natgillin/translations-raw huggingface dataset:
Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Največjo koncentracijo v plazmi doseže v 30 do 120 minutah (mediano v
• A sudden decrease or loss of vision - this occurs rarely
• Nenadno poslabšanje ali izguba vida - to se zgodi redko • Resne kožne reakcije - to se zgodi redko
Other medicines and Sildenafil Teva
Druga zdravila in zdravilo Sildenafil Teva
If you take more Sildenafil Teva than you should:
Če ste vzeli večji odmerek zdravila Sildenafil Teva, kot bi smeli
Sildenafil Teva is a treatment for adult men with erectile dysfunction, sometimes known as impotence.
Zdravilo Sildenafil Teva je zdravilo za odrasle moške z erektilno disfunkcijo, znano tudi kot impotenca.
In a penile plethysmography (RigiScan) study of fasted patients, the median time to onset for those who obtained erections of 60 % rigidity (sufficient for sexual intercourse) was 25 minutes (range 12-37 minutes) on sildenafil.
V študiji s pletizmografijo penisa (RigiScan) in uporabo sildenafila na prazen želodec je bil mediani čas do začetka delovanja pri bolnikih, ki so dosegli erekcijo s 60 % čvrstostjo (zadostno za spolni odnos), 25 minut (razpon: od 12 do 37 minut).
At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE2, 3, 4, 7, 8, 9, 10 and 11.
V največjih priporočenih odmerkih je selektivnost 80-kratna v primerjavi s PDE1 in prek 700-kratna v primerjavi s PDE2, 3, 4,
In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh A and B) sildenafil clearance was reduced, resulting in increases in AUC (84 %) and Cmax (47 %) compared to age-matched volunteers with no hepatic impairment.
Pri prostovoljcih z blago do zmerno cirozo jeter (Child-Pugh A in B) je bil očistek sildenafila zmanjšan, kar je povzročilo zvečanje AUC (84 %) in Cmax (47 %) v primerjavi s prostovoljci primerljive starosti brez okvare jeter.
You should not use Sildenafil Teva with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.
Zdravila Sildenafil Teva ne smete uporabljati skupaj z zdravili za zdravljenje pljučne arterijske hipertenzije (PAH), ki vsebujejo sildenafil ali katerekoli druge zaviralce PDE5.
Hypertension, Hypotension
vročinski oblivi hipertenzija, hipotenzija
Sildenafil Teva tablets may interfere with some medicines, especially those used to treat chest pain.
Zdravilo Sildenafil Teva lahko medsebojno deluje z nekaterimi zdravili, zlasti s tistimi, ki se uporabljajo proti angini pektoris.
Sildenafil Teva is contraindicated in patients who have loss of vision in one eye because of nonarteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Zdravilo Sildenafil Teva je kontraindicirano pri bolnikih, ki so izgubili vid na enem očesu zaradi nearteritične anteriorne ishemične optične nevropatije (NAION), tudi če ta dogodek ni bil povezan s predhodnim jemanjem zaviralcev PDE5 (glejte poglavje 4.4).
Rare (≥ 1/10,000 and <1/1,000)
Redki (≥ 1/10.000 in < 1/1.000)
Paediatric population Sildenafil Teva is not indicated for individuals below 18 years of age.
Zdravilo Sildenafil Teva ni indicirano pri mlajših od 18 let.
Certain patients have experienced these symptoms when taking Sildenafil Teva with alpha-blockers.
Nekateri bolniki so doživeli takšne simptome med jemanjem zdravila Sildenafil Teva z antagonisti adrenergičnih receptorjev alfa.
Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90 % higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Zdravi starejši prostovoljci (stari 65 let ali več) so imeli manjši očistek sildenafila, zato so imeli koncentracijo sildenafila in aktivnega N-desmetilnega presnovka v plazmi približno 90 % večjo kot mlajši zdravi prostovoljci (od 18 do 45 let).
This is most likely to occur within 4 hours post sildenafil dosing (see sections 4.2 and 4.4).
da se to zgodi, je v 4 urah po odmerku sildenafila (glejte poglavji 4.2 and 4.4).
You should not use Sildenafil Teva with any other oral or local treatments for erectile dysfunction.
Hkrati z zdravilom Sildenafil Teva ne smete uporabljati nobenega drugega zdravila za peroralno ali lokalno uporabo za zdravljenje erektilne disfunkcije.
Stevens-Johnson Syndrome (SJS),* Toxic Epidermal Necrolysis (TEN)*
Stevens-Johnsonov sindrom (SJS),*
Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84 %), mixed erectile dysfunction (77 %), organic erectile dysfunction (68 %), elderly (67 %), diabetes mellitus (59 %), ischaemic heart disease (69 %), hypertension (68 %), TURP (61 %), radical prostatectomy (43 %), spinal cord injury (83 %), depression (75 %).
V vseh študijah skupaj so bili deleži bolnikov, ki so s sildenafilom navajali izboljšanje, naslednji: psihogena erektilna disfunkcija (84 %), mešana erektilna disfunkcija (77 %), organska erektilna disfunkcija (68 %), starostniki (67 %), sladkorna bolezen (59 %), ishemična bolezen srca (69 %), zvišan krvni tlak (68 %), transuretralna resekcija prostate (61 %), radikalna prostatektomija (43 %),
The active substance is sildenafil.
Zdravilna učinkovina je sildenafil.
Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g., aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.
Med bolnike z zvečano občutljivostjo za vazodilatatorje spadajo bolniki z obstrukcijo iztoka iz levega prekata (npr. z aortno stenozo, hipertrofično obstruktivno kardiomiopatijo) ali z redkim sindromom multiple sistemske atrofije, ki se kaže kot huda okvara avtonomnega uravnavanja krvnega tlaka.
In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (>70 % stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7 % and 6 % respectively compared to baseline.
V študiji hemodinamičnih učinkov enkratnega peroralnega 100 mg odmerka sildenafila pri 14 bolnikih s hudo boleznijo koronarnih arterij (>70 % stenoza vsaj ene koronarne arterije) se je srednji sistolični tlak v mirovanju v primerjavi z izhodiščem znižal za 7 %, povprečni distolični tlak v mirovanju pa za 6 %.
Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Zdravila za zdravljenje erektilne disfunkcije, vključno s sildenafilom, je treba previdno uporabljati pri bolnikih z anatomskimi deformacijami penisa (npr. z angulacijo, kavernozno fibrozo ali Peyroniejevo boleznijo) in bolnikih z določenimi boleznimi, ki povzročajo nagnjenost k priapizmu (npr.s srpastocelično anemijo, multiplim mielomom ali levkemijo).
In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002 % (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing.
Pri zdravih prostovoljcih, ki so dobili sildenafil (en 100 mg odmerek), je bilo v ejakulatu 90 minut po uporabi manj kot 0,0002 % (povprečno 188 ng) uporabljenega odmerka.
The mean maximum decreases in supine systolic blood pressure following 100 mg oral dosing of sildenafil was 8.4 mmHg.
Srednje največje znižanje sistoličnega krvnega tlaka leže je bilo po 100 mg peroralnem odmerku sildenafila 8,4 mmHg.
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Varnost sildenafila ni razsikana pri naslednjih podskupinah bolnikov, pri katerih je njegova uporaba zato kontraindicirana: huda okvara jeter, hipotenzija (krvni tlak <90/50 mmHg), nedavna možganska kap ali miokardni infarkt in znane dedne degenerativne bolezni mrežnice, npr. retinitis pigmentosa
Doses of 200 mg did not result in increased efficacy but the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased.
Odmerek 200 mg ni bil bolj učinkovit, zvečala pa se je pogostnost neželenih učinkov (glavobola, zardevanja, omotice, dispepsije,
The safety and efficacy of combinations of sildenafil with other PDE5 Inhibitors, or other pulmonary arterial hypertension (PAH) treatments containing sildenafil , or other treatments for erectile dysfunction have not been studied.
Varnost in učinkovitost kombinacije sildenafila z drugimi zaviralci PDE5, drugimi zdravili proti pljučni arterijski hipertenziji (PAH), ki vsebujejo sildenafil, ali drugimi zdravili za zdravljenje erektilne disfunkcije nista raziskani, zato uporaba takih kombinacij ni priporočena.
Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil.
Sok genivke je šibek zaviralec presnove s CYP3A4 v črevesni steni in lahko nekoliko zveča koncentracijo sildenafila v plazmi.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
C. DRUGI POGOJI ALI ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Initiation of sildenafil at a dose of 25 mg should be considered (see section 4.2).
Razmisliti je potrebno o uvedbi sildenafila v odmerku 25 mg (glejte poglavje 4.2).
2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 10 x 1 film-coated tablet 12 film-coated-tablets
2 filmsko obloženi tableti 4 filmsko obložene tablete 8 filmsko obloženih tablet 10 x 1 filmsko obložena tableta 12 filmsko obloženih tablet
Although no increased incidence of adverse events was observed in these patients, when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25 mg should be considered.
Čeprav pri teh bolnikih niso ugotovili večje pogostnosti neželenih učinkov, je pri sočasni uporabi z zaviralci CYP3A4 priporočljivi začetni odmerek 25 mg.
In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in the visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).
V majhni s placebom kontrolirani študiji pri bolnikih s potrjeno zgodnjo starostno degeneracijo makule (n=9) sildenafil v enkratnem 100 mg odmerku ni imel pomembnega vpliva na preiskave vida (ostrina vida, Amslerjeva mrežica, ločevanje barv na simuliranem semaforju,
2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 10 x 1 film-coated tablet 12 film-coated-tablets 24 film-coated tablets
2 filmsko obloženi tableti 4 filmsko obložene tablete 8 filmsko obloženih tablet 10 x 1 filmsko obložena tableta 12 filmsko obloženih tablet 24 filmsko obloženih tablet
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
How to take Sildenafil Teva
Kako jemati zdravilo Sildenafil Teva
Since sildenafil (and its major circulating N-desmethyl metabolite) is 96 % bound to plasma proteins, this results in the mean maximum free plasma concentration for sildenafil of 18 ng/mL (38 nM).
N-desmetilni presnovek) 96 % vezan na beljakovine v plazmi, je srednja največja koncentracija prostega sildenafila v plazmi 18 ng/ml (38 nM).
In vitro studies: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4
Sildenafil je šibek zaviralec izoencimov 1A2, 2C9, 2C19, 2D6, 2E1 in 3A4 citokroma P450 (IC50 >
Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.
Znano je, da sildenafil učinkuje na pot dušikov oksid/ciklični gvanozinmonofosfat (cGMP) (glejte poglavje 5.1), in tako okrepi hipotenzivno delovanje nitratov, zato je njegova sočasna uporaba z donorji dušikovega oksida (npr. amilnitritom) ali nitrati v kakršnikoli obliki kontraindicirana.
Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction.
Farmakoterapevtska skupina: zdravila za bolezni sečil, zdravila za zdravljenje erektilne disfunkcije.
What Sildenafil Teva looks like and contents of the pack
Izgled zdravila Sildenafil Teva in vsebina pakiranja
If Sildenafil Teva is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Če se zdravilo Sildenafil Teva zaužije s hrano, lahko začne delovati pozneje, kot če je zaužito na prazen želodec (glejte poglavje 5.2).
This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50 % that of the parent drug.
Selektivnost tega presnovka za fosfodiesteraze je podobna sildenafilovi, njegov vpliva na PDE5 pa je in vitro približno 50 % vpliva prvotnega zdravila.
Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg).
Sildenafil (50 mg) ni dodatno podaljšal časa krvavitve, podaljšanega zaradi acetilsalicilne kisline
Sildenafil Teva contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5(PDE5) inhibitors.
Zdravilo Sildenafil Teva vsebuje zdravilno učinkovino sildenafil, ki sodi med zdravila, ki jih imenujemo zaviralci fosfodiesteraze tipa 5 (PDE5).
Your doctor may start you on a lower dose (25 mg) of Sildenafil Teva.
Zdravnik vam bo za začetek morda predpisal zdravilo Sildenafil Teva v znižanem odmerku (25 mg).
This includes any possible side effects not listed in this leaflet.
Posvetujte se tudi če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): omedlevica, kap, srčni napad, neenakomeren srčni utrip, prehodno zmanjšanje pretoka krvi skozi dele možganov, občutek zategovanja v grlu, omrtvelost ust, krvavitev v ozadju očesa, dvojni vid, zmanjšana ostrina vida, nenormalen občutek v očesu, oteklost očesa ali veke, drobni delci ali pike v vidnem polju, videnje svetlobnih krogov okoli luči, razširitev očesne zenice, obarvanje očesne beločnice, krvavitev iz penisa,
− If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure.
• Če jemljete zdravila, ki se imenujejo nitrati, ker lahko sočasno jemanje vodi v nevaren padec vašega krvnega tlaka.
• An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Alergijske reakcije - to se zgodi občasno (pojavijo se lahko pri največ 1 od 100 bolnikov) Simptomi vključujejo nenadno zadihanost, težave pri dihanju ali omotico, oteklino očesnih vek,
Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the coadministration may lead to symptomatic hypotension in a few susceptible individuals (see section 4.5).
Previdnost je potrebna med uporabo sildenafila pri bolnikih, ki jemljejo antagoniste adrenergičnih receptorjev alfa, ker sočasna uporaba pri maloštevilnih občutljivih posameznikih lahko povzroči simptomatsko hipotenzijo (glejte poglavje 4.5).
Sildenafil Teva is available in blister packs of 2, 4, 8, 12 and 24 tablets, and perforated unit dose blisters containing 10 x 1 tablet.
Zdravilo Sildenafil Teva je na voljo v pretisnih omotih po 2, 4, 8, 12 in 24 tablet in perforiranih enoodmernih pretisnih omotih, ki vsebujejo 10 x 1 tableto.
Cimetidine (800 mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56 % increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
zaviralec citokroma P450 in nespecifični zaviralec CYP3A4, je ob sočasni uporabi s sildenafilom (50 mg) pri zdravih prostovoljcih povzročil 56 %zvečanje koncentracije sildenafila v plazmi.
Sildenafil Teva is available in blister packs of 2, 4, 8 and 12 tablets, and perforated unit dose blisters containing 10 x 1 tablet.
Zdravilo Sildenafil Teva je na voljo v pretisnih omotih po 2, 4, 8 in 12 tablet in perforiranih enoodmernih pretisnih omotih, ki vsebujejo 10 x 1 tableto.
10 x 1 tablet in PVC/Aluminium perforated unit dose blisters.
10 x 1 tableta v perforiranem enoodmernem pretisnem omotu iz PVC/aluminijske folije.
− If you currently have a stomach ulcer, or a bleeding problem (such as haemophilia).
• Če imate trenutno razjedo na želodcu ali če imate težave, povezane s krvavitvami (npr.
Sildenafil Teva 100 mg film-coated tablets EU/1/09/584/014
Sildenafil Teva 100 mg filmsko obložene tablete EU/1/09/584/014
You should not take Sildenafil Teva if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure.
Zdravila Sildenafil Teva ne smete jemati, če jemljete zdravila, ki jih imenujemo nitrati, ker lahko sočasno jemanje teh zdravil vodi v nevaren padec vašega krvnega tlaka.
The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and.
Pri bolnikih zdravljenih s sildenafilom so v kliničnih študijah najpogosteje poročali o naslednjih neželenih učinkih: glavobol, zardevanje, dispepsija, zamašenost nosu, omotica, navzea, vročinski oblivi, motnje vida, cianopsija in zamegljen vid.
Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.
Sildenafil (100 mg) ni vplival na farmakokinetiko zaviralcev proteaz HIV sakvinavirja in ritonavirja
You should not take Sildenafil Teva if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.
Zdravila Sildenafil Teva ne smete jemati, če jemljete katero od zdravil, ki so znani kot dajalci dušikovega oksida, kakršen je amilnitrit (“poppers” - nelegalno spolno poživilo), ker lahko sočasno jemanje vodi v nevaren padec vašega krvnega tlaka.
Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.
Sildenafil v glavnem odstranjujeta jetrna mikrosomska izoencima CYP3A4 (glavna pot) in CYP2C9 (manj pomembna pot).
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Further information on clinical trials
KLINIČNI PODATKI
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300 % (4-fold) increase in sildenafil Cmax and a 1,000 % (11-fold) increase in sildenafil plasma AUC.
Sočasna uporaba zaviralca proteaz HIV ritonavirja, ki je zelo močan zaviralec P450, je v stanju dinamičnega ravnovesja (500 mg dvakrat na dan) in sildenafila (enkratni odmerek 100 mg) povzročila 300 % (4-kratno) zvečanje Cmax sildenafila in 1.000 % (11-kratno) zvečanje AUC sildenafila v plazmi.
Myocardial infarction, Ventricular arrhythmia,* Atrial fibrillation, Unstable angina
Srčne bolezni tahikardija, palpitacije nenadna srčna smrt,* miokardni infarkt, ventrikularna aritmija,* atrijska fibrilacija, nestabilna angina pektoris
With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).
Pri bolnikih, ki sočasno dobivajo zaviralce CYP3A4, je priporočeni začetni odmerek 25 mg (glejte poglavje 4.5) razen pri ritonavirju, katerega sočasna uporaba s sildenafilom ni priporočena (glejte poglavje 4.4).
In these study populations, mean additional reductions of supine blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, and mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were observed.
V teh študijskih populacijah so opažali povprečno dodatno znižanje krvnega tlaka leže za 7/7 mmHg, 9/5 mmHg in
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200 % and 79 % respectively.
Poleg tega sta se pomembno zvečali tudi AUC (za 200 %) in Cmax (za 79 %) N-desmetilnega presnovka.
Sildenafil Teva 50 mg film-coated tablets EU/1/09/584/008
Sildenafil Teva 50 mg filmsko obložene tablete EU/1/09/584/008
In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment.
Da bo možnost za pojav posturalne hipotenzije čim manjša, morajo biti bolniki pred začetkom zdravljenja s sildenafilom hemodinamsko stabilni na terapiji z antagonisti adrenergičnih receptorjev alfa.
There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6).
Sildenafil po enem samem 100 mg peroralnem odmerku ni vplival na gibljivost ali morfologijo semenčic zdravih prostovoljcev (glejte poglavje 4.6).
Sildenafil Teva 25 mg film-coated tablets EU/1/09/584/002
Sildenafil Teva 25 mg filmsko obložene tablete EU/1/09/584/002
Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems.
Posebna navodila za bolnike, ki imajo težave z ledvicami ali jetri
Pooling of the following classes of antihypertensive medication: diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrallyacting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking sildenafil compared to placebo treatment.
vazodilatacijsko in centralno delujoče antihipertenzive, zaviralce adrenergičnih nevronov, zaviralce kalcijevih kanalčkov in antagoniste adrenergičnih receptorjev alfa, se profil neželenih učinkov ni razlikoval od profila pri bolnikih, ki so dobivali placebo.
Epistaxis, Sinus congestion
ponavljajoče konvulzije,* sinkopa