qanastek/EMEA-V3 huggingface dataset:
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
Minħabba l- possibbiltà ta ’ effetti addittivi, għandha tingħata attenzjoni meta l- pazjenti jkunu qed jieħdu prodotti mediċinali oħrajn jew l- alkoħol flimkien ma ’ pramipexole.
The following adverse reactions are expected under the use of MIRAPEXIN: 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 ’ MIRAPEXIN: 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.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1923 patients on MIRAPEXIN 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 MIRAPEXIN u 1354 pazjent fuq il- plaċebo, ir- reazzjonijiet avversi tal - mediċina kienu rrappurtati b’ mod frekwenti għaż- żewġ gruppi.
The adverse drug reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with MIRAPEXIN and were reported significantly more often in patients taking MIRAPEXIN 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’ MIRAPEXIN u li kienu rrappurtati aktar ta ’ spiss b’ mod sinifikanti f’ pazjenti li jkunu qed jieħdu MIRAPEXIN milli f’ dawk li kienu qed jużaw il - plaċebo, jew fejn l- avveniment kien ikkunsidrat li hu klinikament rilevanti.
Common Vascular disorders
Komuni
visual disturbance including vision blurred and visual acuity reduced
disturb tal- vista li tinkludi vista mċajpra u tnaqqis fiċ- ċarezza tal -
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with MIRAPEXIN 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’ MIRAPEXIN, kienu nawseja, uġigħ ta ’ ras, sturdament u għeja kbira.
nausea constipation, vomiting
nawseja Stitikezza, rimettar
Libido disorders MIRAPEXIN may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
19 Disturbi fil- libido MIRAPEXIN jista ’ jkun assoċjat ma ’ disturbi fil- libido (żieda (0. 1%) jew tnaqqis (0. 4%)).
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
L- immaniġġjar tad - doża eċċessiva jista ’ jkun li tkun teħtieġ miżuri ta ’ sapport ġenerali, flimkien ma ’ ħasil gastriku, fluwidi ġol- vina, l- għoti ta ’ faħam attivat u monitoraġġ permezz ta ’ elettrokardjogramm.
In early and advanced Parkinson’ s disease, efficacy of MIRAPEXIN in the controlled clinical trials was maintained for approximately six months.
20 Fl- istadji bikrin u avvanzati tal- marda ta ’ Parkinson, l- effikaċja ta ’ MIRAPEXIN fil- provi kliniċi kkontrollati, inżammet għal madwar sitt xhur.
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
Fi provi tat- tip open continuation li damu aktar minn tliet snin, ma kien hemm l- ebda sinjali ta ’ tnaqqis fl- effikaċja.
Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect of pramipexole.
21 Studji dwar it- tossiċità ta ’ doża ripetuti wrew li pramipexole ħoloq effetti funzjonali, li primarjament kienu jinvolvu s- CNS u s- sistema riproduttiva fin- nisa u probabbilment irriżultaw minn effett farmakodinamiku esaġerat ta ’ pramipexole.
Decreases in diastolic and systolic pressure and heart rate were noted in the minipig, and a tendency to an hypotensive effect was discerned in the monkey.
Tnaqqis fil- pressjoni dijastolika u sistolika u fir- rata ta ’ taħbit tal- qalb kienu nnutati fil- minipig, u kienet osservata tendenza għal effett ipotensiv fix- xadini.
Mannitol, maize starch, anhydrous colloidal silica, povidone K 25,
Mannitol, maize starch, anhydrous colloidal silica, povidone K 25, magnesium stearate
Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Germany
22 Boehringer Ingelheim International GmbH D- 55216 Ingelheim am Rhein Il- Ġermanja
MIRAPEXIN 0.35 mg tablets
MIRAPEXIN 0. 35 mg pilloli
MIRAPEXIN 0.35 mg tablets contain 0.35 mg of pramipexole base (as 0.5 mg of pramipexole dihydrochloride monohydrate).
Il- pilloli MIRAPEXIN 0. 35 mg fihom 0. 35 mg ta ’ bażi ta ’ pramipexole (bħala 0. 5 mg ta ’ pramipexole dihydrochloride monohydrate).
MIRAPEXIN 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).
MIRAPEXIN 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).
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Kura inizjali:
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
24 li ma jkunux jistgħu jittolleraw, id- dożaġġ għandu jkun ittitrat biex iwettaq l- effett terapewtiku massimu.
Further dose adjustments should be done based on the clinical response and the occurrence of undesirable effects.
Aġġustamenti addizzjonali fid- doża għandhom isiru skond ir- rispons kliniku u t- l- okkorrenza ta ’ effetti mhux mixtieqa.
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25 Id- dożaġġ f’ pazjenti b’ indeboliment epatiku
4.4 Special warnings and precautions for use
26 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
When prescribing MIRAPEXIN 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 MIRAPEXIN lil pazjent bil- marda ta ’ Parkinson li jkollu indeboliment renali, doża mnaqqsa skond kif spjegat f’ sezzjoni 4. 2 hi ssuġġerita.
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy.
Hu rakkomandat li jsir monitoraġġ tal- pressjoni tad- demm, b’ mod speċjali fil- bidu tal- kura, minħabba r- riskju ġenerali ta ’ pressjoni tad - demm baxxa li tiddependi mill- qagħda, assoċjata mat- terapija dopaminerġika.
4.5 Interaction with other medicinal products and other forms of interaction
27 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
As MIRAPEXIN treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Minħabba li l- kura b’ MIRAPEXIN tinibixxi t- tnixxija ta ’ prolactin fil- bnedmin, l- inibizzjoni tat - treddigħ hi mistennija.
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Fil- firien, il - konċentrazzjoni ta ’ radjuattività marbuta mas- sustanza attiva kienet ogħla fil- ħalib tas- sider milli fil - plażma.
Expected adverse events The following adverse reactions are expected under the use of MIRAPEXIN: 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, hyperkinesias, 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 ’ MIRAPEXIN: 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.
Libido disorders MIRAPEXIN may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
30 Disturbi fil- libido MIRAPEXIN jista ’ jkun assoċjat ma ’ disturbi fil- libido (żieda (0. 1%) jew tnaqqis (0. 4%)).
In early and advanced Parkinson’ s disease, efficacy of MIRAPEXIN in the controlled clinical trials was maintained for approximately six months.
31 Fl- istadji bikrin u avvanzati tal- marda ta ’ Parkinson, l- effikaċja ta ’ MIRAPEXIN fil- provi kliniċi kkontrollati, inżammet għal madwar sitt xhur.
This delay in motor complications with pramipexole should be balanced against a greater improvement in motor function with levodopa (as measured by the mean change in UPDRS-score).
Dan id- dewmien fil- kumplikazzjonijiet tal- moviment b’ pramipexole għandu jkun bbilanċjat b’ titjib akbar fil- funzjoni tal- moviment b’ levodopa (kif imkejjel mill- bidla medja fil- punteġġ UPDRS).
Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect of pramipexole.
32 Studji dwar it- tossiċità ta ’ doża ripetuti wrew li pramipexole ħoloq effetti funzjonali, li primarjament kienu jinvolvu s- CNS u s- sistema riproduttiva fin- nisa u probabbilment irriżultaw minn effett farmakodinamiku esaġerat ta ’ pramipexole.
Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Germany
33 Boehringer Ingelheim International GmbH D- 55216 Ingelheim am Rhein Il- Ġermanja
MIRAPEXIN 0.7 mg tablets
MIRAPEXIN 0. 7 mg pilloli
MIRAPEXIN 0.7 mg tablets contain 0.7 mg of pramipexole base (as 1.0 mg of pramipexole dihydrochloride monohydrate).
Il- pilloli MIRAPEXIN 0. 7 mg fihom 0. 7 mg ta ’ bażi ta ’ pramipexole (bħala 1. 0 mg ta ’ pramipexole dihydrochloride monohydrate).
- 35 -
Kura inizjali:
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
35 li ma jkunux jistgħu jittolleraw, id- dożaġġ għandu jkun ittitrat biex iwettaq l- effett terapewtiku massimu.
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with MIRAPEXIN, 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’ MIRAPEXIN, skond ir- reazzjonijiet fil- pazjenti individwali.
- 36 -
36 Id- dożaġġ f’ pazjenti b’ indeboliment epatiku
4.4 Special warnings and precautions for use
37 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
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).
4.5 Interaction with other medicinal products and other forms of interaction
38 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
4.8 Undesirable effects
39 4. 8 Effetti mhux mixtieqa
Expected adverse events The following adverse reactions are expected under the use of MIRAPEXIN: 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, hyperkinesias, 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 ’ MIRAPEXIN: 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, paranojja; 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, ngħas, żieda fil- piż.
Libido disorders MIRAPEXIN may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Disturbi fil- libido 41 MIRAPEXIN jista ’ jkun assoċjat ma ’ disturbi fil- libido (żieda (0. 1%) jew tnaqqis (0. 4%)).
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
42 tliet snin, ma kien hemm l- ebda sinjali ta ’ tnaqqis fl- effikaċja.
Decreases in diastolic and systolic pressure and heart rate were noted in the minipig, and a tendency to an hypotensive effect was discerned in the monkey.
43 Tnaqqis fil- pressjoni dijastolika u sistolika u fir- rata ta ’ taħbit tal- qalb kienu nnutati fil- minipig, u kienet osservata tendenza għal effett ipotensiv fix- xadini.
MIRAPEXIN 1.1 mg tablets
MIRAPEXIN 1. 1 mg pilloli
MIRAPEXIN 1.1 mg tablets contain 1.1 mg of pramipexole base (as 1.5 mg of pramipexole dihydrochloride monohydrate).
Il- pilloli MIRAPEXIN 1. 1 mg fihom 1. 1 mg ta ’ bażi ta ’ pramipexole (bħala 1. 5 mg ta ’ pramipexole dihydrochloride monohydrate).
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Kura inizjali:
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
46 li ma jkunux jistgħu jittolleraw, id- dożaġġ għandu jkun ittitrat biex iwettaq l- effett terapewtiku massimu.
- 47 -
47 Id- dożaġġ f’ pazjenti b’ indeboliment epatiku
4.4 Special warnings and precautions for use
48 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
4.5 Interaction with other medicinal products and other forms of interaction
49 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Combination with levodopa When MIRAPEXIN 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 MIRAPEXIN.
It- teħid flimkien ma ’ levodopa Meta MIRAPEXIN jingħata flimkien ma ’ levodopa, hu rakkomandat li d - levodopa jitnaqqas u li d - dożaġġ ta ’ prodotti mediċinali oħrajn kontra l- marda ta ’ Parkinson jinżamm kostanti, filwaqt li d- doża ta ’ MIRAPEXIN tiżdied.
Patients being treated with MIRAPEXIN 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’ MIRAPEXIN 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).
4.8 Undesirable effects
50 4. 8 Effetti mhux mixtieqa
Expected adverse events The following adverse reactions are expected under the use of MIRAPEXIN: 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, hyperkinesias, 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 ’ MIRAPEXIN: 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, ngħas, 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).
Libido disorders MIRAPEXIN may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
52 Disturbi fil- libido MIRAPEXIN jista ’ jkun assoċjat ma ’ disturbi fil- libido (żieda (0. 1%) jew tnaqqis (0. 4%)).
In early and advanced Parkinson’ s disease, efficacy of MIRAPEXIN in the controlled clinical trials was maintained for approximately six months.
53 Fl- istadji bikrin u avvanzati tal- marda ta ’ Parkinson, l- effikaċja ta ’ MIRAPEXIN fil- provi kliniċi kkontrollati, inżammet għal madwar sitt xhur.
Concomitant administration with food did not reduce the extent of pramipexole absorption, but the rate of absorption was reduced.
L- għoti fl- istess ħin ma ’ l- ikel ma naqqasx il- grad ta ’ l- assorbiment ta ’ pramipexole, iżda r- rata ta ’ l- assorbiment naqset.
5.3 Preclinical safety data
54 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
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56 ANNESS II
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57 A DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Isem u indirizz tal- manifatturi responsabbli għall- ħruġ tal- lott
The MAH commits to performing the studies detailed in the Pharmacovigilance Plan and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 of the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida CHPM dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l- Aġġornament tas- Sigurtà (Periodic Safety Update Report - PSUR) li jkun imiss.
In addition, an updated RMP should be submitted When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached At the request of the EMEA
Flimkien ma ’ dan, RMP aġġornat għandu jkun sottomess Meta informazzjoni ġdida tkun irċevuta li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas - Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jimminimizzaw ir- riskju Fi żmien 60 jum minn meta tintlaħaq milestone importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju) Fuq talba tal- EMEA
In view of the extension of indication to Restless Legs Syndrome, the periodic safety update reports will be submitted every six months during two years, once a year for the following two years and thereafter at three-yearly intervals.
Minħabba l- estensjoni ta 'l- indikazzjoni għas- Sindrome tas- Saqajn Bla Kwiet, ir- rapporti perjodiċi dwar l- aġġornament tas- sigurtà ser ikunu sottomessi kull sitt xhur matul sentejn, darba f' sena għas- sentejn ta' wara, u wara dak il- perjodu, darba kull tliet snin.
- 58 -
58 ANNESS III
- 60 -
60 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
{NATURE/ TYPE}
{NATURA/ TIP}
MIRAPEXIN 0.088 mg tablets Pramipexole
MIRAPEXIN 0. 088 mg pilloli Pramipexole
0.088 mg pramipexole equivalent to pramipexole dihydrochloride monohydrate 0.125 mg
0. 088 mg ta ’ pramipexole ekwivalenti għal pramipexole dihydrochloride monohydrate 0. 125 mg
Tablets also contain mannitol
Il- pilloli fihom ukoll il- mannitol
Do not store above 30°C Store in the original package in order to protect from light
Taħżinx f’ temperatura ’ l fuq minn 30°C Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl
MIRAPEXIN 0.088 mg
MIRAPEXIN 0. 088 mg
- 62 -
62 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
- 64 -
64 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
- 65 -
65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
MIRAPEXIN 0.18 mg tablets Pramipexole
MIRAPEXIN 0. 18 mg pilloli Pramipexole
0.18 mg pramipexole equivalent to pramipexole dihydrochloride monohydrate 0.25 mg
0. 18 mg ta ’ pramipexole ekwivalenti għal pramipexole dihydrochloride monohydrate 0. 25 mg
MIRAPEXIN 0.18 mg
MIRAPEXIN 0. 18 mg
- 67 -
67 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
- 69 -
69 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
- 70 -
70 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT {NATURA/ TIP}
MIRAPEXIN 0.35 mg tablets Pramipexole
MIRAPEXIN 0. 35 mg pilloli Pramipexole
0.35 mg pramipexole equivalent to pramipexole dihydrochloride monohydrate 0.5 mg
0. 35 mg ta ’ pramipexole ekwivalenti għal pramipexole dihydrochloride monohydrate 0. 5 mg
MIRAPEXIN 0.35 mg
MIRAPEXIN 0. 35 mg
- 72 -
72 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
- 74 -
74 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
- 75 -
75 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
MIRAPEXIN 0.7 mg tablets Pramipexole
MIRAPEXIN 0. 7 mg pilloli Pramipexole
0.7 mg pramipexole equivalent to pramipexole dihydrochloride monohydrate 1.0 mg
0. 7 mg ta ’ pramipexole ekwivalenti għal pramipexole dihydrochloride monohydrate 1. 0 mg
MIRAPEXIN 0.7 mg
MIRAPEXIN 0. 7 mg
- 77 -
77 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
- 79 -
79 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
- 80 -
80 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
MIRAPEXIN 1.1 mg tablets Pramipexole
MIRAPEXIN 1. 1 mg pilloli Pramipexole
1.1 mg pramipexole equivalent to pramipexole dihydrochloride monohydrate 1.5 mg
1. 1 mg ta ’ pramipexole ekwivalenti għal pramipexole dihydrochloride monohydrate 1. 5 mg
MIRAPEXIN 1.1 mg
MIRAPEXIN 1. 1 mg
- 82 -
82 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Oral use Read the leaflet before use
Jittieħed mill- ħalq Aqra l- fuljett ta ’ tagħrif qabel l- użu
- 84 -
84 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
- 86 -
86 FULJETT TA ’ TAGĦRIF:
MIRAPEXIN 0.088 mg tablets pramipexole
MIRAPEXIN 0. 088 mg pilloli pramipexole
What MIRAPEXIN is and what it is used for 2.
X’ inhu MIRAPEXIN u għalxiex jintuża 2.
Before you take MIRAPEXIN 3.
Qabel ma tuża MIRAPEXIN 3.
How to take MIRAPEXIN 4.
Kif tuża MIRAPEXIN 4.
How to store MIRAPEXIN 6.
Kif taħżen MIRAPEXIN 6.
WHAT MIRAPEXIN IS AND WHAT IT IS USED FOR
X’ INHU MIRAPEXIN U GĦALXIEX JINTUŻA
MIRAPEXIN belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain.
MIRAPEXIN jappartjeni għal grupp ta ’ mediċini magħrufa bħala agonisti ta ’ dopamine, li jistimulaw ir- riċetturi ta ’ dopamine fil- moħħ.
Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.
L- istimulazzjoni tar- riċetturi ta ’ dopamine tikkawża impulsi tan- nervituri fil- moħħ li jgħinu biex jikkontrollaw il- movimenti tal- ġisem.
MIRAPEXIN is used to:
MIRAPEXIN jintuża biex:
- treat the symptoms of primary Parkinson’ s disease.
- jikkura s- sintomi tal- marda primarja ta ’ Parkinson.
It can be used alone or in combination with
Jista ’ jintuża waħdu jew flimkien ma ’
- treat the symptoms of moderate to severe primary Restless Legs Syndrome (RLS).
- jikkura s- sintomi tas- Sindrome tas- Saqajn Bla Kwiet (Restless Legs Syndrome - RLS) primarju li
BEFORE YOU TAKE MIRAPEXIN
QABEL MA TUŻA MIRAPEXIN
DO NOT take MIRAPEXIN
TIĦUX MIRAPEXIN
- if you are allergic (hypersensitive) to pramipexole or to any of the other ingredients of the
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal pramipexole jew għal xi sustanzi
tablets (see Section 6, “ Further information”).
oħra tal- pilloli (ara Sezzjoni 6 “ Aktar tagħrif ”).
Take special care with MIRAPEXIN Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:
Oqgħod attent ħafna b’ MIRAPEXIN Għid lit- tabib tiegħek jekk għandek (jew kellek), jew jekk tiżviluppa kwalunkwe kundizzjonijiet jew sintomi mediċi, speċjalment xi waħda minn dawn li ġejjin:
- kidney disease
- mard tal- kliewi
- hallucinations (seeing, hearing or feeling things that are not there).
- alluċinazzjonijiet (tara, tisma ’ jew tħoss affarijiet li ma jkunux hemm).
Most hallucinations are
Il- biċċa l- kbira ta ’
visual.
l- alluċinazzjonijiet huma viżwali.
- dyskinesia (e. g. abnormal, uncontrolled movements of the limbs)
- diskinesija (eż. movimenti anormali, mingħajr kontroll tad- dirgħajn/ riġlejn)
If you have advanced Parkinson’ s disease and are also taking levodopa, you might develop dyskinesia during the uptitration of MIRAPEXIN.
Jekk għandek marda ta ’ Parkinson li qiegħda fi stadju avvanzat u qed tieħu wkoll levodopa, inti tista ’ tiżviluppa d- diskinesija matul it- titrazzjoni ’ l fuq ta ’ MIRAPEXIN.
- sleepiness and episodes of suddenly falling asleep
- irqad u episodji li torqod għal għarrieda
- behavioural changes (e. g. pathological gambling, compulsive shopping), increased libido (e. g.
- tibdil fl- imġiba (eż. logħob patoloġiku ta ’ l- azzard, xiri kompulsiv), żieda fil- libido (eż. żieda fl -
increased sexual desire), binge eating.
aptit sesswali), tiekol bl- addoċċ
- severe heart or blood vessels disease
- mard sever tal- qalb jew tal- vini jew arterji
You will need to have your blood pressure checked regularly, especially at the beginning of treatment.
Ser ikollok bżonn li jkollok il- pressjoni tad- demm tiegħek iċċekkjata regolarment, speċjalment fil- bidu tal- kura.
This is to avoid postural hypotension (a fall in blood pressure on standing up)
Dan biex tiġi evitata pressjoni tad- demm baxxa li tiddependi mill- qagħda (il - pressjoni tad- demm titbaxxa malli tqum bilwieqfa).
- augmentation
- tkabbir
You may experience that symptoms start earlier than usual, be more intense and involve other limbs.
Jista ’ jkollok sintomi li jibdew aktar kmieni min- normal, ikunu aktar intensi, u jinvolvi dirgħajn/ riġlejn oħrajn.
Children and adolescents MIRAPEXIN is not recommended for use in children or adolescents under 18 years.
Tfal u adolexxenti MIRAPEXIN mhuwiex rakkomandat għall- użu fit- tfal jew fl- adolexxenti taħt it- 18- il sena.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra.
This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.
Dan jinkludi mediċini, mediċini li ġejjin mill- ħxejjex, health foods jew supplimenti li ksibt mingħajr riċetta.
You should avoid taking MIRAPEXIN together with antipsychotic medicines.
Għandek tevita li tieħu MIRAPEXIN flimkien ma ’ mediċini antipsikotiċi.
Take care if you are taking the following medicines:
Oqgħod attent jekk qed tieħu l- mediċini li ġejjin:
- cimetidine (to treat excess stomach acid and stomach ulcers)
- cimetidine (għall- kura ta ’ aċidu eċċessiv fl- istonku u ulċeri fl- istonku)
- amantadine (which can be used to treat Parkinson’ s disease)
- amantadine (li jista ’ jintuża għall- kura tal- marda ta ’ Parkinson)
If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with MIRAPEXIN.
Jekk qed tieħu levodopa, hu rakkomandat li d- doża ta ’ levodopa titnaqqas meta tibda l- kura b’ MIRAPEXIN.
Take care if you are using any medicines that calme you down (have a sedative effect) or if you are drinking alcohol.
Oqgħod attenta/ a jekk qed tuża kwalunkwe mediċini li jikkalmawk (għandhom effett sedattiv) jew jekk qed tixrob l- alkoħol.
In these cases MIRAPEXIN may affect your ability to drive and operate machinery.
F’ dawn il- każijiet, MIRAPEXIN jista ’ jaffettwa l- ħila tiegħek li ssuq u tħaddem il- makkinarju.
Taking MIRAPEXIN with food and drink You should be cautious while drinking alcohol during treatment with MIRAPEXIN.
Meta tieħu MIRAPEXIN ma ’ l- ikel u max- xorb Għandek toqgħod attent/ a meta tixrob l- alkoħol matul il- kura b’ MIRAPEXIN.
MIRAPEXIN can be taken with or without food.
MIRAPEXIN jista ’ jittieħed ma ’ l- ikel jew mingħajr l- ikel.
Swallow the tablets with water.
Ibla ’ l- pilloli ma ’ l- ilma.
Pregnancy and breast-feeding Tell your doctor if you are pregnant, think you might be pregnant or if you intend to become pregnant.
Tqala u treddigħ Għid lit- tabib tiegħek jekk inti tqila, jekk taħseb li inti tqila jew jekk għandek il- ħsieb li toħroġ tqila.
Your doctor will then discuss with you if you should continue to take MIRAPEXIN.
It- tabib tiegħek imbagħad ser jiddiskuti miegħek jekk għandekx tkompli tieħu MIRAPEXIN.
The effect of MIRAPEXIN on the unborn child is not known.
L- effett ta ’ MIRAPEXIN fuq it- tarbija mhix imwielda mhuwiex magħruf.
Therefore, do not take MIRAPEXIN if you are pregnant unless your doctor tells you to do so.
Għalhekk, tiħux MIRAPEXIN jekk inti tqila ħlief jekk it- tabib tiegħek jgħidlek biex tagħmel hekk.
MIRAPEXIN should not be used during breast-feeding.
MIRAPEXIN m’ għandux jintuża waqt it- treddigħ. MIRAPEXIN jista ’ jnaqqas il- produzzjoni tal- ħalib tas- sider.
Also, it can pass into the breast milk and can reach your baby.
Jista ’ wkoll jgħaddi ġol- ħalib tas- sider u jista ’ jilħaq lit- tarbija tiegħek.
If use of MIRAPEXIN is unavoidable, breast-feeding should be stopped.
Jekk l- użu ta ’ MIRAPEXIN ma jkunx jista ’ jiġi evitat, it- treddigħ għandu jitwaqqaf.
Driving and using machines MIRAPEXIN can cause hallucinations (seeing, hearing or feeling things that are not there).
Sewqan u tħaddim ta ’ magni MIRAPEXIN jista ’ jikkawża alluċinazzjonijiet (tara, tisma ’ jew tħoss affarijiet li ma jkunux hemm).
If affected, do not drive or use machines.
Jekk tkun affettwat/ a, issuqx u tużax magni.
MIRAPEXIN has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’ s disease.
MIRAPEXIN kien assoċjat ma ’ rqad u ma ’ episodji ta ’ rqad li jiġi f’ daqqa, partikularment f’ pazjenti bil- marda ta ’ Parkinson.
If you experience these side effects, you must not drive or operate machinery.
Jekk ikollok dawn l- effetti sekondarji, m’ għandekx issuq jew tħaddem makkinarju.
You should tell your doctor if this occurs.
Għandek tgħid lit- tabib tiegħek jekk dan iseħħ.
Important information about some of the ingredients of MIRAPEXIN tablets MIRAPEXIN tablets contain mannitol.
88 Tagħrif importanti dwar xi wħud mis- sustanzi tal- pilloli MIRAPEXIN Il- pilloli MIRAPEXIN fihom il- mannitol.
This may have a mild laxative (bowel loosening) effect.
Dan jista ’ jkollu effett lassattiv ħafif (tipporga aktar malajr).
HOW TO TAKE MIRAPEXIN
KIF TUŻA MIRAPEXIN
Always take MIRAPEXIN exactly as your doctor has told you.
Dejjem għandek tieħu MIRAPEXIN skond il- parir tat- tabib.
The doctor will advise you on the right dosing.
It- tabib ser jagħtik parir fuq id- dożaġġ korrett.
You can take MIRAPEXIN with or without food.
Tista ’ tieħu MIRAPEXIN ma ’ l- ikel jew mingħajr l- ikel.
Parkinson’ s disease The daily dose is to be taken divided into 3 equal doses.
Il- marda ta ’ Parkinson Id- doża ta ’ kuljum trid tittieħed maqsuma fi 3 dożi ugwali.
During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg three times a day (equivalent to 0.264 mg daily):
Matul l- ewwel ġimgħa, id- doża normali hi ta ’ pillola waħda ta ’ MIRAPEXIN 0. 088 mg tliet darbiet kuljum (ekwivalenti għal 0. 264 mg kuljum):
1st week
1el ġimgħa
1 tablet MIRAPEXIN 0.088 mg three times a day
1 pillola MIRAPEXIN 0. 088 mg tliet darbiet kuljum
Total daily dose (mg)
Doża totali ta ’ kuljum (mg)
0.264
0. 264
This will be increased every 5 - 7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
Din ser tiżdied kull 5 - 7 ijiem skond kif jindikalek it- tabib tiegħek sakemm is- sintomi tiegħek ikunu kkontrollati (doża tal- manteniment).
2nd week
2ni ġimgħa
3rd week
3et ġimgħa
1 tablet MIRAPEXIN 0.18 mg three times a day OR 2 tablets MIRAPEXIN 0.088 mg three times a day
1 pillola MIRAPEXIN 0. 18 mg tliet darbiet kuljum JEW 2 pilloli MIRAPEXIN 0. 088 mg tliet darbiet kuljum
1 tablet MIRAPEXIN 0.35 mg three times a day OR 2 tablets MIRAPEXIN 0.18 mg three times a day
1 pillola MIRAPEXIN 0. 35 mg tliet darbiet kuljum JEW 2 pilloli MIRAPEXIN 0. 18 mg tliet darbiet kuljum
The usual maintenance dose is 1.1 mg per day.
Id- doża normali tal- manteniment hi ta ’ 1. 1 mg darba kuljum.
However, your dose may have to be increased even further.
Madankollu, id- doża tiegħek jista ’ jkollha tiżdied anki iktar minn hekk.
If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of pramipexole a day.
Jekk ikun meħtieġ, it- tabib tiegħek jista ’ jżid id- doża tal- pilloli tiegħek sa massimu ta ’ 3. 3 mg ta ’ pramipexole kuljum.
A lower maintenance dose of three MIRAPEXIN 0.088 mg tablets a day is also possible.
Doża tal- manteniment iktar baxxa ta ’ tliet pilloli MIRAPEXIN 0. 088 mg kuljum hi wkoll possibbli.
Lowest maintenance dose
L- inqas doża tal- manteniment
Highest maintenance dose
L- ogħla doża tal - manteniment:
1 tablet MIRAPEXIN 1.1 mg three times a day
1 pillola MIRAPEXIN 0. 088 mg tliet darbiet kuljum
Patients with kidney disease If you have moderate or severe kidney disease, your doctor will prescribe a lower dose.
Pazjenti b’ mard tal- kliewi Jekk għandek mard moderat jew sever tal- kliewi, it- tabib tiegħek ser jagħtik riċetta għal doża iktar baxxa.
In this case, you will have to take the tablets only once or twice a day.
F’ dan il- każ, inti ser ikollok tieħu l- pilloli biss darba jew darbtejn kuljum.
If you have moderate kidney disease, the usual starting dose is 1 tablet MIRAPEXIN 0.088 mg twice a day.
Jekk għandek mard moderat, id- doża normali tal- bidu hi ta ’ pillola waħda ta ’ MIRAPEXIN 0. 088 mg darbtejn kuljum.
In severe kidney disease, the usual starting dose is just 1 tablet MIRAPEXIN 0.088 mg a day.
F’ mard sever tal- kliewi, id- doża normali tal- bidu hi ta ’ pillola waħda biss ta ’ MIRAPEXIN 0. 088 mg kuljum.
Restless Legs Syndrome The dose is usually taken once a day, in the evening, 2-3 hours before bedtime.
89 Sindrome tas- Saqajn Bla Kwiet Normalment id- doża titttieħed darba kuljum, filgħaxija, 2- 3 sigħat qabel il- ħin ta ’ l- irqad.
During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg once a day (equivalent to 0.088 mg daily):
Matul l- ewwel ġimgħa, id- doża normali hi ta ’ pillola waħda ta ’ MIRAPEXIN 0. 088 mg darba kuljum (ekwivalenti għal 0. 088 mg kuljum):
1 tablet MIRAPEXIN 0.088 mg
0. 088
This will be increased every 4 - 7 days as directed by your doctor until your symptoms are controlled (maintenance dose).
Din ser tiżdied kull 4 - 7 ijiem skond kif jindikalek it- tabib tiegħek sakemm is- sintomi tiegħek ikunu kkontrollati (doża tal- manteniment).
4th week
4ba ġimgħa
1
0. 088 mg
tablet MIRAPEXIN 0.35 mg and 1 tablet MIRAPEXIN 0.18 mg OR tablets MIRAPEXIN 0.18 mg OR
4 pilloli MIRAPEXIN 0. 088 mg
6 tablets MIRAPEXIN 0.088 mg Total
3 pilloli MIRAPEXIN 0. 18 mg JEW 6 pilloli MIRAPEXIN 0. 088 mg
daily dose (mg)
Doża totali ta ’ kuljum (mg)
0.35
0. 18
The daily dose should not exceed 6 tablets MIRAPEXIN 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
Id- doża ta ’ kuljum m’ għandhiex taqbeż 6 pilloli MIRAPEXIN 0. 088 mg jew doża ta ’ 0. 54 mg (0. 75 mg ta ’ melħ ta ’ pramipexole).
If you stop taking your tablets for more than a few days and want to restart the treatment, you must start again at the lowest dose.
Jekk tieqaf tieħu l- pilloli tiegħek għal aktar minn ftit jiem u tkun trid tibda l- kura mill- ġdid, għandek terġa ’ tibda mill- inqas doża.
You can then build up the dose again, as you did the first time.
Imbagħad tkun tista ’ terġa ’ żżid id- doża mill- ġdid, bħalma għamilt l- ewwel darba.
Ask your doctor for advice.
Jekk jogħġbok staqsi lit- tabib tiegħek għal parir.
Your doctor will review your treatment after 3 months to decide whether or not to continue the treatment.
It- tabib tiegħek ser jeżamina l- kura tiegħek wara 3 xhur biex jiddeċiedi jekk il- kura għandhiex titkompla jew le.
Patients with kidney disease:
Pazjenti b’ mard tal- kliewi:
If you have severe kidney disease, MIRAPEXIN may not be a suitable treatment for you.
Jekk għandek mard sever tal- kliewi, MIRAPEXIN jista ’ ma jkunx kura adattata għalik.
If you take more MIRAPEXIN than you should If you accidentally take too many tablets,
Jekk tieħu MIRAPEXIN aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda
- contact your doctor or nearest hospital casualty department immediately for advice.
- ikkuntattja lit- tabib tiegħek jew lill- eqreb dipartiment ta ’ l- emerġenza ta ’ l- isptar immedjament
- you may experience vomiting, restlessness, or any of the side effects as described in chapter 4
- jista ’ jkollok rimettar, nuqqas ta ’ kwiet f’ ġismek, jew kwalunkwe mill- effetti sekondarji
(Possible side effects).
deskritti f’ Kapitlu 4 (Effetti sekondarji li jista ’ jkollu).
If you forget to take MIRAPEXIN Do not worry.
Jekk tinsa tieħu MIRAPEXIN Tinkwetax.
Simply leave out that dose completely and then take your next dose at the right time.
Sempliċement ħalli barra dik id- doża kompletament u mbagħad ħu d- doża tiegħek li jmiss fil- ħin tagħha.
Do not try to make up for the missed dose.
Tippruvax tpatti għad- doża li tkun insejt tieħu.
If you stop taking MIRAPEXIN Do not stop taking MIRAPEXIN without first talking to your doctor.
90 Jekk tieqaf tieħu MIRAPEXIN Tiqafx tieħu MIRAPEXIN mingħajr ma l- ewwel titkellem mat- tabib tiegħek.
If you have to stop taking this medicine, your doctor will reduce the dose gradually.
Jekk ikollok tieqaf tieħu din il- mediċina, it- tabib tiegħek ser tnaqqas id- doża gradwalment.
This reduces the risk of worsening symptoms.
Dan inaqqas ir- riskju li s- sintomi jmorru għall- agħar.
If you suffer from Parkinson’ s disease you should not stop treatment with MIRAPEXIN abruptly.
Jekk tbati mill- marda ta ’ Parkinson, m’ għandekx twaqqaf il- kura b’ MIRAPEXIN f’ daqqa.
A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk.
It- twaqqif f’ daqqa jista ’ jkun il- kawża li tiżviluppa kundizzjoni medika msejħa sindrome malinn newroleptiku li jista ’ jirrappreżenta riskju maġġuri għas- saħħa.
The symptoms include:
Is- sintomi jinkludu:
- akinesia (loss of muscle movement)
- akinesija (telf ta ’ moviment tal- muskoli)
- rigid muscles
- muskoli iebsin
- unstable blood pressure
- pressjoni tad- demm instabbli
- tachycardia (increased heart rate)
- takikardija (żieda fir- rata ta ’ taħbit tal- qalb)
- depressed level of consciousness (e. g. coma)
- livell baxx ta ’ koxjenza (eż. koma)
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, MIRAPEXIN can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, MIRAPEXIN jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Evaluation of these side effects is based on the following frequencies:
L- evalwazzjoni ta ’ dawn l- effetti sekondarji hi bbażata fuq il- frekwenzi li ġejjin:
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data
jaffettwaw iktar minn utent 1 minn kull 10 Komuni ħafna: jaffettwaw minn 1 sa 10 utenti minn kull 100 Komuni: jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 Mhux komuni: jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 Rari: jaffettwaw inqas minn utent 1 minn kull 10, 000 Rari ħafna:
If you suffer from Parkinson’ s disease, you may experience the following side effects (regardless of indication):
Jekk tbati mill- Marda ta ’ Parkinson, jista ’ jkollok dawn l- effetti sekondarji
- Dyskinesia (e. g. abnormal, uncontrolled movements of the limbs)
- Diskinesija (eż. movimenti anormali, mingħajr kontroll tad- dirgħajn/ riġlejn)
- Sleepiness
- Ngħas
- Nausea (sickness)
- Nawseja (dardir)
- Hypotension (low blood pressure)
- Ipotensjoni (pressjoni tad- demm baxxa)
- Urge to behave in an unusual way
- Xewqa kbira li ġġib ruħek b’ mod mhux tas- soltu
- Hallucinations (seeing, hearing or feeling things that are not there)
- Alluċinazzjonijiet (tara, tisma ’ jew tħoss affarijiet li ma jkunux hemm).
- Confusion
- Konfuzjoni
- Tiredness (fatigue)
- Għeja
- Sleeplessness (insomnia)
- Ma tkunx tista ’ torqod (insomnja)
- Excess of fluid, usually in the legs (peripheral oedema)
- Fluwidu eċċessiv, normalment fir- riġlejn (edema periferali)
- Abnormal dreams
- Ħolm anormali
- Constipation
- Stitikezza
- Restlessness
- Nuqqas ta ’ kwiet f’ ġismek
- Amnesia (memory disturbance)
- Amnesija (disturb fil- memorja)
- Visual disturbance
- Disturbi tal- vita
- Vomiting (being sick)
- Rimettar
- Weight loss
- Tnaqqis fil- piż
- Paranoia (e. g. excessive fear for one’ s own well-being)
- Paranojja (eż. biża ’ eċċessiv għall- benesseri tiegħu/ tagħha)
- Delusion
- Delużjoni
- Excessive daytime sleepiness and suddenly falling asleep
- Irqad eċċessiv matul il- jum u torqod għal għarrieda
- Hyperkinesia (increased movements and inability to keep still)
- Iperkinesija (żieda fil- movimenti tal- ġisem u ma tkunx kapaċi twaqqafhom)
- Weight increase
- Żieda fil- piż
- Increased sexual desire (e. g. increased libido)
- Żieda fl- aptit sesswali (eż. żieda fil- libido)
- Allergic reactions (e. g. rash, itching, hypersensitivity)
- Reazzjonijiet allerġiċi (eż. raxx, ħakk, sensittività eċċessiva)
- Fainting
- Iħossok ħażin
- Pathological gambling, especially when taking high doses of MIRAPEXIN
- Logħob patoloġiku tal- azzard, speċjalment meta tieħu dożi qawwija ta ’ MIRAPEXIN
- Hypersexuality
- Ipersesswalità
- Compulsive shopping
- Xiri kompulsiv
Unknown frequency:
Frekwenza mhux magħrufa:
- Increased eating (binge eating, hyperphagia)
- Żieda fl- ammont ta 'ikel li tiekol (tiekol bl- addoċċ, iperfaġja)
If you suffer from Restless Legs Syndrome, you may experience the following side effects:
Jekk tbati mis- Sindrome tas- Saqajn Bla Kwiet, jista ’ jkollok l- effetti sekondarji li ġejjin:
- Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
- Tibdil fir- rittmu ta ’ l- irqad, bħal problemi biex torqod (insomnja) u ngħas
- Vomiting (being sick)
- Rimettar (dardir)
- Excessive daytime sleepiness and suddenly falling asleep
- Irqad eċċessiv matul il- ġurnata u li torqod għal għarrieda
- Visual disturbance
- Disturbi tal- vista
- Pathological gambling, especially when taking high doses of MIRAPEXIN
- Logħob patoloġiku ta ’ l- azzard, speċjalment meta tieħu dożi qawwija ta ’ MIRAPEXIN
- Increased eating (binge eating, hyperphagia)
- Żieda fl- ammont ta ’ ikel li tiekol (tiekol bl- addoċċ, iperfaġja)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
92 Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE MIRAPEXIN
KIF TAĦŻEN MIRAPEXIN
Do not take MIRAPEXIN after the expiry date, which is stated on the pack.
Tużax MIRAPEXIN wara d- data ta ’ skadenza li tidher fuq il- pakkett.
Store in the original package to protect the tablets from light.
Aħżen fil- pakkett oriġinali sabiex tipproteġi l- pilloli mid- dawl.
What MIRAPEXIN contains The active substance is pramipexole.
X’ fih MIRAPEXIN Is- sustanza attiva hi pramipexole.
Each MIRAPEXIN 0.088 mg tablet contains 0.088 mg of pramipexole base (as 0.125 mg of pramipexole dihydrochloride monohydrate).
Kull pillola MIRAPEXIN ta ’ 0. 088 mg fiha 0. 088 mg ta ’ melħ ta ’ bażi ta ’ pramipexole (bħala 0. 125 mg ta ’ pramipexole dihydrochloride monohydrate).
Mannitol, Maize starch, anhydrous colloidal silica, Povidone K 25, Magnesium stearate.
Mannitol, Maize starch, anhydrous colloidal silica, Povidone K 25, Magnesium stearate.