natgillin/translations-raw huggingface dataset:
In vivo, ibandronic acid prevents experimentally-induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts. 
In vivo, ibandronatna kiselina sprječava eksperimentalno induciranu destrukciju kosti uzrokovanu zaustavljanjem gonadnih funkcija, retinoidima, tumorima ili ekstraktima tumora.
Stevens-Johnson Syndrome†, Erythema Multiforme†, Dermatitis Bullous† 
StevensJohnsonov sindrom†, eritema multiforme†, bulozni dermatitis†
Salutas Pharma GmbH Dieselstrasse 5, 70839 Gerlingen Germany 
Salutas Pharma GmbH Dieselstrasse 5, 70839 Gerlingen Njemačka
Then you can have your first food and drink, and take any medicines or supplements (see section 3). 
Nakon toga možete uzeti prvi obrok i piće te druge lijekove ili nadomjesne pripravke (vidjeti dio 3).
Children and adolescents Ibandronic acid Sandoz should not be used in children and adolescents below the age of 18 years. 
Djeca i adolescenti Ibandronatna kiselina Sandoz ne smije se davati djeci i adolescentima mlađim od 18 godina.
Do not chew, suck or crush the tablet. 
Ne žvačite, ne sišite i ne drobite tabletu.
Further, as protein binding of ibandronic acid is approximately 87% at therapeutic concentrations, hypoproteinaemia in severe liver disease is unlikely to lead to clinically significant increases in free plasma concentration. 
Nadalje, budući da pri terapijskim koncentracijama vezanje ibandronatne kiseline za proteine plazme iznosi otprilike 87 %, nije vjerojatno da će hipoproteinemija u bolesnika s teškom bolesti jetre dovesti do klinički značajnih povećanja koncentracije slobodne ibandronatne kiseline u plazmi.
Ibandronic acid belongs to the bisphosphonate group of compounds which act specifically on bone. 
Ibandronatna kiselina pripada skupini bisfosfonata, tvari koje djeluju specifično na kosti.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Polyamide/Al/PVC - Aluminium foil blister 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Poliamid/Al/PVC - blister od aluminijske folije
Total clearance of ibandronic acid is low with average values in the range 84-160 ml/min. 
Ukupni klirens ibandronatne kiseline je nizak, s prosječnim vrijednostima u rasponu od 84160 ml/min.
Patients with disturbances of bone and mineral metabolism Hypocalcaemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Ibandronic acid Sandoz therapy. 
Bolesnici s poremećajima metabolizma kosti i minerala Hipokalcijemiju i ostale poremećaje metabolizma kostiju i minerala potrebno je učinkovito liječiti prije početka terapije Ibandronatnom kiselinom Sandoz.
Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Ibandronic acid Sandoz. 
Mogu se javiti iritiacija, upala ili ulceracija jednjaka (ezofagusa) često sa simptomima jake boli u prsima, jakom boli nakon gutanja hrane i/ili pića, teškom mučninom ili povraćanjem, posebice ako ne popijete punu čašu vode i/ili legnete unutar sat vremena od uzimanja lijeka Ibandronatna kiselina Sandoz.
Paediatric population (see section 4.2 and section 5.1) There are no data on the use of Ibandronic acid Sandoz in patients less than 18 years old. 
Pedijatrijska populacija (vidjeti dijelove 4.2 i 5.1) Ne postoje podaci o primjeni Ibandronatne kiseline Sandoz u bolesnika mlađih od 18 godina.
Ibandronic acid Sandoz 50 mg film-coated tablets are supplied in Polyamide/Al/PVC - Aluminium foil blister with 3, 6, 9, 28 or 84 tablets, packaged in a cardboard box. 
Ibandronatna kiselina Sandoz 50 mg, filmom obložene tablete pakirane su u poliamid/Al/PVCaluminijska folija blistere s 3, 6, 9, 28 ili 84 tablete u kartonskoj kutiji.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw. 
Odmah se obratite svom liječniku i stomatologu ako primijetite bilo kakve tegobe s ustima ili zubima, poput rasklimanih zuba, boli ili oticanja, ranica koje ne cijele ili iscjetka jer bi to mogli biti znakovi osteonekroze čeljusti.
If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Ibandronic acid Sandoz. 
