qanastek/EMEA-V3 huggingface dataset:
Oprymea can be used either on its own or in combination with levodopa (another medicine for Parkinson’ s disease), at any stage of disease including the later stages when levodopa starts becoming less effective.
Oprymea jista ’ jintuża jew waħdu jew flimkien ma ’ levodopa (mediċina oħra għall- marda ta ’ Parkinson) f’ kull stadju tal- marda inkluż fl - aħħar stadji meta levodopa jibda jkun anqas effikaċi.
How is Oprymea used?
Kif jintuża Oprymea?
Oprymea tablets should be swallowed with water, with or without food.
Pilloli Oprymea għandhom jinbelgħu ma ’ l- ilma, ma ’ l- ikel jew fuq stonku vojt.
The starting dose is 0.088 mg three times per day.
Id- doża inizjali hija ta ’ 0. 088 mg tliet darbiet kuljum.
The dose should be increased every five to seven days until symptoms are controlled without causing side effects that cannot be tolerated.
Id- doża għandha tiġi miżjuda kull ħames sa sebat ijiem sakemm is - sintomi jiġu kontrollati mingħajr ma jiġu kkawwżati effetti sekondarji li ma jistgħux jiġu tollerati.
The maximum daily dose is 1.1 mg three times per day.
Id - doża massima kuljum hija ta ’ 1. 1 mg tliet darbiet kuljum.
Oprymea must be given less frequently in patients who have problems with their kidneys.
Oprymea għandu jingħata anqas frekwentement lil pazjenti li għandhom problemi fil- kliewi tagħhom.
If treatment is stopped for any reason, the dose should be decreased gradually.
Jekk jiġi mwaqqaf it- trattament għal kwalunkwe raġuni, id- doża għandha tiġi mnaqqsa gradwalment.
How does Oprymea work?
Kif jaħdem Oprymea?
The active substance in Oprymea, pramipexole, is a dopamine agonist, which imitates the action of dopamine.
Is- sustanza attiva f' Oprymea, pramipexole, hija agonista tad- dopamina li jfisser li timita l- azzjoni tad - dopamina.
In patients with Parkinson's disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases.
Fil- pazjenti li jbatu mill- marda ta 'Parkinson, iċ- ċelluli li jipproduċu d- dopamina jibdew imutu u b' hekk l- ammont ta' dopamina fil- moħħ jonqos.
Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson’ s disease, such as shaking, stiffness and slowness of movement.
Pramipexole tistimola l- moħħ hekk kif tagħmel id- dopamina, biex b' hekk il- pazjenti jkunu jistgħu jikkontrollaw il - movimenti tagħhom u jkollhom inqas sinjali u sintomi tal- marda ta 'Parkinson, bħall- ebusija u d - dewmien fil- movimenti.
How has Oprymea been studied?
Kif ġie studjat Oprymea?
Because Oprymea is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (they produce the same levels of the active substance in the body).
Minħabba li Oprymea huwa mediċina ġenerika, l- istudji ġew limitati għal testijiet biex jintwera illi huwa bioekwivalenti għall- mediċini ta ’ referenza (huma jipproduċu l- istess livelli ta ’ sustanza attiva fil- ġisem).
What is the risk associated with Oprymea?
X’ inhu r- riskju assoċjat ma ’ Oprymea?
Because Oprymea is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Minħabba li Oprymea huwa mediċina ġenerika u huwa bijoekwivalenti għall- mediċini ta ’ referenza, il- benefiċċju u r- riskju tiegħu huma meqjusa li huma l- istess bħal dawk tal- mediċini ta ’ referenza.
Why has Oprymea been approved?
Għaliex ġie approvat Oprymea?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Oprymea has been shown to have comparable quality and to be bioequivalent to Sifrol.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li, b’ mod konformi mal- ħtiġijiet ta ’ l- UE, intwera li Oprymea għandu kwalità komparabbli ma ’ u li hija bijoekwivlenti għal Sifrol.
Therefore, the CHMP’ s view was that, as for Sifrol, the benefit outweighs the identified risk.
Għaldaqstant, il- fehma tas- CHMP kienet li, bħal Sifrol, il- benefiċċji jegħlbu r- riskji identifikati.
The Committee recommended that Oprymea be given marketing authorisation.
Il- Kumitat irrakkomanda li Oprymea jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Oprymea:
Tagħrif ieħor dwar Oprymea:
The European Commission granted a marketing authorisation valid throughout the EU for Oprymea to Krka, d. d., Novo mesto on 12 September 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Oprymea lil Krka, d. d., Novo mesto fit- 12 ta ’ Settembru 2008.
The full EPAR for Oprymea can be found here.
L- EPAR sħiħ għal Oprymea jista ’ jinsab hawn.
The full EPAR for the reference medicine can also be found on the EMEA’ s website.
L- EPARs sħaħ għall- mediċina ta ’ referenza jistgħu jinsabu fuq il- websajt ta ’ l- EMEA ukoll.
This summary was last updated in 07-2008.
Dan is- sommarju ġie aġġornat l- aħħar fis- 07- 2008.
Oprymea 0.088 mg tablets
Oprymea 0. 088 mg pilloli
Each tablet contains 0.088 mg pramipexole base (as 0.125 mg pramipexole dihydrochloride monohydrate).
Kull pillola fiha 0. 088 mg bażi ta ’ pramipexole (bħala 0. 125 mg pramipexole dihydrochloride monohydrate).
Pramipexole doses as published in the literature refer to the salt form.
Id- dożi ta ’ pramipexole kif ippubblikati fil- letteratura jirreferu għal għamla mmellħa.
