natgillin/translations-raw huggingface dataset:
5 Bivirkningerne er opført efter systemorganklasse og hyppighed (antal patienter, der forventes, at opleve en bivirkning) ved brug af følgende kategorier:
Within the system organ classes, adverse reactions are listed under headings of frequency (number of
Meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10); ualmindelig (≥1/ 1. 000, < 1/ 100); sjælden (≥1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000).
5 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).
De mest almindeligt (≥5%) rapporterede bivirkninger hos patienter med Parkinsons sygdom, som oftere ses efter behandling med pramipexol end efter behandling med placebo er kvalme, dyskinesi, hypotension, svimmelhed, somnolens, søvnløshed, forstoppelse, hallucinationer, hovedpine og træthed.
The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson’ s disease more frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Hyppigere bivirkninger i kombination med levodopa var dyskinesi.
More frequent adverse drug reactions in combination with levodopa was dyskinesia.
Unormale drømme, konfusion, hallucinationer, søvnløshed Vrangforestillinger, ændring af libido, paranoia Unormal adfærd, hyperseksualitet, overspisning, ludomani
abnormal dreams, confusion, hallucinations, insomnia delusion, libido disorder, paranoia abnormal behaviour, hypersexuality, increased eating, pathological gambling
Meget almindelig Almindelig Ikke almindelig Vaskulære sygdomme
Very common Common Uncommon Vascular disorders
Svimmelhed, dyskinesi, somnolens Hovedpine Hyperkinesi, pludseligt opstået søvn
dizziness, dyskinesia, somnolence headache hyperkinesias, sudden onset of sleep
Meget almindelig Mave- tarmkanalen
Very common Gastrointestinal disorders
Meget almindelig Almindelig Hud og subkutane væv
Very common Common
Kvalme Forstoppelse
nausea constipation
Ikke almindelig
Skin and subcutaneous tissue disorders
Kvalme og træthed blev oftere rapporteret hos kvindelige patienter behandlet med pramipexol (henholdsvis 20, 8% og 10, 5%) sammenlignet med mandlige patienter (henholdsvis 6, 7% og 7, 3%).
Nausea and fatigue were more often reported in female patients treated with pramipexole (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
Andre indikationer Systemorganklasse Psykiske forstyrrelser
Other Indication System Organ Class Psychiatric disorders
Unormale drømme, søvnløshed Konfusion, hallucinationer, ændring af libido Unormal adfærd, vrangforestillinger, hyperseksualitet, overspisning, paranoia, ludomani
abnormal dreams, insomnia confusion, hallucination, libido disorder abnormal behaviour, delusion, hypersexuality, increased eating, paranoia, pathological gambling
Almindelig Ikke almindelig Ikke kendt Vaskulære sygdomme
Common Uncommon Not known Vascular disorders
Svimmelhed, hovedpine, somnolens Pludseligt opstået søvn Dyskinesi, hyperkinesi
dizziness, headache, somnolence sudden onset of sleep dyskinesia, hyperkinesia
6
Skin and subcutaneous tissue disorders 6
Pramipexol er forbundet med somnolens (8, 6%) og er i usædvanlige tilfælde blevet forbundet med overdreven somnolens i dagtimerne og pludseligt opståede søvnepisoder (0, 1%).
Pramipexole is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
Disse tilstande er sædvanligvis reversible ved dosisreduktion eller seponering.
Patients treated with dopamine agonists for Parkison’ s disease, including pramipexole, especially at high doses, have been reported as exhibiting sings of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Farmakoterapeutisk klassifikation: dopaminagonister, ATC kode:
Pharmacotherapeutic group: dopamine agonists, ATC code:
Det har fuld intrinsic aktivitet.
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.
Pramipexol letter det parkinsonistiske motoriske underskud ved stimulation af dopaminreceptorer i Corpus striatum.
Pramipexole alleviates Parkinsonian motor deficits by stimulation of dopamine receptors in the striatum.
Kliniske forsøg ved Parkinsons sygdom Hos patienter letter pramipexol tegn og symptomer på idiopatisk Parkinsons sygdom.
Clinical trials in Parkinson’ s disease In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
900 på mere fremskredne stadier og modtog ledsagende levodopaterapi og led af motoriske komplikationer.
Out of these, approximately 900 were in more advanced stages, received concomitant levodopa therapy, and suffered from motor complications.
Ved tidlig og fremskreden Parkinsons sygdom, var effekten af pramipexol i de kontrollerede kliniske undersøgelser bevaret i ca.
In early and advanced Parkinson’ s disease, efficacy of pramipexole in the controlled clinical trials was maintained for approximately six months.
Denne forsinkelse af motoriske komplikationer med pramipexol skal opvejes imod en større bedring af motorisk funktion med levodopa (målt ved den gennemsnitlige ændring i UPDRS- score).
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).
Den samlede incidens af hallucinationer og somnolens var generelt højere i den gradvise dosisøgningsfase med pramipexolgruppen.
However there
Imidlertid var der ingen signifikant forskel i vedligeholdelsesfasen.
7 was no significant difference during the maintenance phase.
Disse punkter skal overvejes ved initiering af pramipexolbehandling hos patienter med Parkinsons sygdom.
These points should be considered when initiating pramipexole treatment in patients with Parkinson´s disease.
7 I et placebo- kontrolleret polysomnografistudie over 3 uger reducerede pramipexol signifikant antallet af periodiske benbevægelser mens forsøgspersonerne var sengeliggende.
In a placebo-controlled polysomnography study over 3 weeks pramipexole significantly reduced the number of periodic limb movements during time in bed.
Hos mennesket er proteinbindingen af pramipexol meget lav (< 20%) og distributionsvoluminet stort (400 l).
In humans, the protein binding of pramipexole is very low (< 20%) and the volume of distribution is large (400 l).
90% af en 14°C- mærket dosis udskilles via nyrerne og mindre end 2% via fæces.
Approximately 90% of 14ºC-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Den totale clearance for pramipexol er omkring 500 ml/ min., og den renale clearance er omkring 400 ml/ min.
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
Toksicitetsstudier med gentagen dosering viser, at pramipexol udøver funktionelle virkninger, som hovedsageligt involverer CNS og det kvindelige reproduktionssystem, antagelig stammende fra en overdreven farmakodynamisk virkning af lægemidlet.
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.
I et karcinogenstudie udviklede hanrotter Leydig- cellehyperplasi og adenomer pga. pramipexols prolaktinhæmmende effekt.
In a carcinogenicity study, male rats developed Leydig cell hyperplasia and adenomas, explained by the prolactin-inhibiting effect of pramipexole.
Samme studie viste tillige hos albinorotter, at doser på 2 mg/ kg (salt) pramipexol og derover blev sat i forbindelse med retinal degeneration.
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.
Mannitol Mikrokrystallinsk cellulose Natriumstivelsesglycolat Povidon K25 Magnesiumstearat Natriumstearylfumarat Kolloid siliciumdioxid.
Mannitol Microcrystalline cellulose Sodium starch glycolate Povidone K25 Magnesium stearate Sodium stearyl fumarate Colloidal silicon dioxide.
6. 2 Uforligeligheder
8 6.2 Incompatibilities
8 Ikke relevant.
Not applicable
Aluminium/ Aluminiumblister Pakningsstørrelser:
Aluminium/ Aluminium Blister Pack sizes:
30, 50 x 1 og 100 tabletter
30, 50 x 1 and 100 tablets
Polyethylentabletbeholder med CRC- polypropylenlåg.
Polyethylene tablet container with CRC polypropylene cap.
Detaljeret information vedrørende dette produkt er tilgængelig på European Medicines Agency (EMEA) 's hjemmeside http: // www. emea. europa. eu
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Pramipexol Teva 0, 18 mg tabletter
Pramipexole Teva 0.18 mg tablets
Hver tablet indeholder 0, 18 mg pramipexolbase (som 0, 25 mg pramipexoldihydrochloridmonohydrat).
Each tablet contains 0.18 mg pramipexole base (as 0.25 mg pramipexole dihydrochloride monohydrate).
Hvid, rund, flad tablet med skrå kant, 7, 00 mm diameter, præget med "P2" over "P2" på den side med delekærv og "93" på den anden side.
White, round, flat face bevel edge tablet, 7.00 mm diameter, embossed with "P2" over "P2" on the scored side and "93" on the other side.
Dosis øges gradvist hver 5. - 7. dag fra en startdosis på 0, 264 mg base (0, 375 mg salt) / døgn.
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.
Vedligeholdelsesdosis:
10 Maintenance treatment:
Den individuelle dosis bør være inden for 0, 264 mg base (0, 375 mg salt) - højst 3, 3 mg base (4, 5 mg salt) / døgn.
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.
10 døgndosis på 1, 1 mg base (1, 5 mg salt).
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).
Yderligere dosisjusteringer bør foretages på basis af klinisk respons og forekomst af bivirkninger.
Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions..
4. 2.
When prescribing Pramipexole Teva tablets in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Ved fremskreden Parkinsons sygdom, i kombinationsbehandling med levodopa, kan dyskinesi forekomme i optrapningsfasen med Pramipexol Teva.
11 In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Pramipexole Teva.
11 Pramipexol er blevet forbundet med somnolens og episoder med pludseligt opståede søvnanfald, især hos patienter med Parkinsons sygdom.
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
4. 5)
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
Når Pramipexol Teva gives i kombination med levodopa, anbefales det at reducere doseringen af levodopa og at holde doseringen af andre antiparkinson- lægemidler konstant, mens doseringen af Pramipexol Teva øges.
12 When Pramipexole Teva 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 Pramipexole Teva.
12 Pga. mulig additiv effekt, bør påpasselighed udvises, når patienter tager anden sedativ medicin eller alkohol i kombination med pramipexol.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
Pramipexol Teva kan have stor indvirkning på evnen til at føre motorkøretøj eller betjene maskiner.
Pramipexole Teva can have a major influence on the ability to drive and use machines.
Abnorme drømme, konfusion, forstoppelse, vrangforestillinger, svimmelhed, dyskinesi, træthed, hallucinationer, hovedpine, hyperkinesi, hypotension, overspisning (bulimi- lignende tilstand, uhæmmet madindtagelse), søvnløshed, libidoforstyrrelser, kvalme, perifert ødem, paranoia, ludomani, hyperseksualitet og anden abnorm adfærd, somnolens, vægtøgning, pludseligt opståede søvnepisoder, kløe og udslæt og anden overfølsomhed.
The following adverse reactions are expected under the use of Pramipexole Teva: abnormal dreams, confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesias, hypotension, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia; pathological gambling, hypersexuality and other abnormal behavious, somnolence, weight increase, sudden onset of sleep, pruritus and rash and other hypersensitivity.
63% af patienterne i pramipexolbehandling og 52% af patienterne i placebobehandling rapporterede mindst en bivirkning.
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
Bivirkningerne er opført efter systemorganklasse og hyppighed (antal patienter, der forventes, at opleve en bivirkning) ved brug af følgende kategorier:
Within the system organ classes, adverse reactions are listed under headings of frequency (number of
Meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10); ualmindelig (≥1/ 1. 000, < 1/ 100); sjælden (≥1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000).
13 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).
13 De mest almindeligt (≥5%) rapporterede bivirkninger hos patienter med Parkinsons sygdom, som oftere ses efter behandling med pramipexol end efter behandling med placebo er kvalme, dyskinesi, hypotension, svimmelhed, somnolens, søvnløshed, forstoppelse, hallucinationer, hovedpine og træthed.
The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson’ s disease more frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Hyppigere bivirkninger i kombination med levodopa var dyskinesi.
More frequent adverse drug reaction in combination with levodopa was dyskinesia.
Almindelig Ikke almindelig Ikke kendt
Common Uncommon Not known Vascular disorders
Vaskulære sygdomme
Uncommon Gastrointestinal disorders
Mave- tarmkanalen
Very common Common
Hud og subkutane væv
Skin and subcutaneous tissue disorders 14
Disse tilstande er sædvanligvis reversible ved dosisreduktion eller seponering.
Patients treated with dopamine agonists for Parkinson’ s disease, including, especially at high doses, have been reported as exhibiting sings of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Imidlertid var der ingen signifikant forskel i vedligeholdelsesfasen.
15 was no significant difference during the maintenance phase.
I et placebo- kontrolleret polysomnografistudie over 3 uger reducerede pramipexol signifikant antallet af periodiske benbevægelser mens forsøgspersonerne var sengeliggende.
In a placebo-controlled polysomnography study over 3 weeks pramipexole significantly reduced the number of periodic limb movements during time in bed.
15 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
16 2 år
2 years
Aluminium/ Aluminiumblisterkort Pakningsstørrelser:
Aluminium/ Aluminium Blister Strips Pack sizes:
Pramipexol Teva 0, 35 mg tabletter
Pramipexole Teva 0.35 mg tablets
Hver tablet indeholder 0, 35 mg pramipexolbase (som 0, 5 mg pramipexoldihydrochloridmonohydrat).
Each tablet contains 0.35 mg pramipexole base (as 0.5 mg pramipexole dihydrochloride monohydrate).
Hvid, rund, flad tablet med skrå kant, 8, 82 mm diameter, præget med "8023" over "8023" på den side med delekærv og "93" på den anden side.
White, round, flat face bevel edge tablet, 8.82 mm diameter, embossed with "8023" over "8023" on the scored side and "93" on the other side.
Vedligeholdelsesdosis:
18 Maintenance treatment:
18 døgndosis på 1, 1 mg base (1, 5 mg salt).
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).
Hallucinationer er kendt som bivirkning ved behandling med dopaminagonister og levodopa.
19 Hallucinations are known as an adverse event of treatment with dopamine agonists and levodopa.
Ved fremskreden Parkinsons sygdom, i kombinationsbehandling med levodopa, kan dyskinesi forekomme i optrapningsfasen med Pramipexol Teva.
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Pramipexole Teva.
19 Pramipexol er blevet forbundet med somnolens og episoder med pludseligt opståede søvnanfald, især hos patienter med Parkinsons sygdom.
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Når Pramipexol Teva gives i kombination med levodopa, anbefales det at reducere doseringen af levodopa og at holde doseringen af andre antiparkinson- lægemidler konstant, mens doseringen af Pramipexol Teva øges.
20 When Pramipexole Teva is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medication is kept constant while increasing the dose of Pramipexole Teva.
20 Pga. mulig additiv effekt, bør påpasselighed udvises, når patienter tager anden sedativ medicin eller alkohol i kombination med pramipexol.
Because of possible additive effects, caution should be advised when patients are taking other sedating medication or alcohol in combination with pramipexole.
Hos rotter var koncentrationen af radioaktivitet forbundet med det aktive stof højere i modermælk end i plasma.
In rats, the concentration ofactive substance-related radioactivity was higher in breast milk than in plasma.
Meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10); ualmindelig (≥1/ 1. 000, < 1/ 100); sjælden (≥1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000).
21 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).
21 De mest almindeligt (≥5%) rapporterede bivirkninger hos patienter med Parkinsons sygdom, som oftere ses efter behandling med pramipexol end efter behandling med placebo er kvalme, dyskinesi, hypotension, svimmelhed, somnolens, søvnløshed, forstoppelse, hallucinationer, hovedpine og træthed.
The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson’ s disease more frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
22
nausea constipation 22
Hos patienter letter pramipexol tegn og symptomer på idiopatisk Parkinsons sygdom.
Clinical trials in Parkinson’ s disease In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson 's disease.
Denne forsinkelse af motoriske komplikationer med pramipexol skal opvejes imod en større bedring af motorisk funktion med levodopa (målt ved den gennemsnitlige ændring i UPDRS- score).
The overall incidence of hallucinations and
Den samlede incidens af hallucinationer og somnolens var generelt højere i den gradvise dosisøgningsfase med pramipexolgruppen.
23 somnolence was generally higher in the escalation phase with the pramipexole group.
23 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
24 2 år
24 6.2 Incompatibilities
6. 6 Regler for destruktion
6.6 Instructions for use and handling
Pramipexol Teva 0, 7 mg tabletter
Pramipexole Teva 0.7 mg tablets
Hver tablet indeholder 0, 7 mg pramipexolbase (som 1 mg pramipexoldihydrochloridmonohydrat).
Each tablet contains 0.7 mg pramipexole base (as 1 mg pramipexole dihydrochloride monohydrate).
Hvid, rund, flad tablet med skrå kant, 8, 82 mm diameter, præget med "8024" over "8024" på den side med delekærv og "93" på den anden side.
White, round, flat face bevel edge tablet, 8.82 mm diameter, embossed with "8024" over "8024" on the scored side and "93" on the other side.
mg base (0, 75 mg
0.375 0.75 1.50
salt) ugentligt op til en maksimal døgndosis på 3, 3 mg base (4, 5 mg salt).
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.
Vedligeholdelsesdosis:
Maintenance treatment:
26 døgndosis på 1, 1 mg base (1, 5 mg salt).
The individual dose should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 26 3.3 mg of base (4.5 mg of salt) per day.
Yderligere dosisjusteringer bør foretages på basis af klinisk respons og forekomst af bivirkninger.
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).
I kliniske undersøgelser blev ca.
Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions.
Ved fremskreden Parkinsons sygdom, i kombinationsbehandling med levodopa, kan dyskinesi forekomme i optrapningsfasen med Pramipexol Teva.
27 In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Pramipexole Teva.
27 Pramipexol er blevet forbundet med somnolens og episoder med pludseligt opståede søvnanfald, især hos patienter med Parkinsons sygdom.
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
4. 2).
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2.)
Når Pramipexol Teva gives i kombination med levodopa, anbefales det at reducere doseringen af levodopa og at holde doseringen af andre antiparkinson- lægemidler konstant, mens doseringen af Pramipexol Teva øges.
28 When Pramipexole Teva 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 Pramipexole Teva.
28 Pga. mulig additiv effekt, bør påpasselighed udvises, når patienter tager anden sedativ medicin eller alkohol i kombination med pramipexol.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
Abnorme drømme, konfusion, forstoppelse, vrangforestillinger, svimmelhed, dyskinesi, træthed, hallucinationer, hovedpine, hyperkinesi, hypotension, overspisning (bulimi- lignende tilstand, uhæmmet madindtagelse), søvnløshed, libidoforstyrrelser, kvalme, perifert ødem, paranoia, ludomani, hyperseksualitet og anden abnorm adfærd, somnolens, vægtøgning, pludseligt opståede søvnepisoder, kløe og udslæt og anden overfølsomhed.
The following adverse reactions are expected under the use of Pramipexole Teva: abnormal dreams, confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesias, 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.