qanastek/EMEA-V3 huggingface dataset:
Entacapone has been authorised in the European Union (EU) as Comtess/ Comtan since 1998.
Entacapone ilu awtorizzat fl- Unjoni Ewropea (UE) mill- 1998 bħala Comtess/ Comtan.
The use of combinations of levodopa and carbidopa is well established, with these combinations being in use since the mid-1970s.
L- użu tal - kombinazzjonijiet ta 'levodopa u carbidopa ilu stabbilit sew, u ilhom jintużaw minn nofs is- snin sebgħin.
Having all three substances in the same tablet can lower the number of tablets the patients have to take and help them stick to treatment.
Bis- saħħa tal- kombinazzjoni tat- tliet sustanzi fl- istess pillola, l- għadd ta 'pilloli li l- pazjenti għandhom jieħdu jonqos u dan jgħinhom biex iżommu mat- trattament.
How has Stalevo been studied?
Kif ġie studjat Stalevo?
Because Stalevo is based on another medicine already authorised in the EU, the company used some of the data from Comtess/ Comtan to support the use of Stalevo.
Billi Stalevo ġie prodott abbażi ta 'mediċina oħra diġà awtorizzata fl- UE, il- kumpanija użat xi dejta relatata ma' Comtess/ Comtan biex tappoġġa l- użu ta 'Stalevo.
The company also presented data from the published literature for levodopa and carbidopa.
Il- kumpanija ppreżentat ukoll dejta li ġejja mil- letteratura xjentifika pubblikata għal levodopa u carbidopa.
The company carried out ‘ bioequivalence’ studies to show that taking Stalevo gives the same levels in the blood of levodopa, carbidopa and entecapone as taking the active substances as separate tablets containing entacapone and combination tablets containing both levodopa and carbidopa.
Il- kumpanija wettqet studji biex turi li meta t- teħid ta 'Stalevo jipproduċi l- istess livelli ta' levodopa, carbidopa u entacapone fid- demm bħat- teħid tat- tliet sustanzi attivi fil- forma ta 'pilloli separati ta' entacapone u kombinazzjoni ta 'levodopa u carbidopa f' pilloli (bijoekwivalenza).
What benefit has Stalevo shown during the studies?
X' benefiċċji ta 'Stalevo ntwerew f' dawn l- istudji?
The studies showed that Stalevo is bioequivalent to the separate tablets.
L- istudji wrew li Stalevo huwa bijoekwivalenti għall- pilloli separati.
What is the risk associated with Stalevo?
X' inhu r- riskju assoċjat ma 'Stalevo?
The most common side effects with Stalevo are dyskinesia (uncontrollable movements), nausea (feeling sick), harmless urine discoloration and mental changes including symptoms of paranoia and psychosis (altered sense of reality), depression (possibly with thoughts of suicide) and problems with memory or thinking.
L- effetti sekondarji l- aktar komuni bi Stalevo huma diskinesija (movimenti involontarji), nawżea (dardir), telf tal- kulur ta 'l- awrina li ma jagħmilx ħsara u alterazzjonijiet mentali fosthom sintomi paranojċi u psikotiċi (sens tar- realtà alterat), depressjoni (aktarx bi ħsibijiet ta' suwiċidju) u disturbi tal- memorja jew tal- ħsieb.
For the full list of all side effects reported with Stalevo, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati bi Stalevo, ara l- Fuljett ta' Tagħrif.
Stalevo should not be used in people who may be hypersensitive (allergic) to levodopa, carbidopa, entacapone or any of the other ingredients.
Stalevo ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal levodopa, carbidopa, entacapone jew għal kwalunkwe ingredjent ieħor.
Stalevo should not be used in patients with: • severe liver disease; • narrow-angle glaucoma (increased pressure within the eye); • phaeochromocytoma (a tumour of the adrenal gland); • a history of neuroleptic malignant syndrome (a dangerous nervous disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Stalevo ma għandux jintuża f' pazjenti: • li jbatu minn mard gravi tal- fwied; • bi glawkoma b' angolu dejjaq (żieda fil- pressjoni ta 'l- għajnejn); • li jbatu minn feokromoċitoma (phaeochromocytoma, tumur tal- glandola surrenali [adrenal gland]), • bi storja ta' sindromu newrolettiku malinn (disturb nervuż gravi kkawżat normalment minn mediċini antipsikotiċi) jew rabdomjoliżi (rhabdomyolysis, tkissir tal- fibri muskolari).
Stalevo should not be used together with other medicines that belong to the group ‘ monoamine oxidase inhibitors ’ (a type of antidepressant).
Stalevo ma għandux jintuża flimkien ma 'mediċini oħrajn li jappartjenu għall- grupp ta' l - 'inibituri tal - monoaminoossidażi (monoamine oxidase inhibitors, tip ta' antidepressiv).
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Ara s- Sommarju tal - Karatteristiċi tal- Prodott (parti wkoll mill- EPAR) għad- dettalji kollha.
Why has Stalevo been approved?
Għaliex ġie approvat Stalevo?
The Committee for Medicinal Products for Human Use (CHMP) decided that Stalevo’ s benefits are greater than its risks for the treatment of patients with Parkinson’ s disease and end-of-dose motor fluctuations not stabilised on levodopa/ dopa decarboxylase inhibitor treatment.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Stalevo huma ogħla mir- riskji tiegħu għat- trattament ta' pazjenti li jbatu mill- marda ta 'Parkinson bi fluttwazzjonijiet fiċ- ċaqliq ta' "doża finali" li mhumiex stabbilizzati bit- trattament b' levotopa/ inibituri tad- dopa dekarbossilażi.
The Committee recommended that Stalevo be given marketing authorisation.
Il- Kumitat irrakkomanda li Stalevo jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Stalevo:
Aktar tagħrif dwar Stalevo:
The European Commission granted a marketing authorisation valid throughout the European Union for Stalevo on 17 October 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha, għal Stalevo fis- 17 ta 'Ottubru 2003.
The marketing authorisation holder is Orion Corporation.
Id- deterntur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq huwa Orion Corporation.
The full EPAR for Stalevo is available here.
L- EPAR sħiħ dwar Stalevo jista 'jiġi kkonsultat hawn.
Stalevo 50 mg/ 12.5 mg/ 200 mg film-coated tablets
Stalevo 50 mg/ 12. 5 mg/ 200 mg pilloli miksija b’ rita
Each tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
Kull pillola fiha 50 mg ta ’ levodopa, 12. 5 mg ta ’ carbidopa u 200 mg ta ’ entacapone.
Each tablet contains 1.2 mg of sucrose.
Kull pillola fiha 1. 2 mg ta ’ sucrose
Brownish or greyish red, round, convex, unscored film-coated tablets marked with ‘ LCE 50’ on one side.
Pilloli miskija b’ rita, bla sinjal imnaqqax, ta ’ lewn aħmar fil- kannella jew griż, tondi, bbuzzati, immarkati b ’ ‘ LCE 50 ’ fuq naħa waħda.
Stalevo is indicated for the treatment of adult patients with Parkinson’ s disease and end-of-dose motor fluctuations not stabilised on levodopa/ dopa decarboxylase (DDC) inhibitor treatment.
Stalevo huwa ndikat għall- kura ta ’ pazjenti adulti bil- marda ta ’ Parkinson u b’ oxxillazzjonijiet motorji tat- tmiem tad- doża li mhumiex stabbilizzati fuq kura b’ levodopa/ inibitur ta ’ dopa decarboxylase (DDC).
Each tablet is to be taken orally either with or without food (see section 5.2).
Kull pillola għandha tittieħed mill- ħalq ma ’ l- ikel jew mingħajr ikel (ara sezzjoni 5. 2).
One tablet contains one treatment dose and the tablet may only be administered as whole tablets.
Pillola waħda fiha doża ta ’ kura waħda u l- pillola tista ’ tingħata biss bħala pilloli sħaħ.
The optimum daily dosage must be determined by careful titration of levodopa in each patient.
Id- dożaġġ ottimali ta ’ kuljum għandu jiġi stmat permezz ta ’ titrazzjoni b’ kawtela ta ’ levodopa f’ kull pazjent.
The daily dose should be preferably optimised using one of the four available tablet strengths (50 mg/ 12.5 mg/ 200 mg, 100 mg/ 25 mg/ 200 mg, 150 mg/ 37.5 mg/ 200 mg or 200 mg/ 50 mg/ 200 mg levodopa/ carbidopa/ entacapone).
Id- doża ta ’ kuljum għandha preferibilment tiġi ottimizzata bl- użu ta ’ waħda mill- erba ’ qawwiet ta ’ pilloli disponibbli (50 mg/ 12. 5 mg/ 200 mg, 100 mg/ 25 mg/ 200 mg, 150 mg/ 37. 5 mg/ 200 mg jew 200 mg/ 50 mg/ 200 mg levodopa/ carbidopa/ entacapone).
Patients should be instructed to take only one Stalevo tablet per dose administration.
Il- pazjenti għandhom jiġu mgħallma biex jieħdu biss pillola waħda ta ’ Stalevo kull għotja ta ’ doża.
Patients receiving less than 70-100 mg carbidopa a day are more likely to experience nausea and vomiting.
Pazjenti li qed jirċievu inqas minn 70- 100 mg carbidopa kuljum huma aktar probabbli li jkollhom tqallih u rimettar.
While the experience with total daily dosage greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2000 mg and therefore the maximum dose is 10 tablets per day for the Stalevo strengths of 50 mg/ 12.5 mg/ 200 mg, 100 mg/ 25 mg/ 200 mg and 150 mg/ 37.5 mg/ 200 mg.
Filwaqt li l- esperjenza b’ dożaġġ totali ta ’ kuljum ta ’ aktar minn 200 mg carbidopa hija limitata, id- doża massima ta ’ entacapone rrakkomandata kuljum hija ta ’ 2000 mg u għalhekk id - doża massima hija ta ’ 10 pilloli kuljum għall- qawwiet ta ’ Stalevo ta ’ 50 mg/ 12. 5 mg/ 200 mg, 100 mg/ 25 mg/ 200 mg u 150 mg/ 37. 5 mg/ 200 mg.
Ten tablets of Stalevo 150 mg/ 37.5 mg/ 200 mg equals 375 mg of carbidopa a day.
Għaxar pilloli ta ’ Stalevo 150 mg/ 37. 5 mg/ 200 mg huma ekwivalenti għal 375 mg ta ’ carbidopa kuljum.
According to this daily carbidopa dose, the maximum recommended daily Stalevo 200 mg/ 50 mg/ 200 mg dose is 7 tablets per day.
Skond din id- doża ta ’ kuljum ta ’ carbidopa, d - doża massima rrakkomandata kuljum ta ’ Stalevo 200 mg/ 50 mg/ 200 mg hija 7 pilloli kuljum.
Usually Stalevo is to be used in patients who are currently treated with corresponding doses of standard release levodopa/ DDC inhibitor and entacapone.
Normalment Stalevo għandu jintuża f’ pazjenti li bħalissa qed jiġu kkurati b’ dożi korrispondenti ta ’ levodopa/ inibitur ta ’ DDC u entacapone li jinħelsu b’ mod standard.
How to transfer patients taking levodopa/ DDC inhibitor (carbidopa or benserazide) preparations and entacapone tablets to Stalevo
Kif taqleb pazjenti li qed jieħdu preparazzjonijiet ta ’ levodopa/ inibitur ta ’ DDC (carbidopa jew benserazide) u pilloli entacapone għal Stalevo
Patients who are currently treated with entacapone and with standard release levodopa/ carbidopa in doses equal to Stalevo tablet strengths can be directly transferred to corresponding Stalevo tablets.
Pazjenti li bħalissa qed jiġu kkurati b’ entacapone u b’ levodopa/ carbidopa li jinħelsu b’ mod standard f’ dożi ugwali għall- qawwiet ta ’ pilloli Stalevo jistgħu jinqalbu direttament għall- pilloli Stalevo
2 For example, a patient taking one tablet of 50 mg/ 12.5 mg of levodopa/ carbidopa with one tablet of entacapone 200 mg four times daily can take one 50 mg/ 12.5 mg/ 200 mg Stalevo tablet four times daily in place of their usual levodopa/ carbidopa and entacapone doses.
Per eżempju, pazjent li qed jieħu pillola waħda ta ’ 50 mg/ 12. 5 mg ta ’ levodopa/ carbidopa ma ’ pillola waħda ta ’ entacapone 200 mg erba ’ darbiet kuljum jista ’ jieħu pillola waħda ta ’ 50 mg/ 12. 5 mg/ 200 mg Stalevo erba ’ darbiet kuljum flok id- dożi tas- soltu ta ’ levodopa/ carbidopa u entacapone.
When initiating Stalevo therapy for patients currently treated with entacapone and levodopa/ carbidopa in doses not equal to Stalevo 50 mg/ 12.5 mg/ 200 mg, (or 100 mg/ 25 mg/ 200 mg, or 150 mg/ 37.5 mg/ 200 mg or 200 mg/ 50 mg/ 200 mg) tablets, Stalevo dosing should be carefully titrated for optimal clinical response.
Meta tinbeda kura b’ Stalevo għall- pazjenti li bħalissa qed jiġu kkurati b’ entacapone u b’ levodopa/ carbidopa f’ dożi mhux ugwali għall- pilloli Stalevo ta ’ 50 mg/ 12. 5 mg/ 200 mg, (jew 100 mg/ 25 mg/ 200 mg, jew 150 mg/ 37. 5 mg/ 200 mg jew 200 mg/ 50 mg/ 200 mg), l- iddożar ta ’ Stalevo għandu jiġi ttitrat b’ kawtela għal respons kliniku ottimali.
At the initiation, Stalevo should be adjusted to correspond as closely as possible to the total daily dose of levodopa currently used.
Stalevo għandu jiġi aġġustat biex jikkorrispondi b’ mod viċin kemm jista ’ jkun għad- doża totali ta ’ kuljum ta ’ levodopa li tkun qed tintuża f’ dak il- ħin.
When initiating Stalevo in patients currently treated with entacapone and levodopa/ benserazide in a standard release formulation, discontinue dosing of levodopa/ benserazide the previous night and start Stalevo the next morning.
Meta jinbeda Stalevo f’ pazjenti li f’ dak il- ħin ikunu qed jiġu kkurati b’ entacapone u levodopa/ benserazide f’ preparazzjoni li tinħeles b’ mod standard, waqqaf l- iddożar ta ’ levodopa/ benserazide il- lejl ta ’ qabel u ibda Stalevo l- għada filgħodu.
Begin with a dosage of Stalevo that will provide either the same amount of levodopa or slightly (5-10%) more.
Ibda ’ b’ dożaġġ ta ’ Stalevo li jipprovdi l- istess ammont ta ’ levodopa jew kemmxejn (5- 10%) aktar.
How to transfer patients not currently treated with entacapone to Stalevo
Kif taqleb pazjenti li bħalissa mhux qed jiġu kkurati b’ entacapone għal Stalevo
Initiation of Stalevo may be considered at corresponding doses to current treatment in some patients with Parkinson's disease and end-of-dose motor fluctuations, who are not stabilised on their current standard release levodopa/ DDC inhibitor treatment.
Il- bidu ta ’ Stalevo jista ’ jiġi kkunsidrat f’ dożi korrispondenti għall- kura li tkun għaddejja f’ xi pazjenti bil- marda ta ’ Parkinson u b’ oxxillazzjonijiet motorji tat- tmiem tad- doża, li mhux stabbilizzati fuq il - kura li jkunu qed jieħdu ta ’ levodopa/ inibitur ta ’ DDC li jinħelsu b’ mod standard.
However, a direct switch from levodopa/ DDC inhibitor to Stalevo is not recommended for patients who have dyskinesias or whose daily levodopa dose is above 800 mg.
Iżda, tibdil dirett minn levodopa/ inibitur ta ’ DDC għal Stalevo mhux irrakkomandat għal pazjenti li għandhom diskinesja jew għal dawk li d- doża ta ’ kuljum ta ’ levodopa hija aktar minn 800 mg.
In such patients it is advisable to introduce entacapone treatment as a separate treatment (entacapone tablets) and adjust the levodopa dose if necessary, before switching to Stalevo.
F’ dawn il- pazjenti, ta ’ min jirrikkmanda li kura b’ entacapone tiġi ntrodotta bħala kura separata (pilloli entacapone) u li d - doża ta ’ levodopa tiġi aġġustata jekk hemm bżonn, qabel jinqalbu għal Stalevo.
Entacapone enhances the effects of levodopa.
Entacapone issaħħaħ l- effetti ta ’ levodopa.
It may therefore be necessary, particularly in patients with dyskinesia, to reduce levodopa dosage by 10-30% within the first days to first weeks after initiating Stalevo treatment.
Għalhekk, speċjalment f’ pazjenti b’ diskinesja, għandu mnejn ikun hemm bżonn li d- dożaġġ ta ’ levodopa jiġi mnaqqas b’ 10- 30% fl- ewwel ftit jiem sa ġimgħat wara li tinbeda l- kura b’ Stalevo.
The daily dose of levodopa can be reduced by extending the dosing intervals and/ or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Id- doża ta ’ kuljum ta ’ levodopa tista ’ tiġi mnaqqsa billi jiġu mtawwla l- intervalli ta ’ dożaġġ u/ jew billi jiġi mnaqqas l- ammont ta ’ levodopa ta ’ kull doża, skond il - kundizzjoni klinika tal- pazjent.
Dosage adjustment during the course of the treatment
Aġġustament fid- dożaġġ waqt il- kors ta ’ kura
When more levodopa is required, an increase in the frequency of doses and/ or the use of an alternative strength of Stalevo should be considered, within the dosage recommendations.
Meta jkun hemm bżonn ta ’ aktar levodopa, għandhom jiġu kkunsidrati żjieda fil- frekwenza ta ’ dożi u/ jew l- użu ta ’ qawwa alternattiva ta ’ Stalevo, fir- rakkomandazzjonijiet ta ’ dożaġġ.
When less levodopa is required, the total daily dosage of Stalevo should be reduced either by decreasing the frequency of administration by extending the time between doses, or by decreasing the strength of Stalevo at an administration.
Meta jkun hemm bżonn ta ’ inqas levodopa, id- dożaġġ totali ta ’ kuljum ta ’ Stalevo għandu jitnaqqas billi titnaqqas il- frekwenza ta ’ l- għotja permezz ta ’ ħin itwal bejn id- dożi, jew billi titnaqqas il- qawwa ta ’ Stalevo f’ għotja.
If other levodopa products are used concomitantly with a Stalevo tablet, the maximum dosage recommendations should be followed.
Jekk jintużaw prodotti oħra li fihom levodopa fl- istess ħin ma ’ pillola Stalevo, ir- rakkomandazzjonijet ta ’ dożaġġ massimu għandhom jiġu segwiti.
Discontinuation of Stalevo therapy:
Twaqqif ta ’ terapija b’ Stalevo:
If Stalevo treatment (levodopa/ carbidopa/ entacapone) is discontinued and the patient is transferred to levodopa/ DDC inhibitor therapy without entacapone, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
Jekk kura b’ Stalevo (levodopa/ carbidopa/ entacapone) titwaqqaf u l - pazjent jiġi trasferit għal terapija b’ levodopa/ inibitur ta ’ DDC mingħajr entacapone, huwa neċessarju li d- dożaġġ ta ’ kull kura oħra kontra l- marda ta ’ Parkinson jiġi aġġustat, speċjalment levodopa, sabiex jintlaħaq livell ta ’ kontroll suffiċjenti tas- sintomi tal- marda ta ’ Parkinson.
Stalevo is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Stalevo mhux irrakkomandat għall- użu fit- tfal taħt l- età ta ’ 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
No dosage adjustment of Stalevo is required for elderly patients.
Ma hemm bżonn l- ebda aġġustament fid- dożaġġ ta ’ Stalevo f’ pazjenti anzjani.
It is advised that Stalevo should be administered cautiously to patients with mild to moderate hepatic impairment.
Huwa rrakkomandat li Stalevo għandu jingħata b’ kawtela lill- pazjenti b’ ineboliment epatiku ħafif għal moderat.
Dose reduction may be needed (see section 5.2).
Jista ’ jkun hemm bżonn ta ’ tnaqqis fid- doża (ara sezzjoni 5. 2).
For severe hepatic impairment see section 4.3.
Għall- indeboliment epatiku sever ara sezzjoni 4. 3.
3 Renal impairment:
3 Indeboliment renali:
Renal impairment does not affect the pharmacokinetics of entacapone.
Indeboliment renali ma jaffettwax il- farmakokinetika ta ’ entacapone.
No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, therefore Stalevo therapy should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy (see section 5.2).
Ma ġew irrappurtati l- ebda studji partikolari dwar il- farmakokinetika ta ’ levodopa u carbidopa f’ pazjenti b’ insuffiċjenza renali, għalhekk terapija b’ Stalevo għandha tingħata b’ kawtela lill- pazjenti b’ insuffiċjenza renali severa inkluż dawk li qed jirċievu terapija b’ dijalisi (ara sezzjoni 5. 2).
- Hypersensitivity to the active substances or to any of the excipients.
Sensittività eċċessiva għas- sustanzi attivi jew għal xi sustanzi mhux attivi.
- Severe hepatic impairment.
- Indeboliment epatiku sever.
- Narrow-angle glaucoma.
- Glawkoma ta ’ angolu dejjaq.
- Pheochromocytoma.
- Fejokromoċitoma.
- Concomitant use of Stalevo with non-selective monoamine oxidase (MAO-A and MAO-B)
- L- użu fl- istess ħin ta ’ Stalevo ma ’ inibituri mhux selettivi ta ’ monoamine oxidase (MAO- A u
inhibitors (e. g. phenelzine, tranylcypromine).
MAO- B) (e. ż. phenelzine, tranylcypromine).
- Concomitant use of a selective MAO-A inhibitor and a selective MAO-B inhibitor (see section
- L- użu fl- istess ħin ta ’ inibitur selettiv ta ’ MAO- A u inibitur selettiv ta ’ MAO- B (ara sezzjoni
- A previous history of Neuroleptic Malignant Syndrome (NMS) and/ or non-traumatic
- Okkorrenza minn qabel tas- Sindrome Newrolettiku Malinn (NMS) u/ jew rabdomilożi mhux
rhabdomyolysis.
trawmatika.
- Stalevo is not recommended for the treatment of drug-induced extrapyramidal reactions
- Stalevo mhux irrakkomandat għall- kura ta ’ reazzjonijiet ekstrapiramidali indotti minn prodotti
- Stalevo therapy should be administered cautiously to patients with severe cardiovascular or
- Terapija b’ Stalevo għandha tingħata b’ attenzjoni lill- pazjenti b’ mard kardjovaskulari jew
pulmonary disease, bronchial asthma, renal or endocrine disease, or history of peptic ulcer disease or of convulsions.
pulmonari sever, ażma fil- bronki, mard renali jew endokrinali, jew passat ta ’ mard ta ’ ulċera peptika jew ta ’ konvulżjonijiet.
- In patients with a history of myocardial infarction who have residual atrial nodal, or ventricular
- F’ pazjenti b’ passat ta ’ infart mijokardijaku li għandhom arritmija atrijali nodali, jew ventrikolari
arrhythmias, cardiac function should be monitored with particular care during the period of initial dosage adjustments.
residwali, għandu jkollhom il- funzjoni kardijaka sorveljata b’ attenzjoni partikolari waqt il - perjodu ta ’ aġġustamenti tal- bidu fid- doża.
- All patients treated with Stalevo should be monitored carefully for the development of mental
- Il- pazjenti kollha kkurati b’ Stalevo għandhom jiġu sorveljati b’ attenzjoni għal żvilupp ta ’ bidliet
changes, depression with suicidal tendencies, and other serious antisocial behaviour.
mentali, depressjoni b’ tendenzi ta ’ suwiċidju, u mġiba antisoċjali serja oħra.
Patients with past or current psychosis should be treated with caution.
Pazjenti b’ passat jew bi preżenza ta ’ psikosi għandhom jiġu kkurati b’ kawtela.
- Concomitant administration of antipsychotics with dopamine receptor-blocking properties,
- L- għotja fl- istess waqt ta ’ antipsikotiċi bi proprjetajiet li jimblukkaw ir- riċetturi ta ’ dopamine,
particularly D2 receptor antagonists should be carried out with caution, and the patient carefully observed for loss of antiparkinsonian effect or worsening of parkinsonian symptoms.
partikolarment antagonisti tar- riċetturi D2, għandha ssir b’ kawtela, u l- pazjent għandu jiġi sorveljat għat- telf ta ’ l- effett kontra l- marda ta ’ Parkinson jew rkadar tas- sintomi tal- marda ta ’ Parkinson.
- Patients with chronic wide-angle glaucoma may be treated with Stalevo with caution, provided
- Pazjenti bi glawkoma ta ’ angolu wiesa ’ kronika jistgħu jiġu kkurati b’ Stalevo b’ kawtela, dejjem
the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in intra-ocular pressure.
jekk il- pressjoni intra- okulari tkun ikkontrollata sew u li l- pazjent ikun sorveljat b’ kawtela għal bidliet fil- pressjoni intra- okulari.
- Stalevo may induce orthostatic hypotension.
- Stalevo jista ’ jinduċi ipotensjoni ortostatika.
Therefore Stalevo should be given cautiously to
Għalhekk Stalevo għandu jingħata b’ kawtela lill -
patients who are taking other medicinal products which may cause orthostatic hypotension.
pazjenti li qed jieħdu prodotti mediċinali oħra li jistgħu jikkawżaw ipotensjoni ortostatika.
- Entacapone in association with levodopa has been associated with somnolence and episodes of
- Entacapone flimkien ma ’ levodopa kien assoċjat ma ’ ngħas u episodji ta ’ attakki ta ’ ngħas
sudden sleep onset in patients with Parkinson’ s disease and caution should therefore be exercised when driving or operating machines (see section 4.7).
f’ daqqa f’ pazjenti bil- marda ta ’ Parkinson u għalhekk għandu jkun hemm kawtela waqt is - sewqan jew tħaddim ta ’ magni (ara sezzjoni 4. 7).
- In clinical studies, undesirable dopaminergic effects, e. g. dyskinesia, were more common in
- Fi provi kliniċi, effetti dopaminerġiċi mhux mixtieqa, e. ż. diskinesja, kienu aktar komuni
patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
f’ pazjenti li rċevew entacapone u agonisti ta ’ dopamine (bħal bromocriptine), selegiline jew amantadine meta mqabbel ma ’ dawk li rċevew plaċebo ma ’ din it- taħlita.
The doses of other antiparkinsonian medicinal products may need to be adjusted when Stalevo treatment is substituted for a patient currently not treated with entacapone.
Jista jkun hemm bżonn li d- doża ta ’ prodotti mediċinali oħrajn kontra l- marda ta ’ Parkinson tiġi aġġustata meta jkun hemm sostituzzjoni ta ’ kura b’ Stalevo għall- pazjent li bħalissa mhux qed jiġi kkurat b’ entacapone.
- Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has
- Rabdomijolisi sekondarja għal diskinesja severa jew sindromu newrolettiku malinn (NMS)
been observed rarely in patients with Parkinson’ s disease.
kienet osservata b’ mod rari f’ pazjenti bil- marda ta ’ Parkinson.
Therefore, any abrupt dosage reduction or withdrawal of levodopa should be carefully observed, particularly in patients who are also receiving neuroleptics.
Għalhekk, kull tnaqqis f’ daqqa fid- dożaġġ jew it- twaqqif ta ’ levodopa għandu jiġi osservat b’ attenzjoni, speċjalment f’ pazjenti li qed jirċievu wkoll newrolettiċi.
NMS, including rhabdomyolysis and hyperthermia, is characterised by motor symptoms (rigidity, myoclonus, tremor), mental status changes (e. g., agitation, confusion, coma), hyperthermia, autonomic dysfunction (tachycardia, labile blood pressure) and elevated serum creatine phosphokinase.
NMS, inkluż rabdomijolisi u ipertermja, hija kkarratterizzata minn sintomi motorji (riġidità, mijoklonus, tregħid), tibdil fl- istat mentali (e. ż., aġitazzjoni, konfużjoni, koma), ipertermja, disfunzjoni awtonomika (takikardja, pressjoni tad- demm mhix stabbli) u creatine phosphokinase fis- serum għoli.
In individual cases, only some of these symptoms and/ or findings may be evident.
F’ każijiet individwali, jistgħu jkunu evidenti
4 phosphokinase has been reported with the abrupt withdrawal of antiparkinsonian agents.
Id- dijanjosi bikrija hija importanti għall - immaniġġjar xieraq ta ’ NMS.
Neither NMS nor rhabdomyolysis have been reported in association with entacapone treatment from controlled trials in which entacapone was discontinued abruptly.
La NMS u lanqas rabdomijolisi ma kienu rrappurtati f’ assoċjazzjoni ma ’ kura b’ entacapone minn provi kkontrollati fejn entacapone twaqqaf f’ daqqa.
Since the introduction of entacapone into the market, isolated cases of NMS have been reported, especially following abrupt reduction or discontinuation of entacapone and other concomitant dopaminergic medicinal products.
Minn wara l- introduzzjoni ta ’ entacapone fis- suq, ġew irrappurati każijiet iżolati ta ’ NMS, speċjalment wara t- tnaqqis jew it- twaqqif f’ daqqa ta ’ entacapone u ta ’ prodotti mediċinali dopaminerġiċi oħra li kienu qed jittieħdu fl - istess ħin.
When considered necessary, the replacement of Stalevo with levodopa and DDC inhibitor without entacapone or other dopaminergic treatment should proceed slowly and an increase in levodopa dosage may be necessary.
Meta kkunsidrat neċessarju, it- tibdil ta ’ Stalevo ma ’ levodopa u inibitur DDC mingħajr entacapone jew kura dopaminerġika oħra għandu jsir bil- mod u jista ’ jkun hemm bżonn ta ’ żjieda fid- dożaġġ ta ’ levodopa.
- If general anaesthesia is required, therapy with Stalevo may be continued for as long as the
- Jekk tkun meħtieġa anestesija ġenerali, it- terapija b’ Stalevo tista ’ titkompla sakemm il- pazjent
patient is permitted to take fluids and medicinal products by mouth.
jitħalla jieħu likwidi u prodotti mediċinali mill- ħalq.
If therapy has to be stopped temporarily, Stalevo may be restarted as soon as oral medicinal products can be taken at the same daily dosage as before.
Jekk it- terapija għandha bżonn titwaqqaf temporanjament, Stalevo jista ’ jerġa ’ jinbeda hekk kif prodotti mediċinali orali jistgħu jittieħdu bl- istess dożaġġ ta ’ kuljum bħal qabel.
- Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is
- Hija rrakkomandata evalwazzjoni perjodika tal- funzjoni epatika, emopoetika, kardjovaskulari u
recommended during extended therapy with Stalevo.
renali waqt kura mtawwla b’ Stalevo.
- For patients experiencing diarrhoea, a follow-up of weight is recommended in order to avoid
- Għal dawk il- pazjenti li jkollhom dijarea, huwa rrakkomandat li l- piż jiġi sorveljat sabiex jiġi
potential excessive weight decrease.
evitat l- potenzjal ta ’ tnaqqis żejjed fil- piż.
- Pathological gambling, increased libido and hypersexuality have been reported in Parkinson’ s
- Logħob ta ’ l- azzard patoloġiku, żjieda fil- libido u ipersesswalità ġew irrappurtati f’ pazjenti
disease patients treated with dopamine agonists and other dopaminergic treatments such as Stalevo.
bil- marda ta ’ Parkinson ikkurati b’ agonisti ta ’ dopamine u kura dopaminerġika oħra bħal Stalevo.
- For patients who experience progressive anorexia, asthenia and weight decrease within a
- Għal pazjenti li jesperjenzaw anoreksja progressiva, astenija u tnaqqis fil- piż f’ perijodu ta ’
relatively short period of time, a general medical evaluation including liver function should be considered.
żmien relattivament qasir, evalwazzjoni medika ġenerali li tinkludi l- funzjonalment tal- fwied għandha tiġi kkonsidrata.
- Stalevo contains sucrose, and therefore patients with rare hereditary problems of fructose
- Stalevo fih sucrose, u għalhekk pazjenti bi problemi ereditarji rari ta ’ intolleranza għall- fructose,
intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
assorbiment ħażin ta ’ glucose- galactose, jew insuffiċjenza ta ’ sucrase- isomaltase m’ għandhomx jieħdu din il- mediċina.
Other antiparkinsonian medicinal products:
Prodotti mediċinali kontra l- marda ta ’ Parkinson oħra:
To date there has been no indication of interactions that would preclude concurrent use of standard antiparkinsonian medicinal products with Stalevo therapy.
S’ issa ma kienx hemm indikazzjoni ta ’ interazzjonijiet li ma jippermettux l- użu flimkien ta ’ prodotti mediċinali standard kontra l- marda ta ’ Parkinson ma ’ terapija b’ Stalevo.
Entacapone in high doses may affect the absorption of carbidopa.
Entacapone f’ doża għolja jista ’ jaffettwa l- assorbiment ta ’ carbidopa.
However, no interaction with carbidopa has been observed with the recommended treatment schedule (200 mg of entacapone up to 10 times daily).
Iżda, ma kienet osservata l- ebda interazzjoni ma ’ carbidopa bil- programm ta ’ kura rrakkomandata (200 mg ta ’ entacapone sa 10 darbiet kuljum).
Interactions between entacapone and selegiline have been investigated in repeated dose studies in Parkinson's disease patients treated with levodopa/ DDC inhibitor and no interaction was observed.
Interazzjonijiet bejn entacapone u selegiline ġew investigati fi studji b’ dożi ripetuti f’ pazjenti bil- marda ta ’ Parkinson ikkurati b’ levodopa/ inibitur ta ’ DDC u ma kienet osservata l- ebda interazzjoni.
When used with Stalevo, the daily dose of selegiline should not exceed 10 mg.
Meta wżat ma ’ Stalevo, id - doża ta ’ kuljum ta ’ selegiline m’ għandiex taqbeż 10 mg.
Caution should be exercised when the following active substances are administered concomitantly with levodopa therapy.
Għandha tintuża kawtela meta s- sustanzi attivi li ġejjin jingħataw fl- istess waqt ma ’ terapija b’ levodopa.
Antihypertensives:
Anti- ipertensivi:
Symptomatic postural hypotension may occur when levodopa is added to the treatment of patients already receiving antihypertensives.
Jista ’ jkun hemm ipotensjoni posturali sintomatika meta levodopa jiġi miżjud mal - kura ta ’ pazjenti li diġa qed jingħataw anti- ipertensivi.
Dosage adjustment of the antihypertensive agent may be required.
Jista ’ jkun hemm bżonn ta ’ aġġustament fid - doża tas- sustanza anti- ipertensiva.
Antidepressants:
Antidepressanti:
Rarely, reactions including hypertension and dyskinesia have been reported with the concomitant use of tricyclic antidepressants and levodopa/ carbidopa.
Rarament, reazzjonijiet inkluż ipertensjoni u diskinesja ġew irrappurtati bl- użu fl - istess ħin ta ’ antidepressanti triċikliċi u levodopa/ carbidopa.
Interactions between entacapone and imipramine and between entacapone and moclobemide have been investigated in single dose studies in healthy volunteers.
Interazzjonijiet bejn entacapone u imipramine u bejn entacapone u moclobemide ġew investigati fi studji b’ doża waħda f’ voluntiera b’ saħħithom.
No pharmacodynamic interactions were observed.
Ma ġew osservati l- ebda interazzjonijiet farmakodinamiċi.
A significant number of Parkinson's disease patients have been treated with the combination of levodopa, carbidopa and entacapone with several active substances including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine and medicinal products that are metabolised by COMT (e. g. catechol-structured compounds, paroxetine).
Numru sinifikanti ta ’ pazjenti bil- marda ta ’ Parkinson ġew ikkurati bit- taħlita ta ’ levodopa, carbidopa u entacapone ma ’ bosta sustanzi attivi inkluż inibituri MAO- A, antidepressanti triċikliċi, inibituri tat- teħid mill- ġdid ta ’ noradrenaline bħal desipramine, maprotiline u venlafaxine u prodotti mediċinali li huma metabolizzati minn COMT (e. ż. prodotti li għandhom struttura ta ’ catechol, paroxetine).
No pharmacodynamic interactions have been observed.
Ma ġew osservati l- ebda interazzjonijiet farmakodinamiċi.
However, caution should be exercised when these medicinal products are used concomitantly with Stalevo (see sections 4.3 and 4.4).
Iżda, għandha tintuża kawtela meta dawn il- prodotti mediċinali
Other active substances:
Sustanzi attivi oħra:
Patients taking these
Antagonisti tar- riċetturi ta ’ dopamine (e. ż. ċertu antipsikotiċi u anti- emetiċi), phenytoin u papaverine jistgħu jnaqqsu l- effett terapewtiku ta ’ levodopa.
5 medicinal products with Stalevo should be carefully observed for loss of therapeutic response.
Pazjenti li qed jieħdu dawn il- prodotti mediċinali ma ’ Stalevo għandhom jiġu osservati mill- viċin għat- telf tar- respons terapewtiku.
Due to entacapone's affinity to cytochrome P450 2C9 in vitro (see section 5.2), Stalevo may potentially interfere with active substances whose metabolism is dependent on this isoenzyme, such as S-warfarin.
Minħabba l- affinità ta ’ entacapone għaċ- ċitokromju P450 2C9 in vitro (ara sezzjoni 5. 2), Stalevo jista ’ potenzjalment jinterferixxi ma ’ sustanzi attivi bħal S- warfarin li l- metaboliżmu tagħhom jiddependi minn din l- iso- enżima.
However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11- 26%].
Iżda, fi studju dwar l- interazzjoni f’ voluntiera b’ saħħithom, entacapone ma biddilx il- livelli fil- plażma ta ’ S- warfarin, filwaqt li l- AUC ta ’ R- warfarin żdiedet b’ medja ta ’ 18% [CI90 11- 26%].
The INR values increased on average by 13% [CI90 6-19%].
Il- valuri ta ’ INR żdiedu b’ medja ta ’ 13% [CI90 6- 19%].
Thus, a control of INR is recommended when Stalevo is initiated for patients receiving warfarin.
Għalhekk, huwa rrakkomandat kontroll ta ’ l- INR meta jinbeda Stalevo f’ pazjenti li qed jieħdu warfarin.
Other forms of interactions:
Forom oħra ta ’ interazzjonijiet:
Since levodopa competes with certain amino acids, the absorption of Stalevo may be impaired in some patients on high protein diet.
Peress li levodopa jikkompeti ma ’ ċertu aċidi amminiċi, l- assorbiment ta ’ Stalevo jista ’ jonqos f’ ċertu pazjenti li qegħdin fuq dieta ta ’ ħafna proteini.
Levodopa and entacapone may form chelates with iron in the gastrointestinal tract.
Levodopa u entacapone jistgħu jiffurmaw chelates mal- ħadid fl- apparat gastro- intestinali.
Therefore, Stalevo and iron preparations should be taken at least 2-3 hours apart (see section 4.8).
Għalhekk, Stalevo u preparazzjonijiet li fihom il- ħadid għandhom jittieħdu minn ta ’ l- inqas 2- 3 sigħat ’ l bogħod minn xulxin (ara sezzjoni 4. 8).
In vitro data:
Tagħrif in vitro:
Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Entacapone jeħel mas- sit ta ’ twaħħil II ta ’ l- albumina umana fejn jeħlu wkoll bosta prodotti mediċinali oħrajn, inkluż diazepam u ibuprofen.
According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products.
Skond studji in vitro, mhux mistenni sostituzzjoni sinifikanti f’ konċentrazzjonijiet terapewtiċi tal- prodotti mediċinali.
Accordingly, to date there has been no indication of such interactions.
Għalhekk, s’ issa ma kien hemm l- ebda indikazzjoni ta ’ interazzjonijiet bħal dawn.
There are no adequate data from the use of the combination of levodopa/ carbidopa/ entacapone in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu tat- taħlita ta ’ levodopa/ carbidopa/ entacapone waqt it- tqala.
Studies in animals have shown reproductive toxicity of the separate compounds (see section 5.3).
Studji fuq bhejjem bis- sustanzi separati wrew ħsara fuq is- sistema riproduttiva (ara sezzjoni 5. 3).
Stalevo should not be used during pregnancy unless the benefits for the mother outweigh the possible risks to the foetus.
Stalevo m’ għandux jintuża waqt it- tqala sakemm il - benefiċċji għall- omm huma akbar mir- riskji possibli għall- fetu.
Levodopa is excreted in human breast milk.
Levodopa joħroġ fil- ħalib tas- sider uman.
There is evidence that lactation is suppressed during treatment with levodopa.
Hemm evidenza li t- treddigħ jiġi mrażżan waqt kura b’ levodopa.
Carbidopa and entacapone were excreted in milk in animals but is not known whether they are excreted in human breast milk.
Carbidopa u entacapone tneħħew fil- ħalib fil- bhejjem iżda mhux magħruf jekk jitneħħewx fil- ħalib tas- sider uman.
The safety of levodopa, carbidopa or entacapone in the infant is not known.
Is- sigurtà ta ’ levodopa, carbidopa jew entacapone fit- tarbija mhix magħrufa.
Women should not breast-feed during treatment with Stalevo.
In- nisa m’ għandhomx ireddgħu waqt kura b’ Stalevo.
Stalevo may have major influence on the ability to drive and use machines.
Stalevo jista ’ jkollu influwenza maġġura fuq il- ħila biex issuq u tħaddem inġenji.
Levodopa, carbidopa and entacapone together may cause dizziness and symptomatic orthostatism.
Levodopa, carbidopa u entacapone flimkien jistgħu jikkawżaw sturdament u ortostatiżmu sintomatiku.
Therefore, caution should be exercised when driving or using machines.
Għalhekk, għandha tintuża kawtela fis- sewqan u t- tħaddim ta ’ magni.
Patients being treated with Stalevo and presenting with somnolence and/ or sudden sleep onset episodes must be instructed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e. g. operating machines) until such recurrent episodes have resolved (see section 4.4).
Pazjenti li qed jiġu kkurati b’ Stalevo u jaqbadhom in- ngħas u/ jew episodji f’ daqqa ta ’ attakki ta ’ rqad għandhom jiġu avżati biex ma jsuqux jew jagħmlu attivitajiet fejn nuqqas fil- viġilanza tista ’ tpoġġi lilhom jew lill- oħrajn f’ riskju ta ’ korriment serju jew mewt (e. ż. tħaddim ta ’ magni) sakemm dawn l - episodji rikorrenti ma ġewx riżolti (ara sezzjoni 4. 4).
The following section describes the undesirable effects reported for levodopa/ carbidopa and for entacapone used in combination with levodopa/ DDC inhibitor.
Is- sezzjoni li ġejja tiddeskrivi l- effetti mhux mixtieqa rrappurtati għal levodopa/ carbidopa u għal entacapone użati f’ taħlita flimkien ma ’ levodopa/ inibitur ta ’ DDC.
Adverse reactions that occur frequently with levodopa/ carbidopa are those due to central neuropharmacological activity of dopamine.
Reazzjonijiet avversi li jseħħu b’ mod frekwenti b’ levodopa/ carbidopa huma dawk minħabba l- attività
These reactions can usually be diminished by levodopa dosage reduction.
Dawn ir- reazzjonijiet ħafna drabi jistgħu jitnaqqsu permezz ta ’ tnaqqis fid- doża ta ’ levodopa.
The most common adverse reactions are dyskinesias including choreiform, dystonic and other involuntary movements.
L- aktar reazzjonijiet avversi komuni huma diskinesja inkluż korejiform, distonika u movimenti nvolontarji oħrajn.
Muscle twitching and blepharospasm may be taken as early signs to consider levodopa dosage reduction.
Kontrazzjonijiet mhux volontarji tal- muskoli u blefarospażmu jistgħu jitqiesu bħala sinjali bikrija biex tiġi kkunsidrata tnaqqis fid- doża ta ’ levodopa.
Nausea, also related to enhanced central dopaminergic activity, is a common adverse reaction of levodopa/ carbidopa.
Tqallih, relatat ukoll ma ’ attività dopaminerġika ċentrali msaħħa, huwa reazzjoni avversa komuni ta ’ levodopa/ carbidopa.
6 Other adverse reactions associated with levodopa/ carbidopa therapy are mental changes, including paranoid ideation and psychotic episodes; depression, with or without development of suicidal tendencies; and cognitive dysfunction.
Reazzjonijiet avversi oħrajn assoċjati ma ’ terapija b’ levodopa/ carbidopa huma bidliet mentali, inkluż idejazzjoni paranojdika u episodji psikotiċi; depressjoni, bi jew bla żvilupp ta ’ tendenzi ta ’ suwiċidju; u disfunzjoni konoxxittiva.
Adding of entacapone to levodopa/ DDC inhibitor therapy (carbidopa or benserazide), i. e. initiation of Stalevo treatment in an entacapone naive patient, may aggravate some of these mental changes.
Iż- żjieda ta ’ entacapone ma ’ terapija b’ levodopa/ inibitur ta ’ DDC (carbidopa jew benserazide), i. e. bidu ta ’ kura b’ Stalevo f’ pazjent bla esperjenza ta ’ entacapone, tista ’ taggrava wħud minn dawn il- bidliet mentali.
Less frequent adverse reactions of levodopa/ carbidopa therapy are irregular heart rhythm and/ or palpitations, orthostatic hypotensive episodes, bradykinetic episodes (the'on-off 'phenomenon), anorexia, vomiting, dizziness, and somnolence.
Reazzjonijiet avversi ta ’ terapija b’ levodopa/ carbidopa inqas frekwenti huma ritmu tal- qalb irregolari u/ jew palpitazzjonijiet, episodji ta ’ ipotensjoni ortostatika, episodji bradikinetiċi (il- fenomenu ta ’ 'on - off'), anoressija, rimettar, sturdament u ngħas.
Gastrointestinal bleeding, development of duodenal ulcer, hypertension, phlebitis, leucopenia, haemolytic and non-haemolytic anaemia, thrombocytopenia, agranulocytosis, chest pain, dyspnoea and paraesthesia have occurred rarely with levodopa/ carbidopa.
Fsada gastro- intestinali, żvilupp ta ’ ulċera duwodenali, ipertensjoni, flebite, lewkopenja, anemija emolitika u mhux emolitika, tromboċitopenja, agranuloċitosi, uġigħ fis- sider, qtugħ ta ’ nifs u parasteżija seħħew b’ mod rari b’ levodopa/ carbidopa.
Convulsions have occurred rarely with levodopa/ carbidopa; however a causal relationship to levodopa/ carbidopa therapy has not been established.
Konvulżjonijiet seħħew b’ mod rari b’ levodopa/ carbidopa; iżda relazzjoni kawżali ma ’ terapija b’ levodopa/ carbidopa ma ġietx stabbilita.
Parkinson’ s disease patients treated with dopamine agonists and other dopaminergic treatments such as Stalevo, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Pazjenti bil- marda ta ’ Parkinson kkurati b’ agonisti ta ’ dopamine u b’ kura dopaminerġika oħra bħal Stalevo, speċjalment f’ dożi għolja, ġew irrappurtati li wrew sinjali ta ’ logħob ta ’ l- azzard patoloġiku, żjieda fil- libido u ipersesswalità, ġeneralment riversibbli mat- tnaqqis tad- doża jew mal- waqfien tal - kura.
Other adverse reactions that have been reported with levodopa and may, therefore, be potential adverse reactions of Stalevo as well, include:
Reazzjonijiet avversi oħrajn li ġew irrappurtati b’ levodopa u għalhekk jistgħu jkunu reazzjonijiet avversi potenzjali ta ’ Stalevo wkoll, jinkudu:
Ataxia, numbness, increased hand tremor, muscle twitching, muscle cramp, trismus, activation of latent Horner's syndrome.
Atassja, tirżiħ, żjieda fir- rogħda ta ’ l- idejn, tiġbid tal- muskolu, bugħawwieġ muskolari, trisma, attivazzjoni tas- sindromu moħbi ta ’ Horner.
Also falling and gait abnormalities are potential undesirable effects.
Waqgħat u anormalitajiet fil- mixja ukoll huma effetti mhux mixtieqa potenzjali.
Diplopia, blurred vision, dilated pupils, oculogyric crises.
Diplopja, vista mċajpra, pupilli ta ’ l- għajnejn dilatati, kriżi okuloġirika.
Dry mouth, bitter taste, sialorrhoea, dysphagia, bruxism, hiccups, abdominal pain and distress, constipation, diarrhoea, flatulence, burning sensation of the tongue.
Ħalq xott, togħma morra, sijaloreja, disfaġja, bruxiżmu, sulluzzu, uġigħ u skumdità addominali, stitikezza, dijarea, gass, sensazzjoni ta ’ ħruq fl- ilsien.
Urinary retention, urinary incontinence, dark urine, priapism.
Żamma ta ’ l- awrina, inkontinenza ta ’ l- awrina, awrina skura, prijapiżmu.
Flushing, increased sweating, dark sweat, rash, hair loss.
Fwawar, żjieda fl- għaraq, għaraq skur, raxx, telf ta ’ xagħar.
Metabolism and nutrition disorders:
Disturbi marbuta mal- metaboliżmu u n- nutrizzjon:
Weight gain or loss, oedema.
Ħieda fit- tnaqqis tal- piż, edima.
Confusion, insomnia, nightmares, hallucinations, delusions, agitation, anxiety, euphoria.
Konfużjoni, insomnija inkubi, alluċinazzjonijiet, delużjonijiet, aġitazzjoni, ansjetà, ewforija.
Miscellaneous:
Varji:
Weakness, faintness, fatigue, headache, hoarseness, malaise, hot flushes, sense of stimulation, bizarre breathing patterns, neuroleptic malignant syndrome, malignant melanoma.
Debbulizza, ħass ħażin, għeja, uġigħ ta ’ ras, ħanqa, tħossok ma tiflaħx, fwawar ta ’ sħana, sens ta ’ stimulazzjoni, sekwenza ta ’ nifs stramb, sindrome newrolettiku malinn, melanoma malinna.
Entacapone
7 Entacapone
The most frequent adverse reactions caused by entacapone relate to the increased dopaminergic activity and occur most commonly at the beginning of the treatment.
Ir- reazzjonijiet avversi l- aktar frekwenti kkawżati minn entacapone għandhom x’ jaqsmu ma ’ żjieda fl - attività dopaminerġika u jseħħu l- aktar fl- bidu tal- kura.
Reduction of levodopa dosage decreases the severity and frequency of the reactions.
Tnaqqis fid- dożaġġ ta ’ levodopa inaqqas is - severità u l- frekwenza tar- reazzjonijiet.
The other major class of adverse reactions are gastrointestinal symptoms, including nausea, vomiting, abdominal pain, constipations and diarrhoea.
L- klassi maġġuri l- oħra ta ’ reazzjonijiet avversi huma sintomi gastro- intestinali, inkluż tqallih, rimettar, uġigħ addominali, stitikezza u dijarea.
Urine may be discoloured reddish-brown by entacapone, but this is a harmless phenomenon.
Permezz ta ’ entacapone, l- urina tista ’ tbiddel il- kulur għal ħamranija fil- kannella, iżda dan huwa fenomenu li ma jikkawżax ħsara.
7 with entacapone and since the introduction of entacapone into the market for the combination use of entacapone with levodopa/ DDC inhibitor.
Ir- reazzjonijiet avversi li ġejjin, imniżżla f’ Tabella 1, inġabru kemm minn studji kliniċi b’ entacapone kif ukoll minn meta entacapone ġie introdott fis- suq għall- użu tat- taħlita ta ’ entacapone ma ’ levodopa/ inibitur ta ’ DDC.
Dyskinesia, Parkinsonism aggravated Dizziness, dystonia, hyperkinesia
Diskinesja, l- marda ta ’ Parkinson aggravata Sturdament, distonja, iperkinesja
Nausea Diarrhoea, abdominal pain, dry mouth, constipation, vomiting Anorexia Colitis
Tqallih Dijarea, uġigħ addominali, ħalq xott, stitikezza, rimettar Anoressija Kolite
Renal and urinary disorders Very common:
Disturbi fil- kliewi u fis- sistema urinarja Komuni ħafna:
Urine discolouration
Tibdil fil- kulur ta ’ l- awrina
Skin and subcutaneous tissue disorders Rare:
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Rari:
Erythematous or maculopapular rash Very rare:
Raxx eritematus jew makulopapulari Rari ħafna:
Urticaria Skin, hair, beard and nail discolorations
Urtikarja Tibdil fil- kulur tal- ġilda, ix- xagħar, id- daqna u d- dwiefer
General disorders and administration site conditions Common:
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Komuni:
Fatigue, sweating increased, fall Weight decrease
Għeja, żjieda fl- għaraq, waqa ’ Tnaqqis fil- piż
Hepatobiliary disorders Rare:
Disturbi fil- fwied u fil- marrara Rari:
Hepatic function tests abnormal Not known:
Testijiet tal- funzjoni epatika anormali Mhux magħrufa:
Hepatitis with mainly cholestatic features (see section 4.4)
Epatite b’ karatteristiċi kolestatiċi (ara sezzjoni 4. 4)
Psychiatric disorders Common:
Disturbi psikjatriċi
*Adverse reactions
Komuni:
are ranked under headings of frequency, the most frequent first, using the
Insomnija, alluċinazzjonijiet, konfużjoni, inkubi, aġitazzjoni
following convention:
L- effetti l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji, bl- użu tal - konvenzjoni li ġejja: