FrancophonIA/ELRC3.0 huggingface dataset:
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 intolleranti għal ACE-1 fl-istudju TRANSCEND magħżula b'mod każwali li b'danakolllu kellhom kriterji ta' inklużjoni simili bħal ta' ONTARGET għal telmisartan 80 mg (n=2954) jew plaċebo (n=2972), li t-tnejn ingħataw flimkien mal-kura standard.
English: Excipients with known effect: Each tablet contains 74.9 mg sorbitol (E420) and 28.5 mg lactose.
Maltese: Kull pillola fiha 74.9 mg sorbitol (E420) u 28.5 mg lactose.
English: Excipients with known effect: Each tablet contains 149.8 mg sorbitol (E420) and 57 mg lactose.
Maltese: Kull pillola fiha 149.8 mg sorbitol (E420) u 57 mg lactose.
English: Hypotension 2, orthostatic hypotension
Maltese: 2, pressjoni ortostatika baxxa
English: Cardiovascular prevention
Maltese: Prevenzjoni Kardjovaskulari
English: ul.
Maltese: Kft.
English: Pharmacokinetic objectives included the determination of the steady-state of telmisartan in children and adolescents, and investigation of age-related differences.
Maltese: L-objettivi farmakokinetiċi kienu jinkludu d-determinazzjoni tal-istat fiss ta' telmisartan fit-tfal u adolexxenti, u investigazzjoni ta' differenzi relatati mal-età.
English: By inclusion the presence of secondary hypertension was not investigated.
Maltese: Bl-inklużjoni ilpreżenza ta' pressjoni għolja sekondarja ma ġietx investigata.
English: Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Maltese: Infezzjonijiet fl apparat urinarju, infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju (eż. uġigħ filgriżmejn, sinuses infjammati, riħ komuni), tnaqqis fin-numru ta' ċelluli ħomor tad-demm (anemija), livelli għolja ta' potassium, diffikultà biex torqod, tħossok imdejjaq/imdejqa (dipressjoni), ħass ħażin (sinkope), sensazzjoni li kollox qed idur bik (sturdament), taħbit tal-qalb bil-mod (bradikardija), pressjoni tad-demm baxxa (ipotensjoni) f'persuni kkurati għal pressjoni tad-demm għolja, sturdament meta wieħed iqum bilwieqfa (ipotensjoni ortostatika), qtugħ ta' nifs, sogħla, uġigħ ta' żaqq, dijarea, skonfort fiż-żaqq, nefħa fiż-żaqq, rimettar, ħakk, żieda fl-għaraq, raxx minħabba l-mediċina, uġigħ fiddahar, bugħawwieġ fil-muskoli, uġigħ fil-muskoli (majalġja), indeboliment fil-kliewi li jinkludi insuffiċjenza akuta tal-kliewi, uġigħ fis-sider, sensazzjoni ta' dgħufija, u żieda fil-livell ta' krejatinina fid-demm.
English: Tolura 40 mg tablets
Maltese: Tolura 40 mg pilloli
English: Tolura is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Tolura hu kontraindikat f'pazjenti b'indeboliment serju tal-fwied (ara sezzjoni 4.3).
English: Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion and in a risk of hypotension when initiating therapy with telmisartan.
Maltese: Trattament minn qabel b'dożi qawwija ta' dijuretiċi bħal furosemide (dijuretiku loop) u hydrochlorothiazide (dijuretiku tat-thiazide) jista' jirriżulta fi tnaqqis sostanzjali tal-volum, u f'riskju ta' pressjoni tad-demm baxxa ħafna meta tinbeda t-terapija b'telmisartan.
English: The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo (41.4 % vs 43.9 %) in controlled trials in patients treated for hypertension.
Maltese: L-inċidenza ta' reazzjonijiet avversi rrappurtati kienet ġeneralment komparabbli mal-plaċebo (41.4% vs 43.9%) fil-provi kkontrollati f'pazjenti kkurati għal pressjoni għolja.
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: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased
Maltese: Tnaqqis fl-emoglobina, aċidu uriku fid-demm ogħla, enzima epatika ogħla, creatine phosphokinase fid-demm ogħla
English: When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 6 % (40 mg dose) to approximately 19 % (160 mg dose).
Maltese: Meta telmisartan jittieħed mal-ikel, it-tnaqqis taż-żona taħt il-kurva tal-konċentrazzjoni tal-plażma-żmien (AUC0-∞) ta' telmisartan tvarja minn madwar 6 % (doża ta' 40 mg) sa madwar 19 % (doża ta' 160 mg).
English: Patients with rare hereditary problems of fructose intolerance should not take Tolura.
Maltese: Pazjenti li għandhom problemi ereditarji ta' intolleranza għal fructose m'għandhomx jieħdu Tolura.
English: The pharmacokinetics of two doses of telmisartan were assessed as a secondary objective in hypertensive patients (n = 57) aged 6 to < 18 years after taking telmisartan 1 mg/kg or 2 mg/kg over a four-week treatment period.
Maltese: Il-farmakokinetika ta' żewġ dożi ta' telmisartan ġiet evalwata bħala objettiv sekondarju f'pazjenti bi pressjoni tad-demm għolja (n = 57) li kellhom minn 6 sa < 18-il sena wara li ħadu telmisartan 1 mg/kg jew 2 mg/kg fuq perjodu ta' kura ta' erba' ġimgħat.
English: Tolura 20 mg tablets
Maltese: Tolura 20 mg pilloli
English: ** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.
Maltese: **Każijiet ta' ċikatriċi progressivi tat-tessut tal-pulmun ġew irrappurtati waqt it-teħid ta' telmisartan.
English: At the beginning of the preventive therapy with Tolura 80 mg, blood pressure should be frequently monitored.
Maltese: Fil-bidu tat-terapija preventiva b'Tolura 80 mg, il-pressjoni tad-demm għandha tiġi mmonitorata b'mod frekwenti.
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Maltese: Sepsis* (ta' spiss imsejħa “avvelenament tad-demm”, hi infezzjoni severa b'rispons infjammatorju mal-ġisem kollu li tista' twassal għal mewt), żieda f'ċerti ċelluli bojod tad-demm (eosinofilija), għadd baxx ta' plejtlits (tromboċitopenja), reazzjoni allerġika severa (reazzjoni anafilattika), reazzjoni allerġika (eż. raxx, ħakk, diffikultà biex tieħu n-nifs, tħarħir, nefħa tal-wiċċ jew pressjoni tad-demm baxxa), livelli baxxi ta' zokkor fid-demm (f'pazjenti dijabetiċi, tħossok ansjuż/a, ngħas, indeboliment fil-vista, rata mgħaġġla ta' taħbit tal-qalb (takikardija), ħalq xott, stonku mqalleb, disturb fit-togħma (tibdil fis-sens tat-togħma), funzjoni anormali tal-fwied (hemm aktar ċans li pazjenti Ġappuniżi jkollhom dawn l-effetti sekondarji), nefħa mgħaġġla tal-ġilda u tal-mukuża li tista wkoll twassal għal mewt (anġjoedema wkoll b'riżultat fatali), ekżema (disturb tal-ġilda), ħmura tal-ġilda, urtikarja (ħorriqija), raxx sever minħabba l-mediċina, uġigħ fil-gogi (artralġja), uġigħ fl-estremitajiet, uġigħ fit tendini, mard li jixbah l-influwenza, tnaqqis fl-emoglobina (proteina fid-demm), żieda fil-livelli taluric acid, żieda fl-enzimi epatiċi jew ta' creatine phosphokinase fid-demm.
English: Tolura tablets contain lactose.
Maltese: Tolura fihom lactose u sorbitol.
English: Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants.
Maltese: Barra minn hekk, pressjoni baxxa tad-demm tista' tiġi aggravata b'alkoħol, barbiturati, narkotiċi jew antidepressivi.
English: Tolura 80 mg tablets
Maltese: Tolura 80 mg pilloli
English: As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia (see section 4.4).
Maltese: Bħal fil-każ ta' prodotti mediċinali oħra li jaġixxu fuq is-sistema renin-angiotensin-aldsterone, telemisartan jista' jipprovoka iperkalemija (ara sezzjoni 4.4).
English: Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Maltese: Prodotti mediċinali jew klassi terapewtika ta' prodotti mediċinali li jistgħu jikkawżaw l-iperkalemija huma sostituti tal-melħ li fihom il-potassju, dijuretiċi li ma jneħħux potassju, inibituri ta' ACE, antagonisti tar-riċetturi ta' angiotensin II, mediċini mhux sterojdi kontra l-infjammazzjoni (li jinkludu inibituri COX-2 selettivi), eparina, immunosoppressur (cyclosporin jew tacrolimus), trimethoprim.
English: Non-steroidal anti-inflammatory medicinal products
Maltese: Prodotti mediċinali mhux sterojdi kontra l-infjammazzjoni
English: Tolura may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Tolura.
Maltese: Tolura jista' jintuża flimkien ma' dijuretiċi (“pilloli tal-ilma”) bħal hydrochlorothiazide, li ntwera li għandu effett addizzjonali li jnaqqas il-pressjoni tad-demm b'Tolura.
English: Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption
Maltese: Anġjoedema (ukoll b'riżultat fatali), ekżema, eritema, urtikarja, eruzzjoni minħabba l-mediċina, eruzzjoni tossika tal-ġilda
English: - Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Maltese: - Mediċini li jistgħu jżidu l-livelli ta' potassju fid-demm bħal sostituti għall-melħ li fihom il-potassju, dijuretiċi li jirristrinġu t-tnixxija ta' potassju (ċertu ‘pilloli tal-ilma'), impedituri ta' ACE, antagonisti riċettaturi ta' aniotensin II, NSAIDS (mediċini ta' kontra l-infjammazzjoni mhux sterojdi eż. aspirina jew ibuprofen), eparina, immunosoppressivi (eż. cyclosporin jew tacrolimus) u l-antibijotiku trimethoprim.
English: Bradycardia Tachycardia
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: The blood pressure lowering effects of two doses of telmisartan were assessed in 76 hypertensive, largely overweight patients aged 6 to < 18 years (body weight ≥ 20 kg and ≤ 120 kg, mean 74.6 kg), after taking telmisartan 1 mg/kg (n = 29 treated) or 2 mg/kg (n = 31 treated) over a four-week treatment period.
Maltese: L-effetti li jbaxxu l-pressjoni tad-demm taż-żewġ dożi ta' telmisartan ġew evalwati f'76 pazjenti bi pressjoni għolja, li fil-biċċa l-kbira tagħhom kellhom piż żejjed, li kellhom minn 6 sa < 18-il sena (piż tal-ġisem ta' ≥ 20 kg u ≤ 120 kg, medja ta' 74.6 kg), wara li ħadu telmisartan 1 mg/kg (n = 29 ikkurati) jew 2 mg/kg (n = 31 ikkurati) fuq perjodu ta' kura ta' erba' ġimgħat.
English: Cardiovascular prevention:
Maltese: Kategorija farmakoterapewtika:
English: Nervous system disorders Uncommon:
Maltese: Disturbi tas-sistema nervuża
English: United Kingdom Consilient Health (UK) Ltd. Tel: + 44(0)203 751 1888
Maltese: Tel: + 44(0)203 751 1888
English: Hypotension
Maltese: Anemija
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: L-użu ta' antagonisti għar-riċetturi ta' angiotensin II hu kontraindikat matul it-tieni u t-tielet trimestru tat-tqala (ara sezzjonijiet 4.3 u 4.4).
English: - Intercurrent events, in particular dehydratation, acute cardiac decompensation, metabolic acidosis, worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extend trauma).
Maltese: - Avvenimenti interkurrenti, b'mod partikulari d-deidrazzjoni, dikumpensazzjoni akuta kardijaka, aċidożi metabolika, funzjoni renali li tmur għall-agħar, kundizzjoni renali li tmur għall-agħar għal għarrieda (eż. mard infettiv), lisi ċellulari (eż. iskemija akuta fir-riġlejn jew fid-dirgħajn, rabdomijolosi, estensjoni tat-trawma).
English: Tolura 40 mg tablets telmisartan
Maltese: Tolura 40 mg pilloli telmisartan
English: Back pain (e.g. sciatica), muscle spasms, myalgia Arthralgia, pain in extremity, tendon pain (tendinitis like symptoms)
Maltese: Artralġja, uġigħ fl-estremitajiet, uġigħ fit-tendini (sintomi qishom tendinite)
English: Hepatic function abnormal/liver disorder
Maltese: Funzjoni tal-fwied mhux normali/disturbi fil-fwied
English: Metabolism and nutrition disorders Uncommon:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni
English: In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
Maltese: Fi studju wieħed l-għoti fl-istess ħin ta' telmisartan u ramipril wassal għal żieda ta' 2.5 darbiet fl-AUC0-24 u Cmax ta' ramipril u ramiprilat.
English: The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
Maltese: Ir-riskju jista' jikber f'każ ta' kombinazzjoni ta' trattament ma' prodotti mediċinali oħra li jistgħu jipprovokaw iperkalemija (sostituti tal-melħ li fihom il-potassju, dijuretiċi li jirristrinġu t-tnixxija tal-potassju, inibituri ta' ACE, antagonisti tar-riċetturi ta' angiotensin II, mediċini mhux sterojdi kontra l-infjammazzjoni (NSAIDs li jinkludu inibituri COX-2 selettivi), eparina, immunosoppressuri (cyclosporin jew tacrolimus), u trimethoprim).
English: This is confirmed by trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies.
Maltese: Dan hu kkonfermat mill-proporzjonijiet bejn il-livelli l-aktar baxxi imqabbla mal-ogħla livelli, li kienu aktar minn 80% b'mod konsistenti, osservati wara li ngħataw dożi ta' 40 u 80 mg ta' telmisartan fi provi kliniċi b'telmisartan ikkontrollati bi plaċebo.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan.
Maltese: Żidiet riversibbli fil-konċentrazzjonijiet tal-litju fis-serum u t-tossiċità kienu rrappurtati waqt l-għoti fl-istess ħin ta' litju ma' inibituri tal-enzimi li jikkonvertu angiotensin, u, ma' antagonisti ta' riċettaturi ta' angiotensin II li jinkludu telmisartan.
English: Other conditions with stimulation of the renin-angiotensin-aldosterone system
Maltese: Kundizzjonijiet oħrajn bl-istimulazzjoni tas-sistema renin-angiotensin-aldosterone
English: Hypertension Treatment of essential hypertension in adults.
Maltese: Is-sinifikat u r-rilevanza klinika mhumiex magħrufa.
English: In patients with mild to moderate hepatic impairment the posology should not exceed 40 mg once daily (see section 4.4).
Maltese: F'pazjenti b'indeboliment epatiku minn ħafif sa moderat, il-pożoloġija m'għandhiex taqbeż 40 mg darba kuljum (ara sezzjoni 4.4).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: The occurrence of hyperkalaemia depends on associated risk factors.
Maltese: Il-każijiet ta' iperkalemija jiddependu fuq fatturi marbuta mar-riskju.
English: In human, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase.
Maltese: Mediċina adattata kontra l-pressjoni għolja trid normalment tissostitwixxi Tolura qabel ilbidu ta' tqala.
English: Patients with renal impairment
Maltese: Indeboliment renali u trapjant renali
English: 40 mg: white to almost white, biconvex, oval tablets
Maltese: 40 mg: pilloli ovali ta' lewn bajdani għal kważi bajdani, mżaqqha fuq żewġ naħat
English: Tolura 80 mg tablets Telmisartan
Maltese: Tolura 80 mg pilloli telmisartan
English: Tolura 80 mg tablets telmisartan
Maltese: Tolura 80 mg pilloli Telmisartan
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.
Maltese: Hemm riskju ogħla ta' pressjoni baxxa severa u insuffiċjenza renali meta pazjenti bi stenosi bilaterali fl-arterja renali jew bi stenosi tal-arterja għal kilwa waħda li tkun taħdem, ikunu kkurati bi prodotti mediċinali li jaffettwaw is-sistema renin-angiotensin-aldosterone.
English: The listing also takes into account serious adverse reactions and adverse reactions leading to discontinuation reported in three clinical long-term studies including 21642 patients treated with telmisartan for the reduction of cardiovascular morbidity for up to six years.
Maltese: Il-lista tikkunsidra wkoll reazzjonijiet avversi serji u reazzjonijiet avversi li jwasslu għal twaqqif tal-mediċina rrappurtat fi tliet studji kliniċi fit-tul li kienu jinkludu 21,642 pazjent ikkurati b'telmisartan għat-tnaqqis ta' morbożità kardjovaskulari għal sa sitt snin.
English: 80 mg: white to almost white, biconvex, capsule shape tablets
Maltese: 80 mg: pilloli f'għamla ta' kapsula ta' lewn bajdani għal kważi bajdani, mżaqqha.
English: Tolura 20 mg tablets Telmisartan
Maltese: Tolura 20 mg pilloli Telmisartan
English: Tolura 20 mg tablets telmisartan
Maltese: Tolura 20 mg pilloli telmisartan
English: In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as telmisartan has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Maltese: F'pazjenti fejn it-ton vaskulari u l-funzjoni renali jiddependu b'mod predominanti mill-attività tas-sistema renin-angiotensin-aldosterone (eż. pazjenti b'insuffiċjenza konġestiva severa tal-qalb jew li għandhom mard prinċipali renali, li jinkludi stenosi tal-arterja renali), il-kura bi prodotti mediċinali oħrajn li jaffettwaw din is-sistema kienet assoċjata ma' pressjoni baxxa ħafna akuta, iperażotemija, oligurja, jew b'mod rari ma' insuffiċjenza renali akuta (ara sezzjoni 4.8).
English: CV mortality and all cause mortality were numerically higher with the combination.
Maltese: Il-mortalità kardjovaskulari u l-mortalità minn kwalunkwe kawża kienu numerikament ogħla bil-kombinazzjoni.
English: Hepato-biliary disorders Rare:
Maltese: Disturbi fil-fwied u fil-marrara Rari
English: Tolura is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile.
Maltese: Tolura m'għandhiex tingħata lil pazjenti b'kolestasi, b'disturbi ostruttivi tal-marrara jew li għandhom insuffiċjenza severa epatika (ara sezzjoni 4.3), għax telmisartan huwa eliminat fil-biċċa l-kbira tiegħu mal-bili.
English: No statistically significant difference in the incidence of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure) was found [15.7 % in the telmisartan and 17.0 % in the placebo groups with a hazard ratio of 0.92 (95 % CI 0.81 - 1.05, p = 0.22)].
Maltese: L-ebda differenza statistikament differenti fl-inċidenza tal-punt aħħari prinċipali kompost (mewt kardjovaskulari, infart mijokardjali mhux fatali, puplesija mhix fatali jew itteħid fl-isptar għal falliment tal-qalb konġestiva) ma nstabet [15.7 % fit-telmisartan u 17.0 % filgruppi tal-plaċebo u bi proporzjon ta' ħsara ta 0.
English: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting Dry mouth, stomach discomfort, dysgeusia
Maltese: Uġigħ ta' żaqq, dijarea, dispepsja, gass, remettar
English: Tolura belongs to a class of medicines known as angiotensin II receptor antagonists.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: The safety of long term treatment of telmisartan in children and adolescents was not evaluated.
Maltese: Is-sigurtà ta' kura fit-tul b'telmisartan fit-tfal u fl-adolexxenti ma ġietx evalwata.
English: Each tablet contains 40 mg telmisartan.
Maltese: Kull pillola ta' Tolura fiha 40 mg telmisartan.
English: 14 tablets: EU/1/10/632/008 28 tablets: EU/1/10/632/009 30 tablets: EU/1/10/632/010 56 tablets: EU/1/10/632/011 84 tablets: EU/1/10/632/012 90 tablets: EU/1/10/632/013 98 tablets: EU/1/10/632/014 100 tablets: EU/1/10/632/023
Maltese: EU/1/10/632/013 98 pillola:
English: 14 tablets: EU/1/10/632/001 28 tablets: EU/1/10/632/002 30 tablets: EU/1/10/632/003 56 tablets: EU/1/10/632/004 84 tablets: EU/1/10/632/005 90 tablets: EU/1/10/632/006 98 tablets: EU/1/10/632/007 100 tablets: EU/1/10/632/022
Maltese: EU/1/10/632/001 28 pillola:
English: Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss.
Maltese: Telmisartan għandu jinżamm fil-folja ssiġillata minħabba l-karatteristika igroskopika tal-pilloli.
English: 14 tablets: EU/1/10/632/015 28 tablets: EU/1/10/632/016 30 tablets: EU/1/10/632/017 56 tablets: EU/1/10/632/018 84 tablets: EU/1/10/632/019 90 tablets: EU/1/10/632/020 98 tablets: EU/1/10/632/021 100 tablets: EU/1/10/632/024
Maltese: EU/1/10/632/020 98 pillola:
English: Renovascular hypertension
Maltese: GĦAMLA KWALITATTIVA
English: The safety and efficacy of Tolura in children and adolescents aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Tolura fi tfal u adolexxenti li għandhom inqas minn 18-il sena ma ġewx determinati s'issa.
English: Hyperkalaemia Hypoglycaemia (in diabetic patients)
Maltese: Ipogliċemija (f'pazjenti dijabetiċi)
English: (It is also better to avoid Tolura in early pregnancy see pregnancy section.)
Maltese: Tolura” u “Twissijiet u prekawzjonijiet”).