FrancophonIA/ELRC3.0 huggingface dataset:
English: In vivo studies and population pharmacokinetic analysis Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol.
Croatian: Ispitivanja in vivo i analiza populacijske farmakokinetike Sukladno tome, u ispitivanjima in vivo nisu opažene klinički značajne farmakokinetičke interakcije između pregabalina i fenitoina, karbamazepina, valproične kiseline, lamotrigina, gabapentina, lorazepama, oksikodona ili etanola.
English: Gastrooesophageal reflux disease, salivary hypersecretion, hypoaesthesia oral
Croatian: Manje često gastroezofagealna refluksna bolest, hipersekrecija sline, oralna hipoestezija
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER AND BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER I BOCU
English: In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.
Croatian: U kontroliranim kliničkim ispitivanjima (u trajanju od 4-8 tjedana) u 52% bolesnika liječenih pregabalinom te 38% bolesnika koji su primali placebo je na kraju ispitivanja zabilježeno najmanje 50%-tno poboljšanje ukupnog rezultata na HAM-A ljestvici u odnosu na početne vrijednosti.
English: In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medicinal products.
Croatian: Sukladno postojećoj kliničkoj praksi, nekim bolesnicima sa šećernom bolešću koji dobivaju na težini tijekom liječenja pregabalinom može biti potrebno prilagoditi terapiju antidijabeticima.
English: The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) with partial onset seizures were similar to those observed in adults.
Croatian: Štetni događaji zapaženi u ispitivanju farmakokinetike i podnošljivosti koje je uključivalo bolesnike s parcijalnim napadajima u dobi od 3 mjeseca do 16 godina starosti (n=65) bili su slični onima zapaženima u odraslih.
English: However, administration of pregabalin with food has no clinically significant effect on the extent of pregabalin absorption.
Croatian: Međutim, primjena pregabalina s hranom nema klinički značajnog učinka na opseg apsorpcije pregabalina.
English: Fertility studies in male rats have shown adverse reproductive and developmental effects.
Croatian: Istraživanja plodnosti na mužjacima štakora pokazala su štetne učinke na reprodukciju i razvoj.
English: Pregabalin clearance tends to decrease with increasing age.
Croatian: Klirens pregabalina smanjuje se starenjem.
English: • Cold sweat, tightness of the throat, swollen tongue
Croatian: • hladan znoj, stezanje u grlu, oticanje jezika
English: The most commonly reported adverse reactions were dizziness and somnolence.
Croatian: Najčešće prijavljene nuspojave bile su omaglica i somnolencija.
English: After oral administration of pregabalin in paediatric patients in the fasted state, in general, time to reach peak plasma concentration was similar across the entire age group and occurred 0.5 hours to 2 hours postdose.
Croatian: Nakon peroralne primjene pregabalina u pedijatrijskih bolesnika natašte, vrijeme do vršne koncentracije u plazmi bilo je općenito slično u svim dobnim skupinama, a nastupila je 0,5 do 2 sata nakon doze.
English: In the post-marketing experience, visual adverse reactions have also been reported, including loss of vision, visual blurring or other changes of visual acuity, many of which were transient.
Croatian: Nuspojave povezane s vidom prijavljene su i u razdoblju nakon stavljanja lijeka u promet, uključujući gubitak vida, zamagljen vid ili druge promjene oštrine vida, od kojih su mnoge bile prolazne.
English: Pregabalin is rapidly absorbed when administered in the fasted state, with peak plasma concentrations occurring within 1 hour following both single and multiple dose administration.
Croatian: Pregabalin se brzo apsorbira kad se primijeni natašte, a vršne koncentracije u plazmi postižu se jedan sat nakon primjene jedne ili višestrukih doza.
English: If at any time you have these thoughts, immediately contact your doctor.
Croatian: Ako Vas u bilo kojem trenutku obuzmu takve misli, odmah se javite svom liječniku.
English: • Fluid in the lungs
Croatian: • tekućina u plućima
English: Epilepsy: Pregabalin Mylan Pharma is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Croatian: Epilepsija: Pregabalin Mylan Pharma se koristi za liječenje nekih oblika epilepsije (parcijalnih napadaja sa ili bez sekundarne generalizacije) u odraslih osoba.
English: Your doctor will prescribe Pregabalin Mylan Pharma for you to help treat your epilepsy when your current treatment is not controlling your condition.
