natgillin/translations-raw huggingface dataset:
Competact should not be used where there is alcohol intoxication, diabetic ketoacidosis (high levels of ketones), conditions that may effects the kidneys, and during breast-feeding.
Zdravila Competact se ne sme uporabljati v primeru alkoholiziranosti, diabetične ketoacidoze (visoke koncentracije ketonov), bolezni, ki utegnejo prizadeti ledvice, in med dojenjem.
The Committee for Medicinal products for Human Use (CHMP) concluded that the effectiveness of pioglitazone and metformin in type diabetes 2 had been shown, and that Competact simplifies treatment and improves compliance when a combination of the active substances is required.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bila učinkovitost pioglitazona in metformina pri zdravljenju sladkorne bolezni tipa 2 dokazana in da zdravilo Competact poenostavlja zdravljenje ter izboljšuje zavezanost bolnikov k jemanju zdravila, kadar je potrebna kombinacija zdravilnih učinkovin.
They decided that Competact’ s benefits are greater than its risks for the treatment of type 2 diabetes.
Odbor je zato odločil, da so koristi zdravila Competact pri zdravljenju sladkorne bolezni tipa 2 večje od z njim povezanih tveganj.
They recommended that Competact be given marketing authorisation.
Zato je za zdravilo Competact priporočil odobritev dovoljenja za promet z zdravilom.
Other information about Competact:
Druge informacije o zdravilu Competact:
The European Commission granted a marketing authorisation valid throughout the European Union, for Competact to Takeda Global Research and Development Centre (Europe) Ltd on 28 July 2006.
Evropska komisija je dovoljenje za promet z zdravilom Competact, veljavno po vsej Evropski uniji, odobrila družbi Takeda Global Research and Development Centre (Evropa) Ltd dne 28. julija 2006.
The full EPAR for Competact is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Competact je na voljo tukaj.
This summary was last updated in 06-2006.
Ta povzetek je bil nazadnje posodobljen 06- 2006.
Route of EMEA Procedure number
Način uporabe EMEA številka
administration
zdravila
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu) Blister (alu/ alu)
Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu)
Competact 15 mg/ 850 mg film-coated tablets.
Competact 15 mg/ 850 mg filmsko obložene tablete
The tablets are white to off-white, oblong, film-coated, embossed ‘ 15 / 850’ on one face and ‘ 4833M’ on the other.
Tablete so bele do sivkastobele barve, podolgovate, filmsko obložene, z oznako ‘ 15 / 850 ’ na eni strani in ‘ 4833M ’ na drugi.
Competact is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Competact je indiciran za zdravljenje sladkorne bolezni tipa 2, še posebno pri bolnikih s čezmerno telesno maso, pri katerih ni možno vzdrževati primerne koncentracije glukoze v krvi z največjim dovoljenim peroralnim odmerkom metformina samega.
Dosage in adults:
Odmerjanje pri odraslih:
The usual dose of Competact is 30 mg/ day pioglitazone plus 1700 mg/ day of metformin hydrochloride (this dosage is achievable with one tablet of Competact 15 mg/ 850 mg, taken twice a day).
Običajni odmerek Competacta je 30 mg/ dan pioglitazona in 1700 mg/ dan metforminijevega klorida (dan v obliki ene tablete Competact 15 mg/ 850 mg dvakrat na dan).
Dose titration with pioglitazone (added to the optimal dose of metformin) should be considered before the patient is switched to Competact.
Preden se bolnika prevede na zdravljenje s Competactom, je treba najprej prilagoditi odmerek pioglitazona (dodajanje k optimalnemu odmerku metformina).
When clinically appropriate, direct change from metformin monotherapy to Competact may be considered.
Če je klinično sprejemljivo, se sme razmisliti o neposredni zamenjavi iz monoterapije z metforminom na zdravljenje s Competactom.
Taking Competact with, or just after food, may reduce gastrointestinal symptoms associated with metformin.
Jemanje Competacta sočasno s hrano ali neposredno po obroku lahko ublaži gastrointestinalne simptome, ki so povezani z metforminom.
As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Competact should have their renal function monitored regularly (see sections 4.3 and 4.4).
Zaradi izločanja metformina skozi ledvice in zaradi starostnega nagnjenja k zmanjšanju ledvičnega delovanja je pri starejših bolnikih, ki jemljejo Competact, potrebno redno spremljati delovanje ledvic (glejte poglavji 4. 3 in 4. 4).
Patients with renal impairment:
Bolniki z oslabljenim delovanjem ledvic:
Competact should not be used in patients with renal failure or renal dysfunction (creatinine clearance < 60 ml/ min)(see sections 4.3 and 4.4).
Competacta pri bolnikih z okvarjenim delovanjem jeter ne smemo uporabljati (glejte poglavji 4. 3 in 4. 4).
2 Patients with hepatic impairment:
2 Otroci in mladostniki:
There are no data available on the use of pioglitazone in patients under 18 years of age and therefore the use of Competact in this age group is not recommended.
O uporabi pioglitazona pri bolnikih, mlajših od 18 let, ni razpoložljivih podatkov in zato uporaba Competacta pri tej starostni skupini ni priporočljiva.
Competact is contraindicated in patients with:
Competact je kontraindiciran pri:
- Hypersensitivity to the active substances or to any of the excipients
- preobčutljivosti za zdravilne učinkovine ali za katero koli pomožno snov;
- Cardiac failure or history of cardiac failure (NYHA stages I to IV)
- srčnemu popuščanju ali anamnezi srčnega popuščanja (klasifikacija NYHA, stadiji I do IV);
- Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure,
- akutnih ali kroničnih boleznih, ki so lahko vzrok hipoksije tkiv, npr. srčno ali respiratorno
recent myocardial infarction, shock
popuščanje, nedaven miokardni infarkt, šok;
- Hepatic impairment
- oslabljenem delovanju jeter;
- Acute alcohol intoxication, alcoholism
- akutni zastrupitvi z alkoholom, alkoholizmu;
- Diabetic ketoacidosis or diabetic pre-coma
- diabetični ketoacidozi ali diabetični komi;
- Renal failure or renal dysfunction (creatinine clearance < 60 ml/ min) (see section 4.4).
- ledvični odpovedi ali ledvični disfunkciji, očistek kreatinina < 60 ml/ min (glejte poglavje 4. 4);
- Acute conditions with the potential to alter renal function such as:
- akutnih stanjih, ki lahko spremenijo delovanje ledvic:
- Dehydration
- dehidraciji;
- Severe infection
- hudih okužbah;
- Shock
- šoku;
- Intravascular administration of iodinated contrast agents (see section 4.4)
- intravenski uporabi jodiranih kontrastnih sredstev (glej poglavje 4. 4);
- Lactation
- dojenju.
There is no clinical experience of pioglitazone in triple combination with other oral antidiabetic agents.
Kliničnih izkušenj s pioglitazonom v trojni kombinaciji z drugimi peroralnimi antidiabetiki ni.
Lactic acidosis:
Lacktacidoza:
Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5mmol/ l, and an increased anion gap and lactate/ pyruvate ratio.
Diagnostične laboratorijske ugotovitve so: znižanje pH krvi, koncentracija laktata v plazmi nad 5 mmol/ l, zvečana anionska vrzel in zvečano razmerje laktat/ piruvat.
Renal Function:
Delovanje ledvic:
- at least two to four times a year in patients with serum creatinine levels at the upper limits of
- vsaj dvakrat do štirikrat letno pri bolnikih, ki imajo vrednosti kreatinina v serumu na zgornji
normal and in elderly subjects
dovoljeni meji, in pri starejših bolnikih.
3 Decreased renal function in elderly patients is frequent and asymptomatic.
Pri starejših bolnikih je zmanjšano delovanje ledvic pogosto in asimptomatsko.
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), physicians should start with the lowest available dose and increase the dose gradually.
Pri zdravljenju bolnikov, ki imajo vsaj en dejavnik tveganja za razvoj kongestivnega srčnega popuščanja (npr. predhodni miokardni infarkt ali simptomatska koronarna arterijska bolezen), mora zdravnik začeti zdravljenje z najnižjim možnim odmerkom in ga postopoma višati.
Patients should be observed for signs and symptoms of heart failure, weight gain or oedema particularly those with reduced cardiac reserve.
Bolnike je treba opazovati zaradi znakov in simptomov srčnega popuščanja, povečanja telesne mase ali edema, posebno tiste z
There have been cases of cardiac failure reported from the market when pioglitazone was used in combination with insulin. or patients with a history of cardiac failure.
Poročali so o primerih srčnega popuščanja, ko so pioglitazon uporabljali v kombinaciji z insulinom ali pri bolnikih s srčnim popuščanjem v anamnezi.
Since insulin and pioglitazone are associated with fluid retention, concomitant administration of insulin and Competact may increase the risk of oedema.
Ker sta insulin in pioglitazon povezana z zastajanjem tekočine, lahko sočasno jemanje insulina in Competacta poveča tveganje za edeme.
Competact should be discontinued if any deterioration in cardiac status occurs.
Če se pojavi kakršnokoli poslabšanje srčnega statusa, je treba zdravljenje s Competactom ukiniti.
Monitoring of Liver Function:
Spremljanje delovanja jeter:
There have been rare reports of hepatocellular dysfunction during post-marketing experience with pioglitazone (see section 4.8).
V postmarketinških izkušnjah s pioglitazonom so poročali o redkih primerih hepatocelularne disfunkcije (glejte poglavje 4. 8).
It is recommended, therefore, that patients treated with Competact undergo periodic monitoring of liver enzymes.
Zato je priporočeno, da pri bolnikih, zdravljenih s Competactom, redno spremljate vrednosti jetrnih encimov.
Liver enzymes should be checked prior to the initiation of therapy with Competact in all patients.
Jetrne encime je treba pri vseh bolnikih kontrolirati pred uvedbo zdravljenja s Competactom.
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.
Pri bolnikih s povišanimi izhodiščnimi vrednostmi jetrnih encimov (ALT > 2, 5- kratna zgornja meja normalnih vrednosti) ali s kakršnimi koli drugimi znaki jetrne bolezni zdravljenja s Competactom ne smemo začeti.
Following initiation of therapy with Competact, it is recommended that liver enzymes be monitored periodically according to clinical judgement.
Po uvedbi zdravljenja s Competactom je priporočeno, da jetrne encime spremljate redno po klinični presoji.
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.
Če se med zdravljenjem s Competactom ravni ALT zvišajo do 3- kratne zgornje meje normalnih vrednosti, je treba ravni jetrnih encimov čimprej ponovno kontrolirati.
The decision whether to continue the patient on therapy with Competact should be guided by clinical judgement pending laboratory evaluations.
Odločitev o tem, ali zdravljenje bolnika s Competactom nadaljevati, naj do laboratorijskih vrednotenj temelji na klinični presoji.
Weight Gain:
Pridobivanje telesne mase:
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.
Podobne spremembe so opažali v primerjalnih kontroliranih preskušanjih s pioglitazonom pri bolnikih, zdravljenih z metforminom (hemoglobin 3– 4% in hematokrit 3, 6– 4, 1% relativna znižanja).
Hypoglycaemia 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.
Bolniki, ki prejemajo pioglitazon v dvojnem zdravljenju s sulfonilsečnino, so lahko izpostavljeni tveganju za od odmerka odvisno hipoglikemijo, in je morda potrebno znižati odmerek sulfonilsečnine.
4 Eye disorders:
Očesne bolezni:
Surgery:
Kirurgija:
As Competact contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not be usually resumed earlier than 48 hours afterwards.
Ker Competact vsebuje metforminijev klorid, je potrebno zdravljenje prekiniti 48 ur pred načrtovanim operativnim posegom v splošni anesteziji, z njim pa običajno ne smemo nadaljevati prej kot v 48 urah po posegu.
Administration of iodinated contrast agent:
4 Uporaba jodiranih kontrastnih sredstev:
Therefore, due to the metformin active substance, Competact should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Zaradi vsebnosti zdravilne učinkovine metformin je potrebno Competact ukiniti pred preiskavo ali v času preiskav, ponovno pa se sme uvesti šele po 48 urah in le v primeru, da je bilo pri ponovnem vrednotenju ugotovljeno normalno delovanje ledvic (glejte poglavje 4. 5).
Polycystic ovarian syndrome:
Sindrom policističnih jajčnikov:
The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
Opazovano povečano tveganje za zlom pri ženskah v tej skupini podatkov na pioglitazonu je torej 0, 8 zlomov na 100 bolniških let uporabe.
Glycaemic control should be monitored
Potrebno je skrbno spremljanje glikemičnega nadzora.
Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
There have been no formal interaction studies for Competact.
Formalne študije interakcij za Competact niso bile narejene.
Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Poročali so, da sočasno dajanje pioglitazona z rifampicinom (induktor citokroma P450 2C8) povzroči
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Competact (see section 4.4).
Ker je v Competactu zdravilna učinkovina metformin, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience) povečana nevarnost laktacidoze (glejte poglavje 4. 4).
Cationic drugs that are eliminated by renal tubular secretion (e. g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Pri kationskih zdravilih, ki se izločajo z ledvično tubulno sekrecijo (npr. cimetidin), lahko zaradi tekmovanja za skupne ledvične tubulne transportne sisteme pride do interakcije z metforminom.
Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic drugs that are eliminated by renal tubular secretion are co-administered.
Zato je potrebno pri sočasnem jemanju kationskih zdravil, ki se izločajo z ledvično tubulno sekrecijo, skrbno spremljati koncentracijo glukoze v krvi, prilagoditev odmerka znotraj priporočljivega odmerjanja in spremembe pri zdravljenju sladkorne bolezni.
Combinations requiring precautions for use Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Glukokortikoidi (dani sistemsko ali lokalno), agonisti beta2 in diuretiki imajo intrinzično hiperglikemično aktivnost.
6 Risk related to pioglitazone:
4. 6 Nosečnost in dojenje
Animal studies have not shown teratogenic effects but have shown foetotoxicity related to the pharmacologic action (see section 5.3).
Študije na živalih niso pokazale teratogenih učinkov, vendar pa so pokazale fetotoksičnost, vezano na farmakološko delovanje (glejte poglavje 5. 3).
Risk related to metformin:
Tveganja, ki jih predstavlja metformin:
However, Competact should not be used during pregnancy and in women of child-bearing age not using contraceptive measures.
Vendar se Competacta ne sme dajati ženskam v času nosečnosti in ženskam v rodni dobi, ki ne jemljejo kontracepcijskih sredstev.
If a patient wishes to become pregnant or if a pregnancy occurs, treatment with Competact should be discontinued.
Če bolnice želijo zanositi ali če pride do nosečnosti, je potrebno zdravljenje s Competactom prekiniti.
Competact must therefore not be used in women who are breast-feeding (see section 4.3).
Ni znano, če ima dojenje za posledico izpostavljenost dojenčka zdravilu Competact se torej ne sme uporabljati pri ženskah, ki dojijo (glejte poglavje 4. 3).
4.8 Undesirable effects
6 4. 8 Neželeni učinki
There have been no therapeutic clinical trials conducted with Competact tablets however bioequivalence of Competact with co-administered pioglitazone and metformin has been demonstrated (see section 5.2).
Klinična terapevstka preskušanja s Competact tabletami niso opravljena, vendar je bila bioekvivalenca Competacta dokazana s sočasno uporabo pioglitazona in metformina (glejte poglavje 5. 2).
Adverse reactions reported in excess (> 0.5%) of placebo and as more than an isolated case in patients receiving pioglitazone in combination with metformin in double-blind studies are listed below as MedDRA preferred term by system organ class and absolute frequency.
Neželeni učinki, o katerih so poročali večkrat (> 0, 5%) kot pri placebu in več kot enkrat pri bolnikih, ki so prejemali pioglitazon v kombinaciji z metforminom v dvojno slepih študijah, so našteti spodaj, in sicer po razredih organskih sistemov in absolutni pogostnosti, kot je priporočeno po MedDRA.
Frequencies are defined as: common (> 1/ 100 ,< 1/10); uncommon (> 1/1000 ,< 1/100); rare (> 1/ 10000 ,< 1/1000); very rare (< 1/10000); isolated reports; not known (cannot be estimated from the available data).
Pogostnosti so določene kot: pogosti (> 1/ 100, < 1/ 10); občasni (> 1/ 1000, < 1/ 100); redki (> 1/ 10000, < 1/ 1000); zelo redki (< 1/ 10000); posamezni primeri; neznani (jih ne moremo oceniti iz obstoječih podatkov).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V razvrstitvah pogostosti so neželeni učinki navedeni po padajoči resnosti
PIOGLITAZONE IN COMBINATION THERAPY WITH METFORMIN
PIOGLITAZON V KOMBINIRANEM ZDRAVLJENJU Z METFORMINOM
Eye disorders
Očesne bolezni Pogosti:
Common:
motnje vida
Gastrointestinal disorders
Bolezni prebavil Občasni:
Musculoskeletal system and connective tissue disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva Pogosti:
Renal and urinary disorders
Bolezni sečil Pogosti:
and breast disorders
Motnje reprodukcije in dojk Pogosti:
In active comparator controlled trials oedema was reported in 6.3% of patients treated with metformin and pioglitazone, whereas the addition of sulphonylurea to metformin treatment resulted in oedema in 2.2% of patients.
Kontrolirana preskušanja z aktivno primerjavo poročajo o edemih pri 6, 3% bolnikov, zdravljenih z metforminom in pioglitazonom, medtem ko je dodatek sulfonilsečnine metforminu povzročil edeme pri 2, 2% bolnikov.
In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 – 3 kg over one year.
V kontroliranih preskušanjih z aktivno primerjavo je bilo povprečno povečanje telesne mase pri pioglitazonu, dajanemu kot monoterapija, 2– 3 kg v enem letu.
In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg.
V preskušanjih kombiniranega zdravljenja je pioglitazon, dodan metforminu, povzročil povprečno povečanje telesne mase v enem letu za 1, 5 kg.
Mean levels of liver enzymes decreased with treatment with pioglitazone.
V postmarketinških izkušnjah so se pojavljali redki primeri povišanih vrednosti
Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience.
7 jetrnih encimov in hepatocelularne disfunkcije.
Additional information on the individual active substances of the fixed dose combination
Dodatne informacije o posameznih zdravilnih učinkovinah v točno določeni kombinaciji odmerkov
In double blind placebo controlled clinical trials with pioglitazone upper respiratory tract infection and hypoaesthesia were common; sinusitis and insomnia were uncommon.
V dvojno slepih s placebom kontroliranih kliničnih raziskavah glede uporabe pioglitazona sta bila pogosta infekcija zgornjega dihalnega trakta in hipoastezija; sinusitis in nespečnost sta bila redka.
POST-MARKETING DATA
POSTMARKETINŠKI PODATKI
Macular oedema: not known
Makularni edem: neznani
Decrease of vitamin B12 absorption with decrease of serum levels during long-term use of metformin.
Zelo redko: zmanjšana absorpcija vitamina B12 in posledično zmanjšane koncentracije v serumu med dolgotrajnim jemanjem metformina.
Consideration of such aetiology is recommended if a patient presents with megaloplastic anaemia.
Upoštevanje tega se priporoča pri bolnikih z hudo nespečnostjo.
Lactic acidosis (see 4.4 Special warnings and precautions for use).
Laktacidoza (glejte poglavje 4. 4 Posebna opozorila in previdnostni ukrepi).
Nervous system disorders:
Motnje živčevja:
Gastrointestinal disorders:
Pogosto: motnje okusa
Very common:
Bolezni prebavil:
Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite.
Zelo pogosto: gastrointestinalne motnje, kot so slabost, bruhanje, diareja, bolečine v trebuhu in izguba apetita.
These undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Najpogosteje se pojavijo ob začetku zdravljenja in v večini primerov spontano prenehajo.
Liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.
Posamezni primeri: nenormalni testi delovanja jeter ali hepatitis, stanje se normalizira po ukinitvi zdravljenja z metforminom
Skin and subcutaneous tissue disorders:
Bolezni kože in podkožnih tkiv:
Skin reactions such as erythema, pruritis, urticaria.
Zelo redko: reakcije kože kot so eritem, pruritis, urtikarija.
No data are available with regard to overdose of Competact.
Podatki glede prevelikega odmerjanja Competacta niso na voljo.
Combinations of oral blood glucose lowering drugs, ATC code:
Farmakoterapevtska skupina: kombinacije peroralnih antidiabetikov, Oznaka ATC:
Competact combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: pioglitazone, a member of the thiazolidinedione class and metformin hydrochloride, a member of the biguanide class.
Competact je kombinacija dveh antihiperglikemičnih učinkovin s komplementarnim mehanizmom delovanja, namenjeno pa je izboljšanju urejenosti glikemije pri bolnikih s sladkorno boleznijo tipa 2: pioglitazona iz skupine tiazolidindionov in metforminijevega klorida iz skupine bigvanidov.