natgillin/translations-raw huggingface dataset:
Common (may affect up to 1 in 10 people): insomnia, difficulty in performing voluntary movements, feeling sleepy, dizziness, headache, worsening of Parkinson's disease, clouding of the lens of the eye, fall in blood pressure when rising to a standing position, nausea, falling. 
Često (mogu se javiti u do 1 od 10 osoba): nesanica, teškoće u izvođenju voljnih pokreta, osjećaj pospanosti, omaglica, glavobolja, pogoršanje Parkinsonove bolesti, zamućenje očne leće, pad krvnog tlaka pri dizanju u stojeći položaj, mučnina, padanje.
If you have taken too many Xadago tablets, you may develop raised blood pressure, anxiety, confusion, forgetfulness, sleepiness, lightheadedness; feel sick or be sick; dilated pupils or develop involuntary jerky movements. 
Ako ste uzeli previše Xadago tableta, možete razviti povišeni krvni tlak, tjeskobu, smetenost, zaboravnost, pospanost, ošamućenost, mučninu ili povraćanje, raširene zjenice ili razviti nevoljne trzajne pokrete.
Responder analyses (post-hoc) (e) n(%) ON time increase ≥60 minutes p-value ≥60 minutes increase ON time and decrease in OFF time and ≥ 30% improvement UPDRS III p-value 
≥ 60 minuta produljenje ON razdoblja i skraćivanje OFF razdoblja i ≥ 30 % poboljšanja UPDRS III
Secondary efficacy parameters included OFF Time, UPDRS II and III (Unified Parkinson's Disease Rating Scale - sections II and III), and CGI-C (Clinical Global Impression of Change) 
Unified Parkinson's Disease Rating Scale - sections II and III) i ljestvicu Općeg kliničkog dojma promjene (engl.
There have been reports of medicinal product interactions with the concomitant use of dextromethorphan and non-selective MAO inhibitors. 
Postoje izvještaji o interakcijama lijekova prilikom istodobne primjene dekstrometorfana i neselektivnih MAO inhibitora.
Xadago should not be used during pregnancy or by women of childbearing potential not practicing adequate contraception. 
Xadago se ne smije uzimati tijekom trudnoće i ne smiju ga primjenjivati žene u reproduktivnoj dobi koje ne koriste odgovarajuću kontracepciju.
How to take Xadago 
Kako uzimati Xadago
Drug effect decreased, drug intolerance, feeling cold, malaise, pyrexia, xerosis 
Smanjeni učinak lijeka, nepodnošenje lijeka, osjećaj hladnoće, malaksalost, pireksija, kseroza
Back pain, arthralgia, muscle spasms, muscle rigidity, pain in extremity, muscular weakness, sensation of heaviness 
Bol u leđima, artralgija, spazam mišića, rigidnost mišića, bol u ekstremitetima, slabost u mišićima, osjećaj težine
Serious adverse reactions are known to occur with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors, such as hypertensive crisis (high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, CPK increase), serotonin syndrome (confusion, hypertension, muscle stiffness, hallucinations), and hypotension. 
Poznato je da se ozbiljne nuspojave pojavljuju s istodobnom uporabom SSRI-ja, SNRI-ja, tricikličnih/tetracikličnih antidepresiva i MAO inhibitora, kao što je hipertenzivna kriza (visok krvni tlak, kolaps), neuroleptički maligni sindrom (konfuzija, znojenje, rigidnost mišića, hipertermija, povećanje CPK-a), serotoninski sindrom (konfuzija, hipertenzija, rigidnost mišića, halucinacije) i hipotenzija.
LS Diff vs Placebo 
LS razl. naspram placebo
Serious adverse reactions have been reported with the concomitant use of selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic/tetracyclic antidepressants and MAO inhibitors (see section 4.4). 
Pri istodobnoj primjeni selektivnih inhibitora ponovne pohrane serotonina (SSRI), inhibitora ponovne pohrane serotonina i noradrenalina (engl. serotonin norepinephrine reuptake inhibitors, SNRI), tricikličnih/tetracikličnih antidepresiva i MAO inhibitora (vidjeti dio 4.4) prijavljene su ozbiljne nuspojave.
Fertility studies in female rats showed reduced number of implantations and corpora lutea at exposures in excess of 3 times the anticipated human exposure. 
Ispitivanja plodnosti u ženki štakora pokazala su smanjen broj implantacija i žutog tijela pri izloženostima 3 puta većima od očekivane izloženosti u ljudi.
Safinamide use in patients with severe hepatic impairment is contraindicated (see section 4.3). 
Primjena safinamida u bolesnika s teškim oštećenjem jetre je kontraindicirana (vidjeti dio 4.3).
How to store Xadago 
Kako čuvati Xadago
Another pathway involves oxidative cleavage of the ether bond forming ‘O-debenzylated safinamide' (NW-1199). 
Drugi put uključuje oksidativno cijepanje eterske veze stvarajući „O-debenziliran safinamid“ (NW-1199).
PD Duration (years) (b) 
Randomizirano Dob (godine) (b) Trajanje PB-a (godine) (b)
Common Uncommon 
See seventh uncommon ADR.
Seek medical advice in case of hypertensive crisis (very high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, increase level of enzyme creatine kinase in your blood), serotonin syndrome (confusion, hypertension, muscle stiffness, hallucinations), and hypotension. 
Potražite medicinski savjet u slučaju pojave hipertenzivne krize (vrlo visoki krvni tlak, kolaps), malignog neuroleptičkog sindroma (smetenost, znojenje, ukočenost mišića, povišena tjelesna temperatura, povišene razine enzima kreatin kinaze u krvi), serotoninskog sindroma (smetenost, povišeni krvni tlak, ukočenost mišića, halucinacije) i sniženog krvnog tlaka.
As this may be a class-effect, the concomitant administration of safinamide and pethidine is contraindicated (see section 4.3). 
Kako to može biti učinak skupine, istodobna primjena safinamida i petidina je kontraindicirana (vidjeti dio 4.3).
Palpitations, tachycardia, sinus bradycardia, arrhythmia 
Palpitacije, tahikardija, sinusna bradikardija, aritmija
Cough, dyspnoea, rhinorrhoea 
Kašalj, dispneja, rinoreja
Male rat fertility is not affected (see section 5.3). 
Nema utjecaja na plodnost mužjaka štakora (vidjeti dio 5.3).
Xadago is not recommended during pregnancy and in women of childbearing potential not using contraception. 
Ne preporučuje se koristiti lijek Xadago tijekom trudnoće ni u žena u reproduktivne dobi koje ne koriste kontracepciju.
Safinamide should not be given to women of childbearing potential unless adequate contraception is practiced. 
Safinamid se ženama u reproduktivnoj dobi smije davati samo ako koriste odgovarajuću kontracepciju.
Hyperhidrosis, pruritus generalised, photosensitivity reaction, erythema 
Hiperhidroza, opći svrbež, reakcija fotoosjetljivosti, eritem
Safinamide 
Hipromeloza
Alopecia, blister, dermatitis contact, dermatosis, ecchymosis, lichenoid keratosis, night sweats, pain of skin, pigmentation disorder, psoriasis, seborrhoeic dermatitis 
Alopecija, mjehurići, kontaktni dermatitis, dermatoza, ekhimoza, lihenoidna keratoza, noćno znojenje, bolna koža, poremećaj pigmentacije, psorijaza, seboroični dermatitis
Some reports of ICDs have also been observed with other MAO-inhibitors. 
Neki izvještaji o poremećajima kontrole impulsa primijećeni su i s drugim MAO inhibitorima.
There have been reports of medicinal product interactions with the concomitant use of MAO inhibitors and sympathomimetic medicinal products. 
Postoje izvještaji o interakcijama lijekova prilikom istodobne primjene MAO inhibitora i simpatomimetičkih lijekova.
Erectile dysfunction Benign prostatic hyperplasia, breast disorder, breast pain 
Benigna hiperplazija prostate, poremećaj dojke, bol u dojci
Serious adverse reactions have been reported with the concomitant use of pethidine and MAO inhibitors. 
Ozbiljne nuspojave prijavljene su pri istodobnoj primjeni petidina i MAO inhibitora.
Urinary tract infection Bronchopneumonia, furuncle, nasopharyngitis, pyoderma, rhinitis, tooth infection, viral infection 
Bronhopneumonija, furunkul, nazofaringitis, pioderma, rinitis, infekcija zuba, virusna infekcija
Safinamide treatment has not been associated with any increase in the appearance of ICDs. 
Liječenje safinamidom nije povezano s porastom pojave poremećaja kontrole impulsa.
C-safinamide accounted for approximately 30% of the total radioactivity AUC0-24h, indicative of an extensive metabolism. 
Ispitivanje masene bilance pokazalo je da AUC0-24h nepromijenjenog 14C-safinamida u plazmi čini oko 30% AUC0-24h ukupne radioaktivnosti, ukazujući na opsežan metabolizam.
