natgillin/translations-raw huggingface dataset:
Thiazolidinediones act primarily by reducing insulin resistance and biguanides act primarily by decreasing endogenous hepatic glucose production..
Tiazolidindioni primarno zmanjšujejo insulinsko rezistenco, bigvanidi pa zmanjšujejo endogeno produkcijo glukoze v jetrih.
In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/ creatinine ratio compared to baseline.
9 V enoletnih kliničnih preskušanjih je pioglitazon vedno statistično značilno znižal razmerje albumin/ kreatinin v primerjavi z izhodiščnimi vrednostmi.
Pioglitazone did not cause statistically significant increases in LDL- cholesterol levels compared with placebo, whilst reductions where 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.
In a 20-week study, as well as reducing fasting triglycerides, pioglitazone reduced postprandial hypertriglyceridaemia through an effect on both absorbed and hepatically synthesised
V 20- tedenski študiji je pioglitazon znižal raven trigliceridov na tešče, pa tudi hipertrigliceridemijo po obroku prek učinkovanja na absorbirane in v jetrih sintetizirane trigliceride.
These effects were independent of pioglitazone’ s effects on glycaemia and were statistically significantly different to glibenclamide.
Ti učinki niso bili odvisni od pioglitazonovih učinkov na glikemijo in so se statistično značilno razlikovali od glibenklamida.
In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and pre- existing 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.
To be eligibile patients had to have had one or more of the following: myocardial infarction, stroke, percutaneous cardiac intervention or coronary artery bypass graft, acute coronary syndrome, coronary artery disease, or peripheral arterial obstructive disease.
Da bi bolniki ustrezali kriterijem, so morali imeti v anamnezi eno ali več od sledečega: miokardni infarkt, kap, perkutano srčno intervencijo ali koronarni arterijski transplantatni obvod, akutni koronarni sindrom, koronarno arterijsko bolezen ali periferno arterijsko obstrukcijsko bolezen.
Almost all subjects (95%) were receiving cardiovascular medications (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Skoraj vse osebe (95%) so prejemale kardiovaskularna zdravila (beta blokatorje, ACE inhibitorje, antagoniste angiotenzina II, zaviralce kalcijevih kanalčkov, nitrate, diuretike, aspirin, statine, fibrate),
- in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and
- v mišicah zmerno poveča občutljivost za insulin, izboljša periferni vnos in izkoriščanje
utilisation
glukoze;
In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Slednje je bilo dokazano v kontroliranih, srednje dolgih ali dolgotrajnejših kliničnih raziskavah z
This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDLc and triglyceride levels.
10 uporabo terapevtskih odmerkov: metformin znižuje skupni holesterol, LDL- holesterol in raven trigliceridov.
- a significant reduction of the absolute risk of any diabetes-related complication in the metformin
- značilno zmanjšanje absolutnega tveganja za katerikoli s sladkorno boleznijo povezan zaplet v
group (29.8 events/ 1,000 patient-years) versus diet alone (43.3 events/ 1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/ 1,000 patient-years), p=0.0034
skupini bolnikov, ki so se zdravili z metforminom (29, 8 primerov/ 1. 000 bolnikov letno), v primerjavi s skupino bolnikov, ki je imela predpisano zgolj dieto (43, 3 primerov/ 1000 bolnikov letno), p = 0, 0023 ter v primerjavi s skupino, ki se je kombinirano zdravila s sulfonilsečnino, in skupino, ki je imela monoterapijo z insulinom (40, 1 primerov/ 1000 bolnikov letno), p = 0, 0034;
- a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5
- značilno zmanjšanje absolutnega tveganja za umrljivost, povezano s sladkorno boleznijo:
events/ 1,000 patient-years, diet alone 12.7 events/ 1,000 patient-years, p=0.017
metformin – 7, 5 primerov/ 1000 bolnikov letno, samo dieta – 12, 7 primerov/ 1000 bolnikov letno, p = 0, 017;
- a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/ 1,000
- značilno zmanjšanje absolutnega tveganja za skupno umrljivost: metformin – 13, 5
patient-years versus diet alone 20.6 events/ 1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/ 1,000 patient-years (p=0.021)
primerov/ 1000 bolnikov letno, samo dieta – 20, 6 primerov/ 1000 bolnikov letno (p = 0, 011), v primerjavi s skupinama s kombiniranim zdravljenjem s sulfonilsečnino in monoterapijo z insulinom – 18, 9 primerov/ 1. 00 bolnikov letno (p = 0, 021);
- a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/ 1,000
- značilno zmanjšanje absolutnega tveganja za miokardni infarkt: metformin – 11 primerov/ 1000
patient-years, diet alone 18 events/ 1,000 patient-years, (p=0.01).
bolnikov letno, dieta sama – 18 primerov/ 1. 000 bolnikov letno (p = 0, 01).
11 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
Bioequivalence studies in healthy volunteers have shown Competact to be bioequivalent to the administration of pioglitazone and metformin given as separate tablets.
Biokvivalenčne študije pri zdravih prostovoljcih so pokazale, da je Competact bioekvivalenten sočasnemu jemanju pioglitazona in metformina kot dveh posameznih tablet.
Food had no effect on the AUC and Cmax of pioglitazone when Competact was administered to healthy volunteers.
Pri zdravih prostovoljcih, ki so dobivali Competact hrana ni vplivala na AUC in Cmax pioglitazona.
Tmax was delayed by food by approximately 1.9h for pioglitazone and 0.8 h for metfomin.
Tmax je bil zakasnjen za približno 1, 9 ure pri pioglitazonu in za 0, 8 ure pri metforminu.
When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III contribute equally to efficacy.
Če upoštevamo aktivnost, koncentracije in vezavo na beljakovine, je delež učinkovitosti pioglitazona in presnovka M - III enak.
In vitro studies have shown no evidence that pioglitazone inhibits any subtype of cytochrome P450.
11 Študije in vitro niso dale dokazov, da pioglitazon inhibira katerikoli podtip citokroma P450.
Following oral administration of radiolabeled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Po peroralnem dajanju radioaktivno označenega pioglitazona človeku so označevalec zaznali predvsem v blatu (55%) in manjšo količino v urinu (45%).
12 Elderly:
Starejši:
After an oral dose of metformin, tmax is reached in 2.5 h.
Po peroralnem odmerku metformina je tmax dosežen v 2, 5 urah.
At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ ml.
Pri običajnih odmerkih in shemah odmerjanja metformina je plazemska koncentracija v stanju dinamičnega ravnovesja dosežena v 24 do 48 urah, na splošno pa je manjša od 1 µg/ ml.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ ml, even at maximum doses.
V kontroliranih kliničnih preskušanjih, celo pri največjih dovoljenih odmerkih, maksimalna koncentracija metformina v plazmi (Cmax) ni presegla 4 µg/ ml.
Elimination:
12 Izločanje:
Renal clearance of metformin is > 400ml/ min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Ledvični očistek metformina je > 400 ml/ min, kar kaže na izločanje metformina z glomerularno filtracijo in tubulno sekrecijo.
Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Predklinični podatki o metforminu, ki se naslanjajo na običajne farmakološke raziskave o varnosti, toksičnosti pri večkratnih odmerkih, kancerogenem delovanju in vplivih na sposobnost razmnoževanja, ne kažejo na posebno tveganje za ljudi.
Microcrystalline cellulose Povidone (K30) Croscarmellose sodium Magnesium stearate
Jedro tablete: mikrokristalna celuloza povidon (K30) natrijev karmelozat, premrežen magnezijev stearat
Hypromellose Macrogol 8000 Talc Titanium dioxide.
Filmska obloga: hipromeloza makrogol 8000 smukec titanov dioksid
14 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Aluminium/ aluminium blisters, packs of 14, 28, 30, 50, 56, 60, 90, 98 and 180 tablets.
Aluminij/ aluminij pretisni omoti, pakiranja po 14, 28, 30, 50, 56, 60, 90, 98 in 180 tablet.
28 July 2006
28. julij 2006
15 ANNEX II
14 DODATEK II
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalcev, odgovornih za sproščane serije
Takeda Italia Farmaceutici S. p. A Via Crosa, 86 28065 Cerano (NO) Italy
Takeda Italia Farmaceutici S. p. A Via Crosa, 86 28065 Cerano (NO) Italija
Takeda Ireland Limited Bray Business Park Kilruddery County Wicklow Ireland
Takeda Ireland Limited Bray Business Park Kilruddery County Wicklow Irska
Avda. de la Industria 30 28108 Alcobendas Madrid Spain
Avda. de la Industria 30 28108 Alcobendas Madrid Španija
The MAH must ensure that the system of pharmacovigilance, as described in the July 2007 version, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici iz julija 2007, vzpostavljen in da deluje pred prihodom zdravila na trg in dokler je zdravilo na tržišču.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP), and any subsequent updates of the RMP agreed by the CHMP.
Načrt ukrepanja v primeru tveganja Imetnik dovoljenja za promet se zavezuje k izvedbi študij in dodatnih farmakovigilančnih aktivnosti, ki so opisane v Načrtu za farmakovigilanco, kot je bilo dogovorjeno v različici 3. 0 Načrta ukrepanja v primeru tveganja, predstavljenega v Modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet, in v vseh naknadnih posodobljenih Načrtih ukrepanja v primeru tveganja, sprejetih s strani Odbora za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernico CHMP glede Sistemov za ukrepanje v primeru tveganja za zdravila za uporabo v humani medicini mora biti posodobljen Načrt ukrepanja v primeru tveganja predan hkrati z naslednjim Periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.
Dodatno mora biti predan posodobljen Načrt ukrepanja v primeru tveganja • Ko je znana nova informacija, ki lahko vpliva na sedanjo Specifikacijo varnosti, Načrt za farmakovigilanco ali na aktivnosti za zmanjšanje tveganja • v 60 dneh po dosegu pomembnega mejnika (pri farmakovigilanci ali za zmanjšanje tveganja) • na zahtevo Evropske agencije za zdravila (EMEA)
LABELLING
18 PODATKI NA ZUNANJI OVOJNINI
Competact 15 mg/ 850 mg film-coated tablets
Competact 15 mg/ 850 mg filmsko obložene tablete
Pioglitazone (as hydrochloride) metformin hydrochloride
pioglitazon (v obliki pioglitazonijevega klorida) metforminijev klorid
STATEMENT OF ACTIVE SUBSTANCE(S)
NAVEDBAENE ALI VEČ ZDRAVILNIH UČINKOVIN
14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 60 tablets 90 tablets 98 tablets 180 tablets
14 tablet 28 tablet 30 tablet 50 tablet 56 tablet 60 tablet 90 tablet 98 tablet 180 tablet
Expiry date:
Exp:
{month/ year}
{mesec/ leto}
EU/ 1/ 06/ 354/ 001 14 tablets EU/ 1/ 06/ 354/ 002 28 tablets EU/ 1/ 06/ 354/ 003 30 tablets EU/ 1/ 06/ 354/ 004 50 tablets EU/ 1/ 06/ 354/ 005 56 tablets EU/ 1/ 06/ 354/ 006 60 tablets EU/ 1/ 06/ 354/ 007 90 tablets EU/ 1/ 06/ 354/ 008 98 tablets EU/ 1/ 06/ 354/ 009 180 tablets
EU/ 1/ 06/ 354/ 001 14 tablet EU/ 1/ 06/ 354/ 002 28 tablet EU/ 1/ 06/ 354/ 003 30 tablet EU/ 1/ 06/ 354/ 004 50 tablet EU/ 1/ 06/ 354/ 005 56 tablet EU/ 1/ 06/ 354/ 006 60 tablet EU/ 1/ 06/ 354/ 007 90 tablet EU/ 1/ 06/ 354/ 008 98 tablet EU/ 1/ 06/ 354/ 009 180 tablet
Competact 15 mg/ 850 mg tablets.
Competact 15 mg/ 850 mg tablete
21 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
20 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Competact 15 mg/ 850 mg tablets
Competact 15 mg/ 850 mg tablete
Pioglitazone (as HCl) metformin hydrochloride
pioglitazon (v obliki pioglitazonijevega klorida) metforminijev klorid
MON 1 MON 2 TUE 1 TUE 2 WED 1 WED 2 THU 1 THU 2 FRI 1 FRI 2 SAT 1 SAT 2 SUN 1 SUN 2
PON 1 PON 2 TOR 1 TOR 2 SRE 1 SRE 2 ČET 1 ČET 2 PET 1 PET 2 SOB 1 SOB 2 NED 1 NED 2
PACKAGE LEAFLET
22 NAVODILO ZA UPORABO
INFORMATION FOR THE USER COMPETACT 15 mg/ 850 mg FILM-COATED TABLETS
COMPETACT 15 mg/ 850 mg FILMSKO OBLOŽENE TABLETE
Pioglitazone / Metformin hydrochloride
pioglitazon / metforminijev klorid
Read all of this leaflet carefully before you start taking this medicine.
Pred začetkom jemanja zdravila natančno preberite navodilo.
It may harm them, even
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi lahko celo
What Competact is and what it is used for 2.
Kaj je zdravilo Competact in za kaj ga uporabljamo 2.
Before you take Competact 3.
Kaj morate vedeti, preden boste vzeli zdravilo Competact 3.
How to take Competact 4.
Kako jemati zdravilo Competact 4.
Possible side effects 5 How to store Competact 6.
Možni neželeni učinki 5 Shranjevanje zdravila Competact 6.
WHAT COMPETACT IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO COMPETACT IN ZA KAJ GA UPORABLJAMO
Competact tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus.
Competact tablete so antidiabetično zdravilo za zdravljenje sladkorne bolezni tipa 2 (od insulina neodvisne sladkorne bolezni).
Competact tablets help control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Competact tablete pomagajo nadzorovati raven sladkorja v krvi, če imate sladkorno bolezen tipa 2, in sicer tako, da telesu pomagajo bolje izkoristiti insulin, ki ga izdela.
BEFORE YOU TAKE COMPETACT
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO COMPETACT
Do not take Competact:
Ne jemljite zdravila Competact:
- If you are allergic (hypersensitive) to pioglitazone, metformin or any of the other ingredients of
- če ste alergični (preobčutljivi za) na pioglitazon, metformin ali katerokoli sestavino tablet
Competact tablets.
Competact;
- If you have heart failure.
- če imate srčno popuščanje;
- If you recently had a heart attack, have severe circulatory problems including shock, or
- če ste pred nedavnim doživeli srčni napad, imate hujše probleme s krvnim obtokom, če ste
breathing difficulties.
doživeli šok ali imate težave z dihanjem;
- If you have liver disease.
- če imate obolenje jeter;
- If you drink alcohol excessively (either every day or only from time to time).
- če prekomerno uživate alkohol (bodisi dnevno ali občasno);
- If you have diabetic ketoacidosis (complication of diabetes with rapid weight loss, nausea or
- če imate diabetično ketoacidozo (komplikacijo sladkorne bolezni s hitrim hujšanjem, občutkom
vomiting).
slabosti ali bruhanjem;
- If you have a problem with your kidneys.
- če imate težave z ledvicami;
- If you have a severe infection or are dehydrated.
- če imate hujšo okužbo ali ste dehidrirani;
- If you are going to have a certain type of X-ray with an injectable dye.
- če boste imeli rentgenske preiskave, pri katerih vam bodo vbrizgali barvilo.
You will need to stop
V času preiskav in
taking Competact tablets at the time of and for a few days after the procedure.
nekaj dni po le- teh prenehajte z jemanjem tablet Competact;
- If you are breast-feeding.
- če dojite.
Take special care with Competact:
Bodite posebno pozorni pri jemanju zdravila Competact:
Tell your doctor before you start to take this medicine:
Preden začnete jemati zdravilo, se posvetujte z zdravnikom:
- If you have a special type of diabetic eye disease called macular oedema (swelling of the back
- če imate posebno obliko diabetične očesne bolezni, imenovano makulani edem (otekanje
of the eye).
zadnjega dela očesa);
- If you are planning to become pregnant.
- če načrtujete nosečnost;
- If you are going to have an operation under general anaesthetic, as you may need to stop taking
- če boste imeli operativni poseg v splošni anesteziji (morda boste morali prenehati z jemanjem
Competact for a couple of days before and after the procedure.
Competacta nekaj dni pred posegom in po njem);
- If you have polycystic ovary syndrome.
- če imate sindrom policističnih jajčnikov.
There may be an increased possibility of your
Glede na način delovanja vašega zdravila obstaja večja
becoming pregnant because of how your medicine works.
možnost zanositve;
- If you are under 18 years of age because use in such patients is not recommended.
- če ste mlajši od 18 let, saj pri takšnih bolnikih uporaba zdravila ni priporočljiva;
- If you already take any other tablets to treat diabetes.
- če že jemljete katera koli zdravila za zdravljenje sladkorne bolezni.
Please let your doctor know if you already take cimetidine, glucocorticoids, beta-2-agonists, diuretics or ACE inhibitors.
Obvestite svojega zdravnika ali farmacevta, če že jemljete, cimetidin, glukokortikoide, beta- 2 agoniste, diuretike ali ACE inhibitorje.
Pregnancy and breast-feeding Tell your doctor if you are, you think you might be or are planning to become pregnant.
Nosečnost in dojenje Svojemu zdravniku povejte, če ste, ali če mislite, da bi lahko bili noseči, ali če nameravate zanositi.
Your doctor will advise you to discontinue this medicine.
Vaš zdravnik vam lahko svetuje, da prekinite z jemanjem zdravila.
You should not use Competact if you are breast-feeding or are planning to breast-feed your baby.
Zdravila Competact ne smete jemati, če dojite ali nameravate dojiti svojega otroka.
Driving and using machines:
Vpliv na sposobnostupravljanja vozil in strojev:
This medicine will not affect your ability to drive or operate machinery.
To zdravilo ne bo vplivalo na vašo sposobnost vožnje ali upravljanja s stroji.
HOW TO TAKE COMPETACT
KAKO JEMATI ZDRAVILO COMPETACT
Always take Competact tablets exactly as your doctor has told you.
Pri jemanju zdravila Competact natančno upoštevajte zdravnikova navodila.
The usual dose is one tablet taken twice daily.
Običajni odmerek je ena tableta dvakrat na dan.
If necessary your doctor may tell you to take a different dose.
Po potrebi lahko zdravnik vaš odmerek spremeni.
You should take the tablets with or just after food to reduce the chance of an upset stomach.
Priporočljivo je, da tablete zaužijete med obrokom ali takoj po njem, saj se tako zmanjša možnost želodčnih težav.
If you are following a diabetic diet, you should continue with this while you are taking Competact tablets.
Če ste na diabetični dieti, jo med jemanjem tablet Competact nadaljujte.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Pri nekaterih bolnikih z dolgo trajajočo sladkorno boleznijo tipa 2 in s srčno boleznijo ali predhodno kapjo, ki so bili zdravljeni z pioglitazonom in insulinom, so poročali o razvoju srčnega popuščanja.
In clinical trials in which pioglitazone was compared to other oral anti diabetic drugs or placebo (dummy pill), a higher number of bone fractures was seen in women (but not in men) taking pioglitazone.
V kliničnih preskušanjih, v katerih so primerjali pioglitazon z drugimi peroralnimi antidiabetičnimi zdravili ali placebom (slepa tableta), so opazili večje število zlomov kosti pri ženskah (vendar ne pri moških), ki so jemale pioglitazon.
Your doctor will ask you to have blood tests periodically during treatment with Competact.
Zdravnik vas bo v času zdravljenja s Competactom naročil na redne preiskave krvi.
At least once a year (more often if you are elderly or have kidney problems) your doctor will check that your kidneys are working normally.
Vsaj enkrat letno (pogosteje, če ste starejši ali imate težave z ledvicami) bo zdravnik preveril, če vaše ledvice pravilno delujejo.
If you take more Competact tablets than you should:
Če ste vzeli večji odmerek tablet Competact, kot bi smeli:
If you forget to take Competact:
Če ste pozabili vzeti zdravilo Competact:
Try to take Competact tablets daily as prescribed.
Poskušajte jemati tablete Competact vsak dan, kakor vam je predpisano.
If you stop taking Competact:
24 Če ste prenehali jemati zdravilo Competact:
Do not stop taking Competact tablets without first discussing it with your doctor.
Ne prenehajte z jemanjem tablet Competact dokler se ne posvetujete s svojim zdravnikom.
25 If you have any further questions on the use of Competact tablets ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila Competact, se posvetujte z zdravnikom ali s farmacevtom.
Like all medicines, Competact can have side effects.
Kot vsa zdravila ima lahko tudi zdravilo Competact neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Some patients experience the following side effects whilst taking pioglitazone and/ or metformin (the two active substances of Competact).
Nekateri bolniki med jemanjem pioglitazona in/ ali metformina (dve zdravilni učinkovini zdravila Competact) izkusijo v nadaljevanju naštete neželene učinke.
Very rarely patients taking metformin have experienced a condition called lactic acidosis (excess of lactic acid in your blood), particularly those whose kidneys are not working properly.
Zelo redko so bolniki, ki jemljejo metformin izkusili stanje, ki se imenuje laktacidoza (povečana količina mlečne kisline v vaši krvi), predvsem so to bolniki, katerih ledvice ne delujejo pravilno.
Symptoms include feeling cold and uncomfortable, severe nausea and vomiting, abdominal pain, unexplained weight loss, or rapid breathing.
Simptomi vključujejo: mrazenje in neugoden občutek, močno siljenje na bruhanje in bruhanje, trebušno bolečino, nepojasnjeno hujšanje ali hitrejše dihanje.
If you experience some of these symptoms stop taking Competact and consult a doctor immediately.
Če imate katerega od teh simptomov, prenehajte z jemanjem Competacta in se nemudoma posvetujte z zdravnikom.
Blurred vision due to swelling (or fluid) at the back of the eye has been reported.
Poročali so o motnjah vida zaradi otekanja (ali tekočine) v zadnjem delu očesa.
If you experience these symptoms for the first time or if they get worse talk to your doctor as soon as possible.
Če imate te simptome prvič ali če so se ti simptomi poslabšali, se čim prej posvetujte s svojim zdravnikom.
Between 1 in 10 and 1 in 100 patients experience
Med 1 od 10 in 1 od 100 bolnikov izkusi:
- localised swelling (oedema)
- lokalizirano oteklino (edem)
- respiratory infection
- okužbo dihal
- impotence
- impotenco
- blood in urine
- kri v urinu
- anaemia
- anemijo