qanastek/EMEA-V3 huggingface dataset:
dizziness, orthostatic dizziness*
sturdament, sturdament ortostatiku *
Uncommon: cough
Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni: sogħla
nausea/ vomiting
dardir/ rimettar
Uncommon: diarrhoea, dyspepsia/ heartburn
Mhux komuni: dijarea, dispepsja/ qrusa fl- istonku
Musculoskeletal and connective tissue disorders:
Disturbi muskolu- skeletriku u tat- tessut konnettiv:
musculoskeletal pain*
uġigħ muskolu- skeltriku *
orthostatic hypotension*
pressjoni baxxa ortostatika *
Uncommon: flushing
Mhux komuni: fwawar
Uncommon: chest pain
Mhux komuni: uġigħ fis- sider
6 Reproductive system and breast disorders:
Disturbi fis- sistema riproduttiva u fis- sider:
Uncommon: sexual dysfunction
Mhux komuni: problemi ta ’ funzjoni sesswali
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports and therefore, the frequency of these adverse reactions is not known:
Huma ġejjin minn rapporti spontaneji u għalhekk, il- frekwenza ta ’ dawn ir- reazzjonijiet avversi mhix magħrufa:
Musculoskeletal and connective tissue disorders:
Disturbi muskolu- skeltriku u tat- tessut konnettiv:
Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle Cramps
Artralġja, uġigħ fil- muskoli (f' xi każijiet assoċjati ma 'livelli miżjuda creatine kinase fil- plażma),
Hypersensitivity reactions such as angioedema, rash, urticaria
Reazzjonijiet ta ’ sensittività eċċessiva bħal anġjodema, raxx u urtikarja
Paediatric patients: in a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following related adverse events occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
Pazjenti pedjatriċi: fi prova każwali ta '318- il tifel u tifla bi pressjoni għolja u adoloxxenti ta' bejn is- 6 u s - 16- il sena, dawn l- effetti avversi relatati li ġejjin ġraw fil- fażi double- blind ta 'tliet ġimgħat: uġigħ ta' ras (7. 9%), pressjoni baxxa (2. 2%), sturdament (1. 9%), sogħla (0. 9%).
Experience in adults exposed to doses of up to 900 mg/ day for 8 weeks revealed no toxicity.
Esperjenza f’ adulti esposti għal dożi sa 900 mg/ jum għal 8 ġimgħat ma wriet ebda tossiċità.
The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
L- iktar manifestazzjonijiet probabbli ta ’ doża eċċessiva huma mistennija li jkunu pressjoni baxxa, u takikardija; bradikardija tista ’ wkoll tiġi ikkaġunata minn doża eċċessiva.
No specific information is available on the treatment of overdosage with Irbesartan Krka.
M’ hemmx biżżejjed informazzjoni speċifika disponibbli fuq il- kura tad- doża eċċessiva b’ Irbesartan Krka.
Suggested measures include induction of emesis and/ or gastric lavage.
Miżuri issuġġeriti jinkludu induzzjoni tar - rimettar u / jew tal- ħasil gastriku.
Activated charcoal may be useful in the treatment of overdosage.
Il- faħam attivat jista ’ jkun utli fi trattament ta ’ doża eċċessiva.
5.1 Pharmacodynamic properties Pharmacotherapeutic group: angiotensin II antagonist, plain, ATC code:
5. 1 Tagħrif farmakodinamiku
7 Mechanism of action:
Mekkaniżmu ta ’ azzjoni:
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Irbesartan huwa antagonista qawwi, attiv orali, antagonista selettiv tar- riċettur angiotensin- II (tip AT1).
It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II.
Huwa mistenni li jimblokka l- azzjonijiet kollha ta ’ angiotensin- II medjati mir - riċettur AT1, mingħajr m’ għandu x’ jaqsam ma ’ l- oriġini jew rotta ta ’ sintesi ta ’ l - angiotensin- II.
Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses.
Il- livelli tal- potassium fis- serum mhumiex affettwati b' mod sinifikanti minn irbesartan waħdu fid- dożi rrikmandati.
Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Irbesartan ma jimpedixxix ACE (kininase- II), enzima li tiġġenera angiotensin- II u tiddiżintegra wkoll il - bradikinin f’ metaboliti inattivi.
Clinical efficacy:
Effikaċja klinika:
Hypertension Irbesartan lowers blood pressure with minimal change in heart rate.
Pressjoni għolja Irbesartan iniżżel il- pressjoni b’ tibdil minimu fir- rata tat- taħbit tal- qalb.
Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i. e.
Dożi ta ’ 150- 300 mg darba kuljum iniżżlu l- pressjoni fl- inqas livellmeħudha meta pazjent ikun mindud jew bil- qiegħda (i. e.
Peak reduction of blood pressure is achieved within 3-6 hours after administration and the blood pressure lowering effect is maintained for at least 24 hours.
L- ogħla tnaqqis fil- pressjoni jseħħ fi żmien 3- 6 sigħat wara li jingħata
At 24 hours the reduction of blood pressure was 60-70% of the corresponding peak diastolic and systolic responses at the recommended doses.
F’ 24 siegħa t- tnaqqis tal- pressjoni kien 60% - 70% ta ’ l- ogħla rispons fid- dijastolika u sistolika bid- dożi rrikmandati.
Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice daily dosing on the same total dose.
Doża darba kuljum ta ’ 150 mg tat respons baxx u medju fuq 24 siegħa simili għal doża doppja ta ’ kuljum fuq l- istess doża totali.
The blood pressure lowering effect of irbesartan is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
L- effett li għandu Irbesartan Krka li jbaxxi l- pressjoni jidher fi żmien 1- 2 ġimgħat, bl- effett massimu jseħħ f’ 4- 6 ġimgħat wara li tinbeda t- terapija.
The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
L- effetti ta ’ irbesartan li jbaxxu l- pressjoni u d- dijuretiċi tat- tip thiazide huma addittivi.
In patients not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at trough of 7-10/ 3-6 mm Hg (systolic/ diastolic).
F’ pazjenti li mhux ikkontrollati sew b’ irbesartan waħdu, iż- żieda ta ’ doża baxxa ta ’ hydrochlorothiazide (12. 5 mg) ma ’ irbesartan darba kuljum tirriżulta fi tnaqqis aktar tal- pressjoni fl- inqas livell ta ’ 7- 10/ 3- 6 mm/ Hg (sistolika/ dijastolika) meta aġġustata għall- plaċebo.
The efficacy of irbesartan is not influenced by age or gender.
L- effikaċja ta ’ Irbesartan Krka ma hijiex influwenzata bl- età jew sess.
As is the case with other medicinal products that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy.
Bħal fil- każi ta ’ prodotti mediċinali oħra li jaffettwaw is- sistema renin- angiotensin, pazjenti suwed bi pressjoni għolja wrew ferm inqas respons għal monoterapija b’ irbesartan.
There is no clinically important effect on serum uric acid or urinary uric acid secretion.
M’ hemmx effett ta ’ importanza klinika fil- livelli ta ’ l- uric acid fis- serum jew fl- eliminazzjoni ħruġ ta ’ l - uric acid ma ’ l- awrina.
Reduction of blood pressure with 0.5 mg/ kg (low), 1.5 mg/ kg (medium) and 4.5 mg/ kg (high) target titrated doses of irbesartan was evaluated in 318 hypertensive or at risk (diabetic, family history of hypertension) children and adolescents aged 6 to 16 years over a three week period.
Tnaqqis tal- pressjoni tad- demm b' 0. 5 mg/ kg (baxx), 1. 5 mg/ kg (medju) u 4. 5 mg/ kg (għoli) livelli mixtieqa ddożati ta 'irbesartan kienu evalwati fi 318- il tifel u tifla u adoloxxent ta' bejn 6 u 16- il sena bi pressjoni għolja jew f' riskju (dijabete, storja ta 'pressjoni għolja fil- familja) fuq perjodu ta' tliet ġimgħat.
No significant difference was apparent between these doses.
L- ebda differenza sinifikanti ma kienet tidher bejn dawn id- dożi..
Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows:
Il- bidla medja aġġustata fil- pressjoni dijastolika fl- inqas livell tad- demm meħuda meta pazjent ikun bil- qiegħda (SeDBP) kienet kif ġej:
Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).
Fuq il- perjodu tal- ġimagħtejn ta 'wara fejn il- pazjenti ġew magħżulin b’ mod każwali mill - ġdid jew għal prodott mediċinali attiv jew għal plaċebo il- pazjenti fuq plaċebo kellhom żidiet ta' 2. 4 u 2. 0 mmHg fis- SeSBP u SeDBP meta mqabbla ma 'bidliet rispettivi ta' +0. 1 u 0. 3 mmHg f' dawk fuq id- dożi kollha ta 'irbesartan (ara sezzjoni 4. 2).
Hypertension and type 2 diabetes with renal disease The “ Irbesartan Diabetic Nephropathy Trial (IDNT )” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Pressjoni għolja u dijabete ta ’ tip 2 b’ mard renali Il - “ Prova Dijabete Nefropatika b’ Irbesartan (IDNT) ” juri li irbesartan inaqqas il- progressjoni tal- mard renali fil- pazjenti b’ insuffiċjenza renali kronika u bi protejnurja li tidher.
IDNT was a double blind, controlled, morbidity and mortality trial comparing irbesartan, amlodipine and placebo.
IDNT kienet prova double blind, b’ kontrolli, b’ morbożità u mortalità li qabblet Irbesartan Krka, amlodipine u plaċebo.
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/ day and serum creatinine ranging from 1.0-3.0 mg/ dl, the long-term effects (mean 2.6 years) of irbesartan on the progression of renal
F’ 1, 715- il pazjent bi pressjoni għolja u b’ dijabete ta ’ tip 2, protejnurja ≥ 900 mg/ jum u kreatinina fis- serum li tvarja minn 1. 0 - 3. 0 mg/ dl, ġew eżaminati l- effetti fit- tul (medja ta ’ 2. 6 snin) ta ’ Irbesartan Krkafuq l- avvanz ta ’ mard renali u l- kawżi kollha ta ’ mortalità.
Patients were titrated from 75 mg to a maintenance dose of 300 mg irbesartan, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Il- pazjenti ngħataw doża aġġustata minn 75 mg għal doża ta ’ manteniment ta ’ 300 mg ta ’ Irbesartan Krka, minn 2. 5 mg għal 10 mg ta ’ amlodipine, jew plaċebo skond kemm felħu.
Patients in all treatment groups typically received between 2 and 4 antihypertensive agents (e. g., diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/ 85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg.
Il- pazjenti fil- gruppi ta ’ kura kollha tipikament irċevew bejn 2 u 4 mediċini kontra l- pressjoni għolja (p. e. dijuretiċi, beta blockers, alpha blockers) biex laħqu l- livell imfassal minn qabel ta ’ pressjoni ta ’ ≤ 135/ 85 mmHg jew tnaqqis ta ’ 10 mmHg fil- pressjoni sistolika jekk il- linja bażi kienet > 160 mmHg.
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or allcause mortality.
Irbesartan b’ mod sinifikattiv naqqas ir- riskju relattiv fl- endpoint primarju kombinat fejn il- kreatinina fis- serum tirdoppja, mard renali fl- aħħar stadju (ESRD) jew mortalità mill- kawżi kollha.
Approximately 33% of patients in the irbesartan group reached the primary renal composite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20% relative risk reduction versus placebo (p = 0.024) and 23% relative risk reduction compared to amlodipine (p = 0.006)].
9 amlodipine [20% tnaqqis relattiv tar- riskju kontra l- plaċebo (p = 0. 024) u 23% tnaqqis relattiv tar- riskju mqabbel ma ’ amlodipine (p = 0. 006)].
When the individual components of the primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
Meta il- komponenti individwali ta ’ l- endpoint primarju ġew analiżżati, l- ebda effett fil- mortalità mill- kawżi kollha ma ġie osservat, fil- waqt li tendenza pożittiva fit - tnaqqis f’ ESRD u tnaqqis sinifikanti fil- kreatinina fis- serum milli tirdoppja ġew osservati.
Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect.
Sotto gruppi ta ’ sess, razza, età, tul tad- dijabete, il- linja bażi tal- pressjoni, kreatinina fis- serum, u rata ta ’ tneħħija t’ albumina ġew assessjati għall- effett tal- kura.
In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it.
Fis- sotto gruppi tan- nisa u ta 'dawk ta ’ razza sewda li rrappreżentaw 32% u 26% rispettivament tal- popolazzjoni kollha li ħadet sehem fl- istudju, ma deherx benefiċċju renali, għalkemm l- intervalli ta ’ kunfidenza ma jeskluduhx.
As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebo- based regimen.
Għall- endpoint sekondarju ta ’ każijiet kardjovaskulari fatali u mhux fatali, ma kienx hemm differenza bejn it- tliet gruppi tal- pazjenti fil- popolazzjoni totali, għalkemm inċidenza akbar ta ’ MI mhux fatali ġiet murija f’ nisa u inċidenza inqas ta ’ MI mhux fatali ġiet murija f’ irġiel fil- grupp t’ irbesartan kontra l- grupp ibbażat fuq il- plaċebo.
An increased incidence of non-fatal MI and stroke was seen in females in the irbesartan-based regimen versus the amlodipine-based regimen, while hospitalization due to heart failure was reduced in the overall population.
Kien hemm żieda fl- inċidenza ta ’ MI mhux fatali u puplesija f’ nisa fil- grupp bil - kura fuq l- irbesartan meta mqabbel mal- grupp bil- kura bbażata fuq amlodipine, waqt li l- ammissjoni fl - isptar minħabba kollass tal- qalb naqset fil- popolazzjoni kollha.
However, no proper explanation for these findings in women has been identified.
Madankollu, spjegazzjoni xierqa għal dawn ir- riżultati fin- nisa għadha ma ġietx identifikata.
The study of the “ Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2 Diabetes Mellitus (IRMA 2 )” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
L- istudju ta ’ “ L- effetti ta’ Irbesartan fuq il- Mikroalbuminurja f’ Pazjenti bi Pressjoni Għolja b’ Dijabete Mellitus ta ’ Tip 2 (IRMA) ”, juri li irbesartan 300 mg jittardja il- progressjoni għal protejnurja li tidher f’ pazjenti b’ mikroalbuminurja.
IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/ day) and normal renal function (serum creatinine ≤ 1.5 mg/ dl in males and < 1.1 mg/ dl in females).
IRMA 2 kien studju double blind ikkontrollat bil- plaċebo ta ’ morbożità li sar fuq 590 pazjent b’ dijabete ta ’ tip 2, mikroalbuminurja (30- 300 mg/ jum) u funzjoni renali normali (kreatinina fis- serum ≤ 1. 5 mg/ dl fl- irġiel u < 1. 1 mg/ dl fin- nisa).
The study examined the long-term effects (2 years) of irbesartan on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/ day, and an increase in UAER of at least 30% from baseline).
L- istudju eżamina l- effetti fit- tul (sentejn) ta ’ Irbesartan Krka fuq il- progressjoni għal protejnurja klinikali (li tidher) (ir- rata ta ’ tneħħija t’ albumina fl- urina (UAER) > 300 mg/ jum, u żjieda f’ UAER ta ’ l- inqas 30% mill- linja bażi).
While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Waqt li pressjoni simili ġiet milħuqa fil- gruppi kollha tal- kura, inqas individwi fil- grupp t’ irbesartan 300 mg (5. 2%) minn dawk bil- plaċebo (14. 9%) jew fil- grupp t’ irbesartan 150 mg (9. 7%) laħqu l- endpoint ta ’ protejnurja li tidher, li jfisser 70% ta ’ tnaqqis fir- risku relattiv meta mqabbel mal- plaċebo (p = 0. 0004) għal doża l- għolja.
The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period.
Id- dewmien fil- progressjoni għal protejnurja klinika kien evidenti kmieni sa minn tliet xhur u baqa ’ għal iktar minn perjodu ta ’ 2 snin.
Regression to normoalbuminuria (< 30 mg/ day) was more frequent in the irbesartan 300 mg group (34%) than in the placebo group (21%).
Rigressjoni għal albuminuria normali (< 30 mg/ jum) kienet iktar frekwenti fil- grupp ta ’ Irbesartan Krka 300 mg (34%) milli fil- grupp tal- plaċebo (21%).
After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Wara li jingħata mill- ħalq, irbesartan jiġi assorbit sew: studji ta ’ bijodisponibiltà assoluta wrew valuri ta ’ madwar 60% - 80%.
Concomitant food intake does not significantly influence the bioavailability of irbesartan.
It- teħid ta ’ l- ikel konkomitanti ma jaffettwax b’ mod sinifikkativ il- bijodisponibiltà t’ irbesartan.
Plasma protein binding is approximately 96%, with negligible binding to cellular blood components.
