natgillin/translations-raw huggingface dataset:
There is limited clinical data on the safety of CIALIS in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/ risk evaluation should be undertaken by the prescribing physician.
Pri bolnikih s hudo okvarjenim delovanjem jeter (razred C po Child- Pughu) so na voljo le omejeni klinični podatki o varnosti CIALISA; v kolikor ga predpišemo, naj zdravnik, ki zdravilo predpiše, skrbno ovrednoti razmerje med koristmi in tveganjem pri posamezniku.
There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment.
O dajanju odmerkov tadalafila, višjih od 10 mg, bolnikom z okvarjenim delovanjem jeter ni podatkov.
(See section 5.2).
Pri bolnikih z okvarjenim delovanjem jeter niso ocenjevali odmerjanja enkrat na dan; torej, v kolikor ga predpišemo, naj zdravnik, ki zdravilo predpiše, skrbno ovrednoti razmerje med koristmi in tveganjem pri posamezniku (glejte poglavje 5. 2).
Use in men with diabetes Dose adjustments are not required in diabetic patients.
Uporaba pri moških s sladkorno boleznijo Pri bolnikih s sladkorno boleznijo odmerkov ni potrebno prilagajati.
Use in children and adolescents CIALIS should not be used in individuals below 18 years of age.
Uporaba pri otrocih in mladostnikih CIALISA ne smemo uporabljati pri osebah, mlajših od 18 let.
This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/ cGMP pathway.
To naj bi bila posledica kombiniranih učinkov nitratov in tadalafila na metabolno pot dušikovega oksida/ cGMP.
(See section 4.5).
Zato je dajanje CIALISA bolnikom, ki uporabljajo kakršnokoli obliko organskega nitrata, kontraindicirano (glejte poglavje 4. 5).
Agents for the treatment of erectile dysfunction, including CIALIS, must not be used in men with cardiac disease for whom sexual activity is inadvisable.
Učinkovin za zdravljenje erektilne disfunkcije, vključno s CIALISOM, ne smemo uporabljati pri moških s srčnim obolenjem, katerim je spolna aktivnost odsvetovana.
- patients with myocardial infarction within the last 90 days,
- bolniki z miokardnim infarktom v zadnjih 90 dneh,
- patients with unstable angina or angina occurring during sexual intercourse,
- bolniki z nestabilno angino pektoris ali angino pektoris, ki se pojavlja med spolnim odnosom,
- patients with New York Heart Association Class 2 or greater heart failure in the last 6 months,
- bolniki s srčnim odpovedovanjem razreda 2 ali višjim po NYHA (New York Heart Association)
- patients with uncontrolled arrhythmias, hypotension (< 90/ 50 mm Hg), or uncontrolled
- bolniki z nekontroliranimi aritmijami, hipotenzijo (< 90/ 50 mm Hg) ali nekontrolirano
hypertension,
hipertenzijo,
- patients with a stroke within the last 6 months.
- bolniki, ki so v zadnjih 6 mesecih doživeli kap.
CIALIS is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
CIALIS je kontraindiciran 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).
Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.
Tadalafil ima
Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1) and as such potentiate the hypotensive effect of nitrates (see section 4.3).
3 vazodilatatorne lastnosti, to pa povzroča blaga in prehodna znižanja krvnega tlaka (glejte poglavje 5. 1), in kot tak krepi hipotenzivni učinek nitratov (glejte poglavje 4. 3).
3 In patients receiving concomitant antihypertensive medicines, tadalafil may induce a blood pressure decrease.
Tadalafil lahko inducira znižanje krvnega tlaka pri bolnikih, ki sočasno prejemajo antihipertenzive.
Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/ or in clinical trials.
Med kliničnimi študijami so se pojavili resni srčnožilni dogodki, vključno z miokardnim infarktom, nenadno srčno smrtjo, nestabilno angino pektoris, prekatno aritmijo, kapjo in tranzitornimi ishemičnimi atakami, bolečina za prsnico, palpitacije in tahikardija so bili poročani ali v postmarketinških raziskavah in/ ali v kliničnih raziskavah.
Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
Večina bolnikov, pri katerih so opažali te dogodke, je že prej imela srčnožilne dejavnike tveganja.
However, it is not possible to definitively determine whether these events are related directly to these risk factors, to CIALIS, to sexual activity, or to a combination of these or other factors.
Vendar pa ni mogoče dokončno potrditi, ali so omenjeni dogodki neposredno povezani s temi dejavniki tveganja, s CIALISOM, spolno aktivnostjo ali kombinacijo naštetih ali drugih dejavnikov.
Visual defects and cases of NAION have been reported in connection with the intake of CIALIS and other PDE5 inhibitors.
V povezavi z jemanjem CIALISA in drugih zaviralcev PDE5 so poročali o okvarah vida in primerih NAION.
The patient should be advised that in case of sudden visual defect, he should stop taking CIALIS and consult a physician immediately (see section 4.3).
Bolnika je treba opozoriti, da naj v primeru nenadne okvare vida preneha jemati CIALIS in o tem nemudoma obvesti svojega zdravnika (glejte poglavje 4. 3).
Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of CIALIS is not recommended in patients with severe renal impairment.
Zaradi povečane izpostavljenosti (AUC) tadalafilu, pomanjkanja kliničnih izkušenj in ne vplivanja dialize na klirens, odmerjanje CIALISA enkrat na dan ni priporočljivo za bolnike s hudo okvarjenim delovanjem ledvic.
There is limited clinical data on the safety of single-dose administration of CIALIS in patients with severe hepatic insufficiency (Child-Pugh Class C).
Pri bolnikih s hudo okvarjenim delovanjem jeter (razred C po Child- Pughu) je na voljo le malo kliničnih podatkov o varnosti CIALISA pri enkratnem odmerjanju.
Once-a-day administration has not been evaluated in patients with hepatic insufficiency.
Pri bolnikih z okvarjenim delovanjem jeter niso ocenjevali odmerjanja enkrat na dan.
If CIALIS is prescribed, a careful individual benefit/ risk evaluation should be undertaken by the prescribing physician.
Če zdravnik predpiše CIALIS, mora skrbno ovrednotiti razmerje med koristmi in tveganjem pri posamezniku.
Agents for the treatment of erectile dysfunction, including CIALIS, 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).
Učinkovine za zdravljenje erektilne disfunkcije, vključno s CIALISOM, je potrebno previdno uporabljati pri bolnikih z anatomsko deformacijo penisa (kot so ukrivljenost, kavernozna fibroza ali Peyroniejeva bolezen), ali pri bolnikih s stanji, ki bi lahko povečala dovzetnost za priapizem (kot so srpastocelična anemija, multipli mielom ali levkemija).
It is not known if CIALIS is effective in patients who have undergone pelvic surgery or radical non-nerve- sparing prostatectomy.
Ni znano, ali je CIALIS učinkovit pri bolnikih po operacijah v medenici ali po radikalni prostatektomiji brez ohranjanja živcev.
In patients who are taking alpha1 blockers concomitant administration of CIALIS may lead to symptomatic hypotension in some patients (see section 4.5).
Pri bolnikih, ki jemljejo zaviralce adrenergičnih receptorjev alfa1, lahko sočasno dajanje CIALISA pri nekaterih bolnikih povzroči simptomatsko hipotenzijo (glejte poglavje 4. 5).
Caution should be exercised when prescribing CIALIS to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicines are combined (see section 4.5).
Ko predpisujemo CIALIS bolnikom, ki jemljejo močne inhibitorje CYP3A4 (ritonavir, sakvinavir, ketokonazol, itrakonazol in eritromicin), je potrebna previdnost, ker so pri taki kombinaciji zdravil opažali povečano izpostavitev (AUC) tadalafilu (glejte poglavje 4. 5).
The safety and efficacy of combinations of CIALIS and other treatments for erectile dysfunction have not been studied.
Varnosti in učinkovitosti kombinacij CIALISA in drugih zdravljenj za erektilno disfunkcijo niso preučevali.
Therefore, the use of such combinations is not recommended.
Zato uporaba takih kombinacij ni priporočena.
CIALIS contains lactose monohydrate.
CIALIS vsebuje laktozo monohidrat.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redkimi podedovanimi težavami intolerance za galaktozo, s pomanjkanjem Lapp laktaze ali malabsorpcijo glukoze- galaktoze ne smejo jemati tega zdravila.
Interaction studies were conducted with 10 mg and/ or 20 mg tadalafil, as indicated below.
Študije medsebojnega delovanja so bile opravljene z 10 mg in/ ali 20 mg tadalafila, kot je prikazano spodaj.
A selective inhibitor of CYP3A4, ketoconazole (200 mg daily), increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax values for tadalafil alone.
Selektivni inhibitor CYP3A4, ketokonazol (200 mg dnevno), je povečal izpostavitev (AUC) tadalafilu (10 mg) za 2- krat in Cmax za 15% glede na vrednosti AUC in Cmax za sam tadalafil.
Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold and Cmax by 22%.
Ketokonazol (400 mg dnevno) je povečal izpostavitev (AUC) tadalafilu (20 mg) za 4- krat in Cmax za 22%.
Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in Cmax.
Ritonavir, inhibitor proteaze (200 mg dvakrat dnevno), ki je inhibitor CYP3A4, CYP2C9, CYP2C19 in CYP2D6, je povečal izpostavitev (AUC) tadalafilu (20 mg) za 2- krat brez spremembe Cmax.
Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice should be co-administered with caution as they would be expected to increase plasma concentrations of tadalafil (see section 4.4) Consequently the incidence of the undesirable effects listed in section 4.8 might be increased.
Posledično bi lahko bila incidenca neželenih učinkov, naštetih v poglavju 4. 8, povečana.
The role of transporters (for example p-glycoprotein) in the disposition of tadalafil is not known.
Vloga prenašalcev (na primer p- glikoproteina) pri razpoložljivosti tadalafila ni znana.
There is thus the potential of drug interactions mediated by inhibition of transporters.
Zato obstaja možnost medsebojnih delovanj zdravil, ki jih posreduje inhibicija prenašalcev.
Therefore, administration of CIALIS to patients who are using any form of organic nitrate is contraindicated (see section 4.3).
Zato je dajanje CIALISA bolnikom, ki uporabljajo kakršnokoli obliko organskega nitrata, kontraindicirano (glejte poglavje 4. 3).
Based on the results of a clinical study in which 150 subjects receiving daily doses of tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose.
Na podlagi rezultatov klinične študije, v kateri je 150 oseb prejemalo dnevne odmerke tadalafila 20 mg 7 dni in 0, 4 mg sublingvalnega nitroglicerina ob različnih časih, je to medsebojno delovanje trajalo dalj kot 24 ur in ni bilo več zaznavno po preteku 48 ur od zadnjega odmerka tadalafila.
Thus, in a patient prescribed any dose of CIALIS (2.5 mg-20 mg), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of CIALIS before nitrate administration is considered.
Zato naj pri bolniku, ki ima predpisan katerikoli odmerek CIALISA (2, 5 mg- 20 mg) in kjer je dajanje nitrata zdravstveno nujno v življenje ogrožujoči situaciji, pred dajanjem nitrata preteče vsaj 48 ur po zadnjem odmerku CIALISA.
In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive agents was examined.
V študijah klinične farmakologije so preiskovali možnost, da tadalafil okrepi hipotenzivne učinke antihipertenzivnih učinkovin.
Major classes of antihypertensive agents were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/ or alpha-blockers).
Preučevali so poglavitne razrede antihipertenzivnih učinkovin, vključno z zaviralci kalcijevih kanalčkov (amlodipin), inhibitorji angiotenzin konvertaze (enalapril), zaviralci adrenergičnih receptorjev beta (metoprolol), tiazidnimi diuretiki (bendrofluazid) in zaviralci receptorjev angiotenzina II (različni tipi in odmerki, posamezno ali v kombinaciji s tiazidi, zaviralci kalcijevih kanalčkov, zaviralci adrenergičnih receptorjev beta in/ ali zaviralci adrenergičnih receptorjev alfa).
Analysis of phase 3 clinical trial data showed no difference in adverse events in patients taking
Pri bolnikih, ki sočasno prejemajo antihipertenzivna zdravila, lahko tadalafil 20 mg povzroči znižanje krvnega tlaka, ki je (z izjemo zaviralcev adrenergičnih receptorjev alfa - glejte spodaj -) v splošnem majhno in ni verjetno, da bi bilo klinično pomembno.
5 tadalafil with or without antihypertensive medicines.
5 Analiza podatkov kliničnih preskušanj faze 3 ni pokazala razlike v neželenih dogodkih pri bolnikih, ki so tadalafil jemali skupaj z antihipertenzivnimi zdravili ali brez njih.
However, appropriate clinical advice should be given to patients regarding a possible decrease in blood pressure when they are treated with antihypertensive medicines.
Vendar pa je potrebno bolnikom ustrezno klinično svetovati glede možnega znižanja krvnega tlaka, do katerega lahko pride med zdravljenjem z antihipertenzivnimi zdravili.
The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner.
Pri osebah, ki so sočasno prejemale tadalafil (20 mg) in doksazosin (8 mg dnevno), zaviralec adrenergičnih receptorjev alfa (1), je prišlo do okrepitve hipotenzivnega učinka doksazosina.
This effect lasts at least twelve hours and may be symptomatic, including syncope.
Pri nekaterih se je pojavila omotica, niso pa poročali o sinkopah.
Therefore this combination is not recommended (see section 4.4).
Nižjih odmerkov doksazosina niso preučevali.
In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin.
Zato kombinacija tadalafila in zaviralcev adrenergičnih receptorjev alfa ni priporočena.
However, caution should be exercised when using tadalafil in patients treated with any alpha-blockers, and notably in the elderly.
V študiji pri 18 zdravih prostovoljcih tadalafil (10 mg in 20 mg) ni imel klinično pomembnega učinka na spremembe krvnega tlaka zaradi tamsulosina, selektivnega zaviralca adrenergičnih receptorjev alfa (1A).
Treatments should be initiated at minimal dosage and progressively adjusted.
Ni znano, kako se to nanaša na druge zaviralce adrenergičnih receptorjev alfa (1A).
Alcohol concentrations (mean maximum blood concentration 0.08%) were not affected by co- administration with tadalafil (10 mg or 20 mg).
Sočasno dajanje tadalafila (10 mg ali 20 mg) ni vplivalo na koncentracije alkohola (povprečna maksimalna koncentracija v krvi 0, 08%).
Alcohol was administered in a manner to maximize the rate of alcohol absorption (overnight fast with no food until 2 hours after alcohol).
Alkohol so dajali na način, da bi čimbolj povečali absorpcijo alkohola (na tešče preko noči, brez hrane do preteka 2 ur po zaužitju alkohola).
Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/ kg or approximately 180 ml of 40% alcohol [vodka] in an 80-kg male) but in some subjects, postural dizziness and orthostatic hypotension were observed.
Tadalafil (20 mg) ni povečal povprečnega znižanja krvnega tlaka, ki ga je povzročil alkohol (0, 7 g/ kg ali približno 180 ml 40% alkohola [vodke] pri 80- kg moškem), pri nekaterih osebah pa so opažali posturalno omotico in ortostatsko hipotenzijo.
When tadalafil was administered with lower doses of alcohol (0.6 g/ kg), hypotension was not observed and dizziness occurred with similar frequency to alcohol alone.
Ko so tadalafil dajali z nižjimi odmerki alkohola (0, 6 g/ kg), hipotenzije niso opažali, omotica pa se je pojavljala s podobno pogostnostjo kot pri alkoholu samem.
When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a clinical pharmacology study, there was no pharmacokinetic interaction.
Ko so v študiji klinične farmakologije tadalafil 10 mg dajali skupaj s teofilinom (neselektivnim inhibitorjem fosfodiesteraze), ni bilo farmakokinetičnega medsebojnega delovanja.
The only pharmacodynamic effect was a small (3.5 bpm) increase in heart rate.
Edini farmakodinamični učinek je bil manjše (za 3, 5 utripa na minuto) povišanje srčne frekvence.
Although this effect is minor and was of no clinical significance in this study, it should be considered when co-administering these medicines.
Čeprav je ta učinek manjši in v tej študiji ni bil klinično pomemben, ga je potrebno ob sočasnem dajanju teh zdravil upoštevati.
Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal products metabolised by CYP450 isoforms.
Tadalafil naj ne bi povzročal klinično pomembne inhibicije ali indukcije očistka zdravil, ki se presnavljajo z izooblikami CYP450.
Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19.
Študije so potrdile, da tadalafil ne inhibira oziroma inducira izooblik CYP450, vključno s CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 in CYP2C19.
Tadalafil (10 mg and 20 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin.
Tadalafil (10 mg in 20 mg) ni imel klinično pomembnega učinka na izpostavitev (AUC) S- varfarinu ali R- varfarinu (substrat CYP2C9) niti ni vplival na spremembe protrombinskega časa, ki jih povzroča varfarin.
Specific interaction studies with antidiabetic agents were not conducted.
Specifične študije medsebojnega delovanja z antidiabetičnimi učinkovinami niso bile opravljene.
For tadalafil no clinical data on exposed pregnancies are available.
Za tadalafil ni na voljo kliničnih podatkov o izpostavljenosti nosečnosti.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo direktnih ali indirektnih škodljivih učinkov glede nosečnosti, embrio/ fetalnega razvoja, poroda ali postnatalnega razvoja (glejte poglavje 5. 3).
4.7 Effects on ability to drive and use machines
6 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
6 No studies on the effect on the ability to drive and use machines have been performed.
Študij vpliva na sposobnost vožnje in upravljanja s stroji niso izvajali.
Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to CIALIS, before driving or operating machinery.
Kljub temu, da so bile pogostnosti poročanja o omotici v skupinah prejemanja placeba in tadalafila v kliničnih preskušanjih podobne, naj se bolniki pred vožnjo ali upravljanjem strojev zavedajo, kako se odzovejo na CIALIS.
The most commonly reported adverse reactions were headache and dyspepsia.
Neželena učinka, o katerih so najpogosteje poročali, sta glavobol in dispepsija.
Adverse reaction data are limited in patients over 75 years of age.
Podatkov o neželenih učinkih je pri bolnikih, starejših od 75 let, malo.
The table below lists the adverse reactions reported during placebo-controlled clinical trials for registration in patients treated with CIALIS on demand and daily dosing.
Tabela spodaj navaja neželene učinke, ki so jih poročali med registracijskimi, s placebom kontroliranimi kliničnimi preskušanji, pri bolnikih zdravljenih s CIALISOM po potrebi ter z dnevnim odmerjanjem.
Adverse reactions are also included that have been reported from postmarketing surveillance in patients taking CIALIS on demand.
Neželeni učinki vključujejo tudi tiste, ki so jih poročali iz pomarketinškega spremljanja bolnikov, ki so jemali CIALIS po potrebi.
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) and Not known (events not reported in registration trials cannot be estimated from postmarketing spontaneous reports).
Neželeni učinki Ocene pogostnosti: 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 (< 1/ 10. 000) in ni znano (ocena neželenih učinkov, ki jih niso poročali v registracijskih preskušanjih, ni možna iz poročil pomarketinškega spemljanja).
(≥ 1/ 100 to <  1/ 10) (≥ 1/ 1000 to <  1/ 100)
(≥ 1/ 100 in < 1/ 10)
(≥ 1/ 10,000 to <  1/ 1000)
(≥ 1/ 10. 000 in < 1/ 1. 000)
System Organ Class:
Organski sistem:
Immune system disorders Hypersensitivity reactions System Organ Class:
Bolezni imunskega sistema Preobčutljivostne reakcije Organski sistem:
Nervous System disorders Headache
Bolezni živčevja Kap1, Sinkopa, Glavobol
Stroke1, Syncope, Transient ischaemic attacks1, Migraine
Tranzitorna ishemična ataka1, Migrena
Seizures, Transient amnesia
Epileptični napadi, Tranzitorna amnezija
Blurred vision, Sensations described as eye pain, Swelling of eyelids, Conjunctival hyperaemia
Zamegljen vid, Občutki opisani kot bolečina v očeh, Otečene veke, Konjuktivalna hiperemija
Visual field defect
Izpad v vidnem polju
Non-arteritic anterior ischemic optic neuropathy (NAION), Retinal vascular occlusion
Nearterična anteriorna ishemična optična nevropatija (NAION), Zapora retinalnih žil
Ear and labyrinth disorders Sudden deafness2 1 System Organ Class:
Ušesne bolezni, vključno z motnjami labirinta Nenadna gluhost2 Organski sistem:
Cardiac disorders
Srčne bolezni1
Unstable angina pectoris, Ventricular arrhythmia
Nestabilna angina pektoris, Prekatna aritmija
System Organ Class:
antihipertenzivna zdravila), Hipertenzija Organski sistem:
Respiratory, thoracic and mediastinal disorders Nasal congestion Epistaxis System Organ Class:
Bolezni dihal, prsnega koša in mediastinalnega prostora Nosna kongestija Epistaksa Organski sistem:
Gastrointestinal disorders Dyspepsia
Bolezni prebavil Dispepsija
Abdominal pain, Gastro- oesophageal reflux
Bolečina v trebuhu, Gastroezofagealn a refluksna bolezen
Rash, Urticaria, Hyperhydrosis (sweating)
Izpuščaj, Koprivnica, Hiperhidroza (znojenje)
Stevens-Johnson syndrome, Exfoliative dermatitis
Stevens - Johnsonov sindrom, Eksofoliativni dermatitis