qanastek/EMEA-V3 huggingface dataset:
Additional response after this time is unlikely (see 5.1).
M’ hemmx probabbiltà ta ’ rispons addizzjonali wara dan il- perijodu (ara 5. 1).
The therapeutic benefit should regularly (at least every three months) be reassessed.
Il- benefiċċju terapewtiku għandu jerġa ’ jiġi valutat regolarment (mill- anqas kull tliet xhur).
Elderly Major Depressive Episodes:
Anzjani Episodji Depressivi Maġġuri:
No dosage adjustment is recommended for elderly patients solely on the basis of age.
F’ pazjenti anzjani mhux irrakkomandat li jsir aġġustament tad- doża fuq bażi ta ’ età biss.
However, as with any medicine, caution should be exercised when treating the elderly, especially with CYMBALTA 120 mg per day for which data are limited (see sections 4.4 and 5.2).
Madankollu, bħal b’ mediċina oħra, il- kura ta ’ l- anzjani għandha tiġi segwita b’ attenzjoni, speċjalment b’ CYMBALTA 120 mg kuljum fejn l- informazzjoni hija limitata (ara sezzjonijiet 4. 4 u 5. 2).
Other Indications:
Indikazzjonijiet oħra:
However, caution should be exercised when treating the elderly (see section 5.2).
Madankollu, il- kura ta ’ l- anzjani għandha tiġi segwita b’ attenzjoni (ara sezzjoni 5. 2).
Children and adolescents The safety and efficacy of duloxetine in these age groups have not been studied.
Tfal u adolexxenti Is- sigurtà u l- effikaċja ta ’ duloxetine f’ dawn il- gruppi ta ’ età ma ġewx studjati.
Therefore, administration of CYMBALTA to children and adolescents is not recommended (see section 4.4).
Ghaldaqstant, CYMBALTA mhux irrakkomandat għall- użu fit- tfal u fl- adolexxenti (ara sezzjoni 4. 4).
Hepatic impairment CYMBALTA should not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Indeboliment tal- fwied CYMBALTA 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 tal- kliewi Mhux neċessarju aġġustament tad- doża għal pazjenti b’ disfunzjoni tal- kliewi ħafifa jew moderata (tneħħija tal- kreatinina minn 30 sa 80 ml/ min).
See section 4.3 for severe renal impairment.
Ara sezzjoni 4. 3 għal indeboliment gravi tal- kliewi.
Discontinuation of treatment Abrupt discontinuation should be avoided.
Sospensjoni tal- kura Għandha tiġi evitata sospensjoni f’ daqqa waħda.
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). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Meta l- kura b’ CYMBALTA 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).
Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
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 CYMBALTA with nonselective, irreversible Monoamine Oxidase Inhibitors (MAOIs) is contraindicated (see section 4.5).
L- użu fl- istess ħin ta ’ CYMBALTA ma ’ Inibituri ta ’ Monoamine Oxidase (MAOIs) irriversibbli u mhux selettivi huwa kontra- indikat (ara sezzjoni 4. 5).
Liver disease resulting in hepatic impairment (see section 5.2).
Mard tal- fwied li jwassal għal indeboliment tal- fwied (ara sezzjoni 5. 2).
CYMBALTA 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).
CYMBALTA 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).
3 Indeboliment gravi tal- kliewi (tneħħija tal- kreatinina < 30 ml/ min) (ara sezzjoni 4. 4).
3 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).
Huwa kontra- indikat li tinbeda l- kura b’ CYMBALTA 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 CYMBALTA should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija u aċċessjonijiet CYMBALTA 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 CYMBALTA 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, CYMBALTA għandu jiġi ordnat b’ attenzjoni f’ pazjenti b’ pressjoni għolja fl- għajn, jew f’ dawk b’ riskju ta ’ glawkoma ta ’ angolu dejjaq akuta.
Blood pressure and heart rate Duloxetine has been associated with an increase in blood pressure and clinically significant hypertension in some patients.
Pressjoni tad- demm u rata ta ’ taħbit il- qalb Duloxetine ġie assoċjat ma ’ żieda fil- pressjoni tad- demm u ipertensjoni klinikament sinifikanti f’ xi pazjenti.
This may be due to the noradrenergic effect of duloxetine.
Dan jista ’ jseħħ minħabba l- effett noradrinerġiku ta ’ duloxetine.
Cases of hypertensive crisis have been reported with duloxetine, especially in patients with pre-existing hypertension.
Każi ta ’ kriżi ipertensiva b’ duloxetine ġew irrapurtati, speċjalment f’ pazjenti li diġà kellhom l- ipertensjoni.
Therefore, in patients with known hypertension and/ or other cardiac disease, blood pressure monitoring is recommended, especially during the first month of treatment.
Għaldaqstant, f’ pazjenti li hu magħruf li għandhom l- ipertensjoni u/ jew mard kardijaku ieħor, huwa rrakkomandat li l- pressjoni tad- demm tinżamm taħt osservazzjoni, speċjalment fl- ewwel xahar ta ’ kura.
Duloxetine should be used with caution in patients whose conditions could be compromised by an increased heart rate or by an increase in blood pressure.
Duloxetine għandu jintuża b’ attenzjoni f’ pazjenti li l- kundizzjonijiet tagħhom jistgħu jiġi kompromessi b’ żieda fir- rata ta ’ taħbit il- qalb jew żieda fil- pressjoni tad- demm.
Caution should also be exercised when duloxetine is used with medicinal products that may impair its metabolism (see section 4.5).
Għandha tingħata attenzjoni wkoll meta duloxetine jiġi użat ma ’ prodotti mediċinali li jistgħu jindebbolixxu l- metaboliżmu tiegħu (ara sezzjoni 4. 5).
For patients who experience a sustained increase in blood pressure while receiving duloxetine either dose reduction or gradual discontinuation should be considered (see section 4.8).
F’ pazjenti li jġarrbu żieda sostanzjali fil- pressjoni tad- demm waqt li jingħataw duloxetine għandu jigi kkunsidrat jew tnaqqis fid- doża jew sospensjoni gradwali (ara sezzjoni 4. 8).
In patients with uncontrolled hypertension duloxetine should not be initiated (see section 4.3).
F’ pazjenti b’ ipertensjoni mhux ikkontrollata m’ għandux jinbeda duloxetine (ara sezzjoni 4. 3).
Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance < 30 ml/ min).
Indeboliment tal- kliewi 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.
For patients with severe renal impairment, see section 4.3.
Għal pazjenti b’ indeboliment gravi tal- kliewi, ara sezzjoni 4. 3.
See 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 Caution should be exercised when using CYMBALTA in combination with antidepressants.
Użu ma ’ anti- depressivi L- użu ta ’ CYMBALTA ma ’ anti- depressivi għandha tiġi segwita b’ attenzjoni.
In particular the combination with selective reversible MAOIs is not recommended.
B’ mod partikolari, mhux irrakkomandat l- użu ma ’ MAOIs riversibbli u selettivi.
St John’ s wort Undesirable effects may be more common during concomitant use of CYMBALTA and herbal preparations containing St John’ s wort (Hypericum perforatum).
John’ s wort (Hypericum perforatum).
Suicide Major Depressive Episodes and Generalised Anxiety Disorder Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide- related events).
Suwiċidju Episodji Depressivi Maġġuri u Disturb ta ’ Ansjetà Ġeneralizzata Id- depressjoni hija assoċjata ma ’ riskju akbar ta ’ ħsibijiet suwiċidali, ħsara lill- persuna nnifisha, u suwiċidju (avvenimenti marbuta ma ’ suwiċidju).
This risk persists until significant remission occurs.
Dan ir- riskju jippersisti sakemm iseħħ tnaqqis sinifikanti tad- depressjoni.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Billi waqt l- ewwel ftit ġimgħat jew aktar ta ’ kura jista ’ ma jseħħx titjib, il - pazjenti għandhom jiġu osservati bir- reqqa sakemm dan it- titjib iseħħ.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Hija esperjenza klinika ġenerali li r- riskju ta ’ suwiċidju jista ’ jiżdied fl- istadji bikrijin ta ’ fejqan.
Other psychiatric conditions for which CYMBALTA is prescribed can also be associated with an increased risk of suicide-related events.
Kundizzjonijiet psikjatriċi oħra li għalihom jista ’ jiġi mogħti CYMBALTA huma wkoll assoċjati ma ’ riskju akbar ta ’ avvenimenti marbuta ma ’ suwiċidju.
In addition, these conditions may be co-morbid with major depressive disorder.
Barra minn hekk dawn il- kundizzjonijiet jistgħu jkunu preżenti bħala marda oħra flimkien mad- disturb tad- depressjoni maġġuri.
The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
L- istess prekawzjonijiet meħuda waqt il- kura ta ’ pazjenti b’ disturb ta ’ depressjoni maġġuri għandhom għalhekk jiġu wkoll meħuda waqt il- kura ta ’ pazjenti b’ disturbi psikjatriċi oħra.
A meta-analysis of placebo-controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed
4 Huwa magħruf li pazjenti b’ passat ta ’ avvenimenti marbuta ma ’ suwiċidju jew dawk li juru ammont sinifikanti ta ’ hsibijiet 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.
4 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 bil- 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.
Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
Każi ta ’ formazzjoni ta ’ ħsibijiet suwiċidali u mġiba suwiċidali ġew irrappurtati waqt terapija ta ’ duloxetine jew kmieni wara sospensjoni tal- kura (ara sezzjoni 4. 8).
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes.
Sorveljanza bir- reqqa tal- pazjenti b’ mod partikolari dawk li huma l- iżjed f’ riskju għandha takkumpanja t- terapija mediċinali speċjalment fil- bidu tal- kura u wara xi tibdil fid- doża.
Patients, (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Il- pazjenti, (u min jieħu ħsiebhom) għandhom jiġu mwissija dwar il- ħtieġa li joqgħodu attenti għal xi bidla għall - agħar fil- kwadru kliniku, mġiba jew ħsibijiet suwiċidali jew tibdil fl- imġiba mhux tas- soltu u li jfittxu parir mediku immedjatament jekk joħorġu dawn is- sintomi.
Diabetic Peripheral Neuropathic Pain As with other medicinal products with similar pharmacological action (antidepressants), isolated cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation.
Uġigħ Newropatiku Periferiku Tad- dijabete Bħal bi prodotti mediċinali oħra li għandhom azzjoni farmakoloġika simili (anti- depressivi), ġew irrappurtati każi iżolati ta ’ formazzjoni ta ’ ideat suwiċidali u mġiba suwiċidali waqt terapija ta ’ duloxetine jew kmieni wara sospensjoni tal- kura.
Physicians should encourage patients to report any distressing thoughts or feelings at any time.
Fir- rigward ta ’ fatturi ta ’ riskju għal tendenza ta ’ suwiċidju waqt id- dipressjoni, are fuq It- tobba għandhom iħeġġu lill- pazjenti biex jirrappurtaw xi ħsibijiet jew sentimenti li jnikktu f’ kull ħin.
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 provi kliniċi b’ duloxetine fil- qasam tal- pedjatrija.
CYMBALTA should not be used in the treatment of children and adolescents under the age of 18 years.
CYMBALTA m’ għandux jintuża fil - kura ta ’ tfal u adolexxenti taħt it- 18- il sena.
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.
Haemorrhage There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/ norepinephrine reuptake inhibitors (SNRIs).
Emorraġija Ġew irrappurtati fsada mhux normali, bħal ekimosi, purpura u emorraġija gastro- intestinali b’ inibituri selettivi ta’ ġbir mill- ġdid ta ’ serotonin (SSRIs) u inibituri ta ’ ġbir mill- ġdid ta ’ serotonin / norepinephrine (SNRIs).
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 b ’ tendenzi ta ’ fsada magħrufa.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering CYMBALTA.
Iponatrimja L- iponatrimja ġiet irrappurtata rarament, l- aktar fl- anzjani, fit- teħid ta ’ CYMBALTA.
Caution is required in patients at increased risk for hyponatremia; such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics.
Tinħtieġ attenzjoni f’ pazjenti f’ riskju akbar ta ’ iponatrimja; bħal anzjani, pazjenti b’ ċirrożi jew deidratati, jew pazjenti fuq kura ta ’ dijuretiċi.
Hyponatremia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
L- iponatrimja tista ’ tiġi kkawżata minn sindromu ta ’ sekrezzjoni mhux f’ loku ta ’ ormon anti- dijuretiku (SIADH).
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).
In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with CYMBALTA 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 ’ CYMBALTA u 23% ta ’ pazjenti jieħdu l - plaċebo.
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.
The most commonly reported reactions are listed in section 4.8.
L- aktar reazzjonijiet komuni li ġew irraportati huma mniżżlin f’ sezzjoni 4. 8.
Generally these 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 jkun 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 ’ sospensjoni ta ’ kura, iżda kien hemm rapporti rari ħafna ta ’ dawn is- sintomi f’ pazjenti li bi żball 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).
Għalhekk huwa rrakkomandat li
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).
5 f’ sospensjoni 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).
Data on the use of CYMBALTA 120mg in elderly patients with major depressive disorders are limited.
L- informazzjoni dwar l- użu ta ’ CYMBALTA 120 mg f’ pazjenti anzjani b’ mard depressiv maġġuri hija limitata.
Therefore, caution should be exercised when treating the elderly with the maximum dosage (see sections 4.2 and 5.2).
Għaldaqstant, il- kura ta ’ anzjani b’ doża massima għandha tiġi segwita b’ attenzjoni (ara sezzjonijiet 4. 4 u 5. 2).
Data on the use of CYMBALTA in elderly patients with generalised anxiety disorder are limited.
Huwa limitat it- tagħrif dwar l- użu ta ’ CYMBALTA f’ pazjenti anzjani b’ disturb ta ’ ansjetà ġeneralizzata.
5 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.
This is most likely to occur within the first few weeks of treatment.
Dan hu aktar probabbli li jseħħ fl- ewwel ftit ġimgħat ta ’ kura.
In patients who develop these symptoms, increasing the dose may be detrimental.
F’ pazjenti li jiżviluppaw dawn is- sintomi, jista ’ jkun ta ’ detriment li tiżdied id- doża.
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, disturb ta ’ ansjetà ġeneralizzata kif ukoll inkontinenza ta ’ l - urina minħabba sforz). L- użu fl- istess ħin ta ’ aktar minn wieħed minn dawn il- prodotti għandu jiġi evitat.
Hepatitis/ increased liver enzymes Cases of liver injury, including severe elevations of liver enzymes (> 10 times upper limit of normal), hepatitis and jaundice have been reported with duloxetine (see section 4.8).
Epatite/ żieda fl- enżimi tal- fwied B’ duloxetine ġew irrappurtati każi ta ’ ħsara fil- fwied, fosthom żidiet b’ mod serju ta ’ enżimi tal- fwied (> 10 darbiet il- limitu ta ’ fuq tan- normal), epatite u suffejra (ara sezzjoni 4. 8).
Most of them occurred during the first months of treatment.
Il- biċċa l- kbira tagħhom seħħew waqt l- ewwel ftit xhur ta ’ kura.
The pattern of liver damage was predominantly hepatocellular.
Il- ħsara fil- fwied kienet l- aktar dik epatoċellulari.
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 bi prodotti mediċinali oħra assoċjati ma ’ ħsara fil- fwied.
Sucrose CYMBALTA hard gastro-resistant capsules contain sucrose.
Sucrose CYMBALTA kapsuli gastro- reżistenti ibsin fihom sucrose.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal fructose, assorbiment ħażin ta ’ glucose- galactose jew insuffiċjenza ta ’ sucrose - isomaltase m’ għandhomx jieħdu din il- mediċina.
CNS medicinal products: the risk of using duloxetine in combination with other CNS-active medicinal products has not been systematically evaluated, except in the cases described in this section.
Ma ġiex valutat b’ mod sistemiku r- riskju ta ’ l- użu ta ’ duloxetine ma ’ prodotti mediċinali oħra attivi fuq CNS, barra mill- każi mniżżlin f’ din is- sezzjoni.
Consequently, caution is advised when CYMBALTA 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 CYMBALTA 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, 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.
Inibituri ta ’ Monoamine Oxidase (MAOIs): minħabba r- riskju ta ’ sindromu ta ’ serotonin, CYMBALTA 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.
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).
Fuq il- bażi tal- half- life ta ’ duloxetine, għandhom jgħaddu mill- anqas 5 ijiem minn meta twaqqaf CYMBALTA qabel jinbeda xi MAOI (ara sezzjoni 4. 3).
For selective, reversible MAOIs, like moclobemide, the risk of serotonin syndrome is lower.
Għal MAOIs riversibbli u selettivi, bħal moclobemide, ir- riskju ta ’ sindromu ta ’ serotonin huwa anqas.
However, the concomitant use of CYMBALTA with selective, reversible MAOIs is not recommended (see section 4.4).
Madankollu, mhux irrakkomandat l- użu fl- istess ħin ta ’ CYMBALTA ma ’ MAOIs riversibbli u selettivi (ara sezzjoni 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.
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.
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.
John’ s wort (Hypericum perforatum), venlafaxine jew triptans, tramadol, pethidine u tryptophan.
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:
The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily).
Il- farmakokinetika ta ’ theophylline, sustrat ta ’ CYP1A2, ma ġietx affettwata b’ mod sinifikanti meta ngħata flimkien ma ’ duloxetine (60 mg darbtejn kuljum).
Medicinal products metabolised by CYP2D6:
Prodotti mediċinali li jiġu metabolizzati minn CYP2D6:
Duloxetine is a moderate inhibitor of CYP2D6.
Duloxetine huwa inibitur moderat ta ’ CYP2D6.
When duloxetine was administered at a dose of 60 mg twice daily with a single dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold.
Meta duloxetine jingħata f’ doża ta ’ 60 mg darbtejn kuljum ma ’ doża waħda ta ’ desipramine, sustrat ta ’ CYP2D6, l- AUC ta ’ desipramine żdied bi tliet darbiet.
The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71%, but does not affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is recommended.
L- AUC fiss ta ’ tolterodine (2 mg darbtejn kuljum) tiżdied b’ 71% meta jingħata flimkien ma ’ duloxetine (40 mg darbtejn kuljum), iżda ma jaffettwax il- farmakokinetika tal- metabolat attiv tiegħu 5- hydroxyl u mhux irrakkomandat li jsir aġġustament ta ’ doża.
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).
Hu rrakkomandat li CYMBALTA 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).
Oral contraceptives and other steroidal agents: results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A.
Kontraċettivi orali u sustanzi sterojdi oħra: riżultati ta ’ studji in vitro juru li duloxetine ma jistimulax l- attività katalitika ta ’ CYP3A.
Specific in vivo drug interaction studies have not been performed.
Studji speċifiċi in vivo ta ’ interazzjoni bejn il- mediċini ma sarux.
Anticoagulants and antiplatelet agents:
Sustanzi kontra l- koagulazzjoni tad- demm u kontra l- plejtlits:
Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding.
Għandha tingħata attenzjoni meta duloxetine jingħata flimkien ma ’ sustanzi kontra l- koagulazzjoni tad- demm b’ mod orali u ma ’ sustanzi kontra l- plejtlits minħabba riskju potenzjali akbar ta ’ fsada.
Furthermore, increases in INR values have been reported when duloxetine was co-administered with warfarin.
Aktar minn hekk, żidiet fil- valuri ta ’ l- INR ġew irrappurtati meta duloxetine ngħata flimkien ma ’ warfarin.
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.
Inhibitors of CYP 1A2: because CYP1A2 is involved in duloxetine metabolism, concomitant use of duloxetine with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
Inibituri ta ’ CYP1A2: billi CYP1A2 huwa involut fil- metaboliżmu ta ’ duloxetine, bl- użu fl- istess ħin ta ’ duloxetine ma ’ inibituri qawwija ta ’ CYP1A2 hemm probabbiltà li jirriżultaw konċentrazzjonijiet ogħla ta ’ duloxetine.
Fluvoxamine (100 mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUCo-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.
Therefore CYMBALTA should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Għaldaqstant, CYMBALTA m’ għandux jingħata flimkien ma ’ inibituri qawwija ta ’ CYP1A2 bħal fluvoxamine (ara sezzjoni 4. 3).
Inducers of CYP1A2:
Sustanzi li jistimulaw CYP1A2:
Population pharmacokinetic 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.
Pregnancy There are no adequate data on the use of duloxetine in pregnant women.
Tqala M’ hemmx informazzjoni adegwata 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).
The potential risk for humans is unknown.
Mhux magħruf ir- riskju potenzjali għall- umani.
As with other serotoninergic medicinal products, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term.
Bħal ma jiġri bi prodotti mediċinali serotoninerġiċi oħra, sintomi ta ’ sospensjoni jistgħu jseħħu f’ trabi tat- twelid wara l- użu fl- omm ta ’ duloxetine qrib il - ħlas.
CYMBALTA should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
CYMBALTA għandu jintuża fit- tqala biss jekk is- siwi 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.
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 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.
The estimated daily infant dose on a mg/ kg basis is approximately 0.14% of the maternal dose (see section 5.2).
7 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 CYMBALTA while breast-feeding is not recommended.
Billi mhix magħrufa s - sigurtà ta ’ duloxetine fit- trabi, l- użu ta ’ CYMBALTA waqt it- treddigħ mhux rakkomandat.
CYMBALTA may be associated with sedation and dizziness.
CYMBALTA jista ’ jkun assoċjat ma ’ effett sedattiv u ma ’ sturdament.
Patients should be instructed that if they experience sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating machinery.
Il- pazjenti għandhom jiġu mgħarrfa li jekk iħossuhom taħt effett sedattiv jew sturduti għandhom jevitaw xogħol li jista ’ jkun ta ’ periklu bħas- sewqan jew it- tħaddim ta ’ magni.
7 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
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.
Tabella 1 turi r- reazzjonijiet avversi osservati minn rapporti spontanji u f’ provi kliniċi kkontrollati bil - plaċebo (b’ total ta ’ 8239 pazjent, 5075 minnhom fuq duloxetine u 3164 fuq il- plaċebo) fid - depressjoni, fid- disturb ta ’ l- ansjetà ġeneralizzata u fl- uġigħ newropatiku tad- dijabete u fil - fibromijalġja.
The most commonly reported adverse reactions in patients treated with CYMBALTA were nausea, headache, dry mouth, somnolence, fatigue, insomnia, dizziness and constipation.
L- aktar reazzjonijiet avversi komunement irrappurtati f’ pazjenti fuq kura ta ’ CYMBALTA kienu dardir, uġigħ ta ’ ras, ħalq xott, ngħas, għeja, insomnja, sturdament u stitikezza.
However, the majority of common adverse reactions were mild to moderate, they usually started early in therapy, and most tended to subside even as therapy was continued.
Il- maġġoranza tar - reazzjonijiet avversi komuni, iżda, kienu ħfief jew moderati, ġeneralment bdew kmieni fit- terapija, u ħafna minnhom kellhom tendenza li jonqsu anki waqt it- tkomplija tat- terapija.
Adverse reactions Frequency estimate:
Reazzjonijiet avversi Kalkolu tal- frekwenza:
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).
Komuni ħafna (≥1/ 10), komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥1/ 1, 000 sa < 1/ 100), rari (≥1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla bl- aktar serju l- ewwel segwiti minn dawk anqas serji.
Very common Investigations
Komuni Ħafna Komuni
Common
Rari Rari
Uncommon
Frekwenza
Rare
Komuni
Very Rare
Ħafna
Frequency not known
Disturbi fil- qalb
Weight decrease
Tnaqqis fil- piż
Weight increase Creatine phosphokinase increased
Żieda fil- piż Żieda fil - Creatinine phosphokinase
Blood cholesterol increased
Zieda tal - kolesterol fid- demm
Cardiac Disorders
Palpitazzjonijiet
Palpitations
Takikardija
Tachycardia
Arritmija supra -
Supra- ventricular arrhythmia, mainly atrial fibrillation
ventrikolari, l- aktar fibrillazzjoni ta ’ l- atrija
Nervous System Disorders Headache (15.3%) Somnolence (10.9%) Dizziness (10.3%)
Disturbi fis- sistema nervuża Uġigħ ta ’ ras (15. 3%) Ngħas (10. 9%) Sturdament (10. 3%)
Tremor Paraesthesia Dysgeusia Lethargy
Rogħda Parastiżja Disgewżja Letarġija
Nervousness Disturbance in attention Dyskinesia Poor quality sleep
Nervożità Disturbi fl - attenzjoni Diskinesja Kwalità ħażina ta ’ irqad Disgewżja
Myoclonus Convulsions
Mijoklonus Konvulżjonijiet
Serotonin syndrome Extra- pyramidal symptoms Akathisia Psychomotor restlessness
Sindromu ta ’ serotonin Sintomi ekstra - piramidali Akatiżja Irrekwitezza psikomotorja
Eye Disorders
Disturbi fl- għajnejn Glawkoma
Blurred vision
Vista mċajpra
Mydriasis Visual disturbance
Midrijażi Problemi fil - vista
Glaucoma
Disturbi fil- widnejn u
Ear and Labyrinth Disorders
fis- sistema labirintika
Vertigo Ear pain
Vertigo Uġigħ fil - widnejn
Yawning
Titwib
Throat tightness Epistaxis
Rassa fil - gerżuma Epistassi
Disorders
Disturbi gastro- intestinali
Nausea
Riħa ħażina
Diarrhoea
Emorraġija
Gastroenteritis
Tqalligħ
8
Dijarea
Breath odour
Gastro- enterite
Gastrointesti
fil- ħalq
Very common
gastro- intestinali
Common
(25. 2%)
Uncommon
Rimettar
Rare
Tifwiq
Very Rare
Ematokeżja
Frequency not known
Ħalq xott (13. 8%) Stitikezza (10. 3%)
(25.2%) Dry mouth (13.8%) Constipation (10.3%)
Dispepsja Gass fl- istonku
Vomiting Dyspepsia Flatulence
Gastrite Stomatite
Eructation Gastritis Stomatitis
Disturbi fil- kliewi u fis- sistema urinarja
nal haemorrhage
Żamma ta ’ l - awrina Disurja Eżitazzjoni
Renals and Urinary Disorders
Riħa mhux normali ta ’ l - awrina
Urinary Retention Dysuria Urinary hesitation Nocturia Polyuria Urine flow decreased
9 biex tagħmel l - awrina Awrinazzjoni eċċessiva matul il- lejl Tagħmel ħafna awrina Il- fluss ta ’ l - awrina jonqos
Skin and Subcutaneous Tissue Disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Sweating increased Rash Night sweats
Żieda fl- għaraq Raxx Tegħreq matul il- lejl
Urticaria Dermatitis contact Cold sweat Photo- sensitivity reactions Increased tendency to bruise
Urtikarja Dermatite minħabba kuntatt Għaraq kiesaħ Reazzjonijiet ta ’ fotosensittività Tendenza ogħla li titbenġel
Angio- neurotic oedema Stevens- Johnson Syndrome
Edima angjo - newrotika Sindrome ta ’ Stevens- Johnson
Muscoskeletal and connective tissue disorders
Disturbi muskolu- skeltrali u tal- connective tissue
Musculo- skeletal pain Muscle tightness Muscle spasm
Uġigħ muskolu - Kontrazzjoni skeletrali involontarju tal - Riġidità fil - muskolu muskolu Spażmu tal - muskolu
Trismus
Trismu
Endocrine disorders Hypo- thyroidism Metabolism and Nutrition Disorders
Disturbi fis- sistema endokrinarja Ipotirojdiżmu Disturbi fil- metaboliżmu u n- nutrizzjoni
Decreased Appetite
Tnaqqis fl- aptit
Hyperglycemi a (reported especially in diabetic patients)
Ipergliċemija (irrapportata l - iżjed f’ pazjenti dijabetiċi)
Dehydration SIADH Hyponatremia
Deidrazzjoni SIADH Iponatrimja
Infections and infestations Laryngitis Vascular Disorders
Infezzjonijiet u infestazzjonijiet Larinġite Disturbi vaskulari
Blood pressure increase Peripheral coldness Orthostatic hypotension2 Syncope2
Żieda fil - pressjoni tad - demm Ksieħ periferiku Ipotensjoni ortostatika2 Sinkope2
Hypertension Hypertensive crisis
Ipertensjoni Kriżi ipertensiva
9 Very common
Uġigħ addominali Tkexkix
Common
Ma tħossokx normali Tħoss il - bard Għatx Tħossok mitluq Tħoss is - sħana Problemi fil- mod ta ’ kif timxi
Uncommon
Uġigħ fis- sider
Rare
Disturbi fis- sistema immuni Disturbi fil- fwied u fil- marrara
Very Rare
Mard ta ’ sensitività eċċessiva
Frequency not known
Reazzjoni anafilattika
General Disorders and Administration Site Conditions Fatigue (10.8%)
Enzimi tal - fwied għoljin (ALT, AST, alkaline phosphatase Epatite3 Dannu akut fil- fwied)
Abdominal pain Chills
Suffejra Insuffiċjenza epatika
Feeling abnormal Feeling cold Thirst Malaise Feeling hot Gait disturbance
Disturbi fis- sistema riproduttiva u fis- sider
Chest pain
Il- funzjoni erettili ma
Immune system disorders Hepato-biliary disorders
Problemi ta ’ eġakulazzjoni
Hyper- sensitivity disorder
Sintomi ta ’ menopawża
Anaphylactic reaction
taħdimx normali Dewmien fl - eġakulazzjoni Problemi sesswali Emorraġija ginekoloġika
Elevated liver enzymes (ALT, AST, alkaline phosphatase) Hepatitis3 Acute liver injury
11 Disturbi psikjatriċi Insomnja (10. 4%)
Jaundice Hepatic failure
Aġitazzjoni Tnaqqis fil -
Reproductive System and Breast Disorders
Tgħażżiż tas - snien
Erectile dysfunction
Manija Alluċinazzjonijiet Aggressjoni u
Ejaculation disorder Ejaculation delayed Sexual dysfunction Gynaecologica l haemorrhage
Formazzjoni ta ’ ideat suwiċidali5
Psychiatric Disorders Insomnia
involontarju
Agitation
4
Bruxism
Diżorjentament rabja
Mania
Ansjetà
Suicidal
Imġiba suwiċidali5
Disorientation Hallucinations Apathy Aggression and anger4
Orgażmu mhux normali Ħolm mhux normali Problemi fl - irqad
ideation 5 Suicidal5 behaviour
Apatija
Cases of tinnitus have also been reported after treatment discontinuation.
Każijiet ta ’ tinnitus ġew ukoll irrapportati wara li twaqqfet il- kura.
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.
2 Każijiet ta ’ ipotensjoni ortostatika u sinkope ġew irrappurtati speċjalment fil- bidu tal- kura.
3 See section 4.4 4 Cases of aggression and anger have been reported particularly early in treatment of after treatment discontinuation.
3 Ara sezzjoni 4. 4 4 Ġew irrapportati każijiet ta ’ aggressjoni u ta ’ rabja speċjalment kmieni fil- kura jew wara li twaqqfet il- kura.
5 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4)
5 Ġew irrapportati każijiet ta ’ formazzjoni ta ’ ideat suwiċidali u ta ’ mġiba suwiċidali waqt il- kura b’ duloxetine jew ftit wara li twaqqfet il- kura (ara sezzjoni 4. 4).
Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Sospensjoni tal- kura ta ’ duloxetine (speċjalment meta tkun f’ daqqa) spiss twassal għal sintomi ta ’ rtirar.
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.
Sturdament, disturbi tas- sensi (fosthom parastizja), disturbi fl- irqad, (fosthom insomnja u ħolm intens), għeja, aġitazzjoni jew ansjetà, dardir u/ jew rimettar, rogħda, wġigħ ta ’ ras, irritabilità, dijarea, iperidrożi u vertigo huma l- aktar reazzjonijiet komunement irrappurtati.
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- avveniment jkunu minn ħfief sa moderati u ma jiżdidux, iżda f’ xi pazjenti jistgħu jkunu qawwija u/ jew jieħdu fit- tul.
It is therefore advised that when duloxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
Għaldaqstant, huwa rrakkomandat li meta l- kura b’ duloxetine m’ għadhiex mehtieġa, is- sospensjoni għandha tkun gradwali billi d- doża tiġi mnaqqas bil- ftit il- ftit (ara sezzjonijiet 4. 2 u 4. 4).
In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine- treated patients.
Fil- fażi akuta ta ’ 12- il ġimgħa ta ’ tliet provi kliniċi ta ’ duloxetine f’ pazjenti b’ uġigħ newropatiku tad - dijabete, ġew osservati żidiet żgħar iżda statistikament sinifikanti fil- livell ta ’ glucose fid- demm waqt is- sawm f’ pazjenti fuq kura ta ’ duloxetine.
HbA1c was stable in both duloxetine-treated and placebo-treated patients.
Il- livell ta ’ HbA1c kien stabbli kemm f’ pazjenti fuq kura ta ’ duloxetine kif ukoll f’ pazjenti fuq il- plaċebo.
In the extension phase of these studies, which lasted up to 52 weeks, there was an increase in HbA1c in both the duloxetine and routine care groups, but the mean increase was 0.3% greater in the duloxetine- treated group.
Fil- fażi ta ’ estensjoni ta ’ dawn l- istudji, li damet sejra 52 ġimgħa, kien hemm żieda fil- livell ta ’ HbA1c kemm fil- grupp ta ’ duloxetine kif ukoll f’ dak ta ’ kura ta ’ rutina, iżda ż- żieda medja kienet ta ’ 0. 3% aktar f’ pazjenti fuq kura ta ’ duloxetine.
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.
Kien hemm ukoll żieda żgħira fil- livell ta ’ glucose fid- demm waqt is- sawm u fil- kolesterol totali f’ pazjenti fuq kura ta ’ duloxetine filwaqt li dawn t- testijiet ta ’ laboratorju wrew tnaqqis żgħir fil- grupp ta ’ kura ta ’ rutina.
The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients.
L- intervall QT ikkoreġut f’ pazjenti fuq kura ta ’ duloxetine ma kenitx tvarja minn dik ta ’ pazjenti fuq il- plaċebo.
No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine-treated and placebo-treated patients.
Ma ġiet osservata l- ebda differenza klinikament sinifikanti meta ġie kkalkulat il- QT, il- PR, il- QRS, jew il- QTcB bejn pazjenti fuq kura ta ’ duloxetine u pazjenti fuq il- plaċebo.
Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 4800mg were reported.
Ġew irrappurtati każijiet ta ’ doża eċċessiva b’ dożi ta ’ duloxetine ta ’ 4800 mgmg, meta mgħoti waħdu jew flimkien ma ’ prodotti mediċinali oħra.
Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1000 mg.
Seħħew xi fatalitajiet, primarjament b’ taħlit ta ’ dożi eċċessivi, iżda wkoll b’ duloxetine waħdu b’ doża ta ’ madwar 1000 mg.
Signs and symptoms of overdose (duloxetine alone or with mixed medicinal products) included somnolence, coma, serotonin syndrome, seizures,, vomiting and tachycardia.
Is- sinjali u s- sintomi ta ’ doża eċċessiva (duloxetine waħdu jew b’ taħlit ta ’ prodotti mediċinali) jinkludu ngħas, koma, sindromu ta ’ serotonin, aċċessjonijiet, rimettar u takikardija.
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.
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).
A free airway should be established.
Irid jiġi stabbilit passaġġ ta ’ l- arja bla ebda xkiel.
Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures.
Huwa rrakkomandat li jiġu osservati s- sinjali kardijaċi u dawk vitali, flimkien ma ’ miżuri sintomatiċi u ta ’ sostenn adattati.
Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients.
Jista ’ jkun indikat it- tindif ta ’ l - istonku jekk dan jitwettaq ftit wara l- inġestjoni jew f’ pazjenti sintomatiċi.
Activated charcoal may be useful in limiting absorption.
Activated charcoal jista ’
Duloxetine has a large volume of distribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely to be beneficial.
Duloxetine għandu volum ta ’ distribuzzjoni kbir u mhux probabbli li jkunu ta ’ siwi d- dijureżi sfurzat, il- perfużjoni tad- demm, u l- perfużjoni bil- bdil.
Other antidepressants.
Antidepressivi oħra.
Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor.
Duloxetine huwa inibitur ta ’ ġbir mill- ġdid (reuptake inhibitor) kemm tas- serotonin (5- HT) u kemm tan- norepinephrine.
It weakly inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors.
Huwa jinibixxi b' mod dgħajjef id- dħul mill- ġdid ta ’ dopamine mingħajr affinità sinifikanti għar- reċetturi istaminerġiċi, dopaminerġiċi, kolinerġiċi u adrenerġiċi.
Duloxetine dose-dependently increases extracellular levels of serotonin and noradrenaline in various brain areas of animals.
B’ mod li huwa dipendenti fuq id- doża, duloxetine jżid il- livelli extraċellulari ta ’ serotonin u noradrenaline f’ partijiet differenti tal- moħħ ta ’ l- annimali.