natgillin/translations-raw huggingface dataset:
The adjusted treatment differences between ropinirole and placebo were: sleep disturbance (-15.2, 95% CI -19.37, -10.94; p < 0.0001), sleep quantity (0.7 hours, 95% CI 0.49, 0.94); p < 0.0001), sleep adequacy (18.6, 95% CI 13.77, 23.45; p < 0.0001) and daytime somnolence (-7.5, 95% CI -10.86, -4.23; p < 0.0001).
Prilagojene razlike zaradi zdravljenja med ropinirolom in placebom so: motnje spanja (- 15, 2; 95% interval zaupanja; - 19, 37, - 10, 94; p < 0, 0001), količina spanja (0, 7 ure; 95% interval zaupanja; 0, 49, 0, 94; p < 0. 0001), ustreznost spanja (18, 6; 95% interval zaupanja; 13, 77, 23, 45; p < 0, 0001) in somnolenca preko dneva (- 7, 5; 95% interval zaupanja - 10, 86, - 4, 23; p < 0, 0001).
The bioavailability of ropinirole is about 50% (36% to 57%), with Cmax reached on average 1.5 hours after the dose.
Cmax je dosežen v povprečju 1, 5 ure po prejemu odmerka.
In the presence of food, Cmax is delayed by about 2.6 hours and the peak plasma level is reduced by 25%, with no effect on the bioavailable quantity.
V prisotnosti hrane se Cmax zakasni za približno 2, 6 ure, največje plazemske vrednosti pa se zmanjšajo za 25%, vendar brez učinka na količino biološke uporabnosti.
28/ 94 The binding of ropinirole to plasma proteins is not high (< 40%), with no effect on the distribution, which is very extensive (volume of distribution in the order of 7 l/ kg).
Porazdelitev je zelo ekstenzivna (volumen porazdelitve je 7 l/ kg).
None of the many metabolites formed are involved in the resulting activity of the product and the main metabolite is 100 times less potent than ropinirole in animal models examining dopaminergic function.
Pri raziskovanju dopaminergičnega delovanja na živalskih modelih so bili glavni presnovki 100- krat manj učinkoviti od ropinirola.
The pharmacokinetics of ropinirole are linear overall (Cmax and AUC) in the therapeutic range between 0.25 mg and 4 mg, after a single dose and after repeated dosing.
Tako po enkratnem odmerku kot večkratnih odmerkih v terapevtskem območju med 0, 25 mg in 4 mg so farmakokinetične lastnosti ropinirola linearne v celoti (Cmax in AUC).
In patients over 65 years of age, a reduction in the systemic clearance of ropinirole by about 30% is possible.
Pri bolnikih, starejših od 65 let, je sistemski očistek ropinirola lahko manjši za približno 30%.
In patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml/ min), no change in the pharmacokinetics of ropinirole is observed.
28/ 93 Pri bolnikih z blago do zmerno okvaro ledvic (kreatininski očistek med 30 in 50 ml/ min) spremembe farmakokinetičnih lastnosti ropinirola niso bile opažene.
Toxicology:
Toksikologija:
The toxicology profile is principally determined by the pharmacological activity of the drug: behavioural changes, hypoprolactinaemia, decrease in blood pressure and heart rate, ptosis and salivation.
Toksikološki profil v glavnem določa farmakološka aktivnost ropinirola: vedenjske spremembe, hipoprolaktinemija, zmanjšanje krvnega tlaka in srčne frekvence, ptoza in povečano izločanje sline.
In the albino rat only, retinal degeneration was observed in a long term study at a high dose (50 mg/ kg), probably associated with an increased exposure to light.
Pri dolgotrajnih študijah z velikimi odmerki (50 mg/ kg) so le pri albino podganah ugotovili degeneracijo mrežnice, kar je bilo verjetno povezano s povečano izpostavljenostjo svetlobi.
Genotoxicity was not observed in the usual battery of in vitro and in vivo tests.
Z običajnimi in vitro in in vivo testi genotoksičnosti niso ugotovili.
From two-year studies conducted in the mouse and rat at dosages up to 50 mg/ kg there was no evidence of any carcinogenic effect in the mouse.
Pri miših karcinogenih učinkov ni bilo opaziti.
Reproductive Toxicity:
Vpliv na sposobnost razmnoževanja:
Administration of ropinirole to pregnant rats at maternally toxic doses resulted in decreased foetal body weight at 60 mg/ kg (approximately 15 times the AUC at the maximum dose in humans), increased foetal death at 90 mg/ kg (approximately 25 times the AUC at the maximum dose in humans) and digit malformations at 150 mg/ kg (approximately 40 times the AUC at the maximum dose in humans).
Pri dajanju ropinirola brejim podganam v odmerkih, ki so bili toksični za mater so opazili: pri 60 mg/ kg (približno 15- kraten AUC pri največjem odmerku pri človeku) zmanjšana telesna masa fetusov, pri 90 mg/ kg (približno 25- kraten AUC pri največjem odmerku pri človeku) povečan odstotek smrtnosti fetusov in pri 150 mg/ kg (približno 40- kraten AUC pri največjem odmerku pri človeku) malformacije prstov.
There were no teratogenic effects in the rat at 120 mg/ kg (approximately 30 times the AUC at the maximum dose in humans) and no indication of an effect on development in the rabbit.
Pri odmerku 120 mg/ kg (približno 30- kraten AUC pri največjem odmerku pri človeku) teratogeni učinki pri podganah niso bili opaženi, pri kuncih pa ni bilo indikacij, ki bi nakazovale učinek na razvoj.
29/ 94 6.1 List of excipients
Seznam pomožnih snovi
Tablet cores:
Jedro tablete:
Hypromellose Macrogol 400 Titanium dioxide (E171) Polysorbate 80 (E433).
hipromeloza makrogol 400 titanov dioksid (E171) polisorbat 80 (E433)
2 years.
29/ 93 2 leti
PVC/ PCTFE/ Aluminium blister.
PVC/ PCTFE/ aluminij pretisni omoti.
Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex 30/ 94 France tel +33 1 39 178000
Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly- le- Roi Cedex France tel +33 1 39 178000
9 DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
{DD month YYYY}
{DD mesec LLLL}
31/ 94 1 NAME OF THE MEDICINAL PRODUCT
IME ZDRAVILA
ADARTREL 0.5 mg film-coated tablets.
ADARTREL 0, 5 mg filmsko obložene tablete
Each film-coated tablet contains 0.5 mg of ropinirole (as hydrochloride).
Vsaka filmsko obložena tableta vsebuje 0, 5 mg ropinirola (v obliki klorida).
Individual dose titration against efficacy and tolerability is recommended.
Odrasli Priporočamo individualno povečevanje odmerka, upoštevajoč učinkovitost in prenašanje zdravila.
In clinical
V kliničnih raziskavah so odmerek tedensko povečevali za 0, 5 mg do doseženega odmerka 3 mg enkrat na dan in nato po 1 mg, do največjega
32/ 94 trials the dose was increased by 0.5 mg each week to 3 mg once a day and then by 1 mg up to the maximum recommended dose of 4 mg once a day as shown in table 1.
31/ 93 priporočenega odmerka 4 mg enkrat na dan, kot je prikazano v tabeli 1.
Table 1
Tabela 4
In Parkinson’ s disease, ropinirole has been associated uncommonly with somnolence and episodes of sudden sleep onset (see section 4.8) however, in Restless Legs Syndrome, this phenomenon is very rare.
32/ 93 epizodami nenadnega nastopa spanja (glejte poglavje 4. 8), vendar pa je ta fenomen pri bolnikih s sindromom nemirnih nog zelo redek.
Patients who have experienced
Kljub temu pa je bolnike o tem fenomenu potrebno poučiti in jim svetovati, naj bodo med zdravljenjem z ropinirolom pri vožnji ali upravljanju vozil in strojev previdni.
33/ 94 somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
Bolniki, pri katerih se je pojavila somnolenca in/ ali epizoda nenadnega nastopa spanja, morajo vožnjo ali upravljanje vozil in strojev opustiti.
Hence, ropinirole is unlikely to affect the pharmacokinetics of other medicinal products, via a cytochrome P450 mechanism.
Na osnovi in vitro podatkov lahko ropinirol pri terapevtskih odmerkih le malenkostno zavira citokrom P450, zato je malo verjetno, da bi preko mehanizma citokrom P450 vplival na farmakokinetične lastnosti drugih zdravil.
34/ 94 There are no adequate data from the use of ropinirole in pregnant women.
O uporabi ropinirola pri nosečnicah ni dovolj podatkov.
Table 2
Tabela 5
Fatigue
34/ 93
35/ 94 Paradoxical worsening of Restless Legs Syndrome symptoms occurring with earlier onset (augmentation), and reoccurrence of symptoms in the early morning hours (early morning rebound), may be observed during treatment with ropinirole.
Med zdravljenjem z ropinirolom se lahko pojavi paradoksno poslabšanje simptomov sindroma nemirnih nog z zgodnejšim pojavom (avgmentacija) in ponovitev simptomov v zgodnjih jutranjih urah (zgodnji jutranji rebound).
Table 3
Tabela 6
36/ 94 Pharmacotherapeutic group:
Farmakoterapevtska skupina:
Ropinirole is a non ergoline D2/ D3 dopamine agonist which stimulates striatal dopamine receptors.
Ropinirol je neergolinski D2/ D3 agonist dopamina, ki stimulira dopaminske receptorje v striatumu.
The bioavailability of ropinirole is about 50% (36% to 57%), with Cmax reached on average 1.5 hours after the dose.
Biološka uporabnost ropinirola je približno 50% (med 36% in 57%).
In the presence of food, Cmax is delayed by about 2.6 hours and the peak plasma level is
Cmax je dosežen v povprečju 1, 5 ure po prejemu odmerka.
37/ 94 reduced by 25%, with no effect on the bioavailable quantity.
V prisotnosti hrane se Cmax zakasni za približno 2, 6 ure, največje plazemske vrednosti pa se zmanjšajo za 25%, vendar brez učinka na količino biološke uporabnosti.
The binding of ropinirole to plasma proteins is not high (< 40%), with no effect on the distribution, which is very extensive (volume of distribution in the order of 7 l/ kg).
Porazdelitev je zelo ekstenzivna (volumen porazdelitve je 7 l/ kg).
In patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml/ min), no change in the pharmacokinetics of ropinirole is observed.
Pri bolnikih z blago do zmerno okvaro ledvic (kreatininski očistek med 30 in 50 ml/ min) spremembe farmakokinetičnih lastnosti ropinirola niso bile opažene.
Reproductive Toxicity:
37/ 93 Vpliv na sposobnost razmnoževanja:
38/ 94 6 PHARMACEUTICAL PARTICULARS
FARMACEVTSKI PODATKI
Hypromellose Macrogol 400 Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Indigo carmine aluminium lake (E132).
Filmska obloga: hipromeloza makrogol 400 titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172) indigotin (E132)
6.6 Special precautions for disposal
Posebni varnostni ukrepi za odstranjevanje 38/ 93 Ni posebnih zahtev.
39/ 94 7 MARKETING AUTHORISATION HOLDER
IMETNIK DOVOLJENJA ZA PROMET
Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France tel +33 1 39 178000
Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly- le- Roi Cedex France tel +33 1 39 178000
40/ 94 1 NAME OF THE MEDICINAL PRODUCT
IME ZDRAVILA
ADARTREL 1 mg film-coated tablets.
ADARTREL 1 mg filmsko obložene tablete
In some patients, to achieve optimal
V naslednjih dveh tednih lahko odmerek tedensko povečujemo za 0, 5 mg, do doseženega odmerka 2 mg enkrat na dan.
41/ 94 improvement, the dose may be increased gradually up to a maximum of 4 mg once a day.
Pri posameznih bolnikih bo za dosego optimalnega izboljšanja odmerek morda potrebno postopno povečevati do največjega odmerka 4 mg enkrat na dan.
Doses above 4 mg once daily have not been investigated in Restless Legs Syndrome patients.
40/ 93 Raziskave z odmerki, višjimi od 4 mg enkrat na dan pri bolnikih s sindromom nemirnih nog niso bile izvedene.
Table 1
Tabela 7
Nevertheless, patients must be informed of this phenomenon and advised to exercise caution while driving or operating machines during treatment with ropinirole.
Pri bolnikih s Parkinsonovo boleznijo je bila uporaba ropinirola občasno povezana s somnolenco in z epizodami nenadnega nastopa spanja (glejte poglavje 4. 8), vendar pa je ta fenomen pri bolnikih s
Patients who have experienced 42/ 94 somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
Kljub temu pa je bolnike o tem fenomenu potrebno poučiti in jim svetovati, naj bodo med zdravljenjem z ropinirolom pri vožnji ali upravljanju vozil in strojev previdni.
43/ 94 There are no adequate data from the use of ropinirole in pregnant women.
O uporabi ropinirola pri nosečnicah ni dovolj podatkov.
Table 2
Tabela 8
Hallucinations were reported uncommonly in the open label long-term studies.
43/ 93 V odprtih, dolgotrajnih študijah so občasno poročali o halucinacijah.
44/ 94 Paradoxical worsening of Restless Legs Syndrome symptoms occurring with earlier onset (augmentation), and reoccurrence of symptoms in the early morning hours (early morning rebound), may be observed during treatment with ropinirole.
Med zdravljenjem z ropinirolom se lahko pojavi paradoksno poslabšanje simptomov sindroma nemirnih nog z zgodnejšim pojavom (avgmentacija) in ponovitev simptomov v zgodnjih jutranjih urah (zgodnji jutranji rebound).
Table 3
Tabela 9
45/ 94 Pharmacotherapeutic group:
Farmakoterapevtska skupina:
Absorption
45/ 93 Absorpcija
46/ 94 reduced by 25%, with no effect on the bioavailable quantity.
V prisotnosti hrane se Cmax zakasni za približno 2, 6 ure, največje plazemske vrednosti pa se zmanjšajo za 25%, vendar brez učinka na količino biološke uporabnosti.
Administration of ropinirole to pregnant rats at maternally toxic doses resulted in decreased foetal body weight at 60 mg/ kg (approximately 15 times the AUC at the maximum dose in humans), increased foetal death at 90 mg/ kg (approximately 25 times the AUC at the maximum dose in humans) and digit malformations at 150 mg/ kg (approximately 40 times the AUC at the maximum dose in humans).
46/ 93 človeku) zmanjšana telesna masa fetusov, pri 90 mg/ kg (približno 25- kraten AUC pri največjem odmerku pri človeku) povečan odstotek smrtnosti fetusov in pri 150 mg/ kg (približno 40- kraten AUC pri največjem odmerku pri človeku) malformacije prstov.
47/ 94 6 PHARMACEUTICAL PARTICULARS
FARMACEVTSKI PODATKI
Hypromellose Macrogol 400 Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmine aluminium lake (E132).
hipromeloza makrogol 400 titanov dioksid (E171) rumeni železov oksid (E172) indigotin (E132)
No special requirements.
47/ 93 Ni posebnih zahtev.
48/ 94 7 MARKETING AUTHORISATION HOLDER
IMETNIK DOVOLJENJA ZA PROMET
49/ 94 1 NAME OF THE MEDICINAL PRODUCT
IME ZDRAVILA
ADARTREL 2 mg film-coated tablets.
ADARTREL 2 mg filmsko obložene tablete
In some patients, to achieve optimal
Pri posameznih bolnikih bo za dosego optimalnega izboljšanja odmerek morda potrebno postopno povečevati do največjega odmerka 4 mg enkrat na dan.
50/ 94 improvement, the dose may be increased gradually up to a maximum of 4 mg once a day.
V kliničnih raziskavah so odmerek tedensko povečevali za 0, 5 mg do doseženega odmerka 3 mg enkrat na dan in nato po 1 mg, do največjega
In clinical trials the dose was increased by 0.5 mg each week to 3 mg once a day and then by 1 mg up to the maximum recommended dose of 4 mg once a day as shown in table 1.
49/ 93 priporočenega odmerka 4 mg enkrat na dan, kot je prikazano v tabeli 1.
Table 1
Tabela 10
In Parkinson’ s disease, ropinirole has been associated uncommonly with somnolence and episodes of sudden sleep onset (see section 4.8) however, in Restless Legs Syndrome, this phenomenon is very rare.
50/ 93 epizodami nenadnega nastopa spanja (glejte poglavje 4. 8), vendar pa je ta fenomen pri bolnikih s sindromom nemirnih nog zelo redek.
Patients who have experienced 51/ 94 somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
Bolniki, pri katerih se je pojavila somnolenca in/ ali epizoda nenadnega nastopa spanja, morajo vožnjo ali upravljanje vozil in strojev opustiti.
52/ 94 There are no adequate data from the use of ropinirole in pregnant women.
O uporabi ropinirola pri nosečnicah ni dovolj podatkov.
Table 2
Tabela 11
Fatigue
52/ 93
53/ 94 Paradoxical worsening of Restless Legs Syndrome symptoms occurring with earlier onset (augmentation), and reoccurrence of symptoms in the early morning hours (early morning rebound), may be observed during treatment with ropinirole.
Med zdravljenjem z ropinirolom se lahko pojavi paradoksno poslabšanje simptomov sindroma nemirnih nog z zgodnejšim pojavom (avgmentacija) in ponovitev simptomov v zgodnjih jutranjih urah (zgodnji jutranji rebound).
Table 3
Tabela 12
54/ 94 Pharmacotherapeutic group:
Farmakoterapevtska skupina:
55/ 94 reduced by 25%, with no effect on the bioavailable quantity.
V prisotnosti hrane se Cmax zakasni za približno 2, 6 ure, največje plazemske vrednosti pa se zmanjšajo za 25%, vendar brez učinka na količino biološke uporabnosti.
Reproductive Toxicity:
55/ 93 Vpliv na sposobnost razmnoževanja:
56/ 94 6 PHARMACEUTICAL PARTICULARS
FARMACEVTSKI PODATKI
Hypromellose Macrogol 400 Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172).
hipromeloza makrogol 400 titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172)
6.6 Special precautions for disposal
Posebni varnostni ukrepi za odstranjevanje 56/ 93 Ni posebnih zahtev.
7 MARKETING AUTHORISATION HOLDER 57/ 94 Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France tel +33 1 39 178000
Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly- le- Roi Cedex France tel +33 1 39 178000
LABELLING
OVOJNINA
59/ 94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
58/ 93 PODATKI NA ZUNANJI OVOJNINI
ADARTREL 0.25 mg film-coated tablets Ropinirole
ADARTREL 0, 25 mg filmsko obložene tablete ropinirol
Each tablet contains 0.25 mg of ropinirole (as hydrochloride)
Vsaka tableta vsebuje 0, 25 mg ropinirola (v obliki klorida).
This product contains lactose See leaflet for further information
Za dodatne informacije glejte navodilo za uporabo.
2 film-coated tablets 12 film-coated tablets
2 filmsko obloženi tableti 12 filmsko obloženih tablet
To be taken as directed by your doctor.
Zdravilo uporabljajte natančno po zdravnikovih navodilih!
8.
59/ 93 8.
exp {MM YYYY}
EXP {MM/ LLLL}
Do not store above 25°C Store in the original package
Shranjujte v originalni ovojnini.
Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France
Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly- le- Roi Cedex Francija
{To be completed nationally}
{Izpolni država članica}
61/ 94 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
60/ 93 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
lot {XYYYY}
Lot {XYYYY}
62/ 94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
61/ 93 PODATKI NA ZUNANJI OVOJNINI
ADARTREL 0.5 mg film-coated tablets Ropinirole
ADARTREL 0, 5 mg filmsko obložene tablete ropinirol
Each tablet contains 0.5 mg of ropinirole (as hydrochloride)
Vsaka tableta vsebuje 0, 5 mg ropinirola (v obliki klorida).
10.
62/ 93 10.
64/ 94 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
63/ 93 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
65/ 94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
64/ 93 PODATKI NA ZUNANJI OVOJNINI
ADARTREL 1 mg film-coated tablets Ropinirole
ADARTREL 1 mg filmsko obložene tablete ropinirol
Each tablet contains 1 mg of ropinirole (as hydrochloride)
Vsaka tableta vsebuje 1 mg ropinirola (v obliki klorida).
Do not store above 25°C Store in the original package
Shranjujte pri temperaturi do 25 °C.
66/ 94 11.
65/ 93 Shranjujte v originalni ovojnini.
67/ 94 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
66/ 93 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
68/ 94 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
67/ 93 PODATKI NA ZUNANJI OVOJNINI
ADARTREL 2 mg film-coated tablets Ropinirole
ADARTREL 2 mg filmsko obložene tablete ropinirol
Each tablet contains 2 mg of ropinirole (as hydrochloride)
Vsaka tableta vsebuje 2 mg ropinirola (v obliki klorida).
10.
68/ 93 10.
70/ 94 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
69/ 93 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
72/ 94 PACKAGE LEAFLET:
71/ 93 NAVODILO ZA UPORABO
ADARTREL 0.25 mg film-coated tablets Ropinirole (as hydrochloride)
ADARTREL 0, 25 mg filmsko obložene tablete Ropinirol (v obliki klorida)
- If any of the side effects become serious, or if you notice any side effects not listed in this
- Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni
What ADARTREL is and what it is used for 2.
Kaj je zdravilo ADARTREL in za kaj ga uporabljamo 2.
Before you take ADARTREL 3.
Kaj morate vedeti, preden boste vzeli zdravilo ADARTREL 3.
How to take ADARTREL 4.
Kako jemati zdravilo ADARTREL 4.
How to store ADARTREL 6.
Možni neželeni učinki 5 Shranjevanje zdravila ADARTREL 6.
Restless Legs Syndrome is a condition characterised by an irresistible urge to move the legs and occasionally the arms, usually accompanied by uncomfortable sensations such as tingling, burning or prickling.
Običajno ga spremljajo neprijetni občutki, kot so mravljinčenje, pekoča bolečina ali zbadanje.
Do not take ADARTREL
Ne jemljite zdravila ADARTREL
- if you are allergic (hypersensitive) to the active ingredient, ropinirole, or any of the other
- če ste alergični na (preobčutljivi za) zdravilno učinkovino ropinirol ali katero koli drugo
ingredients of ADARTREL
sestavino zdravila ADARTREL;
- if you have serious liver disease
- če imate hujšo bolezen jeter;
- if you have serious kidney disease
- če imate hujšo bolezen ledvic.
- have liver disease
- če imate bolezen jeter;
- have a serious heart complaint
- če imate hujše težave s srcem;
- have a serious mental health problem
- če imate hujše duševne težave.
In these situations your doctor should carefully supervise the treatment.
V teh primerih mora zdravnik vaše zdravljenje skrbno nadzirati.
If you suffer from extreme sleepiness or suddenly fall asleep without apparently feeling sleepy, do not drive or use machinery, and contact your doctor.
Posvetovati se morate s svojim zdravnikom.
If during treatment your symptoms become worse, start earlier in the day or after less time at rest, or affect other parts of your body such as your arms, you should see your doctor who may adjust the dose of ADARTREL that you are taking.
Zdravnik bo morda odmerek zdravila ADARTREL, ki ga jemljete prilagodil.
These medicines include:
Ta zdravila so predvsem:
- ciprofloxacin (an antibiotic)
- ciprofloksacin (antibiotik);
- enoxacin (an antibiotic)
- enoksacin (antibiotik);
- fluvoxamine (a drug used to treat depression)
- fluvoksamin (zdravilo, ki ga uporabljamo pri zdravljenju depresije);
- theophylline (a drug used to treat asthma)
- teofilin (zdravilo, ki ga uporabljamo pri zdravljenju astme);
- hormone replacement therapy (also called HRT)
- nadomestno hormonsko zdravljanje;
- anti-psychotics and other drugs that block dopamine in the brain (e. g. sulpiride or
- antipsihotiki in druga zdravila, ki zavirajo dopamin v možganih (npr. sulpirid ali
metoclopramide) Tell your doctor if:
Svojemu zdravniku povejte:
- you are already receiving any other medicines for Restless Legs Syndrome.
- če ste se že kdaj zdravili s katerim koli drugim zdravilom za zdravljenje sindroma nemirnih nog.
- you give up or start smoking while taking ADARTREL.
Zdravnik
Your doctor may need to adjust your
bo morda moral odmerek zdravila prilagoditi.
- you are taking ADARTREL and the doctor is going to prescribe you any other medicine.
- če vam zdravnik namerava predpisati katero koli zdravilo, mu povejte, da jemljete zdravilo
Pregnancy The use of ADARTREL during pregnancy is not recommended.
Nosečnost Uporabe zdravila ADARTREL med nosečnostjo ne priporočamo.
ADARTREL should only be used during pregnancy after your doctor has considered the benefit to you and the potential risk of harm to your unborn child.
Zdravilo ADARTREL se sme med nosečnostjo uporabljati le po skrbni presoji zdravnika o možnih koristih za mater in možnih tveganjih, ki jih zdravljenje predstavlja za nerojenega otroka.
Tell your doctor immediately if you are pregnant, you think you might be or are planning to become pregnant.
Če ste noseči, če mislite, da bi lahko bili noseči ali če nameravate zanositi, to nemudoma povejte svojemu zdravniku.
Breast-feeding ADARTREL should not be used during breast-feeding as milk production may be affected.
Dojenje Zdravila ADARTREL med dojenjem ne smete jemati, saj lahko zdravilo ADARTREL vpliva na nastajanje in izločanje mleka.
Tell your doctor immediately if you are breast-feeding or if you are planning to breast-feed.
Če svojega otroka dojite ali ga nameravate dojiti, to nemudoma povejte svojemu zdravniku.