FrancophonIA/ELRC3.0 huggingface dataset:
English: In a pooled analysis of two similar 8 week double-blind placebo-controlled clinical trials vs. valsartan/hydrochlorothiazide 160 mg/25 mg (n=2121 patients evaluated for efficacy) a significantly greater blood pressure lowering effect of 2.2/1.2 mm Hg (SBP/DBP) was demonstrated (difference in adjusted mean changes from baseline, respectively) in favour of telmisartan/hydrochlorothiazide 80 mg/25 mg combination.
Croatian: U združenoj analizi dvaju sličnih dvostruko-slijepih, placebom kontroliranih kliničkih ispitivanja, u trajanju 8 tjedana, u odnosu na valsartan/hidroklorotiazid 160 mg/25 mg (djelotvornost ocjenjivana na n=2 121 bolesnika, pokazao se značajno veći učinak snižavanja krvnog tlaka, u vrijednosti 2,2/1,2 mm Hg (SKT/DKT) (razlika u podešenim prosječnim promjenama u odnosu na početnu vrijednost, po istom redoslijedu) u korist kombinacije telmisartan/hidroklorotiazid 80 mg/25 mg.
English: EU/1/02/214/011 14 tablets EU/1/02/214/012 28 tablets EU/1/02/214/013 28 x 1 tablets EU/1/02/214/014 56 tablets EU/1/02/214/015 98 tablets
Croatian: EU/1/02/214/011 14 tableta EU/1/02/214/012 28 tableta EU/1/02/214/013 28 x 1 tableta EU/1/02/214/014 56 tableta EU/1/02/214/015 98 tableta
English: • Kinzalkomb 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Kinzalmono 80 mg
Croatian: • Kinzalkomb 80 mg/12,5 mg se primjenjuje jedanput dnevno kod bolesnika čiji se krvni tlak adekvatno ne kontrolira Kinzalmonom 80 mg
English: How to store Kinzalkomb
Croatian: Kako čuvati Kinzalkomb
English: Nervous system disorders Rare:
Croatian: Poremećaji živčanog sustava Rijetko:
English: Hyperuricaemia may occur or frank gout may be precipitated in some patients receiving thiazide therapy.
Croatian: Može doći do pojave hiperuricemije ili precipitacije manifestnog gihta kod pojedinih bolesnika liječenih tiazidima.
English: EU/1/02/214/001 14 tablets EU/1/02/214/002 28 tablets EU/1/02/214/003 28 x 1 tablets EU/1/02/214/004 56 tablets EU/1/02/214/005 98 tablets
Croatian: EU/1/02/214/001 14 tableta EU/1/02/214/002 28 tableta EU/1/02/214/003 28 x 1 tableta EU/1/02/214/004 56 tableta EU/1/02/214/005 98 tableta
English: EU/1/02/214/006 14 tablets EU/1/02/214/007 28 tablets EU/1/02/214/008 28 x 1 tablets EU/1/02/214/009 56 tablets EU/1/02/214/010 98 tablets
Croatian: EU/1/02/214/006 14 tableta EU/1/02/214/007 28 tableta EU/1/02/214/008 28 x 1 tableta EU/1/02/214/009 56 tableta EU/1/02/214/010 98 tableta
English: Pancreatitis, stomach discomfort
Croatian: Pankreatitis, nelagoda u želucu
English: Each 80 mg/12.5 mg tablet contains 112 mg of lactose monohydrate and 338 mg sorbitol (E420).
Croatian: Jedna tableta od 80 mg/12,5 mg sadržava 112 mg laktoze hidrata i 338 mg sorbitola (E420).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 April 2002
Croatian: DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
English: Weakness
Croatian: Slabost
English: Blood and lymphatic system disorders Uncommon:
Croatian: Poremećaji krvi i limfnog sustava Rijetko:
English: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 80 mg/25 mg tablets
Croatian: NAZIV LIJEKA Kinzalkomb 80 mg/25 mg tablete
English: Vasculitis necrotizing
Croatian: Nekrotizirajući vaskulitis
English: Blood creatinine increased, blood creatine phosphokinase increased, hepatic enzyme increased
Croatian: Povišene vrijednosti kreatinina u krvi, povišene vrijednosti kreatin fosfokinaze, povišene vrijednosti jetrenih enzima na osnovi iskustva u razdoblju nakon stavljanja lijeka u promet
English: Dizziness or drowsiness may occasionally occur when taking Kinzalkomb.
Croatian: Kod uzimanja Kinzalkomba mogu se povremeno pojaviti omaglica ili omamljenost.
English: Kinzalkomb 80 mg/25 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Kinzalkomb 80 mg/12.5 mg or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Croatian: Kizalkomb 80 mg/25 mg se primjenjuje jedanput dnevno kod bolesnika čiji se krvni tlak adekvatno ne kontrolira s Kinzalkomb 80 mg/12,5 mg ili bolesnika koji su prethodno stabilizirani zasebnim terapijama telmisartana i hidroklorotiazida.
English: Nephritis interstitial, renal dysfunction, glycosuria General disorders and administration site conditions Not known:
Croatian: Intersticijski nefritis, disfunkcija bubrega, glikozurija Opći poremećaji i reakcije na mjestu primjene Nepoznato:
English: Stomach discomfort Skin and subcutaneous tissue disorders Rare:
Croatian: Poremećaji kože i potkožnog tkiva Rijetko:
English: Syncope, paraesthesia Insomnia, sleep disorders
Croatian: Nesanica, poremećaji spavanja
English: - Hyponatraemia and hypochloraemic alkalosis There is no evidence that Kinzalkomb would reduce or prevent diuretic-induced hyponatraemia.
Croatian: Ne postoje dokazi da Kinzalkomb smanjuje ili sprječava hiponatremiju induciranu diureticima.
English: INFORMATION IN BRAILLE Kinzalkomb 80 mg/25 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Kinzalkomb 80 mg/25 mg
English: Hyperkalaemia Hypoglycaemia (in diabetic patients)
Croatian: Hipoglikemija (kod dijabetičara)
English: Eye disorders Not known:
Croatian: Poremećaji oka Nepoznato:
English: Angioedema (also with fatal outcome), erythema, pruritus, rash, hyperhidrosis, urticaria
Croatian: Angioedem (također s fatalnim ishodom), eritem, pruritus, osip, hiperhidroza, urtikarija Poremećaji mišićno-koštanog sustava i vezivnog tkiva Manje često:
English: België / Belgique / Belgien Bayer SA-NV
Croatian: België / Belgique / Belgien
English: Hypokalaemia Hyperuricaemia, hyponatraemia
Croatian: Hiperuricemija, hiponatremija
English: Kinzalkomb fixed dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Kinzalkomb 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Croatian: Kinzalkomb je kombinacija fiksne doze (80 mg telmisartana/25 mg hidroklorotiazida), indicirana kod odraslih osoba čiji se krvni tlak ne može adekvatno kontrolirati s Kinzalkomb 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: Investigations Not known:
Croatian: Pretrage: Nepoznato:
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: 2: For further description, please see sub-section”Description of selected adverse reactions” Additional information on individual components
Croatian: Za dodatni opis, molimo pogledajte odlomak „Opis izabranih nuspojava“
English: Hypotension, orthostatic hypotension Respiratory, thoracic and mediastinal disorders Uncommon: Rare:
Croatian: Hipotenzija, ortostatska hipotenzija Poremećaji dišnog sustava, prsišta i sredoprsja Manje često:
English: Renal impairment and kidney transplantation
Croatian: Oštećenje funkcije bubrega i presađen bubreg
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 dijabetičara), nadražaj želuca, ekcem (poremećaj kože), artroza, upala tetiva, sniženi hemoglobin (protein u krvi), jaka pospanost.
English: INFORMATION IN BRAILLE Kinzalkomb 40 mg/12.5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Kinzalkomb 40 mg/12,5 mg
English: Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract infections, deficiency in red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), kidney impairment including acute kidney failure, weakness, cough.
Croatian: Infekcija gornjeg dišnog sustava (npr. upaljeno grlo, upala sinusa, obična prehlada), infekcije mokraćnog sustava nedostatak crvenih krvnih stanica (slabokrvnost/anemija), visoke vrijednosti kalija, usporena srčana frekvencija (bradikardija), oštećenje bubrega uključujući akutno zatajenje bubrega, slabost, kašalj.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Croatian: KVALITATIVNI I KVANTITAVNI SASTAV Jedna tableta sadržava 80 mg telmisartana i 25 mg hidroklorotiazida.
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).
Croatian: Drugi sastojci su laktoza hidrat, magnezijev stearat, kukuruzni škrob, meglumin, mikrokristalična celuloza, povidon, crveni željezov oksid (E 172), natrijev hidroksid, natrijev škroboglikolat (vrsta A) i sorbitol (E420).
English: - Hyperkalaemia
Croatian: - Hiperkalemija
English: INFORMATION IN BRAILLE Kinzalkomb 80 mg/12.5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Kinzalkomb 80 mg/12,5 mg
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with Kinzalkomb (see section 4.5).
Croatian: Ako se uz Kinzalkomb istodobno primjenjuju diuretici koji štede kalij, nadomjesci kalija, ili zamjene za sol koje sadrže kalij potreban je oprez (vidjeti dio 4.5).
English: Yellow and white oval shaped tablet of 6.2 mm engraved with the code 'H9'.
Croatian: Žuto-bijele dvoslojne ovalne tablete duljine 6,2 mm, s utisnutim logom tvrtke i kodom 'H9'.
English: Investigations Rare:
Croatian: Pretrage Rijetko:
English: Kinzalkomb 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Croatian: Kinzalkomb 80 mg/12,5 mg tablete Jedna tableta sadržava 80 mg telmisartana i 12,5 mg hidroklorotiazida.
English: Kinzalkomb is available in blisters packs containing 14, 28, 56, or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
Croatian: Kinzalkomb je dostupan u blister pakiranjima koja sadrže 14, 28, 56, ili 98 tableta, ili u blisterima s jediničnim dozama s 28 x 1 tableta.
English: Kinzalkomb 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Croatian: Kinzalkomb 40 mg/12,5 mg tablete Jedna tableta sadržava 40 mg telmisartana i 12,5 mg hidroklorotiazida.
English: - Hypokalaemia
Croatian: - Hipokalemija
English: Kinzalkomb 80 mg/25 mg tablets are yellow and white, oval-shaped, two-layer tablets engraved with the code 'H9'.
Croatian: Kinzalkomb 80 mg/25 mg tablete su žuto-bijele dvoslojne tablete ovalnog oblika, s urezanim logom tvrtke i oznakom „H9“.
English: Hydrochlorothiazide may cause or exacerbate hypovolaemia which could lead to electrolyte imbalance (see section 4.4).
Croatian: Za dodatni opis, molimo pogledajte odlomak „Opis izabranih nuspojava“ Hidroklorotiazid: Hidroklorotiazid može uzrokovati ili pogoršati hipovolemiju, što može dovesti do neravnoteže elektrolita (vidjeti dio 4.4).
English: Diabetes mellitus inadequate control
Croatian: Neodgovarajuća kontrola dijabetes melitusa
English: Anaemia Eosinophilia, thrombocytopenia
Croatian: Eozinofilija, trombocitopenija
English: Haemoglobin decreased
Croatian: Sniženi hemoglobin
English: Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Croatian: Jedna tableta sadržava 80 mg telmisartana i 25 mg hidroklorotiazida.
English: Hydrochlorothiazide crosses the placenta.
Croatian: Hidroklorotiazid prolazi kroz posteljicu.
English: Tablets should be taken out of the blister shortly before administration.
Croatian: Tablete se vade iz blistera tek neposredno prije primjene.
English: Pack sizes: - Blister with 14, 28, 56, or 98 tablets or - Perforated unit dose blisters with 28 x 1 tablets.
Croatian: Veličine pakiranja: - Blister s 14, 28, 56, ili 98 tableta ili - Perforirani blisteri s jediničnim dozama s 28 x 1 tableta.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Primjena kroz usta
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and raech of children.
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: Acute Myopia and Angle-Closure Glaucoma
Croatian: Akutna miopija i glaukom zatvorenog kuta
English: Kinzalkomb 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Croatian: Kinzalkomb 80 mg/25 mg tablete telmisartan/hidroklorotiazid
English: Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna tableta sadržava 40 mg telmisartana i 12,5 mg hidroklorotiazida.
English: Inflammation of the lung (bronchitis), activation or worsening of systemic lupus erythematosus (a disease where the body's immune system attacks the body, which causes joint pain, skin rashes and fever); sore throat, inflamed sinuses, feeling sad (depression), difficulty falling asleep (insomnia), impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling sick (vomiting), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are more likely to experience this side effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.
Croatian: Upala pluća (bronhitis), aktivacija ili pogoršanje sistemskog lupus eritematozusa (bolest u kojoj imunološki sustav tijela napada tijelo, što izaziva bolove u zglobovima, osipe po koži i vrućicu), upaljeno grlo, upala sinusa, osjećaj tuge (depresija), problemi s usnivanjem (nesanica), oštećenje vida, otežano disanje, bol u trbuhu, zatvor, nadutost (probavne tegobe), osjećaj mučnine (povraćanje), upala želuca (gastritis), abnormalna jetrena funkcija (Japanska populacija ima veće izglede za ovu nuspojavu), crvenilo kože (eritem), alergijske reakcije kao što su svrbež ili osip, pojačano znojenje, koprivnjača (urtikarija), bol zglobova (artralgija) i bol u udovima, grčevi u mišićima, bolest nalik gripi, bolovi, niske vrijednosti natrija, povišene vrijednosti kreatinina, jetrenih enzima ili kreatin fosfokinaze u krvi.
English: Marketing Authorisation Holder Bayer AG
Croatian: NOSITELJ ODOBRENJA STAVLJANJE LIJEKA U PROMET Bayer AG
English: Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma) Blood and lymphatic system disorders Rare:
Croatian: Nemelanomski rak kože (karcinom bazalnih stanica i karcinom skvamoznih stanica)
English: Eczema, drug eruption, toxic skin eruption Musculoskeletal, connective tissue and bone disorders Rare:
Croatian: Ekcem, izbijanje kožnih promjena uzrokovano lijekom, izbijanje kožnih promjena uzrokovano toksičnim učinkom lijeka Poremećaji mišićno-koštanog sustava i vezivnog tkiva Rijetko:
English: MARKETING AUTHORISATION HOLDER Bayer AG
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Bayer AG
English: Periodic monitoring of serum potassium and ECG is recommended when Kinzalkomb 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: Preporučuje se periodično praćenje kalija u serumu i EKG kada se Kinzalkomb 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, dizopiramid) - skupina III antiaritmika (npr. amiodaron, sotalol, dofetilid, ibutilid) - neki antipsihotici (npr. tioridazin, klorpromazin, levomepromazin, trifluoperazin, cijamemazin,
English: Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants.
Croatian: Nadalje, niski krvni tlak se može pogoršati uzimanjem alkohola, barbiturata, narkotika ili antidepresiva, što se može primijetiti u obliku omaglice prilikom ustajanja.
English: Manufacturer Bayer AG
Croatian: Proizvođač lijeka u promet Bayer AG
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: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 40 mg/12.5 mg tablets
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Kinzalkomb 40 mg/12,5 mg tablete
English: Kinzalkomb 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Croatian: Kinzalkomb 40 mg/12,5 mg tablete telmisartan/hidroklorotiazid
English: Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function.
Croatian: Kod bolesnika s oštećenom bubrežnom funkcijom može doći do pojave azotemije povezane s tiazidskim diuretikom.
English: Erectile dysfunction General disorders and administration site conditions Uncommon: Rare:
Croatian: Erektilna disfunkcija Opći poremećaji i reakcije na mjestu primjene Manje često:
English: Decreased blood potassium levels, anxiety, fainting (syncope), sensation of tingling, pins and needles (paraesthesia), feeling of spinning (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to get or keep an erection), chest pain, increased blood uric acid levels.
Croatian: Snižene vrijednosti kalija u krvi, tjeskoba, nesvjestica (sinkopa), osjećaj trnaca, bockanja i žarenja (parestezija), osjećaj vrtnje (vrtoglavica), brzi otkucaji srca (tahikardija), poremećaji srčanog ritma, niski krvni tlak, iznenadni pad krvnog tlaka prilikom ustajanja, nedostatak zraka (zaduha), proljev, suha usta, vjetrovi, bol u leđima, grčevi mišića, bolovi u mišićima, erektilna disfunkcija (nesposobnost postizanja ili održavanja erekcije), bol u prsnom košu, povišene vrijednosti mokraćne kiseline u krvi.
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.
Croatian: 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, smanjenje vida i bol u očima (mogući znakovi akutne miopije 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 usnama, 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, porast razine glukoze u krvi, poteškoće u kontroliranju razine glukoze u krvi/urinu kod bolesnika s dijagnozom šećerne bolesti, ili masnoća u krvi.
English: Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna tableta sadržava 80 mg telmisartana i 12,5 mg hidroklorotiazida.
English: - Hypercalcaemia
Croatian: - Hiperkalcemija
English: Kinzalkomb 80 mg/12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the code number 'H8'.
Croatian: Kinzalkomb 80 mg/12,5 mg tablete su crveno-bijele dvoslojne tablete ovalnog oblika, s urezanim logom tvrtke i oznakom „H8“.
English: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Croatian: NAZIV LIJEKA Kinzalkomb 80 mg/25 mg tablete telmisartan/hidroklorotiazid
English: Kinzalkomb 80 mg/12.5 mg tablets Red and white oval shaped two layer tablet of 6.2 mm engraved with the code number 'H8'.
Croatian: Kinzalkomb 80 mg/12,5 mg tablete Crveno-bijele dvoslojne ovalne tablete duljine 6,2 mm, s utisnutim logom tvrtke i kodom 'H8'.
English: Kinzalkomb 40 mg/12.5 mg tablets are red and white, oval-shaped two-layer tablets engraved with the code number 'H4'.
Croatian: Kinzalkomb 40 mg/12,5 mg tablete su crveno-bijele dvoslojne tablete ovalnog oblika, s urezanim logom tvrtke i oznakom „H4“.
English: Kinzalkomb 40 mg/12.5 mg tablets Red and white oval shaped two layer tablet of 5.2 mm engraved with the code number 'H4'.
Croatian: Kinzalkomb 40 mg/12,5 mg tablete Crveno-bijele dvoslojne ovalne tablete duljine 5,2 mm, s utisnutim logom tvrtke i kodom 'H4'.
English: The overall incidence and pattern of adverse reactions reported with Kinzalkomb 80 mg/25 mg was comparable with Kinzalkomb 80 mg/12.5 mg. A dose-relationship 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 Kinzalkomb 80 mg/25 mg usporedivi su s Kinzalkomb 80 mg/12,5 mg.