natgillin/translations-raw huggingface dataset:
Your doctor may need to change the dose of these other medicines or take other precautions.
Liječnik će Vam možda morati promijeniti dozu i/ili poduzeti druge mjere opreza.
There is no linear relationship between doses and plasma levels.
Ne postoji linearan odnos između razina doza i razina u plazmi.
• Lithium containing medicines to treat some types of depression.
• Lijekovi koji sadrže litij za liječenje nekih vrsta depresije.
Put the tablet in your mouth and swallow with water or a suitable liquid
Stavite tabletu u usta i progutajte s vodom ili drugom prikladnom tekućinom
Plasma concentrations were higher in females than in males, without relevant influence on efficacy.
Koncentracije u plazmi bile su više u žena nego u muškaraca, bez značajnog utjecaja na djelotvornost.
After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours.
Nakon prve doze telmisartana, antihipertenzivni učinak postupno postaje očit unutar 3 sata.
Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or antidepressants.
Nadalje, ortostatska hipotenzija se može pogoršati konzumacijom alkohola, barbiturata, narkotika ili antidepresiva.
100x1 tablets 30 tablets
100x1 tableta 30 tableta
The clinical relevance of this observation is not known.
Klinički značaj ovog opažanja nije poznat.
An increase in eosinophils reported in this patient population has not been recorded in adults.
Povećanje eozinofila prijavljeno u ovoj skupini bolesnika nije zabilježeno kod odraslih.
The tablets should be swallowed with some water or other non-alcoholic drink.
Tablete treba progutati s malo vode ili drugom bezalkoholnom tekućinom.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav, prikazan u Modulu 1.8.1. odobrenja, ustrojen i funkcionalan prije i za vrijeme dok je lijek na tržištu.
It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity.
Nije poznato jesu li doze niže od 80 mg telmisartana učinkovite u snižavanju kardiovaskularnog morbiditeta.
Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Stoga je važno redovito mjeriti krvni tlak i pratiti da li je unutar normalnog raspona.
Concomitant use requiring caution
Istodobna primjena zahtijeva oprez
East Sussex, BN22 9AG United Kingdom
East Sussex, BN22 9AG Ujedinjeno Kraljevstvo
When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment (see section 5.1).
Kada se razmatra povišenje doze, treba znati da se maksimalni antihipertenzivni učinak općenito postiže četiri do osam tjedana nakon početka liječenja (vidjeti dio 5.1).
Your doctor will normally advise you to stop taking Telmisartan Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan Teva.
Liječnik će Vam obično savjetovati da prestanete uzimati Telmisartan Teva prije nego ostanete trudni ili čim saznate da ste trudni te će Vam savjetovati uzimanje drugog lijeka umjesto Telmisartana Teva.
Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Telmisartan se uvelike veže na proteine plazme (>99,5 %), uglavnom albumin i alfa-1 kiselinski glikoprotein.
Cmax and to a lesser extent AUC increase disproportionately at doses above 40 mg.
Cmax i, u manjoj mjeri AUC povećavaju se disproporcionalno pri dozama iznad 40 mg.
There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Nema dokaza mutagenosti i relevantnog klastogenog djelovanja u in vitro ispitivanjima niti dokaza kancerogenosti u štakora i miševa.
A combination with ACE inhibitors or NSAIDs, for example, presents a lesser risk provided that precautions for use are strictly followed.
Kombinacija s ACE-inhibitorima ili NSAIL, na primjer, predstavlja manji rizik pod uvjetom da se striktno slijede mjere opreza u primjeni.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave, iako se neće razviti kod svakoga.
By 3 hours after administration, plasma concentrations are similar whether telmisartan is taken fasting or with food.
Do 3 sata nakon primjene, koncentracije u plazmi su slične bez obzira uzima li se telmisartan natašte ili s hranom.
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.
Na osnovi njihovih farmakoloških svojstava, može se očekivati da sljedeći lijekovi mogu potencirati hipotenzivne učinke svih antihipertenziva, uključujući telmisartan: baclofen, amifostin.
