FrancophonIA/ELRC3.0 huggingface dataset:
English: o Cerebrovascular disease - current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA).
Croatian: o Cerebrovaskularna bolest - postojeći moždani udar, moždani udar ili prodromalno stanje u anamnezi (npr. tranzitorna ishemijska ataka, TIA).
English: Zoely comes in blisters of 28 film-coated tablets (24 white active film-coated tablets and 4 yellow placebo film-coated tablets) packed in a ply carton.
Croatian: Zoely je dostupan u blister pakiranju sa 28 filmom obloženih tableta (24 bijele filmom obložene tablete s djelatnim tvarima i 4 žute filmom obložene tablete s placebom) u kartonskoj kutiji.
English: Table: Risk factors for VTE Risk factor
Croatian: Tablica: Čimbenici rizika za VTE Čimbenik rizika
English: The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time.
Croatian: Korisnica treba uzeti posljednju propuštenu tabletu čim se sjeti, čak i ako to znači da mora uzeti dvije tablete istodobno.
English: Metabolism and nutrition disorders increased appetite, fluid retention decreased appetite
Croatian: Poremećaji metabolizma i prehrane pojačan tek, retencija tekućine smanjen tek
English: 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; - sweating, nausea, vomiting or dizziness; - extreme weakness, anxiety, or shortness of breath; - rapid or irregular heartbeats.
Croatian: Simptomi infarkta miokarda (IM) mogu uključivati: - bol, nelagodu, pritisak, osjećaj težine, stezanja ili punoće u prsištu, ruci ili ispod prsne kosti; - nelagoda koja se širi u leđa, čeljust, grlo, ruku, želudac; - osjećaj punoće, probavne tegobe ili gušenje; - znojenje, mučnina, povraćanje ili omaglica; - izrazita slabost, tjeskoba ili nedostatak zraka; - ubrzani ili nepravilni otkucaji srca.
English: Six multi-centre clinical trials of up to one year duration were used to evaluate safety of Zoely.
Croatian: Sigurnost lijeka Zoely ispitivana je u 6 multicentričnih kliničkih ispitivanja u trajanju do godine dana.
English: (TIA)
Croatian: (DVT).
English: Drug drug interactions
Croatian: Interakcije između lijekova
English: Take the last missed white active tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time.
Croatian: Uzmite posljednju propuštenu bijelu tabletu s djelatnim tvarima čim se sjetite (čak i ako to znači da morate uzeti dvije tablete u isto vrijeme), a sljedeću tabletu uzmite u uobičajeno vrijeme.
English: When changing from a progestogen-only pill (minipill) You can stop taking the minipill any day and start taking Zoely the next day.
Croatian: Ako prelazite s pilule koja sadrži samo progestagen Bilo kada možete prestati uzimati minipilulu i početi uzimati Zoely.
English: Oral exogenous estradiol is extensively metabolized.
Croatian: Peroralno primijenjen egzogeni estradiol podliježe intenzivnom metabolizmu.
English: However, use a barrier method such as a condom as an extra precaution until you have taken your tablets correctly for 7 days in a row.
Croatian: Međutim, koristite mehaničku metodu, primjerice kondom, kao dodatnu mjeru opreza sve dok niste ispravno uzeli tablete tijekom 7 uzastopnih dana.
English: 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.
Croatian: U žena koje koriste kombinirane hormonske kontraceptive opažen je povećani rizik od arterijskih i venskih trombotičkih 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.
English: Nomegestrol acetate is excreted via urine and faeces.
Croatian: Nomegestrolacetat se izlučuje mokraćom i fecesom.
English: Non-interventional post-authorisation safety study (PASS): 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.
Croatian: Prospektivnu observacijsku studiju koja će ciljano procijeniti rizik od venskih tromboembolijskih događaja (VTE) i arterijskih tromboembolijskih događaja (ATE) u korisnica nomegestrol/estradiola u odnosu na rizik od VTE u korisnica kombiniranih oralnih kontraceptiva koji sadrže levonorgestrel.
English: When changing from an injectable, Zoely should be started on the day when the next injection would have been due.
Croatian: Prilikom prelaska s injekcijskog preparata, s uzimanjem lijeka Zoely treba započeti na dan sljedeće predviđene injekcije.
English: Each white active tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate).
Croatian: Jedna bijela tableta s djelatnim tvarima sadrži 2,5 mg nomegestrolacetata i 1,5 mg estradiola (u obliku hemihidrata).
English: • if you have any unexplained bleeding from the vagina.
Croatian: • ako imate neobjašnjivo krvarenje iz rodnice;
English: Influence of Zoely on other medicinal products
Croatian: Utjecaj lijeka Zoely na druge lijekove
English: • if you have diabetes;
Croatian: • ako imate šećernu bolest;
English: • if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition.
Croatian: • ako imate povišene razine masnoća u krvi (hipertrigliceridemiju) ili se to stanje javljalo u Vašoj obitelji.
English: Effect of renal impairment No studies were performed to evaluate the effect of renal disease on the pharmacokinetics of Zoely.
Croatian: Učinak na oštećenje funkcije bubrega Nisu provedena ispitivanja radi procjene učinka bolesti bubrega na farmakokinetiku lijeka Zoely.
English: Zoely is contraindicated if a woman has multiple risk factors that put her at high risk of venous thrombosis (see section 4.3).
Croatian: Zoely je kontraindiciran u žena s većim brojem čimbenika rizika zbog kojih imaju visok rizik od venske tromboze (vidjeti dio 4.3).
English: Risk of venous thromboembolism (VTE)
Croatian: Rizik od venske tromboembolije (VTE)
English: No clinically relevant effect of food was observed on the bioavailability of nomegestrol acetate.
Croatian: Nije opažen klinički značajan učinak hrane na bioraspoloživost nomegestrolacetata.
English: No epidemiological data on the risk of cervical cancer in users of Zoely are available.
Croatian: Nema epidemioloških podataka o riziku od raka vrata maternice u žena koje uzimaju Zoely.
English: If she is 24 or more hours late in taking any active tablet, contraceptive protection may be reduced.
Croatian: Ako žena kasni s uzimanjem bilo koje tablete s djelatnim tvarima 24 ili više sati, kontracepcijska zaštita može biti umanjena.
English: 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
Croatian: Rak, sistemski lupus eritematosus, hemolitičkouremijski sindrom, kronična upalna bolest crijeva (Crohnova bolest ili ulcerozni kolitis) i anemija srpastih stanica.
English: Table: Risk factors for ATE Risk factor
Croatian: Tablica: Čimbenici rizika za ATE Čimbenik rizika
English: The yellow tablets are placebo tablets which do not contain active substances.
Croatian: Žute tablete su tablete placeba koje ne sadrže djelatne tvari.
English: • rapid or irregular heartbeat;
Croatian: • ubrzani ili nepravilni otkucaji srca;
English: Day 8-17 of white active tablet intake (see picture and schedule) Take the last missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time.
Croatian: 8.-17. dan uzimanja bijelih tableta s djelatnim tvarima (pogledajte sliku i raspored) Uzmite posljednju propuštenu tabletu čim se sjetite (čak i ako to znači da morate uzeti dvije tablete u isto vrijeme), a sljedeću tabletu uzmite u uobičajeno vrijeme.
English: The user should take the last missed white tablet as soon as she remembers, even if this means taking two tablets at the same time.
Croatian: Korisnica treba uzeti posljednju propuštenu bijelu tabletu čim se sjeti, čak i ako to znači da mora uzeti dvije tablete istodobno.
English: With all COCs, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.
Croatian: Neredovito krvarenje (točkasto ili probojno krvarenje) može se javiti kod svih kombiniranih oralnih kontraceptiva, osobito tijekom prvih mjeseci primjene.
English: Reproductive system and breast disorders abnormal withdrawal bleeding metrorrhagia, menorrhagia, breast pain, pelvic pain hypomenorrhoea, breast swelling, galactorrhoea, uterine spasm, premenstrual syndrome, breast mass, dyspareunia, vulvovaginal dryness vaginal odour, vulvovaginal discomfort
Croatian: 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, suhoća vagine i vulve neugodan miris iz vagine, nelagoda u vulvi i vagini
English: Lactose monohydrate (see section 2 ‘Zoely contains lactose'), microcrystalline cellulose (E460), crospovidone (E1201), talc (E553b), magnesium stearate (E572) and colloidal anhydrous silica Tablet coat (white active film-coated tablets):
Croatian: Laktoza hidrat (vidjeti u dijelu 2 'Zoely sadrži laktozu'), mikrokristalična celuloza (E460), krospovidon (E1201), talk (E553b), magnezijev stearat (E572) i koloidni, bezvodni silicijev dioksid.
English: Symptoms of ATE
Croatian: Simptomi ATE
English: However, if you have missed more than 1 tablet, use a barrier method such as a condom as an extra precaution until you have taken your tablets correctly for 7 days in a row.
Croatian: Međutim, ako ste propustili više od jedne tablete, koristite mehaničku metodu, primjerice kondom, kao dodatnu mjeru opreza sve dok niste ispravno uzeli tablete tijekom 7 uzastopnih dana.
English: Diabetes mellitus, hyperhomocysteinaemia, valvular heart disease and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus
Croatian: Druga zdravstvena stanja povezana sa Šećerna bolest, hiperhomocisteinemija, valvularna štetnim krvožilnim događajima bolest srca i atrijska fibrilacija, dislipoproteinemija i sistemski lupus eritematosus.
English: Women who are not using a combined hormonal pill and are not pregnant
Croatian: Žene koje ne uzimaju kombinirane hormonske tablete i nisu trudne oko 2 na 10 000 žena
English: What Zoely contains - The active substances are: nomegestrol acetate and estradiol White active film-coated tablets: Each tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate).
Croatian: Što Zoely sadrži - Djelatne tvari su: nomegestrolacetat i estradiol Bijele filmom obložene tablete s djelatnim tvarima: Jedna tableta sadrži 2,5 mg nomegestrolacetata i 1,5 mg estradiola (u obliku hemihidrata).
English: • if you need an operation or if you are off your feet for a long time (see in section 2 ‘Blood clots).
Croatian: • ako trebate ići na operaciju ili dugo ležeći mirujete (pogledajte dio 2 "Krvni ugrušci"),
English: If you want to use herbal products containing St. John's wort while you are already using Zoely you should consult your doctor first.
Croatian: Ako za vrijeme uzimanja lijeka Zoely želite koristiti biljne lijekove koji sadrže gospinu travu, morate se najprije posavjetovati sa svojim liječnikom.
English: o in a leg or foot (i.e., DVT)
Croatian: o u nozi ili stopalu (tj.duboka venska tromboza)
English: • 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.
Croatian: • Približno 2 žene na njih 10 000 koje ne koriste KHK-e i nisu trudne razvit će VTE u razdoblju od godinu dana.
English: The apparent clearance at steady state is 26 L/h.
Croatian: Prividan klirens u stanju dinamičke ravnoteže iznosi 26 l/h.
English: Whether this also applies to 17β-estradiol-containing COCs remains to be confirmed.
Croatian: Još uvijek nije potvrđeno odnosi li se to i na KOK-e koji sadrže 17-estradiol.
English: Zoely is indicated for the prevention of pregnancy.
Croatian: Plodnost Zoely je indiciran za sprječavanje trudnoće.
English: In rare cases, benign (noncancerous) liver tumours, and in even fewer cases malignant (cancerous) liver tumours have been reported in pill users.
Croatian: U rijetkim su slučajevima u korisnica pilule prijavljeni benigni (dobroćudni) tumori jetre, a još rjeđe maligni (zloćudni) tumori.
English: Nomegestrol acetate
Croatian: Nomegestrolacetat
English: Stop taking the white active tablets and start taking the yellow placebo tablets for a maximum of 3 days so that the total number of placebo plus missed white active tablets is not more than 4.
Croatian: Prestanite uzimati bijele tablete s djelatnim tvarima i počnite uzimati žute tablete placeba tijekom najviše 3 dana tako da ukupni broj tableta placeba plus propuštene bijele tablete s djelatnim tvarima nije veći od 4. Kad završite s razdobljem tableta placeba, počnite uzimati tablete iz sljedećeg blistera.
English: Maximum plasma concentrations of nomegestrol acetate of about 7 ng/mL are reached at 2 h after single administration.
Croatian: Maksimalne koncentracije nomegestrolacetata u plazmi od približno 7 ng/ml postižu se 2 sata nakon primjene jedne doze.
English: In all of these cases, the woman should be advised to additionally use a barrier method until she has completed 7 days of uninterrupted white active tablet-taking.
Croatian: U svim navedenim slučajevima ženi treba preporučiti da koristi dodatnu mehaničku kontracepciju sve dok ne dovrši neprekinuti sedmodnevni niz uzimanja bijelih tableta s djelatnim tvarima.
English: During clinical trials with the HCV combination drug regimen ombitasvir/paritaprevir/ritonavir with and without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN) were significantly more frequent in women using ethinylestradiol-containing medications such as CHCs.
Croatian: Tijekom kliničkih ispitivanja kombiniranog režima liječenja HCV-a ombitasvirom/paritaprevirom/ritonavirom s dasabuvirom ili bez njega, povišenja ALT-a viša od 5 puta iznad gornje granice normale (GGN) bila su značajno češća u žena koje su uzimale lijekove koji sadrže etinilestradiol, kao što su KOK.
English: No clinically relevant effect of food was observed on the bioavailability of estradiol.
Croatian: Nije zamijećen značajan utjecaj hrane na bioraspoloživost estradiola.
English: These include medicines used to treat: - epilepsy (e.g. primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate); - tuberculosis (e.g. rifampicin); - HIV infections (e.g. rifabutin, ritonavir, efavirenz); - Hepatitis C virus (HCV) infection (e.g. boceprevir, telaprevir); - other infectious diseases (e.g. griseofulvin); - high blood pressure in the blood vessels in the lungs (bosentan).
Croatian: topiramat, felbamat); - tuberkuloze (na primjer rifampicin); - HIV infekcije (na primjer rifabutin, ritonavir, efavirenz); - infekcije virusom hepatitisa C (HCV) (na primjer boceprevir, telaprevir) - drugih zaraznih bolesti (na primjer grizeofulvin); - visokog krvnog tlaka u krvnim žilama pluća (bosentan).
English: • upper body discomfort radiating to the back, jaw, throat, arm and stomach;
Croatian: • nelagoda u gornjem dijelu tijela koja se širi u leđa, čeljust,
English: Zoely must not be used by women who are pregnant, or who think they may be pregnant.
Croatian: Žene koje su trudne ili misle da bi mogle biti trudne ne smiju uzimati Zoely.
English: o Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency.
Croatian: 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).
English: In the clinical trial performed with Zoely in the European Union the following Pearl Indices for the age class 18-35 years were calculated:
Croatian: Uniji izračunati su sljedeći Pearlovi indeksi za dobnu skupinu od 18 do 35 godina:
English: Vascular disorders hot flush venous thromboembolism
Croatian: Krvožilni poremećaji valunzi venska tromboembolija
English: Day 1-7 of white active tablet intake (see picture and schedule) Take the last white active missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time.
Croatian: 1.-7. dan uzimanja bijelih tableta s djelatnim tvarima (pogledajte sliku i raspored) Uzmite posljednju propuštenu bijelu tabletu s djelatnim tvarima čim se sjetite (čak i ako to znači da morate uzeti dvije tablete u isto vrijeme), a sljedeću tabletu uzmite u uobičajeno vrijeme.
English: • if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;
Croatian: • ako imate (ili ste ikada imali) krvni ugrušak u krvnoj žili nogu (duboka venska tromboza, DVT),
English: • vaginal smell; discomfort in the vagina or vulva
Croatian: • neugodan miris iz rodnice; nelagoda u rodnici ili stidnici
English: White active film-coated tablets: Each film-coated tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate).
Croatian: Bijele filmom obložene tablete s djelatnim tvarima: Jedna filmom obložena tableta sadrži 2,5 mg nomegestrolacetata i 1,5 mg estradiola (u obliku hemihidrata).
English: Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate
Croatian: Žene koje uzimaju kombiniranu hormonsku kontracepciju u pilulama koje sadrže levonorgestrel, noretisteron ili norgestimat oko 5-7 na 10 000 žena
English: When starting later, the woman should be advised to additionally use a barrier method until she has completed 7 days of uninterrupted white active tablet-taking.
Croatian: Ako započne kasnije, ženi treba preporučiti da koristi dodatnu mehaničku kontracepciju sve dok ne dovrši neprekinuti sedmodnevni niz uzimanja bijelih tableta s djelatnim tvarima.
English: As no epidemiological data are yet available with estradiol containing-CHCs, the warnings are considered applicable to the use of Zoely.
Croatian: S obzirom na to da još uvijek nema epidemioloških podataka za KHK-e koji sadrže estradiol, smatra se da upozorenja za KHK-e koji sadrže etinilestradiol važe i za primjenu lijeka Zoely.
English: How to take Zoely
Croatian: Kako uzimati Zoely
English: Other medical conditions associated with adverse vascular events
Croatian: Druga zdravstvena stanja povezana s VTE
English: Enzyme induction can occur after a few days of treatment.
Croatian: Nakon nekoliko dana liječenja može nastupiti indukcija enzima.
English: • During clinical trials with the Hepatitis C virus (HCV) combination drug regimen ombitasvir/paritaprevir/ritonavir with and without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN) were significantly more frequent in women using ethinylestradiol-containing medications such as CHCs.
Croatian: • Tijekom kliničkih ispitivanja kombiniranog režima liječenja HCV-a ombitasvirom/paritaprevirom/ritonavirom s dasabuvirom ili bez njega, povišenja ALT-a viša od 5 puta iznad gornje granice normale (GGN) bila su značajno češća u žena koje su uzimale lijekove koji sadrže etinilestradiol, kao što su KOK.
English: • fullness, indigestion or choking feeling;
Croatian: • punoća, probavne tegobe ili osjećaj gušenja;
English: Start the next blister as soon as the white active tablets in the current blister are finished, so skip the yellow placebo tablets.
Croatian: Počnite uzimati tablete iz novog blistera čim potrošite sve bijele tablete iz dosadašnjeg blistera, što znači da ćete preskočiti žute tablete placeba.
English: When changing from a progestogen-only injectable, implant or a hormone-medicated intrauterine system (IUS)
Croatian: Ako prelazite s injekcija ili implantata koje sadrže samo progestagen ili s intrauterinog sustava (spirale) koji otpušta hormon
English: • 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 antiphospholipid antibodies;
Croatian: C, nedostatak proteina S, nedostatak antitrombina III, faktor V Leiden ili antifosfolipidna protutijela;
English: DAY LABEL SHEET INCLUDING STICKERS PROVIDED WITH THE LEAFLET
Croatian: LIST S OZNAKAMA ZA DANE I NALJEPNICAMA PRILOŽEN UZ UPUTU O LIJEKU
English: An updated RMP should be submitted: • At the request of the European Medicines Agency;
Croatian: • Na zahtjev Europske agencije za lijekove
English: • disease of the gallbladder
Croatian: • bolest žučnog mjehura
English: Hepatobiliary disorders cholelithiasis, cholecystitis
Croatian: Poremećaji jetre i žuči kolelitijaza, kolecistits
English: • regular but scanty periods; larger breasts; breast lump; milk production while not pregnant;
Croatian: • redovite ali oskudne mjesečnice; povećane grudi; kvržica na dojkama; stvaranje mlijeka iako žena nije trudna; predmenstrualni sindrom; bol tijekom spolnog odnosa; suhoća rodnice ili stidnice; grč maternice
English: The breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users.
Croatian: Rak dojke se u žena koje su bilo kada tijekom života uzimale KOK često dijagnosticira u klinički manje uznapredovaloj fazi nego u žena koje nikada nisu koristile KOK.
English: There have been no reports of serious harmful effects from taking too many Zoely tablets at one time.
Croatian: Ako uzmete više Zoely tableta nego što ste trebali Nisu prijavljeni slučajevi ozbiljnih štetnih učinaka nakon uzimanja previše tableta lijeka Zoely odjednom.
English: If pregnancy occurs while taking Zoely, further intake should be stopped.
Croatian: Ako žena zatrudni tijekom uzimanja lijeka Zoely, treba prekinuti s daljnjim uzimanjem lijeka.
English: Nomegestrol acetate and its hydroxylated metabolites undergo extensive phase 2
Croatian: Nomegestrolacetat i njegovi hidroksilirani metaboliti prolaze opsežan metabolizam 2. faze, u kojem nastaju glukuronidni i sulfatni konjugati.
English: If the balance of benefits and risks is considered to be negative, a CHC should not be prescribed (see section 4.3).
Croatian: Ako se smatra da je omjer koristi i rizika negativan, ne smije se propisati kombinirani hormonski kontraceptiv (vidjeti dio 4.3).
English: • In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of COCs.
Croatian: • U rijetkim su slučajevima u korisnica KOK-a prijavljeni benigni tumori jetre, a još rjeđe maligni tumori jetre.
English: If the balance of benefits and risks is considered to be negative a CHC should not be prescribed (see section 4.3).
Croatian: Ako se omjer koristi i rizika smatra negativnim, ne smije se propisati kombinirani hormonski kontraceptiv (vidjeti dio 4.3).
English: By adjusting your intake schedule this higher risk can be prevented.
Croatian: Taj se povećani rizik može spriječiti prilagođavanjem rasporeda uzimanja tableta.
English: Adverse reaction in MedDRA Term Very common Common
Croatian: Nuspojave prema MedDRA terminologiji
English: • Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum.
Croatian: • Povremeno se može pojaviti i kloazma, osobito u žena koje su je imale u trudnoći.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Theramex Ireland Limited rd
Croatian: Nositelj odobrenja: Theramex Ireland Limited rd