natgillin/translations-raw huggingface dataset:
In an embryotoxicity study in the rabbit, a higher incidence of cardiovascular and skeletal malformations was observed at systemic exposure levels below the maximum clinical exposure (AUC).
U istraživanju embriotoksičnosti u kunića uočena je viša incidencija kardiovaskularnih i skeletnih malformacija pri razinama sistemske izloženosti manjima od maksimalne kliničke izloženosti (AUC).
Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
kliničkim su ispitivanjima suicidalno ponašanje (pokušaji samoubojstva i suicidalne misli) i neprijateljsko ponašanje (prvenstveno agresija, protivljenje i bijes) uočeni češće u djece i adolescenata liječenih antidepresivima u usporedbi s onima koji su dobivali placebo.
EU/1/04/283/012 (98 hard gastro-resistant capsules)
EU/1/04/283/012 (98 tvrdih želučanootpornih kapsula)
• sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome, poor sleep quality
• iznenadno nevoljno treperenje ili trzaji mišića, osjećaj nemira ili nemogućnost mirnog sjedenja ili stajanja, osjećaj nervoze, teškoće s koncentracijom, promjene osjeta okusa, teškoće pri kontroliranju pokreta npr. nedostatak koordinacije ili nevoljni pokreti mišića, sindrom nemirnih nogu, loša kvaliteta sna
Compared with healthy subjects, the apparent plasma clearance of duloxetine was 79% lower, the apparent terminal half-life was 2.3 times longer, and the AUC was 3.7 times higher in patients with moderate liver disease.
U usporedbi sa zdravim ispitanicima, u bolesnika s umjereno teškom bolešću jetre je prividni klirens duloksetina iz plazme bio je 79% niži, prividan terminalni poluvijek bio je 2,3 puta dulji, a AUC je bio 3,7 puta veći.
Duloxetine has been associated with an increase in blood pressure and clinically significant hypertension in some patients.
U nekih je bolesnika duloksetin povezan s povišenjem krvnog tlaka i klinički značajnom hipertenzijom.
There was also a small increase in fasting blood glucose and in total cholesterol in duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care group.
Glukoza u krvi natašte i ukupni kolesterol bili su malo povećani u bolesnika liječenih duloksetinom, dok su laboratorijske pretrage pokazale malo sniženje tih parametara u skupini bolesnika na standardnom liječenju.
MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/008 (7 hard gastro-resistant capsules) EU/1/04/283/009 (28 hard gastro-resistant capsules) EU/1/04/283/010 (98 hard gastro-resistant capsules)
12. BROJEVI ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/04/283/008 (7 tvrdih želučanootpornih kapsula) EU/1/04/283/009 (28 tvrdih želučanootpornih kapsula) EU/1/04/283/010 (98 tvrdih želučanootpornih kapsula)
The pharmacokinetics of duloxetine in patients who are poor metabolisers with respect to CYP2D6 has not been specifically investigated.
Farmakokinetika duloksetina u bolesnika koji su slabi metabolizatori s obzirom na CYP2D6 nije posebno ispitivana.
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping ARICLAIM before starting an MAOI (see section
S obzirom na poluvijek duloksetina, mora proći najmanje 5 dana nakon prestanka primjene lijeka ARICLAIM prije početka liječenja MAOI-ma (vidjeti dio 4.3).
• suicidal thoughts, difficulty sleeping, grinding or clenching the teeth, feeling disorientated, lack
• samoubilačke misli, tegobe sa spavanjem, škripanje ili stiskanje zubima, osjećaj dezorijentiranosti, nedostatak motivacije
You must wait at least 14 days after you have stopped taking an MAOI before you can take ARICLAIM.
Nakon što ste prekinuli uzimati MAOI, morate pričekati najmanje 14 dana prije nego možete uzeti ARICLAIM.
However, concomitant administration of duloxetine with warfarin under steady state conditions, in healthy volunteers, as part of a clinical pharmacology study, did not result in a clinically significant change in INR from baseline or in the pharmacokinetics of R- or S-warfarin.
