FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on cumulative renal excretion of hydrochlorothiazide the absolute bioavailability was about 60 %.
Maltese: Ibbażat fuq it-tneħħija kumulattiva renali ta' hydrochlorothiazide, il-bijodisponibilità assoluta kienet ta' madwar 60%.
English: Food slightly reduces the bioavailability of telmisartan with a reduction in the area under the plasma concentration time curve (AUC) of about 6 % with the 40 mg tablet and about 19 % after a 160 mg dose.
Maltese: L-ikel inaqqas ftit il-bijodisponibilità ta' telmisartan bi tnaqqis fl-erja taħt il-kurva tal-konċentrazzjoni tal-plażma - ħin (AUC) ta' madwar 6% bil-pillola ta' 40 mg, u madwar 19% wara doża ta' 160 mg.
English: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma.
Maltese: Hydrochlorothiazide, li hu sulfonamide, jista' jikkawża reazzjoni idjosinkratika, li tirriżulta f'mijopija akuta temporanja u glawkoma ta' angolu magħluq.
English: There is limited information available for telmisartan with regard to overdose in humans.
Maltese: Hemm informazzjoni limitata disponibbli għal telmisartan fir-rigward ta' doża eċċessiva fil-bnedmin.
English: Kinzalkomb is also available at the dose strengths 40 mg/12.5 mg and 80 mg/12.5 mg Renal impairment
Maltese: Kinzalkomb hu disponibbli wkoll f'dożi b'qawwa ta' 40 mg/12.5 mg u 80 mg/ 12.5 mg
English: Psychiatric disorders Not known:
Maltese: Disturbi psikjatriċi Mhux magħrufa:
English: Based on modest experience in patients with mild to moderate renal impairment (creatinine clearance of 30 - 60 ml/min, mean about 50 ml/min) no dosage adjustment is necessary in patients with decreased renal function.
Maltese: Ibbażat fuq esperjeza modesta f'pazjenti b'indeboliment renali minn ħafif sa moderat (tneħħija tal-krejatinina ta' 30-60 ml/min, medja ta' madwar 50 ml/min), l-ebda aġġustament fid-dożaġġ mhu meħtieġ f'pazjenti b'funzjoni renali mnaqqsa.
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.
Maltese: Ġie osservat riskju akbar ta' kanċer tal-ġilda mhux melanoma (NMSC) [karċinoma ta' ċellola bażali (BCC) u karċinoma ta' ċellola skwamuża (SCC)] b'doża kumulattiva li tiżdied ta' esponiment għal hydrochlorothiazide (HCTZ) fiż-żewġ studji epidemjoloġiċi bbażati fuq ir-Reġistru Nazzjonali talKanċer tad-Danimarka.
English: Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Maltese: Telmisartan ma jesibixxi l-ebda attività agonista parzjali fir-riċettur AT1.
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.
Maltese: Kinzalkomb taħlita fissa tad-doża (80 mg telmisartan/25 mg hydrochlorothiazide) hi indikata f'adulti li pressjoni tad-demm tagħhom ma tkunx ikkontrollata b'mod adegwat b'Kinzalkomb 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) jew f'adulti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.
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
Maltese: EU/1/02/214/006 14-il pillola EU/1/02/214/007 28 pillola EU/1/02/214/008 28 x 1 pillola
English: Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics, including hydrochlorothiazide.
Maltese: It-tħarrix jew l-attivazzjoni ta' lupus erythematosus sistemiku kien irrappurtat bl-użu ta' dijuretiċi ta' thiazide, li jinkludu hydrochlorothiazide.
English: Lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis, erythema multiforme Musculoskeletal, connective tissue and bone disorders Not known:
Maltese: Sindrome qisu tal-lupus, reazzjonijiet ta' sensittività għaddawl, vaskulite fil-ġilda, nekrolisi epidermali tossika, eritema multiforme
English: INFORMATION IN BRAILLE Kinzalkomb 80 mg/12.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Kinzalkomb 80 mg/12.5 mg pilloli
English: Metformin should be used with precaution: risk of lactic acidosis induced by a possible functional renal failure linked to hydrochlorothiazide.
