FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment may be started without interruption as continuation therapy after the initial one-year treatment with Brilique 90 mg or other adenosine diphosphate (ADP) receptor inhibitor therapy in ACS patients with a high risk of an atherothrombotic event.
Croatian: U bolesnika s akutnim koronarnim sindromom s visokim rizikom od aterotrombotskog događaja, liječenje se može započeti bez prekida liječenja kao nastavak terapije nakon početnog jednogodišnjeg liječenja lijekom Brilique od 90 mg ili drugim inhibitorom receptora adenozin difosfata (ADP).
English: Higher exposures to ticagrelor (approximately 25% for both Cmax and AUC) and the active metabolite were observed in elderly (≥75years) ACS patients compared to younger patients by the population pharmacokinetic analysis.
Croatian: Populacijskom farmakokinetičkom analizom primijećene su veće izloženosti tikagreloru (približno 25% za Cmax i AUC) i aktivnom metabolitu kod bolesnika s akutnim koronarnim sindromom starije dobi (≥ 75 godina) u odnosu na mlađe bolesnike.
English: Thrombotic Thrombocytopenic Purpura
Croatian: Trombotična trombocitopenična purpura
English: No dose adjustment is recommended in patients with moderate hepatic impairment (see sections 4.2 and 4.4).
Croatian: Ne preporučuje se prilagodba doze u bolesnika s umjerenim oštećenjem funkcije jetre (vidjeti dijelove 4.2 i 4.4).
English: Brilique 60 mg twice daily is the recommended dose when an extended treatment is required for patients with a history of MI of at least one year and a high risk of an atherothrombotic event (see section 5.1).
Croatian: Kada je u bolesnika s povijesti IM-a u razdoblju od najmanje godinu dana i visokim rizikom od aterotrombotskih događaja potrebno produljeno liječenje, preporučena doza je 60 mg lijeka Brilique dvaput dnevno (vidjeti dio 5.1).
English: Hyperuricaemia d Gout/Gouty Arthritis
Croatian: Giht/Urični artritis
English: AstraZeneca A.E. Τηλ: +30 2 106871500
Croatian: Τηλ: + 30 2 106871500
English: Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, sodium starch glycolate type A, hydroxypropylcellulose (E463), magnesium stearate (E470b).
Croatian: Jezgra tablete: manitol (E421), kalcijev hidrogenfosfat dihidrat, natrijev škroboglikolat tipa A, hidroksipropilceluloza (E463), magnezijev stearat (E470b).
English: Brilique contains ticagrelor, a member of the chemical class cyclopentyltriazolopyrimidines (CPTP), which is an oral, direct acting, selective and reversibly binding P2Y12 receptor antagonist that prevents ADP-mediated P2Y12 dependent platelet activation and aggregation.
Croatian: Brilique sadrži tikagrelor, koji pripada kemijskoj skupini ciklopentiltriazolopirimidina (CPTP), peroralni je, direktno djelujući, selektivni antagonist
English: Tablet film-coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide black (E172), iron oxide red (E172).
Croatian: Film ovojnica tablete: hipromeloza (E464), titanijev dioksid (E171), makrogol 400, crni željezov oksid (E172), crveni željezov oksid (E172).
English: • Diarrhoea or indigestion
Croatian: • Proljev ili probavne tegobe
English: Ticagrelor is well tolerated in single doses up to 900 mg. Gastrointestinal toxicity was dose-limiting in a single ascending dose study.
Croatian: Tikagrelor je dobro podnošljiv u jednokratnim dozama do 900 mg.
English: Ticagrelor 60 mg twice daily + ASA N=6958
Croatian: Tikagrelor 60 mg dvaput dnevno + acetilsalicilatna kiselina N = 6958
English: PLATO Major
Croatian: PLATO ukupno velika
English: Creatinine levels may increase during treatment with ticagrelor.
Croatian: Tijekom liječenja tikagrelorom može doći do povišenja razina kreatinina.
English: Within each SOC the adverse reactions are ranked by frequency category.
Croatian: Unutar svakog SOC-a, nuspojave su navedene prema kategoriji učestalosti i prikazane prema ozbiljnosti, padajućim redoslijedom.
English: Ticagrelor 60 mg twice daily +ASA N = 7045
Croatian: Tikagrelor 60 mg dvaput dnevno + acetilsalicilatna kiselina N = 7045
English: e.g. conjunctival, retinal, intraocular bleeding e.g. epistaxis, haemoptysis e.g. gingival bleeding, rectal haemorrhage, gastric ulcer haemorrhage e.g. ecchymosis, skin haemorrhage, petechiae e.g. haemarthrosis, muscle haemorrhage e.g. haematuria, cystitis haemorrhagic e.g. vaginal haemorrhage, haematospermia, postmenopausal haemorrhage e.g. contusion, traumatic haematoma, traumatic haemorrhage
Croatian: Razina kreatinina se povećava do >50% od početne vrijednosti), a ne učestalost prijave nuspojava. npr. konjunktivalno, retinalno, intraokularno krvarenje npr. epistaksa, hemoptiza npr. gingivalno krvarenje, rektalno krvarenje, krvarenje ulkusa na želucu npr. ekhimoza, kožno krvarenje, petehija npr. hemartroza, krvarenje mišića npr. hematurija, hemoragijski cistitis npr. vaginalno krvarenje, hematospermija, postmenopauzalno krvarenje npr. kontuzija, traumatski hematom, traumatsko krvarenje
English: On a background of daily ASA, ticagrelor 90 mg twice daily showed superiority to 75 mg daily clopidogrel in preventing the composite endpoint of CV death, MI or stroke, with the difference driven by CV death and MI.
Croatian: Tikagrelor od 90 mg dvaput na dan, uz svakodnevno uzimanje acetilsalicilatne kiseline, pokazao je superiornost u odnosu na klopidogrel od 75 mg dnevno u sprječavanju složene mjere ishoda koja se sastojala od KV smrti, infarkta miokarda [IM], ili moždanog udara, što se najviše pokazalo kod KV smrti i IM.
English: Respiratory system bleedings
Croatian: Krvarenja u dišnom sustavu
English: TIMI Minor Bleed: Clinically apparent with 30-50 g/L decrease in haemoglobin.
Croatian: Manje TIMI krvarenje: Klinički vidljiva, sa smanjenjem hemoglobina od 30-50 g/l.
English: ICH: Intracranial haemorrhage.
Croatian: ICH: Intrakranijalno krvarenje
English: CV death, MI (excl. silent MI) or stroke Invasive intent Medical intent CV death
Croatian: pvrijednost kardiovaskularna (KV) smrt, infarkt miokarda (IM) (isklj. tihi IM) ili moždani udar bolesnici predviđeni za invazivno liječenje bolesnici predviđeni za medikamentozno liječenje
English: Round, biconvex, pink tablets marked with ‘60' above ‘T' on one side and plain on the other.
Croatian: Okrugle, bikonveksne, ružičaste tablete, s jedne strane označene oznakom „60“ iznad slova „T“, s druge strane bez oznake.
English: No dose adjustment is necessary for patients with mild hepatic impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze za bolesnike s blagim oštećenjem funkcije jetre (vidjeti dio 5.2).
English: Information on concomitant treatment with ticagrelor is required for interpretation of HIT platelet function tests.
Croatian: Za tumačenje nalaza testova za određivanje funkcije trombocita koji se koriste za dijagnosticiranje HIT-a potrebna je informacija o istodobnom liječenju tikagrelorom.
English: Round, flat, bevelled edged, white to pale pink, orodispersible tablets marked with ‘90' above ‘TI' on one side and plain on the other.
Croatian: Okrugle, plosnate, s kosim rubom, bijele do blijedo roze raspadljive tablete za usta s jedne strane označene oznakom „90“ iznad slova „TI“, s druge strane bez oznake.
English: Brilique 60 mg tablets ticagrelor
Croatian: Brilique 60 mg tablete ticagrelorum
English: Brilique 90 mg orodispersible tablets
Croatian: Brilique 90 mg raspadljive tablete za usta
English: Round, biconvex, yellow tablets marked with ‘90' above ‘T' on one side and plain on the other.
Croatian: Okrugle, bikonveksne, žute tablete, s jedne strane označene oznakom „90“ iznad slova „T“, s druge strane bez oznake.
English: What Brilique looks like and contents of the pack Film-coated tablet (tablet): The tablets are round, biconvex, yellow, film-coated marked with a “90” above “T” on one side.
Croatian: Filmom obložena tableta (tableta): Tablete su okrugle, ispupčene s obje strane, žute, filmom obložene s oznakom „90“ iznad slova „T“ na jednoj strani.
English: What Brilique looks like and contents of the pack Film-coated tablet (tablet): The tablets are round, biconvex, pink, film-coated marked with a “60” above “T” on one side.
Croatian: Filmom obložena tableta (tableta): Tablete su okrugle, ispupčene s obje strane, roze, filmom obložene s oznakom „60“ iznad slova „T“ na jednoj strani.
English: Brilique 60 mg film-coated tablets
Croatian: Brilique 60 mg filmom obložene tablete
English: TIMI Major Bleed: Clinically apparent with >50 g/L decrease in haemoglobin or intracranial haemorrhage.
Croatian: Veliko TIMI (Thrombolysis in Myocardial Infarction) krvarenje: Klinički vidljiva, sa smanjenjem hemoglobina >50 g/l ili intrakranijalnim krvarenjem.
English: TIMI-defined bleeding categories
Croatian: Kategorije krvarenja definirane po TIMI TIMI
English: Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze za bolesnike s oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: What Brilique looks like and contents of the pack The orodispersible tablets are round, flat, bevelled edged, white to pale pink, marked with a “90” above “TI” on one side.
Croatian: Raspadljiva tableta za usta su okrugle, plosnate, s kosim rubom, bijele do blijedo roze, s oznakom „90“ iznad slova „TI“ na jednoj strani.
English: Gastrointestinal haemorrhage g,
Croatian: Potkožno ili kožno krvarenje h,
English: Brilique 90 mg tablets ticagrelor
Croatian: Brilique 90 mg tablete ticagrelorum
English: Patients with an increased risk of bradycardic events (e.g. patients without a pacemaker who have sick sinus syndrome, 2
Croatian: Bolesnici s povećanim rizikom od bradikardijskih događaja (npr. bolesnici bez elektrostimulatora srca koji imaju sindrom bolesnog sinusa, AV blok 2. ili 3. stupnja ili sinkopu povezanu s bradikardijom) bili su isključeni iz glavnih ispitivanja u kojem se procjenjivala sigurnost primjene i djelotvornost tikagrelora.
English: Tablet coating Titanium dioxide (E171) Iron oxide black (E172) Iron oxide red (E172) Macrogol 400
Croatian: Ovojnica tablete titanijev dioksid (E171) željezov oksid, crni (E172) željezov oksid, crveni (E172) makrogol 400 hipromeloza (E464)
English: Oral use
Croatian: Operativni zahvat
English: Therefore, only Brilique 60 mg twice daily co-administered with ASA is recommended for the prevention atherothrombotic events (CV death, MI and stroke) in patients with a history of MI and a high risk of developing an atherothrombotic event.
Croatian: Stoga se za prevenciju aterotrombotskih događaja (KV smrt, IM i moždani udar) u bolesnika s IM u anamnezi i visokim rizikom za razvoj aterotrombotskih događaja preporučuje samo primjena lijeka Brilique od 60 mg dvaput dnevno u kombinaciji s acetilsalicilatnom kiselinom.
English: Brilique 90 mg film-coated tablets
Croatian: Brilique 90 mg filmom obložene tablete
English: Only limited information is available in patients with moderate hepatic impairment.
Croatian: U bolesnika s umjerenim oštećenjem funkcije jetre dostupni su samo ograničeni podaci.
English: Marketing Authorisation Holder: AstraZeneca AB SE-151 85 Södertälje Sweden
Croatian: Nositelj odobrenja: AstraZeneca AB SE-151 85 Södertälje Švedska
English: • Nosebleed
Croatian: • Modrice
English: PLATO-defined bleeding categories
Croatian: Kategorije krvarenja definirane po PLATO PLATO Velika
English: In patients with ACS, it is recommended that renal function is also checked one month after initiating the treatment with ticagrelor, paying special attention to patients ≥75 years, patients with moderate/severe renal impairment and those receiving concomitant treatment with an angiotensin receptor blocker (ARB).
Croatian: ≥ 75 godina, bolesnicima s umjerenim/teškim oštećenjem bubrega i onima koji istodobno primaju terapiju blokatorima angiotenzinskih receptora.
English: Urinary tract bleeding
Croatian: Krvarenje u urinarnom traktu
English: Premature discontinuation
Croatian: Prijevremeni prekid terapije
English: Japanese subjects was approximately 40% (20% after adjusting for body weight) higher compared to that in Caucasians.
Croatian: U kliničkim farmakološkim ispitivanjima, izloženost (Cmax i AUC) tikagreloru kod ispitanika japanskog podrijetla bila je približno 40% (20% nakon prilagodbe tjelesne težine) viša u usporedbi s onom kod bijelaca.
English: Calcium hydrogen phosphate dihydrate Magnesium stearate (E470b) Sodium starch glycolate type A Hydroxypropylcellulose (E463)
Croatian: Jezgra tablete manitol (E421) kalcijev hidrogenfosfat dihidrat magnezijev stearat (E470b) natrijev škroboglikolat vrsta A hidroksipropilceluloza (E463)
English: Titanium dioxide (E171) Iron oxide yellow (E172) Macrogol 400
Croatian: Ovojnica tablete talk titanijev dioksid (E171) željezov oksid, žuti (E172) makrogol 400 hipromeloza (E464)
English: Musculoskeletal connective tissue and bone
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: History of myocardial infarction
Croatian: Studija PEGASUS (infarkt miokarda u anamnezi)
English: • perforated unit-dosed blisters in a carton of 100x1 tablets Not all pack sizes may be marketed.
Croatian: • perforiranim blisterima s jediničnim dozama u kutiji sa 100x1 tabletom
English: Blood disorder bleedings
Croatian: Krvarenja povezana s poremećajima krvi
English: Each film-coated tablet contains 60 mg ticagrelor.
Croatian: Jedna filmom obložena tableta sadrži 60 mg tikagrelora.
English: Each film-coated tablet contains 90 mg ticagrelor.
Croatian: Jedna filmom obložena tableta sadrži 90 mg tikagrelora.
English: Tablet coating Talc
Croatian: Tablični prikaz nuspojava
English: Brilique 90 mg orodispersible tablets ticagrelor
Croatian: Brilique 90 mg raspadljive tablete za usta tikagrelor
English: Brilique 90 mg film-coated tablets ticagrelor
Croatian: Brilique 90 mg filmom obložene tablete tikagrelor (ticagrelorum)
English: Talk to your doctor before taking this medicine if you are breast-feeding.
Croatian: Ako dojite, prije uzimanja ovog lijeka razgovarajte sa svojim liječnikom.
English: Brilique 60 mg film-coated tablets ticagrelor
Croatian: Brilique 60 mg filmom obložene tablete tikagrelor (ticagrelorum)
English: Bleeding risk The use of ticagrelor in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events (see sections 4.8 and 5.1).
Croatian: Primjenu tikagrelora kod bolesnika s poznatim povećanim rizikom od krvarenja treba procijeniti u odnosu na korist u smislu prevencije aterotrombotskih događaja (vidjeti dijelove 4.8 i 5.1).Ako postoje kliničke indikacije, tikagrelor treba koristiti s oprezom u sljedećim skupinama bolesnika:
English: Each orodispersible tablet contains 90 mg ticagrelor.
Croatian: Jedna raspadljiva tableta za usta sadrži 90 mg tikagrelora.
English: Reproductive system bleedings
Croatian: Krvarenje u reproduktivnom sustavu
English: Each film-coated tablet contains 60 mg of ticagrelor.
Croatian: Jedna filmom obložena tableta sadrži 60 mg tikagrelora (ticagrelorum).
English: Brilique, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with - acute coronary syndromes (ACS) or - a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event (see sections 4.2 and 5.1).
Croatian: • infarktom miokarda u anamnezi (IM) i visokim rizikom za razvoj aterotrombotskog događaja (vidjeti dijelove 4.2 i 5.1).
English: Effect of ticagrelor on other P-gp substrates has not been studied.
Croatian: P-gp nije proučavan.
English: Switching data
Croatian: Prijavljivanje nuspojava
English: Each orodispersible tablet contains 90 mg of ticagrelor.
Croatian: Jedna raspadljiva tableta za usta sadrži 90 mg tikagrelora (ticagrelorum).
English: SN:
Croatian: RRR
English: • Bruising
Croatian: • Mučnina
English: Onset of action
Croatian: Nastup djelovanja
English: MicardisPlus with food and alcohol
Croatian: MicardisPlus s hranom i alkoholom
English: It is important that you take MicardisPlus every day until your doctor tells you otherwise.
Croatian: Važno je da uzimate MicardisPlus svaki dan dok Vam liječnik ne propiše drugačije.
English: You can take MicardisPlus with or without food.
Croatian: Možete uzimati MicardisPlus sa ili bez hrane.
English: (It is also better to avoid MicardisPlus in early pregnancy - see pregnancy section.)
Croatian: (Također je bolje izbjegavati MicardisPlus u ranoj trudnoći pogledajte dio o trudnoći.)
English: This applies especially to the medicines listed below taken at the same time with MicardisPlus:
Croatian: Ovo se osobito odnosi na lijekove navedene u nastavku koji se uzimaju istodobno uz MicardisPlus:
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number} {product code}
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC: {broj} [oznaka lijeka]
English: Other medicines and MicardisPlus:
Croatian: Drugi lijekovi i MicardisPlus:
English: Protect your skin from sun exposure and UV rays while taking MicardisPlus.
Croatian: Zaštitite svoju kožu od izlaganja suncu i UV zrakama za vrijeme uzimanja MicardisPlusa.
English: MicardisPlus can have influence on the ability to drive and use machines.
Croatian: MicardisPlus može utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Talk to your doctor before taking MicardisPlus:
Croatian: Obratite se svom liječniku prije nego uzmete MicardisPlus:
English: Talk to your doctor before taking MicardisPlus if you are suffering or have ever suffered from any of the following conditions or illnesses:
Croatian: Obratite se svom liječniku prije nego uzmete MicardisPlus ako bolujete ili ste bolovali od nekih od sljedećih stanja ili bolesti:
English: See also information under the heading “Do not take MicardisPlus”.
Croatian: Vidjeti također informacije pod naslovom „Nemojte uzimati MicardisPlus“.
English: MicardisPlus is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
Croatian: MicardisPlus se ne preporučuje majkama koje doje, a liječnik može odabrati drugo liječenje za Vas ako želite dojiti.
English: Your doctor will normally advise you to stop taking MicardisPlus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of MicardisPlus.
Croatian: Liječnik će Vam, u redovnom slučaju, savjetovati prekid primjene MicardisPlusa prije nego budete trudni ili čim saznate da ste trudni, te će Vam preporučiti drugi lijek umjesto MicardisPlusa.
English: Rare cases have also been reported with angiotensin II receptor antagonists (including MicardisPlus).
Croatian: Rijetki slučajevi također su zabilježeni uz antagoniste receptora angiotenzina II (uključujući MicardisPlus).
English: You should consult with your doctor if you need to adjust the dose of your other medicine while taking MicardisPlus.
Croatian: Potrebno je posavjetovati se s liječnikom ako trebate prilagođavanje doze drugog lijeka dok uzimate MicardisPlus.
English: What MicardisPlus looks like and contents of the pack
Croatian: Kako MicardisPlus izgleda i sadržaj pakiranja
English: What MicardisPlus is and what it is used for
Croatian: Što je MicardisPlus i za što se koristi
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take MicardisPlus” and “Warnings and precautions”).
Croatian: - Ako uzimate ACE-inhibitor ili aliskiren (vidjeti također informacije pod naslovima „Nemojte uzimati MicardisPlus“ i „Upozorenja i mjere opreza“).
English: MicardisPlus once daily produces effective and smooth reductions in blood pressure across the therapeutic dose range.
Croatian: MicardisPlus jedanput dnevno dovodi do učinkovitog i ujednačenog sniženja krvnog tlaka u rasponu terapijskih doza.
English: Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of MicardisPlus, hyperkalaemia might occur.
Croatian: Nasuprot tome, zahvaljujući antagonizmu receptora angiotenzina II (AT1) putem telmisartanske komponente MicardisPlusa, može doći do pojave hiperkalemije.
English: If MicardisPlus is used during breast feeding, doses should be kept as low as possible.
Croatian: Ako se MicardisPlus primjenjuje tijekom dojenja, mora se primijeniti najniža moguća doza.
English: The European Medicines Agency has waived the obligation to submit the results of studies with MicardisPlus in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka MicardisPlus u svim podskupinama pedijatrijske populacije u hipertenziji (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in MicardisPlus, minimal or no effects were reported.
Croatian: Povećanje razine kolesterola i triglicerida povezano je s tiazidnom diuretskom terapijom; međutim, pri dozi od 12,5 mg koja je sadržana u MicardisPlusu, zabilježen je minimalan ili nikakav učinak.
English: What MicardisPlus contains
Croatian: Što MicardisPlus sadrži
English: There are no adequate data from the use of MicardisPlus in pregnant women.
Croatian: Ne postoje adekvatni podaci o primjeni MicardisPlusa kod trudnica.
English: MicardisPlus contains milk sugar (lactose) and sorbitol.
Croatian: MicardisPlus sadrži mliječni šećer (laktoza) i sorbitol.
English: MicardisPlus may be less effective in lowering the blood pressure in black patients.
Croatian: MicardisPlus može biti manje učinkovit u snižavanju krvnog tlaka kod bolesnika crne rase.
English: MicardisPlus tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Croatian: MicardisPlus tablete namijenjene su peroralnoj primjeni jednom dnevno, te se moraju uzimati s tekućinom, sa ili bez hrane.
English: MicardisPlus may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Croatian: MicardisPlus može pojačati učinak snižavanja krvnog tlaka drugih lijekova koji se primjenjuju u liječenju visokog krvnog tlaka ili lijekova s potencijalom snižavanja krvnog tlaka (npr. baklofenak, amifostin).
English: Because no information is available regarding the use of MicardisPlus during breast-feeding, MicardisPlus is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Croatian: S obzirom da ne postoje raspoloživi podaci u vezi primjene MicardisPlusa tijekom dojenja, MicardisPlus se ne preporučuje, te se preferiraju zamjenski lijekovi s utemeljenijim profilima sigurnosti tijekom dojenja, osobito u slučaju novorođenčeta ili prijevremeno rođenog djeteta.
English: Such conditions should be corrected before the administration of MicardisPlus.
Croatian: Takva stanja moraju se korigirati prije primjene MicardisPlusa.
English: The overall incidence of adverse reactions reported with MicardisPlus was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Croatian: Ukupna incidencija nuspojava prijavljenih uz MicardisPlus usporediva je s onima prijavljenima uz sami telmisartan u randomiziranim kontroliranim ispitivanjima koja uključuju 1471 bolesnika randomiziranih za dobivanje telmisartana plus hidroklorotiazid (835) ili samog telmisartana (636).
English: Coadministration of lithium and MicardisPlus is not recommended (see section 4.4).
Croatian: Istodobna primjena litija i MicardisPlusa se ne preporučuje (vidjeti dio 4.4).
English: MicardisPlus is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Croatian: MicardisPlus se ne preporučuje u ranoj trudnoći, te se ne smije uzimati ako ste trudni dulje od 3 mjeseca, jer može izazvati ozbiljna oštećenja bebe ako se primjenjuje u tom stadiju (vidjeti dio o trudnoći).