FrancophonIA/ELRC3.0 huggingface dataset:
English: There is a particularly high risk of becoming pregnant if you miss white active tablets at the beginning or at the end of the blister.
Croatian: Rizik od trudnoće osobito je visok ako propustite bijelu tabletu s djelatnim tvarima na početku ili na kraju blistera.
English: The 4 placebo tablets from the last row must be discarded.
Croatian: Četiri tablete placeba iz posljednjeg reda treba baciti.
English: Schedule: if you are 24 or more hours late taking white tablets
Croatian: Raspored: ako je prošlo 24 ili više sati otkad ste posljednji put uzeli bijele tablete
English: • if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack ) or transient ischaemic attack (TIA - temporary stroke symptoms);
Croatian: • ako imate (ili ste ikada imali) anginu pektoris (stanje koje uzrokuje jaku bol u prsištu i može biti prvi znak srčanog udara) ili prolazni ishemijski napadaj (TIA - prolazni simptomi moždanog udara);
English: o A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as:
Croatian: o Visoki rizik od arterijske tromboembolije zbog prisutnosti višestrukih čimbenika rizika (vidjeti dio 4.4) ili prisutnost jednog ozbiljnog čimbenika rizika kao što je:
English: Factors that increase your risk of a blood clot in an artery
Croatian: Čimbenici koji Vam povećavaju rizik od nastanka krvnog ugruška u arteriji
English: It is unknown whether the amount of estradiol in Zoely is sufficient to maintain adequate levels of estradiol in adolescents, especially for bone mass accrual (see section 5.2).
Croatian: Nije poznato je li količina estradiola u lijeku Zoely dostatna za održavanje odgovarajućih razina estradiola u adolescentica, osobito za prirast koštane mase (vidjeti dio 5.2).
English: • If you have taken all the tablets correctly, and you have not vomited or had severe diarrhoea, or used other medicines, then it is very unlikely that you are pregnant.
Croatian: • Ako ste uzeli sve tablete na pravilan način i niste povraćali ili imali teški proljev ili koristili druge lijekove, onda nije vjerojatno da ste trudni.
English: Concomitant use of rifampicin decreases the AUC0-∞ of nomegestrol acetate by 95 % and increases the AUC0-tlast of estradiol by 25 %.
Croatian: Istodobna primjena rifampicina smanjuje AUC0-∞ nomegestrolacetata za 95% te povećava AUC0-tlast estradiola za 25%.
English: • if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation)
Croatian: • ako imate tegobe sa srcem (poremećaj zalistaka, poremećaj srčanog ritma koji se zove fibrilacija atrija);
English: Clinical data on a limited number of exposed pregnancies indicate no adverse effect of Zoely on the foetus or neonate.
Croatian: Klinički podaci iz ograničenog broja izloženih trudnoća nisu ukazali na štetne učinke lijeka Zoely na fetus ili novorođenče.
English: When is the risk of developing a blood clot in a vein highest?
Croatian: Kada je rizik od razvoja krvnog ugruška u veni najveći?
English: In case of severe gastro-intestinal disturbance (e.g., vomiting or diarrhoea), absorption of the active substances may not be complete and additional contraceptive measures should be taken.
Croatian: U slučaju teških gastrointestinalnih poremećaja (npr. povraćanja ili proljeva), apsorpcija djelatne tvari će možda biti nepotpuna i potrebno je poduzeti dodatne kontracepcijske mjere.
English: Products containing oestrogens may induce or worsen symptoms of angioedema;
Croatian: Lijekovi koji sadrže estrogene mogu izazvati ili pogoršati simptome angioedema;
English: • Some medicines can increase the levels of the active substances of Zoely in the blood.
Croatian: • Neki lijekovi mogu povećati razine djelatnih tvari lijeka Zoely u krvi.
English: If absence of withdrawal bleeding occurs and Zoely has been taken according to the instructions as described in section 4.2, it is unlikely that the woman is pregnant.
Croatian: Ako prijelomno krvarenje izostane, a Zoely se uzimao u skladu s uputama opisanima u dijelu 4.2, žena vjerojatno nije trudna.
English: However, the missed tablets should be discarded to avoid unintentionally prolonging the placebo tablet phase.
Croatian: Međutim, propuštene tablete treba baciti kako bi se izbjeglo nehotično produljivanje faze uzimanja tableta placeba.
English: In the Zoely group, acne was reported by 15.4 % of the women (versus 7.9 % in the comparator group), weight increased was reported by 8.6 % of the women (versus 5.7 % in the comparator group), and abnormal withdrawal bleeding (predominantly absence of withdrawal bleeding) was reported by 10.5 % of the women (versus 0.5 % in the comparator group).
Croatian: U skupini koja je primala Zoely akne su prijavljene u 15,4% žena (naspram 7,9% u skupini koja je primala usporedni lijek), porast tjelesne težine prijavljen je u 8,6% žena (naspram 5,7% u skupini koja je primala usporedni lijek), a poremećaj prijelomnog krvarenja (uglavnom izostanak krvarenja) prijavljen je u 10,5% žena (naspram 0,5% slučajeva u skupini koja je primala usporedni lijek).
English: • as you get older (particularly above about 35 years);
Croatian: • s napredovanjem dobi (osobito nakon približno 35. godine);
English: After finishing the 4 yellow placebo tablets from the second blister, start with the next (third) blister.
Croatian: Nakon što ste uzeli 4 tablete placeba iz drugog blistera, počnite sa sljedećim (trećim) blisterom.
English: You should also tell your doctor if a close relative has, or ever had breast cancer (see section 2 “When to take special care with Zoely”).
Croatian: Morate također reći svom liječniku ako netko od Vaših bliskih krvnih srodnika ima ili je imao rak dojke (pogledajte u dijelu 2 "Kada je potreban poseban oprez sa lijekom Zoely").
English: • if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides);
Croatian: • ako imate ili netko u Vašoj užoj obitelji ima visoke vrijednosti masnoća u krvi (kolesterol ili trigliceride);
English: If you vomit or have severe diarrhoea
Croatian: Ako povraćate ili imate teški proljev
English: • They are one of the most reliable reversible methods of contraception if used correctly.
Croatian: • Ako se ispravno primjenjuju, jedna su od najpouzdanijih reverzibilnih metoda kontracepcije.
English: Since the metabolism of steroid hormones might be impaired in patients with severe hepatic disease, the use of Zoely in these women is not indicated as long as liver function values have not returned to normal (see section 4.3).
Croatian: S obzirom da korisnice s teškom bolesti jetre mogu imati poremećaj metabolizma steroidnih hormona, primjena lijeka Zoely u tih žena nije indicirana sve dok se jetrene funkcije ne vrate na normalne vrijednosti (vidjeti dio 4.3).
English: In a randomized, open label trial, 32 women were treated for 6 cycles with Zoely.
Croatian: U randomiziranom otvorenom ispitivanju 32 su žene primale Zoely tijekom 6 ciklusa.
English: If you follow these instructions, it is not necessary to use an additional contraceptive method.
Croatian: Ako se pridržavate ovih uputa, ne trebate koristiti dodatne mjere kontracepcije.
English: Influence of other medicinal products on Zoely
Croatian: Utjecaj drugih lijekova na Zoely
English: The contraceptive effect of Zoely is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in the cervical secretion.
Croatian: Kontracepcijski učinak lijeka Zoely temelji se na interakciji različitih čimbenika, od kojih se najvažnijima smatraju inhibicija ovulacije i promjene cervikalnog iscjetka.
English: However, if a sustained clinically significant hypertension develops during the use of a COC, then it is prudent for the physician to suspend the intake of the tablets and treat the hypertension.
Croatian: Međutim, ako se tijekom primjene KOK-a razvije dugotrajna i klinički značajna hipertenzija, primjereno je da liječnik obustavi uzimanje tableta i liječi hipertenziju.
English: Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma
Croatian: Dugotrajna imobilizacija, veliki kirurški zahvat, bilo kakav kirurški zahvat na nogama ili zdjelici, neurokirurški zahvat ili velika trauma
English: Interactions between oral contraceptives and enzyme-inducing medicinal products may lead to breakthrough bleeding and/or contraceptive failure.
Croatian: Interakcije između oralnih kontraceptiva i lijekova koji induciraju enzime mogu dovesti do probojnog krvarenja pa čak i/ili neuspjeha kontracepcije.
English: • Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use (see section 4.8).
Croatian: • Depresivno raspoloženje i depresija dobro su poznate nuspojave primjene hormonskih kontraceptiva (vidjeti dio 4.8).
English: [Box for placing day label stating:] Place day label here [Day numbering for each individual tablet:] Start,2, ….28 [Arrows indicating the sequence of the tablets:] 
Croatian: [Okvir za oznake za dane s natpisom:] Ovdje nalijepite naljepnicu s oznakama dana [Broj dana za svaku pojedinu tabletu:] Početak, 2, .... 28 [Strelice koje upućuju na redoslijed tableta:] 
English: These may include curettage.
Croatian: Te mjere mogu podrazumijevati i kiretažu.
English: During clinical trials, absence of withdrawal bleeding ranged over the cycles 1-12 from 18 % to 32 %.
Croatian: Tijekom kliničkih ispitivanja izostanak prijelomnog krvarenja od 1. do 12. ciklusa kretao se u rasponu od 18% do 32%.
English: The hormonal active ingredients in the tablet may have harmful effects if they reach the aquatic environment.
Croatian: Hormonske djelatne tvari u tableti mogu izazvati štetne učinke dospiju li u vodeno okruženje.
English: The oestrogen contained in Zoely is 17β-estradiol, a natural oestrogen identical to the endogenous human 17β-estradiol.
Croatian: Estrogen u lijeku Zoely je 17-estradiol, prirodni estrogen identičan humanom endogenom 17-estradiolu.
English: • There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis.
Croatian: • Nema konsenzusa o mogućoj ulozi varikoznih vena i superficijalnog tromboflebitisa u nastanku ili progresiji venske tromboze.
English: The tablets should be returned to a pharmacy or disposed of in another safe way according to local requirements.
Croatian: Tablete se moraju vratiti u ljekarnu ili zbrinuti na drugi siguran način u skladu s lokalnim propisima.
English: Psychiatric disorders decreased libido, depression/ depressed mood, mood altered increased libido
Croatian: Psihijatrijski poremećaji smanjen libido, depresija/depresivno raspoloženje, promjena raspoloženja pojačan libido
English: If you want to stop Zoely because you want to get pregnant, see in section 3 ‘If you stop taking Zoely'.
Croatian: Ako želite prestati uzimati Zoely jer želite zatrudnjeti, pogledajte u dijelu 3 'Ako prestanete uzimati Zoely'.
English: • An increased risk of cervical cancer in long-term users of COCs (> 5 years) has been reported in some epidemiological studies, but there continues to be controversy about the extent to which this finding is attributable to the confounding effects of sexual behaviour and other factors such as human papilloma virus (HPV).
Croatian: • U nekim je epidemiološkim ispitivanjima prijavljen povećan rizik od raka vrata maternice u dugotrajnih korisnica KOK-a (> 5 godina), no i dalje je sporno u kojoj se mjeri ovaj nalaz može pripisati istodobnim učincima spolnog ponašanja i drugih čimbenika poput humanog papiloma virusa (HPV).
English: You may not have any bleeding during the shortened period of yellow placebo tablet intake.
Croatian: Možda nećete imati krvarenje tijekom skraćenog razdoblja uzimanja žutih tableta placeba.
English: Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.
Croatian: Napomena: Potrebno je provjeriti sažetak opisa svojstava lijekova koji se istodobno primjenjuju kako bi se utvrdile moguće interakcije.
English: In animal studies, reproductive toxicity has been observed with the nomegestrol acetate / estradiol combination (see preclinical safety data in section 5.3).
Croatian: U istraživanjima na životinjama opažena je reproduktivna toksičnost kod primjene kombinacije nomegestrolacetat/estradiol (vidjeti pretkliničke podatke o sigurnosti primjene u dijelu 5.3).
English: In rare cases a blood clot can block blood vessels and cause serious problems.
Croatian: U rijetkim slučajevima krvni ugrušak može začepiti krvnu žilu i prouzročiti ozbiljne tegobe.
English: There is a dynamic equilibrium between estradiol, estrone and estrone-Sulfate due to various enzymatic activities including estradiol-dehydrogenases, sulfotransferases and aryl sulfatases.
Croatian: Postoji dinamička ravnoteža između estradiola, estrona i estronsulfata zbog djelovanja različitih enzima uključujući estradiol-dehidrogenaze, sulfotransferaze i aril sulfataze.
English: Some of these symptoms (e.g. “shortness of breath”, “coughing”) are non-specific and might be misinterpreted as more common or less severe events (e.g. respiratory tract infections).
Croatian: Neki od ovih simptoma (npr. "nedostatak zraka", "kašalj") nisu specifični i mogu se pogrešno zamijeniti za uobičajenije ili manje teške događaje (npr. infekciju dišnih puteva).
English: Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE.
Croatian: Lijekovi koji sadrže levonorgestrel, norgestimat ili noretisteron povezani su s najnižim rizikom od VTE.
English: This results in a highly variable baseline-corrected elimination half-life of estradiol, which is calculated to be 3.6 ± 1.5 h, after intravenous administration.
Croatian: Posljedica toga je vrlo promjenjivo poluvrijeme eliminacije estradiola korigirano prema početnoj vrijednosti, koje iznosi 3,6 ± 1,5 h nakon intravenske primjene.
English: What is the risk of developing a blood clot?
Croatian: Koliki je rizik od razvoja krvnog ugruška?
English: Blood clots blocking other blood vessels
Croatian: Krvni ugrušci koji su začepili druge krvne žile
English: The pharmacokinetics of nomegestrol acetate are not influenced by SHBG.
Croatian: Na farmakokinetiku nomegestrolacetata ne utječe SHBG.
English: Retinal vein thrombosis (blood clot in the eye)
Croatian: Tromboza retinalne vene (krvni ugrušak u oku)
English: • Presence or history of liver tumours (benign or malignant).
Croatian: • Prisutnost ili anamneza tumora jetre (benignih ili malignih).
English: Each pack starts with 24 white active tablets, followed by 4 yellow placebo tablets.
Croatian: Svako pakiranje počinje s 24 bijele tablete s djelatnim tvarima, nakon čega slijede 4 žute tablete placeba.
English: 28 film-coated tablets 84 film-coated tablets 168 film-coated tablets 364 film-coated tablets
Croatian: 28 filmom obloženih tableta 84 filmom obložene tablete 168 filmom obloženih tableta 364 filmom obložene tablete
English: • swelling of one leg or along a vein in the leg or foot especially when accompanied by:
Croatian: • oticanje jedne noge ili oticanje duž vene u nozi ili stopalu osobito ako je praćeno:
English: You should ask your doctor how soon after delivery you can start taking Zoely.
Croatian: Upitajte svog liječnika kada najranije nakon porođaja možete početi uzimati Zoely;
English: If you stop taking Zoely
Croatian: Ako prestanete uzimati Zoely
English: • increased sweating; hair loss; itching; dry skin; oily skin
Croatian: • pojačano znojenje; gubitak kose; svrbež; suha koža; masna koža
English: • sudden unexplained breathlessness or rapid breathing;
Croatian: • iznenadni neobjašnjivi nedostatak zraka ili ubrzano disanje;
English: • severe hypertension
Croatian: • teška hipertenzija
English: Do not use rhythm or temperature methods.
Croatian: Nemojte se služiti metodama određivanja plodnih dana ili tjelesne temperature.
English: Most epidemiological studies have revealed neither an increased risk of birth defects in infants born to women who used ethinylestradiol-containing COCs prior to pregnancy, nor a teratogenic effect when ethinylestradiol-containing COCs were taken inadvertently during early pregnancy.
Croatian: Većina epidemioloških studija nije otkrila povećan rizik od prirođenih anomalija u novorođenčadi čije su majke prije trudnoće uzimale KOK koji je sadržavao etinilestradiol kao ni teratogene učinke kod slučajnog uzimanja KOK-a u ranoj trudnoći.
English: • change in colour of the skin on the leg e.g. turning pale, red or blue
Croatian: • promjena boje kože na nozi, npr. ako poblijedi, pocrveni ili poplavi
English: The situation is similar to if you forget a white active tablet.
Croatian: To je slično kao kad zaboravite uzeti bijelu tabletu s djelatnim tvarima.
English: • 7 days of uninterrupted ‘white active tablet'-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis.
Croatian: • Potrebno je 7 dana neprekidnog uzimanja 'bijele tablete s djelatnim tvarima' kako bi se postigla odgovarajuća supresija osi hipotalamus-hipofiza-jajnik.
English: In two randomized, open-label, comparative efficacy-safety trials, more than 3,200 women have been treated for up to 13 consecutive cycles with Zoely and more than 1,000 women with drospirenone 3 mg - ethinylestradiol 30 μg (21/7 regimen).
Croatian: U dva randomizirana, otvorena, komparativna ispitivanja djelotvornosti i sigurnosti je više od 3200 žena tijekom 13 uzastopnih ciklusa primalo Zoely, a više od 1000 žena kombinaciju drospirenona u dozi od 3 mg i etinilestradiola u dozi od 30 µg (režim 21/7).
English: If you have taken your tablets correctly in the 7 days prior to the missed tablet, the protection against pregnancy is not reduced, and you do not need to use extra precautions.
Croatian: Ako ste ispravno uzimali tablete tijekom 7 dana prije propuštene tablete, zaštita od trudnoće nije smanjena i ne trebate primijeniti dodatne mjere opreza.
English: Withdrawal bleeding usually starts on day 2-3 after intake of the last white tablet and may not have finished before the next pack is started.
Croatian: Prijelomno krvarenje obično počinje 2 do 3 dana nakon uzimanja posljednje bijele tablete i možda neće završiti prije započinjanja sljedećeg pakiranja.
English: Return them to a pharmacy or dispose them in another safe way according to local requirements.
Croatian: Vratite neiskorištene tablete u ljekarnu ili ih zbrinite na drugi siguran način u skladu s lokalnim zahtjevima.
English: What you need to know before you use Zoely
Croatian: Što morate znati prije nego počnete uzimati Zoely
English: After having a baby
Croatian: I DOHVATA DJECE
English: Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
Croatian: Hipertrigliceridemija je povezana s povećanim rizikom za razvoj pankreatitisa (upale gušterače);
English: • increased liver enzymes
Croatian: • povišene razine jetrenih enzima
English: If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g., a ‘common cold').
Croatian: Ako niste sigurni, razgovarajte s liječnikom jer se neki od ovih simptoma, kao što su kašljanje ili nedostatak zraka, mogu zamijeniti s blažim stanjem, kao što je infekcija dišnih puteva (npr. "obična prehlada").
English: Genotoxicity and carcinogenicity studies were not conducted with the combination.
Croatian: Nisu provedena ispitivanja genotoksičnosti i kancerogenosti s kombinacijom ovih dvaju lijekova.
English: Throw away the yellow placebo tablet(s) you missed and continue taking the next tablets at the usual time.
Croatian: Bacite žutu tabletu (tablete) placeba koju ste propustili i nastavite uzimati sljedeće tablete u uobičajeno vrijeme.
English: • Although COCs may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using low-dose COCs (containing  0.05 mg ethinylestradiol).
Croatian: • Iako kombinirani oralni kontraceptivi mogu utjecati na perifernu inzulinsku rezistenciju i toleranciju glukoze, nema dokaza da je potrebno mijenjati terapijski režim u žena sa šećernom bolešću koje koriste KOK u niskim dozama (koji sadrži < 0,05 mg etinilestradiola).
English: However, pregnancy must be ruled out before Zoely use is continued, if Zoely has not been taken as directed or if two consecutive withdrawal bleedings are missed.
Croatian: Ipak, treba isključiti trudnoću prije nastavka uporabe lijeka Zoely ako se lijek nije uzimao prema uputama ili su izostala dva uzastopna prijelomna krvarenja.
English: • swelling and slight blue discolouration of an extremity; • severe pain in your stomach (acute abdomen).
Croatian: • oticanje i blago plavičasta boja ekstremiteta; • jaka bol u trbuhu (akutni abdomen)
English: An implant or IUS may be removed any day, and Zoely should be started on the day of its removal.
Croatian: Implantat ili IUS mogu se ukloniti bilo koji dan, a uzimanje lijeka Zoely treba započeti na dan njihovog uklanjanja.
English: If the condition develops, or gets worse while you are using Zoely, you should also tell your doctor.
Croatian: Ako se neko od navedenih stanja razvije ili pogorša dok uzimate Zoely, također trebate o tome obavijestiti svog liječnika.
English: There were no abnormal results.
Croatian: Rezultati nisu odstupali od normale.
English: Tablets should be taken with some liquid as needed, and in the order as directed on the blister.
Croatian: Tablete po potrebi treba uzimati s malo tekućine te prema redoslijedu naznačenom na blisteru.
English: Concomitant use of ketoconazole (200 mg single dose) does not modify estradiol metabolism whereas increases in the peak concentration (85 %) and AUC0-∞ (115 %) of nomegestrol acetate were observed, which were of no clinical relevance.
Croatian: Istodobna primjena ketokonazola (jedna doza od 200 mg) ne mijenja metabolizam estradiola, no opaženi su slučajevi porasta vršne koncentracije (85%) i AUC0-∞ (115%) nomegestrolacetata koji nisu bili klinički značajni.
English: Women should be advised not to smoke if they wish to use a CHC.
Croatian: Ženama treba savjetovati da ne puše ako žele koristiti kombinirane hormonske kontraceptive.
English: The efficacy of COCs may be reduced in the event of e.g., missed tablets (see section 4.2), gastro-intestinal disturbances during active tablet-taking (see section 4.2) or use of concomitant medicinal products that decrease the plasma concentrations of nomegestrol acetate and/or estradiol (see section 4.5).
Croatian: Djelotvornost kombiniranih oralnih kontraceptiva može biti smanjena u slučaju npr. propuštenih tableta (vidjeti dio 4.2), probavnih poremećaja tijekom uzimanja tableta s djelatnim tvarima (vidjeti dio 4.2) ili istodobnog uzimanja lijekova koji smanjuju koncentraciju nomegestrolacetata i/ili estradiola u plazmi (vidjeti dio 4.5).
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progestogens and oestrogens, fixed combinations, ATC code: G03AA14.
Croatian: Farmakoterapijska skupina: Spolni hormoni i ostali pripravci koji djeluju na spolni sustav, progestageni i estrogeni, fiksne kombinacije, ATK oznaka: G03AA14.
English: Since the effect of another medicine on Zoely may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive method for that long.
Croatian: Budući da učinak drugog lijeka na Zoely može trajati do 28 dana nakon prestanka uzimanja tog lijeka, toliko dugo morate koristiti dodatnu mehaničku metodu kontracepcije.
English: You do not need to use extra precautions if you have taken your tablets correctly in the 7 days prior to the missed tablet.
Croatian: Ne morate primijeniti dodatne mjere opreza ako ste ispravno uzeli tablete tijekom 7 dana prije propuštene tablete.