natgillin/translations-raw huggingface dataset:
What is the risk associated with MicardisPlus?
Koji su rizici povezani s lijekom MicardisPlus?
The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to MicardisPlus.
Tablete od 80/25 mg se koriste u bolesnika čiji se krvni tlak ne može kontrolirati primjenom tableta jačine 80/12,5 mg ili koji su stabilizirani primjenom dvije djelatne tvari koje se uzimaju zasebno prije prelaska na MicardisPlus.
It is available as oval tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).
Dostupan je u obliku tableta (40 mg ili 80 mg irbesartana i 12,5 mg hidroklorotiazida; 80 mg irbesartana i 25 mg hidroklorotiazida).
What is MicardisPlus?
Što je MicardisPlus?
MicardisPlus must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
MicardisPlus se ne smije koristiti ni kod bolesnika s teškim jetrenim, bubrežnim ili žučnim problemima, s preniskom razinom kalija u krvi niti s previsokom razinom kalcija u krvi.
In patients who were not controlled on the 80/12.5 mg tablet, switching to the 80/25 mg tablet was more effective in reducing diastolic blood pressure than remaining on the lower dose.
U bolesnika koji nisu odgovarajuće kontrolirani tabletom jačine 80/12,5 mg, prelazak na tabletu jačine 80/25 mg bio je djelotvorniji u snižavanju dijastoličkog tlaka od ostanka na slabijoj dozi.
MicardisPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
MicardisPlus je lijek koji sadrži dvije djelatne tvari, telmisartan i amlodipin.
The full list of these medicines is given in the Package Leaflet.
Potpuni popis tih lijekova potražite u uputi o lijeku.
MicardisPlus contains two active substances, telmisartan and hydrochlorothiazide.
MicardisPlus sadrži dvije djelatne tvari, telmisartan i hidroklorotijazid.
MicardisPlus is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone.
MicardisPlus se koristi kod odraslih bolesnika s esencijalnom hipertenzijom (visokim krvnim tlakom) koja se ne može na odgovarajući način kontrolirati samo telmisartanom. „Esencijalno” znači da ne postoji očiti uzrok hipertenzije.
For the full list of all side effects reported with MicardisPlus, see the Package Leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka MicardisPlus potražite u uputi o lijeku.
What is MicardisPlus used for?
Za što se MicardisPlus koristi?
How is MicardisPlus used?
Kako se MicardisPlus koristi?
How does MicardisPlus work?
Kako djeluje MicardisPlus?
What benefit has MicardisPlus shown during the studies?
Koje su koristi lijeka MicardisPlus utvrđene u ispitivanjima?
How has MicardisPlus been studied?
Kako je MicardisPlus ispitivan?
You may also feel your heart is beating irregularly and faster.
Također možete osjetiti da Vam srce kuca brže i nepravilno.
The absolute bioavailability is about 75%.
Apsolutna biodostupnost je oko 75%.
Preferably take one dose in the morning and one in the evening.
Najbolje je uzimati jednu dozu ujutro a jednu uvečer.
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose.
Ukoliko zaboravite uzeti dozu, uzmite je čim se sjetite, osim ako je uskoro vrijeme za Vašu sljedeću dozu.
EXP: Use the strip within 30 days of opening.
EXP Iskoristite strip unutar 30 dana od otvaranja.
Maximum plasma concentrations (Cmax) are reached after about 30- 60 minutes.
Najveće plazmatske koncentracije (Cmax) postižu se nakon 30-60 minuta.
There are no special dose requirements for elderly patients, but as with all medicines, use of the lowest effective dose is recommended.
Nema posebnih preporuka za doziranje u starijih bolesnika, ali kao i sa svim lijekovima, preporučuje se primijeniti najnižu djelotvornu dozu.
Monitoring of cardiac function and general supportive measures are recommended.
Preporučuje se nadzor srčane funkcije i opće potporne mjere.
The patients should be advised not to take these tablets.
Bolesnike treba savjetovati da ne uzmu te tablete.
<Invented name> with alcohol
<Invented name> s alkoholom
• Very fast, uneven or forceful heart-beat (palpitations)
• Vrlo brzi, nejednaki ili snažni otkucaji srca (palpitacije)
This may seriously affect your blood pressure.
To može ozbiljno utjecati na Vaš tlak.
If you drink alcohol while you are treated with <Invented name>, your blood pressure may be decreased even further.
Ako pijete alkohol dok se liječite <Invented name>, krvni tlak Vam se može još više sniziti.
• Headache - This especially occurs during the first few days of treatment.
• Glavobolja - posebno često se javlja tijekom prvih nekoliko dana liječenja.
Study follow up for endpoint analysis was between 12 and 36 months with a mean of 1.6 years.
Praćenje u ispitivanju do analize ishoda trajalo je između 12 i 36 mjeseci sa srednjom vrijednošću 1,6 godina.
Children • <Invented name> is not recommended in children.
Djeca <Invented name> se ne preporučuje u djece.
The tablet of 10 mg can be divided into equal doses.
Tableta od 10 mg se može razdijeliti na jednake doze.
If this happens, do not drive or use any tools or machines.
Ako se to dogodi, nemojte upravljati vozilima ili raditi s bilo kakvim alatima ili strojevima.
The plasma concentration (and the area under the curve (AUC)) shows a linear proportionality to the dose.
Plazmatska koncentracija (i površina ispod krivulje (AUC)) linearno je proporcionalna dozi.
You should avoid taking this medicine while you are pregnant.
Trebate izbjegavati uzimanje ovog lijeka za vrijeme trudnoće.
The tablets are to be swallowed in the morning and in the evening as a whole with some liquid.
Tablete ujutro i uvečer treba progutati cijele s nešto tekućine.
• Aching muscles not caused by exercise (myalgia).
• Bol u mišićima koja nije uzrokovana vježbanjem (mijalgija).
Do not take out or separate tablet from the blister strip until intake.
Nemojte vaditi ili odvajati tabletu od blister stripa prije uzimanja.
Do not take aspirin or any medicines for inflammation (corticosteroids).
Nemojte uzeti aspirin ni bilo koji lijek protiv upale (kortikosteroid).
• Feeling of weakness.
• Osjećaj slabosti.
You may have eye injuries, stop taking <Invented name> and contact your doctor immediately.
Moguće je da imate oštećenja očiju, prestanite uzimati <Invented name> i odmah se obratite svom liječniku.
Do not swallow the drying agent which is the bigger tablet on one end of each blister strip.
Nemojte progutati sredstvo za sušenje; to je veća tableta na jednom kraju svakog blister stripa.
• If your eyes become red, itchy or swollen.
• Ako Vam oči postanu crvene, otečene ili Vas svrbe.
Paediatric population <Invented name> is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.
<Invented name> se ne preporučuje u pedijatrijskih bolesnika jer sigurnost i djelotvornost u ovoj skupini bolesnika nisu još ustanovljene.
Detailed information on this medicine is available on the website of {MS/Agency}
Drugi izvori informacija <Detaljne informacije o ovom lijeku dostupne su na internet stranici {naziv države članice/nadležnog tijela}>
Your doctor may progressively increase the dose to reduce the frequency of headaches.
Vaš liječnik može postupno povećavati dozu kako bi se smanjila učestalost glavobolja.
Driving and using machines <Invented name> may cause dizziness or weakness.
Upravljanje vozilima i strojevima <Invented name> može uzrokovati omaglicu ili slabost.
• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
• Oticanje lica, usana, usta, jezika ili grla može uzrokovati otežano gutanje ili disanje
• If you have heart problems such as heart failure.
• Ako imate problema sa srcem kao što je zatajenje srca.
This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Ovaj sažetak opisa svojstava lijeka, označavanje i uputa o lijeku ishod su arbitražnog postupka na koji se odnosi ova odluka Komisije.
Steady state is rapidly achieved (within 4 to 5 days) during repeated oral administration (bid regimen).
Stanje dinamičke ravnoteže postiže se brzo (unutar 4-5 dana) tijekom ponovljene oralne primjene (pri režimu doziranja dva puta dnevno (bid)).
Distribution of the product throughout the body remains stable, irrespective of dose, within the therapeutic range.
Distribucija lijeka u tijelu ostaje stabilna neovisno o dozi unutar terapijskog raspona.
Do not take this medicine and talk to your doctor if you are taking the following:
Nemojte uzimati ovaj lijek i obratite se svome liječniku ako uzimate sljedeće:
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