FrancophonIA/ELRC3.0 huggingface dataset:
English: Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine).
Croatian: Populacijska farmakokinetička analiza podataka iz kliničkog ispitivanja pokazuje smanjenje klirensa sildenafila kada se primjenjuje istodobno s inhibitorima CYP3A4 (kao što su ketokonazol, eritromicin, cimetidin).
English: Vizarsin is not indicated for use by women.
Croatian: Vizarsin nije namijenjen za primjenu u žena.
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200 % and 79 % respectively.
Croatian: Nadalje, vrijednosti AUC i Cmax N-dezmetil metabolita bile su značajno povećane, 200% odnosno 79%.
English: - Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000 people)
Croatian: - Produljene i ponekad bolne erekcije - javljaju se rijetko (mogu se javiti kod do 1 na 1000
English: 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).
Croatian: Zdravi stariji dobrovoljci (65 godina ili stariji) imali su smanjeni klirens sildenafila što je rezultiralo približno 90% višim koncentracijama sildenafila i aktivnog N-dezmetil metabolita u plazmi u usporedbi s koncentracijama opaženim u zdravih mlađih dobrovoljaca (18-45 godina).
English: Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems.
Croatian: Posebna upozorenja za bolesnike s poremećajem bubrega ili jetre Obavijestite svojeg liječnika ako imate poteškoće s bubrezima ili jetrom.
English: If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.
Croatian: Ako imate erekciju koja traje dulje od 4 sata, odmah se trebate obratiti svom liječniku.
English: - If you experience sudden decrease or loss of vision, stop taking Vizarsin and contact your doctor immediately.
Croatian: Ako osjetite iznenadno slabljenje ili gubitak vida, prestanite uzimati Vizarsin i odmah se obratite svom liječniku.
English: If you experience any of the following serious side effects stop taking Vizarsin and seek medical help immediately:
Croatian: Ako primijetite bilo koju od sljedećih nuspojava, prestanite uzimati Vizarsin i odmah zatražite medicinsku pomoć:
English: Vizarsin contains aspartame (E951), a source of phenylalanine which may be harmful for people with phenylketonuria.
Croatian: Vizarsin sadrži aspartam (E951), izvor fenilalanina, koji može biti štetan za osobe s fenilketonurijom.
English: 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.
Croatian: Sigurnost i djelotvornost kombinacija sildenafila s drugim inhibitorima PDE5, s drugim terapijama za plućnu arterijsku hipertenziju (PAH) koje sadrže sildenafil ili s drugim oblicima liječenja erektilne disfunkcije nije ispitana.
English: Talk to your doctor or pharmacist before taking Vizarsin: - If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Vizarsin: - Ako imate anemiju srpastih stanica (poremećaj crvenih krvnih stanica), leukemiju (rak krvnih stanica), multipli mijelom (rak koštane srži).
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne bi trebali uzimati lijek Vizarsin.
English: How to store Vizarsin
Croatian: Kako čuvati Vizarsin
English: (E420)), crospovidone, calcium silicate and magnesium stearate (E572).
Croatian: (E420)), krospovidon, kalcijev silikat i magnezijev stearat (E572).
English: Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).
Croatian: Uvijek obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate bilo koji od ovih lijekova koji se često koriste za ublažavanje angine pektoris (ili „boli u prsima“).
English: 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).
Croatian: U malom placebom kontroliranom ispitivanju bolesnika s dokumentiranom ranom makularnom degeneracijom povezanom s dobi (n=9), sildenafil (jednokratna doza, 100 mg) nije prikazao značajne promjene u provedenim testovima vida (oštrina vida, Amslerova mreža, raspoznavanje boja simulacijom semafora, Humphreyev perimetar i fotostres).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Muškarci s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom laktaze ili glukoza-galaktoza malapsorpcijom, ne bi trebali uzimati lijek Vizarsin.
English: 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.
Croatian: U ispitivanju hemodinamičkih učinaka jednokratne oralne doze sildenafila od 100 mg u 14 bolesnika s teškom bolesti koronarnih arterija (> 70% stenoza barem jedne koronarne arterije), srednji sistolički i dijastolički krvni tlak u mirovanju je snižen za 7%, odnosno 6% u usporedbi s početnom vrijednosti.
English: Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.
Croatian: Sildenafil (100 mg) nije utjecao na farmakokinetiku stanja dinamičke ravnoteže inhibitora HIV proteaze, sakvinavira i ritonavira, koji su supstrati CYP3A4.
English: To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start Vizarsin.
Croatian: Kako bi se smanjila mogućnost pojave tih simptoma, trebate biti na redovitoj dnevnoj dozi alfablokatora prije nego počnete uzimati Vizarsin.
English: Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly.
Croatian: Pojedini bolesnici koji uzimaju alfa-blokatore za liječenje visokog krvnog tlaka ili povećanja prostate mogu imati omaglicu ili ošamućenost, što može biti uzrokovano sniženjem krvnog tlaka nakon naglog uspravljanja u sjedeći ili stojeći položaj.
English: Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant treatment on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates).
Croatian: Iako specifična ispitivanja interakcija nisu provedena za sve lijekove, populacijska farmakokinetička analiza nije pokazivala djelovanje istodobno primijenjenog liječenja na farmakokinetiku sildenafila, grupiranih kao inhibitori CYP2C9 (kao što su tolbutamid, varfarin, fenitoin), inhibitori CYP2D6 (kao što su selektivni inhibitori ponovne pohrane serotonina, triciklični antidepresivi), tiazid i srodni diuretici, diuretici Henleove petlje i oni koji štede kalij, inhibitori angiotenzin konvertirajućeg enzima, blokatori kalcijevih kanala, antagonisti beta-adrenoreceptora ili induktori CYP450 metabolizma (kao što su rifampicin, barbiturati).
English: Film coating:
Croatian: Film ovojnica:
English: 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.
Croatian: Iako u tih bolesnika nije opažena povećana incidencija štetnih događaja, kod istodobne primjene sildenafila s inhibitorima CYP3A4 potrebno je razmotriti primjenu početne doze od 25 mg.
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).
Croatian: S iznimkom ritonavira, kod kojeg se istodobna primjena sa sildenafilom ne savjetuje (vidjeti dio 4.4), u bolesnika koji se istodobno liječe CYP3A4 inhibitorima potrebno je razmotriti primjenu početne doze od 25 mg (vidjeti dio 4.5).
English: - If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).
Croatian: Ako imate anemiju srpastih stanica (poremećaj crvenih krvnih stanica), leukemiju (rak krvnih stanica), multipli mijelom (rak koštane srži).
English: - The other ingredients are hydroxypropylcellulose (E463), mannitol (E421), aspartame (E951),
Croatian: - Drugi sastojci su hidroksipropilceluloza (E463), manitol (E421), aspartam (E951),
English: Vizarsin contains sorbitol (E420).
Croatian: Vizarsin sadrži sorbitol (E420).
English: BLISTER for trilingual packaging
Croatian: BLISTER za trojezično pakiranje
English: The side effects reported in association with the use of Vizarsin are usually mild to moderate and of a short duration.
Croatian: Nuspojave zabilježene kod primjene Vizarsina su obično blage do umjerene i kratko traju.
English: Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction
Croatian: Istodobna primjena s drugim inhibitorima PDE5 ili drugim oblicima liječenja erektilne disfunkcije
English: In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 ml/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
Croatian: U dobrovoljaca s blagim do umjerenim poremećajem funkcije bubrega (klirens kreatinina = 30-80 ml/min), nakon uzimanja jednokratne oralne doze od 50 mg nije bilo promjena u farmakokinetici sildenafila.
English: Vizarsin contains aspartame (E951) and sorbitol (E420) Aspartame is a source of phenylalanine which may be harmful for people with a disorder called phenylketonuria.
Croatian: Vizarsin sadrži aspartam (E951) i sorbitol (E420) Aspartam je izvor fenilalanina koji može biti štetan za osobe s poremećajem pod nazivom fenilketonurija.
English: 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.
Croatian: Bolesnici s povećanom osjetljivošću na vazodilatatore obuhvaćaju one s opstrukcijom izlaznog trakta lijevog ventrikula (npr. aortna stenoza, hipertrofična opstruktivna kardiomiopatija) ili bolesnike s rijetkim sindromom multiple sustavne atrofije koja se manifestira teškim poremećajem autonomne kontrole krvnog tlaka.
English: Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
Croatian: Riociguat: Pretklinička ispitivanja su pokazala aditivan učinak na snižavanje krvnog tlaka kada su se PDE5 inhibitori koristili u kombinaciji sa riociguatom.
English: Contains aspartame (E951) and peppermint oil (sorbitol (E420)).
Croatian: Sadrži aspartam (E951) i ulje paprene metvice (sorbitol (E420)).
English: - The other ingredients are:
Croatian: Ostale nuspojave:
English: Rare ( 1/10000 and
Croatian: Rijetko ( 1/10000 do
English: The dosing recommendations described in ‘Use in adults' apply to patients with mild to moderate renal impairment (creatinine clearance = 30-80 ml/min).
Croatian: Preporuke za doziranje opisane pod „Primjena u odraslih osoba“ odnose se na bolesnike s blagim do umjerenim oštećenjem funkcije bubrega (klirens kreatinina = 30-80 ml/min).
English: *, Myocardial infarction, Ventricular arrhythmia Atrial fibrillation, Unstable angina
Croatian: Iznenadna srčana smrt*, infarkt miokarda, ventrikularna aritmija*, fibrilacija atrija, nestabilna angina
English: Co-administration of sildenafil with ritonavir is not advised (see section 4.5).
Croatian: Istodobna primjena sildenafila s ritonavirom se ne preporučuje (vidjeti dio 4.5).
English: Blister (PVC-foil/Alu-foil): 1 film-coated tablet, in a carton.
Croatian: Blister (PVC folija/Alu folija): 1 filmom obložena tableta, u kutiji.
English: Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated (see section 4.3).
Croatian: Istodobna upotreba riociguata sa PDE5 inhibitorima, uključujući sildenafil je kontraindicirana (vidjeti dio 4.3).
English: BLISTER for monolingual and bilingual packaging
Croatian: BLISTER za monojezično i dvojezično pakiranje
English: - Chest pains - this occurs uncommonly If this occurs during or after intercourse: - Get in a semi-sitting position and try to relax.
Croatian: Ako se to javi tijekom ili nakon spolnog odnosa: - Zauzmite polusjedeći položaj i pokušajte se opustiti.
English: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 μM).
Croatian: Sildenafil je slabi inhibitor citokroma P450 izoformi 1A2, 2C9, 2C19, 2D6, 2E1 i 3A4 (IC50 > 150 μM).
English: 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).
Croatian: Sigurnost sildenafila nije ispitana u sljedećim podskupinama bolesnika te je njegova primjena stoga kontraindicirana: teško oštećenje funkcije jetre, hipotenzija (krvni tlak <90/50 mmHg), anamneza nedavnog moždanog udara ili infarkta miokarda i poznati nasljedni degenerativni poremećaji retine kao što su retinitis pigmentosa (manji dio tih bolesnika ima genetske poremećaje retinalnih fosfodiesteraza).
English: Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”).
Croatian: Obavijestite svog liječnika ako uzimate bilo koji od ovih lijekova koji se često primjenjuju za ublažavanje angine pektoris (ili "boli u prsima").
English: 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.
Croatian: Cimetidin (800 mg), inhibitor citokroma P450 i nespecifični inhibitor CYP3A4, uzrokovao je 56%-tni porast koncentracija sildenafila u plazmi kada se primjenjivao istodobno sa sildenafilom (50 mg) u zdravih dobrovoljaca.
English: A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal medicinal products (except nitrates).
Croatian: U dvostruko slijepom, placebom kontroliranom ispitivanju stresa izazvanog vježbanjem procijenjeno je 144 bolesnika s erektilnom disfunkcijom i kroničnom stabilnom anginom, koji su redovito uzimali lijekove protiv angine (osim nitrata).
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%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%).
Croatian: Uzimajući u obzir sva ispitivanja, udio bolesnika koji su prijavili poboljšanje uz sildenafil bio je sljedeći: psihogena erektilna disfunkcija (84%), mješovita erektilna disfunkcija (77%), organska erektilna disfunkcija (68%), starije osobe (67%), dijabetes melitus (59%), ishemična bolest srca (69%), hipertenzija (68%), TURP (61%), radikalna prostatektomija (43%), ozljeda leđne moždine (83%), depresija (75%).
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).
Croatian: Nije bilo učinka na motilitet ili morfologiju spermija nakon jedne peroralne doze od 100 mg sildenafila u zdravih dobrovoljaca (vidjeti dio 5.1).
English: The mean AUC and Cmax of the N-desmethyl metabolite increased up to 126% and up to 73% respectively, compared to age-matched volunteers with no renal impairment.
Croatian: Srednja AUC i Cmax N-dezmetil metabolita porasla je do 126% odnosno do 73%, u usporedbi s dobrovoljcima odgovarajućim po dobi, bez oštećenja bubrega.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJAZA STAVLJANJE LIJEKA U PROMET
English: neohesperidin-dihydrochalcone (E959), spearmint oil, peppermint oil (containing sorbitol
Croatian: neohesperidin dihidrokalkon (E959), ulje zelene metvice, ulje paprene metvice (sadrži sorbitol
English: Neohesperidin-dihydrochalcone (E959) Spearmint oil
Croatian: Neohesperidin dihidrokalkon (E959) Ulje zelene metvice
English: Given sildenafil peak plasma concentrations of approximately 1 μM after recommended doses, it is unlikely that sildenafil will alter the clearance of substrates of these isoenzymes.