L- irbit mal- proteini tal- plażma kien madwar 96%, b’ irbit negliġibbli ma ’ komponenti 14 ċellulari tad- demm.
Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Wara l- għoti ta 'C irbesartan mill- ħalq jew ġol- vini, 80- 85% tar- radjuattività li tiċċirkola fil- plażma hi attribwita għal irbesartan mhux mibdul.
Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation.
Irbesartan jiġi metabolizzat bil- fwied permezz tal- konjugazzjoni ma ’ glucoronide u ta ’ ossidazjoni.
The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Il - metabolit l- iktar importanti li jiċċirkola huwa irbesartan glucuronide (madwar 6%).
9 Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Inqas minn żieda proporzjonali t’ assorbiment orali b’ dożi ’ il fuq minn 600 mg (id- doppju taddoża
Peak plasma concentrations are attained at 1.5-2 hours after oral administration.
L- ogħla konċentrazzjonijiet fil- plażma jintlaħqu wara 1. 5- 2 sigħat wara li jittieħed mill- ħalq.
The total body and renal clearance are 157-176 and 3-3.5 ml/ min, respectively.
It- tneħħija totali mill- ġisem u mill- kliewi huma ta ’ 157- 176 u 3- 3. 5 ml/ min, rispettivament.
Steady- state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.
Il- konċentrazzjonijiet fissi tal- plażma jintlaħqu wara 3 ijiem wara li tinbeda il- kura b’ doża ta ’ darba kuljum.
Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Akkumulazzjoni limitata t’ irbesartan (< 20%) giet osservata fil - plażma meta doża ta ’ darba kuljum kienet ripetuta.
In a study, somewhat higher plasma concentrations of irbesartan were observed in female hypertensive patients.
Fi studju, il- konċentrazzjoni tal- plażma t’ irbesartan ġiet osservata li kienet xi daqxejn ogħla f’ pazjenti nisa bi pressjoni għolja.
No dosage adjustment is necessary in female patients.
Mhemmx bżonn ta ’ aġġustament fid- doża f’ pazjenti nisa.
However the terminal halflife was not significantly altered.
Madankollu, il- half- life terminali ma tbiddlitx b’ mod sinifikattiv.
No dosage adjustment is necessary in elderly patients.
M’ hemmx bżonn aġġustament fid- doża f’ pazjenti anzjani.
Irbesartan and its metabolites are eliminated by both biliary and renal pathways.
14 Irbesartan u l- metaboliti tiegħu jiġu eliminati permezz ta ’ sistemi biljari u renali.
After either oral or IV administration of 14C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Wara l- għoti ta 'C irbesartan jew orali jew ġol- vini, madwar 20% tar- radjuattività tiġi eliminata ma ’ l- awrina u l - kumplament ma' l- ippurgar.
Less than 2% of the dose is excreted in the urine as unchanged irbesartan.
Inqas minn 2% tad- doża tiġi eliminata fl- awrina bħala irbesartan mhux mibdul.
The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/ kg) up to a maximum daily dose of 150 mg for four weeks.
Il- farmakokinetiċi ta 'irbesartan kienu evalwati fi 23 tifel u tifla bi pressjoni għolja wara l- għoti ta' doża waħda jew aktar kuljum ta 'irbesartan (2 mg/ kg) sa doża massima ta' kuljum ta '150 mg għal erba' ġimgħat.
Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults (twelve children over 12 years, nine children between 6 and 12 years).
Minn dawn it- 23 tifel u tifla, 21 setgħu jiġu evalwati għal taqbil ta 'farmakokinetiċi ma' adulti (tnax- il tifel u tifla 'l fuq minn 12- il sena, disat itfal ta' bejn 6 u 12- il sena).
There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Ma kienx hemm evidenza ta ’ tossiċità sistemika anormali jew tossiċità fl- organu bersalljat b’ dożi klinikament rilevanti.
At very high doses (≥ 500 mg/ kg/ day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
B’ dożi għoljin ħafna (≥ 500 mg/ kg/ jum) tibdil diġenerattiv fil- kliewi (bħal nefrite interstizjali, nefħa tubulari, tubi basofiliċi, żidiet fil- konċentrazjonijiet fil- plażma ta ’ l- urea u kreatinina) ġew stimulati b’ irbesartan f’ firien u f’ makakki u huma meqjusa bħala sekondarji għall- effetti ipotensivi tal- mediċina li kkaġunat tnaqqis fil- perfużjoni renali.
For therapeutic doses of irbesartan in humans, the hyperplasia/ hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Għal dożi terapewtiċi ta ’ irbesartan fil- bnedmin, ma jidhirx li l- iperplasja/ ipertrofija taċ- ċelluli renali ġukstaglomerulari għandha rilevanza.
Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Fil- fniek,
In rabbits, abortion or early resorption were noted at doses causing significant maternal toxicity, including mortality.
11 abort jew assorbiment kmieni mill- ġdid ta ’ l- embriju kienu nnotati b’ dożi li kkaġunaw tossiċità sinifikanti fl- omm, li inkludew mwiet.
No teratogenic effects were observed in the rat or rabbit.
Ma ġewx osservati effetti teratoġeniċi fil- far u fil- fenek
10 6.1 List of excipients
6. 1 Lista ta ’ sustanzi mhux attivi
Mannitol Hydroxypropylcellulose Low-substituted Hydroxypropyl Cellulose (LH-21) Low-substituted Hydroxypropyl Cellulose (LH-11) Talc Macrogol 6000 Castor oil, hydrogenated
Mannitol Hydroxypropylcellulose Low- substituted Hydroxypropyl Cellulose (LH- 21) Low- substituted Hydroxypropyl Cellulose (LH- 11) Talc Macrogol 6000 Hydrogenated, Castor Oil
Film coating:
Il- kisja tar- rita:
Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3000 Talc
Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3000 Talc
Store in the original package in order to protect from moisture.
Sabiex tilqa ’ mill- umdita ’.
Blister pack (PVC/ PE/ PVDC, Al-foil):
Pakett folja (fojl tal- PVC/ PE/ PVDC/ Aluminj):
14, 28, 56, 84 or 98 film-coated tablets in box are available.
14- il pillola, 28, 56, 84 jew 98 pillola miksija b’ rita f’ kaxxa huma disponibbli.
56 x 1 film-coated tablets in perforated unit dose blisters in box.
56 x 1 pillola ta ’ doża waħda miksija b’ rita ġo folji pperforati f’ kaxxa.
Any unused product or waste material should be disposed of in accordance with local requirements.
12 Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l - liġijiet lokali.
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS -
KRKA, d. d., Novo mesto, Š marješ ka cesta 6, 8501 Novo mesto, Slovenia
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo Mesto, Slovenia
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il- mediċini (EMEA) http: // www. emea. europa. eu /
Irbesartan Krka 150 mg film-coated tablets
Irbesartan Krka 150 mg pilloli miksijin b’ rita
Each film-coated tablet contains 150 mg irbesartan (as hydrochloride).
Kull pillola miksija b’ rita fiha 150 mg irbesartan (b ’ hydrochloride).
Mannitol content is below the threshold of the Excipient guideline's annex.
Kull pillola miksija b’ rita fiha 8mg castor oil Il- kontenut ta 'Mannitol huwa inqas minn dak stabbilit fl- Anness tal- Linja Gwida dwar Sustanzi Mhux Attivi.
4.3 Posology and method of administration
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
No dosage adjustment is necessary in patients with impaired renal function.
M’ hemmx bżonn ta 'aġġustament tad- doża f’ pazjenti b’ indeboliment renali.
Hepatic impairment:
14 Indeboliment epatiku:
12 Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Pazjenti AnzjaniGħalkemm għanda tingħata konsiderazzjoni meta tinbeda l’ kura b’ 75mg f’ pazjenti minn 75 sena, m’ hemmx bżonn ta 'aġġustament tad- doża f ’ dawn il- pazjenti.
The combination of lithium and Irbesartan Krka is not recommended (see section 4.5).
It- teħid ta 'litju u Irbesartan Krka fliemkin mhuwiex rakkomandat (ara sezzjoni 4. 5).
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
15 Stenosi tal- valv aortiku u mitrali, kardjomijopatija ipertrofika ostruttiva:
13 In patients whose vascular tone and renal function depend predominantly on the activity of the renin- angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.
F’ pazjenti li għandhom it- ton vaskulari u l- funzjoni renali tagħhom jiddependu l- aktar mill- attività tas - sistema renin- angiotesin- aldosterone (p. e. pazjenti li jbatu minn insuffiċjenza tal- qalb konġestiva jew mard renali, inkluż stenosi ta ’ l- arterja renali), il- kura b’ inibituri ta ’ enzimi li jikkonvertu angiotensin jew antagonisti tar- riċetturi t ’ angiotensin- II li jaffettwaw din is- sistema ġew assoċjati ma ’ pressjoni baxxa akuta, ażotemja, oligurja, jew rarament insuffiċjenza akuta renali.
Based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e. g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Ibbażat fuq l- esperjenza bl- użu ta ’ prodotti mediċinali oħra li jaffettwaw lis- sistema ta ’ renin- angiotensin, l- użu konkomitanti ta ’ dijuretiċi li ma jnixxux il- potassju, supplimenti tal- potassium, sostituti tal- melħ li fihom il- potassium jew prodotti mediċinali oħra li jżidu l- livelli tal- potassium fis- serum (eż. ħeparina) jistgħu jwasslu għal żidiet tal- potassium fis- serum u, għalhekk, mhumiex irrikmandati (ara sezzjoni 4. 4).
Lithium:
16 Lithium:
14 consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Il - pazjenti għandhom ikunu idrati biżżejjed u għandha tingħata kunsiderazzjoni għall- monitoraġġ tal - funzjoni renali wara li tinbeda kura konkomitanti, u kull ċertu żmien wara.
It is not known whether irbesartan is excreted in human milk.
17 jitneħħiex fil- ħalib uman.
15 In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i. e., uncommon) but in excess of placebo.
F’ pazjenti dijabetiċi bi pressjoni għolja b’ mikroalbuminurja u funzjoni normali tal- kliewi, sturdament ortostatiku u pressjoni baxxa ortostatika ġew irrapportati f’ 0. 5% tal- pazjenti (jiġifieri mhux komuni) iżda iżjed milli fil- grupp tal- plaċebo.
None of these increases were associated with identifiable clinical musculoskeletal events.
L- ebda żidiet minn dawn ma ġew assoċjati ma ’ episodji muskolu- skeletriċi li jistgħu jiġu identifikati klinikament.
In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
F’ 1. 7% tal - pazjenti bi pressjoni għolja b’ mard dijabetiku avanzat renali kkurati b’ irbesartan, kien osservat tnaqqis fl- emoglobina *, li ma kienx klinikament sinifikanti.
Cardiac disorders:
18 Disturbi fil- qalb:
16 Reproductive system and breast disorders:
Disturbi fis- sistema riproduttiva u fis- sider:
Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle Cramps
Artralġja, uġigħ fil- muskoli (f' xi każijiet assoċjati ma 'livelli miżjuda creatine kinase fil- plażma), bugħawwieġ fil- muskoli
Hyperkalaemia
19 Iperkalimja
17 Pharmacotherapeutic group: angiotensin II antagonist, plain, ATC code:
Kodiċi ATC:
Peak reduction of blood pressure is achieved within 3-6 hours after administration and the blood pressure lowering effect is maintained for at least 24 hours.
L- ogħla tnaqqis fil- pressjoni jseħħ fi żmien 3- 6 sigħat wara li jingħata u l- effett tat- tnaqqis tal- pressjoni jinżamm mill- inqas għal 24 siegħa.
Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice daily dosing on the same total dose.
20 Doża darba kuljum ta ’ 150 mg tat respons baxx u medju fuq 24 siegħa simili għal doża doppja ta ’ kuljum fuq l- istess doża totali.
Approximately 33% of patients in the irbesartan group reached the primary renal composite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20% relative risk reduction versus placebo (p = 0.024) and 23% relative risk reduction compared to amlodipine (p = 0.006)].
Madwar 33% tal- pazjenti fil- grupp t’ irbesartan laħqu l- endpoint primarju renali kompost mqabbel ma ’ 39% u 41% fil- gruppi tal- plaċebo u amlodipine [20% tnaqqis relattiv tar- riskju kontra l- plaċebo (p = 0. 024) u 23% tnaqqis relattiv tar- riskju mqabbel ma ’ amlodipine (p = 0. 006)].
When the individual components of the primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
21 tnaqqis f’ ESRD u tnaqqis sinifikanti fil- kreatinina fis- serum milli tirdoppja ġew osservati.
19 Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Inqas minn żieda proporzjonali t’ assorbiment orali b’ dożi ’ il fuq minn 600 mg (id- doppju taddoża massima rrikmandata) ġie osservat; Il- mekkaniżmu għal dan għadu mhux magħruf.
The terminal elimination half-life of irbesartan is 11-15 hours.
Il- half- life t’ eliminazzjoni
Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Studji fuq annimali b’ irbesartan urew effetti tossiċi li jgħaddu (żieda fil- formazzjoni tal- kavitajiet fil- pelvi renali, idroureter, jew edema ta ’ taħt il- ġilda) fil- feti tal- firien, li ġew riżolti wara it- twelid.
In rabbits, abortion or early resorption were noted at doses causing significant maternal toxicity, including mortality.
Fil- fniek, abort jew assorbiment kmieni mill- ġdid ta ’ l- embriju kienu nnotati b’ dożi li kkaġunaw tossiċità sinifikanti fl- omm, li inkludew mwiet.
20 Tablet core:
Il- qalba tal- pillola:
Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3000 Talc
Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3000 Talc 6. 2 Inkompatibilitajiet
6.2 Incompatibilities
Ma jgħoddx f’ dan il- każ.
Not applicable.
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
6.6 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l - liġijiet lokali.
KRKA, d. d., Novo mesto, Š marješ ka cesta 6, 8501 Novo mesto, Slovenia
24 KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo Mesto, Slovenia
Irbesartan Krka 300 mg film-coated tablets
Irbesartan Krka 300 mg pilloli miksijin b’ rita
Each film-coated tablet contains 300 mg irbesartan (as hydrochloride).
Kull pillola miksija b’ rita fiha 300 mg irbesartan (b ’ hydrochloride).
Mannitol content is below the threshold of the Excipient guideline's annex.
Kull pillola miksija b’ rita fiha 16mg castor oil Il- kontenut ta 'Mannitol huwa inqas minn dak stabbilit fl- Anness tal- Linja Gwida dwar Sustanzi Mhux Attivi.
4.4 Posology and method of administration
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
Hepatic impairment:
26 Indeboliment epatiku:
22 Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Pazjenti AnzjaniGħalkemm għanda tingħata konsiderazzjoni meta tinbeda l’ kura b’ 75mg f’ pazjenti minn 75 sena, m’ hemmx bżonn ta 'aġġustament tad- doża f ’ dawn il- pazjenti.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
27 Stenosi tal- valv aortiku u mitrali, kardjomijopatija ipertrofika ostruttiva:
23 In patients whose vascular tone and renal function depend predominantly on the activity of the renin- angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.
F’ pazjenti li għandhom it- ton vaskulari u l- funzjoni renali tagħhom jiddependu l- aktar mill- attività tas - sistema renin- angiotesin- aldosterone (p. e. pazjenti li jbatu minn insuffiċjenza tal- qalb konġestiva jew mard renali, inkluż stenosi ta ’ l- arterja renali), il- kura b’ inibituri ta ’ enzimi li jikkonvertu angiotensin jew antagonisti tar- riċetturi t ’ angiotensin- II li jaffettwaw din is- sistema ġew assoċjati ma ’ pressjoni baxxa akuta, ażotemja, oligurja, jew rarament insuffiċjenza akuta renali.
Lithium:
28 Lithium:
24 consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Il - pazjenti għandhom ikunu idrati biżżejjed u għandha tingħata kunsiderazzjoni għall- monitoraġġ tal - funzjoni renali wara li tinbeda kura konkomitanti, u kull ċertu żmien wara.
It is not known whether irbesartan is excreted in human milk.
29 jitneħħiex fil- ħalib uman.
4.10 Undesirable effects
4. 8 Effetti mhux mixtieqa
25 In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i. e., uncommon) but in excess of placebo.
F’ pazjenti dijabetiċi bi pressjoni għolja b’ mikroalbuminurja u funzjoni normali tal- kliewi, sturdament ortostatiku u pressjoni baxxa ortostatika ġew irrapportati f’ 0. 5% tal- pazjenti (jiġifieri mhux komuni) iżda iżjed milli fil- grupp tal- plaċebo.
Cardiac disorders:
30 Disturbi fil- qalb:
26 Reproductive system and breast disorders:
Disturbi fis- sistema riproduttiva u fis- sider:
Hyperkalaemia
31 Iperkalimja
27 Pharmacotherapeutic group: angiotensin II antagonist, plain, ATC code:
Kodiċi ATC:
Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice daily dosing on the same total dose.
32 Doża darba kuljum ta ’ 150 mg tat respons baxx u medju fuq 24 siegħa simili għal doża doppja ta ’ kuljum fuq l- istess doża totali.
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/ day and serum creatinine ranging
F’ 1, 715- il pazjent bi pressjoni għolja u b’ dijabete ta ’ tip 2, protejnurja ≥ 900 mg/ jum u kreatinina fis- serum li tvarja minn 1. 0 - 3. 0 mg/ dl, ġew eżaminati l- effetti fit- tul (medja ta ’ 2. 6 snin) ta ’ Irbesartan Krkafuq l- avvanz ta ’ mard renali u l- kawżi kollha ta ’ mortalità.
When the individual components of the primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.
33 tnaqqis f’ ESRD u tnaqqis sinifikanti fil- kreatinina fis- serum milli tirdoppja ġew osservati.
In vitro studies indicate that
Studji in vitro indikaw li irbesartan huwa primarjament ossidat bl- enzima cytochrome P450 CYP2C9; l- isoenzima CYP3A4 għandha effett negliġibli.
29 irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
Irbesartan jesibixxi farmakokinetika lineari u proporzjonata tad- doża fuq il- firxa mad- doża ta ’ 10 sa 600 mg.
Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Inqas minn żieda proporzjonali t’ assorbiment orali b’ dożi ’ il fuq minn 600 mg (id- doppju taddoża massima rrikmandata) ġie osservat; Il- mekkaniżmu għal dan għadu mhux magħruf.
30 6.
35 6.
Mannitol Hydroxypropylcellulose Low-substituted Hydroxypropyl Cellulose (LH-21) Low-substituted Hydroxypropyl Cellulose (LH-11) Talc Macrogol 6000 Castor oil, hydrogenated
Mannitol Hydroxypropylcellulose Low- substituted Hydroxypropyl Cellulose (LH- 21) Low- substituted Hydroxypropyl Cellulose (LH- 11) Talc Macrogol 6000 Hydrogenated, Castor Oil Il- kisja tar- rita:
6.7 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
14, 28, 56, 56x1, 84 or 98 film-coated tablets in box are available.
14- il pillola, 28, 56, 84 jew 98 pillola miksija b’ rita f’ kaxxa huma disponibbli.
32 ANNEX II
37 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR (I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Krka, d. d., Novo mesto Š marješ ka cesta 6 8501 Novo mesto Slovenia
KRKA, d. d., Novo mesto Šmarješka cesta 6 8501 Novo Mesto Slovenia
The MAH must ensure that the system of pharmacovigilance, as described in version DescPhSys000001/ 4 dated 12/ 12/ 2006– Updated:
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta 'farmakoviġilanza, kif deskritta fil- verżjoni DescPhSys000001/ 4 iddatata 12/ 12/ 2006 – Aġġornata:
24/ 09/ 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
24/ 09/ 2007 ippreżentata f' Modulu 1. 8. 1. tal- Applikazzjoni dwar l- Awtorizzazzjoni għat- Tqegħid fis- Suq, qegħda f' postha u kienet qed taħdem qabel u waqt li l- prodott jinsab fis- suq.
The PSUR submission schedule for Irbesartan Krka film-coated tablets should follow the PSUR schedule for the reference medicinal product.
L- iskeda ta 'sottomissjoni dwar Ir- Rapport Aġġornat dwar is- Sigurtà tal- Prodott (PSUR) għal pilloli miksija b' rita ta' Irbesartan Krka għandhom isegwu l- iskeda ta 'PSUR għar- referenza dwar il- prodott mediċinali.
34 ANNEX III
39 ANNESS III
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
41 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOLDING BOX
KAXXA TAL_ KARTUN LI TINTEWA
Irbesartan Krka 75 mg film-coated tablets Irbesartan
Irbesartan Krka 75 mg pilloli miksija b’ rita irbesartan
Each film-coated tablet contains 75 mg irbesartan (as hydrochloride)
Kull pillola miksija b’ ritafiha: irbesartan 75 mg
Contains castor oil.
Għandu castor oil.
See package leaflet for further information.
Ara fuljett għal- aktar informazzjoni ta’ tagħrif.
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 56x1 film-coated tablets 84 film-coated tablets 98 film-coated tablets
14- il pillola miksija b’ rita 28 pillola miksija b’ rita 56 pillola miksija b’ rita 56 x 1 pillola miksija b’ rita 84 pillola miksija b’ rita 98 pillola
38 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
PVC/ PE/ PVDC, Al-foil
{NATURA/ TIP}
Irbesartan Krka 75 mg film-coated tablets Irbesartan
Irbesartan Krka 75 mg pilloli miksijin b’ rita irbesartan
Batch
43 Lott
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
44 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Irbesartan Krka 150 mg film-coated tablets Irbesartan
Irbesartan Krka 150 mg pilloli miksija b’ rita irbesartan
Each film-coated tablet contains 150 mg irbesartan (as hydrochloride)
Kull pillola miksija b’ ritafiha: irbesartan 150 mg
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 56x1 film-coated tablets 84 film-coated tablets 98 film-coated tablets
14- il pillola 28 pillola miksija b’ rita 56 pillola miksija b’ rita 56 x 1 pillola miksija b’ rita 84 pillola miksija b’ rita 98 pillola miksija b’ rita
41 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Irbesartan Krka 150 mg film-coated tablets Irbesartan
Irbesartan Krka 150 mg pilloli miksijin b’ rita irbesartan
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Irbesartan Krka 300 mg film-coated tablets Irbesartan
Irbesartan Krka 300 mg pilloli miksija b’ rita irbesartan
Each film-coated tablet contains 300 mg irbesartan (as hydrochloride)
Kull pillola miksija b’ ritafiha: irbesartan 300 mg
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 56x1 film-coated tablets 84 film-coated tablets 98 film-coated tablets
14- il pillola miksija b’ rita 28 pillola miksija b’ rita 56 pillola miksija b’ rita 56 x 1 pillola miksija b’ rita 84 pillola miksija b’ rita 98 pillola miksija b’ rita
44 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
49 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Irbesartan Krka 300 mg film-coated tablets Irbesartan
Irbesartan Krka 300 mg pilloli miksijin b’ rita irbesartan
46 PACKAGE LEAFLET:
51 FULJETT TA 'TAGĦRIF:
Irbesartan Krka 75 mg film-coated tablets Irbesartan
Irbesartan Krka 75 mg pilloli irbesartan
It may harm them, even if
Tista 'tagħmlilhom il -
their symptoms are the same as yours.
ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek
What Irbesartan Krka is and what it is used for 2.
X' inhu irbesartan Krka u għalxiex jintuża 2.
Before you take Irbesartan Krka 3.
Qabel ma tieħu Irbesartan Krka 3.
How to take Irbesartan Krka 4.
Kif għandek tieħu Irbesartan Krka 4.
How to store Irbesartan Krka 6.
Kif taħżen Irbesartan Krka 6.
WHAT IRBESARTAN KRKA IS AND WHAT IT IS USED FOR
X' INHU IRBESARTAN KRKA U GĦALXIEX JINTUŻA
Irbesartan Krka belongs to a group of medicines known as angiotensin-II receptor antagonists.
Irbesartan Krka jappartjeni għall- grupp ta ’ mediċini magħrufa bħala antagonisti tar- riċetturi angiotensin - II.
Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten.
Angiontensin- II hija sustanza maħduma fil- ġisem li tintrabat ma ’ riċetturi fil- vini u ġġiegħelhom jibbiesu.
Irbesartan Krka prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Irbesartan Krka jipprevjeni li angiotensin- II jintrabat ma ’ dawn ir- riċetturi, u jwassal il- vini tad- demm biex jirrilassaw u b’ hekk il- pressjoni tinżel.
Irbesartan Krka slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Krka inaqqas ir- rata tat- tnaqqis tal- funzjoni tal- kliewi f’ pazjenti bi pressjoni għolja u b’ dijabete ta 'tip 2.
Irbesartan Krka is used in the treatment of high blood pressure (hypertension) and for the protection of the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function.
Irbesartan Krka jintuża fil- kura għall- pressjoni għolja tad- demm (pressjoni għolja) u għall- protezzjoni tal - kliewi f’ pazjenti dijabete ta 'tip 2 bi pressjoni għolja b’ evidenza mit- testijiet tal- laboratorju ta ’ indeboliment fil- funzjoni renali.
BEFORE YOU TAKE IRBESARTAN KRKA
QABEL MA TIEĦU IRBESARTAN KRKA
Do not take Irbesartan Krka
Tiħux Irbesartan Krka
- if you are allergic (hypersensitive) to irbesartan or any of the other ingredients of Irbesartan
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal irbesartan jew sustanzi oħra ta '
- if you are in the last six months of pregnancy (see section Pregnancy and breastfeeding),
Irbesartan Krka jekk inti fl- aħħar sitt xhur ta ’ tqala (ara s- sezzjoni Tqala u Treddigħ),
- if you are breast-feeding.
- jekk qed tredda ’
Irbesartan Krka should not be given to children and adolescents (< 18 years)
Irbesartan Krka m’ għandux jingħata lit- tfal u adoloxxenti (< 18- il sena).
Take special care with Irbesartan Krka
Oqgħod attent ħafna b' Irbesartan Krka
- if you have excessive vomiting or diarrhoea,
- jekk tbati minn rimettar jew dijarea eċċessiva
- if you have heart problems,
- jekk tbati minn problemi tal- qalb
- if you have kidney problems or are receiving Irbesartan Krka for diabetic kidney disease.
- jekk tbati minn problemi fil- kliewi jew jekk tirċievi Irbesartan Krka
In the
F' dan il- każ, it- tabib tiegħek jista ’ jagħmel testijiet regolari tad -
latter case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function,
52 demm, speċjalment biex ikejjel il- livelli tal- potassium fid- demm f’ każ li l- funzjoni tal- kliewi tkun batuta.
- if you are to undergo any surgery or receive anaesthetics, you should also tell your doctor that
- jekk għandek tagħmel xi tip ta 'kirurġija jew tirċievi xi loppju, għandek tgħid lit- tabib tiegħek
you are taking Irbesartan Krka.
dwar dan ukoll
47 You must tell your doctor if you think that you are (or might become) pregnant.
Għandhekk tgħid lit- tabib jekk inti tqila jew taħseb li tista tigi tqila.
Irbesartan Krka 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 Krka mhux irrakmandat fil- bidu ta ’ tqala u jista jikawza ħsara serja lit- tarbija wara tlett xhur tqala (ara s- sezzjoni Tqala u Treddigħ).
Irbesartan Krka does not usually interact with other medicines.
Irbesartan Krka ma jimpedixix ma ’ mediċini oħra Generalment, Irbesartan Krka ma għandux effetti ma ’ mediċini oħra.
Blood tests may be neccessary if you take:
Testijiet tad- demm għandhom ikunu xierqa jekk int qed tieħu
- potassium supplements,
- supplimenti tal- potassium,
- potassium-containing salt substitutes,
- sostituti tal- melħ li fihom il- potassium,
- potassium-sparing medicines that increase the amount of urine (diuretics) or
- mediċini li ma jnixxux l- potassju (bħal ċertu dijuretiċi) jew
- lithium-containing medicines.
- mediċini li fihom il- lithium.