FrancophonIA/ELRC3.0 huggingface dataset:
English: Old age and low body mass index are known risk factors for common adverse reactions of pharmacological doses of glucocorticoids such as osteoporosis, thinning of skin, diabetes mellitus, hypertension and increased susceptibility to infections.
Croatian: Starost i nizak indeks tjelesne mase poznati su čimbenici rizika za česte neželjene reakcije na farmakološke doze glukokortikoida, kao što su osteoporoza, stanjivanje kože, dijabetes melitus,
English: Additional side effects have been reported for other hydrocortisone medicines.
Croatian: Za druge lijekove s hidrokortizonom zabilježene su dodatne nuspojave.
English: Dosing according to individual clinical response is recommended.
Croatian: Preporučuje se dozu prilagoditi prema kliničkom odgovoru svake bolesnice pojedinačno.
English: If you experience any signs or symptoms listed in the section “The need for additional doses of Plenadren”, contact your doctor immediately.
Croatian: Odmah se obratite liječniku ako opazite bilo koji od znakova ili simptoma navedenih pod naslovom 'Potreba za dodatnim dozama Plenadrena'.
English: Observed mean serum cortisol concentration versus clock time following single and multiple dosing in primary adrenal insufficiency patients (n=62) after oral administration of Plenadren given once daily and hydrocortisone thrice daily.
Croatian: Opažena srednja vrijednost koncentracije kortizola u serumu u odnosu na vrijeme u danu pri jednokratnom ili višekratnom doziranju u bolesnika s primarnom adrenalnom insuficijencijom (n=62), nakon peroralne primjene Plenadrena davanog jedanput na dan i hidrokortizona davanog tri puta na dan
English: Use in intercurrent illness
Croatian: Primjena u slučaju istovremene bolesti
English: The transport of cortisol across membranes is expected to be mediated mainly by passive diffusion and therefore renal and biliary clearances are negligible.
Croatian: Očekuje se da je prijenos kortizola kroz membrane posredovan uglavnom pasivnom difuzijom pa su stoga klirensi bubrega i žuči zanemarivi.
English: Changing from conventional oral glucocorticoid treatment to Plenadren When changing patients from conventional oral hydrocortisone replacement therapy given three times daily to Plenadren, an identical total daily dose may be given.
Croatian: Pri prijelazu bolesnika s konvencionalne peroralne nadomjesne terapije hidrokortizonom uzimane tri puta na dan na Plenadren, može se davati jednaka ukupna dnevna doza.
English: Skin and subcutaneous tissue disorders Cushing-like symptoms, stria, ecchymoses, acne and hirsutism, impaired wound healing.
Croatian: Poremećaji kože i potkožnog tkiva Simptomi slični Cushingovu sindromu, strije, ekhimoze, akne i hirzutizam, usporeno cijeljenje rana.
English: Clinical efficacy
Croatian: UČINKOVITU PRIMJENU LIJEKA
English: Naturally-occurring glucocorticoids (hydrocortisone and cortisol), which also have salt-retaining properties, are used as replacement therapy in adrenal insufficiency.
Croatian: Prirodno prisutni glukokortikoidi (hidrokortizon i kortizol), koji imaju i svojstva zadržavanja soli,
English: Fertility in women with adrenal insufficiency or cortisol deficiency may be reduced.
Croatian: U žena s adrenalnom insuficijencijom ili nedostatkom kortizola plodnost može biti smanjena.
English: Fatigue and episodes of short-lasting vertigo have been reported.
Croatian: Zabilježeni su umor i epizode kratkotrajne vrtoglavice.
English: Metabolism and nutrition disorders Sodium and water retention and oedema tendency, hypertension, hypokalaemia.
Croatian: Zadržavanje natrija i vode te sklonost nastanku edema, hipertenzija, hipokalijemija.
English: Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare.
Croatian: Nakon predoziranja hidrokortizonom rijetko su prijavljene akutna toksičnost i/ili smrt.
English: Upper abdominal pain Nausea
Croatian: Poremećaji probavnog sustava proljev bol u gornjem dijelu abdomena mučnina
English: No study has been performed in patients with hepatic impairment, however data in the literature for hydrocortisone support that no dose adjustment is required in mild to moderate hepatic impairment.
Croatian: Nije provedeno ispitivanje u bolesnika s oštećenjem funkcije jetre, ali literaturni podaci o hidrokortizonu potvrđuju da prilagodba doze nije potrebna u slučajevima blagog do umjerenog oštećenja funkcije jetre.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 50 modified-release tablets
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: 50 modified-release tablets 100 modified-release tablets (2x50)
Croatian: Tableta s prilagođenim oslobađanjem 50 tableta s prilagođenim oslobađanjem 100 tableta s prilagođenim oslobađanjem (2×50)
English: • Erythromycin, telithromycin and clarithromycin - used to treat bacterial infections
Croatian: • eritromicin, telitromicin i klaritromicin - koriste se za liječenje bakterijskih infekcija Plenadren s hranom i pićem
English: On the other hand, the extent of absorption and bioavailability was approximately 30% higher for the 20 mg tablet after food intake compared to fasting and there was no absorption failure or dose dumping.
Croatian: 30% veći poslije unosa hrane u usporedbi s uzimanjem lijeka natašte, i nije bilo neuspješne apsorpcije ili prekomjernog oslobađanja lijeka.
English: Pharmacotherapeutic group: Corticosteroids for systemic use, glucocorticoids.
Croatian: Farmakoterapijska skupina: kortikosteroidi za sistemsku uporabu, glukokortikoidi, ATK oznaka: H02AB09.
English: Gastrointestinal disorders Dyspepsia and deterioration of existing gastric ulcer.
Croatian: Poremećaji probavnog sustava Dispepsija i pogoršanje postojećeg želučanog vrijeda.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/715/002 50 modified-release tablets EU/1/11/715/006 100 (2x50) modified-release tablets
Croatian: EU/1/11/715/002 50 tableta s prilagođenim oslobađanjem EU/1/11/715/006 100 (2×50) tableta s prilagođenim oslobađanjem
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/715/001 50 modified-release tablets EU/1/11/715/003 100 (2x50) modified-release tablets
Croatian: EU/1/11/715/001 50 tableta s prilagođenim oslobađanjem EU/1/11/715/003 100 (2×50) tableta s prilagođenim oslobađanjem
English: Plenadren 5 mg modified-release tablets The tablets are round (diameter 8 mm), convex and pink.
Croatian: Plenadren 5 mg tablete s prilagođenim oslobađanjem Tablete su okrugle (promjera 8 mm), ispupčene i ružičaste boje.
English: High (supra-physiological) dosages of hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.
Croatian: Primjena hidrokortizona u dozama višim od uobičajenih Visoke (suprafiziološke) doze hidrokortizona mogu prouzročiti povišenje krvnog tlaka, zadržavanje soli i vode te povećano izlučivanje kalija.
English: In addition the following adverse reactions have been reported for other hydrocortisone medicinal products given for indications other than adrenal insufficiency replacement therapy in higher doses (frequencies not known).
Croatian: Osim navedenih nuspojava, pri upotrebi većih doza drugih lijekova s hidrokortizonom za indikacije koje nisu nadomjesna terapija adrenalne insuficijencije, prijavljene su sljedeće nuspojave (učestalost nije poznata).
English: Carton containing 2 bottles of 50 modified-release tablets (100 tablets).
Croatian: Kutija sadrži 2 boce po 50 tableta s prilagođenim oslobađanjem (100 tableta).
English: • Stomach pain/heartburn, feeling sick or nauseated
Croatian: • bol u želucu/žgaravica ili mučnina
English: It is therefore important to take this medicine as directed by your doctor when driving or using machines.
Croatian: Stoga, kada vozite ili rukujete strojevima, važno je uzimati ovaj lijek prema uputama liječnika.
English: Frequency of adverse reactions Very common Common
Croatian: Učestalost nuspojava Vrlo često
English: In addition, tell your doctor or pharmacist if you are using any of the following medicines, as the dose of Plenadren may need to be changed:
Croatian: Osim toga, kažite liječniku ili ljekarniku ako uzimate neki od sljedećih lijekova jer može biti potrebno promijeniti dozu Plenadrena: • fenitoin, karbamazepin i barbiturati - koriste se za liječenje epilepsije
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Iron oxide black (E172)
Croatian: Ovojnica tablete makrogol (3350) poli(vinilni alkohol) talk titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, žuti (E172) željezov oksid, crni (E172)
English: Plenadren can be used during breast-feeding.
Croatian: Plenadren se smije primjenjivati u razdoblju dojenja.
English: Overall, the frequency and type of adverse reactions were similar for Plenadren once daily modifiedrelease tablets and hydrocortisone tablets given three times daily in a 12-week study.
Croatian: Sveukupno, u ispitivanju od 12 tjedana, učestalost i vrsta nuspojava bile su slične za Plenadren tablete s prilagođenim oslobađanjem koje se uzimaju jedanput na dan i tablete hidrokortizona uzimane tri puta na dan.
English: In patients with severe renal impairment monitoring of the clinical response is recommended and dose adjustment may be required, see section 5.2.
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega, preporučuje se pratiti klinički odgovor i možda je potrebna prilagodba doze, vidjeti dio 5.2.
English: The clinical response should be monitored in patients with these conditions.
Croatian: U bolesnika s takvim stanjima potrebno je pratiti klinički odgovor.
English: Patients with adrenal insufficiency and concomitant retroviral infection, such as HIV, need careful dose adjustment due to potential interaction with antiretroviral medicinal products and increased hydrocortisone dose due to the infection.
Croatian: potrebno je pažljivo prilagoditi dozu zbog moguće interakcije s antiretrovirusnim lijekovima, i povećati dozu hidrokortizona zbog infekcije.
English: • The other ingredients are hypromellose, microcrystalline cellulose, pregelatinised starch (maize), colloidal anhydrous silica and magnesium stearate.
Croatian: • Drugi sastojci su hipromeloza (E464), mikrokristalična celuloza (E460), prethodno želatinizirani škrob (kukuruzni), koloidni bezvodni silicijev dioksid (E551) i magnezijev stearat.
English: Plenadren 5 mg: Each modified-release tablet contains 5 mg of hydrocortisone.
Croatian: Plenadren 5 mg: jedna tableta s prilagođenim oslobađanjem sadrži 5 mg hidrokortizona.
English: Cortisol is the principal glucocorticoid secreted by the adrenal cortex.
Croatian: Kortizol je glavni glukokortikoid koji izlučuje kora nadbubrežne žlijezde.
English: Psychiatric adverse reactions may occur with systemic glucocorticoids.
Croatian: Uz sistemske glukokortikoide moguće su psihijatrijske nuspojave.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva artralgija
English: th
Croatian: U
English: PHARMACEUTICAL FORM Modified-release tablet.
Croatian: Tableta s prilagođenim oslobađanjem.
English: Plenadren 20 mg: Each modified-release tablet contains 20 mg of hydrocortisone.
Croatian: Plenadren 20 mg: jedna tableta s prilagođenim oslobađanjem sadrži 20 mg hidrokortizona.
English: The clinical response needs to be monitored in patients given medicinal products affecting gastric emptying and motility, see section 4.4.
Croatian: U bolesnika koji uzimaju lijekove koji utječu na pražnjenje želuca i motilitet, potrebno je pratiti klinički odgovor, vidjeti dio 4.4.
English: Increasing the dose of hydrocortisone at one dose occasion increases the total plasma exposure of cortisol less than proportional, see section 5.2.
Croatian: Povećanje doze hidrokortizona jednokratnom dozom, poveća ukupnu izloženost kortizola u plazmi manje nego proporcionalno, vidjeti dio 5.2. Kada epizoda istovremene bolesti završi, bolesnik se može vratiti na uobičajenu dozu održavanja.
English: Adrenal crisis can develop in patients with acute adrenal insufficiency.
Croatian: U bolesnika s akutnom adrenalnom insuficijencijom može se razviti adrenalna kriza.
English: November 2011
Croatian: Datum prvog odobrenja: 3. studenoga 2011.
English: The immediate-release part provides a rapid onset of absorption and the extended-release part provides a more extended plasma profile of cortisol.
Croatian: dok dio s odgođenim oslobađanjem produljuje profil kortizola u plazmi.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava vrtoglavica glavobolja
English: • Heartburn, aggravation of any existing stomach ulcer
Croatian: • žgaravica, pogoršanje čira na želucu ako ga imate
English: Patients should be instructed to take Plenadren orally with a glass of water on awakening at least 30 minutes before food intake, preferably in an upright position and between 6.00 am and 8.00 am in the morning.
Croatian: 30 minuta prije uzimanja hrane, poželjno je da to bude u uspravnom položaju te između 6 i 8 sati ujutro.
English: Vertigo Headache
Croatian: • glavobolja
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Croatian: Lijek čuvajte izvan pogleda i dohvata djece.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Plenadren 20 mg modified-release tablets hydrocortisone
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Plenadren 20 mg tablete s prilagođenim oslobađanjem hidrokortizon
English: Plenadren 5 mg modified-release tablets Plenadren 20 mg modified-release tablets Hydrocortisone
Croatian: Plenadren 5 mg tablete s prilagođenim oslobađanjem Plenadren 20 mg tablete s prilagođenim oslobađanjem hidrokortizon
English: Carton containing one bottle of 50 modified-release tablets.
Croatian: Kutija sadrži jednu bocu s 50 tableta s prilagođenim oslobađanjem.
English: The terminal half-life has been reported to be about 1.5 hours following intravenous and oral dosing of hydrocortisone tablets.
Croatian: Nakon intravenske i peroralne doze tableta hidrokortizona zabilježeni terminalni poluvijek iznosio je oko 1,5 sati.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Akutna adrenalna insuficijencija
English: Carton containing 1 bottle of 50 modified-release tablets.
Croatian: Kutija s 1 bocom koja sadrži 50 tableta s prilagođenim oslobađanjem.
English: Plenadren 20 mg modified-release tablets Each modified-release tablet contains hydrocortisone 20 mg.
Croatian: Plenadren 20 mg tablete s prilagođenim oslobađanjem Jedna tableta s prilagođenim oslobađanjem sadrži 20 mg hidrokortizona.
English: HDPE bottles with PP screw cap containing 50 modified-release tablets.
Croatian: Boce izrađene od polietilena visoke gustoće (HDPE) s polipropilenskim zatvaračem s navojem koje sadrže 50 tableta s prilagođenim oslobađanjem.
English: Hepatic impairment
Croatian: Psihijatrijski poremećaji
English: • Itchiness
Croatian: • proljev
English: Plenadren 20 mg modified-release tablets Tablet coating
Croatian: Plenadren 20 mg tablete s prilagođenim oslobađanjem
English: In less severe situations when intravenous administration of hydrocortisone is not required, for instance low grade infections, fever of any aetiology and stressful situations such as minor surgical procedures, the normal oral daily replacement dose must be increased temporarily; the total daily dose should be increased by administering the maintenance dose twice or thrice daily with 8 ±2 hours intervals (an increase in number of administrations, not increasing the morning dose).
Croatian: uobičajenu peroralnu dnevnu nadomjesnu dozu treba privremeno povećati; ukupnu dnevnu dozu treba povećati primjenom doze održavanja dva ili tri puta na dan u razmacima od 8 ± 2 sata (povećava se broj primjena bez povećanja jutarnje doze).
English: The dose of hydrocortisone should be carefully monitored during pregnancy in women with adrenal insufficiency.
Croatian: U trudnica s adrenalnom insuficijencijom, dozu hidrokortizona valja pažljivo pratiti.
English: Plenadren 5 mg modified-release tablets Each modified-release tablet contains hydrocortisone 5 mg.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Plenadren 5 mg tablete s prilagođenim oslobađanjem Jedna tableta s prilagođenim oslobađanjem sadrži 5 mg hidrokortizona.
English: Plenadren 20 mg modified-release tablets The tablets are round (diameter 8 mm), convex and white.
Croatian: Tablete su okrugle (promjera 8 mm) ispupčene i bijele boje.
English: • Diarrhoea
Croatian: • umor
English: Plenadren 5 mg modified-release tablets Tablet coating
Croatian: Plenadren 5 mg tablete s prilagođenim oslobađanjem
English: Titanium dioxide (E171)
Croatian: Ovojnica tablete makrogol (3350) polivinilni alkohol talk titanijev dioksid (E171)
English: Tablet core
Croatian: Funkcija štitne žlijezde
English: NAME OF THE MEDICINAL PRODUCT Plenadren 5 mg modified-release tablets hydrocortisone
Croatian: NAZIV LIJEKA Plenadren 5 mg tablete s prilagođenim oslobađanjem
English: NAME OF THE MEDICINAL PRODUCT Plenadren 20 mg modified-release tablets hydrocortisone
Croatian: Plenadren 20 mg tablete s prilagođenim oslobađanjem hidrokortizon
English: There is no need for dose adjustment in mild to moderate hepatic impairment.
Croatian: U bolesnika s blagim do umjerenim oštećenjem funkcije jetre prilagodba doze nije potrebna.
English: Arthralgia
Croatian: OBLIK
English: Contact your doctor promptly for advice if you notice any of these.
Croatian: Ako primijetite bilo što od spomenutog, obratite se liječniku za savjet što prije.
English: Adverse reactions from these studies and from postmarketing surveillance are listed below by system organ class and frequency as follows:
Croatian: Nuspojave opažene u tim ispitivanjima i nakon stavljanja lijeka u promet, navedene su niže prema klasifikaciji organskih sustava i učestalosti: Vrlo često (≥1/10); Često (≥1/100 i <1/10).
English: There is no need for dosage adjustment in patients with mild to moderate renal impairment.
Croatian: U bolesnika s blagim do umjerenim oštećenjem funkcije bubrega prilagodba doze nije potrebna.
English: FOSAVANCE with food and drink
Croatian: FOSAVANCE s hranom i pićem
English: This leaflet was last revised in <{MM/YYYY}>
Croatian: Ova uputa je zadnji puta revidirana u
English: Date of first authorisation: 24 August 2005 Date of latest renewal: 24 April 2015
Croatian: Datum prvog odobrenja: 24. kolovoza 2005.
English: Always take FOSAVANCE exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite FOSAVANCE točno onako kako Vam je rekao liječnik ili ljekarnik.
English: It contains important information reminding you how to take FOSAVANCE properly.
Croatian: Ona sadrži važne informacije koje će Vas podsjetiti kako pravilno uzimati FOSAVANCE.
English: FOSAVANCE is effective only if taken when your stomach is empty.
Croatian: FOSAVANCE je djelotvoran samo kada se uzima na prazan želudac.
English: Talk to your doctor or pharmacist before taking FOSAVANCE if:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete FOSAVANCE ako:
English: Children and adolescents FOSAVANCE should not be given to children and adolescents less than 18 years of age.
Croatian: Djeca i adolescenti FOSAVANCE se ne smije davati djeci i adolescentima mlađima od 18 godina.
English: • rash made worse by sunlight;
Croatian: • osip koji se pogoršava izlaganjem sunčevu svjetlu,
English: • you have been told you have trouble absorbing minerals in your stomach or intestines
Croatian: • Vam je rečeno da imate poteškoća s apsorpcijom minerala u želucu ili crijevima
English: Since it is not known how long you should take FOSAVANCE, you should discuss the need to stay on this medicine with your doctor periodically to determine if FOSAVANCE is still right for you.
Croatian: Budući da nije poznato koliko dugo trebate uzimati FOSAVANCE, povremeno biste sa svojim liječnikom trebali razgovarati o potrebi nastavka liječenja ovim lijekom kako biste utvrdili je li FOSAVANCE i dalje dobar lijek za Vas.
English: If you take more FOSAVANCE than you should If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Croatian: Ako greškom uzmete previše tableta, popijte punu čašu mlijeka i odmah se obratite liječniku.
English: The safety and efficacy of FOSAVANCE in children less than 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka FOSAVANCE u djece mlađe od 18 godina nisu ustanovljene.
English: FOSAVANCE has no or negligible direct influence on the ability to drive and use machines.
Croatian: FOSAVANCE ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: What FOSAVANCE is and what it is used for
Croatian: Što je FOSAVANCE i za što se koristi
English: Other medicines and FOSAVANCE
Croatian: Drugi lijekovi i FOSAVANCE
English: What FOSAVANCE is and what it is used for What you need to know before you take FOSAVANCE How to take FOSAVANCE
Croatian: Što je FOSAVANCE i za što se koristi Što morate znati prije nego počnete uzimati FOSAVANCE Kako uzimati FOSAVANCE
English: What FOSAVANCE looks like and contents of the pack
Croatian: Kako FOSAVANCE izgleda i sadržaj pakiranja
English: Therefore, caution should be used when these medicines are taken at the same time as FOSAVANCE.
Croatian: Stoga je potreban oprez kada se ti lijekovi uzimaju istodobno s lijekom FOSAVANCE.
English: It is important that you take FOSAVANCE for as long as your doctor prescribes the medicine.
Croatian: Važno je da uzimate FOSAVANCE sve dok Vam ga liječnik propisuje.
English: An Instruction Card is included in the carton for FOSAVANCE.
Croatian: Kartica s uputama priložena je u kutiji lijeka FOSAVANCE.
English: • Patients should not lie down for at least 30 minutes after taking FOSAVANCE and until after the first food of the day.
Croatian: • Bolesnice ne smiju leći najmanje 30 minuta nakon uzimanja FOSAVANCE tablete i dok ne pojedu svoj prvi dnevni obrok.
English: Once weekly.
Croatian: jedanput na tjedan.
English: • FOSAVANCE should only be swallowed after getting up for the day with a full glass of water (not less than 200 ml).
Croatian: • FOSAVANCE se mora progutati ujutro, nakon ustajanja, s punom čašom vode (najmanje 200 ml).
English: Remember, take FOSAVANCE once each week on that same day for as long as your doctor prescribes it.
Croatian: Upamtite, uzmite FOSAVANCE jedanput na tjedan na isti odabrani dan, onoliko dugo koliko Vam je liječnik propisao.
English: FOSAVANCE is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women.
Croatian: FOSAVANCE je namijenjen samo ženama u postmenopauzi i zbog toga se ne smije davati trudnicama ni dojiljama.
English: What you need to know before you take FOSAVANCE
Croatian: Što morate znati prije nego počnete uzimati FOSAVANCE
English: • allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing; severe skin reactions,
Croatian: • alergijske reakcije kao što su koprivnjača, oticanje lica, usana, jezika i/ili grla, koje može uzrokovati otežano disanje ili gutanje, teške kožne reakcije,
English: What is FOSAVANCE?
Croatian: Što je FOSAVANCE?
English: Your doctor has prescribed FOSAVANCE to treat your osteoporosis and because you are at risk of vitamin D insufficiency.
Croatian: Liječnik Vam je propisao FOSAVANCE za liječenje osteoporoze i zato što imate rizik od nedostatka vitamina D.
English: FOSAVANCE is only intended for use in postmenopausal women.
Croatian: FOSAVANCE je namijenjen isključivo ženama u postmenopauzi.
English: If you miss a dose, take only one FOSAVANCE tablet on the morning after you remember.
Croatian: Ako propustite uzeti dozu, uzmite samo jednu FOSAVANCE tabletu sljedećeg jutra nakon što se sjetite.
English: 4) Do not take FOSAVANCE at bedtime or before getting up for the day.
Croatian: 4) Nemojte uzimati FOSAVANCE navečer prije spavanja niti ujutro prije ustajanja.