qanastek/EMEA-V3 huggingface dataset:
38 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
39 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
38 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
40 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
39 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
41 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
40 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
42 PACKAGE LEFLET
42 FULJETT TA ’ TAGĦRIF:
Efexor and associated names (see Annex I) 25 mg tablets Efexor and associated names (see Annex I) 37.5 mg tablets Efexor and associated names (see Annex I) 50 mg tablets Efexor and associated names (see Annex I) 75 mg tablets
Efexor u ismijiet assoċjati miegħu (ara Anness I), pilloli ta ’ 25 mg Efexor u ismijiet assoċjati miegħu (ara Anness I), pilloli ta ’ 37. 5 mg Efexor u ismijiet assoċjati miegħu (ara Anness I), pilloli ta ’ 50 mg Efexor u ismijiet assoċjati miegħu (ara Anness I), pilloli ta ’ 75 mg
What Efexor is and what is used for 2.
X’ inhu Efexor u għalxiex jintuża 2.
Before you take Efexor 3.
Qabel ma tieħu Efexor 3.
How to take Efexor 4.
Kif għandek tieħu Efexor 4.
How to store Efexor 6.
Kif taħżen Efexor 6.
WHAT EFEXOR IS AND WHAT IT IS USED FOR
X’ INHU EFEXOR U GĦALXIEX JINTUŻA
Efexor is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs).
Efexor 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.
Efexor is a treatment for adults with depression.
Efexor hu kura għal adulti b’ dipressjoni.
Treating depression properly is important to help you get better.
Il- kura adattata ta ’ dipressjoni hi importanti biex tgħinek tħossok aħjar.
BEFORE YOU TAKE EFEXOR
QABEL MA ’ TIEĦU EFEXOR
Do not take Efexor
Tiħux Efexor
• If you are allergic to venlafaxine or any of the other ingredients of Efexor. • 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.
• Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal venlafaxine jew sustanzi oħra ta ’ Efexor. • Jekk qed tieħu wkoll, jew jekk ħadt fi kwalunkwe ħin matul l- aħħar 14- il jum, kwalunkwe mediċini magħrufa bħala inibituri irriversibbli ta ’ monoamine oxidase (MAOIs), użati għall - kura tad- dipressjoni jew tal- marda ta ’ Parkinson.
Taking an irreversible MAOI together with other medicines, including Efexor, can cause serious or even life-threatening side effects.
Li tieħu MAOI irriversibbli flimkien ma ’ mediċini oħrajn, li jinkludu Efexor, jista ’ jikkawża effetti sekondarji serji jew anki effetti li huma ta ’ periklu għall- ħajja.
Also, you must wait at least 7 days after you stop taking Efexor before you take any irreversible MAOI (see also the sections “ Serotonin syndrome” and “ Taking other medicines”).
Flimkien ma ’ dan, trid tistenna mill- inqas 7 ijiem wara li tieqaf tieħu Efexor qabel ma tieħu kwalunkwe MAOI irriversibbli (ara wkoll is- sezzjonijiet “ Is - sindrome ta ’ serotonin ” u “ Meta tuża mediċini oħra ”).
44 Take special care with Efexor
43 Oqgħod attent ħafna b’ Efexor
• If you use other medicines that taken concomitantly with Efexor 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 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 may cause a sensation of restlessness or an inability to sit or stand still.
Efexor jista ’ jikkawża sensazzjoni ta ’ nuqqas ta ’ kwiet f’ ġismek jew nuqqas ta ’ ħila li toqgħod bilqiegħda jew bilwieqfa mingħajr ma titħarrek.
If any of these conditions apply to you, please talk with your doctor before taking Efexor.
Jekk xi kundizzjoni minn dawn tapplika għalik, jekk jogħġbok tkellem mat- tabib tiegħek qabel ma tieħu Efexor.
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.
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.
Efexor should normally not be used for children and adolescents under 18 years.
Efexor 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 they take this class of medicines.
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
Despite this, your doctor may prescribe Efexor 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 lil pazjenti taħt it- 18 il- sena minħabba li hu/ hi jiddeċiedi/ tiddeċiedi li dan hu fl- aħjar interess tal- pazjent.
You should inform your doctor
Jekk it- tabib tiegħek ta riċetta għal Efexor lil pazjent taħt it- 18 il- sena u inti trid tiddiskuti dan, jekk jogħġbok mur lura għand it- tabib tiegħek.
45 if any of the symptoms listed above develop or worsen when patients under 18 are taking Efexor.
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.
Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Efexor 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 f’ dan il- grupp ta ’ età, għadhom ma ntwerewx.
Your doctor should decide whether you can take Efexor with other medicines.
It- tabib tiegħek għandu jiddeċiedi jekk tistax tieħu Efexor ma ’ mediċini oħrajn.
• Monoamine oxidase inhibitors (MAOIs: see the section “ Before you take Efexor”). • 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.
Is- sindrome ta ’ serotonin, kundizzjoni li hi potenzjalment ta ’ periklu għall- ħajja, (ara “ Effetti Sekondarji li Jista ’ Jkollu ”), tista ’ sseħħ bil- kura ta ’ venlafaxine, partikularment meta jittieħed ma ’ mediċini oħrajn.
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.
Eżempji ta ’ dawn il- mediċini jinkludu: • Triptans (jintużaw għall- emigranja) • Mediċini biex jikkuraw id- dipressjoni, per eżempju SNRI, SSRIs, triċikliċi, jew mediċini li fihom il- lithium • 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) • Prodotti li fihom tryptophan (jintużaw għal problemi ta ’ rqad u dipressjoni)
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 tiġri lilek.
The following medicines may also interact with Efexor and should be used with caution.
Il- mediċini li ġejjin jistgħu jinteraġixxu wkoll ma ’ Efexor u għandhom jintużaw bl- attenzjoni.
It is especially important to mention to your doctor or pharmacist if you are taking medicines containing: • Ketoconazole (an antifungal medicine) • Haloperidol or risperidone (to treat psychiatric conditions) • Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Hu importanti b’ mod speċjali li tgħid lit- tabib jew lill- ispiżjar tiegħu jekk qed tieħu mediċini li fihom: • 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 with food and drink
Meta tieħu Efexor ma ’ l- ikel u x- xorb
Efexor should be taken with food (see section 3 “ HOW TO TAKE EFEXOR”).
Efexor jista ’ jittieħed ma ’ l- ikel (ara Sezzjoni 3 “ KIF GĦANDEK TIEĦU EFEXOR ”).
You should avoid alcohol while you are taking Tradename.
Għandek tevita l- alkoħol meta tkun qed tieħu Efexor.
Pregnancy and breast-feeding
45 Tqala u treddigħ
You should use Efexor only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Għandek tuża Efexor biss wara li tiddiskuti l- benefiċċji potenzjali u r- riskji potenzjali għat- tarbija mhux imwielda tiegħek mat - tabib tiegħek.
46 If you are taking Efexor during pregnancy, let your midwife and/ or doctor know as your baby might have some symptoms when it is born.
Jekk qed tieħu Efexor matul it- tqala, avża lill- qabla u/ jew lit- tabib tiegħek għax it- tarbija tiegħek jista ’ jkollha xi sintomi meta 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 passes into breast milk.
Efexor jgħaddi ġol- ħalib tas- sider.
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.
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.
Do not drive or use any tools or machines until you know how Efexor affects you.
Issuqx u tħaddimx tagħmir jew magni sakemm tkun taf kif Efexor jaffettwak.
Important information about some of the ingredients of Efexor
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Efexor
[To be completed nationally]
[Biex jimtela mill- pajjiż partikolari]
HOW TO TAKE EFEXOR
KIF GĦANDEK TIEĦU EFEXOR
Always take Efexor exactly as your doctor has told you.
Dejjem għandek tieħu Efexor skond il- parir tat- tabib.
The usual recommended starting dose is 75 mg per day in divided doses, two or three times a day.
Id- doża rakkomandata tal- bidu hi ta ’ 75 mg/ kuljum f’ dożi maqsumin, darbtejn jew tliet darbiet 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.
Take Efexor at approximately the same time each day, in the morning and in the evening.
Ħu Efexor bejn wieħed u ieħor fl- istess ħin kuljum, filgħodu u filgħaxija.
Efexor should be taken with food.
Efexor għandu jittieħed ma ’ l- ikel.
If you have liver or kidney problems, talk to your doctor, since your dose of Efexor 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 trid tkun differenti.
Do not stop taking Efexor without talking to your doctor (see the section “ If you stop taking Efexor”).
Tiqafx tieħu Efexor mingħajr ma tkellem lit- tabib tiegħek (ara s- sezzjoni “ Jekk tieqaf tieħu Efexor ”).
If you take more Efexor than you should
Jekk tieħu Efexor aktar milli suppost
Call your doctor or pharmacist immediately if you take more than the amount of Efexor prescribed by your doctor.
Ikkuntattja lit- tabib jew lill- ispiżjar tiegħek immedjatament jekk tieħu iktar mill- ammont ta ’ Efexor li għalih ingħatajt riċetta mit- tabib tiegħek.
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.
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
Jekk tinsa tieħu Efexor
Do not take more than the daily amount of Efexor that has been prescribed for you in one day.
F’ ġurnata tiħux aktar mill- ammont ta ’ kuljum ta ’ Efexor għalih ingħatajt riċetta.
47 If you stop taking Efexor
46 Jekk tieqaf tieħu Efexor
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, 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, 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, especially when Efexor is stopped suddenly or the dose is reduced too quickly.
Hu magħruf li jseħħu ċertu effetti sekondarji meta n- nies jieqfu jużaw Efexor, speċjalment meta Efexor 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 treatment.
It- tabib tiegħek ser jagħtik parir dwar kif għandek twaqqaf b’ mod gradwali il- kura b’ Efexor.
Like all medicines, Efexor can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Efexor jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If any of the following happen, do not take more Efexor.
Jekk isseħħ xi waħda minn dawn li ġejjin, tiħux iktar Efexor.
Tell your doctor immediately, or go to the casualty department at your nearest hospital: • 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) • Serious side effects
Għid lit- tabib tiegħek immedjatament, jew mur fis- sezzjoni ta ’ l- emerġenza ta ’ l- eqreb sptar: • 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: • 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, If you stop taking Efexor”)
Jekk tinnota kwalunkwe sinjal minn dawn li ġejjin, jista ’ jkollok bżonn ta ’ attenzjoni medika urġenti: • Problemi tal- qalb, bħal rata ta ’ taħbit tal- qalb mgħaġġla jew irregolari, żieda fil- pressjoni tad - demm • Problemi fl- għajnejn, bħal vista mċajpra jew li l- ħbub ta ’ l- għajnejn ikunu miftuħin • Problemi fin- nervaturi: bħal sturdament, sensazzjoni ta ’ tingiż, disturb tal- moviment, aċċessjonijiet • Problemi psikjatriċi, bħal iperattività u ewforja • Problemi meta tieqaf il- kura (ara “ KIF GĦANDEK TIEĦU EFEXOR, Jekk tieqaf tieħu Efexor ”)
• Blood disorders
• Disturbi fid- demm
48 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
47 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 ca n'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 fil- vista u fis- 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
• Heart or circulation disorders 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
• 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 • 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)
• 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 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)
• 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)
48 • 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
• Skin disorders
• Disturbi fil- muskoli Mhux magħrufa: uġigħ mhux spjegabbli fil- muskoli, sensittività jew dgħjufija (rabdomijolosi)
49 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 fis- sistema urinarja Komuni: diffikultajiet biex tagħmel l- awrina; żieda fil- frekwenza meta tagħmel l- awrina Mhux Komuni:
• Muscle disorders Not known: unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
Ma tkunx tista ’ tagħmel l- awrina
• Urinary system disorders Common: difficulties passing urine; increased frequency in urination Uncommon: inability to pass urine
• Disturbi fis- sistema urinarja Komuni: diffikultajiet biex tagħmel l- awrina; żieda fil- frekwenza meta tagħmel l- awrina Mhux Komuni:
• Reproductive and sexual disorders Common: abnormal ejaculation/ orgasm (males); lack of orgasm; erectile dysfunction (impotence); menstrual irregularities such as increased bleeding or increased irregular bleeding Uncommon: abnormal orgasm (females)
• Disturbi fis- sistema riproduttiva u sesswali Komuni: ejakulazzjoni/ orgażmu anormali (irġiel); nuqqas ta ’ orgażmu; disfunzjoni erettili (impotenza); irregolaritajiet fil- mestrwazzjoni, bħal żieda fil- ħruġ tad- demm jew żieda fil- ħruġ irregolari tad- demm Mhux Komuni: orgażmu anormali (nisa)
Efexor sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heart beat; slight changes in blood levels or liver enzymes, sodium or cholesterol.
Efexor xi kultant jikkawża effetti mhux mixtieqa li int tista ’ ma tkunx konxju tagħhom, bħal żieda fil - pressjoni tad- demm jew taħbit anormali tal- qalb; tibdil żgħir fil- livelli fid- demm jew ta ’ l- enzimi tal - fwied, sodium jew kolesterol.
More rarely, Efexor may reduce the function of platelets in your blood, leading to an increased risk of bruising or bleeding.
B’ mod aktar rari, Efexor jista ’ jnaqqas il- funzjoni tal- plejtlits fid- demm tiegħek, li jwassal għal żieda fir- riskju ta ’ tbenġil jew ħruġ ta ’ demm.
Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Efexor for a long time.
Għalhekk, it- tabib tiegħek jista ’ jkun jixtieq li jagħmel testijiet tad- demm okkażjonalment, partikolarment jekk tkun ilek tieħu Efexor għal żmien twil.
HOW TO STORE EFEXOR
KIF TAĦŻEN EFEXOR
Do not use Efexor after the expiry date, which is stated on the packaging.
Tużax Efexor wara d- data ta ’ skadenza li tidher fuq l- ippakkjar.
What Efexor contains
X’ fih Efexor
50 What Efexor looks like and contents of the pack
Id- dehra ta ’ Efexor u l- kontenuti tal- pakkett
Austria Cyprus, Denmark, Finland, Greece, Iceland, Ireland, Malta, Norway, United Kingdom
L- Awstrija Ċipru, id- Danimarka, il- Finlandja, il - Greċja, l- Islanda, l- Irlanda, Malta, in - Norveġja, Ir- Renju Unit
Spain
Spajna
*[Please note that not all listed products and strengths may be available.]
* [Jekk jogħġbok innota li mhux il- prodotti u l- qawwiet kollha elenkati jistgħu jkunu disponibbli.]
EMEA/ CHMP/ 384875/ 2008
EMEA/ CHMP/ 674028/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Efexor and associated names International Non-Proprietary Name (INN): venlafaxine
OPINJONI WARA REFERENZA SKONT L- ARTIKOLU 30 GĦAL Efexor u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): venlafaxine
Efexor, 25 mg, 37.5 mg, 50 mg, 75 mg, tablets, is an antidepressant indicated for the treatment of major depressive episodes and for the prevention of recurrence of major depressive episodes.
Efexor, disponibbli f’ pilloli ta ’ 25 mg, 37. 5 mg, 50 mg u 75 mg, huwa antidepressiv indikat fit- trattament ta ’ episodji depressivi qawwijin u għall- prevenzjoni ta ’ rikorrenza ta ’ episodji depressivi qawwijin.
On 3 May 2007, the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Efexor.
Fit- 3 ta ’ Mejju 2007, il- Kummissjoni Ewropea ppreżentat referenza lill- EMEA skont l- Artikolu 30 tad - Direttiva 2001/ 83/ KE, kif emendata, sabiex tarmonizza s- Sommarji tal- Karatteristiċi tal- Prodott (SPC) u t - Tikketta u l- Fuljett ta 'Tagħrif tal- prodott mediċinali Efexor.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Efexor approved across EU Member States, with respect to the treatment of major depressive episodes and for the prevention of recurrence of major depressive episodes.
Ir- referenza kienet ibbażata fuq diverġenzi fis- Sommarji tal- Karatteristiċi tal- Prodott (SPC) ta ’ Efexor approvati fl- Istati Membri tal- UE, f’ dak li għandu x’ jaqsam mat- trattament ta ’ episodji depressivi qawwijin u l- prevenzjoni ta ’ rikorrenza ta ’ episodji depressivi qawwijin.
This medicinal product belongs to the 2007 list of products identified for SPC harmonisation.
Dan il- prodott mediċinali jappartjeni għal- lista ta ’ prodotti tal- 2007 li huma identifikati għall - armonizzazzjoni tal- SPC.
The CHMP gave a positive opinion on 24 July 2008 with a subsequent revision on 25 September 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Efexor.
Is- CHMP ta opinjoni pożittiva fl- 24 ta ’ Lulju 2008 b’ reviżjoni sussegwenti fil- 25 ta ’ Settembru 2008 li kienet tirrakkomanda l- armonizzazzjoni tal- SPC, it- Tikketta u l- Fuljett ta ’ Tagħrif għal Efexor.
Marketing Authorisation Holder
Id- Detentur ta ’ l - Awtorizzazzjoni għat- tqegħid fis- suq
oral use
jittieħed mill- ħalq
Invented name
Il- Greċja
Hungary
Qawwa
Strength
L- Italja
Latvia
Qawwa
Film-coated tablets
Pilloli miksijin b’ rita
Invented name
In- Norveġja
Poland
Qawwa
Invented name
Ir- Rumanija
Slovakia
Is- Slovakja
film-coated tablets
jittieħed mill- ħalq
Invented name Turox
Isem Ivvintat
Strength 90 mg
Qawwa
Pharmaceutical form film-coated tablets
Għamla farmaċewtika
Route of administration oral use
Mnjen jingħata
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- EMENDA TAS- SOMMARJU TAL - KARATTERISTIĊI TAL- PRODOTT U TAL- FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL - EMEA
9 SCIENTIFIC CONCLUSIONS
9 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ETORICOXIB CONTAINING MEDICINAL PRODUCTS (see Annex I)
SOMMARJU ĠENERALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ PRODOTTI MEDIĊINALI LI FIHOM ETORICOXIB (ara Anness I)
Etoricoxib was included in previous CHMP referrals on the safety of COX-2 selective inhibitors in which concluded in 2004 and 2005.
Etoricoxib kien inkluż fir- referenzi ta ’ qabel tas- CHMP dwar is- sigurtà ta ’ inibituri selettivi ta ’ COX- 2 li ġew konklużi fl- 2004 u fl- 2005.
Both referral procedures pertained to the safety of the COX-2 inhibitor products, including etoricoxib, with a particular focus on gastrointestinal (GI) and cardiovascular (CV) safety.
Iż- żewġ proċeduri ta ’ referenza kellhom x’ jaqsmu mas- sigurtà tal- prodotti inibituri COX- 2, inkluż etoricoxib, b’ fokus partikolari fuq is- sigurtà gastrointestinali (GI) u kardjovaskulari (KV).
In addition to class warnings and contraindications, introduced for all COX-2 selective inhibitors, a contraindication in patients with hypertension whose blood pressure is not adequately controlled was included specifically for etoricoxib because of evidence of higher rates of cardiorenal events than other COX-2 inhibitor products.
Barra mit- twissijiet tal - klassi u kontraindikazzjonijiet, introdotti għall- inibituri selettivi ta ’ COX- 2 kollha, kienet inkluża kontraindikazzjoni f’ pazjenti li l- pressjoni tad- demm tagħhom mhijiex ikkontrollata b’ mod xieraq speċifikament għal etoricoxib minħabba evidenza ta ’ rati iktar għoljin ta ’ episodji kardjorenali milli bi prodotti inibituri COX- 2 oħrajn.
In March 2006, the marketing authorisation holders (MAH) for etoricoxib submitted an application to extend the licensed indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
F’ Marzu 2006, id- detenturi ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq (MAH) għal etoricoxib issottomettew applikazzjoni biex jestendu l- indikazzjoni liċenzjata biex din tinkludi t- trattament ta ’ spondilite ankilosanti (AS), f’ doża ta ’ kuljum irrakkomandata ta ’ 90mg.
During the assessment of the procedure, concerns were raised over the long-term safety of etoricoxib 90mg in patients with AS.
Waqt il- proċedura ta ’ valutazzjoni tal- proċedura, tqajjem tħassib dwar is- sigurtà fit- tul ta ’ 90mg etoricoxib f’ pazjenti b’ AS.
Following concerns of a possible increased cardiovascular (CV) risk related to the use of the 90mg dose of etoricoxib, France considered that a review of the benefit/ risk profile of medicinal products containing etoricoxib at the dose of 90mg in the AS and RA indications, was of Community interest.
Wara tħassib ta ’ żieda fir- riskju kardjovaskulari (KV) possibbli relatat ma ’ l- użu ta ’ doża ta ’ 90mg ta ’ etoricoxib, Franza ikkunsidrat li eżami mill- ġdid tal- profil benefiċċju/ riskju tal- prodotti mediċinali li fihom etoricoxib f’ doża ta ’ 90mg fl - indikazzjonijiet ta ’ RA u AS, kien ta ’ interess Komunitarju.
Therefore, France sent a notification that was received by the EMEA on 19 September 2007 and a referral under Article 31 of Directive 2001/ 83/ EC, as amended was started on 20 September 2007.
Għalhekk, Franza bagħtet notifika li waslet għand l- EMEA fid- 19 ta ’ Settembru 2007 u fl- 20 ta ’ Settembru 2007, inbdiet referenza skond l- Artikolu 31 tad- Direttiva 2001/ 83/ KE, kif emendata.
The CHMP was requested to give its opinion on whether the marketing authorisations for medicinal products containing 90 mg etoricoxib should be maintained, varied, suspended or revoked.
Is- CHMP intalab jagħti l- opinjoni tiegħu dwar jekk l - awtorizzazzjonijiet għat- tqegħid fis- suq għal prodotti mediċinali li fihom 90 mg etoricoxib għandhomx jinżammu, jiġu varjati, jiġu sospiżi jew jiġu revokati.
The CHMP reviewed the data submitted by the marketing authorisation holders from clinical trials, drug utilisation studies and spontaneous reporting of adverse drug reactions.
Is- CHMP irreveda d- dejta sottomessa mid- detenturi ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq, minn provi kliniċi, studji ta ’ l- użu tal- mediċina u rapportaġġ spontanju ta ’ reazzjonijiet avversi tal- mediċina.
The CHMP concluded on 26 June 2008 that the data confirm the known relatively adverse renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure), but similar CV thrombotic risk as diclofenac and some degree of upper GI safety advantage over naproxen and diclofenac (though no particular lower GI safety advantage).
Fis- 26 ta ’ Ġunju 2008, is- CHMP ikkonkluda li d- dejta tikkonferma l- profil ta ’ sigurtà renovaskulari relattivament avvers magħruf ta ’ etoricoxib (ipertensjoni, edema u falliment konġestiv tal- qalb), iżda riskju trombotiku KV simili għal dak ta ’ diclofenac u ċertu grad ta ’ vantaġġ ta ’ sigurtà tal- parti GI ta ’ fuq, fuq naproxen u diclofenac (iżda l- ebda vantaġġ ta ’ sigurtà partikolari tal- parti GI t’ isfel).
The CHMP therefore recommends the strengthening of the contraindication in hypertensive patients and alerts prescribers that blood pressure needs to be monitored, especially within 2 weeks of treatment initiation.
Is- CHMP għalhekk jirrakkomanda t- tisħiħ tal- kontraindikazzjoni f’ pazjenti ipersensittivi u jwissi lil dawk li jippreskrivuh (jagħtuh b’ riċetta medika), li l- pressjoni jeħtieġ li tkun sorveljata, speċjalment fi żmien ġimagħtejn mill- bidu tat- trattament.
Healthcare professionals were to be reminded of these measures through a communication letter.
Professjonisti fil- qasam tal- kura tas- saħħa kellhom jiġu mfakkrin b’ dawn il- miżuri permezz ta ’ ittra ta ’ komunikazzjoni.
Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for both RA and AS indications; however, some data are available to indicate that lower doses might also show effect.
Dejta minn studji kliniċi wriet effett ta ’ kura klinikament sinifikattiva għad- doża ta ’ 90mg etoricoxib darba kuljum għal indikazzjonijiet kemm AS kif ukoll RA; madankollu, hemm xi dejta disponibbli li tindika li dożi iktar baxxi jistgħu wkoll juru effett.
Based on the review of the available data, the CHMP considers that the benefits of etoricoxib outweigh the risks in the treatment of rheumatoid arthritis and ankylosing spondylitis.
Abbażi tar- reviżjoni tad- dejta disponibbli, is- CHMP ikkunsidra li l- benefiċċji ta ’ etoricoxib jegħlbu r- riskji fit- trattament ta ’ artrite rewmatojde u spondilite ankilosanti.
10 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
10 RAĠUNIJIET GĦALL- EMENDA TAS- SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT U L- FULJETT TA ’ TAGĦRIF
- The Committee considered the referral made under article 31 of Directive 2001/ 83/ EC, as amended,
- Il- Kumitat ikkunsidra r- referenza magħmula skond l- Artikolu 31 tad- Direttiva 2001/ 83/ KE, kif
for medicinal products containing 90 mg etoricoxib.
emendata, għal prodotti mediċinali li fihom 90 mg etoricoxib.
- In view of the available data, the CHMP considered that the benefit/ risk balance for etoricoxib 90mg
- Mil- lat ta ’ dejta disponibbli, is- CHMP ikkunsidra li l- bilanċ benefiċċju/ riskju għad- doża ta ’ 90 mg
dose in the RA and AS indications is positive; however, revisions to the contraindications and warnings sections have been added to the summary of product characteristics and package leaflet in relation to cardiorenal safety.
etoricoxib fl- indikazzjonijiet RA u AS huwa wieħed pożittiv; madankollu, reviżjonijiet għas - sezzjonijiet ta ’ kontraindikazzjonijiet u twissijiet ġew miżjuda fis- sommarju tal- karatteristiċi tal - prodott u fil- fuljett ta ’ tagħrif fir- rigward tas- sigurtà kardjorenali.
As a consequence, the CHMP has recommended to maintain the Marketing Authorisation for all medicinal products containing 90 mg of etoricoxib referred to in Annex I of the Opinion and to amend the relevant sections of the summary of product characteristics and package leaflet, as set out in Annex III of the Opinion in accordance with Article 31 (2) of Directive 2001/ 83/ EC, as amended.
Bħala konsegwenza, is- CHMP irrakkomanda li l- Awtorizzazzjoni għat- Tqegħid fis- Suq tinżamm għall - prodotti mediċinali kollha li fihom 90 mg ta ’ etoricoxib li hemm referenza għalihom fl- Anness I ta ’ l - Opinjoni u li jiġu emendati s- sezzjonijiet relevanti tas- sommarju tal- karatteristiċi tal- prodott u tal- fuljett ta ’ tagħrif, kif stabbilit fl- Anness III ta ’ l- Opinjoni b’ mod konformi ma ’ l- Artikolu 31( 2) tad- Direttiva 2001/ 83/ KE, kif emendata.
< Etoricoxib containing medicinal products (see Annex 1) > 30 mg film-coated tablets< Etoricoxib containing medicinal products (see Annex 1) > 60 mg film-coated tablets< Etoricoxib containing medicinal products (see Annex 1) > 90 mg film-coated tablets < Etoricoxib containing medicinal products (see Annex 1) > 120 mg film-coated tablets [See Annex 1- To be completed nationally]
Prodotti mediċinali li fihom Etoricoxib (ara l- Anness 1) 30 mg pilloli miksijin b’ rita Prodotti mediċinali li fihom Etoricoxib (ara l- Anness 1) 60 mg pilloli miksijin b’ rita Prodotti mediċinali li fihom Etoricoxib (ara l- Anness 1) 90 mg pilloli miksijin b’ rita Prodotti mediċinali li fihom Etoricoxib (ara l- Anness 1) 120 mg pilloli miksijin b’ rita [Ara l- Anness 1 - Għandha timtela fuq livell nazzjonali]
[To be completed nationally.]
[Għandha timtela fuq livell nazzjonali]
For the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis.
Għas- serħan mis- sintomi ta ’ osetoartrite (OA), artrite rewmatojde (RA), ankylosing spondylitis u l- uġigħ u s- sinjali ta ’ infjammazzjoni assoċjati ma ’ artrite tal- gotta akuta.
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks (see sections 4.3, 4.4).
Id- deċiżjoni jekk għandux jiġi preskritt inibitur selettiv COX- 2 għandha tkun ibbażata fuq valutazzjoni tar - riskji ġenerali tal- pazjenti individwali (ara sezzjonijiet 4. 3, 4. 4).
< Etoricoxib > is administered orally and may be taken with or without food.
Etoricoxib jingħata mill- ħalq u jista ’ jittieħed ma ’ l- ikel kif ukoll mhux ma ’ l- ikel.
The onset of the effect of the medicinal product may be faster when< Etoricoxib > is administered without food.
Il- bidu ta ’ l- effett tal - prodott mediċinali jista ’ jkun aktar veloċi meta < Etoricoxib > jingħata mingħajr ikel.
As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Minħabba li r- riskji kardjovaskulari ta ’ etoricoxib jistgħu jiżdiedu mad- doża u t- tul ta ’ l- espożizzjoni, għandha tintuża l- inqas doża effettiva ta ’ kuljum u għall- inqas tul ta ’ żmien possibbli.
The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).
Il- ħtieġa tal- pazjent għal serħan mis- sintomi u għar- rispons għat- terapija għandhom jiġu evalwati mill- ġdid perjodikament f’ pazjenti b’ osteoartrite (ara sezzjonijiet 4. 3, 4. 4, 4. 8 u 5. 1).
14 Rheumatoid arthritis The recommended dose is 90 mg once daily.
Artrite rewmatojde Id- doża rakkomandata hija 90 mg darba kuljum.
Acute gouty arthritis The recommended dose is 120 mg once daily.
14 Artrite tal- gotta akuta Id- doża rakkomandata hija 120 mg darba kuljum.
The use of etoricoxib in patients with creatinine clearance < 30 ml/ min is contra-indicated (see sections 4.3 and 4.4).
L- użu ta ’ etoricoxib f’ pazjenti bi tneħħija tal- kreatinina < 30 ml/ min huwa kontra- indikat (ara sezzjonijiet 4. 3 u 4. 4).
Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
Pazjenti li esperjenzaw bronkospażmu, rinite akuta, qarnita nasali, edema anġjonewrotika, urtikarja jew reazzjonijiet tat- tip allerġiċi wara t- teħid ta ’ acetylsalicylic acid jew NSAIDs inkluż inibituri COX- 2 (cyclooxygenase- 2).
15 Inflammatory bowel disease.
15 Mard infjammatorju ta ’ l- imsaren.
Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.
Hija rrakkomandata l- kawtela fil- kura ta ’ pazjenti li huma l- aktar f’ riskju li jiżviluppaw kumplikazzjoni gastrointestinali bl- NSAIDs; l- anzjani, pazjenti li jużaw kwalunkwe NSAID jew acetylsalicylic acid ieħor jew pazjenti bi storja preċedenti ta ’ mard gastrointestinali, bħall- ulċerazzjoni u fsada GI.
As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Minħabba li r- riskji kardjovaskulari ta ’ etoricoxib jistgħu jiżdiedu mad- doża u mat- tul ta ’ l - espożizzjoni, għandha tintuża l- iżgħar doża effettiva possibbli u għall- iqsar tul ta ’ żmien possibbli.
Therefore antiplatelet therapies should not be discontinued (see sections above, 4.5 and 5.1.).
Għalhekk terpiji kontra l - pjastrini ma għandhomx jitwaqqfu (ara sezzjonijiet fuq, 4. 5 u 5. 1).
Renal effects Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion.
Effetti renali Prostaglandini renali jista ’ jkollhom rwol kumpensatorju fiż- żamma ta ’ perfużjoni renali.
Therefore, under conditions of compromised renal perfusion, administration of etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function.
Għaldaqstant, taħt kundizzjonijiet ta ’ perfużjoni renali kompromessa, l- għoti ta ’ etoricoxib jista ’ jikkawża tnaqqis fil - formazzjoni ta ’ prostaglandin u, t- tieni nett, fil- fluss ta ’ demm fil- kliewi, u b’ hekk jindebolixxi l- funzjoni tal- kliewi.
Patients at greatest risk of this response are those with pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis.
Pazjenti li l- aktar li qegħdin f’ riskju għal dan ir- rispons huma dawk b’ funzjoni tal- kliewi indebolita ferm pre- eżistenti, indeboliment fil- funzjoni tal- qalb mhux ikkumpensat, jew ċirrożi.
Monitoring of renal function in such patients should be considered.
Il - monitoraġġ ta ’ funzjoni renali fuq pazjenti bħal dawn għandu jiġi kkunsidrat.
16 Fluid retention, oedema and hypertension As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention, oedema and hypertension have been observed in patients taking etoricoxib.
Żamma ta ’ fluwidu, edema u pressjoni għolja Bħal bi prodotti mediċinali oħrajn magħrufin li jinibixxu s- sintesi ta ’ prostaglandin, żamma tal- fluwidi, edema u pressjoni għolja ġew osservati f’ pazjenti li qegħdin jieħdu etoricoxib.
All Nonsteroidal Antiinflammatory Drugs (NSAIDs), including etoricoxib, can be associated with new onset or recurrent congestive heart failure.
Il- Mediċini Anti - infjammatorji Mhux- Sterojdali (NSAIDs) kollha nkluż etoricoxib jistgħu jkunu assoċjati ma ’ feġġa ta ’ jew ma ’ kollass konġestiv rikorrenti tal- qalb.
Caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing oedema from any other reason.
Għandha tiġi eżerċitata l- kawtela f’ pazjenti bi storja ta ’ indeboliment kardijaku, malfunzjonament ventrikulari xellugi, jew pressjoni għolja u f’ pazjenti b’ edema pre- eżistenti minn
Any patients with symptoms and/ or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored.
Kull pazjent b’ sintomi u/ jew sinjali li jissuġġerixxu malfunzjonament tal- fwied, jew li sar test tal- funzjoni tal- fwied fuqhom u dan irriżulta bħala mhux normali, għandhom jiġu mmonitorjati.
Medically appropriate supervision should be maintained when using etoricoxib in the elderly and in patients with renal, hepatic, or cardiac dysfunction.
Meta jkun qiegħed jintuża etoricoxib, għandha tinżamm sorveljanza medika xierqa fl- anzjani u fil- pazjenti b’ malfunzjonament renali, epatika jew kardijaka.