natgillin/translations-raw huggingface dataset:
In addition, mean change from baseline in fasting plasma glucose at Week 52 for 25 mg alogliptin plus 30 mg pioglitazone and metformin was significantly greater than that for 45 mg pioglitazone and metformin (p<0.001).
Dodatno, srednja vrijednost promjene od početne vrijednosti glukoze u plazmi natašte bila je u 52. tjednu značajno veća s 25 mg alogliptina i 30 mg pioglitazona i metforminom nego za 45 mg pioglitazona s metforminom (p<0,001).
No dose adjustment of Incresync for patients with mild renal impairment is necessary (see section 4.2).
Nije potrebna prilagodba doze u bolesnika s blagim oštećenjem bubrega (vidjeti dio 4.2)
Infections and infestations upper respiratory tract infections common common common nasopharyngitis common sinusitis uncommon common
Infekcije i infestacije Infekcije gornjeg respiratornog trakta
- Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness,
• problemi s jetrom poput mučnine ili povraćanja, boli u trbuhu, neobičnog ili neobjašnjivog umora, gubitka teka, tamne mokraće ili žutila kože i bjeloočnica.
Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the serum concentration of pioglitazone (see section 4.5).
Opaženo je da istodobna primjena pioglitazona s gemfibrozilom (inhibitor citokroma P450 2C8) povećava, a s rifampicinom (induktor citokroma P450 2C8) snižava koncentracije pioglitazona u serumu (vidjeti dio 4.5).
Therefore, in order to maintain systemic exposures to alogliptin that are similar to those observed in patients with normal renal function, lower doses of alogliptin should be used in patients with moderate or severe renal impairment, or end-stage renal disease requiring dialysis (see above and section 4.2).
Kako bi se održala sistemska izloženost alogliptinu slična onoj opaženom u bolesnika s normalnom funkcijom bubrega, u bolesnika s umjerenim i teškim oštećenjem bubrega, te završnim stadijem bolesti bubrega na dijalizi, potrebno je primijeniti nižu dozu alogliptina (vidjeti dio
A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%).
Viša stopa prijeloma bila je primijećena u žena koje su uzimale pioglitazon (2,6%) naspram usporednog lijeka (1,7%).
It is unknown whether alogliptin and pioglitazone are excreted in human milk.
Nije poznato izlučuju li se alogliptin i pioglitazon u majčino mlijeko kod ljudi.
Marketing Authorisation Holder Takeda Pharma A/S Dybendal Alle 10
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Takeda Pharma A/S
Incresync is not recommended for patients with severe renal impairment or end-stage renal disease requiring dialysis.
Incresync se ne preporučuje bolesnicima s teškim oštećenjem bubrega ili završnim stadijem bolesti bubrega koji zahtijeva dijalizu.
Skin and subcutaneous tissue disorders pruritus common common rash common exfoliative skin conditions including StevensJohnson syndrome not known erythema multiforme not known angioedema not known urticaria not known
Poremećaji kože i potkožnog tkiva Eksfolijativna stanja kože uključujući Stevens-Johnsonov sindrom Erythema multiforme
Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC for pioglitazone.
Prijavljeno je da istodobna primjena pioglitazona s gemfibrozilom (inhibitor citokroma P450 2C8) rezultira 3 puta povećanjem AUC-a pioglitazona.
The results of bioequivalence studies in healthy subjects demonstrated that Incresync film-coated tablets are bioequivalent to the corresponding doses of alogliptin and pioglitazone co-administered as separate tablets.
Rezultati ispitivanja bioekvivalencije u zdravih ispitanika pokazuju da su Incresync filmom obložene tablete bioekvivalentne odgovarajućim dozama alogliptina i pioglitazona primijenjenim istodobno kao zasebne tablete.
Significantly more patients receiving 25 mg alogliptin (49.2%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (34.0%) at Week 26 (p=0.004).
U 26. tjednu je ciljne razine HbA1c od ≤7,0% postiglo značajno više bolesnika koji su primali alogliptin (49,2%) nego oni koji su primali placebo (34,0%) (p<0,004).
Add-on combination therapy studies Alogliptin 25 mg once daily with pioglitazone + metformin vs titrating pioglitazone + metformin
Alogliptin 25 mg jedanput na dan s pioglitazonom + metformin ili sulfonilurejom
MACE Reported in cardiovascular outcomes study Number of Patients (%)
MACE prijavljeni u ispitivanju kardiovaskularnih ishoda
Takeda UAB Tel: +370 521 09 070 lt-info@takeda.com
Lietuva ”Takeda” UAB Tel: +370 521 09 070 info@nycomed.lt
Incresync 12.5 mg/30 mg film-coated tablets Incresync 12.5 mg/45 mg film-coated tablets Incresync 25 mg/30 mg film-coated tablets Incresync 25 mg/45 mg film-coated tablets
Incresync 12,5 mg/30 mg filmom obložene tablete Incresync 12,5 mg/45 mg filmom obložene tablete Incresync 25 mg/30 mg filmom obložene tablete Incresync 25 mg/45 mg filmom obložene tablete
There are no data from the use of alogliptin in pregnant women.
Nema podataka o primjeni alogliptina u trudnica.
Both 25 mg alogliptin alone and in combination with 30 mg pioglitazone demonstrated significant decreases in postprandial glucose and postprandial glucagon whilst significantly increasing postprandial active GLP-1 levels at Week 16 compared to placebo (p<0.05).
U 16. tjednu primjene 25 mg alogliptina, samog i u kombinaciji s 30 mg pioglitazona, postiže se u usporedbi s placebom značajno smanjenje postprandijalne glukoze i postprandijalnog glukagona uz značajni porast postprandijalnih razina aktivnog GLP-1 (p<0,05).
Add-on combination therapy placebo-controlled studies Alogliptin 25 mg once daily with pioglitazone ± metformin or a sulphonylurea (n=195) FAS = full analysis set LOCF = last observation carried forward † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values * p<0.001 compared to placebo or placebo+combination treatment
FAS = analiza svih uključenih bolesnika (engl. full analysis set) LOCF = zadnje opažanje preneseno nadalje (engl. last observation carried forward) †Srednja vrijednost metodom najmanjih kvadrata prilagođena prvobitnom antihiperglikemijskom terapijskom statusu i početnim vrijednostima * p<0,001 u usporedbi s placebom ili liječenjem placebom+kombinacijom
However, the results of bioequivalence studies have demonstrated that Incresync film-coated tablets are bioequivalent to the corresponding doses of alogliptin and pioglitazone co-administered as separate tablets.
Međutim, rezultati ispitivanja bioekvivalencije dokazali su da su Incresync filmom obložene tablete bioekvivalentne odgovarajućim dozama alogliptina i pioglitazona istodobno primijenjenim kao zasebne tablete.
Risk related to pioglitazone
Rizik vezan uz pioglitazon
Date of latest renewal:
ROK VALJANOSTI Rok valjanosti:
In patients with moderate or severe renal impairment, or end-stage renal disease on haemodialysis, an increase in systemic exposure to alogliptin of approximately 2- and 4-fold was observed, respectively.
U bolesnika s umjerenim ili teškim oštećenjem bubrega, ili završnim stadijem bolesti bubrega na hemodijalizi, opaženo je povećanje sistemske izloženosti alogliptinu od približno 2, odnosno 4 puta. (Bolesnici sa završnim stadijem bolesti bubrega su podvrgnuti hemodijalizi odmah nakon doziranja alogliptina.
Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience.
Nakon stavljanja lijeka u promet bilo je rijetkih slučajeva povišenih jetrenih enzima i hepatocelularne disfunkcije.
INFORMATION IN BRAILLE Incresync 25 mg/45 mg
16. PODACI NA BRAILLEOVOM PISMU Incresync 25 mg/45 mg
Table 1: Adverse reactions System organ class Adverse reaction
Tablica 1: Nuspojave opažene objedinjenim pivotalnim kontroliranim ispitivanjima faze 3 Organski sustav
Significantly more patients receiving 25 mg alogliptin plus 30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p<0.001).
U 52. tjednu je ciljne razine HbA1c od ≤7,0% postiglo značajno više bolesnika koji su uzimali 25 mg alogliptina s 30 mg pioglitazona i metforminom (33,2%) nego oni koji su uzimali 45 mg pioglitazona s metforminom (21,3%) (p<0,001).
A higher number of bone fractures was seen in patients, particularly women taking pioglitazone.
U bolesnika, posebno u žena koje su uzimale pioglitazon primijećen je povećan broj prijeloma kostiju.
The studies included 1,269 patients with mild renal impairment and 161 patients with moderate renal impairment treated with alogliptin/pioglitazone.
U ispitivanja je alogliptinom/pioglitazonom liječeno 1269 bolesnika s blagim oštećenjem bubrega i 161 bolesnik s umjerenim oštećenjem bubrega.
Therefore, no dose adjustment of alogliptin is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores of 5 to 9).
Stoga u bolesnika s blagim do umjerenim oštećenjem jetre (Child-Pugh indeks 5 do 9) nije potrebna prilagodba doze.
What Incresync looks like and contents of the pack - Incresync 25 mg/30 mg film-coated tablets (tablets) are peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “25/30” printed in grey ink on one side.
Kako Incresync izgleda i sadržaj pakiranja - Incresync 25 mg/30 mg filmom obložene tablete (tablete) su okrugle (promjera oko 8,7 mm), bikonveksne filmom obložene tablete boje breskve, s oznakama „A/P“ i „25/30“ otisnutim sivom tintom na jednoj strani.
Incresync 12.5 mg/30 mg film-coated tablets Incresync 12.5 mg/45 mg film-coated tablets Incresync 25 mg/30 mg film-coated tablets Incresync 25 mg/45 mg film-coated tablets alogliptin/pioglitazone
Incresync 25 mg/30 mg filmom obložene tablete Incresync 25 mg/45 mg filmom obložene tablete Incresync 12,5 mg/30 mg filmom obložene tablete Incresync 12,5 mg/45 mg filmom obložene tablete alogliptin/pioglitazon
INFORMATION IN BRAILLE Incresync 12.5 mg/30 mg
16. PODACI NA BRAILLEOVOM PISMU Incresync 12,5 mg/30 mg
INFORMATION IN BRAILLE Incresync 12.5 mg/45 mg
16. PODACI NA BRAILLEOVOM PISMU Incresync 12,5 mg/45 mg
No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Nije bilo primijećeno povećanje stopa prijeloma u muškaraca liječenih pioglitazonom (1,3%) naspram usporednog lijeka (1,5%).
Slight changes in cell counts may show up in blood tests.
U krvnim nalazima su moguća manja odstupanja u broju stanica.
Effects of alogliptin on other medicinal products
Učinci alogliptina na druge lijekove
INFORMATION IN BRAILLE Incresync 25 mg/30 mg
16. PODACI NA BRAILLEOVOM PISMU Incresync 25 mg/30 mg
Mean change from baseline in HbA1c (%)† (SE)
Srednja promjena od početne vrijednosti HbA1c (%) (SE)
Incresync is used to lower blood sugar levels in adults with type 2 diabetes.
Incresync je koristi za snižavanje razina šećera u krvi u odraslih bolesnika sa šećernom bolešću tipa 2. Šećerna bolest tipa 2 zove se i inzulin neovisni dijabetes melitus.
Appropriate assessment of renal function is recommended prior to initiation of Incresync and periodically thereafter (see section 4.4).
Prije početka liječenja i povremeno tijekom liječenja Incresyncom preporučuje se procijeniti funkciju bubrega (vidjeti dio 4.4).
Your weight should be checked at regular intervals; if your weight increases, tell your doctor.
Ako Vam se tjelesna težina poveća, obavijestite o tome liječnika.
LOCF = last observation carried forward * Non inferiority and superiority statistically demonstrated † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values
PPS = bolesnici koji su završili ispitivanje po protokolu (engl. per protocol set) LOCF = zadnje opažanje preneseno nadalje (engl. last observation carried forward) * Dokazana je statistička neinferiornost i superiornost
Warnings and precautions Talk to your doctor or pharmacist before taking Incresync: - if you have type 1 diabetes (your body does not produce insulin).
• ako imate šećernu bolest tipa 1 (tijelo ne stvara inzulin)
There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Nakon stavljanja lijeka u promet bilo je prijava slučajeva zatajenja srca kada se pioglitazon primjenjivao ili u bolesnika sa zatajenjem srca u anamnezi ili u kombinaciji s inzulinom.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Tablete Incresync sadrže laktozu i stoga se ne smiju primjenjivati u bolesnika s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcijom glukoze i galaktoze.
• The package leaflet
• zamućen ili iskrivljen vid
There have been spontaneously reported adverse reactions of acute pancreatitis in the post-marketing setting.
Nakon stavljanja lijeka u promet bilo je spontano prijavljenih nuspojava akutnog pankreatitisa.
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Nije bilo primijećeno povećanje stopa prijeloma u muškaraca liječenih pioglitazonom (1,7%) naspram onih liječenih usporednim lijekom (2,1%).
Current bladder cancer or a history of bladder cancer (see section 4.4) Uninvestigated macroscopic haematuria (see section 4.4)
• Postojeći ili rak mokraćnog mjehura u anamnezi (vidjeti dio 4.4)
Placental transfer of alogliptin occurs in rats.
U štakora alogliptin prolazi posteljicu.
Incresync 25 mg/45 mg film-coated tablets
Incresync 25 mg/45 mg filmom obložene tablete
Musculoskeletal and connective tissues disorders myalgia common fracture bone common
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Prijelom kosti
NN:
Nepoznato:
Clinically meaningful reductions in HbA1c compared to control were also observed regardless of baseline background medicinal product dose.
U skupini liječenoj s 25 mg alogliptina klinički značajna sniženja HbA1c također su opažena bez obzira na osnovnu terapijsku dozu.
Incresync 25 mg/30 mg film-coated tablets
Incresync 25 mg/30 mg filmom obložene tablete
and lower than the incidence in patients treated with active-control or placebo (0.1%, 0.1%, 0.4% and 0.4%, respectively).
Ukupna incidencija epizoda teške hipoglikemije bila je usporediva u bolesnika liječenih s 25 mg alogliptina ili 12,5 mg alogliptina, te niža od incidencije u bolesnika liječenih aktivnom kontrolom ili placebom (0,1%, 0,1%, 0,4% i 0,4%, istim redoslijedom).
- Incresync 25 mg/45 mg film-coated tablets (tablets) are red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “25/45” printed in grey ink on one side.
- Incresync 25 mg/45 mg filmom obložene tablete (tablete) su okrugle (promjera oko 8,7 mm), bikonveksne filmom obložene tablete crvene boje, s oznakama „A/P“ i „25/45“ otisnutim sivom tintom na jednoj strani.
25 mg/30 mg film-coated tablets
25 mg/30 mg filmom obložene tablete
Postmarketing reports of hepatic dysfunction including hepatic failure have been received for alogliptin.
Nakon stavljanja alogliptina u promet također su primljene prijave slučajeva poremećaja funkcije jetre uključujući zatajenje jetre.
Each 25 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
Svaka filmom obložena tableta od 25 mg/45 mg sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 25 mg alogliptina i 45 mg pioglitazona.
12.5 mg/45 mg film-coated tablets
12,5 mg/45 mg filmom obložene tablete
12.5 mg/30 mg film-coated tablets
12,5 mg/30 mg filmom obložene tablete
Printing ink 12.5 mg/30 mg film-coated tablets
Tinta za označavanje 12,5 mg/30 mg filmom obložene tablete
- Incresync 12.5 mg/30 mg film-coated tablets (tablets) are pale peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “12.5/30” printed in red ink on one side.
- Incresync 12,5 mg/30 mg filmom obložene tablete (tablete) su okrugle (promjera oko 8,7 mm), bikonveksne filmom obložene tablete svijetle boje breskve, s oznakama „A/P“ i „12.5/30“ otisnutim crvenom tintom na jednoj strani.
Incresync 12.5 mg/30 mg film-coated tablets
Incresync 12,5 mg/30 mg filmom obložene tablete
Each 12.5 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 45 mg pioglitazone.
Svaka filmom obložena tableta od 12,5 mg/45 mg sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 12,5 mg alogliptina i 45 mg pioglitazona.
- Incresync 12.5 mg/45 mg film-coated tablets (tablets) are pale red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “12.5/45” printed in red ink on one side.
- Incresync 12,5 mg/45 mg filmom obložene tablete (tablete) su okrugle (promjera oko 8,7 mm), bikonveksne filmom obložene tablete blijedo crvene boje, s oznakama „A/P“ i „12.5/45“ otisnutim crvenom tintom na jednoj strani.
Diabetic ketoacidosis
Gastroezofagealni refluks
Incresync 12.5 mg/45 mg film-coated tablets
Incresync 12,5 mg/45 mg filmom obložene tablete
Hepatobiliary disorders hepatic dysfunction including hepatic failure not known
Poremećaji jetre i žuči Poremećaj funkcije jetre uključujući zatajenje jetre
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg tablets alogliptin/pioglitazone
NAZIV LIJEKA Incresync 25 mg/30 mg tablete alogliptin/pioglitazon
Each 25 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
Svaka filmom obložena tableta od 25 mg/30 mg sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 25 mg alogliptina i 30 mg pioglitazona.
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 45 mg pioglitazone.
Jedna tableta sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 12,5 mg alogliptina i 45 mg pioglitazona.
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.
Jedna tableta sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 12,5 mg alogliptina i 30 mg pioglitazona.
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
Jedna tableta sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 25 mg alogliptina i 45 mg pioglitazona.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
Jedna tableta sadrži 12,5 mg alogliptina (u obliku alogliptinbenzoata) i 45 mg pioglitazona (u obliku pioglitazonklorida)
Primary Composite Endpoint [First Event of CV Death, Nonfatal MI and Nonfatal Stroke]
Primarni kompozitni ishod [prvi događaj KV smrti, IM bez smrtnog ishoda i moždanog udara bez smrtnog ishoda] Kardiovaskularna smrt* Infarkt miokarda bez smrtnog ishoda Moždani udar bez smrtnog ishoda 29 (1,1)
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg tablets alogliptin/pioglitazone
NAZIV LIJEKA Incresync 12,5 mg/45 mg tablete alogliptin/pioglitazon
Pale red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “12.5/45” printed in red ink on one side.
Okrugle (promjera približno 8,7 mm), bikonveksne filmom obložene tablete, blijedo crvene boje s oznakama „A/P“ i „12,5/45“ otisnutim crvenom tintom na jednoj strani.
Pale peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “12.5/30” printed in red ink on one side.
Okrugle (promjera približno 8,7 mm), bikonveksne filmom obložene tablete boje breskve s oznakama „A/P“ i „12,5/30“ otisnutim crvenom tintom na jednoj strani.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
Jedna tableta sadrži 12,5 mg alogliptina (u obliku alogliptinbenzoata) i 30 mg pioglitazona (u obliku pioglitazonklorida)
NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg tablets alogliptin/pioglitazone
NAZIV LIJEKA Incresync 12,5 mg/30 mg tablete alogliptin/pioglitazon
Red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/45” printed in grey ink on one side.
Okrugle (promjera približno 8,7 mm), bikonveksne filmom obložene tablete crvene boje s oznakama „A/P“ i „25/45“ otisnutim sivom tintom na jednoj strani.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
Jedna tableta sadrži 25 mg alogliptina (u obliku alogliptinbenzoata) i 45 mg pioglitazona (u obliku pioglitazonklorida)
Nervous system disorders headache common common hypoaesthesia common insomnia uncommon
Poremećaji živčanog sustava Hipoestezija
Treatment-corrected change from baseline in HbA1c (%)†
Promjena od početne vrijednosti HbA1c korigirana za liječenje (1-strani CI)
NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg tablets alogliptin/pioglitazone
NAZIV GOTOVOG LIJEKA Incresync 25 mg/45 mg tablete alogliptin/pioglitazon
Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
Jedna tableta sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 25 mg alogliptina i 30 mg pioglitazona.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
Jedna tableta sadrži 25 mg alogliptina (u obliku alogliptinbenzoata) i 30 mg pioglitazona (u obliku pioglitazonklorida)
Each12.5 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.
Svaka filmom obložena tableta od 12,5 mg/30 mg sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 12,5 mg alogliptina i 30 mg pioglitazona.
Uncommon (may affect up to 1 in 100 people): - Symptoms of bladder cancer including blood in your urine, pain when urinating or a sudden need to urinate.
• Simptomi raka mokraćnog mjehura uključujući krv u mokraći, bol pri mokrenju ili neodgodivu potrebu za mokrenjem.
Placebo-corrected change from baseline in HbA1c (%)†
Promjena od početne vrijednosti HbA1c (%) korigirana za placebo (2-strani 95% CI)
- The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac, carnauba wax and glycerol mono-oleate.
- Drugi sastojci su: manitol, mikrokristalična celuloza, hidroksipropilceluloza, umrežena karmelozanatrij, magnezijev stearat, laktoza hidrat, hipromeloza, talk, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), makrogol 8000, šelak, karnauba vosak i glicerolmonooleat.
Renal impairment
Učestalost nuspojava
- The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
- Drugi sastojci su: manitol, mikrokristalična celuloza, hidroksipropilceluloza, umrežena karmelozanatrij, magnezijev stearat, laktoza hidrat, hipromeloza, talk, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), makrogol 8000, šelak i crni željezov oksid (E172).
Peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/30” printed in grey ink on one side.
Okrugle (promjera približno 8,7 mm), bikonveksne filmom obložene tablete boje breskve s oznakama „A/P“ i „25/30“ otisnutim sivom tintom na jednoj strani.
In particular tell your doctor or pharmacist if you are taking any of the following: - gemfibrozil (used to lower cholesterol) - rifampicin (used to treat tuberculosis and other infections)
• rifampicin (koristi se za liječenje tuberkuloze i drugih infekcija).