qanastek/EMEA-V3 huggingface dataset:
blister (PVC/ PE/ PCTFE/ alu)
folja (PVC/ PE/ PCTFE/ alu) 28 kapsula folja (PVC/ PE/ PCTFE/ alu) 28 kapsula folja (PVC/ PE/ PCTFE/ alu) 84 kapsula folja (PVC/ PE/ PCTFE/ alu) 98 kapsula folja (PVC/ PE/ PCTFE/ alu) 56 kapsula folja (PVC/ PE/ PCTFE/ alu) 7 kapsuli folja (PVC/ PE/ PCTFE/ alu) 500 kapsula folja (PVC/ PE/ PCTFE/ alu) 100 kapsula
XERISTAR 30 mg hard gastro-resistant capsules
XERISTAR 30 mg kapsuli gastro- reżistenti ibsin
The XERISTAR 30 mg capsule has an Opaque white body, imprinted with ‘ 30 mg’ and an opaque blue cap, imprinted with ‘ 9543’.
Il- kapsula ta ’ XERISTAR 30 mg għandha l- parti prinċipali tagħha abjad opak, stampat b ’ ‘ 30 mg ’ u għatu blu opak, stampat b ’ ‘ 9543 ’.
After consolidation of the response, it is recommended to continue treatment for several months, in order to avoid relapse.
2 Wara li jintlaħaq rispons suffiċjenti, huwa rakkomandat li l- kura tkompli għal ħafna xhur sabiex jiġi evitat li jkun hemm rikadenza.
2 Diabetic Peripheral Neuropathic Pain:
Uġigħ Newropatiku Periferiku Tad- dijabete:
However, as with any medicine, caution should be exercised when treating the elderly, especially with XERISTAR 120 mg per day for which data are limited (see sections 4.4 and 5.2).
Madankollu, bħal b’ mediċina oħra, il- kura ta ’ l- anzjani għandha tiġi segwita b’ attenzjoni, speċjalment b’ XERISTAR 120 mg kuljum fejn l- informazzjoni hija limitata (ara sezzjonijiet 4. 4 u 5. 2).
Therefore, administration of XERISTAR to children and adolescents is not recommended (see section 4.4).
Ghaldaqstant, XERISTAR mhux irrakkomandat għall- użu fit- tfal u fl- adolexxenti (ara sezzjoni 4. 4).
Hepatic impairment XERISTAR should not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Indeboliment tal- fwied XERISTAR m’ għandhux jintuża f’ pazjenti b’ mard tal- fwied li jwassal għal indeboliment tal- fwied (ara sezzjonijiet 4. 3 u 5. 2).
When stopping treatment with XERISTAR 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’ XERISTAR 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).
Concomitant use of XERISTAR with nonselective, irreversible Monoamine Oxidase Inhibitors (MAOIs) is contraindicated (see section 4.5).
L- użu fl- istess ħin ta ’ XERISTAR ma ’ Inibituri ta ’ Monoamine Oxidase (MAOIs) irriversibbli u mhux selettivi huwa kontra- indikat (ara sezzjoni 4. 5).
XERISTAR should not be used in combination with fluvoxamine, ciprofloxacin or enoxacine (i. e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
XERISTAR m’ għandux jiġi użat flimkien ma ’ fluvoxamine, ciprofloxacin jew enoxacine (jiġifieri inibituri qawwija ta ’ CYP1A2) billi dan iwassal għal konċentrazzjonijiet elevati ta ’ duloxetine fil - plażma (ara sezzjoni 4. 5).
The initiation of treatment with XERISTAR 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’ XERISTAR f’ pazjenti b’ pressjoni għolja mhux ikkontrollata li tista ’ tesponi l- pazjenti għal riskju potenzjali ta ’ kriżi ipertensiva (ara sezzjonijiet 4. 4 u 4. 8).
Mania and seizures XERISTAR should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija u aċċessjonijiet XERISTAR għandu jiġi użat b’ attenzjoni f’ pazjenti b’ storja ta ’ manija jew b’ dijanjosi ta ’ mard bipolari, u/ jew aċċessjonijiet.
Mydriasis Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing XERISTAR to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Midrijasi Ġiet rrapurtata l- midrijasi b’ assoċjazzjoni ma ’ duloxetine, għaldaqstant, XERISTAR għandu jiġi ordnat b’ attenzjoni f’ pazjenti b’ pressjoni għolja fl- għajn, jew f’ dawk b’ riskju ta ’ glawkoma ta ’ angolu dejjaq akuta.
Use with antidepressants Caution should be exercised when using XERISTAR in combination with antidepressants.
Użu ma ’ anti- depressivi L- użu ta ’ XERISTAR ma ’ anti- depressivi għandha tiġi segwita b’ attenzjoni.
St John’ s wort Undesirable effects may be more common during concomitant use of XERISTAR and herbal preparations containing St John’ s wort (Hypericum perforatum).
John’ s wort (Hypericum perforatum).
Other psychiatric conditions for which XERISTAR is prescribed can also be associated with an increased risk of suicide-related events.
Kundizzjonijiet psikjatriċi oħra li għalihom jista ’ jiġi mogħti XERISTAR huma wkoll assoċjati ma ’ riskju akbar ta ’ avvenimenti marbuta ma ’ suwiċidju.
Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal thoughts prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicidal behaviour, and should receive careful monitoring during treatment.
4 Huwa magħruf li pazjenti b’ passat ta ’ avvenimenti marbuta ma ’ suwiċidju jew dawk li juru ammont sinifikanti ta ’ hsibijiet ta ’ suwiċidju qabel ma tibda l- kura huma f’ riskju ogħla li jkollhom ħsibijiet ta ’ suwiċidju jew ta ’ mġiba suwiċidali u għandhom jiġu sorveljati bir- reqqa waqt il- kura.
4 Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes.
Sorveljanza bir- reqqa tal- pazjenti b’ mod partikolari dawk li huma l- iżjed f’ riskju għandha takkumpanja t- terapija mediċinali speċjalment fil- bidu tal- kura u wara xi tibdil fid- doża.
XERISTAR should not be used in the treatment of children and adolescents under the age of 18 years.
XERISTAR m’ għandux jintuża fil - kura ta ’ tfal u adolexxenti taħt it- 18- il sena.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering XERISTAR.
Iponatrimja L- iponatrimja ġiet irrappurtata rarament, l- aktar fl- anzjani, fit- teħid ta ’ XERISTAR.
In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with XERISTAR and 23% of patients taking placebo.
