qanastek/EMEA-V3 huggingface dataset:
YENTREVE should not be used in women with liver disease resulting in hepatic impairment (see section 4.3).
Insuffiċjenza tal- fwied YENTREVE m’ għandhux jintuża f’ nisa b’ mard tal- fwied li jwassal għal indeboliment tal- fwied (ara sezzjoni 4. 3).
No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/ min).
M’ hemmx bżonn ta 'tibdil fid- doża għall- pazjenti b’ disfunzjoni renali ħafifa jew moderata (tneħħija tal- krejatinina 30 sa 80 ml/ min).
2 Children and adolescents:
Tfal u adolexxenti:
The safety and efficacy of duloxetine in patients in these age groups have not been studied.
Is- sigurtà u l- effikaċja ta 'duloxetine f' pazjenti f' dawn il- gruppi ta' etajiet ma ġietx studjata.
Therefore, administration of YENTREVE to children and adolescents is not recommended.
Għalhekk, mhux rakkomandat li jingħata YENTREVE lit- tfal u lill- adoloxxenti.
When stopping treatment with YENTREVE 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’ YENTREVE 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).
YENTREVE should not be used in combination with nonselective, irreversible Monoamine Oxidase Inhibitors - MAOIs (see section 4.5).
YENTREVE m’ għandux jiġi użat flimkien ma ’ Monoamine Oxidase Inhibitors irriversibbli u mhux selettivi – MAOIs (ara sezzjoni 4. 5).
YENTREVE should not be used in combination with CYP1A2 inhibitors, like fluvoxamine, ciprofloxacin or enoxacine since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
YENTREVE m’ għandux jiġi użat flimkien ma ’ inibituri ta ’ CYP1A2, bħal fluvoxamine, ciprofloxacin jew enoxacine peress li dan iwassal għal konċentrazzjonijiet elevati ta ’ duloxetine fil- plażma (ara sezzjoni 4. 5).
The initiation of treatment with YENTREVE 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’ YENTREVE f’ pazjenti bi 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 YENTREVE should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija u aċċessjonijiet YENTREVE għandu jiġi użat b’ attenzjoni f’ pazjenti b’ passat ta ’ manija jew b’ dijanjosi ta ’ mard bipolari, u/ jew aċċessjonijiet.
Use with antidepressants The use of YENTREVE in combination with antidepressants (especially with SSRI, SNRI and reversible MAOIs) is not recommended (see below “ Depression, suicidal ideation and behaviour” and Section 4.5).
L- użu ta ’ YENTREVE flimkien ma ’ antidepressivi (speċjalment ma ’ SSRI, SNRI u MAOIs riversibbli) mhuwiex rakkomandat (ara iżjed l- isfel “ Depressjoni, formazzjoni ta ’ ħsibijiet ta ’ suwiċidju u mġiba u Sezzjoni 4. 5)
St John’ s wort Undesirable effects may be more common during concomitant use of YENTREVE and herbal preparations containing St John’ s wort (Hypericum perforatum).
St. John’ s Wort L- effetti mhux mixtieqa jistgħu jkunu aktar komuni meta YENTREVE u preparazzjonijiet magħmulin mill- ħxejjex li fihom St. John’ s Wort (Hypericum perforatum) jintużaw fl- istess ħin.
Cases of hypertensive crisis have been reported with duloxetine, especially in patients with pre-existing hypertension.
Għaldaqstant,
Therefore, in patients with known hypertension and/ or other cardiac disease, blood pressure monitoring is recommended, especially during the first month of treatment.
3 f’ pazjenti li hu magħruf li għandhom l- ipertensjoni u/ jew mard tal- qalb ieħor, huwa rrakkomandat li l - pressjoni tad- demm tinżamm taħt osservazzjoni, speċjalment fl- ewwel xahar ta ’ kura.
Caution should also be exercised when duloxetine is used 3 with medicinal products that may impair its metabolism (see section 4.5).
Għandha tingħata attenzjoni wkoll meta duloxetine jiġi wżat ma ’ prodotti mediċinali li jistgħu jdgħajjfu l- metaboliżmu tiegħu (ara sezzjoni 4. 5).
In a clinical trial adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with YENTREVE and 24% of patients taking placebo.
Fi provi kliniċi effetti avversi bit- twaqqif tal- kura f’ daqqa seħħew f’ madwar 44% ta ’ pazjenti b’ kura ta ’ YENTREVE u 24% ta ’ pazjenti li ħadu l- plaċebo.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering YENTREVE.
Iponatrimja Iponatrimja ġiet irrappurtata rarament, l- aktar fl- anzjani, meta jkun qed jingħata YENTREVE.
Depression, suicidal ideation and behaviour Although YENTREVE is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
Depressjoni, każijiet ta ’ ħsibijiet ta ’ suwiċidju u mġiba Ghalkemm YENTREVE mhuwiex indikat għal kura ta ’ depressjoni, is- sustanza attiva tiegħu (duloxetine) teżisti wkoll bħala medikazzjoni antidepressiva.
A meta-analysis of placebo- controlled clinical trials of antidepressants 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).
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
Physicians should encourage patients to report any distressing thoughts or feelings or depressive symptoms at any time.
4 sabiex jirrappurtaw kull hsieb jew sentiment ta ’ dwejjaq jew sintomu depressiv f’ kull ħin.
If while on YENTREVE 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’ YENTREVE, il- pazjent jiżviluppa sintomi ta ’ aġitazzjoni jew sintomi depressivi, għandu jittieħed parir mediku speċjalizzat, peress li d- depressjoni hija kundizzjoni medika serja.
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of YENTREVE is recommended (see Section 4.2).
(ara Sezzjoni 4. 2).
4 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.
YENTREVE should not be used in the treatment of children and adolescents under the age of 18 years.
YENTREVE 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 ta ’ suwiċidju), 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.
Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Fit- tfal u fl- adolexxenti, it- tagħrif dwar is- sigurtà fit- tul f’ dak li jirrigwarda l - iżvilupp tal- ġisem, il- maturazzjoni u l- iżvilupp konjittiv u ta ’ l- Imġiba, huwa nieqes.
Sucrose YENTREVE hard gastro-resistant capsules contain sucrose.
Sucrose YENTREVE kapsuli gastro- reżistenti ibsin fihom sucrose.
Monoamine oxidase inhibitors (MAOIs): due to the risk of serotonin syndrome, YENTREVE 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 ’ sindrome ta ’ serotonin, YENTREVE 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 YENTREVE 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 YENTREVE qabel jinbeda xi MAOI (ara sezzjoni 4. 3).
Serotonin syndrome: in rare cases, serotonin syndrome has been reported in patients using SSRIs concomitantly with serotonergic medicinal products.
Sindrome ta ’ serotonin: f’ każijiet rari, ġie rrappurtat sindrome ta ’ serotonin f’ pazjenti li jużaw SSRIs fl- istess ħin ma ’ prodotti mediċinali serotoninerġiċi.
The use of YENTREVE in combination with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, venlafaxine, or triptans, tramadol and tryptophan is not recommended.
L- użu ta ’ YENTREVE flimkien ma ’ anti - depressivi serotoninerġiċi bħal SSRIs, triċikliċi bħal clomipramine jew amitriptyline, venlafaxine jew triptans, tramadol, u tryptophan mhuwiex rakkomandat.
CNS medicinal products: caution is advised when YENTREVE is taken in combination with other centrally acting medicinal product or substances, including alcohol and sedative medicinal product (benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Prodotti mediċinali li jaffettwaw is- CNS: hija rakkomandata l- attenzjoni meta YENTREVE jintuża flimkien ma ’ sustanzi jew prodotti mediċinali oħra li jaġixxu fuq is- sistema nervuża ċentrali, li jinkludi l- alkoħol u l- prodotti mediċinali sedattivi (benzodiazepines, morfinomimetiċi, anti- psikotiċi, phenobarbital u l- antistaminiċi sedattivi)
Effect of duloxetine on other medicinal products Medicinal products metabolised by CYP1A2:
5 Effett ta ’ duloxetine fuq prodotti mediċinali oħra Prodotti mediċinali li jiġu metabolizzati minn CYP1A2:
The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71%, but does not 5 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- metabolu attiv tiegħu 5- hydroxyl u mhux irrakkomandat li jsir aġġustament ta ’ doża.
Caution is advised if YENTREVE 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 YENTREVE jingħata b’ attenzjoni jekk jittieħed flimkien ma ’ prodotti mediċinali li huma fil- biċċa l- kbira metabolizzati minn CYP2D6 (risperidone, anti - depressivi triċikliċi [TCAs] bħal nortriptyline, amitriptyline, u imipramine) speċjalment jekk għandhom indiċi terapewtiku dejjaq (bħal flecainide, propafenone u metoprolol).
Specific in vivo medicinal product interaction studies have not been performed.
Studji speċifiċi in vivo ta ’ interazzjoni bejn il- prodotti mediċinali ma sarux.
Effects of other medicinal products on duloxetine Antacids and H2 antagonists: co-administration of YENTREVE with aluminium- and magnesium- containing antacids or 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- aċidu fl- istonku u antagonisti ta ’ H2: it- teħid ta ’ duloxetine flimkien ma ’ mediċini kontra l- aċidu 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 CYP1A2: because CYP1A2 is involved in duloxetine metabolism, concomitant use of YENTREVE 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.
Therefore YENTREVE should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Għaldaqstant, YENTREVE m’ għandux jingħata flimkien ma ’ inibituri qawwija ta ’ CYP1A2 bħal fluvoxamine (ara sezzjoni 4. 3).
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.
YENTREVE should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
YENTREVE għandu jintuża fit- tqala biss jekk is - siwi potenzjali jiġġustifika r- riskju potenzjali lill- fetu.
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 johroġ fil- halib tal- bniedem huwa żgħir ħafna, fuq il- bażi ta ’ studju fuq 6 pazjenti li kellhom il- ħalib iżda ma tawhx lill- uliedhom.
As the safety of duloxetine in infants is not known, the use of YENTREVE while breast-feeding is not recommended.
Billi mhix magħrufa s- sigurtà ta ’ duloxetine fit- trabi, l- użu ta’ YENTREVE waqt it- treddigħ mhux rakkomandat.
YENTREVE may be associated with sedation and dizziness.
YENTREVE jista ’ jkun assoċjat ma ’ effett sedattiv u ma ’ sturdament.
6 Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 7976 patients, 4370 on duloxetine and 3606 on placebo) in SUI and other lower urinary tract disorders.
Tabella 1 turi r- reazzjonijiet avversi osservati minn rapporti spontanji u fi provi kliniċi kkontrollati bil - plaċebo (b’ total ta ’ 7976 pazjent, 4370 minnhom fuq duloxetine u 3606 fuq il- plaċebo) f’ Inkontinenza Awrinarja minħabba Sforz (SUI) u mard ieħor fil- passaġġ awrinarju t’ isfel.
The most commonly reported adverse events in patients treated with YENTREVE in clinical trials in SUI and other lower urinary tract disorders were nausea, dry mouth fatigue and constipation.
L- aktar reazzjonijiet avversi komunement irrappurtati f’ pazjenti kkurati b’ YENTREVE fi studji kliniċi ta ’ Inkontinenza Awrinarja minħabba Sforz (SUI) u mard ieħor fil- passaġġ awrinarju t’ isfel kienu tqalligħ, ħalq xott, għeja u stitikezza.
Adverse reactions Frequency are defined as:
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 u < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħrufa (ma tistax tittieħed stima mid- dejta disponibbli).
Rare
Rari Ħafna
Very Rare
Frekwenza Mhux Magħrufa
Frequency not known
Investigazzjonijiet
Cardiac Disorders
Żieda fil - Creatinine
Creatine phosphokinase increased
phosphokinase
Palpitations Nervous System Disorders
Disturbi fil- qalb
Headache Dizziness Tremor Lethargy Somnolence Paraesthesia Eye Disorders
Disturbi fis- sistema nervuża
Poor quality sleep Disturbance in attention Nervousness Dysgeusia
Uġigħ ta ’ ras Sturdament Rogħda Letarġija Ngħas Parastiżja
Serotonin syndrome Psychomotor restlessness Convulsions Akathisia Extrapyramidal symptoms
Sindromu ta ’ serotonin Irrekwitezza psikomotorja Konvulżjonijiet Akatiżja Sintomi ekstra - piramidali
Blurred vision Ear and Labyrinth Disorders
Disturbi fl- għajnejn
Visual disturbance Mydriasis
Glawkoma
Glaucoma
Vista mċajpra
Vertigo
Titwib
Tinnitus1 Ear pain
Epistassi Rassa fil - gerżuma
Respiratory, thoracic and mediastinal disorders Gastrointestinal Disorders
Disturbi gastro- intestinali
Yawning
Emorraġija
Epistaxis Throat tightness
gastro- intestinaliI
Nausea Diarrhoea (23.3%) Vomiting Dry mouth Dyspepsia
(23. 3%) Rimettar Ħalq xott Dispepsja (11. 9%) Stitikezza (10. 3%)
Gastroenteritis Stomatitis Gastritis
Stomatite Gastrite Gass fl- istonku Tifwiq Riħa ħażina fil- ħalq
Haematochezia
Disturbi fil- kliewi u fis- sistema urinarja
Gastrointestina l haemorrhage
Żamma ta ’ l - awrina
Very common
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Sindrome ta ’
Common
Żieda fl- għaraq
Uncommon
Raxx
Rare
Reazzjonijiet
Very Rare
Stevens- Johnson
Frequency not known
Tendenza ogħla li
(11.9%) Constipation (10.3%) Renals and Urinary Disorders
ta ’
Flatulence Eructation Breath odour
Edima angjo -
Urinary hesitation Dysuria Nocturia Urine odour abnormal
titbenġel
Urine flow decreased Polyuria
fotosensittività
Urinary retention
newrotika
Skin and Subcutaneous Tissue Disorders
Tegħreq matul il- lejl Għaraq kiesaħ
Sweating increased
Dermatite minħabba kuntatt Urtikarja
Rash Increased tendency to bruise Night sweats Cold sweat
Disturbi muskolu- skeltrali u tal- connective tissueMard tal- widnejn u tas- sistema labirintika
Photo- sensitivity reactions Dermatitis contact Urticaria
Spażmu tal- muskolu Riġidità fil- muskolu
Stevens- Johnson Syndrome Angioneurotic oedema
Kontrazzjoni involontarju
Muscoskeletal and connective tissue disorders Endocrine disorders Metabolism and Nutrition Disorders
Uġigħ muskolu- skeletrali tal- muskolu Trismu
Muscle spasm Muscle tightness Musculo- skeletal pain Trismus Hypo- thyroidism
Disturbi fis- sistema endokrinarja Ipotirojdiżmu Disturbi fil- metaboliżmu u n- nutrizzjoni Ipergliċemija
Muscle twitching
Tnaqqis fl- aptit
Hyperglycemia (reported especially in diabetic patients) SIADH Hyponatremia
(irrapportata l - iżjed f’ pazjenti dijabetiċi) SIADH Iponatrimja
Laryngitis Vascular Disorders
Infezzjonijiet u infestazzjonijiet Larinġite Disturbi vaskulari Sinkope2
Hypertensive crisis Orthostatic hypotension2Pe ripheral coldness
Kriżi ipertensiva Ipotensjoni ortostatika2 Ksieħ periferiku
Malaise Feeling abnormal Feeling hot Thirst
Telqa ġenerali Ma tħossokx normali Tħoss is- sħana Għatx
Immune system disorders
Disturbi fis- sistema immuni Reazzjoni Mard ta ’ sensitività anafilattika eċċessiva
Hyper- sensitivity
Disturbi fil- fwied u fil- marrara
Anaphylactic reaction
Epatite3 Enzimi tal- fwied għoljin
Common
Trismu
Uncommon
Insuffiċjenza epatika
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
(ALT, AST, alkaline phosphatase) Ħsara akuta fil- fwied
Hepatic failure Jaundice
Suffejra
Reproductive System and Breast Disorders Menopausal symptoms Gynaecological haemorrhage Psychiatric Disorders 11
Disturbi fis- sistema riproduttiva u fis- sider Sintomi ta ’ menopawża Emorraġija ginekoloġika Disturbi psikjatriċi 1
Insomnia AnxietySleep disorder Agitation Libido decreased
Nuqqas ta ’ rqad Ansjetà Disturbi fl- irqad Aġitazzjoni Tnaqqis fil- libido
Disorientation Hallucinations Abnormal dreams Apathy BruxismOrgas m abnormal
Diżorjentament Ħolm mhux normali Apatija Tgħażżiż tas- snien involontarju Orgażmu mhux normali
Suicidal behaviour Suicidal ideation4 Mania Aggression and anger5
Imġiba suwiċidali Formazzjoni ta ’ ideat suwiċidali4 Manija Aggressjoni u rabja5
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment 23 See section 4.4 4 Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4) 5 Cases of aggression and anger have been reported particularly early in treatment of after treatment discontinuation.
