natgillin/translations-raw huggingface dataset:
• It is estimated that out of 10,000 women who use a levonorgestrel-containing CHC about 61 will
• Procijenjeno je da će od 10 000 žena koje uzimaju KOK koji sadrži levonorgestrel, njih približno 61 razviti VTE u godinu dana.
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).
vodeći se kontraindikacijama (vidjeti dio 4.3) i upozorenjima (vidjeti dio 4.4).
If pregnancy occurs while taking IOA, further intake should be stopped.
Ako žena zatrudni tijekom uzimanja lijeka IOA, treba prekinuti s daljnjim uzimanjem lijeka.
An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischaemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in section 4.4.
U žena koje koriste kombinirane hormonske kontraceptive opažen je povećani rizik od arterijskih i venskih trombotskih i tromboembolijskih događaja, uključujući infarkt miokarda, moždani udar, tranzitorne ishemijske atake, vensku trombozu i plućnu emboliju, o čemu se detaljnije govori u dijelu 4.4.
• Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of
• Žene s hipertrigliceridemijom ili obiteljskom anamnezom hipertrigliceridemije mogu biti izložene povećanom riziku od pankreatitisa prilikom primjene KOK-a.
IOA is indicated for the prevention of pregnancy.
Plodnost IOA je indiciran za sprječavanje trudnoće.
• if you have liver disease (for instance jaundice) or gallbladder disease (for instance gallstones);
• ako imate bolest jetre (primjerice žuticu) ili žučnog mjehura (primjerice žučne kamence); • ako imate šećernu bolest;
No studies were conducted to evaluate the effect of hepatic disease on the pharmacokinetics of IOA.
Nisu provedena ispitivanja radi procjene učinka bolesti jetre na farmakokinetiku lijeka IOA .
• The increased risk of thromboembolism in pregnancy, and particularly the 6-week period of the puerperium, must be considered (for information on "Pregnancy and lactation" see section 4.6).
6 tjedana babinja (za informacije o "Trudnoći i dojenju" vidjeti dio 4.6).
At the end of the placebo tablet interval, start with the next blister.
Kad završite s razdobljem tableta placeba, počnite uzimati tablete iz sljedećeg blistera.
- sweating, nausea, vomiting or dizziness; - extreme weakness, anxiety, or shortness of breath; - rapid or irregular heartbeats.
- izrazita slabost, tjeskoba ili nedostatak zraka; - ubrzani ili nepravilni otkucaji srca.
IOA 2.5 mg/1.5 mg film-coated tablets Nomegestrol acetate/estradiol
IOA 2,5 mg/1,5 mg filmom obložene tablete nomegestrolacetat/estradiol
If you start later than day 28, you should also use a barrier method of contraception during the first 7 days of IOA use.
28. dana, trebate koristiti mehaničku metodu kontracepcije tijekom prvih 7 dana uzimanja lijeka IOA.
Users of IOA may also miss their withdrawal bleeding although not being pregnant.
prijelomno krvarenje može i izostati iako nisu trudne.
Symptoms of pulmonary embolism (PE) can include: - sudden onset of unexplained shortness of breath or rapid breathing; - sudden coughing which may be associated with haemoptysis;
- iznenadni nastup neobjašnjivog nedostatka zraka ili ubrzanog disanja; - iznenadni kašalj koji može biti povezan s hemoptizom; - oštra bol u prsištu;
• chest pain, discomfort, pressure, heaviness • sensation of squeezing or fullness in the chest, arm or below the
- bol, nelagodu, pritisak, osjećaj težine, stezanja ili punoće u prsištu, ruci ili ispod prsne kosti;
Rare (may affect up to 1 in 1,000 people):
Manje često (mogu se javiti u do 1 na 100 osoba):
• fullness, indigestion or choking feeling; • upper body discomfort radiating to the back, jaw, throat, arm and
• punoća, probavne tegobe ili osjećaj gušenja; • nelagoda u gornjem dijelu tijela koja se širi u leđa, čeljust,
Positive family history (arterial thromboembolism ever in a sibling or parent especially at relatively
Pozitivna obiteljska anamneza (arterijska tromboembolija u braće, sestara ili roditelja osobito u relativno ranoj dobi, npr., prije 50. godine života)
Oral use.
Oralna kontracepcija.
Maximum plasma concentrations of nomegestrol acetate of about 7 ng/ml are reached at 2 h after single administration.
Maksimalne koncentracije nomegestrolacetata u plazmi od približno 7 ng/ml postižu se 2 sata nakon primjene jedne doze.
Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal
Prelazak s kombiniranog hormonskog kontraceptiva (kombiniranog oralnog kontraceptiva (KOK), vaginalnog prstena ili transdermalnog flastera)
No studies were performed to evaluate the effect of renal disease on the pharmacokinetics of IOA.
Nisu provedena ispitivanja radi procjene učinka bolesti bubrega na farmakokinetiku lijeka IOA .
• In women who do not use a CHC and are not pregnant about 2 out of 10,000 will develop a VTE over the period of one year.
• Približno 2 žene na njih 10 000 koje ne koriste KOK-e i nisu trudne razvit će VTE u razdoblju od godinu dana.
• harmful blood clots in a vein or artery, for example: o in a leg or foot (i.e., DVT) o in a lung (i.e., PE) o heart attack o stroke o mini-stroke or temporary stroke-like symptoms known as a transient ischaemic attack (TIA) o blood clots in the liver, stomach/intestine, kidneys or eye.
o u plućima (tj. plućna embolija) o srčani udar o moždani udar o mini-moždani udar ili kratkotrajni simptomi slični simptomima moždanog udara, što se još zove prolazni ishemijski napadaj (TIA) o krvni ugrušci u jetri, želucu/crijevima, bubrezima ili oku.
As no epidemiological data are yet available with estradiol containing-CHCs, the warnings are considered applicable to the use of IOA.
S obzirom na to da još uvijek nema epidemioloških podataka za KOK-e koji sadrže estradiol, smatra se da upozorenja za KOK-e koji sadrže etinilestradiol važe i za primjenu lijeka IOA.
If you need to stop IOA ask your doctor when you
Ako trebate prestati uzimati IOA, upitajte liječnika kada ga ponovno možete početi uzimati.
• if you have sickle cell anaemia (an inherited disease of the red blood cells);
• ako imate hemolitički uremički sindrom (HUS - poremećaj zgrušavanja krvi koji uzrokuje zatajenje bubrega); • ako imate anemiju srpastih stanica (nasljednu bolest crvenih krvnih stanica);
The woman should start with IOA preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC.
(posljednje tablete koja sadrži djelatne tvari) svog prethodnog KOK-a, no najkasnije na dan nakon uobičajenog intervala bez tableta ili intervala s placebom prethodnog KOK-a.
• increased liver enzymes
Pretrage povećanje tjelesne težine povišene vrijednosti jetrenih enzima
Lactose monohydrate (see section 2 ‘IOA contains lactose'), cellulose microcrystalline (E460), crospovidone (E1201), talc (E553b), magnesium stearate (E572) and silica colloidal anhydrous Tablet coating (white active film-coated tablets):
Jezgra tablete (bijele filmom obložene tablete s djelatnim tvarima i žute filmom obložene tablete placeba): laktoza hidrat (vidjeti u dijelu 2 'IOA sadrži laktozu'), mikrokristalična celuloza (E460), krospovidon (E1201), talk (E553b), magnezijev stearat (E572) i silicijev dioksid, koloidni, bezvodni.
In addition, a barrier method such as a condom should be used for the next 7 days.
Osim toga, tijekom sljedećih 7 dana mora koristiti mehaničku kontracepciju, primjerice kondom.
This includes any possible side You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
• The risk of having a blood clot will vary according to your personal medicinal history (see “Factors that increase your risk of a blood clot” below).
• Rizik od krvnog ugruška varira ovisno o osobnoj povijesti bolesti (pogledajte ispod u dijelu
Throw away the yellow placebo tablet(s) you missed and continue taking the next tablets at the usual time.
(tablete) placeba koju ste propustili i nastavite uzimati sljedeće tablete u uobičajeno vrijeme.
When no hormonal contraceptive has been used in the past month Start taking IOA on the first day of your cycle (i.e. the first day of your menstrual bleeding).
Počnite uzimati IOA prvog dana Vašeg ciklusa (tj. prvog dana mjesečnice).
The user is unlikely to have a withdrawal bleed until the end of the active tablets section of the second pack, but she may experience spotting or breakthrough
Nije vjerojatno da će korisnica imati prijelomno krvarenje sve dok ne potroši sve tablete s djelatnim tvarima iz drugog pakiranja, no može imati točkasto ili probojno krvarenje u dane uzimanja tableta.
o A high risk of venous thromboembolism due to the presence of multiple risk factors (see
o Visoki rizik od arterijske tromboembolije zbog prisutnosti višestrukih čimbenika rizika
You can delay your period by not taking the yellow placebo tablets and going straight to a new blister of IOA.
Ako želite odgoditi mjesečnicu Možete odgoditi mjesečnicu tako da ne uzimate žute tablete placeba i odmah započnete s novim blisterom lijeka IOA.
- HIV infections (e.g. ritonavir, nevirapine, nelfinavir, efavirenz); - other infectious diseases (e.g. griseofulvin); - high blood pressure in the blood vessels in the lungs (bosentan).
topiramat, felbamat); - tuberkuloze (na primjer rifampicin); - HIV infekcije (na primjer ritonavir, nevirapin, nelfinavir, efavirenz); - drugih zaraznih bolesti (na primjer grizeofulvin);
If this is not possible or 12 hours have passed, you should follow the advice given under "If you forget to take IOA".
pridržavajte se savjeta iz dijela "Ako ste zaboravili uzeti IOA".
Antithrombotic treatment should be considered if IOA has not been discontinued in advance.
Ako primjena lijeka IOA nije bila prethodno prekinuta,
If you vomit or have severe diarrhoea within 3-4 hours of taking a yellow tablet, the reliability of IOA is maintained.
3-4 sata nakon uzimanja žute tablete, pouzdanost lijeka IOA je održana.
o Known hereditary or acquired predisposition for venous thromboembolism, such as APCresistance (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency,
o Poznata nasljedna ili stečena sklonost venskoj tromboemboliji, kao što je rezistencija na aktivirani protein C (uključujući faktor V Leiden), nedostatak antitrombina III, nedostatak proteina C, nedostatak proteina S. o Veliki kirurški zahvat s dugotrajnom imobilizacijom (vidjeti dio 4.4).
• 7 days of uninterrupted ‘white active tablet'-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis.
Postupanje u slučaju propuštenih tableta može biti u skladu sa sljedeća dva osnovna pravila: • Potrebno je 7 dana neprekidnog uzimanja 'bijele tablete s djelatnim tvarima' kako bi se postigla odgovarajuća supresija osi hipotalamus-hipofiza-jajnik.
• A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using COCs.
• U metaanalizi 54 epidemiološka ispitivanja prijavljeno je da žene koje trenutno koriste KOK
What IOA contains - The active substances are: in the white active film-coated tablets: Each tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate).
Što IOA sadrži - Djelatne tvari su: u bijelim filmom obloženim tabletama s djelatnim tvarima: Jedna tableta sadrži 2,5 mg nomegestrolacetata i 1,5 mg estradiola (u obliku hemihidrata). u žutim filmom obloženim tabletama placeba: Tableta ne sadrži djelatne tvari.
When changing from a progestogen-only pill (minipill) You can stop taking the minipill any day and start taking IOA the next day.
Bilo kada možete prestati uzimati minipilulu i početi uzimati IOA.
Symptoms most commonly occur in one eye: • painless blurring of vision which can progress to loss of vision
• trenutačni gubitak vida ili • bezbolna zamućenost vida, koja može napredovati do gubitka vida
• Presence or risk of arterial thromboembolism (ATE) o Arterial thromboembolism - current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina o Cerebrovascular disease - current stroke, history of stroke or prodromal condition o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies,
• Prisutnost rizika od arterijske tromboembolije (ATE) o Arterijska tromboembolija - prisutna arterijska tromboembolija, arterijska tromboembolija u anamnezi (npr., infarkt miokarda) ili prodromalno stanje (npr. angina pektoris).
If you wish to use the pill while breast-feeding, please seek the advice of your doctor.
Ako za vrijeme uzimanja lijeka IOA želite koristiti biljne lijekove koji sadrže gospinu travu, morate se najprije posavjetovati sa svojim liječnikom.
Other medical conditions associated with VTE Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell disease
Rak, sistemski lupus eritematosus, hemolitičko uremijski sindrom, kronična upalna bolest crijeva
On the basis of general experience with combined oral contraceptives, symptoms that may occur are: nausea, vomiting and, in young girls, slight vaginal bleeding.
Na temelju općeg iskustva s kombiniranim oralnim kontraceptivima, mogu se pojaviti sljedeći simptomi: mučnina,
• if you have any unexplained bleeding from the vagina.
• Vaginalno krvarenje neutvrđenog uzroka.
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:
o Visoki rizik od venske tromboembolije zbog prisutnosti višestrukih čimbenika rizika (vidjeti dio 4.4).
Hepatic impairment
• teška hipertenzija
After finishing the 4 yellow placebo tablets from the second blister,
Nakon što ste uzeli 4 tablete placeba iz drugog blistera, počnite sa sljedećim (trećim) blisterom.
If you have severe diarrhoea, please tell your
Ako imate teški proljev, obratite se svom liječniku.
• Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a year.
noretisteron ili norgestimat, njih oko 5-7 razvit će krvni ugrušak u godinu dana.
• diabetes mellitus with vascular symptoms
• bolest žučnog mjehura
• if you have any of the following diseases that may increase your risk of a clot in the arteries: - severe diabetes with blood vessel damage - very high blood pressure - a very high level of fat in the blood (cholesterol or triglycerides); - a condition known as hyperhomocysteinaemia
• ako imate neku od sljedećih bolesti koje mogu povećati rizik od stvaranja ugruška u arterijama: - tešku šećernu bolest s oštećenjem krvnih žila,
• if you have an inflammation in the veins under the skin (superficial thrombophlebitis);
• ako imate upalu potkožnih vena (površinski tromboflebitis); • ako imate proširene vene;
Hepatobiliary disorders cholelithiasis, cholecystitis hyperhydrosis, alopecia, pruritus, dry skin, seborrhea chloasma, hypertrichosis sensation of heaviness hypomenorrhoea, breast swelling, galactorrhoea, uterine spasm, premenstrual syndrome, breast mass, dyspareunia, vulvovaginal dryness vaginal odour, vulvovaginal discomfort irritability, oedema hunger weight increased hepatic enzyme increased
Poremećaji reproduktivnog sustava i dojki poremećaji prijelomnog krvarenja metroragija, menoragija, bol u dojkama, bol u zdjelici hipomenoreja, oticanje dojki, galaktoreja, spazam maternice, predmenstrualni sindrom, masa na dojkama, dispareunija,
Tumours
Tumori
• heavy menstrual periods; breast pain; pelvic pain
• mučnina • jake mjesečnice; bol u dojkama; bol u zdjelici
Examples of active substances that induce hepatic enzymes and thus result in increased clearance of sex hormones are: phenytoin, phenobarbital, primidone, bosentan, carbamazepine, rifampicin, and medicinal products or herbal preparations containing St. John's wort, and, to a lesser extent, oxcarbazepine, topiramate, felbamate, and griseofulvin.
fenitoin, fenobarbital, primidon, bosentan, karbamazepin, rifampicin i lijekovi ili biljni pripravci koji sadrže gospinu travu te u manjoj mjeri okskarbazepin, topiramat, felbamat i grizeofulvin.
If the woman is less than 12 hours late in taking any active tablet, contraceptive protection is not reduced.
Sljedeći savjeti odnose se samo na propuštene bijele tablete s djelatnim tvarima: Ako žena kasni s uzimanjem bilo koje tablete s djelatnim tvarima manje od 12 sati, kontracepcijska zaštita nije smanjena.
If you vomit within 3-4 hours of taking a white active tablet, or you have severe diarrhoea, the active ingredients of your IOA tablet may not have been completely absorbed into your body.
djelatne tvari iz tablete lijeka IOA možda se neće potpuno apsorbirati u Vaše tijelo.
No epidemiological data on the risk of cervical cancer in
Nema epidemioloških podataka o riziku od raka vrata maternice u žena koje uzimaju IOA.
• if you know you have a disorder affecting your blood clotting - for instance, protein C deficiency, protein S deficiency, antithrombin - III deficiency, Factor V Leiden or
C, nedostatak proteina S, nedostatak antitrombina III, faktor V Leiden ili antifosfolipidna protutijela;
Tel.: +420 233 010 111 dpoc_czechslovak@merck.com
Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111 dpoc_czechslovak@merck.com
Tablet core (white active and yellow placebo film-coated tablets)
Jezgra tablete (bijele filmom obložene tablete s djelatnim tvarima i žute filmom obložene tablete placeba) laktoza hidrat celuloza, mikrokristalična (E460)
In the clinical trial performed with IOA in the European Union the following Pearl Indices for the age
U kliničkom ispitivanju provedenom s lijekom IOA u Europskoj
QUALITATIVE AND QUANTITATIVE COMPOSITION White active film-coated tablets: Each film-coated tablet contains 2.5 mg nomegestrol acetate and Yellow placebo film-coated tablets: The tablet does not contain active substances.
KVALITATIVNI I KVANTITATIVNI SASTAV Bijele filmom obložene tablete s djelatnim tvarima: Jedna filmom obložena tableta sadrži 2,5 mg nomegestrolacetata i 1,5 mg estradiola (u obliku hemihidrata).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Marketing Authorisation Holder:
11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Women who are not using a combined hormonal pill and are not
Žene koje ne uzimaju kombinirane hormonske tablete i nisu trudne oko 2 na 10 000 žena
Day label sheet
• suha usta
The elimination half-life Nomegestrol acetate is excreted via urine and feces.
Nomegestrolacetat se izlučuje mokraćom i fecesom.
Symptoms of a myocardial infarction (MI) can include: - pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone; - discomfort radiating to the back, jaw, throat, arm, stomach; - feeling of being full, having indigestion or choking;
- nelagoda koja se širi u leđa, čeljust, grlo, ruku, želudac; - osjećaj punoće, probavne tegobe ili gušenje; - znojenje, mučnina, povraćanje ili omaglica;
Rare increased appetite, fluid retention decreased appetite increased libido cerebrovascular accident, transient ischaemic attack, disturbance in attention
Psihijatrijski poremećaji smanjen libido, depresija/depresivno raspoloženje, promjena raspoloženja pojačan libido
• sweating, nausea, vomiting or dizziness; • extreme weakness, anxiety, or shortness of breath;
• izrazita slabost, tjeskoba ili nedostatak zraka; • ubrzani ili nepravilni otkucaji srca
Magnesium stearate (E572) Silica, colloidal anhydrous
krospovidon (E1201) talk (E553b) magnezijev stearat (E572) silicijev dioksid, koloidni, bezvodni
A prospective observational study to assess in particular the risk of Venous thromboembolic events (VTE) and ATE in nomegestrol/estradiol users compared with the VTE risk in users of combined oral contraceptives containing levonorgestrel.
(ATE) u korisnica nomegestrol/estradiola u odnosu na rizik od VTE u korisnica kombiniranih oralnih kontraceptiva koji sadrže levonorgestrel.
• if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol
• ako imate ili netko u Vašoj užoj obitelji ima visoke vrijednosti masnoća u krvi (kolesterol ili trigliceride); • ako imate migrene, osobito migrene s aurom;
Following delivery or second-trimester abortion
Trudnoća i dojenje
Tablet coating (white active film-coated tablets) Poly(vinyl alcohol) (E1203) Titanium dioxide (E171)
Ovojnica tablete (bijele filmom obložene tablete s djelatnim tvarima) poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol 3350 talk (E553b)
Factors that increase your risk of a blood clot in an artery It is important to note that the risk of a heart attack or stroke from using IOA is very small but can
Važno je zapamtiti da je rizik od srčanog ili moždanog udara zbog primjene lijeka IOA vrlo mali, ali može se povećati:
No clinically relevant effect of food was observed on the bioavailability
Nije zamijećen značajan utjecaj hrane na bioraspoloživost estradiola.
• With the use of the higher-dosed COCs (50 µg ethinylestradiol) the risk of endometrial and ovarian cancer is reduced.
• Uz primjenu kombiniranih oralnih kontraceptiva s višim dozama (50 µg etinilestradiola)
If you want to start IOA after having a baby and are breast-feeding, see also section 2 ‘Pregnancy and Breast-feeding'.
Ako želite početi uzimati IOA nakon poroda, a dojite,
premenstrual syndrome; pain during intercourse; dryness in the vagina or vulva; spasm of the uterus
suhoća vagine i vulve neugodan miris iz vagine, nelagoda u vulvi i vagini
When changing from a progestogen-only injectable, implant or a hormone-medicated intrauterine Start using IOA when your next injection is due or on the day that your implant or IUS is removed.
Počnite uzimati IOA na dan kada ste trebali primiti sljedeću injekciju ili na dan uklanjanja implantata odnosno IUS-a.
Detailed information on this medicine is available on the European Medicines Agency web site:
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu.
The active film-coated tablets (tablets) are white and round.
Filmom obložena tableta (tableta).
Symptoms of a cerebrovascular accident can include: - sudden numbness or weakness of the face, arm or leg, especially on one side of the body; - sudden trouble walking, dizziness, loss of balance or coordination; - sudden confusion, trouble speaking or understanding; - sudden trouble seeing in one or both eyes; - sudden, severe or prolonged headache with no known cause; - loss of consciousness or fainting with or without seizure.
• iznenadne poteškoće s vidom na jednom ili oba oka; • iznenadne poteškoće s hodanjem, omaglica, gubitak ravnoteže ili koordinacije;
To shift her periods to another day of the week than the woman is used to with her current scheme, she can be advised to shorten her forthcoming yellow placebo tablet phase with a maximum of 4 days.
korisnici se može preporučiti da skrati nadolazeću fazu uzimanja žutih tableta placeba za najviše
Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 3350 and talc (E553b) Tablet coating (yellow placebo film-coated tablets):
Ovojnica tablete (bijele filmom obložene tablete s djelatnim tvarima): poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol 3350 i talk (E553b) Ovojnica tablete (žute filmom obložene tablete placeba): poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol 3350, talk (E553b), žuti željezov oksid (E172) i crni željezov oksid (E172).
Whether this also applies to 17β-estradiol-containing COCs remains
KOK-e koji sadrže 17β-estradiol.