qanastek/EMEA-V3 huggingface dataset:
Consequently, adverse dopaminergic reactions may be more frequent when entacapone is added to levodopa/ benserazide treatment (see also section 4.8).
Għalhekk reazzjonijiet dopaminerġiċi mhux mixtieqa jistgħu jkunu aktar spissi meta jiżdied entacapone mal- kura b’ levodopa/ benserazide (ara wkoll sezzjoni 4. 8).
To reduce levodopa-related dopaminergic adverse reactions, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment, according to the clinical condition of the patient (see sections 4.2 and 4.8).
Sabiex jitnaqqsu effetti avversi dopaminergiċi relatati ma ’ levodopa, ħafna drabi jkun hemm bżonn li tidbidel id- doża ta ’ levodopa fl- ewwel ġranet jew fl - ewwel ġimgħat tal- kura b’ levodopa, skond il- kundizzjoni klinika tal- pazjent (ara sezzjoni 4. 2 u 4. 8).
Entacapone may aggravate levodopa-induced orthostatic hypotension.
Entacapone jista ’ jaggrava l- ipotensjoni ortostatika ikkawżata minn levodopa.
Entacapone should be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension.
Entacapone għandu jingħata b’ kawtela lill- pazjenti li jkunu qed jieħdu prodotti mediċinali oħra li jistgħu jikkawżaw ipotensjoni ortostatika.
In clinical studies, adverse dopaminergic reactions, e. g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
Fi studji kliniċi, irriżulta li reazzjonijiet dopaminerġiċi mhux mixtieqa (ez. diskineżja) kienu aktar komuni f’ pazjenti li ħadu entacapone u agonisti ta ’ dopamine (bħal bromocriptine), selegiline jew amantadine, milli f’ dawk il- pazjenti li rċevew plaċebo ma ’ din it- taħlita ta ’ mediċini.
The doses of other antiparkinsonian medicinal products may need to be adjusted when entacapone treatment is initiated.
Meta tinbeda l - kura b’ entacapone, jista ’ jkun hemm bżonn ta ’ tibdil fid- dożi ta ’ prodotti mediċinali oħra ta ’ kontra l - marda ta ’ Parkinson.
Entacapone in association with levodopa has been associated with somnolence and episodes of sudden sleep onset in patients with Parkinson’ s disease and caution should therefore be exercised when driving or operating machines (see also section 4.7).
L- użu ta ’ entacapone flimkien ma ’ levodopa ġie assoċjat man- nagħas u episodji ta ’ rqad f’ daqqa f’ pazjenti li jbatu bil- marda ta ’ Parkinson u għalhekk għandha tintuża kawtela meta wieħed ikun qed isuq jew iħaddem magni (ara ukoll sezzjoni 4. 7).
For patients experiencing diarrhoea, a follow-up of weight is recommended in order to avoid potential excessive weight decrease.
Għal pazjenti li taqbadhom dijarea, sabiex tiġi evitata l- possibbiltà ta ’ tnaqqis drastiku fil- piż, huwa rakkomondat li l- pazjent jintiżen b’ mod regolari bħala follow- up.
Pathological gambling, increased libido and hypersexuality have been reported in Parkinson’ s disease patients treated with dopamine agonists and other dopaminergic treatments such as entacapone in association with levodopa.
Logħob ta ’ l- ażżard patoloġiku, żieda fil- libido u ipersesswalità kienu rrappurtati f’ pazjenti bil- marda ta ’ Parkinson ikkurati b’ agonisti ta ’ dopamine u b’ kura dopaminerġika oħra bħal entacapone flimkien ma ’ levodopa.
For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.
Għal pazjenti li jkollhom anoressija li tavvanza, astenja u tnaqqis fil- piż fi żmien relattivament qasir, evalwazzjoni medika ġenerali inkluża l- funzjoni tal- fwied għandhom ikunu meqjusa.
Comtan tablets contain sucrose.
Comtan fih is- sucrose.
Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Għalhekk, pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għall - fructose, malassorbiment tal- glucose- galactose jew nuqqas ta ’ sucrase- isomaltase, m’ għandhomx jieħdu din il- mediċina.
4.5 Interaction with other medicinal products and other forms of interaction
Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu 4. 5 l- effett farmaċewtiku tal- prodott
No interaction of entacapone with carbidopa has been observed with the recommended treatment schedule.
Ma ġiet innutata l- ebda interazzjoni ta ’ entacapone ma ’ carbidopa meta ttieħdu skond l- iskeda tal- kura rakkomandata.
Pharmacokinetic interaction with benserazide has not been studied.
L- interazzjoni farmakokinetika ma ’ benserazide ma ġietx studjata.
In single-dose studies in healthy volunteers, no interactions were observed between entacapone and imipramine or between entacapone and moclobemide.
Fi studji b’ doża waħda mgħotija lill- volontiera b’ saħħithom, ma ġew innutati l- ebda interazzjonjiet bejn entacapone u imipramine jew bejn entacapone u moclobemide.
Similarly, no interactions between entacapone and selegiline were observed in repeated-dose studies in parkinsonian patients.
Bl- istess mod ma ġew innutati l - ebda interazzjonjiet bejn entacapone u selegiline fi studji b’ dożi ripetuti, f ’ pazjenti li kienu qed ibatu bil- marda ta ’ Parkinson.
However, the experience of the clinical use of entacapone with several medicinal products, including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e. g. catechol- structured compounds: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine, and paroxetine) is still limited.
Madanakollu, l- esperjenza bl- użu kliniku ta ’ entacapone ma ’ diversi prodotti mediċinali, inklużi l- inibituri MAO- A, antidepressanti triċikliċi, inibituri li jinibbixu r- riassorbiment ta ’ noradrenaline bħal desipramine, maprotiline u venlafaxine u prodotti mediċinali li jiġu metabollizzati b’ COMT (eż. sustanzi bl- istruttura ta ’ catechol: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamina, dobutamine, alpha- methyldopa, apomorphine u paroxetine), għadha limitata.
Caution should be exercised when these medicinal products are used concomitantly with entacapone (see also sections 4.3 and 4.4).
Wieħed għandu joqgħod attent meta dawn il- prodotti mediċinali jintużaw flimkien ma ’ entacapone (ara wkoll sezzjoni 4. 3).
Entacapone may be used with selegiline (a selective MAO-B inhibitor), but the daily dose of selegiline should not exceed 10 mg.
4 Entacapone jista ’ jintuża ma ’ selegiline (inibitur selettiv tal- MAO- B), iżda d- doża ta ’ kuljum ta ’ selegiline mgħandiex taqbeż l- 10 mg.
Entacapone may form chelates with iron in the gastrointestinal tract.
Entacapone jista ’ jifforma kelejts ma ’ l- iron fil- passaġġ gastrointestinali.
Entacapone and iron preparations should be taken at least 2– 3 hours apart (see section 4.8).
Sustanzi ta ’ entacapone u dawk li fihom l- iron għandhom jittieħdu mill- inqas 2- 3 sigħat ’ l bod minn xulxin (ara sezzjoni 4. 8).
4 Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Entacapone jintrabat mas- sit II tal- għaqda ta ’ l- albumina umana, ma fejn jeħlu wkoll diversi prodotti mediċinali oħrajn li jinkludu diazepam u ibuprofen.
Clinical interaction studies with diazepam and non- steroidal anti-inflammatory medicinal products have not been carried out.
Ma sarux studji kliniċi ta ’ interazzjoni ma ’ diazepam u prodotti mediċinali anti- infjammatorji mhux sterojdi.
According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products.
Skond studji in vitro mhuwiex antiċipat li jkun hemm spostament sinifikanti f’ konċentrazzjonijiet terapewtiċi tal- prodotti mediċinali.
Due to its affinity to cytochrome P450 2C9 in vitro (see section 5.2), entacapone may potentially interfere with medicinal products with metabolism dependent on this isoenzyme, such as S-warfarin.
Minħabba l- affinità tiegħu għal cytochrome P450 2C9 in vitro (ara sezzjoni 5. 2), entacapone jista ’ potenzjalment jinterferixxi ma ’ prodotti mediċinali b’ metaboliżmu dipendenti fuq din l- iżoenzima, bħal ma ’ huwa S- warfarin.
However, in an interaction study in healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11– 26%].
Madanakollu, fi studju dwar l- interazzjonijiet, li sar f’ volontiera b’ saħħithom, entacapone ma biddilx il- livelli fil- plażma ta ’ S- warfarin, waqt li l- AUC għall R - warfarin żdied b’ medja ta ’ 18% [CI90 11– 26%].
The INR values increased on average by 13% [CI90 6– 19%].
Il- valuri ta ’ l- INR żdiedu b’ medja ta ’ 13% [CI90 6- 19%].
Thus, control of INR is recommended when entacapone treatment is initiated for patients receiving warfarin.
Għalhekk il- kontroll ta ’ l- INR huwa rakkomandat meta tibda l- kura b’ entacapone f’ pazjenti li jkunu qed jieħdu warfarin.
No overt teratogenic or primary foetotoxic effects were observed in animal studies in which the exposure levels of entacapone were markedly higher than the therapeutic exposure levels.
Ma dehrux effetti teratoġeniċi jew ta ’ tossiċità fuq il- fetu ovvji fi studji fuq annimali fejn il- livelli ta ’ entacapone li kienu esponuti għalihom kienu ferm ogħla mil- livelli terapewtiċi.
As there is no experience in pregnant women, entacapone should not be used during pregnancy.
Peress li ma hemm l - ebda esperjenza dwar l- użu tiegħu minn nisa waqt it- tqala, entacapone m’ għandux jintuża waqt it - tqala.
In animal studies entacapone was excreted in milk.
Fi studji li saru fuq annimali entacapone ħareġ mal- ħalib tas- sider.
The safety of entacapone in infants is unknown.
Is- sigurtà ta ’ entacapone fit- trabi, mhijiex magħrufa.
Women should not breast-feed during treatment with entacapone.
In- nisa ma għandhomx ireddgħu waqt li jkunu qed jieħdu l- kura b’ entacapone.
Comtan in association with levodopa may have major influence on the ability to drive and use machines.
Comtan flimkien ma ’ levodopa jista ’ jkollu effett qawwi ħafna fuq il- ħila biex issuq u tħaddem magni.
Entacapone may, together with levodopa, cause dizziness and symptomatic orthostatism.
Meta jintuża flimkien ma ’ levodopa, entacapone jista ’ jikkawza sturdament u ortostatiżmu sintomatiku.
Therefore, caution should be exercised when driving or using machines.
Għalhekk wieħed għandu joqgħod attent waqt is- sewqan u l- użu ta ’ magni.
Patients being treated with entacapone in association with levodopa and presenting with somnolence and/ or sudden sleep onset episodes must be instructed 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 have resolved (see also section 4.4).
Pazjenti li jkunu qed jiġu ikkurati b’ entacapone flimkien ma ’ levodopa u li jaqbadhom in- ngħas u/ jew episodji ta ’ rqad għall- għarrieda, għandhom jingħataw struzzjonijiet biex ma jsuqux u ma jagħmlux attivitajiet fejn nuqqas ta ’ viġilanza tista ’ tpoġġi lilhom jew lill- oħrajn f’ riskju ta ’ korriment serju jew mewt (eż. tħaddim ta ’ magni), sakemm dawn l- episodji rikorrenti jgħaddu (ara ukoll sezzjoni 4. 4).
The most frequent adverse reactions caused by entacapone relate to the increased dopaminergic activity and occur most commonly at the beginning of treatment.
Ir- reazzjonijiet avversi li huma l- aktar frekwenti, ikkawżati b’ entacapone għandhom x’ jaqsmu ma ’ żieda fl- attivita ’ dopaminerġika u ġeneralment jidhru fil- bidu tal- kura.
Reduction of levodopa dosage decreases the severity and frequency of these reactions.
Tnaqqis fid- doża ta ’ levodopa naqqas is- severita ’ ta ’ dawn r- reazzjonijiet.
The other major class of adverse reactions are gastrointestinal symptoms, including nausea, vomiting, abdominal pain, constipation and diarrhoea.
It- taqsima prinċipali l- oħra ta ’ reazzjonijiet avversi tinkludi sintomi gastro- intestinali, li jinkludu eż. dardir, rimettar, uġigħ fl- addome, stitikezza u dijarea.
Urine may be discoloured reddish-brown by entacapone, but this is a harmless phenomenon.
B’ entacapone l- kulur ta ’ l- awrina jista ’ jinbidel għal aħmar fil- kannella, imma dan huwa fenomenu li ma tagħmilx ħsara.
Usually the adverse reactions caused by entacapone are mild to moderate.
Normalment ir- reazzjonijiet avversi kkawżati b’ entacapone jvarjaw minn ħfief għal moderati.
In clinical studies the most common adverse reactions leading to discontinuation of entacapone treatment have been gastrointestinal symptoms (e. g. diarrhoea, 2.5%) and increased dopaminergic adverse reactions of levodopa (e. g. dyskinesias, 1.7%).
Fi studji kliniċi l- aktar reazzjonijiet avversi komuni li wasslu għat- twaqqif tal- kura b’ entacapone, kienu sintomi gastro- intestinali (eż. dijarea, 2. 5%) u żieda fir- reazzjonijiet avversi dopaminerġiċi ta ’ levodopa (eż. diskineżja, 1. 7%).
Dyskinesias (27%), nausea (11%), diarrhoea (8%), abdominal pain (7%) and dry mouth (4.2%) were reported significantly more often with entacapone than with placebo in pooled data from clinical studies involving 406 patients taking the medicinal product and 296 patients taking placebo.
F’ informazzjoni miġbura minn studji kliniċi li nvolvew 406 pazjent li kienu qed jieħdu l- prodott mediċinali u 296 pazjent li kienu qed jieħdu plaċebo, irriżulta li diskineżja (27%), dardir (11%),
Some of the adverse reactions, such as dyskinesia, nausea, and abdominal pain, may be more common with the higher doses (1,400 to 2,000 mg per day) than with the lower doses of entacapone.
Xi wħud mir- reazzjonijiet avversi, bħal diskineżja, dardir u uġigħ fl- addome, jistgħu jkunu aktar komuni b’ dożi għoljin (1, 400 sa 2, 000 mg kuljum) milli b’ dożi baxxi ta ’ entacapone.
The following adverse drug reactions, listed below in Table 1, have been accumulated both from clinical studies with entacapone and since the introduction of entacapone into the market.
Tabella Numru 1 – Reazzjonijiet avversi tal- mediċina
Table 1* Adverse drug reactions 5 Nervous system disorders
Disturbi fis- sistema nervuża
Dyskinesia Parkinsonism aggravated, dizziness, dystonia, hyperkinesia
Diskineżja Marda ta ’ Parkinson taggrava, sturdament, distonja, iperkineżja
Very rare Not known:
Mhux magħruf:
Nausea Diarrhoea, abdominal pain, dry mouth, constipation, vomiting Anorexia Colitis
Dardir Dijarea, uġigħ fl- addome, ħalq xott, stitikezza, rimettar Anoressija Kolite
Urine discoloration
Awrina titlef il- kulur
Erythematous or maculopapular rash Urticaria Skin, hair, beard and nail discolorations
Raxx bi ħmura jew makulopapulari Urtikarja Ġilda, xagħar u dwiefer jitilfu l- kulur
Very rare
Rari ħafna:
Fatigue, sweating increased, fall Weight decrease
Għeja, żieda fl- għaraq, waqgħa Żieda fil- piż
Hepatic function tests abnormal Hepatitis with mainly cholestatic features (see section 4.4)
Testijiet tal- funzjoni epatika anormali Epatite b’ karatteristiċi li jkunu l- aktar kolestatiċi (ara sezzjoni 4. 4)
Insomnia, hallucinations, confusion, paroniria Agitation
Insomnia, hallucinations, confusion, paroniria Agitation
* Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention:
* Ir- reazzjonijiet avversi jinqasmu skond it- titli tal- frekwenza, b’ dawk l- aktar frekwenti mniżżla l - ewwel skond il- konvenzjoni li ġejja:
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 from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
Komuni ħafna (≥1/ 10); komuni (≥1/ 100, < 1/ 10); mhux komuni (≥1/ 1, 000, < 1/ 100); rari (≥1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000), mhux magħruf (ma tistax tittieħed stima mid- data disponibbli, peress li l- ebda stima valida ma tista ’ tinkiseb mill- provi kliniċi jew studji epidemjoloġiċi).
Entacapone in association with levodopa has been associated with isolated cases of excessive daytime somnolence and sudden sleep onset episodes.
Entacapone flimkien ma ’ levodopa ġie assoċjat ma ’ każijiet iżolati ta ’ ngħas eċċessiv matul il- ġurnata u episodji ta ’ rqad għall- għarrieda.
Parkinson’ s disease patients treated with dopamine agonists and other dopaminergic treatments such as entacapone in association with levodopa, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, which were generally reversible upon reduction of the dose or treatment discontinuation.
Pazjenti bil- marda ta ’ Parkinson ikkurati b’ agonisti ta ’ dopamine u kura dopaminerġika oħra bħal entacapone flimkien ma ’ levodopa, speċjalment b’ dożi qawwijin, kienu rrappurtati li jesibixxu sinjali ta ’ logħob ta ’ l- ażżard patoloġiku, żieda fil- libido u ipersesswalità, li ġeneralment marru lura għan - normal hekk kif tnaqqset id- doża jew twaqqfet il- kura.
Isolated cases of NMS have been reported following abrupt reduction or discontinuation of entacapone and other dopaminergic treatments.
Każijiet iżolati ta ’ NMS kienu rrappurtati wara li entacapone u kura dopaminerġika tnaqqsu jew twaqqfu f’ daqqa.
Isolated cases of rhabdomyolysis have been reported.
Każijiet iżolati ta ’ rabdomajoliżi kienu rrappurtati.
4.9 Overdose
6 4. 9 Doża eċċessiva
The post-marketing data include isolated cases of overdose in which the reported highest daily dose of entacapone has been 16,000 mg.
Data ta ’ wara t- tqegħid fis- suq tinkludi każi iżolati ta ’ doża eċċessiva fejn l- ogħla doża ta ’ entacapone kuljum kienet ta ’ 16, 000 mg.
The acute symptoms and signs in these cases of overdose included confusion, decreased activity, somnolence, hypotonia, skin discolouration and urticaria.
Is- sinjali u s- sintomi akuti f’ dawn il- każi ta ’ doża eċċessiva kienu jinkludu konfużjoni, tnaqqis fl- attività, ħedla tan- ngħas, ipotonja, telf ta ’ kulur fil- ġilda u urtikarja.
Management of acute overdose is symptomatic.
Doża eċċessiva akuta tiġi trattata skond is- sintomi.
Pharmacotherapeutic group: other dopaminergic agents, ATC code:
Kategorija farmakoterapewtika: aġenti dopaminerġiċi oħra, Kodiċi ATC:
6 Entacapone belongs to a new therapeutic class, catechol-O-methyl transferase (COMT) inhibitors.
Entacapone jagħmel parti minn klassi ġdida terapewtika, inibituri ta ’ catechol - O - methyltransferase (COMT).
It is a reversible, specific, and mainly peripherally acting COMT inhibitor designed for concomitant administration with levodopa preparations.
Hu inibitur ta ’ COMT, riversibbli, speċifiku u prinċipalment jaħdem fil- periferija, ippjanat sabiex jingħata flimkien ma ’ sustanzi ta ’ levodopa.
Entacapone decreases the metabolic loss of levodopa to 3- O-methyldopa (3-OMD) by inhibiting the COMT enzyme.
Entacapone jnaqqas it- telf metaboliku ta ’ levodopa għal 3- O- methyldopa (3- OMD) billi jinibixxi l- enzima COMT.
This leads to a higher levodopa AUC.
Dan iwassal għal AUC ta ’ levodopa ogħla.
The amount of levodopa available to the brain is increased.
L- ammont ta ’ levodopa disponibbli għall- moħħ jiżdied.
Entacapone thus prolongs the clinical response to levodopa.
Għalhekk entacapone itawwal r- rispons kliniku għal levodopa.
Entacapone inhibits the COMT enzyme mainly in peripheral tissues.
Entacapone jinibixxi l- enzima COMT prinċipalment fit- tessuti periferali.
COMT inhibition in red blood cells closely follows the plasma concentrations of entacapone, thus clearly indicating the reversible nature of COMT inhibition.
L- inibizzjoni ta ’ COMT fiċ - ċelluli l- ħomor tad- demm issegwi l- konċentrazzjoni ta ’ entacapone fil- plażma, li tindika b’ mod ċar in - natura rreversibbli ta ’ l- inibizzjoni ta ’ COMT.
Clinical studies In two phase III double-blind studies in a total of 376 patients with Parkinson’ s disease and end-of- dose motor fluctuations, entacapone or placebo was given with each levodopa/ dopa decarboxylase inhibitor dose.
Studji Kliniċi F’ żewġ studji tal- Fażi III double- blind, f’ total ta ’ 376 pazjent li jbatu bil- marda ta ’ Parkinson u b’ tibdil fil- moviment fi tmiem it- teħid tad- doża, l- entacapone jew il- plaċebo ngħataw flimkien ma ’ kull doża ta ’ levodopa / inibitur tad- dopa decarboxylase.
The results are given in Table 2.
Ir- riżultati jidhru f ’ Tabella 2.
In study I, daily ON time (hours) was measured from home diaries and in study II, the proportion of daily ON time.
Fi Studju I, il - ħin ON (sigħat) ta ’ kuljum tkejjel mid- djarji tad- dar u fi Studju II tkejjel il- proporzjon tal- ħin ON ta ’ kuljum.
Daily ON time (Mean ± SD)
Ħin ON kuljum (Medja ± SD)
Study I:
Studju I:
Daily On time (h) Baseline
Ħin On kuljum (siegħat) Linja bażi
Entacapone (n=85) 9.3±2.2
Entacapone (n=85) 9. 3±2. 2
Placebo (n=86) 9.2±2.5
Plaċebo (n=86) 9. 2±2. 5
Difference
Differenza
Week 8-24
Ġimgħa 8– 24
1 h 20 min (8.3%) CI95% 45 min, 1 h 56
1 siegħa 20 min (8. 3%) CI95% 45 min, 1siegħa 56
Study II:
Studju II:
Proportion of daily On time (%) Baseline
Proporzjon ta ’ Ħin On kuljum (%) Linja bażi
Entacapone (n=103) 60.0±15.2
Entacapone (n=103) 60. 0±15. 2
Placebo (n=102) 60.8±14.0
Plaċebo (n=102) 60. 8±14. 0
62.8±16.80
62. 8±16. 80
4.5% (0 h 35 min) CI95% 0.93%, 7.97%
4. 5% (0 sigħat 35 min) CI95% 0. 93%, 7. 97%
There were corresponding decreases in OFF time.
OFF.
The% change from baseline in OFF time was – 24% in the entacapone group and 0% in the placebo group in study I.
Il- bdil% mill- bażi fil- ħin OFF kien– 24% fil- grupp ta ’ entacapone u 0% fil- grupp tal- plaċebo fi studju I.
The corresponding figures in study II were – 18% and – 5%.
Il- figuri korrispondenti fi Studju II kienu – 18% u – 5%.
General characteristics of the active substance Absorption There are large intra- and interindividual variations in the absorption of entacapone.
7 Assorbiment Hemm differenzi intra u inter- individwali kbar fl- assorbiment ta ’ entacapone.
The peak concentration (Cmax) in plasma is usually reached about one hour after ingestion of a 200 mg entacapone tablet.
Il- konċentrazzjoni massima (Cmax) fil- plażma ġeneralment tintlaħaq madwar siegħa wara li wieħed ikun ħa pillola ta ’ entacapone ta ’ 200 mg.
The substance is subject to extensive first-pass metabolism.
Is- sustanza hija suġġetta għall- metaboliżmu first- pass estensiv.
The bioavailability of entacapone is about 35% after an oral dose.
Il- biodisponibilità ta ’ entacapone hija ta ’ madwar 35% wara doża meħuda mill- ħalq.
Food does not affect the absorption of entacapone to any significant extent.
L- ikel ma jeffettwax b’ mod sinifikanti, l- assorbiment ta ’ entacapone.
Distribution After absorption from the gastrointestinal tract, entacapone is rapidly distributed to the peripheral tissues with a distribution volume of 20 litres at steady state (Vdss).
Distribuzzjoni Wara l- assorbiment mill- passaġġ gastrointestinali,, entacapone jinfirex malajr fit- tessuti periferali b’ volum ta ’ distribuzzjoni ta ’ 20 litru fi stat fiss (Vdss).
Approximately 92% of the dose is eliminated during ß-phase with a short elimination half-life of 30 minutes.
Madwar 92% tad- doża tiġi eliminata matul il - fazi- ß b’ half- life ta ’ l- eliminazzjoni ta ’ 30 minuta.
The total clearance of entacapone is about 800 ml/ min.
It- tneħħija totali ta ’ entacapone mill- ġisem hija ta ’ madwar 800 ml/ min.
Entacapone is extensively bound to plasma proteins, mainly to albumin.
Entacapone jintrabat b’ mod estensiv mal- proteini tal- plażma, prinċipalment ma ’ l- albumina.
At therapeutic concentrations,
Fil - medda ta ’ konċentrazzjonijiet terapewtiċi, il- porzjon li ma jintrabatx mal- plażma fil- bniedem jammonta għal madwar 2%.
7 entacapone does not displace other extensively bound substances (e. g. warfarin, salicylic acid, phenylbutazone, or diazepam), nor is it displaced to any significant extent by any of these substances at therapeutic or higher concentrations.
F’ konċentrazzjonijiet terapewtiċi, entacapone ma jispostax sustanzi oħra li jintrabtu b’ mod estensiv (eż. warfarin, salicylic acid, phenylbutazone jew diazepam), lanqas ma jiġi spostat b’ xi mod sinifikanti minn xi waħda minn dawn is- sustanzi, f’ konċentrazzjonijiet terapewtiċi jew konċentrazzjonijiet ogħla.
Metabolism A small amount of entacapone, the (E)-isomer, is converted to its (Z)-isomer.
Metaboliżmu Ammont żgħir ta ’ entacapone, l- iżomer (E), jinbidel fl- iżomer( Z) tiegħu.
The (E)-isomer accounts for 95% of the AUC of entacapone.
L- iżomer (E) jikkonstitwixxi 95% ta ’ l- AUC ta ’ entacapone.
The (Z)-isomer and traces of other metabolites account for the remaining 5%.
L- iżomer (Z) u traċċi ta ’ metaboli oħra jikkostitwixxu l- 5% l- oħra.
Data from in vitro studies using human liver microsomal preparations indicate that entacapone inhibits cytochrome P450 2C9 (IC50 ∼ 4 µM).
Informazzjoni miġbura minn studji in vitro fejn ikunu ntużaw sustanzi mikrosomali ta ’ fwied uman, turi li entacapone jinibixxi iċ- ċitokromju P450 2C9 (IC50 ∼4 µM).
Entacapone showed little or no inhibition of other types of P450 isoenzymes (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A and CYP2C19) (see section 4.5).
Entacapone wera ftit jew l- ebda inibizzjoni ta ’ tipi oħra ta ’ iżoenżimi P450 (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A u CYP2C19) (ara sezzjoni 4. 5).
Elimination The elimination of entacapone occurs mainly by non-renal metabolic routes.
Eliminazzjoni L- eliminazzjoni ta ’ entacapone isseħħ prinċipalment permezz ta ’ rotot metaboliċi li ma għandhomx x’ jaqsmu mal- kliewi.
It is estimated that 80– 90% of the dose is excreted in faeces, although this has not been confirmed in man.
Huwa stmat li minn 80 sa 90% tad- doża titneħħa ma ’ l- ippurgar, għalkemm din l- istatistika ma ġietx konfermata fil- bniedem.
Approximately 10– 20% is excreted in urine.
Madwar 10- 20% titneħħa fl- awrina.
Only traces of entacapone are found unchanged in urine.
Fl- awrina jinstabu biss traċċi ta ’ entacapone mhux mibdul.
The major part (95%) of the product excreted in urine is conjugated with glucuronic acid.
Il- parti l- kbira (95%) tal- prodott imneħħi fl- awrina huwa mgħaqqad ma ’ glucuronic acid.
Of the metabolites found in urine only about 1% have been formed through oxidation.
Mill- metaboli misjuba fl- awrina madwar 1% biss ikunu ġew iffurmati permezz ta ’ l- ossidazzjoni.
Characteristics in patients The pharmacokinetic properties of entacapone are similar in both young and elderly adults.
Karatteristiċi fil- pazjenti Il- karatteristiċi farmakokinetiċi ta ’ entacapone huma simili kemm fiż- żgħażagħ kif ukoll fl- adulti.
The metabolism of the medicinal product is slowed in patients with mild to moderate liver insufficiency (Child-Pugh Class A and B), which leads to an increased plasma concentration of entacapone in both the absorption and elimination phases (see section 4.3).
Il - metaboliżmu tal- prodott mediċinali jonqos f’ pazjenti li għandhom insuffiċenza minn ħafifa għal moderata tal- fwied (Klassi Child- Pugh A u B), li jagħti lok għal żieda fil- konċentrazzjoni ta ’ entacapone fil- plażma kemm fil- fażijiet ta ’ l- assorbiment kif ukoll f’ dawk ta ’ l- eliminazzjoni (ara sezzjoni 4. 3).
Renal impairment does not affect the pharmacokinetics of entacapone.
Indeboliment tal- kliewi ma jaffettwax il- farmakokinetika ta ’ entacapone.
However, a longer dosing interval may be considered for patients who are receiving dialysis therapy.
Madanakollu, għal pazjenti li jkunu qed jirċievu terapija ta’ dijaliżi, jista ’ jiġi kkunsidrat, perijodu itwal bejn doża u oħra.
5.3 Preclinical safety data
8 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni u riskju ta ’ kanċer ma turi l- ebda periklu speċjali għall- bendmin.
In repeated dose toxicity studies, anaemia most likely due to iron chelating properties of entacapone was observed.
Fi studji dwar it- tossiċita` minn dożi ripetuti, ġiet innutata anemija, probabbilment dovuta għall- kelazzjoni ta ’ entacapone ma ’ l- iron.
Regarding reproduction toxicity, decreased foetal weight and a slightly delayed bone development were noticed in rabbits at systemic exposure levels in the therapeutic range.
Għal dak li jirrigwarda effett tossiku fuq ir - riproduzzjoni, ġie innutat tnaqqis fil- piż tal- fetu u ittardjar ħafif fl- izvilupp tal- għadam, fi fniek li ġew esposti għal- livelli sistemiċi fil- medda terapewtika.
Tablet core Microcrystalline cellulose Mannitol Croscarmellose sodium Hydrogenated vegetable oil Magnesium stearate
Il- qalba tal- pillola Microcrystalline cellulose Mannitol Croscarmellose sodium Hydrogenated vegetable oil Magnesium stearate
8 Film-coating Hypromellose Polysorbate 80 Glycerol 85% Sucrose Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171)
Il- rita Hypromellose Polisorbate 80 Glycerol 85% Sucrose Iron oxide isfar (E172) Iron oxide aħmar (E172) Titanium Dioxide (E171)
3 years
3 snin.
Amber glass bottles (hydrolytic class III) with white tamper-resistant polypropylene closures containing 30, 60, 100 or 500 tablets.
Flixkun tal- ħġieġ kulur kannella jagħti fl- aħmar (Klassi III Idrolitiċi), b’ tapp abjad tal- polyethylene li jirreżisti għat- tbagħbis li jkun fihom 30, 60, 100 jew 500 pillola.
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH 125AB Ir- Renju Unit
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Novartis Pharmaceuticals UK Ltd Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Novartis Pharmaceuticals UK Ltd Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
12 A.
12 ANNESS III
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
TIKKETTA
CARTON AND BOTTLE LABEL
KARTUNA U TIKKETTA TAL- FLIXKUN
Comtan 200 mg film-coated tablets Entacapone
Comtan 200 mg pilloli miksijin b’ rita Entacapone
1 tablet contains 200 mg of entacapone.
Pillola 1 fiha 200 mg ta ’ entacapone.
Contains sucrose.
Fih sucrose.
See leaflet for further information.
Ara il- fuljett ghall- aktar informazzjoni.
30 film-coated tablets 60 film-coated tablets 100 film-coated tablets 500 film-coated tablets
30 pillola miksija b’ rita 60 pillola miksija b’ rita 100 pillola miksija b’ rita 500 pillola miksija b’ rita
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
PACKAGE LEAFLET
STRUZZJONIJIET DWAR L- UŻU
16 PACKAGE LEAFLET:
INFORMAZZJONI BIL- BRAILLE
What Comtan is and what it is used for 2.
X’ inhu Comtan u għalxiex jintuża 2.
Before you take Comtan 3.
Qabel ma tieħu Comtan 3.
How to take Comtan 4.
Kif għandek tieħu Comtan 4.
How to store Comtan 6.
Kif taħżen Comtan 6.
WHAT COMTAN IS AND WHAT IT IS USED FOR
X’ INHU COMTAN U GĦALXIEX JINTUŻA
Comtan is used together with levodopa to treat Parkinson’ s disease.
Comtan jintuża flimkien ma ’ levodopa għall- kura tal- Marda ta ’ Parkinson.
Comtan improves the therapeutic effect of levodopa in relieving the symptoms of Parkinson's disease.
Comtan itejjeb l- effetti terapewtiċi ta ’ levodopa fis- serħan tas- sintomi tal- Marda ta ’ Parkinson.
Comtan has no antiparkinsonian activity without levodopa.
Comtan m’ għandu l- ebda attività kontra l- marda ta’ Parkinson mingħajr levodopa.
BEFORE YOU TAKE COMTAN
QABEL MA TIEĦU COMTAN
Do not take Comtan
Tieħux Comtan:
- if you are allergic (hypersensitive) to entacapone or any of the other ingredients of Comtan;
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal entacapone jew sustanzi oħra ta ’
- if you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the
- jekk għandek tumur fil- glandola adrenali (magħrufa bħala fejokromoċitoma, din tista ’ żżid ir -
risk of severe high blood pressure);
riskju ta ’ żieda fil- pressjoni tad- demm b’ mod sever);
- if you are taking certain antidepressants (ask your doctor or pharmacist whether your
- jekk int qed tieħu ċerti mediċini kontra d- dipressjoni (saqsi lit- tabib jew lill- ispiżjar tiegħek jekk
antidepressive medicine can be taken together with Comtan);
il- mediċina tiegħek, ta ’ kontra d- dipressjoni tistax titieħed flimkien ma ’ Comtan);
- if you have liver disease;
- jekk għandek mard fil- fwied;
- if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic
- jekk qatt kellek reazzjoni rari għall- mediċini antipsikotiċi msejħa sindromu newrolettiku malinn
malignant syndrome (NMS) and/ or a rare muscle disorder called non-traumatic rhabdomyolysis.
(NMS) u/ jew problemi fil- muskolu imsejjħa rabdomijolożi mhux trawmatika.
Take special care with Comtan
Oqgħod attent ħafna b’ Comtan
- if you are taking a medicine which may cause low blood pressure when rising from a chair or
- jekk qed tieħu mediċina li tista ’ tbaxxilek il- pressjoni meta tqum minn fuq siġġu jew sodda;
- if you experience diarrhoea, monitoring of your weight is recommended in order to avoid
- jekk taqbdek dijarea, intiżen b’ mod regolari sabiex tevita telf eċċessiv tal- piż;
- if you experience excessive gambling or excessive sexual activity;
- jekk tibda tilgħab logħob ta ’ l- ażżard b’ mod eċċessiv jew ikollok attività sesswali eċċessiva;
- if you experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease
- jekk taqbdek anoressija progressiva, astenja (dgħjufija, telqa) u telf tal- piż f’ perijodu
within a relatively short period of time, a general medical evaluation including liver function should be considered.
relattivament qasir, evalwazzjoni medika ġenerali inkluż il- funzjoni tal- fwied għandu jiġi meqjus.
The dose of other antiparkinsonian medicines may need to be adjusted when you start taking Comtan.
Id- doża ta ’ mediċini kontra l- Parkinson jista ’ jkollha bżonn tiġi aġġustata meta tibda tieħu Comtan.
Follow the instructions that your doctor has given you.
Segwi l- istruzzjonijiet li tak it- tabib.
17 Entacapone taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep.
It- teħid ta ’ entacapone ma ’ levodopa jista ’ jqabbdek n- ngħas, jew iġegħluk xi kultant issib ruħhek qed tongħos f’ daqqa waħda.
If this happens, you should not drive or use any tools or machines (see section “ Driving and using machines”).
Jekk dan iseħħ m’ għandekx issuq jew tuża kwalunkwe magni (ara sezzjoni “ Sewqan u tħaddim ta ’ magni ”).
There have been isolated cases of neuroleptic malignant syndrome (NMS), especially when treatment with both entacapone and other dopaminergic medicines has been abruptly discontinued or reduced.
18 Kien hemm każijiet iżolati ta ’ sindrome newrolettiku malinn (NMS), l- aktar meta l- kura b’ entacapone flimkien ma ’ mediċini dopaminerġiċi oħrajn titwaqqaf jew titnaqqas f’ daqqa.
For the characteristics of NMS see section 4.
Għal karatteristiċi ta ’ NMS ara sezzjoni 4.
Your doctor may advise you to slowly discontinue the treatment with entacapone and other dopaminergic medicines.
It- tabib tiegħek jista ’ jtik parir sabiex bil- mod twaqqaf il- kura b’ entacapone u mediċini dopaminerġiċi oħrajn.
Children Experience with Comtan in patients under 18 years is limited.
Tfal L- esperjenza b’ Comtan f’ pazjenti li għandhom inqas minn 18- il sena hija limitata.
Therefore the use of Comtan in children cannot be recommended.
Għalhekk l- użu ta ’ Comtan fit- tfal mhuwiex rakommandat.
Taking other medicines Comtan may increase the effects of other medicinal products (e. g. those containing rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, and apomorphine).
Meta tieħu mediċini oħra Comtan jista ’ jżid l- effetti ta ’ medicini oħra (eż. dawk li fihom rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha methyldopa, u apomorphine).
Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without a prescription or herbal medicines.
Jekk jogħġbok għid lit - tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta jew mediċini tal- ħxejjex.
Comtan may make it harder for you to digest iron.
Comtan jista ’ jagħmel aktar diffiċli biex tiddiġerixxi l- iron.
Therefore, do not take Comtan and iron supplements at the same time.
Allura, tiħux Comtan u supplimenti ta ’ iron fl- istess ħin.
After taking one of them, wait at least 2 to 3 hours before taking the other.
Wara li tieħu wieħed minnhom, stenna mill- inqas 2 jew 3 siegħat qabel ma tieħu l - ieħor.
Pregnancy and breast-feeding Do not use Comtan during pregnancy or if you are breast-feeding.
Tqala u Treddigħ Tużax Comtan waqt t- tqala jew jekk qed tredda ’.
Driving and using machines Comtan taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy.
Sewqan u tħaddim ta ’ magni Comtan meħud flimkien ma ’ levodopa jista ’ jbaxxilek il- pressjoni tad- demm, li tista ’ tikkawżalek li tħoss rasek ħafifa jew tistordi.
Be particularly careful when you drive or when you use tools or machinery.
Oqgħod attent ħafna meta ssuq jew tagħmel użu minn għodda jew tħaddem magni.
Comtan taken with levodopa may make you feel very drowsy, or cause you to sometimes find yourself suddenly falling asleep.
It- teħid ta ’ Comtan ma ’ levodopa jista ’ jqabdek ħafna ngħas, jew iġiegħluk xi kultant issib ruħhek qed tongħos f’ daqqa waħda.
If this happens, you must not drive or do anything else that requires you to be alert (e. g. using tools or machines) until you are clear of such problems.
Jekk dan iseħħ m’ għandekx issuq jew tagħmel xi ħaġa oħra li teħtieġ li tkun attent (eż. uzu ta ’ għodda jew magni) sakemm jgħaddulek dawn il- problemi.
Otherwise you may put yourself and others at risk of serious injury or even death.
Inkella tista ’ tpoġġi lilek innifsek u lill- oħrajn f’ riskju ta ’ inċident serju jew anki mewt.
Important information about some of the ingredients of Comtan Comtan tablets contain a sugar called sucrose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Comtan Il- pilloli Comtan fihom zokkor li jissejjaħ sucrose.
Therefore, if you have been told by your doctor that you have an inherited intolerance to sucrose, contact your doctor before taking Comtan.
Għalhekk, jekk it- tabib tiegħek qallek li intolleranza ereditarja għaz- zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu Comtan.
HOW TO TAKE COMTAN
KIF GĦANDEK TIEĦU COMTAN
Always take Comtan exactly as your doctor has told you.
Dejjem għandek tieħu Comtan skond il- parir tat- tabib.
Comtan is taken together with preparations containing levodopa (either levodopa/ carbidopa preparations or levodopa/ benserazide preparations).
Comtan jittieħed flimkien ma sustanzi li fihom levodopa (jew taħlitiet ta ’ levodopa/ carbidopa jew taħlitiet ta ’ levodopa/ benserazide).
You may also use other antiparkinsonian medicines at the same time.
Tista ’ tuża wkoll mediċini oħra kontra l- marda tal- Parkinson fl - istess ħin.
The usual dose of Comtan is one 200 mg tablet with each levodopa dose.
Id- doża ta ’ Comtan is- soltu tkun pillola waħda ta ’ 200 mg ma ’ kull doża ta ’ levodopa.
If you are receiving dialysis for renal insufficiency, your doctor may tell you to extend the interval between doses.
Jekk qed tirċievi dijaliżi għal insuffiċjenza tal- kliewi, it- tabib tiegħek jista ’ jgħidlek biex ittawal l- intervall bejn doża u oħra.
The maximum recommended dose is 10 tablets per day, i. e.
Id- doża massima rakkomandata hija ta ’ 10 pilloli kuljum, i. e.
2,000 mg of Comtan.
2, 000 mg ta ’ Comtan.
If you forget to take Comtan
Jekk tieħu Comtan aktar milli suppost Fil- każ ta ’ doża aċċessiva, ikkonsulta mat- tabib tiegħek jew mur fl- eqreb sptar immedjatament.
18 If you forget to take the Comtan tablet with your levodopa dose, you should continue the treatment by taking the next Comtan tablet with your next levodopa dose.
19 Jekk tinsa tieħu Comtan Jekk tinsa tieħu pillola ta ’ Comtan mad- doża ta ’ levodopa, għandek tkompli l- kura billi tieħu l- pillola ta ’ Comtan li jmiss mad- doża ta ’ levodopa li jmiss.
Do not take a double dose to make up for a forgotten tablet.
M’ għandekx tieħu doża doppja biex tpatti għal kull pillola li tkun insejt tieħu.
If you stop taking Comtan Do not stop taking Comtan unless your doctor tells you to.
Jekk tieqaf tieħu Comtan Tieqafx tieħu Comtan sakemm ma jkunx qallek it- tabib tiegħek.
In such case, your doctor may need to re- adjust the dosage of your other antiparkinsonian medicines.
It- tabib tiegħek għandu mnejn ikollu bżonn jibdel id- dożi tal- mediċini l- oħra kontra l- marda ta ’ Parkinson jekk tieqaf tieħu Comtan.
Abrupt discontinuation of both Comtan and other antiparkinsonian medicines may result in unwanted side effects.
It - twaqqif f’ daqqa kemm ta ’ Comtan kif ukoll tal- mediċini l- oħrajn kontra l- marda ta ’ Parkinson jista ’ jwassal għal effetti sekondarji mhux mixtieqa.
Like all medicines, Comtan can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Comtan jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Usually side effects caused by Comtan are mild to moderate.
Ġeneralment effetti oħra kkawżati b’ Comtan ikunu minn ħfief għal moderati.
The frequencies are defined as:
Il- frekwenzi huma:
Very common (affects more than 1 patient in 10) Common (affects 1 to 10 patients in 100) Uncommon (affects 1 to 10 patients in 1,000) Rare (affects 1 to 10 patients in 10,000) Very rare (affects less than 1 patient in 10,000) Not known (frequency cannot be estimated from the available data)
Komuni ħafna (jaffettwaw aktar minn 1 f’ kull 10 pazjenti) Komuni (jaffettwa 1 sa 10 pazjenti minn kull 100) Mhux komuni (jaffettwa 1 sa 10 pazjenti minn kull 1, 000) Rari (jaffettwaw 1 sa 10 pazjenti minn kull 10, 000) Rari ħafna (jaffettwaw anqas minn 1 f’ kull 10, 000 pazjent) Mhux maghrufa (il- frekwenza ma tistax tigi estimata mid- dejta disponibbli)
Very common Uncontrollable movements (dyskinesias), feeling sick (nausea) and harmless reddish-brown discoloration of urine.
Komuni ħafna Moviment mhux kontrollabbli (diskineżji), tħossok imqalla (dardir), tibdil fil- kulur ta ’ l- awrina li ma jagħmilx ħsara għal kannella jagħti fl- aħmar
Common Uncontrollable movements (hyperkinesias), being sick (vomiting), worsening of symptoms of Parkinson’ s disease, dizziness, diarrhoea, abdominal pain, constipation, dry mouth, hallucinations (seeing/ hearing/ feeling/ smelling things that are not really there), prolonged muscle contractions (dystonia), tiredness, increased sweating, sleeplessness, vivid dreams, fall and confusion.
Komuni Moviment mhux kontrollabbli (iperkineżji), tkun imqalla (tirremetti), is- sintomi tal- Marda ta’ Parkinson imorru għall- agħar, sturdament, dijarea, uġigħ addominali, stitikezza, ħalq xott, alluċinazzjonijiet, (tara/ tisma ’ / tħoss/ ixxomm affarjiet li mhux vera qegħdin hemm), kontrazzjoni tal - muskolu għal ħin twil (distonja), għeja, żieda fl- għaraq, nuqqas ta ’ rqad, ħolm vivaċi, waqa ’, u konfużjoni.
Rare Rashes and abnormal results in liver function test.
Rari Raxx u testijiet tal- funzjoni tal- fwied jiġu anormali.
Very rare Mental restlessness, decreased appetite, weight decrease, hives.
Rari ħafna Nuqqas ta ’ serħan tal- moħħ, nuqqas t’ aptit, tnaqqis fil- piż, ħorriqija.
The exact frequencies of these side effects are not known but are based on reports received since the product has been on the market:
Kemm huma frekwenti bl- eżattezza dawn l- effetti sekondarji mhux magħruf iżda huma bbażati fuq rapporti li kienu rċevuti minn meta l- prodott kien fuq is- suq.
Colitis (inflammation of the colon), hepatitis and skin, hair, beard and nail discolorations.
Kolite (infjammazzjoni tal- kolon), epatite u telf tal- kulur tal- ġilda, x- xagħar, il- leħja u d- dwiefer.
The side effects are often caused by the increased effects of levodopa therapy and are most common at the start of treatment.
L- effetti sekondarji huma ta ’ spiss ikkawżati minn żieda fl- effetti tat- terapija b’ levodopa u huma iżjed komuni fil- bidu tal- kura.
Some, such as uncontrollable movements, nausea and abdominal pain, may also be more common with higher doses (1,400 to 2,000 mg per day).
Xi wħud, bħal movimenti mhux ikkontrollati, dardir u uġigħ addominali, jistgħu jkunu iżjed komuni b’ dożi ogħla (1, 400 sa 2, 000 mg kuljum).
If you experience such effects at the start of treatment with Comtan you should contact your doctor, who may decide to adjust your dosage of levodopa.
Jekk tħoss effetti bħal dawn fil - bidu tal- kura b’ Comtan għandek tkellem lit- tabib tiegħek li jista ’ jiddeċidi li jibdillek id- dużaġġ ta ’ levodopa.
Excessive daytime drowsiness has been reported in rare cases in patients receiving Comtan with levodopa and there have been isolated cases of sudden sleep onset episodes.
Telqa eċċessiva bi nhar kienet irrapurtata, f’ każijiet rari, f’ pazjenti li kienu qed jieħdu Comtan ma ’ levodopa u kien hemm każijiet iżolati ta ’ episodji ta ’ irqad f’ daqqa.
A few cases of neuroleptic malignant syndrome (NMS) and rhabdomyolysis have been reported.
20 Numru żgħir ta ’ każijiet ta ’ sindrome newrolettiku malinn (NMS) u rabdomajelożi kienu rrappurtati.
NMS is a rare severe reaction to medicines used to treat disorders of the central nervous system and 19 characterised by stiffness, muscle twitching, shaking, mental changes, coma, high body temperature, increased heart rate and unstable blood pressure.
NMS hija reazzjoni rari u severa għall- mediċini li jintużaw għall- kura ta ’ disturbi tas- sistema nervuża ċentrali u hija karatterizzata minn riġidità, ġbid ta ’ muskoli, tregħid, tibdil mentali, koma, temperatura tal- ġisem għolja, rata tal- qalb imgħaġġla u pressjoni tad- demm mhux stabbli.
Rhabdomyolysis is a rare severe muscle disorder.
Rabdomajoliżi hija disturb tal- muskoli rari u sever.
Behavioural changes such as urge to gamble (pathological gambling) or increased sexual desire and urges (increased libido and hypersexuality) have been reported in patients receiving dopaminergic medicines including Comtan with levodopa.
Tibdil fil- komportament bħal xewqa kbira li tilgħab logħob ta ’ l- ażżard (logħob ta ’ l- ażżard patoloġiku) jew żieda fil- ġibda u x- xewqa għas- sess (żieda fil- libido u ipersesswalità) ġew irrappurtati f’ pazjenti li kienu qed jirċievu mediċinali dopaminerġika inkluż Comtan ma ’ levodopa.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW TO STORE COMTAN
KIF TAĦŻEN COMTAN
Do not use Comtan after the expiry date which is stated on the carton and on the bottle label.
Tużax Comtan wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq it- tikketta tal- flixkun.
What Comtan contains
X’ fih Comtan
- The active substance is entacapone.
- Is- sustanza attiva hi entacapone.
Each tablet contains 200 mg of entacapone.
Kull pillola fiha 200 mg entacapone.
- The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium,
- Is- sustanzi l- oħra huma microcrystalline cellulose, mannitol, croscarmellose sodium,
hydrogenated vegetable oil, magnesium stearate.
hydrogenated vegetable oil, magnesium stearate.
- The film-coating contains hypromellose, polysorbate 80, glycerol 85%, sucrose, yellow iron
- Il- kisja tar- rita fiha hypromellose, polysorbate 80, glycerol 85%, sucrose, yellow iron oxide
oxide (E172), red iron oxide (E172) and titanium dioxide (E171).
(E172), red iron oxide (E172) and titanium dioxide (E171).
What Comtan looks like and contents of the pack Comtan 200 mg film-coated tablets are brownish-orange, oval tablets with “ Comtan ” engraved on one side.
Id- Dehra ta ’ Comtan u l- kontenuti tal- pakkett Comtan 200 mg pilloli miksija b’ rita huma pilloli ovali ta ’ kulur oranġjo jagħti fil- kannella, b ’ “ Comtan ” imnaqqxa fuq naħa waħda.
They are packed in bottles.
Jiġu fi fliexken.
There are four different pack sizes (bottles containing 30, 60, 100 or 500 tablets).
Hemm erba ’ daqsijiet differenti tal- pakkett (fliexken li fihom 30, 60, 100 jew 500 pillola).