FrancophonIA/ELRC3.0 huggingface dataset:
English: Tadalafil Mylan is not intended for use by women.
Croatian: Tadalafil Mylan nije namijenjen za primjenu u žena.
English: 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).
Croatian: Iako specifične interakcije nisu ispitane, druge inhibitore proteaze, poput sakinavira, i druge inhibitore CYP3A4, poput eritromicina, klaritromicina, itrakonazola i soka od grejpa, treba primjenjivati uz oprez jer se očekuje da bi ti lijekovi mogli dovesti do povećanja koncentracije tadalafila u plazmi (vidjeti dio 4.4).
English: In the primary efficacy studies of general populations, 81% of patients reported that tadalafil improved their erections as compared to 35% with placebo.
Croatian: U primarnim ispitivanjima djelotvornosti u općoj populaciji, 81 % bolesnika prijavilo je poboljšanje erektilne funkcije kod primjene tadalafila u usporedbi s 35 % bolesnika koji su primali placebo.
English: It is not known if tadalafil is effective in patients who have had: - pelvic surgery.
Croatian: Nije poznato je li tadalafil učinkovit u bolesnika: - koji su bili podvrgnuti kirurškom zahvatu u zdjelici.
English: For the treatment of erectile dysfunction using on-demand tadalafil the recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without food.
Croatian: Kada se uzima po potrebi za liječenje erektilne disfunkcije, preporučena doza lijeka tadalafil je 10 mg, a uzima se prije očekivane seksualne aktivnosti, s hranom ili bez nje.
English: Tadalafil administered to healthy subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (mean maximal decrease of 1.6/0.8 mm Hg, respectively), in standing systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6 mm Hg, respectively), and no significant change in heart rate.
Croatian: Tadalafil primijenjen u zdravih ispitanika nije u odnosu na placebo doveo do značajne razlike u vrijednostima sistoličkog i dijastoličkog krvnog tlaka u ležećem položaju (prosječno maksimalno sniženje za 1,6 odnosno 0,8 mmHg), vrijednostima sistoličkog i dijastoličkog krvnog tlaka u stojećem položaju (prosječno maksimalno sniženje za 0,2 odnosno 4,6 mmHg) kao ni do značajne promjene srčanefrekvencije.
English: Tadalafil Mylan should not be used during breast feeding.
Croatian: Tadalafil Mylan se ne smije primjenjivati tijekom dojenja.
English: In patients who are taking alpha1 blockers, concomitant administration of tadalafil may lead to symptomatic hypotension in some patients (see section 4.5).
Croatian: U bolesnika koji uzimaju blokatore alfa1-receptora istodobna primjena tadalafila može u nekim slučajevima dovesti do simptomatske hipotenzije (vidjeti dio 4.5).
English: In one of the studies, which also included tamsulosin 0.4 mg as an active comparator, the improvement in total international prostate symptom score with tadalafil 5 mg, tamsulosin and placebo were -6.3, -5.7 and -4.2 respectively.
Croatian: U jednom ispitivanju u kojem je kao aktivni usporedni lijek primijenjen tamsulozin u dozi od 0,4 mg poboljšanje ukupnog rezultata na Međunarodnoj ljestvici simptoma prostatizma iznosilo je -6,3 kod primjene lijeka tadalafil od 5 mg, -5,7 kod primjene tamsulozina i -4,2 kod primjene placeba.
English: The mean persubject proportion of successful sexual intercourse attempts was 71.9% with tadalafil 5 mg compared to 48.3% with placebo.
Croatian: Prosječan udio uspješnih pokušaja spolnog odnosa po ispitaniku iznosio je 71,9 % kod primjene lijeka tadalafil u dozi od 5 mg u usporedbi sa 48,3 % nakon primjene placeba.
English: For adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the recommended dose is also 5 mg taken at approximately the same time every day.
Croatian: U odraslih muškaraca koji se liječe i zbog benigne hiperplazije prostate i zbog erektilne disfunkcije preporučena doza također iznosi 5 mg, a uzima se svakodnevno otprilike u isto doba dana.
English: In dogs given tadalafil daily for 6 to 12 months at doses of 25 mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7 - 18.6] than seen in humans given a single 20 mg dose) and above, there was regression of the seminiferous tubular epithelium that resulted in a decrease in spermatogenesis in some dogs.
Croatian: U pasa koji su tijekom 6 do 12 mjeseci svakodnevno primali tadalafil u dozama od 25 mg/kg na dan (što je rezultiralo najmanje trostruko većom izloženošću [raspon 3,7 - 18,6 puta] od one u ljudi kod primjene jedne doze od 20 mg) i većima, zabilježena je regresija epitela sjemenovodnih kanalića, što je u nekih pasa dovelo do smanjene spermatogeneze.
English: 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.
Croatian: Selektivni inhibitor CYP3A4 ketokonazol (200 mg na dan) udvostručio je izloženost (AUC) tadalafilu (10 mg) i povećao Cmax za 15 % u odnosu na vrijednosti AUC-a i Cmax kod primjene samog tadalafila.
English: The improvements in the erectile function domain of the international index of erectile function and the total international prostate symptom score in this study were 6.5 and -6.1 with tadalafil 5 mg compared to 1.8 and -3.8 with placebo, respectively.
Croatian: Poboljšanja erektilne funkcije prema međunarodnom indeksu erektilne funkcije odnosno poboljšanja ukupnog rezultata na Međunarodnoj ljestvici simptoma prostatizma u tom su ispitivanju iznosila 6,5 odnosno6,1 nakon primjene lijeka tadalafil u dozi od 5 mg u usporedbi s vrijednostima od 1,8 odnosno -3,8 nakon primjene placeba.
English: Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness to tadalafil on demand.
Croatian: Provedena su tri klinička ispitivanja s 1054 bolesnika u kućnom okruženju kako bi se utvrdilo razdoblje odgovora na tadalafil kada se uzima po potrebi.
English: Marketing Authorisation Holder Mylan S.A.S.
Croatian: Nositelj odobrenja Mylan S.A.S.
English: For the treatment of benign prostatic hyperplasia The dose is one 5 mg tablet taken once a day at approximately the same time of the day.
Croatian: Za liječenje benigne hiperplazije prostate Doza je jedna tableta od 5 mg koja se uzima jedanput na dan u približno isto doba dana.
English: Other medicines and Tadalafil Mylan Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzimali ili biste mogli uzeti bilo koje druge lijekove.
English: Tadalafil Mylan 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
Croatian: Tadalafil Mylan od 10 mg i 20 mg namijenjene su za uporabu prije planirane seksualne aktivnosti i ne preporučuju se za trajnu svakodnevnu primjenu.
English: Excipient with known effect: Each film-coated tablet contains 118.96 mg of lactose.
Croatian: Jedna filmom obložena tableta sadrži 118,96 mg laktoze.
English: Tadalafil Mylan is available as 2.5, 5, 10, and 20 mg film-coated tablets for oral use.
Croatian: Tadalafil Mylan je dostupan u obliku filmom obloženih tableta od 2,5, 5, 10 i 20 mg za peroralnu primjenu.
English: Tadalafil Mylan is not indicated for use by women.
Croatian: Tadalafil Mylan nije indiciran za primjenu u žena.
English: Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Mylan.
Croatian: Ovisno o Vašem odgovoru na Tadalafil Mylan, liječnik može prilagoditi dozu na 2,5 mg.
English: Tadalafil did not show efficacy in slowing the decline in ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean change in 6MWD at 48 weeks was -51.0 meters (m) in the placebo group, compared with -64.7 m in the tadalafil 0.3 mg/kg group (p = 0.307) and -59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538).
Croatian: 6 minute walk distance, 6MWD): srednja vrijednost promjena 6MWD rezultata u 48. tjednu dobivena metodom najmanjih kvadrata iznosila je -51,0 metar (m) u skupini koja je primala placebo u usporedbi sa -64,7 m u skupini liječenoj tadalafilom u dozi od 0,3 mg/kg (p = 0,307) odnosno -59,1 m u skupini liječenoj tadalafilom u dozi od 0,6 mg/kg (p = 0,538).
English: Tadalafil Mylan 2.5 mg is available in blister packs containing 28 and 56 tablets.
Croatian: Tadalafil Mylan 2,5 mg tablete dostupne su u blister pakiranjima koja sadrže 28 i 56 tableta.
English: 4 film-coated tablets 12 film-coated tablets 24 film-coated tablets
Croatian: 4 filmom obložene tablete 12 filmom obloženih tableta 24 filmom obložene tablete
English: Before treatment with Tadalafil Mylan
Croatian: Prije liječenja lijekom Tadalafil Mylan
English: The recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without food.
Croatian: Preporučena doza tadalafila je 10 mg, a uzima se prije očekivane seksualne aktivnosti, s hranom ili bez nje.
English: In the study in patients with erectile dysfunction secondary to diabetes, the mean per-subject proportion of successful attempts were 41 and 46% on tadalafil 5 mg and 2.5 mg, respectively, as compared to 28% with placebo.
Croatian: U ispitivanju bolesnika s erektilnom disfunkcijom kao posljedicom šećerne bolesti srednji udio uspješnih pokušaja spolnog odnosa po ispitaniku bio je 41 % kod primjene tadalafila u dozi od 5 mg i 46 % kod primjene tadalafila u dozi od 2,5 mg, dok je uspješnost kod primjene placeba bila 28 %.
English: Caution should be exercised when prescribing tadalafil to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined (see section 4.5).
Croatian: Savjetuje se oprez kod propisivanja tadalafila bolesnicima koji uzimaju jake inhibitore CYP3A4 (ritonavir, sakinavir, ketokonazol, itrakonazol i eritromicin) jer je kod kombinacije navedenih lijekova primijećena povećana izloženost tadalafilu (AUC) (vidjeti dio 4.5).
English: The mean per-subject proportion of successful sexual intercourse attempts was 68% for tadalafil patients compared to 52% for patients on placebo.
Croatian: Srednji udio uspješnih pokušaja spolnog odnosa po ispitaniku iznosio je 68 % u bolesnika koji su primali tadalafil i 52 % u bolesnika koji su primali placebo.
English: Respiratory, thoracic and mediastinal disorders Nasal congestion Dyspnoea, Epistaxis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kongestija nosa dispneja, epistaksa
English: Abdominal pain, Vomiting, Nausea, Gastro-oesophageal reflux
Croatian: Poremećaji probavnog sustava dispepsija bol u abdomenu, povraćanje, mučnina, gastroezofagealni refluks
English: 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 24 film-coated tablets
Croatian: 2 filmom obložene tablete 4 filmom obložene tablete 8 filmom obloženih tableta 12 filmom obloženih tableta 24 filmom obložene tablete
English: It is important to note that tadalafil does not work if there is no sexual stimulation.
Croatian: Važno je napomenuti da tadalafil ne djeluje ako izostane seksualna stimulacija.
English: Cardiac disorders
Croatian: Kardiovaskularni događaji
English: For patients with severe renal impairment 10 mg is the maximum recommended dose for on-demand treatment.
Croatian: U bolesnika s teškim oštećenjem bubrežne funkcije maksimalna preporučena doza za liječenje po potrebi je 10 mg.
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Iron oxide yellow (E172) Triacetin
Croatian: laktoza hidrat hipromeloza (E464) titanijev dioksid (E171) željezov oksid, žuti (E172) triacetin
English: In addition,
Croatian: NN:
English: This will be given as a 2.5 mg tablet.
Croatian: Ona se uzima u obliku tablete od 2,5 mg.
English: Excipient with known effect: Each film-coated tablet contains 237.92 mg of lactose.
Croatian: Jedna filmom obložena tableta sadrži 237,92 mg laktoze.
English: The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg).
Croatian: Tadalafil (10 mg) nije pojačao učinak alkohola na kognitivne funkcije.
English: Excipient with known effect: Each film-coated tablet contains 59.48 mg of lactose.
Croatian: Jedna filmom obložena tableta sadrži 59,48 mg laktoze
English: These include: - migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat,
Croatian: Među njih se ubrajaju: - migrena, oticanje lica, ozbiljna alergijska reakcija koja izaziva oticanje lica ili grla, ozbiljni kožni osipi, neki poremećaji koji utječu na dotok krvi u oči, nepravilni otkucaji srca, angina i iznenadna srčana smrt.
English: In the primary efficacy studies, 75% of intercourse attempts were successful in tadalafil treated patients as compared to 32% with placebo.
Croatian: U primarnim ispitivanjima djelotvornosti u bolesnika liječenih lijekomtadalafil 75 % pokušaja spolnog odnosa bilo je uspješno, u usporedbi s 32 % kod primjene placeba.
English: How to take Tadalafil Mylan
Croatian: Kako uzimati Tadalafil Mylan
English: Cytochrome P450 inhibitors
Croatian: Inhibitori citokroma P450
English: Film-coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), iron oxide yellow (E172), triacetin.
Croatian: Film ovojnica: laktoza hidrat, hipromeloza (E464), titanijev dioksid (E171), žuti željezov oksid (E172), triacetin.
English: Alcohol concentrations (mean maximum blood concentration 0.08%) were not affected by co-administration with tadalafil (10 mg or 20 mg).
Croatian: Istodobna primjena tadalafila (10 mg ili 20 mg) ne utječe na koncentraciju alkohola (srednja vrijednost maksimalne koncentracije u krvi bila je 0,08 %).
English: Prolonged erections Priapism, Penile haemorrhage, Haematospermia
Croatian: Poremećaji reproduktivnog sustava i dojki produljena erekcija prijapizam, hemoragija penisa, hematospermija
English: Tablet core: lactose anhydrous (see section 2 ‘Tadalafil Mylan contains lactose'), poloxamer 188, cellulose microcrystalline (pH101), povidone (K-25), croscarmellose sodium, magnesium stearate, sodium laurilsulfate, silica colloidal anhydrous.
Croatian: Jezgra tablete: laktoza bezvodna (pogledajte dio 2 „Tadalafil Mylan sadrži laktozu”), poloksamer 188, mikrokristalična celuloza (pH101), povidon (K-25), umrežena karmelozanatrij, magnezijev stearat, natrijev laurilsulfat, koloidni bezvodni silicijev dioksid.
English: Tadalafil Mylan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Croatian: Tadalafil Mylan sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
English: How to store Tadalafil Mylan
Croatian: Kako čuvati Tadalafil Mylan
English: Excipient with known effect: Each film-coated tablet contains 29.74 mg of lactose.
Croatian: Jedna filmom obložena tableta sadrži 29,74 mg laktoze.
English: Tadalafil Mylan 20 mg is available in blister packs containing 2, 4, 8, 12 and 24 tablets.
Croatian: Tadalafil Mylan 20 mg tablete dostupne su u blister pakiranjima koja sadrže 2, 4, 8, 12 i 24 tablete.
English: Tadalafil Mylan tablets are for oral use in men only.
Croatian: Tadalafil Mylan tablete namijenjene su isključivo za primjenu u muškaraca i uzimaju se kroz usta.
English: Retinal vascular occlusion
Croatian: Tablični prikaz nuspojava
English: It is important to note that Tadalafil Mylan for the treatment of erectile dysfunction does not work if there is no sexual stimulation.
Croatian: Važno je napomenuti da u liječenju erektilne disfunkcije Tadalafil Mylan ne djeluje ako izostane seksualna stimulacija.
English: If you experience any of the following side effects stop using the medicine and seek medical help immediately: - allergic reactions including rashes (frequency uncommon).
Croatian: Ako se pojavi bilo koja od sljedećih nuspojava, prestanite uzimati lijek i odmah zatražite pomoć liječnika: - alergijske reakcije, uključujući osipe (manje česta učestalost). - bol u prsnom košu - ne uzimajte nitrate i odmah zatražite pomoć liječnika (manje česta učestalost). - prijapizam, dugotrajna i potencijalno bolna erekcija nakon uzimanja lijeka tadalafil (rijetka učestalost).
English: - removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non nerve sparing prostatectomy).
Croatian: - kojima je djelomično ili u cijelosti uklonjena prostata i pritom su prerezani živci prostate
English: - if you ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
Croatian: - ako ste ikada izgubili vid zbog nearterijske prednje ishemijske optičke neuropatije (NAION),
English: There are no available data about the administration of once-a-day dosing of tadalafil to patients with hepatic impairment.
Croatian: Nema dostupnih podataka o primjeni tadalafila jedanput na dan u bolesnika s oštećenjem funkcije jetre.
English: Tadalafil Mylan is a treatment for adult men with erectile dysfunction.
Croatian: Tadalafil Mylan se primjenjuje za liječenje erektilne disfunkcije u odraslih muškaraca.
English: Varnavas Hadjipanayis LtdTel: + 357 22207723
Croatian: Κύπρος (Cyprus) Varnavas Hadjipanayis Ltd Tel: + 357 22207723
English: Heart attack and stroke have also been reported rarely in men taking tadalafil.
Croatian: U muškaraca koji uzimaju tadalafil rijetko su prijavljeni srčani i moždani udar.
English: Tadalafil Mylan 10 mg is available in blister packs containing 4, 12 and 24 tablets.
Croatian: Tadalafil Mylan 10 mg tablete dostupne su u blister pakiranjima koja sadrže 4, 12 i 24 tablete.
English: Each tablet contains 20 mg tadalafil.
Croatian: Jedna tableta sadrži 20 mg tadalafila.
English: Each tablet contains 2.5 mg tadalafil.
Croatian: Jedna tableta sadrži 2,5 mg tadalafila.
English: There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
Croatian: Postoje malobrojni klinički podaci o sigurnosti primjene jednokratne doze tadalafila u bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C).
English: If Tadalafil Mylan is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Croatian: Ako se propisuje Tadalafil Mylan, liječnik koji ga propisuje mora pažljivo procijeniti omjer koristi i rizika liječenja za svakog pojedinog bolesnika.
English: Tadalafil Mylan contains lactose.
Croatian: Tadalafil Mylan sadrži laktozu.
English: Visual field defect, Swelling of eyelids, Conjunctival hyperaemia, Non-arteritic anterior ischemic optic neuropathy (NAION) Retinal vascular occlusion
Croatian: Poremećaji oka zamagljen vid, osjeti opisani kao bol u oku poremećaj vidnog polja, oticanje vjeđa, hiperemija konjunktive, nearterijska prednja ishemijska optička neuropatija (NAION) okluzija krvnih žila mrežnice
English: What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 2.5 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL over 1' on the other side.
Croatian: Kako Tadalafil Myla izgleda i sadržaj pakiranja Tadalafil Mylan 2,5 mg je svijetložuta, filmom obložena, okrugla, bikonveksna tableta s oznakom „M” na jednoj strani tablete i „TL” iznad „1” na drugoj strani tablete.
English: Tadalafil Mylan 20 mg tablets tadalafil
Croatian: Tadalafil Mylan 20 mg tablete tadalafil
English: Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.5).
Croatian: Stoga je primjena tadalafila kontraindicirana u bolesnika koji uzimaju bilo koji oblik organskih nitrata (vidjeti dio 4.5).
English: Uncommon (may affect up to 1 in 100 people) - dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba) - omaglica, bol u želucu, mučnina, povraćanje, refluks, zamagljen vid, bol u oku, otežano disanje, prisutnost krvi u urinu, produljena erekcija, osjećaj lupanja srca, brzi srčani otkucaji, visok krvni tlak, nizak krvni tlak, krvarenje iz nosa, zvonjava u ušima, oticanje šaka, gležnjeva ili stopala i osjećaj umora.
English: There is limited clinical data on the safety of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
Croatian: Ograničeni su klinički podaci o sigurnosti primjene tadalafila u bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C).
English: Blurred vision, Sensations described as eye pain
Croatian: stanja koje se opisuje kao „očni udar”.
English: Tadalafil Mylan 10 mg tablets tadalafil
Croatian: Tadalafil Mylan 10 mg tablete tadalafil
English: Tadalafil Mylan 10 mg film-coated tablets Tadalafil Mylan 20 mg film-coated tablets
Croatian: Tadalafil Mylan 10 mg filmom obložene tablete Tadalafil Mylan 20 mg filmom obložene tablete
English: Cytochrome P450 metabolised medicinal products
Croatian: Lijekovi koje metabolizira citokrom P450
English: Tadalafil Mylan 2.5 mg tablets tadalafil
Croatian: Tadalafil Mylan 2,5 mg tablete tadalafil
English: Rare (may affect up to 1 in 1,000 people) - fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing and hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.
Croatian: Rijetko (mogu se javiti u do 1 na 1000 osoba) - nesvjestica, napadaji i prolazni gubitak pamćenja, oticanje vjeđa, crvenilo očiju, iznenadno smanjenje ili gubitak sluha, koprivnjača (crvene mrlje na površini kože koje svrbe), krvarenje penisa, prisutnost krvi u spermi i pojačano znojenje.
English: Tadalafil Mylan 5 mg tablets tadalafil
Croatian: Tadalafil Mylan 5 mg tablete tadalafil
English: Each tablet contains 5 mg tadalafil.
Croatian: Jedna tableta sadrži 5 mg tadalafila.
English: Each tablet contains 10 mg tadalafil.
Croatian: Jedna tableta sadrži 10 mg tadalafila.
English: A light yellow, film-coated, round, biconvex tablet (6.3 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL over 2' on the other side.
Croatian: Svijetložuta, filmom obložena, okrugla, bikonveksna tableta (6,3 ± 0,3 mm) s utisnutom oznakom „M” na jednoj strani tablete i „TL” iznad „2” na drugoj strani tablete.
English: Tadalafil Mylan contains sodium
Croatian: Tadalafil Mylan sadrži natrij
English: Visual field defect, Swelling of eyelids, Conjunctival hyperaemia, Non-arteritic anterior ischemic optic neuropathy (NAION)
Croatian: Poremećaji oka zamagljen vid, osjeti opisani kao bol u oku poremećaj vidnog polja, oticanje vjeđa, hiperemija konjunktive, nearterijska prednja ishemijska optička neuropatija (NAION) okluzija krvnih žilamrežnice
English: A light yellow, film-coated, round, biconvex tablet (8.1 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL3' on the other side.
Croatian: Svijetložuta, filmom obložena, okrugla, bikonveksna tableta (8,1 ± 0,3 mm) s utisnutom oznakom „M” na jednoj strani tablete i „TL3” na drugoj strani tablete.
English: Musculoskeletal and connective tissue disorders Back pain,
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u leđima, mialgija, bol u ekstremitetima
English: Once-a-day dosing has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician (see sections 4.4 and 5.2).
Croatian: Ako se propisuje tadalafil, liječnik koji ga propisuje mora pažljivo procijeniti omjer koristi i rizika liječenja za svakog pojedinog bolesnika. (vidjeti dijelove 4.4 i 5.2).
English: Tadalafil Mylan contains lactose
Croatian: Tadalafil Mylan sadrži laktozu