qanastek/EMEA-V3 huggingface dataset:
Some patients may benefit from starting treatment at a dose of 20 mg twice daily for two weeks before increasing to the recommended dose of 40 mg twice daily.
Xi pazjenti jistgħu jibbenefikaw billi jibdew il- kura b’ doża ta ’ 20 mg darbtejn kuljum għal ġimgħatejn qabel ma jżidu d- doża għal dik rakkomandata ta ’ 40 mg darbtejn kuljum.
However, limited data are available to support the efficacy of ARICLAIM 20 mg twice daily.
Madankollu, it- tagħrif disponibbli huwa limitat biex tkun aċċertata l- effikaċja ta ’ ARICLAIM 20 mg darbtejn kuljum.
The efficacy of ARICLAIM has not been evaluated for longer than 3 months in placebo-controlled studies.
L- effikaċja ta ’ ARICLAIM ma kinitx evalwata għal tul ta ’ żmien ta ’ aktar minn 3 xhur fi studji kliniċi kkontrollati bil- plaċebo.
Combining ARICLAIM with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone.
Jista ’ jkun aktar effettiv li tassoċja ARICLAIM ma ’ programm ta ’ eżerċizzji 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 tal- kura b’ ARICLAIM ikun hemm ukoll programm ta’ PFMT.
The therapeutic benefit should regularly (at least every three months) be reassessed.
2 Il- benefiċċju terapewtiku għandu jerġa ’ jiġi valutat regolarment (mill- anqas kull tliet xhur).
ARICLAIM should not be used in patients with liver disease resulting in hepatic impairment (see section 4.3).
Insuffiċjenza tal- fwied ARICLAIM m’ għandhux jintuża f’ pazjenti b’ mard tal- fwied li jwassal għal indeboliment tal- fwied (ara sezzjoni 4. 3).
ARICLAIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3).
ARICLAIM m’ għandux jiġi użat f’ pazjenti b’ indeboliment renali gravi (tneħħija tal- krejatinina < 30 ml/ min) (ara sezzjoni 4. 3)
When stopping treatment with ARICLAIM 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’ ARICLAIM 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).
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 d- doża preċedenti ordnata.
ARICLAIM should not be used in combination with nonselective, irreversible Monoamine Oxidase Inhibitors - MAOIs (see section 4.5).
ARICLAIM m’ għandux jiġi użat flimkien ma ’ Monoamine Oxidase Inhibitors irriversibbli u mhux selettivi – MAOIs (ara sezzjoni 4. 5).
ARICLAIM should not be used in combination with CYP1A2 inhibitors, like fluvoxamine, ciprofloxacin or enoxacine since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
ARICLAIM m’ għandux jiġi użat flimkien ma ’ inibituri ta ’ CYP1A2, bħal fluvoxamine, ciprofloxacin jew enoxacine peress li dan iwassal għal konċentrazzjonijiet elevati ta ’ duloxetine fil- plażma (ara sezzjoni 4. 5).
The initiation of treatment with ARICLAIM 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’ ARICLAIM f’ pazjenti bi pressjoni għolja mhux ikkontrollata li tista ’ tesponi l- pazjenti għal riskju potenzjali ta ’ kriżi ipertensiva (ara sezzjonijiet 4. 4 u 4. 8).
Mania and Seizures ARICLAIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija u aċċessjonijiet ARICLAIM għandu jiġi użat b’ attenzjoni f’ pazjenti b’ passat ta ’ manija jew b’ dijanjosi ta ’ mard bipolari, u/ jew aċċessjonijiet.
Use with antidepressants The use of ARICLAIM 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 ’ ARICLAIM 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)
3 St John’ s wort Undesirable effects may be more common during concomitant use of ARICLAIM and herbal preparations containing St John’ s wort (Hypericum perforatum).
3 St. John’ s wort L- effetti mhux mixtieqa jistgħu jkunu aktar komuni meta ARICLAIM jintuża fl- istess ħin ma ’ preparazzjonijiet magħmulin mill- ħxejjex li jkun fihom St. John’ s wort (Hypericum perforatum).
In a clinical trial adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with ARICLAIM 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 ’ ARICLAIM u 24% ta ’ pazjenti li ħadu l- plaċebo.
The risk of withdrawal symptoms seen with SSRI’ s and SNRI’ s may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Ir- riskju ta’ sintomi ta ’ rtirar li jidhru b’ SSRIs u SNRIs jistgħu jiddependu minn ħafna fatturi fosthom it- tul u d- doża tat- terapija u r- rata ta ’ tnaqqis fid- doża.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering ARICLAIM.
Iponatrimja Iponatrimja ġiet irrappurtata rarament, l- aktar fl- anzjani, meta jkun qed jingħata ARICLAIM.
4 Depression, suicidal ideation and behaviour Although ARICLAIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
4 Depressjoni, mġiba u formazzjoni ta ’ ħsibijiet suwiċidali Għalkemm ARICLAIM m’ huwiex indikat għal kura ta ’ depressjoni, is- sustanza attiva tiegħu (duloxetine) teżisti wkoll bħala medikazzjoni antidepressiva.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Billi waqt l - ewwel ftit ġimgħat jew aktar ta ’ kura jista ’ ma jseħħx titjib, il- pazjenti għandhom jiġu osservati bir - reqqa sakemm dan it- titjib iseħħ.
A meta-analysis of placebo- controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
Analiżi ta ’ numru ta ’ studji kliniċi kkontrollati bil- plaċebo ta ’ prodotti mediċinali antidepressivi li ntużaw f’ disturbi psikjatriċi wrew riskju ogħla ta ’ mġiba suwiċidali bl- antidipressivi meta mqabbla ma ’ plaċebo f’ pazjenti iżgħar minn 25 sena.
If while on ARICLAIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
Jekk waqt il- kura b’ ARICLAIM, il- pazjent jiżviluppa sintomi ta ’ aġitazzjoni jew sintomi depressivi, għandu jittieħed parir mediku speċjalizzat, peress li d- depressjoni hija kundizzjoni medika serja.
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of ARICLAIM is recommended (see Section 4.2).
(ara Sezzjoni 4. 2).
ARICLAIM should not be used in the treatment of children and adolescents under the age of 18 years.
ARICLAIM m’ għandux jintuża fil - kura ta ’ tfal u adolexxenti taħt it- 18- il sena.
Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Imġiba assoċjata mas- suwiċidju (attentati ta ’ suwiċidju u ħsibijiet ta ’ suwiċidju), u ostilità (l- aktar aggressjoni, imġiba konfrontali, u rabja), kienu osservati aktar spiss fi provi kliniċi fuq tfal u adolexxenti kkurati b’ anti- depressivi meta mqabbla ma ’ dawk ikkurati bi plaċebo.
Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Fit- tfal u fl- adolexxenti, it- tagħrif dwar is- sigurtà fit- tul f’ dak li jirrigwarda l - iżvilupp tal- ġisem, il- maturazzjoni u l- iżvilupp konjittiv u ta ’ l- imġiba, huwa nieqes.
Sucrose ARICLAIM gastro-resistant capsules contain sucrose.
Sucrose ARICLAIM kapsuli gastro- reżistenti ibsin fihom sucrose.
5 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Monoamine oxidase inhibitors (MAOIs): due to the risk of serotonin syndrome, ARICLAIM should not be used in combination with nonselective, irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
Inibituri ta ’ Monoamine Oxidase (MAOIs): minħabba r- riskju ta ’ sindrome ta ’ serotonin, ARICLAIM m’ għandux jintuża flimkien ma ’ inibituri ta ’ monoamine oxidase (MAOIs) irriversibbli u mhux
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping ARICLAIM 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 ARICLAIM qabel jinbeda xi MAOI (ara sezzjoni 4. 3).
Caution is advisable if ARICLAIM is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, St John’ s wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine and tryptophan.
Wieħed għandu joqgħod attent meta ARICLAIM jintuża fl- istess ħin ma ’ antidepressivi serotoninerġiċi bħal SSRI’ s, triċikliċi bħal clomipramine jew amitriptyline, St. John’ s wort (Hypericum perforatum), venlafaxine jew triptans, tramadol, pethidine u tryptophan.
CNS medicinal products: caution is advised when ARICLAIM is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Prodotti mediċinali li jaffettwaw is- CNS: hija rakkomandata l- attenzjoni meta ARICLAIM jintuża flimkien ma ’ sustanzi jew prodotti mediċinali oħra li jaġixxu fuq is- sistema nervuża ċentrali, li jinkludi l- alkoħol u prodotti mediċinali sedattivi (benzodiazepines, morfinomimetiċi, anti- psikotiċi, phenobarbital u l- antistaminiċi sedattivi)
Caution is advised if ARICLAIM is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Hu rrakkomandat li ARICLAIM jingħata b’ attenzjoni jekk jittieħed flimkien ma ’ prodotti mediċinali li huma fil- biċċa l- kbira metabolizzati minn CYP2D6 (risperidone, anti - depressivi triċikliċi [TCAs] bħal nortriptyline, amitriptyline, u imipramine) speċjalment jekk għandhom indiċi terapewtiku dejjaq (bħal flecainide, propafenone u metoprolol).
Effects of other medicinal products on duloxetine Antacids and H2 antagonists: co-administration of ARICLAIM with aluminium- and magnesium- containing antacids or with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Effetti ta ’ prodotti mediċinali oħra fuq duloxetine Mediċini kontra l- aċtu fl- istonku u antagonisti ta ’ H2: it- teħid ta ’ duloxetine flimkien ma ’ mediċini kontra l- aċidu fl- istonku li fihom aluminium u magnesium jew ma ’ famotidine ma kellhiex effett sinifikanti fuq ir- rata jew il- miżura ta ’ assorbiment ta ’ duloxetine wara li ngħatat doża orali ta ’ 40 mg.
Inhibitors of CYP1A2: because CYP1A2 is involved in duloxetine metabolism, concomitant use of ARICLAIM with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine.
Inibituri ta ’ CYP1A2: billi CYP1A2 huwa involut fil- metaboliżmu ta ’ duloxetine, bl- użu fl- istess ħin ta ’ duloxetine ma ’ inibituri qawwija ta ’ CYP1A2 hemm probabbiltà li jirriżultaw konċentrazzjonijiet ogħla ta ’ duloxetine.
Therefore ARICLAIM should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).
Għaldaqstant, ARICLAIM m’ għandux jingħata flimkien ma ’ inibituri qawwija ta ’ CYP1A2 bħal fluvoxamine (ara sezzjoni 4. 3).
Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure (see section 5.3).
Studji fl- annimali wrew tossiċità fuq is- sistema riproduttiva f’ livelli ta ’ esponiment sistemiku (AUC) ta ’ duloxetine anqas mill- massimu ta ’
ARICLAIM should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
ARICLAIM għandu jintuża biss fit- tqala jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali għall- fetu.
Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.
In- nisa għandhom jingħataw parir li javżaw lit- tabib tagħhom jekk isiru tqal jew jekk għandhom l- intenzjoni li jsiru tqal waqt it - terapija.
As the safety of duloxetine in infants is not known, the use of ARICLAIM while breast-feeding is not recommended.
Billi mhix magħrufa s- sigurtà ta ’ duloxetine fit- trabi, l- użu ta’ ARICLAIM waqt it- treddigħ mhux rakkomandat.
ARICLAIM may be associated with sedation and dizziness.
ARICLAIM jista ’ jiġi assoċjat ma ’ sedazzjoni u sturdament.
The most commonly reported adverse events in patients treated with ARICLAIM 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’ ARICLAIM 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).
Gastroenteritis Haematochezia Stomatitis Gastritis Flatulence Eructation Breath odour
Gastro- enterite
Gastrointestinal haemorrhage
Ematokeżja
Renals and Urinary Disorders
Emorraġija gastro- intestinaliI
Urinary hesitation Dysuria Nocturia Urine odour abnormal
(23. 3%) Rimettar Ħalq xott Dispepsja (11. 9%) Stitikezza (10. 3%)
Urine flow decreased Polyuria
Stomatite Gastrite Gass fl- istonku Tifwiq Riħa ħażina fil- ħalq
Urinary retention
Disturbi fil- kliewi u fis- sistema urinarja
Skin and Subcutaneous Tissue Disorders
Eżitazzjoni biex tagħmel l- awrina Disurja Awrinazzjoni eċċessiva matul il- lejl Riħa mhux normali ta ’ l - awrina
Sweating increased
Il- fluss ta ’ l - awrina jonqos Tagħmel ħafna awrina
Rash Increased tendency to
Żamma ta ’ l - awrina
Stevens-Johnson Syndrome Angioneurotic oedema
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Sindrome ta ’
disorders
Disturbi fis- sistema immuni
The most commonly observed adverse reactions in patients with diabetic neuropathic pain treated with ARICLAIM 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 ARICLAIM kienu: tqalligħ, uġigħ ta ’ ras, ħalq xott u ngħas.
General Disorders and Administration Site Conditions
(irrapportata l - iżjed f’ pazjenti dijabetiċi)
Hepato-biliary disorders
Disturbi fis- sistema immuni Reazzjoni Mard ta ’ anafilattika sensitività eċċessiva Disturbi fil- fwied u fil- marrara
The efficacy of ARICLAIM has not been evaluated for longer than 3 months in placebo-controlled studies.
L- effikaċja ta ’ ARICLAIM ma ġietx evalwata għal aktar minn tliet xhur fi studji ikkontrollati bil - plaċebo.
The clinical benefit of ARICLAIM 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 ’ ARICLAIM 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, ARICLAIM may provide no benefit beyond that afforded by more conservative behavioural interventions.
F’ dawn in- nisa, ARICLAIM jista ’ ma jkollux benefiċċju akbar minn dak li jingħata b’ interventi ta ’ mġiba aktar konservattivi.
ARICLAIM and Prior Continence Surgery: there are limited data that suggest that the benefits of ARICLAIM are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
16 ARICLAIM meta jingħata f’ pazjenti li kienet saritilhom operazzjoni għall- inkontinenza: hemm tagħrif limitat li jissuġġerixxi li l- benefiċċji ta ’ ARICLAIM ma kienux imnaqqsa f’ nisa bl- inkontinenza awrinarja dovuta għall- isforz li diġà kienet saritilhom operazzjoni għall- inkontinenza.
ARICLAIM and Pelvic Floor Muscle Training (PFMT): during a 12-week blinded, randomised, controlled study, ARICLAIM demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone.
ARICLAIM u Taħriġ tal- Muskolu tal- Qiegħ tal- Pelvis (PFMT): waqt studju kkontrollat, blinded, randomised, ta '12- il ġimgħa, ARICLAIM 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 ARICLAIM 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 ARICLAIM waħdu jew PFMT waħdu.
The elimination half-life of duloxetine after an oral dose ranges from 8 to 17 hours (mean of 12 hours).
17 Il- half life ta ’ l- eliminazzjoni ta ’ duloxetine tvarja minn 8 sa 17- il siegħa (medja ta '12- il siegħa).
Hydroxypropyl methylcellulose acetate succinate Sucrose Sugar spheres Talc Titanium dioxide (E171) Triethyl citrate.
Il- Kontenut tal- kapsula Hypromellose Hydroxypropyl methylcellulose acetate succinate Sucrose Sferi taz- zokkor Talc Titanium dioxide (E171) Triethyl citrate.
11 August 2004
11 ta ’ Awissu 2004
ARICLAIM 20 mg hard gastro-resistant capsules.
ARICLAIM 20 mg kapsuli ibsin gastro- reżistenti
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 ARICLAIM has not been evaluated for longer than 3 months in placebo-controlled studies.
L- effikaċja ta ’ ARICLAIM ma kinitx evalwata għal tul ta ’ żmien ta ’ aktar minn 3 xhur fi studji kkontrollati bil- plaċebo.
Combining ARICLAIM with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone.
Jista ’ jkun aktar effettiv li tassoċja ARICLAIM 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’ ARICLAIM ikun hemm ukoll programm ta’ PFMT.
The therapeutic benefit should regularly (at least every three months) be reassessed.
21 Il- benefiċċju terapewtiku għandu jerġa ’ jiġi valutat regolarment (mill- anqas kull tliet xhur).
When stopping treatment with ARICLAIM 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’ ARICLAIM 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.
ARICLAIM should not be used in combination with nonselective, irreversible Monoamine Oxidase Inhibitors - MAOIs (see section 4.5).
ARICLAIM m’ għandux jiġi użatt flimkien ma ’ Monoamine Oxidase Inhibitors irreversibli u mhux selettivi – MAOIs (ara sezzjoni 4. 5).
Mania and Seizures ARICLAIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija u aċċessjonijiet ARICLAIM għandu jiġi użat b’ attenzjoni f’ pazjenti bi storja ta ’ manija jew b’ dijanjosi ta ’ mard bipolari, u/ jew aċċessjonijiet.
20 St John’ s wort Undesirable effects may be more common during concomitant use of ARICLAIM and herbal preparations containing St John’ s wort (Hypericum perforatum).
St. John’ s wort L- effetti mhux mixtieqa jistgħu jkunu aktar komuni meta ARICLAIM 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.
22 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.
In a clinical trial, adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with ARICLAIM 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 ’ ARICLAIM u 24% ta ’ pazjenti li ħadu l- plaċebo.
The risk of withdrawal symptoms seen with SSRI’ s and SNRI’ s may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Ir- riskju ta ’ sintomi ta ’ rtirar li jidhru b’ SSRIs u SNRIs jistgħu jiddependu minn ħafna fatturi fosthom it- tul u d- doża tat- terapija u r- rata ta ’ tnaqqis fid- doża.
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering ARICLAIM.
Iponatrimja L- iponatrimja ġiet irrappurtata rarament, l- aktar fl- anzjani, meta jkun qed jingħata ARICLAIM.
21 Depression, suicidal ideation and behaviour Although ARICLAIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
Depressjoni, formazzjoni ta ’ ħsibijiet ta ’ suwiċidju u mġiba Ghalkemm ARICLAIM mhuwiex indikat għal kura ta ’ depressjoni, is- sustanza attiva tiegħu (duloxetine) teżisti wkoll bħala medikazzjoni antidepressiva.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Billi waqt l - ewwel ftit ġimgħat jew aktar ta ’ kura jista ’ ma jseħħx titjib, il- pazjenti għandhom jiġu osservati bir -
A meta-analysis of placebo- controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
Analiżi ta ’ numru ta ’ studji kliniċi kkontrollati bi plaċebo ta ’ prodotti mediċinali antidipressivi li ntużaw f’ disturbi psikjatriċi wrew riskju ogħla ta ’ mġiba suwiċidali bl- antidipressivi meta mqabbla ma ’ plaċebo f’ pazjenti iżgħar minn 25 sena.
If while on ARICLAIM therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
Jekk waqt il- kura b’ ARICLAIM, il- pazjent jiżviluppa sintomi ta ’ aġitazzjoni jew sintomi depressivi, għandu jiġi meħud parir mediku speċjalizzat, peress li d- depressjoni hija kundizzjoni medika serja.
Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Imġiba assoċjata mas- suwiċidju (attentati ta ’ suwiċidju u ħsibijiet suwiċidali), u ostilità (l- aktar aggressjoni, imġiba konfrontali, u rabja), kienu osservati aktar spiss fi provi kliniċi fuq tfal u adolexxenti kkurati b’ anti- depressivi meta mqabbla ma ’ dawk ikkurati bil- plaċebo.
Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Fit- tfal u fl- adolexxenti, it- tagħrif dwar is- sigurtà fit- tul f’ dak li jirrigwarda l- iżvilupp tal - ġisem, il- maturazzjoni u l- iżvilupp konjittiv u ta ’ l- imġiba, huwa nieqes.
22 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Monoamine oxidase inhibitors (MAOIs): due to the risk of serotonin syndrome, ARICLAIM should not be used in combination with nonselective, irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI.
Inibituri ta ’ Monoamine Oxidase (MAOIs): minħabba r- riskju ta ’ sindrome ta ’ serotonin, ARICLAIM 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.
Serotonin syndrome: in rare cases, serotonin syndrome has been reported in patients using SSRIs (e. g. paroxetine, fluoxetine) concomitantly with serotonergic medicinal products.
Wieħed
Caution is advisable if ARICLAIM 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.
24 għandu joqgħod attent meta ARICLAIM jintuża fl- istess ħin ma ’ antidipressivi serotoninerġiċi bħal SSRI’ s, triċikliċi bħal clomipramine jew amitriptyline, St. John’ s wort (Hypericum perforatum), venlafaxine jew triptans, tramadol, pethidine u tryptophan.
ARICLAIM should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
ARICLAIM għandu jintuża biss fit- tqala jekk il - benefiċċju potenzjali jiġġustifika r- riskju potenzjali għall- fetu.
Breast feeding Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
25 Treddigħ L- ammont ta ’ Duloxetine li joħroġ fil- ħalib tal- bniedem huwa żgħir ħafna fuq il- bażi ta ’ studju fuq 6 pazjenti li pproduċew il- ħalib iżda ma tawhx lil uliedhom.
As the safety of duloxetine in infants is not known, the use of ARICLAIM while breast-feeding is not recommended.
Billi mhix magħrufa s- sigurtà ta ’ duloxetine fit- trabi, l- użu ta’ ARICLAIM waqt it- treddigħ mhux rakkomandat
However, the majority of the most frequent adverse events were mild to moderate and resolved within 30 days of occurrence (e. g. nausea).
Iżda il- maġġoranza tar- reazzjonijiet avversi komuni kienu ħfief għal moderati u għebu wara 30 ġurnata minn meta bdew (eż. dardir).
The most commonly observed adverse reactions in patients with diabetic neuropathic pain treated with ARICLAIM 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 ARICLAIM kienu: tqalligħ, uġigħ ta ’ ras ħalq xott u ngħas.
The clinical benefit of ARICLAIM 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 ’ ARICLAIM meta mqabbel mal- plaċebo ma ġiex ipprovat f’ nisa bi grad ħafif ta ’ SUI, definita fi provi randomised bħala dawk b’ IEF < 14 kull ġimgħa.
In these women, ARICLAIM may provide no benefit beyond that afforded by more conservative behavioural interventions.
F’ dawn in- nisa, ARICLAIM jista ’ ma jipprovdix benefiċċju akbar minn dak li jingħata b’ interventi ta ’ komportament aktar konservattivi.
ARICLAIM and Prior Continence Surgery: there are limited data that suggest that the benefits of ARICLAIM are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.
35 ARICLAIM meta jingħata f’ pazjenti li kienet saritilhom operazzjoni għall- inkontinenza: hemm tagħrif limitat li jissuġġerixxi li l- benefiċċji ta ’ ARICLAIM ma kienux imnaqqsa f’ nisa bl- inkontinenza awrinarja dovuta għall- isforz li diġà kienet saritilhom operazzjoni għall- inkontinenza.
Both CYP2D6 and CYP1A2 catalyse the formation of the two major metabolites glucuronide conjugate of 4-hydroxy duloxetine and sulphate conjugate of 5-hydroxy,6-methoxy duloxetine.
Kemm CYP 2D6 kif ukoll CYP 1A2 jikkatalizzaw il- formazzjoni taż- żewġ prodotti metaboliċi prinċipali l- glukuronidu kkonjugat ta '4- hydroxy duloxetine u l- konjugat tas- sulfat ta' 5 - hydroxy, 6- methoxy duloxetine.
The elimination half-life of duloxetine after an oral dose ranges from 8 to 17 hours (mean of 12 hours).
36 Il- half life ta ’ l- eliminazzjoni ta ’ duloxetine tvarja minn 8 sa 17- il siegħa (medja ta '12- il siegħa).
ARICLAIM 30 mg hard gastro-resistant capsules
ARICLAIM 30 mg kapsuli gastro- reżistenti ibsin
Hepatic impairment ARICLAIM should not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Indeboliment tal- fwied ARICLAIM m’ għandhux jintuża f’ pazjenti b’ mard tal- fwied li jwassal għal indeboliment tal- fwied (ara sezzjonijiet 4. 3 u 5. 2).
ARICLAIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3)..
ARICLAIM m’ għandux jiġi użat f’ pazjenti b’ indeboliment renali gravi (tneħħija tal- krejatinina < 30 ml/ min) (ara sezzjoni 4. 3).
When stopping treatment with ARICLAIM the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Jekk ifeġġu sintomi intollerabbli wara tnaqqis fid- doża jew wara sospensjoni tal- kura, jista ’ jiġi kkunsidrat li terġa ’ tinbeda id- doża preċedenti ordnata.
Concomitant use of ARICLAIM with nonselective, irreversible Monoamine Oxidase Inhibitors (MAOIs) is contraindicated (see section 4.5).
L- użu fl- istess ħin ta ’ ARICLAIM ma ’ Inibituri ta ’ Monoamine Oxidase (MAOIs) irriversibbli u mhux selettivi huwa kontra- indikat (ara sezzjoni 4. 5).
ARICLAIM 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).
ARICLAIM 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 ARICLAIM 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’ ARICLAIM 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 ARICLAIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija u aċċessjonijiet ARICLAIM 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 ARICLAIM 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, ARICLAIM għandu jiġi ordnat b’ attenzjoni f’ pazjenti b’ pressjoni għolja fl- għajn, jew f’ dawk b’ riskju ta ’ glawkoma ta ’ angolu dejjaq akuta.
For patients with severe renal impairment, see section 4.3. ee section 4.2 for information on patients with mild or moderate renal dysfunction.
Għal pazjenti b’ indeboliment gravi tal- kliewi, ara sezzjoni 4. 3.
Use with antidepressants
Ara sezzjoni 4. 2 għal informazzjoni f’ pazjenti b’ disfunzjoni tal - kliewi ħafifa jew moderata.
37 Caution should be exercised when using ARICLAIM in combination with antidepressants.
41 Użu ma ’ anti- depressivi L- użu ta ’ ARICLAIM ma ’ anti- depressivi għandha tiġi segwita b’ attenzjoni.
St John’ s wort Undesirable effects may be more common during concomitant use of ARICLAIM and herbal preparations containing St John’ s wort (Hypericum perforatum).
John’ s wort (Hypericum perforatum).
Depression, suicidal ideation and behaviour Although ARICLAIM is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medication.
Depressjoni, imġiba u formazzjoni ta ’ ħsibijiet suwiċidali Għalkemm ARICLAIM m’ huwiex indikat għal kura ta ’ depressjoni, is- sustanza attiva tiegħu (duloxetine) teżisti wkoll bħala medikazzjoni antidepressiva.
A meta-analysis of placebo- controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Analiżi ta ’ numru ta ’ studji kliniċi kkontrollati bi plaċebo ta ’ prodotti mediċinali antidipressivi li ntużaw f’ disturbi psikjatriċi wrew riskju ogħla ta ’ mġiba suwiċidali bl- antidipressivi meta mqabbla ma ’ plaċebo f’ pazjenti iżgħar minn 25 sena.
If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of ARICLAIM is recommended (see section 4.2).
(ara Sezzjoni 4. 2).
Hyponatremia Hyponatremia has been reported rarely, predominantly in the elderly, when administering ARICLAIM.
Iponatrimja L- iponatrimja ġiet irrappurtata rarament, l- aktar fl- anzjani, fit- teħid ta ’ ARICLAIM.
In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with ARICLAIM 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 ’ ARICLAIM u 23% ta ’ pazjenti jieħdu l- plaċebo.
The risk of withdrawal symptoms seen with SSRI’ s and SNRI’ s may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
42 Ir- riskju ta ’ reazzjonijiet ta ’ rtirar li jidhru b’ SSRIs u SNRIs jistgħu jiddependu minn ħafna fatturi fosthom it- tul u d- doża tat- terapija u r- rata ta ’ tnaqqis fid- doża.
The most commonly 38 reported reactions are listed in section 4.8.
L- aktar reazzjonijiet komuni li ġew irraportati huma mniżżlin f’ sezzjoni 4. 8.
Consequently, caution is advised when ARICLAIM 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 ARICLAIM 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, ARICLAIM 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, ARICLAIM 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.
However, the concomitant use of ARICLAIM with selective, reversible MAOIs is not recommended (see section 4.4).
Madankollu, mhux irrakkomandat l- użu fl- istess ħin ta ’ ARICLAIM ma ’ MAOIs riversibbli u selettivi (ara sezzjoni 4. 4).
Caution is advisable if ARICLAIM 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.
The pharmacokinetics of theophylline, a CYP1A2 39 substrate, were not significantly affected by co-administration with duloxetine (60 mg twice daily).
Il- farmakokinetika ta ’ theophylline, sustrat ta ’ CYP1A2, ma ġietx affettwata b’ mod sinifikanti meta ngħata flimkien ma ’ duloxetine (60 mg darbtejn kuljum).
Caution is advised if ARICLAIM is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Hu rrakkomandat li ARICLAIM 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).
ARICLAIM should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
ARICLAIM 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 ARICLAIM while breast-feeding is not recommended.
Billi mhix magħrufa s - sigurtà ta ’ duloxetine fit- trabi, l- użu ta ’ ARICLAIM waqt it- treddigħ mhux rakkomandat.
40 4.7 Effects on ability to drive and use machines
44 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
42
Infezzjonijiet u infestazzjonijiet
Very
47 Larinġite Disturbi vaskulari Sinkope2
43 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, dardir u/ jew rimettar, rogħda, wġigħ ta ’ ras, irritabilità, dijarea, iperidrożi u vertigo huma l- aktar reazzjonijiet komunement irrappurtati.
44 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.
45 Special populations:
Popolazzjonijiet speċjali:
46 Capsule shell:
Il- Qoxra tal- kapsula:
ARICLAIM 30 mg is available in packs of 7, 28 and 98 capsules.
ARICLAIM 30mg issibu f’ pakketti ta ’ 7, 28 u 98 kapsula
ARICLAIM 60 mg hard gastro-resistant capsules
ARICLAIM 60 mg kapsuli gastro- reżistenti ibsin
49 Renal insufficiency No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/ min).
Insuffiċjenza tal- kliewi Mhux neċessarju aġġustament tad- doża għal pazjenti b’ disfunzjoni tal- kliewi ħafifa jew moderata (tneħħija tal- kreatinina minn 30 sa 80 ml/ min).
ARICLAIM should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min; see section 4.3).
ARICLAIM m’ għandux jiġi użat f’ pazjenti b’ indeboliment gravi tal- kliewi (tneħħija tal- krejatinina < 30 ml/ min) (ara sezzjoni 4. 3)
Mania and seizures ARICLAIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/ or seizures.
Manija u aċċessjonijiet ARICLAIM għandu jintuża b’ attenzjoni f’ pazjenti b’ storja ta ’ manija jew b’ dijanjosi ta ’ mard bipolari, u/ jew aċċessjonijiet.
50 Renal impairment Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance < 30 ml/ min).
Indeboliment tal- kliewii Pazjenti b’ indeboliment gravi tal- kliewi li għandhom bżonn dijalisi tad- demm (tneħħija tal- kreatinina < 30 ml/ min) kellhom żieda fil- konċentrazzjoni ta ’ duloxetine fil- plażma.
Use with antidepressants Caution should be exercised when using ARICLAIM in combination with antidepressants.
55 Użu ma ’ anti- depressivi L- użu ta ’ ARICLAIM ma ’ anti- depressivi għandha tiġi segwita b’ attenzjoni.
ARICLAIM should not be used in the treatment of children and adolescents under the age of 18 years.
ARICLAIM m’ għandux jintuża fil- kura ta ’ tfal u adolexxenti taħt it- 18- il sena.
Discontinuation of treatment 51 Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8).
Sospensjoni tal- kura Huma komuni r- reazzjonijiet ta ’ rtirar meta l- kura tiġi sospiża, partikolarment jekk is- sospensjoni ssir f’ daqqa waħda (ara sezzjoni 4. 8).
The risk of withdrawal symptoms seen with SSRI’ s and SNRI’ s may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
56 Ir- riskju ta ’ reazzjonijiet ta ’ rtirar li jidhru b’ SSRIs u SNRIs jistgħu jiddependu minn ħafna fatturi fosthom it- tul u d- doża tat- terapija u r- rata ta ’ tnaqqis fid- doża.
Caution is advisable if 52 ARICLAIM 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:
57 Effett ta ’ duloxetine fuq prodotti mediċinali oħra Prodotti mediċinali li jiġu metabolizzati minn CYP1A2:
Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.
In- nisa għandhom jingħataw parir biex javżaw lit- tabib tagħhom jekk jinqabdu tqal, jew għandhom l - intenzjoni li jinqabdu tqal, waqt it- terapija.
53 Breast feeding Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
Treddigħ Duloxetine joħroġ b’ mod debboli ħafna fil- ħalib uman, fuq il- bażi ta ’ studju fuq 6 pazjenti li pproduċew il- ħalib iżda ma tawhx lil uliedhom.
4.7 Effects on ability to drive and use machines
58 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
54
Disturbi fil - widnejn u fis - sistema labirintika Disturbi respiratorji, toraċiċi u medjastinali
Very
Tinnitus1
Common
Vertiġini Uġigħ tal - widnejn
Uncommon
Titwib
Rare
Epistassi Rassa fil - gerżuma
Very Rare
Disturbi gastro - intestinali
Frequency not
Tqalligħ (21. 7%) Ħalq xott (13. 2%)
common
Dijarrea Stitikezza Rimettar Dispepsja Gass fl - istonku
Tinnitus 1
Gastro- enterite Stomatite Gastrite Tifwiq
Vertigo Ear pain
Ematokeżja Riħa ħażina fil - ħalq
known
Emorraġija gastro - intestinali
Respiratory, thoracic and mediastinal disorders
60 Disturbi fil- kliewi u fis- sistema awrinarja Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Yawning
Żamma ta ’ l - awrina Eżitazzjoni awrinarja Disurja Awrinazzjoni eċċessiva matul il- lejl Tgħaddi ammont eċċessiv ta ’ awrina Tnaqqis fil - fluss ta ’ l - awrina
Epistaxis Throat tightness
Riħa mhux normali ta ’ l - awrina Sindromu ta ’
Gastrointestinal
Reazzjonijiet
Disorders
Stevens -
Nausea (21.7%) Dry mouth (13.2%)
Żieda fl -
Diarrhoea Constipation Vomiting Dyspepsia Flatulence
ta ’
Gastroenteritis Stomatitis Gastritis Eructation
Johnson
Haematochezia Breath odour
għaraq
Gastrointestinal haemorrhage
fotosensittività
Renals and Urinary Disorders
Edima anġjo -
Syncope2 Orthostatic
(irrapportata l - iżjed f’ pazjenti dijabetiċi)
Hypertensive crisis
Iponatrimja
Uncommon
Infezzjonijiet u infestazzjonijiet
Rare
61 Larinġite Disturbi vaskulari Sinkope2
Frequency not
Ħmura fil -
common
Kriżi
known
wiċċ
hypotension2 Blood pressure increase Peripheral coldness
Ipotensjoni ortostatika2 Żieda fil - pressjoni tad - demm Ksieħ periferiku
Hypertension
ipertensiva Ipertensjoni
3 See section 4.4
2 Każijiet ta ’ ipotensjoni ortostatika u sinkope ġew irrappurtati speċjalment fil- bidu tal- kura.
56 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.
57 Duloxetine normalised pain thresholds in several preclinical models of neuropathic and inflammatory pain and attenuated pain behaviour in a model of persistent pain.
Duloxetine reġa ’ ġab għan- normal il- limitu ta ’ l- uġigħ f’ ħafna mudelli prekliniċi ta ’ uġigħ newropatiku u infjammatorju u taffa l- atteġġament ta ’ l- uġigħ f’ mudell ta ’ uġigħ persistenti.
Based upon the overlap in the range of 58 clearance, gender-based pharmacokinetic differences do not justify the recommendation for using a lower dose for female patients.
Minħabba li l- varjazzjonijiet ta ’ tneħħija jikkoinċidu, id- differenzi farmakokinetiċi minħabba s- sess ma jiġġustifikawx ir- rakkomandazzjoni ta ’ tnaqqis fid- doża għal pazjenti nisa.
59 Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Yellow Iron Oxide (E172) Edible White Ink
Gelatin Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Iron Oxide Isfar (E172) Inkjostru Abjad li jittiekel
ARICLAIM 60 mg is available in packs of 28 and 98 capsules.
ARICLAIM 60mg issibu f’ pakketti ta ’ 28 u 98 kapsula.
60 ANNEX II
67 ANNESS II
61 A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
62 ANNEX III
69 ANNESS III
63 A.
70 A.
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
71 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Duloxetine
ARICLAIM 40 mg, kapsuli gastro- reżistenti ibsin Duloxetine