qanastek/EMEA-V3 huggingface dataset:
Metabolism Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups.
Metaboliżmu Pioglitazone jgħaddi minn metaboliżmu epatiku estensiv permeżż ta ’ idroksilazzjoni tal- gruppi ta ’ aliphatic methylene.
This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser
Dan isir primarjament permeżż taċ- ċitokromju P450 2C8, għalkemm isoformi oħra jistgħu jkunu involuti f’ ammont inqas.
Three of the six identified metabolites are active (M-II, M-III, and M-IV).
Tlieta mis- sitt metaboliti identifikati huma attivi (M- II, M- III, u M- IV).
Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5).
L- għoti ta ’ pioglitazone flimkien ma ’ gemfibrozil (inibitur taċ- ċitokromju P450 2C8) jew ma ’ rifampicin (induttur taċ- ċitokromju P450 2C8) huwa rrappurtat li jżid jew inaqqas, rispettivament, il - konċentrazzjoni fil- plażma ta ’ pioglitazone (ara sezzjoni 4. 5).
Elimination Following oral administration of radiolabeled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Eliminazzjoni Wara għoti ta ’ pioglitazone radjutikketjat mill- ħalq lill- bniedem, it- tikkettjar miġbur kien l- aktar fil - ħmieġ (55%) u f’ ammont inqas fl- awrina (45%).
Elderly Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Anzjani Il- farmakokinetika fi stat fiss ta ’ pazjenti b’ età ta ’ 65 sena jew aktar hija simili għal dik ta ’ pazjenti żgħar.
Patients with renal impairment In patients with renal impairment, plasma concentrations of pioglitazone and its metabolites are lower than those seen in subjects with normal renal function, but oral clearance of parent substance is similar.
Pazjenti b’ indeboliment renali F’ pazjenti b’ indeboliment renali, il- konċentrazzjonijiet fil- plażma ta ’ pioglitazone u l- metaboliti tiegħu huma inqas minn dawk li dehru f’ soġġetti b’ funzjoni renali normali, iżda t- tneħħija mill- ħalq tas- sustanża oriġinali hija simili.
Patients with hepatic impairment Total plasma concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Pazjenti b’ indeboliment epatiku Il- konċentrazzjoni totali fil- plażma ta ’ pioglitazone ma nbidlitx, iżda b’ volum ta ’ distribuzzjoni miżjud.
Absorption After an oral dose of metformin, tmax is reached in 2.5 h.
Assorbiment Wara doża orali ta ’ metformin, tmax jintlaħaq f’ 2. 5 h.
After oral administration, metformin absorption is saturable and incomplete.
Wara għoti orali, assorbiment ta ’ metformin huwa saturabbli u mhux komplut.
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 fiss 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- ogħla dożi.
Food decreases the extent and slightly delays the absorption of metformin.
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 għoti ta ’ doża ta ’ 850 mg, kienu osservati tnaqqis ta ’ 40% fl- ogħla konċentrazzjoni fil- plażma, tnaqqis ta’ 25% fl- AUC u dewmien b’ 35 min sal- ħin beix tintlaħaq l- ogħla konċentrazzjoni fil- plażma.
Distribution Plasma protein binding is negligible.
Distribuzzjoni Twaħħil mal- proteini fil- plażma hija ftit li xejn.
The blood peak is lower than the plasma peak and appears at approximately the same time.
L- ogħla kwantità fid- demm hija inqas minn dik fil- plażma u tidher madwar fl- istess ħin.
The mean Vd ranged between 63 – 276 l.
Il- medja ta ’ Vd varjat bejn 63- 276 l.
Metabolism Metformin is excreted unchanged in the urine.
Metaboliżmu Metformin jitneħħa mhux mibdul fl- awrina.
12 Elimination Renal clearance of metformin is > 400ml/ min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Eliminazzjoni Tneħħijja renali ta ’ metformin hija > 400 ml/ min, u b’ hekk tindika li metformin jitneħħa permezz ta ’ filtrazzjoni glomerulari u tneħħijja tubolari.
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 ogħla ta ’ metformin fil- plażma.
No animal studies have been conducted with the combined products in Glubrava.
Ma sarux studji fil- bhejjem bil- prodotti kombinati f’ Glubrava.
These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure.
Dawn is- sejbiet kienu osservati fi speċi differenti b’ konċentrazzjonijiet fil- plażma ≤4 darbiet l - espożizzjoni klinika.
In an animal model of familial adenomatous polyposis (FAP), treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
13 F’ mudell tal- annimali ta ’ adenomatous polyposis familjali (FAP), kura b’ żewġ thiazolidinediones oħra żiedet il- multipliċità tat- tumuri fil- musrana.
Tablet Core Microcrystalline cellulose Povidone (K30) Croscarmellose sodium Magnesium stearate
Qalba tal- Pillola Microcrystalline cellulose Povidone (K30) Croscarmellose sodium Magnesium stearate
Film Coat Hypromellose Macrogol 8000 Talc Titanium dioxide.
Kisja b’ Rita Hypromellose Macrogol 8000 Talc Titanium dioxide.
11 December 2007
11 ta ’ diċembru 2007
15 A.
15 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Name and address of the manufacturers responsible for batch release
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in the July 2007 version presented in Module 1.8.1 of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
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 ippreżentata f’ Modulu 1. 8. 1 ta ’ l - Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, 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) presented in Module 1.8.2 of the Marketing Authorisation Application 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 (RMP) ippreżentata f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni għall - Awtorizzazzjoni għat- Tqegħid fis- Suq, u kull aġġornament sussegwenti ta ’ RMP miftiehem miċ - CHMP.
