qanastek/EMEA-V3 huggingface dataset:
EU/ 1/ 08/ 491/ 060 EU/ 1/ 08/ 491/ 061 EU/ 1/ 08/ 491/ 062 EU/ 1/ 08/ 491/ 063 EU/ 1/ 08/ 491/ 064 EU/ 1/ 08/ 491/ 065 EU/ 1/ 08/ 491/ 066 EU/ 1/ 08/ 491/ 067 EU/ 1/ 08/ 491/ 068 EU/ 1/ 08/ 491/ 069 EU/ 1/ 08/ 491/ 070 EU/ 1/ 08/ 491/ 071 EU/ 1/ 08/ 491/ 072
EU/ 1/ 08/ 491/ 067 EU/ 1/ 08/ 491/ 068 EU/ 1/ 08/ 491/ 069 EU/ 1/ 08/ 491/ 070 EU/ 1/ 08/ 491/ 071 EU/ 1/ 08/ 491/ 072 EU/ 1/ 08/ 491/ 073 EU/ 1/ 08/ 491/ 074 EU/ 1/ 08/ 491/ 075
Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT
Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT
300 mg / 12.5 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg
300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (PCTFE/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PA/ Al/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC)
folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PA/ Al/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC)
280 tablets (multipack) 7 tablets 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 90 tablets (multipack) 98 tablets (multipack) 280 tablets (multipack) 7 tablets 14 tablets 28 tablets
90 pillola (b’ ħafna folji) 98 pillola (b’ ħafna folji) 280 pillola (b’ ħafna folji) 7 pilloli 14- il pillola 28 pillola 30 pillola 50 pillola 56 pillola
2/ 3 EU/ 1/ 08/ 491/ 073 EU/ 1/ 08/ 491/ 074 EU/ 1/ 08/ 491/ 075 EU/ 1/ 08/ 491/ 076 EU/ 1/ 08/ 491/ 077 EU/ 1/ 08/ 491/ 078 EU/ 1/ 08/ 491/ 079
2/ 3 EU/ 1/ 08/ 491/ 076 EU/ 1/ 08/ 491/ 077 EU/ 1/ 08/ 491/ 078 EU/ 1/ 08/ 491/ 079 EU/ 1/ 08/ 491/ 080
Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT
Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT Rasilez HCT
300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg
300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg 300 mg / 25 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali
blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC) blister (PCTFE/ PVC)
folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC) folja (PCTFE/ PVC)
280 tablets (multipack)
56 x 1 pillola 90 pillola 98 pillola 98 x 1 pillola (b’ ħafna folji) 280 pillola (b’ ħafna folji)
Rasilez HCT 150 mg/ 12.5 mg film-coated tablets
Rasilez HCT 150 mg/ 12. 5 mg pilloli miksijin b’ rita
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide.
Kull pillola miksija b’ rita fiha 150 mg aliskiren (bħala hemifumarate) u 12. 5 mg hydrochlorothiazide.
Each tablet contains 25 mg lactose monohydrate and 24.5 mg wheat starch.
Kull pillola fiha 25 mg lactose monohydrate u 24. 5 mg wheat starch.
White, biconvex, ovaloid film-coated tablet imprinted with “ LCI” on one side and “ NVR” on the other.
Pillola bajda, konvessa miż- żewġ naħat, b’ għamla ovali miksija b’ rita stampata b ’ “ LCI ” fuq naħa u “ NVR ” fuq l- oħra.
Treatment of essential hypertension in adults.
Għall- kura ta ’ pressjoni għolja naturali f’ adulti.
Rasilez HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.
Rasilez HCT huwa indikat f’ pazjenti li jkollhom pressjoni tad- demm li ma tkunx qed tiġi ikkontrollata sew b’ aliskiren jew hydrochlorothiazide użati waħidhom.
Rasilez HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.
Rasilez HCT huwa indikat bħala terapija ta ’ sostituzzjoni f’ pazjenti li jkunu kontrollati sew b’ aliskiren u hydrochlorothiazide, mogħtija flimkien, bl- istess livell ta ’ doża tat- taħlita.
The recommended dose of Rasilez HCT is one tablet per day.
Id- doża irrikkmandata ta ’ Rasilez HCT hija pillola waħda kuljum.
Rasilez HCT should be taken with a light meal once a day, preferably at the same time each day.
Rasilez HCT għandu jittieħed ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin tal- ġurnata.
Grapefruit juice should not be taken together with Rasilez HCT.
Il- meraq tal- grejpfrut m’ għandux jittieħed flimkien ma ’ Rasilez HCT.
The antihypertensive effect is largely manifested within 1 week and the maximum effect is generally seen within 4 weeks.
L- effett kontra l- pressjoni għolja jidher l- aktar fi żmien ġimgħa u l- akbar effett ġeneralment jidher fi żmien 4 ġimgħat.
Posology in patients not adequately controlled with aliskiren or hydrochlorothiazide monotherapy Individual dose titration with each of the two components may be recommended before changing to the fixed combination.
Pożoloġija f’ pazjenti li ma jkunux ikkontrollati sew b’ monoterapija ta ’ aliskeren jew hydrochlorothiazide Jista ’ jkun irrikkmandat li d- doża taż- żewġ komponenti individwali tiġi miżjuda bil- mod b’ mod individwali qabel ma ’ jkunu maqluba għat- taħlita fissa.
When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Meta jkun xieraq fis- sens kliniku, bidla diretta mill- monoterapija għat- taħlita fissa tista ’ tiġi ikkunsidrata.
Rasilez HCT 150 mg / 12.5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or hydrochlorothiazide 12.5 mg alone.
Rasilez HCT 150 mg/ 12. 5 mg jista ’ jingħata f’ pazjenti li jkollhom il- pressjoni tad- demm li ma tkunx ikkontrollata kif jixraq b’ aliskiren 150 mg jew hydrochlorothiazide 12. 5 mg waħidhom.
If blood pressure remains uncontrolled after 2-4 weeks of therapy, the dose may be titrated up to a maximum of Rasilez HCT 300 mg/ 25 mg daily.
Jekk il- pressjoni tibqa ’ ma tkunx ikkontrollata wara 2- 4 ġimgħat ta ’ kura, d- doża tista ’ tiġi titrata sa massimu ta ’ Rasilez HCT 300 mg/ 25 mg kuljum.