F’ provi kliniċi avvenimenti mhux mixtieqa b’ sospensjoni tal- kura f’ daqqa seħħew f’ madwar 45% ta ’ pazjenti b’ kura ta ’ XERISTAR u 23% ta ’ pazjenti jieħdu l- plaċebo.
Elderly Major Depressive Episodes:
5 Anzjani Episodji Depressivi Maġġuri:
Data on the use of XERISTAR 120mg in elderly patients with major depressive disorders are limited.
L- informazzjoni dwar l- użu ta ’ XERISTAR 120 mg f’ pazjenti anzjani b’ mard depressiv maġġuri hija limitata.
Data on the use of XERISTAR in elderly patients with generalised anxiety disorder are limited.
Huwa limitat it- tagħrif dwar l- użu ta ’ XERISTAR f’ pazjenti anzjani b’ disturb ta ’ ansjetà ġeneralizzata.
Sucrose XERISTAR hard gastro-resistant capsules contain sucrose.
Sucrose XERISTAR kapsuli gastro- reżistenti ibsin fihom sucrose.
Consequently, caution is advised when XERISTAR is taken in combination with other centrally acting medicinal products and substances including alcohol and sedative medicinal products (e. g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Konsegwentement, huwa rrakkomandat li XERISTAR jingħata b’ attenzjoni meta jittieħed flimkien ma ’ prodotti mediċinali u sustanzi li jaħdmu b’ mod ċentrali fosthom alkoħol u prodotti mediċinali sedattivi (eż. benzodiazepines, morfinomimetiċi, anti- psikotiċi, phenobarbital, anti- istamini sedattivi).
Monoamine Oxidase Inhibitors (MAOIs): due to the risk of serotonin syndrome, XERISTAR should not be used in combination with nonselective irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
Inibituri ta ’ Monoamine Oxidase (MAOIs): minħabba r- riskju ta ’ sindromu ta ’ serotonin, XERISTAR 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 XERISTAR 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 XERISTAR qabel jinbeda xi MAOI (ara sezzjoni 4. 3).
However, the concomitant use of XERISTAR with selective, reversible MAOIs is not recommended (see section 4.4).
Madankollu, mhux irrakkomandat l- użu fl- istess ħin ta ’ XERISTAR ma ’ MAOIs riversibbli u selettivi (ara sezzjoni 4. 4).
Caution is advisable if XERISTAR is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, St John’ s wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan.
John’ s wort (Hypericum perforatum), venlafaxine jew triptans, tramadol, pethidine u tryptophan.
Effect of duloxetine on other medicinal products Medicinal products metabolised by CYP1A2:
6 Effett ta ’ duloxetine fuq prodotti mediċinali oħra Prodotti mediċinali li jiġu metabolizzati minn CYP1A2:
Caution is advised if XERISTAR is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as 6 nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Hu rrakkomandat li XERISTAR jingħata b’ attenzjoni jekk jittieħed flimkien ma ’ prodotti mediċinali li huma fil- biċċa l- kbira metabolizzati min CYP2D6 (risperidone, anti - depressivi triċikliċi [TCAs] bħal nortriptyline, amitriptyline, u imipramine) speċjalment jekk għandhom indiċi terapewtiku dejjaq (bħal flecainide, propafenone u metoprolol).
Therefore XERISTAR should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Għaldaqstant, XERISTAR m’ għandux jingħata flimkien ma ’ inibituri qawwija ta ’ CYP1A2 bħal fluvoxamine (ara sezzjoni 4. 3).
XERISTAR should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
XERISTAR għandu jintuża fit- tqala biss jekk is- siwi potenzjali jiġġustifika r- riskju potenzjali lill- fetu.
As the safety of duloxetine in infants is not known, the use of XERISTAR while breast-feeding is not recommended.
Billi mhix magħrufa s - sigurtà ta ’ duloxetine fit- trabi, l- użu ta ’ XERISTAR waqt it- treddigħ mhux rakkomandat.
XERISTAR may be associated with sedation and dizziness.
XERISTAR jista ’ jkun assoċjat ma ’ effett sedattiv u ma ’ sturdament.
7 The most commonly reported adverse reactions in patients treated with XERISTAR were nausea, headache, dry mouth, somnolence, fatigue, insomnia, dizziness and constipation.
L- aktar reazzjonijiet avversi komunement irrappurtati f’ pazjenti fuq kura ta ’ XERISTAR kienu dardir, uġigħ ta ’ ras, ħalq xott, ngħas, għeja, insomnja, sturdament u stitikezza.
Gastrointestinal
Disturbi gastro- intestinali
Disorders
Riħa ħażina
Nausea (25.2%) Dry mouth (13.8%) Constipation (10.3%)
Emorraġija
Diarrhoea Vomiting Dyspepsia Flatulence
Tqalligħ
Gastroenteritis Eructation Gastritis Stomatitis
Dijarea
Renals and Urinary Disorders
gastro- intestinali
Urinary
(25. 2%)
8
Rimettar
Urine odour
Tifwiq
Very common
Ematokeżja
Common
Ħalq xott (13. 8%) Stitikezza (10. 3%)
Uncommon
Dispepsja Gass fl- istonku
Rare
Gastrite Stomatite
Very Rare
Disturbi fil- kliewi u fis- sistema urinarja
Frequency not known
Żamma ta ’ l - awrina Disurja Eżitazzjoni
Retention Dysuria Urinary hesitation Nocturia Polyuria Urine flow decreased
Riħa mhux normali ta ’ l - awrina
abnormal
9 biex tagħmel l - awrina Awrinazzjoni eċċessiva matul il- lejl Tagħmel ħafna awrina Il- fluss ta ’ l - awrina jonqos
General Disorders and Administration Site Conditions Fatigue (10.8%)
10 Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Għeja (10. 8%)
Feeling abnormal Feeling cold Thirst Malaise Feeling hot
Ma tħossokx normali Tħoss il - bard Għatx Tħossok mitluq Tħoss is - sħana Problemi fil- mod ta ’ kif timxi
9
Disturbi fis- sistema immuni Disturbi fil- fwied u fil- marrara
Common
Reazzjoni anafilattika
Uncommon
Enzimi tal - fwied għoljin (ALT, AST, alkaline phosphatase Epatite3 Dannu akut fil- fwied)
Rare
Suffejra Insuffiċjenza epatika
Very Rare
Disturbi fis- sistema riproduttiva u fis- sider
Frequency not known
Il- funzjoni erettili ma
Gait disturbance
Sintomi ta ’ menopawża
Immune system disorders Hepato-biliary disorders
11 Disturbi psikjatriċi Insomnja (10. 4%)
Hyper- sensitivity disorder
Aġitazzjoni Tnaqqis fil -
Anaphylactic reaction
Tgħażżiż tas - snien
Elevated liver enzymes (ALT, AST, alkaline phosphatase) Hepatitis3 Acute liver injury
Manija Alluċinazzjonijiet Aggressjoni u
Jaundice Hepatic failure
Formazzjoni ta ’ ideat suwiċidali5
Reproductive System and Breast Disorders
involontarju
Erectile dysfunction
Diżorjentament rabja
Ejaculation disorder Ejaculation delayed Sexual dysfunction Gynaecologica l haemorrhage
Ansjetà
Menopausal symptoms
Imġiba suwiċidali5
Agitation Libido decreased Anxiety Orgasm abnormal Abnormal dreams Sleep disorder
Orgażmu mhux normali Ħolm mhux normali Problemi fl - irqad
Bruxism Disorientation Apathy
Apatija
It is therefore advised that when duloxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see
Għaldaqstant, huwa rrakkomandat li meta l- kura b’ duloxetine m’ għadhiex mehtieġa, is- sospensjoni għandha tkun gradwali billi d- doża tiġi mnaqqas bil- ftit il- ftit (ara sezzjonijiet 4. 2 u 4. 4).
Cases of overdoses, alone or in combination with other drugs, with duloxetine doses of 4800mg were reported.
Ġew irrappurtati każijiet ta ’ doża eċċessiva b’ dożi ta ’ duloxetine ta ’ 4800 mgmg, meta mgħoti waħdu jew flimkien ma ’ prodotti mediċinali oħra.
Signs and symptoms of overdose (duloxetine alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures,, vomiting andtachycardia.
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.
XERISTAR was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Episodji Depressivi Maġġuri XERISTAR ġie studjat f’ programm kliniku li kien jinvolvi 3, 158 pazjent (1, 285 pazjenti- snin ta ’ espożizzjoni) li laħaq il- kriterji DSM- IV għal depressjoni maġġuri.
The efficacy of XERISTAR at the recommended dose of 60 mg once a day was demonstrated in three out of three randomized, double- blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
L- effikaċja ta ’ XERISTAR fid - doża rakkomandata ta ’ 60mg darba kuljum ġiet ppruvata fit- tlieta minn tliet studji li saru f’ sitwazzjonijiet akuti, b’ doża fissa, randomised, double- blind u kkontrollati bil- plaċebo f’ pazjenti li mhumiex residenti ġo sptar u li għandhom mard depressiv maġġuri.
Overall, XERISTAR’ s efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomized, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
B’ mod ġenerali, l- effikaċja ta ’ XERISTAR ġiet ipprovata f’ dożaġġi ta ’ kuljum ta ’ bejn 60 u 120 mg f’ total ta ’ ħamsa minn seba ’ studji li saru f’ sitwazzjonijiet akuti, b’ doża fissa, randomised, double- blind u kkontrollati bil- plaċebo f’ pazjenti li mhumiex residenti ġo sptar u li għandhom mard depressiv maġġuri.
XERISTAR demonstrated statistical superiority over placebo as measured by improvement in the 17- 11 item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
XERISTAR statistikament wera superjorità fuq plaċebo kkalkulat skond it- titjib fil- punteġġ totali tal - Hamilton Depression Rating Scale( HAM- D) bi 17- il kriterju (li jinkludu kemm sintomi ta ’ depressjoni emozzjonali kif ukoll dawk somatiċi).
Response and remission rates were also statistically significantly higher with XERISTAR compared with placebo.
Anki r- rati ta ’ rispons u remissjoni kienu b’ mod statistiku sinifikament ogħla b’ XERISTAR meta mqabbla ma ’ plaċebo.
In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label XERISTAR 60 mg once daily were randomised to either XERISTAR 60 mg once daily or placebo for a further 6-months.
Fi studju ta ’ prevenzjoni ta ’ rikaduta, pazjenti li rrispondew għal 12- il ġimgħa ta ’ kura akuta b’ open - label XERISTAR 60mg darba kuljum, kienu b’ mod arbitrarju mgħotija jew XERISTAR 60mg darba kuljum jew plaċebo għal 6 xhur oħra.
XERISTAR 60 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.004) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
XERISTAR 60mg darba kuljum wera superjorità statistikament sinifikanti meta mqabbel ma ’ plaċebo (p=0. 004) f’ daq li għandu x’ jaqsam ir- riżultat primarju, il - prevenzjoni ta ’ rikaduta depressiva, ikkalkulata permezz taż- żmien li għadda sar- rikaduta.
The effect of XERISTAR 60 mg once a day in elderly depressed patients (≥ 65 years) was specifically examined in a study that showed a statistically significative difference in the reduction of the HAMD17 score for duloxetine-treated patients compared to placebo.
L- effett ta ’ XERISTAR 60mg darba kuljum, f’ pazjenti anzjani b’ depressjoni (> 65 sena) ġie speċifikament eżaminat f’ studju li wera differenza statistikament sinifikanti fit- tnaqqis tal- punteġġ ta ’ l- HAMD 17 għal pazjenti kkurati b’ duloxetine meta mqabbel ma ’ plaċebo.
Tolerability of XERISTAR 60 mg once day in elderly patients was comparable to that seen in the younger adults.
It- tollerabilità ta ’ XERISTAR 60mg darba kuljum f’ pazjenti anzjani kien simili għal dak osservat fl- adulti iżgħar.
Generalised Anxiety Disorder XERISTAR demonstrated statistically significant superiority over placebo in five out of five studies including four randomized, double-blind, placebo-controlled acute studies and a relapse prevention study in adult patients with generalised anxiety disorder.
Distrub ta ’ Ansjetà Ġeneralizzata XERISTAR wera superjorità statistikament sinifikanti fuq plaċebo f’ kull wieħed minn ħames studji li jinkludu erba ’ studji magħmula f’ sitwazzjonijiet akuti, ikontrollati bi plaċebo, double- blind u randomized u studju ta ’ prevenzjoni ta ’ rikaduta f’ pazjenti adulti b’ disturb ta ’ ansjetà ġeneralizzata.
XERISTAR demonstrated statistically significant superiority over placebo as measured by improvement in the Hamilton Anxiety Scale (HAM-A) total score and by the Sheehan Disability Scale (SDS) global functional impairment score.
