natgillin/translations-raw huggingface dataset:
After 24 weeks of treatment, the primary endpoint of mean change from baseline in HbA1c was -1.83% in the combination group versus -0.96% in the pioglitazone group (p< 0.0001) and -0.99% in the metformin group (p< 0.0001). 
Nakon 24 tjedna liječenja, primarni ishod bila je prosječna promjena u odnosu na početnu vrijednost HbA1c i iznosila je -1,83% u skupini koja je primala kombinaciju nasuprot -0,96% u skupini koja je primala pioglitazon (p< 0,0001) i -0,99% u skupini koja je primala metformin (p< 0,0001).
Competact may cause a very rare (may affect up to 1 in 10,000), but very serious side effect called lactic acidosis (see section “Risk of lactic acidosis”). 
Competact može uzrokovati vrlo rijetku (može se javiti u manje od 1 korisnika na 10 000), ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza (vidjeti dio “Rizik od laktacidoze”).
How to take Competact 
Kako čuvati Competact
- by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation - by delaying intestinal glucose absorption. 
- smanjenjem sinteze glukoze u jetri inhibicijom glukoneogeneze i glikogenolize - u mišićima, umjerenim povećavanjem osjetljivosti na inzulin, poboljšava periferni unos i iskorištenje glukoze - usporavanjem intestinalne apsorpcije glukoze.
EU/1/06/354/001 EU/1/06/354/002 EU/1/06/354/003 EU/1/06/354/004 EU/1/06/354/005 EU/1/06/354/006 EU/1/06/354/007 EU/1/06/354/008 EU/1/06/354/009 EU/1/06/354/010 EU/1/06/354/011 EU/1/06/354/012 
EU/1/06/354/006 EU/1/06/354/007 EU/1/06/354/008 EU/1/06/354/009 EU/1/06/354/010 EU/1/06/354/011 EU/1/06/354/012
Since insulin and pioglitazone are both associated with fluid retention, concomitant administration of insulin and Competact may increase the risk of oedema. 
Budući da se i inzulin i pioglitazon povezuju sa zadržavanjem tekućine, istovremena primjena inzulina i lijeka Competact može povećati rizik od edema.
Patients receiving pioglitazone in dual oral therapy with a sulphonylurea may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea may be necessary. 
U bolesnika koji u sklopu dvostruke peroralne terapije primaju pioglitazon sa sulfonilurejom može postojati rizik od hipoglikemije povezane s dozom pa može biti potrebno sniziti dozu sulfonilureje.
Competact should not be used in patients with hepatic impairment (see sections 4.3 and 4.4). 
Competact se ne smije primjenjivati u bolesnika s oštećenjem funkcije jetre (vidjeti dijelove 4.3 i 4.4).
Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12,506 patients, 0.15%) than in control groups (7 cases from 10,212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, p=0.029). 
U meta-analizi kontroliranih kliničkih ispitivanja, slučajevi karcinoma mokraćnog mjehura češće su zabilježeni u skupinama koje su primale pioglitazon (19 slučajeva na 12 506 bolesnika, 0,15%) nego u kontrolnim skupinama (7 slučajeva na 10 212 bolesnika, 0,07%) HR = 2,64 (95% CI 1,11-6,31,
For Competact no preclinical or clinical data on exposed pregnancies or lactation are available. 
Nema dostupnih pretkliničkih ili kliničkih podataka o izloženosti lijeku Competact tijekom trudnoće ili dojenja.
Inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked. 
Obavijestite svog liječnika čim prije ako razvijete simptome koji ukazuju na tegobe s jetrom (poput neobjašnjive mučnine, povraćanja, boli u trbuhu, umora, gubitka apetita i/ili tamne mokraće), jer tada treba provjeriti funkciju jetre.
Liver enzymes should be checked prior to the initiation of therapy with Competact in all patients. 
Jetrene enzime treba provjeriti u svih bolesnika prije početka liječenja lijekom Competact.
Competact should be used every day to work properly. 
Da bi Competact valjano djelovao, treba ga uzimati svaki dan.
112 tablets 
112 tableta
Hepatobiliary disorders hepatitis5 
Poremećaji jetre i žuči hepatitis5
Pioglitazone 
Pioglitazona
If ALT levels are increased to 3 x upper limit of normal during Competact therapy, liver enzyme levels should be reassessed as soon as possible. 
Ako se tijekom terapije lijekom Competact vrijednosti ALT povise na vrijednosti koje su 3 puta više od gornje granice normale, razine jetrenih enzima treba čim prije ponovno provjeriti.
6 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration. 
6 Provedena je analiza objedinjenih podataka o prijelomima kostiju kao nuspojavi u randomiziranim, dvostruko slijepim kliničkim ispitivanjima kontroliranima komparatorom u više od 8100 bolesnika liječenih pioglitazonom i 7400 bolesnika liječenih komparatorima u trajanju do najviše 3,5 godine.
A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%. 
Ispitivanje provedeno u sedam normalnih zdravih dragovoljaca pokazalo je da je cimetidin, primijenjen u dozi od 400 mg dvaput na dan, povećao sistemsku izloženost (AUC)
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease. 
Utjecaj pioglitazona na kardiovaskularni ishod ispitan je u bolesnika mlađih od 75 godina sa šećernom bolešću tipa 2 i postojećom teškom makrovaskularnom bolešću.
- Acute conditions with the potential to alter renal function such as: Dehydration Severe infection Shock - Intravascular administration of iodinated contrast agents (see section 4.4) - Breast-feeding (see section 4.6) 
- akutna stanja koja mogu promijeniti funkciju bubrega kao što su: - dehidracija - teška infekcija - šok - intravaskularna primjena kontrastnih sredstava s jodom (vidjeti dio 4.4) - dojenje (vidjeti dio 4.6)
Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin. 
Ispitivanja interakcija pokazala su da pioglitazon nema važnih učinaka niti na farmakokinetiku niti na farmakodinamiku digoksina, varfarina, fenoprokumona i metformina.
Clinical trials have been conducted with Competact tablets and co-administered pioglitazone and metformin (see section 5.1). 
Sažetak sigurnosnog profila Klinička ispitivanja provedena su s tabletama Competact i istovremeno primijenjenima pioglitazonom i metforminom (vidjeti dio 5.1).
When clinically appropriate, direct change from metformin monotherapy to Competact may be considered. 
U klinički opravdanim slučajevima može se razmotriti izravna zamjena monoterapije metforminom s lijekom Competact.
- you must tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. 
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, morate o tome obavijestiti svog liječnika.
In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline. 
U kliničkim ispitivanjima u trajanju od jedne godine, pioglitazon je dosljedno izazivao statistički značajno sniženje omjera albumina i kreatinina u usporedbi s početnim vrijednostima.
In light of age- related risks (especially bladder cancer, fractures and heart failure), the balance of benefits and risks should be considered carefully both before and during treatment in the elderly. 
Kod procjene rizika povezanih sa životnom dobi (osobito karcinoma mokraćnog mjehura, prijeloma kostiju i zatajenja srca), potrebno je pažljivo razmotriti ravnotežu između koristi i rizika kako prije,
The decision whether to continue the patient on therapy with Competact should be guided by clinical judgement pending laboratory evaluations. 
Odluku o nastavku liječenja lijekom Competact treba donijeti na temelju kliničke procjene i ovisno o laboratorijskim nalazima.
Investigations weight increased8 
Pretrage povećana tjelesna težina8
OTHER SPECIAL WARNING(S), IF NECESSARY EXPIRY DATE 
DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO ROK VALJANOSTI
Competact contains pioglitazone and metformin. 
Competact sadrži pioglitazon i metformin.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (98 TABLETS) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA (BEZ PLAVOG OKVIRA) SAMO VIŠESTRUKA PAKIRANJA (98 TABLETA)
Post-marketing cases of peripheral oedema and cardiac failure have also been reported in patients with concomitant use of pioglitazone and nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors. 
Nakon stavljanja lijeka u promet prijavljeni su slučajevi perifernih edema i zatajenja srca kod bolesnika koji su istodobno uzimali pioglitazon s nesteroidnim protuupalnim lijekovima, uključujući i selektivne COX-2 inhibitore.
Adverse reactions reported in double-blind studies and post-marketing experience are listed below as MedDRA preferred term by system organ class and absolute frequency. 
Nuspojave zabilježene u dvostruko slijepim ispitivanjima i nakon stavljanja lijeka u promet navedene su niže prema MedDRA klasifikaciji organskih sustava i apsolutnoj učestalosti.
Since there is a potential for an increase in dose-related adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered. 
Budući da postoji povećana mogućnost nuspojava povezanih s dozom, možda će trebati sniziti dozu pioglitazona kod istovremene primjene gemfibrozila.
Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness. 
U klasifikaciji organskih sustava nuspojave su prikazane u padajućem nizu prema sve manjoj incidenciji i padajućoj ozbiljnosti.
Risk related to pioglitazone 
Trudnoća Rizik povezan s pioglitazonom
The pioglitazone dose may need to be increased when rifampicin is concomitantly administered. 
Dozu pioglitazona možda će trebati povisiti kod istovremene primjene rifampicina.
If you forget to take Competact 
Ako ste zaboravili uzeti lijek Competact
The fixed dose combination tablet of pioglitazone 15 mg/metformin 850 mg BID (N=201), pioglitazone 15 mg BID (N=189), and metformin 850 mg BID (N=210) were evaluated in type 2 diabetes mellitus patients with mean baseline HbA1c of 9.5% in a randomised double-blind, parallel-group study. 
Fiksna kombinacija pioglitazona u dozi od 15 mg i metformina u dozi od 850 mg dvaput na dan u tableti (N = 201), pioglitazon u dozi od 15 mg dvaput na dan (N = 189) i metformin u dozi od 850 mg dvaput na dan (N = 210) ispitana je u randomiziranom, dvostruko slijepom ispitivanju na usporednim skupinama bolesnika sa šećernom bolešću tipa 2 i prosječnim početnim HbA1c od 9,5%.
Women of childbearing potential / Contraception in males and females Competact is not recommended in women of childbearing potential not using contraception. 
Competact se ne preporučuje u žena reproduktivne dobi koje ne koriste kontracepciju.
In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels. 
U većini kliničkih ispitivanja opaženo je sniženje ukupnih triglicerida i slobodnih masnih kiselina u plazmi te povišenje razine HDL-kolesterola u usporedbi s placebom, uz malo, ali ne i klinički značajno povišenje razine
8 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year. 
8 U ispitivanima kontroliranima aktivnim komparatorom, prosječno povećanje tjelesne težine monoterapijom pioglitazonom iznosilo je 2-3 kg tijekom jedne godine.
Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered. 
Potrebne su pažljive kontrole glikemije te razmotriti prilagodbu doze unutar preporučenog raspona doza i promjenu liječenja šećerne bolesti kad se istovremeno primjenjuju kationski lijekovi koji se eliminiraju tubularnom sekrecijom u bubrezima.
Metformin is contra-indicated 
< 30 Metformin je kontraindiciran
The film-coated tablets (tablets) are white to off white, oblong, convex, embossed ‘15 / 850' on one face and ‘4833M' on the other. 
Filmom obložene tablete (tablete) su bijele do gotovo bijele boje, ovalne, konveksne s utisnutim „15 / 850“ na jednoj strani i „4833M“ na drugoj.
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked. 
Ako bolesnik razvije simptome koji ukazuju na poremećaj funkcije jetre, što može uključivati mučninu, povraćanje, umor, anoreksiju i/ili tamnu boju mokraće, potrebno je provjeriti jetrene enzime.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (2 x 98 TABLETS) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA NALJEPNICA (S PLAVIM OKVIROM) SAMO VIŠESTRUKO PAKIRANJE (2 x 98 TABLETA)
In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys. 
U toksikološkim su ispitivanjima dosljedno opažene ekspanzija volumena plazme sa hemodilucijom, anemija i reverzibilna ekscentrična hipertrofija srca nakon ponovljenog doziranja u miševa, štakora,
- if you have uncontrolled diabetes, with for example severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see section“Risk of lactic acidosis”) or ketoacidosis. 
- ako imate nekontroliranu šećernu bolest uz, primjerice, tešku hiperglikemiju (visoka razina glukoze u krvi), mučninu, povraćanje, proljev, brz gubitak tjelesne težine, laktacidozu (vidjeti dio
It is recommended, therefore, that patients treated with Competact undergo periodic monitoring of liver enzymes. 
Stoga se u bolesnika liječenih lijekom Competact preporučuje povremeno kontrolirati jetrene enzime.
The observed excess risk of fractures for women on pioglitazone in this study is therefore 0.5 fractures per 100 patient years of use. 
Opaženo povećanje rizika od prijeloma kosti u žena koje su u ovom ispitivanju uzimale pioglitazon stoga je iznosilo 0,5 prijeloma na 100 bolesnik-godina primjene.
When treating patients who have at least one risk factor for development of congestive heart failure (e.g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start with the lowest available dose and increase the dose gradually. 
(npr. prethodni infarkt miokarda, simptomatska bolest koronarnih arterija ili starija dob), liječnici trebaju započeti s najnižom dostupnom dozom i postupno je povećavati.
Steady state pharmacokinetics are similar in patients age 65 and over and young subjects. 
Stariji bolesnici Farmakokinetika u stanju dinamičke ravnoteže u bolesnika u dobi od 65 ili više godina slična je onoj u mlađih osoba.
- The active substances are pioglitazone and metformin hydrochloride. 
- Djelatne tvari su pioglitazon i metforminklorid.
Each tablet contains 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride. 
Jedna tableta sadrži 15 mg pioglitazona (u obliku pioglitazonklorida) i 850 mg metforminklorida.
Allergic reactions have been reported with frequency not known (cannot be estimated from available data) in patients taking Competact. 
U bolesnika koji su uzimali Competact zabilježene su alergijske reakcije s nepoznatom učestalosti (ne može se procijeniti iz dostupnih podataka).
- if you have a problem with your liver. 
- ako imate tegobe s jetrom.
Animal studies have not shown teratogenic effects but have shown foetotoxicity related to the pharmacologic action (see section 5.3). 
Ispitivanja na životinjama nisu pokazala teratogene učinke, ali opažena je fetotoksičnost povezana s farmakološkim djelovanjem
Thiazolidinediones act primarily by reducing insulin resistance and biguanides act primarily by decreasing endogenous hepatic glucose production. 
Tiazolidindioni primarno djeluju tako da smanjuju inzulinsku rezistenciju, a bigvanidi tako da smanjuju endogenu proizvodnju glukoze u jetri.
General disorders and administration site conditions oedema7 
Opći poremećaji i reakcije na mjestu primjene edemi7
If you experience these symptoms for the first time talk to your doctor as soon as possible. 
Ako je to prvi put da ste osjetili ove simptome, čim prije obavijestite svog liječnika.
Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) treated patients in comparative controlled trials with pioglitazone. 
3-4% i hematokrita za 3,6-4,1%) u usporednim kontroliranim ispitivanjima s pioglitazonom.
Component of a multipack. 
(ISKLJUČUJUĆI VIŠESTRUKA PAKIRANJA)
Competact should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.5. 
Competact treba prekinuti prije ili u vrijeme pretrage metodom oslikavanja i s njegovom primjenom smije se ponovno započeti tek 48 sati poslije, pod uvjetom da je funkcija bubrega bila ponovno procijenjena i da je potvrđeno da je stabilna, vidjeti dijelove 4.2 i 4.5.
Competact must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.4. 
Primjena Competact se mora prekinuti prije ili u vrijeme pretrage metodom oslikavanja i s njegovom primjenom smije se ponovno započeti tek 48 sati poslije, pod uvjetom da je funkcija bubrega bila ponovno procijenjena i da je potvrđeno da je stabilna, vidjeti dijelove 4.2 i 4.4.
Your doctor will ask you to have blood tests periodically during treatment with Competact. 
Liječnik će Vam savjetovati da za vrijeme liječenja lijekom Competact povremeno napravite krvne pretrage, da bi se provjerilo je li funkcija jetre normalna.
abdominal pain very common very common diarrhoea very common very common flatulence uncommon loss of appetite very common very common nausea very common very common vomiting very common very common 
bol u trbuhu vrlo često vrlo često proljev vrlo često vrlo često nadutost manje često gubitak apetita vrlo često vrlo često mučnina vrlo često vrlo često povraćanje vrlo često vrlo često
- a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01). 
1000 bolesničkih godina (p = 0,021) - značajno sniženje rizika od infarkta miokarda: metformin s 11 događaja na 1000 bolesničkih godina, samo dijeta s 18 događaja na 1000 bolesničkih godina, (p = 0,01).
Frequency of adverse reactions Pioglitazone Metformin Competact 
Pioglitazon Metformin Competact
Given the accumulation of data since the implementation of the additional risk minimisation measures, the PRAC agreed with the MAH's proposal to remove the additional risk minimisation measures. 
Uzimajući u obzir akumuljrane podatake od implementacije dodatnih mjera minimizacije rizika,
Maximum daily dose is 1,000 mg. 
30-44 Maksimalna dnevna doza je 1000 mg.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (S PLAVIM OKVIROM)
Metformin is contraindicated in patients with GFR < 30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3. 
GFR je potrebno procijeniti prije početka liječenja i redovito nakon toga, vidjeti dio 4.2. Metformin je kontraindiciran u bolesnika s GFR < 30 ml/min i njegovu je primjenu potrebno privremeno prekinuti ako su prisutna stanja koja mijenjaju funkciju bubrega, vidjeti dio 4.3).
On the basis of the scientific conclusions for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone is unchanged subject to the proposed changes to the product information. 
pioglitazon, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) glimepirid/pioglitazonklorid, metformin/pioglitazon, pioglitazon nepromijenjen, uz predložene izmjene informacija o lijeku.
Some medicinal products that can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDS, including selective cyclo-oxygenase (COX) II inhibitors, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics. 
NSAIL-ovi, uključujući selektivne inhibitore ciklooksigenaze (COX) II, angiotenzin-konvertirajućeg enzima (ACE) inhibitore, antagoniste receptora angiotenzina II i diuretike, osobito diuretike Henleove petlje.
Uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - gas - difficulty sleeping (insomnia) 
Manje često (može se javiti u do 1 na 100 osoba) - upala sinusa (sinusitis) - vjetrovi
1 Post-marketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported. 
1 Nakon stavljanja lijeka na tržište, kod bolesnika liječenih pioglitazonom prijavljeni su slučajevi reakcija preosjetljivosti.
The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease). 
dehidraciju (dodatne informacije vidjeti niže), tegobe s jetrom i sva zdravstvena stanja u kojima dio tijela ima smanjenu opskrbu kisikom (kao što je akutna teška srčana bolest).
Therapy with Competact should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 x upper limit of normal) or with any other evidence of liver disease. 
povišena više od 2,5 puta iznad gornje granice normale) ili nekim drugim dokazom bolesti jetre.
Competact 15 mg/850 mg film-coated tablets 
Competact 15 mg/850 mg filmom obložene tablete
Competact should be discontinued if any deterioration in cardiac status occurs. 
Ako nastupi bilo kakvo pogoršanje srčanog statusa, primjenu lijeka Competact treba prekinuti.
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma. 
Kad je funkcija bubrega oštećena, bubrežni klirens je snižen proporcionalno klirensu kreatinina i stoga je poluvijek eliminacije produljen, što dovodi do povišenja razine metformina u plazmi.
In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin. 
U kontroliranim kliničkim ispitivanjima, zabilježena incidencija zatajenja srca u skupinama liječenima pioglitazonom bila je jednaka kao i u skupinama koje su primale placebo, metformin ili sulfonilureju,
5 How to store Competact Contents of the pack and other information 
Sadržaj pakiranja i druge informacije