FrancophonIA/ELRC3.0 huggingface dataset:
English: - class Ia antiarrythmics (e.g. quinidine, hydroquinidine, disopyramide) - class III antiarrythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide) - some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine,
Slovak: Ia (npr. kinidin, hidrokinidin, dizopiramid), antiaritmiki skupine III (npr. amiodaron, sotalol, dofetilid, ibutilid), nekateri antipsihotiki: (npr. tioridazin, klorpromazin, levomepromazin, trifluorperazin, ciamemazin, sulpirid, sultoprid, amisulprid, tiaprid, pimozid, haloperidol, droperidol), drugo: (npr. bepridil, cisaprid, difemanil, eritromicin iv., halofantrin, mizolastin, pentamidin, sparfloksacin, terfenadin, vinkamin iv.).
English: Kinzalkomb is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by Kinzalkomb 80/12.5 mg or in patients who have been previously stabilised by telmisartan and hydrochlorothiazide given separately.
Slovak: Zdravilo Kinzalkomb je namenjeno za zdravljenje visokega krvnega tlaka (esencialne hipertenzije) pri odraslih, pri katerih s samim zdravilom Kinzalkomb 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: If you get any side effects, talk to your doctor or pharmacist.
Slovak: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo.
Slovak: V primerjavi s placebom se je v raziskavi PRoFESS med zdravljenjem s telmisartanom povečala pojavnost sepse.
English: Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Slovak: Ena tableta vsebuje 40 mg telmisartana in 12,5 mg hidroklorotiazida.
English: Protect your skin from sun exposure and UV rays while taking Kinzalkomb.
Slovak: Med jemanjem zdravila Kinzalkomb zaščitite kožo pred izpostavljenostjo soncu in UV-žarkom.
English: INFORMATION IN BRAILLE Kinzalkomb 40 mg/12.5 mg
Slovak: Kinzalkomb 40 mg/12,5 mg
English: Thiazides should be discontinued before carrying out tests for parathyroid function.
Slovak: Pred preiskavo delovanja obščitnice je treba tiazide ukiniti.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
Slovak: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU
English: MARKETING AUTHORISATION NUMBER(S)
Slovak: ŠTEVILKA(E)
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'.
Slovak: Kinzalkomb 80 mg/12,5 mg tablete Rdeča in bela ovalna, dvoslojna 6,2 mm tableta z vtisnjeno kodno številko 'H8'.
English: Studies with hydrochlorothiazide have shown equivocal evidence for a genotoxic or carcinogenic effect in some experimental models.
Slovak: Raziskave o hidroklorotiazidu so v nekaterih eksperimentalnih modelih nesporno potrdile genotoksični ali kancerogeni učinek, vendar obsežne izkušnje z uporabo hidroklorotiazida pri ljudeh ne kažejo na povezavo med njegovo uporabo in novotvorbami.
English: Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Slovak: Pri bolnikih z zmanjšanim volumnom krvi in/ali zmanjšano količino natrija zaradi intenzivnega diuretičnega zdravljenja, uživanja hrane z omejeno količino soli ter driske ali bruhanja se zlasti po prvem odmerku lahko pojavi simptomatska hipotenzija.
English: Kinzalkomb is also available at the dose strengths 40 mg/12.5 mg and 80 mg/12.5 mg Renal impairment
Slovak: Zdravilo Kinzalkomb je na voljo tudi v jakosti 40 mg/12,5 mg in 80 mg/12,5 mg.
English: Common side effects (may affect up to 1 in 10 people): Dizziness
Slovak: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): omotica.
English: Nausea
Slovak: nemir
English: Medicinal products used in the treatment for gout (e.g. probenecid, sulfinpyrazone and allopurinol) Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Slovak: Včasih je treba prilagoditi odmerek urikozurikov, ker lahko hidroklorotiazid poveča raven sečne kisline v serumu.
English: Muscoloskeletal, connective tissue and bone disorders Uncommon:
Slovak: Bolezni mišično-skeletega sistema, vezivnega tkiva in kosti Neznana:
English: - If you get any side effects talk to your doctor or pharmacist.
Slovak: - Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol) - others (e.g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
Slovak: sulpirid, sultoprid, amisulprid, tiaprid, pimozid, haloperidol, droperidol),
English: Kinzalkomb is available in blisters packs containing 14, 28, 56, or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
Slovak: Zdravilo Kinzalkomb je na voljo v pretisnih omotih po 14, 28, 56, 98 tablet ali pretisnih omotih za enkratni odmerek po 28 x 1 tableta.
English: Syncope, paraesthesia Insomnia, sleep disorders
Slovak: nespečnost, motnje spanja
English: Kinzalkomb 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Slovak: Kinzalkomb 80 mg/25 mg tablete telmisartan/hidroklorotiazid
English: Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5 % CI 0.901.08), p (non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
Slovak: Telmisartan je učinkoval podobno kot ramipril na vnaprej opredeljeni sekundarni opazovani dogodek, ki je zajemal srčnožilno smrt, neusodni miokardni infarkt in neusodno možgansko kap [0,99 (97,5-odstotni IZ 0,90 do 1,08), p (enakovrednost) =
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'.
Slovak: Kinzalkomb 40 mg/12,5 mg tablete Rdeča in bela ovalna, dvoslojna 5,2 mm tableta z vtisnjeno kodno številko 'H4'.
English: Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Slovak: Ena tableta vsebuje 80 mg telmisartana in 12,5 mg hidroklorotiazida.
English: Suggested measures include induction of emesis and/or gastric lavage.
Slovak: Priporočena ukrepa sta povzročitev bruhanja ali izpiranje želodca ali oba.
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
Slovak: EU/1/02/214/006 14 tablet EU/1/02/214/007 28 tablet EU/1/02/214/008 28
English: Hydrochlorothiazide is 68 % protein bound in the plasma and its apparent volume of distribution is 0.83 - 1.14 l/kg.
Slovak: Njegov navidezen volumen porazdelitve je 0,83 do 1,14 l/kg.
English: Keep this medicine out of the sight and reach of children.
Slovak: Zdravilo shranjujte nedosegljivo otrokom!
English: Cholestyramine and colestipol resins
Slovak: Holestiramin in holestipolove smole
English: Metabolism and nutrition disorders Common:
Slovak: Presnovne in prehranske motnje Pogosti:
English: Therefore, in these patients blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.
Slovak: Če za to obstaja indikacija, je včasih treba prilagoditi odmerek insulina ali peroralnega antidiabetika.
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.
Slovak: Občasni neželeni učinki (pojavijo se pri največ 1 od 100 bolnikov): okužba zgornjih dihal (npr. boleče žrelo, vnetje sinusov, prehlad), okužbe sečil, pomanjkanje rdečih krvničk (anemija), visoka raven kalija, počasen srčni utrip (bradikardija), ledvična okvara, tudi akutna ledvična odpoved; oslabelost, kašelj.
English: Very rare side effects (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease) **
Slovak: Progresivno brazgotinjenje pljučnega tkiva (intersticijska pljučna bolezen)**
English: An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Slovak: Dve epidemiološki študiji, izvedeni na podlagi podatkov registra raka za Dansko, sta pokazali, da zaradi izpostavljenosti povečanemu kumulativnemu odmerku hidroklorotiazida obstaja povečano tveganje za razvoj nemelanomskega kožnega raka (bazalnoceličnega karcinoma in ploščatoceličnega karcinoma).
English: Hypochloraemic alkalosis
Slovak: Hiponatriemija in hipokloremična alkaloza
English: Dizziness
Slovak: dispneja
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Slovak: Pri bolnicah, ki načrtujejo nosečnost, je treba čimprej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen, če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
English: Kinzalkomb 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Slovak: Kinzalkomb 40 mg/12,5 mg tablete telmisartan/hidroklorotiazid
English: - Hyperkalaemia
Slovak: hiperkaliemija
English: Elimination Telmisartan: Following either intravenous or oral administration of
Slovak: Po intravenskem ali peroralnem dajanju s
English: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Slovak: Pri bolnikih z obojestransko zožitvijo ledvične arterije ali arterije samo ene delujoče ledvice, zdravljenje z zdravili, ki delujejo na renin-angiotenzin-aldosteronski sistem, poveča nevarnost hude hipotenzije in zmanjšanja delovanja ledvic.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Slovak: Za sočasno jemanje litija in zaviralcev angiotenzinske konvertaze (zaviralci ACE) poročajo o reverzibilnem povečanju serumskih koncentracij litija in njegove toksičnosti.
English: Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
Slovak: Če se očesni tlak ne uravna, je lahko potrebno takojšnje zdravljenje z zdravili ali operativno zdravljenje.
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)
Slovak: Druge sestavine zdravila so laktoza monohidrat, magnezijev stearat, koruzni škrob, meglumin, mikrokristalna celuloza, povidon (K25), rdeč železov oksid (E172), natrijev hidroksid, natrijev karboksimetilškrob (vrsta
English: 4.2 Posology and method of administration
Slovak: Odmerjanje in način uporabe
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with Kinzalkomb (see section 4.5).
Slovak: Če se bolniki zdravijo z zdravilom Kinzalkomb, moramo biti previdni pri sočasnem dajanju diuretikov, ki varčujejo s kalijem, kalijevih pripravkov ali nadomestkov soli, ki vsebujejo kalij (glejte poglavje 4.5).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets
Slovak: Pretisni omot po 7 tablet
English: Exacerbation or activation of systemic lupus erythematosus Metabolism and nutrition disorders Uncommon: Rare:
Slovak: poslabšanje ali aktiviranje sistemskega eritematoznega lupusa
English: Kinzalkomb 80 mg/25 mg tablets are yellow and white, oval-shaped, two-layer tablets engraved with the code 'H9'.
Slovak: Izgled zdravila Kinzalkomb in vsebina pakiranja Tablete zdravila Kinzalkomb 80 mg/25 mg so rumene in bele, ovalne, dvoslojne, z vtisnjeno kodno številko 'H9'.
English: Patients were randomized to one of the three following treatment groups: telmisartan 80 mg (n = 8542), ramipril 10 mg (n = 8576), or the combination of telmisartan 80 mg plus ramipril 10 mg (n = 8502), and followed for a mean observation time of 4.5 years.
Slovak: 8576) ali kombinacijo telmisartana po 80 mg in ramiprila po 10 mg (n =
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.
Slovak: Redki neželeni učinki (pojavijo se pri največ 1 od 1.000 bolnikov): majhno število trombocitov (trombocitopenija), povečano število nekaterih belih krvničk (eozinofilija), resne alergijske reakcije (npr. preobčutljivost, anafilaktična reakcija, medikamentni izpuščaj), nizka raven krvnega sladkorja (pri bolnikih s sladkorno boleznijo), želodčne težave, ekcem (kožna bolezen), artroza, vnetje kit, znižana raven hemoglobina (krvne beljakovine), zaspanost.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Slovak: Predpisovanje in izdaja zdravila je le na recept.
English: - Diabetes.
Slovak: Nephropathy in Diabetes).
English: Posology
Slovak: Preiskave
English: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Slovak: IME ZDRAVILA Kinzalkomb 80 mg/25 mg tablete telmisartan/hidroklorotiazid
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).
Slovak: Druge sestavine zdravila so laktoza monohidrat, magnezijev stearat, koruzni škrob, meglumin, mikrokristalna celuloza, povidon (K25), rumen železov oksid (E172), natrijev hidroksid, natrijev karboksimetilškrob (vrsta
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovak: PRILOGA II A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI)
English: Eye disorders Rare:
Slovak: Očesne bolezni Redki:
English: Stomach discomfort Skin and subcutaneous tissue disorders Rare:
Slovak: Bolezni kože in podkožja Redki:
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.
Slovak: 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: Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with Kinzalkomb.
Slovak: Neželeni učinki, o katerih so poročali za posamezni sestavini zdravila, se lahko pojavijo tudi pri zdravilu Kinzalkomb, čeprav jih v kliničnih preskušanjih kombinacije niso zasledili.
English: Common:
Slovak: Občasni:
English: Kinzalkomb 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Slovak: Kinzalkomb 80 mg/12,5 mg tablete telmisartan/hidroklorotiazid
English: Method of administration
Slovak: Način uporabe
English: • Cholestasis and biliary obstructive disorders.
Slovak: • holestaza in obolenja z zaporo žolčevoda,
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
Slovak: x 1 tableta EU/1/02/214/014 56 tablet EU/1/02/214/015 98 tablet
English: Angioedema (also with fatal outcome), erythema, pruritus, rash, hyperhidrosis, urticaria
Slovak: angioedem (lahko povzroči tudi smrt), eritem, pruritus, izpuščaj, hiperhidroza, urtikarija Bolezni mišično-skeletega sistema, vezivnega tkiva in kosti Občasni:
English: Therefore, the use of Kinzalkomb is not recommended.
Slovak: Sočasno dajanje litija in zdravila Kinzalkomb ne priporočamo.
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.
Slovak: Občasni neželeni učinki (pojavijo se pri največ 1 od 100 bolnikov): znižana raven kalija v krvi, tesnoba, omedlevanje (sinkopa), ščemenje, mravljinci (parestezija), vrtoglavica, hiter srčni utrip (tahikardija), motnje srčnega ritma, nizek krvni tlak, nenadno znižanje krvnega tlaka med vstajanjem, zasoplost (dispneja), driska, suha usta, napenjanje, bolečina v hrbtu, mišični krč, bolečina v mišicah, erektilna disfunkcija (nezmožnost erekcije ali vzdrževanja erekcije), bolečina v prsnem košu, povečana raven sečne kisline v krvi.
English: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Slovak: IME ZDRAVILA Kinzalkomb 40 mg/12,5 mg tablete telmisartan / hidroklorotiazid
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.
Slovak: 2121 bolnikov, pri katerih so ocenili učinkovitost), je bilo znižanje krvnega tlaka pri kombinaciji telmisartan/hidroklorotiazid 80 mg/25 mg značilno večje, in sicer za 2,2/1,2 mm Hg (SKT/DKT)
English: Fertility
Slovak: Litij
English: Kinzalkomb is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
Slovak: Zdravila Kinzalkomb ne priporočajo materam, ki dojijo.
English: Renal impairment and kidney transplantation
Slovak: Motnje reprodukcije in dojk
English: High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness.
Slovak: Posledice takšnih poškodb so lahko srčni infarkt, popuščanje srca ali odpoved ledvic, možganska kap ali slepota.
English: Adverse reactions occurred with similar frequency in placebo and telmisartantreated patients.
Slovak: Pojavnost neželenih učinkov je bila enako pogosta kot pri placebu.
English: Renal impairment
Slovak: Ledvična okvara
English: Meglumine
Slovak: vrtoglavica
English: Feeling sick (nausea), low blood magnesium level.
Slovak: zvišana raven sečne kisline v krvi
English: Dizziness or drowsiness may occasionally occur when taking Kinzalkomb.
Slovak: Zdravilo Kinzalkomb lahko včasih povzroči omotico ali dremavost.
English: Dyspnoea
Slovak: omotica
English: Restlessness
Slovak: anksioznost
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.
Slovak: Redki neželeni učinki (pojavijo se pri največ 1 od 1.000 bolnikov): pljučno vnetje (bronhitis), aktiviranje ali poslabšanje sistemskega eritematoznega lupusa (bolezni, pri kateri telo napade človekov lastni imunski sistem, kar povzroči bolečine v sklepih, kožni izpuščaj in vročino), angina, vnetje sinusov, občutek žalosti (depresija), težave z uspavanjem (nespečnost), motnje vida, težave z dihanjem, trebušna bolečina, zaprtje, spahovanje (dispepsija), slabo počutje (bruhanje), želodčno vnetje (gastritis), motnje v delovanju jeter (pri japonskih bolnikih obstaja večja verjetnost pojavljanja tega neželenega učinka), rdečica na koži (eritem), alergijske reakcije, na primer srbenje ali izpuščaj; povečano znojenje, urtikarija, bolečine v sklepih (artralgija) in v okončinah, mišični krči, gripi podobna bolezen, bolečina,, nizka raven natrija, zvišane ravni kreatinina, jetrnih encimov ali kreatinfosfokinaze v krvi.
English: Kinzalkomb 80 mg/12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the code number 'H8'.
Slovak: Izgled zdravila Kinzalkomb in vsebina pakiranja Tablete zdravila Kinzalkomb 80 mg/12,5 mg so rdeče in bele, ovalne, dvoslojne, z vtisnjeno kodno številko 'H8'.
English: Hypomagnesaemia
Slovak: Hipomagneziemija