FrancophonIA/ELRC3.0 huggingface dataset:
English: Like all medicines, Doxastad 4 mg prolonged release tablets and associated names can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Doxastad 4 mg depottabletter og dermed forbundne navne have bivirkninger, selvom ikke alle får bivirkninger.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: 9 DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: Doxastad 4 mg prolonged release tablets and associated names can be used as monotherapy or in combination with another medicinal product e.g. a thiazide diuretic, a beta-adrenoceptor blocking agent, a calcium antagonist or an ACE-inhibitor if either of them alone does not provide sufficient effect.
Danish: Doxastad 4 mg depottabletter og dermed forbundne navne kan anvendes som monoterapi eller i kombination med andre lægemidler, f.eks. thiaziddiuretika, et beta-adrenoreceptorblokerende middel, en calciumantagonist eller en ACE-hæmmer, hvis nogle af dem ikke giver tilstrækkelig virkning alene.
English: Depending on clinical response, the dosage may be increased to 8 mg doxazosin once daily.
Danish: Afhængigt af det kliniske respons kan dosis øges til 8 mg doxazosin én gang dagligt.
English: Essential hypertension:
Danish: Essentiel hypertension:
English: Doxazosin potentiates the blood pressure lowering effect of other antihypertensives.
Danish: Doxazosin forstærker den blodtrykssænkende virkning af andre antihypertensiver.
English: This leaflet was last approved in [To be completed nationally].
Danish: Denne indlægsseddel blev senest godkendt den [Udfyldes nationalt].
English: There is no information available on accumulation of doxazosin in human breast milk.
Danish: Der er ingen tilgængelige oplysninger om akkumulering af doxazosin i human modermælk.
English: - Hypersensitivity to the active substance, other quinazolines (e.g. prazosin, terazosin) or to any of the excipients.
Danish: Overfølsomhed over for det active indholdsstof, andre quinazoliner (f.eks. prazosin, terazosin) eller over for hjælpestofferne.
English: Take as directed by your doctor.
Danish: Tages efter lægens anvisninger.
English: Blood and lymphatic system disorders: Thrombocytopenia, leukopenia.
Danish: Sygdomme i blod og lymfesystem: Thrombocytopeni, leukopeni.
English: Since no clinical experience from patients with severe hepatic insufficiency exists, use in these patients is not recommended.
Danish: Da der ikke findes klinisk erfaring med patienter med svær leverinsufficiens, anbefales anvendelse til disse patienter ikke.
English: 4 CLINICAL PARTICULARS
Danish: 4 KLINISKE OPLYSNINGER
English: Recommended dose is 4 mg once daily.
Danish: Anbefalet dosis er 4 mg én gang dagligt.
English: Doxastad 4 mg prolonged release tablets and associated names have been specially designed to release the active ingredient slowly throughout the day.
Danish: Doxastad 4 mg depottabletter og dermed forbundne navne er specielt udformede til at frigive det aktive indholdsstof langsomt i løbet af dagen.
English: Data from these studies indicate that patients well controlled on immediate release tablets of doxazosin in doses of 1 mg, 2 mg or 4 mg are equally controlled on doxazosin 4 mg prolonged-release tablets.
Danish: Data fra disse undersøgelser indikerer, at patienter, der er godt kontrollerede på doxazosin-tabletter med umiddelbar frigivelse i doseringer på 1 mg, 2 mg eller 4 mg, er lige så godt kontrollerede på doxazosin 4 mg depottabletter.
English: Most patients treated with Doxastad 4 mg prolonged release tablets and associated names once daily achieve control of blood pressure.
Danish: De fleste patienter, der bliver behandlet en gang dagligt med Doxastad 4 mg depottabletter og dermed forbundne navne, opnår blodtrykskontrol.
English: Tel: 0034 93 4738889 Fax: 0034 93 4737495
Danish: Tlf.: 0034 93 4738889 Fax: 0034 93 4737495
English: Contains butylhydroxytoluene (E321)
Danish: LISTE OVER HJÆLPESTOFFER Indeholder butylhydroxytoluen (E321)
English: Peak/trough ratio of doxazosin prolonged-release tablets is less than half that of immediate release doxazosin tablets.
Danish: Peak/bølgedalsratio for doxazosin-depottabletter er mindre end halvdelen af den for doxazosintabletter med umiddelbar frigivelse.
English: All-rac-α-Tocopherol Colloidal anhydrous silica Sodium stearyl fumarate Butylhydroxytoluene (E321)
Danish: All-rac-α-Tocopherol Kolloidalt vandfrit silica Natriumstearylfumarat Butylhydroxytoluen (E321)
English: Cerntrafarm Services B.V. Nieuwe Donk 9, 4879 AC
Danish: Nieuwe Donk 9, 4879 AC
English: INFORMATION IN BRAILLE [To be completed nationally]
Danish: INFORMATION I BRAILLE-SKRIFT [Udfyldes nationaltionalt]
English: Doxastad 4 mg prolonged release tablets and associated names has influence on the ability to drive and use machines, especially at the beginning of therapy.
Danish: Doxastad 4 mg depottabletter og dermed forbundne navne påvirker evnen til at køre bil og betjene maskiner, især i begyndelsen af behandlingen.
English: Habituation has not been observed during long-term treatment with doxazosin immediate release tablets.
Danish: Der er ikke observeret tilvænning under længerevarende behandling med doxazosin-tabletter med umiddelbar frigivelse.
English: The dose of Doxastad 4 mg prolonged release tablets and associated names is the same whether you are taking it for high blood pressure or to treat the symptoms of BPH.
Danish: Doseringen af Doxastad 4 mg depottabletter og dermed forbundne navne er den samme, hvadenten De tager dem for for højt blodtryk eller for at behandle symptomerne på BPH.
English: • if you have overflow bladder, anuria or progressive renal insufficiency
Danish: • hvis De har en overløbende blære, anuri eller progressiv nyreinsufficiens
English: Simultaneous administration of sildenafil or other PDE-5 inhibitors to patients taking alpha-blocker therapy may lead to symptomatic hypotension in some patients.
Danish: Samtidig administration af sildenafil eller andre PDE-5 hæmmere til patienter, der er i behandling med alfa-blokkere, kan lede til symptomatisk hypotension hos nogle patienter.
English: Blocking alpha-1-adrenoreceptors through doxazosin reduces the tonus of the smooth muscle in the prostatic part of the urethra which facilitates the urinary flow.
Danish: Blokering af alfa-1-adrenoreceptorer via doxazosin reducerer tonus af den glatte muskulatur i prostatadelen af urethra, hvilket letter urinflowet.
English: Patients with acute heart diseases: As for other vasodilating antihypertensives, caution is recommended according to medical praxis, in patients with the following acute heart diseases: - pulmonary oedema as a result of aortic or mitral stenosis - heart failure at high output - left or right sided heart failure as a result of pulmonary embolism, pericardial effusion, high output or low filling pressure
Danish: Patienter med akutte hjertesygdomme: Som ved andre vasodilaterende antihypertensiver anbefales der forsigtighed i henhold til medicinsk praksis hos patienter med følgende akutte hjertesygdomme: - Lungeødem som et resultat af aorta- eller mitralstenose - Hjertesvigt ved højt output - Venstre- eller højresidig hjertesvigt som et resultat af lungeemboli, perikardial effusion, højt output eller lavt fyldningstryk
English: • Drugs indicated for the treatment of erectile dysfunction (PDE-5 inhibitor, e.g. sildenafil, tadalafil, vardenafil)
Danish: • Lægemidler indiceret til behandling af erektil dysfunktion (PDE-5 hæmmer, f.eks. sildenafil,
English: The following adverse events have been reported in clinical use of immediate release tablets of doxazosin:
Danish: Følgende bivirkninger er blevet rapporteret ved klinisk brug af tabletter med umiddelbar frigørelse af doxazosin:
English: Do not use Doxastad 4 mg prolonged release tablets and associated names after the expiry date which is stated on the carton.
Danish: Anvend ikke Doxastad 4 mg depottabletter og de dermed forbundne navne efter udløbsdatoen, der er angivet på æsken.
English: The results are difficult to interpret due to various reasons such as differences in effect on systolic blood pressure and discontinuation of diuretics in the doxazosin-treated group prior to commencement of the treatment.
Danish: Disse grunde omfatter: virkningen på systolisk blodtryk samt seponering af diuretika i den doxazosin-behandlede gruppe forud for starten af behandlingen.
English: Use during lactation
Danish: Anvendelse under amning
English: Uncommon side effects include (occurs in less than 1 patient of 100): thrombocytopenia (low platelets, which may result in easy bleeding), leukopenia (low white blood cells), gout, nervousness, tremor (trembling), blurred vision, tinnitus (ringing or noise in the ears), vertigo (a feeling of dizziness or ‘spinning'), arrythmia (a feeling of irregular heart beat), tachycardia (increased heart rate), palpitations, angina pectoris, myocardial infarction (heart attack), cerebrovascular accident (stroke), dyspnoea (shortage of breath), cough, bronchial spasms, epistaxis (nosebleed), anorexia (loss of appetite), obstipation (constipation), increased appetite, icterus (jaundice), liver enzyme increases, rash, pruritus (itching), purpura (rash caused by bleeding under the skin), myalgia (painful muscles), arthralgia (painful joints), muscle cramps, increased diuresis (increased volume of urine passed), haematuria (blood in the urine), urinary incontinence, priapism (painful persistent erection), impotence, chest pain, agitation , facial flushing.
Danish: Usædvanlige bivirkninger omfatter (forekommer hos færre end 1 patient ud af 100): Thrombocytopeni (lavt antal blodplader, der kan resultere i let blødning), leukopeni (lavt antal hvide blodlegemer), podagra, nervøsitet, tremor (rysten), sløret syn, tinnitus (ringen eller støj i ørene), vertigo (en følelse af svimmelhed eller ‘køren rundt'), arytmi (en følelse af uregelmæssige hjerteslag), takykardi (øget hjertefrekvens), palpitationer, angina pectoris, myokardieinfarkt (hjerteanfald), cerebrovaskulær hændelse (hjerneblødning), dyspnøe (kortåndethed), hoste, bronchialspasmer, epistaxi (næseblod), anorexi (tab af appetit), obstipation (konstipation), øget appetit, ikterus (gulsot), stigning i leverenzymer, udslæt, pruritus (kløen), purpura (udslæt på grund af blødning under huden), myalgi (smertende muskler), arthralgi (smertende led), muskelkramper, øget diurese (øget mængde i vandladning), hæmaturi (blod i urinen), urin inkontinens, priapisme (smertefuld vedblivende erektion), impotens, brystsmerter, ophidselse , rødme i ansigtet.
English: The plasma elimination is biphasic with the terminal elimination half-life being 22 hours and hence this provides the basic for once daily dosing.
Danish: Plasmaeliminationen er bifasisk med en terminal eliminationshalveringstid på 22 timer.
English: The maximum recommended dose is 8 mg doxazosin once daily.
Danish: Den maksimal anbefalede dosis er 8 mg doxazosin én gang daglig.
English: White, round, biconvex tablets, with bossing “DL” on one side.
Danish: Depottablet Hvide, runde bikonvekse tabletter med påtrykt “DL” på den ene side.
English: Analysis of two dose-effect studies (including a total of 630 patients treated with doxazosin) have shown that patients treated with immediate release tablets in dosages of 1 mg, 2 mg or 4 mg are equally controlled on doxazosin prolonged-release tablets containing 4 mg.
Danish: Analyse af to dosis-effekt-undersøgelser (omfattende i alt 630 patienter behandlet med doxazosin) har vist, at patienter behandlet med tabletter med umiddelbar frigivelse i doseringer på 1 mg, 2 mg eller 4 mg kontrolleres lige så godt med doxazosin-depottabletter indeholdende 4 mg.
English: The pharmacokinetic properties of doxazosin in prolonged-release tablets lead to a minor variation in plasma levels.
Danish: De farmakokinetiske egenskaber ved doxazosin som depottabletter leder til en mindre variation i plasmaniveauer.
English: Pharmacokinetic studies with doxazosin immediate release tablets in patients with renal impairment did not show any significant alterations compared to that of patients with normal renal function.
Danish: Farmakokinetiske undersøgelser med doxazosin-tabletter med umiddelbar frigivelse hos patienter med nedsat nyrefunktion viste ingen signifikante ændringer sammenlignet med dem for patienter med normal nyrefunktion.
English: Doxazosin has been shown to inhibit phenylephrine induced contraction in the prostate.
Danish: Doxazosin har vist sig at hæmme kontraktion induceret af fenylefrin i prostata.
English: If you stop taking Doxastad 4 mg prolonged release tablets and associated names Keep taking your tablets until your doctor tells you to stop.
Danish: IHvis De holder op med at tage Doxastad 4 mg depottabletter og dermed forbundne navne Bliv ved med at tage Deres tabletter, indtil Deres læge giver Dem besked på at holde op.
English: Animal studies have shown that doxazosin is accumulated in the milk.
Danish: Dyreforsøg har vist, at doxazosin akkumuleres i mælken.
English: Doxazosin, as other medicinal products metabolised by the liver, should be administered with caution in patients with signs of minor to moderate hepatic impairment (see section 5.2).
Danish: Doxazosin bør, som andre lægemidler, der metaboliseres i leveren, gives med forsigtighed til patienter med tegn på lettere til moderat nedsat leverfunktion (se pkt.
English: The adverse reactions considered at least possibly related to treatment are listed below by body system organ class and absolute frequency.
Danish: Bivirkningerne er angivet efter organsklasse og absolut hyppighed.
English: Tel: 0049 6101 603301 Fax: 0049 6101 603151
Danish: Tlf.: 0049 6101 603301 Fax: 0049 6101 603151
English: The following undesirable effects have been reported in controlled clinical trials with doxaszosin prolonged-release tablets.
Danish: De følgende bivirkninger er blevet rapporteret i kontrollerede kliniske forsøg med doxaszosindepottabletter.
English: Pharmacokinetic studies with doxazosin prolonged-release tablets in the elderly have shown no significant alterations compared to younger patients.
Danish: Farmakokinetiske undersøgelser med doxazosin-depottabletter hos ældre har vist, at der ikke er signifikante ændringer sammenlignet med yngre patienter.
English: Benign Prostatic hyperplasia:
Danish: Benign prostatahyperplasi:
English: Renal and urinary disorders: Increased diuresis, haematuria, urinary incontinence.
Danish: Sygdomme i nyre og urinveje: Øget diurese, haematuri, urin inkontinens.
English: Ear and labyrinth disorders: Tinnitus, vertigo.
Danish: Sygdomme i det ydre og indre øre: Tinnitus, vertigo.
English: 10 Prolonged-release tablets 20 Prolonged-release tablets 28 Prolonged-release tablets 30 Prolonged-release tablets 50 Prolonged-release tablets 56 Prolonged-release tablets 60 Prolonged-release tablets 90 Prolonged-release tablets 98 Prolonged-release tablets 100 Prolonged-release tablets 140 Prolonged-release tablets
Danish: 10 depottabletter 20 depottabletter 28 depottabletter 30 depottabletter 50 depottabletter 56 depottabletter 60 depottabletter 90 depottabletter 98 depottabletter 100 depottabletter 140 depottabletter
English: Methacrylic acid - ethyl acrylate copolymer (1:1) Colloidal anhydrous silica
Danish: Tabletovertræk: Methacrylsyre - ethylakrylat copolymer (1:1)
English: Simultaneous administration of sildenafil or other PDE-5 inhibitors to patients taking alpha-blocker therapy may lead to symptomatic hypotension in some patients (see section 4.5).
Danish: Samtidig administration af sildenafil eller andre PDE-5 hæmmere til patienter, der tager alfablokerende behandling kan lede til symptomatisk hypotension hos visse patienter (se pkt.
English: • if you have or have had any form of obstruction of the digestive tract
Danish: • hvis De har eller har haft tilstoppelse eller forsnævring af fordøjelseskanalen
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Hvis De tager eller for nylig har taget andre lægemidler, bør De oplyse Deres læge herom, også hvis der er tale om ikke-receptpligtige lægemidler.
English: Marketing Authorisation Holder
Danish: Indehaver af markedsføringstilladelse Ansøger
English: Vascular disorders: Cerebrovascular accidents.
Danish: Karsygdomme: Cerebrovaskulære hændelser.
English: The Netherlands Tel: 0031 765 081000 Fax: 0031 765 035614
Danish: Nederlandene Tlf.: 0031 765 081000 Fax: 0031 765 035614
English: Skin and subcutaneous tissue disorders: Rash, pruritus, purpura.
Danish: Sygdomme i hud og subkutane væv: Udslæt, pruritus, purpura.
English: 5 PHARMACOLOGICAL PROPERTIES
Danish: 5 FARMAKOLOGISKE EGENSKABER
English: Eye disorders: Blurred vision.
Danish: Øjensygdomme: Sløret syn.
English: GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ(ER), ETIKETTERING OG INDLÆGSSEDDEL
English: Doxazosin should be administered with caution in patients with signs of minor to moderate hepatic impairment.
Danish: Doxazosin bør gives med forsigtighed til patienter med tegn på mindre til moderat nedsat leverfunktion.
English: Common side effects include (occurs in more than 1 patient of 100): dizziness, postural dizziness (dizziness as a result of getting up from a sitting or lying position), rhinitis (nasal stuffiness and/or runny nose), diarrhoea, nausea, vomiting, gastritis (inflammation of the lining of the stomach), headache, fatigue, oedema (swelling), somnolence, asthenia (weakness), mouth dryness.
Danish: Almindelige bivirkninger omfatter (forekommer hos mere end 1 patient ud af 100): Svimmelhed, postural svimmelhed (svimmelhed som et resultat af at rejse sig fra en siddende eller liggende stilling), rhinit (tilstopning af næsen og/eller løbende næse), diaré, kvalme, opkastning, gastrit (inflammation af mavesækkens slimhinde), hovedpine, træthed, ødem (opsvulmen), somnolens, astheni (svaghed), mundtørhed.
English: What Doxastad 4 mg prolonged release tablets and associated names contains - The active substance is doxazosin (as mesilate).
Danish: Hvad Doxastad 4 mg depottabletter og dermed forbundne navne indeholder - Det aktive stof er doxazosin (som mesilat).
English: Cardiac disorderst: Arrhythmia, tachycardia, palpitations, angina pectoris, myocardial infarction.
Danish: Hjertesygdomme: Arytmi, takykardi, palpitationer, angina pectoris, myokardieinfarkt.
English: Do not take Doxastad 4 mg prolonged release tablets and associated names if you are pregnant or breast-feeding.
Danish: De må ikke tage Doxastad 4 mg depottabletter og dermed forbundne navne, hvis De er gravid eller ammer.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Oral anvendelse
English: High levels of alpha-1-adrenoreceptors have been observed in the prostatic muscular stroma, the proximal part of the urethra and base of the urinary bladder, which medicates smooth muscle tonus in the prostatic part of the urethra.
Danish: Der er observeret høje niveauer af alfa-1-adrenoreceptorer i prostatas muskulære stroma, den proksimale del af urethra og basis af urinblæren.
English: Or you may have been prescribed Doxastad 4 mg prolonged release tablets and associated names to treat the symptoms of Benign Prostatic Hyperplasia (BPH).
Danish: En anden grund til at De har fået ordineret Doxastad 4 mg depottabletter og dermed forbundne navne kan være, at tabletterne skal bruges til at behandle symptomerne på benign prostatahyperplasi (BPH).
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF Doxastad 4 mg prolonged release tablets and associated names (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF Doxastad 4 mg depottabletter og de tilknyttede navne ( se bilag I)
English: If you take too many tablets, the most likely symptoms of overdose would be a feeling of lightheadedness or dizziness due to a fall in blood pressure.
Danish: Hvis De tager flere Doxastad 4 mg depottabletter og dermed forbundne navne, end De bør Hvis De tager for mange tabletter, vil de mest sandsynlige symptomer på overdosering være en følelse af ørhed eller svimmelhed grundet et fald i blodtrykket.
English: Doxastad 4 mg prolonged release tablets and associated names works by relaxing muscle around the bladder exit and prostate gland, making it easier to pass urine.
Danish: Doxastad 4 mg depottabletter og dermed forbundne navne fungerer ved at afslappe musklen omkring blæreudgangen og prostatakirtlen, så det bliver nemmere at lade vandet.
English: • if you have benign prostatic hyperplasia and concomitant congestion of the upper urinary tract,
Danish: • hvis De har benign prostatahyperplasi og samtidig tilstopning af de øvre urinveje, kronisk urinvejsinfektion eller blæresten
English: Animal studies have shown that doxazosin accumulates in breast milk.
Danish: Undersøgelser på dyr har vist, at doxazosin akkumuleres i modermælk.
English: Doxastad 4 mg prolonged release tablets and associated names should therefore not be administered to breastfeeding women.
Danish: Doxastad 4 mg depottabletter og dermed forbundne navne bør derfor ikke gives til ammende mødre.
English: Headache, dizziness, unconsciousness, syncope, dyspnoea, hypotension, palpitations, tachycardia, arrhythmia.
Danish: Hovedpine, svimmelhed, bevidstløshed, synkope, dyspnøe, hypotension, palpitationer, takykardi, arytmi.
English: Patients should be closely monitored in the initial phase of the treatment due to the risk of postural adverse events.
Danish: På grund af risikoen for posturale bivirkninger bør patienterne følges tæt i den indledende fase af behandlingen.
English: Headache, fatigue, malaise, oedema, somnolence, asthenia, mouth dryness.
Danish: Hovedpine, træthed, utilpashed, ødem, somnolens, astheni, mundtørhed.
English: Symptomatic treatment of benign prostatic hyperplasia.
Danish: Symptomatisk behandling af benign prostatahyperplasi.
English: Each prolonged-release tablet contains 4 mg of doxazosin (as mesilate).
Danish: Én depottablet indeholder 4 mg doxazosin (som mesilat).
English: Fax: 01635 568401
Danish: Tlf.: 01635 568400 Fax: 01635 568401
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Spørg Deres læge eller apotek, hvis De har yderligere spørgsmål.
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: Hvis en bivirkning bliver alvorlig, eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge.
English: Patients with renal impairment:
Danish: Patienter med nedsat nyrefunktion:
English: Metabolism and nutrition disorders: Gout.
Danish: Stofskiftesygdomme og ernæringsbetingede sygdomme: Podagra.
English: Symptomatic treatment of Benign prostatic hyperplasia:
Danish: Symptomatisk behandling af benign prostatahyperplasi:
English: As for other antihypertensives, including alpha-blocking agents, the patient should be monitored on initiation of therapy to minimise the potential risk for postural effects.
Danish: For at minimere den mulige risiko for posturale virkninger bør patienten - som ved andre antihypertensiver, inklusive alfa-blokerende midler - overvåges ved indledningen af behandlingen.
English: Musculoskeletal and connective tissue disorders: Myalgia, arthralgia, muscle cramps.
Danish: Sygdomme i bevægeapparatet og bindevæv: Myalgi, arthralgi, muskelkramper.
English: Doxazosin may be used in benign prostatic hyperplasia patients who are either hypertensive or normotensive, as the blood pressure reduction in normotensive patients is generally slight.
Danish: Eftersom reduktionen i blodtrykket hos normotensive patienter generelt er lille, kan Doxazosin anvendes til patienter med benign prostatahyperplasi, der er enten hypertensive eller normotensive.
English: Doxastad 4 mg prolonged release tablets and associated names can be taken with or without food.
Danish: Doxastad 4 mg depottabletter og dermed forbundne navne kan tages med eller uden mad.