natgillin/translations-raw huggingface dataset:
Dizziness, tremor Skin and subcutaneous tissue disorders Common 
Omaglica, tremor Poremećaj kože i potkožnog tkiva Često
After oral administration, metformin absorption is saturable and incomplete. 
Nakon peroralne primjene apsorpcija metformina je nepotpuna i odvija se do zasićenja.
In the overall population, the placebo-adjusted mean reduction from a mean baseline HbA1c 8.8% was -0.72%. 
U sveukupnoj populaciji srednje sniženje, prilagođeno s obzirom na placebo, u odnosu na prosječnu početnu vrijednost HbA1c 8,8% bilo je -0,72%.
Metformin must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and 4.4). 
Primjena metformina se mora prekinuti prije ili u vrijeme pretrage metodom oslikavanja i s njegovom primjenom smije se ponovno započeti tek 48 sati poslije, pod uvjetom da je funkcija bubrega bila ponovno procijenjena i da je potvrđeno da je stabilna (vidjeti dijelove 4.2 i 4.4).
Zomarist is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multipacks containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets. 
Zomarist je dostupan u pakiranjima od 10, 30, 60, 120, 180 ili 360 filmom obloženih tableta i u višestrukim pakiranjima od 120 (2x60), 180 (3x60) ili 360 (6x60) filmom obloženih tableta.
No data are available with regard to overdose of Zomarist. 
Nema dostupnih podataka o predoziranju Zomaristom.
Table 3 Adverse reactions reported in patients who received vildagliptin 100 mg daily in combination with insulin (with or without metformin) in double-blind studies (N=371) 
Tablica 3 Nuspojave zabilježene u bolesnika koji su primali 100 mg vildagliptina na dan u kombinaciji s inzulinom (s ili bez metformina) u dvostruko slijepim ispitivanjima (N=371)
• Common: headache, chills, nausea (feeling sick), low blood glucose, heartburn. 
• često: glavobolja, zimica, mučnina, niska razina glukoze u krvi, žgaravica.
The placebo-adjusted mean reduction from a mean baseline HbA1c of 8.8% was -0.76%. 
Srednja vrijednost sniženja, prilagođena s obzirom na placebo, od početne srednje vrijednosti HbA1c od 8,8% bilo je -0,76%.
Administration of iodinated contrast agents 
Primjena jodiranih kontrastnih sredstava
• Uncommon (may affect up to 1 in 100 people): joint pain, tiredness, constipation, swollen hands, ankle or feet (oedema). 
• manje često (mogu se javiti u do 1 na 100 osoba): bol u zglobovima, umor, zatvor, otečene šake, gležnjevi ili stopala (edem).
At the end of the study, effect on mean body weight was neutral (+0.6 kg change from baseline in the vildagliptin group and no weight change in the placebo group). 
Na kraju ispitivanja učinak na srednju vrijednost tjelesne težine bio je neutralan (promjena od +0,6 kg u odnosu na početnu vrijednost u skupini liječenoj vildagliptinom, dok u skupini liječenoj placebom nije bilo promjene težine).
Zomarist may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening. 
Liječenje Zomaristom može se započeti s jačinom tablete ili od 50 mg/850 mg ili od 50 mg/1000 mg dvaput na dan, kao jedna tableta ujutro i druga navečer.
Table 6 Post-marketing adverse reactions 
Tablica 6 Nuspojave nakon stavljanja lijeka u promet
Skin lesions, including blistering and ulceration have been reported with vildagliptin in extremities of monkeys in non-clinical toxicology studies (see section 5.3). 
U nekliničkim toksikološkim ispitivanjima s vildagliptinom zabilježene su kožne lezije, uključujući pojavu mjehurića i ulceracija na ekstremitetima majmuna (vidjeti dio 5.3).
Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Zomarist (see sections 4.2, 4.3 and 4.8). 
Zomarist se ne smije primjenjivati u bolesnika s oštećenjem funkcije jetre, uključujući one u kojih su ALT ili AST prije početka liječenja bili >3x GGN (vidjeti dijelove 4.2, 4.3 i 4.8).
In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was added to metformin (+0.2 kg and -1.0 kg for vildagliptin and placebo, respectively). 
U kliničkim se ispitivanjima tjelesna težina nije mijenjala od početne vrijednosti kada je 100 mg vildagliptina na dan dodano metforminu (+0,2 kg za vildagliptin odnosno -1,0 kg za placebo).
Polychlorotrifluoroethylene (PCTFE)/PVC/Alu blister Available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets. 
Poliklorotrifluoroetilen (PCTFE)/PVC/Alu blister Dostupno u pakiranjima od 10, 30, 60, 120, 180 ili 360 filmom obloženih tableta i u višestrukim pakiranjima od 120 (2 pakiranja od 60), 180 (3 pakiranja od 60) ili 360 (6 pakiranja od 60) filmom obloženih tableta.
One severe hypoglycaemic event was reported in the vildagliptin group. 
U skupini liječenoj vildagliptinom prijavljen je jedan ozbiljni hipoglikemijski događaj.
LFTs should be performed prior to the initiation of treatment with Zomarist in order to know the patient's baseline value. 
Testove jetrene funkcije treba napraviti prije početka liječenja Zomaristom kako bi se utvrdile početne vrijednosti.
After 1 year, mean reductions in HbA1c were -0.81% with vildagliptin added to metformin (mean baseline HbA1c 8.4%) and -0.85% with gliclazide added to metformin (mean baseline HbA1c 8.5%); statistical non-inferiority was achieved (95% CI -0.11 - 0.20). 
Nakon 1 godine srednje vrijednosti sniženja HbA1c bila su -0,81% uz dodatak vildagliptina metforminu (srednja početna vrijednost HbA1c 8,4%) i -0,85% uz dodatak gliklazida metforminu (srednja početna vrijednost HbA1c 8,5%).
• Uncommon: diarrhoea, flatulence. 
• manje često: proljev, nadutost.
In a 52-week trial, vildagliptin (50 mg twice daily) was compared to gliclazide (mean daily dose: 229.5 mg) in patients inadequately controlled with metformin (metformin dose at baseline 1928 mg/day). 
U ispitivanju koje je trajalo 52 tjedna uspoređivao se vildagliptin (50 mg dva puta na dan) s gliklazidom (srednja dnevna doza: 229,5 mg) u bolesnika u kojih nije bila postignuta dovoljna kontrola metforminom (početna doza metformina od 1928 mg/dan).
In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively). 
U kliničkim se ispitivanjima tjelesna težina nije mijenjala od početne vrijednosti kada se 100 mg vildagliptina na dan primjenjivalo kao monoterapija (-0,3 kg za vildagliptin odnosno -1,3 kg za placebo).
Metformin is eliminated by renal excretion. 
Metformin se eliminira putem bubrega.
Metformin should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and 
Primjenu metformina treba prekinuti prije ili u vrijeme pretrage metodom oslikavanja i s njegovom primjenom smije se ponovno započeti tek 48 sati poslije, pod uvjetom da je funkcija bubrega bila ponovno procijenjena i da je potvrđeno da je stabilna, (vidjeti dijelove 4.2 i 4.5).
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma. 
Ako je bubrežna funkcija oštećena, bubrežni klirens se smanjuje razmjerno smanjenju klirensa kreatinina i stoga se poluvrijeme eliminacije produžuje što dovodi do povećanih razina metformina u plazmi.
Elimination Following oral administration of [ 
Nakon peroralne primjene [
In clinical trials, the incidence of hypoglycaemia was common in patients receiving vildagliptin in combination with metformin (1%) and uncommon in patients receiving placebo + metformin (0.4%). 
U kliničkim je ispitivanjima incidencija hipoglikemije bila česta u bolesnika koji su primali 100 mg vildagliptina na dan u kombinaciji s metforminom (1%) te manje česta u bolesnika koji su primali placebo uz metformin (0,4%).
Table 1 Adverse reactions reported in patients who received vildagliptin 100 mg daily as add-on therapy to metformin compared to placebo plus metformin in double-blind studies (N=208) 
Tablica 1 Nuspojave zabilježene u bolesnika koji su primali 100 mg vildagliptina na dan kao dodatak metforminu u usporedbi s palcebom uz metformin u dvostruko slijepim ispitivanjima (N=208)
All symptoms and laboratory abnormalities resolved without treatment after discontinuation of the study medicinal product. 
Nakon ukidanja ispitivanog lijeka, svi su se simptomi i abnormalne laboratorijske vrijednosti povukli bez liječenja.
Gastrointestinal disorders Very common Nausea, vomiting, diarrhoea, abdominal pain and loss of appetite Hepatobiliary disorders Very rare 
Mučnina, povraćanje, proljev, bol u abdomenu i gubitak apetita
- if you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing which could be a sign of heart problems. 
Simptomi uključuju bol u trbuhu, ubrzano i duboko disanje, pospanost ili Vam dah ima neobičan voćni miris. - ako ste nedavno imali srčani udar ili imate zatajivanje srca ili ozbiljne probleme s cirkulacijom krvi ili poteškoće pri disanju koje mogu biti znak srčanih problema.
What Zomarist looks like and contents of the pack Zomarist 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other. 
Zomarist 50 mg/850 mg filmom obložene tablete su žute, ovalne tablete s oznakom „NVR” na jednoj strain i „SEH” na drugoj strani.
Nasopharyngitis Metabolism and nutrition disorders Uncommon 
Nazofaringitis Poremećaji metabolizma i prehrane Manje često
Musculoskeletal and connective tissue disorders Not known 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Nepoznato
Zomarist 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other. 
Zomarist 50 mg/1000 mg filmom obložene tablete su tamnožute, ovalne tablete s oznakom „NVR” na jednoj strain i „FLO” na drugoj strani.
Maximum daily dose is 2000 mg. 
Maksimalna dnevna doza je 2000 mg.
Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “SEH” on the other side. 
Žuta, ovalna filmom obložena tableta sa zaobljenim rubovima, s utisnutom oznakom „NVR” na jednoj strani i „SEH” na drugoj strani.
In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism. 
Metformin ima korisne učinke na metabolizam lipida u ljudi, neovisno od svom učinku na glikemiju.
Table 4 Adverse reactions reported in patients who received vildagliptin 100 mg daily as monotherapy in double-blind studies (N=1855) 
Tablica 4 Nuspojave zabilježene u bolesnika koji su primali 100 mg vildagliptina na dan kao monoterapiju u dvostruko slijepim ispitivanjima (N=1855)
Skin reactions such as erythema, pruritus and urticaria *A decrease in vitamin B12 absorption with decrease in serum levels has been very rarely observed in patients treated long-term with metformin. 
B12 uz pad razine u serumu vrlo je rijetko zamijećena u bolesnika koji su dugotrajno liječeni metforminom.
Zomarist 50 mg/1000 mg film-coated tablets 
Zomarist 50 mg/1000 mg filmom obložene tablete
Zomarist 50 mg/850 mg film-coated tablets 
Zomarist 50 mg/850 mg filmom obložene tablete
Your doctor may want to reduce your dose of the sulphonylurea when you take it together with Zomarist in order to avoid low blood glucose (hypoglycaemia). 
Da bi izbjegao nisku koncentraciju glukoze u krvi (hipoglikemija), Vaš će liječnik možda htjeti smanjiti Vašu dozu sulfonilureje kad je uzimate zajedno s Zomaristom.
After an oral dose of metformin, the maximum plasma concentration (Cmax) is achieved after about 2.5 h.. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects. 
Nakon oralne doze metformina najveća koncentracija u plazmi (Cmax) se postiže nakon otprilike 2,5 sata.
Treatment with vildagliptin 50-100 mg daily in patients with type 2 diabetes significantly improved markers of beta cell function including HOMA- (Homeostasis Model Assessment-), proinsulin to insulin ratio and measures of beta cell responsiveness from the frequently-sampled meal tolerance test. 
Liječenje vildagliptinom u dozi od 50 do 100 mg na dan u bolesnika sa šećernom bolešću tipa 2 značajno je poboljšalo markere funkcije beta stanica, uključujući HOMA- (engl.
Vildagliptin was not mutagenic in conventional in vitro and in vivo tests for genotoxicity. 
U konvencionalnim in vitro i in vivo testovima genotoksičnosti vildagliptin nije bio mutagen.
DPP-4 contributes partially to the hydrolysis of vildagliptin based on an in vivo study using DPP-4 deficient rats. 
Na osnovu in vivo ispitivanja u kojem su korišteni štakori s manjkom DPP-4 otkriveno je da DPP-4 djelomično doprinosi hidrolizi vildagliptina.
Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “FLO” on the other side. 
Tamnožuta, ovalna filmom obložena tableta sa zaobljenim rubovima, s utisnutom oznakom „NVR” na jednoj strani i „FLO” na drugoj strani.
- Each Zomarist 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin). 
- Jedna Zomarist 50 mg/850 mg filmom obložena tableta sadrži 50 mg vildagliptina i 850 mg metforminklorida (što odgovara 660 mg metformina).
Renal excretion of the unchanged vildagliptin accounted for 23% of the dose after oral administration. 
Nakon peroralne primjene 23% doze izlučuje se putem bubrega kao nepromijenjeni vildagliptin.
- Each Zomarist 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin). 
- Jedna Zomarist 50 mg/1000 mg filmom obložena tableta sadrži 50 mg vildagliptina i 1000 mg metforminklorida (što odgovara 780 mg metformina).
WIN MEDICA ΦΑΡΜΑΚΕΥΤΙΚΗ A.E. Tηλ: +30 210 74 88 821 
Tηλ: +30 210 74 88 821
Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets 
Zomarist 50 mg/850 mg filmom obložene tablete Zomarist 50 mg/1000 mg filmom obložene tablete
Constipation Musculoskeletal and connective tissue disorders Uncommon 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Manje često
Gastrointestinal disorders Not known 
Poremećaj probavnog sustava Nepoznato
- The other ingredients are: Hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 and talc. 
- Drugi sastojci su: hidroksipropilceluloza, magnezijev stearat, hipromeloza, titanijev dioksid
The known effect of increased GLP-1 levels delaying gastric emptying is not observed with vildagliptin treatment. 
Pri liječenju vildagliptinom nije zapažen poznati učinak odgođenog pražnjenja želuca uslijed povišene razine GLP-1.
Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride 
Zomarist 50 mg/850 mg filmom obložene tablete Zomarist 50 mg/1000 mg filmom obložene tablete vildagliptin/metforminklorid
Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma In case of suspected symptoms, the patient should stop taking metformin and seek immediate medical attention. 
Značajke laktacidoze su acidozna dispneja, bol u abdomenu, grčevi u mišićima, astenija i hipotermija nakon koje slijedi koma.
Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride 
Zomarist 50 mg/1000 mg filmom obložene tablete vildagliptin/metforminklorid
Each tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin). 
Jedna tableta sadrži 50 mg vildagliptina i 1000 mg metforminklorida (što odgovara 780 mg metformina).
Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin). 
Jedna tableta sadrži 50 mg vildagliptina i 850 mg metforminklorida (što odgovara 660 mg metformina).
Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin). 
Svaka filmom obložena tableta sadrži 50 mg vildagliptina i 1000 mg metforminklorida (što odgovara 780 mg metformina).
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin). 
Svaka filmom obložena tableta sadrži 50 mg vildagliptina i 850 mg metforminklorida (što odgovara 660 mg metformina).
No severe hypoglycaemic events were reported in the vildagliptin arms. 
U dijelu bolesnika koji su primali vildagliptin nisu zabilježeni teški hipoglikemijski događaji.
Asthenia 
Liječenje
Lactic acidosis 
Hiperhidroza
Zomarist 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride 
Zomarist 50 mg/850 mg filmom obložene tablete vildagliptin/metforminklorid
Nausea 
Mučnina
EU/1/08/483/007 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/008 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/009 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/010 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/011 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/012 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/025 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/026 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/027 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/028 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/029 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/030 360 film-coated tablets (PCTFE/PVC/Alu) 
EU/1/08/483/007 10 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/008 30 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/009 60 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/010 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/011 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/012 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/025 10 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/026 30 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/027 60 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/028 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/029 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/030 360 filmom obloženih tableta (PCTFE/PVC/Al)
Accumulation of foamy alveolar macrophages in the lung was observed in rats and mice. 
U štakora i miševa zapaženo je nakupljanje pjenastih alveolarnih makrofaga u plućima.
EU/1/08/483/001 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/002 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/003 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/004 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/005 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/006 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/019 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/020 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/021 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/022 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/023 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/024 360 film-coated tablets (PCTFE/PVC/Alu) 
EU/1/08/483/001 10 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/002 30 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/003 60 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/004 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/005 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/006 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/019 10 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/020 30 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/021 60 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/022 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/023 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/024 360 filmom obloženih tableta (PCTFE/PVC/Al)
EU/1/08/483/016 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/017 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/018 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/034 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/035 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/036 360 film-coated tablets (PCTFE/PVC/Alu) 
EU/1/08/483/016 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/017 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/018 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/034 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/035 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/036 360 filmom obloženih tablet (PCTFE/PVC/Al)
EU/1/08/483/013 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/014 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/015 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/031 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/032 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/033 360 film-coated tablets (PCTFE/PVC/Alu) 
EU/1/08/483/013 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/014 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/015 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/483/031 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/032 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/483/033 360 filmom obloženih tableta (PCTFE/PVC/Al)
DPP-4 inhibition by vildagliptin is not affected by age. 
Ove se promjene ne smatraju klinički značajnim, međutim dob ne utječe na inhibiciju DPP-4 vildagliptinom.
Oedema peripheral 
Prijavljivanje nuspojava
Talk to your doctor, pharmacist or nurse before taking Zomarist if you have or have had a disease of the pancreas. 
Ako imate ili ste imali bolest gušterače, obratite se svom liječniku, ljekarniku ili medicinskoj prije nego uzmete Zomarist.
Decreased blood glucose 
*Smanjena apsorpcija vitamina
- For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy: The starting dose of Zomarist should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken. 
Uobičajena početna doza Zomariste mora biti 50 mg vildagliptina dvaput na dan (ukupna dnevna doza 100 mg) plus dosadašnja doza metformina.
Fatigue 
Konstipacija
LIST OF EXCIPIENTS 
Opis odabarnih nuspojava
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States 
Popis naziva, farmaceutskih oblika, jačina lijekova, puta primjene, nositelja odobrenja u državama članicama
Co. Tipperary Ireland 
Tipperary Ireland
ANGELINI FARMACEUTICA, S.A. Osi, 7-9 Barcelona. 
Španjolska ANGELINI FARMACEUTICA, S.A. Osi, 7-9 Barcelona.
LABORATORIOS CINFA, S.A. OlazChipi, 10. 
Španjolska LABORATORIOS CINFA, S.A. OlazChipi, 10.
S.C. ANTIBIOTICE S.A., Str. Valea Lupului nr.1, Iaşi, România 
Rumunjska S.C. ANTIBIOTICE S.A., Str. Valea Lupului nr.1, Iaşi, România
BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. 
Španjolska BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor.
Sweden sanofi-aventis AB Box 14142 
Švedska sanofi-aventis AB Box 14142
Latvia sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia 
Latvija sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid). 
Španjolska LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6, Tres Cantos (Madrid).
Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark 
Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense
FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid). 
Španjolska FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid).
Denmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark 
Danska sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas , Madrid. 
Španjolska RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas , Madrid.