FrancophonIA/ELRC3.0 huggingface dataset:
English: • Zoely may also interfere with the working of other medicines - such as the anti-epileptic lamotrigine.
Croatian: • Zoely također može ometati djelovanje drugih lijekova - poput antiepileptika lamotrigina.
English: Are you experiencing any of these signs?
Croatian: Imate li neki od ovih znakova?
English: Particularly important in women with additional risk factors
Croatian: Osobito važno u žena s dodatnim čimbenicima rizika
English: Available pharmacokinetic data are described in section 5.2.
Croatian: Dostupni farmakokinetički podaci opisani su u dijelu 5.2.
English: One tablet is to be taken daily for 28 consecutive days.
Croatian: Uzima se jedna tableta na dan tijekom 28 uzastopnih dana.
English: You can stop taking Zoely at any time.
Croatian: Možete prestati uzimati Zoely bilo kada.
English: For example, if you start taking the placebo tablets on Friday, and you want to change this to a Tuesday (3 days earlier) you must start a new blister 3 days earlier than usual.
Croatian: Primjerice, ako počnete uzimati tablete placeba u petak i želite to promijeniti na utorak (3 dana ranije), morate početi uzimati novi blister 3 dana ranije nego inače.
English: After stopping the combined pill, the increased risk gradually reduces.
Croatian: Nakon prestanka uzimanja pilule povećani rizik se postupno smanjuje.
English: Estradiol is rapidly cleared from the circulation.
Croatian: Estradiol se ubrzano eliminira iz cirkulacije.
English: In these situations it is advisable to discontinue use of the pill (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation.
Croatian: U tim se situacijama savjetuje prekinuti primjenu pilule (u slučaju elektivnog kirurškog zahvata, najmanje 4 tjedna prije) i nastaviti s primjenom tek nakon što prođu 2 tjedna od potpune remobilizacije.
English: Medical examination/consultation
Croatian: Liječnički pregled/savjetovanje
English: The frequency and nature of examinations should be based on established practice guidelines and be adapted to the individual woman.
Croatian: Učestalost i vrsta pregleda trebaju se temeljiti na utvrđenim smjernicama za praksu i biti prilagođeni pojedinoj ženi.
English: Keep taking Zoely as usual.
Croatian: Nastavite uzimati Zoely na uobičajen način.
English: Date of first authorisation: 27 July 2011 Date of latest renewal: 21 April 2016
Croatian: Datum posljednje obnove: 21. travnja 2016.
English: If you have unexpected bleeding
Croatian: Ako imate neočekivano krvarenje
English: Maximal enzyme induction is generally observed within a few weeks.
Croatian: Maksimalna indukcija enzima uglavnom se opaža unutar nekoliko tjedana.
English: Increasing age
Croatian: Povećana dob
English: • Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases are rare.
Croatian: • Iako su prijavljena mala povišenja krvnog tlaka u mnogih žena koje uzimaju KOK, klinički značajni porasti su rijetki.
English: Similar conclusions are expected in women of childbearing potential.
Croatian: Slični se zaključci očekuju i u žena generativne dobi.
English: The management of missed tablets can be guided by the following two basic rules:
Croatian: Postupanje u slučaju propuštenih tableta može biti u skladu sa sljedeća dva osnovna pravila:
English: If you are not sure what to do, consult your doctor.
Croatian: Ako niste sigurni što Vam je činiti, obratite se svom liječniku.
English: Estradiol circulates in the blood bound to SHBG (37 %) and to albumin (61 %), while only approximately 1-2 % is unbound.
Croatian: Estradiol cirkulira u krvi vezan na SHBG (37%) i na albumin (61%), dok samo približno 1-2% ostaje nevezano.
English: You can also start, at the latest, on the day you would have started using the next ring or patch.
Croatian: Također možete početi najkasnije na dan na koji biste trebali početi koristiti sljedeći prsten ili flaster.
English: • if you have depression;
Croatian: • ako imate depresiju;
English: Contact your doctor if you have unusual severe abdominal pain.
Croatian: Obratite se liječniku ako imate neuobičajeno jake bolove u trbuhu.
English: Combined hormonal contraceptives (CHCs) must not be used in the following conditions.
Croatian: Kombinirani hormonski kontraceptivi (KHK-i) ne smiju se koristiti u sljedećim stanjima.
English: The woman should also be instructed to carefully read the user leaflet and to adhere to the advice given.
Croatian: Ženi također treba savjetovati da pažljivo pročita uputu za korisnice i da se pridržava dobivenih savjeta.
English: Note: Temporary immobilisation including air travel > 4 hours can also be a risk factor for VTE, particularly in women with other risk factors.
Croatian: Napomena: privremena imobilizacija uključujući putovanje avionom >4 sata također može biti čimbenik rizika za VTE, osobito u žena s drugim čimbenicima rizika.
English: These methods can be unreliable because the pill alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.
Croatian: Te metode mogu biti nepouzdane jer pilula remeti uobičajene promjene tjelesne temperature i cervikalne sluzi koje se događaju tijekom mjesečnog ciklusa.
English: • immediate loss of vision or
Croatian: • trenutačni gubitak vida ili
English: Cycle control
Croatian: Kontrola ciklusa
English: Advice in case of gastro-intestinal disturbances
Croatian: Savjet u slučaju gastrointestinalnih poremećaja
English: Tablets must be taken every day at about the same time without regard to meals.
Croatian: Tablete se moraju uzimati svaki dan otprilike u isto vrijeme bez obzira na obroke.
English: Therefore you should follow the rules given below.
Croatian: Stoga se trebate pridržavati pravila u nastavku.
English: The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased.
Croatian: Što više uzastopnih tableta propustite, veći je rizik od smanjene djelotvornosti kontracepcije.
English: After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.
Croatian: Nakon prve godine taj rizik postaje manji, ali uvijek ostaje nešto viši nego ako ne uzimate kombinirane hormonske kontraceptive.
English: If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered.
Croatian: U slučaju spolnog odnosa u prethodnih 7 dana treba uzeti u obzir mogućnost trudnoće.
English: In the meantime, use a non-hormonal contraceptive.
Croatian: U međuvremenu koristite nehormonsku kontracepciju.
English: In total 3,434 women, aged 18-50, were enrolled and completed 33,828 cycles.
Croatian: Ukupno su bile uključene 3434 ispitanice u dobi od 18 do 50 godina koje su dovršile ukupno 33 828 ciklusa.
English: In this leaflet, several situations are described where you should stop taking the pill, or where the reliability of the pill may be decreased.
Croatian: U ovoj je uputi opisano nekoliko situacija u kojima morate prestati uzimati pilulu ili u kojima pouzdanost pilule može biti umanjena.
English: • golden brown pigment patches, mostly in the face; excessive hair growth
Croatian: • zlatnosmeđe pigmentne mrlje, ponajviše na licu; prekomjerni rast dlaka
English: If the woman does not want to change her normal tablet-taking schedule, she has to take the extra white tablet(s) from another pack.
Croatian: Ako žena ne želi promijeniti uobičajeni raspored uzimanja tableta, mora uzeti dodatnu bijelu tabletu (tablete) iz drugog pakiranja.
English: The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
Croatian: Taj rizik ovisi o Vašem prirodnom riziku za VTE i vrsti kombiniranog hormonskog kontraceptiva kojeg uzimate.
English: The effectiveness of the pill is maintained, but tell your doctor if you are using anti-fungal medicines containing ketoconazole.
Croatian: Učinkovitost pilule je održana, ali obavijestite svog liječnika ako koristite lijekove protiv gljivica koji sadrže ketokonazol.
English: If this is not possible or 24 or more hours have passed, you should follow the advice given under "If you forget to take Zoely".
Croatian: Ako to nije moguće ili ako su prošla 24 ili više sati, pridržavajte se savjeta iz dijela "Ako ste zaboravili uzeti Zoely".
English: Before you start using Zoely you should read the information on blood clots (thrombosis) in section 2.
Croatian: Prije nego što počnete uzimati Zoely trebate pročitati informacije o krvnim ugrušcima (trombozi) u dijelu 2.
English: Contraceptives containing ethinylestradiol may decrease the concentrations of lamotrigine by approximately 50%.
Croatian: Kontraceptivi koji sadrže etinilestradiol mogu smanjiti koncentracije lamotrigina za približno 50%.
English: If you want to delay your period
Croatian: Ako želite odgoditi mjesečnicu
English: Risk of developing a blood clot in a year
Croatian: Rizik od razvoja krvnog ugruška u godinu dana
English: • Contraceptive pills that contain two different hormones, like Zoely, are called ‘combined pills'.
Croatian: • Kontracepcijske pilule koje sadrže dva različita hormona, poput lijeka Zoely, nazivaju se 'kombinirane pilule'.
English: • headache or migraine
Croatian: • glavobolja ili migrena
English: • The number of VTEs per year with low dose CHCs is fewer than the number expected in women during pregnancy or in the postpartum period.
Croatian: • Broj slučajeva VTE u godinu dana uz nisku dozu KHK-a manji je od broja koji se očekuje u žena tijekom trudnoće ili postpartalnog razdoblja.
English: Tell your doctor if any of the following conditions apply to you.
Croatian: Obavijestite svog liječnika ako se neka od sljedećih stanja odnose na Vas.
English: It is unknown if this finding is due to the use of hormonal contraceptives or to other factors, such as difference in sexual behaviour.
Croatian: Nije poznato je li taj nalaz posljedica uporabe hormonskih kontraceptiva ili drugih čimbenika, poput razlika u spolnom ponašanju.
English: Approximately 80 % of the dose is excreted in urine and faeces within 4 days.
Croatian: Približno 80% doze izluči se mokraćom i fecesom unutar 4 dana.
English: • if you have high blood pressure;
Croatian: • ako imate visok krvni tlak;
English: Endometrial histology was investigated in a subgroup of women (n=32) in one clinical study after 13 cycles of treatment.
Croatian: Histologija endometrija ispitivana je u podskupini žena (n=32) u jednom kliničkom ispitivanju nakon 13 ciklusa liječenja.
English: HOW TO RECOGNISE A BLOOD CLOT
Croatian: KAKO PREPOZNATI KRVNI UGRUŠAK
English: Before you can begin taking Zoely, your doctor will ask you some questions about your personal health history and that of your close relatives.
Croatian: Prije nego počnete uzimati Zoely liječnik će Vam postaviti neka pitanja o Vašem osobnom zdravstvenom stanju i zdravstvenom stanju Vaših bliskih krvnih srodnika.
English: The elimination half-life (t1/2) is 46 h (ranging from 28-83 h) at steady state.
Croatian: Poluvrijeme eliminacije (t1/2) iznosi 46 h (raspon od 28-83 h) u stanju dinamičke ravnoteže.
English: • with increasing age (beyond about 35 years);
Croatian: • s povećanjem dobi (nakon približno 35. godine života);
English: All adverse reactions are listed by system organ class and frequency; very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100) and rare ( 1/10,000 to < 1/1,000).
Croatian: Sve su nuspojave popisane prema organskim sustavima i učestalosti; vrlo često ( 1/10), često ( 1/100 i < 1/10), manje često ( 1/1000 i < 1/100) te rijetko ( 1/10 000 i < 1/1000).
English: You must not use Zoely if you have any of the conditions listed below.
Croatian: Ne smijete uzimati Zoely ako imate neko od niže navedenih stanja.
English: What Zoely is and what it is used for
Croatian: Što je Zoely i zašto se koristi
English: • pain or tenderness in the leg which may be felt only when standing or walking
Croatian: • bolom ili osjetljivošću u nozi, koji se mogu osjećati samo pri stajanju ili hodanju
English: Small amounts of the contraceptive steroids and/or their metabolites may be excreted with the breast milk, but there is no evidence that this adversely affects infant health.
Croatian: Male količine kontracepcijskih steroida i/ili njihovih metabolita mogu se izlučiti u majčino mlijeko, ali nema dokaza da to štetno utječe na zdravlje dojenčeta.
English: For example, it may be that tumours are found more in women on combined pills because they are examined by the doctor more often.
Croatian: Primjerice, možda se tumori otkrivaju češće u žena koje uzimaju kombiniranu pilulu jer ih liječnici češće pregledavaju.
English: Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.
Croatian: Ponekad simptomi moždanog udara mogu biti kratkotrajni uz gotovo neposredan i potpuni oporavak, ali i u tom slučaju morate potražiti hitnu medicinsku pomoć jer možete biti pod rizikom od drugog moždanog udara.
English: Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use Zoely.
Croatian: Također obavijestite i svakog drugog liječnika ili stomatologa koji propisuje druge lijekove (ili ljekarnika koji ih izdaje) da uzimate Zoely.
English: Other medicines and Zoely Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta i biljne lijekove.
English: However, it must be borne in mind that sex steroids can promote the growth of certain hormone-dependent tissues and tumours.
Croatian: Međutim, treba imati na umu da spolni steroidi mogu potaknuti rast određenih tkiva i tumora koji su ovisni o hormonima.
English: If you have to change this day, reduce the number of placebo days - when you take the yellow placebo tablets - (but never increase them - 4 is the maximum).
Croatian: Ako morate promijeniti taj dan, smanjite broj dana kada uzimate žute tablete placeba (ali nemojte nikada uzimati više tih tableta - 4 je maksimalan broj).
English: Women over 35 who continue to smoke should be strongly advised to use a different method of contraception.
Croatian: Ženama u dobi iznad 35 godina koje nastave pušiti treba strogo savjetovati da odaberu drugačiju metodu kontracepcije.
English: Ethnic groups No formal studies were performed to assess pharmacokinetics in ethnic groups.
Croatian: Etničke skupine Nisu provedena formalna ispitivanja radi ocjene farmakokinetike u etničkim skupinama.
English: After a miscarriage or an abortion Follow the advice of your doctor.
Croatian: Nakon spontanog pobačaja ili abortusa Pridržavajte se savjeta svog liječnika.
English: • if you have just given birth you are at an increased risk of blood clots.
Croatian: • ako ste nedavno rodili, imate povećan rizik od krvnih ugrušaka.
English: Zoely contains estradiol instead of ethinylestradiol.
Croatian: Zoely sadrži estradiol umjesto etinilestradiola.
English: Irregular vaginal bleeding usually stops once your body has adjusted to the pill (usually after about 3 months).
Croatian: Nepravilno krvarenje iz rodnice obično prestaje kad se tijelo navikne na pilule (obično nakon približno 3 mjeseca).
English: For more detailed information on the different risks from taking combined hormonal contraceptives, please see section 2, “What you need to know before you use Zoely”.
Croatian: Za dodatne informacije o različitim rizicima zbog uzimanja kombinirane hormonske kontracepcije, molimo pročitajte dio 2 "Što morate znati prije nego počnete uzimati Zoely"
English: The elimination half-life of metabolites was not determined.
Croatian: Poluvrijeme eliminacije metabolita nije utvrđeno.
English: Zoely, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Croatian: Zoely, kao ni drugi hormonski kontraceptivi, ne štiti od infekcije HIV-om (AIDS) ili bilo koje druge spolno prenosive bolesti.
English: Breast cancer has been found slightly more often in women using combined pills, but it is not known whether this is caused by the combined pills.
Croatian: Rak dojke se nešto češće otkriva u žena koje koriste kombinirane pilule, ali nije poznato je li to uzrokovano kombiniranim pilulama.
English: Do not start the next blister of Zoely until your doctor has checked that you are not pregnant.
Croatian: Nemojte započinjati uzimati Zoely iz sljedećeg blistera sve dok liječnik nije provjerio jeste li trudni.
English: The excess risk gradually disappears during the course of the 10 years after cessation of COC use.
Croatian: Dodatan rizik postupno se smanjuje tijekom 10 godina nakon prekida primjene KOK-a.
English: When you stop Zoely your risk of a blood clot returns to normal within a few weeks.
Croatian: Kad prestanete uzimati Zoely, Vaš rizik od krvnih ugrušaka vraća se na normalnu vrijednost unutar nekoliko tjedana.
English: If your present pill blister also contains inactive (placebo) tablets you can start Zoely on the day after taking the last active tablet (if you are not sure which this is, ask your doctor or pharmacist).
Croatian: Ako Vaš sadašnji blister s pilulama sadrži i neaktivne tablete (placebo), možete početi uzimati Zoely na dan nakon uzimanja posljednje djelatne tablete (ako niste sigurni koja je to tableta, upitajte svog liječnika ili ljekarnika).
English: If 24 or more hours have passed since last tablet intake, the advice concerning missed tablets, as given in section 4.2 "Management of missed tablets", is applicable.
Croatian: Ako je prošlo 24 ili više sati od uzimanja zadnje tablete, primjenjuje se savjet o propuštenim tabletama, kako je opisano u dijelu 4.2 "Postupak u slučaju propuštenih tableta".
English: Pack sizes: 28, 84, 168 and 364 film-coated tablets.
Croatian: Veličine pakiranja: 28, 84, 168 i 364 filmom obloženih tableta.
English: 30 June 2020
Croatian: 30. lipanj
English: For information on return to fertility, see section 5.1.
Croatian: Za informacije o povratku plodnosti, vidjeti dio 5.1.
English: • harmful blood clots in a vein or artery, for example:
Croatian: • štetni krvni ugrušci u veni ili arteriji, na primjer:
English: If you have more than one of these conditions or if any of them are particularly severe, the risk of developing a blood clot may be increased even more.
Croatian: Ako imate više od jednog navedenog stanja ili je neko od tih stanja osobito teško, rizik od razvoja krvnog ugruška može biti još veći.
English: • All 24 white film-coated tablets are active tablets that contain a small amount of two different female hormones.
Croatian: • Sve 24 bijele filmom obložene tablete su tablete s djelatnim tvarima koje sadrže malu količinu dvaju različitih ženskih hormona.
English: After discontinuation of Zoely, return to ovulation in the first 28 days after last tablet intake was observed in 79 % of the women.
Croatian: Nakon prekida primjene lijeka Zoely povratak ovulacije u prvih 28 dana nakon uzimanja posljednje tablete opažen je u 79% žena.
English: Arterial thromboembolic events may be fatal.
Croatian: Arterijski tromboembolijski događaji mogu imati smrtni ishod.
English: • if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast.
Croatian: • ako trebate ići na operaciju ili ste dulje vrijeme bili nepokretni zbog ozljede ili bolesti ili imate nogu u gipsu.
English: However, after single oral dosing, for the estradiol component (secondary objective), the exposure was 36 % lower in adolescents versus adult subjects.
Croatian: Međutim, nakon jedne peroralne doze je izloženost komponenti estradiola (sekundarni cilj) bila 36% niža u adolescentica naspram odraslih ispitanica.
English: Another method of contraception should be used to avoid unintentional pregnancy.
Croatian: Potrebno je primjenjivati drugu metodu kontracepcije kako bi se izbjegla neplanirana trudnoća.
English: • The more ‘white active tablets' are missed and the closer the missed tablets are to the 4 yellow placebo tablets, the higher the risk of a pregnancy.
Croatian: • Što se više 'bijelih tableta s djelatnim tvarima' propusti i što su propuštene tablete bliže četirima žutim tabletama placeba, veći je rizik od trudnoće.
English: If you are having any blood or urinary test, tell your doctor that you are using Zoely as it may affect the results of some tests.
Croatian: Ako obavljate pretrage krvi ili mokraće, obavijestite svog liječnika da uzimate Zoely jer to može utjecati na rezultate nekih testova.
English: Blood pressure should be measured and a physical examination should be performed, guided by the contraindications (see section 4.3) and warnings (see section 4.4).
Croatian: Potrebno je izmjeriti krvni tlak i napraviti fizikalni pregled, vodeći se kontraindikacijama (vidjeti dio 4.3) i upozorenjima (vidjeti dio 4.4).
English: Some women using hormonal contraceptives including Zoely have reported depression or depressed mood.
Croatian: Neke žene koje uzimaju hormonsku kontracepciju, uključujući Zoely prijavile su pojavu depresije ili depresivnog raspoloženja.
English: It is important to check your breasts regularly and you should contact your doctor if you feel any lump.
Croatian: Važno je da redovito pregledavate dojke te da se odmah obratite liječniku u slučaju da osjetite bilo kakvu kvržicu.
English: However, diabetic women should be carefully observed while taking a COC, especially in the first months of use.
Croatian: Međutim, žene sa šećernom bolešću treba pomno nadzirati za vrijeme primjene KOK-a, osobito tijekom prvih mjeseci primjene.
English: The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users, the biological effects of COCs or a combination of both.
Croatian: Opaženi uzorak povećanog rizika može biti posljedica ranije dijagnoze raka dojke u korisnica KOK-a, bioloških učinaka KOK-a ili kombinacije obaju čimbenika.
English: In this case you could also have a higher risk of having a heart attack or stroke;
Croatian: U tom slučaju i Vi možete imati veći rizik od srčanog ili moždanog udara;
English: • sudden trouble walking, dizziness, loss of balance or coordination;
Croatian: • iznenadne poteškoće s hodanjem, omaglica, gubitak ravnoteže ili koordinacije;
English: Steady-state is achieved after 5 days.
Croatian: Stanje dinamičke ravnoteže postiže se nakon 5 dana.
English: • increased interest in sex
Croatian: • pojačano zanimanje za spolni odnos
English: It is important to tell your doctor if any of these conditions apply to you, even if you are unsure.
Croatian: Važno je da obavijestite liječnika ako imate neko od navedenih stanja, čak i ako niste sigurni.
English: • sudden confusion, trouble speaking or understanding;
Croatian: • iznenadna smetenost, poteškoće s govorom ili razumijevanjem;
English: • painless blurring of vision which can progress to loss of vision
Croatian: • bezbolna zamućenost vida, koja može napredovati do gubitka vida
English: It is particularly important to read the symptoms of a blood clot - see section 2 “Blood clots”.
Croatian: Osobito je važno pročitati o simptomima krvnog ugruška - pogledajte dio 2 "Krvni ugrušci".
English: In such cases, absence of withdrawal bleeding was not associated with a higher occurrence of breakthrough bleeding/spotting in the subsequent cycles.
Croatian: U tim slučajevima izostanak prijelomnog krvarenja nije bio povezan s većom pojavnošću probojnog/točkastog krvarenja u sljedećim ciklusima.
English: Attention should be paid, notably when introducing a combined contraceptive, even with estradiol, in a well-equilibrated woman given lamotrigine.
Croatian: Potreban je oprez, osobito kad se uvode kombinirani kontraceptivi, čak i s estradiolom, u žena na dobro uravnoteženoj terapiji lamotriginom.