FrancophonIA/ELRC3.0 huggingface dataset:
English: The administration of the losartan/hydrochlorothiazide combination induced a decrease in the red blood cell parameters (erythrocytes, haemoglobin, haematocrit), a rise in urea-N in the serum, a decrease in heart weight (without a histological correlate) and gastrointestinal changes (mucous membrane lesions, ulcers, erosions, haemorrhages).
Slovenian: Uporaba kombinacije losartan/hidroklorotiazid je povzročila zmanjšanje eritrocitnih indeksov (števila eritrocitov, hemoglobina, hematokrita) in povečanje količine N-sečnine v serumu, zmanjšanje teže srca (brez histološke povezave) in spremembe v prebavilih (lezije, ulkusi, erozije in krvavitve mukozne membrane).
English: If you take more Cozaar Comp than you should
Slovenian: Če ste vzeli večji odmerek zdravila Cozaar Comp, kot bi smeli
English: The MAH did not provide data showing that those patients receiving HCTZ had a clinical advantage with respect to clinical endpoints in comparison to those not receiving HCTZ.
Slovenian: Imetnik dovoljenja za promet z zdravilom ni priskrbel podatkov, ki bi kazali, da so imeli tisti bolniki, ki so prejemali tudi HCTZ, glede na klinične pokazatelje klinično prednost v primerjavi s tistimi, ki niso prejemali HCTZ.
English: Because of the potential for adverse effects on the nursing infant, Cozaar Comp is contraindicated during breast-feeding (see section 4.3).
Slovenian: Zaradi možnih neželenih učinkov na dojenčka, je zdravilo Cozaar Comp v času dojenja kontraindicirano (glejte poglavje 4.3).
English: Therefore, the CHMP considered that the benefit risk for the indication Reduction in risk of cardiovascular morbidity and mortality ( or risk of stroke_) in hypertensive patients with left ventricular hypertrophy is negative and this indication is not acceptable for the FDC.
Slovenian: Zaradi tega CHMP meni, da je razmerje med koristnimi učinki in tveganjem za indikacijo Zmanjšanje tveganja kardiovaskularne obolevnosti in umrljivosti (ali tveganje možganske kapi) pri hipertenzivnih bolnikih s hipertrofijo levega ventrikla negativno, tako da ta indikacija ni sprejemljiva za fiksno kombinacijo odmerkov.
English: 2780-730 Paço d´Arcos Portugal
Slovenian: 2780-730 Paço d´Arcos, Portugalska
English: Therefore, whilst the proposed indication for losartan monotherapy was considered approvable after a majority vote by the CHMP plenum and is supported with the following wording: “reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy, documented by ECG”, the following considerations apply for the FDC:
Slovenian: Čeprav so na zasedanju razširjenega odbora CHMP z večino glasov zaključili, da je predlagano indikacijo za monoterapijo z losartanom mogoče odobriti in jo podpreti z besedami: „zmanjšanje tveganja kapi pri hipertenzivnih bolnikih s hipertrofijo levega ventrikla, dokumentirano z EKG“, pa je treba pri zdravljenju s fiksno kombinacijo odmerkov upoštevati naslednje:
English: In clinical trials with losartan potassium salt and hydrochlorothiazide, no adverse events peculiar to this combination of substances were observed.
Slovenian: V kliničnih preizkušanjih s kalijevim losartanatom in hidroklorotiazidom niso opazili nobenih neželenih učinkov, značilnih za to kombinacijo.
English: • Others (eg bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, terfenadine, vincamine IV).
Slovenian: • drugi (npr. bepridil, cisaprid, difemanil, eritromicin i.v., halofantrin, mizolastin, pentamidin, terfenadin, vincamin i.v.)
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyophathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Slovenian: Zožanje aortne in mitralne zaklopke, obstruktivna hipertrofična kardiomiopatija Tako kot pri drugih vazodilatatorjih je posebna previdnost indicirana pri bolnikih, ki imajo zožitev aortne ali mitralne zaklopke ali obstruktivno hipertrofično kardiomiopatijo.
English: • if you have severely impaired liver function
Slovenian: • če imate hudo okvaro jeter.
English: Special precautionary measures (e.g. blood tests) may be appropriate if you take potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines, other diuretics (“water tablets”), some laxatives, medicines for the treatment of gout, medicines to control heart rhythm or for diabetes (oral agents or insulins).
Slovenian: Posebni previdnostni ukrepi (npr. krvni testi) so potrebni, če jemljete dodatke kalija, nadomestke soli, ki vsebujejo kalij, ali zdravila, ki varčujejo kalij, druge diuretike (tablete za odvajanje vode), nekatera odvajala, zdravila za zdravljenje protina, zdravila za nadzor srčnega ritma ali sladkorne bolezni (peroralna zdravila ali insulin).
English: - Reduction in risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy.
Slovenian: - Zmanjšanje tveganja kardiovaskularne obolevnosti in umrljivosti pri hipertenzivnih bolnikih s hipertrofijo levega ventrikla
English: 2770-192 Paço d' Arcos, Portugal
Slovenian: 2770-192 Paço d' Arcos, Portugalska
English: • Therapy resistant hypokalaemia or hypercalcaemia
Slovenian: • Na zdravljenje neodzivna hipokaliemija ali hiperkalciemija.
English: Hypotension and Intravascular volume depletion
Slovenian: Hipotenzija in zmanjšan intravaskularni volumen
English: Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij splošne farmakologije, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: • Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
Slovenian: • zlatenica (porumenitev oči in kože), vnetje trebušne slinavke
English: Cozaar Comp may be administered with other antihypertensive agents.
Slovenian: Zdravilo Cozaar Comp se lahko jemlje skupaj z drugimi antihipertenzivnimi zdravili.
English: Therefore, Cozaar Comp should not be given to children.
Slovenian: Zato se zdravila Cozaar Comp otrokom ne sme dajati.
English: • Class III antiarrythmics (eg amiodarone, sotalol, dofetilide, ibutilide).
Slovenian: • antiaritmiki razreda III (npr. amiodaron, sotalol, dofetilid, ibutilid)
English: If you experience the following, stop taking Cozaar Comp tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:
Slovenian: Zdravilo Cozaar Comp takoj prenehajte jemati in se posvetujte z zdravnikom ali pa takoj pojdite v najbližjo bolnišnico, če se pri vas pojavi kaj od sledečega:
English: Corticosteroids, ACTH Intensified electrolyte depletion, particularly hypokalemia.
Slovenian: Kortikosteroidi, ACTH Potencirajo pomanjkanje elektrolitov, še posebej hipokaliemijo.
English: Infants whose mothers have taken Cozaar Comp should be closely observed for hypotension (see also section 4.3 and 4.4).
Slovenian: Otroke, katerih matere so prejemale zdravilo Cozaar Comp, je treba pozorno spremljati zaradi možnosti pojava hipotenzije (glejte poglavji 4.3 in 4.4).
English: • Pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness,
Slovenian: • bolečine v rokah, ramenih, kolkih, kolenih in drugih sklepih, otekanje sklepov, okorelost, šibkost mišic
English: SPECIAL STORAGE CONDITIONS Store in the original package.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni plastenki.
English: How to store Cozaar Comp Further information
Slovenian: Shranjevanje zdravila Cozaar Comp Dodatne informacije
English: • Reduction of cardiovascular morbidity and mortality (or risk of stroke) in hypertensive patients with left ventricular hypertrophy.
Slovenian: • zmanjšanje kardiovaskularne obolevnosti in umrljivosti (ali tveganje možganske kapi) pri hipertenzivnih bolnikih s hipertrofijo levega ventrikla;
English: Thiazide-induced hypokalaemia or hypomagnesaemia may favour the onset of digitalis-induced cardiac arrhythmias.
Slovenian: S tiazidi povzročena hipokaliemija ali hipomagneziemija lahko vzpodbudi nastanek z digitalisom povzročenih srčnih aritmij.
English: Following oral administration in patients with mild to moderate alcoholic cirrhosis of the liver, plasma concentrations of losartan and its active metabolite were, respectively, 5-fold and 1.7-fold greater than those seen in young male volunteers.
Slovenian: Pri bolnikih z blago do zmerno alkoholno jetrno cirozo so bile plazemske koncentracije losartana oz. njegovega aktivnega presnovka po peroralni aplikaciji 5- oz. 1,7-krat večje od tistih pri mladih moških prostovoljcih.
English: The components of Cozaar Comp have been shown to have an additive effect on blood pressure reduction, reducing blood pressure to a greater degree than either component alone.
Slovenian: Učinkovini zdravila Cozaar Comp imata aditivni učinek na zniževanje krvnega tlaka, saj ga v kombinaciji znižata bolj kot vsaka učinkovina posebej.
English: Losartan is a synthetically produced oral angiotensin-II receptor (type AT1) antagonist.
Slovenian: Losartan je sintetičen peroralni antagonist angiotenzina II (tipa AT1).
English: The use of Cozaar Comp is not recommended during the first trimester of pregnancy (see section 4.4).
Slovenian: Uporaba zdravila Cozaar Comp v prvem trimesečju nosečnosti ni priporočljiva (glejte poglavje 4.4).
English: Uncommon (affecting less than one person in 100 but more than one person in 1,000):
Slovenian: Občasni (pojavijo se pri manj kot eni od 100 oseb in več kot eni od 1.000 oseb):
English: Cozaar Comp contains lactose.
Slovenian: Zdravilo Cozaar Comp vsebuje laktozo.
English: As observed in studies with losartan alone, adverse foetal and neonatal effects, including renal toxicity and foetal death, occurred when pregnant rate were treated with the losartan/hydrochlorothiazide combination during late gestation and/or lactation.
Slovenian: Kot so opazili v študijah s samim losartanom, so se neželeni fetalni in neonatalni učinki, ki so vključevali neželene učinke na ledvice in smrt ploda, pojavili, če so breje podgane prejemale kombinacijo losartan/hidroklorotiazid med visoko brejostjo in/ali dojenjem.
English: Use in patients with hepatic impairment Losartan/HCTZ is contraindicated in patients with severe hepatic impairment (see section 4.3.
Slovenian: Uporaba pri bolnikih z okavaro jeter Zdravilo losartan/HCTZ je kontraindicirano pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
English: Dietary salt in excessive quantities may counteract the effect of Cozaar Comp tablets.
Slovenian: Velike količine soli v hrani lahko izničijo učinek zdravila Cozaar Comp.
English: Yellow, oval film-coated tablets marked 717 on one side and plain or scored on the other.
Slovenian: Rumene, ovalne filmsko obložene tablete z oznako 717 na eni strani in z razdelilno zarezo ali brez na drugi strani.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: In the LIFE study an additional benefit was noted with regards to stroke for the losartan based strategy, and effects were similar with regard to MI and CV mortality, indicating that the demonstrated beneficial effect of beta-blockade on CV morbidity and mortality in general was also present for losartan.
Slovenian: V študiji LIFE so za strategijo zdravljenja na podlagi losartana opazili še dodatno korist, ki se nanaša na možgansko kap, učinki pa so bili podobni glede miokardnega infarkta ali kardiovaskularne umrljivosti, kar je pomenilo, da so bili dokazani koristni učinki zaviranja beta receptorjev na kardiovaskularno obolevnost in umrljivost prisotni tudi pri losartanu.
English: Generally losartan causes a decrease in serum uric acid (usually <0.4 mg/dL) which was persistent in chronic therapy.
Slovenian: Na splošno losartan zmanjša koncentracijo sečne kisline v serumu (običajno < 0,4 mg/dl).
English: Cozaar Comp therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see also 5.3 'Preclinical safety data').
Slovenian: Znano je, da izpostavljenost zdravilu Cozaar Comp v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnija, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (odpoved ledvic, hipotenzija, hiperkalemija) (glejte poglavje 5.3).
English: Quinte da Fonte Edificio Vasco da Gama, 19 P.O.
Slovenian: Edificio Vasco da Gama, 19
English: Reproductive system and breast disorders Uncommon: Decreased libido, impotence
Slovenian: Bolezni spolnih organov in dojk Občasne: zmanjšan libido, impotenca
English: SPECIAL STORAGE CONDITIONS Store in the original bottle.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini.
English: • Decreased sexual appetite, impotence,
Slovenian: • zmanjšan libido, impotenca
English: Thiazide diuretics may increase serum calcium levels due to decreased excretion.
Slovenian: Tiazidni diuretiki lahko povečajo količino kalcija v serumu zaradi njegovega zmanjšanega izločanja.
English: Thiazides may decrease urinary calcium excretion and may cause intermittent and slight elevation of serum calcium.
Slovenian: Tiazidi lahko zmanjšajo izločanje kalcija v urin, kar lahko povzroči občasno in rahlo zvišanje kalcija v serumu.
English: Patients were randomised to once daily losartan 50 mg or once daily atenolol 50 mg.
Slovenian: Bolnike so randomizirali tako, da so enkrat na dan dobivali 50 mg losartana ali 50 mg atenolola.
English: In controlled clinical trials for essential hypertension, dizziness was the only adverse experience reported as substance-related that occurred with an incidence greater than placebo in 1% or more of patients treated with losartan and hydrochlorothiazide.
Slovenian: V kontroliranih kliničnih preizkušanjih esencialne hipertenzije je bila omotica edini neželeni učinek, o katerem so poročali kot o z zdravilom povezanem neželenem učinku, ki se je pojavil pri 1 % ali več bolnikov, zdravljenih z losartanom in hidroklorotiazidom, in pogosteje kot pri placebu.
English: • Anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, sleepiness, memory impairment,
Slovenian: • zaskrbljenost, živčnost, panična motnja (ponavljajoči napadi panike), zmedenost, depresija, nenormalne sanje, motnje spanja, zaspanost, motnje spomina
English: Use in patients with renal impairment and haemodialysis patients No initial dosage adjustment is necessary in patients with moderate renal impairment (i.e. creatinine clearance 30-50 ml/min).
Slovenian: Uporaba pri bolnikih z okvaro ledvic in bolnikih na hemodializi Bolnikom z zmerno okvaro ledvic (to je s kreatininskim očistkom 30-50 ml/min) začetnega odmerka ni treba prilagoditi.
English: Thiazide therapy may precipitate hyperuricemia and/or gout in certain patients.
Slovenian: Zdravljenje s tiazidi lahko pri nekaterih bolnikih povzroči hiperurikemijo in/ali protin.
English: If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
Slovenian: Če je bolnik vzel tudi digitalis, lahko hipokaliemija izzove srčne aritmije.
English: Mean peak concentrations of losartan and its active metabolite are reached in 1 hour and in 3-4 hours, respectively.
Slovenian: Povprečne najvišje koncentracije losartana in njegovega aktivnega presnovka so dosežene po 1 oz. 3-4 urah.
English: Cozaar Comp Forte 100 mg/25 mg filmdragerade tabletter United Kingdom COZAAR-COMP 50/12.5MG FILM COATED TABLETS United Kingdom COZAAR-COMP 100/25MG FILM COATED TABLETS United Kingdom COZAAR-Comp
Slovenian: Cozaar Comp Forte 100 mg/25 mg filmdragerade tabletter Velika Britanija COZAAR-COMP 50/12.5MG FILM COATED TABLETS Velika Britanija COZAAR-COMP 100/25MG FILM COATED TABLETS Velika Britanija COZAAR-Comp
English: Losartan should be used with caution in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
Slovenian: Losartan je treba pri bolnikih z obojestranskim zožanjem ledvične arterije ali zožanjem arterije ene same delujoče ledvice previdno uporabljati.
English: Symptomatic hypotension, especially after the first dose, may occur in patients who are volumeand/or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Slovenian: Simptomatska hipotenzija, posebej po prvem odmerku, se lahko pojavi pri bolnikih z zmanjšanim intravaskularnim volumnom in/ali zmanjšano količino natrija zaradi zdravljenja z velikimi odmerki diuretikov, diete z omejitvijo količine soli v hrani, driske ali bruhanja).
English: • Frequent urination including at night, abnormal kidney function including inflammation of the kidneys, urinary infection, sugar in the urine,
Slovenian: • pogosto uriniranje (tudi ponoči), nenormalno delovanje ledvic, vključno z vnetjem ledvic, vnetjem mehurja in sečnice, sladkor v urinu
English: The occurrence of hypotension was dose related in these heart failure patients.
Slovenian: Pojav hipotenzije je bil pri teh bolnikih s srčnim popuščanjem odvisen od odmerka.
English: - The scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet.
Slovenian: - je bil okvir napotitvenega postopka uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo,
English: If you forget to take Cozaar Comp
Slovenian: Če ste pozabili vzeti zdravilo Cozaar Comp
English: Pharmacotherapeutic group: Combination containing an angiotensin II-receptor(type AT1)-antagonist and a thiazide diuretic, Antihypertensive, ATC code: C09DA01
Slovenian: Farmakoterapevtska skupina: kombinacija antagonista angiotenzina II (tipa AT1) in tiazidnega diuretika, antihipertenziv
English: Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively.
Slovenian: Holestiraminske in kolestipolne smole v enkratnem odmerku vežejo hidroklorotiazid in zmanjšajo njegovo absorpcijo iz prebavnega trakta, in sicer holestiraminske smole za do 85 %, kolestipolne pa za do 43 %.
English: • Treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide.
Slovenian: • zdravljenje hipertenzije pri bolnikih, katerih krvnega tlaka ni mogoče primerno nadzorovati z losartanom ali hidroklorotiazidom.
English: • Blurred vision, burning or stinging in the eyes, conjunctivitis, worsening eyesight, seeing things in yellow,
Slovenian: • zamegljen vid, pekoč občutek ali občutek zbadanja v očeh, vnetje očesne veznice, slabši vid, videnje stvari v rumeni barvi
English: Blood and lymphatic system disorders Uncommon: Anaemia, Henoch-Schönlein purpura, ecchymosis, haemolysis
Slovenian: Bolezni krvi in limfatičnega sistema občasne: anemija, Henoch-Schönleinova purpura, ekhimoza, hemoliza
English: Light yellow, oval film-coated tablets marked 747 on one side and plain on the other.
Slovenian: Svetlo rumene, ovalne filmsko obložene tablete z oznako 747 na eni strani in brez oznake na drugi strani.
English: For patients who do not respond adequately to Cozaar Comp 50 mg/12.5 mg, the dosage may be increased to one tablet of Cozaar Comp 100 mg/25 mg (losartan 100 mg/ HCTZ 25 mg) once daily.
Slovenian: Pri bolnikih, ki se na zdravilo Cozaar Comp 50 mg/12,5 mg ne odzivajo ustrezno, lahko odmerek povečate na eno tableto Cozaar Comp 100 mg/25 mg (losartan 100 mg/HCTZ 25 mg) enkrat na dan.
English: Cytotoxic agents (eg cyclophosphamide, methotrexate) Thiazides may reduce the renal excretion of cytotoxic medicinal products and potentiate their myelosuppressive effects.
Slovenian: Citotoksična zdravila (npr. ciklofosfamid, metotreksat) Tiazidi lahko zmanjšajo izločanje citotoksičnih zdravil skozi ledvice in okrepijo njihove mielosupresivne učinke.
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp and associated names (see Annex I) 50 mg/12.5 mg film-coated tablets Cozaar Comp and associated names (see Annex I) 100 mg/12.5 mg film-coated tablets Cozaar Comp and associated names (see Annex I) 100 mg/25 mg film-coated tablets [To be implemented nationally]
Slovenian: Cozaar Comp in povezana imena (glejte Dodatek I) 50 mg/12,5 mg filmsko obložene tablete Cozaar Comp in povezana imena (glejte Dodatek I) 100 mg/12,5 mg filmsko obložene tablete Cozaar Comp in povezana imena (glejte Dodatek I) 100 mg/25 mg filmsko obložene tablete [Izpolni država članica]
English: HYZAAR (Losartan/Hydrochlorothiazide) Luxembourg COZAAR PLUS FORTE 100 MG/25 MG Luxembourg COZAAR PLUS 50 MG/12,5 MG Luxembourg LOORTAN PLUS FORTE 100 mg/25 mg Luxembourg LOORTAN PLUS 50 mg/12,5 mg Malta
Slovenian: HYZAAR (Losartan/Hydrochlorothiazide) Luksemburg COZAAR PLUS FORTE 100 MG/25 MG Luksemburg COZAAR PLUS 50 MG/12,5 MG Luksemburg LOORTAN PLUS FORTE 100 mg/25 mg Luksemburg LOORTAN PLUS 50 mg/12,5 mg Madžarska Hyzaar 50/12.5 mg
English: Ireland Merck Sharp & Dohme Limited, Hertford Road,
Slovenian: Merck Sharp & Dohme Limited, Hertford Road,
English: After the discontinuation of losartan,PRA and angiotensin II values fell within 3 days to the baseline values.
Slovenian: Po prekinitvi zdravljenja z losartanom so aktivnost renina v plazmi in vrednosti angiotenzina II v 3 dneh padle na začetne vrednosti.
English: • Pins and needles or similar sensations, pain in the extremities, trembling, migraine, fainting,
Slovenian: • mravljinčenje ali podobni občutki, bolečine v udih, tresenje, migrena, omedlevica
English: The data available do not show that a first line therapy with the FDC is of advantage as compared to a stepwise approach within the approved indication.
Slovenian: Razpoložljivi podatki ne kažejo, da bi imelo v okviru odobrene indikacije zdravljenje prve izbire s fiksno kombinacijo odmerkov prednosti v primerjavi s pristopom k zdravljenju po korakih.
English: Increase of the bioavailability to thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Slovenian: Povečanje biološke uporabnosti tiazidnih diuretikov zaradi zmanjšane motilitete prebavil in hitrosti praznjenja želodca.
English: Therefore Cozaar Comp is contraindicated in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
Slovenian: Zato je zdravilo Cozaar Comp pri bolnikih s hudo jetrno okvaro kontraindicirano (glejte poglavja 4.2, 4.3 in 5.2).
English: Cozaar Comp 100/12.5 (losartan 100 mg/ HCTZ 12.5 mg) is available for those patients titrated to 100 mg of Cozaar Comp who require additional blood pressure control.
Slovenian: Cozaar Comp 100 mg/12,5 mg (losartan 100 mg/HCTZ 12,5 mg) je na voljo za bolnike, ki ob zdravljenju z zdravilom Cozaar 100 mg potrebujejo dodaten nadzor krvnega tlaka.
English: Cozaar Comp is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone.
Slovenian: Zdravilo Cozaar Comp je indicirano za zdravljenje esencialne hipertenzije pri bolnikih, pri katerih krvni tlak samo z losartanom ali samo s hidroklorotiazidom ni ustrezno nadzorovan.
English: Administration of losartan blocks all the physiologically relevant actions of angiotensin II and through inhibition of aldosterone could tend to attenuate the potassium loss associated with the diuretic.
Slovenian: Losartan zavira vse fiziološko pomembne učinke angiotenzina II in preko inhibicije aldosterona lahko zmanjša izgubo kalija, ki jo povzroči diuretik.
English: • Sore throat, breathlessness, bronchitis, pneumonia, water on the lungs (which causes difficulty breathing), nosebleed, runny nose, congestion,
Slovenian: • boleče grlo, zasoplost, bronhitis, pljučnica, voda v pljučih (ki otežuje dihanje), krvavitev iz nosu, smrkanje, zamašen nos
English: • if you have heart failure
Slovenian: • če imate srčno popuščanje.