Croatian: Liječnik će Vam propisati lijek Pregabalin Mylan Pharma za liječenje epilepsije kada lijekovi koje ste do sada uzimali bolest ne drže pod kontrolom.
English: In the 12-week placebo-controlled study, paediatric patients were assigned to pregabalin 2.5 mg/kg/day (maximum, 150 mg/day), pregabalin 10 mg/kg/day (maximum, 600 mg/day), or placebo.
Croatian: U 12-tjednom placebom kontroliranom ispitivanju pedijatrijski su bolesnici dobivali pregabalin u dozi od 2,5 mg/kg na dan (maksimalno 150 mg na dan), pregabalin 10 mg/kg na dan (maksimalno 600 mg na dan) ili placebo.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Pregabalin Mylan Pharma.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Pregabalin Mylan Pharma.
English: Pregabalin did not achieve non-inferiority to lamotrigine based on the 6-month seizure freedom endpoint.
Croatian: Pregabalin nije pokazao neinferiornost u odnosu na lamotrigin s obzirom na mjeru ishoda: postizanje 6-mjesečnog razdoblja bez napadaja.
English: Blood and lymphatic system disorders Uncommon
Croatian: Poremećaji krvi i limfnog sustava Manje često neutropenija
English: Mylan Hrvatska d.o.o.
Croatian: Mylan Hrvatskad.o.o.
English: Pregabalin pharmacokinetics are linear over the recommended daily dose range.
Croatian: Farmakokinetika pregabalina je linearna u preporučenom rasponu dnevnih doza.
English: In these patients, visual acuity was reduced in 6.5% of patients treated with pregabalin, and 4.8% of placebo-treated patients.
Croatian: Među tim je bolesnicima oštrina vida bila smanjena u 6,5% bolesnika liječenih pregabalinom i 4,8% onih koji su primali placebo.
English: • Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure,
Croatian: • poremećaji srčanog ritma, ubrzani puls, nizak krvni tlak, visok krvni tlak, promjene otkucaja srca, zatajenje srca
English: Oral contraceptives, norethisterone and/or ethinyl oestradiol Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance.
Croatian: Oralni kontraceptivi, noretisteron i/ili etinilestradiol Istodobna primjena pregabalina s oralnim kontraceptivima noretisteronom i/ili etinilestradiolom ne utječe na farmakokinetiku niti jednog od tih lijekova u stanju dinamičke ravnoteže.
English: • There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin Mylan Pharma when they have other conditions.
Croatian: • Prijavljeno je smanjenje moždane funkcije (encefalopatija) u nekih bolesnika koji su uzimali lijek Pregabalin Mylan Pharma, a bolovali su i od drugih bolesti.
English: • Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased,
Croatian: • promjene u rezultatima pretraga krvi i jetre (povišene vrijednosti kreatin fosfokinaze u krvi, povišene vrijednosti alanin aminotransferaze, povišene vrijednosti aspartat aminotransferaze, smanjen broj krvnih pločica, smanjen broj neutrofila, povećanje kreatinina u krvi, snižene vrijednosti kalija u krvi)
English: A fertility study in female rats has shown adverse reproductive effects.
Croatian: Istraživanje plodnosti na ženkama štakora pokazalo je štetne učinke na reprodukciju.
English: Effective contraception must be used by women of child-bearing potential.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju.
English: It is important to take your Pregabalin Mylan Pharma capsules regularly at the same time each day.
Croatian: Ako ste zaboravili uzeti lijek Pregabalin Mylan Pharma Važno je da Pregabalin Mylan Pharma kapsule uzimate redovito, svakoga dana u isto vrijeme.
English: After discontinuation of short-term and long-term treatment with pregabalin, withdrawal symptoms have been observed in some patients.
Croatian: Nakon prekida kratkotrajnog i dugotrajnog liječenja pregabalinom u nekih su bolesnika opaženi simptomi ustezanja.
English: • Dilated pupils, cross eyes
Croatian: • proširene zjenice, ukrižene oči
English: In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients (see section 5.1).
Croatian: U kliničkim ispitivanjima u kojima su provedene oftalmološke pretrage, smanjenje oštrine vida i promjene vidnog polja javljali su se s većom incidencijom u bolesnika liječenih pregabalinom nego u bolesnika koji su primali placebo; incidencija promjena očne pozadine bila je veća u bolesnika koji su primali placebo (vidjeti dio 5.1).
English: Bottle: Keep the bottle tightly closed in order to protect from moisture.
Croatian: Boca: čuvati bocu dobro zatvorenom radi zaštite od vlage.
English: When taken with certain other medicines, Pregabalin Mylan Pharma may potentiate the side effects seen with these medicines, including respiratory failure and coma.
Croatian: Kada se uzima s nekim drugim lijekovima, Pregabalin Mylan Pharma može pojačati nuspojave tih lijekova, uključujući zatajenje disanja i komu.
English: Pregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Croatian: Pregabalin Mylan Pharma je indiciran kao dodatna terapija u odraslih osoba s parcijalnim napadajima, sa ili bez sekundarne generalizacije.
English: Adverse effects on fertility in male and female rats were only observed at exposures sufficiently in excess of therapeutic exposure.
Croatian: Štetni učinci na plodnost mužjaka i ženki štakora opaženi su samo pri izloženosti dovoljno većoj od terapijske izloženosti.
English: Starting dose (mg/day)
Croatian: Početna doza (mg/dan)
English: Should you experience any of these reactions, you should contact your physician immediately.
Croatian: Ako se pojavi neka od tih reakcija, morate se odmah javiti svom liječniku.
English: Central nervous system influencing medical products Pregabalin may potentiate the effects of ethanol and lorazepam.
Croatian: Pregabalin može pojačati učinke etanola i lorazepama.
English: Pregabalin plasma clearance and renal clearance are directly proportional to creatinine clearance (see section 5.2 Renal impairment).
Croatian: Klirens pregabalina iz plazme i bubrežni klirens upravo su razmjerni klirensu kreatinina (vidjeti dio 5.2, Oštećenje bubrega).
English: • Pregabalin Mylan Pharma has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Croatian: • Liječenje lijekom Pregabalin Mylan Pharma povezuje se s pojavom omaglice i pospanosti, što može povećati broj slučajnih ozljeda (padova) u starijih bolesnika.
English: Visual field changes were detected in 12.4% of pregabalin-treated, and 11.7% of placebo-treated patients.
Croatian: Promjene vidnog polja utvrđene su u 12,4% bolesnika liječenih pregabalinom i 11,7% bolesnika koji su primali placebo.
English: Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug.
Croatian: Pregabalin se iz sustavne cirkulacije primarno odstranjuje izlučivanjem nepromijenjenog lijeka putem bubrega.
English: GAD can also cause restlessness or feeling keyed up or on edge, being easily fatigued (tired), having difficulty concentrating or mind going blank, feeling irritable, having muscle tension or sleep disturbance.
Croatian: GAP može uzrokovati i nemir ili osjećaj napetosti ili bezizlaznosti, brzo iscrpljivanje (umaranje), poteškoće s koncentracijom ili prisjećanjem, razdražljivost, napetost mišića ili poremećaj spavanja.
English: Infections and infestations Common
Croatian: Infekcije i infestacije Često nazofaringitis
English: What you need to know before you take Pregabalin Mylan Pharma 3.
Croatian: Što morate znati prije nego počnete uzimati Pregabalin Mylan Pharma 3.
English: Tachycardia, atrioventricular block first degree, sinus bradycardia, congestive heart failure
Croatian: Srčani poremećaji Manje često tahikardija, atrioventrikularni blok prvog stupnja, sinusna bradikardija, kongestivno zatajenje srca
English: Convulsion, parosmia, hypokinesia, dysgraphia
Croatian: Rijetko konvulzije, parosmija, hipokinezija, disgrafija
English: Pregabalin undergoes negligible metabolism in humans.
Croatian: Metabolizam pregabalina u ljudi je zanemariv.
English: In controlled clinical trials, multiple oral doses of pregabalin co-administered with oxycodone, lorazepam, or ethanol did not result in clinically important effects on respiration.
Croatian: U kontroliranim kliničkim ispitivanjima primjena višekratnih peroralnih doza pregabalina istodobno s oksikodonom, lorazepamom ili etanolom nije izazvala klinički važne učinke na disanje.
English: Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (<2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, pharmacokinetic interactions.
Croatian: (< 2% doze pronađe se u mokraći u obliku metabolita), da ne inhibira metabolizam lijekova in vitro i ne veže se za proteine u plazmi, nije vjerojatno da će izazivati ili ulaziti u farmakokinetičke interakcije.
English: Generalised Anxiety Disorder: Pregabalin Mylan Pharma is used to treat Generalised Anxiety Disorder (GAD).
Croatian: Generalizirani anksiozni poremećaj: Pregabalin Mylan Pharma se koristi za liječenje generaliziranog anksioznog poremećaja (GAP).
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE LIJEKA U PROMET
English: Since pregabalin does not undergo significant metabolism and is excreted predominantly as unchanged drug in the urine, impaired liver function would not be expected to significantly alter pregabalin plasma concentrations.
Croatian: Budući da metabolizam pregabalina nije značajan te da se pretežno izlučuje mokraćom u nepromijenjenom obliku, nije vjerojatno da će oštećenje jetrene funkcije značajno promijeniti koncentracije pregabalina u plazmi.
English: • Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability
Croatian: • ushićenje, smetenost, dezorijentiranost, smanjenje seksualne želje, razdražljivost
English: Funduscopic changes were observed in 1.7% of pregabalin-treated and 2.1% of placebo-treated patients.
Croatian: Promjene očne pozadine opažene su u 1,7% bolesnika liječenih pregabalinom i 2,1% bolesnika koji su primali placebo.
English: Pregabalin Mylan Pharma may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Croatian: Pregabalin Mylan Pharma može izazvati omaglicu i somnolenciju te tako utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: In the post-marketing experience, the most commonly reported adverse reactions observed when pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness.
Croatian: Nakon stavljanja lijeka u promet najčešće prijavljene nuspojave kod predoziranja pregabalinom uključuju somnolenciju, stanje konfuzije, agitaciju i nemir.
English: Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur.
Croatian: Primjenu pregabalina treba odmah prekinuti ako nastupe simptomi angioedema, kao što su oticanje lica, područja oko usta ili gornjih dišnih puteva.
English: BGP Products SIA Tel: +371 676 055 80
Croatian: BGP Products SIA Tel: +371 676 055 80 (Lielbritānija)
English: • Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain
Croatian: • trzanje mišića, oticanje zglobova, ukočenost mišića, bol uključujući bol u mišićima, bol u vratu
English: The most common adverse reactions resulting in discontinuation from pregabalin treatment groups were dizziness and somnolence.
Croatian: Najčešće nuspojave zbog kojih je prekinuto liječenje u skupinama koje su primale pregabalin bile su omaglica i somnolencija.
English: NAME OF THE MEDICINAL PRODUCT
Croatian: 1. NAZIV LIJEKA
English: Other medicines and Pregabalin Mylan Pharma Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Relief of the symptoms of GAD as reflected by the Hamilton Anxiety Rating Scale (HAM-A) was observed by Week 1.
Croatian: Hamilton Anxiety Rating Scale, HAM-A) opaženo je u prvom tjednu liječenja.
English: A reduction in seizure frequency was observed by Week 1.
Croatian: Smanjenje učestalosti napadaja opaženo je u prvom tjednu liječenja.
English: HDPE bottle pack containing 200 hard capsules.
Croatian: Boca od polietilena visoke gustoće (HDPE) koja sadrži 200 tvrdih kapsula.
English: Pregabalin dose adjustment based on renal function
Croatian: Tablica 1: Prilagodba doze pregabalina na temelju funkcije bubrega
English: Euphoric mood, confusion, irritability, disorientation, insomnia, libido decreased
Croatian: Često euforično raspoloženje, konfuzija, razdražljivost, dezorijentacija, nesanica, smanjen libido
English: Additional reactions reported from post-marketing experience are included in italics in the list below.
Croatian: Dodatne nuspojave prijavljene nakon stavljanja lijeka u promet u Tablici ispod su navedene kurzivom.
English: Foetal toxicity in rats and rabbits occurred only at exposures sufficiently above human exposure.
Croatian: Fetotoksičnost je u štakora i kunića nastupila samo pri izloženosti dovoljno većoj od izloženosti u ljudi.
English: • Breast discharge, abnormal breast growth, breast growth in males
Croatian: • iscjedak iz dojke, neuobičajen rast dojki, rast dojki u muškaraca
English: The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Mylan Pharma is taken together with medicinal products containing:
Croatian: Omaglica, pospanost i smanjenje koncentracije mogu se pojačati ako se Pregabalin Mylan Pharma uzima zajedno s lijekovima koji sadrže: Oksikodon - (koristi se protiv bolova)
English: • Blurred vision, double vision
Croatian: • zamagljen vid, dvoslike
English: Very rare: may affect up to 1 in 10,000 people
Croatian: Vrlo rijetke: mogu se javiti u do 1 na 10 000 osoba
English: Overall, the safety and efficacy profiles for BID and TID dosing regimens were similar.
Croatian: Profili sigurnosti i djelotvornosti za režime doziranja dva puta na dan i tri puta na dan općenito su bili podjednaki.
English: Withdrawal of concomitant anti-epileptic medicinal products There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
Croatian: Nema dovoljno podataka za ukidanje istodobno primijenjenih antiepileptika nakon što je dodavanjem pregabalina postignuta kontrola napadaja, a u cilju monoterapije pregabalinom.
English: Pregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Croatian: Pregabalin Mylan Pharma je indicirana za liječenje generaliziranog anksioznog poremećaja (GAP) u odraslih osoba.
English: Single dose+
Croatian: jedna doza
English: Pregabalin has been studied in 3 controlled clinical trials of 12 week duration with either BID or TID dosing.
Croatian: Pregabalin je ispitan u 3 kontrolirana klinička ispitivanja u trajanju od 12 tjedana, s režimom doziranja dva puta na dan ili tri puta na dan.
English: Pregabalin Mylan Pharma may have minor or moderate influence on the ability to drive and use machines.
Croatian: Pregabalin Mylan Pharma može malo ili umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Lactation had little to no influence on pregabalin pharmacokinetics.
Croatian: Dojenje nije utjecalo ili je zanemarivo utjecalo na farmakokinetiku pregabalina.
English: Pregabalin has been studied in 1 controlled clinical trial of 56 week duration with BID dosing.
Croatian: Pregabalin je ispitan u jednom kontroliranom kliničkom ispitivanju u trajanju od 56 tjedana, s režimom doziranja dva puta na dan.
English: Ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy
Croatian: Često ataksija, poremećaj koordinacije, tremor, dizartrija, amnezija, poremećaj pamćenja, poremećaj pažnje, parestezija, hipoestezija, sedacija, poremećaj ravnoteže, letargija
English: In the post-marketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other central nervous system (CNS) depressant medicinal products.
Croatian: Nakon stavljanja lijeka u promet, u bolesnika koji su uzimali pregabalin i druge depresore središnjeg živčanog sustava (SŽS) prijavljeni su zatajenje disanja i koma.
English: In all controlled studies, the discontinuation rate due to adverse reactions was 12% for patients receiving pregabalin and 5% for patients receiving placebo.
Croatian: U svim je kontroliranim kliničkim ispitivanjima udio bolesnika koji su prekinuli liječenje zbog nuspojava iznosio 12% među bolesnicima koji su primali pregabalin te 5% među bolesnicima koji su primali placebo.
English: Mylan Ireland Tel: +353 (0) 87 1694982
Croatian: Tel: +353 (0) 87 1694982
English: Blood creatine phosphokinase increased, blood glucose increased, platelet count decreased, blood creatinine increased, blood potassium decreased, weight decreased
Croatian: Manje često povećanje kreatin fosfokinaze u krvi, povećanje glukoze u krvi, smanjenje broja trombocita, povećanje kreatinina u krvi, snižene vrijednosti kalija u krvi, smanjenje tjelesne težine
English: Psychiatric disorders Common
Croatian: Psihijatrijski poremećaji
English: • Weakness, thirst, chest tightness
Croatian: • slabost, žeđ, stezanje u prsištu
English: Manufacturer
Croatian: Proizvođač:
English: • Sweating, rash, chills, fever
Croatian: • znojenje, osip, zimica, vrućica
English: Mylan BV
Croatian: Nederland Mylan BV
English: What Pregabalin Mylan Pharma contains
Croatian: Što Pregabalin Mylan Pharma sadrži
English: • Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, that have similar side effects to Pregabalin and the severity of these effects may be increased when taken together.
Croatian: • Neke nuspojave, poput pospanosti, mogu se javljati češće jer bolesnici s ozljedom leđne moždine možda uzimaju druge lijekove za liječenje, primjerice, boli ili grčeva, koji imaju slične nuspojave kao pregabalin.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Croatian: 6. POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA