FrancophonIA/ELRC3.0 huggingface dataset:
English: Sepsis* (often called "blood poisoning"), is a severe infection with whole-body inflammatory response, rapid swelling of the skin and mucosa (angioedema), blistering and peeling of the top layer of skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Slovenian: Sepsa* (pogosto poimenovana tudi zastrupitev krvi), je huda okužba, pri kateri pride v vsem telesu do vnetnega odziva in je lahko usodna; hitro otekanje kože in sluznice (angioedem), mehurje in luščenje vrhnjega kožnega sloja (toksična epidermalna nekroliza); ti neželeni učinki so redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) ali neznane pogostnosti (toksična epidermalna nekroliza), toda zelo resni, zato morajo bolniki takoj prenehati z jemanjem zdravila in nemudoma poiskati zdravniško pomoč.
English: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Slovenian: Na splošno se bolniki s primarnim aldosteronizmom ne odzivajo na antihipertenzive, ki delujejo z zaviranjem renin-angiotenzinskega sistema, zato zanje zdravljenja z zdravilom MicardisPlus ne priporočamo.
English: Precautions to be taken before handling or administering the medicinal product MicardisPlus should be kept in the sealed blister due to the hygroscopic property of the tablets.
Slovenian: Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Zdravilo MicardisPlus je treba shranjevati v zaprtem pretisnem omotu, ker so tablete higroskopične.
English: MicardisPlus tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Slovenian: Jemanje tablet MicardisPlus je peroralno enkrat na dan s tekočino, s hrano ali brez nje.
English: MicardisPlus is not indicated in patients with severe hepatic impairment.
Slovenian: Zdravilo MicardisPlus ni indicirano za bolnike s hudim jetrnim odpovedovanjem.
English: Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for MicardisPlus.
Slovenian: Kljub temu, da so povečano pojavnost opazili pri samostojni uporabi telmisartana, je med jemanjem zdravila MicardisPlus ni možno izključiti.
English: 14 tablets 28 tablets 30 x 1 tablets 56 tablets 90 x 1 tablets 98 tablets 28 x 1 tablets
Slovenian: 14 tablet 28 tablet 30 x 1 tableta 56 tablet 90 x 1 tableta 98 tablet 28 x 1 tableta
English: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Slovenian: Enako kot za uporabo drugih vazodilatatorjev velja posebna previdnost pri dajanju zdravila MicardisPlus bolnikom z zožitvijo aorte ali mitralne zaklopke ali obstruktivno hipertrofično kardiomiopatijo.
English: 14 tablets 28 tablets 30 x 1 tablets 56 tablets 84 tablets 90 x 1 tablets 98 tablets 28 x 1 tablets
Slovenian: 14 tablet 28 tablet 30 x 1 tableta 56 tablet 84 tablet 90 x 1 tableta 98 tablet 28 x 1 tableta
English: Based on the experience with the use of other medicinal products that blunt the renin- angiotensin system, concomitant use of the above medicinal products may lead to increases in serum potassium and is, therefore, not recommended (see section
Slovenian: Izkušnje z drugimi zdravili, ki zavirajo delovanje renin-angiotenzinskega sistema, kažejo, da lahko sočasno dajanje teh zdravil poveča raven kalija v serumu, in jih zato ne priporočamo (glejte poglavje 4.4).
English: If MicardisPlus is used during breast feeding, doses should be kept as low as possible.
Slovenian: Če doječe matere zdravilo MicardisPlus uporabljajo med dojenjem, morajo biti njegovi odmerki karseda majhni.
English: MicardisPlus is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Slovenian: Zdravilo MicardisPlus je kombinacija antagonista receptorjev angiotenzina II telmisartana in tiazidnega diuretika hidroklorotiazida.
English: In patients with mild to moderate hepatic impairment the posology should not exceed MicardisPlus 40 mg/12.5 mg once daily.
Slovenian: Odmerek za bolnike z blago do zmerno zmanjšanim jetrnim delovanjem ne sme prekoračiti odmerka zdravila MicardisPlus 40 mg/12,5 mg 1-krat na dan.
English: The effect of MicardisPlus may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen).
Slovenian: Učinek zdravila MicardisPlus se lahko zmanjša, če jemljete NSAR (nesteroidne antirevmatike, npr. acetilsalicilno kislino ali ibuprofen).
English: (It is also better to avoid MicardisPlus in early pregnancy - see pregnancy section.)
Slovenian: • če ste noseči več kot 3 mesece (zdravilu MicardisPlus se je bolje izogibati tudi v zgodnji nosečnosti - glejte poglavje o nosečnosti),
English: MicardisPlus is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when telmisartan is used alone.
Slovenian: Zdravilo MicardisPlus je namenjeno za zdravljenje visokega krvnega tlaka (esencialne hipertenzije) pri odraslih, pri katerih s samim telmisartanom krvnega tlaka ne moremo dovolj uravnati.
English: MicardisPlus fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide and 80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
Slovenian: Zdravilo MicardisPlus, fiksna kombinacija (40 mg telmisartana/12,5 mg hidroklorotiazida in 80 mg telmisartana/12,5 mg hidroklorotiazida), je indicirano za odrasle, pri katerih krvnega tlaka ne moremo ustrezno uravnati s samim telmisartanom.
English: Jaundice hepatocellular, jaundice cholestatic
Slovenian: hepatocelularna zlatenica, holestazna zlatenica
English: MicardisPlus should be kept in the sealed blister due to the hygroscopic property of the tablets.
Slovenian: Zdravilo MicardisPlus je treba shranjevati v zaprtem pretisnem omotu, ker so tablete higroskopične.
English: The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, vomiting, increase in serum creatinine, and acute renal failure have also been reported.
Slovenian: Najizrazitejša učinka po prevelikem odmerku telmisartana sta hipotenzija in tahikardija; poročala navajajo še bradikardijo, vrtoglavico, bruhanje, povečanje ravni kreatinina v serumu in akutno ledvično odpoved.
English: Previous preclinical safety studies performed with co-administration of telmisartan and hydrochlorothiazide in normotensive rats and dogs, in doses producing exposure comparable to that in the clinical therapeutic range, caused no additional findings not already observed with administration of either substance alone.
Slovenian: Predhodne predklinične raziskave o varnosti, v katerih so telmisartan in hidroklorotiazid sočasno dajali normotenzivnim podganam in psom, odmerki, ki so ustrezali tistim v kliničnem terapevtskem razponu, niso imeli učinkov, ki bi se razlikovali od onih, ki so znani za posamezni učinkovin.
English: How to take MicardisPlus
Slovenian: Kako jemati zdravilo MicardisPlus
English: What MicardisPlus contains
Slovenian: Kaj vsebuje zdravilo MicardisPlus
English: • MicardisPlus 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Micardis 40 mg
Slovenian: • Zdravilo MicardisPlus 40 mg/12,5 mg lahko dajemo enkrat na dan bolnikom, pri katerih krvnega tlaka ne moremo ustrezno nadzorovati z zdravilom Micardis 40 mg
English: Anorexia, appetite decreased, electrolyte imbalance, hypercholesterolaemia, hyperglycaemia, hypovolaemia, ,
Slovenian: hipomagneziemija hiperkalciemija hipokloremična alkaloza anoreksija, zmanjšan apetit, elektrolitsko neravnovesje, hiperholesterolemija, hiperglikemija, hipovolemija
English: Aanaemia Eosinophilia, thrombocytopenia
Slovenian: eozinofilija, trombocitopenija
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).
Slovenian: V kliničnih preskušanjih je sodelovalo 1471 bolnikov, ki so bili naključno razvrščeni v skupini, od katerih je ena prejemala telmisartan in hidroklorotiazid (835), druga pa samo telmisartan (636).
English: - Hyponatraemia and hypochloraemic alkalosis There is no evidence that MicardisPlus would reduce or prevent diuretic-induced hyponatraemia.
Slovenian: Ni podatkov, ki bi kazali, da zdravilo MicardisPlus zmanjša ali prepreči hiponatriemijo, ki jo povzročajo diuretiki.
English: There is no experience regarding the administration of MicardisPlus in patients with recent kidney transplantation.
Slovenian: Z uporabo zdravila MicardisPlus pri bolnikih z nedavno presajeno ledvico ni izkušenj.
English: Adverse reactions reported with one of the individual components may be potential adverse reactions with MicardisPlus, even if not observed in clinical trials with this product.
Slovenian: Neželeni učinki, o katerih so poročali za eno od posameznih sestavin, se lahko pojavijo tudi pri zdravilu MicardisPlus, četudi jih v kliničnem preskušanju tega zdravila niso zasledili.
English: Lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis, erythema multiforme Musculoskeletal, connective tissue and bone disorders Not known:
Slovenian: lupusu podoben sindrom, fotosenzibilne reakcije, kožni vaskulitis, toksična epidermalna nekroliza, multiformni eritem
English: Periodic monitoring of serum potassium and ECG is recommended when MicardisPlus is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
Slovenian: Priporočamo periodično spremljanje ravni kalija v serumu in EKG, kadar dajemo zdravilo MicardisPlus hkrati z zdravili, na delovanje katerih vplivajo motnje serumskega kalija (npr. z glikozidi digitalisa ali antiaritmiki).
English: Skin and subcutaneous tissue disorders Not known:
Slovenian: Bolezni kože in podkožja Neznana:
English: D-55216 Ingelheim am Rhein Germany and
Slovenian: D-55216 Ingelheim am Rhein Nemčija in
English: 2.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs.patients taking placebo (0.16 %) [RR 2.07 (95 % confidence interval 1.14 - 3.76)].
Slovenian: Pri bolnikih, ki so jemali telmisartan (0,33 %), se je v primerjavi s placebom (0,16 %) povečala pojavnost usodne sepse [RR 2,07 (95-odstotni interval zaupanja 1,14 do 3,76)].
English: • MicardisPlus 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Micardis 80 mg
Slovenian: • Zdravilo MicardisPlus 80 mg/12,5 mg lahko dajemo enkrat na dan bolnikom, pri katerih krvnega tlaka ne moremo ustrezno nadzorovati z zdravilom Micardis 80 mg
English: NAME OF THE MEDICINAL PRODUCT MicardisPlus 80 mg/25 mg tablets
Slovenian: IME ZDRAVILA MicardisPlus 80 mg/25 mg tablete
English: EU/1/02/213/017 14 tablets EU/1/02/213/018 28 tablets EU/1/02/213/019 28 x 1 tablets EU/1/02/213/020 30 x 1 tablets EU/1/02/213/021 56 tablets EU/1/02/213/022 90 x 1tablets EU/1/02/213/023 98 tablets
Slovenian: EU/1/02/213/017 14 tablet EU/1/02/213/018 28 tablet EU/1/02/213/019 28 x 1 tableta EU/1/02/213/020 30 x 1 tableta EU/1/02/213/021 56 tablet EU/1/02/213/022 90 x 1 tableta EU/1/02/213/023 98 tablet
English: There was a trend towards higher plasma concentrations of hydrochlorothiazide in female than in male subjects.
Slovenian: Tudi plazemske koncenetracije hidroklorotiazida se pri ženskah nagibajo k nekoliko večjim vrednostim.
English: INFORMATION IN BRAILLE MicardisPlus 80 mg/25 mg
Slovenian: PODATKI V BRAILLOVI PISAVI MicardisPlus 80 mg/25 mg
English: Yellow and white oval shaped tablet of 6.2 mm engraved with the company logo and the code 'H9'.
Slovenian: Rumene in bele ovalne 6,2 mm tablete z vtisnjenim znakom podjetja in kodno številko 'H9'.
English: EU/1/02/213/001 14 tablets EU/1/02/213/002 28 tablets EU/1/02/213/003 28 x 1 tablets EU/1/02/213/013 30 x 1 tablets EU/1/02/213/004 56 tablets EU/1/02/213/011 84 tablets EU/1/02/213/014 90 x 1 tablets EU/1/02/213/005 98 tablets
Slovenian: EU/1/02/213/001 14 tablet EU/1/02/213/002 28 tablet EU/1/02/213/003 28 x 1 tableta EU/1/02/213/013 30 x 1 tableta EU/1/02/213/004 56 tablet EU/1/02/213/011 84 tablet EU/1/02/213/014 90 x 1 tableta EU/1/02/213/005 98 tablet
English: - Hypokalaemia
Slovenian: hipokaliemija
English: Talk to your doctor before taking MicardisPlus:
Slovenian: Pred začetkom jemanja zdravila MicardisPlus se posvetujte z zdravnikom:
English: Pack sizes: - Blister with 14, 28, 56, 84, or 98 tablets or - Perforated unit dose blisters with 28 x 1, 30 x 1 or 90 x 1 tablets.
Slovenian: Velikost pakiranja: pretisni omot po 14, 28, 56, 84 ali 98 tablet ali perforirani pretisni omoti za enkratni odmerek po 28 x 1, 30 x 1 ali 90 x 1 tableta.
English: MicardisPlus is available in blisters packs containing 14, 28, 56, 84, or 98 tablets, or unit dose blister packs containing 28 x 1, 30 x 1 or 90 x 1 tablets.
Slovenian: Zdravilo MicardisPlus je na voljo v pretisnih omotih po 14, 28, 56, 84, 98 tablet ali pretisnih omotih za enkratni odmerek po 28 x 1, 30 x 1 ali 90 x 1 tableta.
English: In the "Prevention Regimen For Effectively avoiding Second Strokes" (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.00
Slovenian: V preskušanju PRoFESS (Prevention Regimen For Effectively avoiding Second Strokes) se je pri bolnikih, starih 50 let in starejših, ki so pred kratkim doživeli možgansko kap, med jemanjem telmisartana povečala pojavnost sepse, in sicer pri 0,70 % v primerjavi z 0,49 % pri zdravljenih s placebom [RR 1,43 (95-odstotni interval zaupanja 1,00 do 2,06)].
English: EU/1/02/213/006 14 tablets EU/1/02/213/007 28 tablets EU/1/02/213/008 28 x 1 tablets EU/1/02/213/015 30 x 1 tablets EU/1/02/213/009 56 tablets EU/1/02/213/012 84 tablets EU/1/02/213/016 90 x 1 tablets EU/1/02/213/010 98 tablets
Slovenian: EU/1/02/213/006 14 tablet EU/1/02/213/007 28 tablet EU/1/02/213/008 28 x 1 tableta EU/1/02/213/015 30 x 1 tableta EU/1/02/213/009 56 tablet EU/1/02/213/012 84 tablet EU/1/02/213/016 90 x 1 tableta EU/1/02/213/010 98 tablet
English: MicardisPlus is also available at the dose strengths 40 mg/12.5 mg and 80 mg/ 12.5 mg Renal impairment
Slovenian: Zdravilo MicardisPlus je na voljo tudi v jakosti 40 mg/12,5 mg in 80 mg/12,5 mg.
English: MicardisPlus 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Slovenian: MicardisPlus 80 mg/12,5 mg tablete Ena tableta vsebuje 80 mg telmisartana in 12,5 mg hidroklorotiazida.
English: INFORMATION IN BRAILLE MicardisPlus 40 mg/12.5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI MicardisPlus 40 mg/12,5 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister 7 or 10-count or any non 7 count blister
Slovenian: Perforiran pretisni omot za enkratni odmerek po 7 ali 10 tablet ali vsi tisti pretisni omoti, ki ne vsebujejo po 7 tablet
English: MicardisPlus 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Slovenian: MicardisPlus 40 mg/12,5 mg tablete Ena tableta vsebuje 40 mg telmisartana in 12,5 mg hidroklorotiazida.
English: MicardisPlus fixed dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on MicardisPlus 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Slovenian: Zdravilo MicardisPlus, fiksna kombinacija (80 mg telmisartana in 25 mg hidroklorotiazida), je indicirano za odrasle, pri katerih krvnega tlaka ne moremo ustrezno uravnati z zdravilom MicardisPlus 80 mg/12,5 mg (80 mg telmisartana in 12,5 mg hidroklorotiazida) ali za bolnike, ki jemljejo telmisartan in hidroklorotiazid posebej in imajo ustaljen krvni tlak.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 80 mg telmisartana in 25 mg hidroklorotiazida.
English: The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Slovenian: Tiazidi lahko povečajo hiperglikemični učinek zaviralcev adrenergičnih receptorjev beta in diazoksida.
English: How to store MicardisPlus
Slovenian: Shranjevanje zdravila MicardisPlus
English: Protect your skin from sun exposure and UV rays while taking MicardisPlus.
Slovenian: Med jemanjem zdravila MicardisPlus zaščitite kožo pred izpostavljenostjo soncu in UV-žarkom.
English: Medicines that may increase blood potassium levels such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, - cyclosporin (an immunosuppressant drug) and other medicinal products such as heparin sodium (an anticoagulant).
Slovenian: Zdravila, ki lahko povečajo raven kalija ali povzročijo hiperkaliemijo (npr. zaviralci ACE; diuretiki, ki varčujejo s kalijem; kalijevi pripravki; nadomestki soli, ki vsebujejo kalij; ciklosporin ali druga zdravila, kot je natrijev heparinat)
English: Dizziness or drowsiness may occasionally occur when taking MicardisPlus.
Slovenian: Zdravilo MicardisPlus lahko včasih povzroči omotico ali dremavost.
English: MicardisPlus is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by MicardisPlus 80/12.5 mg or in patients who have been previously stabilised by telmisartan and hydrochlorothiazide given separately.
Slovenian: Zdravilo MicardisPlus je namenjeno za zdravljenje visokega krvnega tlaka (esencialne hipertenzije) pri odraslih, pri katerih s samim zdravilom MicardisPlus 80 mg/12,5 mg krvnega tlaka ne moremo primerno uravnati ali za bolnike, ki jemljejo telmisartan in hidroklorotiazid posebej in imajo ustaljen krvni tlak.
English: MicardisPlus 80 mg/25 mg may be administered once daily in patients whose blood pressure is not adequately controlled by MicardisPlus 80 mg/12.5 mg or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Slovenian: • Zdravilo MicardisPlus 80 mg/25 mg lahko dajemo enkrat na dan bolnikom, pri katerih krvnega tlaka ne moremo ustrezno uravnati z zdravilom MicardisPlus 80 mg/12,5 mg, ali bolnikom, ki jemljejo telmisartan in hidroklorotiazid posebej in imajo ustaljen krvni tlak.
English: What MicardisPlus looks like and contents of the pack
Slovenian: Shranjevanje zdravila MicardisPlus Vsebina pakiranja in dodatne informacije
English: INFORMATION IN BRAILLE MicardisPlus 80 mg/12.5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI MicardisPlus 80 mg/12,5 mg
English: The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420).
Slovenian: Druge sestavine zdravila so laktoza monohidrat, magnezijev stearat, koruzni škrob, meglumin, mikrokristalna celuloza, povidon, rdeč železov oksid (E172), natrijev hidroksid, natrijev karboksimetilškrob (vrsta A) in sorbitol (E420).
English: The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, yellow iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420).
Slovenian: Druge sestavine zdravila so laktoza monohidrat, magnezijev stearat, koruzni škrob, meglumin, mikrokristalna celuloza, povidon, rumen železov oksid (E172), natrijev hidroksid, natrijev karboksimetilškrob (vrsta A) in sorbitol (E420).
English: General disorders and administration site conditions Uncommon:
Slovenian: Splošne težave in spremembe na mestu aplikacije Neznana:
English: MicardisPlus 40 mg/12.5 mg tablets are red and white, oval-shaped two-layer tablets engraved with the company logo and the code 'H4'.
Slovenian: MicardisPlus 40 mg/12,5 mg tablete Rdeče in bele ovalne, dvoslojne 5,2 mm tablete z vtisnjenim znakom podjetja in kodno številko 'H4'.
English: Inflammation of the salivary gland, skin and lip cancer (non-melanoma skin cancer), decreases in the number (or even lack) of cells in the blood, including low red and white blood cell count, serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible signs of acute myopia or acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body's immune system attacks the body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or impaired kidney function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, increased blood levels of glucose, difficulties in controlling blood/ urine levels of glucose in patients with a diagnosis of diabetes mellitus, or fat in the blood.
Slovenian: Neželeni učinki neznane pogostnosti (ni mogoče oceniti iz razpoložljivih podatkov): vnetje žleze slinavke, kožni rak in rak ustnice (nemelanomski kožni rak), zmanjšanje števila (ali celo pomanjkanje) krvnih celic, tudi majhno število rdečih in belih krvničk; resne alergijske reakcije (npr. preobčutljivost, anafilaktična reakcija), zmanjšan tek ali izguba teka, nemir, vrtoglavica, zamegljen vid ali rumenkasta obarvanost, poslabšan vid in očesna bolečina (možna znaka akutne miopije ali akutnega glavkoma zaprtega zakotja), vnetje žil (nekrotizirajoči vaskulitis), vnetje trebušne slinavke, želodčne težave, porumenelost kože ali oči (zlatenica), lupusu podoben sindrom (bolezensko stanje, ki je podobno sistemskemu eritematoznemu lupusu, pri kateri telo napade človekov lastni imunski sistem), kožne motnje, kot so vnetje žil v koži; povečana občutljivost za sončno svetlobo, izpuščaj, pordelost kože, pojav mehurčkov na ustnicah, očeh ali v ustih, luščenje kože, povišana telesna temperatura (možen znak za multiformni eritem), oslabelost, vnetje ledvic ali okvara ledvičnega delovanja, sladkor v urinu (glikozurija), zvišana telesna temperatura, moteno elektrolitsko ravnovesje, visoka raven holesterola, zmanjšan krvni volumen, povečana raven glukoze v krvi, težave pri uravnavanju ravni glukoze v krvi ali urinu pri bolnikih s sladkorno boleznijo, ali maščob v krvi.
English: MicardisPlus 80 mg/12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the company logo and the code 'H8'.
Slovenian: MicardisPlus 80 mg/12,5 mg tablete Rdeče in bele ovalne, dvoslojne 6,2 mm tablete z vtisnjenim znakom podjetja in kodno številko 'H8'.
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with MicardisPlus (see section 4.5).
Slovenian: Če se bolniki zdravijo z zdravilom MicardisPlus, moramo biti previdni pri sočasnem dajanju diuretikov, ki varčujejo s kalijem, kalijevih pripravkov ali nadomestkov soli, ki vsebujejo kalij (glejte poglavje 4.5).