FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 April 2002
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 ta' April 2002
English: Kinzalkomb is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Maltese: Kinzalkomb hu taħlita ta' antagonist tar-riċetturi ta' angiotensin II, telmisartan, u dijuretiku thiazide, hydrochlorothiazide.
English: Pharmacotherapeutic group: Angiotensin II antagonists and diuretics, ATC code: C09DA07
Maltese: Antagonisti ta' angiotensin II u dijuretiċi, Kodiċi ATC:
English: Respiratory distress (including pneumonitis and pulmonary oedema)
Maltese: Dispneja Problemi respiratorji (li jinkludu pnewmonite u edima pulmonari)
English: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Maltese: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) qabblet l-effetti ta' telmisartan, ramipril u l-kombinazzjoni ta' telmisartan u ramipril fuq riżultati kardjovaskulari f'25620 pazjent ta' età minn 55 sena jew aktar bi storja medika ta' mard tal-arterji koronarji, puplesija, TIA, mard fl-arterji periferali, jew dijabete mellitus ta' tip 2 flimkien ma' evidenza ta' ħsara fl-organi aħħarin (eż. retinopatija, ipertrofija ventrikulari tax-xellug, makro jew mikroalbuminurija), li hi popolazzjoni f'riskju ta' avvenimenti kardjovaskulari.
English: The terminal elimination half-life of hydrochlorothiazide is 10 - 15 hours.
Maltese: Il-half-life ta' l-eliminazzjoni terminali ta' hydrochlorothiazide hi ta' 10 - 15-il siegħa.
English: Cholestyramine and colestipol, medicines for lowering blood fat levels.
Maltese: - Cholestyramine u colestipol, mediċini biex ibaxxu l-livelli tax-xaħam fid-demm.
English: The effect of Kinzalkomb may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen).
Maltese: L-effetti ta' Kinzalkomb jistgħu jitnaqqsu meta tieħu NSAIDs (non steroidal anti-inflammatory drugs, eż. aspirina jew ibuprofen).
English: This is not considered to be of clinical relevance.
Maltese: Din ma kinitx ikkunsidrata li għandha rilevanza klinika.
English: Kinzalkomb 80 mg/12.5 mg tablets
Maltese: Kinzalkomb 80 mg/12.5 mg pilloli
English: - Hypokalaemia
Maltese: - Ipokalemija
English: Infections and infestations Rare:
Maltese: Infezzjonijiet u infestazzjonijiet Rari:
English: - Gout.
Maltese: - Gotta.
English: INFORMATION IN BRAILLE Kinzalkomb 40 mg/12.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Kinzalkomb 40 mg/12.5 mg
English: • Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product).
Maltese: • Sensittività eċċessiva għal sustanzi oħrajn derivati minn sulphonamides (għax hydrochlorothiazide hu prodott mediċinali derivat minn sulphonamide).
English: Kinzalkomb contains milk sugar (lactose) and sorbitol.
Maltese: Kinzalkomb fih zokkor tal-ħalib (lactose) u sorbitol.
English: Thiazides may increase the risk of adverse effects caused by amantadine.
Maltese: It-thiazides jistgħu jżidu r-riskju ta' effetti avversi ikkawżati minn amantadine.
English: Nervous system disorders Rare:
Maltese: Disturbi fis-sistema nervuża Rari:
English: Elderly Pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Maltese: Il-farmakokinetika ta' telmisartan mhumiex differenti bejn pazjenti anzjani u dawk li għandhom inqas minn 65 sena.
English: SN: {number} {serial number}
Maltese: {numru} [numru tas-serje]
English: Each 40 mg/12.5 mg tablet contains 112 mg of lactose monohydrate and 169 mg sorbitol (E420).
Maltese: Kull pillola ta' 40 mg/12.5 mg fiha 112 mg ta' lactose monohydrate u 169 mg ta' sorbitol (E420).
English: 1: Based on post-marketing experience 2: For further description, please see sub-section “Description of selected adverse reactions”
Maltese: 1: Ibbażat fuq esperjenza ta' wara t-tqegħid fis-suq 2: Għal deskrizzjoni addizzjonali, jekk jogħġbok ara sottosezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula”
English: Epidemiological studies have shown that long-term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
Maltese: Studji epidemjoloġiċi wrew li kura fit-tul b'hydrochlorothiazide tnaqqas ir-riskju ta' mortalità u lmorbożità kardjovaskulari.
English: Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs.
Maltese: Filwaqt li m'hemm l-ebda dejta epidemjoloġika kkontrollata dwar ir-riskju b'antagonisti tarriċetturi ta' angiotensin II, riskji simili jistgħu jkunu jeżistu għal din il-klassi ta' mediċini.
English: Kinzalkomb must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Maltese: Kinzalkomb ma jistax jintuża f'pazjenti b'indeboliment renali sever (rata ta' tneħħija tal-krejatinina ta' < 30 ml/min) (ara sezzjoni 4.3).
English: Medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid and derivatives)
Maltese: Prodotti mediċinali marbuta ma' telf tal-potassium u ipokalemija (eż. dijuretiċi kaliuretiċi oħrajn, lassattivi, kortikosterojdi, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid u derivattivi tiegħu)
English: The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan.
Maltese: L-isoenzimi ta' ċitokrom P450 mhumiex involuti filmetaboliżmu ta' telmisartan.
English: cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol) - others (e.g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
Maltese: haloperidol, droperidol) - oħrajn (eż. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
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.
Maltese: Il-pazjenti ntgħażlu b'mod każwali għal wieħed mit-tliet gruppi ta' kura li ġejjin: telmisartan 80 mg (n=8542), ramipril 10 mg (n=8576), jew il-kombinazzjoni ta' telmisartan 80 mg flimkien ma' ramipril 10 mg (n=8502), u segwit għal żmien medju ta' osservazzjoni ta' 4.5 snin.
English: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Maltese: Dejta mill-provi kliniċi wriet li imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS) permezz tal-użu kombinat ta' inibituri ta' ACE, imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren hu assoċjat ma' frekwenza ogħla ta' avvenimenti avversi bħal pressjoni baxxa, iperkalemija u tnaqqis fil-funzjoni tal-kliewi (li jinkludi insuffiċjenza akuta tal-kliewi) meta mqabbla mal-użu ta' mediċina waħda li taġixxi fuq RAAS (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: The overall incidence of adverse reactions reported with telmisartan (41.4 %) was usually comparable to placebo (43.9 %) in placebo controlled trials.
Maltese: L-inċidenza totali ta' reazzjonijiet avversi rrappurtati b'telmisartan (41.4%) kienet ġeneralment komparabbli mal-plaċebo (43.9%) fil-provi li saru li kienu kkontrollati bil-plaċebo.
English: Vasculitis necrotizing
Maltese: Vaskulite nekrotizzanti
English: Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis,
Maltese: Anemija aplastika, anemija emolitika, insuffiċjenza filfunzjoni tal-mudullun, lewkopenija, newtropenija, agranuloċitosi
English: For the foetotoxic potential of the telmisartan/hydrochlorothiazide combination see section 4.6.
Maltese: Għall-potenzjal fetotossiku tat-taħlita ta' telmisartan/hydrochlorothiazide, ara sezzjoni 4.6.
English: Each 80 mg/12.5 mg tablet contains 112 mg of lactose monohydrate and 338 mg sorbitol (E420).
Maltese: Kull pillola ta' 80 mg/12.5 mg fiha 112 mg ta' lactose monohydrate u 338 mg ta' sorbitol (E420).
English: This medicinal product contains lactose monohydrate and sorbitol.
Maltese: Dan il-prodott mediċinali fih lactose monohydrate u sorbitol.
English: Each tablet contains 99 mg of lactose monohydrate and 338 mg sorbitol (E420).
Maltese: Kull pillola fiha 99 mg ta' lactose monohydrate u 338 mg ta' sorbitol (E420).
English: Hypersensitivity, anaphylactic reactions Metabolism and nutrition disorders Uncommon: Rare:
Maltese: Sensittività eċċessiva, reazzjonijiet anafilattiċi Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni: Rari:
English: TRANSCEND randomized ACE-I intolerant patients with otherwise similar inclusion criteria as ONTARGET to telmisartan 80 mg (n=2954) or placebo (n=2972), both given on top of standard care.
Maltese: Pazjenti tat-TRANSCEND intolleranti għal ACE-I, magħżula b'mod każwali, bi kriterji ta' inklużjoni li kienu simili bħal dawk ta' ONTARGET għal telmisartan 80 mg (n = 2954) jew plaċebo (n = 2972), it-tnejn mogħtija flimkien mal-kura standard.
English: 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).
Maltese: Fi prova klinika kkontrollata double blind (n=687 pazjenti evalwati għall-effikaċja) f'dawk li ma rrispondewx għat-taħlita ta' 80 mg/12.5 mg, intwera effett inkrementali li jnaqqas il-pressjoni taddemm tat-taħlita ta' 80 mg/25 mg meta mqabbel mal-kura li tkompliet bit-taħlita ta' 80 mg/12.5 mg, ta' 2.7/1.6 mm Hg (SBP/DBP) (differenza fil-medja tat-tibdiliet aġġustati mil-linja bażi).
English: Exacerbation or activation of systemic lupus erythematosus Metabolism and nutrition disorders Uncommon: Rare:
Maltese: Aggravament jew attivazzjoni ta' lupus erythematosus sistemiku Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni: Rari:
English: 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).
Maltese: L-inċidenza totali ta' reazzjonijiet avversi rrappurtati b'Kinzalkomb kienet komparabbli ma' dawk irrappurtati b'telmisartan waħdu fi provi kkontrollati u randomised li saru fuq 1471 pazjent li kienu randomised biex jirċievu telmisartan flimkien ma' hydrochlorothiazide (835) jew telmisartan biss (636).
English: Thrombocytopenia (sometimes with purpura)
Maltese: Tromboċitopenija (xi kultant b'purpura)
English: Hypochloraemic alkalosis
Maltese: Alkalożi ipokloremika
English: Very rare side effects (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease) **
Maltese: Ċikatriċi progressivi ta' tessut tal-pulmun (mard interstizjali tal-pulmun)**
English: Kinzalkomb with food and alcohol
Maltese: Kinzalkomb ma' ikel u alkoħol
English: The concomitant use of Kinzalkomb with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Maltese: L-użu fl-istess ħin ta' Kinzalkomb flimkien ma' prodotti li fihom aliskiren huwa kontraindikat f'pazjenti b'dijabete mellitus jew b'indeboliment tal-kliewi (GFR < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).
English: The antihypertensive efficacy of telmisartan is comparable to that of agents representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril).
Maltese: L-effikaċja anti-ipertensiva ta' telmisartan hi komparabbli ma' dik ta' mediċini li jirrappreżentaw kategoriji oħrajn ta' prodotti mediċinali kontra l-pressjoni għolja (dan intwera fi provi kliniċi li qabblu telmisartan ma' amlodipine, atenolol, enalapril, hydrochlorothiazide, u lisinopril).
English: Co-administration of lithium and Kinzalkomb is not recommended (see section 4.4).
Maltese: lithium u Kinzalkomb mhuwiex rakkomandat (ara sezzjoni 4.4).
English: See also information under the heading “Do not take Kinzalkomb”.
Maltese: Ara wkoll l-informazzjoni taħt t-titlu “Tiħux Kinzalkomb”.
English: 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.
Maltese: Studju ieħor wera assoċjazzjoni possibbli bejn il-kanċer tax-xoffa (SCC) u l-esponiment għal HCTZ: 633 każ ta' kanċer tax-xoffa tqabblu ma' 63,067 kontroll tal-popolazzjoni, bl-użu ta' strateġija ta' teħid ta' kampjuni b'riskju ssettjat.
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.
Maltese: F'analiżi pooled ta' provi kliniċi, ikkontrollati bil-plaċebo u double-blind vs. valsartan/hydrochlorothiazide 160 mg/25 mg (n=2121 pazjenti evalwati għall-effikaċja), intwera effett li jbaxxi l-pressjoni tad-demma li kien akbar b'mod sinifikanti, ta' 2.2/1.2 mm Hg (SBP/DBP) (differenza fil-medja tat-tibdiliet aġġustati mil-linja bażi) favur it-taħlita ta' telmisartan/hydrochlorothiazide 80 mg/25 mg.
English: Kinzalkomb fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide and 80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
Maltese: It-taħlita fissa tad-doża ta' Kinzalkomb (40 mg telmisartan/12.5 mg ta' hydrochlorothiazide u 80 mg telmisartan/12.5 mg hydrochlorothiazide) hi indikata għal adulti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata sew b'telmisartan waħdu.
English: Investigations Uncommon: Rare:
Maltese: Investigazzjonijiet Mhux komuni: Rari:
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).
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, yellow iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420).
English: In functionally anephric patients the elimination half-life is about 34 hours.
Maltese: F'pazjenti li huma funzjonalment aneferiċi, il-half-life ta' l-eliminazzjoni hi ta' madwar 34 siegħa.
English: Tachycardia, arrhythmias
Maltese: Takikardija, arritmiji
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.
Maltese: - Mediċini li fihom il-lithium għall-kura ta' xi tipi ta' dipressjoni - Mediċini marbuta ma' livell baxx ta' potassium fid-demm (ipokalemija) bħal dijuretiċi oħrajn, ('pilloli tal-awrina'), lassattivi (eż. castor oil), kortikosterojdi (eż. prednisone), ACTH (ormon), amphotericin (mediċina antifungali), carbenoxolone (jintuża għall-kura ta' ulċeri tal-ħalq), penicillin G sodium (antibijotiku), u salicylic acid u derivattivi tiegħu.
English: Hydrochlorothiazide is not metabolised in man.
Maltese: Hydrochlorothiazide ma jiġix metabolizzat fil-bniedem.
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).
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420).
English: Therefore, it is not expected to potentiate bradykininmediated adverse effects.
Maltese: Għalhekk mhux mistenni li jsaħħaħ l-effetti avversi medjati minn bradykinin.
English: Telmisartan showed no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Maltese: Telmisartan ma wera l-ebda evidenza ta' mutaġeniċità u ta' attività klastoġenika rilevanti fi studji in vitro, u l-ebda evidenza ta' karċinoġeneċità fil-firien u fil-ġrieden.
English: C-labelled telmisartan most of the administered dose (>97 %) was eliminated in faeces via biliary excretion.
Maltese: C, il-biċċa l-kbira tad-doża li tingħata (>97 %) kienet eliminata fl-ippurgar permezz ta' tneħħija biljari.
English: Uncommon: Rare:
Maltese: Rari ħafna:
English: Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Maltese: Telmisartan ma jinibixxix lenzima li tibdel angiotensin (kininase II), l-enzima li tiddegrada wkoll bradykinin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/214/011-015
Maltese: EU/1/02/214/001-005
English: Kinzalkomb 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Maltese: Kinzalkomb 40 mg/12.5 mg pilloli telmisartan/hydrochlorothiazide
English: Do not take Kinzalkomb
Maltese: Tiħux Kinzalkomb
English: These medicinal products may potentiate the effect of hydrochlorothiazide on serum potassium (see section 4.4).
Maltese: Dawn il-prodotti mediċinali jistgħu jżidu l-effett ta' hydrochlorothiazide fuq is-serum potassium (ara sezzjoni 4.4).
English: Avoid taking alcohol until you have talked to your doctor.
Maltese: Evita li tieħu l-alkoħol sakemm tkun kellimt lit-tabib tiegħek.
English: Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (including hypokalaemia, hyponatraemia and hypochloraemic alkalosis).
Maltese: It-thiazides, inkluż hydrochlorothiazide, jistgħu jikkawżaw żbilanċ fil-fluwidu jew żbilanċ fl-elettroliti (li jinkludi ipokalemija, iponatremija u alkalosi ipokloremika).
English: 2: For further description, please see sub-section”Description of selected adverse reactions” Additional information on individual components
Maltese: 3: Għal deskrizzjoni addizzjonali, jekk jogħġbok ara sottosezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula”
English: - Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease where the body's immune system attacks the body.
Maltese: - Lupus erythematosus sistemiku (imsejjaħ ukoll “lupus” jew “SLE”) marda fejn is-sistema immuni tal-ġisem tattakka lill-ġisem.
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,
Maltese: III (eż. amiodarone, sotalol, dofetilide, ibutilide) - xi tipi ta' mediċini anti-psikotiċi: (eż. thioridazine, chlorpromazine, levomepromazine,
English: In a follow-up trial with the 80 mg/25 mg combination, blood pressure was further decreased (resulting in an overall reduction of 11.5/9.9 mm Hg (SBP/DBP).
Maltese: Fi prova follow-up bit-taħlita 80 mg/25 mg, il-pressjoni tad-demm tnaqqset b'mod ulterjuri (u rriżultat fi tnaqqis totali ta' 11.5/9.9 mm Hg (SBP/DBP)).
English: Kinzalkomb is available in blister packs containing 14, 28, 56, or 98 tablets, or unit dose blister packs containing 28 x 1 tablets
Maltese: Kinzalkomb hu disponibbli f'pakketti tal-folji li fihom 14, 28, 56, 90 jew 98 pillola, jew pakketti talfolji bid-doża ta' l-unità li fihom 28 x 1 pillola.
English: Kinzalkomb 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Maltese: Kinzalkomb 80 mg/25 mg pilloli telmisartan/hydrochlorothiazide
English: Somnolence Respiratory, thoracic and mediastinal disorders Uncommon: Very rare:
Maltese: Ngħas Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni: Rari ħafna:
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
Maltese: EU/1/02/214/011 14-il pillola EU/1/02/214/012 28 pillola EU/1/02/214/013 28 x 1 pillola
English: INFORMATION IN BRAILLE Kinzalkomb 80 mg/25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Kinzalkomb 80 mg/25 mg pilloli
English: Yellow and white oval shaped tablet of 6.2 mm engraved with the code 'H9'.
Maltese: Pillola safra u bajda ta' 6.2 mm, b'forma ovali, imnaqqxa bil-kodiċi 'H9'.
English: Rare cases have also been reported with angiotensin II receptor antagonists (including Kinzalkomb).
Maltese: Każijiet rari kienu irrappurtati wkoll b'antagonisti ta' riċetturi ta' angiotensin II (li jinkludu Kinzalkomb).
English: Kinzalkomb 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Maltese: Kinzalkomb 80 mg/12.5 mg pilloli telmisartan/hydrochlorothiazide
English: Patients with rare hereditary problems of fructose intolerance and/or with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi rari ereditarji ta' intolleranza għal fructose u/jew bi problemi rari ereditarji ta' intolleranza għal galactose, bid defiċjenza ta' Lapp lactase jew b'assorbiment ħażin ta' glucose-galactose, m'għandhomx jieħdu din ilmediċina.
English: - Hyperkalaemia
Maltese: - Iperkalċemija
English: Hypokalaemia Hyperuricaemia, hyponatraemia
Maltese: Ipokalemija Iperurikemija, ipernatremija
English: Pack sizes: - Blister with 14, 28, 56, or 98 tablets or - Perforated unit dose blisters with 28 x 1 tablets.
Maltese: - Folja b'14, 28, 56, jew 98 pillola jew - Folji perforati bid-doża ta' l-unità bi 28 x 1 pillola.
English: The pharmacokinetics of orally administered telmisartan are non-linear over doses from 20 - 160 mg with greater than proportional increases of plasma concentrations (Cmax and AUC) with increasing doses.
Maltese: Il-farmakokinetika ta' telmisartan mogħti mill-ħalq mhux lineari tul dożi minn 20 - 160 mg b'żidiet aktar milli proporzjonali tal-konċentrazzjonijiet fil-plażma (Cmax u AUC) b'żidiet fid-dożi.
English: • Cholestasis and biliary obstructive disorders.
Maltese: • Kolestasi u mard ostruttiv tal-marrara.
English: Telmisartan is metabolised by conjugation to form a pharmacologically inactive acylglucuronide.
Maltese: Telmisartan hu metabolizzat permezz ta' konjugazzjoni li tifforma acylglucuronide, li hu farmakoloġikament inattiv.
English: Hydrochlorothiazide In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Maltese: F'pazjenti li kienu qed jieħdu hydrochlorothiazide waħdu, l-effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
English: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 80 mg/25 mg tablets
Maltese: Kinzalkomb 80 mg/25 mg pilloli