Dosing should be individualised and adjusted according to the patient’ s clinical response.
Id- dożar għandu jkun individwalizzat u aġġustat skond ir- rispons kliniku tal- pazjent.
2 Posology as substitution therapy For convenience, patients receiving aliskiren and hydrochlorothiazide from separate tablets may be switched to a fixed combination tablet of Rasilez HCT containing the same component doses.
2 Pożoloġija bħala terapija ta ’ sostituzzjoni Għall- konvenjenza, pazjenti li jkunu qed jirċievu aliskiren u hydrochlorothiazide minn pilloli separati jistgħu jinqalbu għall- pillola ta ’ taħlita fissa ta ’ Rasilez HCT li fiha l- istess dożi tal- komponenti.
Renal impairment No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.4 and 5.2).
Indeboliment renali M’ hemmx bżonn li jkun hemm aġġustamenti tad- doża tal- bidu għall- pazjenti li jkollhom indeboliment renali ħafif għal moderat (ara sezzjonijiet 4. 4 u 5. 2).
Due to the hydrochlorothiazide component, Rasilez HCT is contraindicated for use in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/ min/ 1.73 m2) (see sections 4.3 and 5.2).
Minħabba l- komponent hydrochlorothiazide, Rasilez HCT huwa kontra- indikat għall- użu f’ pazjenti b’ indeboliment renali sever (rata tal- filtrazzjoni fil- glomeruli (GFR) < 30 ml/ min/ 1. 73 m2) (ara sezzjonijiet 4. 3 u 5. 2).
Hepatic impairment Thiazides should be used with caution in patients with impaired hepatic function.
Indeboliment epatiku Thiazides għandhom jintużaw b’ kawtela f’ pazjenti b’ funzjoni epatika indebolita.
No adjustment of the initial dose is required for patients with mild to moderate hepatic impairment (see section 5.2).
Mhux meħtieġ li jkun hemm aġġustar tad- doża f’ pazjenti b’ indeboliment epatiku ħafif għal moderat (ara sezzjoni 5. 2).
Due to the hydrochlorothiazide component, Rasilez HCT is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Minħabba l- komponent hydrochlorothiazide, Rasilez HCT huwa kontra- indikat f’ pazjenti b’ indeboliment epatiku sever (ara sezzjonijiet 4. 3 u 4. 4).
Elderly patients (over 65 years) No adjustment of the initial dose is required in elderly patients.
Pazjenti anzjani (minn 65 sena ’ l fuq) M’ hemmx bżonn ta ’ tibdil fid- doża tal- bidu għal pazjenti anzjani.
Paediatric patients Rasilez HCT is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Pazjenti pedjatriċi Rasilez HCT mhux irrakkomandat għall- użu fit- tfal u adolexxenti taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
− Hypersensitivity to the active substances or to any of the excipients (see section 6.1), or to other sulphonamide-derived substances. − History of angioedema with aliskiren. − Second and third trimesters of pregnancy, lactation (see section 4.6). − Severe renal impairment (GFR < 30 ml/ min/ 1.73 m2). − Refractory hypokalaemia, hypercalcaemia. − Severe hepatic impairment. − The concomitant use of aliskiren with ciclosporin, a highly potent P-glycoprotein (P-gp) inhibitor, and other potent P-gp inhibitors (quinidine, verapamil), is contraindicated (see section 4.5).
Indeboliment renali sever (GFR < 30 ml/ min/ 1. 73 m2). − − Ipokalimja rifrettorja, iperkalċimja. − Indeboliment epatiku sever. − L- użu konkomittanti ta ’ aliskiren ma ’ ciclosporin, inibitur ta ’ P- glycoprotein (P- gp) qawwi ħafna, u inibituri ta ’ P- gp qawwija oħrajn (quinidine, verapamil), huwa kontra- indikat (ara sezzjoni 4. 5).
Heart failure Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association (NYHA) functional class III-IV).
Insuffiċjenza tal- qalb Aliskiren għandu jintuża b’ attenzjoni f’ pazjenti b’ insuffiċjenza tal- qalb konġestiva serja (klassi funzjonali III- IV tal- Assoċjazzjoni Tal- Qalb ta ’ New York (NYHA)).
Rasilez HCT should be used with caution in patients with heart failure due to limited clinical efficacy and safety data.
Rasilez HCT għandu jintuża b’ attenzjoni f’ pazjenti b’ insuffiċjenza tal- qalb minħabba tagħrif limitat dwar l- effikaċja klinika u s - sigurtà.
Angioedema As with other agents acting on the renin -angiotensin system, angioedema has been reported in patients treated with aliskiren.
Anġjoedima Bħal b’ sustanzi oħra li jaħdmu fuq is- sistema tar- renin – angiotensin, anġjoedima kienet irrappurtata f’ pazjenti kkurati b’ aliskiren.
If angioedema occurs, Rasilez HCT should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Jekk anġjoedima sseħħ, Rasilez HCT għandu jitwaqqaf mill- ewwel u kura xierqa u monitoraġġ għandhom jiġu pprovduti sakemm is- sinjali u s- sintomi jfiequ għalkollox u ma jerġawx ifiġġu.
Where there is involvement of the tongue, glottis or larynx adrenaline should be administered.
Fejn ikun involut l- ilsien, il- glottide jew il- laringi għandha tingħata l- adrenalina.
In addition, measures necessary to ensure patient airways should be provided.
Flimkien ma ’ dan, għandhom jiġu pprovduti l- miżuri meħtieġa biex il- passaġġi tan- nifs tal- pazjent jinżammu miftuħa.
Intravascular volume depletion Symptomatic hypotension may occur in patients who are volume and/ or sodium depleted as a result of vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
3 Tnaqqis tal- volum intravaskulari Ipotensjoni sintomatika tista ’ sseħħ f’ pazjenti li jkollhom nuqqas tal- volum u/ jew sodium b’ konsegwenza ta ’ terapija vigoruża b’ dijuretiċi, restrizzjoni tal- melħ mill- ikel, dijarea jew rimettar.
Such conditions should be corrected before the administration of Rasilez HCT.
Dawn il- kundizzjonijiet għandhom jiġu irranġati qabel ma jingħata Rasilez HCT.
3 Electrolyte imbalance As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Żbilanċ tal- elettroliti Bħal ma jsir għal kull pazjent li jkun qed jirċievi terapija dijuretika, determinazzjoni perjodika tal - elettroliti fis- serum għandha titwettaq f’ intervalli xierqa.
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (including hypokalaemia, hyponatraemia and hypochloraemic alkalosis).
Thiazides, inkluż hydrochlorothiazide, jista ’ jikkawża żbilanċ tal- fluwidi jew tal- elettroliti (inkluż ipokalimja, iponatrimja u alkalożi ipoklorimika).
Warning signs of fluid or electrolyte imbalance are dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting (see section 4.8).
Sinjali ta ’ twissija ta ’ żbilanċ fil- fluwidi jew l- elettroliti huma ħalq xott, għatx, dgħjufija, tħeddil, ngħas, irrikwietazzjoni, uġigħ fil- muskoli jew bugħawwieġ, għeja muskolari, pressjoni baxxa, oligurja, takikardija u disturbi gastro- intestinali bħal dardir jew rimettar (ara sezzjoni 4. 8).
Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with aliskiren may reduce diuretic-induced hypokalaemia.
Għalkemm l- ipokalimja tista ’ tiżviluppa bl- użu ta ’ dijuretiċi thiazide, terapija fl- istess waqt b’ aliskiren tista ’ tnaqqas l- ipokalimja ikkawżata mid- dijuretiċi.
The risk of hypokalaemia is greater in patients with cirrhosis of the liver, patients experiencing brisk diuresis, patients with inadequate oral electrolyte intake and patients receiving concomitant therapy with corticosteroids or adrenocorticotropic hormone (ACTH) (see sections 4.5 and 4.8).
Ir- riskju ta ’ ipokalimja huwa akbar f’ pazjenti b’ ċirrożi tal- fwied, pazjenti li jkunu qed jingħataw dijureżi mgħaġġla, pazjenti li ma jkunux qed jieħdu ammont xieraq ta ’ elettroliti u pazjenti li jkunu qed jirċievu terapija fl- istess ħin b’ kortikosterojdi jew ormon adreno- kortikotropiku (ACTH) (ara sezzjonijiet 4. 5 u 4. 8).
Conversely, due to the aliskiren component of Rasilez HCT, hyperkalaemia might occur.
Minn- naħa l- oħra, minħabba l- komponent aliskiren ta ’ Rasilez HCT, iperkalimja tista ’ sseħħ.
Although clinically significant hyperkalaemia has not been documented with Rasilez HCT, risk factors for the development of hyperkalaemia include renal insufficiency and/ or heart failure, and diabetes mellitus.
Għalkemm iperkalimja klinikament sinifikanti ma kienetx dokumentata b’ Rasilez HCT, il- fatturi ta ’ riskju għall- iżvilupp ta ’ iperkalimja jinkludu insuffiċjenza renali u/ jew insuffiċjenza tal- qalb, u diabete mellitus.
Adequate monitoring of serum potassium in patients at risk is recommended.
Monitoraġġ xieraq tal- potassium fis- serum f’ pazjenti li jkollhom riskju huwa irrikkmandat.
Caution is required when co-administering potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes with Rasilez HCT (see sections 4.5 and 4.8).
Il- kawtela hija meħtieġa meta jingħataw flimkien dijuretiċi li ma jħallux il- potassium jintilef, supplimenti tal- potassium jew sostituti tal- melħ li jkun fihom il- potassium ma ’ Rasilez HCT (ara sezzjonijiet 4. 5 u 4. 8).
There is no evidence that Rasilez HCT would reduce or prevent diuretic-induced hyponatraemia.
M’ hemmx evidenza li Rasilez HCT jista ’ jnaqqas jew jevita iponatrimja ikkawżata mid- dijuretiċi.
Chloride deficit is generally mild and usually does not require treatment.
In - nuqqas tal- chloride ġeneralment ikun ħafif u s- soltu ma jkunx hemm bżonn ta ’ kura.
Thiazides may reduce urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Thiazides jistgħu jnaqqsu l- eskrezzjoni tal- calcium fl- awrina u jikkawżaw żiediet żgħar u intermittenti tal- calcium fis- serum mingħajr ma jkun hemm disturbi fil- metaboliżmu tal- calcium.
Marked hypercalcaemia may be evidence of hidden hyperparathyroidism.
Iperkalċimja qawwija tista ’ tevidenzja iperparatajrojdiżmu li jkun moħbi.
Thiazides should be discontinued before carrying out tests for parathyroid function.
Thiazides għandhom jitwaqqfu qabel ma jsiru testijiet għall- funzjoni tal- paratajrojd.
Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesaemia (see also section 4.5).
Intwera li thiazides iżidu l- eskrezzjoni fl- awrina ta ’ magnesium, li tista ’ twassal għall- ipomagneżimja (ara wkoll sezzjoni 4. 5).
Renal impairment and kidney transplantation When Rasilez HCT is used in patients with impaired renal function, periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Indeboliment renali u trapjant tal- kliewi Meta Rasilez HCT jintuża f’ pazjenti b’ funzjoni renali indebolita, monitoraġġ perjodiku tal- livelli fis - serum tal- potassium, krejatinina u uric acid huwa irrikkmandat.
There is no experience regarding the administration of Rasilez HCT in patients who have recently undergone kidney transplantation.
M’ hemmx esperjenza rigward l- għotja ta ’ Rasilez HCT f’ pazjenti li jkunu għamlu trapjant tal- kliewi.
No dosage adjustment is necessary in patients with renal impairment whose GFR is ≥ 30 ml/ min/ 1.73 m2.
M’ hemmx bżonn ta ’ aġġustar tad - dożaġġ f’ pazjenti b’ indeboliment renali li jkollhom GFR ta ’ ≥ 30 ml/ min/ 1. 73 m2.
However, in patients with mild to moderate renal impairment (GFR ≥ 30 ml/ min/ 1.73 m2 but < 60 ml/ min/ 1.73 m2), Rasilez HCT should be administered with caution.
Madankollu, f’ pazjenti b’ indeboliment renali ħafif għal moderat (GFR ta ’ ≥ 30 ml/ min/ 1. 73 m2 iżda < 60 ml/ min/ 1. 73 m2), Rasilez HCT għandu jingħata b’ kawtela.
As for other agents acting on the renin-angiotensin system, caution should be exercised when aliskiren is given in the presence of conditions pre-disposing to kidney dysfunction such as hypovolaemia (e. g. due to blood loss, severe or prolonged diarrhoea, prolonged vomiting, etc.), heart disease, liver disease or kidney disease.
Bħal sustanzi oħra li jaħdmu fuq is- sistema tar- renin- angiotensin, għandu jkun hemm attenzjoni meta aliskiren jingħata fil- preżenza ta ’ kundizzjonijiet li jippredisponu għal disfunzjoni tal- kliewi bħal ipovolimja (eż. minħabba telf ta ’ demm, dijarea qawwija jew li ddum, rimettar li jdum, eċċ.), mard tal - qalb, mard tal- fwied jew mard tal- kliewi.
Acute renal failure, reversible upon discontinuation of treatment, has been reported in at-risk patients receiving aliskiren in post-marketing experience.
Indeboliment akut tal- kliewi, li jerġa ’ lura meta titwaqqaf il - kura, kien irrappurtat f’ pazjenti li kienu f’ riskju u kienu qed jirċievu aliskiren fl- esperjenza ta ’ wara t - tqegħid fis- suq.
In the event that any signs of renal failure occur, aliskiren should be promptly discontinued.
F’ każ li jseħħu xi sinjali ta ’ insuffiċjenza tal- kliewi, aliskiren għandu jitwaqqaf mill - ewwel.
4 more than plasma concentrations.
4 Indeboliment epatiku Thiazides għandhom jintużaw b’ kawtela f’ pazjenti b’ funzjoni epatika indebolita jew mard tal- fwied li jkun qed javvanza, peress li tibdil żgħir tal- fluwidi u l- elettroliti jista ’ jippreċipita koma epatika.
Therefore caution should be exercised when aliskiren is administered with moderate P-gp inhibitors such as ketoconazole (see section 4.5).
M’ hemmx esperjenza klinika b’ Rasilez HCT f’ pazjenti b’ indeboliment epatiku.
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.
Stenożi tal- valv tal- aorta u mitrali, kardjomijopatija ipertrofika ostruttiva Bħal ma jseħħ b’ vażodilataturi oħrajn, hija indikata kawtela speċjali f’ pazjenti li jsofru minn stenożi tal- aorta jew mitrali, jew kardjomijopatija ipertrofika ostruttiva.
Renal artery stenosis and renovascular hypertension No controlled clinical data are available on the use of Rasilez HCT in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Stenożi tal- arterja renali u pressjoni renovaskulari għolja M’ hemmx tagħrif kliniku kkontrollat dwar l- użu ta ’ Rasilez HCT f’ pazjenti bi stenożi tal- arterja renali unilaterali jew bilaterali, jew fi stenożi f’ kilwa waħda.
However, as with other agents acting on the renin-angiotensin system, there is an increased risk of renal insufficiency, including renal failure, when patients with renal artery stenosis are treated with aliskiren.
Madankollu, kif jiġri b’ sustanzi oħra li jaħdmu fuq is- sistema tar- renin- angiotensin, hemm żieda fir- riskju ta ’ insuffiċjenza tal- kliewi, inkluż indeboliment tal- kiewi, meta l- pazjenti bi stenożi tal- arterja renali jiġu kkurati b’ aliskiren.
Therefore caution should be exercised in these patients.
Għalhekk għandu jkun hemm attenzjoni f’ dawn il- pazjenti.
If renal failure occurs, treatment should be discontinued.
Jekk iseħħ indeboliment tal- kliewi, il- kura għandha titwaqqaf.
Metabolic and endocrine effects Thiazide therapy may impair glucose tolerance.
Effetti metaboliċi u endokrinarji Terapija b’ thiazide tista ’ ittellef it- tolleranza għall- glucose.
In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required.
F’ pazjenti dijabetiċi aġġustamenti tad - dożaġġi tal- insulina jew ta ’ sustanzi ipogliċemiċi orali jistgħu jkunu meħtieġa.
Latent diabetes mellitus may occur during thiazide therapy.
Dijabete mellitus moħbija tista ’ sseħħ waqt terapija b’ thiazide.
To date, no data are available from clinical studies that were specifically-designed to evaluate the safety of Rasilez HCT in diabetic patients.
Sal- lum, ma hija disponibbli l- ebda dejta minn studji kliniċi li kienu ddisinjati b’ mod speċifiku biex jevalwaw is- sigurtà ta ’ Rasilez HCT f’ pazjenti dijabetiċi.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy.
Żiediet tal- livelli tal- kolesterol u trigliċeridi kienu assoċjati ma ’ terapija b’ dijuretiċi thiazide.
Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Iperuriċemija tista ’ sseħħ jew gotta franka tista ’ taggrava f’ daqqa f’ ċerti pazjenti li jkunu qed jirċievu terapija b’ thiazide.
General In the event of severe and persistent diarrhoea, Rasilez HCT therapy should be stopped.
Ġenerali F’ każ ta ’ dijarea severa u persistenti, it- terapija b’ Rasilez HCT għandha titwaqqaf.
As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Bħall ma jseħħ bi kwalunkwe sustanza kontra l- pressjoni għolja, tnaqqis eċċessiv tal- pressjoni tad - demm f’ pazjenti b’ kardjopatija iskemika jew mard kardjovaskulari iskemiku jista ’ jwassal għal infart mijokardijaku jew strowk.
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.
Reazzjonijiet ta ’ sensittività eċċessiva għal hydrochlorothiazide jistgħu jseħħu f’ pazjenti li fil- passat jista ’ jkun li kellhom jew ma kellhomx allerġija jew ażżma tal- bronki, iżda x’ aktarx isseħħ f’ pazjenti li jkollhom passat ta ’ hekk.
Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics.
L- aggravar jew l- attivazzjoni ta ’ lupus erythematosus sistemika kienet irrappurtata bl- użu ta ’ dijuretiċi thiazide.
Excipients Rasilez HCT contains lactose.
Sustanzi mhux attivi Rasilez HCT fih lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għall- galactose, nuqqas ta ’ Lapp lactase jew malassorbiment tal- glucose- galactose m’ għandhomx jieħdu din il - mediċina.
Rasilez HCT contains wheat starch.
Rasilez HCT fih wheat starch.
It is suitable for people with coeliac disease.
Huwa indikat għan- nies li jbatu minn mard tas- coeliac.
Patients with wheat allergy (different from coeliac disease) should not take this medicine.
Pazjenti li jbatu minn allerġija għal qamħ (differenti mill- marda tas- coeliac) m’ għandhomx jieħdu din il- mediċina.
Medicinal products affecting potassium:
Prodotti mediċinali li jeffettwaw il- potassium:
The potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of aliskiren.
L- effett tat- tnaqqis fil- potassium ta ’ hydrochlorothiazide jiddgħajjef bl- effett ta ’ aliskeren li ma jħallix il- potassium jintilef.
However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e. g. other kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium, corticosteroids, ACTH, salicylic acid derivatives).
Madankollu, dan l- effett ta ’ hydrochlorothiazide fuq il- potassium fis- serum ikun mistenni li jitqawwa minn prodotti mediċinali oħrajn assoċjati mat- telf ta ’ potassium u ipokalimja (eż. dijuretiċi kaljuretiċi oħrajn, porog, amphotericin, carbenoxolone, penicillin G sodium, kortikosterojdi, ACTH, derivati ta ’ salicylic acid).
Conversely, based on experience with the use of other medicinal products that blunt the renin-angiotensin system (RAS), 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 sodium) may lead to increases in serum potassium.
5 Bil- kontra, minn esperjenza bi prodotti mediċinali oħrajn li joħonqu s- sistema renin- angiotensin (RAS), l- użu ta ’ dijuretiċi li ma jħallux il- potassium jintilef, supplimenti tal- potassium, sostituti tal - melħ li fihom il- potassium jew prodotti mediċinali oħrajn li jistgħu jżidu l- livelli ta ’ potassium fis - serum (eż. heparin sodium) jistgħu jwasslu għal żidiet tal- potassium fis- serum.
Adequate monitoring of serum potassium in patients at risk is recommended (see sections 4.4 and 4.8).
Monitoraġġ xieraq tal - potassium f’ pazjenti li jkollhom riskju huwa irrikkmandat (ara sezzjonijiet 4. 4 u 4. 8).
Medicinal products affected by serum potassium disturbances:
Prodotti mediċinali effettwati minn disturbi tal- potassium fis- serum:
Periodic monitoring of serum potassium is recommended when Rasilez HCT is administered with medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics).
Monitoraġġ perjodiku tal - potassium fis- serum huwa irrikkmandat meta Rasilez HCT jingħata ma ’ prodotti mediċinali effettwati minn disturbi tal- potassium fis- serum (eż. digitalis glycosides, anti- arritmijaċi).
5 Other antihypertensive agents:
Sustanzi kontra l- pressjoni oħrajn:
The antihypertensive effect of Rasilez HCT may be increased with the concomitant use of other antihypertensive agents.
L- effett kontra l- pressjoni għolja ta ’ Rasilez HCT jista ’ jiżdied bl - użu fl- istess ħin ta ’ sustanzi li jbaxxu l- pressjoni.
Additional information on aliskiren interactions Aliskiren has no known clinically relevant interactions with medicinal products commonly used to treat hypertension or diabetes.
Tagħrif ieħor dwar interazzjonijiet ta ’ aliskiren Aliskiren mhux magħruf li jagħmel interazzjonijiet li għandhom rilevanza klinika ma ’ prodotti mediċinali li jintużaw għall- kura ta ’ pressjoni għolja jew dijabete.
Compounds that have been investigated in aliskiren clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, fenofibrate, pioglitazone, allopurinol, isosorbide-5-mononitrate, irbesartan, digoxin, ramipril, valsartan, metformin, amlodipine, atorvastatin, cimetidine and hydrochlorothiazide.
Sustanzi kimiċi li kienu investigati b’ aliskiren fi studji ta ’ farmakokinetika klinika kienu jinkludu acenocoumarol, atenolol, celecoxib, fenofibrate, pioglitazone, allopurinol, isosorbide- 5- mononitrate, irbesartan, digoxin, ramipril, valsartan, metformin, amlodipine, atorvastatin, cimetidine u hydrochlorothiazide.
No clinically relevant interactions have been identified.
L- ebda interazzjonijiet ta ’ rilevanza klinika ma ġew identifikati.
As a result no dose adjustment for aliskiren or these co-administered medicinal products is necessary.
B’ hekk mhux meħtieġ li jkun hemm aġġustar tad- dożaġġ għal aliskiren jew għal dawn il- prodotti mediċinali li jingħataw flimkien
P-glycoprotein interactions:
Interazzjonijiet ma ’ glikoproteina P:
MDR1/ Mdr1a/ 1b (P-gp) was found to be the major efflux system involved in intestinal absorption and biliary excretion of aliskiren in preclinical studies.
Fi studji ta ’ qabel l- użu kliniku instab li MDR1/ Mdr1a/ 1b (P- gp) hija s- sistema ta ’ effluss li hi l- aktar involuta fl- assorbiment mill- imsaren u tneħħija mill- marrara ta ’ aliskiren.
Inducers of P- gp (St.
Indutturi ta ’ P- gp (St.
John’ s wort, rifampicin) might therefore decrease the bioavailability of aliskiren.
John’ s Wort, rifampicin) għalhekk jistgħu jnaqqsu l- bijodisponibilità ta ’ aliskiren.
Although this has not been investigated for aliskiren, it is known that P-gp also controls tissue uptake of a variety of substrates and P-gp inhibitors can increase the tissue-to-plasma concentration ratios.
Għalkemm din ma ġietx investigata għal aliskiren, huwa magħruf li P- gp jikkontrolla wkoll it- teħid ta ’ varjetà ta ’ sottostrati mit- tessuti u inibituri ta ’ P- gp jistgħu jżidu l- proporzjon tal - konċentrazzjoni tat- tessuti mal- plażma.
Therefore, P-gp inhibitors may increase tissue levels more than plasma levels.
Għalhekk inibituri ta ’ P- gp jistgħu iżidu l- livelli fit- tessuti aktar mil- livelli fil- plażma.
The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
Il- potenzjal ta ’ interazzjonijiet fis- sit P- gp x’ aktarx li jkun jiddependi mill - grad ta ’ inibizzjoni ta ’ dan it- trasportatur.
P-gp potent inhibitors:
Inibituri potenti ta ’ P- gp:
A single dose drug interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold.
Studju dwar interazzjoni b’ doża waħda f’ individwi b’ saħħithom wera li ciclosporin (200 u 600 mg) iżid is- Cmax ta ’ aliskiren 75 mg b’ madwar 2. 5 drabi u l- AUC b’ madwar 5 darbiet.
Moderate P-gp inhibitors:
Inibituri moderati ta ’ P- gp:
Co-administration of ketoconazole (200 mg) with aliskiren (300 mg) resulted in an 80% increase in plasma levels of aliskiren (AUC and Cmax).
L- għoti ta ’ ketoconazole (200 mg) ma ’ aliskiren (300 mg) irriżulta f’ żieda ta ’ 80% fil- livelli tal- plażma ta ’ aliskiren (AUC u Cmax).
The change in plasma levels of aliskiren in the presence of ketoconazole is expected to be within the range that would be achieved if the dose of aliskiren were doubled; aliskiren doses of up to 600 mg, or twice the highest recommended therapeutic dose, have been found to be well tolerated in controlled clinical trials.
Il- bidla fil- livelli tal- plażma ta ’ aliskiren fil- preżenza ta ’ ketoconazole hija mistennija li tkun fil- medda li tintlaħaq li kieku d- doża ta ’ aliskiren kellha tiġi rduppjata; id- dożi ta ’ aliskiren ta ’ mhux aktar minn 600 mg, jew darbtejn l- ogħla d- doża terapewtika rakkomandata, instabu li jkunu ttollerati sewwa fi provi kliniċi kkontrollati.
Yet, P-gp inhibitors are expected to increase tissue concentrations more than plasma concentrations.
Madankollu, inibituri ta ’ P- gp huma mistennija li jgħollu l - konċentrazzjonijiet fit- tessuti aktar milli fil- plażma.
Therefore, caution should be exercised when aliskiren is administered with ketoconazole or other moderate P-gp inhibitors (itraconazol, clarithromycin, telithromycin, erythromycin, amiodarone).
Għalhekk għandha issir kawtela meta aliskiren jingħata ma ’ ketoconazole jew inibituri moderati oħrajn ta ’ P- gp (itraconazol, clarithromycin, telithromycin, erythromycin, amiodarone).
P-gp substrates or weak inhibitors:
Sottostrati ta ’ P- gp jew inibituri dgħajfa:
No relevant interactions with atenolol, digoxin, amlodipine or cimetidine have been observed.
Ma dehru l- ebda interazzjonijiet rilevanti ma ’ atenolol, digoxin, amlodipine jew cimetidine.
Grapefruit juice:
6 Meraq tal- grejpfrut:
Due to the lack of data a potential interaction between grapefruit juice and aliskiren cannot be excluded.
Minħabba nuqqas ta ’ dejta interazzjonijiet li jista ’ jkun hemm bejn il- meraq tal - grejpfrut u aliskiren ma jistgħux jiġu esklużi.
When aliskiren was co-administered with furosemide, the AUC and Cmax of furosemide were reduced by 28% and 49%, respectively.
Meta aliskiren ingħata ma ’ furosemide, l- AUC u Cmax ta ’ furosemide tnaqqsu b’ 28% u 49% rispettivament.
It is therefore recommended to monitor the effects when initiating and adjusting furosemide therapy to avoid possible underutilisation in clinical situations of volume overload.
Għalhekk huwa irrakkomandat li l- effetti jkunu monitorati meta tinbeda u tkun qed tiġi aġġustata t- terapija ta ’ furosemide biex dan ma jkunx sotto- utilizzat f’ sitwazzjonijiet kliniċi ta ’ volum żejjed.
As with other agents acting on the renin-angiotensin system, NSAIDs may reduce the anti-hypertensive effect of aliskiren.
Bħal ma jiġri b’ sustanzi oħra li jaħdmu fuq is - sistema ta ’ renin- angiotensin, l- NSAIDs jistgħu jnaqqsu l- effett li għandu aliskiren kontra l- pressjoni għolja.
In some patients with compromised renal function (dehydrated patients or elderly patients) aliskiren given concomitantly with NSAIDs may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
F’ xi pazjenti b’ funzjoni tal- kliewi kompromessa (pazjenti deidradati jew pazjenti anzjani) aliskiren mogħti flimkien ma ’ NSAIDs jista ’ jwassal għal funzjoni tal- kliewi li aktar tmur għall- agħar, inkluż il- possibiltà ta ’ insuffiċjenza tal- kliewi li s- soltu terġa ’ tmur lura għal dak li kienet.
Therefore the combination of aliskiren with an NSAID requires caution, especially in elderly patients.
Għalhekk it - taħlita ta ’ aliskiren flimkien ma ’ NSAID tinħtieġ attenzjoni, speċjalment f’ pazjenti anzjani.
The effects of aliskiren on warfarin pharmacokinetics have not been evaluated.
L- effetti ta ’ aliskiren fuq il- farmakokinetika ta ’ warfarin ma kienux evalwati.
Food interactions:
Interazzjonijiet mal- ikel:
Meals with a high fat content have been shown to reduce the absorption of aliskiren substantially.
Ikliet b’ kontenut ta ’ xaħam għoli ntwerew li jnaqqsu l- assorbiment ta ’ aliskiren b’ mod sostanzjali.
Additional information on hydrochlorothiazide interactions When administered concurrently, the following medicinal products may interact with thiazide diuretics:
Tagħrif ieħor dwar interazzjonijiet ta ’ hydrochlorothiazide Meta jingħataw flimkien, il- prodott mediċinali li ġejjin jistgħu jinteraġixxu ma ’ dijuretiċi thiazide:
Renal clearance of lithium is reduced by thiazides, therefore the risk of lithium toxicity may be increased with hydrochlorothiazide.
L- eliminazzjoni ta ’ lithium mill- kliewi titnaqqas mit- thiazides, għalhekk ir- riskju ta ’ tossiċità b’ lithium tiżdied b’ hydrochlorothiazide.
Co-administration of lithium and hydrochlorothiazide is not recommended.
L- għotja ta ’ lithium ma ’ hydrochlorothiazide mhux irrikkmandat.
If this combination proves essential, careful monitoring of serum lithium level is recommended during concomitant use.
Jekk din it- taħlita tkun essenzjali, monitoraġġ b’ attenzjoni tal- livell ta ’ sodium fis- serum huwa irrikkmandat waqt l- użu f’ daqqa.
Potentiation of orthostatic hypotension may occur.
Tista ’ taggrava l- ipotensjoni ortostatika.
Antidiabetic medicinal products (oral agents and insulins):
Prodotti mediċinali kontra d- dijabete (sustanzi orali u insulini):
Dosage adjustment of the antidiabetic medicinal product may be required (see section 4.4).
Aġġustar tad- dożaġġ tal- prodott mediċinali kontra d- dijabete jista ’ jkun meħtieġ (ara sezzjoni 4. 4).
Cholestyramine and colestipol resins:
Cholestyramine u reżins tal- colestipol:
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Ipokalimja jew ipomagneżimja ikkawżati minn thiazide jistgħu jikkawżaw arritmiji kardijaċi ikkawżati minn diġitalis (ara sezzjoni 4. 4).
Thiazide-induced hypokalaemia or hypomagnesaemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4).
Ipokalimja jew ipomagneżimja ikkawżati minn thiazide jinkuraġġixxu arritmiji tal- qalb ikkawżati minn digitalis (ara sezzjoni 4. 4).
The administration of an NSAID may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients.
L- għotja ta ’ NSAID tista ’ tnaqqas l- effett dijuretiku, natrijuretiku u l- effetti kontra l - pressjoni ta ’ dijuretiċi thiazide f’ xi pazjenti.
Antigout medicine:
Mediċina kontra l- gotta:
Dosage adjustments of antigout medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Aġġustamenti tad- dożaġġi ta ’ medikazzjonijiet kontra l- gotta jistgħu jkunu meħtiega minħabba li hydrochlorothiazide jista ’ jgħolli l- livell ta ’ sodium uric acid fis- serum.
Increase in dosage of probenecid or sulfinpyrazone may be necessary.
Żieda fid- dożaġġ ta ’ probenecid jew sulfinpyrazone tista ’ tkun meħtieġa.
Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol.
L- għotja fl- istess ħin ta ’ dijuretiċi thiazide tista ’ tikkawża żieda fil- frekwenza ta ’ reazzjonijiet ta ’ sensittività eċċessiva għal allopurinol.
Calcium salts:
Sustanzi tal- melħ bil- calcium:
Thiazide diuretics may increase serum calcium levels due to decreased excretion.
Dijuretiċi thiazide jistgħu jżidu l- livelli ta ’ calcium fis- serum minħabba tnaqqis fl- eskrezzjoni.
If calcium supplements or calcium-sparing medicinal products (e. g. vitamin D therapy) must be prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly.
Jekk ikun hemm bżonn li jiġu ordnati supplimenti tal- calcium jew prodottu li ma jħallux lill- calcium jitneħħa (eż. terapija b’ vitamina D), il- livelli ta ’ calcium fis- serum għandhom jiġu monitorati u d- dożaġġ ta ’ calcium aġġustat kif jixraq.
Curare derivatives (e. g. tubocurarine):
7 Derivati curare (eż. tubocurarine):
The effect of non-depolarising skeletal muscle relaxants may be potentiated by hydrochlorothiazide.
L- effett ta ’ rilassanti tal- muskoli skeletrali li ma jippolarizzawx jista ’ jitqawwa b’ hydrochlorothiazide.
Other interactions:
Interazzjonijiet oħrajn:
The hyperglycaemic effect of beta blockers and diazoxide may be enhanced by thiazides.
L- effett ipergliċemiku ta ’ beta blockers u diazoxide jista ’ jitqawwa b’ thiazides.
Anticholinergic agents (e. g. atropine, biperiden) may increase the bioavailability of thiazide- type diuretics by decreasing gastrointestinal motility and stomach-emptying rate.
Sustanzi antikolinerġiċi (eż. atropine, biperidine) jistgħu jżidu l- biodisponibilità ta ’ dijuretiċi tat- tip thiazide billi jnaqqsu l- moviment gastro- intestinali u r- rata li biha jitbattal l- istonku.
Thiazides may increase the risk of adverse effects caused by amantadine.
Thiazides jistgħu jżidu r- riskju ta ’ effetti avversi ikkawżati minn amantadine.
Thiazides may reduce the renal excretion of cytotoxic medicinal products (e. g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
Thiazides jistgħu jnaqqsu l- eskrezzjoni ta ’ prodotti mediċinali ċitotossiċi (eż. cyclophosphamide, methotrexate) u jqawwu l- effetti majelosoppressivi tagħhom.
Pregnancy There are no data on the use of aliskiren in pregnant women.
Tqala M’ hemmx tagħrif dwar l- użu ta ’ aliskiren waqt it- tqala.
Aliskiren was not teratogenic in rats or rabbits (see section 5.3).
Aliskiren ma kienx teratoġeniku fi frien jew fniek (ara sezzjoni 5. 3).
Other substances that act directly on the RAS have been associated with serious foetal malformations and neonatal death when used during second and third trimesters.
Sustanzi oħra li jaħdmu direttament fuq RAS kienu assoċjati ma ’ malformazzjonijiet tal- feti u mwiet tal- frieħ meta intużaw waqt it- tieni u t- tielet trimestru.
7 Prolonged exposure to thiazides during the third trimester of pregnancy can reduce maternal plasma volume as well as uteroplacental blood flow, which may cause a foeto-placental ischaemia and growth retardation.
Esponiment fit- tul għal thiazides waqt it- tielet trimestru tat- tqala jista ’ jnaqqas il- volum tal- plażma tal - omm kif ukoll il- passaġġ tad- demm bejn l- utru u l- plaċenta, li jista ’ jikkawża iskemija fetu- plaċentali u ittardjar tat- tkabbir.
