qanastek/EMEA-V3 huggingface dataset:
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- ħalib 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 DULOXETINE BOEHRINGER INGELHEIM while breast-feeding is not recommended.
Billi mhix magħrufa s- sigurtà ta ’ duloxetine fit- trabi, l- użu ta’ DULOXETINE BOEHRINGER INGELHEIM waqt it- treddigħ mhux rakkomandat.
DULOXETINE BOEHRINGER INGELHEIM may be associated with sedation and dizziness.
DULOXETINE BOEHRINGER INGELHEIM jista ’ jiġi assoċjat ma ’ sedazzjoni u 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 bi ngħas jew sturduti għandhom jevitaw xogħol li jista ’ jkun ta ’ periklu bħas- sewqan jew it- tħaddim ta ’ magni.
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 DULOXETINE BOEHRINGER INGELHEIM 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’ DULOXETINE BOEHRINGER INGELHEIM fi studji kliniċi ta ’ Inkontinenza Awrinarja minħabba Sforz (SUI) u mard ieħor fil- passaġġ awrinarju t’ isfel kienu tqalligħ, ħalq xott, għeja u stitikezza.
The data analysis of four 12-week, placebo-controlled clinical trials in patients with SUI, including 958 duloxetine-treated and 955 placebo-treated patients, showed that the onset of the reported adverse events typically occurred in the first week of therapy.
L- analiżi tat - tagħrif minn erba ’ studji kliniċi ta ’ 12- il ġimgħa, ikkontrollati bil- plaċebo f’ pazjenti b’ SUI, li kienu jikkonsistu f’ 958 pazjent ikkurat b’ duloxetine u f’ 955 pazjent ikkurat bil- plaċebo, urew li ġeneralment ir- reazzjonijiet avversi li kienu rrapportati jibdew fl- ewwel ġimgħa ta ’ terapija.
However, the majority of the most frequent adverse events were mild to moderate and resolved within 30 days of occurrence (e. g. nausea).
Iżda il- maġġoranza tar - reazzjonijiet avversi komuni kienu ħfief għal moderati u għebu wara 30 ġurnata minn meta bdew (eż. tqalligħ).
Very common (≥ 1/ 10), common (≥ 1/ 100 and < 1/ 10), uncommon (≥ 1/ 1,000 and < 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 u < 1/ 10), mhux komuni (≥1/ 1, 000 u < 1/ 100), rari (≥1/ 10, 000 u < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħrufa (ma tistax tittieħed stima mid- dejta disponibbli).
Very
Komuni Ħafna Komuni
Common
Mhux Komuni
Very Common Uncommon Rare Very
Rari Ħafna
Frequency not known
Frekwenza Mhux Magħrufa
common
Investigazzjonijiet
Rare
Tnaqqis fil- piż Żieda fil- piż
Investigations Cardiac Disorders
Żieda fil - Creatinine
Weight decrease Weight increase Blood cholesterol increased
Żieda tal- kolesterol fid - demm
Creatinine phosphokinase increase
phosphokinase
Palpitations Nervous System Disorders
Palpitazzjonijiet
Supra-ventricular arrhythmia, mainly atrial fibrillation
Arritmija supra - ventrikolari, l - aktar fibrillazzjoni ta ’ l- atrija
Headache Dizziness Tremor Lethargy Somnolence Paraesthesia
Uġigħ ta ’ ras Sturdament Rogħda Letarġija Ngħas Parastiżja
Poor quality of sleep Disturbance in attention Nervousness Dysgeusia
Kwalità ħażina ta ’ irqad Disturbi fl- attenzjoni Nervożità Disgewżja
Dyskinesia Myoclonus
Diskinesja Mijoklonus
Serotonin syndrome Psychomotor restlessness Convulsions AkathisiaExtrapyramidal symptoms
Sindromu ta ’ serotonin Irrekwitezza psikomotorja Konvulżjonijiet Akatiżja Sintomi ekstra - piramidali
Eye Disorders
Disturbi fl- għajnejn
Glaucoma
Glawkoma
Ear and Labyrinth Disorders
Vista mċajpra
Vertigo
Problemi fil- vista Midrijażi
Tinnitus1 Ear pain
Disturbi fil- widnejn u fis- sistema labirintika Tinnitus1 Vertigo Uġigħ fil- widnejn
Respiratory, thoracic and mediastinal disorders Gastrointestinal Disorders
Disturbi respiratorji, toraċiċi u medjastinali
Epistaxis Throat tightness
Epistassi Rassa fil - gerżuma
Nausea (23.3%) Dry mouth (11.9%) Constipation (10.3%)
Disturbi gastro- intestinali
Diarrhoea Vomiting Dyspepsia
Tqalligħ Dijarea
Gastrointestinal haemorrhage
Gastro- enterite
Renals and Urinary Disorders
Ematokeżja
Urinary hesitation Dysuria Nocturia Urine odour abnormal
Emorraġija gastro- intestinaliI
Urine flow decreased Polyuria
(23. 3%) Rimettar Ħalq xott Dispepsja (11. 9%) Stitikezza (10. 3%)
Urinary retention
Stomatite Gastrite Gass fl- istonku Tifwiq Riħa ħażina fil- ħalq
Skin and Subcutaneous Tissue Disorders
Disturbi fil- kliewi u fis- sistema urinarja
Rash Increased tendency to bruise
Eżitazzjoni biex tagħmel l- awrina Disurja Awrinazzjoni eċċessiva matul il- lejl Riħa mhux normali ta ’ l - awrina
Photo- sensitivity reactions Dermatitis
Il- fluss ta ’ l - awrina jonqos Tagħmel ħafna awrina
Stevens-Johnson Syndrome Angioneurotic oedema
Żamma ta ’ l - awrina
Very
Raxx
Common
Reazzjonijiet
Uncommon
Stevens- Johnson
Very Common Uncommon Rare Very
Tendenza ogħla li
Frequency not known
Edima angjo -
common
titbenġel
Night sweats Cold sweat
newrotika
contact Urticaria
Tegħreq matul il- lejl Għaraq kiesaħ
Rare
Dermatite minħabba kuntatt Urtikarja
Muscoskeletal and connective tissue disorders
Disturbi muskolu- skeltrali u tal- connective tissueMard tal- widnejn u tas- sistema labirintika
Muscle spasm Muscle tightness Musculo- skeletal pain Trismus
Spażmu tal- muskolu Riġidità fil- muskolu
Muscle twitching
Kontrazzjoni involontarju
Endocrine disorders
Uġigħ muskolu- skeletrali tal- muskolu Trismu
Hypo- thyroidism Metabolism and Nutrition Disorders
Disturbi fis- sistema endokrinarja Ipotirojdiżmu Disturbi fil- metaboliżmu u n- nutrizzjoni
Appetite decreased
Tnaqqis fl- aptit
Dehydration
Deidrazzjoni
Hyperglycemia (reported especially in diabetic patients) SIADH Hyponatremia
Ipergliċemija (irrapportata l - iżjed f’ pazjenti dijabetiċi) SIADH Iponatrimja
Infections and infestations Laryngitis Vascular Disorders
Infezzjonijiet u infestazzjonijiet Larinġite Disturbi vaskulari Sinkope2
Syncope2 Blood pressure increase
Żieda fil- pressjoni tad - demm
Hypertensive crisis Orthostatic hypotension2 Peripheral coldness
Kriżi ipertensiva Ipotensjoni ortostatika2 Ksieħ periferiku
Hypertension
Ipertensjoni
General Disorders and Administration Site Conditions Fatigue (10.9%)
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Għeja (10. 9%)
Abdominal pain Pruritus Weakness Chills
Uġigħ addominali Ħakk Debbulizza Tkexkix
Malaise Feeling hot Feeling abnormal Thirst
Telqa ġenerali Tħoss is- sħana Ma tħossokx normali Għatx
Gait disturbance Feeling cold
Problemi fil - mod ta ’ kif timxi Tħoss il- bard
Immune system
Disturbi fis- sistema immuni
Hyper- sensitivity disorder
Mard ta ’ sensitività eċċessiva
Anaphylactic reaction
Reazzjoni anafilattika
Hepato-biliary disorders
Disturbi fil- fwied u fil- marrara
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Epatite3 Enzimi tal- fwied għoljin
Hepatic failure Jaundice
Insuffiċjenza epatika
Very
(ALT, AST, alkaline phosphatase) Ħsara akuta fil- fwied
Common
Suffejra
Uncommon
Disturbi fis- sistema riproduttiva u fis- sider Sintomi ta ’ menopawża Emorraġija ginekoloġika Disturbi psikjatriċi
Very Common Uncommon Rare Very
Nuqqas ta ’ rqad Ansjetà Disturbi fl- irqad
Frequency not known
Diżorjentament Ħolm mhux normali Apatija
common
Alluċinazzjonijiet
Gynaecological haemorrhage
Imġiba suwiċidali Formazzjoni ta ’ ideat suwiċidali4
Rare
Aġitazzjoni
Psychiatric Disorders 1
Tgħażżiż tas- snien
Insomnia Anxiety Sleep disorder Agitation Libido decreased
Tnaqqis fil- libido
Disorientation Abnormal dreams Apathy Bruxism Orgasm abnormal
involontarju Orgażmu mhux normali
Hallucinations
Manija Aggressjoni u rabja5
Suicidal behaviour Suicidal ideation 4 Mania Aggression and anger 5
Każijiet ta ’ tinnitus ġew ukoll irrapportati wara li twaqqfet il- kura.
Cases of tinnitus have also been reported after treatment discontinuation.
2 Każijiet ta ’ ipotensjoni ortostatika u sinkope ġew irrappurtati speċjalment fil- bidu tal- kura.
2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment 3 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.
Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/ or vomiting, tremor, headache, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Sturdament, disturbi tas- sensi (fosthom parastizja), disturbi fl- irqad, (fosthom nuqqas ta ’ rqad u ħolm intens), aġitazzjoni jew ansjetà, tqalligħ 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- avvenimenti jkunu minn ħfief għal 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 meħtieġa, it- twaqqif għandu jkun gradwali billi d- doża tiġi mnaqqsa bil- ftit il- ftit (ara sezzjonijiet 4. 2 u 4. 4).
Electrocardiograms were obtained from 755 duloxetine-treated patients with SUI and 779 placebo- treated patients in 12-week clinical trials.
Ittieħdu elettrokardjogrammi minn 755 pazjent b’ SUI kkurati b’ duloxetine u 779 pazjent ikkurati bi plaċebo fi studji kliniċi ta ’ 12- il ġimgħa.
The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients.
L- intervall QT ikkoreġut tat- tħabbit tal- qalb, f’ pazjenti fuq kura b’ duloxetine ma kinitx tvarja minn dik ta ’ pazjenti fuq plaċebo.
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 studji 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.
Diabetic Peripheral Neuropathic Pain Table 2 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 5253 patients, 3289 on duloxetine and 1964 on placebo).
Uġigħ Newropatiku Periferiku Tad- dijabete Tabella 2 turi r- reazzjonijiet avversi osservati minn rapporti spontanji u f’ studji kliniċi kkontrollati bi plaċebo (b’ total ta ’ 5253 pazjent, 3289 minnhom fuq duloxetine u 1964 fuq plaċebo).
The most commonly observed adverse reactions in patients with diabetic neuropathic pain treated with DULOXETINE BOEHRINGER INGELHEIM were: nausea; headache, dry mouth and somnolence.
L- aktar reazzjonijiet avversi osservati b’ mod komuni f’ pazjenti b ’ uġigħ newropatiku tad- dijabete li kienu qed jieħdu DULOXETINE BOEHRINGER INGELHEIM kienu: tqalligħ, uġigħ ta ’ ras, ħalq xott u ngħas.
10 Table 2:
10 Tabella 2:
Very common (≥ 1/ 10), common (≥ 1/ 100 and < 1/ 10), uncommon (≥ 1/ 1,000 and < 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 u < 1/ 10), mhux komuni (≥1/ 1000 u < 1/ 100), rari (≥1/ 10, 000 u < 1/ 1000), rari ħafna (< 1/ 10, 000), mhux magħruf (ma tistax tittieħed stima mid- dejta disponibbli).
Common
Komuni Ħafna Komuni
Uncommon
Mhux
Very Rare
Rari Ħafna
Frequency not
Frekwenza
common
Komuni
known
Mhux
Investigations
Magħrufa Investigazzjonijiet Disturbi fil- qalb
Weight increase Creatinine phosphokinase increase
Żieda fil- piż Żieda fil - Creatinine phosphokinase
Blood cholesterol increased
Zieda tal - kolesterol fid - demm
Cardiac Disorders
Disturbi fis - sistema nervuża
Supra- ventricular arrhythmia, mainly atrial fibrillation
Arritmija supra - ventrikolari, l - aktar fibrillazzjoni ta ’ l- atrija
Headache (13.8%) Somnolence (10.7%) Eye Disorders
Uġigħ ta ’ ras (13. 8%) Ngħas (10. 7%)
Dizziness Tremor Lethargy Paraesthesia
Sturdament Rogħda Ħedla Parastiżja
Dyskinesia Poor quality sleep Nervousness Myoclonus Disturbance in attention Dysgeusia
Diskinesja Kwalità ħażina ta ’ irqad Nervożità Mijoklonus Disturbi fl - attenzjoni Disgewżja
Serotonin syndrome Convulsions Akathisia Psychomotor restlessness Extra- pyramidal symptoms
Sindrome ta ’ serotonin Aċċessjonijiet Akatiżja Irrekwitezza psikomotorja Sintomi ekstra - piramidali
Visual disturbance Mydriasis
Disturbi fl - għajnejn
Ear and Labyrinth Disorders
Disturbi tal - vista Midrijażi
Tinnitus 1
Disturbi fil - widnejn u fis - sistema labirintika Disturbi respiratorji, toraċiċi u medjastinali
Vertigo Ear pain
Tinnitus1
Respiratory, thoracic and mediastinal disorders
Vertiġini Uġigħ tal - widnejn
Disorders
Disturbi gastro - intestinali
Nausea (21.7%) Dry mouth (13.2%)
Tqalligħ (21. 7%) Ħalq xott (13. 2%)
Diarrhoea Constipation Vomiting Dyspepsia Flatulence
Dijarrea Stitikezza Rimettar Dispepsja Gass fl - istonku
Gastroenteritis Stomatitis Gastritis Eructation
Gastro- enterite Stomatite Gastrite Tifwiq
Haematochezia Breath odour
Ematokeżja Riħa ħażina fil - ħalq
Gastrointestinal haemorrhage
Emorraġija gastro - intestinali
Renals and Urinary Disorders
12 Disturbi fil- kliewi u fis- sistema awrinarja Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Urinary Retention Urinary hesitation Dysuria Nocturia
Żamma ta ’ l - awrina Eżitazzjoni awrinarja Disurja Awrinazzjoni eċċessiva matul il- lejl Tgħaddi ammont eċċessiv ta ’ awrina Tnaqqis fil - fluss ta ’ l - awrina
Urine odour abnormal
Riħa mhux normali ta ’ l - awrina Sindromu ta ’
11
Raxx
Very
Reazzjonijiet
Common
Stevens -
Uncommon
Żieda fl -
Rare
ta ’
Very Rare
Johnson
Frequency not
għaraq
common
fotosensittività
Polyuria Urine flow decreased
Edima anġjo -
known
Tegħreq
Skin and Subcutaneous Tissue Disorders
Tendenza ogħla
Rash Sweating increased Night sweats
newrotika
Photo- sensitivity reactions Increased tendency to bruise Dermatitis contact Urticaria Cold sweat
matul il- lejl
Stevens- Johnson Syndrome Angio-neurotic oedema
li titbenġel Dermatite minħabba kuntatt Urtikarja Għaraq kiesaħ
Muscoskeletal and connective tissue disorders
Disturbi muskolu - skeletrali u tal - connective tissue
Musculo- skeletal pain Muscle tightness Muscle spasm
Uġigħ muskolu - skeletali Riġidità tal- muskoli Spażmu muskolari
Muscle twitching
Kontrazzjoni involontarja tal- muskolu
Endocrine disorders Hypo- thyroidism Metabolism and Nutrition Disorders
Disturbi fis - sistema endokrinarja Ipotirojdiżmu Disturbi fil - metaboliżmu u n - nutrizzjoni
Decreased Appetite
Tnaqqis fl -
Hyperglycemia (reported especially in diabetic patients)
Ipergliċemija
Dehydration SIADH Hypo-natremia
Deidrazzjoni SIADH
Flushing
aptit
Feeling hot Malaise Gait disturbance Feeling abnormal Feeling cold Thirst Chills
(irrapportata l - iżjed f’ pazjenti dijabetiċi)
Chest pain
Iponatrimja
Immune system disorders
Infezzjonijiet u infestazzjonijiet
Hyper- sensitivity
13 Larinġite Disturbi vaskulari Sinkope2
Anaphylactic reaction
Ħmura fil -
Very
Kriżi
Common
wiċċ
Uncommon
Ipotensjoni ortostatika2 Żieda fil - pressjoni tad - demm Ksieħ periferiku
Rare
ipertensiva Ipertensjoni
Very Rare
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Frequency not
Għeja Uġigħ addominal i
common
Tħoss is- sħana Telqa ġenerali Problemi fil - mod ta ’ kif timxi Ma tħossokx normali Tħoss il- bard Għatx Tkexkix
disorder
Uġigħ fis - sider
known
Disturbi fis- sistema immuni Reazzjoni Mard ta ’ anafilattika sensitività eċċessiva Disturbi fil- fwied u fil- marrara
Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase)
Epatite3 Enzimi tal - fwied għoljin (ALT, AST, alkaline phosphatase) Ħsara akuta fil- fwied
Hepatic failure Jaundice
Insuffiċjenza epatika Suffejra
Acute liver injury
Disturbi fis - sistema riproduttiva u fis - sider
Reproductive System and Breast Disorders
Disturbi psikjatriċi
Erectile dysfunction
Problemi fil- funzjoni erettili
Sexual dysfunction Ejaculation disorder Ejaculation delayed Gynaecological haemorrhage
Disfunzjoni sesswali Problemi ta ’ eġakulazzjoni Dewmien fl - eġakulazzjoni Emorraġija ginekoloġika
Menopausal symptoms
Sintomi tal - menopawża
Psychiatric Disorders
14 Imġiba suwiċidali4
Insomnia
Insomnja
Aggression
Problemi ta ’
Suicidal
irqad
Abnormal dreams Anxiety
Formazzjoni ta ’ ideat suwiċidali4
Sleep disorder Apathy Disorientation
mhux normali Ansjetà Aġitazzjo ni
and anger 5 Mania
Manija
behaviour4 Suicidal ideation4
Alluċinazzjonijiet
AgitationLibid Bruxism o decreased Orgasm abnormal
Tnaqqis fil- libido Orgażmu mhux normali
3 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.
Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Ħafna drabi sospensjoni tal- kura ta ’ duloxetine (speċjalment meta tkun f’ daqqa) twassal għal sintomi ta ’ rtirar.
Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/ or vomiting, tremor, headache, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Sturdament, disturbi tas- sensi (fosthom parastizja), disturbi fl- irqad, (fosthom insomnja u ħolm intens), aġitazzjoni jew ansjetà, tqalligħ u/ jew rimettar, rogħda, uġigħ ta ’ ras, irritabilità, dijarea, iperidrożi u vertigo huma l- aktar reazzjonijiet irrappurtati b’ mod komuni.
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, għall- SSRIs u SNRIs, dawn l- avveniment jkunu minn ħfief sa moderati u ma jiżdidux, iżda f’ xi pazjenti jistgħu jkunu gravi 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 meħtieġa, is- sospensjoni tal- kura għandha tkun gradwali billi d- doża tiġi mnaqqsa 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 studji 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 b’ duloxetine kif ukoll f’ pazjenti fuq plaċebo.
There was also a small increase in fasting blood glucose and in total cholesterol in
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.
Electrocardiograms were obtained from 528 duloxetine-treated and 205 placebo-treated patients with diabetic neuropathic pain in clinical trials lasting up to 13-weeks.
F’ studji kliniċi, fuq pazjenti b’ uġigħ newropatiku tad- dijabete li damu sejrin 13- il ġimgħa, ġew meħuda elettrokardjogrammi minn 528 pazjent fuq kura ta ’ duloxetine u minn 205 pazjenti fuq plaċebo.
The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients.
L- intervall QT ikkoreġut għar- rata tat- taħbit tal- qalb f’ pazjenti fuq kura ta ’ duloxetine ma kinitx tvarja minn dik ta ’ pazjenti fuq 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 plaċebo.
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 in combination with other 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..
Irid jiġi
A free airway should be established.
15 stabbilit passaġġ ta ’ l- arja bla ebda xkiel.
Activated charcoal may be useful in limiting absorption.
Activated charcoal jista ’ jkun ta ’ għajnuna biex jillimita l- assorbiment.
ATC code:
Antidepressivi oħra, Kodiċi ATC:
Duloxetine is a combined serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor.
Duloxetine huwa inibitur ta ’ ġbir mill- ġdid kemm tas- serotonin (5- HT) kif ukoll ta ’ norepinephrine.
It weakly inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors.
Huwa jinibixxi b' mod dgħajjef il- ġbir mill- ġdid ta ’ dopamine mingħajr affinità sinifikanti għar - reċetturi istaminerġiċi, dopaminerġiċi, kolinerġiċi u adrenerġiċi.
In animal studies, increased levels of 5-HT and NE in the sacral spinal cord, lead to increased urethral tone via enhanced pudendal nerve stimulation to the urethral striated sphincter muscle only during the storage phase of the micturition cycle.
Fl- istudji fuq l- annimali, livelli ogħla ta ’ 5- HT u NE fil- kordun ċentrali nervuż sagro- spinali, iwasslu għall- żieda fis- saħħa muskolari uretrali permezz ta ’ stimulazzjoni aktar b’ saħħitha tan- nerv tal - pudenda għall- muskolu rrigat ta ’ l- isfinster ta 'l- uretra u dan biss waqt il- fażi tal- ħażna ta' l- awrina fiċ - ċiklu tal- passaġġ ta ’ l- awrina.
A similar mechanism in women is believed to result in stronger urethral closure during urine storage with physical stress that could explain the efficacy of duloxetine in the treatment of women with SUI.
Mekkaniżmu simili fin- nisa huwa maħsub li jirriżulta f’ għeluq aktar b’ saħħtu ta ’ l- uretra waqt il- ħażna ta ’ l- awrina waqt sforz fiżiku, li jista ’ jispjega l- effikaċja ta ’ duloxetine fit- trattament ta ’ nisa bis- SUI.
The efficacy of duloxetine 40 mg given twice daily in the treatment of SUI was established in four double-blind, placebo-controlled studies, that randomised 1913 women (22 to 83 years) with SUI; of these, 958 patients were randomised to duloxetine and 955 to placebo.
L- effikaċja ta ’ duloxetine 40 mg li ngħata darbtejn kuljum fit- trattament ta 'SUI ġiet stabbilita f' erba' studji randomised, double blind, ikkontrollati bil- plaċebo, b’ 1913- il mara (22 sa 83 sena) bis- SUI; 958 pazjenti kienu ngħataw b’ mod randomised duloxetine u 955 il- plaċebo.
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).
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 tnaqqis medjan ta' 50% jew aktar fil- IEF meta mqabbel ma '33% fil- grupp ikkurat bil- plaċebo.
Differences were observed at each visit after 4 weeks (duloxetine 54%, and placebo 22%), 8 weeks (52% and 29%), and 12 weeks (52% and 33%) of medication.
Id - differenzi kienu osservati f’ kull viżta wara 4 ġimgħat ta ’ kura (duloxetine 54% u l- plaċebo 22%), 8 ġimgħat ta ’ kura (52% u 29%) u 12- il ġimgħa ta ’ kura (52% u 33%).
14 In an additional study limited to patients with severe SUI, all responses with duloxetine were achieved within 2 weeks.
Fi studju ieħor limitat għall- pazjenti b' SUI gravi, ir- reazzjonijiet kollha b’ duloxetine inkisbu fi żmien ġimgħatejn.
The efficacy of DULOXETINE BOEHRINGER INGELHEIM has not been evaluated for longer than 3 months in placebo-controlled studies.
L- effikaċja ta ’ DULOXETINE BOEHRINGER INGELHEIM ma ġietx evalwata għal aktar minn tliet xhur fi studji ikkontrollati bil- plaċebo.
The clinical benefit of DULOXETINE BOEHRINGER INGELHEIM compared with placebo has not been demonstrated in women with mild SUI, defined in randomised trials as those with IEF < 14 per week.
Il- benefiċċju kliniku ta ’ DULOXETINE BOEHRINGER INGELHEIM meta mqabbel mal- plaċebo ma kienx evidenzjat f’ nisa bi grad ħafif ta ’ SUI, definita fi provi randomised bħala dawk b’ IEF < 14 kull ġimgħa.
In these women, DULOXETINE BOEHRINGER INGELHEIM may provide no benefit beyond that afforded by more conservative behavioural interventions.
F’ dawn in- nisa, DULOXETINE BOEHRINGER INGELHEIM jista ’ ma jkollux benefiċċju akbar minn dak li jingħata b’ interventi ta ’ mġiba aktar konservattivi.
Incontinence Quality of Life (I-QOL) questionnaire scores were significantly improved in the duloxetine-treated patient group compared with the placebo-treated group (9.2 versus 5.9 score improvement, p < .001).
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).
Using a global improvement scale (PGI), significantly more women 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).
DULOXETINE BOEHRINGER INGELHEIM and Prior Continence Surgery: there are limited data that suggest that the benefits of DULOXETINE BOEHRINGER INGELHEIM are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
16 DULOXETINE BOEHRINGER INGELHEIM meta jingħata f’ pazjenti li kienet saritilhom operazzjoni għall- inkontinenza: hemm tagħrif limitat li jissuġġerixxi li l- benefiċċji ta ’ DULOXETINE BOEHRINGER INGELHEIM ma kienux imnaqqsa f’ nisa bl- inkontinenza awrinarja dovuta għall - isforz li diġà kienet saritilhom operazzjoni għall- inkontinenza.
DULOXETINE BOEHRINGER INGELHEIM and Pelvic Floor Muscle Training (PFMT): during a 12- week blinded, randomised, controlled study, DULOXETINE BOEHRINGER INGELHEIM demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone.
DULOXETINE BOEHRINGER INGELHEIM u Taħriġ tal- Muskolu tal- Qiegħ tal- Pelvis (PFMT): waqt studju kkontrollat, blinded, randomised, ta '12- il ġimgħa, DULOXETINE BOEHRINGER INGELHEIM 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 DULOXETINE BOEHRINGER INGELHEIM 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 DULOXETINE BOEHRINGER INGELHEIM waħdu jew PFMT waħdu.
The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in 2 randomised, 12-week, double-blind, placebo-controlled, fixed dose studies in adults (22 to 88 years) having diabetic neuropathic pain for at least 6 months.
L- effikaċja ta ’ duloxetine bħala kura għall- uġigħ newropatiku tad- dijabete kien stabbilit f’ żewġ studji ta ’ 12- il ġimgħa, b’ dożi fissi, ikkontrollati bi plaċebo, randomised u double- blind f’ adulti (22 sa 88 sena) li kellhom uġigħ newropatiku tad- dijabete għallinqas għal 6 xhur.
In both studies, duloxetine 60 mg once daily and 60 mg twice daily significantly reduced pain compared with placebo.
Fiż- żewġ studji, duloxetine 60mg darba kuljum u 60mg darbtejn kuljum naqqsu b’ mod sinifikanti l - uġigħ meta mqabbla ma ’ plaċebo.
Although data from a one-year open label study offer some evidence for longer-term efficacy, no conclusive efficacy data for treatments longer than 12 weeks duration are available from placebo- controlled studies.
Għalkemm tagħrif minn studju open- label ta ’ sena juri xi evidenza ta ’ effikaċja fit- tul, minn studji kkontrollati bi plaċebo m’ hemmx tagħrif konklużiv dwar l- effikaċja tal- kura għal iżjed minn 12- il ġimgħa.
15 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Duloxetine is administered as a single enantiomer.
Duloxetine jingħata bħala enantjomer wieħed.
Duloxetine is extensively metabolised by oxidative enzymes (CYP1A2 and the polymorphic CYP2D6), followed by conjugation.
Duloxetine huwa metabolizzat b' mod estensiv minn enzimi ossidattivi (CYP1A2 u dik polimorfika CYP2D6) u mbagħad ikkonjugat.
The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
Il- farmakokinetika ta ’ duloxetine juru varjabiltà kbira bejn persuna u oħra (ġeneralment 50- 60%), parti minħabba s- sess, l- età, is- sitwazzjoni tat- tipjip kif ukoll minħabba l- istat ta ’ metaboliżmu minn CYP2D6.
The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%; N=8 subjects).
Il- biodisponibiltà orali assoluta ta ’ duloxetine kienet mifruxa bejn 32% sa 80% (medja ta '50%; N=8 soġġetti).
Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11%).
L- ikel iżid il- ħin biex tintlaħaq l- ogħla konċentrazzjoni minn 6 sa 10 sigħat u jnaqqas b’ xi ftit l- ammont ta 'l- assorbiment (bejn wieħed u ieħor 11%).
Duloxetine is approximately 96% bound to human plasma proteins.
Duloxetine huwa bejn wieħed u ieħor 96% marbut mal- proteini tal- plażma tal- bniedem.
Duloxetine binds to both albumin and alpha-1 acid glycoprotein.
Duloxetine jintrabat kemm ma 'l- albumina kif ukoll ma ’ alpha- 1 acid glycoprotein.
Protein binding is not affected by renal or hepatic impairment.
L- indeboliment tal- kliewi jew tal- fwied ma jaffettwax ir- rabta mal- proteini.
Duloxetine is extensively metabolised and the metabolites are excreted principally in urine.
Duloxetine huwa metabolizzat b’ mod estensiv u l- eskrezzjoni tal- prodotti metaboliċi ssir l- aktar fl - awrina.
Both CYP2D6 and CYP1A2 catalyse the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulphate conjugate of 5-hydroxy,6-methoxy duloxetine.
Kemm CYP 2D6 kif ukoll CYP 1A2 jikkatalizzaw il- formazzjoni taż- żewġ prodotti metaboliċi prinċipali l- glukuronidu kkonjugat ta '4- hydroxy duloxetine u l- konjugat tas- sulphate ta' 5 - hydroxy, 6- methoxy duloxetine.
Based upon in vitro studies, the circulating metabolites of duloxetine are considered pharmacologically inactive.
Ibbażati fuq studji in vitro, il- prodotti metaboliċi ta ’ duloxetine li
The elimination half-life of duloxetine after an oral dose ranges from 8 to 17 hours (mean of 12 hours).
Il- half life ta ’ l- eliminazzjoni ta ’ duloxetine tvarja minn 8 sa 17- il siegħa (medja ta '12- il siegħa).
After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/ hr to 46 l/ hr (mean of 36 l/ hr) After an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/ hr (mean 101 l/ hr).
Wara doża orali, it- tneħħija apparenti ta ’ duloxetine mill- plażma tvarja minn 33 sa 261 l/ siegħa (medja 101 l/ siegħa).
Gender: pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximatively 50% lower in females).
Sess: ġew identifikati differenzi farmakokinetiċi bejn l- irġiel u n- nisa (it- tneħħija apparenti mill - plażma hija kważi 50% inqas fin- nisa).
Based upon the overlap in the range of clearance, gender-based pharmacokinetic differences do not justify the recommendation for using a lower dose for female patients.
Minħabba l- fatt li l- marġni tar- rata tat- tneħħija jikkoinċidu fuq xulxin, differenzi farmakokinetiċi bbażati fuq is- sess ma jiġġustifikawx ir- rakkomandazzjoni li tintuża doża inqas f’ pazjenti nisa.
Age: pharmacokinetic differences have been identified between younger and elderly females (≥ 65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Età: differenzi farmakokinetiċi kienu identifikati bejn nisa żgħar u kbar (≥ 65 sena) (l- AUC jiżdied b’ madwar 25% u l- half life hi madwar 25% itwal fl- anzjani), madankollu d- daqs ta 'dawn il- bidliet mhux biżżejjed biex jiġġustifika tibdil fid- doża.
As a general recommendation, caution should be exercised when treating the elderly (see sections 4.2 and 4.4).
Bħala rakkomandazzjoni ġenerali, wieħed għandu joqgħod attent meta jkun qiegħed jikkura l- anzjani (ara sezzjonijiet 4. 2 u 4. 4).
Renal impairment: end stage renal disease (ESRD) patients receiving dialysis had a 2-fold higher duloxetine Cmax and AUC values compared to healthy subjects.
Indeboliment renali: pazjenti b' mard terminali tal- kliewi (ESRD) li jirċievu id- dijaliżi kellhom valuri tas- Cmax u ta ’ l- AUC ta ’ duloxetine darbtejn ogħla minn dawk ta ’ pazjenti b' saħħithom.
Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment.
It- tagħrif farmakokinetiku fuq duloxetine huwa limitat f’ pazjenti b’ indeboliment renali ta ’ grad ħafif jew wieħed moderat.
Hepatic insufficiency: moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
Insuffiċjenza tal- fwied: mard moderat fil- fwied (Child Pugh Klassi B) affettwa l- farmakokinetika ta ’ duloxetine.
Compared with healthy subjects, the apparent plasma clearance of duloxetine was 79% lower, the apparent terminal half-life was 2.3 times longer, and the AUC was 3.7 times higher in patients with moderate liver disease.
Imqabbla ma 'pazjenti b' saħħithom, it- tneħħija apparenti mill- plażma ta ’ duloxetine kienet 79% anqas, il- half life terminali apparenti kienet 2. 3 darbiet itwal u l- AUC kien 3. 7 darbiet ogħla f' pazjenti li kellhom mard moderat fil- fwied.
The pharmacokinetics of duloxetine and its metabolites have not been studied in patients with mild or severe hepatic insufficiency.
Il- farmakokinetika ta ’ duloxetine u l- prodotti metaboliċi tiegħu ma kienux studjati f’ pazjenti b’ insuffiċjenza tal- fwied ħafifa jew severa.
The disposition of duloxetine was studied in 6 lactating women who were at least 12-weeks postpartum.
Id- dispożizzjoni ta ’ duloxetine ġiet studjata f’ 6 nisa li kienu qegħdin jreddgħu u li kienu ilhom mill- inqas 12- il ġimgħa li kienu welldu.
The amount of duloxetine in breast milk is approximately 7 µg/ day while on 40 mg twice daily dosing.
L- ammont ta ’ duloxetine fil- ħalib ta ’ l- omm huwa bejn wieħed u ieħor ta ’ 7 µg/ jum waqt li tkun fuq doża ta ’ 40 mg darbtejn kuljum.
Lactation did not influence duloxetine pharmacokinetics.
It- treddigħ m’ affettwax il- farmakokinetiċi ta ’ duloxetine.
16 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Duloxetine was not genotoxic in a standard battery of tests and was not carcinogenic in rats.
Duloxetine ma kienx ġenotossiku f’ firxa ta 'testijiet standard u ma kienx karċinoġenu fil- firien.
Multinucleated cells were seen in the liver in the absence of other histopathological changes in the rat carcinogenicity study.
Ċelluli multinukleati dehru fil- fwied fl- assenza ta ’ kambjamenti istopatoloġiċi oħra fi studju fuq il - karċinoġeniċità fil- far.
Female mice receiving duloxetine for 2 years had an increased incidence of hepatocellular adenomas and carcinomas at the high dose only (144 mg/ kg/ day), but these were considered to be secondary to hepatic microsomal enzyme induction.
Ġrieden tas- sess femminili li rċevew duloxetine għal sentejn kellhom inċidenza ogħla ta 'adenomi u karċinomi epatoċellulari fid- doża għolja biss (144 mg/ kg/ jum), imma dawn kienu kkunsidrati li huma sekondarji għall- istimulazzjoni ta' l- enzima mikrożomali tal- fwied.
The relevance of this mouse data to humans is unknown.
Ir- relevanza ta 'dan it- tagħrif fil - ġrieden għall- bnedmin mhix magħrufa.
Female rats receiving duloxetine before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
Firien tas- sess femminil li rċevew duloxetine, qabel u waqt li kienu qedgħin jgħammru u fil- bidu tat- tqala, kellhom tnaqqis fil- konsum ta 'l- ikel matern u fil- piż, taqlib fiċ- ċiklu oestrous, nuqqas fl- indiċi ta' twelid ta 'frieħ ħajjin u fis- sopravivenza tal- ferħ ta' l - annimal, u dewmien biex jikbru l- frieħ f’ livelli ta ’ espożizzjoni sistemika, stmata li hija mhux anqas mill- esponiment massimu kliniku (AUC).
In an embryotoxicity study in the rabbit, a higher incidence of cardiovascular and skeletal malformations was observed at systemic exposure levels below the maximun clinical exposure (AUC).
Fi studji embrojotossiċi fil- fenek, inċidenża ogħla ta ’ formazzjonijiet difettużi kardjovaskulari u skeletriċi kienu osservati f’ livelli ta ’ espożizzjoni sistemika anqas mill- esponiment massimu kliniku (AUC).
No malformations were observed in another study testing a higher dose of a different salt of duloxetine.
L’ ebda formazzjonijiet difettużi ma kienu osservati fi studju ieħor li eżamina doża ogħla ta ’ forma kimika differenti ta ’ duloxetine.
In pre/ postnatal toxicity study in the rat, duloxetine induced adverse behavioural effects in the offspring at systemic exposures levels below maximum clinical exposure (AUC).
Fi studju ta ’ tossiċità ta ’ qabel u wara t- twelid fil- far, duloxetine ikkaġuna effetti avversi ta ’ komportament fil- frieħ, f’ livelli ta ’ espożizzjoni sistemika anqas mill- esponiment massimu kliniku (AUC).
Hypromellose Acetate Succinate Sucrose Sugar spheres Talc Titanium dioxide (E171) Triethyl citrate.
Il- Kontenut tal- kapsula Hypromellose Hypromellose Acetate Succinate Sucrose Sferi taz- zokkor Talc Titanium dioxide (E171) Triethyl citrate.
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 tista ’ tittiekel
Black Iron Oxide-Synthetic (E172) Propylene glycol Shellac.
Inka sewda li tista ’ tittiekel Iron Oxide Sintetiku Iswed (E172) Propylene glycol Shellac.
17 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not store above 30°C.
Taħżinx f’ temperatura ’ l fuq minn 30 ° C
Polyvinylchloride (PVC), Polyethylene (PE), and Polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminum foil.
Polyvinylchloride (PVC), Polyethylene (PE), u folja tal- polychlorotrifluoroethylene (PCTFE) issiġillata b' għatu tal- fojl ta 'l- aluminium.
Packs of 28, 56, 98, 140 and 196 (2x98) capsules.
Pakketti ta ’ 28, 56, 98, 140 u 196 (2x98) kapsula.
Boehringer Ingelheim International GmbH, Binger Str.
19 Boehringer Ingelheim International GmbH, Binger Str.
173 D-55216 Ingelheim am Rhein, Germany.
173 D- 55216 Ingelheim am Rhein, Il - Ġermanja
DULOXETINE BOEHRINGER INGELHEIM 20 mg hard gastro-resistant capsules.
DULOXETINE BOEHRINGER INGELHEIM 20 mg kapsuli ibsin gastro- reżistenti
Each capsule contains 20 mg of duloxetine (as hydrochloride).
Kull kapsula għandha 20 mg ta 'duloxetine (bħala hydrochloride)
For a full list of excipients, see section 6.1.
Sustanzi mhux attivi: sucrose 5. 7 mg Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Opaque blue body, imprinted with ‘ 20 mg’ and an opaque blue cap, imprinted with ‘ 9544’.
Il- parti prinċipali ċelesti opak, stampat b ’ '20 mg' u għatu ċelesti opak, stampat b ’ '9544'.
Dose escalation may decrease, though not eliminate, the risk of nausea and dizziness.
Dan il- fatt li tibda b’ doża aktar baxxa jista ’ jnaqqas għalkemm mhux jelimina ir- riskju ta ’ tqallih u sturdament.
The efficacy of DULOXETINE BOEHRINGER INGELHEIM has not been evaluated for longer than 3 months in placebo-controlled studies.
L- effikaċja ta ’ DULOXETINE BOEHRINGER INGELHEIM ma kinitx evalwata għal tul ta ’ żmien ta ’ aktar minn 3 xhur fi studji kkontrollati bil- plaċebo.
Combining DULOXETINE BOEHRINGER INGELHEIM with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone.
Jista ’ jkun aktar effettiv li tassoċja DULOXETINE BOEHRINGER INGELHEIM 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’ DULOXETINE BOEHRINGER INGELHEIM ikun hemm ukoll programm ta’ PFMT.
The medicinal product response should be evaluated after 2 months ’ of treatment.
21 Wara xahrejn ta ’ kura għandu jiġi valutat ir- rispons għall- prodott mediċinali.
19 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).
Hepatic insufficiency:
Insuffiċjenza renali:
Caution should be exercised when treating the elderly.
Trid toqgħod attent meta tkun qiegħed tikkura l- anzjani.
Abrupt discontinuation should be avoided.
Twaqqifi tal- kura Għandha jiġi evitat twaqqif f’ salt.
When stopping treatment with DULOXETINE BOEHRINGER INGELHEIM the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Meta l- kura b’ DULOXETINE BOEHRINGER INGELHEIM tkun ser titwaqqaf id- doża għandha tiġi mnaqqsa gradwalment fuq perjodu ta ’ mill- anqas ġimgħa sa ġimagħtejn sabiex jitnaqqas ir- riskju ta ’ reazzjonijiet ta ’ rtirar (ara sezzjonijiet 4. 4 u 4. 8).
If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Jekk ifeġġu sintomi intollerabbli wara tnaqqis fid- doża jew wara twaqqif tal- kura, jista ’ jiġi kkunsidrat li terġa ’ tinbeda id- doża preċedenti ordnata.
Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.).
Sussegwentement, it- tabib jista ’ jkompli jnaqqas id- doża, iżda b’ rata aktar gradwali.
DULOXETINE BOEHRINGER INGELHEIM should not be used in combination with nonselective, irreversible Monoamine Oxidase Inhibitors - MAOIs (see section 4.5).
DULOXETINE BOEHRINGER INGELHEIM m’ għandux jiġi użatt flimkien ma ’ Monoamine Oxidase Inhibitors irreversibli u mhux selettivi – MAOIs (ara sezzjoni 4. 5).
Severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.4).
Indeboliment sever renali (tneħħija tal- kreatinina < 30 ml/ min) (ara sezzjoni 4. 4).
Mania and Seizures DULOXETINE BOEHRINGER INGELHEIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija u aċċessjonijiet DULOXETINE BOEHRINGER INGELHEIM għandu jiġi użat b’ attenzjoni f’ pazjenti bi storja ta ’ manija jew b’ dijanjosi ta ’ mard bipolari, u/ jew aċċessjonijiet.
Use with antidepressants The use of DULOXETINE BOEHRINGER INGELHEIM 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 ’ DULOXETINE BOEHRINGER INGELHEIM 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)
20 St John’ s wort Undesirable effects may be more common during concomitant use of DULOXETINE BOEHRINGER INGELHEIM and herbal preparations containing St John’ s wort (Hypericum perforatum).
22 St. John’ s wort L- effetti mhux mixtieqa jistgħu jkunu aktar komuni meta DULOXETINE BOEHRINGER INGELHEIM jintuża fl- istess ħin ma ’ preparazzjonijiet magħmulin mill- ħxejjex li jkun fihom St. John’ s wort (Hypericum perforatum).
Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing duloxetine in patients with increased intraocular pressure, or those at risk of acute narrow- angle glaucoma.
Midrijasi Ġiet irrapurtata l- midrijasi b’ assoċjazzjoni ma ’ duloxetine, għaldaqstant, duloxetine għandu jiġi ordnat b’ attenzjoni f’ pazjenti bi pressjoni għolja fl- għajn, jew f’ dawk b’ riskju ta ’ glawkoma ta ’ angolu dejjaq akuta.
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 Kien hemm rapporti tà 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).
Discontinuation of treatment Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
Twaqqif tal- kura Huma komuni s- sintomi ta ’ rtirar meta l- kura tiġi mwaqqfa, partikolarment jekk it- twaqqif issir f’ daqqa waħda (ara sezzjoni 4. 8).
In a clinical trial, adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with DULOXETINE BOEHRINGER INGELHEIM 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 ’ DULOXETINE BOEHRINGER INGELHEIM u 24% ta ’ pazjenti li ħadu l- plaċebo.