natgillin/translations-raw huggingface dataset:
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.
Pacienti lieč Oprymeou, u ktorých sa vyskytne somnolencia a/ alebo epizódy náhleho upadnutia do ení spánku, musia byť informovaní o tom, ž nesmú viesť pozornosti môž znamenať
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.
vozidlá alebo vykonávať innosti, kde zníž č
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).
neho zranenia alebo smrti pacienta alebo jeho okolie (napr. obsluhovanie strojov) až dovtedy, kým neprekonajú takéto rekurentné epizódy a somnolenciu (pozri aj č 4. 4, 4. 5 a 4. 8). asti
Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
4. 8 Než iaduce úč inky
The following dosage schedule is suggested for initiation of therapy:
Pri užívaní Oprymey sa predpokladajú nasledovné než
Patients with a creatinine clearance above 50 ml/ min require no reduction in daily dose.
iaduce účinky: neobvyklé sny, stav zmätenosti,
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).
zápcha, delirantné predstavy, závraty, dyskinéza, únava, halucinácie, bolesť hlavy, hyperkinéza, hypotenzia, zvýš chuť jedlu (nekontrolované prejedanie sa, hyperfágia), nespavosťporuchy
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.
libida, nauzea, periférny edém, paranoja; patologické hráčstvo, hypersexualita a iné neobvyklé správanie; ospanlivosťzvýš telesnej hmotnosti, náhle upadnutie do spánku, svrbenie a vyráž a iná hypersenzitivita.
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%.
Z analýzy združ ených placebom kontrolovaných š túdií vyplýva, ž pri porovnaní celkovo 1 923 e pacientov užívajúcich pramipexol a 1 354 pacientov už ívajúcich placebo boli než iaduce úč č inky asto hlásené u obidvoch skupín.
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.
63% pacientov už ívajúcich pramipexol a 52% pacientov už ívajúcich placebo hlásili aspoň jeden než iaduci účinok.
90% of absorbed active substance is excreted through the kidneys.
Najč astejš hlásené než
However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
(≥ u pacientov s Parkinsonovou chorobou boli nauzea, inky 5%)
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.
dyskinéza, hypotenzia, závrat, ospanlivosťnespavosťzápcha, halucinácie, bolesť a boli hlásené č
4.3 Contraindications
hlavy a únava,
Hypersensitivity to the active substance or to any of the excipients.
Výskyt ospanlivosti sa
4.4 Special warnings and precautions for use
zvyš pri dávkach vyš ako 1, 5 mg/ deň
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.
ších
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
(pozri
If they occur, the dose of levodopa should be decreased.
Č asť
Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
astejš než ími
Dose reduction/ taper or discontinuation should be considered.
iaducimi úč inkami v
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
Na začiatku lieč sa môž objaviť pramipexol titrovaný príliš rýchlo.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
by
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
e
In case of severe cardiovascular disease, care should be taken.
hypotenzia, najmä ak je
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
13 Najč astejš hlásené (≥5%) než
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
ie
4.5 Interaction with other medicinal products and other forms of interaction
iaduce úč u pacientov s inou indikáciou lieč inky
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
boli nauzea, bolesťhlavy, závraty a únava.
There is no pharmacokinetic interaction with selegiline and levodopa.
Nauzea a únava boli č astejš hlásené u ž lieč
20 Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
ie
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.
ien
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
ených s
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
pramipexolom (20, 8%, respektíve 10, 5%) v porovnaní s muž (6, 7% respektíve 7, 3%). mi
4.6 Pregnancy and lactation
Tabuľ 1 a 2 zobrazujú frekvenciu výskytu než
The effect on pregnancy and lactation has not been investigated in humans.
iaducich úč inkov pri placebom kontrolovaných
The excretion of pramipexole into breast milk has not been studied in women.
klinických š túdiách.
In the absence of human data, Oprymea should not be used during breast-feeding.
Nežiaduce úč lieku uvedené v týchto tabuľ
However, if its use is unavoidable, breast-feeding should be discontinued.
kách sú tie, ktoré sa objavili u 1
4.7 Effects on ability to drive and use machines
alebo viac% pacientov lieč
Oprymea can have a major influence on the ability to drive and use machines.
ených pramipexolom a boli hlásené signifikantne č
Hallucinations or somnolence can occur.
astejš
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).
u pacientov ie
4.8 Undesirable effects
už ívajúcich pramipexol než pacientov už
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.
u
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
ívajúcich placebo alebo ak udalosť
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,
bola posúdená ako
21 dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
klinický relevantná.
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
V kaž prípade väčina než závaž zvyč sa zač na zač
More frequent adverse drug reaction in combination with levodopa was dyskinesia.
iaducich úč inkov lieku bola mierna až
The most commonly (≥
stredne
5%) reported adverse drug reactions in patients with other indication treated
ali
with pramipexole were nausea, headache, dizziness and fatigue.
iatku lieč a väčinou mali tendenciu vymiznúťdokonca aj pri by š,
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
pokrač ujúcej liečbe.
Adverse reaction
iaduce úč inky
22 There is no clinical experience with massive overdose.
Oč
Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
alúdka, intravenóznym podaním tekutín, podaním aktívneho uhlia a monitorovaním EKG.
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.
V kontrolovanej dvojroč dvojito zaslepenej š
Approximately 90% of 14 C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Približ 90% dávky ne označ 14C sa vylúčoblič
The total
enej
23 clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximately 400 ml/ min.
je približ 500 ml/ min a renálny klírens je približ 400 ml/ min.
5.3 Preclinical safety data
15 5. 3 Predklinické údaje o bezpeč nosti
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.
Štúdie toxicity po opakovanom podaní ukázali, ž pramipexol má vplyv prevaž na funkcie CNS a
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.
ženského reprodukč ného systému, pravdepodobne v dôsledku svojho zvýšeného farmakodynamického účinku.
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
Pramipexol
Pramipexole was not teratogenic in rats and rabbits but was embryotoxic in the rat at maternally toxic doses.
nebol teratogénny u potkanov a králikov, ale bol embryotoxický u potkanov pri dávkach toxických pre gravidné samice.
Not all pack sizes may be marketed.
Nie vš veľ etky kosti balenia musia byťuvedené do obehu.
24 Any unused product or waste material should be disposed of in accordance with local requirements.
Vš nepouž lieky alebo odpad vzniknutý z liekov majú byť
7.
ité
MARKETING AUTHORISATION HOLDER
zlikvidované v súlade s miestnymi
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovinsko ka
20 tablets:
20 tabliet:
EU/ 1/ 08/ 469/ 011 30 tablets:
EU/ 1/ 08/ 469/ 006 30 tabliet:
EU/ 1/ 08/ 469/ 012 60 tablets:
EU/ 1/ 08/ 469/ 007 60 tabliet:
EU/ 1/ 08/ 469/ 013 90 tablets:
EU/ 1/ 08/ 469/ 008 90 tabliet:
EU/ 1/ 08/ 469/ 014 100 tablets:
EU/ 1/ 08/ 469/ 009 100 tabliet:
Oprymea 0.7 mg tablets
Oprymea 0, 35 mg tablety
Each tablet contains 0.7 mg pramipexole base (as 1 mg pramipexole dihydrochloride monohydrate).
Kaž tableta obsahuje 0, 35 mg bázy pramipexolu (č zodpovedá 0, 5 mg monohydrate dá o pramipexoliumdichloridu).
0.70 mg: white, round, with bevelled edges, both sides scored, with imprint "P9" on both halves of one side of the tablet.
0, 35 mg: biele, oválne, so skosenými hranami, s deliacimi ryhami na oboch stranách a s vyrazeným kódom “ P8 ” na oboch poloviciach jednej strany tablety.
26 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 Treba vš poznamenaťž pri dávkach vyších ako 1, 5 mg/ deň zvyš výskyt somnolencie (pozri
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.
percentuálne v rovnakom rozsahu, ako sa zníž klírens kreatinínu, t. j. ak sa klírens kreatinínu zníž o
Hypersensitivity to the active substance or to any of the excipients.
Precitlivenosť lieč alebo na niektorú z pomocných látok. na ivo
4.4 Special warnings and precautions for use
4. 4 Osobitné upozornenia a opatrenia pri použ ívaní
27 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Pri predpisovaní tabliet Oprymea pacientom s Parkinsonovou chorobou a s poš kodením funkcie oblič sa odporúč zníž dávkovanie podľ č 4. 2.
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
19 Pri lieč dopamínovými agonistami a levodopou sú známym než
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
Pri pokroč Parkinsonovej chorobe sa pri kombinovanej lieč s levodopou môž poč zač nej
In case of severe cardiovascular disease, care should be taken.
adom na vš eobecné riziko posturálnej hypotenzie spojenej s
Therefore, medicinal products
ne
28 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.
Preto lieky, ktoré sú inhibítormi tohto aktívneho renálneho vyluč ovania alebo sa vyluč touto cestou, ako sú cimetidín alebo ujú amantadín, môž vzájomne reagovať pramipexolom, č má za následok zníž klírensu jedného
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly.
Ak sa tieto lieky podávajú súč s Oprymeou, má sa zváž zníž dávky pramipexolu.
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.
20 Ak sa Oprymea podáva v kombinácii s levodopou, odporúč sa pri zvyš
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
sedatívne lieky alebo alkohol v kombinácii s pramipexolom.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
Treba sa vyhýbať asnému podávaniu antipsychotík s pramipexolom (pozri č 4. 4), napr. ak je mož oč
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
dyskinéza, hypotenzia, závrat, ospanlivosťnespavosťzápcha, halucinácie, bolesť a boli hlásené č
More frequent adverse drug
hlavy a únava,
29 reaction in combination with levodopa was dyskinesia.
astejš pri lieč pramipexolom ako pri lieč placebom.
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Výskyt ospanlivosti sa
The most commonly (≥
be
5%) reported adverse drug reactions in patients with other indication treated
zvyš pri dávkach vyš ako 1, 5 mg/ deň
Tables 1 and 2 display the frequency of adverse reactions from placebo-controlled clinical trials.
Tabuľ 1 a 2 zobrazujú frekvenciu výskytu než
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.
pramipexolu, hlavne pri ich vysokých dávkach preukazovali znaky patologického hrá č zvýš stva, eného libida a hypersexuality, ktoré sú vo vš eobecnosti reverzibilné po preruš lieč ení by.
There is no established antidote for overdose 30 of a dopamine agonist.
Pre predávkovanie dopamínovými agonistami nie je stanovená protilátka.
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.
Má plnú vnútornú aktivitu.
The total clearance of pramipexole is approximately 500 ml/ min and the renal clearance is approximat ely 400 ml/ min.
je približ 500 ml/ min a renálny klírens je približ 400 ml/ min.
31 5.3 Preclinical safety data
23 5. 3 Predklinické údaje o bezpeč nosti
Any unused product or waste material should be disposed of in accordance with local requirements.
Vš nepouž lieky alebo odpad vzniknutý z liekov majú byť
32 7.
ité
EU/ 1/ 08/ 469/ 016 30 tablets:
EU/ 1/ 08/ 469/ 011 30 tabliet:
EU/ 1/ 08/ 469/ 017 60 tablets:
EU/ 1/ 08/ 469/ 012 60 tabliet:
EU/ 1/ 08/ 469/ 018 90 tablets:
EU/ 1/ 08/ 469/ 013 90 tabliet:
EU/ 1/ 08/ 469/ 019 100 tablets:
EU/ 1/ 08/ 469/ 014 100 tabliet:
Oprymea 1.1 mg tablets
Oprymea 0, 7 mg tablety
Each tablet contains 1.1 mg pramipexole base (as 1.5 mg pramipexole dihydrochloride monohydrate).
Kaž tableta obsahuje 0, 7 mg bázy pramipexolu (č zodpovedá 1 mg monohydrate dá o pramipexoliumdichloridu).
1.1 mg: white, round, with bevelled edges, both sides scored.
0, 70 mg: biele, okrúhle, so skosenými hranami, s deliacimi ryhami na oboch stranách a s vyrazeným kódom “ P9 ” na oboch poloviciach jednej strany tablety.
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.
Dávka sa má zvyš ovať postupne, kaž dých 5 – 7 dní, so zač nou dávkou 0, 264 mg bázy (0, 375 mg iatoč soli) denne.
34 However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
26 Treba vš poznamenaťž pri dávkach vyších ako 1, 5 mg/ deň zvyš výskyt somnolencie (pozri
Hypersensitivity to the active substance or to any of the excipients.
nosti a účinnosti.
35 When prescribing Oprymea in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Precitlivenosť lieč alebo na niektorú z pomocných látok. na ivo
Hallucinations are known as a side-effect of treatment with dopamine agonists and levodopa.
4. 4 Osobitné upozornenia a opatrenia pri použ ívaní
In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Oprymea.
Pri predpisovaní tabliet Oprymea pacientom s Parkinsonovou chorobou a s poš kodením funkcie oblič sa odporúč zníž dávkovanie podľ č 4. 2.
If they occur, the dose of levodopa should be decreased.
27 Pri lieč dopamínovými agonistami a levodopou sú známym než
Furthermore a reduction of dosage or termination of therapy may be considered.
iaducim úč inkom halucinácie.
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
Pacienti majú byťinformovaní, ž sa môž objaviť
Dose reduction/ taper or discontinuation should be considered.
e
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
u
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.5).
(prevaž vizuálne) halucinácie. ne
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Pri pokroč Parkinsonovej chorobe sa pri kombinovanej lieč s levodopou môž poč zač nej
In case of severe cardiovascular disease, care should be taken.
ilej
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2)
be
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
u
4.5 Interaction with other medicinal products and other forms of interaction
as iatoč
Pramipexole is bound to plasma proteins to a very low (< 20%) extent, and little biotransformation is seen in man.
titrácie dávky Oprymey objaviťdyskinézy.
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Ak sa objavia, dávka levodopy sa má zníž. iť
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Pramipexol sa spája so somnolenciou a epizódami náhleho upadnutia do spánku, obzvlá š u pacientov ť s Parkinsonovou chorobou.
There is no pharmacokinetic interaction with selegiline and levodopa.
Menej č sa zaznamenalo náhle upadnutie do spánku poč bež
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
denných aktivít, niekedy bez toho, aby si to pacient uvedomil alebo pocítil varovné príznaky.
Therefore, medicinal products
Pacienti o tom musia byť informovaní a oboznámení s tým, ž poč už
36 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.
e
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.
as ívania Oprymey musia byť
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole.
opatrní
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
Pacienti, ktorí už
4.6 Pregnancy and lactation
mali problémy so somnolenciou
Oprymea should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
a/ alebo epizódami náhleho upadnutia do spánku, nesmú viesť toho je potrebné zváž zníž dávky alebo ukonč lieč Keďpacienti
The excretion of pramipexole into breast milk has not been studied in women.
vozidlá alebo obsluhovať už
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
by.
4.7 Effects on ability to drive and use machines
ívajú v kombinácii s
Oprymea can have a major influence on the ability to drive and use machines.
pramipexolom aj ď ie sedatívne lieky alebo alkohol musia byť
Hallucinations or somnolence can occur.
oboznámení s tým, ž majú byť e
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).
opatrní, kvôli mož aditívnym vedľ ím úč
4.8 Undesirable effects
ným
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.
ajš
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction.
inkom (pozri č 4. 7 a 4. 8). asť