Maltese: Metformin għandu jintuża bl-attenzjoni: hemm riskju ta' aċidożi lattikali kkaġunata minn insuffiċjenza funzjonali renali marbuta ma' hydrochlorothiazide.
English: Angioedema (also with fatal outcome), erythema, pruritus, rash, hyperhidrosis, urticaria
Maltese: Anġjoedima (ukoll b'riżultat fatali), eritema, ħakk, raxx, iperidrosi, urtikarja
English: Sími: +354 540 8000
Maltese: Icepharma hf Sími: +354 540 80 00
English: 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).
Maltese: Sinjali ta' twissija ta' żbilanċ filfluwidu jew fl-elettroliti huma nixfa fil-ħalq, għatx, astenja, letarġija, ngħas, nuqqas ta' kwiet f'ġismek, uġigħ fil-muskoli jew bugħawwieġ, għeja muskolari, pressjoni baxxa, oligurja, takikardja u disturbi gastro-intestinali bħal nawseja u rimettar (ara sezzjoni 4.8).
English: The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Maltese: L-effett ipergliċemiku ta' imblokkaturi beta u ta' diazoxide jista' jiżdied bit-thiazides.
English: Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Maltese: Telmisartan jieħu post angiotensin II b'affinità għolja ħafna mis-sit fejn jeħel fis-sottotip tar-riċettur AT1, li hu responsabbli għall-azzjonijiet magħrufa ta' angiotensin II.
English: Kinzalkomb is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
Maltese: Kinzalkomb hu taħlita ta' żewġ sustanzi attivi, telmisartan u hydrochlorothiazide f'pillola waħda.
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Maltese: F'xi pazjenti li għandhom il-funzjoni renali kompromessa (eż. pazjenti deidratati jew pazjenti anzjani b'funzjoni renali kompromessa), l-għoti flimkien ta' antagonisti tar-riċettur ta' angiotensin II u mediċini li jinibixxu cyclo-oxygenase, jista' jirriżulta f'deterjorament addizzjonali tal-funzjoni renali, li jinkludi l-possibbiltà ta' insuffiċjenza akuta renali, li normalment tkun riversibbli.
English: Nephritis interstitial, renal dysfunction, glycosuria General disorders and administration site conditions Not known:
Maltese: Nefrite interstizjali, disfunzjoni renali, glikosurja Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Mhux magħrufa:
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
Maltese: EU/1/02/214/001 14-il pillola EU/1/02/214/002 28 pillola EU/1/02/214/003 28 x 1 pillola
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Kinzalkomb” and “Warnings and precautions”).
Maltese: - Jekk qed tieħu inibitur ta' ACE jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux Kinzalkomb” u “Twissijiet u prekawzjonijiet”).
English: Medicines to increase blood pressure, such as noradrenaline.
Maltese: - Mediċini biex iżidu l-pressjoni tad-demm, bħal noradrenaline.
English: Telmisartan does not accumulate significantly in plasma on repeated administration.
Maltese: Telmisartan ma jakkumulaz b'mod sinifikanti filplażma meta jingħata ripetutament.
English: Kinzalkomb 80 mg/12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the code number 'H8'.
Maltese: Kinzalkomb 80 mg/12.5 mg pilloli Pillola ħamra u bajda ta' 6.2 mm b'żewġ saffi, b'forma ovali, imnaqqxa bin-numru tal-kodiċi 'H8'.
English: Kinzalkomb 80 mg/25 mg tablets are yellow and white, oval-shaped, two-layer tablets engraved with the code 'H9'.
Maltese: Il-pilloli Kinzalkomb 80 mg/25 mg huma sofor u bojod, b'forma ovali, b'żewġ saffi, imnaqqxa bilkodiċi 'H9'.
English: The mean duration of follow up was 4 years and 8 months.
Maltese: It-tul medju tal-follow up kien ta' 4 snin u 8 xhur.
English: Kinzalkomb 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Maltese: Kinzalkomb 40 mg/12.5 mg pilloli Kull pillola fiha 40 mg ta' telmisartan u 12.5 mg ta' hydrochlorothiazide.
English: Kinzalkomb 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Maltese: Kinzalkomb 80 mg/12.5 mg pilloli Kull pillola fiha 80 mg ta' telmisartan u 12.5 mg ta' hydrochlorothiazide.
English: Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Maltese: Skont ilmekkaniżmu farmakoloġiku tal-azzjoni ta' hydrochlorothiazide, l-użu tiegħu matul it-tieni u t-tielet trimestru jista' jikkomprometti l-perfużjoni fetoplaċentali u jista' jikkawża effetti lil fetu u lil trabi tattwelid bħal icterus, disturb fil-bilanċ tal-elettroliti u tromboċitopenija.
English: - Heart trouble.
Maltese: - Problemi tal-qalb.
English: Terminal elimination half-life was >20 hours.
Maltese: Il-half-life tat-tneħħija terminali kienet ta' >20 siegħa.
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.
Maltese: Infjammazzjoni tal-pulmun (bronkite), attivazzjoni jew aggravament ta' lupus erythematosus sistemiku (marda fejn is-sistema immuni tal-ġisem tattakka lill-ġisem, u tikkawża wġigħ fil-ġogi, raxx tal-ġilda u deni); uġigħ fil-griżmejn, sinuses infjammati, tħossok imdejjaq (dipressjoni), diffikultà biex torqod (insomnja), indeboliment fil-vista, diffikultà biex tieħu n-nifs, uġigħ addominali, stitikezza, gass żejjed (dispepsja), tħossok imdardar (rimettar), infjammazzjoni tal-istonku (gastrite), funzjoni anormali tal-fwied (hemm aktar ċans li pazjenti Ġappuniżi jkollhom dan l-effett sekondarju), ħmura tal-ġilda (eritema), reazzjonijiet allerġiċi bħal ħakk jew raxx, żieda fl-għaraq, ħorriqija (urtikarja), uġigħ fil-ġogi (artralġja) u uġigħ fl-estremitajiet, bugħawwieġ fil-muskoli, mard qisu influwenza, uġigħ, livelli baxxi ta' sodium, żieda fil-livelli tal-krejatinina, enzimi epatiċi jew creatine phosphokinase fid-demm.
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'.
Maltese: Kinzalkomb 40 mg/12.5 mg pilloli Pillola ħamra u bajda ta' 5.2 mm b'żewġ saffi, b'forma ovali, imnaqqxa bin-numru tal-kodiċi 'H4'.
English: 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.
Maltese: Reazzjonijiet avversi rrappurtati b'wieħed mill-komponenti individwali jistgħu jkunu reazzjonijiet avversi potenzjali b'Kinzalkomb, anki jekk mhux osservati fil-provi kliniċi b'dan il-prodott.
English: Anorexia, appetite decreased, electrolyte imbalance, hypercholesterolaemia, hyperglycaemia, hypovolaemia.
Maltese: Anoreksja, tnaqqis fl-aptit, żbilanċ fl-elettroliti, iperkolesterolemija, ipergliċemija, ipovolemija
English: In a typical study in patients with a mean creatinine clearance of 90 ml/min the elimination half-life of hydrochlorothiazide was increased.
Maltese: Fi studju tipiku f'pazjenti b'medja ta' tneħħija tal-krejatinina ta' 90 ml/min, il-half-life ta' l-eliminazzjoni ta' hydrochlorothiazide żdiedet.
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema), blistering and peeling of the top layer of skin (toxic epidermal necrolysis; these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Maltese: Sepsis* (ta' spiss imsejħa “avvelenament tad-demm”, hi infezzjoni severa b'rispons infjammatorju talġisem kollu), nefħa mgħaġġla tal-ġilda u l-mukuża (anġjoedema), jitilgħu l-infafet u s-saff ta' fuq talġilda jitqaxxar (nekrolisi epidermali tossika); dawn l-effetti sekondarji huma rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000) jew ta' frekwenza mhux magħrufa (nekrolisi epidermali tossika) iżda huma estremament serji u l-pazjenti għandhom jieqfu jieħdu l-mediċina u jaraw lit-tabib tagħhom immedjatament.
English: Eczema, drug eruption, toxic skin eruption Musculoskeletal, connective tissue and bone disorders Rare:
Maltese: Ekżema, eruzzjoni minħabba l-mediċina, eruzzjoni tossika talġilda Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Rari:
English: Triglycerides increased
Maltese: Żieda fit-triglycerides
English: 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.
Maltese: It-thiazides jistgħu jnaqqsu it-tneħħija ta' calcium ma' l-awrina u jikkawżaw żieda żgħira u intermittenti ta' calcium fis-serum fl-assenza ta' disturbi magħrufa tal-metaboliżmu tal-calcium.
English: An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in Kinzalkomb, minimal or no effects were reported.
Maltese: Żieda fil-livelli tal-kolesterol u tat-trigliċeridi kienet assoċjata ma' terapija dijuretika b'thiazide; madankollu, bid-doża ta' 12.5 mg li hemm f'Kinzalkomb, effetti minimi kienu rrappurtati, jew l-ebda effett.
English: Hypomagnesaemia
Maltese: Iperkalċemija
English: Hyperkalaemia Hypoglycaemia (in diabetic patients)
Maltese: Iperkalemija Ipogliċemija (f'pazjenti dijabetiċi)
English: Immune system disorders
Maltese: Disturbi fis-sistema endokrinarja
English: • Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6-12 hours.
Maltese: B'hydrochlorothiazide, bidu ta' dijuresi jseħħ fi żmien sagħtejn, u l-effett massimu jseħħ wara madwar 4 sigħat, waqt li l-azzjoni tippersisti għal madwar 6-12-il siegħa.
English: Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 80 mg ta' telmisartan u 25 mg ta' hydrochlorothiazide.
English: The use of Kinzalkomb in children and adolescents up to the age of 18 years is not recommended.
Maltese: L-użu ta' Kinzalkomb fit-tfal u fl-adolexxenti sa l-età ta' 18-il sena mhuwiex rakkomandat.
English: Side effects of unknown frequency (frequency cannot be estimated from the available data):
Maltese: Effetti sekondarji ta' frekwenza mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli):
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.
Maltese: Għadd baxx ta' plejtlits (tromboċitopenija), żieda f'ċerti ċelluli bojod tad-demm (eosinofilija), reazzjoni allerġika serja (eż. sensittività eċċessiva, reazzjoni anafilattika, raxx minħabba l-mediċina), livelli baxxi ta' zokkor fid-demm (f'pazjenti dijabetiċi), stonku mqalleb, ekżema (disturb fil-ġilda), artosi, infjammazzjoni tat-tendini, tnaqqis fl-emoglobina (proteina fid-demm), ngħas.
English: Cough Interstitial lung disease
Maltese: Mard interstizjali tal-pulmun
English: Renal excretion does not contribute to the clearance of telmisartan.
Maltese: L-eliminazzjoni renali ma tikkontribwixxix għat-tneħħija ta' telmisartan.
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)..
Maltese: - Mediċini li jistgħu jżidu l-livelli tal-potassium fid-demm bħal dijuretiċi li ma jipproduċux potassium, supplimenti tal-potassium, sostituti tal-melħ li jkun fihom il-potassium, inibituri ta' ACE, cyclosporin (mediċina immunosoppressanti) u prodotti mediċinali oħrajn bħal heparin sodium (antikoagulant).
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.
Maltese: Infjammazzjoni tal-glandola tal-bżieq, kanċer tal-ġilda u tax-xoffa (kanċer tal-ġilda mhux melanoma), tnaqqis fin-numru (jew anke nuqqas) ta' ċelluli fid-demm, li jinkludu għadd baxx taċ-ċelluli tad-demm ħomor u taċ-ċelluli tad-demm bojod, reazzjonijiet allerġiċi serji (eż. sensittività eċċessiva, reazzjoni anafilattika), tnaqqis jew telf tal-aptit, nuqqas ta' kwiet f'ġismek, sturdament, vista mċajpra jew tara kollox isfar, tnaqqis fil-vista u wġigħ fl-għajnejn (sinjali possibbli ta' mijopja akuta jew glawkoma ta' angolu magħluq), infjammazzjoni tal-vini jew arterji (vaskulite nekrotizzanti), frixa infjammata, stonku mqalleb, sfurija tal-ġilda jew ta' l-għajnejn (suffejra), sindrome qisu lupus (kundizzjoni li tixbah ħafna lil marda msejħa lupus erythematosus sistemiku fejn is-sistema immuni tal-ġisem tattakka lill-ġisem); disturbi tal-ġilda bħal vini jew arterji infjammati, żieda fis-sensittività għad-dawl taxxemx, raxx, ħmura tal-ġilda, infafet fix-xufftejn, għajnejn jew ħalq, tqaxxir tal-ġilda, deni (sinjali possibbli ta' eritema multiforme), dgħufija, infjammazzjoni tal-kliewi jew indeboliment fil-funzjoni tal-kliewi, glucose fl-awrina (glikosurija), deni, indeboliment fil-bilanċ tal-elettroliti, livelli għolja ta' kolesterol fid-demm, tnaqqis fil-volum tad-demm, żieda fil-livell tal-glucose fid-demm, diffikultajiet biex tikkontrolla l-livelli tal-glucose fid-demm/awrina f'pazjenti b'dijanjosi ta' dijabete mellitus, jew xaħam fid-demm.
English: The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin activity, increases aldosterone secretion, with consequent increases in urinary potassium and bicarbonate loss, and decreases in serum potassium.
Maltese: L-azzjoni dijuretika ta' hydrochlorothiazide tnaqqas il-volum tal-plażma, iżżid l-attività ta' renin fil-plażma, iżżid it-tnixxija ta' aldosterone, b'żidiet konsegwenti fit-tneħħija ta' potassium u bicarbonate fl-awrina, u tnaqqis ta' potassium fis-serum.
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Maltese: Trabi li ommijiethom ikunu ħadu antagonisti tar-riċetturi ta' angiotensin II, għandhom ikunu osservati mill-qrib għal pressjoni baxxa (ara sezzjonijiet 4.3 u 4.4).
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.
Maltese: Monitoraġġ perjodiku tal-livell tal-potassium fis-serum u ECG huma rakkomandati meta Kinzalkomb jingħata ma' prodotti mediċinali affettwati minn disturbi fil-livell tal-potassium fis-serum (eż. digitalis glycosides, u anti-arritimiċi) u mal-prodotti mediċinali li ġejjin li jinduċu torsades de pointes (li jinkludu xi anti-arritimici), bl-ipokalemija, li hi fattur li jippredisponi t-torsades de pointes.
English: Diarrhoea, dry mouth, flatulence Abdominal pain, constipation, dyspepsia, vomiting, gastritis
Maltese: Dijarea, ħalq xott, gass Uġigħ addominali, stitikezza, dispepsja, rimettar, gastrite
English: Slow heartbeat, dizziness, vomiting, reduced kidney function including kidney failure, have also been reported.
Maltese: Taħbit bil-mod tal-qalb, sturdament, rimettar, tnaqqis fil-funzjoni tal-kliewi li tinkludi insuffiċjenza tal-kliewi, ġew irrappurtati wkoll.
English: Cases of photosensitivity reactions have been reported with thiazide diuretics (see section 4.8).
Maltese: Każijiet ta' reazzjonijiet ta' sensittività għad-dawl kienu rrappurtati b'dijuretiċi ta' thiazide (ara sezzjoni 4.8).
English: Sialadenitis Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not known:
Maltese: Sialoadenitis Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Mhux magħrufa:
English: Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 40 mg ta' telmisartan u 12.5 mg ta' hydrochlorothiazide.
English: Thiazide-induced hypokalaemia or hypomagnesaemia favours the onset of digitalis-induced arrhythmia (see section 4.4).
Maltese: Il-monitoraġġ perjodiku tal-funzjoni renali hu rakkomandat (ara sezzjoni 4.4).
English: Telmisartan In patients taking telmisartan alone the following additional side effects have been reported:
Maltese: F'pazjenti li kienu qed jieħdu telmisartan waħdu, l-effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
English: - aliskiren.
Maltese: Sturdament.