natgillin/translations-raw huggingface dataset:
Ascending – Dose Schedule of MIRAPEXIN
22 Shema povečevanja odmerka zdravila MIRAPEXIN Teden
Restless Legs Syndrome
23 Sindrom nemirnih nog
When prescribing MIRAPEXIN in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
Pri predpisovanju zdravila MIRAPEXIN 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 MIRAPEXIN.
24 Diskinezija Pri bolnikih z napredovalo Parkinsonovo boleznijo, ki jemljejo zdravilo v kombinaciji z levodopo, se lahko med začetnim stopnjevanjem odmerka zdravila MIRAPEXIN pojavijo diskinezije.
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
25 raziskovali, je možnost le- teh majhna, ker se antiholinergiki izločajo v glavnem z biotransformacijo.
- 28 -
Pričakovani neželeni dogodki Pričakovani neželeni učinki med zdravljenjem z zdravilom MIRAPEXIN 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
Expected adverse events The following adverse reactions are expected under the use of MIRAPEXIN: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesias, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
26 preobčutljivosti; nemir, zaspanost, nenaden nepremagljiv spanec, sinkopa, motnje vida v obliki meglenega vida in zmanjšane ostrine vida, bruhanje, zmanjšanje telesne mase, povečanje telesne mase.
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).
Neželeni 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).
weight decrease weight increase
zmanjšanje telesne mase zvečanje telesne mase
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with MIRAPEXIN were nausea, headache, dizziness and fatigue.
27 Sindrom nemirnih nog, najpogostnejši neželeni dogodki Najpogostnejši (≥ 5%) neželeni učinki, o katerih so poročali pri bolnikih s sindromom nemirnih nog, ki so se zdravili z zdravilom MIRAPEXIN, so bili navzea, glavobol, omotica in utrujenost.
4.9 Overdose
28 4. 9 Preveliko odmerjanje
The mean change from baseline in the Restless Legs Syndrome Rating Scale (IRLS) and the Clinical Global Impression-Improvement (CGI-I) were the primary efficacy outcome measures.
29 Primarni merili za oceno izida zdravljenja glede na njegovo učinkovitost sta bili srednja sprememba glede na izhodiščno stanje pri vrednotenju z lestvico za oceno sindroma nemirnih nog (Restless Legs Syndrome Rating Scale – RLSRS) in izboljšanje, ocenjeno z lestvico CGI- I (Clinical Global Impression- Improvement).
6.1 List of excipients
30 6. 1 Seznam pomožnih snovi
MIRAPEXIN 0.7 mg tablets
MIRAPEXIN 0, 7 mg tablete
MIRAPEXIN 0.7 mg tablets contain 0.7 mg of pramipexole base (as 1.0 mg of pramipexole dihydrochloride monohydrate).
Zdravilo MIRAPEXIN 0, 7 mg tablete vsebujejo 0, 7 mg pramipeksola (kar ustreza 1, 0 mg pramipeksolijevega dihidroklorid monohidrata).
MIRAPEXIN is indicated for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in dosages up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Zdravilo MIRAPEXIN 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 MIRAPEXIN
32 Shema povečevanja odmerka zdravila MIRAPEXIN Teden
Restless Legs Syndrome
33 Sindrom nemirnih nog
Dyskinesia In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of MIRAPEXIN.
34 Diskinezija Pri bolnikih z napredovalo Parkinsonovo boleznijo, ki jemljejo zdravilo v kombinaciji z levodopo, se lahko med začetnim stopnjevanjem odmerka zdravila MIRAPEXIN pojavijo diskinezije.
Neuroleptic malignant syndrome Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2.).
Nevroleptični maligni sindrom Pri nagli prekinitvi zdravljenja z agonisti dopamina so poročali o pojavu simptomov, ki nakazujejo na nevroleptični maligni sindrom (glejte poglavje 4. 2).
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
35 raziskovali, je možnost le- teh majhna, ker se antiholinergiki izločajo v glavnem z biotransformacijo.
- 39 -
Pričakovani neželeni dogodki Pričakovani neželeni učinki med zdravljenjem z zdravilom MIRAPEXIN 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
Expected adverse events The following adverse reactions are expected under the use of MIRAPEXIN: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesias, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
36 preobčutljivosti; nemir, zaspanost, nenaden nepremagljiv spanec, sinkopa, motnje vida v obliki meglenega vida in zmanjšane ostrine vida, bruhanje, zmanjšanje telesne mase, povečanje telesne mase.
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with MIRAPEXIN were nausea, headache, dizziness and fatigue.
37 Sindrom nemirnih nog, najpogostnejši neželeni dogodki Najpogostnejši (≥ 5%) neželeni učinki, o katerih so poročali pri bolnikih s sindromom nemirnih nog, ki so se zdravili z zdravilom MIRAPEXIN, so bili navzea, glavobol, omotica in utrujenost.
dizziness, headache, somnolence sudden onset of sleep, syncope amnesia, dyskinesia, hyperkinesia
omotica, glavobol, zaspanost nenaden nepremagljiv spanec, sikopa amnezija, diskinezija, hiperkinezija
4.9 Overdose
38 4. 9 Preveliko odmerjanje
The mean change from baseline in the Restless Legs Syndrome Rating Scale (IRLS) and the Clinical Global Impression-Improvement (CGI-I) were the primary efficacy outcome measures.
39 Primarni merili za oceno izida zdravljenja glede na njegovo učinkovitost sta bili srednja sprememba glede na izhodiščno stanje pri vrednotenju z lestvico za oceno sindroma nemirnih nog (Restless Legs Syndrome Rating Scale – RLSRS) in izboljšanje, ocenjeno z lestvico CGI- I (Clinical Global Impression- Improvement).
6.1 List of excipients
40 6. 1 Seznam pomožnih snovi
MIRAPEXIN 1.1 mg tablets
MIRAPEXIN 1, 1 mg tablete
MIRAPEXIN 1.1 mg tablets contain 1.1 mg of pramipexole base (as 1.5 mg of pramipexole dihydrochloride monohydrate).
Zdravilo MIRAPEXIN 1, 1 mg tablete vsebujejo 1, 1 mg pramipeksola (kar ustreza 1, 5 mg pramipeksolijevega dihidroklorid monohidrata).
Ascending – Dose Schedule of MIRAPEXIN
42 Shema povečevanja odmerka zdravila MIRAPEXIN Teden
Restless Legs Syndrome
43 Sindrom nemirnih nog
Dyskinesia In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of MIRAPEXIN.
44 Diskinezija Pri bolnikih z napredovalo Parkinsonovo boleznijo, ki jemljejo zdravilo v kombinaciji z levodopo, se lahko med začetnim stopnjevanjem odmerka zdravila MIRAPEXIN pojavijo diskinezije.
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
45 raziskovali, je možnost le- teh majhna, ker se antiholinergiki izločajo v glavnem z biotransformacijo.
Expected adverse events The following adverse reactions are expected under the use of MIRAPEXIN: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesias, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus, rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, syncope, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
Pričakovani neželeni dogodki Pričakovani neželeni učinki med zdravljenjem z zdravilom MIRAPEXIN 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, patološko hazardiranje, pruritus, izpuščaj in druge oblike preobčutljivosti; nemir, zaspanost, nenaden nepremagljiv spanec, sinkopa, motnje
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)..
Neželeni 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).
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with MIRAPEXIN were nausea, headache, dizziness and fatigue.
47 Sindrom nemirnih nog, najpogostnejši neželeni dogodki Najpogostnejši (≥ 5%) neželeni učinki, o katerih so poročali pri bolnikih s sindromom nemirnih nog, ki so se zdravili z zdravilom MIRAPEXIN, so bili navzea, glavobol, omotica in utrujenost.
Nausea and fatigue were more often reported in female patients treated with MIRAPEXIN (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
O slabosti in utrujenosti so med zdravljenjem z zdravilomMIRAPEXIN pogosteje poročali pri ženskah (20, 8% in 10, 5%) kot pri moških (6, 7% in 7, 3%).
Adverse Drug Reaction
Neželeni učinki
4.9 Overdose
48 4. 9 Preveliko odmerjanje
The mean change from baseline in the Restless Legs Syndrome Rating Scale (IRLS) and the Clinical Global Impression-Improvement (CGI-I) were the primary efficacy outcome measures.
49 Primarni merili za oceno izida zdravljenja glede na njegovo učinkovitost sta bili srednja sprememba glede na izhodiščno stanje pri vrednotenju z lestvico za oceno sindroma nemirnih nog (Restless Legs Syndrome Rating Scale – RLSRS) in izboljšanje, ocenjeno z lestvico CGI- I (Clinical Global Impression- Improvement).
6.1 List of excipients
50 6. 1 Seznam pomožnih snovi
ANNEX II
51 DODATEK II
A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, KI JE ODGOVOREN ZA SPROŠČANJE SERIJE
In addition, an updated RMP should be submitted When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached At the request of the EMEA
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije, podrobno opisane v načrtu izvajanja farmakovigilance.
In view of the extension of indication to Restless Legs Syndrome, the periodic safety update reports will be submitted every six months during two years, once a year for the following two years and thereafter at three-yearly intervals.
Glede na razširitev indikacij na sindrom nemirnih nog bodo redna posodobljena poročila o varnosti zdravila predložena prvi dve leti vsakih šest mesecev, naslednji dve leti enkrat letno in nato vsaka tri leta.
ANNEX III
53 DODATEK III
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
55 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
MIRAPEXIN 0.088 mg tablets Pramipexole
MIRAPEXIN 0, 088 mg tablete pramipeksol
0.088 mg pramipexole equivalent to pramipexole dihydrochloride monohydrate 0.125 mg
0, 088 mg pramipeksola ustreza 0, 125 mg pramipeksolijevega dihidroklorid monohidrata.
Tablets also contain mannitol
Tablete vsebujejo tudi manitol.
Oral use Read the package leaflet before use.
Peroralna uporaba Pred uporabo preberite priloženo besedilo.
Do not store above 30°C Store in the original package in order to protect from light
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
57 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
59 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
60 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
MIRAPEXIN 0.18 mg tablets Pramipexole
MIRAPEXIN 0, 18 mg tablete pramipeksol
0.18 mg pramipexole equivalent to pramipexole dihydrochloride monohydrate 0.25 mg
0, 18 mg pramipeksola ustreza 0, 25 mg pramipeksolijevega dihidroklorid monohidrata.
Oral use Read the package leaflet before use
Peroralna uporaba Pred uporabo preberite priloženo besedilo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
62 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
64 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
65 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
MIRAPEXIN 0.35 mg tablets Pramipexole
MIRAPEXIN 0, 35 mg tablete pramipeksol
0.35 mg pramipexole equivalent to pramipexole dihydrochloride monohydrate 0.5 mg
0, 35 mg pramipeksola ustreza 0, 5 mg pramipeksolijevega dihidroklorid monohidrata.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
67 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
69 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
70 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
MIRAPEXIN 0.7 mg tablets Pramipexole
MIRAPEXIN 0, 7 mg tablete pramipeksol
0.7 mg pramipexole equivalent to pramipexole dihydrochloride monohydrate 1.0 mg
0, 7 mg pramipeksola ustreza 1, 0 mg pramipeksolijevega dihidroklorid monohidrata.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
72 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
74 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
75 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
MIRAPEXIN 1.1 mg tablets Pramipexole
MIRAPEXIN 1, 1 mg tablete pramipeksol
1.1 mg pramipexole equivalent to pramipexole dihydrochloride monohydrate 1.5 mg
1, 1 mg pramipeksola ustreza 1, 5 mg pramipeksolijevega dihidroklorid monohidrata.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
77 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Oral use Read the leaflet before use
Peroralna uporaba Pred uporabo preberite priloženo besedilo.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
79 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
- 85 -
80 B.
INFORMATION FOR THE USER
81 NAVODILO ZA UPORABO
MIRAPEXIN 0.088 mg tablets pramipexole
MIRAPEXIN 0, 088 mg tablete pramipeksol
What MIRAPEXIN is and what it is used for 2.
Kaj je zdravilo MIRAPEXIN in za kaj ga uporabljamo 2.
Before you take MIRAPEXIN 3.
Kaj morate vedeti, preden boste vzeli zdravilo MIRAPEXIN 3.
How to take MIRAPEXIN 4.
Kako jemati zdravilo MIRAPEXIN 4.
How to store MIRAPEXIN 6.
Shranjevanje zdravila MIRAPEXIN 6.
WHAT MIRAPEXIN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO MIRAPEXIN IN ZA KAJ GA UPORABLJAMO
MIRAPEXIN belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain.
Zdravilo MIRAPEXIN sodi v skupino zdravil, poimenovanih dopaminski agonisti, ki spodbujajo dopaminske receptorje v možganih.
MIRAPEXIN is used to:
Zdravilo MIRAPEXIN uporabljamo za:
It can be used alone or in combination with
- zdravljenje simptomov primarne Parkinsonove bolezni; lahko ga uporabljamo samostojno ali v
levodopa.
kombinaciji z levodopo;
- treat the symptoms of moderate to severe primary Restless Legs Syndrome (RLS).
- zdravljenje simptomov zmernega do hudega primarnega sindroma nemirnih nog.
BEFORE YOU TAKE MIRAPEXIN
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO MIRAPEXIN
DO NOT take MIRAPEXIN
NE jemljite zdravila MIRAPEXIN
- if you are allergic (hypersensitive) to pramipexole or to any of the other ingredients of the
- če ste alergični na (preobčutljivi za) pramipeksol ali katerokoli sestavino tablet (glejte poglavje
tablets (see Section 6, “ Further information”).
6, Dodatne informacije).
Take special care with MIRAPEXIN Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:
Bodite posebno pozorni pri uporabi zdravila MIRAPEXIN Obvestite svojega zdravnika, če ste imeli ali se je pri vas razvila katerakoli bolezen, zlasti izmed naslednjih:
- kidney disease
- Ledvična bolezen.
- hallucinations (seeing, hearing or feeling things that are not there).
- Halucinacije (pojav, pri katerem vidite, slišite ali čutite nekaj, česar ni):
Most hallucinations are
Večinoma gre za vidne.
- dyskinesia (e. g. abnormal, uncontrolled movements of the limbs)
- Diskinezija (na primer nenormalni, nenadzorovani gibi udov):
If you have advanced Parkinson’ s disease and are also taking levodopa, you might develop dyskinesia during the uptitration of MIRAPEXIN.
Parkinsonovo bolezen in sočasno jemljete levodopo, se lahko pri vas med povečevanjem odmerkov zdravila MIRAPEXIN razvije diskinezija.
- sleepiness and episodes of suddenly falling asleep
- Zaspanost in epizode nepremagljivega spanca.
- behavioural changes (e. g. pathological gambling, compulsive shopping), increased libido (e. g.
- Vedenjske spremembe (na primer bolezensko hazardiranje, kompulzivno nakupovanje),
increased sexual desire), binge eating.
povečan libido (na primer povečano spolno poželenje), kompulzivno prenajedanje.
- psychosis, (e. g. comparable with symptoms of schizophrenia)
- Psihoza (na primer podobni simptomi kot pri shizofreniji).
- vision impairment
- Motnje vida:
You should have regular eye examinations during treatment with MIRAPEXIN.
Med zdravljenjem z zdravilom MIRAPEXIN morate redno hoditi na preglede oči.
- severe heart or blood vessels disease
- Huda srčna ali žilna bolezen:
You will need to have your blood pressure checked regularly, especially at the beginning of treatment.
tlak.
This is to avoid postural hypotension (a fall in blood pressure on standing up)
To je potrebno, da bi se izognili posturalni hipotenziji (padcu krvnega tlaka pri vstajanju).
- augmentation
- Povečanje simptomov.
You may experience that symptoms start earlier than usual, be more intense and involve other limbs.
da bodo bolj intezivni in bodo prisotnih tudi pri drugih udih.
Children and adolescents MIRAPEXIN is not recommended for use in children or adolescents under 18 years.
82 Otroci in mladostniki Uporabe zdravila MIRAPEXIN pri otrocih in mladostnikih, mlajših od 18 let, ne priporočamo.
- cimetidine (to treat excess stomach acid and stomach ulcers)
- cimetidin (zdravilo za zdravljenje čezmernega izločanja želodčne kisline in želodčnih razjed),
- amantadine (which can be used to treat Parkinson’ s disease)
- amantadin (zdravilo, ki ga lahko uporabljamo v zdravljenju Parkinsonove bolezni).
Take care if you are using any medicines that calme you down (have a sedative effect) or if you are drinking alcohol.
Bodite previdni, če jemljete kakršnakoli zdravila, ki vas pomirijo (imajo sedativni učinek), ali pijete alkohol.
Taking MIRAPEXIN with food and drink You should be cautious while drinking alcohol during treatment with MIRAPEXIN.
Jemanje zdravila MIRAPEXIN skupaj s hrano in pijačo Če med zdravljenjem z zdravilom MIRAPEXIN pijete alkohol, morate biti previdni.
Pregnancy and breast-feeding Tell your doctor if you are pregnant, think you might be pregnant or if you intend to become pregnant.
Nosečnost in dojenje Povejte zdravniku, če ste noseči; menite, da bi lahko bili noseči; ali nameravate zanositi.
Driving and using machines MIRAPEXIN can cause hallucinations (seeing, hearing or feeling things that are not there).
Upravljanje vozil in strojev Zdravilo MIRAPEXIN lahko povzroči halucinacije (pojav, pri katerem vidite, slišite ali čutite nekaj, česar ni).
MIRAPEXIN has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’ s disease.
Zdravilo MIRAPEXIN so zlasti pri bolnikih s Parkinsonovo boleznijo povezovali z zaspanostjo in epizodami nepremagljivega spanca.
Important information about some of the ingredients of MIRAPEXIN tablets MIRAPEXIN tablets contain mannitol.
Pomembne informacije o nekaterih sestavinah tablet zdravila MIRAPEXIN Tablete zdravila MIRAPEXIN vsebujejo manitol.
This may have a mild laxative (bowel loosening) effect.
Ta snov lahko ima blag laksativni (odvajalni) učinek.
HOW TO TAKE MIRAPEXIN
KAKO JEMATI ZDRAVILO MIRAPEXIN
Always take MIRAPEXIN exactly as your doctor has told you.
Pri jemanju zdravila MIRAPEXIN natančno upoštevajte zdravnikova navodila.
The doctor will advise you on the right dosing.
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom.
You can take MIRAPEXIN with or without food.
83 Zdravilo MIRAPEXIN lahko jemljete s hrano ali ne.