Međutim, istodobna primjena duloksetina s varfarinom u stanju dinamičke ravnoteže u zdravih dobrovoljaca, kao dio kliničkog farmakološkog ispitivanja, nije rezultirala klinički značajnom promjenom INR-a u odnosu na početne vrijednosti, kao ni farmakokinetike
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
POSEBNE MJERE ZA UKLANJANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH
ARICLAIM may make you feel sleepy or dizzy.
ARICLAIM može izazvati pospanost ili omaglicu.
Your doctor will tell you if you should be taking ARICLAIM.
Liječnik će Vam reći smijete li uzimati lijek ARICLAIM.
In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with ARICLAIM and 23% of patients taking placebo.
U kliničkom ispitivanju štetni događaji primijećeni nakon naglog prekida liječenja pojavili su se u približno 45% bolesnika liječenih lijekom ARICLAIM i u 23% bolesnika koji su uzimali placebo.
Blood cholesterol increased
Pretrage povišen kolesterol u krvi
The initiation of treatment with ARICLAIM is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and
Kontraindicirano je započeti liječenje lijekom ARICLAIM u bolesnika s nekontroliranom hipertenzijom koja bolesnika može izložiti potencijalnom riziku od hipertenzivne krize (vidjeti dijelove 4.4 i 4.8).
Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Opis odabranih nuspojava Prekid primjene duloksetina (osobito nagli prekid) često dovodi do pojave simptoma prekida primjene lijeka.
ARICLAIM must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
ARICLAIM se ne smije primjenjivati u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min; vidjeti dio 4.3).
Consequently, caution is advised when ARICLAIM is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Stoga se savjetuje oprez kada se ARICLAIM primjenjuje u kombinaciji s drugim lijekovima ili tvarima koje djeluju na SŽS, uključujući alkohol i sedative (npr. benzodiazepine, morfinomimetike, antipsihotike, fenobarbital, sedativne antihistaminike).
• chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait
• bol u prsima, osjećaj hladnoće, žeđ, drhtanje, osjećaj vrućine, poremećen hod
Caution is advised if ARICLAIM is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Savjetuje se oprez ako se ARICLAIM primjenuje istodobno s lijekovima koji se metaboliziraju prvenstveno pomoću CYP2D6 (risperidon, triciklički antidepresivi poput nortriptilina, amitriptilina i imipramina), naročito ako imaju uzak terapijski indeks (poput flekainida, propafenona i metoprolola).
Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function (e.g. NSAIDs or acetylsalicylic acid (ASA)), and in patients with known bleeding tendencies.
Savjetuje se oprez u bolesnika koji uzimaju antikoagulanse i/ili lijekove za koje se zna da utječu na funkciju trombocita (npr. NSAIL ili acetilsalicilatna kiselina (ASK)) te u bolesnika s poznatom sklonošću krvarenjima.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
Renal impairment: End stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine Cmax and AUC values compared with healthy subjects.
Oštećenje bubrežne funkcije: bolesnici u završnom stadiju bubrežne bolesti koji su na dijalizi imali su 2 puta više vrijednosti Cmax i AUC duloksetina u usporedbi sa zdravim ispitanicima.
ARICLAIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Manija i napadaji ARICLAIM se mora s oprezom primjenjivati kod bolesnika s manijom u anamnezi ili s dijagnozom bipolarnog poremećaja i/ili napadaja.
• inflammation of the mouth, passing bright red blood in your stools, bad breath, inflammation of the large intestine (leading to diarrhoea)
• upala usta, svjetlocrvena krv u stolici, neugodan zadah iz usta, upala debelog crijeva (što dovodi do proljeva)
Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing ARICLAIM to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Prijavljeni su slučajevi midrijaze povezani s duloksetinom te se stoga ARICLAIM mora s oprezom propisivati bolesnicima s povišenim intraokularnim tlakom i onima s rizikom od akutnog glaukoma uskog kuta.
ARICLAIM may be associated with sedation and dizziness.
Lijek ARICLAIM može biti povezan s pojavom sedacije i omaglice.
