FrancophonIA/ELRC3.0 huggingface dataset:
English: common uncommon macular oedema not known not known
Croatian: često manje često makularni edem nepoznato nepoznato
English: What Tandemact contains - The active substances are pioglitazone and glimepiride.
Croatian: Što Tandemact sadrži - Djelatne tvari su pioglitazon i glimepirid.
English: If large quantities have been ingested, gastric lavage is indicated, followed by activated charcoal and sodium-sulphate.
Croatian: Ako su progutane velike količine lijeka, indicirano je ispiranje želuca, a potom primjena aktivnog ugljena i natrijevog sulfata.
English: Tandemact contains lactose monohydrate
Croatian: Tandemact sadrži laktozu hidrat
English: A decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Croatian: Moguća je potreba za smanjenjem doze pioglitazona kad se primjenjuje istovremeno uz gemfibrozil.
English: Inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked.
Croatian: Obavijestite čim prije Vašeg liječnika ako razvijete simptome koji ukazuju na tegobe s jetrom (poput neobjašnjive mučnine, povraćanja, boli u trbuhu, umora, gubitka apetita i/ili tamne mokraće), jer tada mora provjeriti funkciju jetre. - ako imate ciste na jajnicima (sindrom policističnih jajnika).
English: The extrapancreatic effects are for example an improvement of the sensitivity of the peripheral tissue for insulin and a decrease of the insulin uptake by the liver.
Croatian: Učinci izvan gušterače su, na primjer, poboljšana osjetljivost perifernog tkiva na inzulin i smanjen unos inzulina iz krvi u stanice jetre.
English: - The other ingredients are cellulose microcrystalline, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate (see section 2 ‘Tandemact contains lactose monohydrate'), magnesium stearate and polysorbate 80.
Croatian: - Drugi sastojci su mikrokristalična celuloza, umrežena karmelozanatrij, hidroksipropilceluloza, laktoza hidrat (vidjeti dio 2 ‘Tandemact sadrži laktozu hidrat'), magnezijev stearat i polisorbat 80.
English: In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline.
Croatian: U kliničkim ispitivanjima u trajanju od jedne godine pioglitazon je dosljedno izazivao statistički značajno sniženje omjera albumina i kreatinina u usporedbi s početnim vrijednostima.
English: These reactions include anaphylaxis, angioedema, and urticaria.
Croatian: Ove reakcije uključivale su anafilaksiju, angioedem i urtikariju.
English: - anabolic steroids (supporting muscle build up) or male sex hormone replacement therapy - fluoxetine, MAO-inhibitors (to treat depression) - angiotensin-converting enzyme (ACE) inhibitors, sympatholytics, disopyramide, pentoxifylline,
Croatian: - anabolički steroidi (za povećanje mase mišića) ili nadomjesna terapija muškim spolnim hormonom - fluoksetin, MAO inhibitori (za liječenje depresije) - inhibitori angiotenzin-konvertirajućeg enzima (ACE), simpatolitici, dizopiramid, pentoksifilin,
English: If patients are receiving pioglitazone in combination with a sulphonylurea other than glimepiride, patients should be stabilised with concomitant pioglitazone and glimepiride before switching to Tandemact.
Croatian: Ako bolesnici uzimaju pioglitazon u kombinaciji s derivatom sulfonilureje koji nije glimepirid, prije nego što se prebace na Tandemact potrebno ih je najprije stabilizirati istovremenom primjenom pioglitazona i glimepirida.
English: Mean levels of liver enzymes decreased with treatment with pioglitazone.
Croatian: Prosječne razine jetrenih enzima opadale su s trajanjem liječenja pioglitazonom.
English: After oral administration of glimepiride, the terminal half-lives of those metabolites were 3 to 6 and 5 to 6 hours respectively.
Croatian: Nakon peroralne primjene glimepirida krajnji poluvijek ta dva metabolita iznosio je 3 do 6 sati za prvi i 5 do 6 sati za drugi metabolit.
English: The following medicines can increase or decrease the blood sugar lowering effect of Tandemact: - H2 antagonists (to treat stomach ulcers) - beta-blockers, clonidine, guanethidine and reserpine (to treat high blood pressure or heart failure).
Croatian: Sljedeći lijekovi mogu pojačati ili oslabiti učinak lijeka Tandemact na snižavanje razine šećera u krvi: - H2 antagonisti (za liječenje vrijeda na želucu) - beta-blokatori, klonidin, gvanetidin i rezerpin (za liječenje povišenog krvnog tlaka ili zatajenja srca).
English: 6.5 Nature and contents of container Aluminium/aluminium blisters; packs of 14, 28, 30, 50, 90 or 98 tablets.
Croatian: Aluminij/aluminij blisteri; pakiranja od 14, 28, 30, 50, 90 ili 98 tableta.
English: Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.
Croatian: U klasifikaciji organskih sustava nuspojave su prikazane slijedom sve manje incidencije i padajuće ozbiljnosti.
English: The bioavailability of glimepiride after oral administration is complete.
Croatian: Bioraspoloživost glimepirida nakon peroralne primjene je potpuna.
English: When meals are taken at irregular hours or skipped altogether, treatment with Tandemact may lead to hypoglycaemia due to the sulphonylurea component.
Croatian: Kod neredovitog uzimanja obroka ili propuštanja obroka, liječenje lijekom Tandemact može dovesti do hipoglikemije zbog toga što Tandemact sadrži sulfonilureju.
English: Gastrointestinal disorders5 flatulence common vomiting very rare very rare diarrhoea very rare very rare nausea very rare very rare abdominal pain very rare very rare abdominal pressure very rare very rare
Croatian: Poremećaji probavnog sustava 5 flatulencija često povraćanje vrlo rijetko vrlo rijetko proljev vrlo rijetko vrlo rijetko mučnina vrlo rijetko vrlo rijetko bolovi u abdomenu vrlo rijetko vrlo rijetko pritisak u abdomenu vrlo rijetko vrlo rijetko osjećaj punoće u želucu vrlo rijetko vrlo rijetko
English: It is known from other sulphonylureas that, despite initially successful countermeasures, hypoglycaemia may recur.
Croatian: Iz iskustva s drugim sulfonilurejama poznato je da se hipoglikemija može vratiti unatoč početno uspješnim protumjerama.
English: In a two-year study of combination therapy comparing pioglitazone with gliclazide when added to metformin, glycaemic control measured as mean change from baseline in HbA1c was similar between treatment groups after one year.
Croatian: U dvogodišnjem ispitivanju kombinirane terapije u kojem se pioglitazon uspoređivao s gliklazidom nakon dodavanja metforminu, kontrola glikemije mjerena kao prosječna promjena HbA1c u odnosu na početnu vrijednost bila je slična u obje terapijske skupine nakon jedne godine.
English: Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, granulocytopenia, agranulocytosis, haemolytic anaemia and pancytopenia may occur rarely (≥ 1/10,000 to < 1/1,000) (see section 4.4).
Croatian: Rijetko se mogu razviti umjerena do teška trombocitopenija, leukopenija, eritropenija, granulocitopenija, agranulocitoza, hemolitička anemija i pancitopenija (≥ 1/10 000 i < 1/1000) (vidjeti dio 4.4).
English: The decision whether to continue the patient on therapy with Tandemact should be guided by clinical judgement pending laboratory evaluations.
Croatian: Odluku o nastavku liječenja lijekom Tandemact treba donijeti na temelju kliničke procjene ovisno o laboratorijskim nalazima.
English: rare rare
Croatian: rijetko rijetko
English: The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
Croatian: Opaženo povećanje rizika od prijeloma u žena u ovom skupu podataka o pioglitazonu stoga iznosi 0,8 prijeloma na 100 bolesnik-godina primjene.
English: The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Croatian: Učinak pioglitazona (monoterapija dozom od 45 mg naspram placeba) proučen je u malom ispitivanju u trajanju od 18 tjedana u osoba sa šećernom bolešću tipa
English: Part of the treatment of diabetes is dietary control.
Croatian: Liječenje šećerne bolesti uključuje i kontrolu bolesti dijetom.
English: Women of childbearing potential / Contraception in males and females Tandemact is not recommended in women of childbearing potential not using contraception.
Croatian: Tandemact se ne preporučuje u žena reproduktivne dobi koje ne koriste kontracepciju.
English: 8 Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
Croatian: 8 Edem je u kontroliranim ispitivanjima zabilježen tijekom jedne godine u 6-9% bolesnika liječenih pioglitazonom.
English: Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following active substances is taken, for example:
Croatian: Može nastupiti pojačanje učinka snižavanja glukoze u krvi, a tako u nekim slučajevima i hipoglikemija, kad se uzimaju sljedeće djelatne tvari kao što su:
English: Studies in human volunteers have shown Tandemact to be bioequivalent to the administration of pioglitazone and glimepiride given as separate tablets.
Croatian: Ispitivanja u zdravih dobrovoljaca pokazala su da je Tandemact bioekvivalentan primjeni pioglitazona i glimepirida kao zasebnih tableta.
English: coumarin derivatives such as warfarin (to treat heart or blood problems) - allopurinol, probenecid, sulfinpyrazone (to treat gout) - cyclophosphamide, ifosfamide, trofosfamide (to treat cancer) - fenfluramine (to reduce weight) - tritoqualine (to treat allergies)
Croatian: derivati kumarina kao što je varfarin (za liječenje tegoba sa srcem ili s krvlju) - alopurinol, probenecid, sulfinpirazon (za liječenje uloga) - ciklofosfamid, ifosfamid, trofosfamid (za liječenje raka) - fenfluramin (za smanjenje tjelesne težine) - tritokvalin (za liječenje alergija)
English: In PROactive, a cardiovascular outcome study, 5,238 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.
Croatian: U PROactive ispitivanju kardiovaskularnog ishoda, 5238 bolesnika sa šećernom bolešću tipa 2 i postojećom velikom makrovaskularnom bolešću bilo je randomizirano u skupinu koja je primala pioglitazon i skupinu koja je primala placebo uz postojeću antidijabetičku i kardiovaskularnu terapiju, u trajanju do 3,5 godine.
English: In vitro studies have shown no inhibition of any subtype of cytochrome P450.
Croatian: In vitro ispitivanja nisu pokazala da postoji inhibicija bilo kojeg podtipa citokroma P450.
English: Hepatic impairment Tandemact should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Croatian: Tandemact se ne smije primjenjivati u bolesnika s oštećenjem funkcije jetre (vidjeti dijelove 4.3 i 4.4).
English: When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III contribute equally to efficacy.
Croatian: Kad se uzmu u obzir aktivnost, koncentracija i vezanje za proteine, pioglitazon i metabolit
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin together experienced the development of heart failure.
Croatian: Neki bolesnici koji već dugo imaju šećernu bolest tipa 2 i srčanu bolest ili su preboljeli moždani udar i koji su bili liječeni zajedno pioglitazonom i inzulinom razvili su zatajenje srca.
English: If a patient wishes to become pregnant, treatment with Tandemact should be discontinued.
Croatian: Ako bolesnica želi zatrudnjeti, liječenje lijekom Tandemact je nužno prekinuti.
English: oestrogens and progestagens, saluretics, thiazide diuretics, thyroid stimulating agents, glucocorticoids, phenothiazine derivatives, chlorpromazine, adrenaline and sympathicomimetics, nicotinic acid (high doses) and nicotinic acid derivatives, laxatives (long-term use), phenytoin, diazoxide, glucagon, barbiturates and rifampicin.
Croatian: estrogeni i progestageni, saluretici, tiazidski diuretici, lijekovi koji stimuliraju štitnjaču, glukokortikosteroidi, derivati fenotiazina, klorpromazin, adrenalin i simpatomimetici, nikotinska kiselina (visoke doze) i derivati nikotinske kiseline, laksativi (dugotrajno uzimanje), fenitoin, diazoksid, glukagon, barbiturati i rifampicin, acetozolamid.
English: not known not known rash2
Croatian: nepoznato nepoznato svrbež2
English: Nausea, vomiting and epigastric pain may occur.
Croatian: Mogu se javiti mučnina, povraćanje i bol u epigastriju.
English: Glimepiride increases very rapidly the number of active glucose transport molecules in the plasma membranes of muscle and fat cells, resulting in stimulated glucose uptake.
Croatian: Glimepirid vrlo brzo povećava broj molekula za aktivni transport glukoze u plazmatskim membranama mišićnih i masnih stanica, što rezultira stimulacijom unosa glukoze iz krvi u stanice.
English: Musculoskeletal and connective tissue disorders bone fracture7
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva prijelomi kosti7
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or other sulphonylureas or sulphonamides - Cardiac failure or history of cardiac failure (NYHA stages I to IV) - Current bladder cancer or a history of bladder cancer - Uninvestigated macroscopic haematuria - Hepatic impairment - Type 1 diabetes mellitus - Diabetic coma - Diabetic ketoacidosis - Severe renal function disorders (creatinine clearance < 30 ml/min) - Pregnancy - Breast-feeding (see section 4.6)
Croatian: - preosjetljivost na djelatne tvari ili neke od pomoćnih tvari navedenih u dijelu 6.1 ili na druge sulfonilureje ili sulfonamide - zatajenje srca ili anamneza zatajenja srca (NYHA stadiji I do IV) - prisutni ili preboljeni karcinom mokraćnog mjehura - neispitana makroskopska hematurija - oštećenje jetre - šećerna bolest tipa 1 - dijabetička koma - dijabetička ketoacidoza - teški poremećaji funkcije bubrega (klirens kreatinina < 30 ml/min) - trudnoća - dojenje (vidjeti dio 4.6)
English: Skin and subcutaneous tissue disorders sweating uncommon hypersensitivity to light very rare very rare urticaria2
Croatian: Poremećaji kože i potkožnog tkiva znojenje manje često preosjetljivost na svjetlo vrlo rijetko vrlo rijetko urtikarija2
English: In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
Croatian: 10 U kliničkim ispitivanjima pioglitazona, povišenje ALT-a više od tri puta iznad gornje granice normale bilo je jednako često kao uz placebo, ali manje često nego u skupinama koje su kao komparator primale metformin ili sulfonilureju.
English: Takeda GmbH Production Site Oranienburg Lehnitzstrasse 70 - 98 16515 Oranienburg, Germany
Croatian: Lehnitzstrasse 70 - 98 16515 Oranienburg, Njemačka
English: Blurred vision due to swelling (or fluid) at the back of the eye (macular oedema) has also been reported in patients taking Tandemact (frequency cannot be estimated from the available data).
Croatian: U bolesnika koji su uzimali Tandemact zabilježen je i zamagljen vid zbog oticanja (ili nakupljanja tekućine) na stražnjoj strani oka (makularni edem) (učestalost se ne može procijeniti iz dostupnih podataka).
English: 9 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 - 3 kg over one year.
Croatian: U ispitivanjima kontroliranima aktivnim komparatorom, prosječno povećanje tjelesne težine uz monoterapiju pioglitazonom iznosilo je 2-3 kg tijekom jedne godine.
English: Metabolism and nutrition disorders hypoglycaemia uncommon appetite increased uncommon
Croatian: Poremećaji metabolizma i prehrane hipoglikemija manje često pojačan apetit manje često
English: Rare changes in haematology have been observed with glimepiride treatment (see section 4.8).
Croatian: Uz liječenje glimepiridom zabilježene su rijetke hematološke promjene (vidjeti dio 4.8).
English: If a pregnancy occurs, treatment with Tandemact should be discontinued.
Croatian: U slučaju trudnoće, liječenje lijekom Tandemact treba prekinuti.
English: Glimepiride is transferred to the placenta.
Croatian: Glimepirid prelazi u posteljicu.
English: In a 20-week study, as well as reducing fasting triglycerides, pioglitazone reduced post prandial hypertriglyceridaemia through an effect on both absorbed and hepatically synthesised triglycerides.
Croatian: U ispitivanju u trajanju od 20 tjedana pioglitazon je uz sniženje triglicerida natašte snizio i postprandijalnu hipertrigliceridemiju putem učinka kako na apsorbirane trigliceride, tako i na one sintetizirane u jetri.
English: In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin.
Croatian: U kontroliranim kliničkim ispitivanjima zatajenje srca bilo je zabilježeno jednako često u skupinama liječenima pioglitazonom kao i u skupinama koje su primale placebo, metformin ili sulfonilureju, ali bilo je češće uz kombiniranu terapiju s inzulinom.
English: Thiazolidinediones act primarily by reducing insulin resistance and sulphonylureas primarily by inducing insulin release from pancreatic beta cells.
Croatian: Tiazolidindioni prvenstveno djeluju tako da smanjuju inzulinsku rezistenciju, dok sulfonilureje prvenstveno induciraju oslobađanje inzulina iz beta stanica gušterače.
English: Adverse reactions reported in double-blind studies and post marketing experience are listed below as MedDRA preferred term by system organ class and absolute frequency.
Croatian: Nuspojave zabilježene u dvostruko slijepim ispitivanjima i razdoblju nakon stavljanja lijeka u promet navedene su niže prema standardnim MedDRA pojmovima, klasifikaciji organskih sustava i učestalosti.
English: If you experience this symptom for the first time, talk to your doctor as soon as possible.
Croatian: Ako prvi put dobijete ovaj simptom, obratite se čim prije svom liječniku.
English: Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur when one of the following active substances is taken, for example:
Croatian: Može nastupiti slabljenje učinka na sniženje glukoze u krvi, a time i povišenje razine glukoze u krvi, kad se uzimaju sljedeće djelatne tvari kao što su:
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Croatian: U razdoblju nakon stavljanja lijeka u promet zabilježeni su slučajevi novonastalog ili pogoršanje postojećeg dijabetičkog makularnog edema sa smanjenjem oštrine vida kod uzimanja tiazolidindiona, uključujući i pioglitazon.
English: The following medicines may decrease the blood sugar lowering effect of Tandemact.
Croatian: Sljedeći lijekovi mogu smanjiti učinak lijeka Tandemact na sniženje šećera u krvi.
English: Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1-2% and haematocrit 1-3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Croatian: U komparativnim kliničkim ispitivanjima pioglitazona slične su promjene viđene u bolesnika liječenih metforminom (relativno sniženje hemoglobina za 3-4% i hematokrita za 3,6-4,1%) te u manjoj mjeri u onih liječenih sulfonilurejom i inzulinom (relativno sniženje hemoglobina za 1-2% i hematokrita za
English: The following medicines can increase the blood sugar lowering effect of Tandemact.
Croatian: Sljedeći lijekovi mogu pojačati učinak lijeka Tandemact na sniženje šećera u krvi.
English: Glimepiride acts mainly by stimulating insulin release from pancreatic beta cells.
Croatian: Glimepirid djeluje uglavnom tako da potiče oslobađanje inzulina iz beta stanica gušterače.
English: The observed excess risk of fractures for women on pioglitazone in this study is therefore 0.5 fractures per 100 patient years of use.
Croatian: Opaženo povećanje rizika od prijeloma u žena koje su u ovom ispitivanju uzimale pioglitazon stoga je iznosilo 0,5 prijeloma na 100 bolesnik-godina primjene.
English: This is similar to that seen in a sulphonylurea active comparator group.
Croatian: To je slično povećanju tjelesne težine u skupini koja je primala sulfonilureju kao aktivni komparator.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Tandemact 30 mg/2 mg tablets
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Tandemact 30 mg/2 mg tablete
English: The symptoms may include cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea.
Croatian: Simptomi mogu uključivati hladan znoj, umor, glavobolju, ubrzan rad srca, jaku glad, razdražljivost, nervozu ili mučninu.
English: How to store Tandemact
Croatian: Kako čuvati Tandemact
English: A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%).
Croatian: Opažena incidencija prijeloma bila je veća u žena koje su uzimale pioglitazon (2,6%) nego u onih koje su uzimale komparator (1,7%).
English: - allergic reactions including allergic shock - feeling sick (nausea), vomiting and diarrhoea - stomach ache - abdominal pressure - feeling of fullness in the stomach - sensitivity to light - decrease in salt (sodium) concentrations in the blood
Croatian: Vrlo rijetko (može se javiti u do 1 na 10 000 osoba) - bolest jetre - alergijske reakcije uključujući alergijski šok - mučnina, povraćanje i proljev - bol u trbuhu - pritisak u trbuhu - osjećaj punoće u želucu - osjetljivost na svjetlost - snižene koncentracije soli (natrija) u krvi
English: This can lead to a risk of hypoglycaemia (low blood sugar): - gemfibrozil and fibrates (to lower high cholesterol level) - insulin, metformin or other medicines to treat diabetes mellitus - phenylbutazone, azapropazone, oxyphenbutazone, aspirin-like medicines (to treat pain and inflammation) - long acting sulphonamides, tetracyclines, chloramphenicol, fluconazole, miconazole,
Croatian: To može stvoriti rizik od hipoglikemije (nizak šećer u krvi): - gemfibrozil i fibrati (za snižavanje povišene razine kolesterola) - inzulin, metformin ili drugi lijekovi za liječenje šećerne bolesti - fenilbutazon, azapropazon, oksifenbutazon, lijekovi slični aspirinu (za liječenje bola i upale) - dugodjelujući sulfonamidi, tetraciklini, kloramfenikol, flukonazol, mikonazol, kinoloni,
English: In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys.
Croatian: U toksikološkim su ispitivanjima nakon ponovljenog doziranja u miševa, štakora, pasa i majmuna dosljedno opažene ekspanzija volumena plazme sa hemodilucijom, anemija i reverzibilna ekscentrična hipertrofija srca.
English: Marketing authorisation holder Takeda Pharma A/S Dybendal Alle 10
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Takeda Pharma A/S
English: Tandemact is contra-indicated during breast-feeding (see section 4.3).
Croatian: Tandemact je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
English: The symptoms may include cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness, nausea, coma or convulsion.
Croatian: Simptomi mogu uključivati hladan znoj, umor, glavobolju, ubrzan rad srca, jaku glad, razdražljivost, nervozu, mučninu, komu ili konvulzije.
English: Hypersensitivity reactions of the skin may occur as itching, rash, and urticaria.
Croatian: Kožne reakcije preosjetljivosti mogu nastati u obliku svrbeža, osipa i urtikarije.
English: Each tablet contains approximately 177 mg lactose monohydrate (see section 4.4).
Croatian: Jedna tableta sadrži približno 177 mg laktoze hidrata (vidjeti dio 4.4).