qanastek/EMEA-V3 huggingface dataset:
In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
Fi PROactive, studju dwar l- effett kardjovaskulari, 5238 pazjent b’ dijabete mellitus tat- tip 2 u b’ mard makrovaskulari maġġur li kien hemm minn qabel kienu randomised għal pioglitazone jew plaċebo li kienu miżjuda ma ’ terapija anti- dijabetika u kardjovaskulari eżistenti, sa 3. 5 snin.
The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Il- popolazzjoni taħt studju kellha eta ’ medja ta ’ 62 sena; it- tul medju tad- dijabete kienet ta ’ 9. 5 snin.
Approximately one third of patients were receiving insulin in combination with metformin and/ or a sulphonylurea.
Madwar terz tal - pazjenti kienu qed jirċievu l- insulina flimkien ma ’ metformin u jew mediċina tat- tip sulphonylurea.
To be eligible patients had to have had one or more of the following: myocardial infarction, stroke, percutaneous cardiac intervention or coronary artery bypass graft, acute coronary syndrome, coronary artery disease, or peripheral arterial obstructive disease.
Biex ikunu eliġibbli, il- pazjenti ried ikollhom waħda jew aktar minn dawn li ġejjin: infart mijokardiku, puplesija, intervent kardijaku perkutanju jew bypass bi graft tal- arterja koronarja, sindromu koronarju akut, mard koronarju arterjali, jew mard tal- arterji periferali miżduda.
Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke.
Kważi nofs il- pazjenti kellhom minn qabel infart mijokardijaku u madwar 20% kellhom puplesija.
Approximately half of the study population had at least two of the cardiovascular history entry criteria.
Madwar nofs il- popolazzjoni taħt studju kellhom minn tal- inqas tnejn minn dawn il- kriterji ta ’ dħul ta ’ passat kardjovaskulari.
Almost all subjects (95%) were receiving cardiovascular medications (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Kważi s - soġġetti kollha (95%) kienu qed jirċievu medikazzjoni kardjovaskulari (imblokkaturi beta, inibituri ACE, antagonisti ta ’ angiotensin II, imblokkaturi tal- kanali tal- kalċju, nitrati, dijuretiċi, aspirina, statins, fibrates).
10 Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non- fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Għalkemm l- istudju falla fil- mira primarja tiegħu, li kienet magħmula mill- kawżi kollha ta ’ mortalità, infart mijokariku mhux fatali, puplesija, sindromu koronarju akut, amputazzjoni maġġura tas- sieq, rivaskularizzazzjoni koronarja u rivaskularizzazzjoni tas- sieq, ir- riżultati ssuġġerixxu li m’ hemmx periklu kardjovaskulari dwar l- użu ta ’ pioglitazone fit- tul.
However, the incidences of oedema, weight gain and heart failure were increased.
Madankollu, l- inċidenza ta ’ edima, żieda fil- piż u insuffiċjenza tal- qalb żdiedu.
No increase in mortality from heart failure was observed.
Ma kienetx osservata żieda fil- mortalità minn insuffiċjenza tal - qalb.
Absorption:
Assorbiment
Following oral administration, pioglitazone is rapidly absorbed, and peak plasma concentrations of unchanged pioglitazone are usually achieved 2 hours after administration.
Wara għotja mill- ħalq, pioglitazone jiġi assorbit malajr, u l- għola konċentrazzjonijiet fil- plażma ta ’ pioglitazone mhux mibdul normalment jintlaħqu sagħtejn wara l- għotja.
Proportional increases of the plasma concentration were observed for doses from 2 – 60 mg.
Żieda proporzjonali fil - konċentrazzjoni fil- plażma kienet osservata f’ dozi minn 2 – 60 mg.
Steady state is achieved after 4– 7 days of dosing.
Stat stabbli jintlaħaq wara erba ’ sa sebat ijiem ta ’ dożaġġ.
Repeated dosing does not result in accumulation of the compound or metabolites.
Dożaġġ ripetut ma jwassalx f’ akkumulazzjoni tal- mediċina jew tal- metaboliti.
Absorption is not influenced by food intake.
L- assorbiment mhux influwenzat mit- teħid ta ’ ikel.
Absolute bioavailability is greater than 80%.
Il- bijodisponibilità assoluta hija aktar minn 80%.
Distribution:
10 Distribuzzjoni
The estimated volume of distribution in humans is 0.25 l/ kg.
Il- volum stmat ta ’ distribuzzjoni fil- bnedmin huwa ta ’ 0. 25 l/ kg.
Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
Pioglitazone u l- metaboliti attivi kollha huma marbuta b’ mod estensiv mal- proteini fil- plażma (> 99%).
Metabolism:
Metaboliżmu
Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups.
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 degree.
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).
When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III contribute equally to efficacy.
Meta l- attività, konċetrazzjonijiet u twaħħil mal- proteini jittieħdu f’ konsiderazzjoni, pioglitazone u l- metabolita M- III ikkontribwew l- istess għall- effikaċja.
On this basis M-IV contribution to efficacy is approximately three-fold that of pioglitazone, whilst the relative efficacy of M-II is minimal.
Fuq din il- bażi, il- kontribut ta ’ M- IV għall- effikaċja huwa madwar tliet- darbiet dik ta ’ pioglitazone, filwaqt li l- effikaċja relattiva ta ’ M- II hija minima.
In vitro studies have shown no evidence that pioglitazone inhibits any subtype of cytochrome P450.
Studji in vitro ma wrew l- ebda evidenza li pioglitazone jinibixxi xi sottotip taċ- ċitokromju P450.
There is no induction of the main inducible P450 isoenzymes 1A, 2C8/ 9, and 3A4 in man.
M’ hemm l- ebda induzzjoni tal- isożimi prinċipali ta ’ P450 induċibbli 1A, 2C8/ 9, u 3A4 fil- bniedem.
Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin.
Studji dwar interazzjoni wrew li pioglitazone m’ għandu l- ebda effett relevanti la fuq il - farmakokinetika u lanqas fuq il- farmakodinamika ta ’ digoxin, warfarin, phenprocoumon u metformin.
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- għotja 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:
Eliminazzjoni
Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Wara għotja mill- ħalq ta ’ pioglitazone radjulabiljat lill- bniedem, it- tikkettjar miġbur kien l- aktar fil - feċi (55%) u f’ ammont inqas fl- awrina (45%).
In animals, only a small amount of unchanged pioglitazone can be detected in either urine or faeces.
Fl- annimali, jista ’ jiġi osservat ammont żgħir biss ta ’ pioglitazone mhux mibdul fl- awrina jew fil- feċi.
The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Il- half- life medja ta ’ eliminazzjoni mill- plażma ta ’ pioglitazone mhux mibdul fil- bniedem hija 5 sa 6 sigħat u għall- metaboliti attivi kollha tiegħu, 16 sa 23 siegħa.
Elderly:
Anzjani
Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Il- farmakokinetika fi stat stabbli ta ’ pazjenti b’ eta ’ ta ’ 65 sena jew aktar hija simili għal dik f’ pazjenti żgħar.
11 Patients with renal impairment:
Pazjenti b’ indeboliment renali
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.
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.
Thus free (unbound) pioglitazone concentration is unchanged.
Għalhekk il- konċentrazzjoni ta ’ pioglitazone ħieles (mhux marbut) baqgħet ma nbidletx.
Total plasma concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Il- konċentrazzjoni totali fil- plażma ta ’ pioglitazone ma mbidletx, iżda b’ volum ta ’ distribuzzjoni miżjud.
Intrinsic clearance is therefore reduced, coupled with a higher unbound fraction of pioglitazone.
Tneħħija intrinsika hija għalhekk imnaqqsa, flimkien ma ’ porzjon ikbar ta ’ pioglitazone mhux marbut.
In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys.
Fi studji tossikoloġiċi, l- espansjoni tal- volum tal- plażma permeżz ta ’ emodiluzzjoni, anemija u ipertrofija kardijaka eċċentrika riversibbli kienet apparenti b’ mod konsistenti wara dożaġġ ripetut fil -
In addition, increased fatty deposition and infiltration were observed.
Kienet osservata wkoll żieda fid- depożizzjoni u l- infiltrazzjoni tax - xaħam.
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.
Foetal growth restriction was apparent in animal studies with pioglitazone.
Restrizzjoni fit- tkabbir tal- fetu kienet apparenti fi studji fl- annimali b’ pioglitazone.
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 lill- azzjoni ta ’ pioglitazone li tnaqqas l- iperinsulinemija fl- omm u liż- żieda fir - reżistenza għall- insulina li sseħħ waqt it- tqala, li b’ hekk inaqqsu d- disponibilità ta ’ substrati metaboliċi għat- tkabbir tal- fetu.
Pioglitazone was devoid of genotoxic potential in a comprehensive battery of in vivo and in vitro genotoxicity assays.
Pioglitazone ma kellux potenzjal ġenotossiku f’ sensiela kompluta ta ’ analiżi ġenotossika in vivo u in vitro.
An increased incidence of hyperplasia (males and females) and tumours (males) of the urinary bladder epithelium was apparent in rats treated with pioglitazone for up to 2 years.
Żieda fl- inċidenza ta ’ iperplażja (rġiel u nisa) u ta ’ tumuri (rġiel) fl- epitilju tal- bużżieqa tal - awrina kienet apparenti fil- firien ikkurati b’ pioglitazone sa sentejn.
The relevance of this finding is unknown.
Ir- rilevanza ta ’ din is- sejba mhix magħrufa.
There was no tumorigenic response in mice of either sex.
Fl- ebda sess ma kien hemm rispons tumuroġeniku fil- ġrieden.
Hyperplasia of the urinary bladder was not seen in dogs or monkeys treated for up to 12 months.
Fil- klieb jew xadini kkurat sa 12- il xahar ma dehritx iperplażja tal- bużżieqa tal- awrina.
In an animal model of familial adenomatous polyposis (FAP), treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
F’ mudell tal- annimali ta ’ adenomatous polyposis familjali (FAP), kura b’ żewġ thiazolidinediones oħra żiedet il- multipliċità tat- tumuri fil- musrana.
Carmellose calcium Hyprolose Lactose monohydrate Magnesium stearate
Carmellose calcium Hyprolose Lactose monohydrate Magnesium stearate
Aluminium/ aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90 and 98 tablets.
Aluminju/ Folja tal- aluminju, pakketti ta ’ 14, 28, 30, 50, 56, 84, 90 u 98 pillola.
Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych London WC2B 4AE United Kingdom
Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych London WC2B 4AE Ir- Renju Unit
Date of first authorisation:
Data ta ’ l- ewwel awtorizazzjoni:
13-10-2000 Date of last renewal:
13- 10- 2000 Data ta ’ l- aħħar tiġdid:
Actos 30 mg tablets.
Pilloli Actos 30 mg.
Each tablet contains 30 mg of pioglitazone as hydrochloride.
Kull pillola fiha 30 mg ta ’ pioglitazone bħala hydrochloride.
The tablets are white to off-white, round, flat and marked ‘ 30’ on one face and ‘ ACTOS’ on the other face.
Il- pilloli huma bojod għal abjad maħmuġ, tondi, ċatti u mmarkati b ’ ‘ 30 ’ fuq naħa waħda u b ’ ‘ ACTOS ’ fuq in- naħa l- oħra.
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.
If patients report hypoglycaemia, the dose of insulin should be decreased.
Jekk il- pazjenti jirrappurtaw ipogliċemija, id- doża ta ’ insulina għandha titnaqqas.
14 Elderly:
14 Anzjani
When treating patients who have at least one risk factor for development of congestive heart failure (e. g. prior myocardial infarction or symptomatic coronary artery disease), physicians should start with the lowest available dose and increase the dose gradually.
Meta jiġu kkurati pazjenti li għandhom ta ’ l- inqas fattur ta ’ riskju wieħed għall- iżvilupp ta ’ insuffiċjenza tal- qalb konġestiva (e. ż. infart mijokardijaku minn qabel jew mard fl- arterji koronarji bis- sintomi), it- tobba għandhom jibdew bl- inqas doża disponibbli u jżidu d- doża bil- mod.
There have been cases of cardiac failure reported from the market when pioglitazone was used in combination with insulinor 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 kardijaka 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:
Sorveljanza tal- funzjoni tal- fwied
Liver enzymes should be checked prior to the initiation of therapy with pioglitazone in all
L- enżimi tal- fwied għandhom jiġu ċċekkjati qabel ma tinbeda
15 patients.
15 terapija b’ pioglitazone f’ kull pazjent.
If jaundice is observed, drug therapy should be discontinued.
Jekk tkun osservata s- suffejra, It- terapija bil- mediċina għandha titwaqqaf.
The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
16 L- inċidenza ta ’ fratturi kkalkulata kienet ta ’ 1. 9 fratturi kull 100 sena ta ’ pazjent f’ nisa kkurati b’ pioglitazone u 1. 1 fratturi kull 100 sena ta ’ pazjent f’ nisa kkurati bi prodott ta ’ paragun.
16 In the 3.5 year cardiovascular risk PROactive study, 44/ 870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/ 905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
Fl- istudju PROactive dwar ir- riskju kardjovaskulari li dam 3. 5 snin, 44/ 870 (5. 1%; 1. 0 fratturi kull 100 sena ta ’ pazjent) tal- pazjenti nisa kkurati b’ pioglitazone kellhom esperjenza ta ’ fratturi meta mqabbel ma ’ 23/ 905 (2. 5%; 0. 5 fratturi kull 100 sena ta ’ pazjent) tal- pazjenti nisa kkurati bi prodott paragun.
Close monitoring of glycaemic control should be considered (see section 4.4).
Jista ’ jkun hemm bżonn li d- doża ta ’ pioglitazone tiżdied meta rifampicin jingħata fl- istess ħin Sorveljanza mill- viċin tal- kontroll gliċemiku għandha tiġi kkunsidrata (ara sezzjoni 4. 4).
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.
17 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:
Użu fit- treddigħ
17 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is - serjetata ’ tagħhom.
Musculoskeletal system and connective tissue disorders
18 Disturbi muskolu- skeltrali u tal- connective tissue Komuni:
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni: għaraq
19 PIOGLITAZONE IN TRIPLE ORAL COMBINATION THERAPY WITH METFORMIN AND SULPHONYLUREA
PIOGLITAZONE F’ TERAPIJA TRIPPLA KOMBINATA MA ’ METFORMIN U SULPHONYLUREA MIL- ĦALQ
arthralgia
19
Oedema was reported in 6 – 9% of patients treated with pioglitazone over one year in controlled clinical trials.
f’ 6 – 9% tal- pazjenti kkurati b’ pioglitazone fuq medda ta ’ sena fi provi
20 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 – 3 kg over one year.
Fi provi attivi kkontrollati ta ’ paragun, iż- żieda medja fil- piż bi pioglitazone mogħti bħala monoterapija kienet ta ’ 2 – 3 kg fuq medda ta ’ sena.
Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic agents.
Disturbi viżwali ġew irrappurtati l- aktar fil- bidu tal- kura u huma relatati ma ’ tibdil fil- glucose fid - demm minħabba alterazzjoni temporanja fit- turġidità u fl- indiċi refrattiv tal- lenti kif osservat b’ aġenti ipogliċemiċi oħra.
Pioglitazone effects may be mediated by a reduction of insulin resistance.
L- effetti ta ’ pioglitazone jistgħu jkunu medjati minn tnaqqis fir- reżistenza għall- insulina.
Treatment with pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose disposal in the case of insulin resistance.
Kura b’ pioglitazone intweriet li tnaqqas il- ħrug ta ’ glucose mill - fwied u żżid it- tneħħijja periferali ta ’ glucose f’ każ ta ’ reżistenza għall- insulina.
21 Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus.
Kontroll gliċemiku waqt is- sawm jew wara l- ikel jitjieb f’ pazjenti b’ dijabete mellitus tat- tip 2.
Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
21 dawk li komplew fuq l- insulina biss, u fil- grupp ikkurat b’ pioglitazone kien hemm tnaqqis fid- doża tal- insulina.
Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non- fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular
Għalkemm l- istudju falla fil- mira primarja tiegħu, li kienet magħmula mill- kawżi kollha ta ’ mortalità, infart mijokariku mhux fatali, puplesija, sindromu koronarju akut, amputazzjoni maġġura tas- sieq, rivaskularizzazzjoni koronarja u rivaskularizzazzjoni tas- sieq, ir- riżultati ssuġġerixxu li m’ hemmx periklu kardjovaskulari dwar l- użu ta ’ pioglitazone fit- tul.
Distribution:
22 Distribuzzjoni
23 Patients with hepatic impairment:
Pazjenti b’ indeboliment epatiku
In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys.
Fi studji tossikoloġiċi, l- espansjoni tal- volum tal- plażma permeżz ta ’ emodiluzzjoni, anemija u ipertrofija kardijaka eċċentrika riversibbli kienet apparenti b’ mod konsistenti wara dożaġġ ripetut fil - 23 ġrieden, firien, klieb u xadini.
Actos 45 mg tablets.
Pilloli Actos 45 mg.
Each tablet contains 45 mg of pioglitazone as hydrochloride.
Kull pillola fiha 45 mg ta ’ pioglitazone bħala hydrochloride.
The tablets are white to off-white, round, flat and marked ‘ 45’ on one face and ‘ ACTOS’ on the other face.
Il- pilloli huma bojod għal abjad maħmuġ, tondi, ċatti u mmarkati b ’ ‘ 45 ’ fuq naħa waħda u b ’ ‘ ACTOS ’ fuq in- naħa l- oħra.
26 Elderly:
26 Anzjani
27 patients.
27 terapija b’ pioglitazone f’ kull pazjent.
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.
Kienet osservata żieda fl- inċidenza ta ’ fratturi fl- għadam fin- nisa f’ analiżi ta ’ ġabra 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 fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
28 L- inċidenza ta ’ fratturi kkalkulata kienet ta ’ 1. 9 fratturi kull 100 sena ta ’ pazjent f’ nisa kkurati b’ pioglitazone u 1. 1 fratturi kull 100 sena ta ’ pazjent f’ nisa kkurati bi prodott ta ’ paragun.
28 In the 3.5 year cardiovascular risk PROactive study, 44/ 870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/ 905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
Fl- istudju PROactive dwar ir- riskju kardjovaskulari li dam 3. 5 snin, 44/ 870 (5. 1%; 1. 0 fratturi kull 100 sena ta ’ pazjent) tal- pazjenti nisa kkurati b’ pioglitazone kellhom esperjenza ta ’ fratturi meta mqabbel ma ’ 23/ 905 (2. 5%; 0. 5 fratturi kull 100 sena ta ’ pazjent) tal- pazjenti nisa kkurati bi prodott paragun.
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.
29 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.
29 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
30 Nervous system disorders
30 Disturbi muskolu- skeltrali u tal- connective tissue Komuni:
headache
Disturbi fis- sistema nervuża Komuni:
31 PIOGLITAZONE IN TRIPLE ORAL COMBINATION THERAPY WITH METFORMIN AND SULPHONYLUREA
PIOGLITAZONE F’ TERAPIJA TRIPPLA KOMBINATA MA ’ METFORMIN U SULPHONYLUREA MIL- ĦALQ
arthralgia
31
32 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 – 3 kg over one year.
Fi provi attivi kkontrollati ta ’ paragun, iż- żieda medja fil- piż bi pioglitazone mogħti bħala monoterapija kienet ta ’ 2 – 3 kg fuq medda ta ’ sena.
A pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
Twettqet analiżi ta ’ ġabra ta ’ rapporti ta ’ avvennimenti avversi ta ’ fratturi fl- għadam minn provi kliniċi randomised, ikkontrollati b’ paragun, u double blind b’ aktar minn 8100 pazjent fil- gruppi kkurati b’ pioglitazone u 7400 pazjent fil- gruppi kkurrati bi prodott paragun li damu sa 3. 5 snin.
33 Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus.
Kontroll gliċemiku waqt is- sawm jew wara l- ikel jitjieb f’ pazjenti b’ dijabete mellitus tat- tip 2.
Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
33 dawk li komplew fuq l- insulina biss, u fil- grupp ikkurat b’ pioglitazone kien hemm tnaqqis fid- doża tal- insulina.
Distribution:
34 Distribuzzjoni
35 Patients with hepatic impairment:
Pazjenti b’ indeboliment epatiku
36 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
MARKTEING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
37 ANNEX II
37 ANNESS II
Ireland.
L- Irlanda.
Avda. de la Industria 30 28108 Alcobendas (Madrid) Spain
Avda. de la Industria 30 28108 Alcobendas (Madrid) Spanja
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.
Fuq il- fuljett ta 'tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli mill- ħruġ tal- lott konċernat
The Marketing Authorisation Holder will submit one additional 6 month Periodic Safety Update Report (PSUR) in September 2005 and thereafter yearly PSURs unless otherwise decided by the CHMP.
Id- Detentur ta ’ l- Awtorizazzjoni għat- Tqegħid fis- Suq ser jissottometti Periodic Safety Update Report (PSUR) ieħor ta ’ 6 xhur f’ Settembru 2005 u minn hemm PSURs kull sena sakemm is- CHMP ma tiddeċidix mod ieħor.
The Marketing Authorisation Holder commits to performing the Pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Id- Detentur ta ’ l- Awtorizazzjoni għat- Tqegħid fuq is- Suq jikkommetti ruħu li jwettaq l- attivitajiet ta ’ Farmakoviġilanza kif iddettaljat fil- Pjan ta ’ Farmakoviġilanza.
An updated Risk Management Plan should be provided as per the CHMP guideline on Risk Management Systems for medicinal products for human use.
Pjan ta ’ Mmaniġġjar ta ’ Riskji mġedded għandu jiġi pprovdut skond il- linji gwida ta ’ CHMP dwar is - Sistemi ta ’ Mmaniġġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil- bniedem.
39 ANNEX III
39 ANNESS III
Actos 15 mg tablets
Actos 15 mg pilloli
Pioglitazone (as hydrochloride)
Pioglitazone (bħala hydrochloride)
Each tablet contains 15 mg pioglitazone (as hydrochloride).
Kull pillola fiha 15 mg pioglitazone (bħala hydrochloride).
14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets
14- il pillola 28 pillola 30 pillola 50 pillola 56 pillola 84 pillola 90 pillola 98 pillola
Read the package leaflet before use.
Użu orali Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Expiry date:
JIS
EU/ 1/ 00/ 150/ 007 14 tablets EU/ 1/ 00/ 150/ 001 28 tablets EU/ 1/ 00/ 150/ 016 30 tablets EU/ 1/ 00/ 150/ 002 50 tablets EU/ 1/ 00/ 150/ 009 56 tablets EU/ 1/ 00/ 150/ 017 84 tablets EU/ 1/ 00/ 150/ 018 90 tablets EU/ 1/ 00/ 150/ 003 98 tablets
EU/ 1/ 00/ 150/ 007 14- il pillola EU/ 1/ 00/ 150/ 001 28 pillola EU/ 1/ 00/ 150/ 016 30 pillola EU/ 1/ 00/ 150/ 002 50 pillola EU/ 1/ 00/ 150/ 009 56 pillola EU/ 1/ 00/ 150/ 017 84 pillola EU/ 1/ 00/ 150/ 018 90 pillola EU/ 1/ 00/ 150/ 003 98 pillola
MANUFACTURER’ S BATCH NUMBER
NUMRU TAL- LOTT
{number}
LOTT
Actos 30 mg tablets
Actos 30 mg pilloli
pioglitazone (as hydrochloride)
Pioglitazone (bħala hydrochloride)
Each tablet contains 30 mg pioglitazone (as hydrochloride).
Kull pillola fiha 30 mg pioglitazone (bħala hydrochloride).
Contains lactose monohydrate.
Fiha lactose monohydrate.
EU/ 1/ 00/ 150/ 008 14 tablets EU/ 1/ 00/ 150/ 004 28 tablets EU/ 1/ 00/ 150/ 019 30 tablets EU/ 1/ 00/ 150/ 005 50 tablets EU/ 1/ 00/ 150/ 010 56 tablets EU/ 1/ 00/ 150/ 020 84 tablets EU/ 1/ 00/ 150/ 021 90 tablets EU/ 1/ 00/ 150/ 006 98 tablets
EU/ 1/ 00/ 150/ 008 14- il pillola EU/ 1/ 00/ 150/ 004 28 pillola EU/ 1/ 00/ 150/ 019 30 pillola EU/ 1/ 00/ 150/ 005 50 pillola EU/ 1/ 00/ 150/ 010 56 pillola EU/ 1/ 00/ 150/ 020 84 pillola EU/ 1/ 00/ 150/ 021 90 pillola EU/ 1/ 00/ 150/ 006 98 pillola
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Actos 45 mg tablets
Actos 45 mg pilloli
Each tablet contains 45 mg pioglitazone (as hydrochloride).
Kull pillola fiha 45 mg pioglitazone (bħala hydrochloride).
EU/ 1/ 00/ 150/ 011 14 tablets EU/ 1/ 00/ 150/ 012 28 tablets EU/ 1/ 00/ 150/ 022 30 tablets EU/ 1/ 00/ 150/ 013 50 tablets EU/ 1/ 00/ 150/ 014 56 tablets EU/ 1/ 00/ 150/ 023 84 tablets EU/ 1/ 00/ 150/ 024 90 tablets EU/ 1/ 00/ 150/ 015 98 tablets
EU/ 1/ 00/ 150/ 011 14- il pillola EU/ 1/ 00/ 150/ 012 28 pillola EU/ 1/ 00/ 150/ 022 30 pillola EU/ 1/ 00/ 150/ 013 50 pillola EU/ 1/ 00/ 150/ 014 56 pillola EU/ 1/ 00/ 150/ 023 84 pillola EU/ 1/ 00/ 150/ 024 90 pillola EU/ 1/ 00/ 150/ 015 98 pillola
47 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
47 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Actos 15 mg tablets
Actos 15 mg tablets
Pioglitazone (as HCl)
Pioglitazone (bħala HCl)
ABBREVIATIONS FOR DAYS OF THE WEEK (PACK SIZES OF 14, 28, 56, 84 AND 98 TABLETS ONLY)
ABBREVJAZZJONIJET GĦALL- ĠRANET TAL- ĠIMGĦA (DAQSIJIET TAL - PAKKETTI TA ’ 14, 28, 56, 84 U 98 PILLOLA BISS)
MON TUE WED THU FRI SAT SUN
It- Tnejn It- Tlieta L- Erbgħa L- Ħamis Il- Ġimgħa Is- Sibt Il- Ħadd
48 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
48 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Actos 30 mg tablets
Actos 30 mg tablets
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
49 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Actos 45 mg tablets
Actos 45 mg tablets
51 PACKAGE LEAFLET:
51 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER ACTOS 15 MG TABLETS
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA PILLOLI ACTOS 15 MG (Pioglitazone (bħala hydrochloride))
Read all of this leaflet carefully before you start taking this medicine.
Aqra dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
- If you have further questions, please ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
It may harm them,
Tista ’ tagħmlilhom
even if their symptoms are the same as yours.
il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
please tell you doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Actos is and what it is used for 2.
X’ inhu Actos u għal xiex jintuża 2.
Before you take Actos 3.
Qabel ma tieħu Actos 3.
How to take Actos 4.
Kif għandek tieħu Actos 4.
How to store Actos 6.
Kif taħżen Actos 6.
WHAT ACTOS IS AND WHAT IT IS USED FOR
X’ INHU ACTOS U GĦALXIEX JINTUŻA
Actos 15mg tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus.
Pilloli Actos 15mg huma mediċina anti- dijabetika wżata biex tikkura dijabete mellitus tat- tip 2 (mhux dipendenti mill- insulina).
This is the diabetes that usually develops in adulthood.
Din hija d- dijabete li ġeneralment tiżviluppa fi stat adult.
Actos 15mg tablets helps 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 Actos 15mg 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.
Actos 15mg tablets may be used on their own or in combination with metformin and / or a sulphonylurea which are also oral anti-diabetic medicines.
Pilloli Actos 15mg jistgħu jintużaw waħedhom jew flimkien ma ’ metformin u / jew mediċina tat- tip sulphonylurea li huma wkoll mediċini anti- dijabetiċi mill- ħalq.
Actos 15 mg tablets may also be used in combination with insulin.
Pilloli Actos 15 mg jistgħu jintużaw ukoll flimkien ma ’ l- insulina.
BEFORE YOU TAKE ACTOS
QABEL MA TIEĦU ACTOS
Do not take Actos 15mg tablets:
Tieħux pilloli Actos 15mg:
- If you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of Actos 15mg
- Jekk inti tbagħti minn sensittività eċċessiva (allerġiku/ a) għal pioglitazone jew sustanzi oħra ta ’
tablets.
pilloli Actos 15mg.
- If you have heart failure.
- Jekk għandek insuffiċjenza tal- qalb.
- If you have liver disease
- Jekk għandek mard tal- fwied.
Take special care with Actos 15mg tablets:
Oqgħod attent ħafna b’ pilloli Actos 15mg
Tell your doctor before you start to take this medicine:
Għid lit- tabib tiegħek qabel tibda tieħu din il- mediċina:
- If you have a special type of diabetic eye disease called macular oedema (swelling of the back of the
- Jekk għandek tip speċjali ta ’ marda dijabetika tal- għajn msejjħa edema makulari (nefħa tal- parti
eye).
ta ’ wara tal- għajn).
- If you are planning to become pregnant.
- Jekk qed tippjana li tinqabad tqila.
- If you are breast-feeding.
- Jekk qed tredda ’.
- If you have polycystic ovary syndrome.
- Jekk għandek is- sindromu tal- ovarji poliċistiċi.
There may be an increased possibility of your becoming
Jista ’ jkun hemm possibilità akbar li inti toħroġ
pregnant because of how your medicine works.
tqila minħabba l- mod kif taħdem il- mediċina tiegħek.
- If you are under 18 years of age because use in such patients is not recommended.
- Jekk inti għandek eta ’ taħt 18- il sena minħabba li l- użu f’ dawn il- pazjenti mhux rakkomandat.
Taking Actos 15mg tablets with food and drink:
Meta tieħu pilloli Actos 15mg ma ’ l- ikel u max- xorb:
You may take your tablets with or after a meal or on an empty stomach.
Tista ’ tieħu l- pilloli tiegħek ma ’ l- ikel jew wara ikla jew fuq stonku vojt.
You should swallow the tablets with a glass of water.
Għandek tibla ’ il- pilloli ma ’ tazza ilma.
Tell your doctor if you are, you think you might be or are planning to become pregnant.
Għid lit- tabib tiegħek jekk inti, taħseb li inti jew qed tippjana biex toħroġ tqila.
Your doctor will advise you to discontinue this medicine.
It- tabib tiegħek se jagħtik parir biex twaqqaf din il- mediċina.
Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby.
Għid lit- tabib tiegħek jekk inti qed tredda ’ jew qed tippjana li tredda ’ lit- tarbija tiegħek.
Your doctor will discontinue this medicine.
It- tabib tiegħek se jwaqqaflek din il- mediċina.
Pioglitazone will not affect your ability to drive or operate machinery.
Pioglitazone ma jaffettwax il- ħila tiegħek li ssuq jew li tħaddem magni.
Important information about some of the ingredients of Actos 15mg tablets:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ pilloli Actos 15mg:
This medicinal product contains lactose monohydrate.
Dan il- prodott mediċinali fih lactose monohydrate.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Actos 15mg tablets.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi żokkrijiet, kellem lit- tabib tiegħek qabel ma tieħu pilloli Actos 15mg.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra anki dawk mingħajr riċetta.
You can usually continue to take other medicines whilst you are being treated with Actos 15mg tablets.
Ġeneralment int se tkun tista ’ tibqa tieħu mediċini oħra waqt li qed tiġi kkurat b’ pilloli Actos 15mg.
HOW TO TAKE ACTOS
KIF GĦANDEK TIEĦU ACTOS
One tablet should be taken once daily.
Pillola waħda għandha tittieħed darba kuljum.
If necessary your doctor may tell you to take a different dose.
Jekk hemm bżonn, it- tabib tiegħek jista ’ jgħidlek tieħu doża differenti.
If you have the impression that the effect of Actos 15mg tablets is too weak, talk to your doctor.
Jekk taħseb li l- effett tal- pilloli Actos 15mg huwa dgħajjef wisq, kellem lit- tabib tiegħek.
Actos 15mg tablets can be taken with or without food.
Pilloli Actos 15mg jistgħu jittieħdu ma ’ l- ikel jew mingħajr ikel.
When Actos 15mg tablets are taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Meta pilloli Actos 15mg jittieħdu flimkien ma ’ mediċini oħra wżati għall- kura tad- dijabete (bħal insulina, chlorpropamide, glibenclamide, gliclazide, tolbutamide), it- tabib tiegħek jgħidlek jekk għandekx bżonn tieħu doża inqas tal- mediċini tiegħek.
Your doctor will ask you to have blood tests periodically during treatment with Actos.
It- tabib tiegħek se jitolbok tagħmel testijiet tad- demm perjodiċi waqt il- kura b’ Actos.
This is to check that your liver is working normally.
Dan sabiex jiċċekkja li l- fwied tiegek qed jaħdem kif suppost.
If you are following a diabetic diet, you should continue with this while you are taking Actos 15mg tablets.
Jekk qed issegwi dieta dijabetika, għandek tkompli biha waqt li qed tieħu l- pilloli Actos 15mg.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Il- piż tiegħek għandu jiġi ċċekkjat f’ intervalli regolari; jekk il- piż tiegħek jiżdied, għid lit- tabib tiegħek.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Actos and insulin experienced the development of heart failure.
Xi pazjenti b’ dijabete mellitus tat- tip 2 għal żmien twil u b’ mard tal- qalb jew aċċessjoni minn qabel li kienu kkurati b’ Actos u insulin kellhom żvilupp ta ’ insuffiċjenza tal- qalb.
Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Kellem lit- tabib tiegħek minnufih jekk ikollok sinjali ta ’ insuffiċjenza tal- qalb bħal qtugħ ta ’ nifs mhux tas- soltu jew żieda f’ daqqa fil- piż jew nefħa lokalizzata (edima).
53 In clinical trials in which pioglitazone was compared to other oral anti diabetic drugs or placebo (dummy pill), a higher number of bone fractures was seen in women (but not in men) taking pioglitazone.
Fi provi kliniċi fejn pioglitazone kien imqabbel ma ’ mediċini mill- ħalq kontra d- dijabete oħrajn jew ma ’ placebo (pillola finta), kien osservat numru akbar ta ’ fratturi fl- għadam fin- nisa (iżda mhux fl -
Your doctor will take this into account when treating your diabetes.
It- tabib tiegħek se jikkunsidra dan waqt li jikkura d- dijabete tiegħek.
If you take more Actos 15mg tablets than you should:
Jekk tieħu pilloli Actos 15mg aktar milli suppost:
If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Jekk bi żball tieħu wisq pilloli, jew jekk xi ħadd ieħor jew tifel/ tifla jieħdu l- mediċina tiegħek, kellem minnufiħ lill- tabib jew spiżjar.
If you forget to take Actos 15mg tablets:
Jekk tinsa tieħu pilloli Actos 15mg:
Try to take Actos 15mg tablets daily as prescribed.
Ipprova ħu pilloli Actos 15mg kuljum kif preskritt.
However if you miss a dose, just carry on with the next dose as normal.
Iżda jekk tinsa tieħu doża, kompli bid- doża li jmiss kif suppost.
Do not take an extra tablet to make up for the one you missed.
M’ għandekx tieħu doża doppja biex tpatti għal kull pillola li tkun insejt tieħu.
Like all medicines, Actos 15mg tablets can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, pilloli Actos 15mg jista ’ jkollhom effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following side effects have been experienced by some patients taking Actos 15mg tablets:
Xi pazjenti esperjenzaw l- effetti sekondarji li ġejjin waqt li qed jieħdu pilloli Actos 15mg:
- localised swelling (oedema)
- nefħa lokalizzata (edima)
- weight gain
- żieda fil- piż
- respiratory infection
- infezzjoni respiratorja
- dizziness
- sturdament
- numbness
- tirżiħ
- abnormal vision
- vista mhux normali
- blurred vision due to swelling (or fluid) in the back of the eye.
- vista mċajpra minħabba nefħa (jew fluwidu) fil- part ta ’ wara tal- għajn.
If you experience these symptoms for
Jekk tħoss dawn is -
the first time or if they get worse tell your doctor as soon as possible.
sintomi għal l- ewwel darba jew jekk imorru għal agħar għid lit- tabib tiegħek minnufiħ.
- flatulence
- gass
- joint pain
- uġigħ fil- ġogi
- sweating
- tgħoroq
- fatigue
- għejja
- insomnia
- insonnja
- decreased blood sugar (hypoglycaemia), sugar in urine, proteins in urine, blood in urine
- tnaqqis taż- żokkor fid- demm (ipogliċemija), żokkor fl- awrina, proteina fl- awrina, demm fl -
- in rare cases, impaired liver function
- f’ każijiet rari, funżjoni mdgħajjfa tal- fwied
- a small reduction in red blood cell count
- tnaqqis żgħir fl- għadd taċ- ċelloli ħomor tad- demm
- back pain
- uġigħ fid- dahar
- shortness of breath.
- qtugħ ta ’ nifs.
HOW TO STORE ACTOS
KIF TAĦŻEN ACTOS
This medicinal product does not require any special storage precautions.
Dan il- prodott mediċinali m’ għandux bżonn ħtiġijiet speċjali ta ’ ħażna.
Do not use after the expiry date stated on the carton.
Tużax wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
What Actos contains The active substance in Actos 15mg tablets is pioglitazone.
Is- sustanza attiva ta ’ pilloli Actos 15mg hija pioglitazone.
Each tablet contains 15mg of pioglitazone (as hydrochloride).
Kull pillola fiha 15mg ta ’ pioglitazone (bħala hydrochloride).
The other ingredients are lactose monohydrate, hyprolose, carmellose calcium and magnesium stearate.
Is- sustanzi l- oħra huma lactose monohydrate, hyprolose, carmellose calcium u magnesium stearate.
What Actos looks like and contents of the pack Actos 15 mg tablets are white to off white, round, convex tablets marked ‘ 15’ on one face and ‘ ACTOS’ on the other face.
Pilloli Actos 15 mg huma pilloli bojod għal abjad maħmuġ, tondi, bbuzzati fuq iż- żewġ naħat immarkati b ’ ‘ 15 ’ fuq naħa waħda u b ’ ‘ ACTOS ’ fuq in- naħa l- oħra.
The tablets are supplied in blister packs of 14, 28, 30, 50, 56, 84, 90 or 98 tablets.
Il- pilloli huma disponibbli f’ pakketti bil- folji ta ’ 14, 28, 30, 50, 56, 84, 90 jew 98 pillola.
Not all the pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Marketing Authorisation Holder and Manufacturer Marketing authorisation holder:
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
Takeda Global Research and Development Centre (Europe) Ltd, 61 Aldwych, London, WC2B 4AE, United Kingdom.
Takeda Global Research and Development Centre (Europe) Ltd, 61 Aldwych, London, WC2B 4AE, Ir- Renju Unit.
Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland.
Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, L- Irlanda.
Lilly S. A, Avda. de la Industria 30, 28108 Alcobendas (Madrid), Spain
Lilly S. A, Avda. de la Industria 30, 28108 Alcobendas (Madrid), Spanja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
This leaflet was last approved on {date}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
56 PACKAGE LEAFLET:
56 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER ACTOS 30 MG TABLETS
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA PILLOLI ACTOS 30 MG (Pioglitazone (bħala hydrochloride))
Actos 30mg tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus.
Pilloli Actos 30mg huma mediċina anti- dijabetika wżata biex tikkura dijabete mellitus tat- tip 2 (mhux dipendenti mill- insulina).
Actos 30mg tablets helps 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 Actos 30mg 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.
Actos 30mg tablets may be used on their own or in combination with metformin and / or a sulphonylurea which are also oral anti-diabetic medicines.
Pilloli Actos 30mg jistgħu jintużaw waħedhom jew flimkien ma ’ metformin u / jew mediċina tat- tip sulphonylurea li huma wkoll mediċini anti- dijabetiċi mill- ħalq.
Actos 30 mg tablets may also be used in combination with insulin.
Pilloli Actos 30 mg jistgħu jintużaw ukoll flimkien ma ’ l- insulina.
Do not take Actos 30mg tablets:
Tieħux pilloli Actos 30mg:
- If you are hypersensitive (allergic) to pioglitazone or any of the other ingredients Actos 30mg tablets.
- Jekk inti tbagħti minn sensittività eċċessiva (allerġiku/ a) għal pioglitazone jew sustanzi oħra ta ’
Take special care with Actos 30mg tablets:
Oqgħod attent ħafna b’ pilloli Actos 30mg
57
57 Meta tieħu pilloli Actos 30mg ma ’ l- ikel u max- xorb:
Important information about some of the ingredients of Actos 30mg tablets:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ pilloli Actos 30mg:
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Actos 30mg tablets.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi żokkrijiet, kellem lit- tabib tiegħek qabel ma tieħu pilloli Actos 30mg.
You can usually continue to take other medicines whilst you are being treated with Actos 30mg tablets.
Ġeneralment int se tkun tista ’ tibqa tieħu mediċini oħra waqt li qed tiġi kkurat b’ pilloli Actos 30mg.
If you have the impression that the effect of Actos 30mg tablets is too weak, talk to your doctor.
Jekk taħseb li l- effett tal- pilloli Actos 30mg huwa dgħajjef wisq, kellem lit- tabib tiegħek.
Actos 30mg tablets can be taken with or without food.
Pilloli Actos 30mg jistgħu jittieħdu ma ’ l- ikel jew mingħajr ikel.
When Actos 30mg tablets are taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Meta pilloli Actos 30mg jittieħdu flimkien ma ’ mediċini oħra wżati għall- kura tad- dijabete (bħal insulina, chlorpropamide, glibenclamide, gliclazide, tolbutamide), it- tabib tiegħek jgħidlek jekk għandekx bżonn tieħu doża inqas tal- mediċini tiegħek.
If you are following a diabetic diet, you should continue with this while you are taking Actos 30mg tablets.
Jekk qed issegwi dieta dijabetika, għandek tkompli biha waqt li qed tieħu l- pilloli Actos 30mg.
58 In clinical trials in which pioglitazone was compared to other oral anti diabetic drugs or placebo (dummy pill), a higher number of bone fractures was seen in women (but not in men) taking pioglitazone.
Fi provi kliniċi fejn pioglitazone kien imqabbel ma ’ mediċini mill- ħalq kontra d- dijabete oħrajn jew ma ’ placebo (pillola finta), kien osservat numru akbar ta ’ fratturi fl- għadam fin- nisa (iżda mhux fl - irġiel) li kienu qed jieħu pioglitazone.
If you take more Actos 30mg tablets than you should:
58 Jekk tieħu pilloli Actos 30mg aktar milli suppost:
If you forget to take Actos 30mg tablets:
Jekk tinsa tieħu pilloli Actos 30mg:
Try to take Actos 30mg tablets daily as prescribed.
Ipprova ħu pilloli Actos 30mg kuljum kif preskritt.
Like all medicines, Actos 30mg tablets can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, pilloli Actos 30mg jista ’ jkollhom effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following side effects have been experienced by some patients taking Actos 30mg tablets:
Xi pazjenti esperjenzaw l- effetti sekondarji li ġejjin waqt li qed jieħdu pilloli Actos 30mg: