qanastek/EMEA-V3 huggingface dataset:
In Parkinson’ s disease, Sifrol has been studied in five main studies involving 1,546 patients.
Fil- marda ta 'Parkinson, Sifrol ġie studjat f' ħames studji ewlenin li fihom ħadu sehem 1, 546 pazjent.
Four studies compared the effects of Sifrol with those of placebo (a dummy treatment): one study in 360 patients with advanced disease who were already taking levodopa that was starting to become less effective, and three studies in a total of 886 patients with early disease who were not receiving levodopa.
Erba 'studji qabblu l- effetti ta' Sifrol ma 'dawk tal- plaċebo (trattament finta): studju wieħed bi 360 pazjent bil- marda fi stadju avvanzat li kienu diġà qed jieħdu levodopa li kienet bdiet ikollha inqas effett, u tliet studji b' total ta' 886 pazjenti bil- marda f' fażi bikrija li ma kinux qed jieħdu levodopa.
The main measure of effectiveness was the change in scores before and after treatment obtained with a standard questionnaire used to measure the severity of Parkinson’ s disease.
Il - kejl ewlieni tal- kejl ta 'l- effikaċja kien it- tibdil fil- punteġġi qabel u wara t- trattament miksuba minn kwestjonarju standard li jkejjel il- gravità tal- marda tal- Parkinson’ s.
The fifth study compared the effects of Sifrol with those of levodopa in 300 patients with early disease.
Il- ħames studju qabbel l- effetti ta 'Sifrol ma' dawk ta 'levodopa fi 300 pazjent bil- marda f' fażi bikrija.
Its main measure of effectiveness was the proportion of patients who had movement symptoms.
Il- mezz ewlieni tal- kejl ta 'l - effikaċja kien il- proporzjon ta' pazjenti li kellhom sintomi relatati maċ- ċaqliq.
In all studies, Sifrol doses were increased gradually over six to ten weeks before being maintained at a stable dose.
Fl- istudji kollha, id- dożi ta 'Sifrol żdiedu gradwalment matul bejn sitta u għaxar ġimgħat qabel ma nżammu fuq doża stabbli.
Sifrol has also been studied in two main studies of patients with restless legs syndrome.
Sifrol ġie studjat ukoll f' żewġ studji ewlenin ta 'pazjenti bis- sindromu tar- riġlejn li ma għandhomx kwiet.
The first included 344 patients and compared the effects of three doses of Sifrol with those of placebo.
Fl- ewwel studju ħadu sehem 344 pazjent u fih tqabblu l- effetti tat- tliet dożi ta 'Sifrol ma' dawk tal- plaċebo.
The main measure of effectiveness was the improvement in symptoms between the start and end of the study, measured using two standard scales.
Il- mezz ewlieni tal- kejl ta 'l- effikaċja kien it- titjib fis- sintomi bejn il- bidu u t- tmiem ta' l - istudju, imkejjel fuq żewġ skali standard.
The other study included 150 patients who took Sifrol for six months, and compared the effects of remaining on Sifrol or switching to placebo.
Fl- istudju l- ieħor ħadu sehem 150 pazjent li ħadu Sifrol għal sitt xhur, u qabblu l- effetti ta 'meta wieħed jibqa' jieħu Sifrol jew li minflok jibda jieħu l- plaċebo.
The main measure of effectiveness was the time until symptoms got worse.
Il - mezz ewlieni tal- kejl ta 'l- effikaċja kien iż- żmien sa ma s- sintomi marru għall- agħar.
What benefit has Sifrol shown during the studies?
X' kienu l- benefiċċji ta 'Sifrol li ntwerew f' dawn l- istudji?
In the study of patients with advanced Parkinson’ s disease, patients taking Sifrol had larger improvements after 24 weeks of steady-dose treatment than those taking placebo.
Fl- istudju f' pazjenti bil- marda ta 'Parkinson fi stadju avvanzat, il- pazjenti li kienu qed jieħdu Sifrol kellhom titjib ikbar wara 24 ġimgħa ta' trattament b' doża fissa meta mqabbla ma 'dawk li kienu qed jieħdu l- plaċebo.
When compared with levodopa, fewer of the patients taking Sifrol had movement symptoms after 21 months:
Meta mqabbel ma 'levodopa, inqas pazjenti li kienu qed jieħdu Sifrol kellhom sintomi taċ- ċaqliq wara 21 xahar:
28% of the patients taking Sifrol had symptoms (42 out of 151) compared with 51% of the patients taking levodopa (76 out of 150).
28% fost dawk il- pazjenti li kienu qed jieħdu Sifrol kellhom is- sintomi (42 mill- 151) mqabbla ma '51% fost dawk il- pazjenti li kienu qed jieħdu levodopa (76 minn 150).
In the first study of restless legs syndrome, symptom scores fell by between 12.8 and 14.0 points after 12 weeks in patients taking Mirapexin, compared with a decrease of 9.3 points in the patients taking placebo.
Il- punteġġi kienu madwar 23 punt fil- bidu ta 'l- istudju.
The difference between placebo and Sifrol was greatest after four weeks before getting smaller.
L- ikbar differenza bejn il- plaċebo u Sifrol dehret wara erba 'ġimgħat u mbagħad ċkienet.
More patients taking Sifrol also had an improvement in symptoms.
Kien hemm iktar pazjenti li kienu qed jieħdu Sifrol li kellhom titjib fis- sintomi.
The results of the other study were insufficient to prove the long-term effectiveness of Sifrol.
Ir- riżultati ta 'l- istudju l- ieħor ma kinux biżżejjed biex jippruvaw l - effikaċja fit- tul ta' Sifrol.
What is the risk associated with Sifrol?
X' inhu r- riskju assoċjat ma 'Sifrol?
The most common side effect with Sifrol (seen in more than 1 patient in 10) is nausea (feeling sick).
L- iktar effetti sekondarji komuni ma 'Sifrol (li dehru f' iktar minn pazjent wieħed minn għaxra) huma nawsea (tħossok ma tiflaħx).
For the full list of all side effects reported with Sifrol, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Sifrol, ara l- Fuljett ta 'Tagħrif.
Sifrol should not be used in people who may be hypersensitive (allergic) to pramipexole or any of the other ingredients.
Sifrol m' għandux jintuża minn persuni li aktarx ikunu ipersensittivi (allerġiċi) għal pramipexole jew għal kwalunkwe mill- ingredjenti l- oħra.
Why has Sifrol been approved?
Għaliex ġie approvat Sifrol?
The Committee for Medicinal Products for Human Use (CHMP) decided that Sifrol’ s benefits are greater than its risks for the treatment of the signs and symptoms of idiopathic Parkinson’ s disease alone or in combination with levodopa, and for the treatment of moderate to severe idiopathic restless legs syndrome in dosages up to 0.54 mg of base.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Sifrol għandu iktar benefiċċji milli riskji meta użat fit- trattament tas- sinjali u s- sintomi tal- marda ta 'Parkinson idjopatika, waħdu jew flimkien ma' levodopa, u għat- trattament tas- sindromu idjopatiku tar- riġlejn li ma għandhomx kwiet li tkun minn moderat għal gravi b' dożi sa 0. 54 mg tal- bażi.
The Committee recommended that Sifrol be given marketing authorisation.
Il- Kumitat irrakkomanda li Sifrol jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 Other information about Sifrol:
2/ 3 Tagħrif ieħor dwar Sifrol:
The European Commission granted a marketing authorisation valid throughout the European Union for Sifrol to Boehringer Ingelheim International GmbH on 14 October 1997.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Sifrol lil Boehringer Ingelheim International GmbH fl- 14 ta 'Ottubru 1997.
The marketing authorisation was renewed on 14 October 2002 and on 14 October 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 14 ta 'Ottubru 2002 u fl- 14 ta' Ottubru 2007.
The full EPAR for Sifrol can be found here.
L- EPAR sħiħ għal Sifrol jista 'jiġi kkonsultat hawn.
EU number
30 pillola
Invented name
EU/ 1/ 97/ 050/ 002
Strength
Użu orali
Route of administration
Folja (polyamide/ aluminju/ PVC)
Packaging
30 pillola
Package size
100 pillola
Sifrol Sifrol Sifrol Sifrol Sifrol Sifrol Sifrol Sifrol Sifrol Sifrol
Folja (polyamide/ aluminju/ PVC)
0.088 mg 0.088 mg 0.18 mg 0.18 mg 0.7 mg 0.7 mg 1.1 mg 1.1 mg 0.35 mg 0.35 mg
Folja (polyamide/ aluminju/ PVC)
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Folja (polyamide/ aluminju/ PVC)
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Folja (polyamide/ aluminju/ PVC)
blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC)
Folja (polyamide/ aluminju/ PVC)
30 100 30 100 30 100 30 100 30 100
100 pillola
SIFROL 0.088 mg tablets
SIFROL 0. 088 mg pilloli
SIFROL 0.088 mg tablets contain 0.088 mg of pramipexole base (as 0.125 mg of pramipexole dihydrochloride monohydrate).
Il- pilloli SIFROL 0. 088 mg fihom 0. 088 mg ta ’ bażi ta ’ pramipexole (bħala 0. 125 mg ta ’ pramipexole dihydrochloride monohydrate).
SIFROL is indicated for treatment of the signs and symptoms of idiopathic Parkinson’ s disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “ on off” fluctuations).
SIFROL hu indikat għall- kura tas- sinjali u tas- sintomi tal- marda idjopatika ta ’ Parkinson, waħidhom (i. e. mingħajr levodopa) jew flimkien ma ’ levodopa, i. e. matul il- kors tal- marda, sa l- istadji aħħarin fejn l- effett ta ’ levodopa jonqos ħafna jew isir inkonsistenti u jseħħu fluttwazzjonijiet ta ’ l- effett terapewtiku (fl- aħħar tad- doża jew fluttwazzjonijiet “ on off ”).
SIFROL is indicated for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of base (0.75 mg of salt) (see section 4.2.).
SIFROL hu indikat għall- kura sintomatika tas- Sindrome tas- Saqajn Bla Kwiet idjopatiku li jkun minn moderat sa sever f’ dożaġġi sa 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ) (ara sezzjoni 4. 2).
Ascending – Dose Schedule of SIFROL
Skeda ta ’ Doża li Tiżdied ta ’ SIFROL
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with SIFROL, depending on reactions in individual patients.
Hu rakkomandat li d- dożaġġ ta ’ levodopa jitnaqqas kemm matul il- perjodu meta d- doża tkun qed tiżdied, kif ukoll matul il- kura tal- manteniment b’ SIFROL, skond ir- reazzjonijiet fil- pazjenti individwali.
In patients with a creatinine clearance between 20 and 50 ml/ min, the initial daily dose of SIFROL should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/ 0.25 mg of salt daily).
F’ pazjenti bi tneħħija tal- krejatinina bejn 20 u 50 ml/ min, id- doża inizjali ta ’ kuljum ta ’ SIFROL għandha tingħata f’ żewġ dożi maqsumin, li jibdew minn 0. 088 mg ta ’ bażi (0. 125 mg ta ’ melħ) darbtejn kuljum (0. 176 mg ta ’ bażi/ 0. 25 mg ta ’ melħ kuljum).
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of SIFROL should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
F’ pazjenti bi tneħħija tal- krejatinina ta ’ inqas minn 20 ml/ min, id- doża ta ’ kuljum ta ’ SIFROL għandha tingħata f’ doża waħda, li tibda b’ 0. 088 mg ta ’ bażi (0. 125 mg ta ’ melħ) kuljum.
If renal function declines during maintenance therapy, reduce SIFROL daily dose by the same percentage as the decline in creatinine clearance, i. e. if creatinine clearance declines by 30%, then reduce the SIFROL daily dose by 30%.
Jekk il- funzjoni renali tonqos matul it- terapija tal- manteniment, naqqas id- doża ta ’ kuljum ta ’ SIFROL bl- istess perċentwali bħat- tnaqqis fit- tneħħija tal- krejatinina, i. e. jekk it- tneħħija tal- krejatinina tonqos bi 30%, naqqas id- doża ta ’ kuljum ta ’ SIFROL bi 30%.
90% of absorbed active substance is excreted through the kidneys.
3 Id- dożaġġ f’ pazjenti b’ indeboliment epatiku L- aġġustament fid- doża f’ pazjenti b’ insuffiċjenza epatika probabbilment ma jkunx meħtieġ, għax madwar 90% tas- sustanza attiva assorbita titneħħa minn ġol- kliewi.
However, the potential influence of hepatic insufficiency on SIFROL pharmacokinetics has not been investigated.
Madankollu, l- influwenza potenzjali ta ’ insuffiċjenza epatika fuq il- farmakokinetiċi ta ’ SIFROL ma kinitx investigtaa.
The recommended starting dose of SIFROL is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Id- doża tal- bidu rakkomandata ta ’ SIFROL hi ta ’ 0. 088 mg ta ’ bażi (0. 125 mg ta ’ melħ) li tittieħed darba kuljum 2- 3 sigħat qabel ħin l- irqad.
Dose Schedule of SIFROL
L- Iskeda tad- Doża ta ’ SIFROL
As long-term efficacy of SIFROL in the treatment of RLS has not been sufficiently tested, patient´s response should be evaluated after 3 months treatment and the need for treatment continuation should be reconsidered.
Minħabba li l- effikaċja fit- tul ta ’ SIFROL fil- kura ta ’ RLS ma kinitx ittestjata suffiċjentement, ir- rispons tal- pazjent għandu jkun evalwat wara 3 xhur ta ’ kura, u l- ħtieġa għat- tkomplija tal- kura għandha tkun ikkunsidrata mill- ġdid.
If treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
Jekk il- kura tkun interrotta għal aktar minn ftit ijiem, din għandha terġa ’ tinbeda mill- ġdid kif spjegat hawn fuq.
Treatment discontinuation Since daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) SIFROL can be discontinued without tapering off.
Twaqqif tal- kura Minħabba li d- doża ta ’ kuljum għall- kura tas- Sindrome tas- Saqajn Bla Kwiet ma taqbiżx 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ), SIFROL jista ’ jitwaqqaf mingħajr ma jkun hemm twaqqif gradwali.
The use of SIFROL has not been studied in hemodialysis patients, or in patients with severe renal impairment.
L- użu ta ’ SIFROL ma kienx studjat f’ pazjenti fuq l- emodijalisi, jew f’ pazjenti b’ indeboliment renali sever.
Dosing in children and adolescents SIFROL is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Id- dożaġġ fit- tfal u fl- adolexxenti SIFROL mhux rakkomandat għall- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena, minħabba nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja.
Hypersensitivity to the active substance or to any of the excipients.
Sensittività eċċessiva għas- sustanza attiva jew xi sustanzi mhux attivi.
-4- 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
When prescribing SIFROL in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Meta tingħata riċetta għal SIFROL lil pazjent bil- marda ta ’ Parkinson li jkollu indeboliment renali, doża mnaqqsa skond kif spjegat f’ sezzjoni 4. 2 hi ssuġġerita.
Hallucinations Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
4 Alluċinazzjonijiet L- alluċinazzjonijiet huma effett sekondarju magħruf tal- kura b’ agonisti ta ’ dopamine u b’ levodopa.
Dyskinesia In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of SIFROL.
Diskinesija Fl- istadju avvanzat tal- marda ta ’ Parkinson, flimkien mal- kura b’ levodopa, id- diskinesija tista ’ sseħħ matul it- titrazzjoni inizjali ta ’ SIFROL.
Sudden onset of sleep and somnolence SIFROL has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Irqad li jiġi għal għarrieda u ngħas SIFROL kien assoċjat man- ngħas u episodji ta ’ rqad li jiġi f’ daqqa, partikularment f’ pazjenti bil - marda ta ’ Parkinson.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with SIFROL.
Il- pazjenti jridu jkunu infurmati b’ dan u jkunu avżati biex joqogħdu attenti waqt is- sewqan jew waqt it- tħaddim tal- magni matul il- kura b’ SIFROL.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see section 4.7 and section 4.8).
Minħabba l- possibbiltà ta ’ effetti addittivi, għandha tingħata attenzjoni meta l- pazjenti jkunu qed jieħdu prodotti mediċinali sedattivi oħrajn jew l- alkoħol flimkien ma ’ pramipexole (ara sezzjoni 4. 7 u sezzjoni 4. 8).
Impulse control disorders and compulsive behaviours Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including SIFROL.
Disturbi fil- kontroll tal- impulsi u mġiba kompulsiva Logħob patoloġiku ta ’ l- azzard, żieda fil- libido u ipersesswalità kienu rrappurtati f’ pazjenti kkurati b’ agonisti ta ’ dopamine għall- marda ta ’ Parkinson, li jinkludu SIFROL.
Furthermore, patients and caregivers should be aware of the fact that other behavioural symptoms of impulse control disorders and compulsions such as binge eating and compulsive shopping can occur.
Flimkien ma ’ dan, il- pazjenti u persuni li jieħdu ħsiebhom għandhom ikunu konxji mill- fatt li sintomi oħrajn tal- imġiba ta ’ disturbi fil- kontroll tal- impulsi, u kompulsjonijiet bħal li wieħed jiekol bl- addoċċ u xiri kompulsiv, jistgħu jseħħu.
Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other extremities.
Iż- żieda tirreferi għall- bidu iktar bikri tas- sintomi filgħaxija (jew anki wara nofsinhar), żieda fis- sintomi, u li s- sintomi jinfirxu u jinvolvu estremitajiet oħrajn.
The frequency of
Il- provi kkontrollati ta ’ SIFROL f’ pazjenti bis- Sindrome tas- Saqajn Bla Kwiet, ġeneralment ma kinux ta ’ tul ta ’ żmien biżżejjed biex il- fenomeni tat- tkabbir ikunu osservati b’ mod adegwat.
-5- augmentation after longer use of SIFROL and the appropriate management of these events have not been evaluated in controlled clinical trials.
Il- frekwenza tat - tkabbir wara użu aktar fit- tul ta ’ SIFROL u l- immaniġġjar adattat ta ’ dawn l- avvenimenti, ma kinux evalwati fil- provi kliniċi kkontrollati.
Plasma protein binding Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
5 Twaħħil mal- proteini fil- plażma Pramipexole jeħel ftit ħafna mal- proteini fil- plażma (< 20%), u ftit bijotrasformazzjoni tkun osservata fil- bniedem.
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Għalhekk, interazzjonijiet ma ’ prodotti mediċinali oħrajn li jaffettwaw it- twaħħil mal - proteini fil- plażma jew l- eliminazzjoni permezz tal- bijotrasformazzjoni, mhumiex mistennija.
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with SIFROL.
It- tnaqqis fid- doża ta ’ pramipexole għandu jkun ikkunsidrat meta dawn il- prodotti mediċinali jingħataw fl- istess ħin ma ’ SIFROL.
Combination with levodopa When SIFROL is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medicinal products is kept constant while increasing the dose of SIFROL.
It- teħid flimkien ma ’ levodopa Meta SIFROL jingħata flimkien ma ’ levodopa, hu rakkomandat li d- dożaġġ ta ’ levodopa jitnaqqas u li d- dożaġġ ta ’ prodotti mediċinali oħrajn kontra l- marda ta ’ Parkinson jinżamm kostanti, filwaqt li d- doża ta ’ SIFROL tiżdied.
SIFROL should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
SIFROL m’ għandux jintuża waqt it- tqala ħlief jekk ikun meħtieġ b’ mod ċar, i. e. li l- benefiċċju potenzjali jiġġustifika r- riskju potenzjali lill- fetu.
As SIFROL treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Minħabba li l- kura b’ SIFROL tinibixxi t- tnixxija ta ’ prolactin fil- bnedmin, l- inibizzjoni tat- treddigħ hi mistennija.
The excretion of SIFROL into breast milk has not been studied in women.
It- tneħħija ta ’ SIFROL fil- ħalib ma kinitx studjata fin- nisa.
In the absence of human data, SIFROL should not be used during breast-feeding.
Fl- assenza ta ’ informazzjoni miksuba mill- bnedmin, SIFROL m’ għandux jintuża matul it- treddigħ.
SIFROL can have a major influence on the ability to drive and use machines.
SIFROL jista ’ jkollu influwenza maġġuri fuq il- ħila biex issuq u biex tuża l- magni.
Patients being treated with SIFROL and presenting with somnolence and/ or sudden sleep episodes must be informed 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 and somnolence have resolved (see also sections 4.4, 4.5 and 4.8).
Pazjenti li qed jiġu kkurati b’ SIFROL u li jkollhom ngħas u/ jew episjodi ta ’ rqad li jiġi għal għarrieda, għandhom ikunu infurmati biex ma jsuqux jew jagħmlu attivitajiet fejn in- nuqqas ta ’ attenzjoni jista ’ jpoġġi lilhom jew lill- oħrajn f’ riskju ta ’ korriment serju jew mewt (eż. jħaddmu l- magni), sakemm dawn l- episodji rikorrenti u ngħas ikunu ġew ikkurati (ara wkoll sezzjonijiet 4. 4 u 4. 5).
-6- 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Expected adverse events The following adverse reactions are expected under the use of SIFROL: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
6 addoċċ, xiri kompulsiv, ipersesswalità u logħob patoloġiku tal- azzard; konfużjoni, stitikezza, delużjoni, sturdament, diskinesija, għeja kbira, alluċinazzjonijiet, uġigħ ta ’ ras, iperkinesija, iperfaġja, pressjoni tad- demm baxxa, nuqqas ta ’ rqad, disturbi fil- libido, nawseja, paranojja; edema periferali, ħakk, raxx u sensittività eċċessiva oħra; nuqqas ta ’ kwiet f’ ġismek, ngħas, irqad li jiġi għal għarrieda, sinkope, disturb tal- vista li jinkludi vista mċajpra u tnaqqis fiċ- ċarezza tal- vista, rimettar, tnaqqis fil - piż, żieda fil- piż.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1923 patients on SIFROL and 1354 patients on placebo, adverse drug reactions were frequently reported for both groups.
Ibbażat fuq l- informazzjoni miġbura minn analiżi ta ’ provi kkontrollati bil- plaċebo, li kienu jinkludu total ta ’ 1923 pazjent fuq SIFROL u 1354 pazjent fuq il- plaċebo, ir- reazzjonijiet avversi tal- mediċina kienu rrappurtati b’ mod frekwenti għaż- żewġ gruppi.
63% of patients on SIFROL and 52% of patients on placebo reported at least one adverse drug reaction.
63% tal- pazjenti fuq SIFROL u 52% tal- pazjenti fuq il- plaċebo, irrappurtaw mill- anqas reazzjoni avversa waħda tal- mediċina.
The adverse drug reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with SIFROL and were reported significantly more often in patients taking SIFROL than placebo, or where the event was considered clinically relevant.
Ir- reazzjonijiet avversi minħabba l- mediċina rrappurtati f’ dawn it- tabelli huma dawk l- avvenimenti li seħħew f’ 0. 1% jew aktar tal- pazjenti kkurati b’ SIFROL u li kienu rrappurtati aktar ta ’ spiss b’ mod sinifikanti f’ pazjenti li jkunu qed jieħdu SIFROL milli f’ dawk li kienu qed jużaw il- plaċebo, jew fejn l- avveniment kien ikkunsidrat li hu klinikament rilevanti.
However, the majority of common adverse drug reactions were mild to moderate, they usually start early in therapy, and most tended to disappear even as therapy was continued.
Madankollu, il- maġġoranza tar- reazzjonijiet avversi komuni minħabba l- mediċina kienu minn ħfief sa moderati, u normalment bdew kmieni fit - terapija, u l- biċċa l- kbira tagħhom għabu anki jekk it- terapija tkompliet.
Parkinson’ s disease, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson’ s disease more frequent with SIFROL treatment than with Placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Il- marda ta ’ Parkinson, l- iktar avvenimenti avversi komuni L- aktar reazzjonijiet avversi (≥ 5%) minħabba l- mediċina rrappurtati b’ mod komuni f’ pazjenti bil - marda ta ’ Parkinson li kienu aktar frekwenti bil- kura b’ SIFROL milli bil- Plaċebo kienu nawseja, diskinesija, pressjoni tad- demm baxxa, sturdament, ngħas, nuqqas ta ’ rqad, stitikezza, alluċinazzjoni, uġigħ ta ’ ras u għeja kbira.
More frequent adverse drug reactions in combination with levodopa were dyskinesia,.
Reazzjonijiet avversi iktar frekwenti minħabba l- mediċina flimkien ma ’ levodopa kienet id- diskinesija.
Hypotension may occur at the beginning of treatment, especially if SIFROL is titrated too fast.
Pressjoni tad- demm baxxa tista ’ sseħħ fil- bidu tal- kura, speċjalment jekk SIFROL ikun ittitrat malajr wisq.
visual disturbance including vision blurred and visual acuity reduced
disturb tal- vista li tinkludi vista mċajpra u tnaqqis fiċ - ċarezza tal- vista
hypotension
Komuni ħafna
Very common Common Skin and subcutaneous tissue Uncommon
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
nausea constipation, vomiting disorders hypersensitivity, pruritus, rash
sensittività eċċessiva, ħakk, raxx
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with SIFROL were nausea, headache, dizziness and fatigue.
Sindrome tas- Saqajn Bla Kwiet, l- iktar avvenimenti avversi komuni L- aktar reazzjonijiet avversi (≥ 5%) li kienu rrappurtati b’ mod komuni fil- pazjenti li kellhom is - Sindrome tas- Saqajn Bla Kwiet, ikkurati b’ SIFROL, kienu nawseja, uġigħ ta ’ ras, sturdament u għeja kbira.
Nausea and fatigue were more often reported in female patients treated with SIFROL (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
In- nawseja u għeja kbira kienu rrappurtati aktar ta ’ spiss f’ pazjenti nisa kkurati b’ SIFROL (20. 8% u 10. 5%, rispettivament) meta mqabbla ma ’ pazjenti rġiel (6. 7% u 7. 3% rispettivament).
-8- Table 2:
8 Tabella 2:
Somnolence SIFROL is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
SIFROL hu assoċjat man- ngħas (8. 6%) u kien assoċjat b’ mod mhux komuni ma ’ ngħas eċċessiv matul il- jum u episodji ta ’ rqad li jiġi f’ daqqa (0. 1%).
Libido disorders SIFROL may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Disturbi fil- libido SIFROL jista ’ jkun assoċjat ma ’ disturbi fil- libido (żieda (0. 1%) jew tnaqqis (0. 4%)).
Impulse control disorders and compulsive behaviours Patients treated with dopamine agonists for Parkinson’ s disease, including SIFROL, 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.
Disturbi fil- kontroll tal- impulsi u mġiba kompulsiva Il- pazjenti kkurati b’ agonisti ta ’ dopamine għal kura tal- marda ta ’ Parkinson, li jinkludu SIFROL, speċjalment b’ dożi qawwija, kienu rrappurtati li wrew sinjali ta ’ logħob patoloġiku ta ’ l- azzard, żieda fil- libido u ipersesswalità, li huma ġeneralment riversibbli malli titnaqqas id- doża jew meta titwaqqaf il- kura.
-9- 4.9 Overdose
4. 9 Doża eċċessiva
There is no clinical experience with massive overdosage.
9 M’ hemm l- ebda esperjenza klinika b’ doża eċċessiva massiva.
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
L- avvenimenti avversi mistennija ser ikunu dawk relatati mal- profil farmakodinamiku ta ’ agonist ta ’ dopamine, li jinkludu nawseja, rimettar, iperkinesija, alluċinazzjonijiet, aġitazzjoni u pressjoni tad- demm baxxa.
In patients SIFROL alleviates signs and symptoms of idiopathic Parkinson’ s disease.
Fil- pazjenti, SIFROL itaffi s- sinjali u s- sintomi tal- marda idjopatika ta ’ Parkinson.
In early and advanced Parkinson’ s disease, efficacy of SIFROL in the controlled clinical trials was maintained for approximately six months.
Fl- istadji bikrin u avvanzati tal- marda ta ’ Parkinson, l- effikaċja ta ’ SIFROL fil- provi kliniċi kkontrollati, inżammet għal madwar sitt xhur.
The efficacy of SIFROL was evaluated in four placebo-controlled clinical trials in approximately 1000 patients with moderate to very severe idiopathic Restless Legs Syndrome.
L- effikaċja ta ’ SIFROL kienet evalwata f’ erba ’ provi kliniċi kkontrollati bil- plaċebo f’ madwar 1000 pazjent li kellhom Sindrome tas- Saqajn Bla Kwiet idjopatiku li kien minn moderat sa sever ħafna.
The mean change from baseline in the Restless Legs Syndrome Rating Scale (IRLS) and the Clinical Global Impression-Improvement (CGI-I) were the primary efficacy outcome measures.
Għaż- żewġ
For both primary endpoints statistically significant differences have been observed for the pramipexole dose groups 0.25 mg, 0.5 mg and 0.75 mg in comparison to placebo.
10 riżultati aħħarin primarji, differenzi statistikament sinifikanti kienu osservati għall- gruppi tad- doża ta ’ 0. 25 mg, 0. 5 mg u 0. 75 mg ta ’ pramipexole, meta mqabbla mal- plaċebo.
The adjusted mean difference was -4.3 points (CI 95% -6.4; -2.1 points, p-value < 0.0001).
Id- differenza medja aġġustata kienet - 4. 3 punti (CI 95% - 6. 4; - 2. 1 punti, valur p < 0. 0001).
In a placebo-controlled polysomnography study over 3 weeks SIFROL significantly reduced the number of periodic limb movements during time in bed.
Fi studju kkontrollat bil- plaċebo dwar il- polisonografija fuq perjodu 3 ġimgħat, SIFROL naqqas b’ mod sinifikanti n- numru ta ’ movimenti perjodiċi tar- riġlejn/ dirgħajn matul il- ħin li l- pazjent kien fis- sodda.
6.1 List of excipients
11 6. 1 Lista ta ’ sustanzi mhux attivi
10 tablets per aluminium blister strips Cartons containing 3 or 10 blister strips (30 or 100 tablets)
10 pilloli f’ kull strixxa bil- folji ta ’ l- aluminju Kaxxi tal- kartun li fihom 3 jew 10 strixxi bil- folja (30 jew 100 pillola)
Not all pack sizes may be marketed
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali
14 October 1997 Date of Renewal of the authorisation:
14 t’ Ottubru 1997 Data tat- Tiġdid ta ’ l- awtorizzazzjoni:
14 October 2007
14 t’ Ottubru, 2007
SIFROL 0.18 mg tablets
SIFROL 0. 18 mg pilloli
SIFROL 0.18 mg tablets contain 0.18 mg of pramipexole base (as 0.25 mg of pramipexole dihydrochloride monohydrate).
Il- pilloli SIFROL 0. 18 mg fihom 0. 18 mg ta ’ bażi ta ’ pramipexole (bħala 0. 25 mg ta ’ pramipexole dihydrochloride monohydrate).
SIFROL is indicated for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
SIFROL hu indikat għall- kura sintomatika tas- Sindrome tas- Saqajn Bla Kwiet idjopatiku li jkun minn moderat sa sever f’ dożaġġi sa 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ) (ara sezzjoni 4. 2).
90% of absorbed active substance is excreted through the kidneys.
14 Id- dożaġġ f’ pazjenti b’ indeboliment epatiku L- aġġustament fid- doża f’ pazjenti b’ insuffiċjenza epatika probabbilment ma jkunx meħtieġ, għax madwar 90% tas- sustanza attiva assorbita titneħħa minn ġol- kliewi.
If the treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
Jekk il- kura tkun interrotta għal aktar minn ftit ijiem, din għandha terġa ’ tinbeda mill- ġdid kif spjegat hawn fuq.
When prescribing SIFROL tablets in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Meta tingħata riċetta għal SIFROL lil pazjent bil- marda ta ’ Parkinson li jkollu indeboliment renali, doża mnaqqsa skond kif spjegat f’ sezzjoni 4. 2 hi ssuġġerita.
Furthermore a reduction of dosage or termination of therapy may be considered.
Flimkien ma ’ dan, it- tnaqqis fid- dożaġġ jew it - twaqqif tat- terapija jistgħu jkunu kkunsidrati.
Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other extremities.
Iż- żieda tirreferi għall- bidu iktar bikri tas- sintomi filgħaxija (jew anki wara nofsinhar), żieda fis - sintomi, u li s- sintomi jinfirxu u jinvolvu estremitajiet oħrajn.
The controlled trials of SIFROL in patients with Restless Legs Syndrome were generally not of sufficient duration to adequately capture augmentation phenomena.
Il- provi kkontrollati ta ’ SIFROL f’ pazjenti bis- Sindrome tas- Saqajn Bla Kwiet, ġeneralment ma kinux ta ’ tul ta ’ żmien biżżejjed biex il- fenomeni tat- tkabbir ikunu osservati b’ mod adegwat.
The frequency of augmentation after longer use of SIFROL and the appropriate management of these events have not been evaluated in controlled clinical trials.
Il- frekwenza tat- tkabbir wara użu aktar fit- tul
- 16 -
16 ta ’ SIFROL u l- immaniġġjar adattat ta ’ dawn l- avvenimenti, ma kinux evalwati fil- provi kliniċi kkontrollati.
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Minħabba li l- antikolinerġiċi huma eliminati primarjament permezz tal- bijotrasformazzjoni, il - potenzjal għal interazzjoni hu limitat, għalkemm l- interazzjoni ma ’ l- antikolinerġiċi ma kinitx investigata.
Patients being treated with SIFROL and presenting with somnolence and/ or sudden sleep episodes must be informed 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 and somnolence have resolved (see also sections 4.4, 4.5 and 4.8).
Pazjenti li qed jiġu kkurati b’ SIFROL u li jkollhom ngħas u/ jew episjodi ta ’ rqad li jiġi għal għarrieda, għandhom ikunu infurmati biex ma jsuqux jew jagħmlu attivitajiet fejn in- nuqqas ta ’ attenzjoni jista ’
Expected adverse events The following adverse reactions are expected under the use of SIFROL: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase, pruritus.
Avvenimenti avversi mistennija Ir- reazzjonijiet avversi li ġejjin huma mistennija waqt l- użu ta ’ SIFROL: ħolm anormali, amnesija, sintomi ta ’ disturbi fl- imġiba tal- kontroll tal- impulsi u kompulsjonijiet, bħal li wieħed jiekol bl - addoċċ, xiri kompulsiv, ipersesswalità u logħob patoloġiku tal- azzard; konfużjoni, stitikezza, delużjoni, sturdament, diskinesija, għeja kbira, alluċinazzjonijiet, uġigħ ta ’ ras, iperkinesija, iperfaġja, pressjoni tad- demm baxxa, nuqqas ta ’ rqad, disturbi fil- libido, nawseja, paranojja, edema periferali, ħakk, raxx u sensittività eċċessiva oħra; nuqqas ta ’ kwiet f’ ġismek, ngħas, irqad li jiġi għal għarrieda, sinkope, disturb tal- vista li jinkludi vista mċajpra u tnaqqis fiċ- ċarezza tal- vista, rimettar, tnaqqis fil - piż, żieda fil- piż.
The adverse drug reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with SIFROL and were reported significantly more often in patients taking SIFROL than placebo, or where the event was considered clinically relevant.
Tabelli 1 u 2 juru l- frekwenza ta ’ reazzjonijiet avversi minħabba l- mediċina mill- provi kliniċi kkontrollati bil- plaċebo f’ pazjenti bil- marda ta ’ Parkinson u bis- Sindrome tas- Saqajn Bla Kwiet. reazzjonijiet avversi minħabba l- mediċina rrappurtati f’ dawn it- tabelli huma dawk l- avvenimenti li seħħew f’ 0. 1% jew aktar tal- pazjenti kkurati b ’ SIFROL u li kienu rrappurtati aktar ta ’ spiss b’ mod sinifikanti f’ pazjenti li jkunu qed jieħdu SIFROL milli f’ dawk li kienu qed jużaw il- plaċebo, jew fejn l- avveniment kien ikkunsidrat li hu klinikament rilevanti.
Very common Common Uncommon Eye disorders
Komuni ħafna Komuni
dizziness, dyskinesia, somnolence amnesia, headache hyperkinesia, sudden onset of sleep, syncope
iperkinesija, irqad li jiġi għal għarrieda, sinkope
- 20 -
20 M’ hemm l- ebda esperjenza klinika b’ doża eċċessiva massiva.
Maintenance of effect has not been sufficiently tested.
Il - manteniment ta ’ l- effett ma kienx ittestjat suffiċjentement.
For both primary endpoints statistically significant differences have been observed for the pramipexole dose groups 0.25 mg, 0.5 mg and 0.75 mg in comparison to placebo.
21 riżultati aħħarin primarji, differenzi statistikament sinifikanti kienu osservati għall- gruppi tad- doża ta ’ 0. 25 mg, 0. 5 mg u 0. 75 mg ta ’ pramipexole, meta mqabbla mal- plaċebo.
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
Fil- bnedmin, it- twaħħil mal- proteina ta ’ pramipexole hu baxx ħafna (< 20%) u l- volum tad- distribuzzjoni hu kbir (400 l).
6.1 List of excipients
22 6. 1 Lista ta ’ sustanzi mhux attivi
SIFROL 0.35 mg tablets
SIFROL 0. 35 mg pilloli
SIFROL 0.35 mg tablets contain 0.35 mg of pramipexole base (as 0.5 mg of pramipexole dihydrochloride monohydrate).
Il- pilloli SIFROL 0. 35 mg fihom 0. 35 mg ta ’ bażi ta ’ pramipexole (bħala 0. 5 mg ta ’ pramipexole dihydrochloride monohydrate).
90% of absorbed active substance is excreted through the kidneys.
25 Id- dożaġġ f’ pazjenti b’ indeboliment epatiku L- aġġustament fid- doża f’ pazjenti b’ insuffiċjenza epatika probabbilment ma jkunx meħtieġ, għax madwar 90% tas- sustanza attiva assorbita titneħħa minn ġol- kliewi.
Rebound (worsening of symptoms after abrupt discontinuation of treatment) can not be excluded.
Ir - rebound (sintomi li jmorru għall- agħar wara t- twaqqif f’ daqqa tal- kura) ma tistax tkun eskluża.
The frequency of augmentation after longer use of SIFROL and the appropriate management of these events have not been evaluated in controlled clinical trials.
Il- frekwenza tat - tkabbir wara użu aktar fit- tul ta ’ SIFROL u l- immaniġġjar adattat ta ’ dawn l- avvenimenti, ma kinux evalwati fil- provi kliniċi kkontrollati.
Expected adverse events The following adverse reactions are expected under the use of SIFROL: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
Avvenimenti avversi mistennija Ir- reazzjonijiet avversi li ġejjin huma mistennija waqt l- użu ta 'SIFROL: ħolm anormali, amnesija, sintomi ta ’ disturbi fl- imġiba tal- kontroll tal- impulsi u kompulsjonijiet, bħal li wieħed jiekol bl - addoċċ, xiri kompulsiv, ipersesswalità u logħob patoloġiku tal- azzard; konfużjoni, stitikezza, delużjoni, sturdament, diskinesija, għeja kbira, alluċinazzjonijiet, uġigħ ta ’ ras, iperkinesija, iperfaġja, pressjoni tad- demm baxxa, nuqqas ta ’ rqad, disturbi fil- libido, nawseja, paranojja, edema periferali, ħakk, raxx u sensittività eċċessiva oħra; nuqqas ta ’ kwiet f’ ġismek, ngħas, irqad li jiġi għal għarrieda, sinkope, disturb tal- vista li jinkludi vista mċajpra u tnaqqis fiċ- ċarezza tal- vista, rimettar, tnaqqis fil - piż, żieda fil- piż.
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated form the available data).
Fil- kategoriji tas- sistemi ta ’ l- organi, ir- reazzjonijiet avversi huma elenkati taħt titli ta ’ frekwenza (numru ta ’ pazjenti li huma mistennija li jkollhom ir- reazzjoni), bl- użu tal- kategoriji li ġejjin: komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100, < 1/ 10); mhux komuni (≥ 1/ 1, 000, < 1/ 100); rari (≥ 1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000) mhux magħrufa (ma tistax tittieħed stima mid- dejta disponibbli).
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with SIFROL were nausea, headache, dizziness and fatigue.
Sindrome tas- Saqajn Bla Kwiet, l- iktar avvenimenti avversi komuni L- aktar reazzjonijiet avversi (≥ 5%) li kienu rrappurtati b’ mod komuni fil- pazjenti li kellhom is - Sindrome tas- Saqajn Bla Kwiet, ikkurati b’ SIFROL, kienu nawseja, uġigħ ta ’ ras, sturdament, u għeja kbira.
Impulse control disorders and compulsive behaviours Patients treated with dopamine agonists for Parkinson’ s disease, including SIFROL, 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.
Disturbi fil- kontroll tal- impulsi u mġiba kompulsiva Il- pazjenti kkurati b’ agonisti ta ’ dopamine għal kura tal- marda ta ’ Parkinson, li jinkludu SIFROL, speċjalment b' dożi qawwija, kienu rrappurtati li wrew sinjali ta ’ logħob patoloġiku ta ’ l- azzard, żieda fil- libido u ipersesswalità, li huma ġeneralment riversibbli malli titnaqqas id- doża jew meta titwaqqaf il- kura.
- 31 -
31 M’ hemm l- ebda esperjenza klinika b’ doża eċċessiva massiva.
For both primary endpoints statistically significant differences have been observed for the pramipexole dose groups 0.25 mg, 0.5 mg and 0.75 mg in comparison to placebo.
32 riżultati aħħarin primarji, differenzi statistikament sinifikanti kienu osservati għall- gruppi tad- doża ta ’ 0. 25 mg, 0. 5 mg u 0. 75 mg ta ’ pramipexole, meta mqabbla mal- plaċebo.
6.1 List of excipients
33 6. 1 Lista ta ’ sustanzi mhux attivi
14 October 1997 Date of Renewal of the authorisation:
16 ta ’ Novembru, 1999 Data tat- Tiġdid ta ’ l- awtorizzazzjoni:
SIFROL 0.7 mg tablets
SIFROL 0. 7 mg pilloli
SIFROL 0.7 mg tablets contain 0.7 mg of pramipexole base (as 1.0 mg of pramipexole dihydrochloride monohydrate).
Il- pilloli SIFROL 0. 7 mg fihom 0. 7 mg ta ’ bażi ta ’ pramipexole (bħala 1. 0 mg ta ’ pramipexole dihydrochloride monohydrate).
As long-term efficacy of SIFROL in the treatment of RLS has not been sufficiently tested, patient´s response should be evaluated after 3 months treatment and the need for treatment continuation should be reconsidered.
Minħabba li l- effikaċja fit- tul ta ’ SIFROL fil- kura ta ’ RLS ma kinitx ittestjata suffiċjentement, ir - rispons tal- pazjent għandu jkun evalwat wara 3 xhur ta ’ kura, u l- ħtieġa għat- tkomplija tal- kura għandha tkun ikkunsidrata mill- ġdid.
Neuroleptic malignant syndrome Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2.).
Sindrome malinn newroleptiku Sintomi li jissuġġerixxu sindrome malinn newroleptiku kienu rrappurtati mat- twaqqif f’ daqqa tat - terapija dopaminerġika (ara sezzjoni 4. 2).
Patients being treated with SIFROL and presenting with somnolence and/ or sudden sleep episodes must be informed 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 and somnolence have resolved (see also sections 4.4, 4.5 and 4.8).
Pazjenti li qed jiġu kkurati b’ SIFROL u li jkollhom ngħas u/ jew episjodi ta ’ rqad li jiġi għal għarrieda, għandhom ikunu infurmati biex ma jsuqux jew jagħmlu attivitajiet fejn in- nuqqas ta ’ attenzjoni jista ’ jpoġġi lilhom jew lill- oħrajn f’ riskju ta ’ korriment serju jew mewt (eż. jħaddmu l- magni), sakemm dawn l- episodji rikorrenti u ngħas ikunu ġew ikkurati (ara wkoll sezzjonijiet 4. 4 u 4. 5)
Expected adverse events The following adverse reactions are expected under the use of SIFROL: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus and rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
39 Avvenimenti avversi mistennija Ir- reazzjonijiet avversi li ġejjin huma mistennija waqt l- użu ta 'SIFROL: ħolm anormali, amnesija, sintomi ta ’ disturbi fl- imġiba tal- kontroll tal- impulsi u kompulsjonijiet, bħal li wieħed jiekol bl - addoċċ, xiri kompulsiv, ipersesswalità u logħob patoloġiku tal- azzard; konfużjoni, stitikezza, delużjoni, sturdament, diskinesija, għeja kbira, alluċinazzjonijiet, uġigħ ta ’ ras, iperkinesija, iperfaġja, pressjoni tad- demm baxxa, nuqqas ta ’ rqad, disturbi fil- libido, nawseja, paranojja, edema periferali, ħakk, raxx u sensittività eċċessiva oħra; nuqqas ta ’ kwiet f’ ġismek, ngħas, irqad li jiġi għal għarrieda, sinkope, disturb tal- vista li jinkludi vista mċajpra u tnaqqis fiċ- ċarezza tal- vista, rimettar, tnaqqis fil - piż, żieda fil- piż.
visual disturbance including vision blurred and visual acuity reduced
disturb tal- vista li tinkludi vista mċajpra u tnaqqis fiċ -
Table 2:
41 Tabella 2:
- 42 -
42 M’ hemm l- ebda esperjenza klinika b’ doża eċċessiva massiva.
For both primary endpoints statistically significant differences have been observed for the pramipexole dose groups 0.25 mg, 0.5 mg and 0.75 mg in comparison to placebo.
43 riżultati aħħarin primarji, differenzi statistikament sinifikanti kienu osservati għall- gruppi tad- doża ta ’ 0. 25 mg, 0. 5 mg u 0. 75 mg ta ’ pramipexole, meta mqabbla mal- plaċebo.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Il- half- life (t½) ta ’ l- eliminazzjoni tvarja minn 8 sigħat fiż- żgħażagħ għal 12- il siegħa fl - anzjani.
6.1 List of excipients
44 6. 1 Lista ta ’ sustanzi mhux attivi
SIFROL 1.1 mg tablets
SIFROL 1. 1 mg pilloli
SIFROL 1.1 mg tablets contain 1.1 mg of pramipexole base (as 1.5 mg of pramipexole dihydrochloride monohydrate).
Il- pilloli SIFROL 1. 1 mg fihom 1. 1 mg ta ’ bażi ta ’ pramipexole (bħala 1. 5 mg ta ’ pramipexole dihydrochloride monohydrate).
Combination with levodopa When SIFROL is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medicinal products is kept constant while increasing the dose of SIFROL.
It- teħid flimkien ma ’ levodopa Meta SIFROL jingħata flimkien ma ’ levodopa, hu rakkomandat li d- dożaġġ ta ’ levodopa jitnaqqas u li d- dożaġġ ta ’ prodotti mediċinali oħrajn kontra l- marda ta ’ Parkinson jinżamm kostanti, filwaqt li d - doża ta ’ SIFROL tiżdied.