FrancophonIA/ELRC3.0 huggingface dataset:
English: If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Slovenian: Če je kombinacija potrebna, je priporočljivo skrbno spremljati raven litija v serumu.
English: Only on blisters containing 7 tablets MON
Slovenian: Samo na pretisnih omotih po 7 tablet: PON
English: In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals.
Slovenian: V predkliničnih študijah o varnosti so se po vnosu odmerkov, po katerih je bila izpostavljenost zdravilu primerljiva s tisto pri kliničnem terapevtskem razponu odmerjanja, zmanjšali parametri rdečih krvničk (eritrociti, hemoglobin, hematokrit), spremenila se je ledvična hemodinamika (povečala se je vsebnost sečnine v krvi in kreatinina) in povečala količina kalija v serumu normotenzivnih živali.
English: Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see sections 4.3 and 4.4).
Slovenian: Otroke, katerih matere so jemale antagoniste angiotenzina II, je treba pozorno spremljati zaradi možnosti pojava hipotenzije (glejte poglavji 4.3 in 4.4).
English: If any of the above applies to you, tell your doctor or pharmacist before taking Tolura.
Slovenian: Če imate karkoli od naštetega, povejte zdravniku ali farmacevtu, preden boste vzeli zdravilo Tolura.
English: Diuretics (thiazide or loop diuretics)
Slovenian: Diuretiki (tiazidni diuretiki ali diuretiki zanke)
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.
Slovenian: Telmisartana ne dajemo bolnikom s holestazo, obolenji z zaporo žolčevoda ali hudo jetrno okvaro (glejte poglavje 4.3), ker se telmisartan izloča pretežno z žolčem.
English: The effect of Tolura may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Slovenian: Učinek zdravila Tolura se lahko zmanjša, če jemljete nesteroidna protivnetna zdravila (npr. aspirin ali ibuprofen) ali kortikosteroide.
English: Differences in plasma concentrations were observed, with Cmax and AUC being approximately 3- and 2-fold higher, respectively, in females compared to males.
Slovenian: Cmax in AUC sta pri ženskah približno trikrat oziroma dvakrat večji kot pri moških.
English: Management depends on the time since ingestion and the severity of the symptoms.
Slovenian: Ukrepe zdravljenja določimo glede na čas, ki je pretekel od zaužitja, in glede na resnost simptomov.
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.
Slovenian: Ker o uporabi telmisartana med dojenjem ni podatkov, ga ne priporočajo, zato je treba med dojenjem, še zlasti med dojenjem novorojenčkov ali prezgodaj rojenih dojenčkov, dajati prednost alternativnim zdravilom, katerih varnostne lastnosti so bolj raziskane.
English: Other conditions with stimulation of the renin-angiotensin-aldosterone system
Slovenian: Druga stanja, pri katerih prihaja do spodbujanja reninsko-angiotenzinsko-aldosteronskega sistema
English: Telmisartan does not show affinity for other receptors, including AT2and other less characterised AT receptors.
Slovenian: Telmisartan nima afinitete za druge receptorje, niti za AT2 niti za druge manj raziskane receptorje AT.
English: How to take Tolura
Slovenian: Kako jemati zdravilo Tolura
English: It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity.
Slovenian: Priporočeni odmerek je 80 mg enkrat na dan. Ni znano, ali so manjši odmerki od 80 mg telmisartana učinkoviti pri zmanjševanju pojavnosti srčno-žilnih bolezni.
English: 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).
Slovenian: Pri bolnikih, pri katerih sta žilni tonus in ledvično delovanje pretežno odvisna od delovanja reninskoangiotenzinsko-aldosteronskega sistema (npr. pri bolnikih s hudim kongestivnim srčnim popuščanjem ali ledvično boleznijo, tudi z zožitvijo ledvične arterije), zdravljenje z drugimi zdravili, ki delujejo na ta sistem, kot je telmisartan, povezujejo z akutno hipotenzijo, s hiperazotemijo, oligurijo in, redko, z akutno ledvično okvaro (glejte poglavje 4.8).
English: Hypotension 2, orthostatic hypotension
Slovenian: 2, ortostatska hipotenzija
English: The adjusted DBP changes from baseline were -8.4 (1.5) mmHg, -4.5 (1.6) mmHg and -3.5 (2.1) mmHg respectively.
Slovenian: Prilagojene spremembe diastoličnega krvnega tlaka v primerjavi z izhodiščno vrednostjo so bile -8,4 (1,5) mmHg, -4,5 (1,6) mmHg in -3,5 (2,1) mmHg.
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Slovenian: Uporaba antagonistov angiotenzina II je kontraindicirana v drugem in tretjem trimesečju nosečnosti (glejte poglavji 4.3. in 4.4).
English: Your doctor has recommended a lower dose of one 20 mg tablet daily.
Slovenian: Zdravnik vam je priporočil manjši odmerek po 20 mg enkrat na dan.
English: When Tolura is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
Slovenian: Kadar bolnike z ledvično okvaro zdravimo z zdravilom Tolura, moramo periodično nadzorovati serumski ravni kalija in kreatinina.
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia KRKA-POLSKA Sp. z o.o., ul.
Slovenian: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija KRKA-POLSKA Sp. z o.o., ul.
English: Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium.
Slovenian: Diuretiki, ki zadržujejo kalij, npr. spironolakton, eplerenon, triamteren ali amilorid, kalijevi nadomestki ali nadomestki soli s kalijem lahko močno zvišajo raven kalija v serumu.
English: As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia (see section 4.4).
Slovenian: Telmisartan lahko tako kot druga zdravila, ki delujejo na reninsko-angiotenzinsko-aldosteronski sistem, povzroči hiperkaliemijo (glejte poglavje 4.4).
English: Common side effects (may affect up to 1 in 10 people): Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) nizek krvni tlak (hipotenzija) pri osebah, pri katerih z zdravljenjem preprečujemo srčnožilne dogodke.
English: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting Dry mouth, stomach discomfort, dysgeusia
Slovenian: Redki trebušna bolečina, driska, dispepsija, napenjanje, bruhanje suha usta, želodčne težave, disgevzija
English: The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4).
Slovenian: Uporaba antagonistov angiotenzina II v prvem trimesečju nosečnosti ni priporočljiva (glejte poglavje 4.4).
English: The observed increased occurrence rate of sepsis associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently known.
Slovenian: Povečana pojavnost sepse med jemanjem telmisartana je lahko naključni dogodek ali pa je povezana s še neznanim mehanizmom.
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.
Slovenian: Bolniki, ki vozijo motorna vozila ali upravljajo stroje, morajo upoštevati, da lahko antihipertenzivno zdravljenje, na primer z zdravilom Tolura, včasih povzroči omotico ali dremavost.
English: Children and adolescents The use of Tolura in children and adolescents up to the age of 18 years is not recommended.
Slovenian: Otroci in mladostniki Zdravila Tolura ne priporočamo otrokom in mladostnikom, starim do 18 let.
English: Anaemia Eosinophilia, thrombocytopenia
Slovenian: anemija eozinofilija, trombocitopenija
English: The blood pressure lowering effects of two doses of telmisartan were assessed in 76 hypertensive, largely overweight patients aged 6 to < 18 years (body weight ≥ 20 kg and ≤ 120 kg, mean 74.6 kg), after taking telmisartan 1 mg/kg (n = 29 treated) or 2 mg/kg (n = 31 treated) over a four-week treatment period.
Slovenian: Učinek dveh odmerkov telmisartana na znižanje krvnega tlaka so ocenili pri 76 hipertenzivnih bolnikih, starih 6 do < 18 let, pretežno s preveliko telesno maso (telesna masa  20 kg in 120 kg, povprečna 74,6 kg), po štiritedenskem zdravljenju s telmisartanom po 1 mg/kg (n = 29 zdravljenih) ali 2 mg/kg (n = 31 zdravljenih).
English: In this respect data concerning diastolic blood pressure (DBP) are inconsistent.
Slovenian: Podatki za diastolični krvni tlak si nasprotujejo.
English: For treatment of high blood pressure, the usual dose of Tolura for most patients is one 40 mg tablet once a day to control blood pressure over the 24 hour period.
Slovenian: Za večino bolnikov je običajni odmerek zdravila Tolura za 24-urni nadzor krvnega tlaka ena tableta po 40 mg enkrat na dan.
English: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Slovenian: Tako kot pri drugih vazodilatatorjih je posebna previdnost potrebna tudi pri dajanju telmisartana bolnikom z zožitvijo aorte ali mitralne zaklopke ali z obstruktivno hipertrofično kardiomiopatijo.
English: sorbitol (E420) and magnesium stearate.
Slovenian: (E420) in magnezijev stearat.
English: Tolura is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Slovenian: Če ste noseči več kot tri mesece, ga ne smete jemati, saj lahko v tem obdobju resno škoduje vašemu otroku (glejte poglavje o nosečnosti).
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.
Slovenian: Če boste želeli dojiti, bo zdravnik za vas izbral drugo zdravilo, še zlasti, če je vaš otrok novorojenček ali se je prezgodaj rodil.
English: This adverse reaction was reported as common in patients with controlled blood pressure who were treated with telmisartan for the reduction of cardiovascular morbidity on top of standard care.
Slovenian: Ta neželena reakcija je bila pogosta pri bolnikih z uravnanim krvnim tlakom, katerim so telmisartan predpisali dodatno ob standardnem zdravljenju, da bi zmanjšali zbolevnost za srčnožilnimi boleznimi.
English: These pharmacologicallymediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
Slovenian: Te farmakološke neželene učinke, ki so jih odkrile predklinične študije tako pri zaviralcih ACE kot antagonistih receptorjev angiotenzina II, so preprečili s peroralnim dajanjem solne raztopine.
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.
Slovenian: Pri izpostavljenosti antagonistom angiotenzina II od drugega trimesečja nosečnosti dalje se priporoča ultrazvočni pregled lobanje in ledvičnega delovanja.
English: Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Slovenian: Z veliko afiniteto spodriva angiotenzin II z njegovega vezivnega mesta na podtipu receptorja AT1, ki je odgovoren za znane učinke angiotenzina II.
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.
Slovenian: Nesteroidna protivnetna zdravila (acetilsalicilna kislina v odmerkih, ki učinkujejo protivnetno, zaviralci ciklooksigenaze 2 in neselektivna nesteroidna protivnetna zdravila) lahko zmanjšajo antihipertenzivni učinek antagonistov receptorjev angiotenzina II.
English: If you are intolerant to some sugars, consult your doctor before taking Tolura.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo zdravila Tolura posvetujte s svojim zdravnikom.
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Slovenian: Bolniki morajo biti ustrezno hidrirani, na začetku sočasnega zdravljenja in v rednih presledkih med njim pa priporočamo spremljanje ledvičnega delovanja.
English: Most cases of hepatic function abnormal/liver disorder from post-marketing experience occurred in patients in Japan, who are more likely to experience these adverse reactions.
Slovenian: O večini primerov nenormalnega jetrnega delovanja ali jetrne bolezni so v obdobju po začetku trženja telmisartana poročali pri japonskih bolnikih, pri katerih tudi sicer obstaja večja verjetnost teh neželenih reakcij.
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and
Slovenian: Pri potrjeni nosečnosti je treba zdravljenje z antagonisti angiotenzina II takoj prekiniti in, če je primerno, začeti alternativno zdravljenje (glejte poglavji 4.3 in 4.6).
English: In patients with mild to moderate hepatic impairment the posology should not exceed 40 mg once daily (see section 4.4).
Slovenian: Odmerek za bolnike z blago do zmerno jetrno okvaro ne sme biti večji od 40 mg enkrat na dan (glejte poglavje
English: The contribution of the medicinal product's diuretic and natriuretic effect to its hypotensive activity has still to be defined.
Slovenian: Ali diuretični in natriuretični učinek zdravila vpliva na hipotenzivni učinek, še ni podrobneje raziskano.
English: Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption
Slovenian: pruritus, hiperhidroza, izpuščaj angioedem (tudi s smrtnim izidom), ekcem, eritem, urtikarija, medikamentni izpuščaj, toksični kožni izpuščaj
English: Telmisartan is highly bound to plasma protein in renal-insufficient patients and cannot be removed by dialysis.
Slovenian: Pri bolnikih z ledvično okvaro se telmisartan obsežno veže na plazemske beljakovine in ga z dializo ne moremo odstraniti.
English: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased
Slovenian: zvišana raven kreatinina v krvi znižana raven hemoglobina, zvišana raven sečne kisline v krvi, zvišana raven jetrnih encimov, zvišana raven kreatin fosfokinaze v krvi
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.
Slovenian: Kaže, da te spremembe, ki so skupna značilnost celotne skupine zdravil, kamor spadajo zaviralci ACE in drugi antagonisti receptorjev angiotenzina II, niso klinično pomembne.
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).
Slovenian: Zdravilo Tolura lahko poveča učinek drugih zdravil za zdravljenje visokega krvnega tlaka ali zdravil z možnim antihipertenzivnim učinkom (npr. baklofen, amifostin).
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.
Slovenian: Pri nekaterih bolnikih z zmanjšanim ledvičnim delovanjem (npr. pri dehidriranih ali starejših z zmanjšanim ledvičnim delovanjem) lahko sočasno dajanje antagonistov receptorjev angiotenzina II in zdravil, ki zavirajo ciklooksigenazo, povzroči poslabšanje ledvičnega delovanja, tudi akutno ledvično odpoved, ki je običajno reverzibilna.
English: The recommended dose of Tolura is one tablet a day.
Slovenian: Priporočeni odmerek zdravila Tolura je ena tableta na dan. Poskusite jemati tablete vsak dan ob isti uri.
English: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Slovenian: V študiji ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) so primerjali učinke telmisartana, ramiprila in kombinacije telmisartana in ramiprila na srčnožilne izide pri 25.620 bolnikih, starih 55 let ali starejših, ki so imeli v anamnezi koronarno arterijsko bolezen, možgansko kap, TIA, periferno žilno bolezen ali sladkorno bolezen tipa 2 hkrati s potrjeno okvaro tarčnih organov (npr. retinopatijo, hipertrofijo levega prekata, makro- ali mikroalbuminurijo) in predstavljajo širok prerez bolnikov s srčnožilnim tveganjem.
English: Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss.
Slovenian: Antagonisti receptorjev angiotenzina II, med katere spada tudi telmisartan, zmanjšajo izgubo kalija, ki jo povzročajo diuretiki.
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.
Slovenian: Enakomerno trajanje učinka potrjujejo razmerja med najmanjšimi in največjimi vrednostmi, ki so bila v s placebom nadzorovanih kliničnih preizkušanjih po vnosu odmerkov po 40 mg in 80 mg telmisartana dosledno večja od 80 %.
English: 20 mg: white to almost white, round tablets
Slovenian: 20 mg: bele do skoraj bele, okrogle tablete.
English: Blood and the lymphatic system disorders Uncommon:
Slovenian: Bolezni krvi in limfatičnega sistema Občasni:
English: - 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.
Slovenian: Posvetujte se z zdravnikom, preden boste vzeli zdravilo Tolura: - če jemljete digoksin - če jemljete katero od naslednjih zdravil, ki se uporabljajo za zdravljenje visokega krvnega tlaka: - zaviralec ACE (na primer enalapril, lizinopril ali ramipril), zlasti če imate kakšne težave z ledvicami, ki so povezane s sladkorno boleznijo - aliskiren.
English: There is no experience regarding the administration of Tolura in patients with recent kidney transplantation.
Slovenian: Pri bolnikih z nedavno presajeno ledvico ni izkušenj z uporabo zdravila Tolura.
English: Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine.
Slovenian: Zdravili, ki zaradi svojih farmakoloških lastnosti lahko povečata hipotenzivne učinke vseh antihipertenzivov, tudi telmisartana, sta baklofen in amifostin.
English: Dyspnoea, cough Interstitial lung disease
Slovenian: dispneja, kašelj intersticijska pljučna bolezen
English: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Slovenian: Na splošno se bolniki s primarnim hiperaldosteronizmom ne odzivajo na antihipertenzive, ki zavirajo reninsko-angiotenzinsko-aldosteronski sistem, zato zdravljenja teh bolnikov s telmisartanom ne priporočamo.
English: Tolura may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Tolura.
Slovenian: Zdravilo Tolura lahko jemljete tudi v kombinaciji z diuretiki, npr. s hidroklorotiazidom, za katerega se je pokazalo, da pri sočasnem jemanju z zdravilom Tolura dodatno znižuje krvni tlak.
English: Excipients with known effect: Each tablet contains 299.7 mg sorbitol (E420) and 114 mg lactose.
Slovenian: Pomožne snovi z znanim učinkom: Ena tableta vsebuje 299,7 mg sorbitola (E420) in 114 mg laktoze.
English: **Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.
Slovenian: **Poročali so o primerih progresivnega brazgotinjenja pljučnega tkiva med jemanjem telmisartana, vendar ni znano, ali je vzrok telmisartan.
English: ** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.
Slovenian: ** Poročali so o primerih progresivnega brazgotinjenja pljučnega tkiva med jemanjem telmisartana, vendar ni znano, ali je vzrok telmisartan.
English: 14 tablets: EU/1/10/632/015 28 tablets: EU/1/10/632/016 30 tablets: EU/1/10/632/017 56 tablets: EU/1/10/632/018 84 tablets: EU/1/10/632/019 90 tablets: EU/1/10/632/020 98 tablets: EU/1/10/632/021 100 tablets: EU/1/10/632/024
Slovenian: 14 tablet: EU/1/10/632/015 28 tablet: EU/1/10/632/016 30 tablet: EU/1/10/632/017 56 tablet: EU/1/10/632/018 84 tablet: EU/1/10/632/019 90 tablet: EU/1/10/632/020 98 tablet: EU/1/10/632/021 100 tablet: EU/1/10/632/024
English: 14 tablets: EU/1/10/632/008 28 tablets: EU/1/10/632/009 30 tablets: EU/1/10/632/010 56 tablets: EU/1/10/632/011 84 tablets: EU/1/10/632/012 90 tablets: EU/1/10/632/013 98 tablets: EU/1/10/632/014 100 tablets: EU/1/10/632/023
Slovenian: 14 tablet: EU/1/10/632/008 28 tablet: EU/1/10/632/009 30 tablet: EU/1/10/632/010 56 tablet: EU/1/10/632/011 84 tablet: EU/1/10/632/012 90 tablet: EU/1/10/632/013 98 tablet: EU/1/10/632/014 100 tablet: EU/1/10/632/023