FrancophonIA/ELRC3.0 huggingface dataset:
English: Generally, a reduction in blood pressure is evident two hours after the first oral dose and lasts for at least 24 hours and the trough/peak ratio is usually well above 50%.
Croatian: Općenito se smanjenje krvnog tlaka očituje dva sata nakon prve oralne doze i traje najmanje 24 sata, pri čemu je T/P omjer obično znatno veći od
English: Volume of distribution at steady state is 10 L/kg.
Croatian: Volumen raspodjele u stanju ravnoteže je 10 l/kg.
English: Sympathomimetic medicinal products with predominant effect on the α1-adrenoceptor may be given if the above-mentioned measures are insufficient.
Croatian: Mogu se dati simpatomimetici s pretežitim djelovanjem na α1-adrenoreceptore ako prethodno navedene mjere nisu dostatne.
English: About 70% of a given dose is excreted as metabolites in the urine; the remaining fraction is excreted in the faeces.
Croatian: Oko 70% primijenjene doze izlučuje se u obliku metabolita u mokraći; ostatak se izlučuje u stolici.
English: However, there have been no reported clinical incidences of phalangeal changes in foetus/neonate exposed to felodipine in-utero, from the information maintained within the internal patient safety databases.
Croatian: Međutim, nisu zabilježene kliničke pojave falangealnih promjena na fetusu/novorođenčetu izloženom felodipinu in-utero, prema informacijama iz internih baza podataka o sigurnosti bolesnika.
English: Additional interactions
Croatian: Ostale interakcije
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
Croatian: <Datum prvog odobrenja: {DD mjesec GGGG}> <Datum posljednje obnove: {DD mjesec GGGG}>
English: Antihypertensive treatment with felodipine is associated with significant regression of pre-existing left ventricular hypertrophy.
Croatian: Antihipertenzijsko liječenje felodipinom povezuje se sa znatnom regresijom postojeće hipertrofije lijevog ventrikula.
English: • Hypersensitivity to felodipine or any of the excipients listed in section 6.1
Croatian: • preosjetljivost na felodipin ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: Patients with rare hereditary problems of galactose intolerance or glucosegalactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze ili malapsorpcije glukoze i galaktoze ne smiju uzimati ovaj lijek.
English: Medicines containing St John's wort (Hypericum perforatum) (herbal product used to treat depression) may reduce the effect of Plendil and should therefore be avoided.
Croatian: Lijekovi koji sadrže gospinu travu (Hypericum perforatum) (biljka koja se koristi za liječenje depresije) mogu umanjiti djelotvornost Plendila te ih stoga treba izbjegavati.
English: Plendil extended release tablets should be taken in the morning and be swallowed with water.
Croatian: Plendil tablete s produljenim oslobađanjem treba uzeti ujutro i progutati s vodom.
English: Felodipine has been detected in breast milk, and due to insufficient data on potential effect on the infant, treatment is not recommended during breastfeeding.
Croatian: Dokazana je prisutnost felodipina u majčinom mlijeku te se zbog nedostatnih podataka o potencijalnom učinku na dojenče ne preporučuje liječenje felodipinom tijekom dojenja.
English: Plendil, like other blood-pressure lowering medicinal products, may in rare cases lead to pronounced low blood pressure which in some patients may result in an inadequate supply of blood to the heart.
Croatian: Plendil, kao i drugi lijekovi za snižavanje krvnog tlaka, može u rijetkim slučajevima uzrokovati iznimno nizak krvni tlak, što u nekih bolesnika može dovesti do nedovoljne opskrbe srca krvlju.
English: Should such reactions occur, they are usually brief and diminish in intensity with time.
Croatian: Nastupe li takve nuspojave, obično traju kratko i s vremenom im se intenzitet smanjuje.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se svom liječniku prije nego počnete uzimati ovaj lijek.
English: Plendil is used in the treatment of high blood pressure (hypertension) and heart and chest pain brought on by for example exercise or stress (angina pectoris).
Croatian: Plendil se koristi za liječenje visokog krvnog tlaka (hipertenzije) i bolova u srcu i prsima koji su uzrokovani primjerice tjelovježbom ili stresom (angina pektoris).
English: • Barbiturates
Croatian: • barbiturati
English: In case of accompanying bradycardia, atropine 0.5-1 mg should be administered intravenously.
Croatian: Ako je prisutna i bradikardija, intravenski treba primijeniti 0,5 - 1mg atropina.
English: Elderly patients and patients with reduced liver function have on average higher plasma concentrations of felodipine than younger patients.
Croatian: Stariji bolesnici i bolesnici sa smanjenom funkcijom jetre prosječno imaju više koncentracije felodipina u plazmi od mlađih bolesnika.
English: The long-term effects of felodipine on growth, puberty and general development have not been studied.
Croatian: Dugotrajni učinci felodipina na rast, pubertet i opći razvoj nisu ispitivani.
English: Plendil contains lactose.
Croatian: Plendil sadrži laktozu.
English: There are no data on the effects of felodipine on patient fertility.
Croatian: Nema podataka o utjecaju felodipina na plodnost bolesnika.
English: Do not drink grapefruit juice if you are treated with Plendil, as this may increase the effect of Plendil and the risk of side effects.
Croatian: Ako uzimate Plendil, ne smijete piti sok od grejpa jer on može pojačati djelovanje Plendila i povećati rizik od nuspojava.
English: Most of these adverse reactions are dose-dependent and appear at the start of treatment or after a dose increase.
Croatian: Većina ovih nuspojava ovisi o dozi i javljaju se na početku liječenja ili nakon povećanja doze.
English: The efficacy and safety of felodipine in the treatment of hypertensive emergencies has not been studied.
Croatian: Djelotvornost i sigurnost felodipina u liječenju hipertenzivnih kriza nije ispitana.
English: • Decompensated heart failure
Croatian: • srčana dekompenzacija
English: The adverse reactions listed below have been identified from clinical trials and from post marketing surveillance.
Croatian: Nuspojave navedene u nastavku utvrđene su kliničkim ispitivanjima i postmarketinškim praćenjem.
English: Depending on the patient's response, the dosage can, where applicable, be decreased to 2.5 mg or increased to 10 mg daily.
Croatian: Ovisno o odgovoru bolesnika, doza se prema potrebi može smanjiti na 2,5 mg ili povećati na 10 mg dnevno.
English: Cyclosporin: Felodipine does not affect plasma concentrations of cyclosporin.
Croatian: Ciklosporin: Felodipin ne utječe na plazmatske koncentracije ciklosporina.
English: The rate but not the extent of absorption of felodipine is increased when taken simultaneously with food with a high fat content.
Croatian: Brzina, ali ne i opseg apsorpcije, povećava se s istovremenim unosom hrane s visokim udjelom masti.
English: Felodipine is a high clearance medicinal product with an average blood clearance of 1200 ml/min.
Croatian: Felodipin je lijek visokog klirensa s prosječnim klirensom iz krvi od 1200 ml/min.
English: Plasma concentrations are directly proportional to dose within the therapeutic dose range 2.5 - 10 mg.
Croatian: Koncentracije u plazmi izravno su proporcionalne dozi unutar terapijskog raspona od 2,5 mg do 10 mg.
English: Overdosage may cause excessive peripheral vasodilatation with marked hypotension and sometimes bradycardia.
Croatian: Predoziranje može uzrokovati značajnu perifernu vazodilataciju praćenu značajnom hipotenzijom, a ponekad i bradikardijom.
English: Rash, pruritus Urticaria
Croatian: Osip, pruritus Urtikarija
English: If you take more than the recommended number of doses of Plendil, you may suffer from very low blood pressure and sometimes palpitations, high or, rarely, slow heart rate.
Croatian: Ako uzmete veću dozu Plendila od preporučene, možete imati vrlo nizak krvni tlak, a ponekad i lupanje srca, visoku ili u rijetkim slučajevima nisku srčanu frekvenciju.
English: If you have any bothersome or unusual reaction while taking Plendil, check with your doctor right away.
Croatian: Ako tijekom uzimanja Plendila imate bilo kakve nelagodne ili neobične reakcije, odmah provjerite sa svojim liječnikom.
English: The patient should be placed supine with the legs elevated.
Croatian: Bolesnika treba poleći na leđa i podignuti mu noge.
English: The usual dose when treating this disease for a long time is 5-10 mg once a day.
Croatian: Uobičajena doza kod dugotrajnog liječenja ove bolesti je 5-10 mg jednom dnevno.
English: In a study on fertility and general reproductive performance in rats treated with felodipine, a prolongation of parturition resulting in difficult labour/increased foetal deaths and early postnatal deaths was observed in the medium and high dose groups.
Croatian: U ispitivanju plodnosti i općeg reproduktivnog djelovanja u štakorica koje su primale felodipin uočeno je produljenje trudnoće koje je rezultiralo otežanim okotom/povećanom fetalnom smrtnošću i ranom postnatalnom smrtnošću u skupinama koje su primale srednje i visoke doze.
English: This results in even felodipine plasma concentrations within the therapeutic range for 24 hours.
Croatian: To rezultira ravnomjernim koncentracijama felodipina u plazmi unutar terapijskog raspona za 24 sata.
English: In the HOT (Hypertension Optimal Treatment) study, the effect on major cardiovascular events (ie, acute myocardial infarction, stroke and cardiovascular death) was studied in relation to diastolic blood pressure targets < 90 mmHg, < 85 mmHg and < 80 mmHg and achieved blood pressure, with felodipine as baseline therapy.
Croatian: Hypertension Optimal Treatment) ispitivanju, ispitivan je učinak na velike kardiovaskularne događaje (akutni infarkt miokarda, moždani udar i kardiovaskularna smrt) u odnosu na ciljne vrijednosti dijastoličkog krvnog tlaka < 90 mmHg, < 85 mmHg i < 80 mmHg i postignuti krvni tlak, s felodipnom kao početnom terapijom.
English: In a nonclinical reproductive study in the rat (see section 5.3), there were effects on fetal development but no effect on fertility at doses approximating to therapeutic.
Croatian: U nekliničkom ispitivanju reproduktivne toksičnosti na štakorima (vidjeti dio 5.3) primijećeni su učinci na razvoj fetusa, ali nije zabilježen učinak na plodnost pri dozama približno jednakim terapijskoj dozi.
English: The following definitions of frequencies are used:
Croatian: Koriste se sljedeće kategorije učestalosti:
English: Practice good oral hygiene to help avoid your gums from swelling (see section 4).
Croatian: Pomno održavajte oralnu higijenu kako biste spriječili oticanje desni (pogledajte dio 4).
English: This medicine can be taken without food or following a light meal not high in fat or carbohydrates.
Croatian: Ovaj lijek može se uzeti bez hrane ili nakon laganog obroka koji nije bogat masnoćama i ugljikohidratima.
English: In order to keep the prolongedrelease properties, the tablets must not be divided, crushed or chewed.
Croatian: Kako bi se održala svojstva produljenog oslobađanja, tablete se ne smiju lomiti, drobiti ni žvakati.
English: PHARMACEUTICAL FORM AND CONTENTS 2.5 mg tablet
Croatian: OBLIK I SADRŽAJ 2,5 mg tableta
English: If any of the following happen to you, stop taking Plendil and tell a doctor straight away:
Croatian: Ako osjetite bilo koju od sljedećih nuspojava, prestanite uzimati Plendil i odmah obavijestite liječnika:
English: Felodipine is administered as extended-release tablets, from which it is completely absorbed in the gastrointestinal tract.
Croatian: Felodipin se primjenjuje u obliku tableta s produljenim oslobađanjem, iz kojih se u potpunosti apsorbira u gastrointestinalnom traktu.
English: The extended-release tablets produce a prolonged absorption phase of felodipine.
Croatian: Tablete s produljenim oslobađanjem stvaraju produženu apsorpcijsku fazu felodipina.
English: Do not use this medicine after the expiry date which is stated on the carton, blister and bottle after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, blisteru, bočici iza oznake „Rok valjanosti“ ili EXP.
English: Should such adverse reactions occur, they are usually transient and diminish with time.
Croatian: Nastupe li takve nuspojave, obično traju kratko i s vremenom se ublažavaju.
English: There were no other pre clinical findings considered to be of concern and the reproductive findings are considered to be related to the pharmacological action of felodipine, when given to normotensive animals.
Croatian: Ne postoje drugi neklinički rezultati koji se smatraju relevantnima, a smatra se da su rezultati reproduktivnih ispitivanja povezani s farmakološkim djelovanjem felodipina kad se primjenjuje na normotenzivnim životinjama.
English: The pharmacokinetics of felodipine is not changed in patients with renal impairment, including those treated with haemodialysis.
Croatian: Farmakokinetika felodipina ne mijenja se u bolesnika s oštećenjem bubrega, uključujući i one koji se liječe hemodijalizom.
English: If you experience symptoms such as feeling faint, light-headedness or dizziness, contact your doctor immediately.
Croatian: Ako osjetite simptome kao što su osjećaj nesvjestice, ošamućenost ili omaglica, odmah obavijestite svog liječnika.
English: Patients with impaired hepatic function may have elevated plasma concentrations of felodipine and may respond to lower doses (see section 4.4).
Croatian: Oštećenje jetre Bolesnici s oštećenjem jetre mogu imati povišene plazmatske koncentracije felodipina i mogu reagirati na niže doze (vidjeti dio 4.4).
English: Table 1 Undesirable effects System organ class
Croatian: Tablica 1 Nuspojave Klasifikacija organskog sustava
English: In a randomised, double-blind, 3-week, parallel group study in children aged 6-16 years with primary hypertension, the antihypertensive effects of once daily felodipine 2.5 mg (n=33), 5 mg (n=33) and 10 mg (n=31) were compared with placebo (n=35).
Croatian: Randomizirano, dvostruko slijepo, trotjedno ispitivanje s paralelnim skupinama provedeno na djeci s primarnom hipertenzijom u dobi od 6 do 16 godina uspoređivalo je antihipertenzijske učinke felodipina primijenjenog jednom dnevno u dozama od 2,5 mg (n=33), 5 mg (n=33) i 10 mg (n=31) u usporedbi s placebom (n=35).
English: It can be used as monotherapy or in combination with other antihypertensive medicinal products, eg, ß-adrenoceptor blockers, diuretics or ACE-inhibitors, in order to achieve an increased antihypertensive effect.
Croatian: Može se koristiti kao monoterapija ili u kombinaciji s drugim antihipertenzivnim lijekovima, npr. β-adrenergičkim blokatorima, diureticima ili ACE inhibitorima, sa svrhom postizanja većeg antihipertenzijskog učinka.
English: This results from precapillary vasodilatation and is not related to any generalised fluid retention.
Croatian: Ono je uzrokovano prekapilarnom vazodilatacijom i nije povezano s općenitom retencijom tekućine.
English: Consequently higher therapeutic concentrations and response can be expected in patients with clearly reduced liver function (see section 4.2).
Croatian: Stoga se mogu očekivati veće terapijske koncentracije i jači terapijski odgovor u bolesnika s vidljivim oštećenjem jetrene funkcije (vidjeti dio 4.2).
English: If you experience any of the following symptoms and they persist, please tell your doctor.
Croatian: Ako osjetite bilo koji od sljedećih simptoma i on potraje, obavijestite svog liječnika.
English: No disturbances of fertility were observed when doses within the therapeutic range were given to rats.
Croatian: Nije uočen poremećaj fertiliteta kad su štakori primali doze u granicama terapijskog raspona.
English: It lowers blood pressure by dilating small blood vessels.
Croatian: Plendil snižava krvni tlak tako što proširuje male krvne žile.
English: If you have liver problems The level of felodipine in your blood may be increased.
Croatian: Razina felodipina u Vašoj krvi može biti povišena.
English: Cimetidine increased the felodipine Cmax and AUC by approximately 55%.
Croatian: Istodobna primjena cimetidina povećala je Cmax i AUC felodipina za približno 55%.
English: Symptoms of excessive low blood pressure and inadequate blood supply to the heart itself, frequently include dizziness and chest pain.
Croatian: Simptomi iznimno niskog krvnog tlaka i nedovoljne opskrbe srca krvlju obično su omaglica i bol u prsima.
English: • Increased liver enzymes
Croatian: • povišene vrijednosti jetrenih enzima
English: Felodipine reduces both systolic and diastolic blood pressure and can be used in isolated systolic hypertension.
Croatian: Felodipin snižava i sistolički i dijastolički krvni tlak i može se primjenjivati kod izolirane sistoličke hipertenzije.
English: According to the STOP-2 (Swedish Trial in Old Patients with Hypertension-2 study), performed in 6614 patients, aged 70-84 years, dihydropyridine calcium antagonists (felodipine and isradipine) have shown the same preventive effect on cardiovascular mortality and morbidity as other commonly used classes of antihypertensive medicinal products - ACE inhibitors, beta-blockers and diuretics.
Croatian: Swedish Trial in old Patients with Hypertension-2 study) provedenog na 6614 bolesnika u dobi od 70 do 84 godine pokazali su da dihidropiridinski antagonisti kalcija (felodipin i israpidin) imaju jednak preventivni učinak na kardiovaskularni mortalitet i morbiditet kao i druge vrste često korištenih antihipertenzivnih lijekova kao što su ACE inhibitori, betablokatori i diuretici.
English: Tacrolimus: Felodipine may increase the concentration of tacrolimus.
Croatian: Takrolimus: Felodipin može povećati koncentraciju takrolimusa.
English: These effects were attributed to the inhibitory effect of felodipine in high doses on uterine contractility.
Croatian: Ti se učinci pripisuju inhibitornom djelovanju visokih doza felodipina na kontraktilnost uterusa.
English: There is limited clinical trial experience of the use of felodipine in hypertensive paediatric patients (see sections 5.1 and 5.2).
Croatian: Iskustvo primjene felodipina u pedijatrijskih bolesnika s hipertenzijom u kliničkim ispitivanjima je ograničeno (vidjeti dijelove 5.1 i 5.2).
English: Hypotension Syncope
Croatian: Hipotenzija Sinkopa
English: Felodipine was given as monotherapy or in combination with a betablocker, and/or an ACE-inhibitor and/or a diuretic.
Croatian: Felodipin je primjenjivan kao monoterapija ili u kombinaciji s betablokatorom i/ili ACE inhibitorom i/ili diuretikom.
English: Felodipine has a natriuretic and diuretic effect due to reduced tubular reabsorption of filtered sodium.
Croatian: Felodipin ima natriuretski i diuretski učinak zahvaljujući tubularnoj reapsorpciji filtriranog natrija.
English: Felodipine can be used as monotherapy or in combination with ß-adrenoceptor blockers in patients with stable angina pectoris.
Croatian: Felodipin se može koristiti kao monoterapija ili u kombinaciji s βadrenergičkim blokatorima u bolesnika sa stabilnom anginom pektoris.
English: Stable angina pectoris
Croatian: Stabilna angina pektoris
English: The tablet must not be divided, crushed or chewed.
Croatian: Tableta se ne smiju lomiti, drobiti ni žvakati.
English: 5 mg tablet
Croatian: 5 mg tableta
English: Nausea, abdominal pain Vomiting
Croatian: Mučnina, bol u abdomenu Povraćanje
English: Due to the high degree of selectivity for smooth muscle in the arterioles, felodipine in therapeutic doses has no direct effect on cardiac contractility or conduction.
Croatian: Zbog vrlo selektivnog učinka na glatke mišiće u arteriolama, felodipin u terapijskim dozama nema izravan učinak na srčanu kontraktilnost ili provodljivost.
English: • Hypersensitivity reactions such as fever or swelling of the lips and tongue
Croatian: • povećana potreba za mokrenjem • reakcije preosjetljivosti poput vrućice ili oticanja usana i jezika
English: There is no risk of accumulation during long-term treatment.
Croatian: Tijekom dugotrajnog liječenja ne postoji opasnost od akumulacije.
English: Detailed information on this medicinal product is available on the website of {name of MS/Agency}
Croatian: [Ispunjava država članica] Detaljnije informacije o ovom lijeku dostupne su na web stranici {naziv države članice/nadležnog tijela}
English: Felodipine in therapeutic doses has no effect on cardiac contractility or atrioventricular conduction or refractoriness.
Croatian: Učinci na srce Felodipin u terapijskim dozama nema učinka na srčanu kontraktilnost, atrioventrikularnu provodljivost ili refraktornost.
English: When used together, the tacrolimus serum concentration should be followed and the tacrolimus dose may need to be adjusted.
Croatian: Kada se primjenjuju istovremeno, valja pratiti serumske koncentracije takrolimusa te prema potrebi prilagoditi dozu takrolimusa.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg felodipine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 2,5 mg felodipina.
English: • tacrolimus (medicine used in organ transplantations)
Croatian: • takrolimus (lijek koji se koristi kod presađivanja organa)
English: Plendil contains castor oil, which may cause stomach upset and diarrhoea.
Croatian: Plendil sadrži ricinusovo ulje koje može uzrokovati nelagodu u želucu i proljev.
English: Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000
Croatian: Često ≥ 1/100 i < 1/10 Manje često ≥ 1/1000 i < 1/100
English: The standard maintenance dose is 5 mg once daily.
Croatian: Uobičajena doza održavanja je 5 mg jednom dnevno.
English: In elderly patients, a starting dose of 2.5 mg daily may be considered.
Croatian: U starijih bolesnika treba razmotriti početnu dozu od 2,5 mg jednom dnevno.
English: Because there is no effect on venous smooth muscle or adrenergic vasomotor control, felodipine is not associated with orthostatic hypotension.
Croatian: Budući da ne utječe na glatke mišiće u venama ni na adrenergički vazomotorni mehanizam, felodipin se ne dovodi u vezu s ortostatskom hipotenzijom.
English: Felodipine has anti-anginal and anti-ischaemic effects due to improved myocardial oxygen supply/demand balance.
Croatian: Felodipin ima antianginozni i antiishemijski učinak zahvaljujući poboljšanoj ravnoteži opskrbe i potrebe miokarda za kisikom.
English: Felodipine is cleared by the liver.
Croatian: Felodipin se eliminira putem jetre.
English: • Gingivitis (swollen gums)
Croatian: • gingivitis (otečene desni)
English: Hydroxypropylcellulose Hypromellose 50 mPa·s Hypromellose 10000 mPa·s Lactose anhydrous Microcrystalline cellulose Polyoxyl 40 hydrogenated castor oil Propyl gallate
Croatian: Jezgra hidroksipropilceluloza hipromeloza 50 mPa s hipromeloza 10000 mPa s laktoza, bezvodna celuloza, mikrokristalična polioksil 40 hidrogenirano ricinusovo ulje propilgalat natrijev aluminijev silikat natrijev stearilfumarat
English: Felodipine may also improve early renal graft function.
Croatian: Felodipin također može poboljšati ranu funkciju bubrežnog presatka.
English: There is no significant accumulation during long-term treatment.
Croatian: Tijekom dugotrajnog liječenja ne dolazi do značajnije akumulacije.
English: Treatment should be started with 5 mg once a day and if needed, your doctor may increase the dose to 10 mg once a day.
Croatian: Liječenje treba započeti dozom od 5 mg jednom dnevno, a Vaš liječnik prema potrebi dozu može povećati na 10 mg jednom dnevno.
English: 1 blister of 28 tablets 2 blisters of 14 tablets 4 blisters of 7 tablets
Croatian: 1 blister s 28 tableta 2 blistera s po 14 tableta 4 blistera s po 7 tableta
English: Plasma concentrations of felodipine are positively correlated to the decrease in total peripheral resistance and blood pressure.
Croatian: Koncentracija felodipina u plazmi u pozitivnoj je korelaciji sa smanjenjem ukupnog perifernog otpora i krvnog tlaka.
English: It is bound pre-dominantly to the albumin fraction.
Croatian: Većinom se veže za albuminsku frakciju.