qanastek/EMEA-V3 huggingface dataset:
Since the introduction of entacapone into the market, isolated cases of NMS have been reported, especially following abrupt reduction or discontinuation of entacapone and other concomitant dopaminergic medicinal products.
Minn wara l- introduzzjoni ta ’ entacapone fis- suq, ġew irrappurtati każijiet iżolati ta ’ NMS, speċjalment wara t- tnaqqis jew it- twaqqif f’ daqqa ta ’ entacapone u ta ’ prodotti mediċinali dopaminerġiċi oħra li kienu qed jittieħdu fl - istess ħin.
- If general anaesthesia is required, therapy with Stalevo may be continued for as long as the patient
- Jekk tkun meħtieġa anestesija ġenerali, it- terapija b’ Stalevo tista ’ titkompla sakemm il- pazjent
38 medicinal products with Stalevo should be carefully observed for loss of therapeutic response.
Pazjenti li qed jieħdu dawn il- prodotti mediċinali ma ’ Stalevo għandhom jiġu osservati mill- viċin għat- telf tar- respons terapewtiku.
The most common adverse reactions are dyskinesias including choreiform, dystonic and other involuntary movements.
Ir- reazzjonijiet avversi l- aktar komuni huma diskinesja inkluż korejiform, distonika u movimenti nvolontarji oħrajn.
Muscle twitching and blepharospasm may be taken as early signs to consider levodopa dosage reduction.
Kontrazzjonijiet mhux volontarji tal - muskoli u blefarospażmu jistgħu jitqiesu bħala sinjali bikrija biex tiġi kkunsidrata tnaqqis fid- doża ta ’ levodopa.
39 Other adverse reactions associated with levodopa/ carbidopa therapy are mental changes, including paranoid ideation and psychotic episodes; depression, with or without development of suicidal tendencies; and cognitive dysfunction.
Reazzjonijiet avversi oħrajn assoċjati ma ’ terapija b’ levodopa/ carbidopa huma bidliet mentali, inkluż idejazzjoni paranojdika u episodji psikotiċi; depressjoni, bi jew bla żvilupp ta ’ tendenzi ta ’ suwiċidju; u disfunzjoni konoxxittiva.
Parkinson’ s disease patients treated with dopamine agonists and other dopaminergic treatments such as Stalevo, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Pazjenti bil- marda ta ’ Parkinson ikkurati b’ agonisti ta ’ dopamine u b’ kura dopaminerġika oħra bħal Stalevo, speċjalment f’ dożi għolja, ġew irrappurtati li wrew sinjali ta ’ logħob ta ’ l- azzard patoloġiku, żjieda fil- libido u ipersesswalità, ġeneralment riversibbli mat- tnaqqis tad- doża jew mal- waqfien tal - kura.
Other adverse reactions that have been reported with levodopa and may, therefore, be potential adverse reactions of Stalevo as well, include:
Reazzjonijiet avversi oħrajn li ġew irrappurtati b’ levodopa u għalhekk jistgħu jkunu reazzjonijiet avversi potenzjali ta ’ Stalevo wkoll, jinkludu:
The most frequent adverse reactions caused by entacapone relate to the increased dopaminergic activity and occur most commonly at the beginning of the treatment.
43 Ir- reazzjonijiet avversi l- aktar frekwenti kkawżati minn entacapone għandhom x’ jaqsmu ma ’ żjieda fl - attività dopaminerġika u jseħħu l- aktar fl- bidu tal- kura.
40 with entacapone and since the introduction of entacapone into the market for the combination use of entacapone with levodopa/ DDC inhibitor.
Ir- reazzjonijiet avversi li ġejjin, imniżżla f’ Tabella 1, inġabru kemm minn studji kliniċi b’ entacapone kif ukoll minn meta entacapone ġie introdott fis- suq għall- użu tat- taħlita ta ’ entacapone ma ’ levodopa/ inibitur ta ’ DDC.
Hepatitis with mainly cholestatic features (see section 4.4)
Epatite b’ karatteristiċi kolestatiċi (ara sezzjoni 4. 4).
Laboratory tests:
44 Testijiet tal- laboratorju:
41 Decreased haemoglobin, haematocrit, elevated serum glucose and white blood cells, bacteria and blood in the urine have been reported.
Ġew irrappurtati tnaqqis fl- emoglobina u fl- ematokrita, żjieda tal- glukosju fis- serum u taċ- ċelluli l - bojod fid- demm, batterja u demm fl- awrina.
With inhibition of the decarboxylase by a DDC inhibitor, COMT becomes the major peripheral metabolic pathway catalyzing the conversion of levodopa to 3-O-methyldopa (3-OMD), a potentially harmful metabolite of levodopa.
Bl- inibizzjoni ta ’ decarboxylase minn inibitur ta ’ DDC, COMT isir il- metodu ta ’ metabolazzjoni periferali maġġuri li tikkatalizza il- konversjoni ta ’ levodopa għal 3- O- methyldopa (3- OMD),
Due to short elimination half-lives, no true accumulation of levodopa or entacapone occurs on repeated administration.
46 Minħabba l- half- lives ta ’ eliminazzjoni qosra, b’ għotja ripetuta ma sseħħ l- ebda akkumulazzjoni vera ta ’ levodopa jew entacapone.
43 Characteristics in patients
Karatteristiċi fil- pazjenti
Film-coating:
47 Kisja b’ rita:
Glycerol (85 per cent) (E422) Hypromellose Magnesium stearate Polysorbate 80 Red iron oxide (E172) Sucrose
Glycerol (85 fil- mija) (E 422) Hypromellose Magnesium stearate Polysorbate 80 Iron oxide aħmar (E 172) Sucrose Titanium dioxide (E 171)
44 Titanium dioxide (E171)
6. 2 Inkompatibilitajiet
10, 30, 100, 130, and 175 tablets.
10, 30, 100, 130, u 175 pillola.
21 April 2008 Date of last renewal:
21 ta ’ April 2008 Data ta ’ l- aħħar tiġdid:
Detailed information on this medicine is available on the European Medicine’ s Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu.
45 ANNEX II
49 ANNESS II
Orion Corporation Orionintie 1 FI-02200 Espoo Finland
Orion Corporation Orionintie 1, FI- 02200 Espoo Il- Finlandja
The MAH must ensure that the system of pharmacovigilance, as described in version 1.2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 1. 2, ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni tal- Awtorizzazzjoni għat- Tqegħid fis- Suq, hija implimentata u qed tiffunzjona qabel u waqt li l - prodott jitqiegħed fis- suq.