Ako ste podvrgnuti liječenju zuba ili se morate podvrgnuti stomatološkom kirurškom zahvatu (npr. vađenju zuba), obavijestite svog liječnika o liječenju zuba i recite svom stomatologu da se liječite Ibandronatnom kiselinom Sandoz.
This was a composite endpoint which had the following skeletal related events (SREs) as sub-components: 
To je bila ukupna mjera ishoda u sklopu koje su se pratili sljedeći događaji vezani uz kosti (SRE, engl. skeletal related events):
If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day. 
Ako imate blage probleme s bubrezima, liječnik Vam može smanjiti dozu na jednu tabletu svaki drugi dan.
Pharmathen S.A. Dervenakion 6 Pallini 15351 Attiki 
Proizvođač Pharmathen S.A. Dervenakion 6 Pallini 15351 Attiki
Medicinal product-Food Interactions 
Interakcije lijeka i hrane
Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Ibandronic acid Sandoz tablets. 
Proizvodi koji sadrže kalcij i ostale multivalentne katione (kao što su aluminij, magnezij, željezo), uključujući mlijeko i hranu, mogu utjecati na apsorpciju tableta Ibandronatne kiseline Sandoz.
The safety and efficacy of ibandronic acid in children and adolescents below the age of 18 years have not been established. 
Sigurnost i djelotvornost ibandronatne kiseline u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
Str. Livezeni nr. 7A, RO-540472 Targu-Mures Romania 
Livezeni nr. 7A, RO-540472 Targu-Mures Rumunjska
- Patients should not chew, suck or crush the tablet because of a potential for oropharyngeal ulceration. 
- Bolesnik ne smije žvakati, sisati ili drobiti tabletu zbog mogućeg nastanka ulceracije u ustima i ždrijelu.
Ibandronic acid is eliminated by renal excretion only and does not undergo any biotransformation. 
Ibandronatna kiselina se uklanja samo renalnom sekrecijom i ne prolazi biotransformaciju.
- Water is the only drink that should be taken with Ibandronic acid Sandoz. 
- Voda je jedino piće s kojim se Ibandronatna kiselina Sandoz smije uzimati.
Patients with known hypersensitivity to other bisphosphonates Caution is to be taken in patients with known hypersensitivity to other bisphosphonates. 
Bolesnici s poznatom preosjetljivošću na druge bisfosfonate Oprez je potreban u bolesnika s poznatom preosjetljivošću na druge bisfosfonate.
In studies in rats using the intravenous route, ibandronic acid decreased fertility at high daily doses (see section 5.3). 
U ispitivanjima na štakorima koji su lijek primali intravenski, ibandronatna kiselina je smanjila plodnost pri visokim dnevnim dozama (vidjeti dio 5.3).
Ibandronic acid Sandoz tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 
Tablete Ibandronatne kiseline Sandoz sadrže laktozu i ne smiju se davati bolesnicima s rijetkim nasljednim poremećajima nepodnošenja galaktoze, deficijencije Lapp laktaze ili malapsorpcije glukoze-galaktoze.
What Ibandronic acid Sandoz is and what it is used for What you need to know before you take Ibandronic acid Sandoz How to take Ibandronic acid Sandoz Possible side effects 
Što je Ibandronatna kiselina Sandoz i za što se koristi Što morate znati prije nego počnete uzimati Ibandronatnu kiselinu Sandoz Kako uzimati Ibandronatnu kiselinu Sandoz Moguće nuspojave
Effects in non-clinical studies were observed only at exposures sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. 
U nekliničkim ispitivanjima zapaženi su učinci samo ekspozicijama dozama koje su znatno veće od maksimalno dozvoljenih u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
Take Ibandronic acid Sandoz at least 6 hours after you last had anything to eat, drink or any other medicines or supplements (e.g. products containing calcium (milk), aluminium, magnesium and iron) except water. 
Ibandronatnu kiselinu Sandoz uzmite najmanje 6 sati nakon posljednjeg obroka, pića, osim vode, ili uzimanja bilo kojeg drugog lijeka i nadomjesnog pripravka (npr. proizvodi koji sadrže kalcij (mlijeko), aluminij, magnezij i željezo).
Decreased renal calcium excretion may be accompanied by a fall in serum phosphate levels not requiring therapeutic measures. 
Smanjeno izlučivanje kalcija putem bubrega može biti popraćeno padom razina fosfata u serumu za koji nije potrebno poduzeti terapijske mjere.
After taking your tablet, wait at least 30 minutes. 
Nakon uzimanja tablete pričekajte najmanje 30 minuta.
Hypersensitivity†, bronchospasm†, angioedema†, Anaphylactic reaction/shock†** 
Poremećaji imunološkog sustava preosjetljivost†, bronhospazam†, angioedem†, anafilaktička reakcija/šok †**
Ibandronic acid Sandoz works by reducing the amount of calcium that is lost from your bones. 
Ibandronatna kiselina Sandoz djeluje tako što smanjuje količinu kalcija koju gube Vaše kosti.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kutija
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. 
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 ibandronatnom kiselinom.
Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Ibandronic acid Sandoz tablets. 
Lijekove i nadomjesne pripravke (uključujući kalcij) također bi trebalo izbjegavati prije uzimanja tableta Ibandronatne kiseline Sandoz.
SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture. 
POSEBNE MJERE ČUVANJA Čuvati u originalnom pakiranju radi zaštite od vlage
• Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements. 
• Uzmite tablete ujutro odmah nakon ustajanja, prije uzimanja prvog jutarnjeg obroka, pića, drugih lijekova ili nadomjesnih pripravaka.
What Ibandronic acid Sandoz is and what it is used for 
Što je Ibandronatna kiselina Sandoz i za što se koristi
Paediatric population (see section 4.2 and section 5.2) The safety and efficacy of ibandronic acid in children and adolescents below the age of 18 years have not been established. 
Pedijatrijska populacija (vidjeti dijelove 4.2 i 5.2) Sigurnost i djelotvornost ibandronatne kiseline u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Ibandronic acid Sandoz administration. 
Tijekom liječenja, invazivne stomatološke zahvate treba provoditi tek nakon pažljivog razmatranja, a izbjegavati ih u razdoblju blizu vremena primjene Ibandronatne kiseline Sandoz.
Temporary interruption of Ibandronic acid Sandoz treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible. 
Ako je moguće, treba razmotriti privremeni prekid liječenja Ibandronatnom kiselinom Sandoz dok se ovo stanje ne povuče i ne ublaže faktori rizika koji su pridonijeli njegovu razvoju.
• severe stomach pain. 
• Ozbiljna želučana bol.
Ibandronic acid Sandoz tablets is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called “bone metastases”). 
Tablete Ibandronatne kiseline Sandoz primjenjuju se u odraslih, a Vama su propisane ako imate rak dojke koji se proširio na kosti (koje se nazivaju „koštane metastaze“).
If you are not sure, talk to your doctor or pharmacist before taking Ibandronic acid Sandoz. 
Ako niste sigurni, posavjetujte se sa svojim liječnikom ili ljekarnikom prije uzimanja Ibandronatne kiseline Sandoz.
Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid. 
Slučajevi anafilaktičke reakcije/šoka, uključujući i smrt, zabilježeni su u bolesnika koji su bili liječeni intravenskom ibandronatnom kiselinom.
What Ibandronic acid Sandoz looks like and contents of the pack The film-coated tablets are white, round biconvex tablets supplied in Polyamide/Al/PVC - Aluminum foil blister. 
Kako Ibandronatna kiselina Sandoz izgleda i sadržaj pakovanja Filmom obložene tablete bijele su i okrugle bikonveksne tablete i isporučuju se u blister pakovanju (poliamid/Al/PVC - aluminijska folija).
Adverse reactions are listed according to MedDRA system organ class and frequency category. 
Nuspojave su navedene prema MedDRA organskom sustavu i kategoriji učestalosti.
Milk or antacids should be given to bind ibandronic acid. 
Potrebno je uzeti mlijeko ili antacide kako bi se ibandronatna kiselina vezala.
Asthma exacerbation 
pogoršavanje astme
Ibandronic acid Sandoz with food and drink 
Ibandronatna kiselina Sandoz uz hranu i piće
How to store Ibandronic acid Sandoz Contents of the pack and other information 
Kako čuvati Ibandronatnu kiselinu Sandoz Sadržaj pakiranja i druge informacije
Domaniewska 50 C 02-672 Warszawa Poland 
Lek S.A. ul. Domaniewska 50 C 02-672 Warszawa Poljska
Marketing Authorisation Holder Sandoz GmbH 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sandoz GmbH
Bioavailability was reduced by approximately 75% when ibandronic acid tablets were administered 2 hours after a standard meal. 
Bioraspoloživost se smanjuje za približno 75 % ako se tablete ibandronatne kiseline uzimaju 2 sata nakon standardnog obroka.
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 Sandoz 50 mg administered orally), and from post-marketing experience. 
U tablici 1 navedene su nuspojave iz 2 ključnih ispitivanja faze III (Prevencija koštanih poremećaja u bolesnika s rakom dojke i koštanim metastazama: 286 bolesnika liječenih ibandronatnom kiselinom Sandoz 50 mg peroralno) te iz iskustava nakon stavljanja gotovog lijeka u promet.
Urinary concentrations of the bone resorption marker CTx (Cterminal telopeptide released from Type I collagen) were significantly reduced in the ibandronic acid group compared to placebo. 
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.
Osteonecrosis of jaw†**, osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) † 
osteonekroza čeljusti†** Osteonekroza vanjskog slušnog kanala (nuspojava razreda bisfosfonata) †.
• new pain, weakness or discomfort in your thigh, hip or groin. 
• bol, slabost ili neugoda u bedru, kuku ili preponama.
Adequate intake of calcium and vitamin D is important in all patients. 
Za sve bolesnike je važno uzimanje odgovarajućih količina kalcija i vitamina D.
Ibandronic acid Sandoz 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. 
Ibandronatna kiselina Sandoz 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.
Metabolic interactions are not considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats (see section 5.2). 
Metaboličke interakcije nisu vjerojatne jer ibandronatna kiselina ne inhibira glavne jetrene izoenzime P450 u ljudi i ne inducira jetreni P450 citokromski sustav u štakora (vidjeti dio 5.2).
You can drive and use machines as it's expected that Ibandronic acid Sandoz has no or negligible effect on your ability to drive and use machines. 
Smijete upravljati vozilom i strojevima jer Ibandronatna kiselina Sandoz ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Also some other medicines can affect the way Ibandronic acid Sandoz works. 
Također, drugi lijekovi mogu utjecati na djelovanje Ibandronatne kiseline Sandoz.
Physicians should be alert to any signs or symptoms signaling a possible oesophageal reaction and patients should be instructed to discontinue Ibandronic acid Sandoz and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. 
Liječnici trebaju biti oprezni prilikom pojave bilo kojeg znaka ili simptoma koji upućuje na moguću reakciju jednjaka, a bolesnici trebaju biti upućeni da prestanu uzimati Ibandronatnu kiselinu Sandoz i potraže liječničku pomoć u slučaju disfagije, odinofagije, bolova iza prsne kosti, ili pojave ili pogoršanja žgaravice.
Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. 
Atipična suptrohanterična i dijafizealna fraktura femura zabilježena je kod liječenja bisfosfonatima, prvenstveno u bolesnika koji su dugotrajno primali lijekove protiv osteoporoze.
Bioavailability is reduced by about 90% when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects. 
Bioraspoloživost se smanjuje za otprilike 90 % ako se ibandronatna kiselina primjenjuje uz standardni doručak, u usporedbi s bioraspoloživosti opaženom u ispitanika koji su je primijenili natašte.
In reproductive studies in rats by the oral route effects on fertility consisted of increased preimplantation losses at dose levels of 1 mg/kg/day and higher. 
U reproduktivnim ispitivanjima peroralne primjene na štakorima, djelovanje na plodnost obuhvaćalo je povećani gubitak prije implantacije pri dozama od 1 mg/kg na dan i višim.
Very rare 
Manje često Rijetko
Atypical subtrochanteric and diaphyseal femoral fractures† 
Atipične suptrohanterične i dijafizealne frakture femura†
Uncommon (may affect less than 1 in 100 people): 
Manje često (može se javiti kod manje od 1 na 100 osoba):
Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Ibandronic acid Sandoz is given to patients with active upper gastrointestinal problems (e.g. known Barrett's oesophagus, dysphagia, other oesophageal diseases, gastritis, duodenitis or ulcers). 
Zbog pojave ovih mogućih iritacija i mogućnosti pogoršanja osnovne bolesti, potreban je oprez kad se Ibandronatna kiselina Sandoz propisuje bolesnicima s problemima gornjeg dijela gastrointestinalnog sustava (na primjer Barrettov jednjak, disfagija, druge bolesti jednjaka, gastritis, upala dvanaesnika ili vrijedovi).
This is because aminoglycosides and Ibandronic acid Sandoz can both lower the amount of calcium in your blood. 
To je važno stoga što i aminoglikozidi i Ibandronatna kiselina Sandoz mogu smanjiti razine kalcija u krvi.
Pooled data from these studies demonstrated a significant advantage for ibandronic acid 50 mg p.o. over placebo in the reduction in SREs measured by the SMPR (p=0.041). 
Zbirni podaci prikupljeni tijekom tih ispitivanja pokazali su znatnu prednost ibandronatne kiseline od 50 mg peroralno u odnosu na placebo u pogledu smanjivanja SRE, mjereno SMPR-om (p=0,041).
- organizačná zložka Galvaniho 15/C 
Slovenská republika Sandoz d.d. - organizačná zložka Galvaniho 15/C
Take your tablet at least 6 hours after you last had anything to eat, drink or any other medicines or supplements except water. 
Tabletu uzmite najmanje 6 sati nakon posljednjeg obroka, pića, osim vode, ili uzimanja bilo kojeg drugog lijeka i nadomjesnog pripravka.
There was also a 38% reduction in the risk of developing an SRE for ibandronic acid treated patients when compared with placebo (relative risk 0.62, p=0.003). 
U usporedbi s placebom, u bolesnika liječenih ibandronatnom kiselinom rizik od razvoja SRE bio je za 38 % manji (relativni rizik 0,62; p=0,003).
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. 
Ovaj se lijek ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blister pakovanju i kutiji iza kratice „EXP“ ili „Rok valjanosti“.
Primary Efficacy Endpoints 
Primarne mjere ishoda djelotvornosti
Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic acid Sandoz. 
Uzimanje lijekova za smanjenje kiseline u želucu poput cimetidina i ranitidina može neznatno povećati učinak Ibandronatne kiseline Sandoz.
On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that ibandronic acid has no or negligible influence on the ability to drive and use machines. 
Na osnovi farmakodinamičkog i farmakokinetičkog profila te zabilježenih nuspojava ibandronatna kiselina ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
You may have early signs of a possible unusual fracture of the thigh bone. 
To mogu biti rani znakovi mogućeg netipičnog loma bedrene kosti.
(dead bone tissue) in the jaw bone). 
mrtvo koštano tkivo) u kostima čeljusti.
While no increased risk was observed in controlled clinical trials there have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications. 
Dok u kontroliranim kliničkim ispitivanjima nije primijećen povećani rizik, nakon stavljanja lijeka na tržište su, kod peroralne primjene bisfosfonata, prijavljeni vrijedovi želuca i dvanaesnika, od kojih su neki bili teški i praćeni komplikacijama.
Ibandronic acid Sandoz therapy should only be initiated by physicians experienced in the treatment of cancer. 
Liječenje Ibandronatnom kiselinom Sandoz smiju započeti samo liječnici s iskustvom u liječenju zloćudnih bolesti.
What you need to know before you take Ibandronic acid Sandoz 
Što morate znati prije nego počnete uzimati Ibandronatnu kiselinu Sandoz
(duodenum) that is bleeding, or that your stomach is inflamed (gastritis) 
odnosno krvarenje, ili upale želudca (gastritis).
You may have early signs of severe jaw problems (necrosis 
To mogu biti rani znakovi ozbiljnih tegoba s čeljusti (nekroza,
Table 1 Adverse Drug Reactions Reported for Oral Administration of Ibandronic acid System Organ 
Tablica 1 Nuspojave lijeka prijavljene uz peroralnu primjenu ibandronatne kiseline
Very rare (may affect up to 1 in 10,000 people) 
Vrlo rijetko (mogu se javiti kod manje od 1 na 10 000 osoba)
Hepatic impairment (see section 4.2) 
Oštećenje jetre (vidjeti dio 4.2)
Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration (see section 4.4). 
Budući da su acetilsalicilna kiselina, nesteroidni protuupalni lijekovi (NSAIDs) i bifosfonati povezani s gastrointestinalnom iritacijom, potreban je oprez pri istodobnoj peroralnoj primjeni (vidjeti dio 4.4).
- Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia - Inability to stand or sit upright for at least 60 minutes - Hypocalcaemia - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Nepravilnosti jednjaka koje dovode do zastoja u pražnjenju jednjaka kao što su striktura ili ahalazija - Nemogućnost stajanja ili uspravnog sjedenja barem 60 minuta - Hipokalcijemija