FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will normally advise you to stop taking Actelsar HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Actelsar HCT.
Danish: Normalt vil din læge anbefale dig at stoppe med at tage Actelsar HCT, før du bliver gravid, eller så snart du ved, du er gravid.
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100%.
Danish: I farmakokinetiske forsøg med patienter med nedsat leverfunktion var der en forøgelse af den absolutte biotilgængelighed på op til næsten 100 %.
English: Sodium starch glycolate (type A) Microcrystalline cellulose Mannitol (E421)
Danish: Natriumstivelsesglycolat (type A) Mikrokrystallinsk cellulose Mannitol (E421)
English: Magnesium stearate (E470b) Potassium hydroxide Meglumine
Danish: Magnesiumstearat (E470b) Kaliumhydroxid
English: For Al/Al blisters and HDPE tablet container: 2 years.
Danish: For Al/Al blister og HDPE tabletbeholder: 2 år.
English: Upper respiratory tract infection, urinary tract infection including cystitis
Danish: Infektion i øvre luftveje, urinvejsinfektion herunder cystitis
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 forsøg 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: 3 For further description, please see sub-section “Description of selected adverse reactions”.
Danish: 3 For yderligere beskrivelse, se underpunktet ”Beskrivelse af udvalgte bivirkninger”
English: Actelsar HCT is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
Danish: Actelsar HCT er en kombination af to aktive stoffer - telmisartan og hydrochlorthiazid - i én tablet.
English: The effects of fixed dose combination of telmisartan/HCT on mortality and cardiovascular morbidity are currently unknown.
Danish: Effekten af en fastdosiskombination af telmisartan/hydrochlorthiazid på dødelighed og kardiovaskulær morbiditet er indtil videre ukendt.
English: In case of surgery or anaesthetics, you should tell your doctor that you are taking Actelsar HCT.
Danish: Før en operation eller bedøvelse bør du fortælle din læge, at du tager Actelsar HCT.
English: Actelsar HCT tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Danish: Actelsar HCT tabletter administreres oralt én gang dagligt med væske, med eller uden mad.
English: The European Medicines Agency has waived the obligation to submit the results of studies with telmisartan hydrochlorothiazide in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med telmisartanhydrochlorthiazid i alle undergrupper af den pædiatriske population med hypertension (se pkt.
English: You must tell your doctor if you think you are (or might become) pregnant.
Danish: Fortæl din læge, hvis du tror, du er gravid (eller kan blive gravid).
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists and diuretics, ATC code: C09DA07
Danish: Farmakoterapeutisk klassifikation: Midler med virkning på renin-angiotensin systemet; angiotensin IIantagonister og diuretika, ATC-kode: C09DA07
English: Experience with telmisartan/hydrochlorothiazide 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 telmisartan/hydrochlorthiazid er begrænsede hos patienter med let til moderat nedsat nyrefunktion, og derfor anbefales periodisk kontrol af serumværdierne for kalium, kreatinin og urinsyre.
English: In addition, Actelsar HCT 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 Actelsar HCT anvendes med forsigtighed til patienter med nedsat leverfunktion eller progredierende leversygdom, idet små forskydninger i væske- og elektrolytbalancen kan udløse hepatiskcoma.
English: Hydrochlorothiazide: Following oral administration of telmisartan/hydrochlorothiazide, peak concentrations of hydrochlorothiazide are reached in approximately 1.0-3.0 hours after dosing.
Danish: Hydrochlorthiazid: Ved oral administration af telmisartan/hydrochlorothiazid nås peakkoncentrationerne af hydrochlorthiazid i løbet af 1,0-3,0 timer efter indgift.
English: Telmisartan: Following oral administration, peak concentrations of telmisartan are reached in 0.5-1.5 h after dosing.
Danish: Telmisartan: Ved oral administration opnås peak-koncentrationerne af telmisartan i løbet af 0,5-1,5 time efter indgift.
English: Dose adjustment of the antidiabetic medicinal products may be required (see section 4.4).
Danish: Dosisjustering af antidiabetika kan blive nødvendig (se pkt.
English: Actelsar HCT may be less effective in lowering the blood pressure in black patients.
Danish: Actelsar HCT kan have en mindre blodtrykssænkende virkning hos sorte patienter.
English: Co-administration of lithium and Actelsar HCT is not recommended (see section 4.4).
Danish: Samtidig administration af lithium og Actelsar HCT kan ikke anbefales (se pkt.
English: Some people feel dizzy or tired when taking Actelsar HCT.
Danish: Man kan føle sig svimmel eller blive træt, når man tager Actelsar HCT.
English: What you need to know before you take Actelsar HCT Do not take Actelsar HCT
Danish: Det skal du vide, før du begynder at tage Actelsar HCT Tag ikke Actelsar HCT
English: In dogs renal tubular dilation and atrophy were observed.
Danish: I hunde blev der observeret tubulær dilatation og atrofi af nyrerne.
English: Contents of the pack and other information What Actelsar HCT contains
Danish: Pakningsstørrelser og yderligere oplysninger Actelsar HCT indeholder
English: There is no experience regarding the administration of telmisartan/hydrochlorothiazide in patients with recent kidney transplantation.
Danish: Der er ingen erfaring med anvendelse af telmisartan/hydrochlorthiazid til patienter, der kort tid forinden har fået foretaget en nyretransplantation.
English: Medicinal products used in the treatment for gout (e.g. probenecid, sulfinpyrazone and allopurinol) Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Danish: Lægemidler, der anvendes til behandling af urinsyregigt (fx probenecid, sulfinpyrazon og allopurinol) Dosisjustering af urikosuriske lægemidler kan være nødvendig, idet hydrochlorthiazid kan øge serumurinsyre.
English: Actelsar HCT 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: Actelsar HCT kan forøge den blodtrykssænkende virkning af andre lægemidler mod for højt blodtryk eller lægemidler, der kan sænke blodtrykket (f.eks. baclofen, amifostin).
English: - Refractory hypokalaemia, hypercalcaemia.
Danish: - Refraktær hypokaliæmi, hyperkalcæmi.
English: - Heart trouble.
Danish: - Hjerteproblemer.
English: Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants.
Danish: Lavt blodtryk kan desuden forværres af alkohol, barbiturater, narkotika eller antidepressive midler.
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: This is confirmed by measurements made at the point of maximum effect and immediately prior to the next dose (through to peak ratios consistently above 80% after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies).
Danish: Dette er bekræftet ved målinger, der blev foretaget på tidspunktet for maksimal effekt og umiddelbart forud for den næste dosis (trough/peak ratio var over 80 % efter dosering af 40 mg og 80 mg telmisartan i alle placebokontrollerede kliniske forsøg).
English: - Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product).
Danish: - Overfølsomhed over for andre derivater af sufonamid (hydrochlorthiazin er et sulfonamidderivat).
English: Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of telmisartan hydrochlorothiazide initiation.
Danish: Symptomerne omfatter akut udbrud af nedsat synsevne eller øjensmerter og forekommer typisk inden for timer eller uger fra behandlingen med telmisartanhydrochlorthiazid.
English: pentamidine, sparfloxacine, terfenadine, vincamine IV)
Danish: sparfloxacin, terfenadin, vincamin i.v.)
English: Very rare (may affect up to 1 in 10,000 people): Increased pH (disturbed acid-base balance) due to low blood chloride level.
Danish: Meget sjældne (kan forekomme hos op til 1 ud af 10.000 brugere): Forhøjet pH-værdi (forstyrrelse i syre-base-balancen) på grund af lavt kloridindhold i blodet.
English: Rare cases have also been reported with angiotensin II receptor antagonists (including telmisartan/hydrochlorothiazide).
Danish: I sjældne tilfælde er dette også set ved behandling med angiotensin II-receptorantagonister (herunder telmisartan/hydrochlorthiazid).
English: In patients taking telmisartan alone the following additional side effects have been reported:
Danish: Hos patienter, der kun får telmisartan, er der i tillæg til ovenstående set følgende bivirkninger:
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 ved brug i andet og tredje trimester kompromittere den føtoplacentale perfusion og forårsage føtale og neonatale bivirkninger såsom ikterus, forstyrrelser i elektrolytbalancen og trombocytopeni.
English: If you forget to take Actelsar HCT
Danish: Hvis du har glemt at tage Actelsar HCT
English: - The active substance hydrochlorothiazide can cause an unusual reaction, resulting in a decrease in vision and eye pain.
Danish: - Det aktive indholdsstof hydrochlorothiazid kan forårsage en usædvanlig reaktion, som fører til synstab og øjensmerter.
English: The overall incidence of adverse reactions reported with telmisartan (41.4%) was usually comparable to placebo (43.9%) in placebo controlled trials.
Danish: I placebo-kontrollerede forsøg var den samlede forekomst af bivirkninger, som blev rapporteret i forbindelse med telmisartan (41,4 %) sædvanligvis sammenlignelig med placebo (43,9 %).
English: Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Danish: Telmisartan blokerer angiotensin IIs virkning, så blodkarrene afslappes, og blodtrykket falder.
English: If calcium supplements or calcium sparing medicinal products (e.g. vitamin D therapy) must be prescribed, serum calcium levels should be monitored and calcium dose adjusted accordingly.
Danish: Hvis der gives calciumsupplement eller calciumbesparende lægemidler (fx D-vitamin), skal serumcalcium monitoreres, og calciumdosis justeres herefter.
English: Interstitial lung disease3
Danish: Interstitiel lungesygdom3
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, hvilket fører til akut transient nærsynethed og akut snævervinklet glaukom.
English: Therefore, the use of Actelsar HCT is not recommended.
Danish: Derfor frarådes brug af Actelsar HCT.
English: Non-steroidal anti-inflammatory medicinal products (NSAIDs) NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dose regimens, COX-2 inhibitors and non-selective 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) NSAID (f.eks. acetylsalicylsyre (ASA) i doser beregnet til anti-inflammatorisk behandling, COX-2hæmmere og ikke-selektive NSAID) kan hos nogle patienter nedsætte den diuretiske, natriuretiske og antihypertensive virkning af thiaziddiuretika og den antihypertensive virkning af angiotensin IIreceptorantagonister.
English: - Severe renal impairment (creatinine clearance <30 ml/min).
Danish: - Svært nedsat nyrefunktion (kreatinin-clearance < 30 ml/min).
English: Talk to your doctor before taking Actelsar HCT if you are taking: - 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: Kontakt lægen, før du tager Actelsar HCT, hvis du tager: - 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.
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 (fx atropin, biperiden) kan øge biotilgængeligheden af diuretika af thiazid-typen ved at nedsætte den gastrointestinale motilitet og mavetømningshastigheden.
English: Actelsar HCT is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when telmisartan is used alone.
Danish: Actelsar HCT bruges til at sænke forhøjet blodtryk (essentiel hypertension) hos voksne, hvis blodtryk ikke er sænket tilstrækkeligt med telmisartan.
English: Although clinically significant hyperkalaemia has not been documented with Actelsar HCT, 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 Actelsar HCT, så omfatter risikofaktorerne for udvikling af hyperkaliæmi blandt andet nyreinsufficiens og/eller hjertesvigt samt diabetes mellitus.
English: 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: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Al/PVC/PVDC blister
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Pap til Al/PVC/PVDC blister
English: Al/Al blisters and HDPE tablet container: This medicinal product does not require any special storage conditions.
Danish: Al/Al blister og HDPE tabletbeholder: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: The other ingredients are magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol (E421).
Danish: Øvrige indholdsstoffer: Magnesiumstearat (E470b), kaliumhydroxid, meglumin, povidon, natriumstivelseglykollat (type A), mikrokrystallinsk cellulose, mannitol (E421).
English: Talk to your doctor before taking Actelsar HCT if you are suffering or have ever suffered from any of the following conditions or illnesses:
Danish: Kontakt lægen, før du tager Actelsar HCT, hvis du har eller har haft en medicinsk lidelse eller sygdom, især hvis det er en af dem, der er nævnt nedenfor:
English: Very rare (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease)**
Danish: Meget sjældne (kan forekomme hos op til 1 ud af 10.000 brugere): Tiltagende arvævsdannelse i lungerne (interstitiel lungesygdom)**
English: The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5% CI 0.93-1.10, p (non-inferiority)=0.0019 at a margin of 1.13).
Danish: Hazard ratio for telmisartan vs. ramipril var 1,01 (97,5 % CI 0,93-1,10; p (non-inferioritet) = 0,0019 ved en margin på 1,13).
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 Actelsar HCT.
Danish: Bivirkninger, der er kendt for de enkelte komponenter, men som ikke er forekommet i de kliniske forsøg, kan forekomme ved behandling med Actelsar HCT.
English: Presumably through blockade of the reninangiotensin-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: As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Danish: Som ved andre antihypertensiva kan en for kraftig reduktion af blodtrykket hos patienter med iskæmiskkardiopati eller iskæmisk kardiovaskulær sygdom resultere i myokardieeinfarkt eller apopleksi (slagtilfælde).
English: In patients with mild to moderate hepatic impairment the posology should not exceed Actelsar HCT 40 mg/12.5 mg once daily.
Danish: Hos patienter med let eller moderat nedsat leverfunktion bør dosis ikke overskride Actelsar HCT 40 mg/12,5 mg én gang daglig.
