natgillin/translations-raw huggingface dataset:
In reproductive toxicity studies, administration of rosiglitazone to rats during mid-late gestation was associated with foetal death and retarded foetal development.
V študijah reproduktivne toksičnosti je bila uporaba rosiglitazona pri podganah med srednjo- pozno gestacijo povezana s fetalnimi smrtmi in zapoznelim razvojem plodov.
In addition, rosiglitazone inhibited ovarian oestradiol and progesterone synthesis and lowered plasma levels of these hormones resulting in effects on oestrus/ menstrual cycles and fertility (see section 4.4).
Poleg tega je rosiglitazon zavrl sintezo estradiola in progesterona v jajčnikih in znižal koncentracijo teh hormonov v plazmi, kar je vplivalo na estrus/ menstruacijske cikluse in plodnost (glejte poglavje 4. 4).
In an animal model for familial adenomatous polyposis (FAP), treatment with rosiglitazone at 200 times the pharmacologically active dose increased tumour multiplicity in the colon.
V živalskem modelu familiarne adenomatozne polipoze (FAP) je uporaba rosiglitazona v 200- kratniku farmakološko aktivnega odmerka povečala število tumorjev v kolonu.
Glimepiride Preclinical effects were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use or were caused by the pharmacodynamic effect (hypoglycaemia) of the substance.
Glimepirid Predklinično so učinke glimepirida opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo, ali jih je povzročil njegov farmakodinamični učinek (hipoglikemija).
Studies on embryofoetal development and pre-and postnatal development revealed eye malformations, skeletal anomalies, abortions, and an increased foetal death rate.
Študije embriofetalnega razvoja ter pred - in ponatalnega razvoja so pokazale malformacije oči, anomalije okostja, splave in večjo umrljivost plodov.
Reproduction toxicology findings may be related to the pharmacodynamic action of glimepiride.
Glimepirid se izloča v mleku doječih podgan.
High doses given to mother rats cause hypoglycaemia in suckling young rats (see section 4.6).
Veliki odmerki, uporabljeni pri samicah- materah povzročijo hipoglikemijo pri dojenih mladičih (glejte poglavje 4. 6).
Sodium starch glycolate Type A Hypromellose (E464) Microcrystalline cellulose (E460) Lactose monohydrate Magnesium stearate.
4/ 4 Jedro tablete: natrijev karboksimetilškrob, vrsta A hipromeloza (E464) mikrokristalna celuloza (E460) laktoza monohidrat magnezijev stearat
Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 Iron oxide black (E172) Iron oxide red (E172).
Filmska obloga: hipromeloza (E464) titanov dioksid (E171) makrogol 400 črni železov oksid (E172) rdeči železov oksid (E172).
6.3 Shelf life
16 6. 3 Rok uporabnosti
Opaque blisters (PVC/ PVDC/ aluminium).
Neprosojni pretisni omoti (PVC/ PVDC/ aluminij).
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS, Velika Britanija.
AVAGLIM 8 mg/ 4 mg film-coated tablets.
AVAGLIM 8 mg/ 4 mg filmsko obložene tablete
- contains lactose (approximately 235 mg)
- vsebuje laktozo (približno 235 mg).
Red, biconvex, rounded triangular tablet with “ gsk” debossed on one side and “ 8/ 4” on the other side
Rdeče, bikonveksne, zaokrožene trikotne tablete z vtisnjeno oznako "gsk" na eni strani in "8/ 4" na drugi.
18 cautiously following appropriate clinical evaluation to assess the patient’ s risk of developing adverse reactions relating to fluid retention (see 4.4 and 4.8).
18 povezanih z zastajanjem tekočine (glejte poglavji 4. 4 in 4. 8).
Patients with renal impairment Mild or moderate renal impairment (creatinine clearance 30 to 80 ml/ min): -Patients changing to AVAGLIM from sulphonylurea therapies other than glimepiride may be at an increased risk of hypoglycaemia (see section 4.4).
Bolniki z okvaro ledvic Blaga ali zmerna okvara ledvic (očistek kreatinina od 30 do 80 ml/ min):
19 Fluid retention and cardiac failure Thiazolidinediones can cause fluid retention which may exacerbate or precipitate signs or symptoms of congestive heart failure.
19 Tiazolidindioni lahko povzročijo zastajanje tekočine, ki lahko poslabša ali povzroči znake ali simptome kongestivnega srčnega popuščanja.
20 oedema if patients report disturbances in visual acuity and appropriate ophthalmologic referral should be considered.
V takšnih primerih morajo pridobiti ustrezno mnenje okulista.
Patients with renal impairment Patients with mild or moderate renal impairment (creatinine clearance 30 to 80 ml/ min) may be at an increased risk of hypoglycaemia (see sections 4.2, 4.3 and 4.4).
20 Bolniki z okvaro ledvic Bolnike z blago ali zmerno okvaro ledvic (očistek kreatinina od 30 do 80 ml/ min) lahko bolj ogroža hipoglikemija (glejte poglavja 4. 2, 4. 3 in 4. 4).
21 Rosiglitazone In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with CYP2C9 as only a minor pathway.
21 Študije in vitro kažejo, da se rosiglitazon presnavlja predvsem s CYP2C8, CYP2C9 pa je le manj pomembna pot.
22 Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur when one of the following drugs is taken, for example:
zmanjša učinek na znižanje glukoze v krvi,
oestrogens and progestagens, saluretics, thiazide diuretics, thyroid stimulating agents, glucocorticoids, phenothiazine derivatives, chlorpromazine, adrenaline and sympathicomimetics, nicotinic acid (high dosages) and nicotinic acid derivatives, laxatives (long term use), phenytoin, diazoxide, glucagon, barbiturates and rifampicin, acetozolamide.
22 estrogeni in progestogeni, saluretiki, tiazidni diuretiki, sredstva, ki stimulirajo ščitnico, glukokortikoidi, fenotiazinski derivati, klorpromazin, adrenalin in simpatikomimetiki, nikotinska kislina (veliki odmerki) in derivati nikotinske kisline, odvajala (dolgotrajna uporaba), fenitoin, diazoksid, glukagon, barbiturati in rifampicin, acetazolamid.
23 AVAGLIM Data from double-blind studies confirm that the safety profile of concomitant rosiglitazone and glimepiride is similar to that of the combined adverse reaction profile for the two active substances.
23 Rosiglitazon
Table 1 lists adverse reactions identified from an integrated clinical trial population of over 5,000 rosiglitazone-treated patients.
V preglednici 1 so navedeni neželeni učinki, ki so se pojavili pri vseh bolnikih, vključenih v klinična preskušanja; to je pri več kot 5. 000 bolnikih, ki so se zdravili z rosiglitazonom.
24 *The frequency category for the background incidence of this event, as taken from placebo group data from clinical trials, is'common '.
* Kategorija pogostnosti glede na osnovno pojavnost tega dogodka, kot izhaja iz podatkov kliničnih preskušanj pri skupinah s placebom, je 'pogosti'.
1 Hypercholesterolaemia was reported in up to 5.3% of patients treated with rosiglitazone (monotherapy or dual oral therapy).
24 1 O hiperholesterolemiji so poročali pri do 5, 3% bolnikov, ki so se zdravili z rosiglitazonom (monoterapija ali peroralno zdravljenje z dvema zdravilnima učinkovinama).
3 In a retrospective analysis of data from 42 pooled short-term clinical studies, the overall incidence of events typically associated with cardiac ischaemia was higher for rosiglitazone containing regimens, 1.99% versus combined active and placebo comparators, 1.51% [Hazard ratio 1.31 (95% confidence interval 1.01 - 1.70)].
3 Pri retrospektivni analizi podatkov iz 42 združenih kratkotrajnih kliničnih študij je bila celotna pojavnost dogodkov, tipično povezanih s srčno ishemijo, višja pri režimih zdravljenja z rosiglitazonom (1, 99%) kot pri primerjalni kombinaciji učinkovine in placeba (1, 51%) [razmerje tveganja 1, 31 (95% interval zaupanja; 1, 01 - 1, 70)].
25 Table 2.
25 Preglednica 2.
Rare cases of elevated liver enzymes and hepatocellular dysfunction have been reported. marketing experience.
V pomarketinškem obdobju so bili opisani redki primeri zvišanja jetrnih encimov in motenega delovanja jetrnih celic.
26 Table 3.
26 Preglednica 3.
Cross-allergenicity with sulphonylureas, sulphonamides or related substances is possible.
Možna je navzkrižna preobčutljivost s sulfonilsečninami, sulfonamidi in sorodnimi učinkovinami.
27 4.9 Overdose
27 4. 9 Preveliko odmerjanje
28 Consistent with the mechanism of action, rosiglitazone reduced insulin resistance and improved pancreatic ß-cell function.
28 prostih maščobnih kislin.
29 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
In a bioequivalence study under fasted conditions, the AUC and Cmax of rosiglitazone and the AUC of glimepiride following a single dose of a 4 mg/ 4 mg combination tablet were bioequivalent to concomitant administration of rosiglitazone 4 mg and glimepiride 4 mg.
29 V bioekvivalenčni študiji na tešče sta bila AUC in Cmax rosiglitazona in AUC glimepirida po posamičnem odmerku kombinirane tablete 4 mg/ 4 mg bioekvivalentna sočasni uporabi 4 mg rosiglitazona in 4 mg glimepirida.
Since there is no significant in vitro inhibition of CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A or 4A with rosiglitazone, there is a low probability of significant metabolism-based interactions with substances
Rosiglitazon in vitro ne zavira pomembno CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A ali 4A, tako da obstaja le majhna verjetnost za pomembne presnovno pogojene interakcije s snovmi, ki se presnavljajo s temi encimi P450.
The terminal half-life for radioactivity was about 130 h indicating that elimination of metabolites is very slow.
30 130 ur, kar kaže, da je izločanje presnovkov zelo počasno.
31 Renal insufficiency:
Insuficienca ledvic:
An increase in plasma volume accompanied by decrease in red cell parameters and increase in heart weight.
31 Rosiglitazon Neželeni učinki, ugotovljeni v študijah na živalih, ki bi lahko bili pomembni za klinično uporabo, so: povečanje količine plazme, ki jo spremlja zmanjšanje parametrov eritrocitov in povečanje mase srca.
Sodium starch glycolate Type A Hypromellose (E464) Microcrystalline cellulose (E460) Lactose monohydrate Magnesium stearate.
8/ 4 Jedro tablete: natrijev karboksimetilškrob, vrsta A hipromeloza (E464) mikrokristalna celuloza (E460) laktoza monohidrat magnezijev stearat
Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 Iron oxide red (E172).
Filmska obloga: hipromeloza (E464) titanov dioksid (E171) makrogol 400 rdeči železov oksid (E172).
6.4 Special precautions for storage
32 6. 4 Posebna navodila za shranjevanje
33 ANNEX II
33 DODATEK II
Avenida de Extremadura, 3 09400 Aranda de Duero Burgos Spain
Avenida de Extremadura, 3 09400 Aranda de Duero Burgos Španija
Not aplicable.
Navedba smiselno ni potrebna.
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Imetnik dovoljenja za promet mora pred začetkom trženja zdravila zagotoviti, da je vzpostavljen in deluje sistem farmakovigilance.
The MAH commits to perform the studies and the additional Pharmacovigliance activities detailed in the Pharmacovigilance Plan.
Imetnik dovoljenja za promet se zavezuje, da bo izvajal študije in dodatne farmakovigilančne dejavnosti, ki so opisane v Farmakovigilančnem načrtu.
35 ANNEX III
35 DODATEK III
37 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
37 PODATKI NA ZUNANJI OVOJNINI
AVAGLIM 4 mg/ 4 mg film-coated tablets. rosiglitazone/ glimepiride
AVAGLIM 4 mg/ 4 mg filmsko obložene tablete rosiglitazon/ glimepirid
film-coated tablets
filmsko obložene tablete
14 tablets 28 tablets 56 tablets 84 tablets 112 tablets
14 tablet 28 tablet 56 tablet 84 tablet 112 tablet
Oral use Use only as directed by your doctor Read the package leaflet before use
Peroralna uporaba Pri uporabi zdravila natančno upoštevajte zdravnikova navodila.
SmithKline Beecham plc 980 Great West Road Brentford, Middlesex TW8 9GS United Kingdom
SmithKline Beecham plc 980 Great West Road Brentford, Middlesex TW8 9GS Velika Britanija
EU/ 1/ 06/ 349/ 001 EU/ 1/ 06/ 349/ 002 EU/ 1/ 06/ 349/ 003 EU/ 1/ 06/ 349/ 004 EU/ 1/ 06/ 349/ 009
EU/ 1/ 06/ 349/ 001 14 tablet EU/ 1/ 06/ 349/ 002 28 tablet EU/ 1/ 06/ 349/ 003 56 tablet EU/ 1/ 06/ 349/ 004 112 tablet EU/ 1/ 06/ 349/ 009 84 tablet
39 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
39 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
40 PODATKI NA ZUNANJI OVOJNINI
AVAGLIM 8 mg/ 4 mg film-coated tablets. rosiglitazone/ glimepiride
AVAGLIM 8 mg/ 4 mg filmsko obložene tablete rosiglitazon/ glimepirid
EU/ 1/ 06/ 349/ 005 EU/ 1/ 06/ 349/ 006 EU/ 1/ 06/ 349/ 007 EU/ 1/ 06/ 349/ 008 EU/ 1/ 06/ 349/ 010
EU/ 1/ 06/ 349/ 005 14 tablet EU/ 1/ 06/ 349/ 006 28 tablet EU/ 1/ 06/ 349/ 007 56 tablet EU/ 1/ 06/ 349/ 008 112 tablet EU/ 1/ 06/ 349/ 010 84 tablet
42 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
42 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
44 PACKAGE LEAFLET:
44 NAVODILO ZA UPORABO
AVAGLIM 4 mg/ 4 mg film-coated tablets AVAGLIM 8 mg/ 4 mg film-coated tablets rosiglitazone/ glimepiride
AVAGLIM 4 mg/ 4 mg filmsko obložene tablete AVAGLIM 8 mg/ 4 mg filmsko obložene tablete rosiglitazon/ glimepirid
leaflet, tell your doctor or pharmacist.
omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
What Avaglim is and what it is used for 2.
Kaj je zdravilo Avaglim in za kaj ga uporabljamo 2.
Before you take Avaglim 3.
Kaj morate vedeti, preden boste vzeli zdravilo Avaglim 3.
How to take Avaglim 4.
Kako jemati zdravilo Avaglim 4.
Possible side effects 5 How to store Avaglim 6.
Shranjevanje zdravila Avaglim 6.
People with type 2 diabetes either don’ t make enough insulin (a hormone that controls blood sugar levels), or don’ t respond normally to the insulin their body makes.
Pri bolnikih s sladkorno boleznijo tipa 2 telo ne proizvaja dovolj insulina (hormon, ki nadzira vrednost krvnega sladkorja) ali pa se telo na insulin, ki nastane v telesu, ne odzove normalno.
BEFORE YOU TAKE AVAGLIM
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO AVAGLIM
Don’ t take Avaglim: • if you are allergic (hypersensitive) to rosiglitazone, glimepiride, or any of the other ingredients of Avaglim (listed in Section 6), or to other medicines called sulphonylureas (like glibenclamide) or sulphonamides • if you have had a heart attack or severe angina, that’ s being treated in hospital • if you have heart failure, or have had heart failure in the past • if you have liver disease • if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting) • if you have severe kidney disease • if you have type 1 diabetes – this needs different treatment.
Ne jemljite zdravila Avaglim: • če ste alergični na (preobčutljivi za) rosiglitazon, glimepirid ali katerokoli drugo sestavino zdravila Avaglim (navedene v poglavju 6), ali na zdravila imenovana sulfonilsečnine (npr. glibenklamid) ali sulfonamide • če ste doživeli srčni napad ali imate hudo angino pektoris in ste se zaradi tega zdravili v bolnišnici • če imate ali ste kdaj imeli srčno popuščanje • če imate bolezen jeter • če imate diabetično ketoacidozo (zaplet sladkorne bolezni s hitrim hujšanjem, siljenjem na bruhanje ali bruhanjem). • če imate hudo bolezen ledvic. • če imate sladkorno bolezen tipa 1 - potrebno je drugačno zdravljenje
Check with your doctor if you think any of these apply to you.
Posvetujte se s svojim zdravnikom, če menite, da se karkoli od navedenega nanaša na vas.
Don’ t take Avaglim.
Ne jemljite zdravila Avaglim.
Take special care with Avaglim
45 Bodite posebno pozorni pri jemanju zdravila Avanglim
45 If you have been diagnosed with angina (chest pain), or peripheral arterial disease (reduced blood flow to the legs):
Če so vam ugotovili angino pektoris (bolečina v prsih) ali bolezen perifernih arterij (zmanjšan pretok krvi v noge):
Check with your doctor, as Avaglim may not be suitable for you.
Posvetujte se s svojim zdravnikom, saj zdravilo Avaglim v tem primeru za vas morda ni primerno.
Haemolytic anaemia:
Hemolitična anemija:
If you have an inherited condition where your red blood cells don’ t produce enough of the enzyme G6PD, Avaglim may cause your red blood cells to be destroyed too quickly (haemolytic anaemia).
Če veste, da vaše rdeče krvne celice ne proizvajajo dovolj encima glukoze- 6- fosfat- dehidrohenaze (G6PD), če boste jemali Avaglim, bi lahko tvegali, da boste zboleli za resnim tipom anemije, ker se vaše rdeče krvničke prehitro razkrojijo (hemolitična anemija).
Tell your doctor if you have this condition, as Avaglim may not be suitable for you.
Posvetujte se s svojim zdravnikom, saj zdravilo Avanglim v tem primeru za vas morda ni primerno.
Conditions to look out for Avaglim and other medicines for diabetes can make some existing conditions worse, or cause serious side effects.
Stanja na katera morate biti pozorni Zdravilo Avanglim in druga zdravila za zdravljenje sladkorne bolezni lahko poslabšajo nekatera že obstoječa bolezenska stanja ali povzročijo hude neželene učinke.
See ‘ Conditions you need to look out for’ in Section 4.
Glejte ‘ Stanja na katere morate biti pozorni ’ v poglavju 4.
Ovulation may restart Women who are infertile due to a condition affecting their ovaries (such as Polycystic Ovarian Syndrome), may start ovulating again when they start taking Avaglim.
Ovulacija se lahko obnovi Pri ženskah, ki so zaradi bolezni jajčnikov (kot je sindrom policističnega jajčnika) neplodne, se lahko po začetku jemanja zdravila Avanglim ponovno pojavi ovulacija.
If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy (see ‘ Pregnancy and breast-feeding’ later in Section 2).
Če se to nanaša na vas, morate za preprečitev neželene nosečnosti uporabljati ustrezno obliko kontracepcije (glejte ‘ Nosečnost in dojenje ’ v nadaljevanju poglavja 2).
You will have regular blood tests Avaglim can cause reductions in some types of blood cells.
Redno je treba izvajati krvne teste Avaglim lahko povzroči zmanjšanje števila neketerih vrst krvnih celic.
Your kidney function will be checked If you have kidney disease, or are over 65, your kidney function should be checked while you are taking Avaglim.
Preverjati je treba delovanje ledvic Med jemanjem zdravila Avaglim je treba preverjati delovanje ledvic, če ste starejši od 65 let ali če imate okvarjeno delovanje ledvic.
This includes herbal medicines and other medicines you bought without a prescription.
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali boste začeli jemati katerokoli novo zdravilo, vključno z zdravili iz zelišč in drugimi zdravili, ki jih lahko dobite brez recepta.
Your blood sugar levels may become too high or too low (see ‘ Low blood sugar’ in Section 4).
Vrednosti vašega krvnega sladkorja lahko postanejo previsoke ali prenizke (glejte "Nizek krvni sladkor « v poglavju 4).
Some of the medicines most likely to do this are: • gemfibrozil (used to lower cholesterol) • rifampicin (used to treat tuberculosis and other infections) • fluconazole (used to treat fungal infections).
Zdravila, ki to lahko povzročijo so: • gemfibrozil (uporabljamo ga za zniževanje holesterola). • rifampicin (uporabljamo ga za zdravljenje tuberkuloze in drugih okužb). • flukonazol (uporabljamo ga za zdravljenje glivičnih okužb).
Tell a doctor or pharmacist if you think that Avaglim is not working as it should, particularly if you are taking any other medicines.
Obvestite svojega zdravnika ali farmacevta, če menite, da zdravilo Avaglim ne deluje, kot bi moralo, še posebej, če jemljete katerokoli druga zdravila.
Checking your blood sugar levels regularly is especially important if you are taking any of these medicines, even if you are feeling well
Redno preverjanje vrednosti vašega krvnega sladkorja je potrebno, še posebej karad jemljete katero od teh zdravil, čeprav se počutite dobro
Avaglim can also strengthen or weaken the effects of medicines to prevent blood clots (anticoagulants such as warfarin).
46 Avaglim lahko okrepi ali zmanjša učinke zdravil za preprečevanje tvorbe krvnih strdkov (antikoagulantov, kot je varfarin).
Tell your doctor or pharmacist if you are taking anticoagulants.
Povejte svojemu zdravniku ali farmacevtu, če jemljete zdravila proti strjevanju krvi.
46 Pregnancy and breast-feeding • Avaglim is not recommended during pregnancy.
Nosečnost in dojenje • Uporaba zdravila Avaglim med nosečnostjo ni priporočljiva.
• Don’ t breast-feed while you are taking Avaglim.
• Med jemanjem zdravila Avaglim ne smete dojiti.
Driving and using machines Avaglim can make you dizzy or cause your blood sugar to become lower than normal (see ‘ Low blood sugar’ in Section 4).
Vpliv na sposobnost upravljanja vozil in strojev Avaglim lahko povzroči omotico ali zniža normalno vrednost vašega krvnega sladkorja (glejte ‘ Nizka vrednost krvnega sladkorja ’ v poglavju 4).
Don’ t drive or operate machinery unless you’ re feeling well.
Ne vozite ali upravljajte strojev, če se ne počutite dobro.
Avaglim contains lactose Avaglim tablets contain a small amount of lactose.
Zdravilo Avaglim vsebuje laktozo Avaglim tablete vsebujejo majhno količino laktoze.
Patients who are intolerant to lactose or have a rare hereditary problem of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Bolniki z intoleranco za laktozo ali z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
How much to take The usual starting dose is one combined tablet (4 mg rosiglitazone and 4 mg glimepiride), taken once a day.
Kakšen odmerek zdravila vzeti Običajni začetni odmerek je ena kombinirana tableta (4 mg rosiglitazona in 4 mg glimepirida) enkrat na dan.
Take your tablets around the same time every day and follow any dietary advice that your doctor has given you.
Upoštevajte vse zdravnikove nasvete o dietni prehrani.
If you take more Avaglim than you should If you accidentally take too many tablets, contact your doctor or pharmacist for advice.
Če ste vzeli večji odmerek zdravila Avaglim, kot bi smeli Če po nesreči vzamete preveč tablet, se posvetujte s svojim zdravnikom ali farmacevtom.
If you forget to take Avaglim Don’ t take extra tablets to make up for a missed dose.
Če ste pozabili vzeti zdravilo Avaglim Ne jemljite dodatnih tablet, da bi tako nadomestili pozabljeni odmerek.
Don’ t stop taking Avaglim Take Avaglim for as long as your doctor recommends.
Ne prenehajte jemati zdravila Avaglim Zdravilo Avaglim morate jemati tako dolgo kot vam to predpiše zdravnik.
These are very rare in people taking Avaglim.
Pri bolnikih, ki se zdravijo z zdravilom Avaglim so alergijske reakcije zelo redke.
Signs include: • raised and itchy rash (hives) • swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing • collapse.
Znaki vključujejo: • privzdignjen in srbeč kožni izpuščaj (koprivnica). • oteklino, včasih obraza ali ust (angioedem), kar povzroča težave pri dihanju. • kolaps.
Contact a doctor immediately if you get any of these symptoms.
Nemudoma se posvetujte z zdravnikom, če se pojavi katerikoli od teh simptomov.
Fluid retention and heart failure:
Zastajanje tekočin in srčno popuščanje:
Avaglim can cause you to retain water (fluid retention) which leads to swelling and weight gain.
Zdravilo Avaglim lahko povzroči zastajanje vode v telesu (zastajanje tekočin), kar povzroči otekline in zvečanje telesne mase.
This is more likely if you are also taking other medicines for your diabetes like insulin, if you have kidney problems, or if you are over 65.
Redno spremljajte svojo telesno maso.
Symptoms of heart failure include: • shortness of breath, waking up short of breath at night • getting tired easily after light physical activity such as walking • rapid increase in your weight • swollen ankles or feet.
Simptomi srčnega popuščanja vključujejo: • težko dihanje, prebujanje ponoči zaradi težkega dihanja. • hitro utrujenost po lahki telesni aktivnosti, kot je hoja. • hitro povečanje telesne mase. • oteklino gležnjev ali nog.