47 ANNEX III
51 ANNESS III
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE LABEL AND OUTER CARTON TEXT
TIKKETTA TAL- FLIXKUN U KLIEM FUQ IL- KARTUNA TA ’ BARRA
Stalevo 50 mg/ 12.5 mg/ 200 mg film-coated tablets levodopa/ carbidopa/ entacapone
Stalevo 50 mg/ 12. 5 mg/ 200 mg pilloli miksija b’ rita levodopa/ carbidopa/ entacapone
See leaflet for further information.
Ara l- fuljett ta ’ tagħrif għall- aktar informazzjoni.
10 film-coated tablets 30 film-coated tablets 100 film-coated tablets 130 film-coated tablets 175 film-coated tablets 250 film-coated tablets
10 pilloli miksija b’ rita 30 pillola miksija b’ rita 100 pillola miksija b’ rita 130 pillola miksija b’ rita 175 pillola miksija b’ rita 250 pillola miksija b’ rita
10 film-coated tablets 30 film-coated tablets 100 film-coated tablets 250 film-coated tablets 175 film-coated tablets 130 film-coated tablets
10 pilloli miksija b’ rita 30 pillola miksija b’ rita 100 pillola miksija b’ rita 250 pillola miksija b’ rita 175 pillola miksija b’ rita 130 pillola miksija b’ rita
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
55 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
Stalevo 100 mg/ 25 mg/ 200 mg film-coated tablets levodopa/ carbidopa/ entacapone
Stalevo 100 mg/ 25 mg/ 200 mg pilloli miksija b’ rita levodopa/ carbidopa/ entacapone
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
57 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
Stalevo 150 mg/ 37.5 mg/ 200 mg film-coated tablets levodopa/ carbidopa/ entacapone
Stalevo 150 mg/ 37. 5 mg/ 200 mg pilloli miksija b’ rita levodopa/ carbidopa/ entacapone
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
59 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
Stalevo 200 mg/ 50 mg/ 200 mg film-coated tablets levodopa/ carbidopa/ entacapone
Stalevo 200 mg/ 50 mg/ 200 mg pilloli miksija b’ rita levodopa/ carbidopa/ entacapone
10 film-coated tablets 30 film-coated tablets 100 film-coated tablets 130 film-coated tablets 175 film-coated tablets
10 pilloli miksija b’ rita 30 pillola miksija b’ rita 100 pillola miksija b’ rita 130 pillola miksija b’ rita 175 pillola miksija b’ rita
Stalevo 50 mg/ 12.5 mg/ 200 mg film-coated tablets Levodopa/ carbidopa/ entacapone
Stalevo 50 mg/ 12. 5 mg/ 200 mg pilloli miksija b’ rita Levodopa/ carbidopa/ entacapone
Do not pass it to others.
M’ għandekx tgħaddiha lil persuni oħra.
It may harm them, even if
Tista ’
their symptoms are the same as yours.
tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
What Stalevo is and what it is used for 2.
X’ inhu Stalevo u għalxiex jintuża 2.
Before you take Stalevo 3.
Qabel ma tieħu Stalevo 3.
How to take Stalevo 4.
Kif għandek tieħu Stalevo 4.
Possible side effects 5 How to store Stalevo 6.
Kif taħżen Stalevo 6.
WHAT STALEVO IS AND WHAT IT IS USED FOR
X’ INHU STALEVO U GĦALXIEX JINTUŻA
Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet.
Stalevo fih tliet sustanzi attivi (levodopa, carbidopa u entacapone) f’ pillola waħda miksija b’ rita.
Stalevo is used for the treatment of Parkinson’ s disease.
Stalevo jintuża għall- kura tal- marda ta ’ Parkinson.
Parkinson’ s disease is caused by low levels of a substance called dopamine in the brain.
Il- marda ta ’ Parkinson hija kkawżata minn livelli baxxi ta ’ sustanza msejħa dopamine fil- moħħ.
Levodopa increases the amount of dopamine and hence reduces the symptoms of Parkinson’ s disease.
Levodopa jżid il- livell ta ’ dopamine u b’ hekk inaqqas is- sintomi tal- marda ta ’ Parkinson.
Carbidopa and entacapone improve the antiparkinson effects of levodopa.
Carbidopa u entacapone itejjbu l- effetti kontra l- marda ta ’ Parkinson ta ’ levodopa.
BEFORE YOU TAKE STALEVO
QABEL MA TIEĦU STALEVO
Do not take Stalevo
Tieħux Stalevo
- if you are allergic (hypersensitive) to levodopa, carbidopa or entacapone, or any of the other
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal levodopa, carbidopa jew entacapone,
ingredients of Stalevo
jew sustanzi oħra ta ’ Stalevo
- if you have narrow-angle glaucoma (an eye disorder)
- jekk għandek glawkoma ta ’ angolu dejjaq (disturb fl- għajn)
- if you have a tumour of the adrenal gland
- jekk għandek tumur tal- glandola adrenali
- if you are taking certain medicines for treating depression (selective MAO-A plus MAO-B
- jekk qed tieħu ċertu mediċini biex tikkura d- depressjoni (inibituri selettivi ta ’ MAO- A flimkien
inhibitors, or non-selective MAO-inhibitors)
ma ’ MAO- B, jew inibituri mhux selettivi ta ’ MAO)
- if you have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to
- jekk qatt kellek sindrome newrolettiku malinn (NMS – dan huwa reazzjoni rara għall- mediċini
medicines used to treat severe mental disorders)
użati fil- kura ta ’ disturbi mentali)
- if you have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
- jekk qatt kellek rabdomijolisi mhux trawmatika (disturb muskolari rari)
- if you have a severe liver disease.
- jekk għandek mard sever tal- fwied.
Take special care with Stalevo
Oqgħod attent ħafna b’ Stalevo
Consult your doctor if you have or have ever had:
Kellem lit- tabib tiegħek jekk għandek jew qatt kellek:
- a heart attack or any other diseases of the heart including cardiac arrythmias, or any other disease
- attakk tal- qalb jew xi mard ieħor tal- qalb inkluż arritmija tal- qalb, jew xi marda oħra tal- kanali
of the blood vessels
tad- demm
- asthma or any other disease of the lungs
- ażżma jew xi marda oħra tal- pulmun
- a liver problem, because your dose may need to be adjusted
- problema fil- fwied, għax id- doża tiegħek jista ’ jkollha bżonn tiġi aġġustata
- kidney or hormone-related diseases
- mard relatat mal- kliewi jew mal- ormoni
- stomach ulcers or convulsions
- ulċeri fl- istonku jew konvulżjonijiet
- any form of severe mental disorder like psychosis
- kull forma ta ’ disturb mentali sever bħal psikosi
- chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your
- glawkoma kronika ta ’ angolu wiesa ’, għax id- doża tiegħek jista ’ jkollha bżonn tiġi aġġustata u l -
eyes may need to be monitored.
pressjoni ta ’ ġo għajnejk jista ’ jkollha bżonn tiġi sorveljata.
Consult your doctor if you are currently taking:
Kellem lit- tabib tiegħek jekk qed tieħu:
- antipsychotics (medicines used to treat psychosis)
- antipsikotiċi (mediċini wżati biex jikkuraw il- psikosi)
- a medicine which may cause low blood pressure when rising from a chair or bed.
- mediċina li tista ’ tnaqqas il- pressjoni tad- demm meta tqum minn siġġu jew sodda.
You should be
Għandek tkun
aware that Stalevo may make these reactions worse.
taf li Stalevo jista ’ jagħmel dawn ir- reazzjonijiet agħar.
Consult your doctor if during the treatment with Stalevo you:
Kellem lit- tabib tiegħek jekk waqt kura b’ Stalevo inti:
- feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
- tħossok depress, ikollok ħsibijiet ta ’ suwiċidju, jew tinnota bidliet mhux tas- soltu fl- imġiba
- find yourself suddenly falling asleep, or if you feel very drowsy.
- torqod f’ daqqa, jew jekk tħossok imħeddel ħafna.
If this happens, you should not
Jekk dan iseħħ, m’ għandekx issuq jew tuża
drive or use any tools or machines (see also section'Driving and using machines')
għodda jew magni (ara wkoll sezzjoni ‘ Sewqan u tħaddim ta ’ magni ’)
If this
- tinnota li wara li tibda tieħu Stalevo jibdew movimenti mhux ikkontrollati jew dawn imorru għal
happens, your doctor may need to change the dose of your antiparkinson medicine
Jekk iseħħ dan, it- tabib tiegħek jista ’ jkollu bżonn ibiddel id- doża tal- mediċina tiegħek kontra l- marda ta ’ Parkinson
- notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation,
- tinnota li l- muskoli tiegħek jibbiesgħu ħafna jew jinġibdu f’ daqqa bis- saħħa, jew jekk ikollok
confusion, fever, rapid pulse, or wide fluctuations in your blood pressure.
tregħid, aġitazzjoni, konfużjoni, deni, polz mgħaġġel, jew oxxillazzjonijiet wiesa ’ fil- pressjoni tad- demm tiegħek.
If any of this happens, contact your doctor immediately
Jekk iseħħ xi wieħed minn dawn, kellem lit- tabib tiegħek minnufih
- experience diarrhoea, monitoring of your weight is recommended in order to avoid potentially
- ikollok esperjenza ta ’ dijarea, huwa rrakkomandat li tissorvelja l- piż tiegħek sabiex tevita l -
excessive weight loss
potenzjal ta ’ telf ta ’ piż eċċessiv
- experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a
- ikollok esperjenza ta ’ anoressija progressiva, astenja (debbulizza, tħossok bla saħħa) u tnaqqis fil -
relatively short period of time.
piż f’ perijodu relattivament qasir.
If this happens, a general medical evaluation including liver function should be considered
Jekk iseħħ dan, għandha tiġi kkunsidrata valutazzjoni medika ġenerali, inkluż il- funzjoni tal- fwied
- experience excessive gambling or excessive sexual activity
- ikollok esperjenza ta ’ logħob ta ’ l- azzard eċċessiv jew attività sesswali eċċessiva
- feel the need to stop using Stalevo, see section'If you stop taking Stalevo '.
- tħoss li għandek bżonn tieqaf tuża Stalevo, ara sezzjoni 'Jekk tieqaf tieħu Stalevo'.
Your doctor may take some regular laboratory tests during a long term treatment with Stalevo.
It- tabib tiegħek jista ’ jagħmel xi testijiet tal- laboratorju regolari waqt kura fit- tul b’ Stalevo.
If you must undergo surgery, please tell your doctor that you are using Stalevo.
Jekk għandek bżonn tagħmel operazzjoni, jekk jogħġbok għid lit- tabib tiegħek li qed tuża Stalevo.
Stalevo is not recommended to be used for treatment of extrapyramidal symptoms (e. g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.
Stalevo mhux irrakkomandat biex jintuża għall- kura ta ’ sintomi ekstrapiramidali (e. ż. movimenti involontarji, rogħda, riġidità tal- muskoli u kontrazzjonijiet tal- muskoli) kkawżati minn mediċini oħra.
Experience with Stalevo in patients under 18 years is limited.
Esperjenza b’ Stalevo f’ pazjenti taħt 18- il sena hija limitata.
Therefore, the use of Stalevo in children cannot be recommended.
Għalhekk, l- użu ta ’ Stalevo fit- tfal ma jistax jiġi rrakkomandat.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and 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 u medicini magħmulin mill- ħxejjex.
Stalevo may increase the effects and side effects of certain medicines.
Stalevo jista ’ jżid l- effetti u l- effetti sekondarji ta ’ xi mediċini.
These include medicines used to treat depression such as MAO-A inhibitors (e. g. moclobemide), tricyclic antidepressants (e. g. amitryptiline) and noradrenaline reuptake inhibitors (e. g. desipramine, maprotiline and venlafaxine), as well as paroxetine, rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa and apomorphine.
Dawn jinkludu mediċini wżati għall - kura tad- depressjoni bħal inibituri ta ’ MAO- A (e. ż. moclobemide), antidepressanti triċikliċi (e. ż. amitryptiline) u inibituri ta ’ assorbiment mill- ġdid ta ’ noradrenaline (e. ż. desipramine, maprotiline u venlafaxine), kif ukoll paroxetine, rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha- methyldopa u apomorphine.
Watch out for additional effects if you take these medicines while being treated with Stalevo.
Oqgħod attent għall- effetti addizjonali jekk tieħu dawn il- mediċini waqt li qed tiġi kkurat b’ Stalevo.
The effects of Stalevo may be weakened by certain medicines.
L- effetti ta ’ Stalevo jistgħu jiġu mdgħajjfa minn ċertu mediċini.
- dopamine antagonists used to treat mental disorders
- antagonisti ta ’ dopamine użati fil- kura ta ’ disturbi mentali
- dopamine antagonists used to treat nausea and vomiting
- antagonisti ta ’ dopamine użati fil- kura ta ’ tqallih u rimettar
- phenytoin (used to prevent convulsions) and papaverine (used to relax the muscles)
- phenytoin (użat biex jipprevjeni konvulżjonijiet) u papaverine (użat biex jirrilassa l- muskoli)
Tell your doctor if you are taking these medicines, or if you notice that Stalevo does not work as well when you take them.
Għid lit- tabib tiegħek jekk qed tieħu dawn il- mediċini, jew jekk tinnota li Stalevo ma jaħdimx kif suppost meta teħodhom.
60 Stalevo may make it harder for you to digest iron.
64 Stalevo jista ’ jagħmila aktar diffiċli biex inti tiddiġerixxi l- ħadid.
Therefore, do not take Stalevo and iron supplements at the same time.
Għalhekk, tieħux Stalevo u supplimenti tal- ħadid 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 minn ta ’ l- inqas 2 sa 3 sigħat qabel ma tieħu l- ieħor.
Taking Stalevo with food and drink
Meta tieħu Stalevo ma ’ l- ikel u max- xorb
- Stalevo may be taken with or without food.
- Stalevo jista ’ jittieħed ma ’ l- ikel jew mingħajr ikel.
- For some patients, Stalevo may not be well absorbed if it is taken with, or shortly after eating
- Għal xi pazjenti, Stalevo jista ’ ma jiġix assorbit sew jekk jittieħed ma ’, jew ftit wara li jittieħed
protein-rich food (such as meats, fish, dairy products, seeds and nuts).
ikel li fiħ ħafna proteini (bħal laħam, ħut, prodotti mill- ħalib, żerriegħa u lewż).
Consult your doctor if you think this applies to you.
Kellem lit- tabib tiegħek jekk taħseb li dan jgħodd għalik.
If you are pregnant or think you may be pregnant, do not take Stalevo before consulting your doctor.
Jekk inti tqila jew taħseb li tista ’ tkun tqila, tieħux Stalevo qabel ma tkellem lit- tabib tiegħek.
You should not breast-feed during treatment with Stalevo.
M’ għandekx tredda ’ waqt kura b’ Stalevo.
Stalevo may lower your blood pressure, which may make you feel light-headed or dizzy.
Stalevo jista ’ jbaxxi l- pressjoni tad- demm tiegħek, li jista ’ jġagħlek tħossok mifxul jew sturdut.
Therefore, be particularly careful when you drive or when you use any tools or machines.
Għalhekk, oqgħod attent ħafna meta ssuq jew meta tuża xi għodda jew magni.
If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel fully awake again before driving or doing anything else that requires you to be alert.
Jekk tħossok imħeddel ħafna, jew jekk xi kultant issib ruħek torqod f’ daqqa waħda, stenna sakemm terġa tħossok imqajjem sewwa qabel ma ssuq jew tagħmel kull ħaġa oħra li teħtieġ li tkun viġilanti.
Otherwise, you may put yourself and others at risk of serious injury or death.
Inkella, tista ’ tpoġġi lilek innifsek jew lil oħrajn f’ riskju ta ’ korriment serju jew ta ’ mewt.
Important information about some of the ingredients of Stalevo
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Stalevo
Stalevo contains sucrose (1.2 mg/ tablet).
Stalevo fih sucrose (1. 2 mg/ pillola).
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tip ta ’ zokkor, kellem lit- tabib tiegħek qabel ma tieħu dan il- prodott mediċinali.
HOW TO TAKE STALEVO
KIF GĦANDEK TIEĦU STALEVO
Always take Stalevo exactly as your doctor has told you.
Dejjem għandek tieħu Stalevo skond il- parir tat- tabib.
Each Stalevo tablet contains one complete dose of levodopa, carbidopa and entacapone.
Kull pillola Stalevo fiha doża waħda kompleta ta ’ levodopa, carbidopa u entacapone.
Four different strengths of this combination are available.
Erba ’ qawwiet differenti ta ’ din it- taħlita huma disponibbli.
Each time you take Stalevo, take only one tablet.
Kull darba li tieħu Stalevo, ħu biss pillola waħda.
The tablet is not intended to be split or broken into smaller pieces.
Il - pillola mhux maħsuba biex tinqasam jew titkisser f’ biċċiet iżgħar.
Your doctor will tell you exactly how many tablets of Stalevo to take each day.
It- tabib tiegħek jgħidlek eżatt kemm għandek tieħu pilloli ta ’ Stalevo kuljum.
Depending on how you respond to treatment, your doctor may suggest a higher or lower dose.
Skond kif tirrispondi għall- kura, it- tabib tiegħek jista ’ jissuġġerilek doża ogħla jew akar baxxa.
Do not take more than 10 tablets of this strength each day.
Tieħux aktar minn 10 pilloli ta ’ din il- qawwa kuljum.
Strictly follow your doctor’ s instructions on when and how to use Stalevo, other levodopa medicines and other antiparkinson medicines.
Segwi bir- reqqa l- istruzzjonijiet tat- tabib tiegħek dawn meta u kif għandek tuża Stalevo, mediċini oħra ta ’ levodopa u mediċini kontra l- marda ta ’ Parkinson oħra.
Check with your doctor or pharmacist if you are unsure about these instructions or the labels on your medicines.
Iċċekkja mat- tabib jew ma ’ l- ispiżjar tiegħek jekk għandek xi dubji dwar dawn l- istruzzjonijiet jew dwar it- tikketti fuq il- mediċini tiegħek.
Talk to your doctor or pharmacist if you think the effect of Stalevo is too strong or too weak, or if you detect possible side effects.
Kellem lit- tabib jew l- ispiżjar tiegħek jekk taħseb li l- effett ta ’ Stalevo huwa qawwi wisq jew dgħajjef wisq, jew jekk tinnota xi effetti sekondarji possibbli.
If you take more Stalevo than you should
Jekk tieħu Stalevo aktar milli suppost
If you have accidentally taken too many Stalevo tablets, talk to your doctor or pharmacist immediately.
Jekk bi żball ħadt pilloli Stalevo aktar milli suppost, kellem lit- tabib jew l- ispiżjar tiegħek minnufih.
61 If you forget to take Stalevo
65 Jekk tinsa tieħu Stalevo
If it is more than an hour until your next dose:
Jekk tkun aktar minn siegħa sad- doża li jmiss tiegħek:
Take one tablet now, and the next tablet at the normal time.
Ħu pillola issa, u l- pillola li jmiss fil- ħin normali.
If it is less than an hour until your next dose:
Jekk tkun inqas minn siegħa sad- doża li jmiss tiegħek:
Take a tablet now, wait an hour, then take another tablet.
Ħu pillola issa, stenna siegħa, wara ħu pillola oħra.
After that go back to your normal schedule.
Wara dan kompli bil- programm normali tiegħek.
Always leave at least an hour between Stalevo tablets, to avoid possible side effects.
Dejjem ħalli minn ta ’ l - inqas siegħa bejn pilloli Stalevo, sabiex tevita effetti sekondarji possibbli.
If you stop taking Stalevo
Jekk tieqaf tieħu Stalevo
Do not stop taking Stalevo unless your doctor tells you to.
Tieqafx tieħu Stalevo sakemm ma jgħidlekx hekk it- tabib tiegħek.
In such a case your doctor may need to adjust your other antiparkinson medicines, especially levodopa, to give sufficient control of your symptoms.
F’ każ bħal dan it- tabib tiegħek jista ’ jkollu bżonn jaġġusta l- mediċini kontra l- marda ta ’ Parkinson l- oħra tiegħek, speċjalment levodopa, biex tingħata kontroll suffiċjenti għas- sintomi tiegħek.
Abrupt discontinuation of Stalevo and other antiparkinsonian medicines may result in unwanted side effects.
Twaqqif f’ daqqa ta ’ Stalevo u ta ’ mediċini kontra l- marda ta ’ Parkinson oħra jista ’ jirriżulta f’ effetti sekondarji mhux mixtieqa.
Like all medicines, Stalevo can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Stalevo jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you experience any of these side effects, talk to your doctor as soon as you can.
Jekk ikollok xi wieħed minn dawn l- effetti sekondarji, kellem lit- tabib tiegħek mill- aktar fis possibbli.
Many of the side effects can be relieved by adjusting the dose.
Ħafna minn dawn l- effetti sekondarji jistgħu jitneħħew billi tiġi aġġustata d- doża.
Very common (affects more than 1 user in 10) Common (affects 1 to 10 users in 100) Uncommon (affects 1 to 10 users in 1,000) Rare (affects 1 to 10 users in 10,000) Very rare (affects less than 1 user in 10,000) Not known (frequency cannot be estimated from the available data).
Komuni ħafna (jaffettwaw aktar minn persuna waħda li qed tużah minn kull 10) Komuni (jaffettwaw minn persuna sa 10 persuni li qed jużawh minn kull 100) Mhux komuni (jaffettwaw minn persuna sa 10 persuni li qed jużawh minn kull 1, 000) Rari (jaffettwaw minn persuna sa 10 persuni li qed jużawh minn kull 10, 000) Rari ħafna (jaffettwaw inqas minn persuna waħda li qed tużah minn kull 10, 000) Mhux magħruf (il- frekwenza ma tistax tiġi stmata mid- data disponibbli).
- uncontrolled movements (dyskinesias), worsening of Parkinson’ s symptoms
- movimenti mhux ikkontrollati (diskinestjasi), is- sintomi tal- marda ta ’ Parkinson imorru għal
- feeling sick (nausea)
- tħossok imdardar (tqallih)
- harmless reddish-brown discoloration of urine.
- l- awrina tibdel il- kulur u ssir kannella fl- aħmar bla effett ħażin.
- light-headedness or fainting due to low blood pressure
- tħossok mifxul jew ikollok ħass ħażin minħabba pressjoni tad- demm baxxa
- dizziness, drowsiness, tingling or numbness
- sturdament, ngħas, tingiż jew tnemnim
- vomiting, abdominal pain, dry mouth, constipation, diarrhoea
- rimettar, uġigħ addominali, ħalq xott, stitikezza, dijarea
- inability to sleep, hallucinations, confusion, nightmares, feeling agitated
- inabbiltà biex torqod, alluċinazzjonijiet, konfużjoni, inkubi, tħossok aġitat
- mental changes – including paranoid and psychotic symptoms, depression (possibly with
- bidliet mentali – inkluż sintomi paranojiċi u psikotiċi, depressjoni (possibilment bi ħsibijiet ta ’
thoughts of suicide) and problems with memory or thinking
suwiċidju) u problemi bil- memorja jew il- ħsieb
- tiredness, chest pain
- għeja, uġigħ fis- sider
- more frequent falling
- waqgħat aktar frekwenti
- increased sweating, itching and rashes
- żjieda fl- għaraq, ħakk u raxx
- muscle cramps
- bugħawwieġ fil- muskoli
- vision disturbances.
- disturbi fil- vista.
62 Uncommon
Mhux komuni
- irregular heart rate and rhythm
- rata u ritmu tal- qalb irregolari
- loss of appetite, weight loss or gain, bleeding in the gut, ulcers
- telf t’ aptit, telf jew żjieda fil- piż, fsada fil- musrana, ulċeri
- high blood pressure
- pressjoni għolja
- changes in the blood cell count (which may result in symptoms such as tiredness, fainting,
- bidliet fl- għadd ta ’ ċelluli tad- demm (li jistgħu jwasslu għal sintomi bħal għeja, ħass ħażin,
infections, bleeding)
infezzjonijiet u fsada)
- inflammation of the veins in the legs
- infjammazzjoni tal- vini fis- saqajn
- convulsions.
- konvulżjonijiet.
The exact frequencies of these side effects are not known, but are based on reports received since the product has been on the market: colitis (inflammation of the colon), hepatitis and skin, hair, beard and nail discolorations.
Il- frekwenzi eżatti ta ’ dawn l- effetti sekondarji m’ humiex magħrufin, imma huma bbażżati fuq rapporti li waslu minn meta l- prodott tqiegħed fis- suq: kolite (infjammazzjoni tal- kolon), epatite u tibdil fil- kulur tal- ġilda, ix- xagħar, id- daqna u d- dwiefer.
A few cases of neuroleptic malignant syndrome (NMS) and rhabdomyolysis have been reported.
Gew rapportati xi każijiet ta ’ sindromu newrolettiku malinn (NMS) u rabdomijolisi.
NMS is a rare severe reaction to medicines used to treat disorders of the central nervous system and characterised by stiffness, muscle twitching, tremor, mental changes, coma, high body temperature, increased heart rate, and unstable blood pressure.
NMS hi reazzjoni severa rari għal mediċini użati biex jittrattaw disturbi tas- sistema nervuża ċentrali u kkaraterizzata b’ ebusija, tiġbid ta ’ muskoli, rogħda, bidliet mentali, koma, temperatura għolja tal- ġisem, rata tal- qalb ogħla, u pressjoni tad- demm mhix stabbli.
Rhabdomyolysis is a rare severe muscle disorder.
Rabdomijolisi hija disturb tal- muskolu 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 Stalevo.
F’ pazjenti li kienu qed jirċievu mediċini dopaminerġiċi inkluż Stalevo kienu rrapportati bidliet fl - imġiba bħal xewqa għall- logħob tal- ażżard (logħob tal- ażżard patoloġiku) jew żjieda fix- xewqa u l - ħajra għas- sess (żjieda fil- libido u ipersesswalità).
HOW TO STORE STALEVO
KIF TAĦŻEN STALEVO
Do not use after the expiry date which is stated on the bottle and the carton after EXP.
Tużax Stalevo wara d- data ta ’ skadenza li tidher fuq il- flixkun u l- kartuna wara JIS.
What Stalevo contains
X’ fih Stalevo
- The active substances of Stalevo are levodopa, carbidopa and entacapone.
- Is- sustanzi attivi huma levodopa, carbidopa u entacapone.
- Each Stalevo 50 mg/ 12.5 mg/ 200 mg tablet contains 50 mg of levodopa, 12.5 mg of carbidopa
- Kull pillola Stalevo 50 mg/ 12. 5 mg/ 200 mg fiha 50 mg ta ’ levodopa, 12. 5 mg ta’ carbidopa u
and 200 mg of entacapone.
200 mg ta ’ entacapone.
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize
- Is- sustanzi l- oħra fil- qalba tal- pillola huma croscarmellose sodium, magnesium stearate, maize
starch, mannitol (E421) and povidone (E1201)
starch, mannitol (E421) u povidone (E1201).
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium
- Is- sustanzi fil- kisja b’ rita huma glycerol (85 fil- mija) (E422), hypromellose, magnesium stearate,
stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171), and yellow iron oxide (E172).
polysorbate 80, iron oxide aħmar (E172), sucrose, titanium dioxide (E171), u iron oxide isfar (E172).
What Stalevo looks like and contents of the pack
Id- dehra ta ’ Stalevo u d- daqs tal- pakkett
Stalevo 50 mg/ 12.5 mg/ 200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with ‘ LCE 50’ on one side.
Pilloli Stalevo 50 mg/ 12. 5 mg/ 200 mg: pilloli miskija b’ rita, bla sinjal imnaqqax, ta ’ lewn aħmar fil - kannella jew fil- griż, tondi, bbuzzati u mmarkati b ’ ‘ LCE 50 ’ fuq naħa waħda.
63 Stalevo comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
Stalevo huwa disponibbli f’ sitt daqsijiet ta ’ pakketti differenti (10, 30, 100, 130, 175 jew 250 pillola).
Marketing Authorisation Holder and Manufacturer
67 Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
Italia Novartis Farma S. p. A.
68 Italia Novartis Farma S. p. A.
Detailed information on this medicine is available on the European Medicine’ s Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
Stalevo 100 mg/ 25 mg/ 200 mg film-coated tablets Levodopa/ carbidopa/ entacapone
Stalevo 100 mg/ 25 mg/ 200 mg pilloli miksija b’ rita Levodopa/ carbidopa/ entacapone
- if you have a severe liverdisease.
- jekk għandek mard sever tal- fwied.
67 Stalevo may make it harder for you to digest iron.
71 Stalevo jista ’ jagħmila aktar diffiċli biex inti tiddiġerixxi l- ħadid.
Therefore, be particularly careful when you drive or when you use any tools or machines.
Għalhekk, oqgħod attent ħafnameta ssuq jew meta tuża xi għodda jew magni.
Stalevo contains sucrose (1.6 mg/ tablet).
Stalevo fih sucrose (1. 6 mg/ pillola).
68 If you forget to take Stalevo
72 Jekk tinsa tieħu Stalevo
The exact frequencies of these side effects are not known, but are based on reports received since the product has been on the market: colitis (inflammation of the colon), hepatitis and skin, hair, beard and nail discolorations.
Il- frekwenzi eżatti ta ’ dawn l- effetti m’ humiex magħrufin, imma huma bbażżati fuq rapporti li waslu minn meta l- prodott tqiegħed fis- suq: kolite (infjammazzjoni tal- kolon), epatite u tibdil fil- kulur tal - ġilda, ix- xagħar, id- daqna u d- dwiefer.
- Each Stalevo 100 mg/ 25 mg/ 200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa
- Kull pillola Stalevo 100 mg/ 25 mg/ 200 mg fiha 100 mg ta ’ levodopa, 25 mg ta’ carbidopa u
starch, mannitol (E421) and povidone (E1201)
starch, mannitol (E 421) u povidone (E 1201).
Stalevo 100 mg/ 25 mg/ 200 mg: brownish or greyish red, oval, unscored film-coated tablets marked with ‘ LCE 100’ on one side.
Pilloli Stalevo 100 mg/ 25 mg/ 200 mg huma: pilloli miskija b’ rita, bla sinjal imnaqqax, ta ’ lewn aħmar fil- kannella jew fil- griż, ovali u mmarkati b ’ ‘ LCE 100 ’ fuq naħa waħda.
70 Stalevo comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
Stalevo huwa disponibbli f’ sitt daqsijiet ta ’ pakketti differenti (10, 30, 100, 130, 175 jew 250 pillola).
Marketing Authorisation Holder and Manufacturer
74 Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
Italia Novartis Farma S. p. A.
75 Italia Novartis Farma S. p. A.
Lietuva UAB Orion Pharma Tel. +370 5 276 9499
Lietuva UAB Orion Pharma Tel. +370 5 2676 9499
Detailed information on this medicine is available on the European Medicine’ s Agency (EMEA) web site: http: / /www. emea. europa. eu
Detailed information on this medicine is available on the European Medicine’ s Agency (EMEA) web site: http: // www. emea. europa. eu
Stalevo 150 mg/ 37.5 mg/ 200 mg film-coated tablets Levodopa/ carbidopa/ entacapone
Stalevo 150 mg/ 37. 5 mg/ 200 mg pilloli miksija b’ rita Levodopa/ carbidopa/ entacapone
Carbidopa and entacapone improve the antiparkinson effects of levodopa.
Levodopa jżid il- livell ta ’ dopamine u b’ hekk inaqqas is- sintomi tal- marda ta ’ Parkinson. Carbidopa u entacapone itejjbu l- effetti kontra l- marda ta ’ Parkinson ta ’ levodopa.
74 Stalevo may make it harder for you to digest iron.
78 Stalevo jista ’ jagħmila aktar diffiċli biex inti tiddiġerixxi l- ħadid.
Stalevo contains sucrose (1.9 mg/ tablet).
Stalevo fih sucrose (1. 9 mg/ pillola).
75 If you forget to take Stalevo
79 Jekk tinsa tieħu Stalevo
- Each Stalevo 150 mg/ 37.5 mg/ 200 mg tablet contains 150 mg of levodopa, 37.5 mg of
- Kull pillola Stalevo 150 mg/ 37. 5 mg/ 200 mg fiha 150 mg ta ’ levodopa, 37. 5 mg ta’ carbidopa u
carbidopa and 200 mg of entacapone.
200 mg ta ’ entacapone.
starch, mannitol (E421) and povidone (E1201).
starch, mannitol (E 421) u povidone (E 1201).
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium
- Is- sustanzi fil- kisja b’ rita huma glycerol (85 fil- mija) (E 422), hypromellose, polysorbate 80, iron
stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171), and yellow iron oxide (E172).
oxide aħmar (E 172), sucrose, titanium dioxide (E 171), u iron oxide isfar (E 172).
Stalevo 150 mg/ 37.5 mg/ 200 mg: brownish or greyish red, elongated-ellipse shaped, unscored film- coated tablets marked with ‘ LCE 150’ on one side.
Pilloli Stalevo 150 mg/ 37. 5 mg/ 200 mg huma: pilloli miskija b’ rita, bla sinjal imnaqqax, ta ’ lewn aħmar fil- kannella jew fil- griż, b’ forma ta ’ elissi mtawwla u huma mmarkati b ’ ‘ LCE 150 ’ fuq naħa waħda.
Not all pack sizes may be marketed.
Stalevo huwa disponibbli f’ sitt daqsijiet ta ’ pakketti differenti (10, 30, 100, 130, 175 jew 250 pillola). Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Marketing Authorisation Holder and Manufacturer
81 Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
78 Ísland Vistor hf.
Ísland Vistorhf.
Italia Novartis Farma S. p. A.
82 Italia Novartis Farma S. p. A.
79 PACKAGE LEAFLET:
83 FULJETT TA ’ TAGĦRIF:
Stalevo 200 mg/ 50 mg/ 200 mg film-coated tablets Levodopa/ carbidopa/ entacapone
Stalevo 200 mg/ 50 mg/ 200 mg pilloli miksija b’ rita Levodopa/ carbidopa/ entacapone
What Stalevo is and what it is used for 2.
X’ inhu Stalevo u għalxiex jintuża 8.
Before you take Stalevo 3.
Qabel ma tieħu Stalevo 9.
How to take Stalevo 4.
Kif għandek tieħu Stalevo 10.
Possible side effects 5 How to store Stalevo 6.
Effetti sekondarji li jista ’ jkollu 11.
Further information
Kif taħżen Stalevo 12.
Consult your doctor if you have or have ever had:
Kellem lit- tabib tiegħek jekk għandek jew qatt kellek: attakk tal- qalb jew xi mard ieħor tal- qalb inkluż arritmija tal- qalb, jew xi marda oħra tal- kanali
- a heart attack or any other diseases of the heart including cardiac arrythmias, or any other disease
-
- asthma or any other disease of the lungs
- ażżma jew xi marda oħra tal- pulmun.
- a liver problem, because your dose may need to be adjusted
- problema fil- fwied, għax id- doża tiegħek jista ’ jkollha bżonn tiġi aġġustata.
- kidney or hormone-related diseases
- mard relatat mal- kliewi jew mal- ormoni.
- stomach ulcers or convulsions
- ulċeri fl- istonku jew konvulżjonijiet.
- any form of severe mental disorder like psychosis
- xi forma ta ’ disturb mentali sever bħal psikosi.
- chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your
- glawkoma kronika ta ’ angolu wiesa ’, għax id- doża tiegħek jista ’ jkollha bżonn tiġi aġġustata u
eyes may need to be monitored.
l- pressjoni ta ’ ġo għajnejk jista ’ jkollha bżonn tiġi sorveljata.
- notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, confusion,
- tinnota li l- muskoli tiegħek jibbiesgħu ħafna jew jinġibdu f’ daqqa bis- saħħa, jew jekk ikollok
fever, rapid pulse, or wide fluctuations in your blood pressure.
tregħid, aġitazzjoni, konfużjoni, deni, polz mgħaġġel, jew oxxillazzjonijiet wiesa ’ fil- pressjoni tad- demm tiegħek.
81 Stalevo may make it harder for you to digest iron.
85 Stalevo jista ’ jagħmila aktar diffiċli biex inti tiddiġerixxi l- ħadid.
Stalevo contains sucrose (2.3 mg/ tablet).
Stalevo fih sucrose (2. 3 mg/ pillola).
Do not take more than 7 tablets of this strength each day.
Tieħux aktar minn 7 pilloli ta ’ din il- qawwa kuljum.
82 If you forget to take Stalevo
86 Jekk tinsa tieħu Stalevo
83
87
- Each Stalevo 200 mg/ 50 mg/ 200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and
- Kull pillola ta ’ Stalevo 200 mg/ 50 mg/ 200 mg fiha 200 mg ta ’ levodopa, 50 mg ta’ carbidopa u
200 mg of entacapone.
200 mg ta ’ entacapone.
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium
- Is- sustanzi fil- kisja b’ rita huma glycerol (85% fil- mija) (E422), hypromellose, magnesium
stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).
stearate, polysorbate 80, iron oxide aħmar (E172), sucrose u titanium dioxide (E171).
Stalevo 200 mg/ 50 mg/ 200 mg: dark brownish red, oval, unscored film-coated tablets marked with ‘ LCE 200’ on one side.
Stalevo 200 mg/ 50 mg/ 200 mg: pilloli miskija b’ rita, bla sinjal imnaqqax, ovali, ta ’ lewn aħmar skur fil- kannella immarkati b ’ ‘ LCE 200 ’ fuq naħa waħda.
Stalevo 200 mg/ 50 mg/ 200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Pilloli Stalevo 200 mg/ 50 mg/ 200 mg huwa disponibbli f’ ħames daqsijiet ta ’ pakketti differenti (10, 30, 100, 130, jew 175 pillola).
84 Marketing Authorisation Holder and Manufacturer
88 Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
Tel: +420 225 775 111
Tel: +420 225 775 111 Danmark Orion Pharma A/ S Tlf: +45 49 12 66 00 Deutschland Orion Pharma GmbH Tel: +49 40 899 689- 0 Eesti Orion Pharma Eesti OÜ Tel: +372 6 616 863
Tel: +31 26 37 82 111 Norge Orion Pharma AS Tlf: +47 40 00 42 10 Österreich Novartis Pharma GmbH Tel: +43 1 86 6570
Tel: +31 26 37 82 111 Norge Orion Pharma AS Tlf: +47 40 00 42 10 Österreich Novartis Pharma GmbH Tel: +43 1 86 6570
85 Italia Novartis Farma S. p. A.
89 Italia Novartis Farma S. p. A.
Detailed information on this medicine is available on the European Medicine’ s Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu.
What is Starlix?
X’ inhu Starlix?
Starlix is a medicine containing the active substance nateglinide.
Starlix hu mediċina li fiha s- sustanza attiva nateglinide.
It is available as pink, round (60 mg), yellow, oval (120 mg) and red, oval (180 mg) tablets.
Jiġi bħala pilloli roża, tondi (60 mg), sofor, ovali (120 mg) u ħomor, ovali (180 mg).
What is Starlix used for?
Għalxiex jintuża Starlix?
Starlix is used in patients who have non insulin-dependent diabetes (type 2 diabetes).
Starlix jintuża f’ pazjenti li jkollhom id- dijabete tat- tieni tip mhux dipendenti mill- insulina.
Starlix is used together with metformin (another antidiabetes medicine) to lower blood glucose (sugar) in patients whose diabetes cannot be controlled by metformin alone.
Starlix jintuża flimkien ma ’ metformin (mediċina oħra għal kontra d- dijabete) biex ibaxxi l- livell tal- glucosju fid- demm f’ pazjenti li d- dijabete tagħhom ma ma tkunx tista ’ tiġi kkontrollata minn metformin waħdu.
How is Starlix used?
Kif jintuża Starlix?
Starlix is given within one to 30 minutes before breakfast, lunch and dinner and the dose is adjusted to give the best control.
Starlix jingħata bejn minuta u 30 minuta qabel il- kolazzjon, l- ikla ta ’ nofsinhar u l- ikla ta ’ filgħaxija u d- doża tiġi aġġustata biex tagħti l- aqwa kontroll.
A doctor should regularly test the patient's blood glucose to find the lowest effective dose.
Il- livell ta ’ zokkor fid- demm tal- pazjent irid jiġi ċċekkjat regolarment minn tabib biex tinstab l- inqas doża effettiva.
The recommended starting dose is 60 mg three times a day before meals.
Id- doża inizjali rakkomandata hi 60 mg tliet darbiet kuljum qabel l- ikliet.
This dose may need to be increased to a daily dose of 120 mg three times a day after one or two weeks.
Din id- doża jista ’ jkollha bżonn tiżdied għal doża ta ’ 120 mg tliet darbiet kuljum wara ġimgħa jew tnejn.
The maximum total daily dose is 180 mg three times a day.
Id- doża totali massima hi ta ’ 180 mg tliet darbiet kuljum.
How does Starlix work?
Kif jaħdem Starlix?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood.
Id- dijabete tat- tieni tip hi marda li fiha, il- frixa ma tagħmilx biżżejjed insulina biex tikkontrolla l- livell ta ’ glucosju fid- demm.
Nateglinide, the active ingredient in Starlix, stimulates the pancreas to produce insulin more quickly.
Nateglinide, is- sustanza attiva fi Starlix, jistimula l- frixa biex tipproduċi l - insulina iktar malajr.
This helps to keep the blood glucose controlled after meals and is used to control type 2 diabetes.
Dan jgħin biex iżomm il- glucosju fid- demm ikkontrollat wara l- ikliet u jintuża biex jikkontrolla d- dijabete tat- tieni tip.
How has Starlix been studied?
Kif ġie studjat Starlix?
A total of 2,122 patients received Starlix in all trials combined.
Fl- istudji kollha b’ kollox kien hemm 2, 122 pazjent li ngħataw Starlix.
The main studies compared Starlix to placebo (a dummy treatment), or to other medicines used in type 2 diabetes (metformin, glibenclamide or troglitazone).
L- istudji ewlenin qabblu Starlix ma ’ plaċebo (trattament finta), jew ma ’ mediċini oħra użati fid- dijabete tat- tieni tip (metformin, glibenclamide jew troglitazone).
Other studies also looked at ‘ switching ’ from an antidiabetes medicine to Starlix, and ‘ adding’ Starlix to other antidiabetes medicines.
Studji oħra studjaw ukoll ‘ il- qlib ’ minn mediċini antidijabetiċi għal Starlix, u ‘ ż- żieda ’ ta ’ Starlix ma ’ mediċini antidijabetiċi oħra.
The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
L- istudji kejlu l- livell ta ’ sustanza fid - demm magħrufa bħala emoglobina glikoċilata (HbA1c), li jagħti indikazzjoni ta ’ kemm kien ikkontrollat tajjeb il- glucosju fid- demm.
Most of the patients received treatment for up to six months:
Ħafna mill- pazjenti ngħataw it- trattament sa sitt xhur:
789 received it for at least six months, and 190 received it for a year.
789 ħaduh għal ta ’ l- anqas sitt xhur, u 190 ħaduh għal sena.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Starlix shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X’ inhu l- benefiċċju ta ’ Starlix li ntwera f’ dawn l- istudji?
On its own, Starlix was shown to be more effective than placebo, but less effective than some antidiabetes medicines such as metformin.
Intwera li Starlix waħdu kien iktar effettiv mill- plaċebo, iżda inqas effettiv minn xi mediċini antidijabetiċi oħra bħal metformin.
In combination with metformin, which mainly affected fasting plasma glucose (the amount of glucose in the blood when the person has not eaten anything), the effect of Starlix on HbA1c was better than either medicine alone.
Flimkien ma ’ metformin, li jaffettwa b’ mod ewlieni l- glucosju fil - plażma meta wieħed ikun sajjem (l- ammont ta ’ glucosju fid- demm meta l- persuna ma tkun kielet xejn), l- effett ta ’ Starlix fuq l- HbA1c kien aħjar minn kwalunkwe mill- mediċini weħidhom.
What is the risk associated with Starlix?
X’ inhu r- riskju assoċjat ma ’ Starlix?
Starlix may in some cases cause hypoglycaemia (low blood glucose).
Starlix f’ xi każi jista ’ jikkawża ipogliċemija (livell baxx ta ’ glucosju fid- demm).
Other common side effects (seen in between 1 and 10 patients in 100) are abdominal (tummy) pain, diarrhoea, dyspepsia (heartburn), and nausea (feeling sick).
Effetti sekondarji oħra li huma komuni (li dehru f’ bejn pazjent wieħed u għaxra minn kull mija) jinkludu l- uġigħ ta ’ żaqq, id- dijarea, il- ħruq fl- istonku, u d- dardir.
For the full list of all side effects reported with Starlix, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rrappurtati bi Starlix, ara l- Fuljett ta ’ Tagħrif.