5 Ġew irrapportati każijiet ta ’ aggressjoni u ta ’ rabja speċjalment kmieni fil- kura jew wara li twaqqfet il- kura.
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 tal- qalb, f’ pazjenti fuq kura b’ duloxetine ma kenitx tvarja minn dik ta ’ pazjenti fuq il- plaċebo.
9 Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 4800mg were reported.
Ġew irrappurtati każijiet ta ’ dożi eċċessivi b’ dożi ta ’ duloxetine ta ’ 4800 mg, meta mgħoti waħdu jew flimkien ma ’ prodotti mediċinali oħra.
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 for duloxetine is known but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/ or temperature control) may be considered..
10 Mhux magħruf antidotu speċifiku għal duloxetine iżda jekk jirriżulta s- sindrome ta ’ serotonin, tista ’ tiġi kkunsidrata kura speċifika (bħal b’ cyproheptadine u/ jew b’ kontroll tat- temperatura).
The primary efficacy measures were Incontinence Episode Frequency (IEF) from diaries and an incontinence specific quality of life questionnaire score (I-QOL).
Il- miżuri primarji ta 'l - effikaċja kienu Frekwenza ta' Episodji ta 'Inkontinenza (IEF) permezz ta ’ dijarji u minn kwestjonarju bil- punteġġi dwar il- kwalità tal- ħajja, speċifiku għall- inkontineza (I- QOL).
The efficacy of YENTREVE has not been evaluated for longer than 3 months in placebo-controlled studies.
L- effikaċja ta ’ YENTREVE ma ġietx evalwata għal aktar minn tliet xhur fi studji ikkontrollati bil - plaċebo.
The clinical benefit of YENTREVE 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 ’ YENTREVE meta mqabbel mal- plaċebo ma kienx evidenzjat f’ nisa bi grad ħafif ta ’ SUI, definita fi provi randomised bħala dawk b’ IEF < 14 kull ġimgħa.
In these women, YENTREVE may provide no benefit beyond that afforded by more conservative behavioural interventions.
F’ dawn in- nisa, YENTREVE jista ’ ma jkollux benefiċċju akbar minn dak li jingħata b’ interventi ta ’ mġiba aktar konservattivi.
10 YENTREVE and Prior Continence Surgery: there are limited data that suggest that the benefits of YENTREVE are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
YENTREVE meta jingħata f’ pazjenti li kienet saritilhom operazzjoni għall- inkontinenza: hemm tagħrif limitat li jissuġġerixxi li l- benefiċċji ta ’ YENTREVE ma kienux imnaqqsa f’ nisa bl- inkontinenza awrinarja dovuta għall- isforz li diġà kienet saritilhom operazzjoni għall- inkontinenza.
YENTREVE and Pelvic Floor Muscle Training (PFMT): during a 12-week blinded, randomised, controlled study, YENTREVE demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone.
11 YENTREVE u Taħriġ tal- Muskolu tal- Qiegħ tal- Pelvis (PFMT): waqt studju kkontrollat, blinded, randomised, ta '12- il ġimgħa, YENTREVE wera tnaqqis akbar fl- IEF meta mqabbel jew ma' kura bil - plaċebo jew ma 'PFMT waħdu.
Combined therapy (duloxetine + PFMT) showed greater improvement in both pad use and condition-specific quality of life measures than YENTREVE alone or PFMT alone.
Terapija kombinata (duloxetine + PFMT) uriet titjib akbar kemm fl - użu tal- pad kif ukoll f' miżuri speċifiċi tal- kwalità tal- ħajja milli YENTREVE waħdu jew PFMT waħdu.
Duloxetine is detected in breast milk, and steady-state concentrations in breast
Duloxetine jinstab fil- ħalib ta ’ l- omm u l - konċentrazzjonijiet fissi fil- ħalib ta ’ l- omm huma kważi kwart dawk fil- plażma.
5.3 Preclinical safety data
12 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Red Iron oxide (E172) Yellow Iron Oxide (E172) Edible black ink.
Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Iron oxide Aħmar (E172) Iron Oxide Isfar (E172) Inka sewda li tittiekel
Black Iron Oxide-Synthetic (E172) Propylene glycol Shellac
Inka li tittiekel Iron Oxide Sintetiku Iswed (E172) Propylene glycol Shellac.
12 6.4 Special precautions for storage
13 6. 4 Prekawzjonijiet speċjali għall- ħażna
YENTREVE 20 mg hard gastro-resistant capsules.
YENTREVE 20 mg kapsuli ibsin gastro- reżistenti
Each capsule contains 20 mg of duloxetine (as hydrochloride).
Kull kapsula għandha 20 mg ta 'duloxetine (bħala hydrochloride).
The capsule has an oOpaque blue body, imprinted with ‘ 20 mg’ and an opaque blue cap, imprinted with ‘ 9544’.
Il- kapsula għandha l- parti prinċipali ċelesti Opak, stampat b ’ '20 mg' u tapp ċelesti opak, stampat b ’ '9544'.
However, limited data are available to support the efficacy of YENTREVE 20 mg twice daily.
Madankollu, it- tagħrif disponibbli huwa limitat biex tkun aċċertata l- effikaċja ta ’ YENTREVE 20 mgdarbtejn kuljum.
The efficacy of YENTREVE has not been evaluated for longer than 3 months in placebo-controlled studies.
L- effikaċja ta ’ YENTREVE ma kinitx evalwata għal tul ta ’ żmien ta ’ aktar minn 3 xhur fi studji kkontrollati bil- plaċebo.
Combining YENTREVE with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone.
Jista ’ jkun aktar effettiv li tassoċja YENTREVE ma ’ programm ta ’ eżerċizji biex jissaħħu l- muskoli tal- qiegħ tal- pelvis (PFMT), milli tuża wieħed minnhom biss.
It is recommended that consideration be given to concomitant PFMT.
Huwa rakkomandat li jkun ikkunsidrat li fl- istess żmien ta ’ kura b’ YENTREVE ikun hemm ukoll programm ta’ PFMT.
Renal insufficiency:
Insuffiċjenza renalii:
No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/ min).
M ’ hemmx bżonn ta 'varjazzjoni fid- doża għall- pazjenti b’ disfunzjoni tal- renali ħafifa jew moderata (tneħħija tal- krejatinina 30 sa 80 ml/ min).
14 Children and adolescents:
15 Tfal u adoloxxenti:
When stopping treatment with YENTREVE 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’ YENTREVE tkun ser titwaqqaf id- doża għandha tiġi mnaqqsa gradwalment fuq perjodu ta ’ mill- anqas ġimgħa sa ġimagħtejn sabiex jitnaqqas ir- riskju ta ’ reazzjonijiet ta ’ rtirar (ara sezzjonijiet 4. 4 u 4. 8).
YENTREVE should not be used in combination with nonselective, irreversible Monoamine Oxidase Inhibitors - MAOIs (see section 4.5).
YENTREVE m’ għandux jiġi użatt flimkien ma ’ Monoamine Oxidase Inhibitors irreversibli u mhux selettivi – MAOIs (ara sezzjoni 4. 5).
Mania and Seizures YENTREVE should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija u aċċessjonijiet YENTREVE għandu jiġi użat b’ attenzjoni f’ pazjenti bi storja ta ’ manija jew b’ dijanjosi ta ’ mard bipolari, u/ jew aċċessjonijiet.
Use with antidepressants The use of YENTREVE in combination with antidepressants (especially with SSRI, SNRI and reversible MAOIs) is not recommended (see below “ Depression, suicidal ideation and behaviour” and Section 4.5).
L- użu ma ’ antidepressivi L- użu ta ’ YENTREVE flimkien ma ’ antidepressivi (speċjalment ma ’ SSRI, SNRI u MAOIs riversibbli) mhuwiex rakkomandat (ara iżjed l- isfel “ Depressjoni, formazzjoni ta ’ ħsibijiet ta ’ suwiċidju u mġiba u Sezzjoni 4. 5) St. John’ s Wort L- effetti mhux mixtieqa jistgħu jkunu aktar komuni meta YENTREVE u preparazzjonijiet magħmulin mill- ħxejjex li fihom St. John’ s Wort (Hypericum perforatum) jintużaw fl- istess ħin.
Duloxetine 15 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 jiġu 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
Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance < 30 ml/ min).
Indeboliment renalii Pazjenti b’ indeboliment renali sever, li għandhom bżonn emodijaliżi (tneħħija tal- krejatinina < 30 ml/ min) ikollhom żieda fil- konċentrazzjoni ta ’ duloxetine fil- plażma.
In a clinical trial, adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with YENTREVE and 24% of patients taking placebo.
Fi provi kliniċi, effetti avversi bit- twaqqif tal- kura f’ daqqa seħħew f’ madwar 44% ta ’ pazjenti b’ kura ta ’ YENTREVE u 24% ta ’ pazjenti li ħadu l- plaċebo.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering YENTREVE.
Iponatrimja L- iponatrimja ġiet irrappurtata rarament, l- aktar fl- anzjani, meta jkun qed jingħata YENTREVE.
Depression, suicidal ideation and behaviour Although YENTREVE is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
Depressjoni, formazzjoni ta ’ ħsibijiet ta ’ suwiċidju u mġiba Ghalkemm YENTREVE mhuwiex indikat għal kura ta ’ depressjoni, is- sustanza attiva tiegħu (duloxetine) teżisti wkoll bħala medikazzjoni antidepressiva.
A meta-analysis of placebo- controlled clinical trials of antidepressants 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 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.
If while on YENTREVE 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’ YENTREVE, il- pazjent jiżviluppa sintomi ta ’ aġitazzjoni jew sintomi depressivi, għandu jiġi meħud parir mediku speċjalizzat, peress li d- depressjoni hija kundizzjoni medika serja.
If a decision to initiate antidepressant 16 pharmacological therapy is taken, the gradual discontinuation of YENTREVE 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.
17 Użu fit- tfal u fl- adolexxenti taħt it- 18- il sena Ma saru l- ebda provi kliniċi b’ duloxetine fil- qasam tal- pedjatrija.
CNS medicinal products: caution is advised when YENTREVE is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Prodotti mediċinali li jaffettwaw is- CNS: hija rakkomandata l- attenzjoni meta YENTREVE jintuża flimkien ma ’ sustanzi jew prodotti mediċinali oħra li jaġixxu fuq is- sistema nervuża ċentrali, li jinkludi l- alkoħol u l- prodotti mediċinali sedattivi (benzodiazepines, morfinomimetiċi, anti- psikotiċi, phenobarbital u l- antistaminiċi sedattivi)
Medicinal products metabolised by CYP2D6:
18 Prodotti mediċinali li jiġu metabolizzati minn CYP2D6:
The co-administration of duloxetine (40 17 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.
Specific in vivo drug interaction studies have not been performed.
Studji speċifiċi in vivo ta ’ interazzjoni bejn il- prodotti mediċinali ma sarux.
As the safety of duloxetine in infants is not known, the use of YENTREVE while breast-feeding is not recommended.
Billi mhix magħrufa s- sigurtà ta ’ duloxetine fit- trabi, l- użu ta’ YENTREVE waqt it- treddigħ mhux rakkomandat
18 Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 7977 patients, 4371 on duloxetine and 3606 on placebo) in SUI and other lower urinary tract disorders.
Tabella 1 turi r- reazzjonijiet avversi osservati minn rapporti spontanji u fi provi kliniċi kkontrollati bil - plaċebo (b’ total ta ’ 7976 pazjent, 4370 minnhom fuq duloxetine u 3606 fuq il- plaċebo) f’ Inkontinenza Awrinarja minħabba Sforz (SUI) u mard ieħor fil- passaġġ awrinarju t’ isfel.
The most commonly reported adverse events in patients treated with YENTREVE in clinical trials in SUI and other lower urinary tract disorders were nausea, dry mouthand fatigue -.
L- aktar reazzjonijiet avversi komunement irrappurtati f’ pazjenti kkurati b’ YENTREVE fi studji kliniċi ta ’ Inkontinenza Awrinarja minħabba Sforz (SUI) u mard ieħor fil- passaġġ awrinarju t’ isfel kienu tqalligħ, ħalq xott, għeja u stitikezza.
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 u < 1/ 1, 000), rari ħafna (< 1/ 10, 000), frekwenza mhux magħrufa (tagħrif minn rapporti spontanjima tistax tittieħed stima mid- data disponibbli).
Immune system disorders
Disturbi fil- fwied u fil- marrara
Hyper- sensitivity
Epatite3 Enzimi tal- fwied għoljin
Anaphylactic reaction
Trismu
20 Very common
Insuffiċjenza epatika
Common
22
Uncommon
Suffejra
Rare
Disturbi fis- sistema riproduttiva u fis- sider Sintomi ta ’ menopawża Emorraġija ginekoloġika Disturbi psikjatriċi
Very Rare
Nuqqas ta ’ rqad Ansjetà Disturbi fl- irqad
disorder Hepato-biliary disorders
Alluċinazzjonijie t
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Imġiba suwiċidali Formazzjoni ta ’ ideat suwiċidali4
Hepatic failure Jaundice
Tgħażżiż tas- snien
Reproductive System and Breast Disorders Menopausal symptoms Gynaecological haemorrhage Psychiatric Disorders 11
1
Insomnia AnxietySleep disorder Agitation Libido decreased
Tnaqqis fil- libido
Disorientation Hallucinations Abnormal dreams Apathy Bruxism Orgasm abnormal
involontarju Orgażmu mhux normali
Suicidal behaviour Suicidal ideation4 Mania Aggression and anger5
Manija Aggressjoni u rabja5
No specific antidote for duloxetine is known but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/ or temperature control) may be considered..
23 Mhux magħruf antidotu speċifiku għal duloxetine iżda jekk jirriżulta s- sindrome ta ’ serotonin, tista ’ tiġi kkunsidrata kura speċifika (bħal b’ cyproheptadine u/ jew b’ kontroll tat- temperatura).
Incontinence Episode Frequency: in all four studies the duloxetine-treated group had a 50% or greater median decrease in IEF compared with 33% in the placebo-treated group.
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.
The clinical benefit of YENTREVE 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 ’ YENTREVE 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, YENTREVE may provide no benefit beyond that afforded by more conservative behavioural interventions.
F’ dawn in- nisa, YENTREVE jista ’ ma jipprovdix benefiċċju akbar minn dak li jingħata b’ interventi ta ’ komportament aktar konservattivi.
Using a global improvement scale (PGI), significantly more women
Kwalità tal- ħajja: il- punteġġi miksuba fil- kwestjonarju dwar l- Inkontinenza u l- Kwalità tal- Ħajja (I - QOL) kienu b’ mod sinifikanti aħjar fil- grupp ta ’ pazjenti kkurati b’ duloxetine, meta mqabbel mal - grupp ikkurat bil- plaċebo (punteġġ ta ’ titjieb 9. 2 kontra 5. 9, p <. 001).
22 using duloxetine considered their symptoms of stress incontinence to be improved with treatment compared with women using placebo (64.6% versus 50.1%, p < .001).
Meta intużat skala li turi t- titjib globali (PGI), numru sinifikanti akbar ta ’ nisa li użaw duloxetine qiesu li s- sintomi ta ’ inkontinenza minħabba sforz kienu tjiebu permezz tal- kura meta mqabbla ma ’ nisa li użaw l- plaċebo (64. 6% kontra 50. 1%, p <. 001).
YENTREVE and Prior Continence Surgery: there are limited data that suggest that the benefits of YENTREVE are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
YENTREVE meta jingħata f’ pazjenti li kienet saritilhom operazzjoni għall- inkontinenza: hemm tagħrif limitat li jissuġġerixxi li l- benefiċċji ta ’ YENTREVE ma kienux imnaqqsa f’ nisa bl- inkontinenza awrinarja dovuta għall- isforz li diġà kienet saritilhom operazzjoni għall- inkontinenza.
YENTREVE and Pelvic Floor Muscle Training (PFMT): during a 12-week blinded, randomised, controlled study, YENTREVE demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone.
24 YENTREVE u Taħriġ tal- Muskolu tal- Qiegħ tal- Pelvis (PFMT): waqt studju kkontrollat, blinded, randomised, ta '12- il ġimgħa, YENTREVE wera tnaqqis akbar fl- IEF meta mqabbel jew ma' kura bil - plaċebo jew ma 'PFMT waħdu.
23 Nursing mothers:
Ommijiet li jreddgħu:
Duloxetine is detected in breast milk, and steady-state concentrations in breast milk are about one-fourth those in plasma.
L- ammont ta ’
The amount of duloxetine in breast milk is approximately 7 µg/ day while on 40 mg twice daily dosing.
25 duloxetine fil- ħalib ta ’ l- omm huwa bejn wieħed u ieħor ta ’ 7µg/ jum waqt li tkun fuq doża ta ’ 40 mg darbtejn kuljum.
Black Iron Oxide-Synthetic (E172) Propylene glycol Shellac.
Iron Oxide Sintetiku Iswed (E172) Propylene glycol Shellac.
24 6.4 Special precautions for storage
26 6. 4 Prekawzjonijiet speċjali għall- ħażna
Packs of 28, 56 and 98 capsules.
Pakketti ta ’ 28, 56 u 98 kapsula.
25 ANNEX II
27 ANNESS II
26 A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Lilly SA Avenida de la Industria No 30 28108 Alcobendas Madrid Spain
Lilly SA Avenida de la Industria No 30 28108 Alcobendas Madrid Spanja
Duloxetine
YENTREVE 40 mg, kapsuli gastro- reżistenti ibsin Duloxetine
See leaflet for further information.
Fih is- sucrose Ara l- fuljett għal aktar informazzjoni
packs of 28 hard gastro-resistant capsules 56 hard gastro-resistant capsules 98 hard gastro-resistant capsules 140 hard gastro-resistant capsules
pakketti ta ’ 28 kapsula iebsa gastro- reżistenti 56 kapsula iebsa gastro- reżistenti 98 kapsula iebsa gastro- reżistenti 140 kapsula iebsa gastro- reżistenti
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 30 OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
YENTREVE 40 mg hard gastro-resistant capsules Duloxetine
YENTREVE 40 mg, kapsuli gastro- reżistenti ibsin Duloxetine
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (2X98 CAPSULES, 40 MG) WRAPPED IN FOIL (INCLUDING BLUE BOX)
TIKKETTA TA ’ BARRA MGEŻWRA MADWAR IL- PAKKETTI MULTIPLI( 2X98 KAPSULA, 40 MG) IMGEŻWRA FIL- FOJL (INKLUŻA L- KAXXA ĊELESTI)
35 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (40 mg hard gastro- resistant capsules)
37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI (kapsuli gastro- reżistenti ibsin ta ’ 40 mg)
YENTREVE 40 mg hard gastro-resistant capsules Duloxetine
YENTREVE 40 mg kapsuli gastro- reżistenti ibsin Duloxetine
Duloxetine
YENTREVE 20 mg, kapsuli gastro- reżistenti ibsin Duloxetine
Packs of 28 hard gastro-resistant capsules Packs of 56 hard gastro-resistant capsules Packs of 98 hard gastro-resistant capsules.
Pakketti ta ’ 28 kapsula iebsa gastro- reżistenti Pakketti ta ’ 56 kapsula iebsa gastro- reżistenti Pakketti ta ’ 98 kapsula iebsa gastro- reżistenti
38 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (20 mg hard gastro- resistant capsules)
40 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI (kapsuli gastro- reżistenti ibsin ta ’ 20 mg)
YENTREVE 20 mg hard gastro-resistant capsules Duloxetine
YENTREVE 20 mg kapsuli gastro- reżistenti ibsin Duloxetine
YENTREVE 40 mg hard gastro resistant capsules YENTREVE 20 mg hard gastro resistant capsules Duloxetine (as hydrochloride)
YENTREVE 40 mg kapsuli gastro- reżistenti ibsin YENTREVE 20 mg kapsuli gastro- reżistenti ibsin Duloxetine (bħala hydrochloride)
What YENTREVE is and what it is used for 2.
X’ inhu YENTREVE u għalxiex jintuża 2.
Before you take YENTREVE 3.
Qabel ma tieħu YENTREVE 3.
How to take YENTREVE 4.
Kif għandek tieħu YENTREVE 4.
How to store YENTREVE 6.
Kif taħżen YENTREVE 6.
WHAT YENTREVE IS AND WHAT IT IS USED FOR
X’ INHU YENTREVE U GĦALXIEX JINTUŻA
YENTREVE increases the levels of serotonin and norepinephrine in the nervous system.
YENTREVE jżid il- livelli ta ’ serotonin u ta ’ norepinephrine fis- sistema nervuża.
YENTREVE is a medicine to be taken by mouth to treat Stress Urinary Incontinence (SUI) in women.
YENTREVE huwa prodott mediċinali li jittieħed mill- ħalq għal kura ta ’ Inkontinenza Awrinarja minħabba Sforz (SUI) fin- nisa.
YENTREVE is believed to work by increasing the strength of the muscle that holds back urine when you laugh, sneeze, or perform physical activities.
Huwa maħsub li YENTREVE jaħdem billi jżid is- saħħa tal- muskolu li jżomm lura l- awrina waqt li tkun qiegħed tidħaq, tgħatas, jew tagħmel xi attivitajiet fiżiċi.
The efficacy of YENTREVE is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT).
L- effikaċja ta ’ YENTREVE tiġi rinforzata meta tkun ikkombinata ma ’ programm ta ’ taħriġ msejjaħ Taħriġ tal- Muskoli tal- Qiegħ tal- Pelvis (PFMT).
BEFORE YOU TAKE YENTREVE
QABEL MA TIEĦU YENTREVE
Do not take YENTREVE
Tieħux YENTREVE
- If you are allergic (hypersensitive) to duloxetine or any of the inactive ingredients of
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal duloxetine jew sustanzi oħra inattivi ta ’
- If you are taking or have taken within the last 14 days, another medicine known as a monoamine
- jekk qiegħed/ qiegħda tieħu jew ħadt reċentement f’ dawn l- aħħar erbatax- il ġurnata, xi mediċina
oxidase inhibitor - MAOI (see section below ‘ Taking other medicines’).
oħra msejħa inibitur ta ’ monoamino oxidase (MAOI) (ara aktar ’ l isfel fis- sezzjoni: ‘ Meta tieħu medicini oħra ’).
- If you have liver disease.
- jekk għandek mard tal- fwied.
- If you are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or
- jekk qiegħed/ qiegħda tieħu fluvoxamine li normalment jintuża għall- kura tad- dipressjoni,
enoxacine which are used to treat some infections.
ciprofloxacin jew enoxacine li jintużaw għall- kura ta ’ xi infezzjonijiet.
- If you have severe kidney disease.
- jekk għandek mard serju tal- kliewi.
- If you suffer from uncontrolled high blood pressure.
- jekk tbati minn pressjoni għolja fid- demm li m’ hijiex ikkontrollata.
41 Take special care with YENTREVE The following are reasons why YENTREVE may not be suitable for you.
43 Oqgħod attent ħafna b’ YENTREVE Li ġejjin huma raġunijiet għaliex YENTREVE jista ’ ma jkunx tajjeb għalik.
- You are taking medicines to treat depression.
- Jekk qiegħed/ qeiegħda tieħu mediċini biex tikkura d- depressjoni.
- You have a history of seizures (fits).
- Għandek passat ta 'aċċessjonijiet.
- You have a history of mania or bipolar disorder.
- Għandek passat ta ’ manija jew mard bipolari.
- You have eye problems such as certain kinds of glaucoma (increased pressure in the eye).
- Għandek problemi f' għajnejk bħal ċerti tipi ta 'glawkoma (pressjoni għolja fl- għajn).
- You have a history of bleeding disorders (tendency to develop bruises).
- Għandek passat ta 'emorraġġija (tendenza li tiżviluppa tbenġil).
- You are younger than 18 years.
- Għandek anqas minn 18- il sena.
- You have high blood pressure.
- Ghandek pressjoni għolja tad- demm
- You are considering stopping YENTREVE (see section 3).
- Qiegħed/ qiegħda taħseb biex twaqqaf YENTREVE (ara sezzjoni 3)
YENTREVE may cause a sensation of restlessness or an inability to sit or stand still.
YENTREVE jista ’ jikkawża sensazzjoni ta ’ irrekwitezza jew l- inkapaċità li wieħed joqgħod bilqiegħda jew bilwieqfa mingħajr ma jiċċaqlaq.
Thoughts of suicide and worsening of your depression or anxiety disorderIf you are depressed and/ or have anxiety disorders you can sometimes have thoughts of harming or killing yourself.
Jekk tbati mid - dipressjoni u/ jew għandek problemi ta ’ ansjetà, xi kultant jista ’ jkollok xi ħsibijiet li tweġġa ’ jew toqtol lilek innifsek.
Use in children and adolescents under 18 years of age YENTREVE should not be used for children and adolescents under the age of 18 years.
Użu fit- tfal jew f’ adolexxenti taħt it- tmintax- il sena YENTREVE m’ għandux jintuża fit- tfal u f’ adolexxenti taħt it- tmintax- il sena.
Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of YENTREVE in this age group have not yet been demonstrated.
Barra minn hekk, f’ dan il- grupp ta ’ etajiet, l- effetti tas- sigurtà fit- tul għadhom ma ġewx ippruvati, f’ dak li għandu x’ jaqsam ma ’ l- iżvilupp tal- ġisem, il- maturazzjoni, u l- iżvilupp kemm konjittiv kif ukoll tal- mod ta ’ imġiba.
The main ingredient of YENTREVE, duloxetine, is used in other medicines for other conditions (diabetic neuropathic pain, depression and urinary incontinence).
Is- sustanza l- aktar importanti f’ YENTREVE, duloxetine, hija wżata f’ medicini oħra għall- kundizzjonijiet oħra (uġigħ newropatiku tad- dijabete, depressjoni u inkontinenza awrinarja).
Your doctor should decide whether you can take YENTREVE with other medicines.
44 It- tabib tiegħek irid jiddeċiedi jekk għandekx tieħu YENTREVE ma ’ mediċini oħra.
42 Monoamine Oxidase Inhibitors (MAOI): you should not take YENTREVE with an MAOI or within 14 days of stopping an MAOI.
M’ għandekx tieħu YENTREVE ma ’ MAOI jew fi żmien 14- il ġurnata minn mindu waqaft tieħu MAOI.
Taking an MAOI together with many prescription medicines, including YENTREVE, can cause serious or even life-threatening side effects.
It- teħid ta 'xi MAOI flimkien ma' ħafna mill- mediċini mgħotija bir- riċetta, inkluż YENTREVE, jista ’ jikkawża effetti sekondarji serji jew li jkunu ta ’ periklu għall- ħajja.
You must wait at least 14 days after you have stopped taking an MAOI before you can take YENTREVE.
Għandek tistenna ta 'l- anqas 14- il ġurnata wara li tkun waqaft tieħu xi MAOI biex tkun tista' tieħu YENTREVE.
Also, you need to wait at least 5 days after you stop taking YENTREVE before you take an MAOI.
Għandek bżonn ukoll tistenna ta 'l- anqas 5 ijiem wara li tieqaf tieħu YENTREVE biex tkun tista' tieħu xi MAOI.