FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents The use of Tolucombi in children and adolescents up to the age of 18 years is not recommended.
Danish: Børn og teenagere Tolucombi bør ikke ordineres til børn og teenagere under 18 år.
English: Some side effects can be serious and need immediate medical attention:
Danish: Nogle bivirkninger kan være alvorlige og kræver omgående lægehjælp: Du skal straks kontakte din læge hvis du får nogle af følgende symptomer:
English: Anticholinergic agents (e.g. atropine, biperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Danish: Antikolinergika (f.eks. atropin, biperiden) kan øge biotilgængeligheden af diuretika af thiazidtypen ved at nedsætte den gastrointestinale motilitet og mavetømningshastigheden.
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Danish: Patienterne skal indtage tilstrækkeligt med væske, og den behandlende læge bør være opmærksom på nødvendigheden af at monitorere nyrefunktionen ved initiering af behandlingen og regelmæssigt derefter.
English: Non-steroidal anti-inflammatory medicinal products (NSAIDs) NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics and the antihypertensive effects of angiotensin II receptor antagonists.
Danish: Non-steroide anti-inflammatoriske lægemidler (NSAID'ere) NSAID'ere (f.eks. acetylsalicylsyre i doser beregnet til anti-inflammatorisk behandling, COX-2hæmmere og ikke-selektive NSAID'ere) kan hos nogle patienter nedsætte den diuretiske, natriuretiske og antihypertensive virkning af thiaziddiuretika og den antihypertensive virkning af angiotensin IIreceptorantagonister.
English: Antidiabetic medicinal products (oral agents and insulin) Dose adjustment of the antidiabetic medicinal products may be required (see section 4.4).
Danish: Antidiabetika (orale præparater og insuliner) Dosisjustering af antidiabetika kan blive nødvendig (se pkt.
English: In the "Prevention Regimen For Effectively avoiding Second Strokes" (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.002.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs. patients taking placebo (0.16 %) [RR 2.07 (95 % confidence interval 1.14 - 3.76)].
Danish: I forsøget "Prevention Regimen For Effectively avoiding Second Strokes" (PRoFESS) hos patienter på 50 år og ældre, som for nylig har oplevet stroke, blev der observeret en øget incidens af sepsis hos patienter behandlet med telmisartan sammenlignet med placebo, 0,70 % vs 0,49 % [RR 1,43 (95 % sikkerhedsinterval 1,00-2,06)]; incidensen af letale sepsistilfælde var øget hos patienter, som fik telmisartan (0,33 %) vs. patienter, som fik placebo (0,16 %) [RR 2,07 (95 % sikkerhedsinterval 1,143,76)].
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Danish: Aorta- og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Som ved brug af andre vasodilatatorer bør særlig forsigtighed udvises hos patienter, der lider af aortaeller mitralstenose eller obstruktiv hypertrofisk kardiomyopati.
English: The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia dizziness, vomiting, increase in serum creatinine, and acute renal failure have also been reported.
Danish: De mest udtalte symptomer ved telmisartan-overdosering var hypotension og takykardi; også bradykardi, svimmelhed, opkastning, forhøjelse i serum-kreatinin og akut nyresvigt er set.
English: If you forget to take Tolucombi
Danish: Hvis du har glemt at tage Tolucombi
English: Hypersensitivity, anaphylactic reactions
Danish: Overfølsomhed, anafylaktiske reaktioner
English: Tolucombi is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Danish: Du bør ikke tage Tolucombi tidligt i graviditeten, og du må ikke tage det, hvis du er mere end 3 måneder henne i graviditeten, da det kan give dit barn alvorlige skader (se afsnittet ”Graviditet og amning”).
English: In preclinical safety studies performed with co-administration of telmisartan and hydrochlorothiazide in normotensive rats and dogs, doses producing exposure comparable to that in the clinical therapeutic range caused no additional findings not already observed with administration of either substance alone.
Danish: I prækliniske sikkerhedsforsøg med samtidig indgift af telmisartan og hydrochlorthiazid i normotensive rotter og hunde i doser, der gav en eksponering sammenlignelig med den i det kliniskterapeutiske område, fandt man ikke andre resultater end dem, der allerede var set ved indgift af de to stoffer hver for sig.
English: Therefore, the use of Tolucombi is not recommended.
Danish: Derfor frarådes brug af Tolucombi.
English: Hydrochlorothiazide may cause or exacerbate hypovolaemia which could lead to electrolyte imbalance (see section 4.4).
Danish: Hydrochlorthiazid kan forårsage eller forværre hypovolæmi, som kan føre til elektrolytforstyrrelser(se pkt.
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with Tolucombi (see section 4.5).
Danish: Kaliumbesparende diuretika, kaliumsupplementer eller kaliumholdige saltsubstitutter skal indgives med forsigtighed sammen med Tolucombi (se pkt.
English: Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with Tolucombi.
Danish: Bivirkninger, der er kendt for de enkelte komponenter, men som ikke er forekommet i de kliniske forsøg, kan forekomme ved behandling med Tolucombi.
English: Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see sections 4.3 and 4.4).
Danish: Spædbørn, hvis mødre har taget AIIRA'er, bør observeres omhyggeligt for hypotension (se også pkt.
English: Patients weighing 58.8 kg or less must take into consideration that sorbitol is a source of fructose and if your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Danish: Hvis din læge har fortalt dig at du (eller dit barn) har intolerance over for nogle sukkerarter eller hvis du er blevet diagnosticeret med arvelig fructoseintolerans (HFI), en sjælden genetisk lidelse, hvor en person ikke kan bryde ned fructose, skal du tale med din læge før du (eller dit barn) tager eller får dette lægemiddel.
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Medmindre fortsat AIIRA-behandling anses for at være essentiel, bør patienter, der planlægger graviditet, skiftes til alternative anithypertensive behandlinger, som har en etableret sikkerhedsprofil for anvendelse under graviditet.
English: cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol) - others (e.g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
Danish: cyamemazin - sulpirid, sultoprid, amisulprid, tiaprid, pimozid, haloperidol, droperidol) - andre (f.eks. bepridil, cisaprid, diphemanil, erythromycin i.v., halofantrin, mizolastin,
English: Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with telmisartan may reduce diuretic-induced hypokalaemia.
Danish: Hypokaliæmi kan forekomme ved anvendelse af thiaziddiuretika, men samtidig behandling med telmisartan kan reducere den diuretika-inducerede hypokaliæmi.
English: Tolucombi is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Danish: Tolucombi er en kombination af en angiotensin II-receptorantagonist, telmisartan og thiazidet hydrochlorthiazid.
English: Other conditions with stimulation of the renin-angiotensin-aldosterone system In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-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 has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Danish: Andre tilstande med stimulering af renin-angiotensin-aldosteronsystemet Hos patienter, hvis vaskulære tonus og nyrefunktion overvejende afhænger af renin-angiotensinaldosteronsystemets aktivitet (f.eks. patienter med svær højresidig hjerteinsufficiens eller tilgrundliggende nyresygdom, herunder nyrearteriestenose), har behandling med lægemidler, som påvirker dette system, været forbundet med akut hypotension, hyperazotæmi, oliguri eller i sjældne tilfælde akut nyresvigt (se pkt.
English: Dizziness or drowsiness may occasionally occur when taking Tolucombi.
Danish: Der kan lejlighedsvis forekomme svimmelhed eller døsighed ved behandling med Tolucombi.
English: Angiotensin II is a substance produced in your body which causes your blood vessels to narrow thus increasing your blood pressure.
Danish: Angiotensin II er et naturligt stof i kroppen, som får blodkarrene til at snævre ind.
English: Blood creatinine increased, blood creatine phosphokinase increased, hepatic enzyme increased
Danish: Forhøjet serumkreatinin, forhøjet kreatinphosphokinase i blodet, forhøjede leverenzymer
English: What Tolucombi contains - The active substances are telmisartan and hydrochlorothiazide.
Danish: Tolucombi indeholder: - Aktive stoffer: telmisartan og hydrochlorthiazid.
English: - The other ingredients are: hydroxypropylcellulose, lactose monohydrate, magnesium stearate, mannitol, meglumine, povidone (K30), red ferric oxide (E172) - only in 40 mg/12.5 mg and 80 mg/12.5 mg tablets, silica colloidal anhydrous, sodium hydroxide (E524), sodium stearyl fumarate, sorbitol (E420) and yellow ferric oxide (E172) - only in 80 mg/25 mg tablets.
Danish: - Øvrige indholdsstoffer: hydroxypropylcellulose, lactosemonohydrat, magnesiumstearat, mannitol, meglumin, povidon (K30), rød jernoxid (E172) - kun i 40 mg/12,5 mg og 80 mg/12,5 mg tabletter, kolloid vandfri silica, natriumhydroxid (E524), natriumstearylfumarat, sorbitol (E420) og gul jernoxid (E172) - kun i 80 mg/25 mg tabletter.
English: - Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for de aktive stoffer eller over for ét eller flere af hjælpestofferne anført i pkt.
English: You can take Tolucombi with or without food.
Danish: Brug af Tolucombi sammen med mad og alkohol Du kan tage Tolucombi med eller uden mad.
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).
Danish: Anvendelse af AIIRA'er er kontraindiceret i 2. og 3. trimester af graviditeten (se pkt.
English: The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: Anvendelse af AIIRA'er kan ikke anbefales i 1. trimester af graviditeten (se pkt.
English: Thiazide diuretics may increase serum calcium levels due to the decreased excretion.
Danish: Thiaziddiuretika kan øge serumcalciumniveauet på grund af nedsat udskillelse.
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Danish: Du skal fortælle din læge, hvis du ammer eller skal til at amme.
English: Interstitial lung disease
Danish: Interstitial lungesygdom
English: - Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Danish: - Andet og tredje trimester af graviditeten (se pkt.
English: Risk factors for developing acute angleclosure glaucoma may include a history of sulfonamide or penicillin allergy.
Danish: Risikofaktorer for at udvikle akut snævervinklet glaukom kan omfatte allergi over for sulfonamider eller antibiotika i anamnesen.
English: Cytotoxic agents (e.g. cyclophosphamide, methotrexate) Thiazides may reduce the renal excretion of cytotoxic medicinal products and potentiate their myelosuppressive effects.
Danish: Cytotoksiske lægemidler (f.eks. cyclophosphamid, methotrexat) Thiazider kan formindske cytotoksiske lægemidlers udskillelse gennem nyrerne og forstærke deres myelosuppressive virkning.
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
Danish: Når graviditet diagnosticeres, bør behandling med AIIRA'er seponeres omgående, og hvis det er hensigtsmæssigt, bør alternativ behandling påbegyndes.
English: If these medicinal products are to be prescribed with the hydrochlorothiazide-telmisartan combination, monitoring of potassium plasma levels is advised.
Danish: Hvis disse lægemidler gives sammen med hydrochlorthiazid-telmisartankombinationen, tilrådes monitorering af kalium-plasmaniveauet.
English: Tolucombi 40 mg/12.5 mg tablets EU/1/13/821/001
Danish: Tolucombi 40 mg/12,5 mg tabletter EU/1/13/821/001
English: Lactose , sorbitol and sodium
Danish: Lactose, sorbitol og natrium
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.
Danish: Thiaziderne kan reducere udskillelsen af calcium i urinen og forårsage en intermitterende og let forhøjelse af serumcalcium, uden andre forstyrrelser i calciumstofskiftet.
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and
Danish: Når graviditet konstateres, bør behandling med AIIRA'er seponeres omgående, og hvis det er hensigtsmæssigt, bør alternativ behandling påbegyndes (se pkt.
English: The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.
Danish: Det er ikke klarlagt, i hvilket omfang hydrochlorthiazid kan fjernes ved hæmodialyse.
English: There is no experience regarding the administration of Tolucombi in patients with recent kidney transplantation.
Danish: Der er ingen erfaring med anvendelse af Tolucombi til patienter, der kort tid forinden har fået foretaget en nyretransplantation.
English: As with all other angiotensin II receptor antagonists telmisartan is apparently less effective in lowering blood pressure in black patients than in non blacks, possibly because of higher prevalence of low renin states in the black hypertensive population.
Danish: Som ved alle andre angiotensin II-receptorantagonister synes telmisartan at virke mindre blodtrykssænkende hos negroide end hos ikke-negroide personer.
English: - Medicines that are affected by changes of the blood potassium level such as heart medicines (e.g. digoxin) or medicines to control the rhythm of your heart (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine) and other medicines such as certain antibiotics (e.g. sparfloxacine, pentamidine) or certain medicines to treat allergic reactions (e.g. terfenadine).
Danish: - Medicin, der påvirkes af ændringer i kaliumindholdet i blodet, såsom hjertemedicin (f.eks. digoxin) eller medicin til at kontrollere hjerterytmen (f.eks. quinidin, disopyramid, amiodaron, sotalol), medicin, som bruges til psykiske lidelser (f.eks. thioridazin, chlorpromazin, levomepromazin) og andre lægemidler, såsom visse antibiotika (f.eks sparfloxacin, pentamidin) eller visse lægemidler til behandling af allergiske reaktioner (f.eks terfenadin).
English: - Anti-cholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia) such as atropine and biperiden.
Danish: - Anti-cholinerge lægemidler (medicin til behandling af en række forskellige lidelser, såsom mavekramper, urinblære spasmer, astma, transportsyge, muskelkramper, Parkinsons sygdom og som en hjælp til bedøvelse) såsom atropin og biperiden.
English: The effect of Tolucombi may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicyl acid or ibuprofen).
Danish: Blodtrykssænkningen med Tolucombi kan, blive mindre ved samtidig brug af medicin mod gigt og lette smerter (non-steroid antiinflammatorisk medicin (NSAID)), f.eks. acetylsalicylsyre eller ibuprofen.
English: KRKA-POLSKA Sp.z.
Danish: KRKA-POLSKA Sp. z. o.o.
English: What you need to know before you take Tolucombi
Danish: Det skal du vide, før du begynder at tage Tolucombi
English: Thiazide-induced hypokalaemia or hypomagnesaemia favours the onset of digitalis-induced arrhythmia (see section 4.4).
Danish: Thiazidbetinget hypokaliæmi eller hypomagnesiæmi øger forekomsten af digitalisinducerede arytmier (se pkt.
English: Not known: Anorexia, appetite decreased, electrolyte imbalance, hypercholesterolaemia, hyperglycaemia, hypovolaemia
Danish: Anoreksi, nedsat appetit, forstyrrelser i elektrolytbalancen, hyperkolesterolæmi, hyperglykæmi, hypovolæmi
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).
Danish: Lægemidler, der forbindes med kaliumtab og hypokaliæmi (f.eks.andre kaliuretiske diuretika, laksantia, kortikosteroider, ACTH, amphotericin, carbenoxolon, benzylpenicillinnatrium, salicylsyre og derivater).
English: Concomitant administration of hydrochlorothiazide and telmisartan does not appear to affect the pharmacokinetics of either substance in healthy subjects.
Danish: Samtidig indgift af hydrochlorthiazid og telmisartan har hos raske personer ingen indflydelse på de to lægemidlers farmakokinetik.
English: Common side effects (may affect up to 1 in 10 people): Dizziness.
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 brugere): Svimmelhed.
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,
Danish: - klasse Ia-antiarytmika, (f.eks. quinidin, hydroquinidin, disopyramid) - klasse III-antiarytmika, (f.eks. amiodaron, sotalol, doftilid, ibutilid) - visse antipsykotika (f.eks. thioridazin, chlorpromazin, levomepromazin, trifluoperazin,
English: Co-administration of thiazide may increase the incidence of hypersensitivity reactions of allopurinol.
Danish: Samtidig indgift af thiazid kan øge forekomsten af overfølsomhedsreaktioner over for allopurinol.
English: If these substances are to be prescribed with the hydrochlorothiazide-telmisartan combination, monitoring of potassium plasma levels is advised.
Danish: Hvis disse stoffer gives sammen med hydrochlorthiazid-telmisartan-kombinationen, tilrådes monitorering af kaliumplasmaniveauet.
English: Blister (OPA/Al/PVC foil//Al foil): 14 x 1 tablet
Danish: Blistekort (OPA/Al/PVC folie//Al folie): 14 x 1 tablet
English: Uncommon: Upper respiratory tract infection, urinary tract infection including cystitis Rare:
Danish: Infektion i øvre luftveje, urinvejsinfektion herunder cystitis
English: There is no clinical experience with Tolucombi in patients with hepatic impairment.
Danish: Der er ingen klinisk erfaring med brug af Tolucombi til patienter med nedsat leverfunktion.
English: - Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists.
Danish: - Telmisartan er en såkaldt angiotensin II-receptorantagonist.
English: Povidone (K30) Red ferric oxide (E172) Silica, colloidal anhydrous Sodium hydroxide (E524) Sodium stearyl fumarate Sorbitol (E420)
Danish: Povidon (K30) Rød jernoxid (E172) Silica, kolloid vandfri Natriumhydroxid (E524) Natriumstearylfumarat Sorbitol (E420)
English: A clear cumulative dose-response relationship was observed for both BCC and SCC.
Danish: Der sås en klar kumulativ dosis/respons relation, hvad angår både basalcellekarcinom og pladecellekarcinom.
English: Adverse reactions reported in all clinical trials and occurring more frequently (p ≤0.05) with telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ class.
Danish: Tabellen nedenfor viser de bivirkninger, der forekom hyppigere (p ≤0,05) for telmisartan plus hydrochlorthiazid end for placebo i de kliniske forsøg.
English: Hydrochlorothiazide:
Danish: Hydrochlorthiazid
English: Hydroxypropylcellulose Lactose monohydrate Magnesium stearate Mannitol
Danish: Hydroxypropylcellulose Lactosemonohydrat Magnesiumstearat
English: Blisters (OPA/Al/PE foil with desiccant//Al foil): 14 x 1 and 98 x 1 tablet in a box.
Danish: Blisterkort (OPA/Al/PE folie med tørremiddel//Al folie): 14 x 1 og 98 x 1 tablet i en æske.
English: Skin and subcutaneous tissue disorders Not known: Lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis, erythema multiforme
Danish: Lupus-lignende syndrom, lysfølsomhedsreaktion, kutan vaskulit, toksisk epidermal nekrolyse, erythema multiforme
English: In preclinical studies, no effects of telmisartan and hydrochlorothiazide on male and female fertility were observed.
Danish: I prækliniske studier blev der ikke påvist nedsat fertilitet hos hunner eller hanner ved brug af telmisartan og hydrochlorothiazid.
English: Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Danish: Intravaskulær hypovolæmi Specielt efter første dosis kan der forekomme symptomatisk hypotension hos patienter, som har for lavt volumen i blodbanen eller natriummangel på grund af kraftig diuretisk behandling, saltfattig diæt, diarré eller opkastning.
English: This applies especially to the medicines listed below taken at the same time with Tolucombi:
Danish: Dette gælder specielt, hvis du samtidig med Tolucombi tager én af de typer medicin, der er angivet herunder:
English: Investigations Not known: Triglycerides increased
Danish: Forhøjede triglycerider
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.
Danish: I en samlet analyse af to ens 8 ugers dobbeltblinde placebo-kontrollerede kliniske forsøg, hvor der blev sammenlignet med valsartan/hydrochlorothiazid 160 mg/25 mg (n=2121 patienter evalueret for effekt) blev der påvist en signifikant større sænkning af blodtrykket på 2,2/1,2 mmHg (SBP/DBP) (gennemsnitlig ændring i forhold til baseline for begge parametre) til fordel for telmisartan/hydrochlorothiazid 80 mg/25 mg kombinationen.