qanastek/EMEA-V3 huggingface dataset:
patient-years versus diet alone 20.6 events/ 1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/ 1,000 patient-years (p=0.021)
snin kontra dieta biss 20. 6 episodji/ 1, 000 pazjent- snin, (p=0. 011), u kontra l- gruppi ta ’ monoterapija b’ sulphonylurea u b’ insulina kombinati, 18. 9 episodji/ 1, 000 pazjent- snin (p=0. 021)
- a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/ 1,000
- tnaqqis sinifikanti fir- riskju assolut ta ’ infart mijokardiku: metformin 11 episodji/ 1, 000 pazjent -
patient-years, diet alone 18 events/ 1,000 patient-years, (p=0.01).
snin, dieta biss 18 events/ 1, 000 pazjent- snin, (p=0. 01).
11 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Bioequivalence studies in healthy volunteers have shown Competact to be bioequivalent to the administration of pioglitazone and metformin given as separate tablets.
Studji ta ’ bijoekwivalenza f’ voluntiera b’ saħħithom urew li Competact huwa bijoekwivalenti għall - għotja ta ’ pioglitazone u metformin mogħtija bħala pilloli separati.
Food had no effect on the AUC and Cmax of pioglitazone when Competact was administered to healthy volunteers.
L- ikel ma kellu l- ebda effett fuq l- AUC u Cmax ta ’ pioglitazone meta Competact ingħata lil voluntiera b’ saħħithom.
However, in the case of metformin, in the fed state the mean AUC and Cmax were lower (13% and 28% respectively).
Iżda, fil- każ ta ’ metformin, l- medja ta ’ AUC u Cmax kienu inqas (13% u 28% rispettivament) wara l- ikel.
Tmax was delayed by food by approximately 1.9h for pioglitazone and 0.8 h for metfomin.
Tmax kien ittardjat bl- ikel b’ madwar 1. 9 h għal pioglitazone u 0. 8 h għal metfomin.
The following statements reflect the pharmacokinetic properties of the individual active substances of Competact.
Id- dikjarazzjonijiet li ġejjin jirriflettu il- proprjetajiet farmakokinetiċi tas- sustanzi attivi individwali Competact.
Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
11 Pioglitazone u l- metaboliti attivi kollha huma marbuta b’ mod estensiv mal- proteini fil- plażma (> 99%).
Following oral administration of radiolabeled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Wara għotja ta ’ pioglitazone radjutikketjat mill- ħalq lill- bniedem, it- tikkettjar miġbur kien l- aktar fil - ħmieġ (55%) u f’ ammont inqas fl- awrina (45%).
In animals, only a small amount of unchanged pioglitazone can be detected in either urine or faeces.
Fl- annimali, jista ’ jiġi osservat ammont żgħir biss ta ’ pioglitazone mhux mibdul fl- awrina jew fil- ħmieġ.
12 Elderly:
Anzjani:
Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Il- farmakokinetika fi stat stabbli ta ’ pazjenti b’ eta ’ ta ’ 65 sena jew aktar hija simili għal dik ta ’ pazjenti żgħar.
Thus free (unbound) pioglitazone concentration is unchanged.
Għalhekk il- konċentrazzjoni ta ’ pioglitazone ħieles (mhux marbut) baqgħet ma nbidlitx.
Patients with hepatic impairment:
Pazjenti b’ indeboliment epatiku:
Total plasma concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Il- konċentrazzjoni totali fil- plażma ta ’ pioglitazone ma nbidlitx, iżda b’ volum ta ’ distribuzzjoni miżjud.
After an oral dose of metformin, tmax is reached in 2.5 h.
Wara doża orali ta ’ metformin, tmax tintlaħaq f’ 2. 5 h.
Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Il- bijodisponibilità assoluta ta ’ pillola ta ’ 500 mg metformin hija ta ’ madwar 50- 60% f’ persuni b’ saħħithom.
After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Wara doża orali, il- frazzjoni mhux assorbita miġbura mill- ħmieġ kienet ta ’ 20- 30%.
After oral administration, metformin absorption is saturable and incomplete.
Wara għotja orali, assorbiment ta ’ metformin huwa saturabbli u mhux komplut.
It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Huwa meqjus li l - farmakokinetika tal- assorbiment ta ’ metformin mhix linejari.
At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ ml.
F’ dożi u programmi ta ’ dożaġġ normali ta ’ metformin, konċentrazzjonijiet fil- plażma fi stat stabbli jintlaħqu f’ madwar 24- 48 h u ġeneralment huma inqas minn 1 µg/ ml.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ ml, even at maximum doses.
Fi provi kliniċi kkontrollati, il- livelli massimi fil- plażma ta ’ metformin (Cmax) ma qabżux 4 µg/ ml, lanqas fl- għola dożi.
Food decreases the extent and slightly delays the absorption of metformin.
12 L- ikel inaqqas il- kwantità u jittardja kemmxejn l- assorbiment ta ’ metformin.
Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Wara għotja ta ’ doża ta ’ 850 mg, kienu osservati tnaqqis ta ’ 40% fl- għola konċentrazzjoni fil- plażma, tnaqqis ta’ 25% fl- AUC u dewmien b’ 35 min sal- ħin beix tintlaħaq l- għola konċentrazzjoni fil- plażma.
The clinical relevance of this decrease is unknown.
Ir- rilevanza klinika ta ’ dan it- tnaqqis mhix magħrufa.
Plasma protein binding is negligible.
Twaħħil mal- proteini fil- plażma hija ftit li xejn.
Metformin partitions into erythrocytes.
Metformin jitqassam fl- eritroċiti.
The blood peak is lower than the plasma peak and appears at approximately the same time.
L- għola kwantità fid- demm hija inqas minn dik fil- plażma u tidher madwar fl- istess ħin.
The red blood cells most likely represent a secondary compartment of distribution.
Iċ- ċelloli ħomor tad- demm jirrappreżentaw wisq probabbli kompartiment sekondarju ta ’ distribuzzjoni.
The mean Vd ranged between 63 – 276 l.
Il- medja ta ’ Vd varjat bejn 63 – 276 l.
Metformin is excreted unchanged in the urine.
Metformin jitneħħa mhux mibdul fl- awrina.
No metabolites have been identified in humans.
Ma ġewx identifikati metaboliti fil- bnedmin.
Renal clearance of metformin is > 400ml/ min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Tneħħijja renali ta ’ metformin hija > 400 ml/ min, u b’ hekk tindika li metformin jitneħħa permezz ta ’ filtrazzjoni glomerulari u tneħħijja tubolari.
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h.
Wara doża orali, il- half- life evidenti ta ’ eliminazzjoni terminali hija ta ’ madwar 6. 5 h.
When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Meta jkun hemm indeboliment tal- funzjoni renali, tneħħijja renali tonqos f’ proporzjon ma ’ dik ta ’ krejatinina u b’ hekk il- half- life ta ’ eliminazzjoni titwal, u twassal għall- livelli għola ta ’ metformin fil- plażma.
No animal studies have been conducted with the combined products in Competact.
Ma sarux studji fil- bhejjem bil- prodotti kombinati Competact.
The following data are findings in studies performed with pioglitazone or metformin individually.
It- tagħrif li ġej huma sejbiet minn studji li twettqu b’ pioglitazone jew metformin għalihom.
In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys.
Fi studji tossikoloġiċi, l- espansjoni tal- volum tal- plażma permeżz ta ’ emodiluzzjoni, anemija u ipertrofija kardijaka eċċentrika riversibbli kienet apparenti b’ mod konsistenti wara dożaġġ ripetut fil - ġrieden, firien, klieb u xadini.
Hyperplasia of the urinary bladder was not seen in dogs or monkeys treated for up to 12 months.
Fil- klieb jew xadini kkurati sa 12- il xahar ma dehritx iperplażja tal- bużżieqa tal- awrina.
Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma ’ turi l- ebda periklu speċjali għall- bnedmin.
Tablet Core:
Qalba tal- Pillola:
Microcrystalline cellulose Povidone (K30) Croscarmellose sodium Magnesium stearate
Microcrystalline cellulose Povidone (K30) Croscarmellose sodium Magnesium stearate
Film Coat:
Kisja b’ Rita:
Hypromellose Macrogol 8000 Talc Titanium dioxide.
Hypromellose Macrogol 8000 Talc Titanium dioxide.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali ma jinħtiegx kundizzjonijiet speċjali ta ’ ħażna.
14 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Aluminium/ aluminium blisters, packs of 14, 28, 30, 50, 56, 60, 90, 98 and 180 tablets.
Folji tal- aluminju/ aluminju, pakketti ta ’ 14, 28, 30, 50, 56, 60, 90, 98 u 180 pillola.
28 July 2006
28 ta 'Lulju 2006
Takeda Italia Farmaceutici S. p. A Via Crosa, 86 28065 Cerano (NO) Italy
Takeda Italia Farmaceutici S. p. A Via Crosa, 86 28065 Cerano (NO) L- Italja
Takeda Ireland Limited Bray Business Park Kilruddery County Wicklow Ireland
Takeda Ireland Limited Bray Business Park Kilruddery County Wicklow L- Irlanda
Avda. de la Industria 30 28108 Alcobendas Madrid Spain
Avda. de la Industria 30 28108 Alcobendas Madrid Spanja
The MAH must ensure that the system of pharmacovigilance, as described in the July 2007 version, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ l- Awtorizazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni ta ’ Lulju 2007 hija implimentata u qed tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP), and any subsequent updates of the RMP agreed by the CHMP.
Pjan għall- Immanniġġjar ta ’ Riskji Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq jwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza oħrajn dettaljati fil- Pjan ta ’ Farmakoviġilanza kif miftiehem f’ verżjoni 3. 0 tal- Pjan għall- Immaniġġjar ta ’ Riskji (RMPu kull aġġornament sussegwenti ta ’ RMP miftiehem miċ- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji Gwida ta ’ CHMP dwar is- Sistemi ta ’ Mmaniġġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil- bniedem, l- RMP mġedded għandu jiġi pprovdut fl- istess żmien mar- Rapport Perjodiku ta ’ Aġġornament dwar is- Sigurtà (PSUR) ta ’ wara.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat • Meta tinkiseb informazzjoni ġdida li jista ’ jkollha effett fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà kurrenti, Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskju • Fi żmien 60 ġurnata wara li tintlaħaq mira ta ’ mportanza (farmakoviġilanza jew tnaqqis ta ’ riskju) • Mat- talba ta ’ l- EMEA
Competact 15 mg/ 850 mg film-coated tablets
Competact 15 mg/ 850 mg pilloli miksija b’ rita
Pioglitazone (as hydrochloride) metformin hydrochloride
Pioglitazone (bħala hydrochloride) metformin hydrochloride
Each tablet contains 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.
Kull pillola fiha 15 mg pioglitazone (bħala hydrochloride) u 850 mg metformin hydrochloride..
14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 60 tablets 90 tablets 98 tablets 180 tablets
14- il pillola 28 pillola 30 pillola 50 pillola 56 pillola 60 pillola 90 pillola 98 pillola 180 pillola
For oral use.
Użu orali.
Expiry date:
JIS:
{month/ year}
{xahar/ sena}
EU/ 1/ 06/ 354/ 001 14 tablets EU/ 1/ 06/ 354/ 002 28 tablets EU/ 1/ 06/ 354/ 003 30 tablets EU/ 1/ 06/ 354/ 004 50 tablets EU/ 1/ 06/ 354/ 005 56 tablets EU/ 1/ 06/ 354/ 006 60 tablets EU/ 1/ 06/ 354/ 007 90 tablets EU/ 1/ 06/ 354/ 008 98 tablets EU/ 1/ 06/ 354/ 009 180 tablets
EU/ 1/ 06/ 354/ 001 14- il pillola EU/ 1/ 06/ 354/ 002 28 pillola EU/ 1/ 06/ 354/ 003 30 pillola EU/ 1/ 06/ 354/ 004 50 pillola EU/ 1/ 06/ 354/ 005 56 pillola EU/ 1/ 06/ 354/ 006 60 pillola EU/ 1/ 06/ 354/ 007 90 pillola EU/ 1/ 06/ 354/ 008 98 pillola EU/ 1/ 06/ 354/ 009 180 pillola
Batch number:
LOTT:
Competact 15 mg/ 850 mg tablets.
Pilloli Competact 15 mg/ 850 mg.
21 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
21 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Competact 15 mg/ 850 mg tablets
Pilloli Competact 15 mg/ 850 mg
Pioglitazone (as HCl) metformin hydrochloride
Pioglitazone (bħala HCl) metformin hydrochloride
OTHER (FOR CALENDARISED PACKS)
OĦRAJN (Ghal paketti b’ kalendarju)
MON 1 MON 2 TUE 1 TUE 2 WED 1 WED 2 THU 1 THU 2 FRI 1 FRI 2 SAT 1 SAT 2 SUN 1 SUN 2
It- Tnejn 1 It- Tnejn 2 It- Tlieta 1 It- Tlieta 2 L- Erbgħa 1 L- Erbgħa 2 L- Ħamis 1 L- Ħamis 2 Il- Ġimgħa 1 Il- Ġimgħa 2 Is- Sibt 1
23 PACKAGE LEAFLET:
23 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER COMPETACT 15 mg/ 850 mg FILM-COATED TABLETS
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA COMPETACT 15 mg/ 850 mg PILLOLI MIKSIJA B’ RITA
Pioglitazone / Metformin hydrochloride
Pioglitazone / Metformin hydrochloride
What Competact is and what it is used for 2.
X’ inhu Competact u għalxiex jintuża 2.
Before you take Competact 3.
Qabel ma tieħu Competact 3.
How to take Competact 4.
Kif għandek tieħu Competact 4.
Possible side effects 5 How to store Competact 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen Competact 6.
WHAT COMPETACT IS AND WHAT IT IS USED FOR
X’ INHU COMPETACT U GĦALXIEX JINTUŻA
Competact tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus.
Pilloli Competact huma mediċina anti- dijabetika wżata biex tikkura dijabete mellitus tat- tip 2 (mhux dipendenti mill- insulina).
Competact tablets help control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Pilloli Competact jgħinu jikkontrollaw il- livell ta ’ żokkor fid- demm tiegħek meta jkollok dijabete tat - tip 2 billi jgħinu lill- ġismek jagħmel użu aħjar mill- insulina li qed jipproduċi.
BEFORE YOU TAKE COMPETACT
QABEL MA TIEĦU COMPETACT
Do not take Competact:
Tieħux pilloli Competact
- If you are allergic (hypersensitive) to pioglitazone, metformin or any of the other ingredients of
- Jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal pioglitazone, metformin jew
Competact tablets.
sustanzi oħra ta ’ pilloli Competact.
- If you recently had a heart attack, have severe circulatory problems including shock, or
- Jekk dan l- aħħar kellek attakk tal- qalb, għandek problemi severi fiċ- ċirkolazzjoni inkluż xokk,
breathing difficulties.
jew diffikultajiet biex tieħu n- nifs.
- If you have liver disease.
- Jekk għandek mard tal- fwied.
- If you drink alcohol excessively (either every day or only from time to time).
- Jekk tixrob wisq alkoħol (kemm kuljum kif ukoll darba kull tant).
- If you have diabetic ketoacidosis (complication of diabetes with rapid weight loss, nausea or
- Jekk għandek ketoaċidosi dijabetika (kumplikazzjoni ta ’ dijabete b’ telf ta ’ piż f’ daqqa, tqalliħ
vomiting).
jew remettar).
- If you have a problem with your kidneys.
- Jekk għandek problema bil- kliewi tiegħek.
- If you have a severe infection or are dehydrated.
- Jekk għandek infezzjoni severa jew int deidratat.
- If you are going to have a certain type of X-ray with an injectable dye.
- Jekk ħa tieħu ċertu tip ta ’ X- ray b’ kulur li jiġi njettat.
You will need to stop
Se jkollok bżonn tieqaf tieħu pilloli
taking Competact tablets at the time of and for a few days after the procedure.
Competact fil- ħin tal- proċedura u għal ftit jiem wara.
- If you are breast-feeding.
- Jekk inti qed tredda ’.
Take special care with Competact:
Oqgħod attent ħafna b’ pilloli Competact
- If you have a special type of diabetic eye disease called macular oedema (swelling of the back
- Jekk għandek tip speċjali ta ’ marda dijabetika tal- għajn msejjħa edema makulari (nefħa tal- parti
of the eye).
ta ’ wara tal- għajn).
- If you are going to have an operation under general anaesthetic, as you may need to stop taking
- Jekk ħa tagħmel operazzjoni taħt anesteżija ġenerali, minħabba li jista ’ jkollok bżonn tieqaf
Competact for a couple of days before and after the procedure.
tieħu Competact għal ftit ġranet qabel u wara l- proċedura.
There may be an increased possibility of your
Jista ’ jkun hemm possibilità akbar li inti toħroġ
becoming pregnant because of how your medicine works.
tqila minħabba l- mod kif taħdem il- mediċina tiegħek.
- If you already take any other tablets to treat diabetes.
- Jekk qed tieħu diġà pilloli oħra biex tikkura d- dijabete.
Please let your doctor know if you already take cimetidine, glucocorticoids, beta-2-agonists, diuretics or ACE inhibitors.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk diġà qed tieħu cimetidine, glukokortikojdi, agonisti- beta- 2, dijuretiċi jew inibituri ACE.
Pregnancy and breast-feeding Tell your doctor if you are, you think you might be or are planning to become pregnant.
Tqala u Treddigħ Għid lit- tabib tiegħek jekk inti, taħseb li inti jew qed tippjana biex toħroġ tqila.
Your doctor will advise you to discontinue this medicine.
It- tabib tiegħek se javżak biex twaqqaf din il- mediċina.
You should not use Competact if you are breast-feeding or are planning to breast-feed your baby.
