natgillin/translations-raw huggingface dataset:
When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Kadar bolnikovo klinično stanje dopušča, se lahko odločimo za neposreden prehod z monoterapije na zdravljenje s fiksno kombinacijo.
- This medicine has been prescribed for you only.
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Muscle relaxing medicines, such as tubocurarine.
Nedepolarizirajoči mišični relaksanti s perifernim delovanjem (npr. tubokurarin)
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder), or any other severe liver disease.
• če imate hude jetrne težave, kot sta holestaza ali zapora žolčevoda (težave z odtekanjem žolča iz jeter in žolčnika), ali katerokoli drugo hudo jetrno bolezen,
• Periodic Safety Update Reports
Redno posodobljena poročila o varnosti zdravila (PSUR)
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 1.002.06)]; 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)].
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)].
Telmisartan showed a similar effect to ramipril in reducing the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure.
Telmisartan je podobno učinkovito kot ramipril zmanjšal primarni, sestavljeni opazovani dogodek, ki je zajemal srčnožilno smrt, neusodni miokardni infarkt, neusodno možgansko kap ali bolnišnično zdravljenje zaradi kongestivnega srčnega popuščanja.
Antidiabetic medicinal products (oral agents and insulin)
Antidiabetiki (peroralni antidiabetiki in insulin)
Telmisartan does not accumulate significantly in plasma on repeated administration.
Telmisartan se po ponovnem dajanju v plazmi pomembneje ne kopiči.
Anorexia, appetite decreased, electrolyte imbalance, hypercholesterolaemia, hyperglycaemia, hypovolaemia.
hipomagneziemija hiperkalciemija hipokloremična alkaloza anoreksija, zmanjšan apetit, elektrolitsko neravnovesje, hiperholesterolemija, hiperglikemija, hipovolemija
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
• če imate hude jetrne težave, kot sta holestaza ali zapora žolčevoda (težave z odtekanjem žolča iz jeter in žolčnika) ali katerokoli drugo hudo jetrno bolezen,
Hydrochlorothiazide is excreted in human milk in small amounts.
Majhna količina hidroklorotiazida se izloča v materino mleko.
In patients with mild to moderate hepatic impairment the posology should not exceed Kinzalkomb 40 mg/12.5 mg once daily.
Odmerek za bolnike z blago do zmerno zmanjšanim jetrnim delovanjem ne sme prekoračiti odmerka zdravila Kinzalkomb 40 mg/12,5 mg 1-krat na dan.
You should store your medicine in the original package in order to protect the tablets from moisture.
Zdravilo shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
What Kinzalkomb is and what it is used for What you need to know before you take Kinzalkomb How to take Kinzalkomb
Kaj je zdravilo Kinzalkomb in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Kinzalkomb Kako jemati zdravilo Kinzalkomb Možni neželeni učinki
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.
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 snovi.
In dogs renal tubular dilation and atrophy were observed.
Pri psih so zasledili razširitev ledvičnih tubulov in atrofijo.
Kinzalkomb may be less effective in lowering the blood pressure in black patients.
Zdravilo Kinzalkomb lahko pri črni rasi manj učinkovito znižuje krvni tlak.
Kinzalkomb is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when telmisartan is used alone.
Zdravilo Kinzalkomb je namenjeno za zdravljenje visokega krvnega tlaka (esencialne hipertenzije) pri odraslih, pri katerih s samim telmisartanom krvnega tlaka ne moremo dovolj uravnati.
If Kinzalkomb is used during breast feeding, doses should be kept as low as possible.
Če doječe matere zdravilo Kinzalkomb uporabljajo med dojenjem, morajo biti njegovi odmerki karseda majhni.
If these medicinal products are to be prescribed with the hydrochlorothiazide-telmisartan combination, monitoring of potassium plasma levels is advised.
Če moramo našteta zdravila predpisati hkrati s kombinacijo hidroklorotiazida in telmisartana, priporočamo spremljanje ravni kalija v plazmi.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer AG
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer AG
When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed.
Pri sočasni uporabi telmisartana in digoksina je prišlo do srednje velikega povečanja največje koncentracije digoksina v plazmi (49
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
Izkušnje z drugimi zdravili, ki zavirajo delovanje reninangiotenzinskega sistema, kažejo, da lahko sočasno dajanje teh zdravil poveča raven kalija v serumu, in jih zato ne priporočamo (glejte poglavje 4.4).
Store in the original package in order to protect from moisture.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
Cases of interstitial lung disease have been reported from post-marketing experience in temporal association with the intake of telmisartan.
V obdobju po začetku trženja zdravila so poročali o primerih intersticijske pljučne bolezni, ki so bili časovno povezani z jemanjem telmisartana.
Each 40 mg/12.5 mg tablet contains 112 mg of lactose monohydrate and 169 mg sorbitol (E420).
Ena 40 mg/12,5 mg tableta vsebuje 112 mg laktoze monohidrata in 169 mg sorbitola (E420).
Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of Kinzalkomb, hyperkalaemia might occur.
Zaradi antagonističnega delovanja telmisartana v zdravilu Kinzalkomb na receptorje za angiotenzin II (AT1) je možna tudi hiperkaliemija.
Diarrhoea, dry mouth, flatulence Abdominal pain, constipation, dyspepsia, vomiting, gastritis
abdominalna bolečina, zaprtje, dispepsija, bruhanje, gastritis
- If you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Brez zdravljenja lahko pride do trajne okvare vida; - če ste imeli kožnega raka ali če se vam med zdravljenjem pojavijo nepričakovane kožne spremembe.
Each tablet contains 99 mg of lactose monohydrate and 338 mg sorbitol (E420).
Ena tableta vsebuje 99 mg laktoze monohidrata in 338 mg sorbitola (E420).
Haemoglobin decreased
znižan hemoglobin
Kinzalkomb is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Zdravilo Kinzalkomb je kombinacija antagonista receptorjev angiotenzina II telmisartana in tiazidnega diuretika hidroklorotiazida.
Another study showed a possible association between lip cancer (SCC) and exposure to HCTZ: 633 cases of lip-cancer were matched with 63,067 population controls, using a risk-set sampling strategy.
S pomočjo strategije vzorčenja iz tveganih populacij so primerjali 633 primerov raka ustnice s kontrolno populacijo 63.067 bolnikov.
Tachycardia, arrhythmias
tahikardija, aritmije
Dosage adjustment of the antidiabetic medicinal products may be required (see section 4.4).
Včasih je treba prilagoditi odmerek antidiabetika (glejte poglavje 4.4).
The incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups.
Podobno pojavnost primarnega opazovanega dogodka so ugotovili v obeh skupinah: s telmisartanom (16,7
There was a trend towards higher plasma concentrations of hydrochlorothiazide in female than in male subjects.
Tudi plazemske koncentracije hidroklorotiazida se pri ženskah nagibajo k nekoliko večjim vrednostim.
Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart rate (faster than 100 beats per minute).
Značilni simptomi neravnovesja tekočine ali elektrolitov so suha usta, šibkost, letargija, dremavost, nemir, mišična bolečina ali krči, slabost (siljenje na bruhanje), bruhanje, utrujene mišice in nenormalno hitro bitje srca (več kot 100 utripov na minuto).
Eczema, drug eruption, toxic skin eruption Musculoskeletal, connective tissue and bone disorders Rare:
ekcem, medikamentni izpuščaj, toksični kožni izpuščaj Bolezni mišično-skeletega sistema, vezivnega tkiva in kosti Redki:
Slow heartbeat, dizziness, vomiting, reduced kidney function including kidney failure, have also been reported.
V poročilih navajajo še počasen srčni utrip, omotico, bruhanje in zmanjšano ledvično delovanje, tudi ledvično odpoved.
Kinzalkomb tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Jemanje tablet Kinzalkomb je peroralno enkrat na dan s tekočino, s hrano ali brez nje.
The observed increased occurrence rate of sepsis associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently known.
Povečana pojavnost sepse med jemanjem telmisartana je lahko naključni dogodek ali pa je povezana s še neznanim mehanizmom.
How to take Kinzalkomb
Kako jemati zdravilo Kinzalkomb
MARKETING AUTHORISATION NUMBER(S) EU/1/02/214/011-015
ZA PROMET Z ZDRAVILOM EU/1/02/214/011-015
In addition, there was a significantly higher incidence of hyperkalaemia, renal failure, hypotension and syncope in the combination arm.
Poleg tega je bila v skupini, ki je jemala kombinacijo zdravil, značilno večja pojavnost hiperkaliemije, ledvične odpovedi, hipotenzije in sinkope.
Upper respiratory tract infection, urinary tract infection including cystitis
okužba zgornjih dihal, okužba sečil, tudi cistitis
The risk of hypokalaemia is greater in patients with cirrhosis of liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or Adrenocorticotropic hormone (ACTH) (see section 4.5).
Možnost, da se bo hipokaliemija pojavila, je večja pri bolnikih z jetrno cirozo, s povečano diurezo ali pri bolnikih, ki peroralno ne dobivajo ustreznih odmerkov elektrolitov, in pri sočasnem zdravljenju s kortikosteroidi ali adrenokortikotropnim hormonom adenokortikotropni hormon (ACTH)
The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.
Koliko hidroklorotiazida se odstrani s hemodializo, ni raziskano.
Renal excretion does not contribute to the clearance of telmisartan.
Izločanje skozi ledvice ne poveča telmisartanovega očistka.
You must tell your doctor if you think you are (or might become) pregnant.
Zdravniku morate povedati, če mislite, da ste noseči ali če načrtujete nosečnost.
In a double-blind controlled clinical trial (n=687 patients evaluated for efficacy) in non-responders to the 80 mg/12.5 mg combination, an incremental blood pressure lowering effect of the 80 mg/25 mg combination compared to continued treatment with the 80 mg/12.5 mg combination of 2.7/1.6 mm Hg (SBP/DBP) was demonstrated (difference in adjusted mean changes from baseline).
V dvojno slepi, nadzorovani klinični raziskavi (n = 687 bolnikov, pri katerih so ocenili učinkovitost) pri bolnikih, ki se niso odzivali na zdravljenje s kombinacijo 80 mg/12,5 mg, je kombinacija 80 mg/25 mg v primerjavi s stalnim zdravljenjem s kombinacijo 80 mg/12,5 dodatno znižala krvni tlak za 2,7/1,6 mm Hg (SKT/DKT)
Elderly
Starejši
Hyperkalaemia Hypoglycaemia (in diabetic patients)
hipoglikemija (pri bolnikih s sladkorno boleznijo)
The effect of Kinzalkomb may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen).
Učinek zdravila Kinzalkomb se lahko zmanjša, če jemljete NSAR (nesteroidne antirevmatike, npr. acetilsalicilno kislino ali ibuprofen).
Visual disturbance, vision blurred
motnje vida, meglen vid
Telmisartan is not removed from blood by haemodialysis.
Telmisartan se s hemodializo ne odstrani.
Endocrine disorders Not known:
Bolezni endokrinega sistema Neznana:
Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, asthenia, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting (see section 4.8).
Opozorilni znaki, ki kažejo na motnje ravnovesja tekočin ali elektrolitov, so suha usta, žeja, astenija, brezvoljnost, dremavica, nemir, mišična bolečina ali krči, mišična utrujenost, hipotenzija, oligurija, tahikardija in prebavne motnje, npr. slabost ali bruhanje (glejte poglavje 4.8).
If you experience any of these you should tell your doctor.
Če opazite katerikoli pojav od naštetih, obvestite svojega zdravnika.
Presumably through blockade of the reninangiotensin-aldosterone system, co-administration of telmisartan tends to reverse the potassium loss associated with these diuretics.
Sočasno dajanje telmisartana domnevno deluje zaradi blokade renin-angiotenzin-aldosteronskega sistema, reverzibilno na izgubo kalija, do katere prihaja pri teh diuretikih.
3: For further description, please see sub-section“Description of selected adverse reactions” Hydrochlorothiazide:
Za podrobnejši opis glejte podpoglavje »Opis izbranih neželenih učinkov« Hidroklorotiazid
Hydrochlorothiazide: Following oral administration of Kinzalkomb peak concentrations of hydrochlorothiazide are reached in approximately 1.0 - 3.0 hours after dosing.
Po peroralnem dajanju zdravila Kinzalkomb doseže hidroklorotiazid največjo koncentracijo v plazmi približno v 1,0 do 3,0 urah.
As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Enako kot pri vseh bolnikih, ki se zdravijo z diuretiki, so potrebni periodični kontrolni pregledi ravni elektrolitov v serumu.
Only minute amounts were found in urine.
V seču so izmerili le neznatno količino.
Very rare side effects (may affect up to 1 in 10,000 people):
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
Hepatic impairment
glavobol omotica
MARKETING AUTHORISATION NUMBER(S) Kinzalkomb 40 mg/12.5 mg tablets EU/1/02/214/001-005
Kinzalkorb 40 mg/12,5 mg tablete EU/1/02/214/001-005
Beta-blockers and diazoxide
Zaviralci adrenergičnih receptorjev beta in diazoksid
UNIQUE IDENTIFIER - HUMAN READABLE DATA
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Na receptorju AT1 nima nikakršnega delnega agonističnega učinka.
Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed.
Na podlagi obstoječih podatkov epidemioloških študij so ugotovili, da obstaja razmerje med kumulativnim odmerkom hidroklorotiazida in nemelanomskim kožnim rakom.
Each 80 mg/12.5 mg tablet contains 112 mg of lactose monohydrate and 338 mg sorbitol (E420).
Ena 80 mg/12,5 mg tableta vsebuje 112 mg laktoze monohidrata in 338 mg sorbitola (E420).
If these effects are not treated they could be fatal.
Brez zdravljenja so lahko usodni za bolnika.
The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Tiazidi lahko povečano hiperglikemični učinek zaviralcev adrenergičnih receptorjev beta in diazoksida.
Telmisartan showed no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Telmisartan v in vitro študijah pri podganah in miših ni imel mutagenih učinkov ali pomembnejšega klastogenega delovanja in ni deloval kancerogeno.
Kinzalkomb should be kept in the sealed blister due to the hygroscopic property of the tablets.
Zdravilo Kinzalkomb je treba shranjevati v zaprtem pretisnem omotu, ker so tablete higroskopične.
6.4 Special precautions for storage
POSEBNA NAVODILA ZA SHRANJEVANJE
The overall incidence of adverse reactions reported with Kinzalkomb 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).
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).
If this combination proves essential, careful monitoring of serum lithium level is recommended during concomitant use.
Če je kombinirano zdravljenje nujno potrebno, je priporočljivo pazljivo spremljanje serumske ravni litija.
Tell your doctor if you are breast-feeding or about to start breast-feeding.
Povejte zdravniku, če dojite ali nameravate začeti dojiti.
Vasculitis necrotizing
nekrotizirajoči vaskulitis
Pregnancy and breast-feeding
Nosečnost in dojenje
C-labelled telmisartan the glucuronide represents approximately 11 % of the measured radioactivity in plasma.
C označenega telmisartana odpade na glukuronid približno 11
Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine.
Zdravili, ki lahko zaradi svojih farmakoloških lastnosti povečata hipotenzivne učinke vseh antihipertenzivov, tudi telmisartana, sta baklofen in amifostin.
General
Splošno
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
V prisotnosti anionskih izmenjalnih smol je motena absorpcija hidroklorotiazida.
Individual dose titration with each of the two components is recommended before changing to the fixed dose combination.
Pred prehodom na zdravljenje s fiksno kombinacijo je priporočljivo, da najprej individualno prilagodimo odmerka posameznih sestavin kombinacije.
A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Razmerje med kumulativnim odmerkom in odzivom so dokazali s tem, da se je prilagojeni OR z 2,1 (95odstotni IZ: 1,7-2,6), zvišal na 3,9 (3,0-4,9) pri velikih odmerkih (~
There is no experience regarding the administration of Kinzalkomb in patients with recent kidney transplantation.
Z uporabo zdravila Kinzalkomb pri bolnikih z nedavno presajeno ledvico ni izkušenj.
Kinzalkomb must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Zdravila Kinzalkomb ne smemo dajati bolnikom z močno zmanjšanim delovanjem ledvic (kreatininskim očistkom < 30 ml/min)
Lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis, erythema multiforme Musculoskeletal, connective tissue and bone disorders Not known:
lupusu podoben sindrom, fotosenzibilne reakcije, kožni vaskulitis, toksična epidermalna nekroliza, multiformni eritem
4.4 Special warnings and precautions for use
Posebna opozorila in previdnostni ukrepi
Hydrochlorothiazide is a thiazide diuretic.
Hidroklorotiazid je zdravilo iz skupine tiazidnih diuretikov.
Hydrochlorothiazide exhibits linear pharmacokinetics.
Hidroklorotiazid kaže linerano farmakinetiko.
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (ledvična odpoved, hipotenzija, hiperkaliemija).
Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.
Tudi resni interesantni neželeni učinki (hiperkaliemija, hipotenzija in disfunkcija ledvic) so bili v skupini, ki je prejemala aliskiren, pogostejši kot v skupini, ki je prejemala placebo.
Cytotoxic agents (e.g. cyclophosphamide, methotrexate)
Citotoksična zdravila (npr. ciklofosfamid, metotreksat)
After a single dose of
Po enkratnem odmerku s
Pancreatitis, stomach discomfort
navzea pankreatitis, želodčne težave
Adverse reactions reported with one of the individual components may be potential adverse reactions with Kinzalkomb, even if not observed in clinical trials with this product.
Neželeni učinki, o katerih so poročali za eno od posameznih sestavin, se lahko pojavijo tudi pri zdravilu Kinzalkomb, četudi jih v kliničnem preskušanju tega zdravila niso zasledili.
NAME OF THE MEDICINAL PRODUCT Kinzalkomb 80 mg/25 mg tablets
IME ZDRAVILA Kinzalkomb 80 mg/25 mg tablete
Japanese patients are more likely to experience these adverse reactions.
Preobčutljivostne reakcije so verjetnejše pri bolnikih, ki imajo omenjena obolenja v anamnezi.
Thiazide-induced hypokalaemia or hypomagnesaemia favours the onset of digitalis-induced arrhythmia (see section 4.4).
Hipokaliemija ali hipomagneziemija, ki jo povzročajo tiazidi, poveča možnost nastanka aritmije, inducirane z digitalisom (glejte poglavje 4.4
1: Based on post-marketing experience 2: For further description, please see sub-section “Description of selected adverse reactions”
znižan hemoglobin 3: Za podrobnejši opis glejte podpoglavje »Opis izbranih neželenih učinkov«
Co-administration of lithium and Kinzalkomb is not recommended (see section 4.4).
Sočasno dajanje litija in zdravila Kinzalkomb ne priporočamo (glejte poglavje 4.4).
Coadministration of thiazide may increase the incidence of hypersensitivity reactions of allopurinol.
Sočasno dajanje tiazida lahko poveča pogostnost preobčutljivostnih reakcij na alopurinol.
Sialadenitis Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not known:
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
Hypokalaemia Hyperuricaemia, hyponatraemia
hiperurikemija, hiponatriemija
Common side effects (may affect up to 1 in 10 people): Feeling sick (nausea), low blood magnesium level.
Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov): slabost (navzea), nizka raven magnezija v krvi.
Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Tiazidi lahko zmanjšajo izločanje kalcija s sečem in občasno blago povečajo njegovo raven v serumu, kadar ni znanih motenj njegove presnove.