English: Anorexia, appetite decreased, electrolyte imbalance, hypercholesterolaemia, hyperglycaemia, hypovolaemia
Danish: Anoreksi, nedsat appetit, forstyrrelser i elektrolytbalancen, hyperkolesterolæmi, hyperglykæmi, hypovolæmi
English: Actelsar HCT should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone.
Danish: Actelsar HCT gives, hvis blodtrykket ikke kan reguleres tilfredsstillende med telmisartan alene.
English: The incidence of dry cough was significantly lower in patients treated with telmisartan than in those given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments.
Danish: Forekomsten af tør hoste var signifikant lavere hos de patienter, der blev behandlet med telmisartanend hos dem, der blev behandlet med ACE-hæmmere i kliniske forsøg, som direkte sammenlignede disse to antihypertensive behandlinger.
English: Actelsar HCT must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Danish: Actelsar HCT må ikke anvendes til patienter med svært nedsat nyrefunktion (kreatinin-clearance <30 ml/min) (se pkt.
English: There is no clinical experience with Actelsar HCT in patients with hepatic impairment.
Danish: Der er ingen klinisk erfaring med brug af Actelsar HCT til patienter med nedsat leverfunktion.
English: Do not store above 30ºC
Danish: Må ikke opbevares ved temperaturer over 30ºC
English: Common (may affect up to 1 in 10 people): Feeling sick (nausea), low blood magnesium level.
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 brugere): Utilpashed (kvalme), lavt magnesiumindhold i blodet.
English: Syncope, paraesthesia
Danish: Synkope, paræstesi
English: Common (may affect up to 1 in 10 people): Dizziness
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 brugere): Svimmelhed
English: - if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
Danish: - hvis du har alvorlige leverproblemer, som f.eks. galdeophobning i galdegangene eller problemer med udskillelse af galde fra leveren og galdeblæren, eller andre alvorlige leversygdomme.
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 has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Danish: Hos patienter, hvis vaskulære tonus og nyrefunktion overvejende afhænger af renin-angiotensinaldosteronsystemets aktivitet (fx 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: The all-cause mortality rate was 11.6% and 11.8% among telmisartan and ramipril treated patients, respectively.
Danish: Død af alle årsager var 11,6 % henholdsvis 11,8 % for telmisartan- og ramiprilbehandlede patienter.
English: Actelsar HCT is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Det frarådes at anvende Actelsar HCT under graviditeten, og det må ikke tages senere end 3 måneder henne i graviditeten, da det kan forårsage alvorlige fosterskader.
English: Thiazide therapy may impair glucose tolerance, whereas hypoglycaemia may occur in diabetic patients under insulin or antidiabetic therapy and telmisartan treatment.
Danish: Thiazidbehandling kan svække glucosetolerancen, mens hypoglykæmi kan forekomme hos diabetikere, der får insulin- eller antidiabetisk behandling og behandling med telmisartan.
English: For Al/Al blisters and HDPE tablet container This medicine does not require any special storage conditions.
Danish: For Al/Al blister og HDPE tabletbeholder: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Dizziness or drowsiness may occasionally occur when taking Actelsar HCT.
Danish: Der kan lejlighedsvis forekomme svimmelhed eller døsighed ved behandling med Actelsar HCT.
English: - Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, vomiting, or haemodialysis.
Danish: - Lavt blodtryk (hypotension), som kan forekomme, når du er dehydreret (har for lidt kropsvæske) eller har saltmangel på grund af enten vanddrivende medicin, saltfattig diæt, diarré, opkastning eller hæmodialyse.
English: This applies especially to the medicines listed below taken at the same time with Actelsar HCT:
Danish: Dette gælder specielt, hvis du samtidig med Actelsar HCT tager én af de typer medicin, der er angivet herunder:
English: Actelsar HCT is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Danish: Actelsar HCT er en kombination af en angiotensin II-receptorantagonist, telmisartan og thiazidethydrochlorthiazid.
English: You should also tell your doctor if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal.
Danish: Fortæl din læge, hvis du ved solbadning hurtigere end ellers oplever symptomer på solskoldning (såsom rødme, kløe, hævelse, blærer).
English: Telmisartan: The pharmacokinetics of orally administered telmisartan are non-linear over doses from 20-160 mg with greater than proportional increases of plasma concentrations (Cmax and AUC) with increasing doses.
Danish: Telmisartan: Farmakokinetikken ved oralt indgivet telmisartan er ikke-lineær ved doser på 20-160 mg, idet der ved stigende doser ses overproportionale stigninger af plasmakoncentrationen (Cmax og AUC).