Telmisartan Teva contains sorbitol.
Telmisartan Teva sadrži sorbitol
The maximum reduction in blood pressure is generally attained 4 to 8 weeks after the start of treatment and is sustained during long-term therapy.
Maksimalno sniženje krvnog tlaka općenito se postiže 4 do 8 tjedana nakon početka liječenja i održava se tijekom dugotrajne terapije.
If you feel dizzy or tired, do not drive or operate machinery.
Ako osjećate omaglicu ili umor, ne upravljajte vozilima ili strojevima.
• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Telmisartan Teva” and “Warnings and precautions”).
• Ako uzimate ACE inhibitor ili aliskiren (vidjeti također informacije pod naslovima „Nemojte uzimati Telmisartan Teva“ i „Upozorenja i mjere opreza“
• Other medicines used to treat high blood pressure
• Drugi lijekovi koji se koriste za snižavanje krvnog tlaka
Sepsis including fatal outcome1
Sepsa uključujući smrtni ishod 1
The safety data from this study in patients aged 6 to < 18 years appeared generally similar to that observed in adults.
Sigurnost i djelotvornost podataka iz ovog ispitivanja na bolesicima u dobi 6 do < 18 godina starosti smatrale su se općenito sličnima onima primijećenima kod odraslih osoba.
Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Bolesnike treba prikladno hidrirati te je potrebno razmotriti praćenje funkcije bubrega nakon početka istodobne terapije, a zatim periodično.
The inhibitory effect is maintained over 24 hours and still measurable up to 48 hours.
Inhibitorni učinak se održava tijekom 24 sata, a još uvijek se može izmjeriti do 48 sati.
The functional role of these receptors is not known, nor is the effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan.
Funkcionalna uloga ovih receptora nije poznata, kao ni učinak njihove moguće prekomjerne stimulacije angiotenzinom II, čije vrijednosti se povećavaju telmisartanom.
After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged compound.
Nakon peroralne (i intravenske) primjene telmisartan se gotovo isključivo izlučuje fecesom, uglavnom u nepromijenjenom obliku.
Absorption of telmisartan is rapid although the amount absorbed varies.
Apsorpcija telmisartana je brza, iako apsorbirana količina varira.
• Second and third trimester of pregnancy (see sections 4.4 and 4.6)
- Drugo i treće tromjesečje trudnoće (vidjeti dijelove 4.4 i 4.6).
The maximum plasma concentration (Cmax) and, to a smaller extent, the area under the plasma concentration-time curve (AUC), increase disproportionately with dose.
Maksimalna koncentracija u plazmi (Cmax) i, u manjoj mjeri, površina ispod krivulje koncentracije u plazmi-vrijeme (AUC), povećava se disproporcionalno s dozom.
Therefore the use of a combination of telmisartan and ramipril is not recommended in this population.
Stoga se primjena kombinacije telmisartana i ramiprila ne preporučuje u ovoj populaciji.
What Telmisartan Teva is and what it is used for
Što je Telmisartan Teva i za što se koristi
Differences in plasma concentrations were observed, with Cmax and AUC being approximately 3- and 2-fold higher, respectively, in females compared to males.
Uočene su razlike u koncentracijama u plazmi, s Cmax i AUC oko 3 odnosno 2 puta više u žena u usporedbi s muškarcima.
The mean steady state apparent volume of distribution (Vdss) is approximately 500 l.
Srednja vrijednost prividnog volumena distribucije u stanju dinamičke ravnoteže (Vdss) je oko 500 l.
The occurrence of hyperkalaemia depends on associated risk factors.
Pojava hiperkalijemije ovisi o udruženim čimbenicima rizika.
Serum electrolytes and creatinine should be monitored frequently.
Elektroliti i kreatinin u serumu se moraju često pratiti.
Carefully peel off the top paper layer
Pažljivo odlijepite gornji papirnati sloj
There is no evidence of clinically relevant accumulation of telmisartan taken at the recommended dose.
Ne postoji dokaz o klinički značajnoj akumulaciji telmisartana ako se uzima u preporučenoj dozi.
The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours before the next dose as shown by ambulatory blood pressure measurements.
Antihipertenzivni učinak je stalno prisutan tijekom 24 sata nakon doziranja te uključuje posljednja 4 sata prije sljedeće doze, kako je prikazano ambulantnim mjerenjima krvnog tlaka.
Patients with rare hereditary problems of fructose intolerance should not take Telmisartan Teva.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne bi trebali uzimati Telmisartan Teva.
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.
Iako je ispitivanje bilo premalo za razumnu ocjenu farmakokinetike djece ispod 12 godine starosti, rezultati su općenito bili konzistentni s otkrićima kod odraslih osoba te potvrđuju nelinearnost telmisartana, osobito za Cmax.
If you have the impression that the effect of Telmisartan Teva is too strong or too weak, talk to your doctor or pharmacist.
Ako mislite da je učinak Telmisartana Teva prejak ili preslab, razgovarajte sa svojim liječnikom ili ljekarnikom.
Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half-life of >20 hours.
Za telmisartan je karakteristična bieksponencijalna farmakokinetika raspada, s terminalnim poluvremenom eliminacije od >20 sati.
Date of the latest renewal: 19 December 2014
Datum posljednje obnove: 19/12/2014
This leaflet was last revised in {12/2014}.
Ova uputa je zadnji puta revidirana u {12/2014}.
Telmisartan does not show affinity for other receptors, including AT2 and other less characterised AT receptors.
Telmisartan ne pokazuje afinitet za druge receptore, uključujući AT2 i druge manje karakteristične AT receptore.
The Marketing Authorisation Holder is:
Nositelj odobrenja je:
Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %.
Farmakokinetička ispitivanja u bolesnika s oštećenjem jetrene funkcije pokazala su porast apsolutne bioraspoloživosti do gotovo 100 %.
Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs.
Iako nema kontroliranih epidemioloških podataka o riziku uz antagoniste receptora angiotenzina II, slični rizici mogu postojati za ovu klasu lijekova.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder
Za sve informacije o ovom lijeku, obratite se lokalnom predstavniku nositelja odobrenja za stavljanje u promet gotovog lijeka:
Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment values over a period of several days without evidence of rebound hypertension.
Nakon naglog prekida liječenja telmisartanom, krvni tlak se postupno vraća na vrijednosti prije liječenja tijekom razdoblja od nekoliko dana, bez dokaza o povratnoj (rebound) hipertenziji.
There are no adequate data from the use of Telmisartan Teva in pregnant women.
Ne postoje odgovarajući podaci o primjeni Telmisartana Teva u trudnica.
The incidence of adverse reactions was not dose related and showed no correlation with gender, age or race of the patients.
Incidencija nuspojava nije bila povezana s dozom te nije pokazala korelaciju sa spolom, dobi ili rasom bolesnika.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 January 2010
DATUM OBNOVE ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET Datum prvog odobrenja: 26. siječnja 2010.
Other medicines and Telmisartan Teva
Drugi lijekovi i Telmisartan Teva
A lower starting dose of 20 mg is recommended in these patients (see section 4.4).
U ovih bolesnika preporučuje se niža početna doza od 20 mg (vidjeti dio 4.4).
Gastric mucosal injury (erosion, ulcers or inflammation) also was noted in rats and dogs.
Ozljeda na sluznici želuca (erozija, ulkusi ili upala) također je primijećena u štakora i pasa.
However, a causal relationship has not been established.
Međutim, nije utvrđena uzročna povezanost.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove (EMA): http://www.ema.europa.eu/.
Total plasma clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 1,500 ml/min).
Ukupni klirens plazme (Cltot) je visok (oko 1000 ml/min) u usporedbi s protokom krvi u jetri (oko 1500 ml/min).
How to store Telmisartan Teva Contents of the pack and other information
Kako čuvati Telmisartan Teva Sadržaj pakovanja i druge informacije
Pharmacokinetic objectives included the determination of the steady-state of telmisartan in children and adolescents, and investigation of age-related differences.
Farmakokinetički ciljevi uključivali su određivanje stanje ravnoteže telmisartana kod djece i adolescenata, te ispitivanje razlika povezanih s dobi.
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attacks, heart or kidney failure, strokes or blindness.
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.
Hypotension2, orthostatic hypotension
Hipotenzija 2, ortostatska hipotenzija
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.
Kod pojedinih ispitivanih bolesnika primjenjivane doze bile su više od preporučenih za liječenje hipertenzije u odrasle populacije, čime je postignuta dnevna doza usporediva s 160 mg koja je bila testirana na odraslim osobama.
Volume and/or sodium depletion should be corrected prior to administration of Telmisartan Teva.
Deplecija volumena i/ili natrija se mora korigirati prije primjene Telmisartana Teva.
Not all pack sizes may be marketed
Na tržištu se ne moraju nalaziti sve veličine pakovanja.
There is no experience regarding the administration of Telmisartan Teva in patients with recent kidney transplantation.
Ne postoji iskustvo u vezi primjene Telmisartana Teva u bolesnika kojima je nedavno transplantiran bubreg.
Plasma aldosterone levels are decreased by telmisartan.
Razine aldosterona u plazmi smanjuju se telmisartanom.
The contribution of the medicinal product's diuretic and natriuretic effect to its hypotensive activity has still to be defined.
Doprinos diuretskog i natriuretskog djelovanja lijeka na hipotenzivno djelovanje tek treba definirati.
• Barbiturates (strong sleeping tablets)
• Barbiturati (jake tablete za spavanje)
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Bolesnici s primarnim aldosteronizmom općenito ne reagiraju na antihipertenzive koji djeluju putem inhibicije sustava renin-angiotenzin.
Combining telmisartan with ramipril did not add further benefit over ramipril or telmisartan alone.
Kombiniranje telmisartana s ramiprilom nije imalo dodatnu korist u odnosu na sam ramipril ili telmisartan.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- Preosjetljivost na djelatnu tvar ili na bilo koju od pomoćnih tvari navedenu u dijelu 6.1.
Separate one individual blister cell from the rest of the strip by gently tearing along the perforations around it
Odvojite pojedini dio blistera od ostatka blister kartice, nježno trgajući uzduž perforirane linije oko tog dijela
Reduction of cardiovascular morbidity in adults with:
Kardiovaskularna prevencija Smanjenje kardiovaskularnog morbiditeta u odraslih osoba s:
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Epidemiološki podaci vezani uz teratogeni rizik nakon izloženosti ACE inhibitorima tijekom prvog tromjesečja trudnoće ne omogućuju konačan zaključak.
There are usually no symptoms of high blood pressure before damage occurs.
Prije pojave oštećenja obično nema simptoma visokog krvnog tlaka.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP“.
Telmisartan Teva 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.
Telmisartan Teva 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.
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
Dry mouth, stomach discomfort, dysgeusia
Suha usta, nelagoda u želucu, disgeuzija
Pruritus, hyperhidrosis, rash
Pruritus, hiperhidroza, osip
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.
U slučajevima gdje nije postignuta ciljna vrijednost krvnog tlaka, doza telmisartana može se povisiti na maksimalno 80 mg jedanput na dan.
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.
Uočena povećana stopa pojave sepse povezane s primjenom telmisartana može biti slučajna ili povezana s trenutno nepoznatim mehanizmom.
Diabetic patients treated with insulin or antidiabetics
Bolesnici s dijabetesom liječeni inzulinom ili antidijabeticima
No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an effect on the postnatal development of the offsprings such as lower body weight and delayed eye opening was observed.
Nije dokazan jasan teratogeni učinak, međutim, pri toksičnim razinama doze telmisartana, uočen je učinak na postnatalni razvoj mladunčadi, kao što su mala tjelesna težina i odgođeno otvaranje očiju.
Japanese patients are more likely to experience these adverse reactions.
Japanska populacija ima veće izglede za razvoj ovih nuspojava.
If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacement given quickly.
Ako se pojavi hipotenzija, bolesnika treba polegnuti na leđa i brzo dati nadomjestke soli i volumena.
Some people feel dizzy or tired when taking Telmisartan Teva.
Neki ljudi osjećaju omaglicu ili umor kada uzimaju Telmisartan Teva.
Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Telmisartan ne inhibira angiotenzin konvertirajući enzim (kininaza II), enzim koji također razgrađuje bradikinin.
Marketing Authorisation Holder and Manufacturer
Nositelj odobrenja i proizvođač
There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure (SBP).
Postoji očiti trend odnosa doze i vremena potrebnog za vraćanje osnovne vrijednosti sistoličkog krvnog tlaka (SKT).
(See section 5.3).
(vidjeti dio 4.4).
• Risk Management Plan (RMP) Not applicable
LIJEKA • Plan upravljanja rizikom (RMP)
Talk to your doctor before taking Telmisartan Teva:
Posavjetujte se s liječnikom prije nego počnete uzimati Telmisartan Teva:
Anaphylactic reaction, hypersensitivity
Anafilaktička reakcija, preosjetljivost
Telmisartan Teva is used to treat essential hypertension (high blood pressure) in adults.
Telmisartan Teva se primjenjuje u liječenju esencijalne hipertenzije (visoki krvni tlak) u odraslih osoba.
- if you are more than 3 months pregnant (It is also better to avoid Telmisartan Teva in early pregnancy
- Ako ste dulje od 3 mjeseca trudni (također je bolje izbjegavati Telmisartan Teva u ranoj trudnoći vidjeti dio o trudnoći).
The usually effective dose is 40 mg once daily.
Uobičajena učinkovita doza je 40 mg jedanput na dan.
In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate.
U bolesnika s hipertenzijom telmisartan snižava i sistolički i dijastolički krvni tlak, bez utjecaja na brzinu pulsa.
Hypertension Treatment of essential hypertension in adults.
Liječenje esencijalne hipertenzije u odraslih osoba.
As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia (see section 4.4).
Poput ostalih lijekova koji djeluju na sustav renin-angiotenzin-aldosteron, telmisartan može izazvati hiperkalijemiju (vidjeti dio 4.4).
The risk is particularly high in combination with potassium sparing-diuretics, and when combined with salt substitutes containing potassium.
Rizik je osobito visok u kombinaciji s diureticima koji štede kalij i u kombinaciji s nadomjescima soli koje sadrže kalij.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
POSEBNE MJERE ZA UKLANJANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH
Elderly patients No dose adjustment is necessary for elderly patients.
Nije potrebno prilagođavati dozu u starijih bolesnika.
The safety profile of telmisartan in patients treated for the reduction of cardiovascular morbidity was consistent with that obtained in hypertensive patients.
Profil sigurnosti telmisartana u bolesnika liječenih radi smanjenja kardiovaskularnog morbiditeta bio je u skladu s onim u bolesnika s hipertenzijom.
In case of surgery or anaesthesia, you should tell your doctor that you are taking Telmisartan Teva.
U slučaju kirurškog zahvata ili anestezije, trebate obavijestiti svog liječnika da uzimate Telmisartan Teva.
Because no information is available regarding the use of Telmisartan Teva during breast-feeding, Telmisartan Teva is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Budući da ne postoje dostupni podaci o primjeni Telmisartana Teva tijekom dojenja, primjena Telmisartana Teva se ne preporučuje i prednost se daje drugim lijekovima s bolje utvrđenim sigurnosnim profilima tijekom dojenja, osobito tijekom razdoblja dojenja novorođenčeta ili nedonoščeta.
• Amifostine (a protective medicine during radiotherapy for cancer treatment)
• Baklofen (mišićni relaksans) • Amifostin (lijek koji se koristi tijekom radioterapije pri liječenju raka)