M’ għandekx tuża Competact jekk qed tredda ’ jew qed tippjana li tredda t- tarbija tiegħek.
This medicine will not affect your ability to drive or operate machinery.
Sewqan u tħaddim ta ’ magni Din il- mediċina ma taffettwax il- ħila tiegħek li ssuq jew li tħaddem magni.
HOW TO TAKE COMPETACT
KIF GĦANDEK TIEĦU COMPETACT
Always take Competact tablets exactly as your doctor has told you.
Dejjem għandek tieħu Competact eżatt kif qallek it- tabib.
The usual dose is one tablet taken twice daily.
Id- doża li ssoltu tingħata hija pillola waħda darbtejn kuljum.
If necessary your doctor may tell you to take a different dose.
Jekk hemm bżonn it- tabib tiegħek jista ’ jgħidlek biex tieħu doża differenti.
You should take the tablets with or just after food to reduce the chance of an upset stomach.
Għandek tieħu l- pilloli ma ’ l- ikel jew eżatt wara l- ikel biex tnaqqas iċ- ċans ta ’ stonku mqalla ’.
If you are following a diabetic diet, you should continue with this while you are taking Competact tablets.
Jekk qed issegwi dieta dijabetika, għandek tkompli biha waqt li qed tieħu l- pilloli Competact 15mg.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Xi pazjenti li kien ilhom b’ dijabete mellitus tat- tip 2 u b’ marda tal- qalb jew puplesija minn qabel, li kienu kkurati b’ pioglitazone u insulina kellhom esperjenza ta ’ żvilupp ta ’ insuffiċjenza tal- qalb.
Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Għid lit- tabib tiegħek malajr kemm jista ’ jkun jekk ikollok esperjenza ta ’ sinjali ta ’ insuffiċjenza tal- qalb bħal qtugħ ta ’ nifs mhux tas- soltu jew żieda f’ daqqa fil- piż jew nefħa lokalizzata (edima).
In clinical trials in which pioglitazone was compared to other oral anti diabetic drugs or placebo (dummy pill), a higher number of bone fractures was seen in women (but not in men) taking pioglitazone.
Fi provi kliniċi fejn pioglitazone kien imqabbel ma ’ mediċini mill- ħalq kontra d- dijabete oħrajn jew ma ’ placebo (pillola finta), kien osservat numru akbar ta ’ fratturi fl- għadam fin- nisa (iżda mhux fl - irġiel) li kienu qed jieħu pioglitazone.
Your doctor will ask you to have blood tests periodically during treatment with Competact.
It- tabib tiegħek se jitolbok tagħmel testijiet tad- demm kull tant żmien waqt il- kura Competact.
At least once a year (more often if you are elderly or have kidney problems) your doctor will check that your kidneys are working normally.
Mill- anqas darba fis- sena (aktar ta ’ spiss jekk int anzjan jew għandek problemi fil- kliewi) it- tabib tiegħek se jiċċekkja li l- kliewi tiegħek qed jaħdmu kif suppost.
If you take more Competact tablets than you should:
Jekk tieħu pilloli Competact 15mg aktar milli suppost:
If you forget to take Competact:
Jekk tinsa tieħu pilloli Competact 15mg:
Try to take Competact tablets daily as prescribed.
Ipprova ħu pilloli Competact 15mg kuljum kif preskritt.
Do not stop taking Competact tablets without first discussing it with your doctor.
M’ għandekx tieħu doża doppja biex tpatti għal kull pillola li tkun insejt tieħu.
25 If you have any further questions on the use of Competact tablets ask your doctor or pharmacist.
Tieqafx tieħu pilloli Competact qabel ma tiddiskuti dan mat- tabib tiegħek.
Like all medicines, Competact can have side effects.
Bħal kull mediċina oħra, Competact jista ’ jkollu effetti sekondarji.
Some patients experience the following side effects whilst taking pioglitazone and/ or metformin (the two active substances of Competact).
Xi pazjenti esperjenzaw l- effetti sekondarji li ġejjin waqt li kienu qed jieħdu pioglitazone u/ jew metformin (iż- żewġ sustanzi attivi ta ’ Competact):
Very rarely patients taking metformin have experienced a condition called lactic acidosis (excess of lactic acid in your blood), particularly those whose kidneys are not working properly.
Rari ħafna, pazjenti li qed jieħdu metformin kellhom esperjenza ta ’ kondizzjoni msejjħa aċidożi lattika (eċċess ta ’ lactic acid fid- demm tiegħek), speċjalment dawk li l- kliewi tagħhom mhux qed jaħdmu sew.
Symptoms include feeling cold and uncomfortable, severe nausea and vomiting, abdominal pain, unexplained weight loss, or rapid breathing.
Sintomi jinkludu tħoss il- bard u tħossok mhux komdu, tqalligħ u rimettar sever, uġigħ addominali, telf ta ’ piż mhux spjegat, jew nifs mgħaġġel.
If you experience some of these symptoms stop taking Competact and consult a doctor immediately.
Jekk ikollok esperjenza ta ’ xi wħud minn dawn is- sintomi waqqaf Pioglitazone / metformin hydrochloride Takeda u kellem tabib minnufih.
Blurred vision due to swelling (or fluid) at the back of the eye has been reported.
Kienet irrapportata vista mċajpra kkawżata minn nefħa (jew fluwidu) fil- parti ta ’ wara ta ’ l- għajn.
If you experience these symptoms for the first time or if they get worse talk to your doctor as soon as possible.
Jekk ikollok esperjenza ta ’ dawn is- sintomi għall- ewwel darba jew jekk imorru għall- agħar kellem lit- tabib tiegħek malajr kemm jista ’ jkun.
Between 1 in 10 and 1 in 100 patients experience
Bejn 1 kull 10 u 1 kull 100 pazjent esperjenzaw
- blood in urine
- demm fl- awrina
Between 1 in 100 and 1 in 1000 patients experience
Bejn 1 kull 100 u 1 kull 1000 pazjent esperjenzaw
- insomnia
- insomnija
Between 1 in 1000 and 1 in 10000 patients experience
Bejn 1 kull 1000 u 1 kull 10000 pazjent esperjenzaw
- impaired liver function
- funzjoni mdgħajjfa tal- fwied
Less than 1 in 10,000 patients experience
Inqas minn 1 kull 10, 000 pazjent esperjenzaw
- a condition called lactic acidosis (excess of lactic acid in your blood) due to metformin,
- kondizzjoni msejjħa aċidożi lattika (eċċess ta ’ lactic acid fid- demm tiegħek) minħabba
particularly those whose kidneys are not working properly
metformin, speċjalment dawk li l- kliewi tagħhom mhux qed jaħdmu sew
- blurred vision due to swelling (or fluid) in the back of the eye.
- vista mċajpra kkawżata minn nefħa (jew fluwidu) fil- parti ta ’ wara ta ’ l- għajn.
HOW TO STORE COMPETACT
KIF TAĦŻEN COMPETACT
This medicinal product does not require any special storage conditions.
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Medicines should not be disposed of via wastewater or household waste.
Tużax Competact wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq il- folja.
26 6.
26 Din il- mediċina m’ għandhiex bżonn ħażna speċjali.
What Competact Tablets contain The active substances are 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.
Is- sustanzi attivi huma 15mg pioglitazone (bħala hydrochloride) u 850 mg metformin hydrochloride.
The other ingredients are, microcrystalline cellulose, povidone (K 30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide.
Is- sustanzi l- oħra huma microcrystalline cellulose, povidone (K 30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc u titanium dioxide.
What Competact Tablets look like and contents of the pack Competact tablets are white to off white, oblong, convex, film-coated tablets embossed ‘ 15 / 850’ on one face and ‘ 4833M’ on the other.
Pilloli Competact huma pilloli bojod għal abjad maħmuġ, oblung, miksija b’ rita, bbuzzati fuq iż- żewġ naħat u mmarkati b ’ ‘ 15 / 850 ’ fuq naħa u b ’ ‘ 4833M ’ fuq in- naħa l- oħra.
The tablets are supplied in blister packs of 14, 28, 30, 50, 56, 60, 90, 98 or 180 tablets.
Il- pilloli huma disponibbli f’ pakketti bil- folji ta ’ 14, 28, 30, 50, 56, 60, 90, 98 jew 180 pillola.
Takeda Global Research and Development Centre (Europe) Ltd, 61 Aldwych, London WC2B 4AE, United Kingdom.
Takeda Global Research and Development Centre (Europe) Ltd, 61 Aldwych, London WC2B 4AE, Ir Renju Unit.
Takeda Italia Farmaceutici SpA, Via Crosa, 86, I-28065 Cerano (NO), Italy.
Takeda Italia Farmaceutici SpA, Via Crosa, 86, I- 28065 Cerano (NO), L- Italja.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok agħmel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni għall- Kummerċ.
Κύπρος Takeda Global R & D Centre (Europe), Ηνω µένο Βασίλειο Τηλ: +44 (0)20 3116 8000
Κύπρος Takeda Global R & D Centre (Europe) Ηνωµένο Βασίλειο Τηλ: +44 (0) 20 3116 8000
This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f ’ {data}
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) 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.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT TAL- VALUTAZZJONI PUBBLIKA EWROPEW (EPAR)
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqin, biex jissodisfa r- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (ukoll parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Comtan?
X’ inhu Comtan?
Comtan is a medicine that contains the active substance entacapone.
Comtan hu mediċina li fiha s- sustanza attiva entacapone.
It is available as brown-orange tablets (200 mg).
Jiġi bħala pilloli kannella fl- oranġjo (200 mg).
What is Comtan used for?
Għal xiex jintuża Comtan?
Comtan is used to treat patients with Parkinson’ s disease.
Comtan jintuża fit- trattament ta ’ pazjenti bil- marda tal- Parkinson.
Parkinson’ s disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Il- marda tal- Parkinson’ s hija marda progressiva tal- moħħ li tikkawwża rogħda, tnaqqis fil- ħeffa taċ- ċaqliq u ebusija tal- muskoli.
Comtan is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘ fluctuations ’ towards the end of the period between two doses of their medication.
Comtan jintuża flimkien ma ’ levodopa (jew f’ taħlita ta ’ levedopa u benserazide jew taħlita ta ’ levodopa u carbidopa) meta l- pazjent ikollu ‘ tibdiliet f’ daqqa ’ lejn tmiem il- perjodu bejn iż- żewġ dożi tal - mediċina tagħhom.
Fluctuations happen when the effects of the medication wear off and symptoms re-emerge.
It- tibdiliet f’ daqqa jseħħu meta l- effetti tal- mediċina jkunu battew u s- sintomi jerġgħu jitfaċċaw.
Comtan is used when these fluctuations cannot be treated with the standard levodopa- containing combination alone.
Huma assoċjati ma ’ tnaqqis fl- effetti ta ’ levodopa, meta l- pazjent jesperjenza tibdiliet f’ daqqa, filli jkun ‘ on ’ u kapaċi jimxi, u filli jkun ‘ off ’ u jsibha diffiċli jimxi minn naħa għal oħra,, Comtan jintuża meta dawn it- tibdiliet f’ daqqa ma jkunux jistgħu jiġu ttrattati bil- kombinazzjoni standard biss li jkun fiha levodopa..
How is Comtan used?
Kif jintuża Comtan?
Comtan is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Comtan jintuża biss f’ kombinazzjoni jew ma ’ levodopa u benserazide jew ma ’ levodopa u carbidopa.
It is taken as one tablet with each dose of the other medicine, up to a maximum of 10 tablets a day.
Jittieħed bħala pillola waħda ma ’ kull doża tal- mediċina l- oħra, sa mhux iktar minn 10 pilloli kuljum.
It can be taken with or without food.
Jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
When patients first add Comtan to their exiting medication, they may need to take a lower daily dose of levodopa, either by changing how often they take it, or by reducing the amount of levodopa taken in each dose.
Meta l- pazjent iżid Comtan mal- mediċini eżistenti għall - ewwel darba, jistgħu jkunu jeħtieġu li d- doża ta ’ kuljum ta ’ levodopa titnaqqas, jew billi jeħduha inqas spiss jew billi jintuża ammont iżgħar ta ’ levodopa f’ kull doża.
Comtan can only be used with conventional combinations of levodopa.
Comtan jista ’ jintuża biss ma ’ kombinazzjonjiet konvenzjonali ta ’ levodopa.
It should not be used with combinations that are ‘ modified release’ (when the levodopa is released slowly over a few hours).
Ma għandux jintuża ma ’ taħlitiet b ’ ‘ rilaxx modifikat ’ (meta levodopa tiġi rilaxxata bil- mod ftit sigħat wara l- għoti).
How does Comtan work?
Kif jaħdem Comtan?
In patients with Parkinson’ s disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases.
Fil- pazjenti bil- marda tal- Parkinson, iċ- ċelloli fil- moħħ li jipproduċu n- newrotrasmettitur magħruf bħala dopamina jibdew imutu u l- ammont ta ’ dopamina fil- moħħ tonqos.
The patients then lose their ability to control their movements reliably.
Il- pazjenti mbagħad jitilfu l - abilità li jikkontrollaw il- moviment b’ mod affidabbli.
The active substance in Comtan, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Is- sustanza attiva f’ Comtan, entacapone, taħdem billi treġġa ’ għan- normal il- livelli ta ’ dopamina fil- partijiet tal- moħħ li jikkontrollaw il- moviment u l - ko- ordinazzjoni.
It only works when it is taken with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
Jaħdem biss meta jittieħed ma ’ levodopa, kopja tan- newrotrasmettitur dopamine, li jista ’ jinbela ’.
Entacapone blocks an enzyme that is involved in the break down of levodopa in the body called 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Minħabba f’ hekk, levodopa jibqa ’ attiv għal 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. catechol-O-methyl transferase (COMT).
Reproduction is authorised provided the source is acknowledged żmien itwal.
This helps to improve the symptoms of Parkinson’ s disease, such as stiffness and slowness of movement.
Dan jgħin fit- titjib tas- sintomi tal- marda tal- Parkinson, bħall- ebusija u t- tnaqqis fil- ħeffa tal- moviment.
How has Comtan been studied?
Kif ġie studjat Comtan?
Comtan has been studied in a total of 376 patients with Parkinson’ s disease, in two six-month studies that measured the effects of adding Comtan or placebo (a dummy medicine) to the patient’ s combination of levodopa and carbidopa or levodopa and benserazide.
Comtan ġie studjat fi 376 pazjent bil- marda tal- Parkinson, f’ żewġ studji li damu sitt xhur li kejlu l - effetti taż- żieda ta ’ Comtan jew plaċebo (mediċina finta) mal- kombinazzjoni ta ’ levodopa u carbidopa jew levodopa u benserazide.
The main measure of effectiveness was the time spent in the ‘ on’ state (the time when levodopa is controlling the symptoms of Parkinson’ s disease) after the first levodopa dose of the morning in the first study, and over one day in the second study.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien iż- żmien li l- pazjenti kienu fi stat ‘ on ’ (iż- żmien li fih levodopa jkun qed jikkontrolla s- sintomi tal- marda tal- Parkinson) wara l - ewwel doża ta ’ levodopa fl- għodwa ta ’ l- ewwel studju, u matul jum wieħed fit- tieni studju.
What benefit has Comtan shown during the studies?
X’ inhuma l- benefiċċji ta ’ Comtan li ntwerew f’ dawn l- istudji?
Comtan was more effective than placebo in both studies.
Comtan kien iktar effettiv mill- plaċebo fiż- żewġ studji.
In the first study, adding Comtan increased the ‘ on’ time by 1 hour and 18 minutes more than adding placebo.
Fl- ewwel studju, iż- żieda ta ’ Comtan żiedet il - ħin li jkunu ‘ on ’ b ’ siegħa u 18- il minuta iktar miż- żieda tal- plaċebo.
In the second study, the ‘ on’ time was increased by 35 minutes compared with placebo.
Fit- tieni studju, il- ħin ‘ on ’ żdied b’ 35 minuta meta mqabbel mal- plaċebo.
What is the risk associated with Comtan?
X’ inhu r- riskju assoċjat ma ’ Comtan?
The most common side effects with Comtan (seen in between 1 and 10 patients in 100) are dyskinesia (uncontrollable movements), nausea (feeling sick) and harmless urine discoloration.
L- iktar effetti sekondarji komuni ma ’ Comtan (li dehru f’ bejn pazjent wieħed u 10 minn kull 100) huma d- diskinesja (movimenti inkontrollabbli), id- dardir u tibdil fil- kulur ta ’ l- awrina li ma jagħmilx ħsara.
For the full list of all side effects reported with Comtan, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati b’ Comtan, ara l- Fuljett ta ’ Tagħrif.
Comtan should not be used in people who may be hypersensitive (allergic) to entacapone or any of the other ingredients.
Comtan m’ għandux jintuża f’ persuni li jistgħu jkunu allerġiċi għal entacapone jew xi sustanza oħra tiegħu.
Comtan should not be used in patients with: • liver disease; • phaeochromocytoma (a tumour of the adrenal gland); • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Comtan m’ għandux jintuża f’ pazjenti li jkollhom: • mard tal- fwied; • phaeochromocytoma (tumur tal- glandola adrenali); • każijiet preċedenti tas- sindromu newrolettiku malinn (disturb perikoluż tas- sistema nervuża ikkawżata minn mediċini antipsikotiċi) jew rabdomjolożi (rhabdomyolysis - tkissir tal- fibri tal - muskoli).
Comtan should not be used together with other medicines that belong to the group ‘ monoamine oxidase inhibitors ’ (a type of antidepressant).
Comtan m’ għandux jintuża flimkien ma ’ mediċini oħra li jagħmlu parti mill- grupp ta ’ ‘ inibituri tal - monoamino ossidażi ’ (monoamine oxidase - tip ta ’ mediċina kontra d- dipressjoni).
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Ara s- Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR) għad- dettalji kolha.
Why has Comtan been approved?
Għaliex ġie approvat Comtan?
The Committee for Medicinal Products for Human Use (CHMP) decided that Comtan’ s benefits are greater than its risks as an adjunct to standard preparations of levodopa/ benserazide or levodopa/ carbidopa for use in patients with Parkinson’ s disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Comtan huma akbar mir- riskji tiegħu bħala aġġunt ta ’ preparazzjonijiet standard ta ’ levodopa/ benserazide jew levodopa/ carbidopa għall- użu f’ pazjenti bil- marda tal- Parkinson u għal tibdiliet f’ daqqa fil- moviment fi tmiem id- doża, li ma jkunux jistgħu jiġu stabbiliti f’ dawn il - kombinazzjonijiet.
The Committee recommended that Comtan be given marketing authorisation.
Il- Kumitat irrakkomanda li Comtan jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Comtan:
Informazzjoni oħra dwar Comtan:
The European Commission granted a marketing authorisation valid throughout the European Union for Comtan to Novartis Europharm Limited on 22 September 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Comtan lil Novartis Europharm Limited fit- 22 ta ’ Settembru 1998.
The marketing authorisation was renewed on 22 September 2003 and on 22 September 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 22 ta ’ Settembru 2003 u fit- 22 ta ’ Settembru 2008.
The full EPAR for Comtan is available here.
L- EPAR sħiħ dwar Comtan jista ’ jiġi kkonsultat hawn.
This summary was last updated in 08-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Comtan 200 mg film-coated tablets
Comtan 200 mg pilloli miksijin b’ rita
Each film-coated tablet contains 200 mg entacapone.
Kull pillola miksija b’ rita jkun fiha 200 mg ta ’ entacapone.
Each tablet contains 1.82 mg sucrose.
Kull pillola fiha 1. 82 mg sucrose.
Brownish-orange, oval, biconvex film-coated tablet with “ Comtan ” engraved on one side.
Pillola miksija b’ rita ta ’ kulur oranġjo jagħti fil- kannella b’ forma ovali b ’ “ Comtan ” imnaqqxa fuq naħa waħda.
Entacapone is indicated as an adjunct to standard preparations of levodopa/ benserazide or levodopa/ carbidopa for use in adult patients with Parkinson’ s disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Entacapone huwa indikat biex jittieħed flimkien ma sustanzi standard ta ’ levodopa/ benserazide jew levodopa/ carbidopa li jintużaw f’ pazjenti adulti li għandhom il- marda ta ’ Parkinson jew tibdil fil - moviment fit- tmiem tat- teħid tad- dożi mediċinali, li ma jistgħux jiġu kkontrollati b’ dawk is- sustanzi kombinati.
Entacapone should only be used in combination with levodopa/ benserazide or levodopa/ carbidopa.
Entacapone għandu jintuża biss flimkien ma ’ levodopa/ benserazide jew levodopa/ carbidopa.
The prescribing information for these levodopa preparations is applicable to their concomitant use with entacapone.
L - informazzjoni dwar kif jiġu ordnati dawn is- sustanzi ta ’ levodopa hija applikabbli għall- użu tagħhom flimkien ma ’ entacapone.
Posology One 200 mg tablet is taken with each levodopa/ dopa decarboxylase inhibitor dose.
Pożoloġija Pillola waħda ta ’ 200 mg għandha tittieħed ma ’ kull doża ta ’ levodopa/ inibitur ta ’ dopa decarboxylase.
2,000 mg of entacapone.
Id- doża massima rrakkomandata hija ta ’ 200 mg għaxar darbiet kuljum, jiġifieri 2, 000 mg ta ’ entacapone.
Entacapone enhances the effects of levodopa.
Entacapone ikattar l- effetti ta ’ levodopa.
Hence, to reduce levodopa-related dopaminergic adverse reactions, e. g. dyskinesias, nausea, vomiting and hallucinations, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment.
Għalhekk sabiex jitnaqqsu l- effetti avversi dopaminerġiċi relatati ma ’ levodopa, eż. każijiet ta ’ diskajneżja, dardir, rimettar u alluċinazzjonijiet, ta ’ spiss ikun neċessarju tibdil tad- dożaġġ ta ’ levodopa, fl- ewwel ġranet jew fl- ewwel ġimgħat tal- kura b’ entacapone.
The daily dose of levodopa should be reduced by about 10– 30% by extending the dosing intervals and/ or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Id- doża ta ’ kuljum ta ’ levodopa għandha titnaqqas b’ 10- 30%, billi wieħed jestendi l- ħin ta ’ bejn id- dożi u/ jew billi jitnaqqas l- ammont ta ’ levodopa f’ kull doża, skond il- kundizzjoni klinika tal- pazjent.
If entacapone treatment is discontinued, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
Jekk il- kura b’ entacapone titwaqqaf, ikun hemm bżonn li jinbidel d- dożaġġ ta ’ trattamenti oħra ta ’ kontra l- marda ta ’ Parkinson, speċjalment ta ’ levodopa, sabiex jintlaħaq livell suffiċjenti ta ’ kontroll tas- sintomi ta ’ Parkinson.
Entacapone increases the bioavailability of levodopa from standard levodopa/ benserazide preparations slightly (5– 10%) more than from standard levodopa/ carbidopa preparations.
Għalhekk pazjenti li jkunu
Hence, patients who are taking standard levodopa/ benserazide preparations may need a larger reduction of levodopa dose when entacapone is initiated.
2 qed jieħdu sustanzi standard ta ’ levodopa/ benserazide, jista ’ jkollhom bżonn ta ’ tnaqqis akbar tad- doża ta ’ levodopa meta tibda l- kura b’ entacapone.
Renal insufficiency does not affect the pharmacokinetics of entacapone and there is no need for dose adjustment.
Insuffiċjenza tal- kliewi ma teffetwax il- farmakokinetika ta ’ entacapone u m’ hemmx bżonn ta ’ tibdil fid- doża.
However, for patients who are receiving dialysis therapy, a longer 2 dosing interval may be considered (see section 5.2).
Madanakollu, għal dawk il- pazjenti li qed jirċievu terapija tad - dijaliżi, wieħed jista ’ jikkunsidra żieda fl- intervall bejn doża u oħra (ara sezzjoni 5. 2).
Hepatic impairment: see section 4.3.
Indeboliment tal- fwied: ara sezzjoni 4. 3.
Elderly:
L- Anzjani:
No dosage adjustment of entacapone is required for elderly patients.
M’ hemm bżonn ta ’ l- ebda tibdil fid- doża ta ’ entacapone għal pazjenti anzjani.
Comtan is not recommended for use in children below age 18 due to lack of data on safety and efficacy.
Comtan mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
Method of administration Entacapone is administered orally and simultaneously with each levodopa/ carbidopa or levodopa/ benserazide dose.
Mod ta ’ kif għandu jingħata Entacapone jittieħed mill- ħalq fl- istess ħin ma ’ kull doża ta ’ levodopa/ carbidopa jew levodopa/ benserazide.
Entacapone can be taken with or without food (see section 5.2).
Entacapone jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt (ara sezzjoni 5. 2).
- Hypersensitivity to the active substance or to any of the excipients.
- Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
- Hepatic impairment.
- Indeboliment tal- fwied.
- Phaeochromocytoma.
- Fejokromoċitoma.
- Concomitant use of entacapone and non-selective monoamine oxidase (MAO-A and MAO-B)
- L- użu ta ’ entacapone flimkien ma ’ inibituri mhux selettivi ta ’ monoamine oxidase (MAO- A u
inhibitors (e. g. phenelzine, tranylcypromine).
MAO- B).
- Concomitant use of a selective MAO-A inhibitor plus a selective MAO-B inhibitor and
- L- użu ta ’ inibitur selettiv ta ’ MAO- A flimkien ma ’ inibitur selettiv ta ’ MAO- B u entacapone
entacapone (see section 4.5).
(ara sezzjoni 4. 5).
- A previous history of neuroleptic malignant syndrome (NMS) and/ or non-traumatic
- Passat mediku tas- sindrome newroleptiku malinn (NMS) u/ jew rabdomajoliżi mhux trawmatika.
Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson’ s disease.
Rabdomajoliżi konsegwenza ta ’ diskineżja severa jew sindrome newroleptiku malinn (NMS) ġew osservati f’ każijiet rari f’ pazjenti li jsofru bil- marda ta ’ Parkinson.
NMS, including rhabdomyolysis and hyperthermia, is characterised by motor symptoms (rigidity, myoclonus, tremor), mental status changes (e. g. agitation, confusion, coma), hyperthermia, autonomic dysfunction (tachycardia, labile blood pressure) and elevated serum creatine phosphokinase.
NMS, b’ rabdomajoliżi u ipertermja, hija ikkaratterizzata b’ sintomi ta ’ diffikultajiet fiċ- ċaqliq (riġidità, majoklonus, tregħid), bidliet fl- istat mentali (eż. aġitazzjoni, konfużjoni, koma), ipertermja, disfunzjoni awtonomika (takikardja, pressjoni tad- demm mhux stabbli) u żieda fil- livell ta ’ creatinine phosphokinase.
In individual cases, only some of these symptoms and/ or findings may be evident.
F’ każi individwali jista ’ jagħti l- każ li xi wħud biss minn dawn is- sintomi u/ jew sejbiet jkunu evidenti.
Neither NMS nor rhabdomyolysis have been reported in association with entacapone treatment from controlled trials in which entacapone was discontinued abruptly.
Fi provi kontrollati assoċjati mal- kura b’ entacopone fejn entacapone twaqqaf għall- għarrieda, la l - NMS u lanqas r- rabdomajoliżi ma ġew irrapurtati.
Since the introduction 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 meta tqiegħed fis- suq, ġew rrapurtati każijiet rari ta ’ NMS speċjalment meta endacopone u prodotti mediċinali dopaminerġiċi oħra li kienu qed jittieħdu flimkien miegħu, twaqqfu għall- għarrieda.
When considered necessary, withdrawal of entacapone and other dopaminergic treatment should proceed slowly, and if signs and/ or symptoms occur despite a slow withdrawal of entacapone, an increase in levodopa dosage may be necessary.
Meta jkun meqjus essenzjali it- waqqif tal- kura b’ entacapone u mediċini oħra dopaminerġiċi għandu jsir bil- mod u jekk is- sinjali u/ jew is- sintomi jitfaċċjaw, allavolja entacapone jitwaqqaf bil- mod, jista ’ jkun hemm bżonn ta ’ żieda fid- dożaġġ ta ’ levodopa.
Because of its mechanism of action, entacapone may interfere with the metabolism of medicinal products containing a catechol group and potentiate their action.
Għalhekk entacapone għandu
Thus, entacapone should be administered cautiously to patients being treated with medicinal products metabolised by catechol-O- methyl transferase (COMT), e. g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, and apomorphine (see also section 4.5).
3 jingħata b’ kawtela lil dawk il- pazjenti li jkunu qed jiġu kkurati bi prodotti mediċinali li jiġu metabolizzati b’ catechol- O- methyl transferase (COMT), eż. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha- methyldopa u apomorphine (ara wkoll sezzjoni 4. 5).
Entacapone is always given as an adjunct to levodopa treatment.
Entacapone dejjem jingħata flimkien mal- kura b’ levodopa.
Hence, the precautions valid for 3 levodopa treatment should also be taken into account for entacapone treatment.
Għalhekk il- prekawzjonijiet li għandhom jittieħdu għall- kura b’ levodopa għandhom jitqiesu wkoll waqt il- kura b’ entacapone.
Entacapone increases the bioavailability of levodopa from standard levodopa/ benserazide preparations 5– 10% more than from standard levodopa/ carbidopa preparations.
Entacapone iżid il- biodisponibilità ta ’ levodopa minn preparazzjonijiet standard ta ’ levodopa/ benserazide b’ 5- 10% aktar milli minn preparazzjonijiet standard ta ’ levodopa/ carbidopa.