FrancophonIA/ELRC3.0 huggingface dataset:
English: MA (EU) Number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size blister (PVC/alu)
Slovenian: Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
English: Medicinal product no longer authorised
Slovenian: Zdravilo nim a več dovoljenja za prom et
English: In some Member States, these medicines were available without prescription.
Slovenian: V nekaterih državah članicah so bila ta zdravila na voljo brez recepta.
English: The review of fusafungine-containing medicines was initiated on 11 September 2015 at the request of Italy, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled zdravil, ki vsebujejo fuzafungin, se je začel 11. septembra 2015 na zahtevo Italije v skladu s členom 31 Direktive 2001/83/ES.
English: They were authorised through national approval procedures under various trade names (Bioparox, Fusaloyos, Locabiotal and Locabiosol) in the following countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Portugal, Romania, Slovakia and Spain.
Slovenian: Odobrena so bila z nacionalnimi postopki odobritve pod različnimi tržnimi imeni (Bioparox, Fusaloyos, Locabiotal and Locabiosol) v naslednjih državah: Avstrija, Belgija, Bolgarija, Ciper, Češka republika, Estonija, Nemčija, Grčija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Malta, Portugalska, Romunija, Slovaška in Španija.
English: Fusafungine-containing medicines have been available in several EU countries for over 50 years.
Slovenian: Zdravila, ki vsebujejo fuzafungin, so bila na voljo v različnih državah EU več kot 50 let.
English: • Healthcare professionals should advise patients on alternative treatments, if needed.
Slovenian: • Zdravstveni delavci bi morali bolnikom po potrebi svetovati nadomestno zdravljenje.
English: The CMDh is a regulatory body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Slovenian: Skupina CMDh je regulativni organ, ki zastopa države članice EU ter Islandijo, Lihtenštajn in Norveško.
English: As fusafungine-containing medicines are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position on 31 March 2016.
Slovenian: Ker so vsa zdravila, ki vsebujejo fuzafungin, odobrena na nacionalni ravni, so bila priporočila odbora PRAC posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče 31. marca 2016.
English: • These sprays are being taken off the market in the EU because of rare cases of serious allergic reactions and the lack of strong evidence that these medicines work.
Slovenian: • Ta pršila se jemljejo s trga v EU zaradi redkih primerov resnih alergijskih reakcij in pomanjkanja trdnih dokazov, da so ta zdravila učinkovita.
English: In addition, there were concerns about the potential for fusafungine to promote antibiotic resistance (the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth).
Slovenian: Poleg tega se je pojavila zaskrbljenost, da ima fuzafungin potencial za spodbujanje antibiotične odpornosti (sposobnosti bakterij, da rastejo v prisotnosti antibiotika, ki bi jih navadno ubil ali omejil njihovo rast).
English: During its review the PRAC consulted EMA's paediatric scientific committee as well as experts in the field of anti-infective medicines.
Slovenian: Med pregledom se je odbor PRAC posvetoval z znanstvenim odborom za pediatrijo agencije EMA in s strokovnjaki za zdravila proti okužbam.
English: Although the review found that serious allergic reactions are rare, they can be life-threatening and no measures have been identified to sufficiently reduce or manage this risk.
Slovenian: Čeprav je bilo med pregledom ugotovljeno, da so resne alergijske reakcije redke, so lahko smrtno nevarne, poleg tega ni opredeljenih ukrepov, ki bi zadostno zmanjšali ali obvladali to tveganje.
English: Medicines to be withdrawn due to serious allergic reactions and limited evidence of benefit
Slovenian: Zdravila, ki jih je treba umakniti zaradi resnih alergijskih reakcij in omejenih dokazov o koristih.
English: The benefit-risk balance for fusafungine-containing medicines is therefore negative for all currently authorised uses.
Slovenian: Razmerje med tveganji in koristmi zdravil, ki vsebujejo fuzafungin, je zato negativno za vse trenutno odobrene uporabe.
English: With regard to the benefits, the evidence for beneficial effects of fusafungine is weak.
Slovenian: Kar zadeva koristi, so dokazi za koristne učinke fuzafungina šibki.
English: This follows a review by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which concluded that the benefits of fusafungine do not outweigh its risks, particularly the risk of serious allergic reactions.