Effects of other medicinal products on duloxetine Antacids and H2 antagonists: Co-administration of duloxetine with aluminium- and magnesiumcontaining antacids or duloxetine with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Učinci drugih lijekova na duloksetin Antacidi i antagonisti H2 receptora: istodobna primjena duloksetina i antacida koji sadrže aluminij ili magnezij ili duloksetina i famotidina nije značajno utjecala na brzinu ni opseg apsorpcije duloksetina nakon peroralne primjene doze od 40 mg.
These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ARICLAIM, you should see your doctor.
Ako primijetite bilo koji neuobičajen simptom dok uzimate neki od tih lijekova zajedno s lijekom ARICLAIM, morate se javiti svom liječniku.
ARICLAIM 30 mg is available in packs of 7, 28 and 98 capsules.
ARICLAIM 30 mg dostupan je u pakiranjima od 7, 28 i 98 kapsula.
Also, you need to wait at least 5 days after you stop taking ARICLAIM before you take a MAOI.
Također, nakon što ste prekinuli uzimati lijek ARICLAIM, morate pričekati najmanje 5 dana prije nego uzmete MAOI.
Angio-neurotic oedema6
angioneurotski edem6
SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture.
POSEBNE MJERE ČUVANJA Čuvati u originalnom pakovanju radi zaštite od vlage.
Feeling abnormal Feeling cold Thirst
bol u prsima neuobičajeno osjećanje osjećaj hladnoće žeđ zimica
In prenatal/postnatal toxicity studies in the rat, duloxetine induced adverse behavioural effects in the offspring at exposures below maximum clinical exposure (AUC).
U ispitivanju pre/postnatalne toksičnosti u štakora duloksetin je izazvao štetne bihevioralne učinke u mladunčadi pri razinama manjima od maksimalne kliničke izloženosti (AUC).
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of ARICLAIM is recommended (see section 4.2).
Ako se donese odluka o uvođenju antidepresivne farmakološke terapije, preporučuje se postupan prekid liječenja lijekom ARICLAIM
• fainting, dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes
• nesvjestica, omaglica, ošamućenost ili nesvjestica pri ustajanju, hladni prsti na rukama i/ili nogama • stezanje u grlu, krvarenja iz nosa
ARICLAIM 60 mg is available in packs of 28 and 98 capsules.
ARICLAIM 60 mg dostupan je u pakiranjima od 28 i 98 kapsula.
Concomitant use of ARICLAIM with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Kontraindicirana je istodobna primjena lijeka ARICLAIM s neselektivnim, ireverzibilnim inhibitorima monoamino-oksidaze (MAO) (vidjeti dio 4.5).
In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of ARICLAIM 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
8-tjedno akutno liječenje lijekom ARICLAIM u dozi od 60 mg jednom dnevno održalo se tijekom sljedećih 6 mjeseci, mjereno promjenom 24-satnih podataka o prosječnoj boli u kratkom upitniku o boli (eng.
Infections and infestations Immune system disorders
Infekcije i infestacije
Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of ARICLAIM in this age group have not yet been demonstrated.
ARICLAIM na rast, sazrijevanje te intelektualni razvoj i razvoj ponašanja nisu još dokazani u ovoj dobnoj skupini.
The 60 mg capsules are blue and green and are printed with ‘60 mg' and the code ‘9542'.
Kapsule od 60 mg su plave i zelene boje s otisnutim oznakom ‘60 mg' i oznakom ‘9542'.
Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John's Wort and MAOIs (such as moclobemide and linezolid).
Lijekovi koji povećavaju razinu serotonina: triptani, tramadol, triptofan, SSRI (poput paroksetina i fluoksetina), inhibitori ponovne pohrane serotonina i noradrenalina (poput venlafaksina), triciklički antidepresivi (poput klomipramina, amitriptilina), petidin, gospina trava i inhibitori MAO (poput moklobemida i linezolida).
Read the leaflet before use.
Prije uporabe pročitati uputu o lijeku.
ARICLAIM hard gastro-resistant capsules contain sucrose.
ARICLAIM tvrde želučanootporne kapsule sadrže saharozu.
ARICLAIM must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Oštećenje jetrene funkcije ARICLAIM se ne smije primjenjivati u bolesnika s bolešću jetre čija je posljedica oštećenje jetrene funkcije (vidjeti dijelove 4.3 i 5.2).
The 30 mg capsules are blue and white and are printed with ‘30 mg' and the code ‘9543'.
Kapsule od 30 mg su plave i bijele boje s otisnutim oznakom ‘30 mg' i oznakom ‘9543'.
No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min).
U bolesnika s blagom ili umjerenom disfunkcijom bubrežne funkcije (klirens kreatinina 30 do 80 ml/min) nije potrebna prilagodba doze.
7 hard gastro-resistant capsules 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
7 tvrdih želučanootpornih kapsula 28 tvrdih želučanootpornih kapsula 98 tvrdih želučanootpornih kapsula
The use of ARICLAIM while breastfeeding is not recommended.
Ne preporučuje se uzimanje lijeka ARICLAIM za vrijeme dojenja.
Stomatitis Haematochezia Breath odour Microscopic colitis
Poremećaji probavnog sustava mučnina suha usta stomatitis hematohezija zadah iz usta mikroskopski kolitis9
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE
Dehydration Hyponatraemia SIADH6
Poremećaji metabolizma i prehrane dehidracija hiponatrijemija SIADH6
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač Nositelj odobrenja za stavljanje gotovog lijeka u promet: Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
Syncope2 Hypertension3,7
crvenilo uz osjećaj vrućine sinkopa2 hipertenzija3,7
Edible white ink: titanium dioxide (E171), propylene glycol, shellac, povidone.
Jestiva bijela tinta: titanijev dioksid (E171), propilenglikol, šelak, povidon
− have severe kidney disease
− imate tešku bolest bubrega
• difficulty or inability to pass urine, difficulty to start urinating, needing to pass urine during the night, needing to pass more urine than normal, having a decreased urine flow
• otežano ili nemogućnost mokrenja, otežan početak mokrenja, potreba za mokrenjem tijekom noći, pojačana potreba za mokrenjem, smanjen protok mokraće
MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/011
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/283/011
MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/008
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/283/008
ARICLAIM contains sucrose.
ARICLAIM sadrži saharozu.
Despite this, your doctor may prescribe ARICLAIM for patients under 18 because he/she decides that this is in their best interests.
bolesnicima mlađima od 18 godina ako procijeni da je to u njihovu najboljem interesu.
ARICLAIM contains sucrose
ARICLAIM sadrži saharozu
• problems getting an erection, changes in ejaculation
• bolno mokrenje, često mokrenje • otežano postizanje erekcije, promjene u ejakulaciji
Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Neprozirno tijelo bijele boje s otisnutom oznakom ‘30 mg' i neprozirna plava kapica s otisnutom oznakom ‘9543'.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT REACH AND SIGHTREACH OF CHILDREN
POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
Edible green ink: synthetic black iron oxide (E172), synthetic yellow iron oxide (E172), propylene glycol, shellac.
Jestiva zelena tinta: sintetski crni željezov oksid (E172), sintetski žuti željezov oksid (E172), propilenglikol, šelak
Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Neprozirno tijelo zelene boje s otisnutom oznakom ‘60 mg' i neprozirna plava kapica s otisnutom oznakom ‘9542'.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/011 (28 hard gastro-resistant capsules)
12. BROJEVI ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/04/283/011 (28 tvrdih želučanootpornih kapsula)
28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
28 tvrdih želučanootpornih kapsula 98 tvrdih želučanootpornih kapsula
Multinucleated cells were seen in the liver in the absence of other histopathological changes in the rat carcinogenicity study.
ispitivanju karcinogenosti u štakora primijećene su multinuklearne stanice u jetri, ali ne i druge histopatološke promjene.
• dehydration, low levels of sodium in the blood (mostly in elderly people; the symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious symptoms are fainting, fits or falls), syndrome of inappropriate secretion of anti-diuretic hormone (SIADH)
• dehidracija, niske razine natrija u krvi (uglavnom u starijih ljudi; simptomi mogu uključivati osjećaj omaglice, slabost, smetenost, pospanost ili izrazit umor, mučninu ili povraćanje;
See section 4.2 for information on patients with mild or moderate renal dysfunction.
Za bolesnike s teškim oštećenjem bubrežne funkcije vidjeti dio 4.3. Vidjeti dio 4.2 za informacije o bolesnicima s blagim ili umjerenim poremećajem bubrežne funkcije.
Adverse reactions may be more common during concomitant use of ARICLAIM and herbal preparations containing St John's wort (Hypericum perforatum).
Pri istodobnom uzimanju lijeka ARICLAIM i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
• large pupils (the dark centre of the eye), problems with eyesight
• velike zjenice (tamno središte oka), poteškoće s vidom • osjećaj omaglice ili „vrtnje“ (vrtoglavica), bol u uhu
Package leaflet: information for the user ARICLAIM 30 mg hard gastro-resistant capsules ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
ARICLAIM 30 mg tvrde želučanootporne kapsule ARICLAIM 60 mg tvrde želučanootporne kapsule duloksetin (u obliku duloksetinklorida)
Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30 ml/min).
Oštećenje bubrežne funkcije U bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min) koji su na hemodijalizi, koncentracije duloksetina u plazmi su povećane.
• weight gain
• pojačano zijevanje
The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with ARICLAIM (see section 4.4).
inhibitor i ne smije se davati bolesnicima koji se liječe lijekom ARICLAIM (vidjeti dio 4.4).
• constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking
• zatvor, proljev, bol u želucu, povraćanje, žgaravica ili probavne tegobe, vjetrovi
The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
12-tjedna, dvostruko slijepa, placebom kontrolirana ispitivanja fiksnih doza u odraslih (22 do
Very rare side effects (may affect up to 1 in 10,000 people) • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) • glavobolja, osjećaj pospanosti
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
60 mg: želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) željezov oksid, žuti (E172) bijela tinta, jestiva
Very common side effects (may affect more than 1 in 10 people)
Vrlo rijetke nuspojave (mogu se javiti u najviše 1 na 10 000 osoba)
Caution is advisable if ARICLAIM is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
tricikličkih antidepresiva poput klomipramina ili amitriptilina, inhibitora MAO poput moklobemida ili linezolida, gospine trave (Hypericum perforatum) ili triptana, tramadola, petidina i triptofana (vidjeti dio 4.4).
The corresponding figures for at least 50% pain reduction were 50% and 26% respectively.
Smanjenje boli od najmanje 50% zabilježeno je u
ARICLAIM is for oral use.
ARICLAIM se uzima kroz usta.
• suicidal behaviour, mania (over activity, racing thoughts and decreased need for sleep),
• samoubilačko ponašanje, manija (prekomjerna aktivnost, brze misli i smanjena potreba za spavanjem), halucinacije, agresivnost i bijes • "serotoninski sindrom" (rijetka reakcija koja može uzrokovati osjećaj velike sreće,
General disorders and administration site conditions Falls8
Opći poremećaji i reakcije na mjestu primjene umor padovi8
NAME OF THE MEDICINAL PRODUCT ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine
ARICLAIM 60 mg tvrde želučanootporne kapsule duloksetin
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
OD LIJEKA, KADA JE POTREBNO
− are taking other medicines containing duloxetine (see ‘Other medicines and ARICLAIM') Talk to your doctor if you have high blood pressure or heart disease.
− uzimate druge lijekove koji sadrže duloksetin (vidjeti ‘Drugi lijekovi i ARICLAIM'')
ARICLAIM contains the active substance duloxetine.
Što je ARICLAIM i za što se koristi ARICLAIM sadrži djelatnu tvar duloksetin.
NAME OF THE MEDICINAL PRODUCT ARICLAIM 30 mg hard gastro-resistant capsules Duloxetine
ARICLAIM 30 mg tvrde želučanootporne kapsule duloksetin
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET