FrancophonIA/ELRC3.0 huggingface dataset:
English: 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%),
Slovenian: V vseh preskušanjih 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 %), poškodba hrbtenjače (83 %), depresija (75 %).
English: In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg.
Slovenian: V specifični študiji interakcij, v kateri so bolniki z zvišanim krvnim tlakom uporabljali sildenafil (100 mg) sočasno z amlodipinom, se je sistolični krvni tlak leže dodatno znižal za 8 mmHg, diastolični krvni tlak leže pa za 7 mmHg.
English: The maximum recommended dosing frequency is once per day.
Slovenian: Največji priporočeni odmerek je 100 mg. Največja priporočena pogostnost odmerjanja je enkrat na dan.
English: There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 5.1).
Slovenian: Ni bilo vpliva na gibljivost ali morfologijo semenčic zdravih prostovoljcev po enem samem 100 mg peroralnem odmerku sildenafila (glejte poglavje 5.1).
English: (≥ 1/10,000 and eye,
Slovenian: Redki (≥ 1/10000 in očeh, edem vek,
English: Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Slovenian: Posledica je zvečanje ravni cikličnega gvanozinmonofosfata (cGMP), to pa povzroči sprostitev gladkih mišic v corpusu cavernosumu in omogoči dotok krvi.
English: Some patients taking alpha blockers may experience dizziness or light-headedness when getting up.
Slovenian: Pri nekaterih bolnikih, ki jemljejo antagoniste adrenergičnih receptorjev alfa, se lahko pri vstajanju pojavi omotica ali vrtoglavica.
English: Heart rate increased
Slovenian: Preiskave zvišan srčni utrip
English: - if you are taking medicines that contain nitrates (e.g. glycerol trinitrate) or nitric oxide donors (e.g. amyl nitrite, also called “poppers”).
Slovenian: če jemljete zdravila, ki vsebujejo nitrate (npr. gliceriltrinitrat) ali donorje dušikovega oksida (npr. amilnitrit, imenovan tudi »poppers«).
English: Do NOT take Sildenafil ratiopharm if you are taking medicines that contain nitrates (e.g. glycerol trinitrate) or nitric oxide donors (e.g. amyl nitrite, also called “poppers”).
Slovenian: NE vzemite zdravila Sildenafil ratiopharm, če jemljete zdravila, ki vsebujejo nitrate (npr. gliceriltrinitrat) ali donorje dušikovega oksida (npr. amilnitrit, imenovan tudi »poppers«).
English: Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals.
Slovenian: Sočasna uporaba sildenafila pri bolnikih, ki jemljejo antagoniste adrenergičnih receptorjev alfa, lahko pri maloštevilnih občutljivih posameznikih povzroči simptomatsko hipotenzijo.
English: In a study of healthy male volunteers, co-administration of the endothelin antagonist, bosentan, (an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19) at steady state (125 mg twice a day) with sildenafil at steady state (80 mg three times a day) resulted in 62.6% and 55.4% decrease in sildenafil AUC and Cmax, respectively.
Slovenian: V študiji pri zdravih moških prostovoljcih, ki so sočasno jemali antagonist endotelina, bosentan, (induktor CYP3A4 (zmeren), CYP2C9 in morda CYP2C19) v stanju dinamičnega ravnotežja (125 mg dvakrat na dan) in sildenafil v stanju dinamičnega ravnotežja (80 mg trikrat na dan) je povzročilo 62,6 % in 55,4 % zmanjšanje AUC sildenafila in Cmax.
English: Ask your pharmacist how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte farmacevtom.
English: This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug.
Slovenian: Selektivnost tega presnovka za fosfodiesteraze je podobna sildenafilovi, njegov vpliv na PDE5 pa je in vitro približno 50 % vpliva prvotnega zdravila.
English: Sudden cardiac death*, Myocardial infarction, Ventricular arrhythmia*, Atrial fibrillation, Unstable angina
Slovenian: Srčne bolezni tahikardija, palpitacije nenadna srčna smrt,* miokardni infarkt, ventrikularna aritmija,* atrijska fibrilacija, nestabilna angina pektoris
English: 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.
Slovenian: 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 kakršni koli obliki kontraindicirana.
English: This is when a man cannot get or keep a hard, erect penis suitable for sexual activity.
Slovenian: Gre za motnjo, pri kateri moškemu spolni ud ne otrdi ali ne ostane dovolj otrdel, da bi bila mogoča spolna dejavnost.
English: Pooling of the following classes of antihypertensive medication, diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrally-acting), 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.
Slovenian: Pri bolnikih, ki so hkrati s sildenafilom jemali zdravila iz naslednjih skupin antihipertenzivov: diuretike, antagoniste adrenergičnih receptorjev beta, zaviralce ACE, antagoniste angiotenzina II, vazodilatacijsko in centralno delujoče antihipertenzive, antagoniste adrenergičnih nevronov, zaviralce kalcijevih kanalčkov in antagoniste adrenergičnih receptorjev alfa, se profil neželenih učinkov ni razlikoval od profila pri bolnikih, ki so dobivali placebo.
English: Talk to your doctor or pharmacist before taking Sildenafil ratiopharm - if you have problems with your heart.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Sildenafil ratiopharm se posvetujte z zdravnikom ali farmacevtom: če imate težave s srcem.
English: Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany
Slovenian: Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Nemčija
English: NAME OF THE MARKETING AUTHORISATION HOLDER ratiopharm
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM ratiopharm
English: In order to minimise the potential for developing postural hypotension, patients should be haemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Sildenafil ratiopharm is a treatment for adult men with erectile dysfunction, sometimes known as impotence.
Slovenian: Za kaj uporabljamo zdravilo Sildenafil ratiopharm Zdravilo Sildenafil ratiopharm je zdravilo za odrasle moške z erektilno disfunkcijo, znano tudi kot impotenca.
English: If you are not certain, ask your doctor or pharmacist.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
English: 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 vision blurred.
Slovenian: 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.
English: When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
Slovenian: Ob uporabi enega 100-mg odmerka sildenafila hkrati z eritromicinom, zmernim zaviralcem CYP3A4, je v stanju dinamičnega ravnovesja (500 mg dvakrat na dan 5 dni) prišlo do 182-odstotnega zvečanja sistemske izpostavljenosti (AUC) sildenafilu.
English: Teva Nederland B.V. Tel: +31 (0) 800 0228 400
Slovenian: Tel: +31 (0) 800 0228 400
English: Sildenafil has a peripheral site of action on erections.
Slovenian: Sildenafil vpliva na erekcijo periferno.
English: Co-administration of sildenafil with ritonavir is not advised (see section 4.5).
Slovenian: Sočasna uporaba z ritonavirjem Sočasna uporaba sildenafila z ritonavirjem ni priporočljiva (glejte poglavje 4.5).
English: Hypertension, Hypotension
Slovenian: Žilne bolezni zardevanje, vročinski oblivi hipertenzija, hipotenzija
English: 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.
Slovenian: 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.
English: Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route).
Slovenian: Sildenafil v glavnem odstranjujeta jetrna mikrosomska izoencima CYP3A4 (glavna pot) in CYP2C9 (manj pomembna pot).
English: - if you are already undergoing treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.
Slovenian: NE jemljite tega zdravila če prejemate druge oblike zdravljenja za erektilno disfunkcijo, če se zaradi pljučne arterijske hipertenzije (PAH) že zdravite z zdravili, ki vsebujejo sildenafil ali katere koli druge zaviralce PDE5.
English: 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).
Slovenian: 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 priporočljiva (glejte poglavje 4.4).
English: In order to minimise the potential of developing postural hypotension in patients receiving alpha-blocker treatment, patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil treatment.
Slovenian: Da bo možnost za pojav posturalne hipotenzije čim manjša med bolniki, ki prejemajo terapijo z zaviralci adrenergičnih receptorjev alfa, morajo biti bolniki pred začetkom zdravljenja s sildenafilom stabilni na terapiji z antagonisti adrenergičnih receptorjev alfa.
English: Manufacturer Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Germany
Slovenian: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Nemčija
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200% and 79% respectively.
Slovenian: Poleg tega sta se pomembno zvečali tudi AUC (za 200 %) in Cmax (za 79 %) N-desmetilnega presnovka.
English: This medicine might make some people feel dizzy or affect their vision or hearing.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev To zdravilo lahko pri nekaterih ljudeh povzroči omotico in vpliva na vid ali sluh.
English: There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6).
Slovenian: Sildenafil po enem samem 100-mg peroralnem odmerku ni vplival na gibljivost ali morfologijo semenčic zdravih prostovoljcev (glejte poglavje 4.6).
English: Rare
Slovenian: Pogosti
English: Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
Slovenian: Pri nekaterih preiskovancih so s Farnsworth-Munsellovim testom s 100 barvnimi odtenki 1 uro po 100-mg odmerku ugotovili blage in prehodne spremembe razločevanja barv (modra/zelena); 2 uri po odmerku ta učinek ni bil več opazen.
English: Effects of sildenafil on other medicinal products In vitro studies
Slovenian: Učinki sildenafila na druga zdravila
English: Renal and urinary disorders
Slovenian: Infekcijske in parazitske bolezni rinitis
English: resulted in a 49.8% increase in bosentan AUC and a 42% increase in bosentan Cmax (125 mg b.i.d.
Slovenian: Pri zdravih moških prostovoljcih je sildenafil v stanju dinamičnega ravnotežja (80 mg trikrat na dan) povzročil 49,8 % povečanje AUC bosentana in 42 % povečanje Cmax bosantana (125 mg dvakrat na dan).
English: Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the co-administration may lead to symptomatic hypotension in a few susceptible individuals (see section 4.5).
Slovenian: Sočasna uporaba z zaviralci adrenergičnih receptorjev alfa Previdnost je potrebna med uporabo sildenafila pri bolnikih, ki jemljejo antagoniste adrenergičnih receptrojev alfa, ker sočasna uporaba pri maloštevilnih občutljivih posameznikih lahko povzroči simptomatsko hipotenzijo (glejte poglavje 4.5).
English: What Sildenafil ratiopharm looks like and contents of the pack Sildenafil ratiopharm are white to off-white, oblong film-coated tablets with edge.
Slovenian: Izgled zdravila Sildenafil ratiopharm in vsebina pakiranja Sildenafil ratiopharm so bele do belkaste, podolgovate, filmsko obložene tablete z robom.
English: Immune system disorders
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije
English: Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Slovenian: Sočasna uporaba zaviralca proteaz HIV sakvinavirja, ki zavira CYP3A4, je v stanju dinamičnega ravnovesja (1.200 mg trikrat na dan) in sildenafila (enkratni odmerek 100 mg) povzročila 140 % zvečanje Cmax sildenafila in 210 % zvečanje AUC sildenafila.
English: The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).
Slovenian: Sildenafil se po peroralni in intravenski uporabi izloča v obliki presnovkov, pretežno z blatom (približno 80 % peroralnega odmerka) in v manjši meri z urinom (približno 13 % peroralnega odmerka).
English: 1 film-coated tablet 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 24 film-coated tablets 48 film-coated tablets
Slovenian: 1 filmsko obložena tableta 2 filmsko obloženi tableti 4 filmsko obložene tablete 8 filmsko obloženih tablet 12 filmsko obloženih tablet 24 filmsko obloženih tablet 48 filmsko obloženih tablet
English: Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of sildenafil.
Slovenian: V obdobju trženja so bili v časovni povezanosti z uporabo sildenafila opisani resni kardiovaskularni dogodki, med drugim miokardni infarkt, nestabilna angina pektoris, nenadna srčna smrt, ventrikularna aritmija, cerebrovaskularna krvavitev, tranzitorna ishemična ataka, hipertenzija in hipotenzija.
English: The mean AUC and Cmax of the N-desmethyl metabolite increased up to 126% and up to 73% respectively,
Slovenian: Srednja AUC N-desmetilnega presnovka se je zvečala za do 126 %, srednji Cmax pa za do 73 % v primerjavi s prostovoljci primerljive starosti brez okvare ledvic.
English: NAME OF THE MEDICINAL PRODUCT Sildenafil ratiopharm 25 mg film-coated tablets Sildenafil ratiopharm 50 mg film-coated tablets Sildenafil ratiopharm 100 mg film-coated tablets
Slovenian: Sildenafil ratiopharm 25 mg filmsko obložene tablete Sildenafil ratiopharm 50 mg filmsko obložene tablete Sildenafil ratiopharm 100 mg filmsko obložene tablete
English: Therefore, tell your doctor if you are taking any of the following medicines: - ritonavir or saquinavir (medicines for the treatment of HIV infections); - ketoconazole or itraconazole (medicines for the treatment of fungal infections); - erythromycin (an antibiotic); - cimetidine (medicine for the treatment of heartburn and peptic ulcers);
Slovenian: ritonavir ali sakvinavir (zdravili za zdravljenje okužbe s HIV); ketokonazol ali itrakonazol (zdravili za zdravljenje glivičnih okužb); eritromicin (antibiotik); cimetidin (zdravilo za zdravljenje zgage in peptičnih ulkusov); antagonisti adrenergičnih receptorjev alfa (skupina zdravil za zdravljenje visokega krvnega tlaka ali povečane prostate [benigne hiperplazije prostate]).
English: What Sildenafil ratiopharm looks like and contents of the pack Sildenafil ratiopharm are white to off-white, oblong film-coated tablets with edge and score line on one side.
Slovenian: Izgled zdravila Sildenafil ratiopharm in vsebina pakiranja Sildenafil ratiopharm so bele do belkaste, podolgovate, filmsko obložene tablete z robom in razdelilno zarezo na eni strani.
English: EU/1/09/603/009 1 film-coated tablet EU/1/09/603/010 4 film-coated tablets EU/1/09/603/011 8 film-coated tablets EU/1/09/603/012 12 film-coated tablets EU/1/09/603/015 2 film-coated tablets EU/1/09/603/016 24 film-coated tablets EU/1/09/603/018 48 film-coated tablets
Slovenian: EU/1/09/603/009 1 filmsko obložena tableta EU/1/09/603/010 4 filmsko obložene tablete EU/1/09/603/011 8 filmsko obloženih tablet EU/1/09/603/012 12 filmsko obloženih tablet EU/1/09/603/015 2 filmsko obloženi tableti EU/1/09/603/016 24 filmsko obloženih tablet EU/1/09/603/018 48 filmsko obloženih tablet
English: Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3
Slovenian: Imetnik dovoljenja za promet z zdravilom ratiopharm GmbH
English: 1 film-coated tablet 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets
Slovenian: 1 filmsko obložena tableta 2 filmsko obloženi tableti 4 filmsko obložene tablete 8 filmsko obloženih tablet 12 filmsko obloženih tablet
English: Eyelid oedema, Scleral discoloration
Slovenian: Bolezni sečil hematurija
English: Sildenafil ratiopharm 25 mg film-coated tablets White to off-white, oblong film-coated tablet with edge.
Slovenian: Sildenafil ratiopharm 25 mg filmsko obložene tablete Bela do belkasta, podolgovata, filmsko obložena tableta z robom.
English: 1 film-coated tablet 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 24 film-coated tablets
Slovenian: 1 filmsko obložena tableta 2 filmsko obloženi tableti 4 filmsko obložene tablete 8 filmsko obloženih tablet 12 filmsko obloženih tablet 24 filmsko obloženih tablet
English: In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
Slovenian: V treh specifičnih študijah interakcij med zdravili so bolnikom z benigno hiperplazijo prostate (BPH), pri katerih bolezen ni napredovala pri zdravljenju z doksazosinom, dali antagonist adrenergičnih receptorjev alfa doksazosin (4 mg in 8 mg) sočasno s sildenafilom (25 mg, 50 mg oz. 100 mg).
English: INFORMATION IN BRAILLE Sildenafil ratiopharm 25 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Sildenafil ratiopharm 25 mg
English: Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Slovenian: V povezavi z jemanjem sildenafila in drugih zaviralcev PDE5 so spontano in med opazovalno študijo poročali o primerih nearteritične anteriorne ishemične optične nevropatije, redke bolezni (glejte poglavje 4.8).
English: INFORMATION IN BRAILLE Sildenafil ratiopharm 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Sildenafil ratiopharm 100 mg
English: 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.
Slovenian: 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, prisotnost krvi v spermi, suh nos, oteklost notranjosti nosu, razdražljivostkrvavitev iz nosu, nenadno zmanjšanje ali izguba sluha
English: EU/1/09/603/005 1 film-coated tablet EU/1/09/603/006 4 film-coated tablets EU/1/09/603/007 8 film-coated tablets EU/1/09/603/008 12 film-coated tablets EU/1/09/603/014 2 film-coated tablets EU/1/09/603/017 24 film-coated tablets
Slovenian: EU/1/09/603/005 1 filmsko obložena tableta EU/1/09/603/006 4 filmsko obložene tablete EU/1/09/603/007 8 filmsko obloženih tablet EU/1/09/603/008 12 filmsko obloženih tablet EU/1/09/603/014 2 filmsko obloženi tableti EU/1/09/603/017 24 filmsko obloženih tablet
English: EU/1/09/603/001 1 film-coated tablet EU/1/09/603/002 4 film-coated tablets EU/1/09/603/003 8 film-coated tablets EU/1/09/603/004 12 film-coated tablets EU/1/09/603/013 2 film-coated tablets
Slovenian: EU/1/09/603/001 1 filmsko obložena tableta EU/1/09/603/002 4 filmsko obložene tablete EU/1/09/603/003 8 filmsko obloženih tablet EU/1/09/603/004 12 filmsko obloženih tablet EU/1/09/603/013 2 filmsko obloženi tableti