Slovenian: To izhaja iz pregleda Odbora za oceno tveganja na področju farmakovigilance (PRAC) agencije EMA, ki je sklenil, da koristi fuzafungina ne odtehtajo njegovih tveganj, zlasti tveganja za resne alergijske reakcije.
English: Although there is insufficient evidence to establish that fusafungine can increase the risk of resistance, this risk could not be ruled out.
Slovenian: Čeprav ni dovolj dokazov za utemeljitev, da lahko fuzafungin poveča tveganje za razvoj odpornosti, tega tveganja ni mogoče izključiti.
English: The CMDh1 has endorsed by consensus the revocation of marketing authorisations for fusafungine sprays in the EU.
Slovenian: Skupina CMDh1 je soglasno podprla razveljavitev dovoljenj za promet s pršili s fuzafunginom v EU.
English: Serious allergic reactions have occurred soon after the use of these sprays and involved bronchospasm (excessive and prolonged contractions of the airway muscles leading to difficulty breathing).
Slovenian: Kmalu po uporabi teh pršil so se pojavile resne alergijske reakcije, med drugim bronhospazem (čezmerno in podaljšano krčenje mišic dihal, ki povzroči oteženo dihanje).
English: • Upper airway infections are usually mild and self-limiting.
Slovenian: • Okužbe zgornjih dihal so navadno blage in izzvenijo same.
English: Following the CMDh consensus position, EU Member States will start revoking the marketing authorisations of these medicines in their territories, according to an agreed timetable.
Slovenian: V skladu s soglasnim stališčem skupine CMDh bodo države članice EU začele z razveljavitvijo dovoljenj za promet s temi zdravili na svojih ozemljih po dogovorjeni časovnici.
English: Fusafungine is an antibiotic and anti-inflammatory medicine used in the form of a nasal and oromucosal (to be applied to the mouth) spray for the treatment of the following infections of the upper airways: sinusitis (sinus infection), rhinitis (stuffy and runny nose), rhinopharyngitis (common cold), tonsillitis (inflammation of the tonsils caused by an infection) and laryngitis (inflammation of the voice box).
Slovenian: Fuzafungin je antibiotično in protivnetno zdravilo, ki se uporablja v obliki nazalnega in oromukoznega (za uporabo v ustih) pršila za zdravljenje teh okužb zgornjih dihal: sinuzitis (okužba sinusov), rinitis (zamašen nos ali izcedek iz nosu), rinofaringitis (običajen prehlad), tonzilitis (vnetje mandljev zaradi okužbe) in laringitis (vnetje glasilk).
English: Taking into account the mild and self-limiting nature of upper airway infections such as rhinopharyngitis, the benefits of fusafungine were not considered to outweigh the risks.
Slovenian: Ob upoštevanju blage narave okužb zgornjih dihal, kot je rinofaringitis, in dejstva, da izzvenijo same, koristi fuzafungina ne odtehtajo tveganj.
English: • Fusafungine nose and mouth sprays have been used to treat upper airway infections.
Slovenian: • Pršila s fuzafunginom za nos in usta so se uporabljala za zdravljenje okužb zgornjih dihal.
English: As the CMDh adopted its position by consensus, the measures recommended by the PRAC will be implemented directly by the Member States where the medicines are authorised, according to an agreed timetable.
Slovenian: Skupina CMDh je soglasno sprejela svoje stališče, zato bodo države članice, v katerih so zdravila odobrena, morale izvajati ukrepe odbora PRAC v skladu z dogovorjeno časovnico.
English: Fusafungine is an antibiotic and anti-inflammatory nose and mouth spray used to treat upper airway infections such as rhinopharyngitis (common cold).
Slovenian: Fuzafungin je antibiotično in protivnetno pršilo za nos in usta, ki se uporablja za zdravljenje okužb zgornjih dihal, kot je rinofaringitis (običajni prehlad).
English: • Orthostatic hypotension
Slovenian: • ortostatska hipotenzija
English: • Symptomatic treatment of veno-lymphatic insufficiency All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Slovenian: • simptomatsko zdravljenje veno-limfatične insuficience Vse reference, ki se nanašajo na zgoraj omenjene indikacije je treba izbrisati iz preostalih ustreznih poglavij povzetkov glavnih značilnosti zdravila.
English: • Prophylaxis of migraine headache
Slovenian: • profilaksa migrenskih glavobolov
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Slovenian: 4.1 Terapevtske indikacije [trenutno odobrene spodaj naštete indikacije je treba izbrisati (specifično besedilo za indikacije lahko varira od zdravila do zdravila)]
English: A. Summary of Product Characteristics
Slovenian: A. POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Slovenian: Vse reference, ki se nanašajo na zgoraj omenjene indikacije je treba izbrisati iz ustreznih poglavij navodil za uporabo.
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Slovenian: Priloga III Popravki ustreznih poglavij v povzetku glavnih značilnosti zdravila in navodilu za uporabo
English: B. Package Leaflet
Slovenian: B. NAVODILO ZA UPORABO
English: 21 February 2006 EMEA/CHMP/373083/2005
Slovenian: EMEA/CHMP/373083/2005
English: During its September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Lansoprazol AbZ-Pharma.
Slovenian: Na sestanku v septembru 2005 je CHMP glede na vse predložene podatke ter znanstvene razprave znotraj Odbora menil, da je razmerje med koristmi in tveganji za zdravilo Lansoprazol AbZ-Pharma ugodno.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansoprazol AbZ-Pharma 15 mg and 30 mg International Non-Proprietary Name (INN): Lansoprazole
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(2)1 ZA Lansoprazol AbZ-Pharma 15 mg in 30 mg Mednarodno nelastniško ime (INN): Lansoprazol
English: A Marketing Authorisation for Lansoprazol AbZ-Pharma (15 mg and 30 mg) was previously granted to ratiopharm GmbH in Finland on 7 November 2003.
Slovenian: Dovoljenje za promet z zdravilom Lansoprazol AbZ-Pharma (15 mg in 30 mg) je bilo prvotno dodeljeno družbi ratiopharm GmbH s Finske 7. novembra 2003.
English: Lansoprazol AbZ-Pharma (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, gastro-oesophageal reflux disease, treatment and prophylaxis of NSAID-associated gastric and duodenal ulcers, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Slovenian: Lansoprazol AbZ-Pharma (lansoprazol) je zaviralec protonske črpalke, ki zavira izločanje želodčne kisline in se uporablja za zdravljenje razjed dvanajstnika in želodca, refluksnega ezofagitisa, gastroezofagealne refluksne bolezni, zdravljenje in preprečevanje razjed želodca in dvanajstnika, povezanih z jemanjem nesteroidnih protivnetnih zdravil (NSAID), zdravljenje Zollinger-Ellisonovega sindroma in v kombinaciji z ustreznim protibakterijskim zdravljenjem za eradikacijo Helicobacter pylori ter preprečevanje ponovitve želodčne razjede pri bolnikih z razjedami, povezanimi s H. pylori.
English: Oral use bottle (glass)
Slovenian: Peroralna uporaba Steklenica (steklo)
English: EU/1/19/1389/001 Epidyolex 100 mg/mL Oral Solution
Slovenian: EU/1/19/1389/001
English: 1 bottle + 2 syringes of 1 ml + 2 syringes of 5 ml + 2 bottle adaptors
Slovenian: 1 steklenica + 2 brizgi s 1 ml +
English: Pack size
Slovenian: Peroralna raztopina
English: Then go on as before.
Slovenian: Nato nadaljujte jemanje tako kot prej.
English: Do not chew or crush them.
Slovenian: Ne žvečite jih in jih ne zdrobite.
English: Taking too many tablets at once can make you feel unwell.
Slovenian: Če vzamete preveč tablet hkrati, se boste mogoče počutili slabo.
English: If you forget to take your tablet, leave the dose out completely.
Slovenian: Če pozabite vzeti tableto, spustite odmerek v celoti.
English: Frequencies are defined as very common (≥1/10); common (>1/100 to <1/10); uncommon (>1/1000 to <1/100); rare (>1/10 000 to <1/1000); very rare (<1/10 000).
Slovenian: Pogostost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (> 1/100 do < 1/10), občasni (> 1/1000 do < 1/100), redki (> 1/10.000 do < 1/1000), zelo redki
English: If you take too many tablets, tell your doctor immediately or go to the nearest hospital casualty department.
Slovenian: Če vzamete preveč tablet, takoj povejte zdravniku ali obiščite najbližji bolnišnični nezgodni oddelek.
English: Winthrop Arzneimittel GmbH Industriestrasse 10 82256 Furstenfeldbruck Germany
Slovenian: Winthrop Arzneimittel GmbH Industriestrasse 10 82256 Furstenfeldbruck Nemčija
English: • if you suffer from diabetic autonomic neuropathy, a disease associated with diabetes which affects your nervous system.
Slovenian: • če imate diabetično avtonomno nevropatijo, bolezen, povezano s sladkorno boleznijo, ki vpliva na živčevje.
English: Your doctor may wish to increase your dose to 8mg.
Slovenian: Zdravnik bo morda povečal odmerek na 8 mg.
English: Chapeltown Distribution Centre 51 Cart Road, Chapeltown, Sheffield, S35 2PF United Kingdom
Slovenian: Chapeltown Distribution Centre 51 Cart Road, Chapeltown, Sheffield, S35 2PF Velika Britanija
English: Fax: 0036 1 505 0005
Slovenian: Faks: 0036 1 505 0005
English: Do not use after the expiry date which is stated on the carton.
Slovenian: Zdravila ne smete uporabljati po izteku roka uporabnosti, ki je naveden na škatli.
English: Methacrylic acid copolymer (Eudragir L30 D-55) Macrogol 1300-1600
Slovenian: Kopolimer metakrilne kisline (Eudragir L30 D-55) Makrogol 1300-1600
English: • if you are suffering from heart disease
Slovenian: • če imate bolezen srca;
English: Chinoin Pharmaceuticals and Chemical Works Co Ltd 1045 Budapest, To utca 1-5 HUNGARY Tel: 0036 1 505 0000
Slovenian: Chinoin Pharmaceuticals and Chemical Works Co Ltd 1045 Budapest, To utca 1-5 MADŽARSKA Tel: 0036 1 505 0000
English: CHMP was of the opinion that the bioequivalence was sufficiently established after single dose administration in two different bioequivalence studies (study 463/04 and 1995/04-05) and after multiple dose administration (study5208/02-3) according to the CHMP guidelines.
Slovenian: CHMP je menil, da je bila bioekvivalenca po uporabi enega odmerka zadostno dokazana v dveh različnih bioekvivalenčnih raziskavah (raziskavi 463/04-05) in po uporabi večkratnega odmerka (raziskava 5208/02-3) v skladu s smernicami CHMP.
English: It is unlikely that these differences will result in clinically relevant adverse events.
Slovenian: Ni pričakovati, da bi posledice teh razlik lahko bili klinično pomembni neželeni učinki.
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
Slovenian: Winthrop Medicaments 113, Bd Romain Rolland, 75014, Paris Francija Tel: 0033 (0) 1 57 63 33 33 Faks: 0033 (0) 1 57 63 33
English: Winthrop Pharmaceuticals UK Ltd 1 Onslow Street, Guildford, Surrey GU1 4YS United Kingdom
Slovenian: Winthrop Pharmaceuticals UK Ltd 1 Onslow Street, Guildford, Surrey GU1 4YS Združeno kraljestvo
English: • medicine containing Dopamine, Metaraminol, Methoxamine, Adrenaline (Epinephrine)
Slovenian: • zdravila, ki vsebujejo dopamin, metaraminol, metoksamin, adrenalin (epinefrin);
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.
Slovenian: Doksazosin spada v skupino zdravil, imenovanih alfa-blokatorji, lahko pa se uporablja za zdravljenje povišanega krvnega tlaka ali simptomov, ki jih povzroča povečanje prostate pri moških.
English: Your tablets should be swallowed whole.
Slovenian: Tablete je treba pogoltniti cele.
English: Your medicine is in the form of a round biconvex white prolonged release tablet.
Slovenian: Vaše zdravilo je v obliki okroglih, bikonveksnih tablet s podaljšanim sproščanjem.
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.
Slovenian: Bolniki z ledvično okvaro: Pri bolnikih z ledvično okvaro ni sprememb farmakokinetike in ni znakov, da tablete doksazosina s podaljšanim sproščanjem poslabšajo obstoječo ledvično okvaro, zato se pri teh bolnikih lahko uporabi običajni odmerek.
English: In patients with an enlargement to the prostate gland, a common side effect is poor and/or frequent passing of urine.
Slovenian: Pri bolnikih s povečano prostato je pogosti neželeni učinek šibko in/ali pogosto uriniranje.
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.
Slovenian: Med zelo redkimi neželenimi učinki, ki so jih opazili pri manj kot 1 bolniku od 10.000, so zmanjšanje števila eritrocitov, levkocitov in trombocitov v krvi ter zvišanje ravni uree in kreatinina v krvi.
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,
Slovenian: - Namen napotitve je bil doseči soglasje o tem, ali se zdravilo Doxazosin “Winthrop” 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 CHMP pri oblikovanju bioekvivalenčnih raziskav, zlasti kar se tiče učinka, ki bi ga lahko imela hrana na ustreznost občutljivosti za zaznavanje razlik med zdraviloma,
English: Fax: 0049 (0) 81 41 3572
Slovenian: Faks: 0049 (0) 81 41 3572
English: This effect is thought to result from selective blockade of the alpha-1adrenoceptors located in the vasculature.
Slovenian: Menijo, da je ta učinek posledica selektivnega blokiranja alfa-adrenergičnih receptorjev v žilah.
English: Caution is also recommended when doxazosin prolonged release tablets is administered concomitantly with medicinal products which may influence hepatic metabolism (e.g. cimetidine).
Slovenian: Previdnost je priporočljiva tudi, kadar se tablete doksazosina s podaljšanim sproščanjem uporablja hkrati z zdravili, ki vplivajo na presnovo v jetrih (npr. cimetidin).
English: PHARMACEUTICAL FORM AND CONTENTS 28 Prolonged-release tablets 30 Prolonged-release tablets 100 Prolonged-release tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 28 tablet s podaljšanim sproščanjem 30 tablet s podaljšanim sproščanjem 100 tablet s podaljšanim sproščanjem
English: cough and cold remedies as they may contain Ephedrine, Phenylephrine.
Slovenian: zdravila proti kašlju in prehladu, ker lahko vsebujejo efedrin ali fenilefrin.
English: Each tablet contains the active ingredient doxazosin mesilate equivalent to 4mg of doxazosin.
Slovenian: Vsaka tableta vsebuje zdravilno učinkovino doksazosinijev mesilat, ki ustreza 4 mg doksazosina.
English: Pack sizes: 28, 30 & 100 tablets Not all pack sizes may be marketed.
Slovenian: Velikosti pakiranj: 28, 30 in 100 tablet.
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.
Slovenian: - Pomožne snovi so: zmesi pripravkov iz polietilenoksida, ki vsebujejo butilhidroksitoluen (E 321), mikrokristalna celuloza, povidon, α-tokoferol, koloidni brezvodni silicijev dioksid in natrijev stearilfumarat.
English: Hypersensitivity to the active substance, other quinazolines (e.g. prazosin, terazosin), or to any of the excipients
Slovenian: • Preobčutljivost za zdravilno učinkovino, druge kinazoline (npr. prazosin, terazosin) ali katero koli pomožno snov;
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]is contraindicated during lactation as the medicinal product accumulates in the milk of lactating rats (see section 5.3) and there is no information about the excretion of the medicinal product into human breast milk.
Slovenian: Zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena je med dojenjem kontraindicirano, ker se zdravilo kopiči v mleku doječih podgan (glejte poglavje 5.3), o izločanju zdravila v mleko pri človeku pa ni podatkov.
English: If you stop taking {Invented name}: Keep taking your tablets until your doctor tells you to stop.
Slovenian: Tablete jemljite, dokler vam zdravnik ne naroči, da prenehate.
English: • painkillers called non-steroidal anti-inflammatory medicine (NSAIDs) eg.
Slovenian: • zdravila proti bolečinam, imenovana protivnetna zdravila (nesteroidni antirevmatiki), npr. ibuprofen;
English: The tablet coating contains methacrylic acid copolymer, colloidal anhydrous silica, macrogol and titanium dioxide (E171).
Slovenian: Obloga tablete vsebuje kopolimer metakrilne kisline, silicijev dioksid, koloidni, brezvodni, makrogol in titanov dioksid (E 171).
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.
Slovenian: Zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena je treba dajati posebno previdno bolnikom z naslednjimi akutnimi srčnimi boleznimi: pljučni edem, ki je posledica aortne ali mitralne stenoze, srčna odpoved pri velikem minutnem volumnu, desnostranska srčna odpoved, ki je posledica pljučne embolije ali perikardnega izliva, in levostranska ventrikularna srčna insuficienca z nizkim tlakom polnjenja srca.