natgillin/translations-raw huggingface dataset:
If you take more ADARTREL than you should or if someone else has taken your medicine, tell a doctor or pharmacist immediately.
Če ste vzeli večji odmerek zdravila ADARTREL kot bi smeli, ali če je kdo drug vzel vaše zdravilo, se o tem nemudoma posvetujte s svojim zdravnikom ali farmacevtom.
In a combined analysis of moderate to severe Restless Legs Syndrome patients from the four 12-week studies, the adjusted treatment difference for the change from baseline in IRLS scale total score at week 12 Last Observation Carried Forward (LOCF) Intention To Treat population was -4.0 points (95% CI -5.6,2.4, p<0.0001; baseline and week 12 LOCF mean IRLS points: ropinirole 28.4 and 13.5; placebo 28.2 and 17.4).
S kombinirano analizo podatkov, pridobljenih pri bolnikih z zmernim do hudim sindromom nemirnih nog, vključenih v štiri 12-tedenske študije so ugotovili, da je bila prilagojena razlika zaradi zdravljenja, glede na spremembo skupnega rezultata na MLSNN od izhodišča do 12. tedna (Last Observation Carried Forward; LOCF) -4,0 točke (95 % interval zaupanja: -5,6, -2,4; p < 0,0001; povprečno število točk v izhodišču oziroma v 12. tednu LOCF na MLSNN: ropinirol 28,4 oziroma 13,5; placebo 28,2 oziroma 17,4).
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION {DD month YYYY}
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET {DD mesec LLLL} [Izpolni država članica]
Film coat:
Filmska obloga:
Management of undesirable effects
Ukrepanje v primeru pojava neželenih učinkov
Use of ropinirole in Restless Legs Syndrome
Uporaba ropinirola pri zdravljenju sindroma nemirnih nog
[See Annex I- to be completed nationally]
[Glejte Dodatek I - Izpolni država članica]
If this occurs, treatment should be reviewed and dosage adjustment or discontinuation of treatment may be considered.
V takšnih primerih je treba zdravljenje ponovno ovrednotiti in po potrebi odmerek prilagoditi ali zdravljenje opustiti.
If you suffer from extreme sleepiness or suddenly fall asleep without apparently feeling sleepy, do not drive or use machinery, and contact your doctor.
Če vas muči huda zaspanost ali če nenadoma zaspite, ne da bi bili pred tem zaspani, vozil in strojev ne smete voziti ali upravljati.
The mean dose of ropinirole for the moderate to severe patients was 2.0 mg/day.
Srednji odmerek ropinirola, ki so ga prejemali bolniki z zmerno do hudo obliko bolezni je bil 2,0 mg/dan.
If you take more ADARTREL than you should Someone who has taken an overdose may experience; feeling or being sick, dizziness (or spinning sensation), feeling drowsy, fatigue (mental or physical tiredness), stomach pain, fainting or nervousness.
Če ste vzeli večji odmerek zdravila ADARTREL, kot bi smeli Pri posamezniku, ki je vzel prevelik odmerek zdravila ADARTREL se lahko pojavijo slabost ali občutek slabosti, omotica (ali vrtoglavica), zaspanost, utrujenost (duševna ali fizična izčrpanost), bolečine v trebuhu, omedlevica ali živčnost.
The average dose in clinical trials, in patients with moderate to severe Restless Legs Syndrome, was 2 mg once a day.
V kliničnih preskušanjih je bil pri bolnikih z zmernim do hudim sindromom nemirnih nog srednji odmerek 2 mg enkrat na dan.
You should continue to take your medicine even if you do not feel better, as it may take a number of weeks for your medicine to work for you.
Tudi če ne opazite izboljšanja, zdravila ne smete prenehati jemati, saj se učinek zdravila lahko opazi šele po nekaj tednih jemanja.
Hence, in patients already receiving ropinirole, the dose of ropinirole may need to be adjusted when medicinal products known to inhibit CYP1A2, e.g. ciprofloxacin, enoxacin or fluvoxamine, are introduced or withdrawn.
Če se pri bolnikih, ki že prejemajo ropinirol, uvedejo ali ukinejo zdravila, ki so znani zaviralci CYP1A2, npr. ciprofloksacin, enoksacin ali fluvoksamin, bo odmerek ropinirola torej morda potrebno prilagoditi.
If your symptoms worsen after you stop treatment with ADARTREL, you should contact your doctor.
Če se po prenehanju zdravljenja z zdravilom ADARTREL bolezenski znaki poslabšajo, se morate posvetovati s svojim zdravnikom.
In the rat, the only drug-related lesions were Leydig cell hyperplasia and testicular adenoma resulting from the hypoprolactinaemic effect of ropinirole.
Pri podganah so bile edine z ropinirolom povezane spremembe (posledica hipoprolaktinemičnega učinka) hiperplazija Leydigovih celic in adenom testisov.
Moderate to severe idiopathic Restless Legs Syndrome is typically represented by patients who suffer with insomnia or severe discomfort in the limbs.
Zmeren do hud idiopatični sindrom nemirnih nog imajo običajno bolniki, ki trpijo zaradi nespečnosti ali hudega neugodja v okončinah.
Hallucinations were reported uncommonly in the open label long-term studies.
V odprtih, dolgotrajnih študijah so občasno poročali o halucinacijah.
Anti-nausea medicinal products that are not centrally active dopamine antagonists, such as domperidone, may be used, if required.
Po potrebi se lahko uporabijo zdravila proti slabosti, ki niso centralno delujoči antagonisti dopamina, npr. domperidon.
In some patients with insufficient improvement, the dose may be increased gradually up to a maximum of 4mg daily.
Pri posameznih bolnikih z nezadostnim izboljšanjem lahko zdravnik odmerek postopoma še povečuje, do največjega odmerka 4 mg enkrat na dan.
Ropinirole should not be used in nursing mothers as it may inhibit lactation.
Doječe matere ropinirola ne smejo uporabljati, saj lahko deluje zaviralno na izločanje mleka.
No pharmacokinetic interaction has been seen between ropinirole and domperidone (a medicinal product used to treat nausea and vomiting) that would necessitate dosage adjustment of either medicinal product.
Med ropinirolom in domperidonom (zdravilom za zdravljenje navzee in bruhanja) niso opazili farmakokinetičnih interakcij, ki bi terjale prilagoditev odmerka katerega od obeh zdravil.
The effect of ADARTREL may be increased or decreased by other medicines and vice versa.
Učinek zdravila ADARTREL lahko nekatera druga zdravila okrepijo ali oslabijo, oziroma lahko zdravilo ADARTREL okrepi ali oslabi učinek nekaterih drugih zdravil.
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 %).
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
Če se ne morete spomniti, kdaj in kako morate jemati zdravilo, za navodilo vprašajte svojega farmacevta.
In some patients, to achieve optimal 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.
ADARTREL is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti, uporabe zdravila ADARTREL pri otrocih, mlajših od 18 let ne priporočamo.
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.
Če se med zdravljenjem bolezenski znaki poslabšajo, tekom dneva pojavijo prej oziroma pojavijo v kratkem po počitku, ali prizadenejo druge dele telesa, npr. roke, morate obiskati svojega zdravnika.
In clinical trials, although the average IRLS total scores 7-10 days after withdrawal of therapy were higher in ropinirole-treated patients than in placebo-treated patients, the severity of symptoms following withdrawal of therapy generally did not exceed the baseline assessment in ropinirole-treated patients.
Kljub temu, da je bil 7 do 10 dni po prekinitvi zdravljenja povprečni skupni rezultat na MLSNN višji pri bolnikih, ki so prejemali ropinirol kot pa pri bolnikih, ki so prejemali placebo, v kliničnih raziskavah pri bolnikih, ki so prejemali ropinirol resnost simptomov po prekinitvi zdravljenja na splošno ni presegala tistih v izhodišču.
Taking ADARTREL with food may decrease the occurrence of nausea (feeling sick) which is a possible side effect of ADARTREL.
Jemanje zdravila ADARTREL skupaj s hrano lahko zmanjša pojavnost siljenja na bruhanje (občutka slabosti), ki je lahko eden od neželenih učinkov zdravila ADARTREL.
ADARTREL should not be used during breast-feeding as milk production may be affected.
Zdravila ADARTREL med dojenjem ne smete jemati, saj lahko zdravilo ADARTREL vpliva na nastajanje in izločanje mleka.
Moderate to severe Restless Legs Syndrome is typically represented by patients who have difficulty sleeping or severe discomfort in their legs or arms.
Zmerno do hudo obliko sindroma nemirnih nog imajo običajno bolniki, ki imajo zaradi tega težave s spanjem ali pa čutijo hujše neugodje v nogah ali rokah.
The MAH has defined severe idiopathic RLS as those patients who have an International Restless Legs Syndrome Rating Scale (IRLS) baseline score of 24 points or more.
Imetnik dovoljenja za promet z zdravilom je definiral idiopatični sindrom nemirnih nog kot hud pri tistih bolnikih, ki na mednarodni lestvici sindroma nemirnih nog (MLSNN) dosežejo izhodiščni rezultat 24 točk ali več.
Postural hypotension, hypotension
Žilne bolezni občasni ortostatska hipotenzija, hipotenzija
6.4 Special precautions for storage Do not store above 25 °C.
Posebna navodila za shranjevanje Shranjujte pri temperaturi do 25 °C.
A statistically significant difference in the periodic leg movements of sleep was seen between ropinirole and placebo from baseline to week 12.
Od izhodišča do 12. tedna so med ropinirolom in placebom opazili statistično pomembno razliko pri periodičnem gibanju nog med spanjem.
lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
Monohidrat laktoze, mikrokristalna celuloza, natrijev premrežen karmelozat in magnezijev stearat.
PHARMACEUTICAL FORM AND CONTENTS 2 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 2 filmsko obloženi tableti 12 filmsko obloženih tablet
Syncope, somnolence, dizziness (including vertigo)
Bolezni živčevja pogosti sinkopa, somnolenca, omotica (vključno z vrtoglavico)
Individual dose titration against efficacy and tolerability is recommended.
Priporočamo individualno povečevanje odmerka, upoštevajoč učinkovitost in prenašanje zdravila.
Carcinogenicity: 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.
Karcinogenost: Izvedene so bile dveletne študije, v katerih so miši in podgane dobivale odmerke do 50 mg/kg.
Take special care with ADARTREL
Bodite posebno pozorni pri jemanju zdravila ADARTREL
However, it may be necessary to adjust the ropinirole dose, in accordance with clinical response, if hormone replacement therapy is stopped or introduced during treatment with ropinirole.
Če pa se nadomestna hormonska terapija prekine ali uvede med zdravljenjem z ropinirolom, bo morda potrebno odmerek ropinirola prilagoditi v skladu s kliničnim odzivom.
Increased plasma concentrations of ropinirole have been observed in patients treated with hormone replacement therapy.
Pri bolnikih, ki so se zdravili z nadomestno hormonsko terapijo so bile ugotovljene povečane koncentracije ropinirola v plazmi.
This product contains lactose
Pomožne snovi: laktoza
Therefore, it is not expected that ropinirole will compete with the metabolism of other medicinal products which are metabolised by CYP1A2.
Kompetitivne presnove ropinirola in drugih zdravil, ki se presnavljajo s pomočjo CYP1A2 torej ne pričakujemo.
No dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml/min).
Pri bolnikih z blago do zmerno okvaro ledvic (kreatininski očistek med 30 in 50 ml/min) odmerka ni potrebno prilagajati.
If this dose is well tolerated the dose should be increased to 0.5 mg once daily for the remainder of week 1.
Če bolnik začetni odmerek dobro prenaša, je potrebno v preostanku prvega tedna odmerek povečati na 0,5 mg enkrat na dan.
General disorders and administration site conditions Common
Splošne težave in spremembe na mestu aplikacije pogosti
Ropinirole is mainly metabolised by the isoform CYP1A2 of cytochrome P450.
Ropinirol se v glavnem presnavlja s pomočjo izoencima CYP1A2, ki pripada družini encimov citokrom P450.
The clearance of ropinirole is decreased in patients over 65 years of age.
Pri bolnikih, starejših od 65 let, je očistek ropinirola manjši.
EXPIRY DATE exp {MM YYYY}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {MM/LLLL}
If you suffer from these effects you must not drive or put yourself in a situation where sleepiness or falling asleep may put you at risk of serious injury or death (for example using machinery) until these episodes have been resolved.
Če imate tovrstne neželene učinke ne smete, dokler le-ti ne minejo, voziti vozil ali opravljati tistih del (npr. upravljanje strojev ali orodij), kjer bi se lahko zaradi zaspanosti ali nenadnega nastopa spanja huje ali celo smrtno poškodovali.
ADARTREL should only be prescribed to patients with moderate to severe idiopathic Restless Legs Syndrome.
Zdravilo ADARTREL se sme predpisati le bolnikom z zmernim do hudim idiopatičnim sindromom nemirnih nog.
In Parkinson's disease, ropinirole is associated with somnolence and has been associated uncommonly (>1/1,000, <1/100) with excessive daytime somnolence and sudden sleep onset episodes, however, in Restless Legs Syndrome, this phenomenon is very rare (<1/10,000).
Občasno (> 1/1.000, < 1/100) je bila povezana s prekomerno somnolenco preko dneva in epizodami nenadnega nastopa spanja, vendar pa je ta fenomen pri bolnikih s sindromom nemirnih nog zelo redek
However, ADARTREL can cause extreme sleepiness (somnolence) and sudden sleep onset episodes.
Vendar pa lahko zdravilo ADARTREL povzroča zelo močno zaspanost (somnolenco), bolnik, ki se z njim zdravi, pa lahko tudi nenadoma zaspi.
Based on in-vitro data, ropinirole has little potential to inhibit cytochrome P450 at therapeutic doses.
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.
Although sufficient data are not available to adequately demonstrate the long term efficacy of ropinirole in Restless Legs Syndrome (see section 4.2), in a 36-week study, patients who continued on ropinirole demonstrated a significantly lower relapse rate compared with patients randomised to placebo (33% versus 58%, p=0.0156).
V 36-tedenski študiji je bil odstotek ponovitev pomembno nižji pri bolnikih, ki so kontinuirano prejemali ropinirol kot pa pri bolnikih, ki so bili randomizirani na placebo (33 % versus 58 %; p = 0,0156).
Patients with major psychotic disorders should not be treated with dopamine agonists unless the potential benefits outweigh the risks.
Bolniki s hujšimi psihozami se z agonisti dopamina ne smejo zdraviti.
Following ropinirole therapy, postural hypotension or hypotension has been reported uncommonly (>1/1,000, <1/100), rarely severe.
Po zdravljenju z ropinirolom so občasno (> 1/1.000, < 1/100) poročali o ortostatski hipotenziji ali hipotenziji, ki sta bili v redkih primerih hudi.
- you give up or start smoking while taking ADARTREL.
- če ste med zdravljenjem z zdravilom ADARTREL opustili kajenje ali pričeli z njim.
The recommended initial dose is 0.25 mg once daily (administered as above) for 2 days.
V prvih dveh dnevih zdravljenja priporočamo začetni odmerek 0,25 mg enkrat na dan (odmerek bolnik vzame, kot je navedeno zgoraj).
What ADARTREL contains
Kaj vsebuje zdravilo ADARTREL
- are pregnant or think you are pregnant - are breast-feeding - are intolerant to some sugars (e.g. lactose) - have liver disease - have a serious heart complaint - have a serious mental health problem In these situations your doctor should carefully supervise the treatment.
- če ste noseči ali mislite, da bi lahko bili noseči; - če dojite; - če ne prenašate nekaterih sladkorjev (npr. laktoze); - če imate bolezen jeter; - če imate hujše težave s srcem; - če imate hujše duševne težave.
The dose may then be increased by 0.5 mg per week over the next two weeks to a dose of 2 mg once a day.
V naslednjih dveh tednih lahko odmerek tedensko povečujemo za 0,5 mg, do doseženega odmerka 2 mg enkrat na dan.
{See Annex I- to be completed nationally}
{Glejte Dodatek I - Izpolni država članica}
The adverse drug reactions reported in patients with Parkinson's disease on ropinirole monotherapy and adjunct therapy at doses up to 24 mg/day at an excess incidence over placebo are described below.
V nadaljevanju so navedene neželene reakcije o katerih so poročali pri bolnikih s Parkinsonovo boleznijo, ki so se zdravili samo z ropinirolom ali pa so se zdravili z ropinirolom kot dodatnim zdravilom v odmerkih do 24 mg/dan in katerih pojavnost je bila večja od pojavnosti pri placebu.
Tell your doctor before you start to take this medicine if you: - are pregnant or think you are pregnant - are breast-feeding - are intolerant to some sugars (e.g. lactose) - have liver disease - have a serious heart complaint - have a serious mental health problem In these situations your doctor should carefully supervise the treatment.
Preden začnete jemati zdravilo ADARTREL, morate svojemu zdravniku povedati: - če ste noseči ali mislite, da bi lahko bili noseči; - če dojite; - če ne prenašate nekaterih sladkorjev (npr. laktoze); - če imate bolezen jeter; - če imate hujše težave s srcem; - če imate hujše duševne težave.
Undesirable effects were normally mild to moderate and experienced at the start of therapy or on increase of dose and few patients withdrew from the clinical studies due to undesirable effects.
Neželeni učinki so bili običajno blagi do zmerni, pojavili pa so se ob začetku zdravljenja ali pri povečevanju odmerka.
3 HOW TO TAKE ADARTREL
KAKO JEMATI ZDRAVILO ADARTREL
A detailed assessment of the most common adverse events in the target population (IRLS baseline score 24-40 points) has been provided.
Predložena je bila podrobna ocena najpogostejših neželenih učinkov pri ciljni populaciji (izhodiščni rezultat na MLSNN 24-40 točk) Obravnavani so bili neželeni učinki, ki so specifični za bolnike z sindromom nemirnih nog, kot je avgmentacija, ter rebound učinki.
The dose may be increased to 1 mg once a day at week 2.
V 2. tednu zdravljenja lahko odmerek povečamo na 1 mg enkrat na dan.
Adverse drug reactions reported in 12-week Restless Legs Syndrome clinical trials (ropinirole n=309, placebo n=307)
Tabela 11 Neželene reakcije, o katerih so poročali pri bolnikih s sindromom nemirnih nog med 12tedenskimi kliničnimi raziskavami (ropinirol n = 309, placebo n = 307)
See leaflet for further information
Za dodatne informacije glejte navodilo za uporabo.
In the four 12-week efficacy studies, patients with Restless Legs Syndrome were randomised to ropinirole or placebo, and the effects on the IRLS scale scores at week 12 were compared to baseline.
V štirih 12-tedenski študijah učinkovitosti so bili bolniki s sindromom nemirnih nog randomizirani tako, da so prejemali bodisi ropinirol bodisi placebo.
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.
Vomiting, abdominal pain, heartburn General disorders and administration site conditions Common
Navzea pogosti bruhanje, abdominalna bolečina, zgaga Splošne težave in spremembe na mestu aplikacije pogosti edem okončin
Do not store above 25 °C.
Shranjujte pri temperature do 25 °C.
Titanium dioxide (E171) Polysorbate 80 (E433).
hipromeloza makrogol 400 titanov dioksid (E171) polisorbat 80 (E433)
Film-coated tablet.
Filmska obloga tablete:
The side effects are generally mild and may become less after you have taken the medicine for a short time.
Neželeni učinki so običajno blagi oziroma se lahko kmalu po pričetku jemanja ublažijo.
White oval-shaped, marked "GS" on one side and "MLE" on the other.
Bele, ovalne tablete, označene z "GS" na eni in "MLE" na drugi strani.
ADARTREL is used to treat the symptoms of moderate to severe idiopathic Restless Legs Syndrome.
Zdravilo ADARTREL uporabljamo za zdravljenje bolezenskih znakov zmernega do hudega idiopatičnega sindroma nemirnih nog.
Then your doctor may increase your dose by 0.5mg per week over three weeks to a dose of 2mg per day.
V naslednjih treh tednih lahko zdravnik odmerek povečuje po 0,5 mg na teden, do doseženega odmerka 2 mg enkrat na dan.
Pharmaceutical form Route of administra tion
Farmacevtska oblika Način uporabe zdravila
How to store ADARTREL Further information
5 Shranjevanje zdravila ADARTREL Dodatne informacije
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).
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.
Sindrom nemirnih nog je bolezensko stanje, za katerega je značilna nevzdržna potreba po premikanju nog in občasno tudi rok.
Marketing authorisation Holder
IMETNIK DOVOLJENJA ZA PROMET
BATCH NUMBER {To be completed nationally} 14.
ŠTEVILKA SERIJE {Izpolni država članica}
CONDITIONS OF THE MARKETING AUTHORISATION
DODATEK IV POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
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. Tell your doctor immediately if you are pregnant, you think you might be or are planning to become pregnant.
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.
Each film-coated tablet contains 1 mg of ropinirole (as hydrochloride).
Vsaka filmsko obložena tableta vsebuje 1 mg ropinirola (v obliki klorida).
2 BEFORE YOU TAKE ADARTREL
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ADARTREL
Adverse drug reactions reported in Parkinson's disease clinical trials at doses up to 24 mg/day
Tabela 12 Neželene reakcije, o katerih so poročali pri bolnikih s Parkinsonovo boleznijo, ki so se v kliničnih raziskavah zdravili z odmerki do 24 mg/dan
Taking ADARTREL with food and drink Taking ADARTREL with food may reduce the likelihood of you feeling or being sick.
Jemanje zdravila ADARTREL skupaj s hrano in pijačo Jemanje zdravila ADARTREL skupaj s hrano lahko zmanjša pojavnost ali občutek slabosti.
NAME OF THE MEDICINAL PRODUCT ADARTREL 1 mg film-coated tablets Ropinirole NAME OF THE MARKETING AUTHORISATION HOLDER Laboratoire GlaxoSmithKline {See Annex I- to be completed nationally} EXPIRY DATE exp {MM YYYY} BATCH NUMBER lot {XYYYY} OTHER
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Laboratoire GlaxoSmithKline {Glejte Dodatek I - Izpolni država članica}
Smoking is known to induce CYP1A2 metabolism, therefore if patients stop or start smoking during treatment with ropinirole, dose adjustment maybe required.
Če bolniki med zdravljenjem z ropinirolom kajenje opustijo ali z njim pričnejo, bo torej morda potrebno odmerek ropinirola prilagoditi.
4 POSSIBLE SIDE EFFECTS
MOŽNI NEŽELENI UČINKI
- The active substance is ropinirole (as hydrochloride) - The other ingredients are
- Zdravilna učinkovina je ropinirol (v obliki klorida).
Unchanged ropinirole and the metabolites are mainly excreted through the kidneys.
Ropinirol se v glavnem izloča preko ledvic v nespremenjeni obliki in v obliki presnovkov.
ADARTREL 1 mg film-coated tablets
ADARTREL 1 mg filmsko obložene tablete
Each film-coated tablet contains 2 mg of ropinirole (as hydrochloride).
Vsaka filmsko obložena tableta vsebuje 2 mg ropinirola (v obliki klorida).