FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall incidence of adverse reactions reported with Tolucombi 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' avvenimenti avversi rrappurtati b'Tolucombi 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: 56 x 1 tablet
Maltese: 56 x 1 pillola
English: Each 40 mg/12.5 mg tablet contains 57 mg of lactose (as monohydrate) and 147.04 mg sorbitol (E420).
Maltese: Kull pillola ta' 40 mg/12.5 mg fiha 57 mg ta' lactose (bħala monohydrate) u 147.04 mg ta' sorbitol (E420).
English: 84 x 1 tablet
Maltese: 84 x 1 pillola
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 mmHg (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 tad-demm 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 mmHg (SBP/DBP) (differenza fil-medja tat-tibdiliet aġġustati mil-linja bażi).
English: - If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Tolucombi” and “Warnings and precautions”).
Maltese: - Jekk qed tieħu inibitur ta' ACE jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux Tolucombi” u “Twissijiet u prekawzjonijiet”).
English: Each 80 mg/12.5 mg tablet contains 114 mg of lactose (as monohydrate) and 294.08 mg sorbitol (E420).
Maltese: Kull pillola ta' 80 mg/12.5 mg fiha 114 mg ta' lactose (bħala monohydrate) u 294.08 mg ta' sorbitol (E420).
English: Blister (OPA/Al/PE foil with desiccant//Al foil): 14 x 1 tablet
Maltese: Folja (fojl tal-OPA/Al/PE b'dessikant//fojl tal-Al) 14 x 1 pillola
English: Tolucombi must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Maltese: Tolucombi ma jridx jintuża f'pazjenti b'indeboliment renali sever (rata ta' tneħħija tal-kreatinina ta' < 30 ml/min) (ara sezzjoni 4.3).
English: Blisters (OPA/Al/PE foil with desiccant//Al foil): 14 x 1 and 98 x 1 tablet in a box.
Maltese: Folji (fojl tal-OPA/Al/PE b'dessikant//fojl tal-Al): 14 x 1 u 98 x 1 pillola f'kaxxa.
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: Tolucombi with food and alcohol
Maltese: Tolucombi ma' ikel u alkoħol
English: Therefore, it is not expected to potentiate bradykinin-mediated adverse effects.
Maltese: Għalhekk mhux mistenni li jsaħħaħ l-effetti avversi medjati minn bradykinin.
English: Tolucombi 40 mg/12.5 mg tablets Tolucombi 80 mg/12.5 mg tablets
Maltese: Tolucombi 40 mg/12.5 mg pilloli Tolucombi 80 mg/12.5 mg pilloli
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 alkalożi ipokloremika).
English: Tolucombi 80 mg/25 mg tablets
Maltese: Tolucombi 80 mg/25 mg pilloli
English: Cholestyramine and colestipol resins Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Maltese: Cholestyramine u colestipol resins L-assorbiment ta' hydrochlorothiazide hu indebolit fil-preżenza ta' reżini tal-iskambju enajoniċi.
English: Coadministration of lithium and Tolucombi is not recommended (see section 4.4).
Maltese: L-għoti flimkien ta' lithium u Tolucombi mhuwiex rakkomandat (ara sezzjoni 4.4).
English: Tolucombi 40 mg/12.5 mg tablets Tolucombi 80 mg/12.5 mg tablets Tolucombi 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Maltese: Tolucombi 40 mg/12.5 mg pilloli Tolucombi 80 mg/12.5 mg pilloli Tolucombi 80 mg/25 mg pilloli telmisartan/hydrochlorothiazide
English: 98 x 1 tablet
Maltese: 98 x 1 pillola
English: Tolucombi 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Maltese: Tolucombi 80 mg/25 mg pilloli telmisartan/hydrochlorothiazide
English: Endocrine disorders Not known: Diabetes mellitus inadequate control
Maltese: Kontroll inadegwat ta' dijabete mellitus
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: 90 x 1 tablet
Maltese: 90 x 1 pillola
English: Skin and subcutaneous tissue disorders Not known: Lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis, erythema multiforme
Maltese: Sindrome qisu tal-lupus, reazzjonijiet ta' sensittività għaddawl, vaskulite fil-ġilda, nekrolisi epidermali tossika, eritema multiforme
English: ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporine or other medicinal products such as heparin sodium).
Maltese: ACE, dijuretiċi potassium-sparing, supplimenti tal-potassium, sostituti tal-melħ li fihom il-potassium, cyclosporin jew prodotti mediċinali oħrajn, bħal heparin sodium).
English: Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea Rare:
Maltese: Ngħas Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni: Rari ħafna:
English: 28 x 1 tablet
Maltese: 28 x 1 pillola
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 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 flgħajnejn (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 tal-għajnejn (suffejra), sindrome qisu lupus (kundizzjoni li tixbah ħafna lil marda msejħa lupus erythematosus sistemiku fejn is-sistema immuni tal-ġisem tattakka lillġisem); disturbi tal-ġilda bħal vini jew arterji infjammati, żieda fis-sensittività għad-dawl tax-xemx, 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-livelli 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 use of HCTZ may also need to be reconsidered in patients who have experienced previous NMSC (see also section 4.8).
Maltese: HCTZ jista' jkun li jrid jerġa' jiġi kkunsidrat f'pazjenti li esperjenzaw NMSC qabel (ara wkoll sezzjoni 4.8).
English: 30 x 1 tablet
Maltese: 30 x 1 pillola
English: Tolucombi 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Maltese: Tolucombi 40 mg/12.5 mg pilloli telmisartan/hydrochlorothiazide
English: o.o.
Maltese: A.
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-kreatinina, enzimi epatiċi jew creatine phosphokinase fid-demm.
English: ** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.
Maltese: ** Każijiet ta' ġrieħi progressivi ta' tessut tal-pulmun ġew rapportati waqt it-teħid ta' telmisartan.
English: Tolucombi 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' Tolucombi (40 mg telmisartan/12.5 mg ta' hydrochlorothiazide u 80 mg telmisartan/12.5 mg hydrochlorothiazide) hi indikata għal pazjenti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata sew b'telmisartan waħdu.
English: The terminal elimination half-life of hydrochlorothiazide is 10 - 15 hours.
Maltese: Il-half-life tal-eliminazzjoni terminali ta' hydrochlorothiazide hi ta' 10 - 15il siegħa.
English: Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for Tolucombi.
Maltese: Ġiet osservata żieda flinċidenza b'telmisartan biss, biss din ma tistax tiġi eskluża għal Tolucombi.
English: 60 x 1 tablet
Maltese: 60 x 1 pillola
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-kreatinina ta' 3060 ml/min, medja ta' madwar 50 ml/min), l-ebda aġġustament fid-dożaġġ mhu meħtieġ f'pazjenti b'funzjoni renali mnaqqsa.
English: - Medicines to increase blood pressure, such as noradrenaline.
Maltese: - Mediċini biex iżidu l-pressjoni tad-demm, bħal noradrenaline.
English: The concomitant use of Tolucombi 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' Tolucombi ma' prodotti li jkun fihom aliskiren hu kontraindikat f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (GFR < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u
English: Tolucombi 80 mg/12.5 mg and Tolucombi 80 mg/25 mg contain 294.08 mg sorbitol in each tablet, which is equivalent to 5 mg/kg/day, if the body weight is 58.8 kg.
Maltese: Tolucombi 80 mg/12.5 mg u Tolucombi 80 mg/25 mg fihom 294.08 mg sorbitol f'kull pillola, li hu ekwivalenti għal 5 mg/kg/jum jekk il-piż tal-ġisem ikun 58.8 kg.
English: In functionally anephric patients the elimination half-life is about 34 hours.
Maltese: F'pazjenti li huma funzjonalment aneferiċi, il-half-life tal-eliminazzjoni hi ta' madwar 34 siegħa.
English: 100 x 1 tablet
Maltese: 100 x 1 pillola
English: Excipient(s) with known effect: Each tablet contains 114 mg of lactose (as monohydrate) and 294.08 mg sorbitol (E420).
Maltese: Kull pillola fiha 114 mg ta' lactose (bħala monohydrate) u 294.08 mg ta' sorbitol (E420).
English: Hyperuricaemia, hyponatraemia
Maltese: Ipokalemija, Iperurikemija, iponatremija
English: Tolucombi 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Maltese: Tolucombi 80 mg/12.5 mg pilloli telmisartan/hydrochlorothiazide
English: Tolucombi 80 mg/12.5 mg tablets
Maltese: Tolucombi 80 mg/12.5 mg pilloli
English: 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).
Maltese: Studju ieħor wera assoċjazzjoni possibbli bejn il-kanċer tax-xoffa (SCC) u lesponiment għal HCTZ: 633 każ ta' kanċer tax-xoffa tqabblu ma' 63,067 kontroll tal-popolazzjoni, blużu ta' strateġija ta' teħid ta' kampjuni b'riskju ssettjat Intweriet relazzjoni għar-rispons tad-doża kumulattiva b'OR aġġustata ta' 2.1 (95 % CI: 1.7-2.6) li tiżdied għal OR 3.9 (3.0-4.9) għal użu kbir (~25,000 mg) u OR 7.7 (5.7-10.5) għall-ogħla doża kumulattiva (~100,000 mg) (ara wkoll issezzjoni 4.4).
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: EU/1/13/821/001 EU/1/13/821/002 EU/1/13/821/003 EU/1/13/821/004 EU/1/13/821/005 EU/1/13/821/006 EU/1/13/821/007 EU/1/13/821/008 EU/1/13/821/009 EU/1/13/821/010 EU/1/13/821/031
Maltese: EU/1/13/821/005 EU/1/13/821/006 EU/1/13/821/007 EU/1/13/821/008 EU/1/13/821/009 EU/1/13/821/010 EU/1/13/821/031
English: There is no clinical experience with Tolucombi in patients with hepatic impairment.
Maltese: M'hemm l-ebda esperjenza klinika b'Tolucombi f'pazjenti b'indeboliment epatiku.
English: EU/1/13/821/011 EU/1/13/821/012 EU/1/13/821/013 EU/1/13/821/014 EU/1/13/821/015 EU/1/13/821/016 EU/1/13/821/017 EU/1/13/821/018 EU/1/13/821/019 EU/1/13/821/020 EU/1/13/821/032
Maltese: EU/1/13/821/015 EU/1/13/821/016 EU/1/13/821/017 EU/1/13/821/018 EU/1/13/821/019 EU/1/13/821/020 EU/1/13/821/032
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 mmHg (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 mmHg (SBP/DBP)).
English: Musculoskeletal, connective tissue and bone disorders Rare:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Rari:
English: Eye disorders Not known: Xanthopsia, acute myopia, acute angle-closure glaucoma
Maltese: Ksantopsija, mijopja akuta, glawkoma tal-għeluq tal-angolu akuta
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 mmHg (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 mmHg (SBP/DBP)
English: Rare cases have also been reported with angiotensin II receptor antagonists (including Tolucombi).
Maltese: Każijiet rari kienu irrappurtati wkoll b'antagonisti ta' riċetturi ta' angiotensin II (li jinkludu Tolucombi).
English: Patients weighing 58.8 kg or less with hereditary fructose intolerance (HFI) should not take this medicinal product.
Maltese: Pazjenti li jiżnu 58.8 kg jew inqas b'intolleranza ereditarja tal-fruttozju (HFI, hereditary fructose intolerance) m'għandhomx jieħdu dan il-prodott mediċinali.
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: 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-prodott u jaraw lit-tabib tagħhom immedjatament.
English: Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine) The effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide.
Maltese: Rilassanti tal-muskoli skeletriċi li mhumiex depolarizzanti (eż. tubocurarine) L-effett tar-rilassanti tal-muskoli skeletriċi li mhumiex depolarizzanti jista' jissaħħaħ b'hydrochlorothiazide.
English: What Tolucombi contains - The active substances are telmisartan and hydrochlorothiazide.
Maltese: X'fih Tolucombi - Is-sustanzi attivi huma telmisartan u hydrochlorothiazide.
English: Children and adolescents The use of Tolucombi in children and adolescents up to the age of 18 years is not recommended.
Maltese: Tfal u adolexxenti L-użu ta' Tolucombi fit-tfal u fl-adolexxenti sa l-età ta' 18-il sena mhuwiex rakkomandat.
English: Tolucombi fixed dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Tolucombi 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Maltese: Tolucombi taħlita fissa tad-doża (80 mg telmisartan/25 mg hydrochlorothiazide) hi indikata f'pazjenti li pressjoni tad-demm tagħhom ma tkunx ikkontrollata b'mod adegwat b'Tolucombi 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) jew f'pazjenti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.
English: EU/1/13/821/021 EU/1/13/821/022 EU/1/13/821/023 EU/1/13/821/024 EU/1/13/821/025 EU/1/13/821/026 EU/1/13/821/027 EU/1/13/821/028 EU/1/13/821/029 EU/1/13/821/030 EU/1/13/821/033
Maltese: EU/1/13/821/025 EU/1/13/821/026 EU/1/13/821/027 EU/1/13/821/028 EU/1/13/821/029 EU/1/13/821/030
English: Tolucombi may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Maltese: Tolucombi jista' jżid l-effett li jbaxxi l-pressjoni tad-demm ta' mediċini oħrajn jew ta' mediċini b'potenzjal li jbaxxu l-pressjoni tad-demm (eż. baclofen, amifostine).
English: Medicinal products affected by serum potassium disturbances Periodic monitoring of serum potassium and ECG is recommended when Tolucombi 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: Prodotti mediċinali affettwati minn disturbi fil-livell tal-potassium fis-serum Monitoraġġ perjodiku tal-livell tal-potassium fis-serum u ECG huma rakkomandati meta Tolucombi 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: Very rare side effects (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease)**
Maltese: Hrieħi progressivi ta' tessut tal-pulmun (mard interstizzjali tal-pulmun)**