Hypertension, hypotension, varicose vein 
Hipertenzija, hipotenzija, varikozne vene
Somnolence and dizziness may occur during safinamide treatment; you should be cautious about operating hazardous machines or driving, until you are reasonably certain that Xadago does not affect you in any way. 
Trebate biti oprezni pri upravljanju opasnim strojevima ili vozilima sve dok niste razumno sigurni da Xadago ne utječe štetno na Vas ni na koji način.
Hypromellose Macrogol (6000) Titanium dioxide (E171) Iron oxide red (E172) Mica (E555) 
Titanijev dioksid (E171)
Dyskinesia somnolence dizziness, headache, Parkinson's disease 
Diskinezija somnolencij a, omaglica, glavobolja, Parkinsonov a bolest
Paraesthesia, balance disorder, hypoaesthesia, dystonia, head discomfort, dysarthria, syncope, cognitive disorder 
Parestezija, poremećaj ravnoteže, hipoestezija, distonija, nelagoda u glavi, dizartrija, sinkopa, kognitivni poremećaj
Fatigue, asthenia, gait disturbance, oedema peripheral, pain, feeling hot 
Umor, astenija, poremećaj hoda, periferni edem, bol, osjećaj vrućine
What Xadago contains - The active substance is safinamide. 
Što Xadago sadrži Djelatna tvar je safinamid.
SE Standard Error, SD Standard deviation, LSM Least Square Mean, LS Diff. 
Standard Error) standardna greška, SD (engl.
Warnings and precautions Talk to your doctor before taking Xadago - If you have liver problems - Patients and carers should be made aware that certain compulsive behaviours such as compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive spending or buying have been reported with other medicines for Parkinson's disease. 
- Ako imate probleme s jetrom - Bolesnici i njegovatelji moraju biti upoznati da su određena kompulzivna ponašanja, kao što su kompulzije, opsesivne misli, patološko kockanje, povećan libido, hiperseksualnost, impulzivno ponašanje i kompulzivno trošenje i kupovanje, prijavljena s drugim lijekovima za Parkinsonovu bolest.
A washout period corresponding to 5 half-lives of the SSRI used previously should be considered prior to initiating treatment with safinamide. 
Prije uvođenja liječenja safinamidom potrebno je uzeti u obzir razdoblje ispiranja, koje odgovara trajanju 5 poluživota prethodno primijenjenog SSRI-ja.
Cachexia, hyperkalaemia 
Kaheksija, hiperkalemija
Ask your doctor for advice before taking any of the following medicines together with Xadago: - Cold or cough remedies containing dextromethorphan, ephedrine or pseudoephedrine - Medicines called selective serotonin reuptake inhibitors (SSRIs) typically used to treat anxiety disorders, and some personality disorders (e.g. fluoxetine or fluvoxamine) - Medicines called serotonin-norepinephrine reuptake inhibitors (SNRIs), used in the treatment of major depression and other mood disorders, such as venlafaxine - Medicines for high cholesterol such as rosuvastatin, pitavastatin, pravastatin - Fluoroquinolone antibiotic such as ciprofloxacin - Medicines that affect the immune system such as methotrexate - Medicines to treat metastatic carcinoma such as topotecan - Medicine to treat pain and inflammation such as diclofenac - Medicines to treat type 2 diabetes such as glyburide, metformin - Medicines to treat virus infection such as aciclovir, ganciclovir 
lijekovi za povišen kolesterol poput rosuvastatina, pitavastatina, pravastatina fluorokinolonski antibiotik, poput ciprofloksacina lijekovi koji utječu na imunološki sustav, poput metotreksata lijekovi za liječenje metastatskog karcinoma, poput topotekana lijek za liječenje boli i upale, poput diklofenaka lijekovi za liječenje dijabetesa tipa 2, poput gliburida i metformina lijekovi za liječenje virusnih infekcija, poput aciklovira i ganciklovira
Rare abnormal dreams, anxiety, confusional state, affect lability, libido increased, psychotic disorder, restlessness, sleep disorder disorientation, illusion, impulsive behaviour, loss of libido, obsessive thoughts, paranoia, premature ejaculation, sleep attacks, social phobia, suicidal ideation 
Kompulzije, delirij, dezorijentacija, iluzija, impulzivno ponašanje, gubitak libida, opsesivne misli, paranoja, preuranjena ejakulacija, napadi spavanja, društvene fobije, suicidalne ideje
Vision blurred, scotoma, diplopia, photophobia, retinal disorder, conjunctivitis, glaucoma 
Zamagljen vid, skotom, diplopija, fotofobija, poremećaj mrežnice, konjuktivitis, glaukom
Coordination abnormal, disturbance in attention, dysgeusia, hyporeflexia, radicular pain, Restless Legs Syndrome, sedation 
Poremećena koordinacija, smetnja pažnje, disgeuzija, hiporefleksija, radikularna bol, sindrom nemirnih nogu, sedacija
If patients progress from moderate to severe hepatic impairment safinamide should be stopped (see section 4.4). 
U slučaju da bolesnici uznapreduju od umjerenog do teškog oštećenja jetre, primjenu safinamida potrebno je prekinuti (vidjeti dio 4.4).
Renal impairment No change in dose is required for patients with renal impairment. 
Nije potrebna promjena doze u bolesnika s oštećenjem bubrega.
OFF time (hrs) (c) Baseline (b) 
OFF razdoblje (sati) (c)
ON time without troublesome dyskinesia (hrs) (c) Baseline (b) 
ON razdoblje bez problematične diskinezije (sati) (c) Početna vrijednost (b) 9,3 (2,2
Via Lillo del Duca 10 20091 Bresso (MI) - Italy 
20091 Bresso (MI) - Italija
Each film-coated tablet contains safinamide methansulfonate equivalent to 50 mg safinamide. 
Jedna filmom obložena tableta sadrži safinamidmetansulfonat u količini koja odgovara 50 mg safinamida.
Each film-coated tablet contains safinamide methansulfonate equivalent to 100 mg safinamide. 
Jedna filmom obložena tableta sadrži safinamidmetansulfonat u količini koja odgovara 100 mg safinamida.
Acrochordon, melanocytic naevus, seborrhoeic keratosis, skin papilloma 
Karcinom bazalnih stanica Akrohordon, melanocitni nevus, seboroična keratoza, papilom na koži
Bronchospasm, dysphonia, oropharyngeal pain, oropharyngeal spasm 
Bronhospazam, disfonija, orofaringealna bol, orofaringealni spazam
Uncommon (may affect up to 1 in 100 people): urine infection, skin cancer, low iron in your blood, low white cell count, red blood cell abnormality, decreased appetite, high fat in blood, increased appetite, high blood sugar, seeing things that are not there, feeling sad, abnormal dreams, fear and worry, confusional state, mood swings , increased interest in sex, abnormal thinking and perception, restlessness, sleep disorder, numbness, unsteadiness, loss of sensation, sustained abnormal muscle contraction, head discomfort, difficulty in speaking, fainting, memory impairment, blurring of vision, blind spot, double vision, aversion to light, disorders of the light sensitive layer at the back of your eye, redness of the eyes, increased pressure in the eye, sensation of room spinning, feeling of heart beating, fast heartbeat, irregular heartbeat, slowed heartbeat , high blood pressure, low blood pressure, veins that have become large and twisted, cough, difficult breathing, runny nose, constipation, heartburn, vomiting, dry mouth, diarrhoea, abdominal pain, burning stomach, wind, feeling full, drooling, mouth ulcer, sweating, itching, sensitive to light, redness of the skin, back pain, joint pain, cramps, stiffness, pain in legs or arms, muscle weakness, sensation of heaviness, increased urination at night, pain upon urination, difficulty in having sex in males, fatigue, feeling weak, unsteady walking, swelling of your feet, pain, feeling hot, weight loss, weight gain, abnormal blood tests, high fat in your blood, increased sugar in your blood, abnormal ECG, liver function test abnormal, abnormal urine tests, blood pressure decreased, blood pressure increased, abnormal eye test, fracture of your foot. 
Manje često (mogu se javiti u do 1 od 100 osoba): infekcija mokraćnih puteva, rak kože, niska razina željeza u krvi, smanjen broj bijelih krvnih stanica, poremećaj broja crvenih krvnih stanica, smanjeni apetit, visoke razine masnoća u krvi, povećani apetit, visoka razina šećera u krvi, priviđanje stvari koje ne postoje, osjećaj tuge, poremećeni snovi, strah i zabrinutost, stanje smetenosti, promjene raspoloženja, povećana seksualna želja, poremećaj razmišljanja i percepcije, nemir, poremećaj spavanja, utrnulost, nesigurnost, gubitak osjeta, dugotrajne abnormalne kontrakcije mišića, nelagoda u glavi, poteškoće u govoru, nesvjestica, oštećenje pamćenja, zamućenje vida, slijepa pjega, dvoslike, nepodnošenje svjetlosti, poremećaj sloja osjetljivog na svjetlost u stražnjem dijelu oka, crvenilo očiju, povećan pritisak u oku, osjećaj da se soba vrti, osjećaj kucanja srca, ubrzani otkucaji srca, nepravilni otkucaji srca, usporeni otkucaji srca, povišeni krvni tlak, sniženi krvni tlak, vene koje su postale velike i prepletene, kašalj, otežano disanje, curenje iz nosa, zatvor, žgaravica, povraćanje, suha usta, proljev, bol u trbuhu, osjećaj žarenja u želucu, vjetrovi, osjećaj punine, slinjenje, vrijed u ustima, znojenje,
+) channels, and modulation of stimulated release of glutamate. 
Safinamid je povezan s inhibicijom ovisnom o stanju natrijskih (Na+) kanala reguliranih naponom i modulaciji stimuliranog oslobađanja glutamata.
Weight decreased, weight increased, blood creatine phosphokinase increased, blood triglycerides increased, blood glucose increased, blood urea increased, blood alkaline phosphatase increased, blood bicarbonate increased, blood creatinine increased, electrocardiogram QT prolonged, liver function test 
Smanjena tjelesna težina, povećana tjelesna težina, povišena kreatin fosfokinaza u krvi, povišeni trigliceridi u krvi, povišena glukoza u krvi, povišena urea u krvi,
Amblyopia, chromatopsia, diabetic retinopathy, erythropsia, eye haemorrhage, eye pain, eyelid oedema, hypermetropia, keratitis, lacrimation increased, night blindness, papilloedema, presbyopia, strabismus 
Ambliopija, kromatopsija, dijabetička retinopatija, eritropsija, krvarenje u oku, bol u oku, edem kapka, hipermetropija, keratitis, pojačano suzenje, noćno sljepilo, edem papile, prezbiopija, strabizam
Peptic ulcer, retching, upper gastrointestinal haemorrhage 
Peptički ulkus, dizanje želuca, krvarenje u gornjem dijelu gastrointestinalnog sustava
Nocturia, dysuria 
Noćno mokrenje, dizurija
Nausea Constipation, dyspepsia, vomiting, dry mouth, diarrhoea, abdominal pain, gastritis, flatulence, abdominal distension, 
Mučnina Zatvor, dispepsija, povraćanje, suha usta, proljev, bol u abdomenu, gastritis, flatulencija, distenzija abdomena, hipersekrecija sline, bolest gastroezofagealnog refluksa, aftozni stomatitis
The concomitant use of safinamide and fluoxetine or fluvoxamine should be avoided (see section 4.4), this precaution is based on the occurrence of serious adverse reactions (e.g. serotonin syndrome), although rare, that have occurred when SSRIs and dextromethorphan have been used with MAO inhibitors. 
Ova mjera opreza temelji se na pojavi ozbiljnih nuspojava (npr. serotoninskog sindroma), koji se, iako rijetko, javlja kada se SSRI-ijevi i dekstrometorfan primjenjuju zajedno s MAO inhibitorima.
Xadago 50 mg film-coated tablets Xadago 100 mg film-coated tablets 
Xadago 50 mg filmom obložene tablete Xadago 100 mg filmom obložene tablete
20091 Bresso (MI) - Italy Tel: +39 02 665241 
20091 Bresso (MI) - Italija tel: +39 02 665241 fax: +39 02 66501492 e-mail: info.zambonspa@zambongroup.com
Xadago 100 mg tablets safinamide 
NAZIV LIJEKA Xadago 100 mg tablete safinamid
Ankylosing spondylitis, flank pain, joint swelling, musculoskeletal pain, myalgia, neck pain, osteoarthritis, synovial cyst 
Ankilozantni spondilitis, bol u boku, oticanje zglobova, mišićno-koštana bol, mialgija, bol u vratu, osteoartritis, sinovijalna cista
Xadago 50 mg tablets safinamide 
NAZIV LIJEKA Xadago 50 mg tablete safinamid
Xadago 50 mg film-coated tablets 
Xadago 50 mg filmom obložene tablete
Xadago 100 mg are orange to copper, round, biconcave film-coated tablets 9 mm diameter with metallic gloss, embossed with “100” on one side of the tablet. 
Xadago 100 mg su okrugle, bikonkavne, filmom obložene tablete promjera 9 mm, narančaste do bakrene boje metalik odsjaja, s otisnutom jačinom „100“ na jednoj strani tablete.
Xadago 100 mg film-coated tablets 
Xadago 100 mg filmom obložene tablete
Orange to copper, round, biconcave, film-coated tablet of 9 mm diameter with metallic gloss, embossed with the strength “100” on one side of the tablet. 
Okrugla, bikonkavna, filmom obložena tableta promjera 9 mm, narančaste do bakrene boje metalik odsjaja, s otisnutom jačinom „100“ na jednoj strani tablete.
Orange to copper, round, biconcave, film-coated tablet of 7 mm diameter with metallic gloss, embossed with the strength “50” on one side of the tablet. 
Okrugla, bikonkavna, filmom obložena tableta promjera 7 mm, narančaste do bakrene boje metalik odsjaja, s otisnutom jačinom „50“ na jednoj strani tablete.
Male rat fertility was not affected. 
Nije bilo učinka na plodnost mužjaka štakora.
Blood calcium decreased, blood potassium decreased, blood cholesterol decreased, body temperature increased, cardiac murmur, cardiac stress test abnormal, haematocrit decreased, haemoglobin decreased, international normalised ratio decreased, lymphocyte count decreased, 
Rijetko povišena alkalna fosfataza u krvi, povišen bikarbonat u krvi, povišen kreatinin u krvi, produljen QT elektrokardiograma, abnormalni nalaz pretrage funkcije jetre, abnormalni nalaz analize urina, povišeni krvni tlak, sniženi krvni tlak, abnormalni nalaz postupaka očne dijagnostike opterećenja srca, snižen hematokrit, snižen hemoglobin, snižen međunarodni normaliziran omjer, smanjen broj limfocita, smanjen broj trombocita, povišen lipoprotein vrlo niske gustoće
Cardiac disorders 
Erektilna disfunkcija
95% CI p-value UPDRS II (c) Baseline (b) 
UPDRS III (c) Početna vrijednost (b) 28,6 Promjena LSM (SE) -4,5
Xadago 100 mg film-coated tablets safinamide 
Xadago 100 mg filmom obložene tablete safinamid
Xadago 50 mg film-coated tablets safinamide 
Xadago 50 mg filmom obložene tablete safinamid
No dose adjustment is required in patients with mild hepatic impairment. 
U bolesnika s blagim oštećenjem jetre nije potrebna prilagodba doze.
Microcrystalline cellulose Crospovidone type A Magnesium stearate Silica, colloidal anhydrous 
FARMACEUTSKI PODACI Popis pomoćnih tvari Jezgra tablete Celuloza, mikrokristalična
xadago 100 mg 
16. PODACI NA BRAILLEOVOM PISMU xadago 100 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - filmom obložene tablete
ANNEX I 
Krospovidon vrste A
Use in patients with severe hepatic impairment (see section 4.2). 
Istodobno liječenje petidinom (vidjeti dijelove 4.4 i 4.5) Primjena u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2).
Xadago 50 mg film-coated tablets Xadago 100 mg film-coated tablets safinamide 
Uputa o lijeku: Informacije za bolesnika Xadago 50 mg filmom obložene tablete Xadago 100 mg filmom obložene tablete safinamid
Micturition urgency, polyuria, pyuria, urinary hesitation 
Hitno mokrenje, poliurija, piurija, otežan početak mokrenja
What Xadago looks like and contents of the pack Xadago 50 mg are orange to copper, round, biconcave film-coated tablets of 7 mm diameter with metallic gloss, embossed with “50” on one side of the tablet. 
Xadago 50 mg su okrugle, bikonkavne, filmom obložene tablete promjera 7 mm, narančaste do bakrene boje metalik odsjaja, s otisnutom jačinom „50“ na jednoj strani tablete.
Zambon Italia S.r.l. 
Zambon Nederland B.V.
Tel: +39 02665241 
Zambon Italia S.r.l. Tel: + 39 02665241
BLISTER 
Nuspojave
General warning 
Opća upozorenja
Hepatobiliary disorders 
Metabolit
Tablet core 
Magnezijev stearat
Fax: +39 02 66501492 
Italija tel: +39 02665241 fax: +39 02 66501492 e-mail: info.zambonspa@zambongroup.com
It may harm them, 
poremećaji štitnjače
Symptoms may disappear completely or partly. 
Simptomi mogu nestati potpuno ili djelomično.
The instructions include the following main steps: 
Upute uključuju sljedeće glavne korake: