natgillin/translations-raw huggingface dataset:
Yellow, biconvex, approximately 1.1 x 0.8 cm diagonally diamond-shaped, film-coated tablets with “10” engraved on one side and “1428” engraved on the other side. 
Rumene, bikonveksne, rombaste, filmsko obložene tablete s približnimi diagonalami 1,1 x 0,8 cm in z vtisnjeno oznako "10" na eni strani ter "1428" na drugi strani.
In subjects ≥ 65 years of age, a higher proportion of subjects treated with dapagliflozin had adverse reactions related to renal impairment or failure compared with placebo. 
Pri preiskovancih, starih ≥ 65 let, je bil delež preiskovancev, zdravljenih z dapagliflozinom, pri katerih so se pojavili z okvaro ali odpovedjo ledvic povezani neželeni učinki, večji v primerjavi s placebom.
Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with dapagliflozin (see sections 4.2 and 4.8). 
Zato bo pri uporabi v kombinaciji z dapagliflozinom morda potreben manjši odmerek insulina ali zdravila, ki spodbuja izločanje insulina, da bi zmanjšali tveganje za pojav hipoglikemije (glejte poglavji 4.2 in 4.8).
The tablets contain lactose anhydrous. 
Tablete vsebujejo brezvodno laktozo.
Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post-marketing in patients treated with SGLT2 inhibitors, including dapagliflozin. 
V kliničnih preskušanjih in v obdobju trženja so bili pri bolnikih, zdravljenih z zaviralci SGLT2 (vključno z dapagliflozinom), opisani redki primeri diabetične ketoacidoze (DKA), med njimi tudi smrtno nevarni.
Remember to take these other medicine(s) as your doctor has told you. 
Pri jemanju teh drugih zdravil upoštevajte navodila zdravnika.
Dapagliflozin as an add-on with either metformin, glimepiride, metformin and a sulphonylurea, sitagliptin (with or without metformin) or insulin resulted in statistically significant reductions in HbA1c at 24 weeks compared with subjects receiving placebo (p < 0.0001; Tables 4, 5 and 6). 
Dapagliflozin je kot dodatek bodisi k metforminu, glimepiridu, metforminu in sulfonilsečnini, sitagliptinu (z ali brez metformina) ali insulinu po 24 tednih statistično značilno zmanjšal HbA1c v primerjavi z osebami, ki so prejemale placebo (p < 0,0001; Preglednice 4, 5 in 6).
EU/1/12/795/004 30 x 1 (unit dose) film-coated tablets EU/1/12/795/005 90 x 1 (unit dose) film-coated tablets 
EU/1/12/795/004 30 x 1 (enkratni odmerek) filmsko obložena tableta EU/1/12/795/005 90 x 1 (enkratni odmerek) filmsko obložena tableta
See corresponding subsection below for additional information. 
Za dodatne informacije glejte ustrezno podpoglavje v nadaljevanju.
Urinary tract infections 
Laboratorijske preiskave urina
Musculoskeletal and connective tissue disorders 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečine v hrbtu
− film-coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b), 
filmska obloga: polivinilalkohol (E1203), titanov dioksid (E171), makrogol 3350, smukec (E553b), rumeni železov oksid (E172).
Dapagliflozin did not induce tumours in either mice or rats at any of the doses evaluated in two-year carcinogenicity studies. 
V dveletni študiji kancerogenosti dapagliflozin tako pri miših kot pri podganah ni sprožil nastanka tumorjev pri nobenem od ocenjevanih odmerkov.
At Week 48 when added to sitagliptin (with or without metformin), the adjusted mean change from baseline for dapagliflozin 10 mg and placebo was -0.30% and 0.38%, respectively. 
V 48. tednu študije dodatka k sitagliptinu (z ali brez metformina) je bila prilagojena povprečna sprememba od izhodišča -0,30 % z 10 mg dapagliflozina in 0,38 % s placebom.
Effect of other medicinal products on dapagliflozin Interaction studies conducted in healthy subjects, using mainly a single dose design, suggest that the pharmacokinetics of dapagliflozin are not altered by metformin, pioglitazone, sitagliptin, glimepiride, voglibose, hydrochlorothiazide, bumetanide, valsartan, or simvastatin. 
