qanastek/EMEA-V3 huggingface dataset:
Population pharmacokinetic analysis demonstrated less fluctuation in peak to trough plasma concentration but no differences in steady state AUC as weight increases.
L- analiżi tal- komportament farmakokinetiku fi grupp ta ’ persuni wera anqas varjazzjoni fl- ogħla (peak) u fl- anqas (trough) livelli do
As weight increases from 65 to 200 kg, Cmax is expected to decrease 24% and Ctrough is expected to increase by 5%.
Meta l- piż jiżdied minn 65 għal 200 kg, Cmax huwa mistenni li jonqos b’ 24% u Ctrough jiżdied b’ 5%.
Population no
Iż- żmien biex il- livell fid- demm jistabiliżża huwa aktar f’ pazjenti b’ obeżità (25 jum), bħala kosegwenza tal - Pro
pharmacokinetic analysis indicated that rimonabant pharmacokinetics are similar between healthy non-smoking subjects and patients who smoke.
L- analizi tal- komportament farmakokinetiku f’ gruppi ta ’ persuni jindika li l- komportament ta ’ rimonabant huwa l- istess, kemm f’ suggetti b’ saħħithom li ma jpejpux kif ukoll pazjenti li jpejpu.
Administration of rimonabant to healthy subjects in the fasted state or with a high fat meal demonstrated that Cmax and AUC were increased 67% and 48% respectively, under fed conditions.
9 L- effett ta ’ l- ikel: l- għoti ta ’ rimonabant lil suġġetti b’ saħħithom meta dawn kienu sajmin, jew li ħadu ikla li kien fiha persentaġġ għoli ta ’ xaħam, wera li Cmax u l- AUC kienu żdiedu b’ 67% u 48%, rispettivament, f’ sitwazzjoni mitmugħa.
In clinical studies, ACOMPLIA 20 mg was taken in the morning usually before breakfast. du
Fi studji kliniċi, 20 mg ta ’ ACOMPLIA ittieħdu filgħodu, normalment qabel il- kolazzjon.
Distribution:
at Distribuzzjoni:
The in vitro human plasma protein binding of rimonabant is high (> 99.9%) and non-saturable over a ro
Ir- rabta ta ’ rimonabant mal- proteini tal- plażma fil- bniedem in vitro huwa għoli (> 99. 9%) u ma jistax
wide concentration range.
izz ikun issaturat fuq medda wiesa ’ ta ’ konċentrazzjoni.
The apparent peripheral volume of distribution of rimonabant appears to be related to body weight, with obese patients having a higher volume of distribution than normal-weight subjects. lp
Il- volum periferali apparenti ta ’ distribuzzjoni ta ’ rimonabant jidher li huwa relatat mal- piż tal- ġisem; il- pazjenti li għandhom l- obeżità juru volum ogħla ta ’ distribuzzjoni minn suġġetti li għandhom piż normali.
Biotransformation:
tor Trasformazzjoni bijoloġika:
Rimonabant is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in ina
Rimonabant hu metaboliżżat in vitro kemm mis - sistema CYP3A kif ukoll dik amidohydrolase
vitro.
aw (predominantement fil- fwied).
Circulating metabolites do not contribute to its pharmacologic activity.
Il- prodotti metaboliċi li jiċċirkulaw ma jikkontribixxux fuq l- attività farmakoloġika tiegħu.
Elimination:
Tneħħija:
an approximate 3% of the dose of rimonabant is eliminated in the urine, while approximately 86% of the dose is excreted in the faeces as unchanged drug and metabolites.
Madwar 3% biss tad- doża ta ’ rimonabant hija eliminata fl- urina, fil- waqt li madwar 86% tad- doża titneħħa fl- ippurgar, bħala s- sustanza mhux ad mibdula u bħala sustanzi metaboliċi.
9 Special Populations Race:
F ’ pazjenti li qed ibatu mill- obeżità, l’ half- life ta ’ eliminazzjoni huwa itwal (madwar 16- il jum), minn pazjenti li mhumiex ħoxnin (madwar 9 ijiem), dovut għall - għ volum akbar ta ’ distribuzzjoni.
In single- and repeat-dose studies, the Cmax and AUC of rimonabant were similar in healthy Japanese
Popolazzjonijiet speċjali: m ’
The difference in half-life was due to differences in
Fi studji ibbażati fuq doża waħda u dawk repetuti, Cmax u l- AUC ta ’ rimonabant kienu simili f’ suġġetti Ġappuniżi u Kawkasi b’ saħħithom, filwaqt li l’ half- life ta ’ eliminazzjoni kien iqsar f’ suġġetti li li
ise peripheral volume of distribution as a consequence of lower weight in Japanese subjects.
Ġappuniżi (3 – 4 ijiem), meta mqabbel ma ’ suġġetti Kawkasi (madwar 9 ijiem).
Black patients may have up to a 31% lower Cmax and a 43% lower AUC than patients of other races.
Pazjenti Suwed jistgħu jkollhom sa 31% anqas f’ Cmax u 43% anqas fl - a
Gender:
AUC, meta mqabbla ma pazjenti ta ’ razez oħra. iċin
or The pharmacokinetics of rimonabant are similar in female and male patients.
Il- komportament farmakokinetiku ta’ rimonabant huwa l- istess f’ pazjenti nisa u rġiel. ed
uth Elderly patients have slightly higher exposure than young patients.
Pazjenti anzjani għandhom espożizzjoni ftit ogħla minn pazjenti żgħar.
Based on a population pharmacokinetic analysis (age range 18 - 81 years) a 75 year old patient is estimated to have a 21% higher Cmax and a 27% higher AUC than a 40 year old patient.
għandu 21% Cmax ogħla u 27% ogħla fl- AUC, meta mqabbel ma ’ pazjent ta ’ 40 sena.
ra Patients with hepatic insufficiency:
Pazjenti b’ insuffiċjenza tal- fwied:
Mild hepatic impairment does not alter rimonabant exposure.
Indeboliment ħafif tal- fwied ma jbiddilx l- espożizzjoni għal rimonabant.
Data are insufficient to draw conclusions regarding pharmacokinetics in moderate hepatic impairment.
tippermetti li wieħed jasal għal konklużjonijiet rigward il- komportament farmakokinetiku f’ indeboliment moderat tal- fwied.
Patients with severe hepatic impairment were not evaluated.
Pro
ge Patients with renal impairment:
Pazjenti b’ indeboliment renali:
The effect of renal function on the pharmacokinetics of rimonabant has not been studied specifically. lon Based on data from population pharmacokinetic studies, mild renal impairment do not seem to affect the pharmacokinetics of rimonabant.
Ibbażat fuq data minn studji farmakokinetiċi fuq gruppi ta ’ individwi, l - indeboliment renali ħafif ma jidhirx li jeffetwa l- komportament farmakokinetiku ta ’ rimonabant.
Limited data suggest an increased exposure in patients with moderate renal impairment (40% increase in AUC).
Data limitata tissuġġerixxi espożżizjoni miżjuda f’ pazjenti li għandhom indeboliment moderat tal- kliewi (40% żieda f’ AUC).
There are no data in severe renal impairment.
M’ hemmx data dwar l- indeboliment renali sever.
5.3 Preclinical safety data no
10 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
No convulsions were ct
Ma dehrux effetti mhux mixtieqa waqt studji tal- użu kliniku, iżda dehru f’ annimali li ġew mogħtija doża daqs dik klinika u jista 'jkollhom rilevanza għall- użu kliniku, kif spjegat: L- aċċessjonijiet intwerew b’ mod sporadiku fi studji fl- annimali gerriema u x- xadini tar- razza Makakki.
observed in dogs during a 3 month study.
Fil- klieb ma kienx hemm aċċessjonijiet waqt studju ta ’ 3 xhur.
In some, but not all cases, initiation of convulsions appeared to be associated with procedural stress such as handling of the animals.
Fi ftit, iżda mhux fil- każijiet kollha, il- bidu ta ’ l - aċċessjoni deheret li kienet assoċjata ma ’ l- istress assoċjat mal- proċedura, bħall- immaniġġar ta ’ l -
A proconvulsant activity of rimonabant was found in one of two safety pharmacology studies.
Attività ta ’ rimonabant li wasslet għall- aċcessjoni instabet f’ wieħed minn żewġ studji dwar is- sigurtà farmakoloġika.
No adverse effect of rimonabant du
It- trattament b’ rimonabant ma weriex effetti avversi fuq id- disinn ta ’ l- EEG
treatment was observed on EEG patterns in rats.
izz fil- firien.
Increased incidence and/ or severity of clinical signs suggestive of increased tactile hyperesthesia were ro
Iż- żieda fl- inċidenza u/ jew is- severità tas- sinjali kliniċi suġġestivi ta ’ żieda ta ’ iperestesja tal- ħass
observed in rodent studies.
tor intwerew fi studji fuq l- annimali gerriema.
A direct effect of rimonabant cannot be ruled out.
Effett dirett ta ’ rimonabant ma jistax ikun eskluż.
Liver steatosis and a dose-related increase in centrilobular necrosis were observed in long-term studies lp
Kienu innotati, fi studji fit- tul fuq il- far, li l- fwied sar xaħmi u kien hemm żieda fl- inċidenza tan -
in the rat.
aw nekrosi tal- lobuli ċentrali tal- fwied, relatati mad- daqs tad- doża.
In standard fertility studies in female rats (dosing for 2 weeks prior to mating) there was abnormal ina
Fi studji ‘ standard ’ fuq il- fertilità fil- firien ta ’ sess femminil, meta ngħataw dożi fil- ġimgħatejn qabel
oestrous cyclicity and a decrease in corpora lutea and fertility index at doses of rimonabant that induced maternal toxicity (30 and 60 mg/ kg/ day).
ux it- tgħammir, kien hemm ċikli abnormali fis- saħna sesswali u t- tnaqqis fil- corpora lutea u l- indiċi tal - fertilità, b’ dożi ta ’ rimonabant li ikkaġunaw tossiċità lill- omm (30 sa 60 mg/ kg/ jum).
Following dosing for a longer treatment duration prior to mating (9 weeks) that permitted recovery from the initial effects of rimonabant, no adverse effects were seen on fertility or oestrous cyclicity.
Wara li ngħata dożaġġ aktar fit- tul ta 9 ġimgħat, qabel it- tgħammir, li ippermettew l- irkupru mill- effetti inizjali ta ’ ad rimonabant, ma kienx hemm effetti avversi fuq il- fertilità jew fiċ- ċiklu tas- saħħna sesswali.
Regarding reproductive parameters, at 30 mg/ kg no dic
Fir - rigward tal- parametri riproduttivi, f’ doża ta ’ 30 mg/ kg, ma kienux innotati xi differenzi bejn l - għ annimali ittrattati u dawk li ma kienux.
differences were observed between treated animals and controls, at 60 mg/ kg effects were still observed (decreased number of corpora lutea, implantations, total and viable fetuses).
F’ dożaġġ ta ’ 60 mg/ kg l- effetti avversi kienu, madankollu, innotati (it- tnaqqis fil- formazzjoni tal corpora lutea, fit- taħwil taż- żigot fit- tessut ta ’ l- utru, u fin - numru totali u ta ’ dawk vijabbli tal- fetijiet). m ’
Sporadic malformations (anencephaly, micro-ophthalmia, widened brain ventricles and omphalocele) Me
Malformazzjonijiet sporadiċi, (l- assenza ta ’ partijiet kbar tal- moħħ flimkien ma ’ malformazzjonijiet tal- parti t’ isfel tal- moħħ fejn tingħaqad mal- korda spinali, nuqqas ta ’ żvilupp ta ’ l- għajnejn, il - li li
were observed in the rabbit embryofetal toxicity studies at doses resulting in exposures comparable with the clinical exposures.
ventrikoli tal- moħħ imwessgħin, u ftuq estensiv ta ’ l- organi addominali fir- reġjun umbiliku, bħala konsegwenza ta ’ nuqqas ta ’ żvilupp, fil- ġuf, tal- muskoli u t- tessuti molli taż- żaqq) kienu innotati fl - istudji dwar l- effetti tossiċi fuq l- embriju/ fetu tal- fniek, f’ dozi li rriżultaw f- espożizzjoni komparabbli a
Although maternal toxicity was observed at these doses, a relation to treatment cannot be excluded.
ma ’ livelli ta ’ l- espożizzjoni klinika.
No treatment-related malformations were seen in the rat.
Għalkemm tossiċità fuq l- omm kienet irrapportata b’ dawn id- dożi, ir- relazzjoni mat- trattament ma tistax tkun eskluża.
10 Effects of rimonabant on pre- and post-natal development were assessed in the rat at doses up to 10 mg/ kg/ day.
L- effetti ta ’ rimonabant fuq l- iżvilupp qabel u wara t- twelid kienu studjati fil- far f’ dożi sa ed
There was a treatment related increase in pup mortality in the pre-weaning period.
Kien hemm żieda fil- mortalità relatata mat- trattament tal- wild u fil- perijodu qabel dawn infattmu minn ommhom.
The increased pup mortality might be attributable to a failure of the dam to nurse or ingestion of
Iż- zieda fil- mortalità tal- wild tista ’ tkun dovuta għan- nuqqas tat - treddigħ mill- omm, jew il- preżenza ta’ rimonabant fil- ħalib u/ jew l- inibizzjoni ta ’ l- azzjoni riflessa tad - tt m
d rimonabant in milk and/ or inhibition of the suckling reflex that is reported in the literature to be initiated in neonatal mice by endocannabinoid signalling via CB1 receptors.
treddigħ, minn naħa tal- wild; din ta ’ l- aħħar hija irrapportata fil- letteratura xjentifika li tinbeda fil - ġrieden tat- twelid, permezz ta ’ sinjali minn endocannabinoid diretti lejn ir- reċetturi CB1.
There are reports in the
Ir- relevanza do
The potential relevance of this to administration of a CB1 antagonist is unknown.
potenzjali ta ’ dan, għall- għoti ta ’ sustanza antagonistika għar- reċetturi CB1, mhux magħruf.
In the pre- and post-natal development study in rats, exposure to rimonabant in utero and via lactation produced no alterations on learning or memory, but equivocal effects on motor
Fi studju fuq il- firien tqal, qabel u wara t- twelid, l- espożizzjoni għal rimonabant waqt it- tqala u l- irdigħ ma ikkawżawx ħsara fuq l- abbiltà tat- tagħlim jew fuq il- memorja, iżda effetti mhux ċari fuq il - Pro
or activity and auditory startle response were observed in the pups as a result of rimonabant exposure.
movimenti, u r- reazzjoni tal- ġisem għal stimoli akustiċi kienu innotati fil- wild, bħala riżultat ta ’ l - espożizzjoni għal rimonabant.
ra Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201),
at lactose monohydrate, povidone K 30 (E1201),
ge croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate lon Tablet coating: lactose monohydrate, hypromellose 15 mPa. s (E464), no
izz croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460),
titanium dioxide (E171), macrogol 3000
tor magnesium stearate
Tablet polishing: ct
Ir- rita tal- pillola:
carnauba wax (E903)
aw lactose monohydrate, hypromellose 15 mPa. s (E464), titanium dioxide (E171), macrogol 3000
6.2 Incompatibilities du
ux Il- lostru tal- pillola: carnauba wax (E903) ad 6. 2 Inkompatibilitajiet għ Ma jgħoddx f’ dan il- każ m ’
Not applicable ro
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
3 years lp
3 snin li li
6.4 Special precautions for storage ina
6. 4 Prekawzjonijiet speċjali għall- ħażna a
This medicinal product does not require any special storage conditions.
Din il- mediċina m’ għandiex bżonn ħażna speċjali. iċin
6.5 Nature and contents of container dic
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
PVC-aluminium blister packs containing 14, 28, 30, 56, 84, 90 and 98 film-coated tablets.
Folja tal- PVC u l- aluminju f’ pakketti ta ’ 14, 28, 30, 56, 84, 90 u 98 pilloli miksija b’ rita. ed
70 x 1 film-coated tablets in PVC-aluminium perforated unit dose blister packs.
70 x 1 pilloli miksija b’ rita ġo folja tal- PVC u l- aluminju, imtaqqba biex titneħħa doża waħda.
Opaque white HDPE bottles containing 28, 98 and 500 film-coated tablets.
Fliexken opaki u bojod tal- HDPE li fihom 28, 98 u 500 pillola miksija b’ rita.
Me
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali. tt m
No special requirements
L- ebda ħtiġijiet speċjali. do
MARKETING AUTHORIZATION HOLDER
ID- DETENUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ Pro
174 Avenue de France
sanofi- aventis, 174 avenue de France, F- 75013 Paris, Franza
MARKETING AUTHORIZATION NUMBER
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
19 June 2006
at 19 Ġunju 2006
ra 10.
izz 10.
ge Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu. lon no ct du ro lp ina dic Me
tor aw Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
CONDITIONS OF THE MARKETING AUTHORISATION ct du ro
ux ad għ m ’ li li a iċin ed tt m do Pro
13 A.
13 at izz tor aw ux ad ANNESS II għ A.
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT m ’
d Name and address of the manufacturers responsible for batch release
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ li li a iċin ed tt m do Pro
ise Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, France
Sanofi Winthrop Industrie, 30- 36 avenue Gustave Eiffel, BP 27166, F- 37071 Tours Cedex 2, Franza
sanofi-aventis S. p. A., Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy
at sanofi- aventis S. p. A., Strada Statale 17, Km 22, 67019 Scoppito (AQ), L- Italja
or The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
izz Fuq il- fuljett ta 'tagħrif tal- prodott medicinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli għall- ħrug tal- lott konċernat.
uth B.
tor B.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
aw • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DENTENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Medicinal product subject to medical prescription.
ux Prodott mediċinali jingħata b’ riċetta tat- tabib.
ge • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT lon Not applicable.
• ad KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI għ Ma jgħoddx f’ dan il- każ.
• OTHER CONDITIONS no
• KUNDIZZJONIJIET OĦRA m ’
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market. ct
Id- denentur tal- awtorizzazzjoni għat- tqegħid fis- suq (MAH) irid jiżgura li s- sistema tal - farmakoviġilanza hija stabbilita u qed taħdem, qabel il- prodott jinħareġ fis- suq. li li
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan. du
L- MAH jintrabat li jagħmel l- istudji u attivitajiet oħra ta ’ farmakoviġilanza, deskritti fil- Pjan tal - Farmakoviġilanza a iċin
An updated risk management plan should be provided as per the CHMP guideline on risk management systems for medicinal products for human use. ro lp ina dic Me
Pjan aġġornat fil- kontroll tar- riskji jrid ikun ipprovdut skond il- linji gwida maħruġa minn CHMP fuq is- sistemi tal- kontroll tar- riskju dwar il- prodotti mediċinali użati fil- bniedem. ed tt m do Pro
15 Me dic ina lp ro du ct
15 at izz tor aw ux ad ANNESS III għ TIKKETTA U FULJETT TA ’ TAGĦRIF m ’ li li a iċin ed tt m do Pro
16 no A.
16 Pro do tt m ed iċin a
LABELLING lon ge ra uth or ise d PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for the presentations of 14, 28, 30 56, 70, 84, 90 and 98 film-coated tablets in blisters
Kaxxa tal- kartun magħmula ghal 14, 28, 30, 56, 70, 84, 90 u 98 pilloli miksija b’ rita fil- folji
or ACOMPLIA 20 mg film-coated tablets rimonabant
at ACOMPLIA 20 mg pilloli miksija b’ rita rimonabant
uth 2.
izz 2.
Each tablet contains 20 mg of rimonabant.
tor Kull pillola fiha 20 mg ta ’ rimonabant
ra 3.
aw 3.
ge Also contains lactose monohydrate.
ux Fihom ukoll il- lactose monohydrate.
See leaflet for further information. lon 4.
Aqra l- fuljett għal aktar informazzjoni ad għ 4.
14 film-coated tablets no
14- il pillola miksija b’ rita m ’
28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 70x1 film coated-tablets ct
28 pillola miksija b’ rita 30 pillola miksija b’ rita 56 pillola miksija b’ rita li li
84 film-coated tablets 90 film-coated tablets du
70x1 pillola miksija b’ rita 84 pillola miksija b’ rita 90 pillola miksija b’ rita a
98 film-coated tablets
98 pillola miksija b’ rita iċin
METHOD AND ROUTE(S) OF ADMINISTRATION ro
MOD TA ’ KIF U MNEJN JINGĦATA ed
Oral use. lp
Użu orali.
Read the package leaflet before use ina
Aqra il- fuljett ta ’ tagħrif qabel l- użu tt m
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA do
Keep out of the reach and sight of children. dic
Pro
OTHER SPECIAL WARNING(S), IF NECESSARY Me
TWISSIJA( IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA
SPECIAL STORAGE CONDITIONS
18 9 KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TAL- PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK
ra sanofi-aventis 174 avenue de France F-75013 Paris
aw 174 avenue de France F- 75013 Paris Franza
ge France
ux 12.
MARKETING AUTHORISATION NUMBER(S) lon EU/ 1/ 06/ 344/ 001 EU/ 1/ 06/ 344/ 002 EU/ 1/ 06/ 344/ 003 EU/ 1/ 06/ 344/ 004 no
ad EU/ 1/ 06/ 344/ 001 EU/ 1/ 06/ 344/ 002 għ EU/ 1/ 06/ 344/ 003 EU/ 1/ 06/ 344/ 004 EU/ 1/ 06/ 344/ 005 m ’
EU/ 1/ 06/ 344/ 005 EU/ 1/ 06/ 344/ 006 EU/ 1/ 06/ 344/ 010 EU/ 1/ 06/ 344/ 011 ct du
EU/ 1/ 06/ 344/ 006 EU/ 1/ 06/ 344/ 010 EU/ 1/ 06/ 344/ 011 li li
BATCH NUMBER
NUMRU TAL- LOTT a iċin
GENERAL CLASSIFICATION FOR SUPPLY lp
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA ed
Medicinal product subject to medical prescription. ina
Prodott mediċinali jingħata bir- riċetta tat- tabib. tt m
INSTRUCTIONS ON USE dic
STRUZZJONIJIET DWAR L- UŻU do
INFORMATION IN BRAILLE
INFORMAZZJONI BIL- BRAILLE Pro
18 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
19 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
d Blisters of the presentations of 14, 28, 56, 84 and 98 film-coated tablets
Folji ta ’ daqsijiet ta ’ 14, 28, 56, 84 u 98 pilloli miksija b’ rita
ACOMPLIA 20 mg film-coated tablets
at ACOMPLIA 20 mg pilloli miksija b’ rita rimonabant
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DENTENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
sanofi-aventis
tor sanofi- aventis
ge EXP {MM/ YYYY}
ux EXP {XX/ SSSS}
BATCH NUMBER lon Lot
NUMRU TAL- LOTT għ Lot m ’
OTHER no
OĦRAJN
Monday Tuesday Wednesday ct
It- Tlieta L- Erbgħa Il- Ħamis a
Thursday Friday du
Il- Ġimgħa iċin
Saturday Sunday ro lp ina dic Me
Is- Sibt Il- Ħadd ed tt m do Pro
19 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
20 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
d Blisters of the presentations of 30, 70 x 1 and 90 film-coated tablets
Folji ta ’ daqs ta 30, 70 x 1 u 90 pilloli miksija b’ rita
OTHER no ct du ro lp ina dic Me
OĦRAJN li li a iċin ed tt m do Pro
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
d Carton of the presentations of 28, 98 and 500 film-coated tablets in HDPE bottles / HDPE bottle
Kaxxa tal- kartun ta ’ daqsijiet ta ’ 28, 98 u 500 pilloli miksija b’ rita fi fliexken HDPE / it- tikketta tal- flixkun HDPE għad- daqsijiet ta ’ 28, 98 u 500 pilloli miksija b’ rita
1.
at 1.
or ACOMPLIA 20 mg film-coated tablets rimonabant
izz ACOMPLIA 20 mg pilloli miksija b’ rita rimonabant
uth 2.
tor 2.
ra Each tablet contains 20 mg of rimonabant.
aw Kull pillola fiha 20 mg ta ’ rimonabant.
ge 3.
ux 3.
See leaflet for further information.
Fihom ukoll il- lactose monohydrate. ad Aqra l- fuljett għal aktar informazzjoni għ
PHARMACEUTICAL FORM AND CONTENTS no
GĦAMLA FARMAĊEWTIKA U KONTENUT m ’
28 film-coated tablets 98 film-coated tablets 500 film-coated tablets ct
28 pillola miksija b’ rita 98 pillola miksija b’ rita li li
METHOD AND ROUTE(S) OF ADMINISTRATION du
MOD TA ’ KIF U MNEJN JINGĦATA iċin
Oral use.
Użu orali.
Read the package leaflet before use. ro
Aqra il- fuljett ta ’ tagħrif qabel l- użu. ed tt m
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT lp
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
Keep out of the reach and sight of children. ina
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. do
OTHER SPECIAL WARNING(S), IF NECESSARY dic
TWISSIJA( IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA Pro
EXP {MM/ YYYY} Me
EXP {XX/ SSSS}
SPECIAL STORAGE CONDITIONS
22 9 KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TAL- PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
ise 11.
at izz 11.
or 174 avenue de France F-75013 Paris France
tor sanofi- aventis 174 avenue de France
uth 12.
ux 12.
ra EU/ 1/ 06/ 344/ 007 EU/ 1/ 06/ 344/ 008 EU/ 1/ 06/ 344/ 009
EU/ 1/ 06/ 344/ 007 ad EU/ 1/ 06/ 344/ 008 EU/ 1/ 06/ 344/ 009 għ
BATCH NUMBER
NUMRU TAL- LOTT m ’
lon
Lot li li
GENERAL CLASSIFICATION FOR SUPPLY no
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA a
Medicinal product subject to medical prescription.
Prodott mediċinali jingħata bir- riċetta tat- tabib iċin
INSTRUCTIONS ON USE ct du
STRUZZJONIJIET DWAR L- UŻU ed
INFORMATION IN BRAILLE
INFORMAZZJONI BIL- BRAILLE tt m
22 Me dic ina lp ro du ct
ACOMPLIA do Pro
23 no B.
23 Pro do tt m ed iċin a
PACKAGE LEAFLET lon ge ra uth or ise d PACKAGE LEAFLET:
24 li li m ’ għ ad
INFORMATION FOR THE USER
FULJETT TA ’ TAGĦRIF:
ACOMPLIA 20 mg film-coated tablets
ACOMPLIA 20 mg pilloli miksija b' rita (rimonabant)
ise Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tuża din il- mediċina.
or their symptoms are the same as yours.
il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
- If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
tell your doctor or pharmacist.
tor imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
- You are advised to share the information in this leaflet with relatives or other relevant persons.
- Qed tingħata parir biex taqsam l- informazzjoni f’ dan il- fuljett ma ’ qraba jew nies oħra relevanti.
In this leaflet:
aw F’ dan il- fuljett:
What ACOMPLIA is and what it is used for 2.
X’ inhu ACOMPLIA u għalxiex jintuża 2.
Before you take ACOMPLIA 3.
ux 3.
How to take ACOMPLIA 4.
Kif għandek tieħu ACOMPLIA 4.
Possible side effects
Effetti sekondarji li jista ’ jkollu 5.
ge 5 How to store ACOMPLIA 6.
Kif taħżen ACOMPLIA ad 6.
1.
Aktar tagħrif għ 1.
Further information WHAT ACOMPLIA IS AND WHAT IT IS USED FOR
X’ INHU ACOMPLIA U GĦALXIEX JINTUŻA m ’
The active ingredient of ACOMPLIA is rimonabant.
Is- sustanza attiva ta ’ ACOMPLIA huwa rimonabant.
It works by blocking specific receptors in the brain and fat tissues called CB1 receptors.
Jaħdem billi jibblokka reċetturi speċifiċi fil - moħħ u t- tessut xaħmi, msejjħa reċetturi CB1.
ACOMPLIA is indicated in the treatment of obese or no
ACOMPLIA huwa indikat fit- trattament ta ’ pazjenti li qed ibatu mill- obeżità jew jiżnu aktar minn normal u li għandhom fatturi ta ’ riskju oħra, bħal dijabete, li li
overweight patients with additional risk factors such as diabetes or high levels of fatty substances in the blood called lipids (dyslipidaemia; mainly cholesterol and triglycerides) as adjunct to diet and exercise. ct
jew livelli għolja ta’ sustanzi xaħmin fid- demm magħrufa bħala lipidi (livelli abnormali ta ’ xaħam fid - demm; prinċalment kolesterol u triglycerides), flimkien mad- dieta u l- eżerċizzju. a iċin
BEFORE YOU TAKE ACOMPLIA du
QABEL MA TIEĦU ACOMPLIA
Do not take ACOMPLIA − if you currently suffer from depression − if you are currently being treated for depression ro
- jekk bħalissa qed tiġi kkurat għal depressjoni
− if you are allergic (hypersensitive) to rimonabant, or any of the other ingredients of ACOMPLIA − if you are breast-feeding. lp
- jekk int allerġiku/ a (tbagħti minn sensittività eċċessiva) għal rimonabant, jew sustanzi oħra ta ’
Take special care with ACOMPLIA Tell your doctor before you start to take this medicine − if you have previously suffered from depression or have had suicidal thoughts ina
- jekk qabel kont tbati minn depressjoni jew kellek ħsibijiet suwiċidali
− if you have impaired liver function − if you have severely impaired renal function − if you have diabetes (see section 4) − if you are currently being treated for epilepsy dic
- jekk inti għandek id- dijabete (ara sezzjoni 4)
− if you are less than 18 years of age.
- jekk int taħt l- età ta ’ 18- il sena.
There is no information available on the use of ACOMPLIA in people under 18 years of age.
M’ hemmx informazzjoni disponibbli dwar l- użu ta ’
Me
ACOMPLIA f’ persuni taħt it- 18- il sena.
Serious psychiatric events including depression or mood changes have been reported in patients taking ACOMPLIA (see section POSSIBLE SIDE EFFECTS).
Ġrajjiet psikjatriċi serji nklużi depressjoni jew bidla fil- burdata ġew irrapportati f’ pazjenti li kienu qed jieħdu ACOMPLIA (ara sezzjoni EFFETTI SEKONDARJI LI JISTA ’ JKOLLU).
If you experience symptoms of depression (see below) during treatment with ACOMPLIA you should contact your doctor and stop the treatment.
25 Jekk iġġarrab sintomi ta ’ depressjoni (ara hawn taħt) waqt il- kura b’ ACOMPLIA inti għandek tikkuntattja lit- tabib tiegħek u twaqqaf il- kura.
24 Signs and symptoms associated with depression could be:
Sinjali u sintomi assoċjati mad- depressjoni jistgħu ikunu:
Sadness, depressed mood; loss of interest in previously pleasurable activities; agitation; irritability;
Swied il- qalb, burdata depressiva; nuqqas ta’ interess f’ attivitajiet li qabel kienu jagħtu gost; aġitazzjoni; irritabilità; inibizzjoni u dewmien biex tagħmel xi ħaġa; konċentrazzjoni baxxa; ansjetà;
d slowed, inhibited actions; poor concentration; anxiety; difficulty in sleeping (insomnia); thoughts or words about death or suicide.
Għandek tgħarraf lit- tabib tiegħek jekk wara li tinbeda l- kura jiżviluppaw jew jiħżienu xi wieħed mis -
ise You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
izz sintomi mniżżla hawn fuq.
or The activity of ACOMPLIA is increased by simultaneous use of some drugs (so-called CYP3A4 inhibitors) such as: − itraconazole (antifungal medicine)
tor L- attività ta ’ ACOMPLIA tiżdied jekk tieħu miegħu xi sustanzi mediċinali oħra (hekk imsejjħa inibituri ta ’ CYP3A4) bħal:
uth − ketoconazole (antifungal medicine) − ritonavir (medicine for the treatment of HIV infections) − telithromycin (antibiotic) − clarithromycin (antibiotic)
- ketoconazole (mediċina kontra l- infezzjoni bil- moffa)
ra − nefazodone (anti-depressor) Please inform your doctor or pharmacist if you are taking or have recently taken the above mentioned medicines or any other medicines, including those obtained without a prescription such as St John ’ s
- ritonavir (mediċina għall- kura ta ’ l- infezzjonijiet bl- HIV)
ge wort, rifampicin (antibiotic), medicines for weight loss, medicines to improve blood lipids (fats), antidiabetes medicines and medicines to treat epilepsy (e. g. phenytoin, phenobarbital, carbamazepine) or depression.
Jekk jogħgbok, għid lit- tabib jew lill- ispiżjar tiegħek jekk int qiegħed tieħu jew ħadt dan l- aħħar il - ad mediċini msemmija hawn fuq jew xi mediċini oħra, anki dawk mingħajr riċetta, bħal St John’ s wort, rifampicin (antibijotiku), mediċini biex tonqos fil- piż, mediċini biex tikkontrolla x- xaħmijiet fid - għ demm, mediċini għad- dijabete u mediċini biex tikkura l- epilessija (bħal phenytoin, phenobarbital, carbamazepine) jew id- depressjoni. m ’
Pregnancy and breast-feeding ACOMPLIA should not be taken during pregnancy.
Tqala u Treddigħ ACOMPLIA m’ għandux jittieħed waqt it- tqala.
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking ACOMPLIA. no
tippjana biex toħroġ tqila, waqt li qed tieħu ACOMPLIA.
Do not take this medicine when breast-feeding.
Tieħux din il- mediċina meta qed tredda ’.
Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby.
Għid lit- tabib tiegħek jekk int qed tredda ’ jew għandek a
Driving and using machines ct
f’ moħħok li ser tredda ’ lit- tarbija tiegħek. iċin
At the recommended dose, ACOMPLIA is not expected to reduce your ability to drive and use machines. du
Sewqan u tħaddim ta ’ magni Fid- doża irrakkomandata, ACOMPLIA mhux mistenni li jnaqqas il- ħila biex issuq jew tħaddem magni. ed
Important information about some of the ingredients of ACOMPLIA ACOMPLIA tablets include lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ ACOMPLIA Il- pilloli ta ’ ACOMPLIA fihom il- lattosju.
If you are intolerant to some sugars, contact your doctor before taking this medicine. ro lp
tiegħek qabel ma tibda tieħu din il- mediċina.
HOW TO TAKE ACOMPLIA
KIF GĦANDEK TIEĦU ACOMPLIA do
Always take ACOMPLIA exactly as your doctor has told you.
Dejjem għandek tieħu ACOMPLIA skond il- parir eżatt tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat - tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
The usual dose is one 20 mg tablet to be taken once daily in the ina
Id- doża li ssoltu tingħata hija pillola waħda ta ’ Pro
morning before breakfast.
20 mg, li tittieħed darba kuljum filgħodu qabel il- kolazzjon.
Swallow the tablet whole.
Ibla ’ l- pillola sħiħa.
You need to start and continue a reduced calorie diet and a physical activity program to get best results.
Għandek tibda dieta u tkompliha biex tnaqqas l- ammont ta ’ kaloriji u tibda programm ta ’ attività fiżika biex ikollok l- aħjar riżultati.
Your doctor should recommend the type of diet and the level of physical activity required, that dic
It- tabib tiegħek għandu jirrakkomanda it- tip ta ’ dieta u l- livell ta ’ attività fiżika meħtieġa, li jaqblu mal- kondizzjoni speċifika tiegħek u saħħtek in ġenerali.
Me
Tieħu ACOMPLIA ma ’ l- ikel u x- xorb ACOMPLIA għandu jittieħed darba kuljum filgħodu qabel il- kolazzjon.
If you take more ACOMPLIA than you should If you take more ACOMPLIA than you should tell a doctor or pharmacist.
26 Jekk tieħu ACOMPLIA aktar milli suppost Jekk ħadt aktar ACOMPLIA milli suppost għid lit- tabib jew lill- ispiżjar.
25 If you forget to take ACOMPLIA Take it as soon as you remember but do not take a double dose to make up for any forgotten dose.
Jekk tinsa tieħu ACOMPLIA Ħudha hekk kif tiftakar iżda m’ għandekx tieħu doża doppja biex tpatti għad- doża li tkun insejt tieħu.
d If you have any further questions on the use of this product ask your doctor or your pharmacist.
at Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
ise 4.
izz 4.
Like all medicines, ACOMPLIA can cause side effects, although not everybody gets them
L- effetti sekondarji komuni ħafna, li jidhru f’ aktar minn 1 f’ kull 10, li kellhom il- pazjenti fuq
or Very common side effects, that affect more than 1 per 10, that have occurred in patients on ACOMPLIA include: nausea and upper respiratory tract infection.
Id- dardir u l- infezzjonijiet tal- passaġġi tan- nifs, tal- parti ta ’ fuq.
uth Common side effects, that affect more than 1 per 100 but less than1 per 10, that have occurred in patients on ACOMPLIA include: upset stomach, vomiting, trouble with sleeping, nervousness, depression, irritability, dizziness,
Effetti sekondarji komuni, li jidhru f’ aktar minn 1 f’ kull 100 iżda anqas minn 1 f’ kull 10, li kellhom il -
ra diarrhoea, anxiety, itching, excessive sweating, muscle cramps or spasm, fatigue, bruising, tendon pain and inflammation (tendonitis), memory loss, back pain (sciatica), altered sensitivity (less sensitivity or abnormal burning or prickling sensation) of the hands and feet, hot flush, fall, influenza, and joint sprain.
Stonku mqalleb, rimettar, problemi fl- irqad, nervożiżmu, depressjoni, irritabilità, sturdament, dijarrea, anzjetà, ħakk, tagħriq eċċessiv, bugħawwieġijiet u spażmu tal- muskoli, għejja, tbenġil, uġigħ fl- għeruq ad u infjammazzjoni tagħhom (tendonitis), tnaqqis fil- memorja, uġigħ fid- dahar (xjatika), tibdil fil- ħass (inqass ħass jew sensazzjoni abnormali ta ’ ħruq jew tingiż) ta ’ l- idejn u s- saqajn, sħanat, waqgħat, l - għ influwenza u tfekkik ta’ ġog.
ge Uncommon side effects, that affect less than 1 per 100 but more than1 per 1000, that have occurred in patients on ACOMPLIA include: lon Sleepiness (lethargy), tremor, night sweats, panic symptoms, hiccups, anger, restlessness (dysphoria), emotional disorder, suicidal thoughts, aggressiveness or aggressive behaviour, hypoglycaemia (low blood sugar).
Effetti sekondarji mhux komuni, li jidhru f’ anqas minn 1 f’ kull 100 iżda aktar minn 1 f’ kull 1000, li m ’
Rare side effects, that affect less than 1 per 1000, that have occurred in patients on ACOMPLIA no
Effetti sekondarji rari, li jinsabu f’ anqas minn 1 f’ kull 1000, li kellhom il- pazjenti b’ ACOMPLIA a
include: hallucinations.
kienu jinkludu: l- alluċinazzjonijiet. iċin
During post-marketing experience the following side effects have also been reported (frequency not known): ct
Mill- esperjenza wara li l- prodott tqiegħed fis- suq ġew irrapportati wkoll dawn l- effetti sekondarji li ġejjin (il- frekwenza m’ hijiex magħrufa): ed
Convulsion, disturbance in attention, delusion (false belief), paranoia, rash, headache and stomach pain. du
Konvulżjonijiet, disturbi fl- attenzjoni, taqriq (konvinzjoni qarrieqa) paranojja, raxx, uġigħ ta ’ ras u uġigħ fl- istonku. tt m
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. ro
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek. do Pro
HOW TO STORE ACOMPLIA lp
KIF TAĦŻEN ACOMPLIA
The ina
Tużax ACOMPLIA wara d- data ta ’ skadenza li tidher fuq il- kartuna wara EXP.
expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
This medicinal product does not require any special storage conditions dic
at Din il- mediċina m’ għandiex bżonn ħażna speċjali.
Medicines should not be disposed of via wastewater or household waste.
izz Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew l- iskart domestiku.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill- ispiżjar tiegħek kif għandek tarmi mediċini li m’ għandekx bżonn.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall- protezzjoni ta ’
Me
tor l- ambjent.
26 6.
aw 6.
What ACOMPLIA contains
X’ fih ACOMPLIA:
d The active substance is rimonabant.
Is- sustanza attiva hi rimonabant.
One film-coated tablet contains 20 mg rimonabant.
Pillola waħda miksija b’ rita fiha 20 mg rimonabant.
The other ingredients are:
ux Is- sustanzi l- oħra huma:
ise Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate Tablet coating: lactose monohydrate, hypromellose 15 mPa. s (E464), titanium dioxide (E171), macrogol 3000
Il- qalba tal- pillola: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate ad Ir- rita tal- pillola: lactose monohydrate, hypromellose 15 mPa. s (E464), titanium dioxide (E171), macrogol 3000 għ Il- lostru tal- pillola: carnauba wax (E903)
What ACOMPLIA looks like and contents of the pack
Id- Dehra ta ’ ACOMPLIA u l- kontenuti tal- pakkett: m ’
uth ACOMPLIA 20 mg is supplied as teardrop-shaped, white film-coated tablets debossed with “ 20 ” on one side.
ACOMPLIA 20 mg huwa fornit bħala pilloli bojod taħt forma ta ’ qatra dmugħ, u miksija b’ rita, imnaqqxin bin- numru “ 20 ” fuq faċċata waħda. li li
ACOMPLIA is available in blister packs of 14, 28, 30, 56, 84, 90 and 98 tablets, in perforated unit
ACOMPLIA huwa disponibbli f’ folja ta ’ 14, 28, 30, 56, 84, 90 u 98 pilloli, f’ folji imtaqqbin doża waħda, doża waħda li fihom 70 x 1 pillola, u fi fliexken bojod tal- plastik li fihom 28, 98 u 500 pillola. a
ra dose blister packs containing 70 x 1 tablets, and in white plastic bottles containing 28, 98 and 500 tablets.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
Not all pack sizes may be marketed.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq ed
ge Marketing Authorisation Holder and Manufacturer lon Marketing Authorisation Holder sanofi-aventis 174, avenue de France F-75013 Paris France no
sanofi- aventis 174, avenue de France F- 75013 Paris tt m
Manufacturers Sanofi Winthrop Industrie ct
Manifatturi Sanofi Winthrop Industrie do
30-36, avenue Gustave Eiffel – BP 27166 F-37071 Tours Cedex 2 France du
30- 36, avenue Gustave Eiffel – BP 27166 F- 37071 Tours Cedex 2 Franza Pro
Strada Statale 17, Km 22 ro
Strada Statale 17, Km 22 67019 Scoppito (AQ) L- Italja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: ina dic Me
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
d България
България sanofi- aventis Bulgaria EOOD
ise sanofi-aventis Bulgaria EOOD Тел.: +359 (0)2 970 53 00
at Тел.: +359 (0) 2 970 53 00
or sanofi-aventis, s. r. o.
izz Česká republika sanofi- aventis, s. r. o.
uth Danmark sanofi-aventis Denmark A/ S Tlf: +45 45 16 70 00
tor Danmark sanofi- aventis Denmark A/ S
ra Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010
Deutschland Sanofi- Aventis Deutschland GmbH
Österreich sanofi-aventis GmbH Tel: +43 1 80 185 – 0 lon
sanofi- aventis GmbH Tel: +43 1 80 185 – 0 għ
Tel: +34 93 485 94 00
Tel: +34 93
ct
485 94 00 a
du
+33 1 57 63 23 23 ed
Tel: +353 (0) 1 403 56 00 lp
Tel: +353 (0) 1 403 56 00 tt m
Italia sanofi-aventis S. p. A.
Pro
28 Lietuva UAB sanofi-aventis Lietuva Tel: +370 5 2755224
Lietuva UAB sanofi- aventis Lietuva
d ise This leaflet was last approved in
izz Dan il- fuljett kien approvat l- aħħar f ’
or Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
tor Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu.
uth ra ge lon no ct du ro lp ina dic Me
aw ux ad għ m ’ li li a iċin ed tt m do Pro
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 għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
What is Actos?
X' inhu Actos?
Actos is a medicine containing the active substance pioglitazone.
Actos huwa mediċina li fiha s- sustanza attiva pioglitazone.
The white, round tablets contain 15, 30 or 45 mg of pioglitazone.
Il- pilloli bojod, tondi fihom 15, 30 jew 45 mg ta 'pioglitazone.
What is Actos used for?
Għal x' hiex jintuża Actos?
Actos is used to treat type 2 diabetes (also known as non insulin-dependent diabetes). • It can be used on its own (monotherapy) in patients (particularly those who are overweight) who cannot use metformin (an antidiabetic medicine). • It can be used together with one other antidiabetic medicine (dual therapy).
Actos jintuża biex jikkura dijabete ta 'tip 2 (magħrufa wkoll bħala dijabete mhux dipendenti fuq l - insulina). • Jista' jintuża waħdu (monoterapija) f' pazjenti (b’ mod partikolari dawk li għandhom piż eċċessiv) li ma jistgħux jużaw metformin (mediċina kontra d- dijabete). • Jista ’ jintuża flimkien ma ’ mediċina oħra kontra d- dijabete (terapija konġunta).
It can be added to metformin in patients (particularly those who are overweight) who are not satisfactorily controlled on metformin used on its own and at the maximum tolerated dose.
Jista ’ jiżdied ma ’ metaformin f’ pazjenti (b’ mod partikolari dawk li għandhom piż eċċessiv) li mhumiex ikkontrollati b’ mod sodisfaċenti meta jkunu fuq metformin użata waħidha fid- doża massima ttollerata.
Alternatively, it can be added to a sulphonylurea (another antidiabetic medicine) in patients for whom metformin is not suitable and who are not satisfactorily controlled with the sulphonylurea used on its own at the maximum tolerated dose. • It can be used together with two other antidiabetic medicines, metformin and a sulphonylurea, as triple therapy in patients (particularly those who are overweight) who are not satisfactorily controlled with these two medicines. • It can be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Inkella, jista ’ jiżdied ma ’ sulphonylurea (mediċina oħra kontra d- dijabete) meta metformin ma tkunx adegwata u l- pazjenti ma jkunux ikkontrollati b’ mod sodisfaċenti meta jkunu fuq sulphonylurea użat waħdu fid- doża massima ttollerata • Jista 'jintuża flimkien ma' żewġ mediċini oħra kontra d- dijabete, metformin u sulphonylurea, bħala terapija trippla f' pazjenti (b’ mod partikolari dawk li għandhom piż eċċessiv) li m' humiex ikkontrollati b' mod sodisfaċenti b' dawn iż- żewġ mediċini. • Jista 'jintuża flimkien ma' l- insulina f' pazjenti li m' humiex ikkontrollati b' mod sodisfaċenti bl - insulina waħidha u li ma jistgħux jieħdu metformin.
How is Actos used?
Kif jintuża Actos?
Actos is taken once daily with or without food.
Actos jittieħed darba kuljum ma ’ l- ikel jew mhux ma ’ l- ikel.
The dose is adjusted to give the best control.
Id- doża hija aġġustata sabiex tagħti l - aqwa kontroll.
The recommended starting dose is 15 mg or 30 mg once daily.
Id- doża tal- bidu rakkomandata hija 15 mg jew 30 mg darba kuljum.
This dose may need to be increased after one or two weeks to up to 45 mg once daily.
Jista ’ jkun hemm bżonn li din id- doża tiżdied wara ġimgħa jew ġimagħtejn sa 45 mg darba kuljum.
In combination with metformin, the current metformin dose can be continued when starting Actos treatment.
F’ kombinazzjoni ma ’ metformin, id- doża ta ’ metformin kurrenti tista ’ titkompla meta tinbeda l- kura b' Actos.
In combination with a sulphonylurea or insulin, the current sulphonylurea or insulin dose can be continued when starting Actos treatment unless the patient has hypoglycaemia (low blood glucose), when the dose of the sulphonylurea or insulin should be decreased.
F’ kombinazzjoni ma ’ sulphonylurea jew ma 'l- insulina, id- doża kurrenti ta ’ sulphonylurea jew insulina tista ’ titkompla meta tinbeda kura b' Actos sakemm il- pazjent ikollu hypoglycaemia (livell baxx ta ’ glukosju fid- demm), meta d- doża ta ’ sulphonylurea jew insulina għandha titnaqqas.
How does Actos work?
Kif jaħdem Actos?
Pioglitazone, the active ingredient in Actos, makes the cells more sensitive to
Id- dijabete tat- Tip 2 hija marda li fiha, il- frixa ma tagħmilx biżżejjed insulina sabiex tikkontrolla l - livell ta ’ glucosju fid- demm.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Pioglitazone, is- sustanza attiva f' Actos, tagħmel iċ- ċelloli aktar sensittivi 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 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 insulin, which means that the body makes better use of the insulin it produces, the blood glucose is reduced and this helps to control type 2 diabetes.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 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 għall- insulina, li jfisser li l- ġisem jagħmel użu aħjar ta ’ l- insulina li jipproduċi, il- livell ta ’ glucosju fid- demm jonqos u dan jgħin biex tiġi kkontrollata d- dijabete ta ’ tip 2.
How has Actos been studied?
Kif ġie studjat Actos?
Actos has been studied in clinical pharmacology studies and in clinical trials.
Actos ġie studjat fi studji kliniċi tal- farmakoloġija u fi provi kliniċi.
Almost 7,000 patients received Actos in all trials combined.
Kważi 7, 000 pazjent irċevew Actos fil- provi kollha flimkien.
The studies compared Actos to placebo (a dummy treatment), or to other antidiabetic medicines (metformin, gliclazide).
L- istudji qabblu Actos ma ’ plaċebo (trattament finta), jew ma ’ mediċini oħra kontra d- dijabete (metformin, gliclazide).
Some studies also looked at combining Actos with other antidiabetic medicines (sulphonylureas, insulin, metformin).
Xi studji studjaw ukoll il- kombinazzjoni ta ’ Actos ma ’ mediċini oħra kontra d- dijabete (sulphonylureas, insulin, metformin).
Further studies also looked at long-term use of Actos.
Studji oħra studjaw l - użu fuq perjodu ta 'żmien twil ta' Actos.