FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 13 March 2013 Date of latest renewal: 8 January 2018
Danish: Dato for første markedsføringstilladelse: 13/03/2013 Dato for seneste fornyelse: 08/01/2018
English: An updated RMP shall be submitted by CHMP agreed deadline.
Danish: En opdateret RMP skal fremsendes senest tidsfrist fastsat af CHMP.
English: Total plasma clearance of telmisartan after oral administration is >1500 ml/min.
Danish: Telmisartans totale plasmaclearance efter oral administration er >1500 ml/min.
English: Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.
Danish: Alkohol kan få dit blodtryk til falde yderligere og/eller øge risikoen for at du bliver svimmel eller føler dig mat.
English: Do not take a double dose to make up for forgotten individual doses.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan.
Danish: Cytokrom P450-isoenzymer er ikke involveret i metaboliseringen af telmisartan.
English: Tolucombi can have influence on the ability to drive and use machines.
Danish: Tolucombi kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Telmisartan is highly bound to plasma proteins (>99.5 %) mainly albumin and alpha l-acid glycoprotein.
Danish: Telmisartan er i høj grad bundet til plasmaproteiner (>99,5%), hovedsagelig albumin og alfa-I-syre glycoprotein.
English: Only on blisters containing 7 tablets MON
Danish: Kun i blisterkort med 7 tabletter MAN
English: C-labelled telmisartan most of the administered dose (>97 %) was eliminated in faeces via biliary excretion.
Danish: C-mærket telmisartan blev størstedelen af den administrerede dosis (> 97%) udskilt i fæces via biliær ekskretion.
English: If Tolucombi is used during breast feeding, doses should be kept as low as possible.
Danish: Hvis Tolucombi anvendes ved amning, skal dosis holdes så lav som muligt.
English: About 60 % of the oral dose is eliminated within 48 hours.
Danish: Ca. 60% af den perorale dosis udskilles uforandret i løbet af 48 timer.
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking Tolucombi.
Danish: Disse kan være symptomer på et øget tryk i dit øje og kan forekomme indenfor timer til uger efter indtagelse af Tolucombi.
English: Renal clearance is about 250 - 300 ml/min.
Danish: Den renale clearance er ca. 250-300 ml/min.
English: Your doctor may need to change the dose of these other medications or take other precautions.
Danish: Det kan måske være nødvendigt at ændre doseringen af medicinen eller tage andre forholdsregler.
English: - If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Tolucombi” and “Warnings and precautions”).
Danish: - Hvis du samtidig tager en ACE-hæmmer eller aliskiren - se også information under overskriften ”Tag ikke Tolucombi” og ”Advarsler og forsigtighedsregler”.
English: Patients weighing 58.8 kg or less with hereditary fructose intolerance (HFI) should not take this medicinal product.
Danish: Patienter, der vejer 58,8 kg eller derunder med hereditær fructoseintolerans (HFI) bør ikke tage/få dette lægemiddel.
English: If you accidentally take too many tablets you may experience symptoms such as low blood pressure and rapid heartbeat.
Danish: Hvis du har taget for mange tabletter, kan du få symptomer såsom lavt blodtryk og hjertebanken.
English: - if you have severe kidney disease.
Danish: - hvis du har alvorlig nyresygdom.
English: Respiratory distress (including pneumonitis and pulmonary oedema)
Danish: Åndedrætsbesvær (inklusive pneumonit og lungeødem)
English: There are no adequate data from the use of Tolucombi in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af Tolucombi til gravide kvinder.
English: The terminal elimination half-life of hydrochlorothiazide is 10 - 15 hours.
Danish: Den terminale eliminationshalveringstid for hydrochlorthiazid er 10-15 timer.
English: - Medicines for the treatment of diabetes (insulins or oral agents such as metformin).
Danish: - Medicin til behandling af diabetes (insulin eller orale lægemidler såsom metformin).
English: When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Danish: Hvis det er klinisk relevant, kan et direkte skift fra monoterapi til den faste kombination overvejes.
English: - Muscle relaxing medicines, such as tubocurarine.
Danish: - Muskelafslappende medicin, såsom tubocurarin.
English: The effects of fixed dose combination of telmisartan/HCTZ on mortality and cardiovascular morbidity are currently unknown.
Danish: Effekten af en fastdosiskombination af telmisartan/HCT på dødelighed og kardiovaskulær morbiditet er indtil videre ukendt.
English: Most cases of hepatic function abnormal / liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Danish: De fleste tilfælde af unormal leverfunktion/leversygdom fra post-marketing erfaring for telmisartan, forekom hos japanske patienter.
English: Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics, including hydrochlorothiazide.
Danish: Forværring eller aktivering af systemisk lupus erythematosus er rapporteret ved anvendelsen af thiaziddiuretika herunder hydrochlorthiazid.
English: pentamidine, sparfloxacine, terfenadine, vincamine IV.)
Danish: pentamidin, sparfloxacin, terfenadin, vincamin i.v.)
English: - Cholestyramine and colestipol, medicines for lowering blood fat levels.
Danish: - Colestyramin og colestipol, medicin til at sænke blodets fedtindhold.
English: Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for Tolucombi.
Danish: En øget forekomst af sepsis er kun set med telmisartan, men kan ikke udelukkes for Tolucombi.
English: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Danish: Patienter med primær aldosteronisme vil generelt ikke respondere på antihypertensiva, som virker ved at hæmme renin-angiotensin-systemet.
English: No additional preclinical studies have been performed with the Fixed Dose Combination product 80 mg/25 mg.
Danish: Der er ikke udført yderligere kliniske studier med den faste kombination 80 mg/25 mg.
English: 1: Based on post-marketing experience 2: For further description, please see sub-section “Description of selected adverse reactions”
Danish: 1: Baseret på erfaringer efter markedsføringen 2: For yderligere beskrivelse, se underafsnittet ”Beskrivelse af udvalgte bivirkninger”
English: See section 2 "Tolucombi contains lactose, sorbitol and sodium".
Danish: Se punkt 2 "Tolucombi indeholder lactose, sorbitol og natrium".
English: Hydrochlorothiazide is not metabolised in man.
Danish: Hydrochlorthiazid metaboliseres ikke hos mennesker.
English: 3: For further description, please see sub-section “Description of selected adverse reactions”
Danish: 3: For yderligere beskrivelse, se underafsnittet ”Beskrivelse af udvalgte bivirkninger”
English: Other antihypertensive agents Telmisartan may increase the hypotensive effect of other antihypertensive agents.
Danish: Andre antihypertensiva Telmisartan kan øge den hypotensive virkning af andre antihypertensiva.
English: Protect your skin from sun exposure and UV rays while taking Tolucombi.
Danish: Beskyt huden mod sollys og UVstråler, mens du tager Tolucombi.
English: Holjevca 20/E, 10 450 Jastrebarsko, Croatia
Danish: Holjevca 20/E, 10450 Jastrebarsko, Kroatien
English: The safety and efficacy of Tolucombi in children and adolescents aged below 18 have not been established.
Danish: Tolucombi's sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: - if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicines.
Danish: - hvis du er allergisk over for hydrochlorthiazid eller andet sulphonamidholdigt lægemiddel.
English: Pressor amines (e.g. noradrenaline) The effect of pressor amines may be decreased.
Danish: Pressor-aminer (f.eks. noradrenalin) Virkningen af pressor-aminer kan være forringet.
English: Talk to your doctor before taking Tolucombi, if you are taking: - digoxin.
Danish: Kontakt lægen, før du tager Tolucombi, hvis du tager: - digoxin.
English: You must tell your doctor if you think you are (or might become) pregnant.
Danish: Du skal fortælle din læge, hvis du tror, du er gravid (eller planlægger at blive det).
English: Tolucombi should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone.
Danish: Tolucombi bør tages af patienter, hvis blodtryk ikke kan reguleres tilfredsstillende med telmisartan alene.
English: Równoległa 5, 02-235 Warszawa, Poland TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany KRKA - FARMA d.o.o.,V.
Danish: Równoległa 5, 02-235 Warszawa, Polen TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Tyskland KRKA - FARMA d.o.o.,V.
English: Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of medicinal product initiation.
Danish: Symptomerne omfatter akut synsnedsættelse eller øjensmerter og opstår typisk inden for timer til uger efter behandlingsstart.
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.
Danish: I et studie medførte samtidig administration af telmisartan og ramipril en stigning i AUC0-24 og Cmax af ramipril og ramiprilat på op til 2,5 gange.
English: Tolucombi once daily produces effective and smooth reductions in blood pressure across the therapeutic dose range.
Danish: Tolucombi administreret én gang dagligt giver en effektiv og jævn reduktion i blodtrykket i hele det terapeutiske dosisinterval.
English: Because no information is available regarding the use of Tolucombi during breast-feeding, Tolucombi is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Danish: Da der ikke er tilgængelig information vedrørende anvendelse af Tolucombi under amning, frarådes det at anvende Tolucombi, og alternative behandlinger med en mere kendt sikkerhedsprofil vedrørende brug under amning foretrækkes, især hvis barnet er nyfødt eller præmaturt.
English: Marked hypercalcaemia may be evidence of hidden hyperparathyroidism.
Danish: Tydelig hypercalciæmi kan være et tegn på skjult hyperparatyroidisme.
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.
Danish: Selvom der ikke findes kontrollerede epidemiologiske data vedrørende risikoen ved angiotensin IIreceptorhæmmere (AIIRA'er), kan de samme risici være forbundet med denne lægemiddelklasse.
English: Thiazides in high doses causing intense diuresis can inhibit the milk production.
Danish: Thiazider i store doser medfører voldsomme diureser og kan hæmme mælkeproduktionen.
English: Hydrochlorothiazide is 68 % protein bound in the plasma and its apparent volume of distribution is 0.83 - 1.14 l/kg.
Danish: 68% af hydrochlorthiazidet er bundet i plasma, og det tilsyneladende fordelingsvolumen er 0,831,14 l/kg.
English: In addition, Tolucombi should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Danish: Desuden skal Tolucombi anvendes med forsigtighed til patienter med nedsat leverfunktion eller progredierende leversygdom, idet små forskydninger i væske- og elektrolytbalancen kan udløse hepatisk coma.
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).
Danish: I et opfølgningsstudie med 80 mg/25 mg kombination sås en yderligere reduktion af blodtrykket (resulterende i en samlet reduktion på 11,5/9,9 mmHg (SBP/DBP).
English: Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Danish: Baseret på hydrochlorthiazids farmakologiske virkningsmekanisme kan brugen af denne i andet og tredje trimester kompromittere føto-placental perfusion og kan forårsage føtale og neonatale bivirkninger som ikterus, forstyrrelser af elektrolytbalancen og thrombocytopeni.
English: Experience with Tolucombi is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Danish: Erfaringer med Tolucombi er begrænsede hos patienter med let til moderat nedsat nyrefunktion, og derfor anbefales periodisk kontrol af serumværdierne for kalium, kreatinin og urinsyre.
English: Gastric lesions could be prevented/ameliorated by oral sodium chloride solution supplementation and group housing of animals.
Danish: Gastriske læsioner kunne forhindres/afhjælpes ved peroral tilførsel af natriumklorid og gruppevis opstaldning af dyrene.
English: Your doctor will normally advise you to stop taking Tolucombi before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Tolucombi.
Danish: Din læge vil normalt råde dig til at stoppe med at tage Tolucombi og tage en anden medicin i stedet for, før du bliver gravid, eller så snart du finder ud af, at du er gravid.
English: Possible side effects of Tolucombi:
Danish: Bivirkninger ved Tolucombi:
English: If any of the above applies to you, tell your doctor or pharmacist before taking Tolucombi.
Danish: Hvis et af ovennævnte punkter gælder for dig, skal du tale med din læge eller apoteket om det, inden du tager Tolucombi.
English: Coadministration of lithium and Tolucombi is not recommended (see section 4.4).
Danish: Samtidig administration af lithium og Tolucombi kan ikke anbefales (se pkt.
English: Insomnia, sleep disorders
Danish: Søvnløshed, søvnforstyrrelser
English: Blisters (OPA/Al/PVC foil//Al foil): 3 years Blisters (OPA/Al/PE foil with desiccant//Al foil): 2 years
Danish: Blisterkort (OPA/Al/PVC//Al folie): 3 år Blisterkort (OPA/Al/PE folie med tørremiddel//Al folie): 2 år
English: Tolucombi tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Danish: Administration Tolucombi tabletter administreres oralt én gang daglig med væske, med eller uden mad.
English: The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.
Danish: Primær behandling er seponering af lægemidlet så hurtigt som muligt.
English: Tolucombi may be less effective in lowering the blood pressure in black patients.
Danish: Tolucombi kan have en mindre blodtrykssænkende virkning hos sorte patienter.
English: - Refractory hypokalaemia, hypercalcaemia.
Danish: - Refraktær hypokaliæmi, hypercalcæmi.
English: Telmisartan: Following oral administration peak concentrations of telmisartan are reached in 0.5 - 1.5 h after dosing.
Danish: Telmisartan: Ved peroral administration opnås peak-koncentrationerne af telmisartan i løbet af 0,5-1,5 time efter indgift.
English: - any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Danish: - et af følgende lægemidler til behandling af for højt blodtryk: - en ACE-hæmmer (f.eks. enalapril, lisinopril, ramipril), især hvis du har nyrerproblemer i forbindelse med sukkersyge - aliskiren.
English: Such conditions should be corrected before the administration of Tolucombi.
Danish: Sådanne tilstande bør korrigeres, før behandling med Tolucombi initieres.
English: Hydrochlorothiazide: Following oral administration of Tolucombi peak concentrations of hydrochlorothiazide are reached in approximately 1.0 - 3.0 hours after dosing.
Danish: Hydrochlorthiazid: Ved peroral administration af Tolucombi nås peak-koncentrationerne af hydrochlorthiazid i løbet af 1,0-3,0 time efter indgift.
English: - Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product).
Danish: - Overfølsomhed over for andre derivater af sulphonamid (hydrochlorthiazid er et sulphonamidderivat).
English: Both of these substances help to control high blood pressure.
Danish: Begge lægemiddelstoffer anvendes til at sænke forhøjet blodtryk.
English: Some people feel dizzy or tired when taking Tolucombi.
Danish: Man kan føle sig svimmel eller blive træt, når man tager Tolucombi.
English: Tolucombi contains lactose, sorbitol and sodium If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Tolucombi indeholder lactose, sorbitol og natrium Kontakt lægen, før De/du tager denne medicin, hvis lægen har fortalt Dem/dig, at De/du ikke tåler visse sukkerarter.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists and diuretics, ATC code:C09DA07.
Danish: Farmakoterapeutisk klassifikation: Midler virkning på renin-angiotensin-systemet; angiotensin IIreceptorantagonister og diuretika, ATC-kode: C09DA07
English: Therefore, in these patients blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.
Danish: Derfor bør monitorering af glucose hos disse patienter overvejes, og dosisjusteringer af insulin eller antidiabetikakan være nødvendig.
English: In case of surgery or anaesthetics, you should tell your doctor that you are taking Tolucombi.
Danish: Før en operation eller bedøvelse bør du fortælle din læge, at du tager Tolucombi.
English: - if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
Danish: - hvis din læge i en blodprøve finder for lavt indhold af kalium eller for højt indhold af calcium og dette ikke bedres ved behandling.
English: Do not take Tolucombi: - if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Tolucombi - hvis du er allergisk over for telmisartan eller et af de øvrige indholdsstoffer i Tolucombi
English: Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine.
Danish: Følgende præparater har farmakologiske egenskaber, der kan forventes at forstærke den hypotensive effekt af alle antihypertensiva, herunder telmisartans: Baclofen, amifostin.
English: Blisters (OPA/Al/PVC foil//Al foil): 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1 and 100 x 1 tablet in a box.
Danish: Blisterkort (OPA/Al/PVC//Al folie): 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1 og 100 x 1 tablet i en æske.
English: Cholestyramine and colestipol resins Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Danish: Colestyramin og colestipolresiner Absorptionen af hydrochlorthiazid svækkes ved tilstedeværelsen af anioniske resiner.
English: Tolucombi is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
Danish: Tolucombi er en kombination af to aktive stoffer - telmisartan og hydrochlorthiazid - i én tablet.
English: Rare cases have also been reported with angiotensin II receptor antagonists (including Tolucombi).
Danish: I sjældne tilfælde er dette også set ved behandling med angiotensin II-receptorantagonister (som Tolucombi).
English: Angioedema (also with fatal outcome), erythema, pruritus, rash, hyperhidrosis, urticaria
Danish: Angioødem (også med fatal udfald), erytem, pruritus, udslæt, hyperhidrose, urticaria
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).
Danish: Tolucombi kan øge den blodtrykssænkende virkning, både af anden blodtrykssænkende medicin og af medicin, der potentielt kan sænke blodtrykket (f.eks. baclofen eller amifostin).
English: Although clinically significant hyperkalaemia has not been documented with Tolucombi, risk factors for the development of hyperkalaemia include renal insufficiency and/or heart failure, and diabetes mellitus.
Danish: Skønt der ikke er set nogen klinisk signifikant hyperkaliæmi i forbindelse med Tolucombi, så omfatter risikofaktorerne for udvikling af hyperkaliæmi blandt andet nyreinsufficiens og/eller hjertesvigt samt diabetes mellitus.
English: Elderly Pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Danish: Der er ingen forskelle med hensyn til telmisartans farmakokinetik hos personer over eller under 65 år.
English: Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease.
Danish: Hydrochlorthiazid må ikke bruges mod graviditetsødem, forhøjet blodtryk under graviditet eller svangerskabsforgiftning på grund af risikoen for nedsat plasmavolumen og placental hypoperfusion uden gavnlig virkning på sygdomsforløbet.
English: Influenza-like illness, pain
Danish: Influenzalignende symptomer, smerter
English: Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine) The effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide.
Danish: Ikke-depolariserende muskelrelaksantia (f.eks. tubocurarin) Virkningen af ikke-depolariserende muskelrelaksantia kan forstærkes af hydrochlorthiazid.
English: - Severe renal impairment (creatinine clearance <30 ml/min).
Danish: - Svært nedsat nyrefunktion (kreatinin-clearance <30 ml/min).
English: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma.
Danish: Hydrochlorthiazid, et sulfonamid, kan medføre en idiosynkratisk reaktion, som kan forårsage forbigående myopi og akut snævervinklet glaukom.
English: Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of telmisartan tends to reverse the potassium loss associated with these diuretics.
Danish: Sandsynligvis pga. blokering af renin-angiotensinaldosteronsystemet synes telmisartan at modvirke det kaliumtab, der er forbundet med disse diuretika.
English: Tolucombi must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Danish: Tolucombi må ikke anvendes til patienter med svært nedsat nyrefunktion (kreatinin-clearance <30 ml/min) (se pkt.
English: Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: Hvis eksponering for AIIRA'er har fundet sted fra 2. trimester af graviditeten, anbefales ultralydskontrol af nyrefunktionen og kraniet.
English: Periodic monitoring of renal function is advised (see section 4.4).
Danish: Ndsat nyrefunktion Periodisk monitorering af nyrefunktionen tilrådes (se pkt.
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).
Danish: Samtidig brug af Tolucombi og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: In patients with mild to moderate hepatic impairment the posology should not exceed Tolucombi 40 mg/12.5 mg once daily.
Danish: Hos patienter med let eller moderat nedsat leverfunktion bør dosis ikke overskride Tolucombi 40 mg/12,5 mg én gang dagligt.