, Tolura is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Croatian: Budući da ne postoje dostupni podaci o primjeni Tolure tijekom dojenja, primjena Tolure se ne preporučuje i prednost se daje drugim lijekovima s bolje utvrđenim sigurnosnim profilima tijekom dojenja, osobito tijekom razdoblja dojenja novorođenčeta ili nedonoščeta.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Tolura.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatkom Lapp laktaze ili glukoza-galaktoza malapsorpcijom ne bi trebali uzimati Toluru.
English: Tolura is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile.
Croatian: Tolura se ne smije davati bolesnicima s kolestazom, bilijarnom opstrukcijom ili teškim oštećenjem jetre (vidjeti dio 4.3), s obzirom da se telmisartan uglavnom eliminira putem žuči.
English: When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Tolura.
Croatian: Prilikom upravljanja vozilima ili strojevima, povremeno može doći do pojave omaglice ili pospanosti, kada se uzima antihipertenzivna terapija poput Tolure.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER
English: When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed.
Croatian: Kada se telmisartan istodobno primjenjivao s digoksinom, uočen je porast medijana kod vršne koncentracije digoksina u plazmi (49%) te kod najniže koncentracije (20%).
English: The usually effective dose is 40 mg once daily.
Croatian: Uobičajena učinkovita doza je 40 mg jednom dnevno.
English: Tolura may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Croatian: Tolura može povećati učinak snižavanja krvnog tlaka drugih lijekova koji se primjenjuju u liječenju visokog krvnog tlaka ili lijekova koji mogu sniziti krvni tlak (primjerice baklofen, amifostin).
English: Differences in plasma concentrations were observed, with Cmax and AUC being approximately 3- and 2-fold higher, respectively, in females compared to males.
Croatian: Uočene su razlike u koncentracijama u plazmi, sa Cmax i AUC oko 3 odnosno 2 puta više u žena u usporedbi s muškarcima.
English: 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 svojem liječniku, ljekarniku ili u hitnu službu najbliže bolnice.
English: The incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups.
Croatian: Učestalost primarnog ishoda bila je slična u skupinama na telmisartanu (16,7 %) i ramiprilu (16,5 %).
English: Angiotensin II receptor antagonists should not be initiated during pregnancy.
Croatian: Primjena antagonista receptora angiotenzina II ne smije započinjati tijekom trudnoće.
English: If you are intolerant to some sugars, consult your doctor before taking Tolura.
Croatian: Ako ne podnosite neke šećere, posavjetujte se sa svojim liječnikom prije uzimanja Tolure.
English: Read the package leaflet for further information.
Croatian: Pročitajte Uputu o lijeku za dodatne informacije.
English: Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants.
Croatian: Nadalje, ortostatska hipotenzija se može pogoršati konzumacijom alkohola, barbiturata, narkotika ili antidepresiva.
English: The effect of Tolura may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Croatian: Učinak Tolure se može smanjiti kada uzimate NSAIL (nesteroidne protupalne lijekove, npr. aspirin ili ibuprofen) ili kortikosteroide.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku, obratite se lokalnom predstavniku nositelja odobrenja za stavljanje u promet gotovog lijeka:
English: - if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of the bile from the liver and gall bladder) or any other severe liver disease.
Croatian: - Ako imate teške probleme s jetrom kao što su kolestaza ili bilijarna opstrukcija (problemi s drenažom žuči iz jetre i žučnog mjehura) ili neku drugu tešku bolest jetre.
English: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting Dry mouth, stomach discomfort, dysgeusia
Croatian: Abdominalna bol, proljev, dispepsija, flatulencija, povraćanje Suha usta, nelagoda u želucu, disgeuzija
English: Tolura is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes.
Croatian: Tolura se također primjenjuje za smanjivanje kardiovaskularnih događaja (tj. srčanog udara ili moždanog udara) u rizičnih odraslih osoba koji imaju smanjenu ili prekinutu opskrbu krvlju srca ili nogu, ili su imali moždani udar, ili imaju šećernu bolest s visokim rizikom za oštećenje organa.
English: *The event may have happened by chance or could be related to a mechanism currently not known.
Croatian: Događaj je mogao biti slučajan ili povezan s trenutno nepoznatim mehanizmom.
English: - Liver disease.
Croatian: - Bolest jetre.
English: Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:
Croatian: Upozorenja i mjere opreza Obavijestite svog liječnika ako imate ili ste ikada imali neko od sljedećih stanja ili bolesti:
English: - Diuretics ('water tablets'), especially if taken in high doses together with Tolura, may lead to excessive loss of body water and low blood pressure (hypotension).
Croatian: - Diuretici ('tablete za mokrenje'), osobito ako se uzimaju visoke doze zajedno s Tolurom, mogu dovesti do prekomjernog gubitka vode u tijelu te niskog krvnog tlaka (hipotenzija).
English: Busuttil Ltd.
Croatian: E.J. Busuttil Ltd.
English: Tolura is contraindicated in patients with severe hepatic impairment (see section 4.3).
Croatian: Tolura je kontraindicirana u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
English: In patients with mild to moderate hepatic impairment the posology should not exceed 40 mg once daily (see section 4.4).
Croatian: U bolesnika s blagim do umjerenim oštećenjem jetre doza ne smije prelaziti 40 mg jednom dnevno (vidjeti dio 4.4).
English: Infections and infestations Uncommon:
Croatian: Infekcije i infestacije Manje često:
English: If any of the above applies to you, tell your doctor or pharmacist before taking Tolura.
Croatian: Ako se nešto od prethodno navedenog odnosi na Vas, obavijestite liječnika ili ljekarnika prije početka uzimanja Tolure.
English: In preclinical studies, no effects of Tolura on male and female fertility were observed.
Croatian: U nekliničkim ispitivanjima učinci Tolure na plodnost muškaraca i žena nisu uočeni.
English: NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
Croatian: NSAIL (tj. acetilsalicilna kiselina u protuupalnim režimima doziranja, COX-2-inhibitori i neselektivni NSAIL) mogu smanjiti antihipertenzivni učinak antagonista receptora angiotenzina II.
English: Hypertension Treatment of essential hypertension in adults.
Croatian: Hipertenzija Liječenje esencijalne hipertenzije u odraslih osoba.
English: Children and adolescents The use of Tolura in children and adolescents up to the age of 18 years is not recommended.
Croatian: Djeca i adolescenti Primjena Tolure u djece i adolescenata do dobi od 18 godina se ne preporučuje.
English: Symptoms: The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also been reported.
Croatian: Simptomi: Najizraženije manifestacije predoziranja telmisartanom bile su hipotenzija i tahikardija; također su zabilježeni bradikardija, omaglica, porast kreatinina u serumu i akutno zatajenje bubrega.
English: Povidone (K30) Meglumine Sodium hydroxide Lactose monohydrate Sorbitol (E420) Magnesium stearate
Croatian: Povidon (K30) Meglumin Natrijev hidroksid Laktoza hidrat Sorbitol (E420) Magnezijev stearat
English: Before considering the concomitant use of medicinal products that affect the renin-angiotensinaldosterone system, the benefit risk ratio should be evaluated.
Croatian: Prije razmatranja istodobne primjene lijekova koji utječu na sustav renin-angiotenzin-aldosteron, potrebno je procijeniti omjer koristi i rizika.
English: Telmisartan should be kept in the sealed blister due to the hygroscopic property of the tablets.
Croatian: Telmisartan treba čuvati u zapečaćenom blisteru zbog higroskopskog svojstva tableta.