natgillin/translations-raw huggingface dataset:
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. 
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenosti.
Pharmacotherapeutic group: Other vasodilators used in cardiac diseases, ATC code: C01DX16 
Farmakoterapijska skupina: Ostali vazodilatatori za liječenje bolesti srca, ATK oznaka: C01DX16 Mehanizam djelovanja
Fertility There are insufficient data on fertility to estimate the risk for humans (see section 5.3). 
Plodnost Nema dovoljno podataka o plodnosti za procjenu rizika u ljudi (vidjeti dio 5.3).
The usual therapeutic range is 10 to 20 mg twice daily. 
Uobičajen terapijski raspon je 10 do 20 mg dva puta dnevno.
These metabolites represented the major route of transformation of nicorandil. 
Ovi metaboliti predstavljaju glavni put transformacije nikorandila.
• Dapoxetine, a medicine used to treat premature ejaculation. 
• Dapoksetin, lijek koji se koristi za liječenje prijevremene ejakulacije.
Progressive dose titration may reduce the frequency of these headaches (see section 4.2). 
Postupno povećavanje doze može smanjiti učestalost ovih glavobolja (vidjeti dio 4.2).
For the tablet of 20 mg, the score line is only there to help you break the tablet if you have difficulty swallowing it whole. 
Razdjelna crta na tableti od 20 mg služi samo da Vam pomogne prelomiti tabletu ako je ne možete progutati cijelu.
Upon cessation of treatment, recovery from nicorandil-induced testicular toxicity was observed after 4 weeks; which indicates that the observed changes are reversible. 
Nakon ukidanja liječenja, oporavak od toksičnog djelovanja nikorandila na testise uočen je nakon 4 tjedna; što upućuje na zaključak da su uočene promjene reverzibilne.
The tablets are sensitive to moisture; hence the patients should be advised to keep the tablets in their blister until intake. 
Tablete su osjetljive na vlagu; stoga bolesnike treba savjetovati da do uzimanja tablete čuvaju u blisteru.
If not successful, increase in circulating plasma volume by substitution of fluid is recommended. 
Ako to nije dovoljno, preporučuje se povećati cirkulirajući volumen plazme nadoknadom tekućine.
Hyperkalaemi a (see section 4.4 and 4.5) 
Hiperkalijemija (vidjeti dio 4.4 i 4.5)
• Medicines for depression. 
• Lijekove za liječenje depresije.
In life-threatening situations, administration of vasopressors must be considered. 
U životno ugrožavajućim situacijama potrebno je razmotriti primjenu vazopresora.
Also some medicines may affect the way <Invented name> works. 
Također, neki lijekovi mogu utjecati na djelovanje <Invented name>.
If you do accidentally take any of these drying agent tablets, they should not harm you but you should straight away talk to your doctor. 
Ako slučajno progutate neku od tableta sredstva za sušenje, ne bi Vam trebale naškoditi, ali se odmah javite svome liječniku.
• if you have low blood pressure (hypotension). 
• ako imate nizak krvni tlak (hipotenziju).
On the blister, it is clearly indicated which tablet is the drying agent. 
Na blisteru je jasno označeno koja tableta je sredstvo za sušenje.
OTHER SPECIAL WARNING(S), IF NECESSARY Contains a drying agent in each blister strip. 
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Svaki blister strip sadrži sredstvo za sušenje.
There is no significant hepatic first pass effect. 
Nema značajnog učinka prvog prolaska kroz jetru.
Feeling of weakness 
Osjećaj slabosti
• Yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine - This may be signs of liver problems. 
• Žutilo kože i očiju, svijetla boja stolice, tamna boja mokraće - to mogu biti znakovi problema s jetrom
• Medicines to treat high blood pressure. 
• Lijekove za liječenje visokog krvnog tlaka.
Nicorandil does not affect the pharmacodynamics of acenocoumarol. 
Nikorandil ne utječe na farmakodinamiku acenokumarola.
It works by increasing the blood flow through the blood vessels of the heart. 
Djeluje tako što povećava protok krvi kroz krvne žile srca.
Patients should be advised of the signs and symptoms and monitored closely for corneal ulcerations. 
Bolesnike treba savjetovati o znakovima i simptomima kornealnih ulceracija te ih pažljivo nadzirati.
The volume of distribution of nicorandil after intravenous (iv) dosing is 1.04 L/kg of body weight. 
Volumen distribucije nikorandila nakon intravenske (i.v.) primjene iznosi 1,04 l/kg tjelesne težine.
<Invented name> has an influence on the ability to drive and use machines. 
<Invented name> utječe na sposobnost upravljanja vozilima i rada na strojevima.
Administration is independent from food intake. 
Primjena ne ovisi o unosu hrane.
(≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1,000, <1/100), Rare (≥1/10,000, <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data). 
Učestalosti su definirane kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).Unutar svake skupine učestalosti nuspojave su prikazane redoslijedom od ozbiljnijih prema manje ozbiljnima.
The recommended dose is: - The usual starting dose is 10 mg twice daily. 
Preporučena doza je: - Uobičajena početna doza je 10 mg dva puta dnevno.
PHARMACEUTICAL FORM AND CONTENTS Tablets 
OBLIK I SADRŽAJ tablete
The usual starting dose is 10 mg twice daily (bid), in the morning and in the evening preferably. 
Uobičajena početna doza je 10 mg dva puta dnevno (bid), najbolje ujutro i navečer.
• if you have a low blood volume. 
• ako imate malen volumen krvi.
It is recommended that the dose be titrated upwards in accordance with the patient's needs, response and tolerance up to 40 mg twice daily, if necessary. 
Ako je potrebno, preporučuje se polagano povećanje doze, u skladu s bolesnikovim potrebama, odgovorom i podnošenjem, sve do 40 mg dva puta dnevno.
This is because <Invented name> may affect the way some other medicines work. 
To je potrebno jer <Invented name> može utjecati na djelovanje drugih lijekova.
It is used in adult patients who do not tolerate or cannot take heart medicines called beta-blockers and/or calcium antagonists. 
Primjenjuje se u odraslih bolesnika koji ne podnose ili ne mogu uzimati lijekove za srce koji se zovu beta blokatori i/ili antagonisti kalcija.
It improves the blood and oxygen supply of your heart muscle and reduces its workload. 
Poboljšava opskrbu srčanog mišića krvlju i kisikom te smanjuje njegovo radno opterećenje.
You should not breast-fed while you are taking this medicine. 
Ne smijete dojiti za vrijeme uzimanja ovog lijeka.
After 4-5 mg intravenous dosing (5 min infusion), the total body clearance was approximately 40-55 L/hour. 
Nakon intravenske doze od 4-5 mg (5-minutna infuzija),ukupan tjelesni klirens bio je otprilike 40-55 l/sat.
As a precautionary measure, it is preferable to avoid the use of <Invented name> during pregnancy. 
Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka <Invented name> tijekom trudnoće.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister strip/ 10 mg and 20 mg 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister strip/ 10 mg i 20 mg
You may feel blood pressure lowering effect such as dizziness, feeling of weakness. 
Možete osjetiti učinke pada krvnog tlaka kao što je omaglica i osjećaj slabosti.
It is included in the pack to protect <Invented name> tablets from moisture. 
Ona je uključena u pakiranje kako bi štitila tablete <Invented name> od vlage.
Based on available information, the time between starting nicorandil use and the onset of ulceration ranges from shortly after initiating nicorandil treatment to several years after starting nicorandil. 
Na temelju dostupnih informacija, vrijeme između početka primjene nikorandila i pojave ulceracija varira od kratko nakon uvođenja liječenja nikorandilom do nekoliko godina nakon početka primanja nikorandila.
Due to its nitrate moiety, nicorandil relaxes also vascular smooth muscle, particularly in the venous system via an increase in intracellular cyclic guanosine monophosphate (cGMP). 
Zbog svog nitratnog dijela, nikorandil također opušta glatke mišiće krvnih žila, osobito u venskom sustavu, putem povećanja intracelularnog cikličkog gvanozin monofosfata (cGMP-a).
Although any accidental intake of this desiccant is usually harmless, it may alter the scheduled intake of the active tablets. 
Iako je slučajan unos tog sredstva za sušenje obično bezopasan, može poremetiti raspored uzimanja djelatnih tableta.
• Hypersensitivity to nicorandil or to any of the excipients listed in section 6.1 
• Preosjetljivost na nikorandil ili neku od pomoćnih tvari navedenih u dijelu 6.1.
Nicorandil and its metabolites are mainly excreted by urinary route, faecal excretion being very low. 
Nikorandil i njegovi metaboliti uglavnom se izlučuju urinom, izlučivanje putem fecesa je vrlo slabo.
There was no evidence of teratogenicity (rat and rabbit), or abnormal pre- or post-natal physical or behavioural development (rat). 
Nije bilo dokaza teratogenosti (u štakora i kunića) ili abnormalnog prenatalnog ili postnatalnog tjelesnog ili bihevioralnog razvoja (u štakora).
Fertility studies showed no effects on mating ability in either male or female rats, but decreases in the number of live fetuses and implantation sites were noted at high doses. 
Ispitivanja plodnosti nisu pokazala utjecaj na sposobnost parenja ni u mužjaka ni u ženki štakora, ali je pri visokim dozama primijećen smanjen broj živih fetusa i mjesta implantacije.
Gastrointestinal ulcerations 
Gastrointestinalne ulceracije
Furthermore, the reduction of end-diastolic pressure and wall tension decreases the extravascular component of vascular resistance. 
Nadalje, smanjenje tlaka na kraju dijastole i napetosti stijenke smanjuje ekstravaskularnu komponentu vaskularnog otpora.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON for 10 mg and 20 mg 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA za 10 mg i 20 mg
N-(2-hydroxyethyl)-nicotinamide is the most abundant metabolite (about 8.9% of the administered dose within 48 hours) followed by nicotinuric acid, (5.7%), nicotinamide (1.34%), N-methyl-nicotinamide (0.61%) and nicotinic acid (0.40%). 
N-(2-hidroksietil)-nikotinamid je najzastupljeniji metabolit (oko 8,9% primjenjene doze unutar 48 sati), a zatim slijede nikotinurična kiselina (5,7%), nikotinamid (1,34%), N-metilnikotinamid (0,16%) i nikotinska kiselina (0,40%).
Nicorandil is mainly eliminated in urine as metabolites since parent product is less than 1%, of the administered dose in human urines (0-48 hours). 
Nikorandil se uglavnom eliminira urinom u obliku metabolita jer je u ljudskom urinu prisutno manje od 1% primjenjene doze izvornog spoja (0-48 sati).
• if you have a build-up of fluid in the lungs (pulmonary oedema). 
• ako Vam se nakuplja tekućina u plućima (plućni edem).
The metabolism of organic nitrates can result in the formation of nitrites which may trigger methemoglobinemia in patients with glucose-6-phosphate dehydrogenase deficiency. 
Metabolizam organskih nitrata može dovesti do nastanka nitrita koji mogu uzrokovati methemoglobinemiju u bolesnika s nedostatkom glukoza-6-fosfat dehidrogenaze.
Nicorandil is only slightly bound to human plasma proteins (bound fraction estimated at about 25%). 
Nikorandil se samo slabo veže na ljudske plazmatske proteine (vezana frakcija se procjenjuje na oko 25%).
G6PD deficiency <Invented name> should be used with caution in patients with glucose-6-phosphate-dehydrogenase deficiency. 
Nedostatak G6PD <Invented name> treba primjenjivati s oprezom u bolesnika s nedostatkom glukoza-6-fosfat dehidrogenaze.
The composite primary endpoint (coronary heart disease (CHD) death, non-fatal myocardial infarction, or unplanned hospital admission for cardiac chest pain), occurred in 337 patients (13.1%) of patients treated with nicorandil 20 mg twice daily compared with 389 patients (15.5%) of patients receiving placebo (hazard ratio 0.83; 95% confidence interval (CI) 0.72 to 0.97; p=0.014). 
Složeni primarni ishod (smrt od koronarne bolesti srca (KBS), infarkt miokarda bez smrtnog ishoda ili neplanirana hospitalizacija zbog bolova u prsima) nastupila je u 337 (13,1%) bolesnika liječenih s 20 mg nikorandila dva puta dnevno u usporedbi s 389 (15,5%) bolesnika koji su primali placebo (omjer hazarda 0,83; interval pouzdanosti (CI) 0,72 do 0,97; p=0,014).
Talk to your doctor or pharmacist before taking <Invented name>: 
Obratite se svom liječniku ili ljekarniku prije nego uzmete <Invented name>:
These side effects can occur at the beginning of treatment or latter in the treatment course. 
Ove nuspojave mogu se javiti na početku liječenja ili kasnije tijekom liječenja.
In case of acute overdose, the likely symptomatology may be peripheral vasodilation with a fall in blood pressure and reflex tachycardia. 
U slučaju akutnog predoziranja vjerojatno će se javiti simptomi periferne vazodilatacije s padom krvnog tlaka i refleksnom tahikardijom.
Absorption After oral administration, nicorandil is absorbed rapidly and completely from the gastrointestinal tract, independent from food intake. 
Nakon peroralne primjene nikorandil se brzo i potpuno apsorbira iz gastrointestinalnog sustava, neovisno o unosu hrane.
- Your doctor may increase the dose up to 20 mg twice daily depending on your needs, response to treatment and tolerance. 
- Vaš liječnik Vam može povisiti dozu sve do 20 mg dva puta dnevno, ovisno o Vašim potrebama,
• Medicine for impotence such as sildenafil, tadalafil or vardenafil. 
• Lijek za impotenciju kao što je sildenafil, tadalafil ili vardenafil.
In plasma unchanged nicorandil accounted for 45.5% of the radioactive AUC and the alcohol metabolite, N-(2-hydroxyethyl)-nicotinamide for 40.5%. 
Nepromijenjenom nikorandilu u plazmi pripisuje se 45,5% radioaktivnosti AUC-a, a alkoholnom metabolitu, N-(2-hidroksietil)-nikotinamidu 40,5%.
Other medicines and <Invented name> 
Drugi lijekovi i <Invented name>
• If you have glucose 6 Phosphate Deshydrogenase deficiency. 
• Ako imate nedostatak glukoza-6-fosfat dehidrogenaze.
Decrease of blood-pressure 
Pad krvnog tlaka
- Gastrointestinal ulcerations Nicorandil induced ulceration may occur at different locations in the same patient. 
Ulceracije uzrokovane nikorandilom mogu se pojaviti na različitim mjestima u istog bolesnika.
Embryotoxicity and peri- and post-natal toxicity 
Embriotoksičnost, perinatalna i postnatalna toksičnost
Therefore caution is advised when concomitant use of acetylsalicylic acid or NSAIDs and nicorandil is considered (see section 4.5). 
Stoga se preporučuje oprez pri razmatranju istovremene primjene acetilsalicilatne kiseline ili NSAIL-ova i nikorandila (vidjeti dio 4.5).
Additional investigative studies for testicular toxicity revealed decreased blood flow in the testis and decreased blood levels of testosterone. 
Dodatna ispitivanja toksičnog djelovanja na testis otkrila su smanjen protok krvi u testisima i smanjene razine testosterona u krvi.
Liver disorders such as hepatitis, cholestasis, or jaundice 
Poremećaji jetre kao što su hepatitis, kolestaza ili žutica
<Invented name> 10 mg [To be completed nationally] <Invented name> 20 mg [To be completed nationally] 
[Ispunjava država članica] <Invented name> 20 mg
• Medicines for inflammation (corticosteroids, non-inflammatory steroidal drugs such as ibuprofen). 
• Lijekove protiv upale (kortikosteroidi, nesteroidni protuupalni lijekovi kao što je ibuprofen).
Caution is advised when concomitant use is considered. 
Preporučuje se oprez pri razmatranju istovremene primjene.
<Invented name> is used to prevent or attenuate painful, straining symptoms (angina pectoris) of your heart disease. 
<Invented name> se koristi za sprečavanje ili ublažavanje simptoma boli i pritiska kod bolesti srca (angina pektoris).
Nicorandil has no direct effect on myocardial contractility. 
Nikorandil nema izravan utjecaj na kontraktilnost miokarda.
• if you are taking medicines to treat erectile dysfunction such as sildenafil, tadalfil, vardenafil (phosphodiesterase inhibitors) or medicines to treat pulmonary hypertension such as riociguat (guanylate cyclase stimulators). 
• ako uzimate lijekove za liječenje erektilne disfunkcije kao što su sildenafil, tadalafil, vardenafil (inhibitore fosfodiesteraze) ili lijekove za liječenje plućne hipertenzije kao što je riocigvat (stimulatore gvanilat ciklaze).
Ultimately, this results in an improved oxygen balance in the myocardium and improved blood flow in the post-stenotic areas of the myocardium. 
To konačno ima za posljedicu poboljšanu oksigenaciju miokarda i poboljšan protok krvi u poststenotičnim dijelovima miokarda.
Nicorandil has been shown to exert a direct effect on the coronary arteries, both on normal and stenotic segments, without leading to a steal phenomenon. 
Dokazano je da nikorandil djeluje izravno na koronarne arterije, i na normalne i stenotične dijelove, bez izazivanja sindroma koronarne krađe.
No clinically relevant modifications of the nicorandil pharmacokinetic profile is evidenced in population at risk such as elderly people, liver disease patients and chronic renal failure patients. 
Nisu zapažene klinički značajne promjene farmakokinetičkog profila nikorandila u populacijama s rizikom kao što su starije osobe, bolesnici s jetrenim bolestima i bolesnici s kroničnim zatajenjem bubrega.
Following exposure to nicorandil at doses that were maternally toxic, embryotoxicity was observed in the rat and rabbit. 
Nakon izloženosti nikorandilu u dozama toksičnima za majku, uočena je embriotoksičnost u štakora i kunića.
• Patients with shock (including cardiogenic shock), severe hypotension, or left ventricular dysfunction with low filling pressure or cardiac decompensation 
• Bolesnici u šoku (uključujući kardiogeni šok), s teškom hipotenzijom ili disfunkcijom lijevog ventrikula s niskim tlakom punjenja ili dekompenzacijom srca.
Dapoxetine should be prescribed with caution in patients taking nicorandil due to possible reduced orthostatic tolerance. 
Dapoksetin treba propisivati uz oprez u bolesnika koji uzimaju nikorandil zbog mogućnosti pojave ortostatske intolerancije.
Indeed, as with other vasodilators, blood pressure-lowering effects as well as dizziness and feeling weakness induced by nicorandil can reduce the ability to drive or to use machines. 
Naravno, kao i kod drugih vazodilatatora, učinak snižavanja krvnog tlaka, kao i omaglica i osjećaj slabosti izazvan nikorandilom može smanjiti sposobnost upravljanja vozilima i rada sa strojevima.
Patients with diverticular disease may be at particular risk of fistula formation or bowel perforation during nicorandil treatment. 
Bolesnici s divertikulozom mogu imati poseban rizik od nastanka fistula ili perforacije crijeva tijekom liječenja nikorandilom.
Nicorandil pharmacokinetics are linear from 5 mg to 40 mg. 
Farmakokinetika nikorandila je linearna za doze od 5 do 40 mg.
• Medicines to treat pulmonary hypertension such as riociguat. 
• Lijekove za liječenje plućne hipertenzije kao što je riocigvat.
• Eye injuries 
• Oštećenja oka
Tell your doctor, if you are taking any of the following: 
Obratite se svome liječniku ako uzimate bilo što od sljedećeg:
Animal studies have shown that nicorandil is excreted in small amounts into the breast milk. 
Ispitivanja na životinjama pokazuju da se nikorandil izlučuje u mlijeko u malim količinama.
Due to lack of data, caution is advised to use nicorandil in patients with heart failure class NHYA III or IV. 
Zbog nedostatka podataka, savjetuje se oprez pri primjeni nikorandila u bolesnika s zatajenjem srca III ili IV stupnja prema NYHA klasifikaciji.
If nicorandil is used concomitantly with antihypertensive agents or other medicinal products with blood pressure lowering effect (e.g. vasodilators, tricyclic antidepressants, alcohol), the blood pressure lowering effect may be increased. 
Ako se nikorandil primjenjuje istovremeno s antihipertenzivima ili drugim lijekovima koji imaju učinak snižavanja krvnog tlaka (npr. vazodilatatori, triciklički antidepresivi, alkohol), učinak snižavanja krvnog tlaka može biti pojačan.
Therefore, caution is advised when concomitant use of corticosteroids is considered. 
Stoga se preporučuje oprez pri razmatranju istovremene primjene kortikosteroida.
At steady state, the accumulation ratio (based on AUC) is around 2 for 20 mg bid tablet and 1.7 for 10 mg bid tablet. 
U stanju dinamičke ravnoteže omjer akumulacije (temeljeno na AUC) je oko 2 za bid tablete od 20 mg i 1,7
• Aspirin (acetylsalicylic acid). 
• acetilsalicilatnu kiselinu.
The IONA study was a randomised, double blind, placebo controlled study carried out in 5126 patients more than 45 years old with chronic stable angina, treated with standard antianginal therapies and at high risk of cardiovascular events defined by either: 1) previous myocardial infarction, or 2) coronary artery bypass grafting , or 3) coronary artery disease confirmed by angiography, or a positive exercise test in the previous two years, together with one of the following: left ventricular hypertrophy on the ECG, left ventricular ejection fraction ≤45%, or an end diastolic dimension of >55 mm, age 
5126 bolesnika starijih od 45 godina s kroničnom stabilnom anginom, liječenih standardnim antianginoznim terapijama i s visokim rizikom od kardiovaskularnih događaja koji su definirani kao: 1) prethodni infarkt miokarda ili 2) aortokoronarna premosnica ili 3) koronarna bolest potvrđena angiografijom ili pozitivna ergometrija u posljednje dvije godine zajedno s jednim od sljedećeg: hipertrofijom lijevog ventrikula vidljivom u EKG-u, ejekcijskom frakcijom lijevog ventrikula ≤45% ili promjerom ventrikula na kraju dijastole >55 mm, dobi ≥65 godina, dijabetesom, hipertenzijom, perifernom vaskularnom bolešću ili cerebrovaskularnom bolešću.
It is not known whether nicorandil is excreted in human milk, therefore <Invented name> is not recommended during breastfeeding. 
Nije poznato izlučuje li se nikorandil u majčino mlijeko, stoga se <Invented name> ne preporučuje tijekom dojenja.
<Invented name> is indicated in adults for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or have a contraindication or intolerance to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists). 
<Invented name> je indiciran u odraslih za simptomatsko liječenje bolesnika sa stabilnom anginom pektoris koja nije odgovarajuće kontrolirana antianginoznim lijekovima prve linije (kao što su beta blokatori i/ili antagonisti kalcija) ili za njih postoji kontraindikacija ili ih bolesnik ne podnosi.
In addition, the activation of the potassium channel leads to cardioprotective effects mimicking ischemic pre-conditioning. 
Dodatno, aktivacija kalijskih kanala dovodi do kardioprotektivnog učinka oponašajući ishemijsko prekondicioniranje.
Ulcers can occur at other site such as: skin, genital tract and nasal passages or around a stoma (in those with an artificial opening for waste removal such as a colostomy or ileostomy). 
Ulkusi se mogu pojaviti i na drugim mjestima kao što su: koža, genitalije, nosni hodnici ili oko stome (u osoba s umjetnim otvorom za izlazak crijevnog sadržaja kao što je kolostoma ili ileostoma).
There are no or limited amount of data from the use of nicorandil in pregnant women. 
Nema podataka ili su podaci o primjeni nikorandila u trudnica ograničeni.
What you need to know before you take <Invented name> 
Što morate znati prije nego počnete uzimati <Invented name>
Patients were excluded from the study if they were receiving a sulphonylurea as it was felt these patients may not benefit; (sulphonylurea agents have the potential to close potassium channels and may thus antagonise some of the effects of nicorandil). 
Bolesnici koji su primali sulfonilureju isključeni su iz ispitivanja zbog pretpostavke da neće imati dobrobiti od liječenja (lijekovi sa sulfonilurejom mogu zatvoriti kalijske kanale i na taj način antagonizirati neke od učinaka nikorandila).
Decrease in blood pressure (see section 
Pad krvnog tlaka (vidjeti dio 4.4)