natgillin/translations-raw huggingface dataset:
Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets
Aluminij/aluminij pretisni omoti, pakiranja po 14, 28, 30, 50, 56, 84, 90, 98, 112 in 196 tablet.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
common common uncommon macular oedema not known not known not known not known not known
občasni makularni edem neznana neznana neznana neznana neznana
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Teva and insulin experienced the development of heart failure.
Nekateri bolniki z dolgotrajno sladkorno boleznijo tipa 2 in srčno boleznijo ali predhodno kapjo, ki so bili zdravljeni z zdravilom Pioglitazon Teva in insulinom so doživeli razvoj srčnega popuščanja.
• The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.
• Izobraževalno gradivo za zdravnike mora vsebovati: Povzetek glavnih značilnosti zdravila,
14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets 112 tablets 196 tablets
14 tablet 28 tablet 30 tablet 50 tablet 56 tablet 84 tablet 90 tablet 98 tablet 112 tablet 196 tablet
The decision whether to continue the patient on therapy with pioglitazone should be guided by clinical judgement pending laboratory evaluations.
Odločitev o tem, ali zdravljenje bolnika s pioglitazonom nadaljevati, naj do laboratorijskih vrednotenj temelji na klinični presoji.
In clinical trials with pioglitazone there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention.
V kliničnih preskušanjih s pioglitazonom so opažali pridobivanje telesne mase povezano z odmerkom, ki je lahko posledica nabiranja maščob in v nekaterih primerih povezano z zadrževanjem tekočine.
This is to check that your liver is working normally.
To je potrebno zaradi nadzora normalnega delovanja vaših jeter.
- The other ingredients are mannitol, carmellose calcium, hydroxypropylcellulose and magnesium stearate.
- Druge pomožne snovi so: manitol, hidroksipropilceluloza, kalcijev karmelozat in magnezijev stearat.
• Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure)
• Opozorilo o uporabi pri starejših glede na s starostjo povezana tveganja (zlasti za rak mehurja,
- Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Pioglitazon je indiciran tudi za kombinacijo z insulinom pri odraslih bolnikih s sladkorno boleznijo tipa 2 z nezadostnim nadzorom glikemije, ki se zdravijo z insulinom, za katere je metformin, zaradi kontraindikacij ali neprenašanja, neprimeren (glejte poglavje 4.4).
There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
V postmarketinških izkušnjah so poročali o redkih primerih hepatocelularne disfunkcije (glejte poglavje 4.8).
as monotherapy
kot monoterapija
very common (may affect more than 1 in 10 people) - decreased blood sugar (hypoglycaemia)
zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) - znižanje ravni krvnega sladkorja (hipoglikemija)
In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged ≥65 years compared with those less than 65 years (9.7% compared to 4.0%).
V tej študiji so pri bolnikih, ki so se zdravili s pioglitazonom in z insulinom, večji odstotek srčnega popuščanja opazili pri bolnikih, starih 65 let in starejših, v primerjavi z bolniki, mlajšimi od 65 let (9,7 % v primerjavi s 4,0 %).
What Pioglitazone Teva is and what it is used for What you need to know before you take Pioglitazone Teva How to take Pioglitazone Teva Possible side effects
Kaj je zdravilo Pioglitazon Teva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Pioglitazon Teva Kako jemati zdravilo Pioglitazon Teva
- if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss,
- če ste imeli diabetično ketoacidozo (zaplet sladkorne bolezni, ki povzroča hitro hujšanje, slabost ali bruhanje).
3 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.
3 V kontroliranih kliničnih preskušanjih je bila incidenca poročil o srčnem popuščanju ob zdravljenju s pioglitazonom enaka kot v skupinah zdravljenja s placebom, metforminom in sulfonilsečnino, vendar je bila povečana pri uporabi kombiniranega zdravljenju z insulinom.
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 zmanjšano srčno rezervo.
Environmental Risk Assessment (ERA): No environmental impact is anticipated from the clinical use of pioglitazone.
Ocena tveganja za okolje: Pri klinični uporabi pioglitazona ni pričakovati vpliva na okolje.
Following initiation of therapy with pioglitazone, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Po uvedbi zdravljenja s pioglitazonom je priporočeno, da jetrne encime spremljate redno po klinični presoji.
If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Če ste vzeli večji odmerek zdravila Pioglitazon Teva, kot bi smeli Če po nesreči zaužijete preveč tablet ali če kdo drug ali otrok zaužije vaša zdravila, nemudoma obvestite svojega zdravnika ali farmacevta.
Therefore, pioglitazone should not be administered to breast-feeding women.
Zato se pioglitazona doječim ženskam ne sme dajati.
Since insulin and pioglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema.
Ker sta insulin in pioglitazon povezana z zastajanjem tekočine, lahko sočasno jemanje poveča tveganje za edeme.
In the 3.5 year PROactive study, 44/870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%) of female patients treated with comparator.
V 3,5 letni PROactive študiji, je 44/870 (5,1 %) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/905 (2,5 %) žensk, zdravljenih s primerjalnim zdravilom.
It is not known whether pioglitazone is secreted in human milk.
Ni znano, ali se pioglitazon izloča v materino mleko.
Pioglitazone should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Jetrna okvara Pioglitazona pri bolnikih z jetrno okvaro ne smemo uporabljati (glejte poglavji 4.3 in 4.4).
Symptomatic and general supportive measures should be taken in case of overdose.
V primerih prevelikega odmerjanja so potrebni splošni podporni ukrepi ter lajšanje simptomov.
Bladder cancer
Rak mehurja
This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth.
To pripisujemo delovanju pioglitazona pri zniževanju materine hiperinsulinemije in povečani rezistenci na insulin, ki se pojavi med nosečnostjo, ter posledičnemu zmanjšanju razpoložljivosti presnovnih substratov za rast plodu.
Other medicines and Pioglitazone Teva
Druga zdravila in zdravilo Pioglitazon Teva
Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin
Kombinacija z metforminom s sulfonil sečnino z metforminom in sulfonil sečnino z inzulinom
Pioglitazone did not cause statistically significant increases in LDL cholesterol levels compared with placebo, whilst reductions were observed with metformin and gliclazide.
Pioglitazon ni povzročil statistično značilnih povišanj ravni LDL holesterola v primerjavi s placebom, pri metforminu in gliklazidu pa so opazili znižanja teh vrednosti.
Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
Ni videti, da bi sočasno dajanje pioglitazona s sulfonilsečninami vplivalo na farmakokinetiko sulfonilsečnine.
If you experience this symptom for the first time, talk to your doctor as soon as possible.
Če ste prvič opazili ta simptom, se posvetujte s svojim zdravnikom kakor hitro mogoče.
Since there is a potential for an increase in doserelated adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Ker obstaja možnost povečanja od odmerka odvisnih neželenih učinkov, bo morda ob sočasnem dajanju gemfibrozila potrebno znižati odmerek pioglitazona.
In combination with insulin, the current insulin dose can be continued upon initiation of pioglitazone therapy.
V kombinaciji z insulinom lahko ob uvedbi zdravljenja s pioglitazonom nadaljujemo z dotedanjim odmerkom insulina.
In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
V kliničnih študijah so bolniki jemali pioglitazon v višjem od najvišjega priporočenega odmerka
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov proizvajalca,
Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Pretehtati je potrebno prilagoditev odmerka pioglitazona v okviru priporočenega odmerjanja ali spremeniti zdravljenje sladkorne bolezni (glejte poglavje 4.5).
Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na pretisnem omotu, poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
If you are following a special diet for diabetes, you should continue with this while you are taking Pioglitazone Teva.
Če ste na posebni dieti za sladkorno bolezen, jo med jemanjem zdravila Pioglitazon Teva nadaljujte.
In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and preexisting major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
V PROaktivni kardiovaskularni študiji izida je bilo 5238 bolnikov s sladkorno boleznijo tipa 2 in že prej obstoječimi težjimi makrovaskularnimi boleznimi naključno dodatno zdravljenih s pioglitazonom ali placebom k že obstoječemu antidiabetičnemu in kardiovaskularnemu zdravljenju, v trajanju do 3,5 let.
It is recommended, therefore, that patients treated with pioglitazone undergo periodic monitoring of liver enzymes.
Zato je priporočeno, da pri bolnikih, zdravljenih s pioglitazonom, redno spremljate vrednosti jetrnih encimov.
Blood and lymphatic system disorders anaemia common
Bolezni krvi in limfatič-nega sistema anemija
Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when pioglitazone is used in combination with insulin.
Bolnike je treba opazovati zaradi znakov in simptomov srčnega popuščanja, povečanja telesne mase in edema, ko se pioglitazon uporablja v kombinaciji z insulinom.
Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Študije pri človeku ne kažejo nobenih indukcij poglavitnih inducibilnih citokromov P450, 1A, 2C8/9
Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1-2% and haematocrit 1-3.2% 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), in v manjšem obsegu pri bolnikih, zdravljenih s sulfonilsečnino in insulinom (hemoglobin 1-2 % in hematokrit 1-3,2 % relativna znižanja).
In comparator groups addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg.
V primerjalnih skupinah je dodatek sulfonilsečnine metforminu povzročil povprečno povečanje telesne mase za 1,3 kg in dodatek metformina sulfonilsečnini povprečno zmanjšanje telesne mase za 1,0 kg.
The dose may be increased in increments up to 45 mg once daily.
Odmerek lahko postopoma zvišujemo do 45 mg enkrat dnevno.
Visceral fat was significantly decreased, while there was an increase in extra-abdominal fat mass.
Količina visceralnega maščevja se je značilno zmanjšala, medtem ko se je masa ekstraabdominalnega maščevja zvečala.
In vitro studies have shown no inhibition of any subtype of cytochrome P450.
Študije in vitro niso pokazale inhibicije kakega podtipa citokroma P450.
No dose adjustment is necessary in patients with impaired renal function (creatinine clearance > 4 ml/min) (see section 5.2).
Pri bolnikih z okvarjenim delovanjem ledvic (očistek kreatinina > 4 ml/min) odmerka ni treba prilagajati (glejte poglavje 5.2).
Investigations weight increased6 common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon alanine aminotransferase increased7
povišana vrednost keratin fosfokinaze v krvi povišana vrednost laktatne dehidro-genaze občasni povišana vrednost alanin aminotransferaze7
However, the incidences of oedema, weight gain and heart failure were increased.
Vendar je bila povečana incidenca edemov, pridobivanja telesne mase in srčnih odpovedi.
Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure.
Zastajanje tekočine in srčno popuščanje Pioglitazon lahko povzroči zastajanje tekočine, to pa lahko poslabša ali pospeši srčno popuščanje.
- if you have cysts on your ovaries (polycystic ovary syndrome).
- če imate ciste na jajčnikih (sindrom policističnih jajčnikov).
In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg and added to a sulphonylurea of 2.8 kg.
V preskušanjih kombiniranega zdravljenja je pioglitazon, dodan metforminu, povzročil povprečno povečanje telesne mase v enem letu za 1,5 kg oziroma, dodan sulfonilsečnini, za 2,8 kg.
Contents of the pack and other information What Pioglitazone Teva contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Pioglitazon Teva
In a 20-week study, as well as reducing fasting triglycerides, pioglitazone reduced post prandial hypertriglyceridaemia through an effect on both absorbed and hepatically synthesised triglycerides.
20-tedenski študiji je pioglitazon znižal raven trigliceridov na tešče, pa tudi hipertrigliceridemijo po obroku prek učinkovanja na absorbirane in v jetrih sintetizirane trigliceride.
Reproductive system and breast disorders erectile dysfunction common
Motnje reproduk-cije in dojk erektilna disfunkcija
- The active substance is pioglitazone.
- Zdravilna učinkovina je pioglitazon.
However if you miss a dose, just carry on with the next dose as normal.
nadaljujte z naslednjim odmerkom kot sicer.
Talk to your doctor or pharmacist before taking Pioglitazone Teva (also see section 4)
Pred začtkom jemanja zdravila Pioglitazon Teva se posvetujte z zdravnikom ali farmacevtom (glejte tudi poglavje 4):
Liver enzymes should be checked prior to the initiation of therapy with pioglitazone in all patients.
Jetrne encime je treba pri vseh bolnikih kontrolirati pred uvedbo zdravljenja s pioglitazonom.
Eye disorders visual disturbance2
Očesne bolezni motnje vida2
How to store Pioglitazone Teva Contents of the pack and other information
Shranjevanje zdravila Pioglitazon Teva Vsebina pakiranja in dodatne informacije
4 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
4 Opravljena je bila skupna analiza neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom nadzorovanih, dvojno slepih kliničnih preskušanj pri več kot 8100 bolnikov v skupini zdravljeni s pioglitazonom in 7400 v skupini zdravljeni s primerjalnim zdravilom, ki so trajale do 3,5 let.
Fractures were observed in 2.6% of women taking pioglitazone compared to 1.7% of women treated with a comparator.
Zlome so opazili pri 2,6 % žensk, ki so jemale pioglitazon v primerjavi s 1,7 % žensk, zdravljenih s primerjalnim zdravilom.
There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution.
(4 % relativno znižanje) in hematokrita (4,1 % relativno znižanje), skladno s hemodilucijo.
In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those ≥65 years compared to 4.0% in patients less than 65 years.
Pri bolnikih, ki so se zdravili samo z insulinom, brez pioglitazona, je odstotek srčnega popuščanja pri bolnikih, starih 65 let in starejših, znašal 8,2 %, pri bolnikih, mlajših od 65 let, pa 4,0 %.
very common fatigue uncommon
zelo pogosti utrujenost občasni
- diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
- z rakom mehurja ali rakom mehurja v anamnezi - z neraziskano makroskopsko hematurijo
In clinical trials of up to two years duration, pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HDL cholesterol levels, compared with placebo, metformin or gliclazide.
V kliničnih preskušanjih, ki so trajala do dve leti, je pioglitazon znižal skupne plazemske trigliceride in proste maščobne kisline ter povišal ravni HDL holesterola v primerjavi s placebom, metforminom ali gliklazidom.
If you stop taking Pioglitazone Teva
Če ste prenehali jemati zdravilo Pioglitazon Teva
7 In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
7V kliničnih preskušanjih pioglitazona je bila incidenca povišanih vrednosti ALT, višjih kot trikratna zgornja meja normalnih vrednosti, enaka kot pri placebu, vendar nižja kot v primerjalnih skupinah z metforminom ali sulfonilsečnino.
Skin and subcutaneous tissue disorders sweating uncommon
Bolezni kože in podkožja znojenje občasni
The usual starting dose is one tablet of 15 mg or of 30 mg of pioglitazone to be taken once daily.
Običajni začetni odmerek je ena 15-miligramska ali 30-miligramska tableta pioglitazona enkrat dnevno.
Heart failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
O srčnem popuščanju so poročali tudi pri tržni uporabi pioglitazona, in sicer pogosteje pri uporabi pioglitazona v kombinaciji z insulinom ali pri bolnikih z anamnezo srčnega popuščanja.
When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III contribute equally to efficacy.
koncentracije in vezavo na beljakovine, je delež učinkovitosti pioglitazona in presnovka M-III enak.
Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, the treatment should be discontinued (see section 4.6).
Zato se morajo tveganja za zanositev zavedati, in če bolnica želi zanositi ali zanosi, je treba zdravljenje prekiniti
6 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
6V kontroliranih preskušanjih s primerjalnim zdravilom je bilo povprečno povečanje telesne mase pri pioglitazonu, dajanemu kot monoterapija, 2-3 kg v enem letu.
Frequency of adverse reactions of pioglitazone by treatment regimen
Neželeni učinki Pogostnost neželenih učinkov pioglitazona glede na režim zdravljenja
Therapy with pioglitazone 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 ravnmi jetrnih encimov (ALT > 2,5-kratna zgornja meja normalnih vrednosti) ali s kakršnimikoli drugimi znaki jetrne bolezni zdravljenja s pioglitazonom ne smemo začeti.
Pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below:
Pioglitazon je indiciran za zdravljenje sladkorne bolezni tipa 2:
Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon
Infekcijske in parazitske bolezni okužba zgornjih dihal bronhitis sinusitis občasni občasni občasni občasni občasni
What Pioglitazone Teva looks like and contents of the pack
Izgled zdravila Pioglitazon Teva in vsebina pakiranja
Heart failure has been experienced commonly (may affect up to 1 in 10 people) in patients taking pioglitazone in combination with insulin.
Odpoved srca je bila pogosto (pojavijo se lahko pri največ 1 od 10 bolnikov) ugotovljena pri pacientih, ki so jemali pioglitazon v kombinaciji z insulinom.
nausea or vomiting).
zlome in srčno popuščanje).
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.
V toksikoloških študijah so se po večkratnem odmerjanju mišim, podganam, psom in opicam stalno pojavljali povečanje volumna plazme s hemodilucijo, anemija in reverzibilna ekscentrična hipertrofija srca.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
B. POGOJI ALI OMEJITVE GLEDE OSKERBE IN UPORABE
Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience.
V postmarketinških izkušnjah so se pojavljali redki primeri povišanih vrednosti jetrnih encimov in hepatocelularne disfunkcije.
Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Teva.
Zdravnik vas bo v času zdravljenja z zdravilom Pioglitazon Teva naročil na redne preiskave krvi.
The other side effects that have been experienced by some patients when pioglitazone is taken with other antidiabetic medicines are:
Pri nekaterih bolnikih, ki so jemali pioglitazon skupaj z drugimi antidiabetičnimi zdravili, so se pojavili naslednji dodatni neželeni učinki:
In the 3.5 year cardiovascular risk PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
V 3,5 letni PROactive študiji kardiovaskualarnega tveganja, je 44/870 (5,1 %; 1,0 zlom na 100 bolniških let) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/905 (2,5 %;
Pioglitazone was associated with significant weight gain.
Pioglitazon je bil povezan z značilnim povečanjem telesne mase.
The risk of fractures should be considered in the long term care of patients treated with pioglitazone (see section 4.8).
Pri dolgoročnem zdravljenju bolnikov s pioglitazonom, je potrebno upoštevati tveganje za zlome (glejte poglavje 4.8).