Izvedene študije medsebojnega delovanja pri zdravih osebah, ki so bile v glavnem izvedene po raziskovalnem načrtu z uporabo enkratnega odmerka, ne kažejo, da bi metformin, pioglitazon, sitagliptin, glimepirid, vogliboza, hidroklorotiazid, bumetanid, valsartan ali simvastatin spremenili farmakokinetiko dapagliflozina.
At Weeks 24 and 104, minor episodes of hypoglycaemia were reported, respectively, in 40.3% and 53.1% of subjects who received dapagliflozin 10 mg plus insulin and in 34.0% and 41.6% of the subjects who received placebo plus insulin. 
Do 24. oziroma 104. tedna so blage hipoglikemije zabeležili pri 40,3 % oziroma 53,1 % prejemnikov kombinacije 10 mg dapagliflozina in insulina ter pri 34,0 % oziroma 41,6 % prejemnikov kombinacije placeba in insulina.
At Week 104 for insulin (with or without additional oral glucose-lowering medicinal products), the HbA1c reductions were -0.71% and -0.06% adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively. 
104. teden je bilo z insulinom povzročeno (z dodatnim peroralnim antidiabetikom ali brez njega) znižanje HbA1c -0,71 % oziroma -0,06 % prilagojene povprečne spremembe od izhodišča z 10 mg dapagliflozina oziroma s placebom.
The removal of dapagliflozin by haemodialysis has not been studied. 
Odstranjevanje dapagliflozina s hemodializo ni bilo raziskano.
The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. 
Če se pojavijo nespecifični simptomi, npr. navzea, bruhanje, anoreksija, bolečine v trebuhu, prekomerna žeja, težko dihanje, zmedenost, neobičajna utrujenost ali zaspanost, je treba upoštevati možnost, da gre za diabetično ketoacidozo.
At steady-state (20 mg once-daily dapagliflozin for 7 days), subjects with type 2 diabetes mellitus and mild, moderate or severe renal impairment (as determined by iohexol plasma clearance) had mean systemic exposures of dapagliflozin of 32%, 60% and 87% higher, respectively, than those of subjects with type 2 diabetes mellitus and normal renal function. 
V primerjavi z osebami s sladkorno boleznijo tipa 2 in normalnim delovanjem ledvic so v stanju dinamičnega ravnovesja (20 mg dapagliflozina enkrat na dan, 7 dni) imele osebe s sladkorno boleznijo tipa 2 in z blago okvaro ledvic povprečno sistemsko izpostavljenost dapagliflozinu večjo za 32 %, tiste z zmerno okvaro 60 % in tiste s hudo okvaro 87 % (stopnja okvare je bila ugotovljena s plazemskim očistkom joheksola).
No dosage adjustment is indicated in patients with mild renal impairment. 
Prilagoditev odmerjanja pri bolnikih z blago okvaro ledvic ni potrebna.
Fasting plasma glucose 
Glukoza v plazmi na tešče
The steady-state 24-hour urinary glucose excretion was highly dependent on renal function and 85, 52, 18 and 11 g of glucose/day was excreted by subjects with type 2 diabetes mellitus and normal renal function or mild, moderate or severe renal impairment, respectively. 
Štiriindvajseturno izločanje glukoze z urinom v stanju dinamičnega ravnovesja je bilo močno odvisno od delovanja ledvic: pri osebah s sladkorno boleznijo tipa 2 z normalnim delovanjem ledvic je to bilo 85 g glukoze/dan, z blago okvaro ledvic 52 g/dan, z zmerno okvaro 18 g/dan in s hudo okvaro 11 g/dan.
Temporary interruption of treatment with dapagliflozin is recommended for patients who develop volume depletion until the depletion is corrected (see section 4.8). 
Če se pri bolniku pojavi pomanjkanje volumna, je priporočljivo začasno prekiniti zdravljenje z dapagliflozinom dokler pomanjkanje ni odpravljeno (glejte poglavje 4.8).
Dapagliflozin 10 mg as an add-on to metformin, glimepiride, metformin and a sulphonylurea, sitagliptin (with or without metformin) or insulin resulted in statistically significant body weight reduction at 24 weeks (p < 0.0001, Tables 4 and 5). 
10 mg dapagliflozina kot dodatka bodisi metforminu, glimepiridu, metforminu in sulfonilsečnini sitagliptinu (z ali brez metformina) ali insulinu, je do 24. tedna statistično značilno zmanjšalo telesno maso (p < 0,0001, preglednici 4 in 5).
Protein binding was not altered in various disease states (e.g. renal or hepatic impairment). 
Različne bolezni (npr. okvara ledvic ali jeter) niso spremenile vezave na beljakovine.
In subjects ≥ 65 years of age, a higher proportion of subjects treated with dapagliflozin had adverse reactions related to volume depletion (see section 4.8). 
Pri preiskovancih, starih ≥ 65 let, je bil delež preiskovancev, zdravljenih z dapagliflozinom, pri katerih so se pojavili neželeni učinki povezani s pomanjkanjem volumna, večji (glejte poglavje 4.8).
Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters Not all pack sizes may be marketed. 
Velikosti pakiranj s 30 x 1 in 90 x 1 filmsko obloženo tableto v perforiranih pretisnih omotih za posamezni odmerek.
At Week 208, adjusted mean change from baseline in HbA1c was -0.10% for dapagliflozin and 0.20% for glipizide. 
208. teden je bila prilagojena povprečna sprememba HbA1c od izhodišča pri dapagliflozinu -0,10 % in pri glipizidu 0,20 %.
dUrinary tract infection includes the following preferred terms, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection and prostatitis. 
Okužbe sečil obsegajo naslednje prednostne izraze, naštete v zaporedju opisanih pogostnosti: okužba sečil, cistitis, okužba sečil z Escherichio, okužba genitourinarnega trakta, pielonefritis, trigonitis, uretritis, okužba ledvic in prostatitis.
The proportion of subjects remaining in the study at Week 104 was 72.4% for the group treated with dapagliflozin 10 mg and 54.8% for the placebo group. 
Delež preiskovancev, ki so 104. teden še ostali v študiji, je bil v skupini z 10 mg dapagliflozina 72,4 % in v skupini s placebom
Dapagliflozin exposure increased proportional to the increment in dapagliflozin dose over the range of 0.1 to 500 mg and its pharmacokinetics did not change with time upon repeated daily dosing for up to 24 weeks. 
Izpostavljenost dapagliflozinu se je v razponu odmerkov od 0,1 do 500 mg povečevala sorazmerno s povečevanjem odmerka.
• urinary tract infection, seen commonly. 
• okužba sečil, ki se lahko pojavi pogosto.
The mean plasma terminal half-life (t1/2) for dapagliflozin was 12.9 hours following a single oral dose of dapagliflozin 10 mg to healthy subjects. 
Po enkratnem peroralnem odmerku 10 mg dapagliflozina pri zdravih osebah je bil povprečni plazemski končni razpolovni čas (t1/2) dapagliflozina 12,9 ure.
What Forxiga contains 
Kaj vsebuje zdravilo Forxiga
Kidney function Your kidneys should be checked before you start taking and whilst you are on this medicine. 
Pred začetkom jemanja in med zdravljenjem s tem zdravilom je treba preverjati vaše ledvice.
6.6 Special precautions for disposal No special requirements. 
6.6 Posebni varnostni ukrepi za odstranjevanje
Approximately 70 g of glucose was excreted in the urine per day (corresponding to 280 kcal/day) at a dapagliflozin dose of 10 mg/day in subjects with type 2 diabetes mellitus for 12 weeks. 
Med 12-tedensko uporabo dapagliflozina v odmerku 10 mg na dan, se je pri osebah s sladkorno boleznijo tipa 2 izločilo z urinom približno 70 g glukoze na dan (to ustreza 280 kcal/dan).
• Forxiga 10 mg film-coated tablets are yellow and diamond-shaped approximately 1.1 x 0.8 cm diagonally. 
• Tablete zdravila Forxiga 10 mg filmsko obložene tablete so rumene barve in rombaste oblike s približnimi diagonalami 1,1 x 0,8 cm. Na eni strani imajo vtisnjeno oznako "10" in na drugi strani "1428".
Constipation** Dry mouth** 
Bolezni prebavil zaprtost suha usta
It is not known if DKA is more likely to occur with higher doses of dapagliflozin. 
Ali je verjetnost za DKA med uporabo večjih odmerkov dapagliflozina večja, ni znano.
In the extension period, HbA1c reductions were sustained through Week 102 (-0.61%, and -0.17% adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively). 
V obdobju podaljšanja se je zmanjšanje HbA1c ohranilo do 102. tedna (prilagojena povprečna sprememba od izhodišča -0,61 % z 10 mg dapagliflozina in -0,17 % s placebom).
See package leaflet for further information. 
Za dodatne informacije glejte navodilo za uporabo.
Body weight (kg) Baseline (mean) Change from baseline c 
Telesna masa (kg) Izhodišče (povprečje) Sprememba od izhodišča c
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12 November, 2012 
12. november 2012
Dapagliflozin 10 mg + insulin ± oral glucose-lowering medicinal products2 
Parameter dapagliflozin 10 mg + insulin ± peroralni antidiabetiki placebo + insulin ± peroralni antidiabetiki b
A double-blind, placebo-controlled study of 24-week duration (with an additional extension period) was conducted to evaluate the safety and efficacy of monotherapy with Forxiga in subjects with inadequately controlled type 2 diabetes mellitus. 
Za oceno varnosti in učinkovitosti monoterapije z zdravilom Forxiga pri osebah z neustrezno urejeno sladkorno boleznijo tipa 2 so izvedli 24-tedensko, dvojno slepo, s placebom kontrolirano študijo (z dodatnim obdobjem podaljšanja).
This grouping of reactions was reported in 3.2% and 1.8% of patients who received dapagliflozin 10 mg and placebo, respectively. 
Ta skupina učinkov je bila opisana pri 3,2 % bolnikov, ki so prejemali 10 mg dapagliflozina, in pri 1,8 % tistih, ki so prejemali placebo.
Results at Week 24 (LOCFa) in a placebo-controlled study of dapagliflozin in combination with insulin (alone or with oral glucose-lowering medicinal products) 
Rezultati s placebom kontrolirane študije dapagliflozina v kombinaciji z insulinom (samim ali skupaj s peroralnim antidiabetikom) po 24 tednih (LOCF
Dapagliflozin did not show any toxicity in healthy subjects at single oral doses up to 500 mg (50 times the maximum recommended human dose). 
Enkratni peroralni odmerki dapagliflozina do 500 mg (tj. 50-kratnik največjega priporočenega odmerka za človeka) pri zdravih preiskovancih niso povzročili toksičnih učinkov.
Alu/Alu blister Pack sizes of 14, 28 and 98 film-coated tablets in non-perforated calendar blisters 
Velikosti pakiranj s 14, 28 in 98 filmsko obloženimi tabletami v neperforiranih koledarskih pretisnih omotih.
At 48 weeks, the difference for dapagliflozin as add-on to sitagliptin (with or without metformin) compared with placebo was -2.22 kg. At 102 weeks, the difference for dapagliflozin as add-on to metformin compared with placebo, or as add-on to insulin compared with placebo was -2.14 and -2.88 kg, respectively. 
Po 102 tednih je bila razlika z dapagliflozinom kot dodatkom metforminu v primerjavi s placebom -2,14 kg in kot dodatkom insulinu v primerjavi s placebom -2,88 kg.
≥ 0.2% of subjects and ≥ 0.1% more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo. 
Opisano pri ≥ 2 % preiskovancev ter pri ≥ 1 % več in pri vsaj 3 preiskovancih več med uporabo 10 mg dapagliflozina kot med uporabo placeba.
At Weeks 48 and 104, the insulin dose remained stable compared to baseline in subjects treated with dapagliflozin 10 mg at an average dose of 76 IU/day. 
Pri preiskovancih, zdravljenih z 10 mg dapagliflozina je ostal odmerek insulina 48. in 104. teden v primerjavi z izhodiščem stabilen, povprečni odmerek je bil 76 i.e./dan.
Dapagliflozin + metformin 
Parameter dapagliflozin + metformin glipizid + metformin b
Blood creatinine increased**,b 
**,b povečanje sečnine v krvi
Reactions related to volume depletion (including, reports of dehydration, hypovolaemia or hypotension) were reported in 1.1% and 0.7% of subjects who received dapagliflozin 10 mg and placebo, respectively; serious reactions occurred in < 0.2% of subjects balanced between dapagliflozin 10 mg and placebo (see section 4.4). 
O učinkih, povezanih s pomanjkanjem volumna (vključno s poročili o dehidraciji, hipovolemiji ali hipotenziji) so poročali pri 1,1 % oseb, ki so prejemale 10 mg dapagliflozina, in 0,7 % oseb, ki so prejemale placebo.
For the add-on to metformin study, HbA1c reductions were sustained through Week 102 (-0.78% and 0.02% adjusted mean change from baseline for 10 mg and placebo, respectively). 
V študiji dodatka k metforminu se je zmanjšanje HbA1c ohranilo do 102. tedna (prilagojena povprečna sprememba od izhodišča -0,78 % z 10 mg dapagliflozina in 0,02 % s placebom).
At Week 104, adjusted mean change from baseline in HbA1c was -0.32% for dapagliflozin and -0.14% for glipizide. 
104. teden je bila prilagojena povprečna sprememba HbA1c od izhodišča pri dapagliflozinu -0,32 % in pri glipizidu -0,14 %.
Urinary tract infections were more frequently reported for dapagliflozin 10 mg compared to placebo in a pooled analysis up to 24 weeks (see section 4.8). 
V kumulativni analizi so okužbe sečil v obdobju do 24 tednov pogosteje zabeležili med uporabo 10 mg dapagliflozina kot med uporabo placeba (glejte poglavje 4.8).
Tabulated list of adverse reactions 
Pregledni seznam neželenih učinkov
Do not drive or use any tools or machines, if you feel dizzy taking Forxiga. 
Če med jemanjem zdravila Forxiga občutite omotico, ne vozite in ne uporabljajte orodij ali strojev.
Results at Week 24 (LOCFa) of a placebo-controlled study of dapagliflozin as monotherapy 
Rezultati s placebom kontrolirane študije dapagliflozina kot monoterapije po 24 tednih (LOCF
Not applicable. 
Ni posebnih zahtev.
Forxiga 5 mg film-coated tablets Forxiga 10 mg film-coated tablets dapagliflozin 
Forxiga 5 mg filmsko obložene tablete Forxiga 10 mg filmsko obložene tablete dapagliflozin
Bone mineral density measurements in patients with normal or mildly impaired renal function did not indicate bone loss over a treatment period of two years. 
Poročali so o majhnih povečanjih vrednosti PTH v serumu, ki so bila izrazitejša pri preiskovancih z večjo izhodiščno koncentracijo PTH. Merjenja mineralne kostne gostote pri bolnikih z normalno ali blago okvaro ledvic v dveletnem obdobju zdravljenja niso pokazala izgube kostne mase.
Mean changes from baseline in haematocrit were 2.30% for dapagliflozin 10 mg versus -0.33% for placebo. 
Povprečni odstotek spremembe hematokrita od izhodišča je bil 2,30 % z 10 mg dapagliflozina in -0,33 % s placebom.
HbA1c < 7% 
HbA1c < 7 % (LOCF)
NAME OF THE MARKETING AUTHORISATION HOLDER AstraZeneca AB 
Imetnik dovoljenja za promet z zdravilom AstraZeneca AB
Diuretics 
Dojenje
Use in patients with hepatic impairment 
Uporaba pri bolnikih z okvaro jeter
Dapagliflozin 10 mg 
Monoterapija dapagliflozin 10 mg placebo b
Add-on combination therapy 
Dodatek h kombiniranemu zdravljenju
In an add-on to insulin study, episodes of major hypoglycaemia were reported in 0.5% and 1.0% of subjects treated with dapagliflozin 10 mg plus insulin at Weeks 24 and 104, respectively, and in 0.5% of subjects treated with placebo plus insulin groups at Weeks 24 and 104. 
V študiji dodatka k insulinu so hude hipoglikemije do 24. oziroma 104. tedna zabeležili pri 0,5 % oziroma 1,0 % prejemnikov kombinacije 10 mg dapagliflozina in insulina ter pri 0,5 % prejemnikov kombinacije placeba in insulina.
Use in patients with renal impairment 
Uporaba pri bolnikih z okvaro ledvic
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 
Filmska obloga polivinilalkohol (E1203) titanov dioksid (E171) makrogol 3350 smukec (E553b) železov oksid, rumeni (E172)
• Your doctor may start you on a 5 mg dose if you have a liver problem. 
• Če imate težave z jetri, vam zdravnik lahko predpiše začetni odmerek 5 mg.
adverse reactions of volume depletion, most commonly reported as hypotension, were reported in 1.7% and 0.8% of dapagliflozin-treated subjects and placebo-treated subjects, respectively (see section 4.4). 
Pri osebah, starih ≥ 65 let, so o pomanjkanju volumna kot neželenemu učinku, najpogosteje poročali kot o hipotenziji in jo zabeležili pri 1,7 % oseb, ki so prejemale dapagliflozin in pri 0,8 % oseb, ki so prejemale placebo (glejte poglavje 4.4).
(95% CI) Subjects (%) achieving: HbA1c < 7% (LOCF)d Adjusted for baseline Body weight (kg) (LOCF)d Baseline (mean) Change from baselinec Difference from placeboc (95% CI) 1glimepiride 4 mg/day; 2Metformin (immediate- or extended-release formulations) ≥1500 mg/day plus maximum tolerated dose, which must be at least half maximum dose, of a sulphonylurea for at least 8 weeks prior to enrollment. 
2Metformin (oblike s takojšnjim ali podaljšanim sproščanjem) ≥ 1500 mg/dan ter največji tolerirani odmerek (ki mora biti vsaj polovičen maksimalni odmerek) sulfonilsečnine vsaj 8 tednov pred zajetjem v študijo.
LIST OF EXCIPIENTS Contains lactose. 
Zdravilo Forxiga vsebuje laktozo
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 10 mg dapagliflozina.
The mean change from baseline in HbA1c at 24 weeks was -0.44% and -0.33%, for dapagliflozin 10 mg and placebo, respectively. 
Povprečna sprememba HbA1c od izhodišča za 10 mg dapagliflozina je bila 24. teden -0,44 % in -0,33 % za placebo.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 5 mg dapagliflozina.
Each Forxiga 5 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin. 
Ena tableta zdravila Forxiga 5 mg filmsko obložene tablete vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 5 mg dapagliflozina.
Stop taking Forxiga and see a doctor as soon as possible if you notice any of the following serious side effects: 
Če opazite katerega od naslednjih resnih neželenih učinkov, prenehajte z jemanjem zdravila Forxiga in čim prej obiščite zdravnika:
• dizziness 
• omotica
• genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour) 
• okužba spolovil (glivice) na spolnem udu ali v nožnici (med znaki so lahko draženje, srbenje,
Each Forxiga 10 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin. 
Ena tableta zdravila Forxiga 10 mg filmsko obložene tablete vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 10 mg dapagliflozina.
Contact your doctor as soon as possible if you have any of the following side effects: 
Čim prej se posvetujte z zdravnikom, če imate katerega od naslednjih neželenih učinkov: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov):
Evidence of sustained glucose excretion was seen in subjects with type 2 diabetes mellitus given dapagliflozin 10 mg/day for up to 2 years. 
Pri osebah s sladkorno boleznijo tipa 2, ki so prejemale 10 mg dapagliflozina na dan, do 2 leti, so ugotovili ohranjeno izločanje glukoze.
Dizziness 
Malignomi
Results at Week 52 (LOCFa) in an active-controlled study comparing dapagliflozin to glipizide as add-on to metformin 
Rezultati z zdravilno učinkovino kontrolirane študije, ki je primerjala dapagliflozin z glipizidom kot dodatkom k metforminu po 52 tednih (LOCF
Talk to your doctor if you would like to or are breast-feeding before taking this medicine. 
Če dojite ali želite dojiti, se posvetujte z zdravnikom pred jemanjem tega zdravila.
• Keep this medicine out of the sight and reach of children. 
• Zdravilo shranjujte nedosegljivo otrokom!
• Forxiga 5 mg film-coated tablets are yellow and round with diameter of 0.7 cm. 
• Tablete zdravila Forxiga 5 mg filmsko obložene tablete so rumene barve, okrogle oblike s premerom 0,7 cm. Na eni strani imajo vtisnjeno oznako "5" in na drugi strani "1427".
(95% CI) Mean daily insulin dose (IU)1 
Razlika glede na placebo (95 % IZ) Povprečni dnevni odmerek insulina (i.e.) Izhodišče (povprečje) Sprememba od izhodišča c