qanastek/EMEA-V3 huggingface dataset:
PIOGLITAZONE IN COMBINATION THERAPY WITH INSULIN
PIOGLITAZONE F’ TERAPIJA KOMBINATA MA ’ INSULINA
Metabolism and nutrition disorders Common: hypoglycaemia
Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni:
General disorders and administration site conditions Very common:
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Komuni ħafna: edima
Infections and infestations Common: bronchitis
Infeżżjonijiet u infestazzjonijiet Komuni:
7 Investigations Common: weight increase
7 Investigazzjonijiet Komuni:
Musculoskeletal system and connective tissue disorders Common: back pain, arthralgia
Disturbi muskolu- skeltrali u tal- connective tissue Komuni:
Respiratory, thoracic and mediastinal disorders Common: dyspnoea
Disturbi respiratorji, toraċiċi u medjastinali Komuni:
Cardiac disorders Common: heart failure
insuffiċjenza tal- qalb
POST-MARKETING DATA
T- TQEGĦID FIS- SUQ
Eye disorders Not known: macular oedema
Disturbi fl- għajnejn Edima makulari:
Oedema was reported in 6 – 9% of patients treated with pioglitazone over one year in controlled clinical trials.
Edima kienet irrappurtata f’ 6- 9% tal- pazjenti kkurati b’ pioglitazone fuq medda ta ’ sena fi provi kliniċi kkontrollati.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2 – 5%.
Ir- rati ta ’ edima għall- gruppi ta ’ paragun (sulphonylurea, metformin) kienu ta ’ 2- 5%.
The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Ir- rapporti ta ’ edima ġeneralment kienu ħfief għal moderati u normalment ma kienux jinħtieġu t- twaqqif tal- kura.
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.
This is similar to that seen in a sulphonylurea active comparator group.
Dan huwa simili għal dak osservat fi grupp attiv ta ’ paragun b’ sulphonylurea.
In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
Disturbi viżwali ġew irrappurtati l- aktar fil- bidu tal- kura u huma relatati ma ’ tibdil fil- glucose Fi provi klinċi b’ pioglitazone l- inċidenża ta ’ elevazzjonijiet ta ’ ALT aktar minn tlett darbiet l- għola limitu tan- normal kienet daqs il- plaċebo iżda inqas minn dik li deheret fil- grupp ta ’ paragun b’ metformin jew b’ sulphonylurea.
However, this did not lead to an increase in mortality in this study.
Madankollu dan ma wassalx għall- żieda fil - mortalità f’ dan l- istudju.
8 In the 3.5 year PROactive study, 44/ 870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/ 905 (2.5%) of female patients treated with comparator.
Fl- istudju PROactive ta ’ 3. 5 snin, 44/ 870 (5. 1%) tal- pazjenti nisa kkurati b’ pioglitazone kellhom esperjenza ta ’ fratturi meta mqabbel ma ’ 23/ 905 (2. 5%) tal- pazjenti nisa kkurati bi prodott paragun.
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
8 Ma kinietx osservata żieda fir- rata ta ’ fratturi f’ irġiel ikkurati b’ pioglitazone (1. 7%) meta mqabbla ma ’ prodott paragun (2. 1%).
Pioglitazone effects may be mediated by a reduction of insulin resistance.
L- effetti ta ’ pioglitazone jistgħu jkunu medjati minn tnaqqis fir- reżistenza ta ’ l- insulina.
Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals.
Pioglitazone jidher li jaħdem permezz ta ’ attivazzjoni ta ’ riċetturi nuklejari speċifiċi (peroxisome proliferator activated receptor gamma) li jwassal għal żieda fis- sensitività għall- insulina tal- fwied, xaħam u ċelloli tal- muskoli skeletrali fl- annimali.
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.
Pazjenti li rċevew pioglitazone kellhom tnaqqis medju f’ HbA1c ta ’ 0. 45% meta mqabbel ma ’ dawk li komplew fuq l- insulina biss, u fil- grupp ikkurat b’ pioglitazone kien hemm tnaqqis fid- doża tal- insulina.
In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased
Fil- biċċa l- kbira tal- provi kliniċi, kienu osservati tnaqqis fit- triġliċeridi totali
9 HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
9 fil- plażma u fil- fatty acids ħielsa, u żieda fil- livelli ta ’ HDL- kolesterol meta mqabbel mal- plaċebo, b’ żiediet żgħar, iżda klinikament rilevanti fil- livelli ta ’ LDL- kolesterol.
Pioglitazone did not cause statistically significant increases in LDL cholesterol levels compared with placebo, whilst reductions were observed with metformin and gliclazide.
Pioglitazone ma wassalx għall- żieda statistikament sinifikanti fil- livell ta ’ LDL kolesterol meta mqabbel mal- plaċebo, filwaqt li tnaqqis kien osservat b’ metformin u gliclazide.
In a 20-week study, as well as reducing fasting triglycerides, pioglitazone reduced post prandial hypertriglyceridaemia through an effect on both absorbed and hepatically synthesised triglycerides.
Fi studju ta ’ 20 ġimgħa, minbarra li naqqas it- triġliċeridi waqt is- sawm, pioglitazone naqqas l- ipertrigliċeridemija wara l- ikel permezz ta ’ effett kemm fuq it- trigliċeridi assorbiti kif ukoll fuq dawk prodotti mill- fwied.
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.
To be eligible patients had to have 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.
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 incidence of oedema, weight gain and heart failure were increased.
Madankollu, l- inċidenza ta ’ edima, żieda fil- piż u insuffiċjenza tal- qalb żdiedu.
Absorption Following oral administration, pioglitazone is rapidly absorbed, and peak plasma concentrations of unchanged pioglitazone are usually achieved 2 hours after administration.
Assorbiment Wara għotja mill- ħalq, pioglitazone jiġi assorbit malajr, u l- għola konċentrazzjonijiet fil- plażma ta ’ pioglitazone mhux mibdul normalment jintlaħqu sagħtejn wara l- għotja.
Steady state is achieved after 4-7 days of dosing.
Stat stabbli jintlaħaq wara erba ’ sa sebat ijiem ta ’ dożaġġ.
In vitro studies have shown no evidence that pioglitazone inhibits any subtype of cytochrome P450.
10 Studji in vitro ma wrew l- ebda evidenza li pioglitazone jinibixxi xi sottotip taċ- ċitokromju P450.
10 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 inducer 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 Following oral administration of radiolabeled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Eliminazzjoni 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%).
Elderly Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Anzjani Il- farmakokinetika fi stat stabbli ta ’ pazjenti b’ eta ’ ta ’ 65 sena jew aktar hija simili għal dik f’ pazjenti żgħar.
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 mbidletx, iżda b’ volum ta ’ distribuzzjoni miżjud.
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 ta ’ l- insulina li sseħħ waqt it- tqala, li b’ hekk inaqqsu d- disponibilità ta ’ substrati metaboliċi għat- tkabbir tal- fetu.
11 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
This medicinal product does not require any special storage precautions.
Din il- mediċina m’ għandhiex bżonn ħażna speċjali.
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.
11 October 2000.
11 ta ’ Ottubru 2000.
11 October 2005
11 ta ’ Ottubru 2005.
Glustin 30 mg tablets.
Pilloli Glustin 30 mg.
The tablets are white to off-white, round, flat and marked ‘ 30 ’ on one face, AD4 on the other.
Il- pilloli huma bojod għal abjad maħmuġ, tondi, ċatti u mmarkati b ’ ‘ 30 ’ fuq naħa waħda, AD4 fuq in - naħa l- oħra.
Elderly No dosage adjustment is necessary for elderly patients (see section 5.2).
13 Anzjani L- ebda aġġustament fid- doża ma huwa neċessarju għall- pazjenti anzjani (ara sezzjoni 5. 2).
13 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).
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 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.
If ALT
Jekk il- livelli ta ’ ALT jiżdiedu sa 3 X l- għola limitu tan -
14 levels remain > 3 X the upper limit of normal, therapy should be discontinued.
Jekk il- livelli ta ’ ALT jibqgħu > 3 X l- għola limitu tan- normal, it- terapija għandha titwaqqaf.
Patients should be advised to adhere strictly to a calorie- controlled diet.
Ematoloġija:
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.
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).
Eye disorders Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased 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.
The risk of fractures should be considered in the long term care of women treated with pioglitazone.
15 Ir- riskju ta ’ fratturi għandu jiġi kkunsidrat fil- kura fit- tul ta ’ nisa kkurati b’ pioglitazone.
15 Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, the treatment should be discontinued (see section 4.6).
Il- pazjenti għandhom ikunu konxji tar- riskju ta ’ tqala u jekk il- pazjenta tixtieq tinqabad tqila jew jekk it- tqala sseħħ, il- kura għandha titwaqqaf (ara sezzjoni 4. 6).
Pioglitazone dose adjustment within the recommended Posology or changes in 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).
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 sulphonylureas ma tidhirx li taffettwa il- farmakokinetika tal - mediċini tat- tip sulphonylurea.
Close monitoring of glycaemic control should be considered (see section 4.4)
Sorveljanza mill- viċin tal- kontroll gliċemiku għandha tiġi kkunsidrata (ara sezzjoni 4. 4).
Frequencies are defined as: very common > 1/ 10; common > 1/ 100 ,< 1/10; uncommon > 1/1000 ,< 1/100; rare > 1/ 10000 ,< 1/1000; very rare < 1/10000;
Il- frekwenzi huma definiti bħala: komuni ħafna > 1/ 10; komuni > 1/ 100, < 1/ 10; mhux komuni > 1/ 1000, < 1/ 100; rari > 1/ 10000, < 1/ 1000; rari ħafna < 1/ 10000; mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
16 not known (cannot be estimated from the available data).
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is - serjetata ’ tagħhom.
Gastrointestinal disorders Uncommon:
disturbi viżwali
flatulence
Disturbi gastro- intestinali Mhux komuni: gass
Investigations
Investigazzjonijiet Komuni:
Common: weight increased
żieda fil- piż
Nervous system disorders Common: headache
artralġja
Renal and urinary disorders Common: haematuria
Disturbi fis- sistema nervuża Komuni:
Reproductive system and breast disorders Common: erectile dysfunction
uġigħ ta ’ ras
Ear and labyrinth disorders Uncommon:
Disturbi fil- kliewi u fis- sistema urinarja Komuni:
vertigo
ematurja
Eye disorders
Disturbi fis- sistema riproduttiva u fis- sider Komuni:
visual disturbance
disfunzjoni erettili
17 Gastrointestinal disorders Common: flatulence
17 PIOGLITAZONE F’ TERAPIJA KOMBINATA MA ’ SULPHONYLUREA
General disorders and administration site conditions Uncommon:
Disturbi fil- widnejn u fis- sistema labirintika Mhux komuni: vertigo
fatigue
gass
increased lactic dehydrogenase
Mhux komuni: żieda ta ’ lactic dehydrogenase
headache
Mhux komuni: uġigħ ta ’ ras
Renal and urinary disorders Uncommon:
Disturbi fil- kliewi u fis- sistema urinarja Mhux komuni: glikosurja, proteina fl- awrina
Skin and subcutaneous tissue disorders Uncommon:
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni: għaraq
oedema
bronkite
Infections and infestations Common: bronchitis
18 Investigazzjonijiet Komuni:
Investigations Common: weight increase
żieda fil- piż
18 Cardiac disorders Common: heart failure
insuffiċjenza tal- qalb
POST-MARKETING DATA
TAGĦRIF TA ’ WARA
Eye disorders Not known: macular oedema
T- TQEGĦID FIS- SUQ
Oedema was reported in 6 – 9% of patients treated with pioglitazone over one year in controlled clinical trials.
Disturbi fl- għajnejn Edima makulari: mhux magħruf Edima kienet irrappurtata f’ 6 – 9% tal- pazjenti kkurati b’ pioglitazone fuq medda ta ’ sena fi provi kliniċi kkontrollati.
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
19 Ma kinietx osservata żieda fir- rata ta ’ fratturi f’ irġiel ikkurati b’ pioglitazone (1. 7%) meta mqabbla ma ’ prodott paragun (2. 1%).
19 Hypoglycaemia may occur in combination with sulphonylureas or insulin.
Ipogliċemija tista ’ sseħħ f’ għotja flimkien ma ’ sulphonylureas jew insulina.
Similar changes in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity.
Fil- biċċa l- kbira tal- provi kliniċi, kienu osservati tnaqqis fit- triġliċeridi totali
In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
20 fil- plażma u fil- fatty acids ħielsa, u żieda fil- livelli ta ’ HDL- kolesterol meta mqabbel mal- plaċebo, b’ żiediet żgħar, iżda klinikament rilevanti fil- livelli ta ’ LDL- kolesterol.
Pioglitazone did not cause statistically significant increases in LDL cholesterol levels compared with placebo, whilst reductions were observed with metformin and gliclazide.
Pioglitazone ma wassalx għall- żieda statistikament sinifikanti fil- livell ta ’ LDL cholesterol meta mqabbel mal- plaċebo, filwaqt li tnaqqis kien osservat b’ metformin u gliclazide.
20 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.
In vitro studies have shown no evidence that pioglitazone inhibits any subtype of cytochrome P450.
21 Studji in vitro ma wrew l- ebda evidenza li pioglitazone jinibixxi xi sottotip taċ- ċitokromju P450.
21 Elderly Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Anzjani Il- farmakokinetika fi stat stabbli ta ’ pazjenti b’ eta ’ ta ’ 65 sena jew aktar hija simili għal dik f’ pazjenti żgħar.
This medicinal product does not require any special storage precautions.
Din il- mediċina m’ għandhiex bżonn ħażna speċjali
22 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Glustin 45 mg tablets.
Pilloli Glustin 45 mg.
The tablets are white to off-white, round, flat and marked ‘ 45 ’ on one face, AD4 on the other.
Il- pilloli huma bojod għal abjad maħmuġ, tondi, ċatti u mmarkati b ’ ‘ 45 ’ fuq naħa waħda, AD4 fuq in - naħa l- oħra.
- in patients (particularly overweight patients) inadequately controlled by diet and exercise for
- F’ pazjenti (speċjalment pażjenti b’ piż żejjed) li mhumiex ikkontrollati sew minn
whom metformin is inappropriate because of contraindications or intolerance.
dieta u eżerċizzju li għalihom metformin mhux adattat minħabbla kontra - indikazzjonijiet jew intolleranza
- metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient
- metformin u mediċina tat- tip sulphonylurea, f’ pazjenti (speċjalment pażjenti
glycaemic control despite dual oral therapy.
b’ piż żejjed) b’ kontroll gliċemiku insuffiċjenti minkejja terapija doppja mill - ħalq.
In combination with insulin, the current insulin dose can be continued upon initiation of pioglitazone therapy.
F’ ghotja flimkien ma ’ insulina, id- doża kurrenti ta ’ insulina tista ’ titkompla hekk kif tinbeda terapija b’ pioglitazone.
Elderly No dosage adjustment is necessary for elderly patients (see section 5.2).
24 Anzjani L- ebda aġġustament fid- doża ma huwa neċessarju għall- pazjenti anzjani (ara sezzjoni 5. 2).
24 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).
- diabetic ketoacidosis.
- ketoaċidożi dijabetika
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.
Jekk il- livelli ta ’ ALT jiżdiedu sa 3 X l- għola limitu tan -
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting,
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 risk of fractures should be considered in the long term care of women treated with pioglitazone.
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.
26 Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e. g. gemfibrozil) or inducers (e. g. rifampicin).
Pioglitazone għandu jintuża b’ attenzjoni waqt l- għotja fl- istess ħin ta ’ inibituri (e. ż. gemfibrozil) jew indutturi (e. ż. rifampicin) taċ- ċitokromju P450 2C8.
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 jew assorbiment ħażin ta ’ glucose- galactose.
Since there is a potential for an increase in dose- related adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Sorveljanza mill- viċin tal- kontroll gliċemiku
Close monitoring of glycaemic control should be considered (see section 4.4).
27 għandha tiġi kkunsidrata (ara sezzjoni 4. 4).
27 PIOGLITAZONE MONOTHERAPY
MONOTERAPIJA B’ PIOGLITAZONE
Eye disorders
28 Disturbi fl- għajnejn Komuni:
Musculoskeletal system and connective tissue disorders Common:
Disturbi muskolu- skeletrali u tal- connective tissue Komuni:
PIOGLITAZONE IN COMBINATION THERAPY WITH SULPHONYLUREA
PIOGLITAZONE F’ TERAPIJA KOMBINATA MA ’ SULPHONYLUREA
Ear and labyrinth disorders Uncommon:
Disturbi fil- widnejn u fis- sistema labirintika Mhux komuni: vertigo
Eye disorders
Disturbi fl- għajnejn Mhux komuni: disturbi viżwali
28 General disorders and administration site conditions Uncommon:
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Mhux komuni: għejja
Metabolism and nutritional disorders Uncommon:
Disturbi fil- metaboliżmu u n- nutrizzjoni Mhux komuni: żieda fl- aptit, ipogliċemija
PIOGLITAZONE IN TRIPLE ORAL COMBINATION THERAPY WITH METFORMIN AND SULPHONYLUREA
29 PIOGLITAZONE F’ TERAPIJA TRIPPLA KOMBINATA MA ’ METFORMIN U SULPHONYLUREA MIL- ĦALQ
weight increased, blood creatinine phosphokinase increased
żieda fil- piż, żieda fil- creatine phosphokinase fid- demm
Musculoskeletal and connective tissue disorders Common:
Disturbi muskolu- skeltrali u tal- connective tissue Komuni:
Infections and infestations Common:
Infeżżjonijiet u infestazzjonijiet Komuni:
bronchitis
bronkite
Musculoskeletal system and connective tissue disorders Common:
Disturbi muskolu- skeltrali u tal- connective tissue Komuni:
back pain, arthralgia
uġigħ fid- dahar, artralġja
dyspnoea
qtugħ ta ’ nifs
Cardiac disorders
Disturbi fil- qalb Komuni:
heart failure
insuffiċjenza tal- qalb
29
TAGĦRIF TA ’ WARA
Eye disorders Not known macular oedema
Disturbi fl- għajnejn Edima makulari:
In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
30 Fi provi klinċi b’ pioglitazone l- inċidenża ta ’ elevazzjonijiet ta ’ ALT aktar minn tlett darbiet l- għola limitu tan- normal kienet daqs il- plaċebo iżda inqas minn dik li deheret fil- grupp ta ’ paragun b’ metformin jew b’ sulphonylurea.
Kaplan-Meier analysis showed shorter time to treatment failure in patients treated with gliclazide, compared with pioglitazone.
31 għall- falliment tal- kura f’ pazjenti kkurati b’ gliclazide, meta mqabbla ma ’ pioglitazone.
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
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.
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.
Madankollu, l- inċidenza ta ’ edima, żieda
However, the incidence of oedema, weight gain and heart failure were increased.
32 fil- piż u insuffiċjenza tal- qalb żdiedu.
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.
32 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.
33 Pazjenti b’ indeboliment epatiku Il- konċentrazzjoni totali fil- plażma ta ’ pioglitazone ma mbidletx, iżda b’ volum ta ’ distribuzzjoni miżjud.
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.
33 Not all pack sizes may be marketed
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
35 A.
35 ANNESS II
Name and address of the manufacturers responsible for batch release
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Takeda Ireland Limited.
Isem u indirizz tal- manifatturi responsabbli għall- ħruġ tal- lott.
Bray Business Park Kilruddery County Wicklow Ireland
Takeda Ireland Limited Bray Business Park Kilruddery County Wicklow L’ Irlanda.
An updated Risk Management Plan should be provided as per the CHMP guideline on Risk Management System 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.
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
TIKKETTA
Glustin 15 mg tablets Pioglitazone (as hydrochloride)
Glustin 15 mg pilloli Pioglitazone (bħala hydrochloride)
EU/ 1/ 00/ 151/ 007 EU/ 1/ 00/ 151/ 001 EU/ 1/ 00/ 151/ 014 EU/ 1/ 00/ 151/ 002 EU/ 1/ 00/ 151/ 023 EU/ 1/ 00/ 151/ 015 EU/ 1/ 00/ 151/ 016 EU/ 1/ 00/ 151/ 003
EU/ 1/ 00/ 151/ 007 14- il pillola EU/ 1/ 00/ 151/ 001 28 pillola EU/ 1/ 00/ 151/ 014 30 pillola EU/ 1/ 00/ 151/ 002 50 pillola EU/ 1/ 00/ 151/ 023 56 pillola EU/ 1/ 00/ 151/ 015 84 pillola EU/ 1/ 00/ 151/ 016 90 pillola EU/ 1/ 00/ 151/ 003 98 pillola
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
41 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FEJN M’ HEMMX PAKKETT TA ’ BARRA, FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Glustin 30 mg tablets Pioglitazone (as hydrochloride)
Glustin 30 mg pilloli Pioglitazone (bħala hydrochloride)
EU/ 1/ 00/ 151/ 008 EU/ 1/ 00/ 151/ 004 EU/ 1/ 00/ 151/ 017 EU/ 1/ 00/ 151/ 005 EU/ 1/ 00/ 151/ 024 EU/ 1/ 00/ 151/ 018 EU/ 1/ 00/ 151/ 019 EU/ 1/ 00/ 151/ 006
EU/ 1/ 00/ 151/ 008 14- il pillola EU/ 1/ 00/ 151/ 004 28 pillola EU/ 1/ 00/ 151/ 017 30 pillola EU/ 1/ 00/ 151/ 005 50 pillola EU/ 1/ 00/ 151/ 024 56 pillola EU/ 1/ 00/ 151/ 018 84 pillola EU/ 1/ 00/ 151/ 019 90 pillola EU/ 1/ 00/ 151/ 006 98 pillola
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FEJN M’ HEMMX PAKKETT TA ’ BARRA, FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Glustin 45 mg tablets Pioglitazone (as hydrochloride)
Glustin 45 mg pilloli Pioglitazone (bħala hydrochloride)
EU/ 1/ 00/ 151/ 009 EU/ 1/ 00/ 151/ 010 EU/ 1/ 00/ 151/ 020 EU/ 1/ 00/ 151/ 011 EU/ 1/ 00/ 151/ 012 EU/ 1/ 00/ 151/ 021 EU/ 1/ 00/ 151/ 022 EU/ 1/ 00/ 151/ 013
EU/ 1/ 00/ 151/ 009 14- il pillola EU/ 1/ 00/ 151/ 010 28 pillola EU/ 1/ 00/ 151/ 020 30 pillola EU/ 1/ 00/ 151/ 011 50 pillola EU/ 1/ 00/ 151/ 012 56 pillola EU/ 1/ 00/ 151/ 021 84 pillola EU/ 1/ 00/ 151/ 022 90 pillola EU/ 1/ 00/ 151/ 013 98 pillola
44 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
45 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Glustin 15 mg tablets Pioglitazone (as HCl)
Glustin 15 mg tablets 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 TA ’ PAKKETTI 14, 28, 56, 84 U 98 PILLOLA BISS)
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Glustin 30 mg tablets Pioglitazone (as HCl)
Glustin 30 mg tablets Pioglitazone (bħala HCl)
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
47 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Glustin 45 mg tablets Pioglitazone (as HCl)
Glustin 45 mg tablets Pioglitazone (bħala HCl)
48 PACKAGE LEAFLET
FULJETT TA ’ TAGĦRIF
GLUSTIN 15 MG TABLETS (Pioglitazone (as hydrochloride))
PILLOLI GLUSTIN 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:
What Glustin is and what it is used for 2.
X’ inhu Glustin u għal xiex jintuża 2.
Before you take Glustin 3.
Qabel ma tieħu Glustin 3.
How to take Glustin 4.
Kif għandek tieħu Glustin 4.
How to store Glustin 6.
Kif taħżen Glustin 6.
WHAT GLUSTIN IS AND WHAT IT IS USED FOR
X’ INHU GLUSTIN U GĦALXIEX JINTUŻA
Glustin 15 mg tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus.
Pilloli Glustin 15 mg huma mediċina anti- dijabetika wżata biex tikkura dijabete mellitus tat- tip 2 (mhux dipendenti mill- insulina).
Glustin 15 mg 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 Glustin 15 mg 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.
Glustin 15 mg tablets may be used on their own or in combination with metformin and/ or a sulphonylurea which are also oral anti-diabetic medicines.
Pilloli Glustin 15 mg jistgħu jintużaw waħedhom jew flimkien ma ’ metformin u / jew mediċina tat- tip sulphonylurea li huma wkoll mediċini anti- dijabetiċi orali.
Glustin 15 mg tablets may also be used in combination with insulin.
Pilloli Glsutin 15 mg jistgħu jintużaw ukoll flimkien ma ’ l- insulina.
BEFORE YOU TAKE GLUSTIN
QABEL MA TIEĦU GLUSTIN
Do not take Glustin 15 mg tablets:
Tieħux pilloli Glustin 15 mg:
- If you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of Glustin
- Jekk inti tbagħti minn sensittività eċċessiva (allerġiku/ a) għal pioglitazone jew sustanzi oħra ta ’
15 mg tablets.
pilloli Glustin 15 mg.
Take special care with Glustin 15 mg tablets:
Oqgħod attent ħafna b’ pilloli Glustin 15 mg:
of the 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 ’
becoming pregnant because of how your medicine works.
tqila minħabba l- mod kif taħdem il- mediċina tiegħek
- If you have a problem with your liver or heart.
- Jekk għandek problema bil- fwied jew bil- qalb 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
49 Taking Glustin 15mg tablets with food and drink:
Meta tieħu pilloli Glustin 15 mg ma ’ l- ikel u max- xorb:
Important information about some of the ingredients of Glustin 15 mg tablets:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ pilloli Glustin 15 mg:
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Glustin 15 mg tablets.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi żokkrijiet, kellem lit- tabib tiegħek qabel ma tieħu pilloli Glustin 15 mg.
You can usually continue to take other medicines whilst you are being treated with Glustin 15 mg tablets.
Ġeneralment int se tkun tista ’ tibqa tieħu mediċini oħra waqt li qed tiġi kkurat b’ pilloli Glustin 15 mg.
HOW TO TAKE GLUSTIN
KIF GĦANDEK TIEĦU GLUSTIN
If you have the impression that the effect of Glustin 15 mg tablets is too weak, talk to your doctor.
Jekk taħseb li l- effett tal- pilloli Glustin 15 mg huwa dgħajjef wisq, kellem lit- tabib tiegħek.
Glustin 15 mg tablets can be taken with or without food.
Pilloli Glustin 15 mg jistgħu jittieħdu ma ’ l- ikel jew mingħajr ikel.
When Glustin 15 mg 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 Glustin 15 mg 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 Glustin.
It- tabib tiegħek se jitolbok tagħmel testijiet tad- demm perjodiċi waqt il- kura b’ Glustin.
This is to check that your liver is working normally.
Dan sabiex jiċċekkja li l- fwied tiegħek qed jaħdem kif suppost.
If you are following a diabetic diet, you should continue with this while you are taking Glustin 15 mg tablets.
Jekk qed issegwi dieta dijabetika, għandek tkompli biha waqt li qed tieħu l- pilloli Glustin 15 mg.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Glustin and insulin experienced the development of heart failure.
51 Xi pazjenti b’ dijabete mellitus tat- tip 2 għal żmien twil u b’ mard tal- qalb jew aċċessjoni minn qabel li kienu kkurati b’ Glustin u insulin kellhom żvilupp ta ’ insuffiċjenza tal- qalb.
50 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 Glustin 15 mg tablets than you should:
Jekk tieħu pilloli Glustin 15 mg aktar milli suppost:
If you forget to take Glustin 15 mg tablets:
Jekk tinsa tieħu pilloli Glustin 15 mg:
Try to take Glustin 15 mg tablets daily as prescribed.
Ipprova ħu pilloli Glustin 15 mg kuljum kif preskritt.
Like all medicines, Glustin 15 mg tablets can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Glustin 15 mg jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following side effects have been experienced by some patients taking Glustin 15 mg tablets:
Xi pazjenti esperjenzaw l- effetti sekondarji li ġejjin waqt li kienu qed jieħdu pilloli Glustin 15 mg:
- blurred vision due to swelling (or fluid) in the back of the eye.
- vista mċajpra minħabba nefħa (jew fluwidu) fil- parti ta ’ wara tal- għajn.
If you experience these
Jekk tħoss dawn is -
symptoms for 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.
- in rare cases, impaired liver function
awrina f’ każijiet rari, funżjoni mdgħajjfa tal- fwied
- a small reduction in red blood cell count.
- tnaqqis żgħir fl- għadd taċ- ċelloli ħomor tad- demm
- shortness of breath.
- qtugħ ta ’ nifs
HOW TO STORE GLUSTIN
KIF TAĦŻEN GLUSTIN
51 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Glustin contains
X’ fih Glustin:
The active substance is Glustin 15 mg tablets is pioglitazone.
Is- sustanza attiva ta ’ pilloli Glustin 15 mg hija pioglitazone.
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Kull pillola fiha 15 mg ta ’ pioglitazone (bħala hydrochloride).
What Glustin looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
Glustin 15 mg tablets are white to off-white, round, convex tablets marked 15 on one face, AD4 on the other..
Pilloli Glustin 15 mg huma pilloli bojod għal abjad maħmuġ, tondi, bbuzzati fuq iż- żewġ naħat immarkati b’ 15 fuq wiċċ minnhom, AD4 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.
Marketing authorisation holder:
Detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Danmark Takeda Global Research and Development Centre (Europe) Ltd., Storbritannien Tlf: +44 (0)20 3116 8000
53 Danmark Takeda Global Research and Development Centre (Europe) Ltd., Storbritannien Tlf: +44 (0) 20 3116 8000
Eesti Takeda Global Research and Development Centre (Europe) Ltd., Ühendkuningriik Tel: +44 (0)20 3116 8000
Eesti Österreich Takeda Global Research and Development Centre (Europe) Ltd., Ühendkuningriik Tel: +44 (0) 20 3116 8000
Lietuva Takeda Global Research and Development Centre (Europe) Ltd., Jungtinė Karalystė Tel. +44 (0)20 3116 8000
54 Lietuva Takeda Global Research and Development Centre (Europe) Ltd., Jungtinė Karalystė Tel. +44 (0) 20 3116 8000
53 PACKAGE LEAFLET
55 FULJETT TA ’ TAGĦRIF:
GLUSTIN 30 MG TABLETS (Pioglitazone (as hydrochloride))
PILLOLI GLUSTIN 30 MG (Pioglitazone (bħala hydrochloride))
Glustin 30 mg tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus.
Pilloli Glustin 30 mg huma mediċina anti- dijabetika wżata biex tikkura dijabete mellitus tat- tip 2 (mhux dipendenti mill- insulina).
Glustin 30 mg 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 Glustin 30 mg 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.
Glustin 30 mg tablets may be used on their own or in combination with metformin and/ or a sulphonylurea which are also oral anti-diabetic medicines.
Pilloli Glustin 30 mg jistgħu jintużaw waħedhom jew flimkien ma ’ metformin u / jew mediċina tat- tip sulphonylurea li huma wkoll mediċini anti- dijabetiċi orali.
Glustin 30 mg tablets may also be used in combination with insulin.
Pilloli Glustin 30 mg jistgħu jintużaw ukoll flimkien ma ’ l- insulina.
Do not take Glustin 30 mg tablets:
Tieħux pilloli Glustin 30 mg:
30 mg tablets.
pilloli Glustin 30 mg
- If you have heart failure.
- Jekk għandek insuffiċjenza tal- qalb
Take special care with Glustin 30 mg tablets:
Oqgħod attent ħafna b’ pilloli Glustin 30 mg:
- If you have a special type of diabetic disease called macular oedema (swelling of the back of
- Jekk għandek tip speċjali ta ’ marda dijabetika tal- għajn msejjħa edema makulari (nefħa tal- parti
the eye).
ta ’ wara tal- għajn).
Taking Glustin 30 mg tablets with food and drink:
Meta tieħu pilloli Glustin 30 mg ma ’ l- ikel u max- xorb:
Important information about some of the ingredients of Glustin 30 mg tablets:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ pilloli Glustin 30 mg:
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Glustin 30 mg tablets.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi żokkrijiet, kellem lit- tabib tiegħek qabel ma tieħu pilloli Glustin 30 mg.
You can usually continue to take other medicines whilst you are being treated with Glustin 30 mg tablets.
Ġeneralment int se tkun tista ’ tibqa tieħu mediċini oħra waqt li qed tiġi kkurat b’ pilloli Glustin 30 mg.
If you have the impression that the effect of Glustin 30 mg tablets is too weak, talk to your doctor.
Jekk taħseb li l- effett tal- pilloli Glustin 30 mg huwa dgħajjef wisq, kellem lit- tabib tiegħek.
Glustin 30 mg tablets can be taken with or without food.
Pilloli Glustin 30 mg jistgħu jittieħdu ma ’ l- ikel jew mingħajr ikel.
When Glustin 30 mg 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 Glustin 30 mg 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 Glustin 30 mg tablets.
Jekk qed issegwi dieta dijabetika, għandek tkompli biha waqt li qed tieħu l- pilloli Glustin 30 mg.
55 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Glustin and insulin experienced the development of heart failure.
57 Xi pazjenti b’ dijabete mellitus tat- tip 2 għal żmien twil u b’ mard tal- qalb jew aċċessjoni minn qabel li kienu kkurati b’ Glustin u insulin kellhom żvilupp ta ’ insuffiċjenza tal- qalb.
If you take more Glustin 30 mg tablets than you should:
Jekk tieħu pilloli Glustin 30 mg aktar milli suppost:
If you forget to take Glustin 30 mg tablets:
Jekk tinsa tieħu pilloli Glustin 30 mg:
Try to take Glustin 30 mg tablets daily as prescribed.
Ipprova ħu pilloli Glustin 30 mg kuljum kif preskritt.
Like all medicines, Glustin 30 mg tablets can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Glustin 30 mg jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following side effects have been experienced by some patients taking Glustin 30 mg tablets:
Xi pazjenti esperjenzaw l- effetti sekondarji li ġejjin waqt li kienu qed jieħdu pilloli Glustin 30 mg:
symptoms for 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
56 This medicinal product does not require any special storage precautions.
Din il- mediċina m’ għandhiex bżonn ħażna speċjali.
These measures will help protect the environment.
Dawn il- miżuri jgħinu għal protezzjoni ta ’ l- ambjent.
The active substance in Glustin 30 mg tablets is pioglitazone.
Is- sustanza attiva ta ’ pilloli Glustin 30 mg hija pioglitazone.
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Kull pillola fiha 30 mg ta ’ pioglitazone (bħala hydrochloride).
Glustin 30 mg tablets are white to off white, round, flat tablets marked 30 on one face, AD4 on the other..
Pilloli Glustin 30 mg huma pilloli bojod għal abjad maħmuġ, tondi, ċatti u mmarkati b’ 30 fuq wiċċ minnhom, AD4 fuq in- naħa l- oħra.
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.
België/ Belgique/ Belgien Takeda Global Research and Development Centre (Europe) Ltd, Royaume-Uni Tél/ Tel: +44 (0)20 3116 8000
België/ Belgique/ Belgien Takeda Global Research and Development Centre (Europe) Ltd, Royaume- Uni Tél/ Tel: +44 (0) 20 3116 8000 България Takeda Global Research and Development Centre (Europe) Ltd., Обединеното кралство Teл.: +44 (0) 20 3116 8000
Luxembourg/ Luxemburg Takeda Global Research and Development Centre (Europe) Ltd., Royaume-Uni Tél/ Tel: +44 (0)20 3116 8000
Luxembourg/ Luxemburg Takeda Global Research and Development Centre (Europe) Ltd., Royaume- Uni Tél/ Tel: +44 (0) 20 3116 8000 Magyarország Takeda Global Research and Development Centre (Europe) Ltd., Nagy- Britannia Tel.: +44 (0) 20 3116 8000
Danmark Takeda Global Research and Development Centre (Europe) Ltd., Storbritannien Tlf: +44 (0)20 3116 8000
59 Danmark Takeda Global Research and Development Centre (Europe) Ltd., Storbritannien Tlf: +44 (0) 20 3116 8000
57 Eesti Österreich Takeda Global Research and Development Centre (Europe) Ltd., Ühendkuningriik Tel: +44 (0)20 3116 8000
Eesti Österreich Takeda Global Research and Development Centre (Europe) Ltd., Ühendkuningriik Tel: +44 (0) 20 3116 8000
Lietuva Takeda Global Research and Development Centre (Europe) Ltd., Jungtinė Karalystė Tel. +44 (0)20 3116 8000
60 Lietuva Takeda Global Research and Development Centre (Europe) Ltd., Jungtinė Karalystė Tel. +44 (0) 20 3116 8000
58 PACKAGE LEAFLET
61 FULJETT TA ’ TAGĦRIF:
GLUSTIN 45 MG TABLETS (Pioglitazone (as hydrochloride))
PILLOLI GLUSTIN 45 MG (Pioglitazone (bħala hydrochloride))