13 XERISTAR wera superjorità statistikament sinifikanti fuq plaċebo kemm meta kkalkulat skond it - titjib fil- punteġġ totali tal- Hamilton Anxiety Scale( HAM- A) u kemm skond il- punteġġ ta ’ indeboliment funzjonali globali tas- Sheehan Disability Scale (SDS).
Response and remission rates were also higher with XERISTAR compared to placebo.
Ir- rati ta ’ rispons u ta ’ remissjoni kienu wkoll ogħla b ’ XERISTAR meta mqabbla ma ’ plaċebo.
XERISTAR showed comparable efficacy results to venlafaxine in terms of improvements on the HAM-A total score.
XERISTAR wera riżultati ta ’ effikaċja simili għal venlafaxine f’ dak li għandu x’ jaqsam titjib fil- punteġġ totali tal- HAM- A.
In a relapse prevention study, patients responding to 6 months of acute treatment with open-label XERISTAR were randomised to either XERISTAR or placebo for further 6-months.
F’ studju ta ’ prevenzjoni ta ’ rikaduta, pazjenti li kienu qed jirrispondu għal 6 xhur ta ’ kura b’ mod akut b ’ XERISTAR open- label, ġew mogħtija b’ mod arbitrarju jew XERISTAR jew plaċebo għal 6 xhur oħra.
XERISTAR 60 mg to 120 mg once daily demonstrated statistically significant superiority compared to placebo (p < 0.001) on the prevention of relapse, as measured by time to relapse.
XERISTAR 60 mg sa 120 mg kuljum wera superjorità statistikament sinifikanti meta mqabbel ma ’ plaċebo (p < 0. 001) fil- prevenzjoni ta ’ rikaduta, ikkalkulata skond iż- żmien għar- rikaduta.
The incidence of relapse during the 6-months double-blind follow-up period was 14% for XERISTAR and 42% for placebo.
L - inċidenza ta ’ rikaduta waqt il- perijodu miżjud ta ’ 6 xhur li kien double- blind kien ta ’ 14% b ’ XERISTAR u ta ’ 42% bi plaċebo.
The efficacy of XERISTAR 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 ’ XERISTAR bħala kura għall- uġigħ newropatiku tad- dijabete kien stabbilit f’ żewġ studji ta ’ 12- il ġimgħa, b’ dożi fissi, ikkontrollati bil- plaċebo, randomised u double- blind f’ adulti (22 sa 88 sena) li kellhom uġigħ newropatiku tad- dijabete għallinqas għal 6 xhur.
In both studies, XERISTAR 60 mg once daily and 60 mg twice daily significantly reduced pain compared with placebo.
Fiż- żewġ studji, XERISTAR 60mg darba kuljum u 60mg darbtejn kuljum naqqsu b’ mod sinifikanti l - uġigħ meta mqabbla ma ’ plaċebo.
12 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 bil- plaċebo m’ hemmx tagħrif konklużiv dwar l- effikaċja ta ’ kura għal iżjed minn 12- il ġimgħa.
13 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
XERISTAR 30 mg is available in packs of 7 and 28 capsules.
XERISTAR 30mg issibu f’ pakketti ta ’ 7 u 28 kapsula
173 D-55216 Ingelheim am Rhein, Germany.
173 D- 55216 Ingelheim am Rhein, Il - Ġermanja.
XERISTAR 60 mg hard gastro-resistant capsules
XERISTAR 60 mg kapsuli gastro- reżistenti ibsin
The XERISTAR 60 mg capsule has an opaque green body, imprinted with ‘ 60 mg’ and an opaque blue cap, imprinted with ‘ 9542’.
Il- kapsula ta ’ XERISTAR 60 mg għandha l- parti prinċipali tagħha aħdar opak, stampat b ’ ‘ 60 mg ’ u għatu blu opak, stampat b ’ ‘ 9542 ’.
Mania and seizures XERISTAR should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija u aċċessjonijiet XERISTAR għandu jintuża b’ attenzjoni f’ pazjenti b’ storja ta ’ manija jew b’ dijanjosi ta ’ mard bipolari, u/ jew aċċessjonijiet.
Data on the use of XERISTAR 120mg in elderly patients with major depressive disorders are limited..
L- informazzjoni dwar l- użu ta ’ XERISTAR 120 mg f’ pazjenti anzjani b’ mard depressiv maġġuri hija limitata.
Caution is advised if XERISTAR is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as 20 nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Hu rrakkomandat li XERISTAR jingħata b’ attenzjoni jekk jittieħed flimkien ma ’ prodotti mediċinali li huma fil- biċċa l- kbira metabolizzati min CYP2D6 (risperidone, anti - depressivi triċikliċi [TCAs] bħal nortriptyline, amitriptyline, u imipramine) speċjalment jekk għandhom indiċi terapewtiku dejjaq (bħal flecainide, propafenone u metoprolol).
21 The most commonly reported adverse reactions in patients treated with XERISTAR were nausea, headache, dry mouth, somnolence, fatigue, insomnia, dizziness and constipation.
L- aktar reazzjonijiet avversi komunement irrappurtati f’ pazjenti fuq kura ta ’ XERISTAR kienu dardir, uġigħ ta ’ ras, ħalq xott, ngħas, għeja, insomnja, sturdament u stitikezza.
22 Very common
gastro- intestinali
Malaise Feeling hot Gait disturbance
Problemi ta ’ eġakulazzjoni
Immune system disorders Hepato-biliary disorders
27 Disturbi psikjatriċi Insomnja (10. 4%)
Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting, however, in
Ġeneralment, fl- SSRIs u fl- SNRIs, dawn l- avveniment jkunu minn ħfief sa moderati u ma jiżdidux, iżda f’ xi pazjenti jistgħu jkunu qawwija u/ jew jieħdu fit- tul.
Signs and symptoms of overdose (duloxetine alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures,, vomiting andtachycardia.
Is- sinjali u s- sintomi ta ’ doża eċċessiva (duloxetine waħdu jew b’ taħlit ta ’ prodotti mediċinali) jinkludu ngħas, koma, sindromu ta ’ serotonin, rimettar u takikardija.
Overall, XERISTAR’ s efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomized, double-blind, placebo-controlled, fixed dose acute studies in adult 25 outpatients with major depressive disorder.
B’ mod ġenerali, l- effikaċja ta ’ XERISTAR ġiet ipprovata f’ dożaġġi ta ’ kuljum ta ’ bejn 60 u 120 mg f’ total ta ’ ħamsa minn seba ’ studji li saru f’ sitwazzjonijiet akuti, b’ doża fissa, randomised, double- blind u kkontrollati bil- plaċebo f’ pazjenti li mhumiex residenti ġo sptar u li għandhom mard depressiv maġġuri.
XERISTAR demonstrated statistical superiority over placebo as measured by improvement in the 17- item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
XERISTAR statistikament wera superjorità fuq plaċebo ikkalkulat skond it- titjib fil- punteġġ totali tal - Hamilton Depression Rating Scale( HAM- D) bi 17- il kriterju (li jinkludu kemm sintomi ta ’ depressjoni emozzjonali kif ukoll dawk somatiċi).
XERISTAR demonstrated statistically significant superiority over placebo as measured by improvement in the Hamilton Anxiety Scale (HAM-A) total score and by the Sheehan Disability Scale (SDS) global functional impairment score.
29 XERISTAR wera superjorità statistikament sinifikanti fuq plaċebo kemm meta kkalkulat skond it - titjib fil- punteġġ totali tal- Hamilton Anxiety Scale( HAM- A) u kemm skond il- punteġġ ta ’ indeboliment funzjonali globali tas- Sheehan Disability Scale (SDS).
Clinical response rates in patients experiencing somnolence were 60% on duloxetine and
Ir- rati ta ’ rispons kliniku f’ pazjenti li qabadhom in- ngħas kien ta ’ 60% għal dawk fuq duloxetine u ta ’ 30% għal dawk fuq plaċebo.
The pharmacokinetics of duloxetine in patients who are poor metabolisers with respect to CYP2D6 has not been specifically investigated.
30 metabolizzaturi dgħajjfa fir- rigward ta ’ CYP2D6 ma kinitx investigata b’ mod speċifiku.
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.
XERISTAR 60 mg is available in packs of 28, 56, 84, 98, 100 (Each pack contains 5 cartons of 20 capsules) and 500 capsules (Each pack contains 25 cartons of 20 capsules).
XERISTAR 60mg issibu f’ pakketti ta ’ 28, 56, 84, 98, 100 (Kull pakkett fih 5 kartuni ta ’ 20 kapsula) u 500 kapsula (Kull pakkett fih 25 kartuna ta ’ 20 kapsula).
Duloxetine
XERISTAR 30mg, kapsuli gastro- reżistenti ibsin Duloxetine
7 hard gastro-resistant capsules 28 hard gastro-resistant capsules
7 kapsuli gastro- reżistenti ibsin 28 kapsula gastro- reżistenti iebsa
Lot.:
Lott:
XERISTAR 30 mg
XERISTAR 30mg
35 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 30 mg hard gastro-resistant capsules
39 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ FUQ IL- FOLJI JEW L- ISTRIXXI
XERISTAR 30 mg hard gastro-resistant capsules Duloxetine
XERISTAR 30mg kapsuli gastro- reżistenti ibsin Duloxetine
Duloxetine
XERISTAR 60mg, kapsuli gastro- reżistenti ibsin Duloxetine
Contains sucrose See leaflet for further information
Fih is- sucrose Ara l- fuljett għal aktar tagħrif
Do not store above 30°C 37 10.
Taħżinx f’ temperatura ’ l fuq minn 30°C
EU/ 1/ 04/ 297/ 002-005 EU/ 1/ 04/ 297/ 007 EU/ 1/ 04/ 297/ 008
EU/ 1/ 04/ 297/ 002 - 005 EU/ 1/ 04/ 297/ 007 EU/ 1/ 04/ 297/ 008
XERISTAR 60 mg
XERISTAR 60mg
38 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 60 mg hard gastro-resistant capsules
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW L- ISTRIXXI
XERISTAR 60 mg hard gastro-resistant capsules Duloxetine
XERISTAR 60mg kapsuli gastro- reżistenti ibsin Duloxetine
XERISTAR 30 mg hard gastro-resistant capsules XERISTAR 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
XERISTAR 30 mg kapsuli gastro- reżistenti ibsin XERISTAR 60 mg kapsuli gastro- reżistenti ibsin Duloxetine (bħala hydrochloride)
What XERISTAR is and what it is used for 2.
X’ inhu XERISTAR u għalxiex jintuża 2.
Before you take XERISTAR 3.
Qabel ma tieħu XERISTAR 3.
How to take XERISTAR 4.
Kif għandek tieħu XERISTAR 4.
Possible side effects 5 How to store XERISTAR 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen XERISTAR 6.
WHAT XERISTAR IS AND WHAT IT IS USED FOR
X’ INHU XERISTAR U GĦALXIEX JINTUŻA
XERISTAR increases the levels of serotonin and norepinephrine in the nervous system.
XERISTAR jżid il- livelli ta ’ serotonin u ta ’ norepinephrine fis- sistema nervuża.
You have been given XERISTAR to treat either 1) depression, 2) generalised anxiety disorder (chronic feeling of anxiety or nervousness) or 3) a condition called diabetic neuropathic pain.
Ġejt mogħti XERISTAR bħala kura ta ’ jew 1) d- depressjoni, 2) disturb ta ’ l- ansjetà ġeneralizzata (sensazzjoni kronika ta ’ ansjetà jew nervożità) jew 3) kundizzjoni li tissejjaħ uġigħ newropatiku tad - dijabete.
XERISTAR starts to work in most people with depression or anxiety within two weeks of starting treatment.
Fil- parti l- kbira tan- nies li jbatu mid- depressjoni jew mill- ansjetà XERISTAR jibda jaħdem fi żmien ħmistax minn mindu tibda l- kura.
Your doctor may continue to give you XERISTAR when you are feeling better to prevent your depression or anxiety from returning.
It- tabib tiegħek jista ’ jkompli jagħtik XERISTAR meta tkun qiegħed tħossok aħjar sabiex jimpedixxi milli tirritorna d- depressjoni jew l- ansjetà.
The effect of XERISTAR may be noticeable in many patients with diabetic neuropathic pain within 1 week of treatment.
F’ ħafna pazjenti b’ uġigħ newropatiku tad- dijabete, l- effett ta ’ XERISTAR jista ’ jidher fi żmien ġimgħa minn mindu tibda l- kura..
BEFORE YOU TAKE XERISTAR
QABEL MA TIEĦU XERISTAR
Do not take XERISTAR − If you are allergic (hypersensitive) to duloxetine or any of the other ingredients of XERISTAR. − If you are taking or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) (see also below in section: ‘ Taking other medicines’). − If you have liver disease. − If you have severe kidney disease. − If you are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacine which are used to treat some infections. − If you are taking other medicines containing duloxetine. − If you suffer from uncontrolled high blood pressure.
oħra kontra d- depressjoni msejħa inibituri ta ’ monoamino oxidase (MAOI) (ara aktar ’ l isfel fis - sezzjoni: ‘ Meta tieħu medicini oħra ’)
41 Take special care with XERISTAR The following are reasons why XERISTAR may not be suitable for you.
dipressjoni,, ciprofloxacine jew enoxacine li jintużaw għall- kura ta ’ xi infezzjonijiet.
- If yYou have high blood pressure.
- Jekk ghandek pressjoni għolja tad- demm
- You are considering stopping XERISTAR (see section 3).
- Qiegħed/ qiegħda taħseb biex twaqqaf XERISTAR (ara sezzjoni 3)
XERISTAR may cause a sensation of restlessness or an inability to sit or stand still.
XERISTAR jista ’ jikkawża sensazzjoni ta ’ irrekwitezza jew l- inkapaċità li wieħed joqgħod mingħajr ma jiċċaqlaq.
Use in children and adolescents under 18 years of age XERISTAR should normally not be used for children and adolescents under 18 years.
Użu fit- tfal jew adolexxenti taħt it- tmintax- il sena Normalment XERISTAR m’ għandux jintuza fit- tfal u f’ adolexxenti taħt it- tmintax- il sena.
Despite this, your doctor may prescribe XERISTAR for patients under 18 because he/ she decides that this is in their best interests.
Madankollu, it- tabib tiegħek jista ’ jordna XERISTAR lil pazjenti taħt it- 18 għax jiddeċiedi/ tiddeċiedi li huwa fl- aħjar interess għalihom.
If your doctor has prescribed XERISTAR for a patient under 18 and you want to discuss this, please go back to your doctor.
Jekk it- tabib ordna XERISTAR għal pazjent taħt it- 18 u tixtieq xi spjegazzjonijiet, jekk jogħġbok erġa ’ mur għand it- tabib tiegħek.
You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking XERISTAR.
Għandek tavża lit- tabib tiegħek jekk jiżviluppaw jew jiggravaw xi sintomi li ssemmew hawn fuq, meta pazjenti taħt it- 18 ikunu qegħdin jieħdu XERISTAR.
Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of XERISTAR in this age group have not yet been demonstrated.
Barra minn hekk, f’ dan il- grupp ta ’ età, l- effetti tas- sigurtà fit- tul għadhom ma ġewx ippruvati, f’ dak li għandu x’ jaqsam l- iżvilupp tal- ġisem, il - maturazzjoni, u l- iżvilupp kemm konjittiv kif ukoll tal- mod ta ’ komportament.
The main ingredient of XERISTAR, duloxetine, is used in other medicines for other conditions (diabetic neuropathic pain, depression, anxiety and urinary incontinence).
Is- sustanza l- aktar importanti f’ XERISTAR, duloxetine, hija użata f’ medicini oħra għal kundizzjonijiet oħra (uġigħ newropatiku tad- dijabete,
Your doctor should decide whether you can take XERISTAR with other medicines.
It- tabib tiegħek irid jiddeċiedi jekk għandekx tieħu XERISTAR ma ’ mediċini oħra.
42 Monoamine Oxidase Inhibitors (MAOIs):
Inibituri ta ’ Monoamine Oxidase( MAOI):
You should not take XERISTAR if you are taking, or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
M’ għandekx tieħu XERISTAR jekk qiegħed/ qiegħda tieħu jew ħadt recentament f’ dawn l- aħħar 14- il ġurnata, xi mediċina oħra kontra d- depressjoni msejħa inibitur ta ’ monamino oxidase.
Taking a MAOI together with many prescription medicines, including XERISTAR, can cause serious or even life-threatening side effects.
It- teħid ta 'xi MAOI flimkien ma' ħafna mill- mediċini mgħotija bir - riċetta, inkluż XERISTAR, 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 XERISTAR.
Għandek tistenna ta 'l- anqas 14- il ġurnata wara li tkun waqaft tieħu xi MAOI biex tkun tista' tieħu XERISTAR.
Also, you need to wait at least 5 days after you stop taking XERISTAR before you take a MAOI.
Għandek bżonn ukoll tistenna ta 'l- anqas 5 ijiem wara li tieqaf tieħu XERISTAR biex tkun tista' tieħu xi MAOI.
These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with XERISTAR, you should see your doctor.
Dawn il- mediċini jżidu r- riskju ta ’ effetti sekondarji; jekk ikollok xi sintomu li mhux mistenni meta qiegħed/ qiegħda tieħu xi mediċini minn dawn flimkien ma ’ XERISTAR, għandek tmur għand it- tabib tiegħek.
Taking XERISTAR with food and drink XERISTAR may be taken with or without food.
Meta tieħu XERISTAR ma ’ l- ikel u max- xorb XERISTAR jista 'jittieħed ma' l- ikel jew fuq stonku vojt.
Care should be taken if you drink alcohol while you are being treated with XERISTAR.
Għandek toqgħod attent jekk tixrob l- alkoħol waqt li tkun qiegħed/ qiegħda tirċievi l- kura b’ XERISTAR.
You should use XERISTAR only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Tqala u Treddigħ Għid lit- tabib tiegħek jekk issir tqila jew qiegħda tipprova ssir tqila, waqt li qiegħda tieħu XERISTAR. Ghandek biss tuża XERISTAR wara li tkun iddiskutejt mat- tabib tiegħek il- benefiċċji possibbli u kull riskju possibbli għat- tarbija li għada ma twelditx.
The use of XERISTAR while breastfeeding is not recommended.
Mhuwiex rakkomandat l- użu ta ’ XERISTAR waqt it- treddigħ.
Do not drive or use any tools or machines until you know how XERISTAR affects you.
Sewqan u tħaddim ta ’ magni Issuqx u tagħmilx użu minn għodda jew tħaddem magni sakemm tkun taf b’ liema mod jaffettwak XERISTAR.
Important information about some of the ingredients of XERISTAR XERISTAR contains sucrose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ XERISTAR XERISTAR fih s- sucrose.
HOW TO TAKE XERISTAR
KIF GĦANDEK TIEĦU XERISTAR
Always take XERISTAR exactly as your doctor has told you.
Dejjem għandek tieħu XERISTAR skond il- parir tat- tabib.
The usual dose of XERISTAR is one capsule (60 mg duloxetine) once a day, but your doctor will prescribe the dose that is right for you.
47 Id- doża ta ’ XERISTAR li ssoltu tingħata hija ta ’ kapsula waħda (60 mg duloxetine) darba kuljum, iżda it- tabib jiktiblek ricetta skond id- doza li tgħodd għalik.
The usual starting dose of XERISTAR is 30 mg once a day after which most patients will receive 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Normalment id- doża inizjali ta ’ XERISTAR hi ta ’ 30 mg darba kuljum, iżda maż- żmien il- parti l- kbira tal- pazjenti jibdew jirċievu 60 mg darba kuljum, madankollu t- tabib jiktiblek ricetta skond id- doza li tgħodd għalik.
The dose may be adjusted up to 120 mg a day based on your response to XERISTAR.
Id- doża tista ’ tiġi aġġustata ’ l fuq sa 120 mg skond ir- rispons tiegħek għal XERISTAR.
43 XERISTAR is for oral use.
XERISTAR għandu jittieħed mill- ħalq.
To help you remember to take XERISTAR, you may find it easier to take it at the same times every day.
Biex tiftakar tieħu XERISTAR, tista ’ ssibha aktar faċli li teħodha kuljum fl- istess ħinijiet.
Do not stop taking XERISTAR without talking to your doctor.
Tkellem mat- tabib tiegħek dwar kemm trid iddum tieħu XERISTAR. Tieqafx tieħu XERISTAR mingħajr ma tkellem lit- tabib tiegħek.
If you take more XERISTAR than you should Call your doctor or pharmacist immediately if you take more than the amount of XERISTAR prescribed by your doctor.
Ċempel immedjatament lit- tabib jew lill- ispiżjar tiegħek jekk tieħu aktar ammont ta 'XERISTAR minn kemm ordnalek it- tabib.
If you forget to take XERISTAR Do not take a double dose to make up for a forgotten dose.
Jekk tinsa tieħu XERISTAR M’ għandekx tieħu doża doppja biex tpatti għal doża li tkun insejt tieħu.
Do not take more than the daily amount of XERISTAR that has been prescribed for you in one day.
Tieħux iżjed mill- ammont ta 'XERISTAR li ordnalek it- tabib għal ġurnata waħda.
If you stop taking XERISTAR Do not stop taking your capsules without the advice of your doctor even if you feel better.
Jekk tieqaf tieħu XERISTAR Tieqafx tieħu l- kapsuli tiegħek mingħajr ma tieħu l- parir tat- tabib anki jekk tħossok aħjar.
If your doctor thinks that you no longer need XERISTAR he will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Jekk it- tabib tiegħek jaħseb li m' għadx għandek bżonn tieħu XERISTAR huwa se jgħidlek biex tnaqqas id- doża fuq perijodu ta ’ għallinqas ġimgħatejn qabel ma twaqqaf għal kollox il- kura.
Some patients who stop taking XERISTAR suddenly have had symptoms such as dizziness, fatigue, tingling feelings like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), tremor (shakiness), headaches, feeling irritable, diarrhoea, excessive sweating or vertigo.
Xi pazjenti li waqqfu jieħdu XERISTAR f' daqqa kellhom sintomi bħal sturdament, għeja, sensazzjonijiet ta ’ tniggiż, problemi ta ’ irqad( ħolm stramb, ħmar il- lejl, ma tkunx tista ’ torqod), iħossuhom irrekweti u aġitati, iħossuhom ansjużi, iħossuhom ħażin (dardir) jew jgħamillhom ħażin (rimettar), tregħid (ċaqliq ripetut) uġigħ ta 'ras, iħossuhom irritabbli, dijarea, għaraq esaġerat jew vertigo.
Like all medicines, XERISTAR can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, XERISTAR jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects (these can affect from 1 to 10 users in 100 patients treated) • Tiredness, trouble sleeping, anxiety, feeling agitated or having abnormal dreams. • Tremor or numbness, including numbness or tingling of the skin. • Diarrhoea, being sick (vomiting), heartburn, breaking wind, stomach pain. • Tinnitus (perception of sound in the ear when there is no external sound). • Blurred eyesight. • Feeling the heart pumping in the chest, flushing, increased sweating, night sweats • Problems getting an erection, less sex drive. • (Itchy) rash. • Muscle pain, muscle tightness, muscle spasm. • Increased yawning. • Lack of appetite, weight loss.
Effetti sekondarji komuni (dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn kull 100 pazjent ikkurat) • Ħedla, diffikultà biex torqod, ansjetà, tħossok aġitat u jkollok ħolm mhux tas- soltu. • Rogħda jew tirżiħ, inkluż it- tirżiħ jew tnemnin tal- ġilda
Uncommon side effects (these can affect from 1 to 10 users in 1,000 patients treated) • Throat inflammation. • Feeling disorientated, feeling sleepy, lack of motivation.
48 • Dijarea, tħossok ma tiflaħx (rimettar), ħruq ta ’ l- istonku, tgħaddi l- arja, uġigħ fl- istonku. • Tinnitus (is- sensazzjoni ta ’ ħsejjes fil- widnejn meta m’ hemm ebda ħoss madwarek) • Vista mċajpra • Tħoss il- qalb tħabbat f’ sidrek, ħmura fil- wiċċ, tegħreq iżjed, tegħreq matul il- lejl. • Problemi biex ikollok erezzjoni, tnaqqis fil- ħajra għas- sess. • Raxx (bil- ħaqq) • Uġigħ fil- muskoli, riġidità fil- muskoli, spażmu fil- muskolu. • Tittewweb iżjed mis- soltu. • Imurlek l- aptit, tnaqqis fil- piż.
44 • Tasting things differently than usual, disturbance in attention, stiffness, spasms and involuntary movements of the muscles, muscle twitching, abnormal manner of walking. • Poor sleep quality • Burping, indigestion, gastroenteritis • Vertigo, ear pain. • Inflammation of the liver that may cause abdominal pain • Large pupils (the dark centre of the eye), visual disturbance. • Fast or irregular heart beat • Sexual problems, including changes in ejaculation, orgasm. • Abnormal periods, including heavy or prolonged periods. • Allergic reactions, increased tendency to bruise, blisters or sensitivity to sunlight • Increase in blood pressure, feeling cold in your fingers and/ or toes, feeling dizzy (particularly when standing up too quickly), cold sweats, shivering or fainting. • An increased level of sugar in the blood. • Need to pass more urine than normal, need to pass urine during the night, difficulty or inability to pass urine or having an urine flow decreased. • Grinding of teeth, feeling hot/ cold, thirst, throat tightness, nose bleeds. • Weight gain
Effetti sekondarji mhux komuni( dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn 1, 000 pazjent ikkurat) • Infjammazzjoni tal- gerżuma. • Tħossok diżorjentat, tħossok bi ngħas, nuqqas ta ’ motivazzjoni. • Ttiegħem l- affarijiet differenti mis- soltu, disturbi ta ’ attenzjoni, ebusija, spażmi u movimenti involontarji tal- muskoli, ġbid involontarju tal- muskoli, timxi b’ mod mhux normali. • Kwalità hażina ta ’ irqad • Tfewwiq, indiġestjoni, gastroenterite. • Vertigo, uġigħ fil- widnejn. • Infjammazzjoni tal- fwied li tista ’ tkun il- kawża ta ’ uġigħ addominali. • Il- ħabba ta ’ l- għajn tkun kbira (iċ- centru skur ta ’ l- għajnejn), disturbi fil- vista. • Tħabbit mgħaġġel jew irregolari tal- qalb. • Problemi sesswali, li jinkludu bdil fl- eġakulazzjoni jew fl- orgażmu, • Pirjids mhux tas- soltu, li jinkludu pirjids b’ ħafna demm jew li jdumu • Reazzjonijiet allerġiċi, tendenza ogħla li titbenġel, infafet jew sensittività għad- dawl tax- xemx. • Żieda fil- pressjoni tad- demm, tħoss is- swaba ’ ta ’ idejk jew/ u ta ’ saqajk kesħin, tħossok se tistordi (speċjalment meta tqum bil- wieqfa malajr wisq), tħoss l- għaraq ixoqq għalik, tregħid jew ħass ħażin. • Jiżdied il- livell taz- zokkor fid- demm • Il- bżonn li tgħaddi iżjed awrina mis- soltu, il- bżonn li tgħaddi l- awrina matul il- lejl, diffikultà jew inabbiltà biex tgħaddi l- awrina jew ikun hemm tnaqqis fil- fluss ta ’ l- awrina. • Tagħżiż tas- snien, tħossok sħun/ kiesaħ, għatxan, rassa fil- gerżuma, tinfaraġ. • Żieda fil- piż.
If any of the side effects gets serious, or if you notice any side effects not mentioned listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE XERISTAR
KIF TAĦŻEN XERISTAR
Do not use XERISTAR after the expiry date which is stated on the carton.
Tużax XERISTAR wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
What XERISTAR contains XERISTAR is available in two strengths:
X’ fih XERISTAR:
What XERISTAR looks like and contents of the pack XERISTAR is a hard gastro-resistant capsule Each capsule of XERISTAR contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Kull kapsula ta ’ XERISTAR fiha pritkuni ta ’ duloxetine hydrochloride b’ kisja sabiex tipproteġihom mill- aċtu ta ’ l- istonku.
XERISTAR is available in 2 strenghts:
XERISTAR huwa disponibbli f’ żewġ dożi:
XERISTAR 60 mg is available in packs of 28, 56, 84, 98, 100 and 500 capsules.
XERISTAR 30mg issibu f’ pakketti ta ’ 7 u 28 kapsula XERISTAR 60 mg issibu f’ pakketti ta ’ 28, 56, 84, 98, 100 u 500 kapsula.
173 D- 55216, Ingelheim am Rhein, Germany.
173 D- 55216, Ingelheim am Rhein, Il- Ġermanja.
What is Xigris?
X’ inhu Xigris?
Xigris is a powder in a vial, which is made up into a solution for infusion (drip into a vein).
Xigris huwa trab f’ kunjett, li jitħallat f’ soluzzjoni għal infużjoni (drip ġol- vina).
Xigris contains the active ingredient drotrecogin alfa (activated).
Xigris fih is- sustanza attiva drotrecogin alfa (attivata).
What is Xigris used for?
Għal x’ hiex jintuża Xigris?
Xigris is used in adult patients with severe sepsis, when bacteria get in the bloodstream and produce substances which are harmful (toxins).
Xigris jintuża f’ pazjenti adulti b’ sepsis serja, meta batterji jidħlu fin- nixxiegħa tad- demm fil- ġisem u jipproduċu sustanzi li huma ta ’ ħsara (tossini).
The toxins cause the patient ’ s organs to fail (heart, lungs, kidneys, etc).
It- tossini jikkaġunaw ħsara fl- organi tal- pazjent (qalb, pulmun, kliewi, eċċ.).
Xigris is used when the patient has two or more organs failing, in addition to best standard care (antibiotics, medicines to support the organs, use in a specialised unit, etc.).
Xigris jintuża meta pazjent ikollu żewġ organi jew aktar li ma jkunux qegħdin jaħdmu sewwa, flimkien ma ’ l- aħjar kura standard (antibijotiċi, mediċini ta ’ appoġġ għall- organi, użu f’ taqsima speċjalizzata, eċċ.).
It should be used mainly when it can be started within 24 hours of the organ failure.
Huwa għandu jintuża prinċipalment meta jkun jista ’ jinbeda fi żmien 24 siegħa minn meta l- organi ma jibqgħux jaħdmu sew.
Xigris is intended for short- term use.
Xigris huwa intenzjonat għal użu fuq perjodu ta ’ żmien qasir.
How is Xigris used?
Kif jintuża Xigris?
Xigris should be used by experienced doctors in institutions skilled in the care of patients with severe sepsis.
Xigris għandu jintuża minn tobba esperjenzati f’ istituzzjonijiet imħarrġa fil- kura ta ’ pazjenti b’ sepsis serja.
Xigris should be given by infusion into a vein.
Xigris għandu jingħata permezz ta ’ infużjoni ġo vina.
The recommended dose of Xigris is 24 micrograms per kilogram body weight per hour, given as a continuous infusion for 96 hours.
Id- doża irrakkomandata hija 24 mikrogramma kull kilogramma tal- piż tal- ġisem, kull siegħa, mogħtija bħala infużjoni kontinwa għal 96- il siegħa.
Administering Xigris using an infusion pump is the recommended way for ensuring that the infusion rates are well controlled.
L- amministrazzjoni ta ’ Xigris permezz ta ’ pompa ta ’ l- infużjoni hija l- mod irrakkomandat biex jiġi assigurat li r- rati ta ’ l- infużjoni jkunu ikkontrollati sewwa.