natgillin/translations-raw huggingface dataset:
2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 10 x 1 film-coated tablet 12 film-coated-tablets 
2 filmom obložene tablete 4 filmom obložene tablete 8 filmom obloženih tableta 10 x 1 filmom obloženih tableta 12 filmom obloženih tableta
This is most likely to occur within 4 hours post sildenafil dosing (see sections 4.2 and 4.4). 
sata nakon primjene doze sildenafila (vidjeti dijelove 4.2 i 4.4).
What you need to know before you take sildenafil Teva Do not take Sildenafil Teva 
Što morate znati prije nego počnete uzimati Sildenafil Teva
You should not take Sildenafil Teva if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure. 
Ne smijete uzimati Sildenafil Teva ako uzimate lijekove koji se nazivaju nitrati, jer kombinacija ovih lijekova može dovesti do opasnog pada krvnog tlaka.
How to store Sildenafil Teva 
Kako čuvati Sildenafil Teva
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing. 
nepravilni otkucaji srca, privremeno smanjenje protoka krvi u određene dijelove mozga, osjećaj stezanja u grlu, gubitak osjeta u ustima, krvarenje u očnoj pozadini, dvostruki vid, smanjena oštrina vida, neuobičajen osjet u oku, oticanje oka ili očnog kapka, sitne čestice ili mrlje u vidnom polju, aureole oko izvora svjetlosti, širenje zjenice oka, promjena boje bjeloočnice, krvarenje iz penisa, krv u sjemenoj tekućini, suhoća nosne sluznice, oticanje unutrašnjosti nosa, osjećaj razdražljivosti i iznenadno smanjenje ili gubitak sluha.
Sildenafil Teva 100 mg film-coated tablets EU/1/09/584/014 
Sildenafil Teva 100 mg filmom obložene tablete EU/1/09/584/014
In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. 
nuspojave su bile slične onima uočenim pri nižim dozama, međutim stope incidencije i težina bile su povećane.
This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50 % that of the parent drug. 
Ovaj metabolit ima profil selektivnosti za fosfodiesterazu koji je sličan sildenafilu te in vitro djelovanje na
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, croscarmellose sodium, magnesium stearate. 
Jezgra tablete celuloza, mikrokristalična kalcijev hidrogenfosfat, bezvodni karmelozanatrij, umrežena magnezijev stearat
You should not use Sildenafil Teva with any other oral or local treatments for erectile dysfunction. 
Ne smijete uzimati Sildenafil Teva s drugim oralnim (primijenjenim kroz usta) ili lokalnim lijekovima za erektilnu disfunkciju (poremećaj erekcije).
• Serious skin reactions - this occurs rarely. 
• Jake kožne reakcije - javljaju se rijetko
Penile haemorrhage, Priapism,* Haematospermia , Erection increased 
Penilna hemoragija, Prijapizam, * hematospermija, produžena erekcija
Sildenafil Teva 50 mg film-coated tablets EU/1/09/584/008 
Sildenafil Teva 50 mg filmom obložene tablete EU/1/09/584/008
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300 % (4-fold) increase in sildenafil Cmax and a 1,000 % (11-fold) increase in sildenafil plasma AUC. 
Istodobna primjena inhibitora HIV proteaze, ritonavira, koji je jaki P450 inhibitor, u stanju dinamičke ravnoteže (500 mg dva puta dnevno) sa sildenafilom (100 mg u jednoj dozi) rezultirala je 300%-tnim (4 puta) porastom Cmax sildenafila i 1000%-tnim (11 puta) porastom AUC sildenafila u plazmi.
Sildenafil Teva 25 mg film-coated tablets EU/1/09/584/002 
Sildenafil Teva 25 mg filmom obložene tablete EU/1/09/584/002
However, you may find that Sildenafil Teva takes longer to start working if you take it with a heavy meal. 
Međutim, ako uzmete Sildenafil Teva uz obilniji obrok, možda će proći više vremena do početka njegovog djelovanja.
Your doctor should carefully check whether your heart can take the additional strain of having sex. 
Vaše srce podnijeti dodatni napor spolnog odnosa.
Myopia, 
Mučnina,
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140 % increase in sildenafil Cmax and a 210 % increase in sildenafil AUC. 
Istodobna primjena inhibitora HIV proteaze, sakvinavira, inhibitora CYP3A4, u stanju dinamičke ravnoteže (1200 mg tri puta dnevno) sa sildenafilom (100 mg u jednoj dozi) rezultirala je 140%-tnim porastom Cmax sildenafila i 210%-tnim porastom AUC sildenafila.
If Sildenafil Teva does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor. 
Trebate obavijestiti svog liječnika ako Vam Sildenafil Teva ne pomaže u postizanju erekcije ili ukoliko erekcija ne traje dovoljno dugo za dovršetak spolnog odnosa.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
DODATAK II A. PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
Uncommon (≥ 1/1,000 and 
(≥ 1/1000 do
No significant interactions were shown when sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9. 
(250 mg) ili varfarinom (40 mg), lijekovima koji se metaboliziraju putem CYP2C9.
The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80 % of administered oral dose) and to a lesser extent in the urine (approximately 13 % of administered oral dose). 
Nakon peroralne ili intravenske primjene, sildenafil se izlučuje u obliku metabolita, uglavnom stolicom (približno 80% primijenjene oralne doze) i u manjoj mjeri mokraćom (približno 13%
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder 
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač
In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility. 
700 puta u usporedbi s PDE2, 3, 4, 7, 8, 9, 10 i 11. Posebno, sildenafil ima preko 4000 puta veću selektivnost za PDE5 u usporedbi s PDE3, cAMP-specifičnoj izoformi fosfodiesteraze uključenoj u kontrolu kontraktilnosti srca.
In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002 % (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing. 
U zdravih dobrovoljaca koji su primali sildenafil (100 mg u jednokratnoj dozi), manje od 0,0002%
6.6 Special precautions for disposal and other handling 
6.6 Posebne mjere za zbrinjavanje
You should not take Sildenafil Teva if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure. 
Ne smijete uzimati Sildenafil Teva ako uzimate bilo koje od lijekova poznatih kao donori dušikovog oksida poput amil nitrita, jer kombinacija, također, može dovesti do opasnog pada krvnog tlaka.
In a study of healthy male volunteers, co-administration of the endothelin antagonist, bosentan, (an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19) at steady state (125 mg twice a day) with sildenafil at steady state (80 mg three times a day) resulted in 62.6% and 55.4% decrease in sildenafil AUC and Cmax, respectively. 
U ispitivanju sa zdravim muškim dobrovoljcima, istodobna primjena antagonista endotelina, bosentana (induktor CYP3A4 [umjereni], CYP2C9 i vjerojatno CYP2C19), u stanju dinamičke ravnoteže (125 mg dva puta dnevno) sa sildenafilom u stanju dinamičke ravnoteže
Sildenafil Teva is available in blister packs of 2, 4, 8 and 12 tablets, and perforated unit dose blisters containing 10 x 1 tablet. 
Sildenafil Teva dostupan je u blisterima od 2, 4, 8 i 12 tableta, te u perforiranim blisterima djeljivim na jedinične doze koji sadrže 10 x 1 tabletu.
Sildenafil Teva is available in blister packs of 2, 4, 8, 12 and 24 tablets, and perforated unit dose blisters containing 10 x 1 tablet. 
Sildenafil Teva dostupan je u blisterima od 2,4, 8, 12 i 24 tableta, te u perforiranim blisterima djeljivim na jedinične doze koji sadrže 10 x 1 tabletu.
Sildenafil Teva 25 mg film-coated tablets Sildenafil Teva 50 mg film-coated tablets Sildenafil Teva 100 mg film-coated tablets 
Sildenafil Teva 25 mg filmom obložene tablete Sildenafil Teva 50 mg filmom obložene tablete Sildenafil Teva 100 mg filmom obložene tablete
The European Medicines Agency has waived the obligation to submit the results of studies with Sildenafil Teva in all subsets of the paediatric population for the treatment of erectile dysfunction. 
Pedijatrijska populacija Europska Agencija za lijekove se odrekla obaveze da prijavljuje rezultate studija s lijekom Sildenafil
In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken Sildenafil Teva and when you did. 
ljekarnika ili medicinsku sestru da ste uzeli Sildenafil Teva te kada ste ga uzeli.
Sudden cardiac death,* 
Poremećaj suzenja očiju***,
In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg. 
primjenjivao istodobno s amlodipinom u bolesnika s hipertenzijom, došlo je do dodatnog sniženja sistoličkog krvnog tlaka u ležećem položaju od 8 mmHg.
Sildenafil Teva 100 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets. 
Sildenafil Teva 100 mg filmom obložene tablete Blisteri od PVC/aluminija u kutijama sa 2, 4, 8, 12 ili 24 tablete.
Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. 
120 minuta (medijan 60 minuta) od oralnog doziranja natašte.
10 x 1 tablet in PVC/Aluminium perforated unit dose blisters. 
Perforirani blisteri djeljivi na jedinične doze od PVC/aluminija koji sadrže 10 x 1 tabletu.
− If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure. 
• Ako uzimate bilo koje od lijekova poznatih kao donori dušikovog oksida poput amil nitrita, jer kombinacija također može dovesti do opasnog pada krvnog tlaka.
Sildenafil Teva 50 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets. 
Sildenafil Teva 50 mg filmom obložene tablete Blisteri od PVC/aluminija u kutijama sa 2, 4, 8, 12 ili 24 tablete.
Sildenafil Teva 25 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8 or 12 tablets. 
Sildenafil Teva 25 mg filmom obložene tablete Blisteri od PVC/aluminija u kutijama sa 2,4, 8 ili 12 tableta.
Lacrimation disorders***, Eye pain, Photophobia, Photopsia, Ocular hyperaemia, Visual brightness, Conjunctivitis 
bol u oku, fotofobija, fotopsija, kromatopsija, hiperemija oka,
With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5). 
u bolesnika koji se istodobno liječe CYP3A4 inhibitorima potrebno je razmotriti primjenu početne doze od 25 mg (vidjeti dio 4.5).
In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in the visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress). 
(jednokratna doza, 100 mg) nije prikazao značajne promjene u provedenim testovima vida (oštrina vida, Amslerova mreža, raspoznavanje boja simulacijom semafora, Humphreyev perimetar i fotostres).
Sildenafil Teva 25 mg are white, oval-shaped film-coated tablets, engraved with ‘S 25' on one side, and plain on the other side. 
Sildenafil Teva 25 mg su bijele, ovalne filmom obložene tablete, s oznakom “S 25” na jednoj strani, te bez oznaka na drugoj strani.
resulted in a 49.8% increase in bosentan AUC and a 42% increase in bosentan Cmax (125 mg b.i.d. 
U zdravih muških dobrovoljaca, sildenafil je u stanju dinamičke ravnoteže (80 mg tri puta na dan) rezultirao sa 49,8%-tnim povećanjem AUC bosentana i 42%-tnim povećanjem Cmax bosentana (125
Dizziness 
Gluhoća
Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8). 
Slučajevi nearteritične anteriorne ishemijske optičke neuropatije, rijetkog stanja, prijavljeni su spontano i u opservacijskom ispitivanju vezano uz uzimanje sildenafila i dugih
Sildenafil Teva 100 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil. 
Sildenafil Teva 100 mg filmom obložene tablete Svaka tableta sadrži sildenafilcitrat, što odgovara 100 mg sildenafila.
Rare (≥ 1/10,000 and <1/1,000) 
(≥ 1/10 000 do
You may find that Sildenafil Teva takes longer to work if you take it with a heavy meal. 
Ako uzmete Sildenafil Teva uz obilniji obrok, možda će proći više vremena do početka njegovog djelovanja.
Sildenafil Teva 100 mg are white, oval-shaped film-coated tablets, engraved with ‘S 100' on one side, and plain on the other side. 
Sildenafil Teva 100 mg su bijele, ovalne filmom obložene tablete, s oznakom “S 100” na jednoj strani te bez oznaka na drugoj strani.
Sildenafil Teva 25 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil. 
Sildenafil Teva 25 mg filmom obložene tablete Svaka tableta sadrži sildenafilcitrat, što odgovara 25 mg sildenafila.
Sildenafil Teva 50 mg are white, oval-shaped film-coated tablets, engraved with ‘S 50' on one side, and plain on the other side. 
Sildenafil Teva 50 mg su bijele, ovalne filmom obložene tablete, s oznakom s “S 50” na jednoj strani, te bez oznaka na drugoj strani.
Each tablet contains 25 mg of sildenafil (as the citrate salt). 
Svaka tableta sadrži 25 mg sildenafila (u obliku sildenafilcitrata).
Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates. 
Sildenafil (100 mg) nije utjecao na farmakokinetiku stanja dinamičke ravnoteže inhibitora HIV
Each tablet contains 100 mg of sildenafil (as the citrate salt). 
Svaka tableta sadrži 100 mg sildenafila (u obliku sildenafilcitrata).
Irritability 
Preosjetljivost
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - Sildenafil Teva 25 mg Film-coated tablets 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - Sildenafil Teva 25 mg filmom obložene tablete
Read the package leaflet before use For oral use. 
Prije uporabe pročitajte uputu o lijeku.
Package leaflet: Information for the patient Sildenafil Teva 25 mg film-coated tablets 
Uputa o lijeku: Informacija za bolesnika Sildenafil Teva 25 mg filmom obložene tablete sildenafil
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 25 mg Film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - Sildenafil Teva 25 mg filmom obložene tablete
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - Sildenafil Teva 100 mg Film-coated tablets 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - Sildenafil Teva 100 mg filmom obložene tablete
Each tablet contains 50 mg of sildenafil (as the citrate salt). 
Svaka tableta sadrži 50 mg sildenafila (u obliku sildenafilcitrata).
Deafness 
dispepsija
Sildenafil Teva 50 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil. 
Sildenafil Teva 50 mg filmom obložene tablete Svaka tableta sadrži sildenafilcitrat, što odgovara 50 mg sildenafila.
White, oval-shaped film-coated tablets, engraved with ‘S 25' on one side, and plain on the other side. 
Bijele, ovalne filmom obložene tablete, s oznakom “S 25” na jednoj strani, te bez oznaka na drugoj strani.
Package leaflet: Information for the patient Sildenafil Teva 100 mg film-coated tablets 
Uputa o lijeku: Informacija za bolesnika Sildenafil Teva 100 mg filmom obložene tablete sildenafil
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 100 mg Film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - Sildenafil Teva 100 mg filmom obložene tablete
White, oval-shaped film-coated tablets, engraved with ‘S 100' on one side, and plain on the other side. 
Bijele, ovalne filmom obložene tablete, s oznakom “S 100” na jednoj strani, te bez oznaka na drugoj strani.
Sildenafil Teva 25 mg film-coated tablets sildenafil 
Sildenafil Teva 25 mg filmom obložene tablete sildenafil
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - Sildenafil Teva 50 mg Film-coated tablets 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - Sildenafil Teva 50 mg filmom obložene tablete
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 50 mg Film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - Sildenafil Teva 50 mg filmom obložene tablete
Sildenafil Teva 100 mg film-coated tablets sildenafil 
Sildenafil Teva 100 mg filmom obložene tablete sildenafil
Package leaflet: Information for the patient Sildenafil Teva 50 mg film-coated tablets 
Uputa o lijeku: Informacija za bolesnika Sildenafil Teva 50 mg filmom obložene tablete sildenafil
Sildenafil Teva 25 mg film-coated tablets 
Sildenafil Teva 25 mg filmom obložene tablete
Sildenafil Teva 50 mg film-coated tablets sildenafil 
Sildenafil Teva 50 mg filmom obložene tablete sildenafil
• Seizures or fits - this occurs rarely 
• Napadaji - javljaju se rijetko
White, oval-shaped film-coated tablets, engraved with ‘S 50' on one side, and plain on the other side. 
Bijele, ovalne filmom obložene tablete, s oznakom “S 50” na jednoj strani, te bez oznaka na drugoj strani.
The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and. 
dispepsija, nazalna kongestija, omaglica, mučnina, navale vrućine, poremećaji vida, cijanopsija i zamagljen vid.
In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 mL/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose. 
nakon uzimanja jednokratne oralne doze od 50 mg nije bilo promjena u farmakokinetici sildenafila.
Throat tightness, Nasal oedema, Nasal dryness 
neuobičajena osjetljivost oka, edem kapka, diskoloracija bjeloočnice
Sildenafil Teva 100 mg film-coated tablets 
Sildenafil Teva 100 mg filmom obložene tablete
Sildenafil Teva 50 mg film-coated tablets 
Sildenafil Teva 50 mg filmom obložene tablete
Asthenopia, Vitreous floaters, Iris disorder, Mydriasis, 
midrijaza, svjetlosne aureole, edem oka, oticanje oka,
Sildenafil 
Sildenafil Teva.
Diplopia, Visual acuity reduced, 
glaukom, ispadi vidnog polja diplopija,
Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil 
Svaka tableta sadrži 25 mg sildenafila u obliku sildenafilcitrata.
Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil 
Svaka tableta sadrži 100 mg sildenafila u obliku sildenafilcitrata.
Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil 
Svaka tableta sadrži 50 mg sildenafila u obliku sildenafilcitrata.
Heart rate increased 
MATERIJALA KOJI POTJEČU
When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182 % increase in sildenafil systemic exposure (AUC). 
inhibitorom, u stanju dinamičke ravnoteže (500 mg dva puta dnevno tijekom 5 dana), uočen je 182%
STATEMENT OF ACTIVE SUBSTANCE(S) 
toksična epidermalna nekroliza (TEN) *
Chest pain, Fatigue, Feeling hot 
Razdražljivost mjestu primjene osjećaj vrućine
Gastrointestin al disorders 
Prijavljivanje nuspojava
Tabulated list of adverse reactions 
Opći poremećaji i reakcije na
o Gastrointestinal: diarrhea, bloody stool, abdominal pain, nausea, or vomiting o Liver: yellowing of your skin or whites of your eyes o Skin: rash, blisters and/or peeling, mouth sores o Eye: blurred vision, vision changes, eye pain, o General: fever, headache, feeling tired, dizziness or fainting, dark urine, bleeding, weakness, numbness of legs, arms, or faces, changes in behavior, such as less sex drive, being irritable or forgetful 
o probavni sustav: proljev, krvava stolica, bol u trbuhu, mučnina ili povraćanje o jetra: žutilo kože ili bjeloočnica o koža: osip, mjehurići na koži i/ili ljuštenje kože, afte u ustima o oči: zamagljen vid, promjene vida, bol u očima o opći simptomi: vrućica, glavobolja, umor, omaglica ili nesvjestica, tamna boja mokraće, krvarenje, slabost, utrnulost nogu, ruku ili lica, promjene ponašanja poput slabljenja spolne želje, razdražljivosti ili zaboravljivosti.
The Member States shall ensure that the Marketing Authorisation Holder provides all physicians who are expected to prescribe YERVOY with the following: 
Zemlje članice će osigurati da Nositelj odobrenja svim liječnicima za koje se očekuje da će propisivati YERVOY dostavi:
• Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and need to be addressed immediately 
• Informacija o tome da ipilimumab može izazvati ozbiljne nuspojave u brojnim dijelovima tijela koje mogu imati smrtni ishod i moraju se odmah liječiti.
It also contains prompts to enter contact details of the physician and to alert other physicians that the patient is treated with ipilimumab. 
Ona sadrži i naputke da se zabilježe kontaktni podaci nadležnog liječnika te upozorenje drugim liječnicima da se bolesnik liječi ipilimumabom.
• Importance of evaluating liver function tests (LFTs), TSH and signs/symptoms of irARs before each treatment. 
• Važnost procjene rezultata testova jetrene funkcije, TSH-a i znakova/simptoma imunološki uzrokovanih nuspojava prije svake terapije.
The Card reminds patients about key symptoms that need to be reported immediately to the physician/nurse. 
Kartica podsjeća bolesnika na najvažnije simptome koje odmah mora prijaviti liječniku ili medicinskoj sestri.
• Request to inform the physician of all medical conditions before treatment. 
• Zahtjev bolesniku da prije liječenja obavijesti liječnika o svim medicinskim problemima.
• Description of the main symptoms of irARs and the importance of notifying their treating physician immediately if symptoms occur, persist or worsen. 
• Opis glavnih simptoma imunološki uzrokovanih nuspojava i naglašavanje da je važno da bolesnik odmah obavijesti nadležnog liječnika ako se simptomi pojave, ne prolaze ili se pogoršavaju.
• Follow-up of patients due to late onset (months after treatment) of irARs 
• Praćenje bolesnika zbog mogućeg kasnog nastupaimunološki uzrokovanih nuspojava (mjesecima nakon liječenja).