FrancophonIA/ELRC3.0 huggingface dataset:
English: Ulipristal acetate is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant.
Croatian: Ulipristalacetat nije namijenjen uporabi tijekom trudnoće i ne smiju ga uzimati žene koje sumnjaju ili znaju da su trudne.
English: Ulipristal acetate is extensively metabolised to mono-demethylated, di-demethylated and hydroxylated metabolites.
Croatian: Ulipristalacetat se opsežno metabolizira u mono-demetilirane, di-demetilirane i hidroksilirane metabolite.
English: Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator which acts via high-affinity binding to the human progesterone receptor.
Croatian: Ulipristalacetat je peroralni sintetski selektivni modulator progesteronskih receptora koji djeluje vežući se visokim afinitetom na humani progesteronski receptor.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Croatian: 6. FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari
English: ellaOne is available in a carton containing one blister of 1 tablet.
Croatian: ellaOne je dostupna u kutiji koja sadrži jedan blister s 1 tabletom.
English: Post-marketing experience: the adverse reactions spontaneously reported in post-marketing experience were similar in nature and frequency to the safety profile described during the phase III program.
Croatian: Iskustvo nakon stavljanja lijeka u promet: spontano prijavljene nuspojave tijekom uporabe nakon stavljanja lijeka u promet bile su po svojoj prirodi i učestalosti slične sigurnosnom profilu opisanom tijekom ispitivanja faze III.
English: Limited and inconclusive data suggest that there may be reduced efficacy of ellaOne with increasing body weight or body mass index (BMI) (see section 5.1).
Croatian: Ograničeni podaci koji ne dopuštaju donošenje konačnih zaključaka ukazuju na to da se djelotvornost ellaOne može smanjivati s porastom tjelesne težine ili indeksa tjelesne mase (ITM) (vidjeti dio 5.1).
English: Liek, s.r.o.
Croatian: Slovenská republika Liek, s.r.o.
English: Therefore, if a woman wishes to start or continue using hormonal contraception, she can do so after using ellaOne, however, she should be advised to use a reliable barrier method until the next menstrual period.
Croatian: Stoga žena nakon uzimanja ellaOne može početi ili nastaviti koristiti hormonsku kontracepciju, međutim, treba je savjetovati da do sljedeće menstruacije koristi pouzdano mehaničko kontracepcijsko sredstvo.
English: If a woman's menstrual period is late or in case of symptoms of pregnancy, pregnancy should be excluded before the tablet is administered.
Croatian: Ako ženi kasni menstruacija ili u slučaju simptoma trudnoće, prije primjene tablete potrebno je isključiti trudnoću.
English: - CYP3A4 inhibitors
Croatian: - Inhibitori CYP3A4
English: - The other ingredients are lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate.
Croatian: • Drugi sastojci su laktoza hidrat, povidon, umrežena karmelozanatrij, magnezijev stearat.
English: - CYP3A4 inducers
Croatian: - Induktori CYP3A4
English: Do not take ellaOne together with another emergency contraceptive pill that contains levonorgestrel.
Croatian: ellaOne nemojte uzeti zajedno s drugim hitnim kontracepcijskim tabletama koje sadrže levonorgestrel.
English: Titanium dioxide (E171) Polysorbate 80 (E433) Iron oxide yellow (E172) Potassium aluminium silicate (E555)
Croatian: (E171), polisorbat 80 (E433), žuti željezov oksid (E172), kalijev aluminijev silikat (E555)
English: In vivo results show that the administration of ulipristal acetate with a strong CYP3A4 inducer such as rifampicin markedly decreases Cmax and AUC of ulipristal acetate by 90% or more and decreases ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-fold decrease of ulipristal acetate exposure.
Croatian: In vivo rezultati pokazuju da primjena ulipristalacetata s jakim induktorima CYP3A4 kao što je rifampicin značajno smanjuje Cmax i AUC ulipristalacetata za 90% ili više i smanjuje poluvrijeme eliminacije ulipristalacetata za 2,2 puta što približno odgovara smanjenju izlaganja ulipristalacetatu za 10 puta.
English: The carton contains one blister.
Croatian: Kutija sadrži jedan blister.
English: Contraception after ellaOne intake
Croatian: Kontracepcija nakon uzimanja ellaOne
English: Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended (see section 4.5).
Croatian: Ne preporučuje se istovremeno uzimanje ulipristalacetata i hitne kontracepcije koja sadrži levonorgestrel (vidjeti dio 4.5).
English: ellaOne is available in a carton containing one blister of 1 film-coated tablet.
Croatian: ellaOne je dostupna u kutiji koja sadrži jedan blister s 1 filmom obloženom tabletom.
English: If you are pregnant, it is important that you see your doctor.
Croatian: Ako ste trudni, važno je otići kod liječnika.
English: The terminal half-life of ulipristal acetate in plasma following a single 30 mg dose is estimated to 32.4 ± 6.3 hours, with a mean oral clearance (CL/F) of 76.8 ± 64.0 L/h.
Croatian: Terminalni poluvijek ulipristalacetata u plazmi nakon primjene pojedinačne doze od 30 mg procjenjuje se na 32,4 ± 6,3 sata, uz srednju vrijednost oralnog klirensa (CL/F) od 76,8 ± 64,0 L/h.
English: Limited and inconclusive data from clinical trials suggest a possible trend for a reduced contraceptive efficacy of ulipristal acetate with high body weight or BMI (see section 4.4).
Croatian: Ograničeni podaci iz kliničkih ispitivanja koji ne dopuštaju donošenje konačnih zaključaka ukazuju na mogući trend smanjenja kontracepcijske djelotvornosti ulipristalacetata u žena velike tjelesne težine ili s visokim ITM-om (vidjeti dio 4.4).
English: The effects of ulipristal acetate on BCRP are unlikely to have any clinical consequences.
Croatian: Nije vjerojatno da učinci ulipristalacetata na BCRP imaju ikakve kliničke posljedice.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: For example: - if you had sex without protection; - if your or your partner's condom tore, slipped or came off, or if you forgot to use one; - if you did not take your contraceptive pill as recommended.
Croatian: • ako se Vaš ili kondom Vašeg partnera ošteti, sklizne, ispadne ili ga zaboravite uporabiti;
English: Use in women with severe asthma treated by oral glucocorticoid is not recommended.
Croatian: Ne preporučuje se primjena u žena s teškim oblikom astme koje se liječe oralnim glukokortikoidima.
English: Ulipristal acetate n=34
Croatian: Ulipristalacetat n=34
English: Skin lesion Pruritus
Croatian: Kožne lezije Svrbež
English: Golden film-coated tablet of shield shape (around 10,8 mm diameter) with “ella” engraved on both sides.
Croatian: Filmom obložena tableta zlatne boje u obliku štita (promjera približno 10,8 mm) s utisnutom oznakom „ella“ na obje strane.
English: If you experience these symptoms, do not drive or use machines ellaOne contains lactose
Croatian: Ako primijetite ove simptome, nemojte upravljati vozilima ili strojevima.
English: Ulipristal acetate is a lipophilic compound and is distributed in breast milk, with a mean daily excretion of 13.35 µg [0-24 hours], 2.16 µg [24-48 hours], 1.06 µg [48-72 hours], 0.58 µg [72-96 hours], and 0.31 µg [96-120 hours].
Croatian: Ulipristalacetat je lipofilna tvar i izlučuje se u majčino mlijeko u prosječnim dnevnim količinama od 13,35 μg [0 - 24 sata], 2,16 μg [24 - 48 sati], 1,06 μg [48 - 72 sata], 058 μg [72 - 96 sati], 0,31 μg [96 - 120 sati].
English: After single dose administration induction of CYP1A2 and CYP3A4 by ulipristal acetate or its active metabolite is not likely.
Croatian: Nakon primjene pojedinačne doze nije vjerojatna indukcija CYP1A2 i CYP3A4 ulipristalacetatom ili njegovim aktivnim metabolitom.
English: Take one tablet as soon as possible after unprotected sex or contraceptive failure.
Croatian: Uzmite jednu tabletu što prije nakon nezaštićenog snošaja ili zatajenja kontracepcijske metode.
English: Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a Cu-IUD.
Croatian: Vaš liječnik Vam može propisati drugu vrstu (nehormonskog) hitnog kontraceptiva, tj.
English: Following oral administration of a single 30 mg dose, ulipristal acetate is rapidly absorbed, with a peak plasma concentration of 176 ± 89 ng/ml occurring approximately 1 hour (0.5-2.0 h) after ingestion, and with an AUC0-∞ of 556 ± 260 ng.h/ml.
Croatian: Primijenjen peroralno u jednokratnoj dozi od 30 mg, ulipristalacetat se brzo apsorbira dostižući vršnu koncentraciju u plazmi od 176 ± 89 ng/ml oko 1 sat (0,5-2,0 h) nakon ingestije, s AUC0-∞ od 556 ± 260 ng.h/ml.
English: p<0.005*
Croatian: n=8 p<0,005*
English: (See section “Pregnancy, breast-feeding and fertility”)
Croatian: (Pogledajte dio „Trudnoća, dojenje i plodnost“).
English: Do not take this medicine together with another emergency contraceptive pill that contains levonorgestrel.
Croatian: Ovaj lijek nemojte upotrebljavati zajedno s drugim hitnim kontracepcijskim tabletama koje sadrže levonorgestrel.
English: Ulipristal acetate is an emergency contraceptive that decreases pregnancy risk after unprotected intercourse but does not confer contraceptive protection for subsequent acts of intercourse.
Croatian: Ulipristalacetat hitna je kontracepcija koja smanjuje rizik od trudnoće nakon nezaštićenog snošaja, ali ne štiti od začeća pri sljedećim snošajima.
English: If you have sex again after taking ellaOne
Croatian: Ako ponovno imate snošaj nakon uzimanja ellaOne
English: What ellaOne looks like and contents of the pack ellaOne is a golden film-coated tablet of shield shape (around 10.8 mm diameter) with “ella” engraved on both sides.
Croatian: Kako ellaOne izgleda i sadržaj pakiranja ellaOne je filmom obložena tableta zlatne boje u obliku štita (promjera približno 10,8 mm) s utisnutom oznakom „ella“ na obje strane.
English: If you vomit (be sick, throw up) within 3 hours of taking the tablet, take another tablet as soon as possible.
Croatian: Ako povratite unutar 3 sata nakon uzimanja tablete, uzmite drugu tabletu što je prije moguće.
English: In the absence of specific studies, no alternate dose recommendations for ulipristal acetate can be made.
Croatian: Zbog nedostatka odgovarajućih ispitivanja ne mogu se dati drugačije preporuke za doziranje ulipristalacetata.
English: In vitro data indicate that this is predominantly mediated by CYP3A4, and to a small extent by CYP1A2 and CYP2A6.
Croatian: Prema podacima dobivenim in vitro, metabolizam je predominantno posredovan CYP3A4, a u manjoj mjeri CYP1A2 i CYP2A6.
English: Concomitant use of ellaOne with CYP3A4 inducers is not recommended due to interaction (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicinal products containing Hypericum perforatum (St. John's wort), rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine and long term use of ritonavir).
Croatian: Istodobna primjena ellaOne s induktorima CYP3A4 ne preporučuje se zbog interakcija (npr. barbiturati (uključujući primidon i fenobarbital), fenitoin, fosfenitoin, karbamazepin, okskarbazepin, biljni lijekovi koji sadrže Hypericum perforatum (gospinu travu), rifampicin, rifabutin, grizeofulvin, efavirenz, nevirapin i dugotrajna primjena ritonavira).
English: Administration of ulipristal acetate together with a high-fat breakfast resulted in approximately 45% lower mean Cmax, a delayed Tmax (from a median of 0.75 hours to 3 hours) and 25% higher mean AUC0-∞ compared with administration in the fasted state.
Croatian: Primjena ulipristalacetata uz doručak bogat mastima rezultirala je s oko 45% smanjenjem srednje vrijednosti Cmax, odgođenim Tmax (sa medijana od 0,75 sati na 3 sata) i 25% višom srednjom vrijednosti AUC0-∞ u usporedbi s primjenom natašte.
English: The tablet can be taken at any time during the menstrual cycle.
Croatian: Tableta se smije uzeti bilo kada tijekom menstruacijskog ciklusa.
English: The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir is used for a longer period.
Croatian: Inhibitor CYP3A4, ritonavir, također može pri dugotrajnoj primjeni imati inducirajući učinak na CYP3A4.
English: Midsona Finland Oy Puh/Tel: + 358-(0) 20 743 4755
Croatian: Suomi/Finland Midsona Finland Oy Puh/Tel: + 358-(0) 20 743 4755
English: Ulipristal acetate for emergency contraception is suitable for any woman of child bearing age, including adolescents.
Croatian: Ulipristalacetat kao hitna kontracepcija pogodan je za sve žene reproduktivne dobi, uključujući adolescentice.
English: If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant.
Croatian: Ako imate nezaštićen snošaj nakon uzimanja tablete, to neće spriječiti trudnoću.
English: If you miss your period and experience such symptoms after taking ellaOne, you should do a pregnancy test (see section 2 “Pregnancy, breastfeeding and fertility”).
Croatian: Ako Vaša menstruacija izostane, a imate ove simptome nakon uzimanja ellaOne, trebali biste napraviti test na trudnoću (pogledajte dio 2 „Trudnoća, dojenje i plodnost”).
English: Ulipristal acetate is excreted in breast milk (see section 5.2).
Croatian: Ulipristalacetat se izlučuje u majčino mlijeko (vidjeti dio 5.2).
English: ESTONIA
Croatian: ESTONIJA
English: What ellaOne looks like and contents of the pack ellaOne is a white to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on both sides.
Croatian: Kako ellaOne izgleda i sadržaj pakiranja ellaOne je okrugla tableta bijele do mramorno krem boje sa zaobljenim stranama promjera 9 mm s utisnutom oznakom „ella“ na obje strane.
English: Genital pruritus Dyspareunia Ruptured ovarian cyst Vulvovaginal pain Hypomenorrhea*
Croatian: Svrbež spolovila Dispareunija Prsnuće ciste jajnika Bol vulve i vagine Hipomenoreja*
English: ellaOne 30 mg tablet
Croatian: ellaOne 30 mg tableta
English: If you have unprotected sex after taking this medicine, it will not stop you from becoming pregnant.
Croatian: Ako imate nezaštićen snošaj nakon uzimanja ovog lijeka, to neće spriječiti trudnoću.
English: HRA Pharma Benelux Tel: +32 2 709 2295
Croatian: Nederland HRA Pharma Benelux Tel: +32 2 709 2295
English: The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure.
Croatian: Postupak se sastoji od peroralne primjene jedne tablete što je prije moguće, ali ne kasnije od 120 sati (5 dana) nakon nezaštićenog snošaja ili zatajenja kontracepcijske metode.
English: If you miss your period and experience such symptoms after taking ellaOne, you should do a pregnancy test (See section “Pregnancy, breastfeeding and fertility”).
Croatian: Ako Vaša menstruacija izostane, a imate ove simptome nakon uzimanja ellaOne, trebali biste napraviti test na trudnoću (pogledajte dio „Trudnoća, dojenje i plodnost”).
English: If you become pregnant despite taking the tablet, it is important that you see your doctor.
Croatian: Ako zatrudnite iako ste uzeli tabletu, važno je da se obratite svom liječniku.
English: GREECE
Croatian: GRČKA
English: Treatment after LH surge but before LH peak n=10
Croatian: Primjena nakon početka LH vala, ali prije vršne koncentracije LH
English: Emotional disorder Anxiety
Croatian: Emocionalni poremećaj Anksioznost Nesanica
English: Treatment before LH surge n=16
Croatian: Primjena prije početka LH vala n=16
English: Ulipristal acetate does not interrupt an existing pregnancy.
Croatian: Ulipristalacetat ne prekida postojeću trudnoću.
English: Medicinal product not subject to medical prescription.
Croatian: Lijek se izdaje bez recepta.
English: Administration of ulipristal acetate (10 mg tablet) together with the proton pump inhibitor esomeprazole (20 mg daily for 6 days) resulted in approximately 65% lower mean Cmax, a delayed Tmax (from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC.
Croatian: Primjena ulipristalacetata (tableta od 10 mg) zajedno s inhibitorom protonske pumpe esomeprazolom (20 mg dnevno tijekom 6 dana) rezultirala je s oko 65% nižom srednjom vrijednosti Cmax, kasnijim Tmax (od medijana 0,75 sati do 1,0 sata) i 13% višom srednjom vrijednosti AUC-a.
English: If you have any further questions on the use of this medicine, ask your pharmacist, doctor or other healthcare professional.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom ljekarniku, liječniku ili drugom zdravstvenom djelatniku.
English: How to take ellaOne
Croatian: Kako uzeti ellaOne
English: In vivo results show that administration of ulipristal acetate with a potent and a moderate CYP3A4 inhibitor increased Cmax and AUC of ulipristal acetate with a maximum of 2- and 5.9-fold, respectively.
Croatian: In vivo rezultati pokazuju da primjena ulipristalacetata s jakim i umjerenim inhibitorima CYP3A4 povećava Cmax odnosno AUC ulipristalacetata do najviše 2 odnosno 5,9 puta.
English: - Take one tablet by mouth as soon as possible and no later than 5 days (120 hours) after unprotected sex or contraceptive failure.
Croatian: • Uzmite jednu tabletu kroz usta što je prije moguće, ali ne kasnije od 5 dana (120 sati) nakon nezaštićenog snošaja ili zatajenja kontracepcijske metode.
English: In vitro data indicate that ulipristal acetate may be an inhibitor of P-gp at clinically relevant concentrations.
Croatian: In vitro podaci pokazuju da ulipristalacetat u klinički značajnim koncentracijama može biti inhibitor P-gp.
English: Premenstrual syndrome
Croatian: Navala vrućine Predmenstruacijski sindrom
English: A&D Pharma Bulgaria Teл.
Croatian: A&D Pharma Romania
English: Abdominal pain* Abdominal discomfort Vomiting*
Croatian: Bol u abdomenu* Nelagoda u abdomenu Povraćanje*
English: See section “Pregnancy, breast-feeding and fertility” for more information.
Croatian: Više informacija potražite u dijelu „Trudnoća, dojenje i plodnost”.
English: If you become pregnant despite taking this medicine, it is important that you see your doctor.
Croatian: Ako zatrudnite iako ste uzeli ovaj lijek, važno je da se obratite svom liječniku.
English: Rare side effects (may affect up to 1 in 1,000 people)
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba)
English: If you wish to start or continue with a regular method of contraception after using this medicine, you can do so but you should also use condoms until your next period.
Croatian: Nakon uzimanja ovog lijeka možete početi ili nastaviti s uzimanjem redovne kontracepcije, ali do sljedeće menstruacije trebate upotrebljavati i kondome.
English: If you vomit after taking ellaOne
Croatian: Ako povratite nakon uzimanja ellaOne
English: - muscle pain, back pain, tiredness
Croatian: • bol u mišićima, bol u leđima, umor
English: You can take the tablet at any time in the menstrual cycle.
Croatian: Tabletu možete uzeti u bilo kojem trenutku menstruacijskog ciklusa.
English: Placebo n=50
Croatian: Sprječavanje ovulacije1,§ Placebo n=50
English: Name and address of the manufacturers responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet Cenexi
English: Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
Croatian: Hitna kontracepcija unutar 120 sati (5 dana) nakon nezaštićenog snošaja ili zatajenja kontracepcijske metode.
English: Ulipristal acetate
Croatian: Ulipristalacetat
English: PVC-PE-PVDC-Aluminium blister of 1 tablet.
Croatian: 1 tableta u PVC-PE-PVDC-aluminijskom blisteru.
English: Women should be advised to use a reliable barrier method for all subsequent acts of intercourse until the next menstrual period.
Croatian: Žene treba savjetovati da kod sljedećih snošaja upotrebljavaju pouzdana mehanička kontracepcijska sredstva do sljedeće menstruacije.
English: Tablet White to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on both sides.
Croatian: Okrugla tableta bijele do mramorno krem boje sa zaobljenim stranama promjera 9 mm s utisnutom oznakom „ella“ na obje strane.
English: Pregnancy, breast-feeding and fertility
Croatian: Trudnoća, dojenje i plodnost Trudnoća
English: Ulipristal acetate inhibits or postpones ovulation (see section 5.1).
Croatian: Ulipristalacetat sprječava ili odgađa ovulaciju (vidjeti dio 5.1).
English: <{DD/MM/YYYY}>
Croatian: DATUM REVIZIJE TEKSTA <{DD/MM/GGGG}>
English: Common side effects (may affect up to 1 in 10 people)
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba)
English: How to take the ellaOne film-coated tablet
Croatian: Kako uzeti filmom obloženu tabletu ellaOne
English: Reporting of suspected adverse reactions after authorisation of the medicinal product is important.
Croatian: Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.
English: Package leaflet: Information for the user ellaOne 30 mg tablet
Croatian: Uputa o lijeku: Informacija za korisnika ellaOne 30 mg tableta ulipristalacetat
English: sucursal em Portugal Tel: +351 707 501 996
Croatian: HRA Pharma Iberia S.L. sucursal em Portugal Tel: +351 707 501 996
English: Normal
Croatian: Često
English: FINLAND
Croatian: FINSKA
English: If you are currently taking hormonal contraception, continue to use it as usual after taking this medicine, but be sure to use condoms every time you have sex until your next period.
Croatian: Ako trenutačno uzimate hormonsku kontracepciju, nakon uzimanja ovog lijeka nastavite je uzimati kao i obično, ali do sljedeće menstruacije pri svakom spolnom odnosu upotrebljavajte kondome.
English: If you are currently taking hormonal contraception, continue to use it as usual after taking the tablet, but be sure to use condoms every time you have sex until your next period.
Croatian: Ako trenutačno uzimate hormonsku kontracepciju, nakon uzimanja tablete nastavite je uzimati kao i obično, ali do sljedeće menstruacije pri svakom spolnom odnosu upotrebljavajte kondome.
English: The effects of the P-gp substrates are unlikely to have any clinical consequences.
Croatian: P-gp supstrata imaju ikakve kliničke posljedice.
English: Ulipristal acetate has minor or moderate influence on the ability to drive or use machines: mild to moderate dizziness is common after ellaOne intake, somnolence and blurred vision are uncommon; disturbance in attention has been rarely reported.
Croatian: Nakon uzimanja ellaOne blaga do umjerena omaglica je česta, somnolencija i zamagljen vid su manje česti, a poremećaj pažnje prijavljen je rijetko.
English: Disorientation
Croatian: Dezorijentacija
English: Disturbance in attention Dysgueusia
Croatian: Poremećaj pažnje Disgeuzija Sinkopa
English: Tablet core: lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate Film coating: poly(vinyl alcohol) (E1203), macrogol (E1521), talc (E553b), titanium dioxide (E171), polysorbate 80 (E433), iron oxide yellow (E172), potassium aluminium silicate (E555)
Croatian: - Drugi sastojci su: - Jezgra tablete: laktoza hidrat, povidon, umrežena karmelozanatrij, magnezijev stearat - Film ovojnica: poli(vinilni alkohol) (E1203), makrogol (E1521), talk (E553b), titanijev dioksid
English: Uncommon side effects (may affect up to 1 in 100 people)
Croatian: Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba)
English: after using emergency contraception, women should be advised to use a reliable barrier method until her next menstrual period.
Croatian: Stoga bi žene trebalo savjetovati da nakon uzimanja hitne kontracepcije upotrebljavaju pouzdano mehaničko kontracepcijsko sredstvo do sljedeće menstruacije.
English: PVC-PVDC-Aluminium blister of 1 tablet.
Croatian: 1 tableta u PVC-PVDC-aluminijskom blisteru.