17 ANNEX III
17 Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat:
LABELLING AND PACKAGE LEAFLET
PSURs Iċ- ċiklu ta ’ PSUR ta ’ Glubrava 15 mg/ 850 mg pilloli miksija b’ rita se jikkorrispondi ma ’ dak attribwit lill- prodott ta ’ referenza, Competact, sakemm speċifikat mod ieħor.
Glubrava 15 mg/ 850 mg film-coated tablets
Glubrava 15 mg/ 850 mg pilloli miksija b’ rita
Pioglitazone (as hydrochloride) Metformin hydrochloride
Pioglitazone (bħala hydrochloride) Metformin hydrochloride
EU/ 1/ 07/ 421/ 001 14 tablets EU/ 1/ 07/ 421/ 002 28 tablets EU/ 1/ 07/ 421/ 003 30 tablets EU/ 1/ 07/ 421/ 004 50 tablets EU/ 1/ 07/ 421/ 005 56 tablets EU/ 1/ 07/ 421/ 006 60 tablets EU/ 1/ 07/ 421/ 007 90 tablets EU/ 1/ 07/ 421/ 008 98 tablets EU/ 1/ 07/ 421/ 009 180 tablets
EU/ 1/ 07/ 421/ 001 14- il pillola EU/ 1/ 07/ 421/ 002 28 pillola EU/ 1/ 07/ 421/ 003 30 pillola EU/ 1/ 07/ 421/ 004 50 pillola EU/ 1/ 07/ 421/ 005 56 pillola EU/ 1/ 07/ 421/ 006 60 pillola EU/ 1/ 07/ 421/ 007 90 pillola EU/ 1/ 07/ 421/ 008 98 pillola EU/ 1/ 07/ 421/ 009 180 pillola
Glubrava15 mg/ 850 mg tablets.
Pilloli Glubrava 15 mg/ 850 mg.
21 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
22 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Glubrava15 mg/ 850 mg tablets
Pilloli Glubrava 15 mg/ 850 mg
Pioglitazone (as HCl) Metformin hydrochloride
Pioglitazone (bħala HCl) metformin hydrochloride
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- Tlieta 1 L- Erbgħa 1 L- Ħamis 1 Il- Ġimgħa 1 Is- Sibt 1 Il- Ħadd 1
PACKAGE LEAFLET
It- Tnejn 2 It- Tlieta 2 L- Erbgħa 2 L- Ħamis 2 Il- Ġimgħa 2 Is- Sibt 2 Il- Ħadd 2
GLUBRAVA 15 mg/ 850 mg FILM-COATED TABLETS
GLUBRAVA 15 mg/ 850 mg PILLOLI MIKSIJA B’ RITA
Pioglitazone/ Metformin hydrochloride
Pioglitazone/ Metformin hydrochloride
Read all of this leaflet carefully before you start taking this medicine
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina
What Glubrava is and what it is used for 2.
X’ inhu Glubrava u għalxiex jintuża 2.
Before you take Glubrava 3.
Qabel ma tieħu Glubrava 3.
How to take Glubrava 4.
Kif għandek tieħu Glubrava 4.
Possible side effects 5 How to store Glubrava 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen Glubrava 6.
WHAT GLUBRAVA IS AND WHAT IT IS USED FOR
X’ INHU GLUBRAVA U GĦALXIEX JINTUŻA
Glubrava tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus.
Pilloli Glubrava huma mediċina anti- dijabetika wżata biex tikkura dijabete mellitus tat- tip 2 (mhux dipendenti mill- insulina).
Glubrava 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 Glubrava 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 GLUBRAVA
QABEL MA TIEĦU GLUBRAVA
Do not take Glubrava:
Tieħux pilloli Glubrava
Glubrava tablets.
sustanzi oħra ta ’ pilloli Glubrava.
- 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, jew
breathing difficulties.
diffikultajiet biex tieħu n- nifs.
- 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 jew
vomiting).
remettar).
taking Glubrava tablets at the time of and for a few days after the procedure.
Glubrava fil- ħin tal- proċedura u għal ftit jiem wara.
24 Take special care with Glubrava Tell your doctor before you start to take this medicine:
25 Oqgħod attent ħafna b’ pilloli Glubrava Għid lit- tabib tiegħek qabel tibda tieħu din il- mediċina:
Glubrava for a couple of days before and after the procedure.
tieħu Glubrava għal ftit ġranet qabel u wara l- proċedura.
- If you are under 18 years of age because use in such patients is not recommended.
- Jekk inti għandek età taħt 18- il sena minħabba li l- użu f’ dawn il- pazjenti mhux rakkomandat.
Please let your doctor know if you already take cimetidine, glucocorticoids, beta-2-agonists, diuretics or ACE inhibitors.
Jekk jogħġbok għid lit- tabib tiegħek jekk diġà qed tieħu cimetidine, glukokortikojdi, agonisti- beta- 2, dijuretiċi jew inibituri ACE.
You should not use Glubrava if you are breast-feeding or are planning to breast-feed your baby.
M’ għandekx tuża Glubrava jekk qed tredda ’ jew qed tippjana li tredda t- tarbija tiegħek.
This medicine will not affect your ability to drive or operate machinery.
Din il- mediċina ma taffettwax il- ħila tiegħek li ssuq jew li tħaddem magni.
HOW TO TAKE GLUBRAVA
KIF GĦANDEK TIEĦU GLUBRAVA
Always take Glubrava tablets exactly as your doctor has told you.
Dejjem għandek tieħu Glubrava eżatt kif qallek it- tabib.
If you are following a diabetic diet, you should continue with this while you are taking Glubrava tablets.
Jekk qed issegwi dieta dijabetika, għandek tkompli biha waqt li qed tieħu l- pilloli Glubrava.
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’ mard tal- qalb jew puplesija minn qabel, li kienu kkurati b’ pioglitazone u insulina kellhom esperjenza ta ’ żvilupp ta ’ insuffiċjenza tal- qalb.
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 ’ plaċebo (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 Glubrava.
It- tabib tiegħek se jitolbok tagħmel testijiet tad- demm kull tant żmien waqt il- kura b’ Glubrava.
If you take more Glubrava tablets than you should:
26 Jekk tieħu pilloli Glubrava aktar milli suppost:
25 If you forget to take Glubrava:
Jekk tinsa tieħu pilloli Glubrava:
Try to take Glubrava tablets daily as prescribed.
Ipprova ħu pilloli Glubrava kuljum kif preskritt.
If you stop taking Glubrava:
Jekk tieqaf tieħu Glubrava:
Do not stop taking Glubrava tablets without first discussing it with your doctor.
Tieqafx tieħu pilloli Glubrava qabel ma tiddiskuti dan mat- tabib tiegħek.
If you have any further questions on the use of Glubrava tablets ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ pilloli Glubrava, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Glubrava can have side effects.
Bħal kull mediċina oħra, Glubrava jista ’ jkollu effetti sekondarji.
Some patients experience the following side effects whilst taking pioglitazone and/ or metformin (the two active substances of Glubrava).
Xi pazjenti esperjenzaw l- effetti sekondarji li ġejjin waqt li kienu qed jieħdu pioglitazone u/ jew metformin (iż- żewġ sustanzi attivi ta ’ Glubrava):
If you experience some of these symptoms stop taking Glubrava and consult a doctor immediately.
Jekk ikollok esperjenza ta ’ xi wħud minn dawn is- sintomi waqqaf Glubrava u kellem tabib minnufih.
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.
HOW TO STORE GLUBRAVA
KIF TAĦŻEN GLUBRAVA
Do not use Glubrava after the expiry date which is stated on the carton and blister.
Tużax Glubrava wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq il- folja.
26 This medicinal product does not require any special storage conditions.
Din il- mediċina m’ għandhiex bżonn ħażna speċjali.
What Glubrava Tablets contain The active substances are 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.
X’ fih Glubrava Is- sustanzi attivi huma 15 mg pioglitazone (bħala hydrochloride) u 850 mg metformin hydrochloride.
What Glubrava Tablets look like and contents of the pack Glubrava tablets are white to off white, oblong, convex, film-coated tablets embossed ‘ 15 / 850’ on one face and ‘ 4833M’ on the other.
Id- Dehra tal- prodott u d- daqs tal- pakkett Pilloli Glubrava 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.
Marketing Authorisation Holder and Manufacturer Marketing authorisation holder:
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur Detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
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.
This leaflet was last approved on {date}
29 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 /.
EU Number EU/ 1/ 00/ 151/ 001 EU/ 1/ 00/ 151/ 002 EU/ 1/ 00/ 151/ 003 EU/ 1/ 00/ 151/ 004 EU/ 1/ 00/ 151/ 005 EU/ 1/ 00/ 151/ 006 EU/ 1/ 00/ 151/ 007 EU/ 1/ 00/ 151/ 008 EU/ 1/ 00/ 151/ 009 EU/ 1/ 00/ 151/ 010 EU/ 1/ 00/ 151/ 011 EU/ 1/ 00/ 151/ 012 EU/ 1/ 00/ 151/ 013 EU/ 1/ 00/ 151/ 014 EU/ 1/ 00/ 151/ 015 EU/ 1/ 00/ 151/ 016 EU/ 1/ 00/ 151/ 017 EU/ 1/ 00/ 151/ 018 EU/ 1/ 00/ 151/ 019 EU/ 1/ 00/ 151/ 020 EU/ 1/ 00/ 151/ 021 EU/ 1/ 00/ 151/ 022 EU/ 1/ 00/ 151/ 023 EU/ 1/ 00/ 151/ 024
Numru ta ’ l- EU EU/ 1/ 00/ 151/ 001 EU/ 1/ 00/ 151/ 002 EU/ 1/ 00/ 151/ 003 EU/ 1/ 00/ 151/ 004 EU/ 1/ 00/ 151/ 005 EU/ 1/ 00/ 151/ 006 EU/ 1/ 00/ 151/ 007 EU/ 1/ 00/ 151/ 008 EU/ 1/ 00/ 151/ 009 EU/ 1/ 00/ 151/ 010 EU/ 1/ 00/ 151/ 011 EU/ 1/ 00/ 151/ 012 EU/ 1/ 00/ 151/ 013 EU/ 1/ 00/ 151/ 014 EU/ 1/ 00/ 151/ 015 EU/ 1/ 00/ 151/ 016 EU/ 1/ 00/ 151/ 017 EU/ 1/ 00/ 151/ 018 EU/ 1/ 00/ 151/ 019 EU/ 1/ 00/ 151/ 020 EU/ 1/ 00/ 151/ 021 EU/ 1/ 00/ 151/ 022 EU/ 1/ 00/ 151/ 023 EU/ 1/ 00/ 151/ 024
Invented name Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin
Isem inventat Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin Glustin
Strength 15 mg 15 mg 15 mg 30 mg 30 mg 30 mg 15 mg 30 mg 45 mg 45 mg 45 mg 45 mg 45 mg 15 mg 15 mg 15 mg 30 mg 30 mg 30 mg 45 mg 45 mg 45 mg 15 mg 30 mg
Qawwa 15 mg 15 mg 15 mg 30 mg 30 mg 30 mg 15 mg 30 mg 45 mg 45 mg 45 mg 45 mg 45 mg 15 mg 15 mg 15 mg 30 mg 30 mg 30 mg 45 mg 45 mg 45 mg 15 mg 30 mg
Pharmaceutical Form Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Għamla farmaċewtika Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Mnejn jingħata Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Packaging blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu)
Il- pakkett Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu) Folja (alu/ alu)
Package size 28 50 98 28 50 98 14 14 14 28 50 56 98 30 84 90 30 84 90 30 84 90 56 56
Daqs tal- pakkett 28 50 98 28 50 98 14 14 14 28 50 56 98 30 84 90 30 84 90 30 84 90 56 56
EPAR summary for the public
Sommarju tal- EPAR g all- pubbliku
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.
Jispjega kif il- Kumitat g all- Prodotti Medi inali g all- U u mill- Bniedem (CHMP) ivvaluta l - istudji mwettqin, biex jissodisfa ir- rakkomandazzjonijiet tag hom dwar kif tintu a l- medi ina.
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 te tie aktar informazzjoni dwar il- kondizzjoni medika tieg ek jew it- trattament tieg ek, aqra l- Fuljett ta ’ Tag rif (ara parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispi jar tieg ek.
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 relatata mar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Glustin?
X’ inhu Glustin?
Glustin is a medicine containing the active substance pioglitazone.
Glustin huwa medi ina li fiha s- sustanza attiva pioglitazone.
The white, round tablets contain 15, 30 or 45 mg of pioglitazone.
Il- pilloli tondi bojod fihom 15, 30, jew 45 mg pioglitazone.
What is Glustin used for?
G al xiex jintu a Glustin?
Glustin 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 also be used together with one other antidiabetic medicine (dual therapy).
Glustin jintu a sabiex g at- trattament tad- dijabete ta ’ tip 2 (mag rufa wkoll b ala dijabete mhux dipendenti mill- insulina). • Jista ’ jintu a wa du (monoterapija) f’ pazjenti (b’ mod partikolari dawk li g andhom pi e essiv) li ma jistg ux ju aw metformina (medi ina kontra d- dijabete). • Jista ’ jintu a flimkien ma ’ medi ina o ra kontra d- dijabete (terapija kon unta).
It can be added to metformin in patients (particularly those who are overweight) who are not satisfactorily controlled on metformin used on its own at the maximum tolerated dose.
Jista ’ ji died ma ’ metaformina f’ pazjenti (b’ mod partikolari dawk li g andhom pi e essiv) li mhumiex ikkontrollati b’ mod sodisfa enti meta jkunu fuq metformina u ata wa idha fid- do a 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 on 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 on 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 ’ ji died ma ’ sulfonilurea (medi ina o ra kontra d- dijabete) g al pazjenti meta metformina ma tkunx adegwata u li ma jkunux ikkontrollati b’ mod sodisfa enti meta jkunu fuq sulfonilurea u at wa du fid- do a massima ttollerata. • Jista ’ jintu a flimkien ma ’ ew medi in dijabeti i o ra, metformina u sulfonilurea, b ala terapija trippla g al pazjenti (b’ partikolari dawk li g andhom pi e essiv) li mhumiex ikkontrollati b’ mod sodisfa enti b’ dawn i - ew medi ini. • Jista ’ jintu a wkoll flimkien ma ’ l- insulina g al pazjenti li mhumiex ikkontrollati b’ mod sodisfa enti bl- insulina biss u ma jistg ux jie du l- metformina.
How is Glustin used?
Kif jintu a Glustin?
Glustin is taken once daily with or without food.
Glustin jittie ed darba kuljum ma ’ l- ikel jew mhux ma ’ l- ikel.
The dose is adjusted to give the best control.
Id- do a hija a ustata sabiex tag ti l - aqwa kontroll.
The recommended starting dose is 15 mg or 30 mg once daily.
Id- do a 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 b onn li din id- do a ti died wara img a jew imag tejn sa 45 mg darba kuljum.
In combination with metformin, the current metformin dose can be continued when starting Glustin treatment.
F’ kombinazzjoni ma ’ metformina, id- do a ta ’ metformina attwali tista ’ titkompla meta jinbeda t- trattament bi Glustin.
In combination with a sulphonylurea or insulin, the current sulphonylurea or insulin dose can be continued when starting Glustin treatment unless the patient has hypoglycaemia (low blood glucose), when the dose of the sulphonylurea or insulin should be decreased.
F’ kombinazzjoni ma ’ sulfonilurea jew ta ’ insulina, id- do a attwali ta ’ sulfonilurea jew ta ’ insulina tista ’ titkompla meta jinbeda trattament bi Glustin sakemm il- pazjent ikollu ipogli emija (livell baxx ta ’ gluko ju fid- demm), meta d- do a ta ’ sulfonilurea jew ta ’ insulina g andha titnaqqas.
How does Glustin work?
Kif ja dem Glustin?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood.
Id- dijabete tat- tip 2 hija marda li fiha, il- frixa (pankreas) ma tipprodu ix bi ejjed insulina sabiex tikkontrolla l- livell ta ’ gluko ju fid- demm.
Pioglitazone, the active ingredient in Glustin, makes the cells more sensitive to 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.
Pioglitazone, is- sustanza attiva fi Glustin, tag mel i - elloli aktar sensittivi g all- insulina, li jfisser li l - isem jag mel u u a jar ta ’ l- insulina li jipprodu i, il- livell ta ’ gluko ju fid- demm jonqos u dan jg in biex ti i kkontrollata d- dijabete ta ’ tip 2.
How has Glustin been studied?
Kif ie studjat Glustin?
Glustin has been studied in clinical pharmacology studies and in clinical trials.
Glustin ie studjat fi studji klini i farmakolo i i u fi provi klini i.
Almost 7,000 patients received Glustin in all trials combined.
Madwar 7, 000 pazjent ir evew Glustin fil- provi kollha flimkien.
The studies compared Glustin with placebo (a dummy treatment), or with other antidiabetic medicines (metformin, gliclazide).
L- istudji qabblu Glustin ma ’ pla ebo (trattament finta), jew ma ’ medi ini o ra kontra d- dijabete (metformina, gliclazide).
Some studies also looked at combining Glustin with other anti-diabetes medicines (sulphonylureas, insulin or metformin).
Xi studji e aminaw ukoll il- kombinazzjoni ta ’ Glustin ma ’ medi ini o ra kontra d- dijabete (sulfonilurej, insulina jew metformina).
Further studies also looked at long-term use of Glustin.
Fit- terapija trippla, l- effika ja ta ’ Glustin iet
In triple therapy, the effectiveness of Glustin was studied in more than 1,400 patients who were receiving a combination of metformin and a sulphonylurea, to which was added either Glustin or placebo for up to 3.5 years.
studjata f’ aktar minn 1, 400 pazjent li kienu qed jir ievu kombinazzjoni ta ’ metformina u sulfonilurea, li flimkien mag hom ew mi juda jew Glustin jew pla ebo fuq perjodu sa 3. 5 snin.
The studies measured the level in the blood of a substance (glycosylated haemoglobin, HbA1c), which gives an indication of how well the blood glucose is controlled.
L- istudji kejlu l- livell fid- demm ta 'sustanza (emoglobina glikosilata, HbA1c), li tag ti indikazzjoni ta ’ kemm il- gluko ju fid- demm huwa kkontrollat tajjeb.
What benefit has Glustin shown during the studies?
X’ benefi ju wera Glustin matul l- istudji?
Glustin led to a decrease in the level of HbA1c, indicating that blood glucose levels had been reduced at doses of 15, 30 and 45 mg.
Glustin wassal g al tnaqqis fil- livell ta ’ HbA1c, u dan jindika li l- livelli tal- gluko ju fid- demm tnaqqsu f’ do i ta ’ 15, 30 u 45 mg.
Doses below 15 mg were not effective, and doses above 45 mg (once daily) did not show additional benefit.
Do i ta t il- 15 mg ma kinux effika i, u do i og la minn 45 mg (darba kuljum) ma wrew ebda benefi ju addizzjonali.
Glustin on its own was shown to be as effective as metformin and gliclazide.
Glustin wa du ntwera li huwa effika i daqs il - metformina u gliclazide.
In combination, Glustin showed that it improves the control obtained in type 2 diabetes when added to existing treatment.
F’ kombinazzjoni, Glustin wera li jtejjeb il- kontroll miksub f’ dijabete ta ’ tip 2 meta mi jud mat- trattament e istenti.
At the end of the triple therapy study, the effect of adding Glustin to the existing treatment with metformin and a sulphonylurea was a 0.94% reduction in HbA1c levels, while adding placebo led to a 0.35% reduction.
Fi studju ta '
In a small study examining the combination of Glustin and insulin in 289 patients, patients adding Glustin to insulin had a 0.69% reduction in HbA1c levels after six months, compared with 0.14% in those adding placebo.
li je amina l- kombinazzjoni ta ’ Glustin ma ’ l- insulina f’ 289 pazjent, pazjenti li j idu Glustin ma ’ l - insulina kellhom tnaqqis ta ’ 0. 69% fil- livelli HbA1c wara sitt xhur, meta mqabbel ma 0. 14% f’ dawk li j idu l- pla ebo.
What is the risk associated with Glustin?
X’ inhu r- riskju asso jat ma ’ Glustin?
The most common side effects with Glustin are visual disturbance, upper respiratory tract infection (colds), weight increase, and hypoaesthesia (decreased sensitivity to a stimulus).
L- aktar effetti sekondarji komuni bi Glustin huma disturbi fil- vista, infezzjoni fil- parti ta ’ fuq ta ’ l - apparat respiratorju (irji at), ieda fil- pi, u ipoestesija (tnaqqis fis- sensittività g al stimulu).
For the full list of all side effects reported with Glustin, see the Package Leaflet.
G al - lista s i a ta ’ l- effetti sekondarji kollha rrapportati bi Glustin, ara l- Fuljett ta ’ Tag rif.
Glustin should not be used in people who may be hypersensitive (allergic) to pioglitazone or any of the other ingredients, in patients with liver problems, heart failure or diabetic ketoacidosis (high levels of ketones [acids] in the blood).
g al xi sustanza o ra, f’ pazjenti bi problemi fil- fwied, bi problemi fil- qalb jew dijabete ketoa ido i (livelli g oljin ta ’ ketoni (a idi) fid- demm).
Why has Glustin been approved?
G aliex ie approvat Glustin?
The Committee for Medicinal products for Human Use (CHMP) decided that Glustin’ s benefits are greater than its risks for the treatment of type 2 diabetes.
Il- Kumitat g all- Prodotti Medi inali g all- U u mill- Bniedem (CHMP) idde ieda li l- benefi ji ta ’ Glustin huma og la mir- riskji tieg u g at- trattament ta 'dijabete tat- tip 2.
The Committee recommended that Glustin be given marketing authorisation.
Il- Kumitat irrakkomanda li Glustin jing ata awtorizzazzjoni g at- tqeg id fis- suq.
In monotherapy (used on its own), the Committee decided that Glustin should be an alternative to the standard treatment, metformin, to be used when patients cannot take metformin.
F’ monoterapija (u at wa du), il- Kumitat idde ieda li Glustin g andu jkun alternattiva g at- trattament standard, metformina, li g andu jintu a meta pazjenti ma jkunux jistg u jie du metformina.
Other information about Glustin:
Tag rif ie or dwar Glustin:
The European Commission granted a marketing authorisation valid throughout the European Union for Glustin to Takeda Europe R & D Centre Limited on 11 October 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni g at- tqeg id fis- suq valida madwar l- Unjoni Ewropea kollha g al Glustin lil Takeda Europe R & D Centre Limited fil- 11 ta ’ Ottubru 2000.
The marketing authorisation was renewed on 13 October 2005.
L - awtorizzazzjoni iet im edda fit- 13 ta ’ Ottubru 2005.
The full EPAR for Glustin is available here.
EPAR s i g al Glustin jista ’ ji i kkonsultat hawn.
This summary was last updated in 08-2007.
Dan is- sommarju ie a ornat l- a
Glustin 15 mg tablets.
Pilloli Glustin 15 mg.
The tablets are white to off-white, round, convex and marked ‘ 15 ’ on one face, AD4 on the other.
Il- pilloli huma bojod għal abjad maħmuġ, tondi, bbużżati miż- żewġ naħat u mmarkati b ’ ‘ 15 ’ fuq naħa waħda, AD4 fuq in- naħa l- oħra
Pioglitazone is indicated in the treatment of type 2 diabetes mellitus:
- Pioglitazone huwa ndikat fil- kura ta ’ dijabete mellitus tat- tip 2:
- in patients (particularly overweight patients) inadequately controlled by diet and exercise for
- F’ pazjenti (speċjalment pażjenti b’ piż żejjed) li mhumiex ikkontrollati sew minn dieta
whom metformin is inappropriate because of contraindications or intolerance.
u eżerċizzju li għalihom metformin mhux adattat minħabbla kontra- indikazzjonijiet jew intolleranza
- metformin, in patients (particularly overweight patients) with insufficient glycaemic control
- metformin, f’ pazjenti (speċjalment pażjenti b’ piż żejjed) b’ kontroll gliċemiku
despite maximal tolerated dose of monotherapy with metformin
insuffiċjenti minkejja monoterpija b’ metformin fl- għola doża ttollerata
- a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is
- mediċina tat- tip sulphonylurea, f’ pazjenti li wrew intolleranza għal metformin jew li
contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.
għalihom metformin huwa kontra- indikat, b’ kontroll gliċemiku insuffiċjenti minkejja monoterpija b’ mediċina tat- tip sulphonylurea fl- għola doża ttollerata
Pioglitazone may be initiated at 15 mg or 30 mg once daily.
Pioglitazone jista ’ jinbeda b’ 15 mg jew 30 mg darba kuljum.
The dose may be increased in increments up to 45 mg once daily.
Id- doża tista ’ tiġi miżjuda bil- mod sa 45 mg darba kuljum.
In combination with insulin, the current insulin dose can be continued upon initiation of pioglitazone therapy.
F’ għotja flimkien ma ’ insulina, id- doża kurrenti ta ’ insulina tista ’ titkompla hekk kif tinbeda terapija b’ pioglitazone.
2 Elderly No dosage adjustment is necessary for elderly patients (see section 5.2).
2 Anzjani L- ebda aġġustament fid- doża ma huwa neċessarju għall- pazjenti anzjani (ara sezzjoni 5. 2).
Patients with renal impairment No dosage adjustment is necessary in patients with impaired renal function (creatinine clearance > 4 ml/ min) (see section 5.2).
Pazjenti b’ indeboliment renali L- ebda aġġustament fid- doża ma huwa neċessarju f’ pazjenti b’ indeboliment renali (tneħħijja ta ’ creatinine > 4 ml/ min) (ara sezzjoni 5. 2).
No information is available from dialysed patients therefore pioglitazone should not be used in such patients.
M’ hemmx tagħrif disponibbli minn pazjenti fuq dijalisi u għalhekk pioglitazone m’ għandux jintuża f’ dawn il- pazjenti.
Patients with hepatic impairment Pioglitazone should not be used in patients with hepatic impairment (see section 4.4).
Pazjenti b’ indeboliment epatiku Pioglitazone m’ għandux jintuża f’ pazjenti b’ indeboliment epatiku (ara sezzjoni 4. 4).
Children and adolescents There are no data available on the use of pioglitazone in patients under 18 years of age, and therefore its use is not recommended in this age group.
Tfal u adolexxenti M’ hemmx dejta disponibbli dwar l- użu ta ’ pioglitazone f’ pazjenti taħt l- eta ’ ta ’ 18- il sena, u għalhekk l- użu tiegħu mhux rakkomandat f’ dan il- grupp ta ’ eta ’.
- hepatic impairment.
- indeboliment epatiku
Fluid retention and cardiac failure Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure.
Żamma ta ’ fluwidu u insuffiċjenza kardijaka Pioglitazone jista ’ jikkawża żamma ta ’ fluwidu, li tista ’ tirkada jew twassal għall- insuffiċjenza tal - qalb.
Patients should be observed for signs and symptoms of heart failure, weight gain or oedema, particularly those with reduced cardiac reserve.
Il- pazjenti għandhom jiġu osservati għal sinjali u sintomi ta ’ insuffiċjenza tal- qalb, żieda fil- piż jew edima, speċjalment dawk b’ riserva kardijaka mnaqqsa.
There have been cases of cardiac failure reported from the market when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure patients should be observed for signs and symptoms of heart failure, weight gain and oedema when pioglitazone is used in combination with insulin.
Kien hemm każijiet ta ’ insuffiċjenza kardijaku rrappurtati mis- suq meta pioglitazone intuża flimkien ma ’ insulina jew f’ pazjenti b’ insuffiċjenza tal - qalb; pazjenti għandhom jiġu osservati għal sinjali u sintomi ta ’ insuffiċjenza tal- qalb, żieda fil- piż jew edima meta pioglitazone jingħata flimkien ma ’ insulina.
Monitoring of liver function There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
Sorveljanza tal- funzjoni tal- fwied Kien hemm rapporti rari ta ’ disfunzjoni epatoċellolari waqt l- esperjenza ta ’ wara t- tqegħid fis- suq (ara sezzjoni 4. 8).
Liver enzymes should be checked prior to the initiation of therapy with pioglitazone in all patients.
L- enżimi tal- fwied għandhom jiġu ċċekkjati qabel ma tinbeda terapija b’ pioglitazone f’ kull pazjent.
3 Following initiation of therapy with pioglitazone, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Jekk il- livelli ta ’ ALT jiżdiedu sa 3 X l- għola limitu tan -
If ALT levels are increased to 3 X upper limit of normal during pioglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
3 normal waqt it- terapija b’ pioglitazone, il- livelli ta ’ l- enżimi tal- fwied għandhom jerġu jiġu ċċekkjati mill- aktar fis possibli.
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/ or dark urine, liver enzymes should be checked.
Jekk xi pazjent jiżviluppa sintomi li jissuġġerixxu disfunzjoni epatika, li jistgħu jinkludu tqallih mhux spjegat, rimettar, uġigħ addominali, għejja, anoressija u/ jew awrina skura, l - enżimi tal- fwied għandhom jiġu ċċekkjati.
The decision whether to continue the patient on therapy with pioglitazone should be guided by clinical judgement pending laboratory evaluations.
Id- deċiżjoni dwar jekk il- pazjent għandux jitkompla bit - terapija b’ pioglitazone għandha tiġi ggwidata minn ġudiżżju kliniku sakemm isiru l- valutazzjonijiet tal- laboratorju.
Weight gain In clinical trials with pioglitazone there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention.
Żieda fil- piż Fi provi kliniċi b’ pioglitazone kien hemm evidenza ta ’ żieda fil- piż relatata mad- doża, li setgħet kienet minħabba akkumulazzjoni ta ’ xaħam u f’ xi każijiet assoċjata ma ’ żamma ta ’ fluwidu.
Patients should be advised to adhere strictly to a calorie- controlled diet.
Il- pazjenti għandhom jiġu rakkomandati biex isegwu b’ reqqa dieta li tikkontrolla l- ammont ta ’ kaloriji.
Haematology There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution.
Ematoloġija Kien hemm tnaqqis żgħir fil- medja ta ’ emoglobina (tnaqqis relattiv ta ’ 4%) u ematokrita (tnaqqis relattiv ta ’ 4. 1%) waqt terapija b’ pioglitazone, konsistenti ma ’ emodiluzzjoni.
Similar changes were seen in metformin (haemoglobin 3 - 4% and haematocrit 3.6 – 4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1 – 2% and haematocrit 1 – 3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Tibdiliet simili dehru fi provi kkontrollati komparattivi b’ pioglitazone f’ pazjenti kkurati b’ metformin (tnaqqis relattiv ta ’ 3 – 4% fl- emoglobina u ta ’ 3. 6 – 4. 1% fl- ematokrita) u fi kwantità inqas b’ sulphonylurea u bl- insulina (tnaqqis relattiv ta ’ 1 – 2% fl- emoglobina u ta ’ 1 – 3. 2% fl- ematokrita).
Hypoglycaemia As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual or triple oral therapy with a sulphonylurea or in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea or insulin may be necessary.
Ipogliċemija Bħala konsegwenza ta ’ żieda fis- sensittività għall- insulina, pazjenti li qed jirċievu pioglitazone f’ terapija mill- ħalq doppja jew trippla ma ’ mediċina tat- tip sulphonylurea jew f’ terapija doppja mal - insulina jistgħu jkunu f’ riskju ta ’ ipogliċemija relatat mad- doża, u tista ’ tkun neċessarja tnaqqis fid - doża tal- mediċina tat- tip sulphonylurea jew tal- insulina.
Eye disorders Post-marketing reports of new-onset or worsening diabetic macular oedema with increased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Mard fl- għajnejn Rapporti ta ’ wara t- tqegħid fis- suq ta ’ żvilupp jew irkadar ta ’ edima makulari dijabetika bi tnaqqis fl - akutezza viżiva ġew irrappurtati b’ thiazolidinediones, inkluż pioglitazone.
Others An increased incidence in bone fractures in women was seen in a pooled analysis of adverse event reports of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.
Oħrajn Kienet osservata żieda fl- inċidenza ta ’ fratturi fl- għadam fin- nisa f’ analiżi globali ta ’ rapporti ta ’ avvennimenti avversi ta ’ fratturi fl- għadam miksuba minn provi kliniċi randomised, ikkontrollati u double blind b’ aktar minn 8100 pazjent ikkurat b’ pioglitazone u 7400 pazjent ikkurat bi prodott paragun, fuq kura sa 3. 5 snin.
The risk of fractures should be considered in the long term care of women treated with pioglitazone.
4 Ir- riskju ta ’ fratturi għandu jiġi kkunsidrat fil- kura fit- tul ta ’ nisa kkurati b’ pioglitazone.
4 As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation.
Bħala konsegwenza ta ’ azzjoni msaħħa ta ’ l- insluina, kura b’ pioglitazone f’ pazjenti bis- sindromu ta ’ ovarji poliċistiċi jista ’ jwassal għal bidu mill- ġdid tal- ovulazzjoni.
Pioglitazone dose adjustment within the recommended Posology or changes I diabetic treatment should be considered (see section 4.5).
Għandhom jiġu kkunsidrati aġġustament fid- doża ta ’ pioglitazone fil- firxa ta ’ dożaġġ rakkomandat jew bidliet fil- kura dijabetika (ara sezzjon 4. 5).
Glustin tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Il- pilloli Glustin fihom lactose monohydrate u għalhekk m’ għandhomx jingħataw lill- pazjenti bi problemi ereditarji rari ta ’ intolleranza għall- galactose, d- defiċjenza Lapp lactase jew assorbiment ħażin ta ’ glucose- galactose.
Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
L- għotja ta ’ pioglitazone flimkien ma ’ mediċini tat- tip sulphonylurea ma tidhirx li taffettwa il- farmakokinetika tal - mediċini tat- tip sulphonylurea.
Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/ 9 and 3A4.
Studji fil- bniedem jissuġġerixxu li m’ hemm l- ebda induzzjoni taċ- ċitokromju induċibbli prinċipali P450, 1A, 2C8/ 9 u 3A4.
In vitro studies have shown no inhibition of any subtype of cytochrome P450.
Studji in vitro wrew li m’ hemmx induzzjoni ta ’ l- ebda sottotip ta ’ ċitokromju P450.
Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Ħija rrappurtata li l- għotja ta ’ piogltazone flimkien ma ’ rifampicin (induttur taċ- ċitokromju P450 2C8) twassal għal tnaqqis ta ’ 54% fl- AUC ta ’ pioglitazone.
Use in pregnancy There are no adequate human data to determine the safety of pioglitazone during pregnancy.
Użu fit- tqala M’ hemmx dejta biżżejjed fil- bniedem sabiex tiġi determinata is- sigurtà ta ’ pioglitazone waqt it- tqala.
Foetal growth restriction was apparent in animal studies with pioglitazone.
Restrizzjoni tat- tkabbir tal- fetu kienet evidenti fi istudji b’ pioglitazone fuq il- bhejjem.
This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth.
Dan kien attribwit għall- azzjoni ta ’ pioglitazone li jnaqqas l- iperinsulinemija fl- omm u jżid ir- reżistenza għall - insulina li jseħħu waqt it- tqala u b’ hekk inaqqas id- disponibilità tas- substrati metaboliċi għat- tkabbir tal- fetu.
Use in breast-feeding Pioglitazone has been shown to be present in the milk of lactating rats.
Użu fit- treddigħ Intwera li pioglitazone jinstab fil- ħalib ta ’ firien li qed ireddgħu.
Therefore, pioglitazone should not be administered to breast- feeding women.
Għalhekk, pioglitazone m’ għandux jingħata lill- nisa li qed ireddgħu.
5 4.8 Undesirable effects
5 4. 8 Effetti mhux mixtieqa
PIOGLITAZONE MONOTHERAPY
MONOTERAPIJA B’ PIOGLITAZONE
Eye disorders Common: visual disturbance
Disturbi fl- għajnejn Komuni:
Infection and infestations Common: upper respiratory tract infection
infestazzjonijiet infezzjoni fil- passaġġ respiratorju ta ’ fuq
Investigations Common: weight increased
Investigazzjonijiet Komuni:
Nervous system disorders Common: hypoaesthesia
Disturbi fis- sistema nervuża Komuni:
Blood and lymphatic system disorders Common: anaemia
Disturbi tad- demm u tas- sistema limfatika Komuni:
Gastrointestinal disorders Uncommon: flatulence
Disturbi gastro- intestinali Mhux komuni: gass
Musculoskeletal system and connective tissue disorders Common: arthralgia
Disturbi muskolu- skeletrali u tal- connective tissue Komuni:
Nervous system disorders Common: headache
Disturbi fis- sistema nervuża Komuni:
Renal and urinary disorders Common: haematuria
Disturbi fil- kliewi u fis- sistema urinarja Komuni:
Reproductive system and breast disorders Common: erectile dysfunction
Disturbi fis- sistema riproduttiva u fis- sider Komuni:
6 PIOGLITAZONE IN COMBINATION THERAPY WITH SULPHONYLUREA
6 PIOGLITAZONE F’ TERAPIJA KOMBINATA MA ’ SULPHONYLUREA
Ear and labyrinth disorders Uncommon: vertigo
Disturbi fil- widnejn u fis- sistema labirintika Mhux komuni: vertigo
Eye disorders Uncommon: visual disturbance
Disturbi fl- għajnejn Mhux komuni: disturbi viżwali
Gastrointestinal disorders Common: flatulence
Disturbi gastro- intestinali Komuni:
General disorders and administration site conditions Uncommon: fatigue
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Mhux komuni: għejja
Metabolism and nutritional disorders Uncommon: appetite increased, hypoglycaemia
Disturbi fil- metaboliżmu u n- nutrizzjoni Mhux komuni: żieda fl- aptit, ipogliċemija
Nervous system disorders Common: dizziness
Disturbi fis- sistema nervuża Komuni:
Uncommon: headache
Mhux komuni: uġigħ ta ’ ras
Renal and urinary disorders Uncommon: glycosuria, proteinuria
Disturbi fil- kliewi u fis- sistema urinarja Mhux komuni: glikosurja, proteina fl- awrina
Skin and subcutaneous tissue disorders Uncommon: sweating
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni: għaraq
Investigations Common: weight increased, blood creatinine phosphokinase increased
żieda fil- piż, żieda fil- creatine phosphokinase fid- demm
Metabolism and nutrition disorders Very common:
Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni ħafna: iopogliċemija
Musculoskeletal and connective tissue disorders Common: arthralgia
Disturbi muskolu- skeltrali u tal- connective tissue Komuni: