qanastek/EMEA-V3 huggingface dataset:
Other antihypertensive agents: the antihypertensive effect of Irbesartan Hydrochlorothiazide Winthrop may be increased with the concomitant use of other antihypertensive agents.
Mediċini oħra kontra l- pressjoni għolja: l- effett ta ’ Irbesartan Hydrochlorothiazide Winthrop kontra l - pressjoni għolja jista ’ jiżdied meta jingħata flimkien ma ’ mediċini oħra ta ’ kontra l- pressjoni għolja.
Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Irbesartan Hydrochlorothiazide Winthrop.
U wkoll, tneħħija renali ta ’ lithium titnaqqas b’ thiazides u għalhekk, ir- riskju ta ’ tossiċita ’ minn lithium tista ’ tiżdied b’ Irbesartan Hydrochlorothiazide Winthrop.
Therefore, the combination of lithium and Irbesartan Hydrochlorothiazide Winthrop is not recommended (see section 4.4).
Għalhekk, il- kombinazzjoni ta ’ lithium u Irbesartan Hydrochlorothiazide Winthrop mhiex irrikkmandata (ara sezzjoni 4. 4).
Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when Irbesartan Hydrochlorothiazide Winthrop is administered with medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics).
Prodotti mediċinali affettwati b’ tibdil tal- potassium fis- serum: osservazzjoni perjodika tal - potassium fis- serum hija rrikmandata meta Irbesartan Hydrochlorothiazide Winthrop jiġi mogħti flimkien ma ’ prodotti mediċinali oħra affettwati b’ disturbi tal- potassium fis- serum (p. e. digitalis glycosides, antiarritmiċi).
As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Bħal fil- każ ta ’ l- inibituri ACE, l- użu konkomitanti ta ’ antagonisti ta ’ angiotensin II u NSAIDs jista ’ jwassal għal riskju akbar ta ’ deterjorament tal- funzjoni renali, inkluża l- possibbilità ta 'insuffiċjenza
Irbesartan is mainly metabolised by CYP2C9 and to a lesser
Irbesartan jiġi metabolizzat prinċipalment b’ CYP2C9 u b’ mod anqas estensiv bi glukuronidazzjoni.
4.6 Pregnancy and lactation
6 4. 6 Tqala u Treddigħ
Unless continued
Filwaqt li ma hemm ebda data epidemijoloġika dwar ir- riskji b’ Antagonisti ta ’ Reċetturi ta ’ Angiotensin II (AIIRAs), jistgħu jeżistu riskji simili għal din il- klassi ta ’ mediċini.
6 AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm terapija AIIRAs kontinwa mhijiex meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti alternattivi ta ’ kontra l- pressjoni għolja li għandhom profil ta ’ sigurtà stabbilit għal użu waqt tqala.
Since Irbesartan Hydrochlorothiazide Winthrop contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Billi Irbesartan Hydrochlorothiazide Winthrop fih hydrochlorothiazide, mhux irrikkmandat waqt l- ewwel trimestru tat- tqala.
Irbesartan Hydrochlorothiazide Winthrop is contraindicated during breast-feeding.
Irbesartan Hydrochlorothiazide Winthrop huwa kontra- indikat waqt it- treddigħ.
Based on its pharmacodynamic properties, Irbesartan Hydrochlorothiazide Winthrop is unlikely to affect this ability.
Skond il- kwalitajiet farmakodinamiċi tiegħu, Irbesartan Hydrochlorothiazide Winthrop mhux suppost li jkollu effett fuq din il- ħila.
Nervous system disorders:
7 Disturbi fis- sistema nervuża:
7
Mhux komuni: dijarea
Uncommon:
Mhux komuni: nefħa fl- estremitajiet
8 Irbesartan:
8
Adverse reactions reported with the use of irbesartan alone include:
Rari ħafna:
General disorders and administration site conditions:
indeboliment tal- funzjoni renali li tinkludi każijiet iżolati ta ’ insuffiċjenza renali f’ pazjenti b’ riskju (ara sezzjoni 4. 4)
Uncommon:
Aktar tagħrif fuq prodott kombinat,
chest pain
Irbesartan:
General disorders and administration site conditions: fever
9 Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata: deni
Investigations: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
Investigazzjonijiet: żbilanċ fl- elettroliti (li tinkludi l- ipokalemija u l- iponatremja, ara sezzjoni 4. 4), iperuriċemija glikożurja, ipergliċemija, żieda fil- kolesterol u trigliċeridi
9 The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
4. 9 Doża eċċessiva
No specific information is available on the treatment of overdose with Irbesartan Hydrochlorothiazide Winthrop.
M’ hemmx biżżejjed informazzjoni speċifika fuq il- kura ta ’ doża eċċessiva ta ’ Irbesartan Hydrochlorothiazide Winthrop.
Irbesartan Hydrochlorothiazide Winthrop is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Winthrop huwa kombinazzjoni ta ’ antagonist ta ’ riċettur angiotensin - II, irbesartan u dijuretiku thiazide, hydrochlorothiazide.
Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
10 tar- riassorbiment ta ’ l- elettroliti u jżidu direttament l- eskrezzjoni tas- sodium u tal- chloride f’ ammonti kważi ekwivalenti.
10 The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges.
Il- kombinazzjoni ta ’ hydrochlorothiazide u irbesartan tipproduċi tnaqqis addittiv relatat mad- doża fil - pressjoni tad- demm tul il- firxa terapewtika tad- doża.
When measured by ambulatory blood pressure monitoring, the trough to peak effects of Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg were 100%.
Meta mkejla permezz ta ’ osservazzjoni tal- pressjoni ambulatorja l- effetti mill- inqas għal aktar ta ’ Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg kienu 100%.
The trough to peak effects measured by cuff during office visits were 68% and 76% for Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg and Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg, respectively.
L- effetti mill- inqas għal aktar mkejla mid- dirgħajn waqt il- viżti għand it - tabib kienu 68% u 76% għal Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg u Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12. 5 mg, rispettivament.
Although not specifically studied with the Irbesartan Hydrochlorothiazide Winthrop, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Għalkemm ma ġiex speċifikament studjat b’ Irbesartan Hydrochlorothiazide Winthrop, il- pressjoni ma reġgħetx għoliet kemm b’ irbesartan jew b’ hydrochlorothiazide.
There is no difference in response to Irbesartan Hydrochlorothiazide Winthrop, regardless of age or gender.
Ir- rispons għal Irbesartan Hydrochlorothiazide Winthrop ma jiddependix mill- età u lanqas mis- sess.
12.5 mg daily), the antihypertensive response in black patients approaches that of non-black patients.
Meta irbesartan jingħata flimkien ma ’ doża baxxa ta ’ hydrochlorothiazide (p. e 12. 5 mg kuljum), ir- rispons kontra il - pressjoni għolja f’ pazjenti suwed javviċina lil dak f’ pazjenti mhux suwed.
Efficacy and safety of Irbesartan Hydrochlorothiazide Winthrop as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double- blind, active-controlled, 8-week, parallel-arm study.
11 L- effikaċja u s- sigurtà ta ’ Irbesartan Hydrochlorothiazide Winthrop bħala terapija inizjali għal pressjoni għolja severa (definita bħala SeDBP ≥ 110 mmHg) ġew evalwati fi studju b’ aktar minn ċentru wieħed, b’ mod każwali, double- blind, ikkontrollat b’ mod attiv ta ’ 8 ġimgħat, parallel- arm.
A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/ hydrochlorothiazide 150 mg/ 12.5 mg or to irbesartan 150 mg and systematically force-titrated (before assessing the response to the lower dose) after one week to irbesartan/ hydrochlorothiazide 300 mg/ 25 mg or irbesartan 300 mg, respectively.
B’ kollox 697 pazjent intagħżlu b’ mod każwali fi proporzjon ta ’ 2: 1 jew għal irbesartan/ hydrochlorothiazide 150 mg/ 12. 5 mg jew għal irbesartan 150 mg u ġew titrati bil- forza b’ mod sistematiku (qabel ma r- rispons tagħhom għal doża iktar baxxa ġie vvalutat) wara ġimgħa għal irbesartan/ hydrochlorothiazide 300 mg/ 25 mg jew irbesartan 300 mg, rispettivament.
11 The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at Week 5 of treatment.
L- għan ewlieni ta ’ dan l- istudju kien li jqabbel il- proporzjon ta ’ pazjenti li l- SeDBP tagħhom kien ikkontrollat (SeDBP < 90 mmHg) f’ Ġimgħa 5 tat- trattament.
Forty-seven percent (47.2%) of patients on the combination achieved trough SeDBP < 90 mmHg compared to 33.2% of patients on irbesartan (p = 0.0005).
Sebgħa u erbgħin fil- mija (47. 2%) tal - pazjenti fuq il- kombinazzjoni laħqu livell minimu ta ’ SeDBP < 90 mmHg meta mqabbel ma ’ 33. 2% tal- pazjenti fuq irbesartan (p = 0. 0005).
Following oral administration of Irbesartan Hydrochlorothiazide Winthrop, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Wara li jingħata mill- ħalq Irbesartan Hydrochlorothiazide Winthrop il - biodisponibilità assoluta orali hija 60 - 80% u 50 - 80% għal irbesartan u hydrochlorothiazide, rispettivament.
Food does not affect the bioavailability of Irbesartan Hydrochlorothiazide Winthrop.
L- ikel ma jaffettwax il- biodisponibilità ta ’ Irbesartan Hydrochlorothiazide Winthrop.
Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
12 Wara li 14C irbesartan jingħata mill- ħalq jew ġol- vini, 80 - 85% tar- radjuattività li tiċċirkola fil- plażma hi attribwita għal irbesartan mhux mibdul.
Irbesartan is not removed by
Indeboliment Renali: f’ pazjenti b’ indeboliment renali jew li qed jagħmlu l- emodijalisi, il- parametri farmakokinetiċi ta ’ irbesartan ma tbiddlux b’ mod sinifikanti.
12 haemodialysis.
Irbesartan ma jitneħħiex bl- emodijalisi.
There was no evidence of mutagenicity or clastogenicity with the irbesartan/ hydrochlorothiazide combination.
13 Ma kienx hemm evidenza ta ’ mutaġeniċità jew klasroġenitiċità bil- kombinazzjoni ta ’ irbesartan/ hydrochlorothiazide.
In rabbits,
Studji fuq annimali b’ irbesartan urew effetti tossiċi li jgħaddu (żieda fil- formazzjoni tal- ħofor fil- pelvi renali, hydroureter, edema ta ’ taħt il- ġilda) fil- feti tal- firien, li ġew risolvuti wara t- twelid.
13 abortion or early resorption was noted at doses causing significant maternal toxicity, including mortality.
Fil- fniek, abort jew reassorbiment kmieni ta ’ l- embriju ġie nnotat b’ dożi li kkaġunaw tossiċita` sinifikanti fl - omm, li nkludew mwiet.
Cartons of 98 tablets; 7 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
14 Pakketti ta ’ 98 pillola; 7 strixxi ta ’ 14- il pillola f’ folji tal- PVC/ PVDC/ Aluminju.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg tablets.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12. 5 mg pilloli.
16 Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan Hydrochlorothiazide Winthrop.
16 Tnaqqis fil- volum intravaskulari: tnaqqis ta ’ volum u/ jew ta ’ sodium, għandhom jiġu ikkoreġuti qabel ma ’ jingħata Irbesartan Hydrochlorothiazide Winthrop.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
17 Stenożi tal- valv aortiku u mitrali, kardjomijopatija ipertrofika ostruttiva: bħal fil- każ ta ’ vażodilatorji oħra, għandha tingħata attenzjoni speċjali f’ pazjenti li jsofru minn stenożi aortika jew mitrali jew kardjomijopatija ipertrofika ostruttiva.
17 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Aldosteroniżmu primarju: pazjenti b’ aldosteroniżmu primarju ġeneralment ma jirrispondux għall - prodotti mediċinali ta ’ kontra l- pressjoni li jaħdmu billi jinpedixxu s- sistema tar- renin- angiotensin.
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
18 Reazzjonijiet ta ’ sensittività eċċessiva għal hydrochlorothiazide jistgħu jinħassu f’ pazjenti li għandhom jew m’ għandhomx rekord ta ’ allerġija jew ażżma tal- bronki, imma hemm aktar ċans li jiġru f’ pazjenti li kellhom dawn l- attakki.
18 Pregnancy:
Tqala:
4.6 Pregnancy and lactation
20 4. 6 Tqala u Treddigħ
20 AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm terapija AIIRAs kontinwa mhijiex meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti alternattivi ta ’ kontra l- pressjoni għolja li għandhom profil ta ’ sigurtà stabbilit għal użu waqt tqala.
Nervous system disorders:
21 Disturbi fis- sistema nervuża:
21
Mhux komuni: dijarea
22 Irbesartan:
22
General disorders and administration site conditions: fever
23 Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata: deni
23 The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
L- episodji avversi dipendenti fuq id- doża ta 'hydrochlorothiazide (b' mod partikolari disturbi elettrolitiċi) jistgħu jiżdiedu meta jkun qed jiġi ttitrat il- hydrochlorothiazide.
Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
24 tar- riassorbiment ta ’ l- elettroliti u jżidu direttament l- eskrezzjoni tas- sodium u tal- chloride f’ ammonti kważi ekwivalenti.
24 The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges.
Il- kombinazzjoni ta ’ hydrochlorothiazide u irbesartan tipproduċi tnaqqis addittiv relatat mad- doża fil - pressjoni tad- demm tul il- firxa terapewtika tad- doża.
Efficacy and safety of Irbesartan Hydrochlorothiazide Winthrop as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double- blind, active-controlled, 8-week, parallel-arm study.
25 L- effikaċja u s- sigurtà ta ’ Irbesartan Hydrochlorothiazide Winthrop bħala terapija inizjali għal pressjoni għolja severa (definita bħala SeDBP ≥ 110 mmHg) ġew evalwati fi studju b’ aktar minn ċentru wieħed, b’ mod każwali, double- blind, ikkontrollat b’ mod attiv ta ’ 8 ġimgħat, parallel- arm.
25 The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at Week 5 of treatment.
L- għan ewlieni ta ’ dan l- istudju kien li jqabbel il- proporzjon ta ’ pazjenti li l- SeDBP tagħhom kien ikkontrollat (SeDBP < 90 mmHg) f’ Ġimgħa 5 tat- trattament.
Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
26 Wara li 14C irbesartan jingħata mill- ħalq jew ġol- vini, 80 - 85% tar- radjuattività li tiċċirkola fil- plażma hi attribwita għal irbesartan mhux mibdul.
26 haemodialysis.
Irbesartan ma jitneħħiex bl- emodijalisi.
There was no evidence of mutagenicity or clastogenicity with the irbesartan/ hydrochlorothiazide combination.
27 Ma kienx hemm evidenza ta ’ mutaġeniċità jew klasroġenitiċità bil- kombinazzjoni ta ’ irbesartan/ hydrochlorothiazide.
27 abortion or early resorption was noted at doses causing significant maternal toxicity, including mortality.
Fil- fniek, abort jew reassorbiment kmieni ta ’ l- embriju ġie nnotat b’ dożi li kkaġunaw tossiċita` sinifikanti fl - omm, li nkludew mwiet.
Cartons of 98 tablets; 7 blister cards of 14 tablets in PVC/ PVDC/ Aluminium blisters.
28 Pakketti ta ’ 98 pillola; 7 strixxi ta ’ 14- il pillola f’ folji tal- PVC/ PVDC/ Aluminju.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg film-coated tablets.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg pilloli miksijin b' rita.
30 Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan Hydrochlorothiazide Winthrop.
30 Tnaqqis fil- volum intravaskulari: tnaqqis ta ’ volum u/ jew ta ’ sodium, għandhom jiġu ikkoreġuti qabel ma ’ jingħata Irbesartan Hydrochlorothiazide Winthrop.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
31 Stenożi tal- valv aortiku u mitrali, kardjomijopatija ipertrofika ostruttiva: bħal fil- każ ta ’ vażodilatorji oħra, għandha tingħata attenzjoni speċjali f’ pazjenti li jsofru minn stenożi aortika jew mitrali jew kardjomijopatija ipertrofika ostruttiva.
31 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Aldosteroniżmu primarju: pazjenti b’ aldosteroniżmu primarju ġeneralment ma jirrispondux għall - prodotti mediċinali ta ’ kontra l- pressjoni li jaħdmu billi jinpedixxu s- sistema tar- renin- angiotensin.
32 Pregnancy:
32 Reazzjonijiet ta ’ sensittività eċċessiva għal hydrochlorothiazide jistgħu jinħassu f’ pazjenti li għandhom jew m’ għandhomx rekord ta ’ allerġija jew ażżma tal- bronki, imma hemm aktar ċans li jiġru f’ pazjenti li kellhom dawn l- attakki.
4.6 Pregnancy and lactation
34 4. 6 Tqala u Treddigħ
34 AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm terapija AIIRAs kontinwa mhijiex meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti alternattivi ta ’ kontra l- pressjoni għolja li għandhom profil ta ’ sigurtà stabbilit għal użu waqt tqala.
Nervous system disorders:
35 Disturbi fis- sistema nervuża:
35
Mhux komuni: dijarea
36 Irbesartan:
36
General disorders and administration site conditions: fever
37 Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata: deni
37 The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
L- episodji avversi dipendenti fuq id- doża ta 'hydrochlorothiazide (b' mod partikolari disturbi elettrolitiċi) jistgħu jiżdiedu meta jkun qed jiġi ttitrat il- hydrochlorothiazide.
Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
38 tar- riassorbiment ta ’ l- elettroliti u jżidu direttament l- eskrezzjoni tas- sodium u tal- chloride f’ ammonti kważi ekwivalenti.
38 The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges.
Il- kombinazzjoni ta ’ hydrochlorothiazide u irbesartan tipproduċi tnaqqis addittiv relatat mad- doża fil - pressjoni tad- demm tul il- firxa terapewtika tad- doża.
Efficacy and safety of Irbesartan Hydrochlorothiazide Winthrop as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double- blind, active-controlled, 8-week, parallel-arm study.
39 L- effikaċja u s- sigurtà ta ’ Irbesartan Hydrochlorothiazide Winthrop bħala terapija inizjali għal pressjoni għolja severa (definita bħala SeDBP ≥ 110 mmHg) ġew evalwati fi studju b’ aktar minn ċentru wieħed, b’ mod każwali, double- blind, ikkontrollat b’ mod attiv ta ’ 8 ġimgħat, parallel- arm.
39 The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at Week 5 of treatment.
L- għan ewlieni ta ’ dan l- istudju kien li jqabbel il- proporzjon ta ’ pazjenti li l- SeDBP tagħhom kien ikkontrollat (SeDBP < 90 mmHg) f’ Ġimgħa 5 tat- trattament.
Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
40 Wara li 14C irbesartan jingħata mill- ħalq jew ġol- vini, 80 - 85% tar- radjuattività li tiċċirkola fil- plażma hi attribwita għal irbesartan mhux mibdul.
40 haemodialysis.
Irbesartan ma jitneħħiex bl- emodijalisi.
There was no evidence of mutagenicity or clastogenicity with the irbesartan/ hydrochlorothiazide combination.
41 Ma kienx hemm evidenza ta ’ mutaġeniċità jew klasroġenitiċità bil- kombinazzjoni ta ’ irbesartan/ hydrochlorothiazide.
41 abortion or early resorption was noted at doses causing significant maternal toxicity, including mortality.
Fil- fniek, abort jew reassorbiment kmieni ta ’ l- embriju ġie nnotat b’ dożi li kkaġunaw tossiċita` sinifikanti fl - omm, li nkludew mwiet.
Store in the original package in order to protect from moisture.
42 Aħżen fil- pakkett oriġinali biex tilqa ’ mill- umdità.
42 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg film-coated tablets.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12. 5 mg pilloli miksijin b' rita.
44 Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan Hydrochlorothiazide Winthrop.
44 Tnaqqis fil- volum intravaskulari: tnaqqis ta ’ volum u/ jew ta ’ sodium, għandhom jiġu ikkoreġuti qabel ma ’ jingħata Irbesartan Hydrochlorothiazide Winthrop.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
45 Stenożi tal- valv aortiku u mitrali, kardjomijopatija ipertrofika ostruttiva: bħal fil- każ ta ’ vażodilatorji oħra, għandha tingħata attenzjoni speċjali f’ pazjenti li jsofru minn stenożi aortika jew mitrali jew kardjomijopatija ipertrofika ostruttiva.
45 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Aldosteroniżmu primarju: pazjenti b’ aldosteroniżmu primarju ġeneralment ma jirrispondux għall - prodotti mediċinali ta ’ kontra l- pressjoni li jaħdmu billi jinpedixxu s- sistema tar- renin- angiotensin.
46 Pregnancy:
46 Reazzjonijiet ta ’ sensittività eċċessiva għal hydrochlorothiazide jistgħu jinħassu f’ pazjenti li għandhom jew m’ għandhomx rekord ta ’ allerġija jew ażżma tal- bronki, imma hemm aktar ċans li jiġru f’ pazjenti li kellhom dawn l- attakki.
4.6 Pregnancy and lactation
48 4. 6 Tqala u Treddigħ
48 AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm terapija AIIRAs kontinwa mhijiex meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti alternattivi ta ’ kontra l- pressjoni għolja li għandhom profil ta ’ sigurtà stabbilit għal użu waqt tqala.
49
Mhux komuni: dijarea
50 Irbesartan:
50
General disorders and administration site conditions: fever
51 Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata: deni
51 The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
L- episodji avversi dipendenti fuq id- doża ta 'hydrochlorothiazide (b' mod partikolari disturbi elettrolitiċi) jistgħu jiżdiedu meta jkun qed jiġi ttitrat il- hydrochlorothiazide.
Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
52 tar- riassorbiment ta ’ l- elettroliti u jżidu direttament l- eskrezzjoni tas- sodium u tal- chloride f’ ammonti kważi ekwivalenti.
52 The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges.
Il- kombinazzjoni ta ’ hydrochlorothiazide u irbesartan tipproduċi tnaqqis addittiv relatat mad- doża fil - pressjoni tad- demm tul il- firxa terapewtika tad- doża.
Efficacy and safety of Irbesartan Hydrochlorothiazide Winthrop as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double- blind, active-controlled, 8-week, parallel-arm study.
53 L- effikaċja u s- sigurtà ta ’ Irbesartan Hydrochlorothiazide Winthrop bħala terapija inizjali għal pressjoni għolja severa (definita bħala SeDBP ≥ 110 mmHg) ġew evalwati fi studju b’ aktar minn ċentru wieħed, b’ mod każwali, double- blind, ikkontrollat b’ mod attiv ta ’ 8 ġimgħat, parallel- arm.
53 The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at Week 5 of treatment.
L- għan ewlieni ta ’ dan l- istudju kien li jqabbel il- proporzjon ta ’ pazjenti li l- SeDBP tagħhom kien ikkontrollat (SeDBP < 90 mmHg) f’ Ġimgħa 5 tat- trattament.
Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
54 Wara li 14C irbesartan jingħata mill- ħalq jew ġol- vini, 80 - 85% tar- radjuattività li tiċċirkola fil- plażma hi attribwita għal irbesartan mhux mibdul.
54 haemodialysis.
Irbesartan ma jitneħħiex bl- emodijalisi.
There was no evidence of mutagenicity or clastogenicity with the irbesartan/ hydrochlorothiazide combination.
55 Ma kienx hemm evidenza ta ’ mutaġeniċità jew klasroġenitiċità bil- kombinazzjoni ta ’ irbesartan/ hydrochlorothiazide.
55 abortion or early resorption was noted at doses causing significant maternal toxicity, including mortality.
Fil- fniek, abort jew reassorbiment kmieni ta ’ l- embriju ġie nnotat b’ dożi li kkaġunaw tossiċita` sinifikanti fl - omm, li nkludew mwiet.
Store in the original package in order to protect from moisture.
56 Aħżen fil- pakkett oriġinali biex tilqa ’ mill- umdità.
56 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg film-coated tablets.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg pilloli miksijin b' rita.
58 Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan Hydrochlorothiazide Winthrop.
58 Tnaqqis fil- volum intravaskulari: tnaqqis ta ’ volum u/ jew ta ’ sodium, għandhom jiġu ikkoreġuti qabel ma ’ jingħata Irbesartan Hydrochlorothiazide Winthrop.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
59 Stenożi tal- valv aortiku u mitrali, kardjomijopatija ipertrofika ostruttiva: bħal fil- każ ta ’ vażodilatorji oħra, għandha tingħata attenzjoni speċjali f’ pazjenti li jsofru minn stenożi aortika jew mitrali jew kardjomijopatija ipertrofika ostruttiva.
59 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Aldosteroniżmu primarju: pazjenti b’ aldosteroniżmu primarju ġeneralment ma jirrispondux għall - prodotti mediċinali ta ’ kontra l- pressjoni li jaħdmu billi jinpedixxu s- sistema tar- renin- angiotensin.
60 Pregnancy:
60 Reazzjonijiet ta ’ sensittività eċċessiva għal hydrochlorothiazide jistgħu jinħassu f’ pazjenti li għandhom jew m’ għandhomx rekord ta ’ allerġija jew ażżma tal- bronki, imma hemm aktar ċans li jiġru f’ pazjenti li kellhom dawn l- attakki.
4.6 Pregnancy and lactation
62 4. 6 Tqala u Treddigħ
62 AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm terapija AIIRAs kontinwa mhijiex meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti alternattivi ta ’ kontra l- pressjoni għolja li għandhom profil ta ’ sigurtà stabbilit għal użu waqt tqala.
Nervous system disorders:
63 Disturbi fis- sistema nervuża:
63
Mhux komuni: dijarea
64 Irbesartan:
64
General disorders and administration site conditions: fever
65 Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata: deni
65 The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
L- episodji avversi dipendenti fuq id- doża ta 'hydrochlorothiazide (b' mod partikolari disturbi elettrolitiċi) jistgħu jiżdiedu meta jkun qed jiġi ttitrat il- hydrochlorothiazide.
Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
66 tar- riassorbiment ta ’ l- elettroliti u jżidu direttament l- eskrezzjoni tas- sodium u tal- chloride f’ ammonti kważi ekwivalenti.
66 The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges.
Il- kombinazzjoni ta ’ hydrochlorothiazide u irbesartan tipproduċi tnaqqis addittiv relatat mad- doża fil - pressjoni tad- demm tul il- firxa terapewtika tad- doża.
Efficacy and safety of Irbesartan Hydrochlorothiazide Winthrop as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double- blind, active-controlled, 8-week, parallel-arm study.
67 L- effikaċja u s- sigurtà ta ’ Irbesartan Hydrochlorothiazide Winthrop bħala terapija inizjali għal pressjoni għolja severa (definita bħala SeDBP ≥ 110 mmHg) ġew evalwati fi studju b’ aktar minn ċentru wieħed, b’ mod każwali, double- blind, ikkontrollat b’ mod attiv ta ’ 8 ġimgħat, parallel- arm.
67 The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at Week 5 of treatment.
L- għan ewlieni ta ’ dan l- istudju kien li jqabbel il- proporzjon ta ’ pazjenti li l- SeDBP tagħhom kien ikkontrollat (SeDBP < 90 mmHg) f’ Ġimgħa 5 tat- trattament.
Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
68 Wara li 14C irbesartan jingħata mill- ħalq jew ġol- vini, 80 - 85% tar- radjuattività li tiċċirkola fil- plażma hi attribwita għal irbesartan mhux mibdul.
68 haemodialysis.
Irbesartan ma jitneħħiex bl- emodijalisi.
There was no evidence of mutagenicity or clastogenicity with the irbesartan/ hydrochlorothiazide combination.
69 Ma kienx hemm evidenza ta ’ mutaġeniċità jew klasroġenitiċità bil- kombinazzjoni ta ’ irbesartan/ hydrochlorothiazide.
69 abortion or early resorption was noted at doses causing significant maternal toxicity, including mortality.
Fil- fniek, abort jew reassorbiment kmieni ta ’ l- embriju ġie nnotat b’ dożi li kkaġunaw tossiċita` sinifikanti fl - omm, li nkludew mwiet.
6.4 Special precautions for storage
70 6. 4 Prekawzjonijiet speċjali għall- ħażna
The PSUR cycle of Irbesartan Hydrochlorothiazide Winthrop is aligned with the cross-referred product, COAPROVEL, until otherwise specified.
Iċ- ċiklu tal- PSUR ta ’ Irbesartan Hydrochlorothiazide Winthrop huwa allinjat mal- prodott cross - referred, COAPROVEL, sakemm mhux speċifikat mod ieħor.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Pilloli Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
EU/ 1/ 06/ 377/ 001 14 tablets EU/ 1/ 06/ 377/ 002 28 tablets EU/ 1/ 06/ 377/ 003 56 tablets EU/ 1/ 06/ 377/ 004 56 x 1 tablets EU/ 1/ 06/ 377/ 005 98 tablets
EU/ 1/ 06/ 377/ 001 14- il pillola EU/ 1/ 06/ 377/ 002 28 pillola EU/ 1/ 06/ 377/ 003 56 pillola EU/ 1/ 06/ 377/ 004 56 x 1 pillola EU/ 1/ 06/ 377/ 005 98 pillola
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg pilloli irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Pilloli Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
EU/ 1/ 06/ 377/ 006 14 tablets EU/ 1/ 06/ 377/ 007 28 tablets EU/ 1/ 06/ 377/ 008 56 tablets EU/ 1/ 06/ 377/ 009 56 x 1 tablets EU/ 1/ 06/ 377/ 010 98 tablets
EU/ 1/ 06/ 377/ 006 14- il pillola EU/ 1/ 06/ 377/ 007 28 pillola EU/ 1/ 06/ 377/ 008 56 pillola EU/ 1/ 06/ 377/ 009 56 x 1 pillola EU/ 1/ 06/ 377/ 010 98 pillola
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12. 5 mg
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12. 5 mg pilloli irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12. 5 mg pilloli miksijin b' rita irbesartan/ hydrochlorothiazide
EU/ 1/ 06/ 377/ 011 14 tablets EU/ 1/ 06/ 377/ 012 28 tablets EU/ 1/ 06/ 377/ 013 56 tablets EU/ 1/ 06/ 377/ 014 56 x 1 tablets EU/ 1/ 06/ 377/ 015 84 tablets EU/ 1/ 06/ 377/ 016 98 tablets
EU/ 1/ 06/ 377/ 011 14- il pillola EU/ 1/ 06/ 377/ 012 28 pillola EU/ 1/ 06/ 377/ 013 56 pillola EU/ 1/ 06/ 377/ 014 56 x 1 pillola EU/ 1/ 06/ 377/ 015 84 pillola EU/ 1/ 06/ 377/ 016 98 pillola
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide Winthrop Pilloli 150 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg film-coated tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12. 5 mg pilloli miksijin b' rita irbesartan/ hydrochlorothiazide
EU/ 1/ 06/ 377/ 017 14 tablets EU/ 1/ 06/ 377/ 018 28 tablets EU/ 1/ 06/ 377/ 019 56 tablets EU/ 1/ 06/ 377/ 020 56 x 1 tablets EU/ 1/ 06/ 377/ 021 84 tablets EU/ 1/ 06/ 377/ 022 98 tablets
EU/ 1/ 06/ 377/ 017 14- il pillola EU/ 1/ 06/ 377/ 018 28 pillola EU/ 1/ 06/ 377/ 019 56 pillola EU/ 1/ 06/ 377/ 020 56 x 1 pillola EU/ 1/ 06/ 377/ 021 84 pillola EU/ 1/ 06/ 377/ 022 98 pillola
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide Winthrop Pilloli 300 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg film-coated tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg pilloli miksijin b' rita irbesartan/ hydrochlorothiazide
EU/ 1/ 06/ 377/ 023 14 tablets EU/ 1/ 06/ 377/ 024 28 tablets EU/ 1/ 06/ 377/ 025 56 tablets EU/ 1/ 06/ 377/ 026 56 x 1 tablets EU/ 1/ 06/ 377/ 027 84 tablets EU/ 1/ 06/ 377/ 028 98 tablets
EU/ 1/ 06/ 377/ 023 14- il pillola EU/ 1/ 06/ 377/ 024 28 pillola EU/ 1/ 06/ 377/ 025 56 pillola EU/ 1/ 06/ 377/ 026 56 x 1 pillola EU/ 1/ 06/ 377/ 027 84 pillola EU/ 1/ 06/ 377/ 028 98 pillola
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg tablets irbesartan/ hydrochlorothiazide
Irbesartan Hydrochlorothiazide Winthrop Pilloli 300 mg/ 25 mg irbesartan/ hydrochlorothiazide
INFORMATION FOR THE USER Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg tablets irbesartan/ hydrochlorothiazide
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Irbesartan Hydrochlorothiazide Winthrop Pilloli 150 mg/ 12. 5 mg irbesartan/ hydrochlorothiazide
What Irbesartan Hydrochlorothiazide Winthrop is and what it is used for 2.
X’ inhu Irbesartan Hydrochlorothiazide Winthrop u għalxiex jintuża 2.
Before you take Irbesartan Hydrochlorothiazide Winthrop 3.
Qabel ma tieħu Irbesartan Hydrochlorothiazide Winthrop 3.
How to take Irbesartan Hydrochlorothiazide Winthrop 4.
Kif għandek tieħu Irbesartan Hydrochlorothiazide Winthrop 4.
How to store Irbesartan Hydrochlorothiazide Winthrop 6.
Kif taħżen Irbesartan Hydrochlorothiazide Winthrop 6.
WHAT IRBESARTAN HYDROCHLOROTHIAZIDE WINTHROP IS AND WHAT IT IS USED FOR
X’ INHU IRBESARTAN HYDROCHLOROTHIAZIDE WINTHROP U GĦALXIEX JINTUŻA
Irbesartan Hydrochlorothiazide Winthrop is a combination of two active substances, irbesartan and hydrochlorothiazide.
Irbesartan Hydrochlorothiazide Winthrop hu kombinazzjoni ta ’ żewġ sustanzi attivi, irbesartan u hydrochlorothiazide.
The two active ingredients in Irbesartan Hydrochlorothiazide Winthrop work together to lower blood pressure further than if either was given alone.
Iż- żewġ sustanzi attivi f’ Irbesartan Hydrochlorothiazide Winthrop jaħdmu flimkien biex inaqqsu l - pressjoni iktar milli kieku jingħataw waħidhom.
Irbesartan Hydrochlorothiazide Winthrop is used in the treatment of high blood pressure (essential hypertension), when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
Irbesartan Hydrochlorothiazide Winthrop jintuża fil- kura għall- pressjoni għolja (pressjoni għolja essenzjali), meta l- kura b’ irbesartan jew hydrochlorothiazide waħedhom ma tipprovdix kontroll adattat għall- pressjoni tiegħek.
BEFORE YOU TAKE IRBESARTAN HYDROCHLOROTHIAZIDE WINTHROP
QABEL MA TIEĦU IRBESARTAN HYDROCHLOROTHIAZIDE WINTHROP
Do not take Irbesartan Hydrochlorothiazide Winthrop if you are allergic (hypersensitive) to irbesartan and hydrochlorothiazide, or any of the other ingredients of Irbesartan Hydrochlorothiazide Winthrop or to sulfonamide-derived medicines during the last 6 months of pregnancy, see section Pregnancy and breastfeeding if you are breast-feeding if you have severe liver or kidney problems if you have difficulty in producing urine if you have a condition which is associated with persistently high calcium or low potassium levels in your blood
Tiħux Irbesartan Hydrochlorothiazide Winthrop jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal irbesartan u hydrochlorothiazide jew sustanzi oħra ta 'Irbesartan Hydrochlorothiazide Winthrop jew għall- mediċini derivati mis - sulfonamide matul l- aħħar sitt xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ jekk qegħda tredda ’ jekk inti għandek problemi severi tal- fwied jew tal- kliewi jekk inti għandek diffikultà biex tagħmel l- awrina jekk inti għandek kondizzjoni assoċjata ma ’ livelli persistenti ta ’ calcium għoli jew potassium baxx fid- demm tiegħek
Irbesartan Hydrochlorothiazide Winthrop should not be given to children and adolescents (< 18 years).
Irbesartan Hydrochlorothiazide Winthrop m’ għandux jingħata lit- tfal u lill- adoloxxenti (< 18- il sena).
Take special care with Irbesartan Hydrochlorothiazide Winthrop if you suffer from excessive vomiting or diarrhoea if you suffer from kidney problems, including kidney transplantation
Oqgħod attent ħafna b’ Irbesartan Hydrochlorothiazide Winthrop jekk inti tbati minn rimettar jew dijarea eċċessiva
92 if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) You must tell your doctor if you think that you are (or might become) pregnant.
92 jekk inti tbati minn problemi tal- kliewi, li jinkludu trapjant tal- kliewi jekk inti tbati minn problemi tal- qalb jekk inti tbati minn problemi tal- fwied jekk inti tbati mid- dijabete jekk inti tbati minn lupus erythematosus (magħruf ukoll bħala lupus jew SLE) Għandek tavża lit- tabib tiegħek jekk taħseb li inti tqila (jew li tista ’ tinqabad tqila).
Irbesartan Hydrochlorothiazide Winthrop is not recommended in early pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section Pregnancy and breastfeeding.
Irbesartan Hydrochlorothiazide Winthrop mhuwiex rakkomandat kmieni matul it- tqala u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek wara l- ewwel 3 xhur tat- tqala, ara s- sezzjoni Tqala u Treddigħ.
You should also tell your doctor: if you are on a low-salt diet if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan Hydrochlorothiazide Winthrop) if you are to undergo any surgery or receive anaesthetics
Int għandek tgħid ukoll lit- tabib tiegħek: jekk int qiegħed/ qiegħda fuq dieta nieqsa mill- melħ jekk int qed turi sinjali bħal għatx mhux tas- soltu, ħalq xott, għejja ġenerali, ngħas, uġigħ fil - muskoli jew bugħawwieġ, dardir, rimettar jew taħbit tal- qalb mgħaġġel mhux normali li jistgħu jseħħu minħabba effett eċċessiv ta ’ hydrochlorothiazide (li hemm f’ Irbesartan Hydrochlorothiazide Winthrop) jekk inti għandek bżonn tagħmel xi operazzjoni jew tirċievi anistetiku
Diuretic agents such as the hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide Winthrop may interact with other medicines.
Dijuretiċi bħal hydrochlorothiazide li jinstab f’ Irbesartan Hydrochlorothiazide Winthrop jista ’ jkun ikollhom interazzjoni ma ’ mediċini oħra.
Preparations containing lithium should not be taken with Irbesartan Hydrochlorothiazide Winthrop without close supervision by your doctor.
Preparazzjonijiet li fihom lithium m’ għandhomx jittieħdu ma ’ Irbesartan Hydrochlorothiazide Winthrop jekk ma tkunx taħt is- superviżjoni mill- viċin tat- tabib tiegħek.
Special precautionary measures (e. g. blood tests) may be appropriate if you take potassium supplements, potassium- containing salt substitutes or potassium sparing medicines, other diuretics (water tablets), some laxatives, medicines for the treatment of gout, therapeutic vitamin D supplements, medicines to control heart rhythm or for diabetes (oral agents or insulins).
Jista ’ jkun tajjeb li jittieħdu miżuri speċjali ta ’ prekawzjoni (p. e. testijiet tad- demm) jekk int tieħu supplimenti tal- potassium, sostituti tal- melħ li fihom il- potassium, jew mediċini potassium sparing, dijuretiċi oħra (pilloli ta ’ l- ilma), xi lassattivi, mediċini għall- kura tal- gotta, supplimenti terapewtiċi tal- vitamina D, mediċini biex jikkontrolaw ir- ritmu tal- qalb jew għad- dijabete (mediċini li jittieħdu mill- ħalq jew insulina).
Taking Irbesartan Hydrochlorothiazide Winthrop with food and drink Irbesartan Hydrochlorothiazide Winthrop can be taken with or without food.
Meta tieħu Irbesartan Hydrochlorothiazide Winthrop ma ’ l- ikel u max- xorb Irbesartan Hydrochlorothiazide Winthrop jista ’ jittieħed bi jew mingħajr ikel.
Usually, your doctor will advise you to take another medicine instead of Irbesartan Hydrochlorothiazide Winthrop, as Irbesartan Hydrochlorothiazide Winthrop is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Normalment, it- tabib tiegħek jagħtik parir li tieħu mediċina oħra minflok Irbesartan Hydrochlorothiazide Winthrop, minħabba li Irbesartan Hydrochlorothiazide Winthropmhuwiex rakkomandat kmieni matul it- tqala, u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek jekk jintuża wara l- ewwel 3 xhur tat- tqala.
Appropriate antihypertensive drug must usually replace Irbesartan Hydrochlorothiazide Winthrop before starting a pregnancy.
Mediċina xierqa kontra l- pressjoni għolja għandha normalment tissostitwixxi Irbesartan Hydrochlorothiazide Winthropqabel il- bidu ta ’ tqala.
Your doctor will normally advise you to stop taking Irbesartan Hydrochlorothiazide Winthrop as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu Irbesartan Hydrochlorothiazide Winthrop malli ssir taf li inti ħriġt tqila.
If you become pregnant during therapy with Irbesartan Hydrochlorothiazide Winthrop, please inform and see your doctor without delay.
Jekk toħroġ tqila matul terapija b ’ Irbesartan Hydrochlorothiazide Winthrop, jekk jogħġbok avża u ara lit- tabib tiegħek minnufih.
Irbesartan Hydrochlorothiazide Winthrop is unlikely to affect your ability to drive or use machines.
Irbesartan Hydrochlorothiazide Winthrop mhux suppost li jtellfek milli ssuq jew tħaddem magni.
Important information about some of the ingredients of Irbesartan Hydrochlorothiazide Winthrop Irbesartan Hydrochlorothiazide Winthrop contains lactose monohydrate (see “ Further information”).
93 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Irbesartan Hydrochlorothiazide Winthrop Irbesartan Hydrochlorothiazide Winthrop fih il- lactose monohydrate (ara “ Aktar tagħrif ”).
If you have been told by your doctor that you have an intolerance to some sugars (e. g. lactose), contact your doctor before taking this medicine.
Jekk it - tabib tiegħek qallek li għandek intolleranza għal xi zokkor (ngħidu aħna lactose), ikkuntattja lit- tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE IRBESARTAN HYDROCHLOROTHIAZIDE WINTHROP
KIF GĦANDEK TIEĦU IRBESARTAN HYDROCHLOROTHIAZIDE WINTHROP
Always take Irbesartan Hydrochlorothiazide Winthrop exactly as your doctor has told you.
Dejjem għandek tieħu Irbesartan Hydrochlorothiazide Winthrop skond il- parir tat- tabib.
Irbesartan Hydrochlorothiazide Winthrop will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction.
Irbesartan Hydrochlorothiazide Winthrop ġeneralment jiġi preskritt mit- tabib tiegħek meta l- kura li kont tieħu qabel għal kontra l- pressjoni għolja ma pprovdietx tnaqqis xieraq tal- pressjoni.
Your doctor will instruct you how to switch from the previous treatment to Irbesartan Hydrochlorothiazide Winthrop.
It- tabib tiegħek igħidlek kif għandek tagħmel biex taqleb mill- kura li kont qed tieħu qabel għal Irbesartan Hydrochlorothiazide Winthrop.
The usual dose of Irbesartan Hydrochlorothiazide Winthrop is one or two tablets a day.
Id- doża normali ta ’ Irbesartan Hydrochlorothiazide Winthrop hija ta ’ pillola waħda jew tnejn kuljum.
You can take Irbesartan Hydrochlorothiazide Winthrop with or without food.
Irbesartan Hydrochlorothiazide Winthrop jista ’ jittieħed ma ’ l- ikel jew waħdu.
It is important that you continue to take Irbesartan Hydrochlorothiazide Winthrop until your doctor tells you otherwise.
Huwa importanti li tkompli tieħu Irbesartan Hydrochlorothiazide Winthrop sakemm it- tabib ma jgħidlekx mod ieħor.
If you take more Irbesartan Hydrochlorothiazide Winthrop than you should If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately.
Jekk tieħu Irbesartan Hydrochlorothiazide Winthrop aktar milli suppost Jekk aċċidentalment tieħu ħafna pilloli, jew jekk tifel/ tifla tibla ’ xi ftit, għid lit- tabib tiegħek immedjatament.
If you forget to take Irbesartan Hydrochlorothiazide Winthrop If you accidentally miss a daily dose, just take the next dose as normal.
Jekk tinsa tieħu Irbesartan Hydrochlorothiazide Winthrop Jekk aċċidentalment taqbeż id- doża tal- ġurnata, ħu d- doża li jmiss bħas- soltu.
Like all medicines, Irbesartan Hydrochlorothiazide Winthrop can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Irbesartan Hydrochlorothiazide Winthrop jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects reported in clinical studies for patients treated with Irbesartan Hydrochlorothiazide Winthrop were:
L- effetti sekondarji rrapportati fi studji kliniċi għal pazjenti kkurati b’ Irbesartan Hydrochlorothiazide Winthrop kienu: