FrancophonIA/ELRC3.0 huggingface dataset:
English: In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
Croatian: U ispitivanjima kontroliranima aktivnim usporednim lijekom, prosječno povećanje tjelesne težine tijekom monoterapije pioglitazonom iznosilo je 2-3 kg tijekom jedne godine.
English: Cardiac disorders heart failure common
Croatian: Srčani poremećaji zatajenje srca često
English: Each tablet contains 37.77 mg of lactose monohydrate (see section 4.4).
Croatian: Jedna tableta sadrži 37,77 mg laktoza hidrata (vidjeti dio 4.4).
English: A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
Croatian: Provedena je analiza objedinjenih podataka o prijelomima kostiju kao nuspojavama u randomiziranim, usporednim lijekom kontroliranim, dvostruko slijepim kliničkim ispitivanjima u više od 8100 bolesnika u skupinama liječenima pioglitazonom i 7400 bolesnika u skupinama liječenima usporednim lijekom u trajanju do 3,5 godine.
English: Each tablet contains 15 mg, 30 mg or 45 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta sadrži 15 mg, 30 mg ili 45 mg pioglitazona (u obliku hidroklorida).
English: If you stop taking Pioglitazone Actavis
Croatian: Ako prestanete uzimati Pioglitazon Actavis
English: Each tablet contains 75.54 mg of lactose monohydrate (see section 4.4).
Croatian: Jedna tableta sadrži 75,54 mg laktoza hidrata (vidjeti dio 4.4).
English: If you forget to take Pioglitazone Actavis
Croatian: Ako ste zaboravili uzeti Pioglitazon Actavis
English: EU/1/12/755/008 EU/1/12/755/009 EU/1/12/755/010 EU/1/12/755/011 EU/1/12/755/012 EU/1/12/755/013 EU/1/12/755/014 EU/1/12/755/015 EU/1/12/755/016 EU/1/12/755/017 EU/1/12/755/018 EU/1/12/755/019 EU/1/12/755/020 EU/1/12/755/021 EU/1/12/755/022 EU/1/12/755/023 EU/1/12/755/024 EU/1/12/755/025 EU/1/12/755/026 EU/1/12/755/027
Croatian: EU/1/12/755/001 EU/1/12/755/002 EU/1/12/755/003 EU/1/12/755/004 EU/1/12/755/005 EU/1/12/755/006 EU/1/12/755/007 EU/1/12/755/008 EU/1/12/755/009 EU/1/12/755/010 EU/1/12/755/011 EU/1/12/755/012 EU/1/12/755/013 EU/1/12/755/014 EU/1/12/755/015 EU/1/12/755/016 EU/1/12/755/017 EU/1/12/755/018 EU/1/12/755/019 EU/1/12/755/020 EU/1/12/755/021 EU/1/12/755/022 EU/1/12/755/023 EU/1/12/755/024 EU/1/12/755/025 EU/1/12/755/026 EU/1/12/755/027
English: Pioglitazone Actavis 15 mg, 30 mg and 45 mg tablets Pioglitazone Actavis 15 mg tablets
Croatian: Pioglitazon Actavis 15, 30 mg i 45 mg tablete Pioglitazon Actavis 15 mg tablete
English: How to take Pioglitazone Actavis
Croatian: Kako uzimati Pioglitazon Actavis
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon uncommon uncommon uncommon
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) karcinom mokraćnog mjehura manje često manje često manje često manje često manje često
English: What Pioglitazone Actavis looks like and contents of the pack Pioglitazone Actavis 15 mg tablets are white, round, flat, bevelled, 5.5 mm in diameter and engraved with ‘TZ15' on one side.
Croatian: Kako Pioglitazon Actavis izgleda i sadržaj pakiranja - Pioglitazon Actavis 15 mg tablete su bijele, okrugle, ravne s ukošenim rubom, promjera 5,5 mm s utisnutom oznakom ‘TZ15' na jednoj strani.
English: Each tablet contains 113.31 mg of lactose monohydrate (see section 4.4).
Croatian: Jedna tableta sadrži 114,51 mg laktoza hidrata (vidjeti dio 4.4).
English: How to store Pioglitazone Actavis
Croatian: Kako čuvati Pioglitazon Actavis
English: The packs with 14, 28, 56, 84 and 98 tablets contain blisters with abbreviations for days of the week printed on the blister (Mon, Tue, Wed, Thu, Fri, Sat, Sun).
Croatian: Pakiranja s 14, 28, 56, 84 i 98 tableta sadrže blistere s tiskanim kraticama naziva dana u tjednu (Pon, Uto, Sri, Čet, Pet, Sub, Ned).
English: Investigations weight increased common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon
Croatian: Pretrage povećana tjelesna težina često često često često često povišena kreatin fosfokinaza u krvi često povišena laktična dehidrogenaza manje često povišena alanin aminotransferaza nepoznato nepoznato nepoznato nepoznato nepoznato
English: Aurobindo Pharma B.V. Tel: +31 (0)35 542 99 33
Croatian: Aurobindo Pharma (Italia) s.r.l. Tel: +39 0296392601
English: Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Actavis.
Croatian: Liječnik će tražiti da za vrijeme liječenja lijekom Pioglitazon Actavis povremeno napravite krvne pretrage da bi se provjerilo radi li Vaša jetra normalno.
English: Pioglitazone Actavis contains lactose monohydrate If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Pioglitazone Actavis.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije nego što uzmete Pioglitazon Actavis.
English: Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
Croatian: Nakon stavljanja lijeka na tržište, kod bolesnika koji su liječeni pioglitazonom prijavljeni su slučajevi reakcija preosjetljivosti.
English: You can usually continue to take other medicines whilst you are being treated with Pioglitazone Actavis.
Croatian: Za vrijeme liječenja lijekom Pioglitazon Actavis obično možete nastaviti uzimati druge lijekove.
English: Common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence (wind)
Croatian: često (mogu se javiti u do 1 na 10 ljudi) - glavobolja - omaglica - bol u zglobovima - impotencija - križobolja
English: as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin.
Croatian: kao dvojna peroralna terapija u kombinaciji s - metforminom, u odraslih bolesnika (osobito bolesnika s prekomjernom tjelesnom težinom) s nedostatnom kontrolom glikemije usprkos monoterapiji metforminom u najvećoj podnošljivoj dozi - sulfonilurejom, samo u odraslih bolesnika s nepodnošenjem metformina ili u kojih je metformin kontraindiciran, s nedostatnom kontrolom glikemije usprkos monoterapiji sulfonilurejom u najvećoj podnošljivoj dozi.
English: EU/1/12/755/001 [14 tablets] EU/1/12/755/002 [28 tablets] EU/1/12/755/003 [30 tablets] EU/1/12/755/004 [50 tablets] EU/1/12/755/005 [56 tablets] EU/1/12/755/006 [84 tablets] EU/1/12/755/007 [90 tablets] EU/1/12/755/008 [98 tablets] EU/1/12/755/009 [100 tablets]
Croatian: EU/1/12/755/001 [14 tableta] EU/1/12/755/002 [28 tableta] EU/1/12/755/003 [30 tableta] EU/1/12/755/004 [50 tableta] EU/1/12/755/005 [56 tableta] EU/1/12/755/006 [84 tablete] EU/1/12/755/007 [90 tableta] EU/1/12/755/008 [98 tableta] EU/1/12/755/009 [100 tableta]
English: Pioglitazone Actavis 45 mg tablets are white, round, flat, bevelled, 8 mm in diameter and engraved with ‘TZ45' on one side.
Croatian: - Pioglitazon Actavis 45 mg tablete su bijele, okrugle, ravne s ukošenim rubom, promjera 8 mm s utisnutom oznakom ‘TZ45' na jednoj strani.
English: EU/1/12/755/019 [14 tablets] EU/1/12/755/020 [28 tablets] EU/1/12/755/021 [30 tablets] EU/1/12/755/022 [50 tablets] EU/1/12/755/023 [56 tablets] EU/1/12/755/024 [84 tablets] EU/1/12/755/025 [90 tablets] EU/1/12/755/026 [98 tablets] EU/1/12/755/027 [100 tablets]
Croatian: EU/1/12/755/019 [14 tableta] EU/1/12/755/020 [28 tableta] EU/1/12/755/021 [30 tableta] EU/1/12/755/022 [50 tableta] EU/1/12/755/023 [56 tableta] EU/1/12/755/024 [84 tablete] EU/1/12/755/025 [90 tableta] EU/1/12/755/026 [98 tableta] EU/1/12/755/027 [100 tableta]
English: NAME OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Actavis Group PTC ehf.
English: EU/1/12/755/010 [14 tablets] EU/1/12/755/011 [28 tablets] EU/1/12/755/012 [30 tablets] EU/1/12/755/013 [50 tablets] EU/1/12/755/014 [56 tablets] EU/1/12/755/015 [84 tablets] EU/1/12/755/016 [90 tablets] EU/1/12/755/017 [98 tablets] EU/1/12/755/018 [100 tablets]
Croatian: EU/1/12/755/010 [14 tableta] EU/1/12/755/011 [28 tableta] EU/1/12/755/012 [30 tableta] EU/1/12/755/013 [50 tableta] EU/1/12/755/014 [56 tableta] EU/1/12/755/015 [84 tablete] EU/1/12/755/016 [90 tableta] EU/1/12/755/017 [98 tableta] EU/1/12/755/018 [100 tableta]
English: Pioglitazone Actavis 30 mg tablets are white, round, flat, bevelled, 7 mm in diameter and engraved with ‘TZ30' on one side.
Croatian: - Pioglitazon Actavis 30 mg tablete su bijele, okrugle, ravne s ukošenim rubom, promjera 7 mm s utisnutom oznakom ‘TZ30' na jednoj strani.
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Actavis.
Croatian: Kad uzimate Pioglitazon Actavis, možete ponovno imati ovulaciju pa mogućnost trudnoće može biti povećana.
English: Pioglitazone Actavis 15 mg tablets pioglitazone
Croatian: Pioglitazon Actavis 15 mg tablete pioglitazon
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pioglitazone Actavis 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta lijeka Pioglitazon Actavis od 15 mg sadrži 15 mg pioglitazona (u obliku pioglitazonklorida).
English: Pioglitazone Actavis 30 mg tablets
Croatian: Pioglitazone Actavis 30 mg tablete
English: Allergic reactions have been reported (frequency not known) in patients taking Pioglitazone Actavis.
Croatian: Kod bolesnika koji su uzimali Pioglitazon Actavis prijavljene su alergijske reakcije (nepoznate učestalosti).
English: Pioglitazone Actavis 45 mg tablets pioglitazone
Croatian: Pioglitazon Actavis 45 mg tablete pioglitazon
English: Pioglitazone Actavis 45 mg tablets
Croatian: Pioglitazone Actavis 45 mg tablete
English: Musculoskeletal and connective tissue disorders fracture bone common common common common common arthralgia common common common back pain common
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva prijelom kosti često često često često često artralgija često često često križobolja često
English: Pioglitazone Actavis 30 mg tablets pioglitazone
Croatian: Pioglitazon Actavis 30 mg tablete pioglitazon
English: Pioglitazone Actavis 15 mg tablets
Croatian: Pioglitazone Actavis 15 mg tablete
English: Pioglitazone Actavis 45 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pioglitazon Actavis 45 mg
English: Pioglitazone Actavis 15 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pioglitazon Actavis 15 mg
English: The risk of fractures should be considered in the long term care of patients treated with pioglitazone (see section 4.8).
Croatian: Rizik od prijeloma treba uzeti u obzir kod dugotrajnog liječenja bolesnika pioglitazonom.
English: Pioglitazone Actavis 30 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Pioglitazon Actavis 30 mg
English: NAME OF THE MEDICINAL PRODUCT Pioglitazone Actavis 15 mg tablets
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Pioglitazone Actavis 15 mg tablete
English: General disorders and administration site conditions oedema very common fatigue uncommon
Croatian: Opći poremećaji i reakcije na mjestu primjene edem vrlo često umor manje često
English: Exforge HCT with food, drink and alcohol
Croatian: Exforge HCT s hranom, pićem i alkoholom
English: Date of first authorisation: 16 October 2009 Date of latest renewal: 30 June 2014
Croatian: Datum posljednje obnove odobrenja: 30. lipnja 2014.
English: • ACE inhibitors or aliskiren (see also information under the headings “Do not take Exforge HCT” and “Warnings and precautions”).
Croatian: ACE inhibitori ili aliskiren (vidjeti također informacije pod naslovom „Nemojte uzimati Exforge HCT“ i „Upozorenja i mjere opreza“).
English: Do not take Exforge HCT if you are more than 3 months pregnant.
Croatian: Nemojte uzimati Exforge HCT ako ste trudni više od 3 mjeseca.
English: Children and adolescents The use of Exforge HCT in children and adolescents under 18 years of age is not recommended.
Croatian: Djeca i adolescenti Primjena Exforge HCT-a u djece i adolescenata mlađih od 18 godina se ne preporučuje.
English: See also information under the heading “Do not take Exforge HCT”.
Croatian: Vidjeti također informacije pod naslovom „Nemojte uzimati Exforge HCT“.
English: Exforge HCT is not recommended in early pregnancy and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Croatian: Exforge HCT se ne preporučuje u ranoj trudnoći te se ne smije uzimati kada ste trudni više od 3 mjeseca, jer može ozbiljno naštetiti Vašem djetetu ako se uzima nakon trećeg mjeseca trudnoće.
English: Protect your skin from sun exposure and UV rays while taking Exforge HCT.
Croatian: Zaštitite svoju kožu od izlaganja suncu i UV zrakama za vrijeme uzimanja Exforge HCT.
English: Your doctor will normally advise you to stop taking Exforge HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Exforge HCT.
Croatian: Liječnik će Vas u pravilu savjetovati da prekinete uzimati Exforge HCT prije trudnoće ili čim saznate da ste trudni te će Vas savjetovati da uzmete drugi lijek umjesto Exforge HCT-a.
English: The usual dose of Exforge HCT is one tablet per day.
Croatian: Uobičajena doza Exforge HCT-a je jedna tableta na dan.
English: Before switching to Exforge HCT patients should be controlled on stable doses of the monocomponents taken at the same time.
Croatian: Prije prelaska na Exforge HCT bolesnici trebaju biti kontrolirani na stabilnim dozama monokomponenti koje se uzimaju u isto vrijeme.
English: (It is also recommended to avoid Exforge HCT in early pregnancy - see Pregnancy section.)
Croatian: (Preporučuje se izbjegavati Exforge HCT u ranoj trudnoćividjeti dio Trudnoća.)
English: Exforge HCT is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn, or was born prematurely.
Croatian: Exforge HCT se ne preporučuje majkama koje doje, a ako želite dojiti liječnik Vam može odabrati drugo liječenje, posebno ako je Vaše dijete novorođenče ili je prijevremeno rođeno.
English: To date there is no experience of the safe use of Exforge HCT in patients who have had a recent kidney transplantation.
Croatian: Do danas ne postoji iskustvo o sigurnoj primjeni Exforge HCT-a u bolesnika kojima je nedavno transplantiran bubreg.
English: Do not take Exforge HCT with grapefruit or grapefruit juice.
Croatian: Ne uzimajte Exforge HCT s grejpom ili sokom od grejpa.
English: There is no relevant use of Exforge HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.
Croatian: Nema relevantne primjene Exforge HCT-a u pedijatrijskoj populaciji (bolesnici mlađi od 18 godina) za indikaciju esencijalne hipertenzije.
English: However, it is important to take into account that Exforge HCT may increase the hypotensive effect of other antihypertensive agents.
Croatian: No važno je uzeti u obzir da Exforge HCT može povećati hipotenzivni učinak drugih antihipertenzivnih lijekova.
English: Exforge HCT was studied in a double-blind, active controlled study in hypertensive patients.
Croatian: Exforge HCT je ispitivan u dvostruko slijepoj, aktivno kontroliranom ispitivanju u hipertenzivnih bolesnika.
English: What Exforge HCT is and what it is used for
Croatian: Što je Exforge HCT i za što se koristi
English: The full blood pressure lowering effect was achieved 2 weeks after being on their maximal dose of Exforge HCT.
Croatian: Potpuni učinak na sniženje krvnog tlaka postignut je nakon 2 tjedna primjene najviše doze Exforge HCT-a.
English: What Exforge HCT is and what it is used for What you need to know before you take Exforge HCT How to take Exforge HCT
Croatian: Što je Exforge HCT i za što se koristi Što morate znati prije nego počnete uzimati Exforge HCT Kako uzimati Exforge HCT
English: The recommended dose of Exforge HCT is one tablet per day, to be taken preferably in the morning.
Croatian: Preporučena doza Exforge HCT-a je jedna tableta na dan koju je najbolje uzimati ujutro.
English: Patients taking Exforge HCT and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Croatian: Bolesnici koji uzimaju Exforge HCT i upravljaju vozilima ili rade na strojevima trebaju imati na umu da se katkada mogu javiti omaglica ili iscrpljenost.
English: If patients taking Exforge HCT suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired.
Croatian: Ako bolesnici koji uzimaju Exforge HCT pate od omaglice, glavobolje, umora ili mučnine, njihova sposobnost reagiranja mogla bi biti narušena.
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to a week of taking Exforge HCT.
Croatian: Ti bi mogli biti simptomi povišenog tlaka u Vašem oku, koji se može pojaviti unutar nekoliko sati do tjedan dana nakon uzimanja Exforge HCT-a.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Exforge HCT in all subsets of the paediatric population in essential hypertension (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Exforge HCT u svim podskupinama pedijatrijske populacije u liječenju esencijalne hipertenzije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Talk to your doctor or pharmacist before taking Exforge HCT if you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Exforge HCT ako imate nisku razinu kalija ili magnezija u Vašoj krvi (sa ili bez simptoma kao što su slabost mišića, spazmi mišića, poremećen srčani ritam).
English: Therefore, Exforge HCT is not recommended in this population.
Croatian: Stoga se u ovoj populaciji Exforge HCT ne preporučuje.
English: Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Exforge HCT (71%) compared to each of the three dual combination therapies (45-54%) (p<0.0001).
Croatian: Statistički veći udjeli bolesnika postigli su kontrolu krvnog tlaka (<140/90 mmHg) s Exforge HCT-om (71%) u usporedbi s primjenom bilo koje od tri dvojne kombinacijske terapije (45-54%) (p<0,0001).
English: The dose of Exforge HCT should be based on the doses of the individual components of the combination at the time of switching.
Croatian: Dozu Exforge HCT-a treba temeljiti na dozama pojedinih komponenata kombinacije u vrijeme prelaska.
English: Due to the hydrochlorothiazide component, Exforge HCT is contraindicated in symptomatic hyperuricaemia.
Croatian: Zbog hidroklortiazidne komponente Exforge HCT je kontraindiciran u simptomatskoj hiperuricemiji.
English: If you think you may be allergic, do not take Exforge HCT and talk to your doctor.
Croatian: Ako mislite da biste mogli biti alergični, nemojte uzeti Exforge HCT i porazgovarajte sa svojim liječnikom.
English: Exforge HCT can be used by people aged 65 years and over at the same dose as for other adults and in the same way as they have already taken the three substances called amlodipine, valsartan and hydrochlorothiazide.
Croatian: Osobe u dobi od 65 i više godina mogu uzimati Exforge HCT u istoj dozi kao i druge odrasle osobe i na isti način na koji su do sada već uzimale tri djelatne tvari zvane amlodipin, valsartan i hidroklorotiazid.
English: Elderly patients, particularly those taking the maximum dose of Exforge HCT (10 mg/320 mg/25 mg), should have their blood pressure checked regularly.
Croatian: Starijim bolesnicima, posebno onima koji uzimaju najvišu dozu Exforge HCT-a (10 mg/320 mg/25 mg), treba redovito kontrolirati krvni tlak.
English: If hypokalaemia develops during hydrochlorothiazide therapy, Exforge HCT should be discontinued until stable correction of the potassium balance.
Croatian: Ako se hipokalijemija razvije tijekom terapije hidroklorotiazidom, potrebno je prekinuti uzimanje Exforge HCT-a sve dok se postigne stabilna korekcija ravnoteže kalija.
English: Clinically significant hypotension due to Exforge HCT overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Croatian: Klinički značajna hipotenzija zbog predoziranja Exforge HCT-om zahtijeva aktivnu kardiovaskularnu potporu, uključujući često praćenje srčane i respiratorne funkcije, podizanje ekstremiteta, uz praćenje volumena cirkulirajuće tekućine i mokrenja.
English: What you need to know before you take Exforge HCT
Croatian: Što morate znati prije nego počnete uzimati Exforge HCT
English: Exforge HCT can be taken with or without food.
Croatian: Exforge HCT se može uzimati s hranom ili bez nje.
English: In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Exforge HCT were dizziness and hypotension (0.7%).
Croatian: Najčešći razlozi prekida terapije Exforge HCT-om u ovom aktivno kontroliranom kliničkom ispitivanju bili su omaglica i hipotenzija (0,7%).
English: You can take Exforge HCT with or without food.
Croatian: Exforge HCT možete uzimati s hranom ili bez nje.
English: Stopping your treatment with Exforge HCT may cause your disease to get worse.
Croatian: Prestanak liječenja Exforge HCT-om može dovesti do pogoršanja bolesti od koje bolujete.
English: Exforge HCT is available in packs containing 14, 28, 30, 56, 90, 98 or 280 film-coated tablets, in multipacks of 280 tablets (comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets), and in hospital packs containing 56, 98 or 280 tablets in single perforated dose blisters.
Croatian: Exforge HCT je dostupan u pakiranjima koja sadrže 14, 28, 30, 56, 90, 98 ili 280 filmom obloženih tableta, u višestrukim pakiranjima od 280 tableta (koja sadrže 4 kutije, od kojih svaka sadrži 70 tableta, ili 20 kutija, od kojih svaka sadrži 14 tableta), i u bolničkim pakiranjima koja sadrže 56, 98 ili 280 tableta u perforiranim blisterima djeljivim na jedinične doze.
English: If Exforge HCT is used during breast-feeding, doses should be kept as low as possible.
Croatian: Ako se Exforge HCT uzima tijekom dojenja, doze moraju biti najmanje moguće.
English: Based on the existing data with the components, the use of Exforge HCT is not recommended during first trimester and contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Croatian: Na temelju postojećih podataka o komponentama, primjena Exforge HCT-a ne preporučuje se tijekom prvog tromjesečja, dok je tijekom drugog i trećeg tromjesečja trudnoće kontraindicirana (vidjeti dijelove 4.3 i 4.4).
English: Exforge HCT should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Croatian: Exforge HCT se treba primjenjivati s oprezom u liječenju hipertenzije u bolesnika s jednostranom ili obostranom stenozom bubrežne arterije ili stenozom bubrežne arterije kod postojanja samo jednog bubrega budući da se u ovih bolesnika može povisiti urea u krvi i serumski kreatinin.
English: The rate and extent of absorption of amlodipine, valsartan and hydrochlorothiazide from Exforge HCT are the same as when administered as individual dosage forms.
Croatian: Brzina i opseg apsorpcije amlodipina, valsartana i hidroklorotiazida iz Exforge HCT-a jednaki su onima pri primjeni pojedinačnih dozirnih oblika.