FrancophonIA/ELRC3.0 huggingface dataset:
English: They should be informed about the potential risk for injuries and measures of precaution to minimise orthostatic symptoms.
Danish: De skal orienteres om den potentielle risiko for læsioner og om foranstaltninger med henblik på at minimere ortostatiske symptomer.
English: If these symptoms persist or become a problem please contact your doctor.
Danish: Hvis symptomerne fortsætter eller bliver problematiske, så kontakt lægen.
English: Your doctor may wish to increase your dose to 8mg.
Danish: Deres læge kan vælge at øge doseringen til 8 mg.
English: You may feel faint or dizzy when standing up from a sitting or lying position especially at the beginning of your treatment or if you restart your treatment after a break.
Danish: De kan føle Dem svag eller svimmel, når De rejser Dem op efter at have siddet eller ligget, navnlig i begyndelsen af behandlingen, eller hvis De begynder på behandlingen igen efter en pause.
English: There are no adequate data from the use of doxazosin prolonged release tablets in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af doxazosin depottabletter hos gravide kvinder.
English: If you take too many tablets, tell your doctor immediately or go to the nearest hospital casualty department.
Danish: Hvis De kommer til at tage for mange tabletter, skal De straks kontakte Deres læge eller den nærmeste skadestue..
English: There are no studies concerning interactions with agents influencing hepatic metabolism.
Danish: Der er ingen studier vedrørende interaktionen med lægemidler, der påvirker levermetabolismen.
English: Chinoin Pharmaceuticals and Chemical Works Co Ltd 1045 Budapest, To utca 1-5 HUNGARY Tel: 0036 1 505 0000
Danish: Chinoin Pharmaceuticals and Chemical Works Co Ltd 1045 Budapest, To utca 1-5 UNGARN Tlf.: 0036 1 505 0000
English: Microcrystalline cellulose Povidone α-tocopherol
Danish: Mikrokrystallinsk cellulose Povidon α-tocopherol
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity.
Danish: De prækliniske sikkerhedsdata viser ingen særlig fare for mennesker på grundlag af konventionelle studier af sikkerhedsfarmakologi, toksicitet ved gentagen dosering, genotoksicitet og karcinogenicitet.
English: cough and cold remedies as they may contain Ephedrine, Phenylephrine.
Danish: hoste og kold afhjælpning, idet de kan indeholde efedrin, phenylephrin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Danish: OPLYSNINGER, SOM SKAL FREMGÅ AF EMBALLAGENS YDERSIDE ÆSKE
English: • medicine containing Dopamine, Metaraminol, Methoxamine, Adrenaline (Epinephrine)
Danish: • medicin der indeholder Dopamin, Metaraminol, Methoxamin, Adrenalin (Epinephrin)
English: Tell your doctor if you are already taking any of the following:
Danish: De skal fortælle det til lægen, hvis De tager et eller flere af følgende lægemidler::
English: Non-steroidal antirheumatics or estrogens may reduce the antihypertensive effect of doxazosin.
Danish: Ikke-steroidalt antireumatikum eller estrogener kan reducere doxazosins antihypertensive effekt.
English: With once daily dosing, clinically significant reductions in blood pressure are present throughout the day and at 24-hours post dose.
Danish: Med en daglig dosering opnås der en klinisk signifikant reduktion af blodtrykket hele dagen og 24 timer efter administration af dosis.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Nærværende lægemiddel er godkendt i medlemsstaterne i EØS med følgende navne [Udfyldes ved afslutning af proceduren]
English: Winthrop Medicaments 113, Bd Romain Rolland, 75014, Paris France Tel: 0033 (0) 1 57 63 33 33 Fax: 0033 (0) 1 57 63 33 30
Danish: Winthrop Medicaments 113, Bd Romain Rolland, 75014, Paris, Frankrig Tlf.: 0033 (0) 1 57 63 33 33 Fax: 0033 (0) 1 57 63 33 30
English: Winthrop Pharmaceuticals UK Ltd 1 Onslow Street, Guildford, Surrey GU1 4YS United Kingdom
Danish: Winthrop Pharmaceuticals UK Ltd 1 Onslow Street, Guildford, Surrey GU1 4YS Det Forenede Kongerige
English: • if you suffer from kidney problems, overflow incontinence (you do not feel the urge to urinate) or anuria
Danish: • Hvis De lider af nyreproblemer, ischuria paradoxa (De føler ikke behov for at urinere) eller anuri
English: Very rare effects seen in less than 1 in 10,000 patients include a reduction in red and white cells and platelets in the blood and an increase in urea and creatinine levels in the blood.
Danish: Meget sjældne bivirkninger, som ses hos færre end 1 ud af 10.000 patienter, omfatter: reduktion af erytrocytter, leukycytter og trombocytter i blodet og forhøjet urea- og creatininniveau i blodet.
English: Choose a time that is convenient and take your tablet at this time each day.
Danish: Vælg et tidspunkt på dagen, hvor det passer Dem bedst at tage tabletten.
English: Blood and the lymphatic system disorders: Very rare: Reduction of erythrocytes, leucocytes and thrombocytes
Danish: Sygdomme i blod- og lymfesystem: Meget sjælden: Reduktion af erytrocytter, leukocytter og trombocytter
English: Your medicine is in the form of a round biconvex white prolonged release tablet.
Danish: Deres medicin har form af en rund biconvex-depottablet.
English: • if you are suffering from heart disease
Danish: • Hvis De har en hjertesygdom
English: Doxazosin is one of a group of medicines called alpha-blockers and can be used to treat high blood pressure, or the symptoms caused by the enlargement of the prostate in men.
Danish: Doxazosin tilhører gruppen af alfa-blokkere og kan bruges til at behandle højt blodtryk eller symptomer på forstørret prostata hos mænd.
English: There are only limited data in patients with liver impairment and on the effects of medicinal products known to influence hepatic metabolism (e.g. cimetidine).
Danish: Der findes kun begrænsede data for patienter med leverforringelse og for effekten af lægemidler, som vides at påvirke levermetabolismen (fx cimetidin).
English: - The scope of the referral was to agree whether Doxazosin “Winthrop” 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food with concern regarding the adequate sensitivity of to detect a difference between products,
Danish: - hensigten med indbringelsen var at opnå enighed om, hvor vidt frigivelsesprofilen for Doxazosin “Winthrop” 4mg depottabletter og de tilknyttede navne afviger væsentligt fra det oprindelige lægemiddel og eventuelt medfører øget forekomst af bivirkninger såsom hypotension og svimmelhed, hvorvidt der er væsentlige forskelle i resultaterne af testbatcher i enkeltdosisfasen af undersøgelserne 5208 og 1995, hvor vidt ansøgeren ved udformningen af bioækvivalensundersøgelserne afviger fra CHMP's retningslinjer, navnlig når det gælder virkningen af fødevarer, og spørgsmålet om, hvorvidt denne afvigelse medfører, at undersøgelserne ikke er tilstrækkeligt følsomme til at kunne registrere forskelle mellem præparaterne,
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 eller apotek.
English: Polyethylene oxide
Danish: Polyetylenoxid
English: Psychiatric disorders:
Danish: Psykiatriske sygdomme:
English: • other medicine to lower blood pressure
Danish: • anden blodtryksregulerende medicin
English: Doxazosin potentiates the blood pressure lowering effect of other antihypertensives.
Danish: Doxazosin potenserer blodtrykket og reducerer antihypertensivas effekt.
English: Methacrylic acid copolymer (Eudragir L30 D-55) Macrogol 1300-1600
Danish: Natrium stearylfumarat Methacrylsyrecopolymer (Eudragir L30 D-55) Macrogol 1300-1600
English: - The other ingredients are: blends of polyethylene oxide preparations containing butylhydroxytoluene (E321), microcrystalline cellulose, povidone, α- tocopherol, colloidal anhydrous silica and sodium stearyl fumarate.
Danish: − Øvrige indholdsstoffer: blanding af polyetylenoxidpræparater indeholdende butylhydroxytoluen (E321), mikrokrystallinsk cellulose, polyvidon, α- tocopherol, kolloid ren silika og natriumstearylfumarat.
English: Symptomatic treatment of benign prostatic hyperplasia.
Danish: Symptomatisk behandling af benign prostatisk hyperplasi.
English: - The active substance is doxazosin mesilate.
Danish: − Det aktive indholdsstof doxazosinmesilat.
English: • painkillers called non-steroidal anti-inflammatory medicine (NSAIDs) eg.
Danish: • smertestillende medicin i form af ikke-steroide anti-inflammatoriske farmaka (NSAID), fx Ibuprofen
English: Benign hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infections or bladder stones
Danish: • Benign hyperplasi og samtidig kongestion af de øvre urinveje, kronisk urinvejsinfektion eller blæresten
English: The tablet coating contains methacrylic acid copolymer, colloidal anhydrous silica, macrogol and titanium dioxide (E171).
Danish: Tabletten er belagt med methacrylsyrecopolymer, kolloid ren silika, macrogol og titaniumdioxid (E171).
English: • If you have any kind of congestion or blockage in your urinary tract, an infection of the urinary tract or have bladder stones
Danish: • Hvis De har nogen form for tilstopning eller blokering i urinvejene, infektion i urinvejene eller blæresten
English: In hypertensive patients with one or more additional risk factors for cardiovascular disease, doxazosin prolonged release tablets should not be used as a single agent for the first-line treatment of hypertension due to a possible increased risk for development of heart failure.
Danish: På grund af en eventuel forhøjet risiko for udvikling af hjertefejl bør doxazasin-tabletter med forlænget afgivelse ikke anvendes som eneste behandlende middel ved førstevalgsbehandling af hypertension hos hypertensive patienter med en eller flere yderligere risikofaktorer for kardiovaskulær sygdom.
English: Each tablet contains the active ingredient doxazosin mesilate equivalent to 4mg of doxazosin.
Danish: Hver tablet indeholder det aktive indholdsstof doxazosinmesilat svarende til 4 mg doxazosin.
English: • if you are suffering from liver disease
Danish: • Hvis De har en leversygdom
English: Tel: 0049 (0) 81 41 3572
Danish: Tlf.: 0049 (0) 81 41 3572
English: Additionally, doxazosin improves insulin sensitivity in patients with impaired sensitivity to insulin, but also concerning this finding the clinical relevance is still uncertain.
Danish: Endvidere styrker doxazosin insulinsensitiviteten hos patienter med forringet sensitivitet for insulin.
English: Hypersensitivity to the active substance, other quinazolines (e.g. prazosin, terazosin), or to any of the excipients
Danish: • Overfølsomhed for det aktive stof, quinazolin (fx prazosin, terazosin), eller for et af hjælpestofferne
English: In patients with an enlargement to the prostate gland, a common side effect is poor and/or frequent passing of urine.
Danish: Hos patienter med forstørret prostata er dårlig og/eller jævnlig vandladning en normal bivirkning.
English: Like all medicines, Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne have bivirkninger, selvom ikke alle får bivirkninger.
English: Renal and urinary disorders:
Danish: Sygdomme i nyre og urinveje:
English: Caution is also recommended when doxazosin prolonged release tablets is administered concomitantly with medicinal products which may influence hepatic metabolism (e.g. cimetidine).
Danish: Det anbefales at være forsigtig med at give doxazosin-tabletter med forlænget afgivelse samtidigt med lægemidler, som kan påvirke levermetabolismen (fx cimetidin).
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]should be administered with caution in patients with the following acute heart diseases: Pulmonary oedema as a result of aortic or mitral stenosis, heart failure at high output, right sided heart failure as a result of pulmonary embolism or pericardiac effusion and left sided ventricular heart insufficiency with low filling pressure.
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne skal gives med forsigtighed til patienter med følgende akutte hjertesygdomme: Lungeødem som følge af aorta- eller mitralstenose, hjertefejl ved høj volumen, højresidet hjertefejl som følge af lungeembolisme eller perikardial ekssudation og venstresidet ventrikulær hjerteinsufficiens med lavt fyldningstryk.
English: Uncommon: flushing, fever/shiver, paleness Rare: low body temperature in elderly
Danish: Ualmindelig: blussen, feber/kulderysten, bleghed Sjælden: lav kropstemperatur hos ældre
English: At steady-state, the relative bioavailability of doxazosin from Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]prolonged release tablets compared to immediate release form was 54% at the 4 mg dose and 59% at the 8 mg dose.
Danish: Ved steady state udgjorde den relative biotilgængelighed af doxazosin fra Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne og tabletter med forlænget afgivelse - sammenlignet med tabletter med øjeblikkelig afgivelse - 54 % ved dosering på 4 mg og 59 % ved dosering på 8 mg.
English: Special care should be taken with hypotensive patients or patients with known orthostatic dysregulation taking doxazosin prolonged release tablets to treat benign prostatic hyperplasia (BPH).
Danish: Hypotensive patienter eller patienter med kendt ortostatisk dysregulation, som tager doxazosin-tabletter med forlænget afgivelse, kræver særlig opmærksomhed med henblik på behandling af benign prostatahyperplasi (BPH).
English: EXPIRY DATE
Danish: UDLØBSDATO UDLØB
English: In patients treated for benign prostatic hyperplasia and without hypertension mean blood pressure changes are small, but hypotension, dizziness, fatigue occur in 10 - 20% of the patients and oedema and dyspnoea occur in less than 5% of patients.
Danish: 10 - 20 % af patienterne oplever hypotension og træthed, og mindre end 5 % af patienterne oplever ødem og dyspnø.
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]are available in blister packs of 28, 30 and 100 tablets.
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne fås i blisterpakninger med 28, 30 og 100 tabletter.
English: Overflow bladder, anuria or progressive renal insufficiency History of oesophageal or gastrointestinal obstruction or decreased lumen diameter of the gastrointestinal tract
Danish: • Tidligere øsofageal eller gastrointestinel obstruktion eller reduceret lumendiameter af mave-tarm kanalen
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]may be used in benign prostatic hyperplasia (BPH) patients who are either hypertensive or normotensive, as the blood pressure changes in normotensive patients are clinically insignificant.
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne kan anvendes til patienter med benign prostatahyperplasi (BPH), som enten er hypertensive eller normotensive, idet blodtryksændringer i normotensive patienter er klinisk insignifikant.
English: Winthrop Pharmaceuticals UK Ltd 1 Onslow Street, Guildford, Surrey GU1 4YS United Kingdom Tel: 00 44 (0) 1483 55 4831 Fax: 00 44 (0) 1483 55 4831
Danish: Winthrop Pharmaceuticals UK Ltd 1 Onslow Street, Guildford, Surrey GU1 4YS Det Forenede Kongerige Tlf.: 00 44 (0) 1483 55 4831 Fax: 00 44 (0) 1483 55 4831
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]should not be used during pregnancy unless clearly needed.
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne må ikke bruges ved graviditet, medmindre der er et tydeligt behov herfor.
English: Throughout the recommended dosage range, Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]has only a minor or no effect on blood pressure in normotensive benign prostatic hyperplasia (BPH) patients.
Danish: For hele det anbefalede doseringsområde har Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne kun mindre eller ingen effekt på blodtrykket i patienter med normotensiv benign prostatahyperplasi (BPH).
English: Headache, dizziness, unconsciousness, syncope, dyspnoea, hypotension, palpitation, tachycardia, arrhythmia.
Danish: Hovedpinde, svimmelhed, bevidstløshed, dyspnø, hypotension, hjertebanken, takykardi, arytmi.
English: Patients with renal impairment: Since there is no change in pharmacokinetics in patients with impaired renal function, and since there are no signs that doxazosin prolonged release tablets aggravates existing renal impairment, the usual dose can be used in these patients.
Danish: : Der forekommer ikke ændringer i farmakokinetikken hos patienter med nyreskader, og der er heller ikke er tegn på, at doxazosin-tabletter med forlænget afgivelse forværrer allerede eksisterende nyreskader.
English: Winthrop Pharmaceuticals UK Ltd 1 Onslow Street, Guildford, Surrey GU1 4YS United Kingdom Tel: 00 44 (0) 1483 55 4831 Fax: 00 44 (0) 1483 55
Danish: Winthrop Pharmaceuticals UK Ltd 1 Onslow Street, Guildford, Surrey GU1 4YS Det Forenede Kongerige Tlf.: 00 44 (0) 1483 55 4831 Fax: 00 44 (0) 1483 55
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]may influence plasma renin activity and urinary excretion of vanillylmandelic acid.
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne kan påvirke plasmareninaktiviteten og urinekskretion af vanillinmandelsyre.
English: • if you have or have had in the past any form of obstruction of the digestive tract.
Danish: • Hvis De har eller har haft tilstopning af mave-tarm-kanalen.
English: Before surgery or anaesthesia even at the dentist, you should tell the doctor or the dentist that you are taking {Invented name}.
Danish: Før operation eller anæstesi (også hos tandlægen) skal De oplyse lægen eller tandlægen om, at De tager Doxazosin Winthrop 4 mg depottablette og dermed forbundne navne.
English: Animal studies have shown reduced foetal survival at high doses (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet (se pkt.
English: In patients with hypertension, the decrease in blood pressure during treatment with Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]was similar in both the sitting and standing position.
Danish: Hos patienter med hypertension var blodtrykssænkningen under behandlingen med Doxazosin Winthrop 4 mg med forlænget afgivelse og tilhørende navne den samme målt både i siddende og stående tilstand.
English: Rare side effects, seen in more than 1 in 10,000 patients but less than 1 out of 1,000, include low blood sugar levels, depression, feeling restless (agitation), pins and needles, blurred vision, stroke (cerebrovascular disturbance), swelling of the voice box, abdominal pain, diarrhoea, vomiting, jaundice, increased liver enzymes in the blood, rash, itching or reddening of the skin, impotence, painful, persistent erection of the penis and low body temperature (especially in the elderly).
Danish: Sjældne bivirkninger, som ses hos mere end 1 ud af 10.000 patienter men mindre end 1 ud af 1.000, omfatter: lavt blodsukker, depression, rastløshed (agitation), paræstesi, sløret syn, slagtilfælde (cerebrovaskulær forstyrrelse), hævelse af stemmebåndet, abdominal smerte, diarré, opkastning, gulsot, øget leverenzymer i blodet, udslæt, kløe og rødmen af huden, impotens, smerte, vedvarende erektion af penis og lav kropstemperatur (navnlig hos ældre).
English: Patients with hepatic impairment: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]should be given with particular caution to patients with evidence of impaired liver function.
Danish: Patienter med leverskader: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne skal gives med særlig forsigtighed til patienter med alvorlige leverskader.
English: Uncommon effects, seen in more than 1 out of 1,000 patients but less than 1 in 100 patients, include low levels of potassium in the blood, gout, increased thirst, nightmares, forgetfulness (amnesia), emotional instability, tremor, muscle stiffness, increased tear production, abnormal intolerance to light, ringing in the ears (tinnitus), heart flutters, angina pectoris, an increase or slowing of the heart rate, heart attack, low blood pressure especially on getting up from a sitting or lying position, reduced blood supply to the limbs, dizziness on standing (syncope), nose bleeds, tightening of the chest, cough, throat inflammation, lack of appetite or increased appetite, taste disturbances, hair loss, swelling of the face and joints, muscle pain, swelling of joint and pain (arthralgia), muscle weakness, incontinence, difficulty with or pain on urinating, flushing, fever (shivers) and loss of colour.
Danish: Unormale bivirkninger, som ses hos mere end 1 ud af 1.000 patienter men mindre end 1 ud af 100 patienter omfatter: lavt kaliumindhold i blodet, gigt, forhøjet tørst, mareridt, glemsomhed (amnesi), labilitet, rystebevægelse, muskelstivhed, øget tåreproduktion, abnorm lysfølsomhed, ringen for øret (tinnitus), hjerteflimren, angina pectoris, øget eller langsommere hjerteslag, hjerteanfald, lavt blodtryk navnlig når man rejser sig efter at have siddet eller ligget, reduceret blodtilførsel til benene, svimmelhed når man står op (besvimelse), næseblødning, sammentrækning i brystet, hoste, halsbetændelse, manglende appetit eller øget appetit, smagsforstyrrelse, hårtab, hævelse i ansigtet eller led, muskelsmerte, hævelse af led og smerte (ledsmerte), muskelsvækkelse, inkontinens, problemer med eller smerte ved urinering, rødmen, feber (kulderysten) og farvetab.
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]should be used with care in patients with Diabetic Autonomic Neuropathy.
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne skal anvendes med forsigtighed til patienter med diabetisk autonomisk neuropati.
English: Children and adolescents: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]is not recommended for use in children and adolescents due to a lack of clinical experience.
Danish: Børn og unge: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne anbefales ikke til børn og unge på grund af manglende klinisk erfaring.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Tal med lægen eller apoteket, hvis der er noget, De føler Dem usikker på eller er i tvivl om.
English: Since no clinical experience from patients with severe hepatic insufficiency exists, use in these patients is not recommended.
Danish: Der er ingen klinisk erfaring med patienter med alvorlig leverinsufficiens.
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]work by relaxing the muscle around the bladder exit and prostate gland, which allows the urine to pass more easily.
Danish: Doxazosin Winthrop 4 mg depottabletter og dermed forbundne navne fungerer ved at afslappe musklen omkring blæreåbningen og prostata, så det bliver nemmere for urinen at passere.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF Doxazosin “Winthrop” 4 mg depottabletter og de tilknyttede navne ( se bilag I)