qanastek/EMEA-V3 huggingface dataset:
The risk of withdrawal symptoms seen with SSRI’ s and SNRI ’ s may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Ir- riskju ta ’ sintomi ta ’ rtirar li jidhru b’ SSRIs u SNRIs jistgħu jiddependu minn ħafna fatturi fosthom it- tul u d- doża tat- terapija u r- rata ta ’ tnaqqis fid- doża.
Generally the symptoms are mild to moderate, however, in some patients they may be severe in intensity.
Ġeneralment dawn is- sintomi huma ħfief jew moderati, madankollu, f’ xi pazjenti jistgħu jkunu ta ’ intensità qawwija.
They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.
Is- soltu dawn jidhru fl- ewwel ftit jiem ta ’ twaqqif tal - kura, iżda kien hemm rapporti rari ħafna ta ’ dawn is- sintomi f’ pazjenti li involontarjament kienu nsew jieħdu doża.
Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
Ġeneralment dawn is- sintomi jgħadu waħedhom u s- soltu jieqfu fi żmien ġimagħtejn, għalkemm f’ xi individwi jistgħu jdumu aktar (2- 3 xhur jew aktar).
It is therefore advised that duloxetine should be gradually tapered when discontinuing treatment over a period of no less than 2 weeks, according to the patient’ s needs (see section 4.2).
Għalhekk huwa rrakkomandat li f’ twaqqif tal- kura duloxetine jiġi mnaqqas bil- ftit il- ftit fuq perijodu ta ’ mhux anqas minn ġimagħtejn, skond il- bżonnijiet tal- pazjent (ara sezzjoni 4. 2).
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering DULOXETINE BOEHRINGER INGELHEIM.
Iponatrimja L- iponatrimja ġiet irrappurtata rarament, l- aktar fl- anzjani, meta jkun qed jingħata DULOXETINE BOEHRINGER INGELHEIM.
21 Depression, suicidal ideation and behaviour Although DULOXETINE BOEHRINGER INGELHEIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
23 Depressjoni, formazzjoni ta ’ ħsibijiet ta ’ suwiċidju u mġiba Ghalkemm DULOXETINE BOEHRINGER INGELHEIM mhuwiex indikat għal kura ta ’ depressjoni, is- sustanza attiva tiegħu (duloxetine) teżisti wkoll bħala medikazzjoni antidepressiva.
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Id- depressjoni hija assoċjata ma ’ riskju akbar ta ’ ħsibijiet suwiċidali, ħsara lill- persuna nnifisha, u suwiċidju (avvenimenti marbuta ma ’ suwiċidju).
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 Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
Analiżi ta ’ numru ta ’ studji kliniċi kkontrollati bi plaċebo ta ’ prodotti mediċinali antidipressivi li ntużaw f’ disturbi psikjatriċi wrew riskju ogħla ta ’ mġiba suwiċidali bl- antidipressivi meta mqabbla ma ’ plaċebo f’ pazjenti iżgħar minn 25 sena.
Physicians should encourage patients to report any distressing thoughts or feelings or depressive symptoms at any time.
Każijiet ta ’ ħsibijiet ta ’ suwiċidju u mġiba ta ’ tendenza għal suwiċidju ġew irrapportati waqt il- kura b’ duloxetine jew ftit wara t- twaqqif tal- kura (ara sezzjoni 4. 8). It- tobba għandhom iħeġġu lill- pazjenti sabiex jirrappurtaw kull ħsieb jew sentiment ta ’ dwejjaq jew sintomu depressiv f’ kull ħin.
If while on DULOXETINE BOEHRINGER INGELHEIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
Jekk waqt il- kura b’ DULOXETINE BOEHRINGER INGELHEIM, il- pazjent jiżviluppa sintomi ta ’ aġitazzjoni jew sintomi depressivi, għandu jiġi meħud parir mediku speċjalizzat, peress li d- depressjoni hija kundizzjoni medika serja.
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.
Imġiba assoċjata mas- suwiċidju (attentati ta ’ suwiċidju u ħsibijiet suwiċidali), u ostilità (l- aktar aggressjoni, imġiba konfrontali, u rabja), kienu osservati aktar spiss fi provi kliniċi fuq tfal u adolexxenti kkurati b’ anti - depressivi meta mqabbla ma ’ dawk ikkurati bil- plaċebo.
Sucrose DULOXETINE BOEHRINGER INGELHEIM gastro-resistant capsules contain sucrose.
Sucrose DULOXETINE BOEHRINGER INGELHEIM kapsuli gastro- reżistenti ibsin fihom sucrose.
22 4.5 Interaction with other medicinal products and other forms of interaction
24 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Serotonin syndrome: in rare cases, serotonin syndrome has been reported in patients using SSRIs (e. g. paroxetine, fluoxetine) concomitantly with serotonergic medicinal products.
Sindrome ta ’ serotonin: f’ każijiet rari, ġie rrappurtat sindrome ta ’ serotonin f’ pazjenti li jużaw SSRIs (per eżempju paroxetine, fluoxetine) fl- istess ħin ma ’ prodotti mediċinali serotoninerġiċi.
Caution is advisable if DULOXETINE BOEHRINGER INGELHEIM 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.
Wieħed għandu joqgħod attent meta DULOXETINE BOEHRINGER INGELHEIM jintuża fl- istess ħin ma ’ antidipressivi serotoninerġiċi bħal SSRI’ s, triċikliċi bħal clomipramine jew amitriptyline, St. John’ s wort (Hypericum perforatum), venlafaxine jew triptans, tramadol, pethidine u tryptophan.
Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUC0-t 6-fold.
Fluvoxamine (100 mg darba kuljum), inibitur qawwi ta ’ CYP1A2, naqqas it - tneħħija tal- plażma apparenti ta ’ duloxetine b’ madwar 77% u żied b’ 6 darbiet l- AUCo- t.
Inducers of CYP1A2:
25 Sustanzi li jistimulaw CYP1A2:
Population pharmacokinetic studies analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
Analiżi farmakokinetiċi ta ’ popolazzjoni juru li min ipejjep għandu kważi 50% anqas konċentrazzjonijiet fil- plażma ta ’ duloxetine meta mqabbla ma ’ min ma jpejjipx
23 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure (see section 5.3).
Studji fl- annimali wrew tossiċità fuq is- sistema riproduttiva f’ livelli ta ’ esponiment sistemiku (AUC) ta ’ duloxetine anqas mill- massimu ta ’ l- espożizzjoni klinika (ara sezzjoni 4. 3).
As with other serotoninergic medicinal product, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term.
Bħal ma jiġri f’ prodotti mediċinali serotinerġiċi oħra, sintomi ta ’ irtirar jistgħu jseħħu fit- tarbija tat- twelid wara li duloxetine jintuża fl- omm viċin it- tmiem tat- tqala.
DULOXETINE BOEHRINGER INGELHEIM should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
DULOXETINE BOEHRINGER INGELHEIM għandu jintuża biss fit- tqala jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali għall- fetu.
Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.
In - nisa għandhom jingħataw parir li javżaw lit- tabib tagħhom jekk isiru tqal jew jekk għandhom l - intenzjoni li jsiru tqal waqt it- terapija.
Breast feeding Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
Treddigħ L- ammont ta ’ Duloxetine li joħroġ fil- ħalib tal- bniedem huwa żgħir ħafna fuq il- bażi ta ’ studju fuq 6 pazjenti li pproduċew il- ħalib iżda ma tawhx lil uliedhom.
The estimated daily infant dose on a mg/ kg basis is approximately 0.14% of the maternal dose (see section 5.2).
Huwa kkalkulat li d- doża ta ’ kuljum fit - trabi fuq bażi ta ’ mg/ kg hija bejn wieħed u ieħor 0. 14% tad- doża materna (ara sezzjoni 5. 2).
As the safety of duloxetine in infants is not known, the use of DULOXETINE BOEHRINGER INGELHEIM while breast-feeding is not recommended.
Billi mhix magħrufa s- sigurtà ta ’ duloxetine fit- trabi, l- użu ta’ DULOXETINE BOEHRINGER INGELHEIM waqt it- treddigħ mhux rakkomandat
However, the majority of the most frequent adverse events were mild to moderate and resolved within 30 days of occurrence (e. g. nausea).
Iżda il- maġġoranza tar - reazzjonijiet avversi komuni kienu ħfief għal moderati u għebu wara 30 ġurnata minn meta bdew (eż. dardir).
Diarrhoea Vomiting Dyspepsia
Emorraġija gastro- intestinaliI
Gastroenteritis Haematochezia Stomatitis Gastritis Flatulence Eructation Breath odour
(23. 3%) Rimettar Ħalq xott Dispepsja (11. 9%) Stitikezza (10. 3%)
Gastrointestinal haemorrhage
Stomatite Gastrite Gass fl- istonku Tifwiq Riħa ħażina fil- ħalq
Renals and Urinary Disorders
Disturbi fil- kliewi u fis- sistema urinarja
Urinary hesitation Dysuria Nocturia Urine odour abnormal
Eżitazzjoni biex tagħmel l- awrina Disurja Awrinazzjoni eċċessiva matul il- lejl Riħa mhux normali ta ’ l - awrina
Urine flow decreased Polyuria
Il- fluss ta ’ l - awrina jonqos Tagħmel ħafna awrina
Urinary retention
Żamma ta ’ l - awrina
Skin and Subcutaneous Tissue Disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Sindrome ta ’
Sweating increased
Żieda fl- għaraq
Rash Increased tendency to
Raxx
Photo- sensitivity reactions 25
Reazzjonijiet
Stevens-Johnson Syndrome Angioneurotic oedema
Stevens- Johnson
Very
Tendenza ogħla li
Common
ta ’
Uncommon
Edima angjo -
Very Common Uncommon Rare Very
titbenġel
Frequency not known
fotosensittività
bruise Night sweats Cold sweat
newrotika
Dermatitis contact Urticaria
Tegħreq matul il- lejl Għaraq kiesaħ
Hepatic failure Jaundice
Trismu
Reproductive System and Breast Disorders Menopausal
Insuffiċjenza epatika
symptoms Gynaecological haemorrhage
Imġiba suwiċidali Formazzjoni ta ’ ideat suwiċidali4
Insomnia AnxietySlee p disorder Agitation Libido decreased
Tnaqqis fil- libido
Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting, however, in some patients they may be severe and/ or prolonged.
Ġeneralment, fl- SSRIs u fl - SNRIs, dawn l- avvenimenti jkunu minn ħfief għal moderati u ma jiżdidux, iżda f’ xi pazjenti jistgħu jkunu qawwija u/ jew jieħdu fit- tul.
Electrocardiograms were obtained from 755 duloxetine-treated patients with SUI and 779 placebo- treated patients in 12-week clinical trials.
Ittieħdu elettrokardjogrammi minn 755 pazjent b’ SUI kkurati b’ duloxetine u 779 pazjent ikkurati bil - plaċebo fi provi kliniċi ta ’ 12- il ġimgħa.
The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients.
L- intervall QT ikkoreġut tat- tħabbit ta ’ qalb, f’ pazjenti fuq kura b’ duloxetine ma kenitx tvarja minn dik ta ’ pazjenti fuq il- plaċebo.
The most commonly observed adverse reactions in patients with diabetic neuropathic pain treated with DULOXETINE BOEHRINGER INGELHEIM were: nausea; headache, dry mouth and somnolence.
L- aktar reazzjonijiet avversi osservati b’ mod komuni f’ pazjenti b ’ uġigħ newropatiku tad- dijabete li kienu qed jieħdu DULOXETINE BOEHRINGER INGELHEIM kienu: tqalligħ, uġigħ ta ’ ras ħalq xott u ngħas.
27 Table 2:
29 Tabella 2:
Very
30
Renals and Urinary Disorders
31 Disturbi fil- kliewi u fis- sistema awrinarja Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
28
Raxx
Hyper- sensitivity
32 Larinġite Disturbi vaskulari Sinkope2
29
Kriżi
Very
wiċċ
Common
Ipotensjoni ortostatika2 Żieda fil - pressjoni tad - demm Ksieħ periferiku
Uncommon
ipertensiva Ipertensjoni
Rare
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Psychiatric Disorders
33 Imġiba suwiċidali4
A free airway should be established.
34 stabbilit passaġġ ta ’ l- arja bla ebda xkiel.
Duloxetine is a combined serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor.
Duloxetine huwa inibitur ta ’ ġbir mill- ġdid kemm tas- serotonin (5- HT) kif ukoll tan- norepinephrine.
Differences were observed
Frekwenza ta 'Episodji ta' Inkontinenza: fl- erba 'studji kollha l- grupp ikkurat b’ duloxetine kellu nuqqas medjan ta' 50% jew aktar fil- IEF meta mqabbel ma '33% fil- grupp ikkurat bil- plaċebo.
31 at each visit after 4 weeks (duloxetine 54%, and placebo 22%), 8 weeks (52% and 29%), and 12 weeks (52% and 33%) of medication.
Id - differenzi kienu osservati f’ kull viżta wara 4 ġimgħat ta ’ kura (duloxetine 54% u l- plaċebo 22%), 8 ġimgħat ta ’ kura (52% u 29%) u 12- il ġimgħa ta ’ kura (52% u 33%).
In an additional study limited to patients with severe SUI, all responses with duloxetine were achieved within 2 weeks.
Fi studju ieħor limitat għall- pazjenti b' SUI gravi, ir- reazzjonijiet kollha b’ duloxetine inkisbu fi żmien ġimgħatejn.
The clinical benefit of DULOXETINE BOEHRINGER INGELHEIM compared with placebo has not been demonstrated in women with mild SUI, defined in randomised trials as those with IEF < 14 per week.
Il- benefiċċju kliniku ta ’ DULOXETINE BOEHRINGER INGELHEIM meta mqabbel mal- plaċebo ma ġiex ipprovat f’ nisa bi grad ħafif ta ’ SUI, definita fi provi randomised bħala dawk b’ IEF < 14 kull ġimgħa.
In these women, DULOXETINE BOEHRINGER INGELHEIM may provide no benefit beyond that afforded by more conservative behavioural interventions.
F’ dawn in- nisa, DULOXETINE BOEHRINGER INGELHEIM jista ’ ma jipprovdix benefiċċju akbar minn dak li jingħata b’ interventi ta ’ komportament aktar konservattivi.
DULOXETINE BOEHRINGER INGELHEIM and Prior Continence Surgery: there are limited data that suggest that the benefits of DULOXETINE BOEHRINGER INGELHEIM are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
35 DULOXETINE BOEHRINGER INGELHEIM meta jingħata f’ pazjenti li kienet saritilhom operazzjoni għall- inkontinenza: hemm tagħrif limitat li jissuġġerixxi li l- benefiċċji ta ’ DULOXETINE BOEHRINGER INGELHEIM ma kienux imnaqqsa f’ nisa bl- inkontinenza awrinarja dovuta għall - isforz li diġà kienet saritilhom operazzjoni għall- inkontinenza.
32 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Duloxetine is extensively metabolised by oxidative enzymes (CYP1A2 and the polymorphic CYP2D6), followed by conjugation.
Duloxetine huwa metaboliżżat b' mod estensiv minn enzimi ossidattivi (CYP1A2 u dik polymorfika CYP2D6) u mbagħad ikkonjugat.
Duloxetine is extensively metabolised and the metabolites are excreted principally in urine.
Duloxetine huwa metaboliżżat b’ mod estensiv u l- eskrezzjoni tal- prodotti metaboliċi jsir l- aktar fl - awrina.
Both CYP2D6 and CYP1A2 catalyse the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulphate conjugate of 5-hydroxy,6-methoxy duloxetine.
Kemm CYP 2D6 kif ukoll CYP 1A2 jikkatalizzaw il- formazzjoni taż- żewġ prodotti metaboliċi prinċipali l- glukuronidu kkonjugat ta '4- hydroxy duloxetine u l- konjugat tas- sulfat ta' 5 -
Based upon the overlap in the range of clearance, gender-based pharmacokinetic differences do not justify the recommendation for using a lower dose for female patients.
Minħabba l- fatt li l- marġni tat- tneħħija jikkoinċidu fuq xulxin, differenzi farmakokinetiċi bbażati fuq is- sess ma jiġġustifikawx ir- rakkomandazzjoni li tintuża doża inqas f’ pazjenti nisa.
Renal impairment: end stage renal disease (ESRD) patients receiving dialysis had a 2-fold higher duloxetine Cmax and AUC values compared to healthy subjects.
Indeboliment renalii: pazjenti b' mard terminali tal- kliewi (ESRD) li jirċievu id- dijaliżi kellhom valuri tas- Cmax u ta ’ l- AUC ta ’ duloxetine darbtejn ogħla minn dawk ta ’ pazjenti b' saħħithom.
The amount of duloxetine in breast milk is approximately 7 µg/ day while on 40 mg twice daily dosing.
L- ammont ta ’ duloxetine fil- ħalib ta ’ l- omm huwa bejn wieħed u ieħor ta ’ 7µg/ jum waqt li tkun fuq doża ta ’ 40 mg darbtejn kuljum.
33 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
The relevance of this mouse data to humans is unknown.
Ir- relevanza ta 'dan it- tagħrif fil - ġrieden għall- bniedem mhix magħrufa.
Female rats receiving duloxetine before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
Firien tas- sess femminil li rċevew duloxetine, qabel u waqt li kienu qedgħin jgħammru u fil- bidu tat- tqala, kellhom tnaqqis fil- konsum ta 'l- ikel matern u fil- piż, diżordni fiċ- ċiklu oestrous, nuqqas fl- indiċi ta' twelid ta 'frieħ ħajjin u fis- sopravivenza tal- ferħ ta' l - annimal, u dewmien biex jikbru l- frieħ f’ livelli ta ’ espożizzjoni sistemika, stmata li hija mhux anqas mill- esponiment massimu kliniku (AUC).
In an embryotoxicity study in the rabbit, a higher incidence of cardiovascular and skeletal malformations was observed at systemic exposure levels below the maximun clinical exposure (AUC).
Fi studji embrojotossiċi fil- fenek, inċidenża ogħla ta ’ formażżjoniijiet difettużi kardjovaskulari u skeletriċi kienu osservati f’ livelli ta ’ espożiżżjoni sistemika anqas mill- esponiment massimu kliniku (AUC).
No malformations were observed in another study testing a higher dose of a different salt of duloxetine.
L’ ebda formażżjoni difettużi ma ’ kienu osservati fi studju ieħor li eżamina doża ogħla ta ’ forma kimika differenti ta ’ duloxetine.
Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Edible Black Ink.
Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Inkjostru iswed li jista ’ jittiekel
Edible Ink:
Inkjostru li jista ’ jittiekel:
Black Iron Oxide-Synthetic (E172) Propylene glycol Shellac
Iron Oxide Sintetiku Iswed (E172) Propylene glycol Shellac.
34 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Packs of 28 and 56 capsules.
Pakketti ta ’ 28 u 56 kapsula.
35 1.
39 1.
DULOXETINE BOEHRINGER INGELHEIM 30 mg hard gastro-resistant capsules
DULOXETINE BOEHRINGER INGELHEIM 30 mg kapsuli gastro- reżistenti ibsin
Opaque white body, imprinted with ‘ 30 mg’ and an opaque blue cap, imprinted with ‘ 9543’.
Il- parti prinċipali abjad opak, stampat b ’ ‘ 30 mg ’ u l- parti ta ’ fuq blu opak, stampat b ’ ‘ 9543 ’.
Adults The starting and recommended maintenance dose is 60 mg daily with or without food.
Adulti Id- doża tal- bidu u dik irrakkomandata ta ’ manteniment hija ta ’ 60 mg darba kuljum ma ’ l- ikel jew fuq stonku vojt.
Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials.
Dożi ta ’ aktar minn 60 mg darba kuljum, sa doża massima ta ’ 120 mg kuljum mogħtija f’ dożi mqassma ndaqs, ġew valutati mill- aspett tas- sigurtà f’ studji kliniċi.
The medicinal product response should be evaluated after 2 months ’ of treatment.
Wara xahrejn ta ’ kura għandu jiġi valutat ir- rispons għall- prodott mediċinali.
Elderly No dosage adjustment is recommended for elderly patients solely on the basis of age.
Anzjani F’ pazjenti anzjani mhux irrakkomandat li jsir aġġustament tad- doża fuq bażi ta ’ età biss.
Children and adolescents There is no experience in children (see section 4.4).
Tfal u adolexxenti M’ hemm ebda esperjenza fit- tfal (ara sezzjoni 4. 4).
Hepatic impairment DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Indeboliment tal- fwied DULOXETINE BOEHRINGER INGELHEIM m’ għandhux jintuża f’ pazjenti b’ mard tal- fwied li jwassal għal indeboliment tal- fwied (ara sezzjonijiet 4. 3 u 5. 2).
Renal insufficiency No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/ min).
Insuffiċjenza renali Mhux neċessarju aġġustament tad- doża għal pazjenti b’ disfunzjoni tal- kliewi ħafifa jew moderata (tneħħija tal- kreatinina minn 30 sa 80 ml/ min).
DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3)..
DULOXETINE BOEHRINGER INGELHEIM m’ għandux jiġi użat f’ pazjenti b’ indeboliment renali gravi (tneħħija tal- krejatinina < 30 ml/ min) (ara sezzjoni 4. 3).
36 Discontinuation of treatment Abrupt discontinuation should be avoided.
40 Sospensjoni tal- kura Għandha tiġi evitata sospensjoni f’ daqqa waħda.
When stopping treatment with DULOXETINE BOEHRINGER INGELHEIM 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). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Jekk ifeġġu sintomi intollerabbli wara tnaqqis fid- doża jew wara sospensjoni tal- kura, jista ’ jiġi kkunsidrat li terġa ’ tinbeda id- doża preċedenti ordnata.
Concomitant use of DULOXETINE BOEHRINGER INGELHEIM with nonselective, irreversible Monoamine Oxidase Inhibitors (MAOIs) is contraindicated (see section 4.5).
L- użu fl- istess ħin ta ’ DULOXETINE BOEHRINGER INGELHEIM ma ’ Inibituri ta ’ Monoamine Oxidase (MAOIs) irriversibbli u mhux selettivi huwa kontra- indikat (ara sezzjoni 4. 5).
DULOXETINE BOEHRINGER INGELHEIM should not be used in combination with fluvoxamine, ciprofloxacin or enoxacine (i. e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
DULOXETINE BOEHRINGER INGELHEIM m’ għandux jiġi użat flimkien ma ’ fluvoxamine, ciprofloxacin jew enoxacine (jiġifieri inibituri qawwija ta ’ CYP1A2) billi dan iwassal għal konċentrazzjonijiet elevati ta ’ duloxetine fil- plażma (ara sezzjoni 4. 5).
Severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.4).
Indeboliment gravi tal- kliewi (tneħħija tal- kreatinina < 30 ml/ min) (ara sezzjoni 4. 4).
The initiation of treatment with DULOXETINE BOEHRINGER INGELHEIM 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).
Huwa kontra- indikat li tinbeda l- kura b’ DULOXETINE BOEHRINGER INGELHEIM f’ pazjenti b’ pressjoni għolja mhux ikkontrollata li tista ’ tesponi l- pazjenti għal riskju potenzjali ta ’ kriżi ipertensiva (ara sezzjonijiet 4. 4 u 4. 8).
Mania and seizures DULOXETINE BOEHRINGER INGELHEIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija u aċċessjonijiet DULOXETINE BOEHRINGER INGELHEIM għandu jiġi użat b’ attenzjoni f’ pazjenti b’ storja ta ’ manija jew b’ dijanjosi ta ’ mard bipolari, u/ jew aċċessjonijiet.
Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing DULOXETINE BOEHRINGER INGELHEIM to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Midrijasi Ġiet rrapurtata l- midrijasi b’ assoċjazzjoni ma ’ duloxetine, għaldaqstant, DULOXETINE BOEHRINGER INGELHEIM għandu jiġi ordnat b’ attenzjoni f’ pazjenti b’ pressjoni għolja fl- għajn, jew f’ dawk b’ riskju ta ’ glawkoma ta ’ angolu dejjaq akuta.
For patients with severe renal impairment, see section 4.3. ee section 4.2 for information on patients with mild or moderate renal dysfunction.
Ara sezzjoni 4. 2 għal informazzjoni f’ pazjenti b’ disfunzjoni tal - kliewi ħafifa jew moderata.
Use with antidepressants 37 Caution should be exercised when using DULOXETINE BOEHRINGER INGELHEIM in combination with antidepressants.
41 Użu ma ’ anti- depressivi L- użu ta ’ DULOXETINE BOEHRINGER INGELHEIM ma ’ anti- depressivi għandha tiġi segwita b’ attenzjoni.
St John’ s wort Undesirable effects may be more common during concomitant use of DULOXETINE BOEHRINGER INGELHEIM and herbal preparations containing St John’ s wort (Hypericum perforatum).
John’ s wort (Hypericum perforatum).
Depression, suicidal ideation and behaviour Although DULOXETINE BOEHRINGER INGELHEIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
Depressjoni, imġiba u formazzjoni ta ’ ħsibijiet suwiċidali Għalkemm DULOXETINE BOEHRINGER INGELHEIM m’ huwiex indikat għal kura ta ’ depressjoni, is- sustanza attiva tiegħu (duloxetine) teżisti wkoll bħala medikazzjoni antidepressiva.
Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal thoughts prior to commencement of treatment are known to be at a greater risk of suicidal thoughts or suicidal behaviour, and should receive careful monitoring during treatment.
Huwa magħruf li pazjenti b’ passat ta ’ avvenimenti marbuta ma ’ suwiċidju jew dawk li juru ammont sinifikanti ta ’ ħsibijiet ta ’ suwiċidju qabel ma tibda l- kura huma f’ riskju ogħla li jkollhom ħsibijiet ta ’ suwiċidju jew ta ’ mġiba suwiċidali u għandhom jiġu sorveljati bir- reqqa waqt il- kura.
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.
Analiżi ta ’ numru ta ’ studji kliniċi kkontrollati bi plaċebo ta ’ prodotti mediċinali antidipressivi li ntużaw f’ disturbi psikjatriċi wrew riskju ogħla ta ’ mġiba suwiċidali bl- antidipressivi meta mqabbla ma ’ plaċebo f’ pazjenti iżgħar minn 25 sena.
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of DULOXETINE BOEHRINGER INGELHEIM is recommended (see section 4.2).
(ara Sezzjoni 4. 2).
Use in children and adolescents under 18 years of age No clinical trials have been conducted with duloxetine in paediatric populations.
Użu fit- tfal u fl- adolexxenti taħt it- 18- il sena Ma saru l- ebda studji kliniċi b’ duloxetine fil- qasam tal- pedjatrija.
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.
Imġiba assoċjata mas- suwiċidju (attentati ta ’ suwiċidju u ħsibijiet suwiċidali), u ostilità (l- aktar aggressjoni, imġiba konfrontali, u rabja), kienu osservati aktar spiss f’ provi kliniċi fuq tfal u adolexxenti kkurati b’ anti - depressivi meta mqabbla ma ’ dawk ikkurati bil- plaċebo.
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Jekk, fuq il- bażi tal- bżonn kliniku, madankollu tittieħed deċiżjoni biex tingħata l- kura, il- pazjenti għandu jinżamm taħt osservazzjoni għad- dehra ta ’ sintomi suwiċidali.
In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Barra dan, hemm nuqqas ta ’ informazzjoni f’ tfal u f’ adolexxenti dwar is- sigurtà fit- tul li jirrigwarda l- iżvilupp tal- ġisem, il- maturazzjoni u l- iżvilupp konjittiv u ta ’ l - imġiba.
Caution is advised in patients taking anticoagulants and/ or medicinal products known to affect platelet function, and in patients with known bleeding tendencies.
Hija rrakkomandata l- attenzjoni f’ pazjenti li qed jieħdu sustanzi kontra l - koagulazzjoni tad- demm u/ jew prodotti mediċinali magħrufa li jaffettwaw il- funzjoni tal- plejtlits, u f’ pazjenti li għandhom tendenza li d- demm idum biex jieqaf.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering DULOXETINE BOEHRINGER INGELHEIM.
Iponatrimja L- iponatrimja ġiet irrappurtata rarament, l- aktar fl- anzjani, fit- teħid ta ’ DULOXETINE BOEHRINGER INGELHEIM.
Discontinuation of treatment Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
42 Sospensjoni tal- kura Huma komuni r- reazzjonijiet ta ’ rtirar meta l- kura tiġi sospiża, partikolarment jekk is- sospensjoni ssir f’ daqqa waħda (ara sezzjoni 4. 8).
In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with DULOXETINE BOEHRINGER INGELHEIM and 23% of patients taking placebo.
F’ provi kliniċi avvenimenti mhux mixtieqa b’ sospensjoni tal- kura f’ daqqa seħħew f’ madwar 45% ta ’ pazjenti b’ kura ta ’ DULOXETINE BOEHRINGER INGELHEIM u 23% ta ’ pazjenti jieħdu l- plaċebo.
38 The risk of withdrawal symptoms seen with SSRI’ s and SNRI ’ s may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Ir- riskju ta ’ reazzjonijiet ta ’ rtirar li jidhru b’ SSRIs u SNRIs jistgħu jiddependu minn ħafna fatturi fosthom it- tul u d- doża tat- terapija u r- rata ta ’ tnaqqis fid- doża.
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.
Akatiżja/ irrekwitezza psikomotorja L- użu ta ’ duloxetine ġie assoċjat ma ’ żvilupp ta ’ akatiżja, ikkaraterrizzata minn irrekwitezza soġġettivament mhux pjaċevoli jew ta ’ sofferenza u mill- ħtieġa ta ’ tħarrik spiss flimkien ma ’ l - inabbilità li wieħed joqgħod bilqiegħda jew ma jitħarrikx.
The use of more than one of these products concomitantly should be avoided.
Prodotti mediċinali li fihom duloxetine Duloxetine huwa użat taħt trejdmarks differenti f’ ħafna indikazzjonijiet (kura ta ’ uġigħ newropatiku tad- dijabete, episodji depressivi maġġuri kif ukoll inkontinenza ta ’ l- urina minħabba sforz). L- użu fl - istess ħin ta ’ aktar minn wieħed minn dawn il- prodotti għandu jiġi evitat.
Consequently, caution is advised when DULOXETINE BOEHRINGER INGELHEIM is taken in combination with other centrally acting medicinal products and substances including alcohol and sedative medicinal products (e. g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Konsegwentement, huwa rrakkomandat li DULOXETINE BOEHRINGER INGELHEIM jingħata b’ attenzjoni meta jittieħed flimkien ma ’ prodotti mediċinali u sustanzi li jaħdmu b’ mod ċentrali fosthom alkoħol u prodotti mediċinali sedattivi (eż. benzodiazepines, morfinomimetiċi, anti- psikotiċi, phenobarbital, anti- istamini sedattivi).
Monoamine Oxidase Inhibitors (MAOIs): due to the risk of serotonin syndrome, DULOXETINE BOEHRINGER INGELHEIM 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.
Inibituri ta ’ Monoamine Oxidase (MAOIs): minħabba r- riskju ta ’ sindromu ta ’ serotonin, DULOXETINE BOEHRINGER INGELHEIM m’ għandux jintuża flimkien ma ’ inibituri ta ’ monoamine oxidase (MAOIs) irriversibbli u mhux selettivi, jew fi żmien ta ’ mill- anqas 14- il ġurnata minn meta ġiet sospiża l- kura b’ xi MAOI.
For selective, reversible MAOIs, like moclobemide, the risk of serotonin syndrome is lower.
43 Għal MAOIs riversibbli u selettivi, bħal moclobemide, ir- riskju ta ’ sindromu ta ’ serotonin huwa anqas.
However, the concomitant use of DULOXETINE BOEHRINGER INGELHEIM with selective, reversible MAOIs is not recommended (see section 4.4).
Madankollu, mhux irrakkomandat l- użu fl- istess ħin ta ’ DULOXETINE BOEHRINGER INGELHEIM ma ’ MAOIs riversibbli u selettivi (ara sezzjoni 4. 4).
Caution is advisable if DULOXETINE BOEHRINGER INGELHEIM 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.
John’ s wort (Hypericum perforatum), venlafaxine jew triptans, tramadol, pethidine u tryptophan.
39 Effect of duloxetine on other medicinal products Medicinal products metabolised by CYP1A2:
Effett ta ’ duloxetine fuq prodotti mediċinali oħra Prodotti mediċinali li jiġu metabolizzati minn CYP1A2:
Caution is advised if DULOXETINE BOEHRINGER INGELHEIM 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).
Hu rrakkomandat li DULOXETINE BOEHRINGER INGELHEIM jingħata b’ attenzjoni jekk jittieħed flimkien ma ’ prodotti mediċinali li huma fil- biċċa l- kbira metabolizzati min CYP2D6 (risperidone, anti- depressivi triċikliċi [TCAs] bħal nortriptyline, amitriptyline, u imipramine) speċjalment jekk għandhom indiċi terapewtiku dejjaq (bħal flecainide, propafenone u metoprolol).
Effects of other medicinal products on duloxetine Antacids and H2 antagonists: co-administration of duloxetine with aluminium- and magnesium- containing 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.
Effetti ta ’ prodotti mediċinali oħra fuq duloxetine Mediċini kontra l- aċtu fl- istonku u antagonisti ta ’ H2: it- teħid ta ’ duloxetine flimkien ma ’ mediċini kontra l- aċtu fl- istonku li fihom aluminium u magnesium jew ma ’ famotidine ma kellhiex effett sinifikanti fuq ir- rata jew il- miżura ta ’ assorbiment ta ’ duloxetine wara li ngħatat doża orali ta ’ 40 mg.
Pregnancy There are no data on the use of duloxetine in pregnant women.
Tqala M’ hemmx informazzjoni dwar l- użu ta ’ duloxetine f’ nisa tqal.
Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure (see section 5.3).
Studji fl- annimali juru tossiċità fis - sistema riproduttiva f’ livelli ta ’ esponiment sistemiku (AUC) ta ’ duloxetine anqas mill- esponiment kliniku massimu (ara sezzjoni 5. 3).
As with other serotoninergic medicinal products, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term.
Bħal bl- użu ta ’ prodotti mediċinali serotoninerġiċi oħra, sintomi ta ’ sospensjoni jistgħu jseħħu f’ trabi tat- twelid wara l- użu fl- omm ta ’ duloxetine qrib il - ħlas.
DULOXETINE BOEHRINGER INGELHEIM should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
44 potenzjali jiġġustifika r- riskju potenzjali lill- fetu.
Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.
In- nisa għandhom jingħataw parir biex javżaw lit - tabib tagħhom jekk jinqabdu tqal, jew għandhom l- intenzjoni li jinqabdu tqal, waqt it- terapija.
As the safety of duloxetine in infants is not known, the use of DULOXETINE BOEHRINGER INGELHEIM while breast-feeding is not recommended.
Billi mhix magħrufa s - sigurtà ta ’ duloxetine fit- trabi, l- użu ta ’ DULOXETINE BOEHRINGER INGELHEIM waqt it - treddigħ mhux rakkomandat.
4.7 Effects on ability to drive and use machines 40 No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 5253 patients, 3289 on duloxetine and 1964 on placebo).
Tabella 1 turi r- reazzjonijiet avversi osservati minn rapporti spontanji u f’ studji kliniċi kkontrollati bi plaċebo (b’ total ta ’ 5253 pazjent, 3289 minnhom fuq duloxetine u 1964 fuq plaċebo).
41
Dijarrea Stitikezza Rimettar Dispepsja Gass fl - istonku
Very
Gastro- enterite Stomatite Gastrite Tifwiq
Common
Ematokeżja Riħa ħażina fil - ħalq
Uncommon
Emorraġija gastro - intestinali
Rare
46 Disturbi fil- kliewi u fis- sistema awrinarja Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Very Rare
Żamma ta ’ l - awrina Eżitazzjoni awrinarja Disurja Awrinazzjoni eċċessiva matul il- lejl Tgħaddi ammont eċċessiv ta ’ awrina Tnaqqis fil - fluss ta ’ l - awrina
Frequency not
Riħa mhux normali ta ’ l - awrina Sindromu ta ’
common
Raxx
known
Reazzjonijiet
Gastrointestinal Disorders Nausea (21.7%) Dry mouth (13.2%)
Stevens -
Diarrhoea Constipation Vomiting Dyspepsia Flatulence
Żieda fl -
Gastroenteritis Stomatitis Gastritis Eructation
ta ’
Haematochezia Breath odour
Johnson
Gastrointestinal haemorrhage
għaraq
Renals and Urinary Disorders
fotosensittività
Urinary Retention Urinary hesitation Dysuria Nocturia Polyuria Urine flow decreased
Edima anġjo -
Urine odour abnormal
Tegħreq
Syncope2 Orthostatic hypotension2 Blood pressure increase Peripheral coldness
(irrapportata l - iżjed f’ pazjenti dijabetiċi)
Hypertensive crisis Hypertension
Iponatrimja
General Disorders and Administration Site Conditions
Infezzjonijiet u infestazzjonijiet
42
47 Larinġite Disturbi vaskulari Sinkope2
Common
Ħmura fil -
Uncommon
Kriżi
Rare
wiċċ
Very Rare
Ipotensjoni ortostatika2 Żieda fil - pressjoni tad - demm Ksieħ periferiku
Frequency not
ipertensiva Ipertensjoni
common
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Fatigue Abdominal pain
Għeja Uġigħ addominal i
Feeling hot Malaise Gait disturbance Feeling abnormal Feeling cold Thirst Chills
Tħoss is- sħana Telqa ġenerali Problemi fil - mod ta ’ kif timxi Ma tħossokx normali Tħoss il- bard Għatx Tkexkix
Chest pain
Uġigħ fis - sider
Immune system disorders Hepato-biliary disorders
Disturbi fis- sistema immuni Reazzjoni Mard ta ’ anafilattika sensitività eċċessiva Disturbi fil- fwied u fil- marrara
Psychiatric Disorders
48 Imġiba suwiċidali4
43 intense dreams), agitation or anxiety, nausea and/ or vomiting, tremor, headache, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Sturdament, disturbi tas- sensi (fosthom parastizja), disturbi fl- irqad, (fosthom insomnja u ħolm intens), aġitazzjoni jew ansjetà, dardir u/ jew rimettar, rogħda, wġigħ ta ’ ras, irritabilità, dijarea, iperidrożi u vertigo huma l- aktar reazzjonijiet komunement irrappurtati.
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.
49 Mhux magħruf antidotu speċifiku għal duloxetine iżda jekk jirriżulta s- sindromu ta ’ serotonin, tista ’ tiġi kkunsidrata kura speċifika (bħal b’ cyproheptadine u/ jew b’ kontroll tat- temperatura).
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) 44 having diabetic neuropathic pain for at least 6 months.
L- effikaċja ta ’ duloxetine bħala kura għall- uġigħ newropatiku tad- dijabete kien stabbilit f’ żewġ studji ta ’ 12- il ġimgħa, b’ dożi fissi, ikkontrollati bi plaċebo, randomised u double- blind f’ adulti (22 sa 88 sena) li kellhom uġigħ newropatiku tad- dijabete għallinqas għal 6 xhur.
Although data from a one-year open label study offer some evidence for longer-term efficacy, no conclusive efficacy data for treatments longer than 12 weeks duration are available from placebo- controlled studies.
Għalkemm tagħrif minn studju open- label ta ’ sena juri xi evidenza ta ’ effikaċja fit- tul, minn studji kkontrollati bi plaċebo m’ hemmx tagħrif konklużiv dwar l- effikaċja ta ’ kura għal iżjed minn 12- il ġimgħa.
These changes do not have any clinical significance.
50 L- ikel iżid il- ħin biex tintlaħaq l- ogħla konċentrazzjoni minn 6 sa 10 sigħat u jnaqqas b’ xi ftit l - ammont ta 'l- assorbiment (bejn wieħed u ieħor 11%). Dawn il- varjazzjonijiet m’ għandhom ebda sinifikat klinikament.
Gender: pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximatively 50% lower in females).
Sess: differenzi farmakokinetiċi kienu identifikati bejn l- irġiel u n- nisa (it- tneħħija apparenti mill - plażma huwa bejn wieħed u ieħor 50% inqas fin- nisa).
45 Renal impairment: end stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine Cmax and AUC values compared with healthy subjects.
Indeboliment tal- kliewi: pazjenti b' mard terminali tal- kliewi (ESRD) li jirċievu id- dijaliżi kellhom valuri tas- Cmax u ta ’ l- AUC ta ’ duloxetine darbtejn ogħla minn dawk ta ’ pazjenti b' saħħithom.
Female rats receiving duloxetine (45 mg/ kg/ day) before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
Firien tas- sess femminil li rċevew duloxetine, qabel u waqt li kienu qed jgħamlu s- sess u fil- bidu tat- tqala, kellhom tnaqqis fil- konsum ta 'l- ikel matern u fil- piż, diżordni fiċ- ċiklu oestrous, nuqqas fl- indiċi ta' twelid ta 'frieħ hajjin u fis- sopravivenza tal- ferħ ta' l - annimal, u dewmien biex jikbru l- frieħ f’ livelli ta ’ espożizzjoni sistemika, stmata li hija mhux anqas
Hypromellose Acetate Succinate Sucrose Sugar spheres Talc Titanium dioxide (E171) Triethyl citrate.
Hypromellose Hypromellose Acetate Succinate Sucrose Sferi taz- zokkor Talc Titanium dioxide (E171) Triethyl citrate.
46 Black Iron Oxide-Synthetic (E172) Yellow Iron Oxide- Synthetic (E172) Propylene glycol Shellac.
Iron oxide sintetiku iswed (E172) Iron oxide sintetiku isfar (E172) Propylene glycol Shellac
Do not store above 30 C.
Taħżinx f’ temperatura ’ l fuq minn 30°C
DULOXETINE BOEHRINGER INGELHEIM 30 mg is available in packs of 7, 28 and 98 capsules.
DULOXETINE BOEHRINGER INGELHEIM 30mg issibu f’ pakketti ta ’ 7, 28 u 98 kapsula
6.6 Special precautions for disposal
52 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
48 1.
53 1.
DULOXETINE BOEHRINGER INGELHEIM 60 mg hard gastro-resistant capsules
DULOXETINE BOEHRINGER INGELHEIM 60 mg kapsuli gastro- reżistenti ibsin
Opaque green body, imprinted with ‘ 60 mg’ and an opaque blue cap, imprinted with ‘ 9542’.
Il- parti prinċipali aħdar opak, stampat b ’ ‘ 60 mg ’ u l- parti ta ’ fuq blu opak, stampat b ’ ‘ 9542 ’.
Elderly Diabetic Peripheral Neuropathic Pain:
Anzjani Uġigħ Newropatiku Periferiku Tad- dijabete:
49 Renal insufficiency No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/ min).
DULOXETINE BOEHRINGER INGELHEIM
DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3).
54 m’ għandux jiġi użat f’ pazjenti b’ indeboliment gravi tal- kliewi (tneħħija tal- krejatinina < 30 ml/ min) (ara sezzjoni 4. 3) (ara sezzjoni 4. 3).
When stopping treatment with DULOXETINE BOEHRINGER INGELHEIM 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).
Meta l- kura b’ DULOXETINE BOEHRINGER INGELHEIM tkun ser titwaqqaf id- doża għandha tiġi mnaqqsa gradwalment fuq perijodu ta ’ mill - anqas ġimgħa sa ġimagħtejn sabiex jitnaqqas ir- riskju ta ’ reazzjonijiet ta ’ rtirar (ara sezzjonijiet 4. 4 u 4. 8).
Mania and seizures DULOXETINE BOEHRINGER INGELHEIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija u aċċessjonijiet DULOXETINE BOEHRINGER INGELHEIM għandu jintuża b’ attenzjoni f’ pazjenti b’ storja ta ’ manija jew b’ dijanjosi ta ’ mard bipolari, u/ jew aċċessjonijiet.
50 Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance < 30 ml/ min).
55 Pazjenti b’ indeboliment gravi tal- kliewi li għandhom bżonn dijalisi tad- demm (tneħħija tal- kreatinina < 30 ml/ min) kellhom żieda fil- konċentrazzjoni ta ’ duloxetine fil- plażma.
Use with antidepressants Caution should be exercised when using DULOXETINE BOEHRINGER INGELHEIM in combination with antidepressants.
Użu ma ’ anti- depressivi L- użu ta ’ DULOXETINE BOEHRINGER INGELHEIM ma ’ anti- depressivi għandha tiġi segwita b’ attenzjoni.
Use in children and adolescents under 18 years of age No clinical trials have been conducted with duloxetine in paediatric populations.
Użu fit- tfal u fl- adolexxenti taħt it- 18- il sena Ma sarux studji kliniċi b’ duloxetine fil- qasam tal- pedjatrija.
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.
Imġiba assoċjata mas- suwiċidju (attentati ta ’ suwiċidju u ħsibijiet suwiċidali), u ostilità (l- aktar aggressjoni, imġiba konfrontali, u rabja), kienu osservati aktar spiss f’ provi kliniċi fuq tfal u adolexxenti kkurati b’ anti - depressivi meta mqabbla ma ’ dawk ikkurati bil - plaċebo.
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Jekk, fuq il- bażi tal- bżonn kliniku, madankollu tittieħed deċiżjoni biex tingħata l- kura, il- pazjent għandu jinżamm taħt osservazzjoni għad- dehra ta ’ sintomi suwiċidali.
Caution is required in patients at increased risk for hyponatremia; such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics.
56 anzjani, pazjenti b’ ċirrożi jew diżidratati, jew pazjenti fuq kura ta ’ dijuretiċi.
51 Discontinuation of treatment Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
Sospensjoni tal- kura Huma komuni r- reazzjonijiet ta ’ rtirar meta l- kura tiġi sospiża, partikolarment jekk is- sospensjoni ssir f’ daqqa waħda (ara sezzjoni 4. 8).
The risk of withdrawal symptoms seen with SSRI’ s and SNRI ’ s may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Ir- riskju ta ’ reazzjonijiet ta ’ rtirar li jidhru b’ SSRIs u SNRIs jistgħu jiddependu minn ħafna fatturi fosthom it- tul u d- doża tat- terapija u r- rata ta ’ tnaqqis fid- doża.
Duloxetine should be used with caution in patients treated with other medicinal products associated with hepatic injury.
Duloxetine għandu jintuża b’ attenzjoni f’ pazjenti li jkunu fuq kura b’ mediċini oħra assoċjati ma ’ ħsara fil- fwied.
For selective, reversible MAOIs, like moclobemide, the risk of serotonin syndrome is lower.
57 Għal MAOIs riversibbli u selettivi, bħal moclobemide, ir- riskju ta ’ sindromu ta ’ serotonin huwa anqas.
52 Serotonin syndrome: in rare cases, serotonin syndrome has been reported in patients using SSRIs (e. g. paroxetine, fluoxetine) concomitantly with serotonergic medicinal products.
Sindromu ta ’ serotonin: f’ każi rari, ġie rrappurtat sindromu ta ’ serotonin f’ pazjenti li jużaw SSRIs (eż. paroxetine, fluoxetine) fl- istess ħin ma ’ prodotti mediċinali serotoninerġiċi.
As with other serotoninergic medicinal products, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term.
Bħal bl- użu ta ’ mediċini serotoninerġiċi oħra, sintomi ta ’ sospensjoni jistgħu jseħħu f’ trabi tat- twelid wara l- użu fl- omm ta ’ duloxetine qrib il- ħlas.
DULOXETINE BOEHRINGER INGELHEIM should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
DULOXETINE BOEHRINGER INGELHEIM għandu jintuża fit- tqala biss jekk is- siwi potenzjali
Breast feeding 53 Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
Treddigħ Duloxetine joħroġ b’ mod debboli ħafna fil- ħalib uman, fuq il- bażi ta ’ studju fuq 6 pazjenti li pproduċew il- ħalib iżda ma tawhx lil uliedhom.
Very
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