natgillin/translations-raw huggingface dataset:
Monoamine Oxidase Inhibitors (MAOIs): due to the risk of serotonin syndrome, CYMBALTA should not be used in combination with nonselective irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
Zaviralci monoaminooksidaze (MAOI): zaradi nevarnosti za serotoninski sindrom CYMBALTE ne smemo uporabljati v kombinaciji z neselektivnimi ireverzibilnimi zaviralci monoaminooksidaze (MAOI) ali v 14 dneh po prenehanju zdravljenja z MAOI.
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping CYMBALTA before starting an MAOI (see section 4.3).
Na podlagi razpolovnega časa duloksetina pa mora po prenehanju jemanja CYMBALTE preteči vsaj 5 dni pred začetkom jemanja MAOI (glejte poglavje 4. 3).
However, the concomitant use of CYMBALTA with selective, reversible MAOIs is not recommended (see section 4.4).
Vendar pa sočasno uporabo CYMBALTE s selektivnimi reverzibilnimi MAOI odsvetujemo (glejte poglavje 4. 4).
Serotonin syndrome: in rare cases, serotonin syndrome has been reported in patients using SSRIs (e. g. paroxetine, fluoxetine) concomitantly with serotonergic medicinal products.
Serotoninski sindrom: pri bolnikih, ki so SSRI (denimo paroksetin, fluoksetin) uporabljali sočasno s serotoninergičnimi zdravili, so v redkih primerih poročali o serotoninskem sindromu.
Caution is advisable if CYMBALTA is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, St John’ s wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan.
Če CYMBALTO uporabljamo sočasno s serotoninergičnimi antidepresivi, kot so SSRI, tricikličnimi antidepresivi, denimo, klomipraminom ali amitriptilinom, šentjanževko (Hypericum perforatum), venlafaksinom ali triptani, tramadolom, petidinom in triptofanom, priporočamo previdnost.
Effect of duloxetine on other medicinal products Medicinal products metabolised by CYP1A2:
Učinek duloksetina na druga zdravila
The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily).
6 Zdravila, ki jih presnavlja CYP1A2: sočasno dajanje duloksetina (60 mg dvakrat na dan) ni značilno vplivalo na farmakokinetiko teofilina, substrata CYP1A2.
Caution is advised if CYMBALTA is co-administered with medicinal products that are 6 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).
Če CYMBALTO dajemo sočasno z zdravili, ki jih presnavlja predvsem CYP2D6 (risperidon, triciklični antidepresivi [tricyclic antidepressants, TCAs], kot so nortriptilin, amitriptilin in imipramin) in zlasti če imajo ozek terapevtski indeks (kot na primer s flekainidom, propafenonom in metoprololom), svetujemo previdnost.
Therefore CYMBALTA should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Zato CYMBALTE ne smemo dajati skupaj z močnimi zaviralci CYP1A2, denimo s fluvoksaminom (glejte poglavje 4. 3).
CYMBALTA should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
CYMBALTO naj se v nosečnostu uporablja le, če možna korist upravičuje možno tveganje za plod.
As the safety of duloxetine in infants is not known, the use of CYMBALTA while breast-feeding is not recommended.
Ker varnost uporabe duloksetina pri dojenčkih ni znana, odsvetujemo uporabo CYMBALTE med dojenjem.
7 4.8 Undesirable effects
7 Študij vpliva na sposobnost vožnje in upravljanja s stroji niso izvedli.
Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 8239 patients, 5075 on duloxetine and 3164 on placebo) in depression, generalized anxiety disorder and diabetic neuropathic pain and fibromyalgia.
Preglednica 1 prikazuje neželene učinke, ki so jih opažali v spontanih poročanjih in v s placebom kontroliranih kliničnih preskušanjih (skupno 8239 bolnikov, 5075 jih je jemalo duloksetin, 3164 jih je dobilo placebo) za zdravljenje depresije, generalizirane anksiozne motnje in bolečine diabetične nevropatije ter fibromialgije.
The most commonly reported adverse reactions in patients treated with CYMBALTA were nausea, headache, dry mouth, somnolence, fatigue, insomnia, dizziness and constipation.
Neželeni učinki, o katerih so pri bolnikih, zdravljenih s CYMBALTO, najpogosteje poročali, so bili slabost, glavobol suha usta, zaspanost, utrujenost, nespečnost, omotica in zaprtje.
Very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 and < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Neželeni učinki Ocene pogostnosti: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 in < 1/ 10), občasni (≥ 1/ 1. 000 in < 1/ 100), redki (≥ 1/ 10. 000 in < 1/ 1. 000), zelo redki (< 1/ 10. 000), ni znano (ocena iz danih podatkov ni možna).
Very common Investigations
Zelo pogosti
Weight decrease
Zmanjšanje telesne mase
Weight increase Creatine phosphokinase increased
Povečanje telesne mase Zvišanje kreatinin - fosfikinaze
Nervous System Disorders Headache (15.3%) Somnolence (10.9%) Dizziness (10.3%)
Glavobol (15, 3%) Zaspanost (10, 9%) Omotica (10, 3%) Očesne bolezni
Tremor Paraesthesia Dysgeusia Lethargy
Tremor Parestezija Disgvezija Letargija
Nervousness Disturbance in attention Dyskinesia Poor quality sleep
Živčnost Motnja pozornosti Diskinezija Slaba kvaliteta spanja
Myoclonus Convulsions
Mioklonus Konvulzije
Serotonin syndrome Extra- pyramidal symptoms Akathisia Psychomotor restlessness
Serotoninski sindrom Ekstrapirami dni simptomi Akatizija Psihomotorič ni nemir
Eye Disorders
Zamegljen vid
Blurred vision
Midriaza Motnja vida
(25.2%) Dry mouth (13.8%) Constipation (10.3%)
Navzea (25, 2%) Suha usta (13, 8%) Zaprtje (10, 3%) Bolezni sečil
Vomiting Dyspepsia Flatulence
Driska Bruhanje Dispepsija Napenjanje
Eructation Gastritis Stomatitis
Gastroenteritis Slab zadah Kolcanje Hematohezija Gastritis Stomatitis Zastajanje seča Nenormalen Disurija vonj urina Odlašanje uriniranja Nokturija Poliurija Slabši curek urina
nal haemorrhage
Gastrointesti nalna krvavitev
Renals and Urinary Disorders
Bolezni kože in podkožja
Urinary Retention Dysuria Urinary hesitation Nocturia Polyuria Urine flow decreased
Povečano znojenje Izpuščaj Nočno znojenje
Skin and Subcutaneous Tissue Disorders
Urtikarija Kontaktni dermatitis Hladen znoj Fotosenzitivno stne reakcije Povečano nagnjenje k modricam
Sweating increased Rash Night sweats
Angio - nevrotični edem Stevens - Johnsonov sindrom
Urticaria Dermatitis contact Cold sweat Photo- sensitivity reactions Increased tendency to bruise
9
Angio- neurotic oedema Stevens- Johnson Syndrome
Bolezni mišično- skeletnega sistema in vezivnega tkiva
Decreased Appetite
Zmanjšan apetit
Hyperglycemi a (reported especially in diabetic patients)
Hiperglikemija Dehidracija (poročana Sindrom zlasti pri neustreznega diabetičnih izločanja bolnikih) antidiuretičneg a hormona Hiponatriemija
Infections and infestations Laryngitis Vascular Disorders
Infekcijske in parazitske bolezni Laringitis Žilen bolezni
Blood pressure increase Peripheral coldness Orthostatic hypotension2 Syncope2
Zvišan krvni tlak Hladni periferni deli Ortostatska hipotenzija2 Sinkopa2
Hypertension Hypertensive crisis
Hipertenzija Hipertenzivn a kriza
General Disorders and Administration Site Conditions Fatigue (10.8%)
Splošne težave in spremembe na mestu aplikacije Utrujenost (10, 8%)
Abdominal pain Chills
Bolečina v trebuhu Mrzlica
Feeling abnormal Feeling cold Thirst Malaise Feeling hot Gait disturbance
Neobičajno počutje Občutek mraza Žeja Bolehnost Občutek vročine Motnja hoje
Immune system disorders Hepato-biliary disorders
Zvišani jetrni encimi (ALT, AST, alkalna fosfataza) Hepatitis3 Akutna okvara jeter
Hyper- sensitivity disorder
Zlatenica Odpoved jeter
Anaphylactic reaction
Erektilna disfunkcija
Elevated liver enzymes (ALT, AST, alkaline phosphatase) Hepatitis3 Acute liver injury
Motnja ejakulacije Zapoznela ejakulacija Seksualna disfunkcija Ginekološka krvavitev
Jaundice Hepatic failure
Menopavzalni simptomi
Reproductive System and Breast Disorders
Psihiatrične motnje Nespečnost
Erectile dysfunction
Agitacija
Ejaculation disorder Ejaculation delayed Sexual dysfunction Gynaecologica l haemorrhage
Bruksizem
Menopausal symptoms
Manija
Psychiatric Disorders Insomnia
Razmišljanje o samomoru5
Bruxism
Zmanjšanje libida
Mania
Dezorientacija Halucinacije Apatija Agresija in 4
Suicidal
Samomorilno obnašanje5
Disorientation Hallucinations Apathy Aggression and anger4
Anksioznost Nenormalen orgazem Nenavadne sanje Motnja spanja
ideation 5 Suicidal5 behaviour
jeza
3 See section 4.4 4 Cases of aggression and anger have been reported particularly early in treatment of after treatment discontinuation.
4 O primerih agresije in jeze so poročali zlasti ob začetku zdravljenja in po prekinitvi zdravljenja.
5 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4)
5 Med zdravljenjem z duloksetinom ali kmalu po prekinitvi zdravljenja so poročali o primerih razmišljanja o samomoru in samomorilnem obnašanju (glejte poglavje 4. 4).
10 Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), fatigue, agitation or anxiety, nausea and/ or vomiting, tremor, headache, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Reakcije, o katerih najpogosteje poročajo so omotica, senzorične motnje (vključno s parestezijo), motnje spanja (vključno z nespečnostjo in intenzivnimi sanjami), utrujenost, agitacija ali tesnobnost, slabost in/ ali bruhanje, tresenje, glavobol, razdražljivost, driska, hiperhidroza in vrtoglavica.
Signs and symptoms of overdose (duloxetine alone or with mixed medicinal products) included somnolence, coma, serotonin syndrome, seizures,, vomiting and tachycardia.
Znaki in simptomi prevelikega odmerjanja (duloksetina samega ali v kombinaciji z drugimi zdravili) so vključevali zaspanost, komo, serotoninski sindrom, epileptične napade, bruhanje in tahikardijo.
No specific antidote is known for duloxetine but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/ or temperature control) may be considered.
11 Specifičnega antidota za duloksetin ne poznamo, vendar v primeru pojava serotoninskega sindroma pretehtamo možnost uvedbe specifičnega zdravljenja (s ciproheptadinom in/ ali nadzorom temperature).
Major Depressive Episodes:
Velike depresivne epizode:
CYMBALTA was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
CYMBALTO so preučevali v kliničnem programu, v katerem je sodelovalo 3. 158 bolnikov (1. 285 bolniških let izpostavljenosti), ki so izpolnjevali merila DSM- IV za veliko depresivno motnjo.
The efficacy of CYMBALTA at the 11 recommended dose of 60 mg once a day was demonstrated in three out of three randomized, double- blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Učinkovitost CYMBALTE v priporočenem odmerku 60 mg enkrat na dan so pokazali v treh od treh randomiziranih dvojno slepih s placebom kontroliranih akutnih preskušanjih z določenim odmerkom pri odraslih bolnikih z veliko depresivno motnjo, zdravljenih ambulantno.
Overall, CYMBALTA’ s efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomized, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Splošno so učinkovitost CYMBALTE pokazali pri dnevnih odmerkih med 60 in 120 mg v skupaj petih od sedmih randomiziranih dvojno slepih s placebom kontroliranih akutnih preskušanjih z določenim odmerkom pri odraslih bolnikih z veliko depresivno motnjo, zdravljenih ambulantno.
CYMBALTA demonstrated statistical superiority over placebo as measured by improvement in the 17-item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
CYMBALTA se je izkazala za statistično boljšo kot placebo, kar so izmerili z izboljšanjem skupnega števila točk po Hamiltonovi lestvici za ocenjevanje depresije s 17 postavkami (Hamilton Depression Rating Scale, HAM- D), ki vključuje čustvene in tudi somatske simptome depresije.
Response and remission rates were also statistically significantly higher with CYMBALTA compared with placebo.
Ob uporabi CYMBALTE v primerjavi s placebom so bile značilno višje tudi stopnje odziva in remisije.
Only a small proportion of patients included in pivotal clinical trials had severe depression (baseline HAM-D > 25).
Le majhen delež bolnikov, sodelujočih v presečnih kliničnih preskušanjih, je imel hudo depresijo (izhodiščno število točk po HAM- D > 25).
In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label CYMBALTA 60 mg once daily were randomised to either CYMBALTA 60 mg once daily or placebo for a further 6-months.
V študiji preprečevanja relapsa so bolnike, ki so se odzvali na 12- tedensko akutno zdravljenje z znanim zdravilom, CYMBALTO 60 mg enkrat na dan, naključno razporedili v skupini, kjer so nadaljnjih 6 mesecev prejemali ali CYMBALTO 60 mg enkrat na dan ali placebo.
CYMBALTA 60 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.004) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
Zdravljenje s CYMBALTO 60 mg enkrat na dan se je izkazalo za statistično značilno boljše v primerjavi s placebom (p = 0, 004) pri merilu primarnega izida, preprečevanju relapsa depresije, kot so izmerili s časom do relapsa.
The incidence of relapse during the 6-months double-blind follow-up period was 17% and 29% for duloxetine and placebo, respectively.
Incidenca relapsa v 6- mesečnem obdobju dvojno slepega sledenja je bila 17% oziroma 29% ob uporabi duloksetina oziroma placeba.
The effect of CYMBALTA 60 mg once a day in elderly depressed patients (≥ 65 years) was specifically examined in a study that showed a statistically significative difference in the reduction of the HAMD17 score for duloxetine-treated patients compared to placebo.
Pri starejših depresivnih bolnikih (≥ 65 let) so posebej preučevali učinek CYMBALTE 60 mg enkrat na dan v študiji, ki je pokazala statistično značilno razliko v zmanjšanju HAMD17 rezultata za bolnike, ki so bili zdravljeni z duloksetinom, v primerjavi s tistimi, ki so prejemali placebo.
Tolerability of CYMBALTA 60 mg once day in elderly patients was comparable to that seen in the younger adults.
Prenašanje CYMBALTE 60 mg enkrat na dan pri starejših bolnikih je bilo primerljivo s tistim, ki je bilo opaženo
However, data on elderly patients exposed to the maximum dose (120mg per day) are limited and thus, caution is recommended when treating this population.
Vendar pa so podatki pri starejših bolnikih, ki so bili izpostavljeni maksimalnemu odmerku (120 mg na dan) omejeni, in je zato pri zdravljenju te populacije potrebna previdnost.
Generalised Anxiety Disorder CYMBALTA demonstrated statistically significant superiority over placebo in five out of five studies including four randomized, double-blind, placebo-controlled acute studies and a relapse prevention study in adult patients with generalised anxiety disorder.
CYMBALTA se je izkazala za statistično značilno boljšo kot placebo v petih izmed petih študij, vključno s štirimi randomiziranimi, dvojno slepimi, s placebom kontroliranimi akutnimi študijami in študijo preprečevanja relapsa pri odraslih bolnikih z generalizirano anksiozno motnjo.
CYMBALTA demonstrated statistically significant superiority over placebo as measured by improvement in the Hamilton Anxiety Scale (HAM-A) total score and by the Sheehan Disability Scale (SDS) global functional impairment score.
CYMBALTA se je izkazala za statistično značilno boljšo kot placebo, kar so izmerili z izboljšanjem skupnega števila točk po Hamiltonovi lestvici za ocenjevanje anksioznosti (Hamilton Anxiety Scale, HAM- A) in s skupnim rezultatom poslabšanja sposobnosti po Sheehanovi lestvici za ocenjevanje nesposobnosti (Sheehan Disability Scale, SDS).
Response and remission rates were also higher with CYMBALTA compared to placebo.
Ob uporabi CYMBALTE v primerjavi s placebom so bile višje tudi stopnje odziva in remisije.
CYMBALTA showed comparable efficacy results to venlafaxine in terms of improvements on the HAM-A total score.
CYMBALTA je pokazala primerljive rezultate učinkovitosti v primerjavi z venlafaksinom glede izboljšanja skupnega števila točk po HAM- A.
In a relapse prevention study, patients responding to 6 months of acute treatment with open-label CYMBALTA were randomised to either CYMBALTA or placebo for further 6-months.
V študiji preprečevanja relapsa so bolnike, ki so se odzvali na 6- tedensko akutno zdravljenje z znanim zdravilom CYMBALTO, naključno razporedili v skupini, kjer so nadaljnjih 6 mesecev prejemali ali CYMBALTO ali placebo.
CYMBALTA 60 mg to 120 mg once daily demonstrated statistically significant superiority compared to placebo (p < 0.001) on the prevention of relapse, as measured by time to relapse.
Zdravljenje s CYMBALTO 60 mg do 120 mg enkrat na dan se je izkazalo za statistično značilno boljše v primerjavi s placebom (p < 0, 001) pri preprečevanju relapsa, kar so izmerili s časom do relapsa.
The incidence of relapse during the 6-months double-blind follow-up period was 14% for CYMBALTA and 42% for placebo.
Incidenca relapsa v 6- mesečnem obdobju dvojno slepega sledenja je bila 14% pri prejemnikih CYMBALTE oziroma 42% pri prejemnikih placeba.
The efficacy of CYMBALTA 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.
Učinkovitost CYMBALTE kot zdravila za bolečino pri diabetični nevropatiji so ugotavljali v 2 randomiziranih 12- tedenskih dvojno slepih s placebom kontroliranih študijah z določenim odmerkom pri odraslih (starih od 22 do 88 let), ki so imeli bolečino diabetične nevropatije vsaj 6 mesecev.
In both studies, CYMBALTA 60 mg once daily and 60 mg twice daily significantly reduced pain compared with placebo.
V obeh študijah je CYMBALTA 60 mg enkrat na dan in 60 mg dvakrat na dan značilno zmanjšal bolečino v primerjavi s placebom.
Clinical response rates (50% or greater improvement in pain) were analysed according to 12 whether or not the patient experienced somnolence during treatment.
Stopnje kliničnega odziva (50% ali večje zmanjšanje bolečine) smo razčlenili na podlagi tega, ali je bolnik med zdravljenjem izkusil zaspanost.
Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11%).
Hrana podaljša čas, potreben za doseganje najvišje koncentracije, s 6 na 10 ur in mejno zmanjša obseg
Gender: pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Spol: med moškimi in ženskami so ugotovili farmakokinetične razlike (očitni plazemski očistek je pri ženskah približno 50% nižji).
13 Nursing mothers:
Doječe matere:
No malformations were observed in another study testing a higher dose of a different salt of duloxetine.
V študijah pre - in
In prenatal/ postnatal toxicity studies in the rat, duloxetine induced adverse behavioural effects in the offspring at exposures below maximum clinical exposure (AUC).
14 postnatalne toksičnosti pri podganah je duloksetin povzročil neželene vedenjske učinke pri mladičih ob ravneh sistemskih izpostavljenosti, nižjih od največje klinične izpostavljenosti (AUC).
14 6.3 Shelf life
6. 3 Rok uporabnosti
CYMBALTA 30 mg is available in packs of 7, 28 and 98 capsules.
CYMBALTA 30 mg je na voljo v pakiranju po 7, 28 in 98 kapsul.
CYMBALTA 60 mg hard gastro-resistant capsules
CYMBALTA 60 mg trde gastrorezistentne kapsule
The CYMBALTA 60 mg capsule has an opaque green body, imprinted with ‘ 60 mg’ and an opaque blue cap, imprinted with ‘ 9542’.
Kapsula CYMBALTA 60 mg ima neprozorno zeleno telo z vtisnjenim napisom ‘ 60 mg ’ ter neprozoren moder pokrovček z vtisnjeno oznako ‘ 9542 ’.
16 Diabetic Peripheral Neuropathic Pain:
17 Bolečina diabetične periferne nevropatije:
When stopping treatment with CYMBALTA the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Ob prenehanju zdravljenja s CYMBALTO je treba odmerek zdravila v obdobju najmanj enega do dveh tednov postopoma zmanjševati, da zmanjšamo tveganje za pojav odtegnitvenih reakcij (glejte poglavji 4. 4 in 4. 8).
The initiation of treatment with CYMBALTA is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
18 Uvedba zdravljenja s CYMBALTO je kontraindicirana pri bolnikih z nenadzorovano hipertenzijo, ki lahko izpostavi bolnike možnemu tveganju za hipertenzivno krizo (glejte poglavje 4. 4 in 4. 8).
A meta-analysis of placebo-controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
19 pokazala, da pri bolnikih, mlajših od 25 let, pri uporabi antidepresivov obstaja večje tveganje za pojav samomorilnega vedenja kot pri uporabi placeba.
18 Close supervision of patients and in particular those at high risk should accompany medicinal product therapy especially in early treatment and following dose changes.
Še posebej skrbno je treba nadzirati bolnike z velikim tveganjem.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering CYMBALTA.
Hiponatremija. Ob dajanju CYMBALTE so redko poročali o hiponatremiji, zlasti pri starejših.
Elderly Major Depressive Episodes:
20 Starejši Velike depresivne epizode:
Data on the use of CYMBALTA 120mg in elderly patients with major depressive disorders are limited..
Podatki o uporabi CYMBALTE 120 mg pri starejših bolnikih z velikimi depresivnimi motnjami so omejeni.
19 Akathisia/ psychomotor restlessness The use of duloxetine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Akatizija/ psihomotorični nemir Jemanje duloksetina so povezovali s pojavom akatizije, za katero je značilen subjektivno neprijeten ali mučen nemir in potreba po gibanju, ki ju pogosto spremlja nezmožnost sedenja ali stanja pri miru.
The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily).
21 Zdravila, ki jih presnavlja CYP1A2: sočasno dajanje duloksetina (60 mg dvakrat na dan) ni značilno vplivalo na farmakokinetiko teofilina, substrata CYP1A2.
Caution is advised if CYMBALTA is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as 20 nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Če CYMBALTO dajemo sočasno z zdravili, ki jih presnavlja predvsem CYP2D6 (risperidon, triciklični antidepresivi [tricyclic antidepressants, TCAs], kot so nortriptilin, amitriptilin in imipramin) in zlasti če imajo ozek terapevtski indeks (kot na primer s flekainidom, propafenonom in metoprololom), svetujemo previdnost.
As with other serotoninergic medicinal product, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term.
Kot pri drugih serotoninergičnih zdravilih se lahko pri novorojenčku pojavijo odtegnitveni simptomi, če mati pred porodom uporablja duloksetin.