natgillin/translations-raw huggingface dataset:
Simultaneously press down (2a) and turn the child-resistant cap (2b) to open the bottle.
Steklenico odprete tako, da za otroke varno zaporko hkrati pritisnete navzdol (2a) in zavrtite (2b).
If the amount poured into the cup exceeds the required dose,
Če v odmerno posodico nalijete preveč raztopine, presežek zavrzite v odtok.
discard the excess in the sink.
Ne zlivajte ga nazaj v steklenico.
Sifrol is a medicine containing the active substance pramipexole base.
Sifrol je zdravilo, ki vsebuje zdravilno učinkovino pramipeksolijev hidroksid.
Sifrol is used to treat the symptoms of the following diseases: • Parkinson’ s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Zdravilo Sifrol se uporablja za zdravljenje simptomov naslednjih bolezni: • Parkinsonove bolezni, tj. napredujoče okvare možganov, ki povzroča tresavico, upočasnjeno izvajanje gibov in okorelost mišic.
Sifrol 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; • moderate to severe restless legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Zdravilo Sifrol se lahko uporablja samostojno ali v kombinaciji z levodopo (drugim zdravilom za zdravljenje Parkinsonove bolezni) v katerem koli stadiju bolezni, vključno s kasnejšimi stadiji, ko začne učinkovitost levodope upadati; • zmernega do hudega sindroma nemirnih nog, tj. motnje, pri kateri ima bolnik nenadzorovano potrebo po premikanju okončin, da bi se znebil neprijetnih, bolečih ali nenavadnih občutkov v telesu, navadno ponoči.
Sifrol tablets should be swallowed with water, with or without food.
Tablete Sifrol se pogoltnejo z vodo, hrano ali brez nje.
Sifrol must be given less frequently in patients who have problems with their kidneys.
Zdravilo Sifrol je treba bolnikom, ki imajo težave z ledvicami, dajati manj pogosto.
For restless legs syndrome, Sifrol should be taken once a day, two to three hours before going to bed.
Pri sindromu nemirnih nog je treba zdravilo Sifrol jemati enkrat dnevno, dve do tri ure pred spanjem.
The active substance in Sifrol, pramipexole, is a dopamine agonist, which imitates the action of dopamine.
Zdravilna učinkovina zdravila Sifrol, pramipeksol, je agonist dopamina, ki posnema delovanje dopamina.
In Parkinson’ s disease, Sifrol has been studied in five main studies involving 1,546 patients.
Pri Parkinsonovi bolezni so zdravilo Sifrol proučevali v petih glavnih študijah, v katere je bilo vključenih 1546 bolnikov.
Four studies compared the effects of Sifrol with those of placebo (a dummy treatment): one study in 360 patients with advanced disease who were already taking levodopa that was starting to become less effective, and three studies in a total of 886 patients with early disease who were not receiving levodopa.
V štirih študijah so primerjali učinke zdravila Sifrol z učinki placeba (zdravila brez zdravilne učinkovine): v eni študiji s 360 bolniki z napredovalo boleznijo, ki so že jemali levodopo, katere učinkovitost je začela upadati, in v treh študijah s skupno 886 bolniki z boleznijo v zgodnjem stadiju, ki niso prejemali levodope.
The fifth study compared the effects of Sifrol with those of levodopa in 300 patients with early disease.
V peti študiji so primerjali učinke zdravila Sifrol z učinki levodope pri 300 bolnikih z boleznijo v zgodnjem stadiju.
In all studies, Sifrol doses were increased gradually over six to ten weeks before being maintained at a stable dose.
V vseh študijah so odmerke zdravila Sifrol postopoma povečevali šest do deset tednov, nato pa vzdrževali stalni odmerek.
Sifrol has also been studied in two main studies of patients with restless legs syndrome.
Zdravilo Sifrol so proučevali tudi v dveh glavnih študijah z bolniki s sindromom nemirnih nog.
The first included 344 patients and compared the effects of three doses of Sifrol with those of placebo.
V prvi študiji, v katero je bilo vključenih 344 bolnikov, so primerjali učinke treh odmerkov zdravila Sifrol z učinki placeba.
The other study included 150 patients who took Sifrol for six months, and compared the effects of remaining on Sifrol or switching to placebo.
V drugo študijo je bilo vključenih 150 bolnikov, ki so zdravilo Sifrol jemali šest mesecev; v njej so primerjali učinke nadaljevanja jemanja zdravila Sifrol z učinki prehoda na placebo.
In the study of patients with advanced Parkinson’ s disease, patients taking Sifrol had larger improvements after 24 weeks of steady-dose treatment than those taking placebo.
V študiji z bolniki z napredovalo Parkinsonovo boleznijo je bilo pri bolnikih, ki so jemali zdravilo Sifrol, po 24 tednih zdravljenja s stalnim odmerkom doseženo večje izboljšanje kot pri bolnikih, ki so jemali placebo.
28% of the patients taking Sifrol had symptoms (42 out of 151) compared with 51% of the patients taking levodopa (76 out of 150).
Po 21 mesecih je imelo motorične simptome manjše število bolnikov, ki so jemali zdravilo Sifrol, kot bolnikov, ki so jemali levodopo: simptome je imelo 28% bolnikov, ki so jemali zdravilo Sifrol (42 od 151), v primerjavi z 51% bolnikov, ki so jemali levodopo (76 od 150).
In the first study of restless legs syndrome, symptom scores fell by between 12.8 and 14.0 points after 12 weeks in patients taking Mirapexin, compared with a decrease of 9.3 points in the patients taking placebo.
V prvi študiji sindroma nemirnih nog so se pri bolnikih, ki so jemali zdravilo Sifrol, ocene simptomov po 12 tednih izboljšale za 12, 8 do 14, 0 točke v primerjavi z zmanjšanjem za 9, 3 točke pri bolnikih, ki so jemali placebo.
The difference between placebo and Sifrol was greatest after four weeks before getting smaller.
Razlika med učinki placeba in zdravila Sifrol je bila največja po štirih tednih, nato pa se je zmanjšala.
More patients taking Sifrol also had an improvement in symptoms.
Poleg tega je doseglo izboljšanje simptomov več tistih bolnikov, ki so jemali zdravilo Sifrol.
The results of the other study were insufficient to prove the long-term effectiveness of Sifrol.
Rezultati druge študije niso zadostovali, da bi dokazali dolgoročno učinkovitost zdravila Sifrol.
The most common side effect with Sifrol (seen in more than 1 patient in 10) is nausea (feeling sick).
Najpogostejši neželeni učinek zdravila Sifrol (opažen pri več kot 1 bolniku izmed 10) je navzeja (občutek slabosti).
For the full list of all side effects reported with Sifrol, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Sifrol, glejte navodilo za uporabo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Sifrol’ s benefits are greater than its risks for the treatment of the signs and symptoms of idiopathic Parkinson’ s disease alone or in combination with levodopa, and for the treatment of moderate to severe idiopathic restless legs syndrome in dosages up to 0.54 mg of base.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Sifrol pri zdravljenju znakov in simptomov idiopatske Parkinsonove bolezni samostojno ali v kombinaciji z levodopo in pri zdravljenju zmernega do hudega idiopatskega sindroma nemirnih nog v odmerkih do 0, 54 mg hidroksida večje od z njim povezanih tveganj.
The Committee recommended that Sifrol be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Sifrol odobri dovoljenje za promet.
2/ 3 Other information about Sifrol:
2/ 3 Druge informacije o zdravilu Sifrol:
The marketing authorisation was renewed on 14 October 2002 and on 14 October 2007.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 14. oktobra 2002 in 14. oktobra 2007.
The full EPAR for Sifrol can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Sifrol je na voljo tukaj.
Packaging
100 tablet
Package size
100 tablet
Sifrol Sifrol Sifrol Sifrol Sifrol Sifrol Sifrol Sifrol Sifrol Sifrol
Pretisni omot (poliamid/ aluminij/ PVC)
0.088 mg 0.088 mg 0.18 mg 0.18 mg 0.7 mg 0.7 mg 1.1 mg 1.1 mg 0.35 mg 0.35 mg
Pretisni omot (poliamid/ aluminij/ PVC)
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Pretisni omot (poliamid/ aluminij/ PVC)
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Pretisni omot (poliamid/ aluminij/ PVC)
blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC) blister (polyamide/ aluminium/ PVC)
Pretisni omot (poliamid/ aluminij/ PVC)
30 100 30 100 30 100 30 100 30 100
100 tablet
SIFROL 0.088 mg tablets
SIFROL 0, 088 mg tablete
SIFROL 0.088 mg tablets contain 0.088 mg of pramipexole base (as 0.125 mg of pramipexole dihydrochloride monohydrate).
Zdravilo SIFROL 0, 088 mg tablete vsebujejo 0, 088 mg pramipeksola (kar ustreza 0, 125 mg pramipeksolijevega dihidroklorid monohidrata).
SIFROL is indicated for treatment of the signs and symptoms of idiopathic Parkinson’ s disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “ on off” fluctuations).
Zdravilo SIFROL je indicirano za zdravljenje znakov in simptomov idiopatske Parkinsonove bolezni, same (brez levodope) ali v kombinaciji z levodopo, to je v napredovanem in poznem stadiju bolezni, ko prične z napredovanjem bolezni učinek levodope popuščati, postane nestalen in se pojavljajo fluktuacije terapevtskega učinka (konec odmerka ali vklopno- izklopni pojavi).
SIFROL is indicated for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of base (0.75 mg of salt) (see section 4.2.).
Zdravilo SIFROL je indicirano za simptomatsko zdravljenje zmernega do hudega idiopatskega sindroma nemirnih nog v odmerkih do 0, 54 mg pramipeksola (0, 75 mg soli) (glejte poglavje 4. 2).
Ascending – Dose Schedule of SIFROL
2 Shema povečevanja odmerka SIRFOLA Teden
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with SIFROL, depending on reactions in individual patients.
Priporočljivo je, da se glede na reakcije posameznih bolnikov odmerjanje levodope zmanjša tako med povečevanjem odmerka zdravila SIFROL kot med vzdrževalnim zdravljenjem z zdravilom SIFROL.
In patients with a creatinine clearance between 20 and 50 ml/ min, the initial daily dose of SIFROL should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/ 0.25 mg of salt daily).
Začnemo z dajanjem 0, 088 mg pramipeksola (0, 125 mg soli) dvakrat dnevno (0, 176 mg h pramipeksola/ 0, 25 mg soli na dan).
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of SIFROL should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
Bolnikom z očistkom kreatinina manjšim kot 20 ml/ min damo dnevni odmerek zdravila SIFROL v enkratnem odmerku, pri čemer začnemo z dajanjem 0, 088 mg pramipeksola (0, 125 mg soli) dnevno.
If renal function declines during maintenance therapy, reduce SIFROL daily dose by the same percentage as the decline in creatinine clearance, i. e. if creatinine clearance declines by 30%, then reduce the SIFROL daily dose by 30%.
Če na primer očistek kreatinina upade za 30%, tudi dnevni odmerek zdravila SIFROL zmanjšamo za 30%.
The recommended starting dose of SIFROL is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Priporočeni začetni odmerek zdravila SIFROL je 0, 088 mg pramipeksola (0, 125 mg soli) enkrat na dan, 2- 3 ure pred spanjem.
Titration Step
Stopnje večanja odmerka 1 2 * 3 * 4 * * če je potrebno
As long-term efficacy of SIFROL in the treatment of RLS has not been sufficiently tested, patient´s response should be evaluated after 3 months treatment and the need for treatment continuation should be reconsidered.
Ker učinkovitost zdravila SIFROL med dolgotrajnim zdravljenjem sindroma nemirnih nog še ni dovolj preskušena, moramo bolnikov odziv na zdravljenje po 3 mesecih oceniti in presoditi, ali je treba zdravljenje nadaljevati.
Treatment discontinuation Since daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) SIFROL can be discontinued without tapering off.
Prekinitev zdravljenja Ker dnevni odmerek za zdravljenje sindroma nemirnih nog ni večji od 0, 54 mg pramipeksola (0, 75 mg soli), lahko zdravilo SIFROL ukinemo brez postopnega zmanjševanja odmerka.
The use of SIFROL has not been studied in hemodialysis patients, or in patients with severe renal impairment.
Pri bolnikih na hemodializi ali s hudo ledvično okvaro uporabe zdravila SIFROL niso raziskovali.
Dosing in children and adolescents SIFROL is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Odmerjanje za otroke in mladostnike Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila SIFROL pri otrocih pod 18 let ni priporočljiva.
-4- 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
When prescribing SIFROL in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Pri predpisovanju zdravila SIFROL bolnikom s Parkinsonovo boleznijo in ledvično okvaro je priporočljivo zmanjšano odmerjanje, opisano v poglavju 4. 2.
Dyskinesia In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of SIFROL.
Diskinezija 4 Pri bolnikih z napredovalo Parkinsonovo boleznijo, ki jemljejo zdravilo v kombinaciji z levodopo, se lahko med začetnim stopnjevanjem odmerka zdravila SIFROL pojavijo diskinezije.
Sudden onset of sleep and somnolence SIFROL has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’ s disease.
Nenaden nepremagljiv spanec in zaspanost Zdravilo SIFROL povezujejo z zaspanostjo in nenadnimi epizodami spanja, zlasti pri bolnikih s Parkinsonovo boleznijo.
Impulse control disorders and compulsive behaviours Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including SIFROL.
Motnje nadzora impulzov in kompulzivno vedenje Pri bolnikih, pri katerih so Parkinsonovo bolezen zdravili z dopaminskimi agonisti, tudi zdravilom SIFROL, so poročali o patološkem hazardiranju, povečanem libidu in hiperseksualnosti.
The frequency of
Nadzorovana preskušanja zdravila SIFROL pri bolnikih s sindromom nemirnih nog večinoma niso bila dovolj dolgotrajna, da bi lahko ustrezno zajela pojave poslabšanja simptomov.
-5- augmentation after longer use of SIFROL and the appropriate management of these events have not been evaluated in controlled clinical trials.
Pogostnosti poslabšanja simptomov po dolgotrajnejši uporabi zdravila SIFROL in ustreznega zdravljenja teh dogodkov v nadzorovanih kliničnih preskušanjih niso ovrednotili.
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Čeprav interakcij z antiholinergiki niso raziskovali, je možnost le- teh majhna, ker se antiholinergiki izločajo v glavnem z biotransformacijo.
Inhibitors/ competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
5 Zaviralci/ snovi, ki tekmujejo za aktivno pot izločanja skozi ledvice Cimetidin je zmanjšal ledvični očistek pramipeksola za približno 34%, verjetno z inhibicijo kationskega sekretornega transportnega sistema v ledvičnih tubulih.
Combination with levodopa When SIFROL is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medicinal products is kept constant while increasing the dose of SIFROL.
Kombiniranje z levodopo Če se zdravilo SIFROL daje skupaj z levodopo, in povečujemo njegov odmerek, je priporočljivo zmanjšati odmerek levodope, medtem ko naj ostanejo odmerki drugih antiparkinsonikov enaki.
SIFROL should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
Zdravilo SIFROL uporabljamo med nosečnostjo le, če potencialne koristi opravičujejo potencialno tveganje za plod.
As SIFROL treatment inhibits secretion of prolactin in humans, inhibition of lactation is expected.
Ker zdravljenje z zdravilom SIFROL zavira izločanje prolaktina pri človeku, je pričakovana inhibicija dojenja.
The excretion of SIFROL into breast milk has not been studied in women.
Izločanja zdravila SIFROL v materino mleko pri ženskah niso raziskovali.
Patients being treated with SIFROL and presenting with somnolence and/ or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e. g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5 and 4.8).
Bolnikom, pri katerih se med zdravljenjem z zdravilom SIFROL pojavlja zaspanost in/ ali imajo nenadne epizode spanja, je treba svetovati, naj ne vozijo in naj se ne ukvarjajo z dejavnostmi, pri katerih se zaradi poslabšane budnosti poveča nevarnost resnih poškodb ali smrti (npr. pri upravljanju strojev), dokler ponavljajoče se epizode nenadnega spanja in zaspanost ne minejo (glejte še poglavja 4. 4, 4. 5 in 4. 8).
Expected adverse events The following adverse reactions are expected under the use of SIFROL: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
Pričakovani neželeni dogodki Pričakovani neželeni učinki med zdravljenjem z zdravilom SIFROL so: nenormalne sanje, amnezija, vedenjski simptomi motenj nadzora impulzov in kompulzije, kot so prenajedanje in kompulzivno nakupovanje, hiperseksualnost in patološko hazardiranje, stanje zmedenosti, zaprtost, omotica, blodnje, diskinezije, utrujenost, halucinacije, glavobol, hiperkinezija, hiperfagija, hipotenzija, nespečnost, motnje libida, slabost, paranoja, periferni edem,, pruritus, izpuščaj in druge oblike preobčutljivosti; nemir, zaspanost, nenaden nepremagljiv spanec, sinkopa, motnje vida v obliki meglenega vida in zmanjšane ostrine vida, bruhanje, zmanjšanje telesne mase, povečanje telesne mase.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1923 patients on SIFROL and 1354 patients on placebo, adverse drug reactions were frequently reported for both groups.
6 Analiza zbranih s placebom nadzorovanih preskušanj, ki je zajela 1923 bolnikov, zdravljenih z zdravilom SIFROL, in 1354 bolnikov, ki so prejemali placebo, je pokazala, da so o neželenih učinkih pogosto poročali v obeh skupinah.
63% of patients on SIFROL and 52% of patients on placebo reported at least one adverse drug reaction.
V skupini z zdravilom SIFROL je poročalo 63%, v skupini s placebom pa 52% bolnikov o vsaj enem neželenem učinku.
The adverse drug reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with SIFROL and were reported significantly more often in patients taking SIFROL than placebo, or where the event was considered clinically relevant.
Neželeni učinki v preglednicah, o katerih so poročali, so dogodki, ki so se pojavili pri 0, 1% z zdravilom SIFROL zdravljenih bolnikov ali več, in o katerih so poročali pomembno pogosteje pri bolnikih, ki so jemali zdravilo SIFROL, kot pri tisti, ki so jemali placebo, ali pa je bil dogodek ocenjen kot klinično pomemben.
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated form the available data).
Neželen učinki so navedeni po organskih sistemih in razvrščeni po pogostnosti (pričakovano število bolnikov, ki bodo doživeli neželen učinek) v naslednje skupine: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100, < 1/ 10); občasni (≥ 1/ 1. 000, < 1/ 100); redki (≥ 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Parkinson’ s disease, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson’ s disease more frequent with SIFROL treatment than with Placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Parkinsonova bolezen, najpogostnejši neželeni dogodki Neželeni učinki, o katerih so najpogosteje poročali (≥ 5%) pri bolnikih s Parkinsonovo boleznijo in so bili med zdravljenjem z zdravilom SIFROL pogostnejši kot med jemanjem placeba, so bili slabost, diskinezija, hipotenzija, omotica, zaspanost, nespečnost, zaprtost, halucinacije, glavobol in utrujenost.
More frequent adverse drug reactions in combination with levodopa were dyskinesia,.
Pogostnejši neželeni učinki v kombinaciji z levodopo so bile diskinezije.
Hypotension may occur at the beginning of treatment, especially if SIFROL is titrated too fast.
Hipotenzija se lahko pojavi na začetku zdravljenja, zlasti če prehitro večamo odmerek zdravila SIFROL.
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with SIFROL were nausea, headache, dizziness and fatigue.
O slabosti in
Nausea and fatigue were more often reported in female patients treated with SIFROL (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
7 utrujenosti so med zdravljenjem z zdravilom SIFROL pogosteje poročali pri ženskah (20, 8% in 10, 5%) kot pri moških (6, 7% in 7, 3%).
nausea constipation, vomiting
nevzea zaprtje, bruhanje
Somnolence SIFROL is associated with somnolence (8.6%) and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (0.1%).
Zaspanost Zdravilo SIFROL povezujejo z zaspanostjo (8, 6%), občasno tudi s preveliko zaspanostjo čez dan in epizodami nenadnega spanca (0, 1%).
Libido disorders SIFROL may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
Motnje libida Zdravilo SIFROL lahko povzroči motnje libida (povečanje (0, 1%) ali zmanjšanje (0, 4%)).
See also section 4.4.
Motnje nadzora impulzov in kompulzivno vedenje Pri bolnikih, ki so se zdravili z dopaminskimi agonisti, tudi z zdravilom SIFROL, zaradi Parkinsonove bolezni, so poročali o znakih patološkega hazardiranja, povečanem libidu in hiperseksualnosti, ki so po zmanjšanju odmerka ali ukinitvi zdravljenja prenehali (Glejte tudi poglavje 4. 4).
-9- 4.9 Overdose
4. 9 Preveliko odmerjanje
The expected adverse events would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Pričakovani neželeni učinki bi morali biti povezani s farmakodinamskimi lastnostmi agonistov dopamina, vključno z navzeo, bruhanjem,