Croatian: S obzirom da su nakon preporučenih doza vršne koncentracije sildenafila u plazmi približno 1 μM, nije vjerojatno da će sildenafil promijeniti klirens supstrata tih izoenzima.
English: Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 ml/min) a 25 mg dose should be considered.
Croatian: Budući da je klirens sildenafila smanjen u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina <30 ml/min), potrebno je razmotriti primjenu doze od 25 mg.
English: Given sildenafil peak plasma concentrations of approximately 1 M after recommended doses, it is unlikely that sildenafil will alter the clearance of substrates of these isoenzymes.
Croatian: S obzirom da su nakon preporučenih doza vršne koncentracije sildenafila u plazmi približno 1 M, nije vjerojatno da će sildenafil promijeniti klirens supstrata tih izoenzima.
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.
Croatian: U skladu s njegovim poznatim učincima na put dušikovog oksida/cikličkog gvanozin monofosfata (cGMP) (vidjeti dio 5.1) ustanovljeno je da sildenafil pojačava hipotenzivne učinke nitrata te je zbog toga kontraindicirana njegova istodobna primjena s donorima dušikovog oksida (kao što je amil nitrit) ili nitratima u bilo kojem obliku.
English: The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section
Croatian: Istodobna primjena s PDE5 inhibitiorima, uključujnući sildenafil, zajedno sa stimulatorima gvanilat ciklaze, kao što je riociguat, je kontrainidicirana i može potencijalno dovesti do simptomatske hipotenzije (vidjeti dio 4.5).
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518)
Croatian: Laktoza hidrat Hipromeloza (E464) Titanijev dioksid (E171) Triacetin (E1518)
English: Peppermint oil (containing sorbitol (E420)) Crospovidone
Croatian: Ulje paprene metvice (sadrži sorbitol (E420)) Krospovidon
English: Hydroxypropylcellulose (E463) Mannitol (E421)
Croatian: Hidroksipropilceluloza (E463) Manitol (E421)
English: - If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy
Croatian: Ako ste ikada imali gubitak vida zbog nearteritične anteriorne ishemijske optičke neuropatije
English: Common ( 1/100 and
Croatian: Često ( 1/100 do
English: Film coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518).
Croatian: Film ovojnica: laktoza hidrat, hipromeloza (E464), titanijev dioksid (E171), triacetin (E1518).
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog(odgovornih) za puštanje serije lijeka u promet
English: 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.
Croatian: Analiza podataka sljedećih skupina antihipertenzivnih lijekova: diuretika, beta-blokatora, ACE inhibitora, antagonista angiotenzina II, antihipertenzivnih lijekova (vazodilatatora i onih sa središnjim djelovanjem), blokatora adrenergičkog neurona, blokatora kalcijevih kanala i blokatora alfaadrenoceptora, nije pokazala razlike u profilu nuspojava u bolesnika koji uzimaju sildenafil u usporedbi s liječenjem placebom.
English: 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.
Croatian: U dobrovoljaca s blagom do umjerenom cirozom jetre (Child-Pugh A i B) klirens sildenafila bio je snižen što je rezultiralo porastom AUC (84%) i Cmax (47%) u usporedbi s dobrovoljcima odgovarajućim po dobi bez oštećenja funkcije jetre.
English: - If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).
Croatian: Ako ste ikada imali gubitak vida zbog nearteritične anteriorne ishemijske optičke neuropatije (NAION).
English: You should not use Vizarsin with any other oral or local treatments for erectile dysfunction.
Croatian: Ne smijete uzimati Vizarsin s drugim oralnim (primijenjenim kroz usta) ili lokalnim lijekovima za erektilnu disfunkciju (poremećaj erekcije).
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože, potkožnog i mekog tkiva
English: *Reported during post-marketing surveillance only **Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia ***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased
Croatian: *Prijavljeno isključivo nakon stavljanja lijeka u promet ** Vizualni poremećaj percepcije boja: kloropsija, kromatopsija,cijanopsija, eritropsija i ksantopsija ***Poremećaji suzenja: suho oko, suzni poremećaji i pojačano suženje
English: Each orodispersible tablet contains 0.375 mg aspartame (E951) and 0.00875 mg sorbitol (E420).
Croatian: Jedna raspadljiva tableta za usta sadrži 0,375 mg aspartama (E951) i 0,00875 mg sorbitola (E420).