qanastek/EMEA-V3 huggingface dataset:
The efficacy of venlafaxine prolonged-release capsules as a treatment for social anxiety disorder was established in four double-blind, parallel-group, 12-week, multi-center, placebo-controlled, flexible-dose studies and one double-blind, parallel-group, 6-month, placebo-controlled, fixed/ flexible-dose study in adult outpatients.
L- effikaċja tal- kapsuli ta ’ venlafaxine li jerħu l- mediċina bil- mod bħala kura għad- disturb ta ’ ansjetà soċjali kienet stabbilita f’ erba ’ studji li damu 12- il ġimgħa, double- blind, parallel- group, multi - ċentriċi, ikkontrollati bil- plaċebo, li fihom ingħatat doża flessibbli, u studju li dam 6 xhur, double - blind, parallel- group, ikkontrollat bil- plaċebo, li fih ingħatat doża fissa/ flessibbli f’ pazjenti adulti outpatients.
Patients received doses in a range of 75 to 225 mg/ day.
Il- pazjenti rċivew dożi fil- medda ta ’ 75 sa 225 mg/ kuljum.
There was no evidence for any greater effectiveness of the 150 to 225 mg/ day group compared to the 75 mg/ day group in the 6-month study.
Ma kien hemm l- ebda evidenza għal kwalunkwe effettività ikbar tal- grupp li ngħata 150 sa 225 mg/ kuljum meta mqabbel mal- grupp li ngħata 75 mg/ kuljum fl- istudju li dam 6 xhur.
The efficacy of venlafaxine prolonged-release capsules as a treatment for panic disorder was established in two double-blind, 12-week, multi-center, placebo-controlled studies in adult outpatients with panic disorder, with or without agoraphobia.
L- effikaċja tal- kapsuli ta ’ venlafaxine li jerħu l- mediċina bil- mod bħala kura għal disturb ta ’ paniku kienet stabbilita f’ żewġ studji li damu 12- il ġimgħa, li kienu double- blind, multi- ċentriċi, ikkontrollati bil- plaċebo, f’ pazjenti adulti outpatients b’ disturb ta ’ paniku, bi jew mingħajr agorafobija.
The initial dose in panic disorder studies was 37.5 mg/ day for 7 days.
Id- doża tal - bidu fi studji dwar disturb ta ’ paniku kienet ta ’ 37. 5 mg/ kuljum għal 7 ijiem.
Patients then received fixed doses of 75 or 150 mg/ day in one study and 75 or 225 mg/ day in the other study.
Il- pazjenti imbagħad rċivew dożi fissi ta ’ 75 jew 150 mg/ kuljum fi studju wieħed, u 75 jew 225 mg/ kuljum fl- istudju l - ieħor.
Efficacy was also established in one long-term double-blind, placebo-controlled, parallel-group study of the long-term safety, efficacy, and prevention of relapse in adult outpatients who responded to open-label treatment.
L- effikaċja kienet stabbilita wkoll fi studju fit- tul li kien double- blind, ikkontrollat bil- plaċebo, parallel- group dwar is- sigurtà, l- effikaċja, u l- prevenzjoni ta ’ rikaduta f’ pazjenti adulti outpatients li rrispondew għall- kura open- label.
Patients continued to receive the same dose of venlafaxine prolonged-release that they had taken at the end of the open-label phase (75, 150, or 225 mg).
Il- pazjenti komplew jirċievu l- istess doża ta ’ venlafaxine li jerħi bil- mod li kienu ħadu fit- tmiem tal- fażi open- label (75, 150, jew 225 mg).
Venlafaxine is extensively metabolised, primarily to the active metabolite, O-desmethylvenlafaxine (ODV).
Venlafaxine hu metabolizzat b’ mod estensiv, primarjament għall- metabolit attiv O - desmethylvenlafaxine (ODV).
Mean ± SD plasma half-lives of venlafaxine and ODV are 5±2 hours and 11±2 hours, respectively.
Il- medja ± SD tal- half- lives tal- plażma ta ’ venlafaxine u ODV huma ta ’ 5±2 sigħat u ta ’ 11±2 sigħat, rispettivament.
Steady-state concentrations of venlafaxine and ODV are attained within 3 days of oral multiple-dose therapy.
Il- konċentrazzjonijiet fl- istat fiss ta ’ venlafaxine u ODV jintlaħqu fi żmien 3 ijiem ta ’ terapija b’ doża orali multipla.
Venlafaxine and ODV exhibit linear kinetics over the dose range of 75 mg to 450 mg/ day.
Venlafaxine u ODV juru kinetiċi lineari fuq il- medda tad- doża ta ’ 75 mg sa 450 mg/ kuljum.
34 Absorption
Assorbiment
At least 92% of venlafaxine is absorbed following single oral doses of immediate-release venlafaxine.
Mill- inqas 92% ta ’ venlafaxine jiġi assorbit wara dożi orali waħidhom ta ’ venlafaxine li jerħi b’ mod immedjat.
Absolute bioavailability is 40% to 45% due to presystemic metabolism.
Il- bijodisponibilità assoluta hi ta ’ 40% sa 45% minħabba metaboliżmu presistemiku.
After immediate-release venlafaxine administration, the peak plasma concentrations of venlafaxine and ODV occur in 2 and 3 hours, respectively.
Wara l- għoti ta ’ venlafaxine li jerħi b’ mod immedjat, il- konċentrazzjonijiet massimi fil- plażma ta ’ venlafaxine u ODV iseħħu fi żmien 2 u 3 sigħat, rispettivament.
Following the administration of venlafaxine prolonged-release capsules, peak plasma concentrations of venlafaxine and ODV are attained within 5.5 hours and 9 hours, respectively.
Wara l- għoti ta ’ kapsuli ta ’ venlafaxine li jerħu l- mediċina bil- mod, il- konċentrazzjonijiet massimi fil- plażma ta ’ venlafaxine u ta ’ ODV jintlaħqu fi żmien 5. 5 sigħat u 9 sigħat, rispettivament.
When equal daily doses of venlafaxine are administered as either an immediate-release tablet or prolonged-release capsule, the prolonged-release capsule provides a slower rate of absorption, but the same extent of absorption compared with the immediate-release tablet.
Meta dożi ugwali ta ’ kuljum ta ’ venlafaxine jingħataw jew bħala pillola li terħi l- mediċina b’ mod immedjat, jew bħala kapsula li terħi l- mediċina bil- mod, il- kapsula li terħi l- mediċina bil- mod tipprovdi rata aktar baxxa ta ’ assorbiment, iżda l- istess grad ta ’ assorbiment meta mqabbel mal- pillola li terħi l- mediċina b’ mod immedjat.
Food does not affect the bioavailability of venlafaxine and ODV.
L- ikel ma jaffettwax il- bijodisponibilità ta ’ venlafaxine u ta ’ ODV.
Venlafaxine and ODV are minimally bound at therapeutic concentrations to human plasma proteins (27% and 30%, respectively).
Venlafaxine u ODV jeħlu minimament f’ konċentrazzjonijiet terapewtiċi mal- proteini tal- plażma tal - bniedem (27% u 30%, rispettivament).
The volume of distribution for venlafaxine at steady-state is 4.4±1.6 L/ kg following intravenous administration.
Il- volum tad- distribuzzjoni għal venlafaxine fl- istat fiss hu ta ’ 4. 4±1. 6 L/ kg wara l- għoti ġol- vini.
Venlafaxine undergoes extensive hepatic metabolism.
Venlafaxine jgħaddi minn metaboliżmu epatiku estensiv.
In vitro and in vivo studies indicate that venlafaxine is biotransformed to its major active metabolite, ODV, by CYP2D6.
Studji in vitro u in vivo jindikaw li venlafaxine jiġi bijotrasformat għal metabolit attiv maġġuri tiegħu, ODV, minn CYP2D6.
In vitro and in vivo studies indicate that venlafaxine is metabolised to a minor, less active metabolite, N-desmethylvenlafaxine, by CYP3A4.
Studji in vitro u in vivo jindikaw li venlafaxine ikun metabolizzat għal metabolit minuri, inqas attiv, N -
In vitro and in vivo studies indicate that venlafaxine is a weak inhibitor of CYP2D6.
Studji in vitro u in vivo jindikaw li venlafaxine hu inibitur dgħajjef ta ’ CYP2D6.
Venlafaxine did not inhibit CYP1A2, CYP2C9, or CYP3A4.
Venlafaxine ma inibixxiex CYP1A2, CYP2C9, jew CYP3A4.
Venlafaxine and its metabolites are excreted primarily through the kidneys.
Venlafaxine u l- metaboliti tiegħu jitneħħew primarjament minn ġol- kliewi.
Approximately 87% of a venlafaxine dose is recovered in the urine within 48 hours as either unchanged venlafaxine (5%), unconjugated ODV (29%), conjugated ODV (26%), or other minor inactive metabolites (27%).
Madwar 87% tad- doża ta ’ venlafaxine tkun irkuprata fl- awrina fi żmien 48 siegħa bħala jew venlafaxine mhux mibdul (5%), ODV mhux konjugat (29%), ODV konjugat (26%), jew metaboliti inattivi minuri oħrajn (27%).
Mean ± SD plasma steady-state clearances of venlafaxine and ODV are 1.3±0.6 L/ h/ kg and 0.4±0.2 L/ h/ kg, respectively.
Il - medja ± SD tat- tneħħija mill- plażma ta ’ venlafaxine u ODV fl- istat fiss hi ta ’ 1. 3±0. 6 L/ siegħa/ kg u 0. 4±0. 2 L/ siegħa/ kg, rispettivament.
Age and gender Subject age and gender do not significantly affect the pharmacokinetics of venlafaxine and ODV.
Età u sess L- età u s- sess tal- pazjent ma jaffettwawx b’ mod sinifikanti il- farmakokinetika ta ’ venlafaxine u ta ’ ODV.
CYP2D6 extensive/ poor metabolisers Plasma concentrations of venlafaxine are higher in CYP2D6 poor metabolisers than extensive metabolisers.
Metabolizzaturi estensivi/ batuti ta ’ CYP2D6 Il- konċentrazzjonijiet fil- plażma ta ’ venlafaxine huma ogħla f’ metabolizzaturi batuti ta ’ CYP2D6 milli f’ metabolizzaturi estensivi.
Because the total exposure (AUC) of venlafaxine and ODV is similar in poor and extensive metabolisers, there is no need for different venlafaxine dosing regimens for these two groups.
Minħabba l- espożizzjoni totali (AUC) ta ’ venlafaxine u ODV hi simili f’ metabolizzaturi batuti u estensivi, m’ hemm l- ebda ħtieġa għal korsijiet differenti ta ’ dożaġġ ta ’ venlafaxine għal dawn iż- żewġ gruppi.
The oral
Pazjenti b’ indeboliment epatiku F’ pazjenti b’ Child- Pugh A (indeboliment epatiku ħafif) u Child- Pugh B (indeboliment epatiku moderat), il- half- lives ta ’ venlafaxine u ODV kienu itwal, meta mqabbla ma ’ individwi normali.
35 clearance of both venlafaxine and ODV was reduced.
It - tneħħija orali kemm ta ’ venlafaxine kif ukoll ta ’ ODV kienet imnaqqsa.
A large degree of intersubject variability was noted.
Grad kbir ta ’ varjabilità bejn il- pazjenti kien innutat.
There are limited data in patients with severe hepatic impairment (see section 4.2).
Hemm dejta limitata f’ pazjenti b’ indeboliment epatiku sever (ara wkoll sezzjoni 4. 2).
Patients with renal impairment In dialysis patients, venlafaxine elimination half-life was prolonged by about 180% and clearance reduced by about 57% compared to normal subjects, while ODV elimination half-life was prolonged by about 142% and clearance reduced by about 56%.
Pazjenti b’ indeboliment renali F’ pazjenti li kienu fuq id- dijalisi, il- half- life ta ’ l- eliminazzjoni ta ’ venlafaxine twalet b’ madwar 180% u t- tneħħija tnaqqset b’ madwar 57% meta mqabbla ma ’ persuni normali, filwaqt li l- half- life ta ’ l - eliminazzjoni ta ’ ODV twalet b’ madwar 142% u tneħħija tnaqqset b’ madwar 56%.
Dosage adjustment is necessary in patients with severe renal impairment and in patients that require haemodialysis (see section 4.2).
L- aġġustament fid- dożaġġ hu meħtieġ f’ pazjenti b’ indeboliment renali sever u f’ pazjenti li jeħtieġu l- emodijalisi (ara sezzjoni 4. 2).
Studies with venlafaxine in rats and mice revealed no evidence of carcinogenesis.
Studji b’ venlafaxine fil- firien u fil- ġrieden ma żvelaw l- ebda evidenza ta ’ karċinoġenesi.
Venlafaxine was not mutagenic in a wide range of in vitro and in vivo tests.
Venlafaxine ma kienx mutaġeniku f’ firxa wiesgħa ta ’ testijiet in vitro u in vivo.
Animal studies regarding reproductive toxicity have found in rats a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation.
Studji fuq l- annimali dwar it- tossiċità riproduttiva fil- firien sabu tnaqqis fil- piż tal- frieħ, żieda fin - numru ta ’ frieħ li jitwieldu mejtin, u żieda fl- imwiet tal- frieħ matul l- ewwel 5 ijiem ta ’ treddigħ.
The cause of these deaths is unknown.
Il - kawża ta ’ dawn l- imwiet mhijiex magħrufa.
These effects occurred at 30 mg/ kg/ day, 4 times the human daily dose of 375 mg of venlafaxine (on an mg/ kg basis).
Dawn l- effetti seħħew meta ngħatat doża ta ’ 30 mg/ kg/ kuljum, 4 darbiet tad- doża umana ta ’ kuljum ta ’ 375 mg ta ’ venlafaxine (fuq bażi ta ’ mg/ kg).
The no-effect dose for these findings was 1.3 times the human dose.
Id- doża li ma tħalli l- ebda effett għal dawn is- sejbiet kienet ta ’ 1. 3 darbiet tad- doża umana.
Reduced fertility was observed in a study in which both male and female rats were exposed to ODV.
Tnaqqis fil- fertilità kien osservat fi studju li fih kemm firien irġiel u kemm nisa kienu esposti għal ODV.
This exposure was approximately 1 to 2 times that of a human venlafaxine dose of 375 mg/ day.
Din l- espożizzjoni kienet ta ’ madwar darba sa darbtejn id- doża fil- bniedem ta ’ 375 mg/ kuljum.
The human relevance of this finding is unknown.
Ir- rilevanza ta ’ din is- sejba għall- bniedem mhijiex magħrufa.
{Name and address} {tel} {fax} {e-mail}
{Isem u indirizz} {tel} {fax} {e- mail}
{MM/ YYYY
{XX/ SSSS}
37 LABELLING
35 TIKKETTA
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
36 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
CARTON/ BOTTLE
KARTUNA/ FLIXKUN
Efexor depot and associated names (see Annex I) 37.5 mg prolonged-release capsules, hard
Efexor depot u ismijiet assoċjati miegħu (ara Anness I), 37. 5 mg kapsuli iebsin li jerħu l- mediċina bil - mod
Prolonged-release capsule, hard
Kapsula iebsa li terħi l- mediċina bil- mod
{Name and Address} {tel} {fax} {e-mail}
{Isem u Indirizz} {tel} {fax} {e- mail}
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Efexor depot and associated names (see Annex I) 75 mg prolonged-release capsules, hard
Efexor depot u ismijiet assoċjati miegħu (ara Anness I), 75 mg kapsuli iebsin li jerħu l- mediċina bil - mod
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Efexor depot and associated names (see Annex I) 150 mg prolonged-release capsules, hard
Efexor depot u ismijiet assoċjati miegħu (ara Anness I), 150 mg kapsuli iebsin li jerħu l- mediċina bil - mod
43 [To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
44 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Efexor depot and associated names (see Annex I) 37.5 mg prolonged-release capsules
Efexor depot u ismijiet assoċjati miegħu (ara Anness I), 37. 5 mg kapsuli li jerħu l- mediċina bil- mod
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Efexor depot and associated names (see Annex I) 75 mg prolonged-release capsules
Efexor depot u ismijiet assoċjati miegħu (ara Anness I), 75 mg kapsuli li jerħu l- mediċina bil- mod
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
44 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Efexor depot and associated names (see Annex I) 150 mg prolonged-release capsules
Efexor depot u ismijiet assoċjati miegħu (ara Anness I), 150 mg kapsuli li jerħu l- mediċina bil- mod
47 PACKAGE LEAFLET
45 FULJETT TA ’ TAGĦRIF
48 PACKAGE LEAFLET:
46 FULJETT TA ’ TAGĦRIF:
Efexor depot and associated names (see Annex I) 37.5 mg prolonged-release capsules, hard Efexor depot and associated names (see Annex I) 75 mg prolonged-release capsules, hard Efexor depot and associated names (see Annex I) 150 mg prolonged-release capsules, hard
Efexor depot u ismijiet assoċjati miegħu (ara Anness I) kapsuli iebsin ta ’ 37. 5 mg li jerħu l - mediċina bil- mod Efexor depot u ismijiet assoċjati miegħu (ara Anness I) kapsuli iebsin ta ’ 75 mg li jerħu l - mediċina bil- mod Efexor depot u ismijiet assoċjati miegħu (ara Anness I) kapsuli iebsin ta ’ 150 mg li jerħu l - mediċina bil- mod
It may harm them, even if their symptoms are the same than yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bhal tiegħek. • 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.
What Efexor depot is and what is used for 2.
X’ inhu Efexor depot u għalxiex jintuża 2.
Before you take Efexor depot 3.
Qabel ma tieħu Efexor depot 3.
How to take Efexor depot 4.
Kif għandek tieħu Efexor depot 4.
How to store Efexor depot 6.
Kif taħżen Efexor depot 6.
WHAT EFEXOR DEPOT IS AND WHAT IT IS USED FOR
X’ INHU EFEXOR DEPOT U GĦALXIEX JINTUŻA
Efexor depot is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs).
Efexor depot hu anti- dipressant li jappartjeni għal grupp ta ’ mediċini msejħa inibituri ta ’ l - assorbiment mill- ġdid ta ’ serotonin u norepinephrine (SNRIs).
This group of medicines is used to treat depression and other conditions such as anxiety disorders.
Dan il- grupp ta ’ mediċini jintuża għall - kura ta ’ dipressjoni u kundizzjonijiet oħrajn bħal disturbi ta ’ l- ansjetà.
It is thought that people who are depressed and/ or anxious have lower levels of serotonin and noradrenaline in the brain.
Hu maħsub li nies li jkunu dipressi u/ jew ansjużi, ikollhom liveli iktar baxxi ta ’ serotonin u noradrenaline fil- moħħ.
It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.
Mhuwiex mifhum b’ mod sħiħ kif jaħdmu l- anti- dipressanti, iżda jistgħu jgħinu billi jżidu l- livelli ta ’ serotonin u noradrenaline fil- moħħ.
Efexor depot is a treatment for adults with depression.
Efexor depot hu kura għal adulti b’ dipressjoni.
Efexor depot is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic attacks).
Efexor depot hu wkoll kura għal adulti b’ dawn id - disturbi ta ’ l- ansjetà li ġejjin: disturb ta ’ ansjetà ġeneralizzata, disturb ta ’ ansjetà soċjali (biża ’ jew li wieħed jevita sitwazzjonijiet soċjali), u disturb ta ’ paniku (attakki ta ’ paniku).
Treating depression or anxiety disorders properly is important to help you get better.
Il- kura adattata ta ’ dipressjoni jew disturbi ta ’ l- ansjetà hi importanti biex tgħinek tħossok aħjar.
If it is not treated, your condition may not go away and may become more serious and more difficult to treat.
Jekk ma tkunx ikkurata, il- kundizzjoni tiegħek tista ’ ma tfieqx u tista ’ tiggrava u ssir iktar diffiċli biex tikkuraha.
BEFORE YOU TAKE EFEXOR DEPOT
QABEL MA ’ TIEĦU EFEXOR DEPOT
Do not take Efexor depot
Tiħux Efexor depot
• If you are allergic to venlafaxine or any of the other ingredients of Efexor depot. • If you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson’ s disease.
Li tieħu MAOI irriversibbli flimkien ma ’
Taking an irreversible MAOI together with other medicines, including Efexor depot, can cause serious or even life-threatening side effects.
47 mediċini oħrajn, li jinkludu Efexor depot, jista ’ jikkawża effetti sekondarji serji jew anki effetti li huma ta ’ periklu għall- ħajja.
Also, you must wait at least 7 days after
Flimkien ma ’ dan, trid tistenna mill- inqas 7 ijiem wara li tieqaf tieħu Efexor depot qabel ma tieħu kwalunkwe MAOI (ara wkoll is- sezzjonijiet “ Is- Sindrome ta ’ serotonin ” u “ Meta tuża mediċini oħra ”).
Take special care with Efexor depot
Oqgħod attent ħafna b’ Efexor depot
• If you use other medicines that taken concomitantly with Efexor depot could increase the risk of developing serotonin syndrome (see the section “ Taking other medicines”). • If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye). • If you have a history of high blood pressure. • If you have a history of heart problems. • If you have a history of fits (seizures). • If you have a history of low sodium levels in your blood (hyponatraemia). • If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding. • If your cholesterol levels get higher. • If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric). • If you have a history of aggressive behaviour.
• Jekk tuża mediċini oħrajn li meta jittieħdu fl- istess ħin ma ’ Efexor depot jistgħu jżidu r- riskju li tiżviluppa s- sindrome ta ’ serotonin (ara s- sezzjoni “ Meta tuża mediċini oħra ”). • Jekk għandek problemi fl- għajnejn, bħal ċerti tipi ta ’ glawkoma (żieda fil- pressjoni fl - għajnejn). • Jekk għandek storja medika ta ’ pressjoni tad- demm għolja. • Jekk għandek storja medika ta ’ problemi tal- qalb. • Jekk għandek storja medika ta ’ aċċessjonijiet. • Jekk għandek storja medika ta ’ livelli baxxi ta ’ sodium fid- demm (iponatremija). • Jekk għandek tendenza li tiżviluppa tbenġil jew tendenza li joħroġlok id- demm faċilment (storja medika ta ’ disturbi ta ’ ħruġ ta ’ demm), jew jekk qed tieħu mediċini oħrajn li jistgħu jżidu r - riskju ta ’ ħruġ ta ’ demm. • Jekk il- livelli tal- kolesterol tiegħek jogħlew. • Jekk għandek storja medika ta ’, jew jekk xi ħadd fil- familja tiegħek kellu, manija jew disturb bipolari (tħossok eċċitat/ a żżejjed jew ewforiku/ a). • Jekk għandek storja medika ta ’ imġiba aggressiva.
Efexor depot may cause a sensation of restlessness or an inability to sit or stand still.
Efexor depot jista ’ jikkawża sensazzjoni ta ’ nuqqas ta ’ kwiet f’ ġismek jew nuqqas ta ’ ħila li toqgħod bilqiegħda jew bilwieqfa mingħajr ma titħarrek.
You should tell your doctor if this happens to you.
Għandek tgħid lit- tabib tiegħek jekk dan iseħħ lilek.
If any of these conditions apply to you, please talk with your doctor before taking Efexor depot.
Jekk xi kundizzjoni minn dawn tapplika għalik, jekk jogħġbok tkellem mat- tabib tiegħek qabel ma tieħu Efexor depot.
Thoughts of suicide and worsening of your depression or anxiety disorder
Ħsibijiet ta ’ suwiċidju u l- aggravament tad- disturb tad- dipressjoni jew ta ’ l- ansjetà tiegħek
If you are depressed and/ or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself.
Jekk inti dipress/ a u/ jew għandek disturbi ta ’ l- ansjetà, dan jista ’ jwassal biex kultant ikollok ħsibijiet li tagħmel ħsara jew li toqtol lilek innifsek.
These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer.
Dawn jistgħu jiżdiedu meta tibda tieħu l- anti- dipressanti għall- ewwel darba, għax dawn il- mediċini kollha jieħdu ż- żmien biex jibdew jaħdmu, normalment madwar ġimagħtejn, iżda xi kultant aktar.
You may be more likely to think like this: • If you have previously had thoughts about killing yourself or harming yourself. • If you are a young adult.
Taf taħseb aktar b’ dan il- mod: • Jekk fil- passat kellek ħsibijiet dwar li toqtol jew tagħmel ħsara lilek innifsek. • Jekk inti adult żagħżugħ.
Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.
Informazzjoni mill- provi kliniċi wriet żieda fir- riskju ta ’ mġiba suwiċidali f’ adulti żgħażagħ (ta ’ inqas minn 25 sena) b’ kundizzjonijiet psikjatriċi li kienu kkurati b’ anti- dipressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Jekk ikollok ħsibijiet dwar li tagħmel ħsara lilek innifsek jew li toqtol lilek innifsek fi kwalunkwe ħin, ikkuntattja lit- tabib tiegħek jew mur l- isptar immedjatment.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.
Tista ’ ssibha utli li tgħid lil xi qarib jew ħabib tal- qalb li għandek dipressjoni jew li qed tbati minn disturb ta ’ ansjetà, u itlobhom biex jaqraw dan il- fuljett.
You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Tista ’ tistaqsihom biex jgħidulek jekk jaħsbux li d- dipressjoni jew l- ansjetà tiegħek qed jiggravaw, jew jekk humiex inkwetati dwar tibdil fl - imġiba tiegħek.
This may increase the risk of caries.
Dan jista ’ jżid ir- riskju ta ’ taħsir tas- snien.
Therefore, you should take special care in your dental hygiene.
Għalhekk, għandek tieħu ħsieb bir- reqqa l- indafa ta ’ snienek.
Use in children and adolescents under 18 years of age
48 L- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena
Efexor depot should normally not be used for children and adolescents under 18 years.
Efexor depot normalment m’ għandux jintuża fi tfal u adolexxenti taħt it- 18- il sena.
Also, you should know that patients under 18 have an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when
Flimkien ma ’ dan, għandek tkun taf li pazjenti taħt it- 18- il sena għandhom żieda fir- riskju ta ’ effetti sekondarji bħal attentat ta ’ suwiċidju, ħsibijiet suwiċidali u ostilità (il- biċċa l- kbira aggressjoni, imġiba oppozizzjonali u rabja) meta jieħdu din il- klassi ta ’ mediċini.
Despite this, your doctor may prescribe Efexor depot for patients under 18 because he/ she decides that this is in their best interests.
Minkejja dan, it- tabib tiegħek jista ’ jagħti riċetta għal Efexor depot lil pazjenti taħt it- 18 il- sena minħabba li hu/ hi jiddeċiedi/ tiddeċiedi li dan hu fl- aħjar interess tal- pazjent.
If your doctor has prescribed Efexor depot for a patient under 18, and you want to discuss this, please go back to your doctor.
Jekk it- tabib tiegħek ta riċetta għal Efexor depot lil pazjent taħt it- 18 il- sena u inti trid tiddiskuti dan, jekk jogħġbok mur lura 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 Efexor depot.
Għandek tinforma lit- tabib tiegħek jekk kwalunkwe mis- sintomi elenkati hawn fuq, jiżviluppaw jew imorru għall- agħar meta pazjenti taħt it- 18- il sena jkunu qed jieħdu Efexor depot.
Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Efexor depot in this age group has not yet been demonstrated.
Flimkien ma ’ dan, l- effetti fit- tul fuq is- sigurtà fir- rigward tat- tkabbir, tal- maturazzjoni u ta ’ l- iżvilupp konoxxittiv u ta ’ l- imġiba ta ’ Efexor depot f’ dan il- grupp ta ’ età, għadhom ma ntwerewx.
Your doctor should decide whether you can take Efexor depot with other medicines.
It- tabib tiegħek għandu jiddeċiedi jekk tistax tieħu Efexor depot ma ’ mediċini oħrajn.
Do not start or stop taking any medicines, including those bought without a prescription, natural and herbal remedies, before checking with your doctor or pharmacist.
Tibdiex tieħu jew tieqaf tieħu kwalunkwe mediċini, inklużi dawk li tkun xtrajt mingħajr riċetta, mediċini naturali jew li ġejjin mill- ħxejjex, qabel ma tiċċekkja mat- tabib jew ma ’ l- ispiżjar tiegħek.
• Monoamine oxidase inhibitors (MAOIs: see the section “ Before you take Efexor depot”). • Serotonin syndrome: • Serotonin syndrome, a potentially life-threatening condition (see the section “ Possible Side Effects”), may occur with venlafaxine treatment, particularly when taken with other medicines.
Eżempji ta ’ dawn il- mediċini jinkludu:
Examples of these medicines include: • Triptans (used for migraine) • Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines containing lithium • Medicines containing linezolid, an antibiotic (used to treat infections) • Medicines containing moclobemide, a reversible MAOI (used to treat depression) • Medicines containing sibutramine (used for weight loss) • Medicines containing tramadol (a pain-killer) • Products containing St.
Mediċini li fihom linezolid, antibijotiku (jintuża biex jikkura l- infezzjonijiet) Mediċini li fihom moclobemide, MAOI riversibbli (jintuża biex jikkura d- dipressjoni) Mediċini li fihom sibutramine (jintuża biex inaqqas il- piż) Mediċini li fihom tramadol (itaffi l- uġigħ) Prodotti li fihom St.
John’ s Wort (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression) • Products containing tryptophan (used for problems such as sleep and depression)
John’ s Wort (imsejjaħ ukoll “ Hypericum perforatum ”, mediċina naturali jew li ġejja mill- ħxejjex li tintuża għall- kura ta ’ dipressjoni ħafifa)
Signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting.
Is- sinjali u s- sintomi tas- sindrome ta ’ serotonin jistgħu jinkludu kumbinazzjoni ta ’ dawn li ġejjin: nuqqas ta ’ kwiet f’ ġismek, alluċinazzjonijiet, telf ta ’ koordinazzjoni, taħbit mgħaġġel tal- qalb, żieda fit- temperatura tal- ġisem, tibdil mgħaġġel fil- pressjoni tad- demm, riflessi sensittivi żżejjed, dijarea, koma, nawseja, rimettar.
Get medical care right away if you think serotonin syndrome is happening to you.
Ikseb kura medika immedjatament jekk taħseb li s- sindrome ta ’ serotonin qed jiġri lilek.
The following medicines may also interact with Efexor depot and should be used with caution.
Il- mediċini li ġejjin jistgħu jinteraġixxu wkoll ma ’ Efexor depot u għandhom jintużaw bl- attenzjoni.
It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
Hu importanti b’ mod speċjali li tgħid lit- tabib jew lill- ispiżjar tiegħu jekk qed tieħu mediċini li fihom:
• Ketoconazole (an antifungal medicine) • Haloperidol or risperidone (to treat psychiatric conditions) • Metoprolol (a beta blocker to treat high blood pressure and heart problems)
• Ketoconazole (mediċina antifungali) • Haloperidol jew risperidone (għall- kura ta ’ kundizzjonijiet psikjatriċi) • Metoprolol (beta blocker għall- kura ta ’ pressjoni tad- demm għolja u problemi tal- qalb)
Taking Efexor depot with food and drink
Meta tieħu Efexor depot ma ’ l- ikel u x- xorb
Efexor depot should be taken with food (see section 3 “ HOW TO TAKE EFEXOR DEPOT”).
49 Efexor depot jista ’ jittieħed ma ’ l- ikel (ara Sezzjoni 3 “ KIF GĦANDEK TIEĦU EFEXOR DEPOT ”).
You should avoid alcohol while you are taking Efexor depot.
Għandek tevita l- alkoħol meta tkun qed tieħu Efexor depot.
51 Pregnancy and breast-feeding
Tqala u treddigħ
Tell your doctor if you become pregnant, or you are trying to become pregnant.
Għid lit- tabib tiegħek jekk toħroġ tqila, jew jekk qed tipprova toħroġ tqila.
You should use Efexor depot only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Għandek tuża Efexor depot biss wara li tiddiskuti l- benefiċċji potenzjali u r- riskji potenzjali għat- tarbija mhux imwielda tiegħek mat- tabib tiegħek.
If you are taking Efexor depot during pregnancy, let your midwife and/ or doctor know, as your baby might have some symptoms when it is born.
Jekk qed tieħu Efexor depot matul it- tqala, avża lill- qabla u/ jew lit- tabib tiegħek, għax it- tarbija tiegħek jista ’ jkollha xi sintomi meta titwieled.
These symptoms usually begin during the first 24 hours after the baby is born.
Dawn is- sintomi normalment jibdew matul l- ewwel 24 siegħa wara li t- tarbija titwieled.
They include not feeding properly and trouble with breathing.
Dawn jinkludu problemi biex it- tarbija tixrob kif suppost u problemi biex tieħu n- nifs.
If your baby has these symptoms when it is born and you are concerned, contact your doctor and/ or midwife who will be able to advise you.
Jekk it- tarbija tiegħek ikollha dawn is- sintomi meta titwieled, u dan qed jinkwetak, ikkuntattja lit- tabib u/ jew lill- qabla tiegħek, u dawn ser jagħtuk parir dwar x’ għandek tagħmel.
Efexor depot passes into breast milk.
Efexor depot jgħaddi ġol- ħalib tas- sider.
There is a risk of an effect on the baby.
Hemm riskju ta ’ effett fuq it- tarbija.
Therefore, you should discuss the matter with your doctor, and he/ she will decide whether you should stop breast-feeding or stop the therapy with Efexor depot.
Għalhekk, għandek tiddiskuti dan il- fatt mat- tabib tiegħek, u hu/ hi ser jiddeċiedi jekk għandekx twaqqaf it- treddigħ jew twaqqafx it- terapija b’ Efexor depot.
Do not drive or use any tools or machines until you know how Efexor depot affects you.
Issuqx u tħaddimx tagħmir jew magni sakemm tkun taf kif Efexor depot jaffettwak.
HOW TO TAKE EFEXOR DEPOT
KIF GĦANDEK TIEĦU EFEXOR DEPOT
Always take Efexor depot exactly as your doctor has told you.
Dejjem għandek tieħu Efexor depot skond il- parir tat- tabib.
The usual recommended starting dose for treatment of depression, generalised anxiety disorder and social anxiety disorder is 75 mg per day.
Id- doża rakkomandata tal- bidu għall- kura tad- dipressjoni, disturb ta ’ ansjetà ġeneralizzata u disturb ta ’ ansjetà soċjali hi ta ’ 75 mg kuljum.
The dose can be raised by your doctor gradually, and if needed, even up to a maximum dose of 375 mg daily for depression.
Id- doża tista ’ tiżdied gradwalment mit- tabib tiegħek u, jekk meħtieġ, anki sa doża massima ta ’ 375 mg kuljum għad- dipressjoni.
If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then increase the dose gradually.
Jekk qed tkun ikkurat għal disturb ta ’ paniku, it- tabib tiegħek ser jibda b’ doża iktar baxxa (37. 5 mg) u mbagħad iżidha gradwalment.
The maximum dose for generalised anxiety disorder, social anxiety disorder and panic disorder is 225 mg/ day.
Id - doża massima għal disturb ta ’ ansjetà ġeneralizzata, disturb ta ’ ansjetà soċjali u disturb ta ’ paniku hi ta ’ 225 mg/ kuljum.
Take Efexor depot at approximately the same time each day, either in the morning or in the evening.
Ħu Efexor depot bejn wieħed u ieħor fl- istess ħin kuljum, jew filgħodu jew filgħaxija.
Capsules must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.
Il- kapsuli għandhom jinbelgħu sħaħ ma ’ xi likwidu, u m’ għandhomx jinqasmu, jitgħaffġu, jintmagħdu, jew jinħallu.
Efexor depot should be taken with food.
Efexor depot għandu jittieħed ma ’ l- ikel.
If you have liver or kidney problems, talk to your doctor, since your dose of Efexor depot may need to be different.
Jekk għandek problemi tal- fwied jew tal- kliewi, kellem lit- tabib tiegħek, għax jista ’ jkun li d- doża tiegħek ta ’ Efexor depot trid tkun differenti.
Do not stop taking Efexor depot without talking to your doctor (see the section “ If you stop taking Efexor depot”).
Tiqafx tieħu Efexor depot mingħajr ma tkellem lit- tabib tiegħek (ara s- sezzjoni “ Jekk tieqaf tieħu Efexor depot ”).
If you take more Efexor depot than you should
Jekk tieħu Efexor depot aktar milli suppost
Call your doctor or pharmacist immediately if you take more than the amount of Efexor depot prescribed by your doctor.
Ikkuntattja lit- tabib jew lill- ispiżjar tiegħek immedjatament jekk tieħu iktar mill- ammont ta ’ Efexor depot li għalih ingħatajt riċetta mit- tabib tiegħek.
52 The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.
50 Is- sintomi ta ’ doża eċċessiva possibbli jistgħu jinkludu taħbit mgħaġġel tal- qalb, tibdil fil- livell ta ’ l - attenzjoni (li jvarja minn irqad sa koma), vista mċajpra, aċċessjonijiet jew puplesiji, u rimettar.
If you forget to take Efexor depot
Jekk tinsa tieħu Efexor depot
If you miss a dose, take it as soon as you remember.
Jekk tinsa tieħu doża, ħudha hekk kif tiftakar.
However, if it is time for your next dose, skip the missed dose and take only a single dose as usual.
Madankollu, jekk ikun wasal il- ħin għad- doża li jmiss, aqbeż id- doża li tkun insejt tieħu, u ħu doża waħda biss bħas- soltu.
Do not take more than the daily amount of Efexor depot that has been prescribed for you in one day.
F’ ġurnata, tiħux aktar mill - ammont ta ’ kuljum ta ’ Efexor depotli għalih ingħatajt riċetta.
If you stop taking Efexor depot
Jekk tieqaf tieħu Efexor depot
Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better.
Tiqafx tieħu l- kura jew tnaqqas id- doża mingħajr il- parir tat- tabib tiegħek anki jekk tħossok aħjar.
If your doctor thinks that you no longer need Efexor depot, he/ she may ask you to reduce your dose slowly before stopping treatment altogether.
Jekk it- tabib tiegħek jaħseb li m’ għandekx bżonn iktar ta ’ Efexor depot, hu/ hi jistgħu jistaqsuk biex tnaqqas id- doża tiegħek bil- mod qabel ma twaqqaf il- kura għal kollox.
Side effects are known to occur when people stop using Efexor depot, especially when Efexor depot is stopped suddenly or the dose is reduced too quickly.
Hu magħruf li jseħħu ċertu effetti sekondarji meta n- nies jieqfu jużaw Efexor depot, speċjalment meta Efexor depot jitwaqqaf għal għarrieda jew id- doża titnaqqas malajr wisq.
Some patients may experience symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.
Xi pazjenti jista ’ jkollhom sintomi bħal għeja, sturdament, mejt, uġigħ ta ’ ras, nuqqas ta ’ rqad, ħmar il- lejl, ħalq xott, telf ta ’ aptit, nawseja, dijarea, nervożità, aġitazzjoni, konfużjoni, tisfir fil- widnejn, tnemnim jew, rarament, sensazzjonijiet ta ’ xokk elettriku, dgħjufija, għaraq, aċċessjonijiet jew sintomi bħal ta ’ l- influwenza..
Your doctor will advise you on how you should gradually discontinue Efexor depot treatment.
It- tabib tiegħek ser jagħtik parir dwar kif għandek twaqqaf b’ mod gradwali il- kura bi Efexor depot.
If you experience any of these or other symptoms that are troublesome, ask your doctor for further advice.
Jekk ikollok kwalunkwe minn dawn is- sintomi, jew sintomi oħrajn li jinkwetawk, staqsi lit- tabib tiegħek għal parir addizzjonali.
Like all medicines, Efexor depot can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Efexor depot jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Do not be concerned if you see small white granules or balls in your stools after taking Efexor depot.
Tinkewtax jekk tara granijiet jew blalen żgħar bojod fl- ippurgar tiegħek wara li tieħu Efexor depot.
Inside Efexor depot capsules are spheroids or small white balls that contain the venlafaxine active ingredient.
Ġol- kapsuli ta ’ Efexor depot hemm sferojdi jew blalen żgħar bojod li fihom is- sustanza attiva ta ’ venlafaxine.
These spheroids are released from the capsule into your gastrointestinal tract.
Dawn l- isferojdi jintreħew mill- kapsula għal ġo l- apparat gastrointestinali tiegħek.
As the spheroids travel the length of your gastrointestinal tract, venlafaxine is slowly released.
Hekk kif l- isferojdi jimxu tul l- apparat gastrointestinali tiegħek, venlafaxine jintreħa bil- mod.
The spheroid “ shell” remains undissolved and is eliminated in your stools.
Il - “ qoxra ” ta ’ l- isferojde tibqa ’ ma tinħallx u titneħħa fl- ippurgar tiegħek.
Therefore, even though you may see spheroids in your stools, your dose of venlafaxine has been absorbed.
Għalhekk, għalkemm tista ’ tara l- isferojdi fl- ippurgar tiegħek, id- doża tiegħek ta ’ venlafaxine tkun ġiet assorbita.
If any of the following happen, do not take more Efexor depot.
Jekk isseħħ xi waħda minn dawn li ġejjin, tiħux iktar Efexor depot.
Tell your doctor immediately, or go to the casualty department at your nearest hospital:
Għid lit- tabib tiegħek immedjatament, jew mur fis- sezzjoni ta ’ l- emerġenza ta ’ l- eqreb sptar:
• Chest tightness, wheezing, trouble swallowing or breathing • Swelling of the face, throat, hands, or feet • Feeling nervous or anxious, dizziness, throbbing sensations, sudden reddening of the skin and/ or a warm feeling • Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
• Tagħfis fis- sider, tħarħir, problemi biex tibla ’ jew biex tieħu n- nifs. • Nefħa tal- wiċċ, fil- gerżuma, fl- idejn, jew fis- saqajn. • Tħossok nervuż jew ansjuż, sturdament, sensazzjonijiet ta ’ tektik, ħmura tal- ġilda għal għarrieda u/ jew sensazzjoni ta ’ sħana. • Raxx, ħakk, jew urtikarja severi (irqajja ’ elevati ta ’ ġilda ħamra jew pallida li ta ’ spiss tieklok).
If you notice any signs of the following, you may need urgent medical attention:
Jekk tinnota kwalunkwe sinjal minn dawn li ġejjin, jista ’ jkollok bżonn ta ’ attenzjoni medika urġenti: • Problemi tal- qalb, bħal rata ta ’ taħbit mgħaġġel jew irregolari tal- qalb, żieda fil- pressjoni tad - demm. • Problemi fl- għajnejn, bħal vista mċajpra jew li l- ħbub ta ’ l- għajnejn ikunu miftuħin.
53 • Heart problems, such as fast or irregular heart rate, increased blood pressure • Eye problems, such as blurred vision, dilated pupils • Nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits • Psychiatric problems, such as hyperactivity and euphoria • Treatment withdrawal (see the section “ HOW TO TAKE EFEXOR DEPOT, if you stop taking Efexor depot”).
51 • Problemi fin- nervaturi: bħal sturdament, sensazzjoni ta ’ tingiż, disturb tal- moviment, aċċessjonijiet. • Problemi psikjatriċi, bħal iperattività u ewforja. • Problemi meta tieqaf tieħu l- kura (ara s- sezzjoni “ KIF GĦANDEK TIEĦU EFEXOR DEPOT, Jekk tieqaf tieħu Efexor depot ”).
Complete side effect listing
Lista sħiħa ta ’ l- effetti sekondarji
The frequency (likelihood of occurring) of side effects is classified as follows:
Il- frekwenza (kemm x’ aktarx li jseħħu) ta ’ l- effetti sekondarji hi kklassifikata kif ġej:
Very common Common Uncommon Rare Not known
Komuni ħafna Komuni Mhux Komuni Rari Mhux magħrufa
Affects more than 1 user in 10 Affects 1 to 10 users in 100 Affects 1 to 10 users in 1,000 Affects 1 to 10 users in 10,000 Frequency cannot be estimated from the available data
Jaffettwaw iktar minn utent 1 f’ kull 10 Jaffettwaw minn 1 sa 10 utenti f’ kull 100 Jaffettwaw minn 1 sa 10 utenti f’ kull 1, 000 Jaffettwaw minn 1 sa 10 utenti f’ kull 10, 000 Frekwenza ma tistax tkun stmata mid- dejta disponibbli
Uncommon: bruising; black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding Not known: reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding; blood disorders which may lead to an increased risk of infection
• Disturbi fid- demm Mhux Komuni: tbenġil; ippurgar iswed qisu qatran jew demm fl- ippurgar, li jista ’ jkun sinjal ta ’ ħruġ ta ’ demm intern Mhux magħrufa: tnaqqis fin- numru ta ’ plejtlits fid- demm tiegħek, li jwassal għal żieda fir- riskju ta ’ tbenġil jew ħruġ ta ’ demm; disturbi fid- demm li jistgħu jwasslu għal żieda fir- riskju ta ’ infezzjoni
• Metabolism/nutritional disorders Common: weight loss; increased cholesterol Uncommon: weight gain Not known: slight changes in blood levels of liver enzymes; decrease in blood sodium levels; itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); confusion, excessive water intake (known as SIADH); abnormal breast milk production
• Disturbi metaboliċi/ tan- nutriment Komuni: telf ta ’ piż; żieda fil- livell tal- kolesterol Mhux Komuni: żieda fil- piż Mhux magħrufa: tibdil żgħir fil- livelli ta ’ enzimi tal- fwied fid- demm; tnaqqis fil- livelli tas - sodium fid- demm; ħakk, sfura fil- ġilda jew fl- għajnejn, awrina skura, jew sintomi bħal dawk ta ’ l- influwenza, li huma sintomi ta ’ infjammazzjoni tal- fwied (epatite); konfużjoni, teħid eċċessiv ta ’ ilma (magħruf bħala SIADH); produzzjoni anormali ta ’ ħalib tas- sider
• Nervous system disorders Very common: dry mouth; headache Common: abnormal dreams; decreased libido; dizziness; increased muscle tonus; insomnia; nervousness; pins and needles; sedation; tremor; confusion; feeling separated (or detached) from yourself and reality Uncommon: lack of feeling or emotion; hallucinations; involuntary movement of the muscles; agitation; impaired coordination and balance Rare: a sensation of restlessness or an inability to sit or stand still; seizures or fits; feeling over- excited or euphoric Not known: a high temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky muscle movements which you can't control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles, which are symptoms of serotonergic syndrome; disorientation and confusion often accompanied by hallucination (delirium); stiffness, spasms and involuntary movements of the muscles; thoughts of harming or killing yourself
• Disturbi fis- sistema nervuża Komuni ħafna: ħalq xott; uġigħ ta ’ ras Komuni: ħolm anormali; tnaqqis fil- libido; sturdament; żieda fit- tonus tal- muskoli; nuqqas ta ’ rqad; nervożità; sensazzjoni ta ’ tingiż; sedazzjoni; tregħid; konfużjoni; tħossok separat (jew maqtugħ) minnek innifsek u mir- realtà Mhux Komuni: nuqqas ta ’ sensazzjoni jew emozzjoni; alluċinazzjonijiet; moviment involontarju tal- muskoli; aġitazzjoni; indeboliment fil- koordinazzjoni u fil- bilanċ Rari: sensazzjoni ta ’ nuqqas ta ’ kwiet f’ ġismek jew nuqqas ta ’ ħila li toqgħod bilqiegħda jew bilwieqfa mingħajr ma titħarrek; aċċessjonijiet; tħossok eċċitat/ a jew ewforiku/ a żżejjed Mhux magħrufa: temperatura għolja flimkien ma ’ muskoli iebsin, konfużjoni jew aġitazzjoni, u għaraq, jew jekk ikollok movimenti għal għarrieda tal- muskoli li ma tistax tikkontrolla; dawn jistgħu jkunu sintomi ta ’ kundizzjonijiet serji magħrufa bħala sindrome malinn newroleptiku; sensazzjonijiet ewforiċi, ngħas, moviment mgħaġġel u sostnut ta ’ l- għajnejn, guffaġni, nuqqas ta ’ kwiet f’ ġismek, tħossok qisek fis- sakra, għaraq jew muskoli iebsin, li huma sintomi ta ’ sindrome serotonerġiku; diżorjentament u konfużjoni ta ’ spiss akkompanjati minn alluċinazzjoni (delirju); ebusija, spażmi u movimenti involontarji tal- muskoli; ħsibijiet li tagħmel ħsara jew li toqtol lilek innifsek
• Sight and hearing disorders Common: blurred vision Uncommon: altered taste sensation; ringing in the ears (tinnitus) Not known: severe eye pain and decreased or blurred vision
• Disturbi tal- vista u tas- smigħ Komuni: vista mċajpra Mhux Komuni: sensazzjoni ta ’ tibdil fit- togħma; tisfir fil- widnejn (tinnitus) Mhux magħrufa: uġigħ sever fl- għajnejn u tnaqqis fil- vista jew vista mċajpra
54 Common: increase in blood pressure; flushing; palpitations Uncommon: feeling dizzy (particularly when standing up too quickly), fainting, fast heartbeat Not known: decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting
52 • Disturbi tal- qalb jew taċ- ċirkolazzjoni Komuni: żieda fil- pressjoni tad- demm; fwawar; palpitazzjonijiet Mhux Komuni: sturdament (partikularment meta tqum bilwieqfa malajr wisq), ħass ħażin, taħbit mgħaġġel tal- qalb Mhux magħrufa: tnaqqis fil- pressjoni tad- demm; taħbit tal- qalb anormali, mgħaġġel jew irregolari li jista ’ jwassal għal ħass ħażin
• Breathing disorders Common: yawning Not known: coughing, wheezing, shortness of breath and a high temperature, which are symptoms of inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia)
• Disturbi fin- nifs Komuni: titwib Mhux magħrufa: sogħla, tħarħir, qtugħ ta ’ nifs u deni, li huma sintomi ta ’ infjammazzjoni tal - pulmun assoċjata ma ’ żieda fiċ- ċelluli bojod tad- demm (eosinofilja pulmonari)
• Digestive disorders Very common: nausea Common: appetite decreased; constipation; vomiting Uncommon: grinding of the teeth; diarrhoea Not known: severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)
• Disturbi diġestivi Komuni ħafna: nawseja Komuni: nuqqas t’ aptit; stitikezza; rimettar Mhux Komuni: tgħażżiż tas- snien; dijarea Mhux magħrufa: uġigħ sever addominali jew fid- dahar (li jistgħu jindikaw problema serja fl - imsaren, fil- fwied jew fil- frixa)
• Skin disorders Very common: sweating (including night sweats) Uncommon: rash; abnormal hair loss Not known: skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
• Disturbi tal- ġilda Komuni ħafna: għaraq (li jinkludi għaraq matul il- lejl) Mhux Komuni: raxx; telf anormali ta ’ xagħar Mhux magħrufa: raxx tal- ġilda li jista ’ jwassal għal infafet u tqaxxir sever tal- ġilda; ħakk; raxx ħafif
• Muscle disorders Not known: unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Disturbi tal- muskoli Mhux magħrufa: uġigħ mhux spjegabbli fil- muskoli, sensittività jew dgħjufija (rabdomijolosi)