FrancophonIA/ELRC3.0 huggingface dataset:
English: As renal function decreases with age, this is the only factor to take into consideration (see renal impairment section).
Croatian: Kako se bubrežna funkcija smanjuje s godinama, to je jedini faktor koji treba uzeti u obzir (vidjeti odjeljak o oštećenju bubrega).
English: There was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats at an extrapolated exposure of at least 35 times above human exposure.
Croatian: Nije bilo dokaza izravne toksičnosti za plod ili teratogenog učinka u štakora i zečeva kojima je ibandronatna kiselina primijenjena peroralno niti je bilo nuspojava vezanih uz razvoj u F1 potomstva štakora pri izloženosti dozi dobivenoj ekstrapolacijom barem 35 puta većoj od maksimalno dopuštene izloženosti u ljudi.
English: Existing hypocalcaemia must be corrected before starting Ibandronic Acid Teva therapy.
Croatian: Postojeća hipokalcijemija mora se korigirati prije početka terapije Ibandronatnom kiselinom Teva.
English: Some people need to be especially careful while they're taking Ibandronic Acid Teva.
Croatian: Neki ljudi trebaju biti osobito oprezni pri uzimanju Ibandronatne kiseline Teva.
English: Gastrointestinal irritation
Croatian: Gastrointestinalna iritacija
English: In animal models ibandronic acid produced biochemical changes indicative of dose-dependent inhibition of bone resorption, including suppression of urinary biochemical markers of bone collagen degradation (such as deoxypyridinoline, and cross-linked N-telopeptides of type I collagen (NTX)).
Croatian: Ibandronatna kiselina u životinjskim modelima uzrokuje biokemijske promjene povezane s inhibicijom resorpcije kosti ovisnom o dozi, uključujući supresiju biokemijskih biljega razgradnje koštanog kolagena (kao što je deoksipiridinolin i poprečno vezani N-telopeptidi kolagena tipa I (NTX)) u urinu.
English: In studies in rats using the intravenous route, ibandronic acid decreased fertility at high daily doses (see section 5.3).
Croatian: U ispitivanjima na štakorima koji su lijek primali intravenski, ibandronatna je kiselina smanjila plodnost pri visokim dnevnim dozama (vidjeti dio 5.3).
English: Do not take Ibandronic Acid Teva with food.
Croatian: Ne uzimajte Ibandronatnu kiselinu Teva s hranom.
English: Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thus interaction with other medicinal products, due to displacement is unlikely.
Croatian: Vezanje za proteine plazme u ljudi iznosi otprilike 87% pri terapijskim koncentracijama, i stoga interakcija s drugim lijekovima zbog istiskivanja nije vjerojatna.
English: Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause.
Croatian: Osteoporoza je bolest koja dovodi do stanjenja i slabljenja kosti, a uobičajena je u žena u postmenopauzi.
English: In humans, the efficacy of both daily and intermittent administration with a dose-free interval of 9-10 weeks of ibandronic acid was confirmed in a clinical trial (MF 4411), in which ibandronic acid demonstrated anti-fracture efficacy.
Croatian: U ljudi je djelotvornost dnevne i intermitentne primjene s intervalom od 9 do 10 tjedana bez primanja doze ibandronatne kiseline potvrđena kliničkim ispitivanjem (MF 4411), u kojemu je ibandronatna kiselina pokazala djelotvornost u sprečavanju prijeloma.
English: - If you forgot to take your tablet on your chosen day and your next scheduled dose is more than 7 days away…
Croatian: Ako ste zaboravili uzeti tabletu na odabran dan, a sljedeću dozu trebate uzeti za više od 7 dana…
English: Increases at the hip compared to baseline were 2.8 % at the femoral neck, 3.4 % at the total hip, and 5.5 % at the trochanter.
Croatian: Povećanja mineralne gustoće kosti kuka u usporedbi s početnim vrijednostima iznosila su 2,8 % za vrat bedrene kosti, 3,4 % za cijeli kuk i 5,5 % za trohanter.
English: Efficacy results are summarised in Table 2.
Croatian: Rezultati djelotvornosti sažeto su prikazani u tablici 2.
English: If you take more Ibandronic Acid Teva than you should If you've taken more than one tablet by mistake, drink a full glass of milk and talk to your doctor straight away.
Croatian: Ako ste greškom uzeli više od jedne tablete, popijte cijelu čašu mlijeka i odmah konzultirajte svog liječnika.
English: Ibandronic acid was taken 60 minutes before the first food or drink of the day (post-dose fasting period).
Croatian: Ibandronatna kiselina se uzimala 60 minuta prije uzimanja prvog obroka ili pića (razdoblje gladovanja nakon doze).
English: Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa.
Croatian: Peroralno primijenjeni bisfosfonati mogu uzrokovati lokalnu iritaciju sluznice gornjeg dijela gastrointestinalnog trakta.
English: Three-year lumbar spine BMD increase compared to placebo was 5.3 % and 6.5 % compared to baseline.
Croatian: Nakon tri godine uočeno je povećanje BMD lumbalne kralježnice u usporedbi s placebom od 5,3 % i 6,5 % naspram početnih vrijednosti.
English: Keep out of the sight and reach of children.
Croatian: Čuvati izvan pogleda i dohvata djece
English: Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Croatian: Slučajevi anafilaktičke reakcije/šoka, uključujući događaje sa smrtnim ishodom, prijavljeni su u bolesnika liječenih intravenski primijenjenom ibandronatnom kiselinom.
English: StevensJohnson syndrome†, erythema multiforme†, dermatitis bullous†
Croatian: StevensJohnsonov sindrom†, multiformni eritem†, bulozni dermatitis†
English: Their selective action on bone tissue is based on the high affinity of bisphosphonates for bone mineral.
Croatian: Njihovo selektivno djelovanje na koštano tkivo temelji se na visokom afinitetu bisfosfonata prema mineralima koji se nalaze u kostima.
English: - Tablets should be swallowed whole with a glass of water (180 to 240 ml) while the patient is sitting or standing in an upright position.
Croatian: - Tabletu treba progutati cijelu uz čašu obične vode (180 do 240 ml) dok bolesnik stoji ili sjedi u uspravnom položaju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA
English: If you develop these symptoms, stop taking Ibandronic Acid Teva and tell your doctor straight away (see sections 3 and 4).
Croatian: Ako se ovi simptomi pojave, prekinite uzimati Ibandronatnu kiselinu Teva i odmah se obratite svom liječniku (vidjeti dijelove 3 i 4).
English: • inflammation of the duodenum (first section of the bowel) causing stomach pain
Croatian: • upala dvanaesnika (prvog dijela crijeva), koja uzrokuje bol u želucu
English: Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with Ibandronic Acid Teva.
Croatian: Unatoč tome, na temelju kliničke procjene za pojedinog bolesnika, preporučuje se praćenje bubrežne funkcije te kalcija, fosfata i magnezija u serumu, u bolesnika koji se liječe lijekom Ibandronatna kiselina Teva.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su navedene u padajućem nizu prema ozbiljnosti.
English: Protein binding in human plasma is approximately 85 %-87 % (determined in vitro at therapeutic concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Croatian: Vezanje na proteine plazme iznosi otprilike 85% do 87 % (određeno in vitro pri terapijskim koncentracijama lijeka) i stoga je mala vjerojatnost interakcije s drugim lijekovima zbog istiskivanja.
English: Elderly population (see section 4.2)
Croatian: Starije osobe (vidjeti dio 4.2)
English: Ibandronic acid selectively inhibits osteoclast activity, reducing bone resorption and thereby reducing skeletal complications of the malignant disease.
Croatian: Ibandronatna kiselina selektivno inhibira aktivnost osteoklasta, smanjujući resorpciju kostiju i time smanjuje koštane komplikacije zloćudnih bolesti.
English: Patients should pay particular attention and be able to comply with the dosing instructions (see section 4.2).
Croatian: Bolesnici trebaju obratiti posebnu pozornost i pridržavati se uputa o doziranju (vidjeti dio 4.2).
English: Ibandronic Acid Teva is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Croatian: Ibandronatna kiselina Teva je namijenjena samo za žene u postmenopauzi i ne smiju je uzimati žene koje još mogu imati djecu.
English: The study enrolled women aged 55 to 80 years, who were at least 5 years postmenopausal, who had a BMD at lumbar spine of 2 to 5 SD below the premenopausal mean (T-score) in at least one vertebra [L1-L4], and who had one to four prevalent vertebral fractures.
Croatian: U ispitivanju su bile uključene žene od 55 do 80 godina koje su bile u postmenopauzi najmanje pet godina i u kojih je BMD lumbalne kralježnice iznosio od 2 do 5 SD manje od premenopauzalne srednje vrijednosti (Tvrijednost) na barem jednom kralješku [L1-L4], a koje su imale od jednog do četiri postojeća prijeloma kralježaka.
English: The anti-fracture effect was consistent over the duration of the study.
Croatian: Učinak na sprječavanje prijeloma bio je nepromijenjen za vrijeme trajanja ispitivanja.
English: • flatulence (farting, feeling bloated)
Croatian: • nadutost (vjetrovi, osjećaj nadimanja)
English: The pain reduction was consistently below baseline throughout the entire study and accompanied by a significantly reduced use of analgesics compared to placebo.
Croatian: Smanjenje boli bilo je tijekom cjelokupnog ispitivanja ispod početne vrijednosti i praćeno značajno smanjenom uporabom analgetika, u usporedbi s placebom.
English: Pharmacotherapeutic group: Medicinal products for treatment of bone diseases, bisphosphonate, ATC Code: M05BA06
Croatian: Farmakoterapijska skupina: Pripravci za liječenje bolesti kostiju, bisfosfonati, ATK oznaka: M05BA06
English: Marketing Authorisation Holder and Manufacturer
Croatian: Nositelj odobrenja za stavljanje u promet lijeka i proizvođač
English: The primary endpoint of the trials was the skeletal morbidity period rate (SMPR).
Croatian: Primarna mjera ishoda ispitivanja bila je određivanje stope razdoblja s morbiditetom kostiju (SMPR; engl. skeletal morbidity period rate).
English: Oral bioavailability of ibandronic acid is generally reduced in the presence of food.
Croatian: Bioraspoloživost peroralno uzete ibandronatne kiseline općenito je smanjena u prisutnosti hrane.
English: Total clearance of ibandronic acid is low with average values in the range 84-160 ml/min.
Croatian: Ukupni je klirens ibandronatne kiseline nizak, s prosječnim vrijednostima u rasponu od 84-160 ml/min.
English: However, since this increase is within the normal variability of the bioavailability of ibandronic acid, no dose adjustment is considered necessary when Ibandronic Acid Teva is administered with H2-antagonists or other active substances which increase gastric pH.
Croatian: Međutim, budući da je to povećanje u okviru normalne varijabilnosti bioraspoloživosti ibandronatne kiseline, prilagodba doze nije potrebna kada se Ibandronatna kiselina Teva primjenjuje s H2-antagonistima ili drugim lijekovima koji povećavaju pH želučane kiseline.
English: After 5 years of using Ibandronic Acid Teva, please consult with your doctor whether you should continue to take Ibandronic Acid Teva.
Croatian: Nakon 5 godina primjene Ibandronatne kiseline Teva posavjetujte se sa svojim liječnikom o tome trebate li ga nastaviti uzimati.
English: Do not take Ibandronic Acid Teva with food or any other drinks except water as Ibandronic Acid Teva is less effective if it is taken with food or drink (see section 3).
Croatian: Ne uzimajte Ibandronatnu kiselinu Teva s hranom ili nekim drugim pićem osim vodom jer hrana ili druga pića smanjuju djelotvornost lijeka (vidjeti dio 3).
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare
Croatian: Kategorije učestalosti definirane su na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Do not take this medicine if any of the above apply to you.
Croatian: Ukoliko se bilo što od gore navedenog odnosi na Vas, ne smijete uzimati ovaj lijek.
English: Temporary interruption of Ibandronic Acid Teva treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Croatian: Ako je moguće, treba razmotriti privremen prekid liječenja lijekom Ibandronatna kiselina Teva dok se ovo stanje ne povuče i ublaže faktori rizika koji su pridonijeli njegovu razvoju.
English: Ibandronic Acid Teva is indicated in adults for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
Croatian: Ibandronatna kiselina Teva indicirana je u odraslih za sprječavanje koštanih poremećaja (patološki prijelomi, komplikacije na kostima koje zahtijevaju radioterapiju ili operaciju) u bolesnika s rakom dojke i koštanim metastazama.
English: Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Croatian: Tablica 2 Rezultati djelotvornosti (bolesnici s rakom dojke i koštanim metastazama)
English: United Kingdom
Croatian: Velika Britanija
English: Oesophagitis including oesophageal ulcerations or strictures and dysphagia, Vomiting, Flatulence
Croatian: Ezofagitis uključujući ulceracije ili strikture jednjaka i disfagiju, povraćanje, flatulencija
English: • pain or sore in your mouth or jaw.
Croatian: • bol ili rana u ustima ili čeljusti.
English: Ibandronic Acid Teva is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called bone “metastases”).
Croatian: Ibandronatna kiselina Teva je namijenjena liječenju odraslih bolesnika i biti će Vam propisana ako imate rak dojke koji se proširio na Vaše kosti (što se naziva koštane „metastaze“).
English: Take your tablet at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements except water.
Croatian: Uzmite tabletu najmanje 6 sati nakon što ste posljednji puta uzeli hranu, piće ili bilo koje druge lijekove ili nadomjeske, osim vode.
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Croatian: Nuspojave su popisane prema MedDRA klasifikaciji organskih sustava i kategorijama učestalosti.
English: Chest pain, influenza-like illness, malaise, pain
Croatian: Bolovi u prsima, bolest slična gripi, slabost, bol
English: Table 1 lists adverse reactions from 2 pivotal phase III studies (Prevention of skeletal events in patients with breast cancer and bone metastases: 286 patients treated with ibandronic acid 50 mg administered orally), and from post-marketing experience.
Croatian: Tablici 1 popisane su nuspojave iz 2 pivotalna ispitivanja faze III (Sprječavanje koštanih događaja u bolesnika s rakom dojke i koštanim metastazama: 286 bolesnika liječena ibandronatnom kiselinom od 50 mg primijenjenom peroralno) i iz iskustva nakon stavljanja lijeka na tržište.
English: Urinary concentrations of the bone resorption marker CTx (C-terminal telopeptide released from Type I collagen) were significantly reduced in the ibandronic acid group compared to placebo.
Croatian: Koncentracije biljega resorpcije kostiju CTx (Cterminalni telopeptid otpušten iz kolagena tipa I) u urinu bile su znatno smanjene u grupi koja je primala ibandronatnu kiselinu u usporedbi s placebo grupom.
English: Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act selectively on bone tissue and specifically inhibit osteoclast activity without directly affecting bone formation.
Croatian: Ibandronatna kiselina je visoko potentan bisfosfonat iz skupine bisfosfonata koji sadrže dušik, koji selektivno djeluje na koštano tkivo i ciljano inhibira aktivnost osteoklasta bez izravnog učinka na formiranje kosti.
English: For patients with severe renal impairment (CLcr <30 mL/min) the recommended dose is one 50 mg film-coated tablet once weekly.
Croatian: Za bolesnike s teškim oštećenjem bubrega (CLcr <30 ml/min) preporučena doza je jedna 50 mg filmom obložena tableta jedanput tjedno.
English: The range of observed apparent half-lives is broad, the apparent terminal half-life is generally in the range of 10-72 hours.
Croatian: Raspon prividnog poluvijeka je širok, a prividni terminalni poluvijek u načelu ima raspon od 10 do 72 sata.
English: This is because aminoglycosides and Ibandronic Acid Teva can both lower the amount of calcium in your blood.
Croatian: To je važno stoga što - aminoglikozidi i Ibandronatna kiselina Teva mogu smanjiti razine kalcija u krvi.
English: They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome).
Croatian: Uključuju smanjeni broj mjesta implantacije, poremećaje prirodnog poroda (distocija) i povećanje visceralnih varijacija (sindrom bubrega, zdjelice i mokraćovoda).
English: Month 3 __/__/__
Croatian: Mjesec 3 __ /__ /__
English: Table 3 Secondary Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease)
Croatian: Tablica 3 Sekundarni rezultati djelotvornosti (bolesnici s rakom dojke i koštanim metastazama)
English: However, no dosage adjustment is required when Ibandronic Acid Teva is administered with H2-antagonists or medicinal products that increase gastric pH.
Croatian: No nije potrebna prilagodba doze kad se Ibandronatna kiselina Teva primjenjuje s H2-antagonistima ili drugim lijekovima koji povećavaju pH želučane kiseline.
English: Furthermore, ibandronic acid 150 mg once monthly was proven superior to ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p=0.002, and at two years, p<0.001.
Croatian: Nadalje, ibandronatna kiselina 150 mg jedanput mjesečno dokazano je bolja od ibandronatne kiseline 2,5 mg jedanput dnevno u povećavanju BMD lumbalne kralježnice u prospektivno planiranoj analizi nakon jedne godine, p=0,002, i nakon dvije godine, p<0,001.
English: • flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints.
Croatian: • simptomi nalik gripi, uključujući vrućicu, tresavicu i drhtanje, osjećaj nelagode, bol u kostima, mišićima i zglobovima.
English: The range of observed apparent half-lives is broad and dependent on dose and assay sensitivity, but the apparent terminal half-life is generally in the range of 10-60 hours.
Croatian: Raspon opaženih prividnih poluživota širok je te ovisi o dozi i osjetljivosti metode, no prividni krajnji poluživot u načelu ima raspon od 10 do 60 sati.
English: The treatment effect of ibandronic acid was further assessed in an analysis of the subpopulation of patients who at baseline had a lumbar spine BMD T-score below -2.5.
Croatian: Učinak liječenja ibandronatnom kiselinom dodatno je procijenjen analizom populacijske podskupine bolesnika čija je početna T-vrijednost BMD lumbalne kralježnice bila manja od -2,5.
English: Daily treatment with 2.5 mg resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Croatian: Liječenje s 2,5 mg dnevno dovelo je do progresivnih povećanja BMD kralježaka i ostalih dijelova skeleta.
English: The pharmacodynamic action of ibandronic acid is inhibition of bone resorption.
Croatian: Farmakodinamički učinak ibandronatne kiseline je inhibicija resorpcije kosti.
English: Anaphylactic reaction/shock
Croatian: Anafilaktička reakcija/šok
English: Pharmacokinetics in special populations
Croatian: Farmakokinetika u posebnim skupinama
English: Month 1 __/__/__
Croatian: Mjesec 1 __ /__ /__
English: The pharmacokinetics of ibandronic acid in these patients is unknown, and ibandronic acid should not be used under these circumstances.
Croatian: Nisu poznata farmakokinetska svojstva ibandronatne kiseline u ovih bolesnika te se ibandronatna kiselina ne bi smjela koristiti u takvim slučajevima.
English: The absorbed fraction of ibandronic acid is removed from the circulation via bone absorption (estimated to be 40-50% in postmenopausal women) and the remainder is eliminated unchanged by the kidney.
Croatian: Apsorbirani udio ibandronatne kiseline uklanja se iz cirkulacije koštanom apsorpcijom (procijenjeno na 40-50% u žena u postmenopauzi), a ostatak se nepromijenjen eliminira putem bubrega.
English: If you develop these symptoms, stop taking Ibandronic Acid Teva and tell your doctor straight away (see section 3).
Croatian: Ako se jave ti simptomi, prestanite uzimati Ibandronatnu kiselinu Teva i odmah se javite svom liječniku (vidjeti dio 3).
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as ibandronic acid (see section 4.4.)
Croatian: Prijavljeni su slučajevi osteonekroze čeljusti, pretežno u bolesnika oboljelih od raka liječenih lijekovima koji inhibiraju resorpciju kosti, kao što je ibandronatna kiselina (vidjeti dio 4.4).
English: In healthy male volunteers and postmenopausal women, intravenous ranitidine caused an increase in ibandronic acid bioavailability of about 20% (which is within the normal variability of the bioavailability of ibandronic acid), probably as a result of reduced gastric acidity.
Croatian: U zdravih muških ispitanika i žena u postmenopauzi, intravenski ranitidin uzrokovao je povećanje bioraspoloživosti ibandronatne kiseline za otprilike 20% (što je u okviru normalne varijabilnosti bioraspoloživosti ibandronatne kiseline), vjerojatno kao rezultat smanjene kiselosti želuca.
English: However, early plasma levels fall quickly, reaching 10% of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Croatian: Početne vrijednosti u plazmi, međutim, brzo padaju, dostižući 10% vršnih vrijednosti u roku od 3 do 8 sati nakon intravenske ili peroralne primjene.
English: Following treatment discontinuation, there is a reversion to the pathological pre-treatment rates of elevated bone resorption associated with postmenopausal osteoporosis.
Croatian: Nakon prekida liječenja došlo je do vraćanja na patološke vrijednosti povećane resorpcije kosti koje su postojale prije liječenja, koje su povezane s osteoporozom u postmenopauzi.
English: Ibandronic Acid Teva belongs to a group of medicines called bisphosphonates.
Croatian: Ibandronatna kiselina Teva pripada skupini lijekova koji se nazivaju bisfosfonati.
English: Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: U nekliničkim ispitivanjima učinci su zamijećeni samo pri izloženosti lijeku znatno višoj od maksimalne izloženosti kod ljudi, što ukazuje na malu važnost za kliničku primjenu.
English: The extent of absorption is impaired when taken together with food or beverages (other than water).
Croatian: Apsorpcija je smanjena ako se lijek uzima s hranom ili pićem (osim s vodom).
English: - Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine.
Croatian: ˗ acetilsalicilnu kiselinu i druge nesteroidne protuupalne lijekove (NSAIL) (uključujući ibuprofen, natrij-diklofenak i naproksen) koji mogu nadražiti želudac i crijeva.
English: Otherwise, some of the medicine could leak back into your food pipe/gullet (oesophagus).
Croatian: U suprotnom, dio lijeka vam se može vratiti u jednjak (ezofagus).