natgillin/translations-raw huggingface dataset:
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v Načrtu za obvladovanje tveganja, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12506 patients, 0.15%) than in control groups (7 cases from 10212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029).
O primerih raka sečnega mehurja so pogosteje poročali v meta-analizi kontroliranih kliničnih preskušanjih s pioglitazonom (19 primerov od 12.506 bolnikov, 0,15 %) kot v kontrolnih skupinah (7 primerov od 10.212 bolnikov, 0,07 %) HR = 2,64 (95% IZ 1,11-6,31, P = 0,029).
What Pioglitazone Accord is and what it is used for
Kaj je zdravilo Pioglitazone Accord in za kaj ga uporabljamo
Read the package leaflet before use.
Pred uporabo preberite priloženo navodilo za uporabo.
If you have the impression that the effect of Pioglitazone Accord is too weak, talk to your doctor.
Če menite, da je učinek zdravila Pioglitazone Accord prešibak, se posvetujte z zdravnikom.
If ALT levels are increased to 3 X upper limit of normal during pioglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Če se med zdravljenjem s pioglitazonom ravni ALT zvišajo do 3-kratne zgornje meje normalnih vrednosti, je treba ravni jetrnih encimov čim prej ponovno kontrolirati.
2 Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic treatments.
2 O motnjah vida so poročali predvsem zgodaj v poteku zdravljenja, povezane pa so s spremembami vrednosti glukoze v krvi zaradi začasnih sprememb turgidnosti in refrakcijskega indeksa leče, kot jih opažamo tudi pri pri drugih hipoglikemičnih učinkovinah.
The Prescriber Guide highlights the following:
Priročnik za predpisovanje zdravila mora izpostavljati:
Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
Bolniki, ki so prejemali pioglitazon, so imeli povprečno znižan HbA1c za 0,45% v primerjavi s tistimi, ki so nadaljevali zdravljenje samo z insulinom, in znižan odmerek insulina v skupini zdravljeni s pioglitazonom.
Before you start taking Pioglitazone Accord you will have a blood sample taken to check your liver function.
Pred začetkom jemanja zdravila Pioglitazone Accord vam bodo odvzeli vzorec krvi, da se preveri delovanje jeter.
The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
Izračunana incidenca zlomov je bila 1,9 zlomov na 100 bolniških let pri ženskah, zdravljenih s pioglitazonom in 1,1 zlomov na 100 bolnikov-let pri ženskah, zdravljenih s primerjalnim zdravilom.
This leaflet was last revised in <{MM/YYYY}>
Navodilo je bilo nazadnje revidirano
• The risk of bladder cancer and relevant risk minimisation advice.
• tveganje za nastanek raka mehurja ter ustrezne nasvete za zmanjševanje tveganja
Tablet 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets 112 tablets 196 tablets
tableta 14 tablet 28 tablet 30 tablet 50 tablet 56 tablet 84 tablet 90 tablet 98 tablet 112 tablet 196 tablet
Since insulin and pioglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema.
Ker sta oba, insulin in pioglitazon povezana z zastajanjem tekočine, lahko sočasno jemanje poveča tveganje za edeme.
What you need to know before you take Pioglitazone Accord
Kaj morate vedeti, preden boste vzeli zdravilo Pioglitazone Accord
If you are following a special diet for diabetes, you should continue with this while you are taking Pioglitazone Accord.
Če ste na posebni dieti za sladkorno bolezen, morate z dieto med jemanjem zdravila Pioglitazone Accord nadaljevati.
Postmarketing, bone fractures have been reported in both male and female patients (see section 4.4).
V poročilih po pridobitvi dovoljenja za promet so poročali o zlomih kosti tako pri moških kot ženskah (glejte poglavje 4.4).
It is an anti-diabetic medicine used to treat type 2 (noninsulin dependent) diabetes mellitus in adults, when metformin is not suitable or has failed to work adequately.
Je antidiabetično zdravilo za zdravljenje sladkorne bolezni tipa 2 (od insulina neodvisne sladkorne bolezni) pri odraslih, če zdravljenje z metforminom ni primerno ali ne deluje dovolj dobro.
Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.
V vsaki skupini organskih sistemov so razvrščeni najprej po padajoči pogostnosti in nato po padajoči resnosti.
Pharmacovigilance system
Farmakoviligančni sistem
common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness
pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - glavobol - omotica - bolečine v sklepih - impotenca - bolečine v hrbtu - težko dihanje - majhno znižanje števila rdečih krvnih celic - vetrovi občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - sladkor v urinu, beljakovine v urinu - povišanje vrednosti encimov - občutek vrtenja (vrtoglavica) - znojenje - utrujenost - povečan apetit
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).
• if you have cysts on your ovaries (polycystic ovary syndrome).
• če imate ciste na jajčnikih (sindrom policističnih jajčnikov).
• The risk of heart failure and relevant risk minimisation advice.
• tveganje za nastanek srčnega popuščanja ter ustrezne nasvete za zmanjševanje tveganja
The other side effects that have been experienced by some patients taking Pioglitazone Accord are:
Drugi neželeni učinki, ki so se pojavili pri nekaterih bolnikih, ki so jemali zdravilo Pioglitazone Accord, so:
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.
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.
Študijo s pioglitazonom, kjer so spremljali kardiovaskularni izid, so opravili pri bolnikih, mlajših od 75 let s sladkorno boleznijo tipa 2 in že obstoječimi težjimi makrovaskularnimi boleznimi.
The European Medicines Agency has waived the obligation to submit the results of studies with Pioglitazone in all subsets of the paediatric population in Type 2 Diabetes Mellitus.
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Pioglitazone pri pri vseh podskupinah pediatrične populacije s sladkorno boleznijo tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• Patient selection criteria including that Pioglitazone should not be used as first line therapy and emphasising the need for regular review of treatment benefit.
• kriterije izbora bolnikov, vključno z navodilom, da pioglitazona ne smemo uporabljati kot zdravilo prve izbire.
There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
V okviru izkušenj v obdonju trženja so poročali o redkih primerih hepatocelularne disfunkcije (glejte poglavje 4.8).
- hypersensitivity to the active substance or to any of the excipients listed in 6.1 - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
- s preobčutljivostjo na zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1 - s srčnim popuščanjem ali srčnim popuščanjem v anamnezi (NYHA razredi od I do IV) - z okvarjenim delovanjem jeter - z diabetično ketoacidozo - z rakom mehurja ali rakom mehurja v anamnezi - z neraziskano makroskopsko hematurijo
Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Combination with with sulpho with with insulin therapy metformin nylurea metformin and sulphonylurea
Kombinacija z metfor-min om s sulfonil-seč nino z metfor-min om in sulfonil-seč nino z insulinom
Do not take Pioglitazone Accord: • if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in Section
• če ste alergični na pioglitazon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Musculoskeletal and connective tissue disorders fracture bone4
Bolezni mišično-skel etnega sistema in vezivnega tkiva zlomi kosti4
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
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to< 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Neželeni učinki, o katerih so poročali večkrat (> 0,5%) kot pri placebu in več kot enkrat pri bolnikih, ki so prejemali pioglitazon v dvojno slepih študijah, so našteti spodaj, in sicer po skupinah organskih sistemov in absolutni pogostnosti, kot je priporočeno po MedDRA. Pogostnosti so določene kot: zelo pogosti (≥1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
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).
Warnings and precautions Talk to your doctor or pharmacist before taking Pioglitazone Accord (also see Section 4)
Pred začetkom jemanja zdravila Pioglitazone Accord se posvetujte z zdravnikom ali farmacevtom (glejte tudi poglavje 4):
Conditions or restrictions with regard to the safe and effective use of the medicinal product
Pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila
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 mg ali 30 mg tableta pioglitazona enkrat na dan.
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.
Carmellose calcium Hydroxypropyl cellulose Lactose monohydrate Magnesium stearate
6.1 Seznam pomožnih snovi kalcijev karmelozat hidroksipropilceluloza laktoza monohidrat magnezijev stearat
Blood and lymphatic system disorders anaemia common
Bolezni krvi in limfatič-neg a sistema anemija pogosti
Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Pioglitazone Accord and have also been reported in male patients (frequency cannot be estimated from the available data) taking Pioglitazone Accord.
Pri bolnicah, ki so jemale zdravilo Pioglitazone Accord, so pogosto (pri največ 1 od 10 bolnikov) poročali o zlomih kosti, o zlomih kosti pa so poročali tudi pri moških bolnikih (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti), ki so jemali zdravilo Pioglitazone Accord.
Metabolism and nutrition disorders hypo-glycaemia uncommon very common common appetite increased uncommon
Presnovne in prehranske motnje hipo-glikemi ja občasni zelo pogosti pogosti povečan apetit občasni
There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Accord.
Obstaja povečana možnost zanositve, saj se vam pri jemanju zdravila Pioglitazone Accord ovulacija lahko povrne.
The other side effects that have been experienced by some patients when Pioglitazone Accord is taken with other antidiabetic medicines:
Drugi neželeni učinki, ki so se pojavili pri nekaterih bolnikih, ki so jemali zdravilo Pioglitazone Accord skupaj z drugimi antidiabetičnimi zdravili, so:
Pioglitazone Accord contains pioglitazone.
Zdravilo Pioglitazone Accord vsebuje pioglitazon.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Accord and insulin experienced the development of heart failure.
Pri nekaterih bolnikih z dolgotrajno sladkorno boleznijo tipa 2 in srčno boleznijo ali predhodno kapjo se je pri zdravljenju z zdravilom Pioglitazone Accord in insulinom pojavilo srčno popuščanje.
Pioglitazone Accord is available in Aluminium/Aluminium blister packs containing 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.
Pioglitazon Accord je na voljo v pretisnih omotih (Alu/Alu) po 14, 28, 30, 50, 56, 84, 90, 98, 112 ali 196 tablet.
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 kakršnimi koli drugimi znaki jetrne bolezni zdravljenja s pioglitazonom ne smemo začeti.
MARKETING AUTHORISATION NUMBER (S)
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
How to store Pioglitazone Accord Contents of the pack and other information
Shranjevanje zdravila Pioglitazone Accord Vsebina pakiranja in dodatne informacije
Pioglitazone Accord 15 mg tablets: 3 years Pioglitazone Accord 30 mg/ 45 mg tablets: 4 years
Pioglitazone Accord 15 mg tablete: 3 leta Pioglitazone Accord 30 mg/ 45 mg tablete: 4 leta
Reproductive system and breast disorders erectile dysfunction common
Motnje reproduk-ci je in dojk erektilna disfunkcija pogosti
Each tablet contains 111.70 mg of lactose monohydrate (see section 4.4).
Ena tableta vsebuje 111,70 mg laktoze monohidrata (glejte poglavje 4.4).
Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Accord.
Zdravnik vas bo v času zdravljenja z zdravilom Pioglitazone Accord naročal na redne preiskave krvi.
Each tablet contains 37.24 mg of lactose monohydrate (see section 4.4).
Ena tableta vsebuje 37,24 mg laktoze monohidrata (glejte poglavje 4.4).
Each tablet contains 74.46 mg of lactose monohydrate (see section 4.4).
Ena tableta vsebuje 74,46 mg laktoze monohidrata (glejte poglavje 4.4).
How to take Pioglitazone Accord
Kako jemati zdravilo Pioglitazone Accord
465), magnesium stearate (E 572).
- Pomožne snovi so laktoza monohidrat, kalcijev karmelozat, hidroksipropilceluloza (E 465) in magnezijev stearat (E 572).
Marketing Authorisation Holder: Accord Healthcare S.L.U.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom Accord Healthcare S.L.U.
Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience.
V okviru izkušenj v obdonju trženja so se pojavljali redki primeri povišanih vrednosti jetrnih encimov in hepatocelularne disfunkcije.
A higher number of bone fractures was seen in patients, particularly women taking pioglitazone.
Pri bolnikih, ki so se zdravili s pioglitazonom, še posebej ženskah, so poročali o večjem zlomov kosti.
common common common common common blood creatine phosphokinase increased common increased lactic dehydrogenase uncommon alanine aminotransferase increased 7
pogosti pogosti pogosti pogosti pogosti povišana vrednost keratin fosfokinaze v krvi pogosti povišana vrednost laktatne dehidro-gen aze občasni zvišana vrednost alaninaminotransfe raze7
Your blood sugar will be checked, and your dose of Pioglitazone Accord may need to be changed.
Odmerek zdravila Pioglitazone Accord bo morda treba spremeniti.
Adverse reaction Frequency of adverse reactions of pioglitazone by treatment regimen
Pogostnost neželenih učinkov pioglitazona glede na režim zdravljenja Mono-terap ija
Pioglitazone Accord contains lactose monohydrate If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Pioglitazone Accord.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo zdravila Pioglitazone Accord posvetujte z zdravnikom.
- you are breast-feeding or if you are planning to breast-feed your baby.
- če dojite ali nameravate dojiti
as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is in appropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin
kot dvojno peroralno zdravljenje v kombinaciji: - z metforminom pri odraslih bolnikih (predvsem bolnikih s prekomerno telesno maso) z nezadostnim nadzorom glikemije kljub najvišjemu toleriranemu odmerku metformina v monoterapiji - s sulfonilsečnino, le pri odraslih bolnikih, ki ne prenašajo metformina ali je metformin pri njih kontraindiciran, z nezadostnim nadzorom glikemije kljub najvišjemu toleriranemu odmerku sulfonilsečnine v monoterapiji.
Pioglitazone Accord may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulfonylurea or insulin) which have failed to provide sufficient control of blood sugar.
Zdravilo Pioglitazone Accord se lahko uporablja kot samostojno zdravilo pri bolnikih, ki ne morejo jemati metformina, in ko zdravljenje z dieto in s telesno vadbo ni uspešno pri nadzoru krvnega sladkorja.
Respiratory, thoracic and mediastinal disorders dyspnoea common
Bolezni dihal, prsnega koša in media-stinal nega prostora dispneja pogosti
Pioglitazone Accord should be used every day to work properly.
Če ste prenehali jemati zdravilo Pioglitazone Accord Za pravilno delovanje morate zdravilo Pioglitazone Accord jemati vsak dan.
An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.
V skupni analizi neželenih učinkov zlomov kosti iz randomiziranih, nadzorovanih, dvojno slepih kliničnih preskušanj pri več kot 8.100 s pioglitazonom in 7.400 s primerjalnim zdravilom zdravljenimi bolniki, ki so se zdravili do 3,5 let, so opazili povečano incidenco zlomov kosti pri ženskah.
Other medicines and Pioglitazone Accord
Shranjevanje zdravila Pioglitazone Accord
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Poleg tega je treba posodobljen RMP predložiti: po prejemu novih informacij, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja, v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja),
Allergic reactions have been reported (frequency cannot be estimated from the available data) in patients taking Pioglitazone Accord.
Pri bolnikih, ki so jemali zdravilo Pioglitazone Accord, so poročali o alergijskih reakcijah (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
If you get any side effects, talk to your doctor, pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
Pioglitazone Accord tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Pioglitazone Accord.
Pri bolnikih, ki so jemali zdravilo Pioglitazone Accord, so občasno (pri največ 1 od 100 bolnikov) poročali o pojavu raka sečnega mehurja.
EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister)
EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 Tableta alu/alu Pretisni omot) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 Tableta alu/alu Pretisni omot) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 Tableta alu/alu Pretisni omot)
• Pioglitazone Accord 45 mg tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘45' on the other side.
- Pioglitazone Accord 45 mg tablete so bele ali skoraj bele barve, ploščate, okrogle, neobložene tablete s poševnim robom, z oznako ‘PIO' na eni in ‘45' na drugi strani.
Take Pioglitazone Accord daily as prescribed.
Če ste pozabili vzeti zdravilo Pioglitazone Accord Zdravilo Pioglitazone Accord jemljite vsak dan, kakor vam je predpisano.
Blurred vision due to swelling (or fluid) at the back of the eye (frequency cannot be estimated from the available data) has also been reported in patients taking Pioglitazone Accord.
Pri bolnikih, ki so jemali zdravilo Pioglitazone Accord, so poročali tudi o zamegljenem vidu zaradi otekanja (ali tekočine) očesnega ozadja (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Pioglitazone Accord 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Pioglitazone Accord 15 mg tablete Ena tableta vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida).