natgillin/translations-raw huggingface dataset:
They should be informed about the potential risk for injuries and measures of precaution to minimise orthostatic symptoms.
Treba jih je opozoriti na morebitno tveganje poškodb in obvestiti o ukrepih za zmanjševanje ortostatskih simptomov.
6 FURTHER INFORMATION
6 DODATNE INFORMACIJE
Doxazosin has a minor or moderate influence on the ability to drive and use machines, especially at the beginning of therapy.
Doksazosin ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji, zlasti na začetku zdravljenja.
Children and adolescents: Doxazosin is not recommended for use in children and adolescents due to a lack of clinical experience.
Otroci in mladostniki: Uporaba doksazosina pri otrocih se zaradi pomanjkanja kliničnih izkušenj ne priporoča.
Additionally, doxazosin improves insulin sensitivity in patients with impaired sensitivity to insulin, but also concerning this finding the clinical relevance is still uncertain.
Poleg tega doksazosin poveča občutljivost za insulin pri bolnikih z okvarjeno občutljivostjo za insulin, vendar tudi klinični pomen teh ugotovitev še ni znan.
Doxazosin is not considered appropriate as first-line treatment, this does not exclude the second- or third-line use in combination with other types of antihypertensives.
Doksazosin ni primeren kot prvo zdravljenje, vendar to ne izključuje uporabe pri drugem ali tretjem zdravljenju v kombinaciji z drugimi antihipertenzivi.
The observed differences in Tmax are modest and the Cmax of the test tablet is not higher than the innovator tablet.
Opažene razlike v Tmax so zmerne in Cmax testnih tablet ni višji kot v originatorjevem zdravilu.
A dosage regime of 82 mg/kg/day (8 times the human exposure) was associated with reduced foetal survival.
Odmerki 82 mg/kg/dan (8-kratna izpostavljenost pri človeku) so bili povezani z zmanjšanim preživetjem fetusov.
Very rare (affecting less than one person in 10,000): a reduction in red and white cells in the blood and an increase in urea and creatinine levels in the blood.
Zelo redki (pojavijo se pri manj kot eni osebi od 10.000): zmanjšanje števila eritrocitov in levkocitov v krvi ter zvišanje ravni uree in kreatinina v krvi.
• if you are allergic (hypersensitive) to doxazosin or any of the other ingredients of Doxazosin Retard
• če ste preobčutljivi za (alergični na) doksazosin ali katero koli sestavino zdravila Doxazosin Retard
If these symptoms persist or become a problem please contact your doctor.
Če ti simptomi ne izginejo ali postanejo težava, se posvetujte z zdravnikom.
Your doctor may wish to increase your dose to 8 mg per day.
Zdravnik bo morda povečal odmerek na 8 mg na dan.
This helps to lower blood pressure.
Tako se zniža krvni tlak.
Butylhydroxytoluene (E321) α-Tocopherol
Butilhidroksitoluen (E 321) α-tokoferol
On initiation of therapy or increasing of dose the patient should be monitored to minimise the potential for postural effects, e.g. hypotension and syncope.
Na začetku zdravljenja ali ob povečanju odmerka je treba bolnika opazovati, da bi zmanjšali morebitno tveganje posturalnih učinkov, npr. hipotenzije in sinkope.
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.
Morda boste čutili omedlevico ali vrtoglavico ob vstajanju iz sedečega ali ležečega položaja, zlasti na začetku zdravljenja ali po nadaljevanju zdravljenja po premoru.
Common : apathia
Pogosti: apatija
Very rare : increase of serum creatinine.
Zelo redki: zvišane vrednosti kreatinina v serumu
• if you have problems with your heart or a history of heart disease
• če imate težave s srcem ali ste v preteklosti imeli srčno bolezen;
Doxazosin 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.
Doksazosin je med dojenjem kontraindiciran, ker se zdravilo kopiči v mleku doječih podgan (glejte poglavje 5.3), o izločanju zdravila v mleko pri človeku pa ni podatkov.
Arrow Generics Limited, Unit 4/5 Willsborough Cluster, Clonshaugh Industrial Estate, Clonshaugh, Dublin 17, Republic of Ireland.
Arrow Generics Limited, Unit 4/5 Willsborough Cluster, Clonshaugh Industrial Estate, Clonshaugh, Dublin 17, Republika Irska.
If you become pregnant whilst taking this medicine you should contact your doctor as soon as possible.
Če med jemanjem tega zdravila zanosite, čim prej povejte zdravniku.
Pack sizes: 28, 30, 56, 98, and 100 prolonged-release tablets
Velikosti pakiranj: 28, 30, 56, 98 in 100 tablet s podaljšanim sproščanjem.
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 aggravates existing renal impairment, the usual dose can be used in these patients (see section 4.4).
Bolniki z ledvično okvaro: Pri bolnikih z ledvično okvaro ni sprememb farmakokinetike in ni znakov, da doksazosin poslabša obstoječo ledvično okvaro, zato se pri teh bolnikih lahko uporabi običajni odmerek (glejte poglavje 4.4).
Patients with acute heart diseases:
Bolniki z akutnimi srčnimi boleznimi:
The plasma elimination is biphasic with the terminal elimination half-life being 22 hours and hence this provides the basic for once daily dosing
Izločanje iz plazme je dvofazno, končni razpolovni čas izločanja je 22 ur, kar omogoča odmerjanje enkrat dnevno.
Doxazosin is highly bound to plasma proteins (98%).
Doksazosin se v veliki meri veže na beljakovine v plazmi (98 %).
Blood and the lymphatic system disorders: Very rare : Reduction of erythrocytes, leucocytes and thrombocytes
Bolezni krvi in limfatičnega sistema: Zelo redki: zmanjšanje števila eritrocitov, levkocitov in trombocitov
• if you have liver disease or you are taking medicines to control the way your liver works such as cimetidine or if you are undergoing dialysis
• če imate bolezen jeter ali jemljete zdravila za nadzor delovanja jeter, kot je cimetidin, ali ste na dializi;
This medicinal product is authorised in the Member States of the EEA under the following names:
Zdravilo je pridobilo dovoljenje za promet v državah članicah EGP pod naslednjimi imeni: [Izpolni država članica]
Adults: Usually 4 mg doxazosin once daily.
Odrasli: Običajno 4 mg doksazosina enkrat dnevno.
Studies in lactating rats given a single oral dose of radioactive doxazosin gave an accumulation in the breast milk with a maximum concentration of about 20 times greater than the maternal plasma concentration.
V študijah na doječih podganah, ki so jim dali enkratni peroralni odmerek radioaktivnega doksazosina, so ugotovili kopičenje v mleku, kjer je bila najvišja koncentracija približno 20-krat višja od koncentracije v plazmi matere.
- Essential hypertension - Symptomatic treatment of benign prostatic hyperplasia.
- Esencialna hipertenzija, - simptomatsko zdravljenje benigne hiperplazije prostate.
Your medicine is in the form of prolonged-release tablets.
Vaše zdravilo je v obliki tablet s podaljšanim sproščanjem.
• if you have or have had in the past any form of obstruction of the digestive tract.
• če imate ali ste v preteklosti imeli kakršno koli obliko zapore prebavil.
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.
Pri bolnikih, ki se zdravijo zaradi benigne hiperplazije prostate in ki niso hipertenzivni, so spremembe srednje vrednosti krvnega tlaka majhne, vendar pri 10-20 % bolnikov pride do hipotenzije, vrtoglavice in utrujenosti, pri manj kot 5 % pa do edema in dispneje.
• if you have a serious kidney disorder (anuria or progressive renal insufficiency)
• če imate resno bolezen ledvic (anurijo ali progresivno ledvično okvaro);
The majority of patients are controlled on the initial dose of 4 mg doxazosin.
Pri večini bolnikov za nadzor bolezni zadostuje začetni odmerek 4 mg doksazosina.
They are used to treat high blood pressure or the symptoms caused by enlargement of the prostate gland in men.
Lahko se uporablja za zdravljenje povišanega krvnega tlaka ali simptomov, ki jih povzroča povečanje prostate pri moških.
Doxazosin should be used with care in patients with Diabetic Autonomic Neuropathy.
Doksazosin je treba pri bolnikih z diabetično avtonomno nevropatijo uporabljati previdno.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EMEA
- The scope of the referral was to agree whether Doxazosin “Arrow” 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,
- Namen napotitve je bil doseči soglasje o tem, ali se zdravilo Doksazosin Retard Arrow 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.
Caution is also recommended when doxazosin is administered concomitantly with medicinal products which may influence hepatic metabolism (e.g. cimetidine).
Previdnost je priporočljiva tudi, kadar se doksazosin uporablja sočasno z zdravili, ki vplivajo na presnovo v jetrih (npr. cimetidin).
Distribution: App. 98% of doxazosin is protein-bound in plasma.
Porazdelitev: Približno 98 % doksazosina se veže na beljakovine v plazmi.
10 DATE OF REVISION OF THE TEXT [To be completed nationally]
10 DATUM ZADNJE REVIZIJE BESEDILA [Izpolni država članica]
PVC/PVDC/aluminium blister.
Pretisni omot iz PVC/PVDC/aluminija.
Administration of doxazosin in hypertensive patients causes a clinically significant reduction in blood pressure as a result of a reduction in systemic vascular resistance.
Uporaba doksazosina pri hipertenzivnih bolnikih povzroča klinično pomembno znižanje krvnega tlaka zaradi zmanjšanja sistemskega žilnega upora.
Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom
Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, Velika Britanija.
The adverse reaction profile in clinical trials with patients with benign prostatic hyperplasia corresponded to the one seen in hypertension.
Profil neželenih učinkov v kliničnih preskušanjih pri bolnikih z benigno hiperplazijo prostate je bil podoben kot pri bolnikih s hipertenzijo.
If necessary, the dosage may be increased to 8 mg doxazosin once daily.
Po potrebi se lahko odmerek poveča na 8 mg doksazosina enkrat dnevno.
In a clinical study in 12 subjects with moderate hepatic impairment, single dose administration of doxazosin resulted in an increase of AUC of 43% and a decrease in oral clearance of app. 40%.
V klinični študiji pri 12 bolnikih z zmerno jetrno okvaro je uporaba enega odmerka doksazosina povzročila povečanje vrednosti AUC za 43 % in zmanjšanje peroralnega očistka za približno 40 %.
Postural hypotension and in rare cases syncope may occur at the beginning of therapy, especially at very high doses but also when treatment is recommenced after a break.
Na začetku zdravljenja lahko pride do posturalne hipotenzije in redko do sinkope, zlasti pri zelo velikih odmerkih, vendar tudi pri ponovnem zdravljenju po premoru.
Pharmacokinetic studies with doxazosin in the elderly have shown no significant alterations compared to younger patients.
Farmakokinetične študije doksazosina pri starejših bolnikih niso pokazale pomembnih razlik v primerjavi z mlajšimi bolniki.
- 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.
- Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Treatment with doxazosin has been shown to result in regression of left ventricular hypertrophy, inhibition of platelet aggregation as well as enhanced capacity of tissue plasminogen-activator.
Pokazali so, da zdravljenje z doksazosinom zmanjša hipertrofijo levega prekata, zavira agregacijo trombocitov in poveča zmogljivost tkivnega aktivatorja plazminogena.
Doxazosin may influence plasma renin activity and urinary excretion of vanillylmandelic acid.
Doksazosin lahko vpliva na aktivnost renina v plazmi in izločanje vanililmandljeve kisline z urinom.
Administration of doxazosin to patients with prostatic hyperplasia results in a significant improvement in urodynamics and symptoms as a result of a selective blockade of alpha-adrenoceptors located in the prostatic muscular stroma, capsule and bladder neck.
Uporaba doksazosina pri bolnikih s hiperplazijo prostate pomembno izboljša urodinamiko in simptome zaradi selektivnega blokiranja alfa-adrenergičnih receptorjev v mišični stromi prostate, kapsuli in vratu mehurja.
The pharmacokinetic properties of doxazosin lead to a minor variation in plasma levels.
Farmakokinetične lastnosti doksazosina so vzrok za manjše razlike pri koncentracijah v plazmi.
Headache, dizziness, unconsciousness, syncope, dyspnoea, hypotension, palpitation, tachycardia, arrhythmia.
Glavobol, vrtoglavica, izguba zavesti, sinkopa, dispneja, hipotenzija, palpitacije, tahikardija, aritmija.
Doxazosin 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.
Doksazosin je treba uporabljati previdno pri bolnikih 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.
In vitro data in human plasma indicate that doxazosin has no effect on protein binding of digoxin, warfarin, phenytoin or indomethacin.
Podatki in vitro na človeški plazmi kažejo, da doksazosin ne vpliva na vezavo digoksina, varfarina, fenitoina ali indometacina na beljakovine.
Studies in pregnant rabbits and rats at daily doses resulting in plasma concentrations 4 and 10 times the human exposure (Cmax and AUC), respectively, revealed no evidence of harm to the foetus.
Študije na brejih kuncih in podganah, pri katerih so uporabili dnevne odmerke, ki so povzročili koncentracije v plazmi, pri katerih so bile vrednosti Cmax 4-krat, vrednosti AUC pa 10-krat večje od izpostavljenosti pri človeku, niso pokazale dokazov za poškodbe ploda.
Doxazosin Retard Arrow 4 mg prolonged release tablets and associated names are available in blister packs of 28, 30, 56, 98 and 100 tablets.
Zdravilo Doxazosin Retard Arrow 4 mg tablete s podaljšanim sproščanjem in povezana imena je na voljo v pretisnih omotih po 28, 30 56, 98 in 100 tablet.
The active substance is doxazosin (as doxazosin mesilate).
Zdravilna učinkovina je doksazosin (v obliki doksazosinijevega mesilata).
In patients with hypertension, the decrease in blood pressure during treatment with doxazosin was similar in both the sitting and standing position.
Pri bolnikih s hipertenzijo je bilo med zdravljenjem z doksazosinom znižanje krvnega tlaka v sedečem in stoječem položaju podobno.
Uncommon : nightmares, amnesia, emotional instability Rare : depression, agitation
Občasni: nočne more, amnezija, čustvena nestabilnost Redki: depresija, nemir
If you are planning to have surgery and anaesthesia (even at the dentist) you should tell your doctor or dentist that you are taking Doxazosin Retard Arrow 4 mg prolonged release tablets and associated names .
Pred kirurškim posegom in anestezijo (tudi pri zobozdravniku) morate zdravniku ali zobozdravniku povedati, da jemljete zdravilo Doxazosin Retard Arrow 4 mg tablete s podaljšanim sproščanjem in povezana imena.
If any of the side effects listed above gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Most of the patients with prostatic hyperplasia are controlled with the initial dose.
Pri večini bolnikov s hiperplazijo prostate za nadzor bolezni zadostuje začetni odmerek.
• if you suffer from kidney problems, overflow incontinence (you do not feel the urge to urinate) or anuria
• če imate težave z ledvicami, prelivno inkontinenco (ne čutite potrebe po uriniranju) ali anurijo (vaše telo ne proizvaja urina);
Doxazosin therapy in patients with hepatic impairment should be performed with caution (see section 4.4.
Pri zdravljenju bolnikov z jetrno okvaro z doksazosinom je treba biti previden (glejte poglavje 4.4).
Peak plasma levels are approximately one third of those of the same dose of immediate release doxazosin tablets.
Najvišje koncentracije v plazmi so približno ena tretjina koncentracij po uporabi enakega odmerka tablet doksazosina s takojšnjim sproščanjem.
4 POSSIBLE SIDE EFFECTS
4 MOŽNI NEŽELENI UČINKI
This effect is thought to result from selective blockade of the alpha-1-adrenoceptors located in the vasculature.
Menijo, da je ta učinek posledica selektivnega blokiranja alfaadrenergičnih receptorjev v žilah.
Symptomatic treatment of prostatic hyperplasia:
Simptomatsko zdravljenje hiperplazije prostate:
White, round, biconvex tablets with bossing "DL"
Bele, okrogle, bikonveksne tablete z reliefnim napisom "DL".
Doxazosin potentiates the blood pressure lowering effect of other antihypertensives.
Doksazosin okrepi učinek drugih antihipertenzivov na nižanje krvnega tlaka.
Pharmacokinetic studies with doxazosin in patients with renal impairment also showed no significant alterations compared to patients with normal renal function.
Farmakokinetične študije tablet doksazosina pri bolnikih z ledvično okvaro niso pokazale pomembnih razlik v primerjavi z uporabo pri bolnikih z normalnim delovanjem ledvic.
Special care should be taken with hypotensive patients or patients with known orthostatic dysregulation taking doxazosin to treat benign prostatic hyperplasia (BPH).
Pri hipotenzivnih bolnikih ali bolnikih z znano ortostatsko disregulacijo, ki jemljejo doksazosin za zdravljenje benigne hiperplazije prostate (BPH), je treba biti posebno previden.
Do not chew, crush or divide them.
Tablet ne žvečite, drobite ali prepolovite.
Since doxazosin is strongly bound to plasma proteins dialysis is not indicated.
Doksazosin se močno veže na beljakovine v plazmi, zato dializa ni indicirana.
Patients with hepatic impairment: Doxazosin should be given with particular caution to patients with evidence of impaired liver function.
Bolniki z jetrno okvaro: Bolnikom z jetrno okvaro je treba doksazosin dajati posebno previdno.
In patients with severe hepatic impairment clinical experience is lacking and therefore the use of doxazosin is not recommended.
Kliničnih izkušenj pri bolnikih s hudo jetrno okvaro ni, zato se uporaba doksazosina pri teh bolnikih ne priporoča.
Doxazosin has shown to be free of metabolic adverse effects and is suitable for treatment of patients with coexistent asthma, diabetes, left ventricular dysfunction or gout.
Pokazali so, da doksazosin nima neželenih presnovnih učinkov in da je primeren za zdravljenje bolnikov, ki imajo hkrati astmo, diabetes, disfunkcijo levega prekata ali protin.
The other ingredients in the tablet core are macrogol, microcrystalline cellulose, povidone, butylhydroxytoluene (E-321), α-tocopherol, silica colloidal anhydrous and sodium stearyl fumarate.
Pomožne snovi v jedru tablete so makrogol, mikrokristalna celuloza, povidon, butilhidroksitoluen (E 321), αtokoferol, koloidni brezvodni silicijev dioksid in natrijev stearilfumarat.
• medicines which work on the nervous system such as dopamine, ephedrine, epinephrine, metaraminol, methoxamine and phenylephrine as these can also reduce the effect of Doxazosin Retard Arrow 4 mg prolonged release tablets and associated names.
• zdravila, ki delujejo na živčevje, kot so dopamin, efedrin, epinefrin, metaraminol, metoksamin in fenilefrin, ker tudi lahko zmanjšajo učinek zdravila Doxazosin Retard Arrow 4 mg tablete s podaljšanim sproščanjem in povezana imena.
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).
Podatki o bolnikih z jetrno okvaro in učinku zdravil, ki vplivajo na presnovo v jetrih (npr. cimetidin), so omejeni.
The tablets are white, round and biconvex with the embossing ‘DL'.
Tablete so bele, okrogle, bikonveksne tablete z reliefnim napisom "DL".
Prostatic hyperplasia:
Hiperplazija prostate:
The usual dose of Doxazosin Retard Arrow 4 mg prolonged release tablets and associated names is one tablet (4 mg) taken as a single dose each day.
Običajen odmerek zdravila Doxazosin Retard Arrow 4 mg tablete s podaljšanim sproščanjem in povezana imena je ena tableta (4 mg) v obliki enega odmerka vsak dan.
Trough levels at 24 hours are, however, similar.
Po 24 urah so koncentracije pred naslednjim odmerkom pri obeh formulacijah podobne.
Uncommon : flushing, fever/shiver, paleness Rare : low body temperature in elderly
Občasni: vročinski oblivi, zvišana telesna temperatura/mrzlica, bledost Redki: nizka telesna temperatura pri starejših bolnikih
• certain non-steroidal medicines used to treat rheumatism or the female hormone, estrogen, as these can reduce the effect of Doxazosin Retard Arrow 4 mg prolonged release tablets and associated names
• nekatera nesteroidna zdravila za zdravljenje revmatizma ali ženski hormon estrogen, ker lahko zmanjšajo učinek zdravila Doxazosin Retard Arrow 4 mg tablete s podaljšanim sproščanjem in povezana imena;
Doxazosin can be used as sole agent or in combination with another medicinal product e.g. a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an ACE-inhibitor.
Doksazosin se lahko uporablja samostojno ali v kombinaciji z drugimi zdravili, npr. tiazidnimi diuretiki, blokatorji beta-adrenergičnih receptorjev, kalcijevimi antagonisti ali zaviralci ACE.
- Hypersensitivity to the active substance, other quinazolines (e.g. prazosin, terazosin), or to any of the excipients - Benign hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infections or bladder stones - Overflow bladder, anuria or progressive renal insufficiency - History of esophageal or gastrointestinal obstruction or decreased lumen diameter of the gastrointestinal tract - Lactation.
- Preobčutljivost za zdravilno učinkovino, druge kinazoline (npr. prazosin, terazosin) ali katero koli pomožno snov; - benigna hiperplazija prostate in sočasna obstrukcija zgornjih sečil, kronična okužba sečil ali kamni v mehurju; - prelivna inkontinenca, anurija ali progresivna ledvična insufienca; - ezofagealna ali gastrointestinalna obstrukcija v anamnezi ali zmanjšan premer lumna prebavil; - dojenje.