FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Slovenian: Zaradi tega je možno, da ta Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo ne predstavljajo trenutno veljavnega besedila.
English: Effect and safety studies (with a total of 1,317 patients treated with doxazosin) have only been performed in patients with a baseline of ≥ 12 on the International Prostate Symptom Score and a maximum urinary flow of <15 ml/sec.
Slovenian: Študije učinkovitosti in varnosti (pri kateri je sodelovalo 1317 bolnikov, ki so jih zdravili z doksazosinom) so opravili samo na bolnikih z izhodiščnim rezultatom ≥ 12 na mednarodni lestvici prostatičnih simptomov in največjim pretokom urina < 15 ml/s.
English: Note: This SPC, labelling and package leaflet is the version that was annexed to the Commission Decision on this Article 29 referral for doxazosin mesilate containing medicinal products.
Slovenian: Opomba: Ta Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo so bili priloženi k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu z členom 29, za zdravila, ki vsebujejo doksazosinmezilat.
English: 4 CLINICAL PARTICULARS
Slovenian: 4 KLINIČNI PODATKI
English: Hypertension:
Slovenian: Hipertenzija:
English: - The scope of the referral was to agree whether Doxastad 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,
Slovenian: - Namen napotitve je bil doseči soglasje o tem, ali se zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem, kar se tiče profila sproščanja, pomembno razlikuje od originatorjevega zdravila, in ali je možnost pojavov neželenih učinkov, kot so omotica in hipotenzija, morebiti povečana; nadalje ali so bile razlike v rezultatih iz študij 5208 in 1995 testnih serij pri enkratnem odmerjanju pomembne, ter končno ali se je vlagatelj oddaljil od smernic pri oblikovanju bioekvivalenčnih raziskav, zlasti kar se tiče učinka, ki bi ga lahko imela hrana na ustrezno občutljivost za zaznavanje razlik med zdraviloma.
English: Doxazosin is extensively metabolised with <5% excreted as unchanged product.
Slovenian: V veliki meri se doksazosin presnavlja, v nespremenjeni obliki se ga izloči < 5 %.
English: The patient should not chew, divide or crush the tablet.
Slovenian: Bolnik tablete ne sme žvečiti, prelomiti ali zdrobiti.
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.
Slovenian: Blokiranje alfa-1-adrenoreceptorjev z doksazosinom zmanjšuje tonus gladkih mišic v prostatičnem delu uretre, kar olajša pretok urina.
English: Concomitant intake of food results in a somewhat higher degree of absorption, AUC is 14% higher and Cmax 23% higher compared with intake when fasting.
Slovenian: Vrednost AUC je za 14 % večja, vrednost Cmax pa je za 23 % večja v primerjavi z jemanjem na tešče.
English: Cerntrafarm Services B.V. Nieuwe Donk 9, 4879 AC
Slovenian: Nieuwe Donk 9, 4879 AC
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA(OV) GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EMEA
English: Treatment with doxazosin immediate release tablets has been shown to result in regression of left ventricular hypertrophy.
Slovenian: Pokazali so, da zdravljenje s tabletami doksazosina s takojšnjim sproščanjem povzroča regresijo hipertrofije levega prekata.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINOV UPORABE ZDRAVILA, VLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Tel: 0049 6101 603301 Fax: 0049 6101 603151
Slovenian: Tel: 0049 6101 603301 Faks: 0049 6101 603151
English: Most patients treated with Doxastad 4 mg prolonged release tablets and associated names once daily achieve control of blood pressure.
Slovenian: Večina bolnikov, ki jemlje zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena enkrat dnevno, doseže ustrezen nadzor krvnega tlaka.
English: Since there is no change in pharmacokinetics in patients with impaired renal function and since there are no signs that doxazosin aggravates existing renal impairment, normal dose can generally be used in these patients.
Slovenian: Pri bolnikih z ledvično okvaro ni sprememb farmakokinetike in ni znakov, da doksazosin poslabša obstoječo ledvično okvaro, zato se pri teh bolnikih lahko na splošno uporabi običajni odmerek.
English: • if you are undergoing dialysis
Slovenian: • če ste na dializi;
English: The tablets are white, round, biconvex tablets with “DL” embossed on one side.
Slovenian: Tablete so bele, okrogle, bikonveksne tablete z reliefnim napisom "DL" na eni strani.
English: Your doctor may have prescribed Doxastad 4 mg prolonged release tablets and associated names because your blood pressure is high, which if left uncontrolled can increase the risk of heart disease or stroke.
Slovenian: Zdravnik vam je morda predpisal zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena, ker imate visok krvni tlak, ki, če se ne zdravi, lahko poveča tveganje za nastanek srčne bolezni ali možganske kapi.
English: • if you have overflow bladder, anuria or progressive renal insufficiency
Slovenian: • če imate prelivno inkontinenco, anurijo ali progresivno ledvično okvaro.
English: Doxazosin improves insulin sensitivity in patients with impaired sensitivity to insulin.
Slovenian: Pri bolnikih z okvarjeno občutljivostjo za insulin doksazosin poveča občutljivost za insulin.
English: After oral administration of therapeutic doses, doxazosin prolonged-release tablets are well absorbed with peak blood levels gradually reached at 6 to 8 hours after dosing.
Slovenian: Po peroralnem jemanju terapevtskih odmerkov se tablete doksazosina s podaljšanim sproščanjem dobro absorbirajo, najvišje koncentracije v plazmi pa so postopoma dosežene v 6 do 8 urah po odmerjanju.
English: There are no studies available concerning interactions with agents influencing hepatic metabolism.
Slovenian: Študij o interakcijah s snovmi, ki vplivajo na jetrno presnovo, ni na voljo.
English: Do not chew, divide or crush the tablets.
Slovenian: Tablet ne žvečite, prepolovite ali zdrobite.
English: If you are not sure what to do, ask your doctor or pharmacist.
Slovenian: Če ne veste, kaj storiti, se posvetujte z zdravnikom.
English: Depending on clinical response, the dosage may be increased to 8 mg doxazosin once daily.
Slovenian: Glede na klinični odziv se lahko dnevni odmerek poveča na 8 mg doksazosina enkrat dnevno.
English: White, round, biconvex tablets, with bossing “DL” on one side.
Slovenian: Bela, okrogla, bikonveksna tableta z reliefnim napisom "DL" na eni strani.
English: Contains butylhydroxytoluene (E321)
Slovenian: Butilhidroksitoluen (E 321)
English: Use during lactation
Slovenian: Uporaba med dojenjem
English: Nervous system disorders: Tremor.
Slovenian: Bolezni živčevja: tremor.
English: The maximum recommended dose is 8 mg doxazosin once daily.
Slovenian: Največji priporočeni odmerek je 8 mg doksazosina enkrat dnevno.
English: - The other ingredients are polyethylene oxide, microcrystalline cellulose, povidone, butylhydroxytoluene (E321), all-rac-α-Tocopherol, colloidal anhydrous silica, sodium stearyl fumarate, methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30%, macrogol, and titanium dioxide (E171).
Slovenian: - Pomožne snovi so polietilenoksid, mikrokristalna celuloza, povidon, butilhidroksitoluen (E 321), dl-α-tokoferol, koloidni brezvodni silicijev dioksid, natrijev stearilfumarat, kopolimer metakrilne kisline in etilakrilata (1 : 1, 30-odstotna disperzija), makrogol in titanov dioksid (E 171).
English: Fax: 01635 568401
Slovenian: Faks: 01635 568401
English: Simultaneous administration of sildenafil or other PDE-5 inhibitors to patients taking alpha-blocker therapy may lead to symptomatic hypotension in some patients.
Slovenian: Sočasna uporaba sildenafila ali drugih zaviralcev PDE-5 pri bolnikih, ki jemljejo alfa-blokatorje, lahko pri nekaterih bolnikih povzroči simptomatsko hipotenzijo.
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).
Slovenian: Sočasna uporaba sildenafila ali drugih zaviralcev PDE-5 pri bolnikih, ki jemljejo alfa-blokatorje, lahko pri nekaterih bolnikih povzroči simptomatsko hipotenzijo (glejte poglavje 4.5).
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.
Slovenian: Med občasnimi neželenimi učinki (pojavijo se pri manj kot 1 bolniku od 100) so trombocitopenija (majhno število trombocitov, zaradi katerega lažje pride do krvavitev), levkopenija (majhno število levkocitov), putika, živčnost, tremor (tresenje), zamegljen vid, tinitus (zvenenje ali hrup v ušesih), vertigo (občutek vrtoglavice ali "vrtenja"), aritmija (občutek nerednega srčnega utripa), tahikardija (povečan srčni utrip), razbijanje srca, angina pektoris, miokardni infarkt (srčna kap), cerebrovaskularni inzult (možganska kap), dispneja (kratka sapa), kašelj, krčenje bronhijev, epistaksa (krvavitev iz nosu), anoreksija (izguba apetita), obstipacija (zaprtje), povečan apetit, ikterus (zlatenica), zvišanje vrednosti jetrnih encimov, izpuščaj, pruritus (srbenje), purpura (izpuščaj zaradi krvavitve pod kožo), mialgija (bolečine v mišicah), artralgija (bolečine v sklepih), mišični krči, povečana diureza (povečana prostornina izločenega urina), hematurija (kri v urinu), urinarna inkontinenca, priapizem (boleča vztrajna erekcija), impotenca, bolečine v prsnem košu, razdržljivost, zardevanje obraza.
English: Since no clinical experience from patients with severe hepatic insufficiency exists, use in these patients is not recommended.
Slovenian: Kliničnih izkušenj pri bolnikih s hudo jetrno okvaro ni, zato se uporaba pri teh bolnikih ne priporoča.
English: Choose a time that is convenient for you and take your tablets at this time each day.
Slovenian: Izberite si čas, ki vam ustreza, in jih jemljite ob tem času vsak dan. Tablete je treba pogoltniti cele z zadostno količino vode.
English: Animal studies have shown that doxazosin accumulates in breast milk.
Slovenian: Študije na živalih so pokazale, da se doksazosin kopiči v materinem mleku.
English: Vascular disorders: Cerebrovascular accidents.
Slovenian: Žilne bolezni: cerebrovaskularni inzult.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Slovenian: Zdravilo je pridobilo dovoljenje za promet v državah članicah EGP pod naslednjimi imeni: [Podatke je treba dopolniti ob zaključku postopka]
English: • if you suffer from liver disease
Slovenian: • če imate bolezen jeter;
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: Like all medicines, Doxastad 4 mg prolonged release tablets and associated names can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila lahko tudi zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena povzroči neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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
Slovenian: Bolniki z akutnimi srčnimi boleznimi: Kot pri drugih vazodilatatornih antihipertenzivih je treba biti v skladu z zdravniško prakso previden pri bolnikih z naslednjimi akutnimi srčnimi boleznimi: pljučni edem, ki je posledica aortne ali mitralne stenoze; srčna odpoved pri velikem minutnem volumnu; levo- ali desnostranska srčna odpoved, ki je posledica pljučne embolije, perikardnega izliva, velikega minutnega volumna ali nizkega tlaka polnjenja srca.
English: Essential hypertension:
Slovenian: Esencialna hipertenzija:
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).
Slovenian: Morda pa so vam predpisali zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena za zdravljenje simptomov benigne hiperplazije prostate (BPH - benign prostatic hyperplasia).
English: There are only limited data concerning patients with liver impairment and on the effects of medicinal products known to influence hepatic metabolism (e.g. cimetidine).
Slovenian: Podatki o bolnikih z jetrno okvaro in učinku zdravil, ki vplivajo na presnovo v jetrih (npr. cimetidin), so omejeni.
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.
Slovenian: Farmakokinetične študije tablet doksazosina s takojšnjim sproščanjem pri bolnikih z ledvično okvaro niso pokazale pomembnih razlik v primerjavi z uporabo pri bolnikih z normalnim delovanjem ledvic.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Slovenian: 9 DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET [Izpolni država članica]
English: Gastrointestinal disorders: Anorexia, obstipation, increased appetite.
Slovenian: Bolezni prebavil: anoreksija, zaprtost, povečan apetit.
English: Eye disorders: Blurred vision.
Slovenian: Očesne bolezni: zamegljen vid.
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.
Slovenian: Zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena se lahko uporablja samostojno ali v kombinaciji z drugimi zdravili, npr. tiazidnimi diuretiki, blokatorji betaadenoceptorjev, kalcijevimi antagonisti ali zaviralci ACE, če s samostojnim zdravljenjem z nobenim od teh zdravil ni mogoče doseči zadostnega učinka.
English: Peak plasma levels are approximately one third of the level obtained after administration of immediate release doxazosin tablets.
Slovenian: Najvišje koncentracije v plazmi so približno ena tretjina koncentracij po uporabi tablet doksazosina s takojšnjim sproščanjem.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated toxicity, toxicity to reproduction, genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki na podlagi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, vpliva na sposobnost razmnoževanja, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: - This medicine has been prescribed for you.
Slovenian: - Zdravilo je bilo predpisano vam osebno in ga NE smete dajati drugim.
English: Cartons with 10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 140 (10x14) prolonged-release tablets Calendar packs of 28 and 98 prolonged-release tablets Unit dose pack of 50 x 1 prolonged-release tablets Not all pack sizes may be marketed.
Slovenian: Škatle z 10, 20, 28, 30, 50, 56, 60, 90, 98, 100 in 140 (10 x 14) tabletami s podaljšanim sproščanjem.
English: Headache, fatigue, malaise, oedema, somnolence, asthenia, mouth dryness.
Slovenian: glavobol, utrujenost, občutek nelagodja, edem, somnolenca, astenija, suha usta.
English: Doxazosin has a beneficial effect on blood lipids with significant increase of HDL/total cholesterol ratio (app. 4-13% of base line values).
Slovenian: Doksazosin ima ugoden učinek na lipide v krvi ter pomembno poveča razmerje holesterola HDL in skupnega holesterola (pribl.
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.
Slovenian: Odmerek zdravila Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena je enak, ne glede na to, ali ga jemljete za zdravljenje visokega krvnega tlaka ali simptomov benigne hiperplazije prostate.
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.
Slovenian: Analiza dveh študij odmerka in učinka (pri katerih je sodelovalo 630 bolnikov, ki so jih zdravili z doksazosinom) je pokazala, da je bil nadzor bolezni pri bolnikih, ki so prejemali odmerke 1 mg, 2 mg ali 4 mg v obliki tablet s takojšnjim sproščanjem, enak kot pri bolnikih, ki so prejemali 4-miligramske tablete doksazosina s podaljšanim sproščanjem.
English: Pharmacotherapeutic group: Alpha-adrenoreceptor antagonists
Slovenian: Farmakoterapevtska skupina: zaviralci alfa-adrenergičnih receptorjev.
English: 4 POSSIBLE SIDE EFFECTS
Slovenian: 14 MOŽNI NEŽELENI UČINKI
English: Headache, dizziness, unconsciousness, syncope, dyspnoea, hypotension, palpitations, tachycardia, arrhythmia.
Slovenian: Glavobol, vrtoglavica, nezavest izguba zavesti, sinkopa, dispneja, hipotenzija, palpitacije, tahikardija, aritmija.
English: The Netherlands Tel: 0031 765 081000 Fax: 0031 765 035614
Slovenian: Tel: 0031 765 081000 Faks: 0031 765 035614
English: 8 MARKETING AUTHORISATION NUMBER [To be completed nationally]
Slovenian: 8 ŠTEVILKA DOVOLJENJA ZA PROMET [Izpolni država članica]
English: Pharmacokinetic studies with doxazosin prolonged-release tablets in the elderly have shown no significant alterations compared to younger patients.
Slovenian: Farmakokinetične študije tablet doksazosina s podaljšanim sproščanjem pri starejših bolnikih niso pokazale pomembnih razlik v primerjavi z mlajšimi bolniki.
English: Cardiac disorderst: Arrhythmia, tachycardia, palpitations, angina pectoris, myocardial infarction.
Slovenian: Srčne bolezni: aritmija, tahikardija, palpitacije, angina pektoris, miokardni infarkt.
English: Ear and labyrinth disorders: Tinnitus, vertigo.
Slovenian: Ušesne bolezni, vključno z motnjami labirinta: tinitus, vertigo.
English: Blood and lymphatic system disorders: Thrombocytopenia, leukopenia.
Slovenian: Bolezni krvi in limfatičnega sistema: trombocitopenija, levkopenija.
English: If necessary, the dose can thereafter be increased to 8 mg once daily depending on the clinical response.
Slovenian: Po potrebi se glede na klinični odziv lahko odmerek nato poveča na 8 mg enkrat dnevno.
English: The pharmacokinetic properties of doxazosin in prolonged-release tablets lead to a minor variation in plasma levels.
Slovenian: Farmakokinetične lastnosti tablet doksazosina s podaljšanim sproščanjem so vzrok za manjše razlike pri koncentracijah v plazmi.
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.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena vpliva na sposobnost vožnje in upravljanja s stroji, zlasti na začetku zdravljenja.
English: This leaflet was last approved in [To be completed nationally].
Slovenian: Navodilo je bilo odobreno [Izpolni država članica].
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF Doxastad 4 mg prolonged release tablets and associated names (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA Doxastad 4 mg tablete s podaljšanim sproščanjem in z njim povezanih imen (glejte Dodatek I)
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).
Slovenian: Pri bolnikih z znaki manjše do zmerne jetrne okvare je treba doksazosin tako kot druga zdravila, ki se presnavljajo v jetrih, uporabljati previdno (glejte poglavje 5.2).
English: Tablet coat:
Slovenian: Obloga tablete:
English: Patients with renal impairment:
Slovenian: Bolniki z ledvično okvaro:
English: Renal and urinary disorders: Increased diuresis, haematuria, urinary incontinence.
Slovenian: Bolezni sečil: povečana diureza, hematurija, urinarna inkontinenca.
English: There is no information available on accumulation of doxazosin in human breast milk.
Slovenian: Podatkov o kopičenju doksazosina v materinem mleku ni.
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.
Slovenian: Med pogostimi neželenimi učinki (pojavijo se pri več kot 1 bolniku od 100) so vrtoglavica, položajna vrtoglavica (vrtoglavica, ki je posledica vstajanja iz sedečega ali ležečega položaja), vnetje nosne sluznice (zamašen nos in/ali izcedek iz nosu), driska, slabost, bruhanje, gastritis (vnetje želodčne sluznice), glavobol, utrujenost, edem (otekanje), zaspanost, astenija (šibkost), suha usta.
English: Increase in plasma renin activity and tachycardia have rarely been seen during long-term treatment.
Slovenian: Pri dolgotrajnem zdravljenju so redko opazili povečanje aktivnosti renina v plazmi in tahikardijo.
English: The generic name for the active substance in Doxastad 4 mg prolonged release tablets and associated names is doxazosin, which is a quinazoline derivative.
Slovenian: Generično ime zdravilne učinkovine zdravila Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena je doksazosin, ki je derivat kinazolina.
English: Methacrylic acid - ethyl acrylate copolymer (1:1) Colloidal anhydrous silica
Slovenian: Kopolimer metakrilne kisline in etilakrilata (1 : 1)
English: Skin and subcutaneous tissue disorders: Rash, pruritus, purpura.
Slovenian: Bolezni kože in podkožja: izpuščaj, pruritus, purpura.