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
Għalhekk id- dożi għandhom jiġu mogħtija f’ termini kemm ta ’ bażi ta ’ pramipexole u tal- melħ ta ’ pramipexole (fil- parentesi).
0.088 mg: white, round, with bevelled edges and imprint "P6" on one side of the tablet.
0. 088 mg: bajda, tonda, bi truf iċċanfrati u b’ intaljar "P6" fuq naħa waħda tal- pillola.
Oprymea 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).
Oprymea hi indikata għal trattament tas- sinjali u s- sintomi tal- marda idjopatika ta ’ Parkinson, waħidha (mingħajr levodopa) jew flimkien ma ’ levodopa, i. e. matul il- kors tal- marda, sa l- istadji ta ’ l- aħħar meta l- effett ta ’ levodopa jonqos ħafna jew isir inkonsistenti u jseħħu varjazzjonijiet ta ’ l- effett terapewtiku (fl- aħħar tad- doża jew varjazzjonijiet “ on off ”).
Parkinson’ s disease The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
Marda ta ’ Parkinson Il- pilloli għandhom jittieħdu mill- ħalq, jinbelgħu ma ’ l- ilma u jistgħu jittieħdu ma ’ l- ikel jew mingħajr ikel.
Initial treatment Dosages should be increased gradually from a starting-dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5 - 7 days.
Trattament tal- bidu Id- dożaġġi għandhom jiżdiedu gradwalment minn doża tal- bidu ta ’ 0. 264 mg ta ’ bażi (0. 375 mg ta ’ melħ) kuljum u mbagħad jiżdiedu kull 5 - 7 ijiem.
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
Kemm- il darba pazjenti ma jkollhomx effetti oħra intollerabbli, id- dożaġġ għandu jkun ittitrat biex jilħaq l- effett terapewtiku massimu.
Ascending – Dose Schedule of OPRYMEA Week
Skeda ta ’ Tiżjid tad- Doża għal OPRYMEA Ġimgħa
If a further dose increase is necessary the daily dose should be increased by 0.54 mg base (0.75 mg salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day.
Jekk żieda fid- doża hi meħtieġa, id- doża ta ’ kuljum għandha tiżdied b’ 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ) f’ intervalli ta ’ ġimgħa sa doża massima ta ’ 3. 3 mg ta ’ bażi (4. 5 mg ta ’ melħ) kuljum.
2 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
2 Madankollu, għandu jkun innutat li l- inċidenza ta ’ ngħas tiżdied f’ dożi ogħla minn 1. 5 mg/ kuljum (ara sezzjoni 4. 8).
Maintenance treatment The individual dose should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 3.3 mg of base (4.5 mg of salt) per day.
Trattament ta ’ manteniment Id- doża individwali għandha tkun fil- medda ta ’ bejn 0. 264 mg ta ’ bażi (0. 375 mg ta ’ melħ) sa massimu ta ’ 3. 3 mg ta ’ bażi (4. 5 mg ta ’ melħ) kuljum.
During dose escalation in three pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt).
Waqt eskalazzjoni tad- doża fi tliet studji ewlenin, l- effikaċja kienet osservata b’ doża ta ’ kuljum li tibda b’ 1. 1 mg ta ’ bażi (1. 5 mg ta ’ melħ).
Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions.
Aġġustamenti oħra fid- doża għandhom isiru skond ir- rispons kliniku ta ’ l- okkorrenza ta ’ reazzjonijiet avversi.
In clinical trials approximately 5% of patients were treated at doses below 1.1 mg (1.5 mg of salt).
Fi provi kliniċi madwar 5% ta ’ pazjenti kienu trattati f’ dożi ta ’ anqas minn 1. 1 mg (1. 5 mg ta ’ melħ).
In advanced Parkinson’ s disease, doses higher than 1.1 mg (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Fil- marda ta ’ Parkinson fi stadju avvanzat, dożi ogħla minn 1. 1 mg (1. 5 mg ta ’ melħ) kuljum jistgħu jkunu utli f’ pazjenti meta it- tnaqqis fit- terapija ta ’ levodopa hu maħsub.
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with Oprymea, depending on reactions in individual patients.
Hu rakkomandat li d - doża ta ’ levodopa għandha titnaqqas meta d- doża tkun qed tiżdied, kif ukoll matul il- kura tal - manteniment b’ Oprymea, skond ir- reazzjonijiet fil- pazjenti individwali.
Treatment discontinuation Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome.
It- twaqqif tat- trattament It- twaqqif f’ daqqa tat- terapija dopaminerġika jista ’ jwassal għall- iżvilupp ta ’ sindromu newrolettiku malinn.
Therefore, pramipexole should be tapered off at a rate of 0.54 mg of base (0.75 mg of salt) per day until the daily dose has been reduced to 0.54 mg of base (0.75 mg of salt).
Għalhekk, pramipexole għandu jitwaqqaf b’ mod gradwali b’ rata ta ’ 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ) kuljum sakemm id- doża ta ’ kuljum tkun tnaqqset għal 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ).
Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
Minn hemm ’ il quddiem, id- doża għandha titnaqqas b’ 0. 264 mg ta ’ bażi (0. 375 mg ta ’ melħ) kuljum (ara sezzjoni 4. 4).
Dosing in patients with renal impairment The elimination of pramipexole is dependent on renal function.
Id- doża f’ pazjenti b’ indeboliment renali L- eliminazzjoni ta ’ pramipexole tiddependi fuq il- funzjoni renali.
The following dosage schedule is suggested for initiation of therapy:
L- iskeda tad- dożaġġ li ġejja hi suġġerita għal bidu tat- terapija:
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
Pazjenti bi tneħħija ta ’ kreatinina ta ’ aktar minn 50 ml/ min ma jeħtieġu l- ebda tnaqqis fid- doża ta ’ kuljum.
In patients with a creatinine clearance between 20 and 50 ml/ min, the initial daily dose of Oprymea 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- kreatinina bejn 20 u 50 ml/ min, id- doża inizjali ta ’ kuljum ta ’ Oprymea għandha tingħata f’ żewg dożi ugwali 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 Oprymea 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- kreatinina ta ’ inqas minn 20 ml/ min, id- doża ta ’ kuljum ta ’ Oprymea 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 Oprymea daily dose by the same percentage as the decline in creatinine clearance, i. e. if creatinine clearance declines by 30%, then reduce the Oprymea daily dose by 30%.
Jekk il- funzjoni renali tonqos matul it- terapija tal- manteniment, naqqas id- doża ta ’ kuljum ta ’ Oprymea bl- istess perċentwali bħat- tnaqqis fit- tneħħija ta ’ kreatinina, i. e. jekk it- tneħħija tal- kreatinina tonqos bi 30%, naqqas id- doża ta ’ kuljum ta ’ Oprymea bi 30%.
The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/ min, and as a single daily dose if creatinine clearance is less than 20 ml/ min.
Id- doża ta ’ kuljum tista ’ tingħata f’ żewġ dożi separati jekk it- tneħħija tal- kreatinina tkun bejn 20 u 50 ml/ min, u bħala doża waħda kuljum jekk it- tneħħija tal- kreatinina tkun inqas minn 20 ml/ min.
90% of absorbed active substance is excreted through the kidneys.
Id- dożaġġ f’ pazjenti b’ indeboliment epatiku L- aġġustament fid- doża f’ pazjenti b’ insuffiċjenza epatika probabbilment ma jkunx meħtieġ peress li madwar 90% tas- sustanza attiva assorbita titneħħa minn ġol- kliewi.
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
Madankollu, l- influwenza potenzjali ta ’ insuffiċjenza epatika fuq il- farmakokinetiċi ta ’ Oprymea ma ġietx mistħarrġa.
Dosing in children and adolescents Oprymea is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Id- dożaġġ fi tfal u adoloxxenti Oprymea mhux rakkomandat għall- użu fi tfal u adoloxxenti li għandhom inqas minn 18- il sena, minħabba nuqqas ta ’ informazzjoni dwar siġurtà u effikaċja.
3 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
3 Meta tingħata riċetta għal Oprymea f’ pazjent bil- marda ta ’ Parkinson b’ indeboliment renali, doża mnaqqsa hi suġġerita skond kif spjegat f’ sezzjoni 4. 2.
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
L- alluċinazzjonijiet huma effett oħra magħruf tal- kura b’ agonisti ta ’ dopamine u b’ levodopa.
Patients should be informed that (mostly visual) hallucinations can occur.
Il- pazjenti ghandhom ikunu infurmati li alluċinazzjonijiet (l- aktar viżwali) jistgħu jseħħu.
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
Fi stadju avvanzat ta ’ Parkinson, flimkien ma ’ trattament b’ levodopa, id- diskinesiji jistgħu jseħħu matul it- titrazzjoni inizjali ta ’ Oprymea.
If they occur, the dose of levodopa should be decreased.
Jekk dan iseħħ, id- doża ta ’ levodopa għandha titnaqqas.
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Pramipexole kien assoċjat ma ’ ngħas u episodji ta ’ rqad li jiġi f’ daqqa, partikularment f’ pazjenti bil- marda ta ’ Parkinson.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
Irqad li jiġi f’ daqqa waqt attivitajiet ta ’ kuljum, f’ xi każijiet mingħajr sinjali konxji jew ta ’ twissija, kien irrapurtat b’ mod mhux komuni.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Oprymea.
Il- pazjenti għandhom ikunu infurmati b’ dan u jkunu avżati biex joqgħodu attenti waqt is- sewqan jew tħaddim ta ’ inġenji waqt it- trattament b’ Oprymea.
Patients who have experienced somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
Pazjenti li kellhom ngħas u/ jew episodju ta ’ irqad f’ daqqa m’ għandhomx isuqu jew iħaddmu magni.
Furthermore a reduction of dosage or termination of therapy may be considered.
Barraminhekk jistgħu jkunu kkunsidrati tnaqqis fid- dożaġġ jew it- twaqqif ta ’ terapija.
Because of possible additive effects, caution should be advised when patients are taking other sedating medication or alcohol in combination with pramipexole (see section 4.7 and section 4.8).
Minħabba l- possibbiltà ta ’ effetti addittivi, hija rakkomandata l- kawtela meta l- pazjenti jkunu qed jieħdu prodotti mediċinali sedattivi oħrajn jew alkoħol flimkien ma ’ pramipexole (ara sezzjoni 4. 7 u sezzjoni 4. 8).
Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole.
Logħob patoloġiku ta ’ l- ażżard, żieda fil- libido u ipersesswalità kienu rapportati f’ pazjenti trattati b’ agonisti ta ’ dopamine għal marda ta ’ Parkinson, li jinkludu pramipexole.
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
Barraminhekk, pazjenti u persuni li jieħdu ħsiebhom għandhom ikunu konxji mill- fatt li bidliet fl- imġieba jistgħu jseħħu.
Dose reduction/ taper or discontinuation should be considered.
Tnaqqis / tnaqqis gradwali jew waqfien tad- doża għandhom jiġu kkunsidrati.
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
Pazjenti b’ mard psikotiku għandhom ikunu trattati b’ agonisti ta ’ dopamine biss jekk il- benefiċċju potenzjali huwa ogħla mir- riskji.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
L- għoti ta ’ prodotti mediċinali antipsikotiċi flimkien ma ’ pramipexole għandu jkun evitat (ara sezzjoni 4. 5).
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Monitoraġġ oftalmoloġiku hu rakkomandat li jsir f’ intervalli regolari jew jekk iseħħu anormalitajiet fil- vista.
In case of severe cardiovascular disease, care shou ld be taken.
Għandu jkun hemm attenzjoni f’ każ ta ’ mard kardjovaskulari severi.
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 jkun hemm monitoraġġ tal- pressjoni tad- demm, b’ mod speċjali fil- bidu tal- kura, minħabba r- riskju potenzjali ta ’ pressjoni posturali tad- demm baxxa assoċjata mat- terapija dopominerġika.
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
Sintomi li jissuġerixxu sindromu newrolettiku mallinn kienu rapportati mat- twaqqif f’ daqqa tat- terapija dopaminerġika (ara sezzjoni 4. 2).
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
Rapporti fil- letteratura medika jindikaw li l- kura ta ’ indikazzjonijiet oħra ma ’ prodotti mediċinali dopominerġiċi jista ’ jirriżulta fi tħarriex.
Augmentation refers to the earlier onset of symptoms in the evening (or even afternoon), increase in symptoms, and spread of symptoms to involve other extremities.
It- tħarriex jirreferi għall- bidu aktar bikri tas- sintomi ta ’ filgħaxija (jew anke wara nofsinhar), żieda fis- sintomi, u l- firxa ta ’ sintomi biex jiġu involuti aktar estremitajiet.
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
Il- frekwenza tat- tħarriex wara użu aktar fit- tul ta ’ pramipexole u l- immaniġġjar xieraq ta ’ dawn l- avvenimenti ma kienux evalwati fil- provi kliniċi b’ kontrolli.
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
Pramipexole jintrabat mal- proteini fil- plażma f’ livelli baxxi ħafna (< 20%), u hemm ftit bijotrasformazzjoni osservata fil- bniedem.
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Għalhekk, effetti ma ’ prodotti mediċinali oħra li jaffettwaw ir- rabta ta ’ proteini mal- plażma mhumiex probabbli.
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Peress li antikolinerġiċi huma prinċipalment eliminati b’ bijotransformazzjoni, il- potenzjal għal interazzjoni hu limitat, għalkemm l- interazzjoni ma ’ antikolinerġiċi ma ġietx mistħarrġa.
There is no pharmacokinetic interaction with selegiline and levodopa.
M’ hemm l- ebda interazzjoni farmakokinetika b’ selegiline u levodopa.
Therefore, medicinal products
4 Cimetidine naqqas it- tneħħija renali ta ’ pramipexole b’ madwar 34%, preżumibilment permezz ta ’ l- inibizzjoni tas- sistema tat- trasport li tnixxi l- ketajins tat- tubuli renali.
4 that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products.
Għalhekk, prodotti mediċinali li huma inibituri ta ’ dan il- passaġġ attiv ta ’ l- eliminazzjoni renali, jew li jkunu mneħħija permezz ta ’ dan il- passagg, bħal cimetidine u amantadine, jistgħu jirreaġixxu ma ’ pramipexole, u dan jirrizulta fi tneħħija mnaqqsa ta ’ wieħed jew iż- żewġ prodotti mediċinali.
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
It- tnaqqis fid- doża ta ’ pramipexole ghandu jkun ikkunsidrat meta dawn il- prodotti medicinali jinghataw fl- istess hin.
When Oprymea 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 Oprymea.
Meta Oprymea tingħata 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 ’ Oprymea tiżdied.
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- possibilità ta ’ effetti addittivi, kawtela hija rakkomandata meta l- pazjenti jkunu qed jieħdu prodotti mediċinali sedattivi oħrajn jew alkoħol flimkien ma ’ pramipexole.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
L- għoti flimkien ta ’ prodotti mediċinali antipsikotiċi ma ’ pramipexole ghandu jkun evitat (ara sezzjoni 4. 4), eż. jekk ikunu mistennija effetti antagonisti.
Oprymea should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
Oprymea m’ għandiex tingħata waqt it- tqala għajr meta jkun meħtieġ b’ mod ċar, i. e. il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali lill- fetu.
As pramipexole treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Peress li t- trattament b’ pramipexole jimpedixxi t- tnixxija ta ’ prolactin fil- bniedem, l- inibizzjoni tat- treddigħ hi mistennija.
The excretion of pramipexole into breast milk has not been studied in women.
It- tneħħija ta ’ pramipexole fil- ħalib ta ’ l- omm ma kinetx studjata fin- nisa.
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.
In the absence of human data, Oprymea should not be used during breast-feeding.
Fin- nuqqas ta ’ informazzjoni miksuba mill- bniedem, Oprymea m’ għandiex tintuża waqt it- treddigħ.
However, if its use is unavoidable, breast-feeding should be discontinued.
Madankollu, jekk l- użu tagħha ma jkunx jista ’ jigi evitat, it- treddigħ għandu jitwaqqaf.
Oprymea can have a major influence on the ability to drive and use machines.
Oprymea tista ’ jkollha effett prinċipali fuq il- ħila biex issuq u biex tuża magni.
Hallucinations or somnolence can occur.
Jista ’ jkun hemm alluċinazzjonijiet jew ngħas.
Patients being treated with Oprymea 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 ttrattati b’ Oprymea u li jkollhom ngħas u/ jew episodji ta ’ rqad li jiġi f’ daqqa għandhom ikunu infurmati biex ma jsuqux jew jagħmlu attivitajiet fejn prontezza indebolita tista ’ tpoġġi lilhom jew lil persuni oħra f’ riskju ta ’ ferriment serju jew mewt (eż. tħaddim ta ’ magni) sakemm dawn l- episodji rikorrenti u ngħas ikunu ġew ikkurati (ara wkoll sezzjonijiet 4. 4, 4. 5, u 4. 8).
The following adverse reactions are expected under the use of Oprymea: abnormal dreams, confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hypotension, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia, pathological gambling, hypersexuality and other abnormal behaviour; somnolence, weight increase, sudden onset of sleep; pruritus and rash and other hypersensitivity.
Ir- reazzjonijiet avversi li ġejjin huma mistennija li jseħħu waqt l- użu ta ’ Oprymea: ħolm anormali, konfużjoni, stitikezza, delużjoni, sturdament, diskinesja, għeja, alluċinazzjonijiet, uġigh ta ’ ras, iperkinesja, pressjoni tad- demm baxxa, tiekol ħafna (tiekol bl- addoċċ, iperfaġja), nuqqas ta ’ rqad, disturbi fil- libido, dardir, edema periferali, paranoja, logħob patoloġiku ta ’ l- ażżard, ipersesswalità u mġieba abnormali oħra; ngħas, żieda fil- piż, irqad li jiġi f’ daqqa; ħakk u raxx u sensittivitajiet eċċessivi oħrajn.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both groups.
Minn analiżi bbażżata fuq provi puljati li saru b’ kontrolli ta ’ plaċebo, li kienu jinkludu total ta ’ 1, 923 pazjent fuq pramipexole u 1, 354 pazjent fuq il- plaċebo, reazzjonijiet avversi tal- mediċina kienu rrappurtati b’ mod frekwenti fiż- żewġ gruppi.
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
63% ta ’ pazjenti fuq pramipexole u 52% ta ’ pazjenti fuq il- plaċebo rrappurtaw minn ta ’ lanqas reazzjoni avversa waħda għall- mediċina.
The most commonly (≥ reported adverse reactions in patients with Parkinson’ s disease more 5%) frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
5 L- aktar reazzjonijiet avversi komuni (≥5%) rapportati f’ pazjenti bil- marda ta ’ Parkinson li kienu aktar frekwenti bit- trattament b’ pramipexole milli bi plaċebo kienu dardir, diskinesja, pressjoni baxxa, sturdament, ngħas, nuqqas ta ’ rqad, stitikezza, alluċinazzjoni, uġigħ ta ’ ras u għeja.
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
L- inċidenza ta ’ ngħas tiżdied f’ dożi ogħla minn 1. 5 mg/ kuljum (ara sezzjoni 4. 2).
5 reaction in combination with levodopa was dyskinesia.
Reazzjoni avversa aktar frekwenti tal- mediċina flimkien ma ’ levodopa kienet diskinesja.
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Pressjoni baxxa tista ’ sseħħ fil- bidu tal- kura, speċjalment jekk pramipexole jiġi tittrat malajr wisq.
5%) reported adverse drug reactions in patients with other indication treated
L- aktar reazzjonijiet avversi komuni (≥ 5%) rapportati f’ pazjenti b’ indikazzjoni oħra trattata b’ pramipexole kienu dardir, uġigħ ta ’ ras, sturdament u għeja.
Nausea and fatigue were more often reported in female patients (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
Id- dardir u l- għeja kienu rapportati aktar ta ’ spiss f’ pazjenti nisa (20. 8% u 10. 5%, rispettivament) milli f’ irġiel (6. 7% u 7. 3%, rispettivament).
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
Tabelli 1 u 2 juru l- frekwenza ta ’ reazzjonijiet avversi minħabba l- mediċina mill- provi kliniċi li jsiru b’ kontrolli ta ’ plaċebo.
The adverse reactions reported in these tables are those events that occurred in 1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Ir- reazzjonijiet avversi rapportati f’ dawn il- pilloli huma dawk li seħħew f’ 1% tal- pazjenti jew aktar ta ’ pazjenti trattati bi pramipexole u kienu rapportati aktar ta ’ spiss b’ mod sinifikanti f’ pazjenti li kienu fuq pramipexole milli fuq il- plaċebo, jew meta l- avveniment kien ikkonsidrat li hu klinikament rilevanti.
However, the majority of common adverse reactions were mild to moderate, they usually start early in therapy, and most tended to disappear even as therapy was continued.
Madankollu, il- maġġoranza ta ’ reazzjonijiet avversi komuni kienu ħfief għal moderati, u normalment jibdew kmieni fit- terapija, u l- biċċa l- kbira tagħhom għebu kif it- terapija kompliet.
Very common Adverse Reactions (≥ 1/ 10) System organ class
Reazzjonijiet Avversi Komuni Ħafna (≥1/ 10) Sistema tal- klassifika ta ’ l- organi
Pramipexole N= 1,923 (%)
Pramipexole N= 1, 923 (%)
Dizziness Dyskinesia
Sturdament Diskinesja
15.5 12.9
15. 5 12. 9
Gastrointestinal disorders Vascular disorders
Disturbi gastro- intestinali Disturbi vaskulari
Nausea Hypotension
Dardir Pressjoni baxxa
17.2 12.6
17. 2 12. 6
Common Adverse Reactions (≥ 1/ 100 to < 1/ 10) System organ class
Reazzjonijiet Avversi Komuni (≥1/ 100 to < 1/ 10) Sistema tal- klassifika ta ’ l- organi
Abnormal dreams Confusional state Hallucinations Insomnia
Ħolm abnormali Stat konfużjonali Alluċinazzjonijiet Nuqqas ta ’ rqad
3.5 3.0 6.6 8.2
3. 5 3. 0 6. 6 8. 2
Somnolence Headache
Ngħas Uġigħ ta ’ ras
8.6 6.5
8. 6 6. 5
General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
Pramipexole hu assoċjat ma ’ ngħas (8. 6%) u ġie assoċjat b’ mod mhux komuni ma ’ ngħas eċċessiv matul il- jum u episodji ta ’ rqad li jiġu f’ daqqa (0. 1%).
Pramipexole may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Pramipexole jista ’ jkun assoċjat ma ’ disturbi fil- libido (żieda (0. 1%) jew tnaqqis (0. 4%)).
Patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole, especially at high doses, have been reported as exhibiting signs of pathological gambling, increase libido and hypersexuality, generally reversible upon treatment discontinuation.
Pazjenti trattati b’ agonisti ta ’ dopamine għal marda ta ’ Parkinson, li jinkludu pramipexole, speċjalment f’ dożi għoljin, ġew rapportati li wrew sinjali ta ’ logħob patoloġiku ta ’ l- azzard, żieda fil- libido u ipersesswalità, li ġeneralment hija riversibbli mat- twaqqif tat- trattament.
There is no clinical experience with massive overdose.
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.
Il- każijiet avversi mistennija għandhom ikunu dawk relatati mal- profil farmakodinamiku ta ’ agonista ta ’ dopamine, li jinkludi dardir, remettar, iperkinesja, alluċinazzjonijiet, aġitazzjoni u pressjoni baxxa.
There is no established antidote for overdose 6 of a dopamine agonist.
M’ hemm l- ebda antidot stabbilit ghal doza eċċessiva ta ’ agonist ta ’ dopamine.
If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Jekk ikun hemm sinjali ta ’ stimulazzjoni tas- sistema nervuża ċentrali preżenti, jista ’ jkun meħtieġ li tingħata sustanza newrolettika.
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
Il- ġestjoni tad- doża jista ’ jkun jeħtieġ miżuri ta ’ appoġġ ġenerali, flimkien ma ’ ħasil gastriku, fluwidi ġol- vina, l- għoti ta ’ faħam attivat u monitoraġġ permezz ta ’ elettrokardjogramm.
Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D 3 receptors, and has full intrinsic activity.
Pramipexole hu agonist ta ’ dopamine li jeħel b’ selettività u speċifiċità qawwija mas- sotto- familja D2 ta ’ riċettaturi ta ’ dopamine li minnhom għandu affinità preferenzjali għar- riċetturi D3 li magħhom għandu affinità intriniska sħiħa.
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Pramipexole jtaffi n- nuqqasijiet tal- moviment kawżati bil- marda ta ’ Parkinsonian permezz ta ’ stimulazzjoni tar- riċettaturi ta ’ dopamine fl- istrajatum.
Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
Studji fuq l- annimali wrew li pramipexole jimpedixxi s- sintesi ta ’ dopamine, it- tnixxija u r- rendiment.
In human volunteers, a dose-dependent decrease in prolactin was observed.
F’ voluntiera umani, kien osservat tnaqqis li jiddependi mid- doża fil- prolaċtin.
In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
Fil- pazjenti pramipexole jtaffi s- sinjali u s- sintomi tal- marda idjopatika ta ’ Parkinson.
Controlled clinical trials included approximately 2100 patients of Hoehn and Yahr stages I – IV.
Provi kliniċi b’ kontrolli kienu jinkludu 2100 pazjent fi stadji I – IV ta ’ Hoehn u Yahr.
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
Minn dawn, madwar 900 kienu fi stadji avvanzati, u rċevew terapija flimkien ma ’ levodopa, u ġarrbu kumplikazzjonijiet fil- moviment.
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
Fl- istadji bikrin u avvanzati tal- marda ta ’ Parkinson, l- effikaċja ta ’ pramipexole fil- provi kliniċi b’ kontrolli inżammet għal madwar sitt xhur.
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
Fil- provi ta ’ kontinwazzjoni miftuħin li damu sejrin għal aktar minn tliet snin ma kien hemm l- ebda sinjali ta ’ tnaqqis fl- effikaċja.
In a controlled double blind clinical trial of 2 year duration, initial treatment with pramipexole significantly delayed the onset of motor complications, and reduced their occurrence compared to initial treatment with levodopa.
Fi prova klinika double blind b’ kontrolli li damet sejra għal sentejn, it- trattament inizjali b’ pramipexole dewwem b’ mod sinifikanti l- bidu ta ’ komplikazzjonijiet tal- moviment, u naqqas l- okkorenza tagħhom meta mqabbla ma ’ trattament inizjali b’ levodopa.
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 ghandu jkun bilanċjat b’ titjib akbar fil- funzjoni tal- moviment b’ levodopa (kif imkejjel bil- bidla medja fil- punteġġ UPDRS).
The overall incidence of hallucinations and somnolence was generally higher in the escalation phase with the pramipexole group.
L- inċidenza globali ta ’ alluċinazzjonijiet u ngħas kienu ġeneralment ogħla fil - fażi ta ’ eskalazzjoni fil- grupp ta ’ pramipexole.
However there was no significant difference during the maintenance phase.
Madankollu ma kien hemm ebda differenza sinifikanti matul il- fażi ta ’ żamma.
These points should be considered when initiating pramipexole treatment in patients with Parkinson´s disease.
Dawn il- punti għandhom jiġu kkonsidrati meta jinbeda trattament b’ pramipexole f’ pazjenti bil- marda ta ’ Parkinson.
Pramipexole is rapidly and completely absorbed following oral administration.
Pramipexole jiġi assorbit malajr u b’ mod komplet wara l- għoti mill- halq.
The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours.
Il- bijodisponibilità assoluta hi ogħla minn 90% u l- konċentrazzjonijiet massimi fil- plażma jseħħu bejn 1 u 3 sigħat wara.
Concomitant administration with food did not reduce the extent of pramipexole absorption, but the rate of absorption was reduced.
L- għoti fl- istess hin ma ’ l- ikel ma naqqasx il- grad ta ’ l- assorbiment ta ’ pramipexole, izda r- rata ta ’ l - assorbiment tnaqqset.
Pramipexole shows linear kinetics and a small inter-patient variation of plasma levels.
Pramipexole juri kinetiċi lineari u varjazzjoni zgħira fil- livelli tal- plażma bejn pazjenti.
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
Fil- bniedem, ir- rabta ta ’ pramipexole ma ’ proteini hi baxxa ħafna (< 20%) u l- volum ta ’ distribuzzjoni hu kbir (400 l).
8-fold compared to plasma).
Konċentrazzjonijiet qawwija fit- tessut tal- moħħ kienu osservati fil- firien (madwar 8 darbiet aktar meta mqabbel mal- plażma).
Pramipexole is metabolised in man only to a small extent.
Pramipexole jiġi metabolizzat fil- bniedem f’ ammonti żgħar ħafna.
Renal excretion of unchanged pramipexole is the major route of elimination.
7 Pramipexole mhux mibdul jiġi eliminat prinċipalment mill- kliewi.
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Madwar 90% ta ’ doża tikkettata ta ’ 14 C hi eliminata mill- kliewi waqt li inqas minn 2% jiġi eliminat ma ’ l- ippurgar.
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
It- tneħħija totali ta ’ pramipexole hi madwar 500 ml/ min u t- tneħħija mill- kliewi hi madwar 400 ml/ min.
The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Il- half- life ta ’ eliminazzjoni (t½) tvarja minn 8 sigħat fiż- żgħar sa 12- il siegħa fl- anzjani.
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.
Studji dwar it- tossiċità ta ’ doża ripetuta wrew li pramipexole eżerċita effetti funzjonali, li prinċipalment kienu jinvolvu s- SNĊ u s- sistema riproduttiva tan- nisa, u probabilment rriżulta minn effett farmakodinamiku esaġerat ta ’ pramipexole.
Decreases in diastolic and systolic pressure and heart rate were noted in the mini pig, and a tendency to an hypotensive effect was discerned in the monkey.
Tnaqqis fil- pressjoni dijastolika u sistolika u fir- rata tal- qalb kienu nnutati fil- qażquż ċkejken, u tendenza għal effett ta ’ pressjoni baxxa kienet osservata fix- xadina.
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
L- effetti potenzjali ta ’ pramipexole fuq il- funzjoni riproduttiva ġew mistħarrġa fil- firien u l- fniek.
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
Pramipexole ma kienx teratoġeniku fil- firien u l- fniek imma kien embrijotossiku fil- far f’ dożi tossiċi għall- omm.
Due to the selection of animal species and the limited parameters investigated, the adverse effects of pramipexole on pregnancy and male fertility have not been fully elucidated.
Minħabba l- għażla ta ’ speċi ta ’ annimali u l- parametri ristretti mistħarrġa, l- effetti avversi ta ’ pramipexole fit- tqala u fil- fertilità tar- raġel għadhom m’ humiex mifhuma b’ mod sħiħ.
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Fi studju karċinoġeniku, il- firien irġiel żviluppaw iperplasja taċ- ċelluli Leydig u adenomi, u dawn kienu spjegati bl- effett ta ’ pramipexole li jinibixxi l- effett ta ’ prolactin.
This finding is not clinically relevant to man.
Dan ir- riżultat mhux klinikament rilevanti għal bniedem.
The same study also showed that, at doses of 2 mg/ kg (of salt) and higher, pramipexole was associated with retinal degeneration in albino rats.
L- istess studju wera wkoll li, f’ dożi ta ’ 2 mg/ kg (ta ’ melħ) u ogħla, pramipexole kien assoċjat ma ’ deġenerazzjoni retinali fil- firien albini.
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Dan ir- riżultat ta ’ l- aħħar ma kienx osservat f’ firien bil- pigmentazzjoni, u lanqas fl- istudju ta ’ sentejn fuq il- ġurdien albino jew f’ kull speċi oħra mistħarrġa.
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
Mannitol Maize starch Pregelatinised maize starch Povidone K25 Colloidal anhydrous silica Magnesium stearate
Blister pack (Al/ Al foil):
Pakkett ta ’ folji (fojl Al/ Al):
20, 30, 60, 90 or 100 tablets.
20, 30, 60, 90 jew 100 pillola.
6.6 Special precautions for disposal
8 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is- Slovenja
20 tablets:
20 pillola:
EU/ 1/ 08/ 469/ 001 30 tablets:
EU/ 1/ 08/ 469/ 001 30 pillola:
EU/ 1/ 08/ 469/ 002 60 tablets:
EU/ 1/ 08/ 469/ 002 60 pillola:
EU/ 1/ 08/ 469/ 003 90 tablets:
EU/ 1/ 08/ 469/ 003 90 pillola:
EU/ 1/ 08/ 469/ 004 100 tablets:
EU/ 1/ 08/ 469/ 004 100 pillola:
Oprymea 0.18 mg tablets
Oprymea 0. 18 mg pilloli
Each tablet contains 0.18 mg pramipexole base (as 0.25 mg pramipexole dihydrochloride monohydrate).
Kull pillola fiha 0. 18 mg bażi ta ’ pramipexole (bħala 0. 25 mg pramipexole dihydrochloride monohydrate).
0.18 mg: white, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet.
0. 18 mg: bajda, ovali, bi truf iċċanfrati, u b’ ferq fuq iż- żewġ naħat u b’ intaljar ta ’ "P7" fuq iż- żewġ nofsijiet ta ’ naħa waħda tal- pillola.
10 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
10 Madankollu, għandu jkun innutat li l- inċidenza ta ’ ngħas tiżdied f’ dożi ogħla minn 1. 5 mg/ kuljum (ara sezzjoni 4. 8).
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of Oprymea shou ld be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
F’ pazjenti bi tneħħija tal- kreatinina ta ’ inqas minn 20 ml/ min, id- doża ta ’ kuljum ta ’ Oprymea għandha tingħata f’ doża waħda, li tibda b’ 0. 088 mg ta ’ bażi (0. 125 mg ta ’ melħ) kuljum.
11 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
11 Meta tingħata riċetta għal Oprymea f’ pazjent bil- marda ta ’ Parkinson b’ indeboliment renali, doża mnaqqsa hi suġġerita skond kif spjegat f’ sezzjoni 4. 2.
In case of severe cardiovascular disease, care should be taken.
Għandu jkun hemm attenzjoni f’ każ ta ’ mard kardjovaskulari severi.
Therefore, medicinal products
Cimetidine naqqas it- tneħħija renali ta ’ pramipexole b’ madwar 34%, preżumibilment permezz ta ’
12 that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipex ole resulting in reduced clearance of either or both medicinal products.
Għalhekk, prodotti mediċinali li huma inibituri ta ’ dan il- passaġġ attiv ta ’ l- eliminazzjoni renali, jew li jkunu mneħħija permezz ta ’ dan il- passagg, bħal cimetidine u amantadine, jistgħu jirreaġixxu ma ’ pramipexole, u dan jirrizulta fi tneħħija mnaqqsa ta ’ wieħed jew iż- żewġ prodotti mediċinali.
The most commonly (≥ reported adverse reactions in patients with Parkinson’ s disease more 5%) frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
L- aktar reazzjonijiet avversi komuni (≥5%) rapportati f’ pazjenti bil- marda ta ’ Parkinson li kienu aktar frekwenti bit- trattament b’ pramipexole milli bi plaċebo kienu dardir, diskinesja, pressjoni baxxa,
13 reaction in combination with levodopa was dyskinesia.
13 sturdament, ngħas, nuqqas ta ’ rqad, stitikezza, alluċinazzjoni, uġigħ ta ’ ras u għeja.
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
L- inċidenza ta ’ ngħas tiżdied f’ dożi ogħla minn 1. 5 mg/ kuljum (ara sezzjoni 4. 2).
The most commonly (≥
Reazzjoni avversa aktar frekwenti tal- mediċina flimkien ma ’ levodopa kienet diskinesja.
There is no clinical experience with massive overdose.
14 M’ hemm l- ebda esperjenza klinika b’ doża eċċessiva massiva.
There is no established antidote for overdose 14 of a dopamine agonist.
M’ hemm l- ebda antidot stabbilit ghal doza eċċessiva ta ’ agonist ta ’ dopamine.
Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D 2 subfamily of dopamine receptors of which it has a preferential affinity to D 3 receptors, and has full intrinsic activity.
Pramipexole hu agonist ta ’ dopamine li jeħel b’ selettività u speċifiċità qawwija mas- sotto- familja D2 ta ’ riċettaturi ta ’ dopamine li minnhom għandu affinità preferenzjali għar- riċetturi D3 li magħhom għandu affinità intriniska sħiħa.
Renal excretion of unchanged pramipexole is the major route of elimination.
Pramipexole mhux mibdul jiġi eliminat prinċipalment mill- kliewi.
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
It- tneħħija totali ta ’
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximat ely 400 ml/ min.
15 pramipexole hi madwar 500 ml/ min u t- tneħħija mill- kliewi hi madwar 400 ml/ min.
15 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
6.6 Special precautions for disposal
16 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
EU/ 1/ 08/ 469/ 006 30 tablets:
EU/ 1/ 08/ 469/ 006 30 pillola:
EU/ 1/ 08/ 469/ 007 60 tablets:
EU/ 1/ 08/ 469/ 007 60 pillola:
EU/ 1/ 08/ 469/ 008 90 tablets:
EU/ 1/ 08/ 469/ 008 90 pillola:
EU/ 1/ 08/ 469/ 009 100 tablets:
EU/ 1/ 08/ 469/ 009 100 pillola:
Oprymea 0.35 mg tablets
Oprymea 0. 35 mg pilloli
Each tablet contains 0.35 mg pramipexole base (as 0.5 mg pramipexole dihydrochloride monohydrate).
Kull pillola fiha 0. 35 mg bażi ta ’ pramipexole (bħala 0. 5 mg pramipexole dihydrochloride monohydrate).
0.35 mg: white, oval, with bevelled edges, both sides scored, with imprint "P8" on both halves of one side of the tablet.
0. 35 mg: bajda, ovali, bi truf iċċanfrati, u b’ ferq fuq iż- żewġ naħat u b’ intaljar ta ’ "P8" fuq iż- żewġ nofsijiet ta ’ naħa waħda tal- pillola.
18 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
18 Madankollu, għandu jkun innutat li l- inċidenza ta ’ ngħas tiżdied f’ dożi ogħla minn 1. 5 mg/ kuljum (ara sezzjoni 4. 8).
4.4 Special warnings and precautions for use
19 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
19 When prescribing Oprymea 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 Oprymea f’ pazjent bil- marda ta ’ Parkinson b’ indeboliment renali, doża mnaqqsa hi suġġerita skond kif spjegat f’ sezzjoni 4. 2.