FrancophonIA/ELRC3.0 huggingface dataset:
English: Metabolism and nutrition disorders Uncommon: Hypokalaemia Rare:
Croatian: Poremećaji metabolizma i prehrane Manje često: hipokalemija Rijetko:
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 levels of glucose, difficulties in controlling blood/ urine levels of glucose in patients with a diagnosis of diabetes mellitus, or fat in the blood.
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može utvrditi iz dostupnih podataka): Upala žlijezda slinovnica, rak kože i usana (nemelanomski rak kože), smanjenje broja (ili čak nedostatak) stanica u krvi, uključujući niske vrijednosti crvenih i bijelih krvnih stanica, ozbiljne alergijske reakcije (npr. preosjetljivost, anfilaktička reakcija), smanjeni ili gubitak apetita, nemir, ošamućenost, zamućeni vid ili žutilo pred očima, slabljenje vida ili bol u očima (mogući znakovi akutne miopatije ili akutnog glaukoma zatvorenog kuta), upala krvnih žila (nekrotizirajući vaskulitis), upala gušterače (pankreatitis), nadražen želudac, žutilo kože ili bjeloočnica (žutica), sindrom sličan lupusu (stanje koje oponaša bolest koja se naziva sistemski lupus eritematozus pri kojem imunološki sustav tijela napada tijelo), poremećaji kože kao što je upala krvnih žila kože, povećana osjetljivost na sunčevu svjetlost, osip, crvenilo kože, mjehurići na usnicama, očima ili u ustima, ljuštenje kože, vrućica (mogući znakovi multiformnog eritema), slabost, upala bubrega ili oštećenje bubrežne funkcije, glukoza u urinu (glikozurija), vrućica, poremećena ravnoteža elektrolita, visoke vrijednosti kolesterola u krvi, smanjeni volumen krvi, povišene vrijednosti glukoze u krvi, poteškoće u kontroliranju razine glukoze u krvi/urinu kod bolesnika s dijagnozom šećerne bolesti, ili masnoća u krvi.
English: Tolucombi 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.
Croatian: Tolucombi kombinacija fiksne doze (40 mg telmisartana/12,5 mg hidroklorotiazida i 80 mg telmisartana/12,5 mg hidroklorotiazida) indicirana je kod odraslih bolesnika čiji se krvni tlak ne može adekvatno kontrolirati samo telmisartanom.
English: - Medicines associated with low blood potassium (hypokalaemia) such as other diuretics, ('water tablets'), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
Croatian: - Lijekovi koji su povezani s niskim vrijednostima kalija u krvi (hipokalemija) kao što su drugi diuretici („tablete za izmokravanje”), laksativi (npr. ricinusovo ulje), kortikosteroidi (npr. prednizon), ACTH (hormon), amfotericin (protugljivični lijek), karbenoksolon (koji se primjenjuje u liječenju ulkusa u ustima), penicilin-G-natrij (antibiotik), te salicilatna kiselina i derivati.
English: Tolucombi (40 mg/12.5 mg, 80 mg/12.5 mg) is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when telmisartan is used alone.
Croatian: Tolucombi (40 mg/12,5 mg, 80 mg/12,5 mg) se primjenjuje u liječenju visokog krvnog tlaka (esencijalna hipertenzija) kod odraslih osoba čiji krvni tlak nije dobro kontroliran uz primjenu samog telmisartana.
English: Hyperuricaemia may occur or frank gout may be precipitated in some patients receiving thiazide therapy.
Croatian: Može doći do pojave hiperuricemije ili manifestacije gihta kod pojedinih bolesnika liječenih tiazidima.
English: Eosinophilia, thrombocytopenia
Croatian: eozinofilija, trombocitopenija
English: Arthralgia, muscle cramps, pain in limb
Croatian: artralgija, grčevi mišića, bol u udovima
English: 56 x 1 tablet
Croatian: 56 x 1 tableta
English: Hyperuricaemia, hyponatraemia
Croatian: hiperuricemija, hiponatremija
English: Blister (OPA/Al/PE foil with desiccant//Al foil): 14 x 1 tablet
Croatian: Blister (OPA/Al/PE folija sa sredstvom za sušenje//Al folija): 14 x 1 tableta
English: Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), serious allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), upset stomach, eczema (a skin disorder), arthrosis, inflammation of the tendons, decreased haemoglobin (a blood protein), somnolence.
Croatian: Niski broj trombocita (trombocitopenija), porast određenih bijelih krvnih stanica (eozinofilija), ozbiljna alergijska reakcija (npr. preosjetljivost, anafilaktička reakcija, osip pri uzimanju lijeka), niske vrijednosti šećera u krvi (kod osoba koje imaju šećernu bolest), nadražaj želuca, ekcem (poremećaj kože), artroza, upala tetiva, sniženi hemoglobin (protein u krvi), izrazita pospanost.
English: Tolucombi 80 mg/12.5 mg and Tolucombi 80 mg/25 mg contain 294.08 mg sorbitol in each tablet, which is equivalent to 5 mg/kg/day, if the body weight is 58.8 kg.
Croatian: Tolucombi 80 mg/12,5 mg i Tolucombi 80 mg/25 mg sadrže 294,08 mg sorbitola u jednoj tableti, što odgovara 5 mg/kg/dan, ako je tjelesna težina 58,8 kg.
English: - Tolucombi 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 40 mg.
Croatian: - Tolucombi 40 mg/12,5 mg se primjenjuje jedanput dnevno kod bolesnika čiji se krvni tlak adekvatno ne kontrolira telmisartanom od 40 mg.
English: Tolucombi 40 mg/12.5 mg contains 147.04 mg sorbitol in each tablet, which is equivalent to 5 mg/kg/day, if the body weight is 29.8 kg.
Croatian: Tolucombi 40 mg/12,5 mg sadrži 147,04 mg sorbitola u jednoj tableti, što odgovara 5 mg/kg/dan, ako je tjelesna težina 29,8 kg.
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).
Croatian: - Lijekovi koji mogu povisiti vrijednosti kalija u krvi kao što su diuretici koji štede kalij, nadomjesci kalija, zamjenske soli koje sadrže kalij, ACE inhibitori, ciklosporin (imunosupresivni lijek) i drugi lijekovi kao što je heparinnatrij (lijek protiv zgrušavanja krvi).
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with Tolucombi (see section 4.5).
Croatian: Ako se uz Tolucombi istodobno primjenjuju diuretici koji štede kalij, nadomjesci kalija ili zamjene za sol koje sadrže kalij potreban je oprez (vidjeti dio 4.5).
English: - Tolucombi 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 80 mg.
Croatian: - Tolucombi 80 mg/12,5 mg se primjenjuje jedanput dnevno kod bolesnika čiji se krvni tlak adekvatno ne kontrolira telmisartanom od 80 mg.
English: Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Croatian: Jedna tableta sadrži 80 mg telmisartana i 25 mg hidroklorotiazida.
English: 84 x 1 tablet
Croatian: 84 x 1 tableta
English: Hypochloraemic alkalosis
Croatian: - Hiponatremija i hipokloremična alkaloza
English: - Kidney disease or kidney transplant.
Croatian: - Bolest bubrega ili presađeni bubreg.
English: Povidone (K30) Red ferric oxide (E172) Silica, colloidal anhydrous Sodium hydroxide (E524) Sodium stearyl fumarate Sorbitol (E420)
Croatian: 6.1 Popis pomoćnih tvari hidroksipropilceluloza laktoza hidrat magnezijev stearat manitol meglumin povidon (K30) željezov oksid, crveni (E172) silicijev dioksid, koloidni, bezvodni natrijev hidroksid (E524) natrijev stearilfumarat sorbitol (E420)
English: Povidone (K30) Silica, colloidal anhydrous Sodium hydroxide (E524) Sodium stearyl fumarate Sorbitol (E420) Yellow ferric oxide (E172)
Croatian: 6.1 Popis pomoćnih tvari hidroksipropilceluloza laktoza hidrat magnezijev stearat manitol meglumin povidon (K30) silicijev dioksid, koloidni, bezvodni natrijev hidroksid (E524) natrijev stearilfumarat sorbitol (E420) željezov oksid, žuti (E172)
English: Hepatobiliary disorders Not known: Jaundice hepatocellular, jaundice cholestatic
Croatian: Nepoznato: hepatocelularna žutica, kolestatska žutica
English: Talk to your doctor before taking Tolucombi, if you are taking: - digoxin.
Croatian: Obratite se svom liječniku prije nego uzmete Tolucombi ako bolujete ili ste bolovali od nekih od sljedećih stanja ili bolesti:
English: 98 x 1 tablet
Croatian: 98 x 1 tableta
English: 28 x 1 tablet
Croatian: 28 x 1 tableta
English: Tolucombi 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Croatian: Tolucombi 80 mg/12,5 mg tablete Jedna tableta sadrži 80 mg telmisartana i 12,5 mg hidroklorotiazida.
English: Tolucombi (80 mg/25 mg) is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by Tolucombi 80 mg/12.5 mg or in patients who have been previously stabilised by telmisartan and hydrochlorothiazide given separately.
Croatian: Tolucombi (80 mg/25 mg) se primjenjuje u liječenju visokog krvnog tlaka (esencijalna hipertenzija) kod odraslih osoba čiji krvni tlak nije dobro kontroliran uz primjenu Tolucombi 80 mg/12,5 mg tableta ili kod bolesnika koji su prethodno stabilizirani telmisartanom i hidroklorotiazidom davanim zasebno.
English: Uncommon: Upper respiratory tract infection, urinary tract infection including cystitis Rare:
Croatian: Infekcije i infestacije Manje često: infekcije gornjeg dišnog sustava, infekcije mokraćnog sustava uključujući cistitis
English: Tolucombi 40 mg/12.5 mg tablets Tolucombi 80 mg/12.5 mg tablets Tolucombi 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Croatian: Tolucombi 40 mg/12,5 mg tablete Tolucombi 80 mg/12,5 mg tablete Tolucombi 80 mg/25 mg tablete telmisartan/hidroklorotiazid
English: Tolucombi 40 mg/12.5 mg tablets Tolucombi 80 mg/12.5 mg tablets
Croatian: Tolucombi 40 mg/12,5 mg tablete Tolucombi 80 mg/12,5 mg tablete
English: Tolucombi 80 mg/25 mg tablets
Croatian: Tolucombi 80 mg/25 mg tablete
English: Tolucombi fixed dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Tolucombi 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.
Croatian: Tolucombi kombinacija fiksne doze (80 mg telmisartana/25 mg hidroklorotiazida) indicirana je kod odraslih osoba čiji se krvni tlak ne može adekvatno kontrolirati s Tolucombi 80 mg/12,5 mg (80 mg telmisartana/12,5 mg hidroklorotiazida) ili odraslih osoba koje su prethodno stabilizirane zasebnim terapijama telmisartana i hidroklorotiazida.
English: Musculoskeletal, connective tissue and bone disorders Rare:
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Rijetko:
English: - Tolucombi 80 mg/25 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Tolucombi 80 mg/12.5 mg or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Croatian: - Tolucombi 80 mg/25 mg se primjenjuje jedanput dnevno kod bolesnika čiji se krvni tlak adekvatno ne kontrolira s Tolucombi 80 mg/12,5 mg ili bolesnika koji su prethodno stabilizirani zasebnim terapijama telmisartana i hidroklorotiazida.
English: 90 x 1 tablet
Croatian: 90 x 1 tableta
English: Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna tableta sadrži 40 mg telmisartana i 12,5 mg hidroklorotiazida.
English: Each 40 mg/12.5 mg tablet contains 57 mg of lactose (as monohydrate) and 147.04 mg sorbitol (E420).
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Jedna tableta 40 mg/12,5 mg sadrži 57 mg laktoze (u obliku hidrata) i 147,04 mg sorbitola (E420).
English: - any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Croatian: Obratite se svom liječniku prije uzimanja lijeka Tolucombi ako uzimate: - digoksin. - bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog krvnog tlaka: - ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću. - aliskiren.
English: - Severe hepatic impairment.
Croatian: - Teško oštećenje jetrene funkcije.
English: Renal and urinary disorders Not known: Nephritis interstitial, renal dysfunction, glycosuria
Croatian: Poremećaji bubrega i mokraćnog sustava Nepoznato: intersticijski nefritis, disfunkcija bubrega, glikozurija
English: Renal impairment and kidney transplantation
Croatian: Oštećenje bubrežne funkcije i presađen bubreg
English: 30 x 1 tablet
Croatian: 30 x 1 tableta
English: Tolucombi 80 mg/12.5 mg contains 294.08 mg sorbitol in each tablet, which is equivalent to 5 mg/kg/day, if the body weight is 58.8 kg.
Croatian: Tolucombi 80 mg/12,5 mg sadrži 294,08 mg sorbitola u jednoj tableti, što odgovara 5 mg/kg/dan, ako je tjelesna težina 58,8 kg.
English: KRKA-POLSKA Sp. z o.o.
Croatian: Sp. z o.o., ul.
English: Haemoglobin decreased
Croatian: sniženi hemoglobin
English: KRKA-POLSKA Sp.z.
Croatian: KRKA-POLSKA
English: 60 x 1 tablet
Croatian: 60 x 1 tableta
English: Headache Not known: Light-headedness
Croatian: Nepoznato: ošamućenost
English: 100 x 1 tablet
Croatian: 100 x 1 tableta
English: o.o.
Croatian: A.
English: The overall incidence and pattern of adverse reactions reported with telmisartan/hydrochlorothiazide 80 mg/25 mg was comparable with telmisartan/hydrochlorothiazide 80 mg/12.5 mg. A doserelationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients.
Croatian: Ukupna incidencija i obrazac nuspojava prijavljenih uz telmisartan/hidroklorotiazid 80 mg/25 mg usporedivi su s telmisartanom/hidroklorotiazidom 80 mg/12,5 mg.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not known: Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma)
Croatian: Nepoznato: nemelanomski rak kože (karcinom bazalnih stanica i karcinom skvamoznih stanica)
English: Medicinal products affected by serum potassium disturbances Periodic monitoring of serum potassium and ECG is recommended when Tolucombi 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.
Croatian: Lijekovi na koje utječu poremećaji kalija u serumu Preporučuje se periodično praćenje kalija u serumu i EKG kada se Tolucombi uzima s lijekovima na koje utječu poremećaji kalija u serumu (npr. glikozidi digitalisa, antiaritmici) i sljedećim lijekovima koji induciraju torsades de pointes (što uključuje pojedine antiaritmike), s hipokalemijom kao predisponirajućim faktorom za torsades de pointes. - skupina Ia antiaritmika (npr. kinidin, hidrokinidin, disopiramid) - skupina III antiaritmika (npr. amiodaron, sotalol, dofetilid, ibutilid) - neki antipsihotici (npr. tioridazin, klorpromazin, levomepromazin, trifluoperazin, cijamemazin,
English: Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Croatian: ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) i VA NEPHRON-D (engl.
English: Tolucombi 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Croatian: Tolucombi 80 mg/25 mg tablete telmisartan/hidroklorotiazid
English: Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna tableta sadrži 80 mg telmisartana i 12,5 mg hidroklorotiazida.
English: Ear and labyrinth disorders Uncommon: Vertigo
Croatian: Poremećaji uha i labirinta Manje često: vrtoglavica
English: ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporine or other medicinal products such as heparin sodium).
Croatian: Lijekovi koji mogu povisiti vrijednosti kalija ili inducirati hiperkalemiju (npr. ACE inhibitori, diuretici koji štede kalij, nadomjesci kalija, zamjenske soli koje sadrže kalij, ciklosporin ili drugi lijekovi kao što je heparin natrij).
English: Tolucombi 80 mg/12.5 mg tablets
Croatian: Tolucombi 80 mg/12,5 mg tablete
English: White to almost white or pinkish white on one side and pink marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 15 mm x 7 mm.
Croatian: Dvoslojna, bikonveksna, ovalna tableta, bijela do gotovo bijela ili ružičasto-bijela na jednoj strani te ružičasto mramorirana na suprotnoj strani, veličine 15 mm x 7 mm.
English: Thrombocytopenia (sometimes with purpura) Not known: Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis
Croatian: Nepoznato: aplastična anemija, hemolitička anemija, zatajenje koštane srži, leukopenija, neutropenija, agranulocitoza
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.
Croatian: Također su prijavljeni bradikardija, omaglica, povraćanje, povišene razine serumskog kreatinina i akutno zatajenje bubrega.
English: Renal and urinary disorders Uncommon: Renal impairment (including acute renal failure)
Croatian: Poremećaji bubrega i mokraćnog sustava Manje često: oštećenje bubrežne fukcije (uključujući akutno zatajenje bubrega)
English: Tolucombi 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Croatian: Tolucombi 40 mg/12,5 mg tablete telmisartan/hidroklorotiazid
English: White to almost white or pinkish white on one side and pink marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 18 mm x 9 mm.
Croatian: Dvoslojna, bikonveksna, ovalna tableta, bijela do gotovo bijela ili ružičasto-bijela na jednoj strani te ružičasto mramorirana na suprotnoj strani, veličine 18 mm x 9 mm.
English: White to yellowish white on one side and yellow marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 18 mm x 9 mm.
Croatian: Dvoslojna, bikonveksna, ovalna tableta, bijela do žućkasto-bijela na jednoj strani te žuto mramorirana na suprotnoj strani, veličine 18 mm x 9 mm.
English: Warnings and precautions Talk to your doctor before taking Tolucombi if you are suffering or have ever suffered from any of the following conditions or illnesses: - Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, vomiting, or haemodialysis.
Croatian: - Niski krvni tlak (hipotenzija), može nastati uslijed dehidracije (prekomjerni gubitak vode iz tijela) ili manjka soli zbog terapije diureticima („tablete za izmokravanje”), prehrane s niskim unosom soli, proljeva, povraćanja ili hemodijalize.
English: Eczema, drug eruption, toxic skin eruption
Croatian: ekcem, izbijanje kožnih promjena uzrokovano lijekom, izbijanje kožnih promjena uzrokovano toksičnim učinkom lijeka
English: - if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from liver and the gall bladder) or any other severe liver disease.
Croatian: - ako ste trudni više od 3 mjeseca (Također je bolje izbjegavati Tolucombi u ranoj trudnoći pogledajte dio o trudnoći.)- ako imate teške jetrene tegobe kao što je zastoj žuči ili opstrukcija žuči (poteškoće s istjecanjem žuči iz jetre i žučnog mjehura) ili neku drugu tešku bolest jetre.
English: Dizziness or drowsiness may occasionally occur when taking Tolucombi.
Croatian: Kod uzimanja lijeka Tolucombi mogu se povremeno pojaviti omaglica ili omamljenost.
English: Therefore, in these patients blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.
Croatian: Stoga se kod ovih bolesnika mora razmotriti praćenje glukoze u krvi.
English: Tolucombi 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Croatian: Tolucombi 80 mg/12,5 mg tablete telmisartan/hidroklorotiazid
English: MARKETING AUTHORISATION HOLDER
Croatian: NOSITELJ ODOBRENJA STAVLJANJE LIJEKA U PROMET
English: Respiratory, thoracic and mediastinal disorders Uncommon: Cough
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Manje često: kašalj
English: Tolucombi 40 mg/12.5 mg tablets:
Croatian: Tolucombi 40 mg/12,5 mg tablete
English: If you get any side effects, talk to your doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika ili medicinsku sestru.
English: 80 mg/12.5 mg tablets: White to almost white or pinkish white on one side and pink marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 18 mm x 9 mm.
Croatian: 40 mg/12,5 mg tablete: dvoslojna, bikonveksna, ovalna tableta, bijela do gotovo bijela ili ružičastobijela na jednoj strani te ružičasto mramorirana na suprotnoj strani, veličine 15 mm x 7 mm. 80 mg/12,5 mg tablete: dvoslojna, bikonveksna, ovalna tableta, bijela do gotovo bijela ili ružičastobijela na jednoj strani te ružičasto mramorirana na suprotnoj strani, veličine 18 mm x 9 mm. 80 mg/25 mg tablete: dvoslojna, bikonveksna, ovalna tableta, bijela do žućkasto-bijela na jednoj strani te žuto mramorirana na suprotnoj strani, veličine 18 mm x 9 mm.
English: Pressor amines (e.g. noradrenaline) The effect of pressor amines may be decreased.
Croatian: Presorni amini (npr. noradrenalin)
English: Absorption:
Croatian: Apsorpcija
English: Hypomagnesaemia
Croatian: hipomagnezemija
English: KRKA - FARMA d.o.o.
Croatian: KRKA, d.d,.
English: The full EPAR for Lixiana can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Lixiana nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Lixiana.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Lixiana.
English: Lixiana is available as tablets (15, 30 and 60 mg) and can only be obtained with a prescription.
Croatian: Lijek Lixiana dostupan je u obliku tableta (od 15, 30 i 60 mg) te se izdaje samo na liječnički recept.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lixiana on 19 June 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Lixiana u promet koje vrijedi na prostoru Europske unije od 19. lipnja 2015.