Moreover, rare cases of hypoglycaemia and thrombocytopenia in neonates have been reported following exposure near term.
Minbarra hekk, każijiet rari ta ’ ipogliċemija u tromboċitopenja fi trabi tat- twelid kienu rrappurtati wara esponiment lejn l- aħħar tat- tqala.
No specific clinical studies have been performed with this combination, therefore Rasilez HCT should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Ma sarux studji kliniċi speċifiċi b’ din it- taħlita, għalhekk Rasilez HCT m’ għandux jintuża waqt l - ewwel trimestru tat- tqala jew f’ nisa li qed jippjanaw biex joħorġu tqal u huwa kontraindikat waqt it - tieni u t- tielet trimestri (ara sezzjoni 4. 3).
A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.
Għandha ssir bidla għal kura alternattiva xierqa qabel ma tkun ippjanta tqala.
If pregnancy is detected during therapy, Rasilez HCT should be discontinued as soon as possible.
Jekk jinsab li hemm tqala waqt it- terapija, Rasilez HCT għandu jitwaqqaf kemm jista ’ jkun malajr.
Lactation Rasilez HCT is contraindicated during lactation (see section 4.3).
Treddigħ Rasilez HCT huwa kontra- indikat waqt it- treddigħ (ara sezzjoni 4. 3).
It is not known whether aliskiren is excreted in human milk.
Mhux magħruf jekk aliskiren jgħaddix fil- ħalib tal- mara.
Aliskiren was secreted in the milk of lactating rats.
Aliskiren għadda fil- ħalib ta ’ firien li kienu qed ireddgħu.
Thiazides appear in human milk and may inhibit lactation.
Thiazides jidhru fil- ħalib tal- bniedem u jistgħu jtelfu t- treddigħ.
They can produce adverse biological effects including hypokalaemia, haemolysis (glucose-6-phosphate dehydrogenase (G6PD) defect) and hypersensitivity due to sulphonamide properties.
Jistgħu jikkawżaw effetti bioloġiċi avversi inkluż ipokalimja, emoliżi (difett tal- glucose- 6- phosphate dehydrogenase (G6PD)) u sensittività eċċessiva minħabba l- karatteristiċi ta ’ sulphonamide.
Rasilez HCT is unlikely to affect the ability to drive and use machines.
Rasilez HCT x’ aktax ma jaffettwax il- ħila biex ssuq u tħaddem magni.
However, when driving vehicles or operating machinery it must be borne in mind that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy.
Madankollu, waqt is- sewqan jew tħaddim ta ’ magni għandu jkun meqjus il- fatt li jista ’ jkun hemm, xi kultant, sturdament jew għeja bl- użu ta ’ terapija kontra l- pressjoni għolja.
Aliskiren/ hydrochlorothiazide combination The safety of Rasilez HCT has been evaluated in 9 clinical trials with more than 3,900 patients, including over 700 treated for over 6 months, and 190 for over 1 year.
Taħlita aliskiren/ hydrochlorothiazide Is- sigurtà ta ’ Rasilez HCT kienet evalwata f’ 9 provi kliniċi b’ aktar minn 3, 900 pazjent, inklużi aktar minn 700 ikkurati għal aktar minn 6 xhur, u 190 għal aktar minn sena.
The incidence of adverse reactions showed no association with gender, age, body mass index, race or ethnicity.
Il- frekwenza ta ’ reazzjonijiet avversi wriet li m’ hemmx assoċjazzjoni mas- sess, età, indiċi tal- massa tal- ġisem, razza jew etniċità.
Treatment with Rasilez HCT had an overall incidence of adverse experiences at doses up to 300 mg/ 25 mg similar to placebo.
Kura b’ Rasilez HCT kellha frekwenza globali ta ’ esperjenzi avversi b’ dożi sa ’ 300 mg/ 25 mg simili għall- plaċebo.
Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
Reazzjonijiet avversi ġeneralment kienu ħfief fin- natura tagħhom u rarament kienu jeħtieġu twaqqif tat- terapija.
The most common adverse drug reaction is diarrhoea.
L- aktar reazzjoni avversa tal- mediċina komuni hija dijarea.
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
8 Il- frekwenza tar- reazzjonijiet avversi elenkati hawn taħt hija definita permezz tal- konvenzjoni li ġejja: komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100 sa < 1/ 10); mhux komuni (≥ 1/ 1, 000 sa < 1/ 100); rari (≥ 1/ 10, 000 sa < 1/ 1, 000); rari ħafna (< 1/ 10, 000), mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
Diarrhoea:
Dijarea:
Diarrhoea is a dose-related adverse drug reaction for aliskiren.
Id- dijarea hija reazzjoni avversa għall- mediċina marbuta mad- doża għal aliskiren.
In controlled clinical trials, the incidence of diarrhoea in Rasilez HCT-treated patients was 1.3% compared to 1.4% for aliskiren- or 1.9% for hydrochlorothiazide-treated patients.
Fi provi kliniċi kontrollati, il- frekwenza ta ’ dijarea f’ pazjenti kkurati b’ Rasilez HCT kienet 1. 3% meta mqabbla ma ’ 1. 4% f’ pazjenti kkurati b’ aliskiren jew 1. 9% f’ pazjenti kkurati b’ hydrochlorothiazide.
In a large placebo-controlled clinical trial, the opposite effects of aliskiren (150 mg or 300 mg) and hydrochlorothiazide (12.5 mg or 25 mg) on serum potassium approximately balanced each other in many patients.
Fi prova klinika kbira ikkontrollata bi plaċebo, l- effetti opposti ta ’ aliskiren (150 mg jew 300 mg) u hydrochlorotiazide (12. 5 mg jew 25 mg) fuq il- potassium fis- serum bejn wieħed u ieħor ibbilanċaw lill- xulxin f’ ħafna pazjenti.
In other patients, one or the other effect may be dominant.
F’ pazjenti oħrajn, wieħed jew l- ieħor mill - effetti jista ’ jiddomina.
Periodic determinations of serum potassium to detect possible electrolyte imbalance should be performed in patients at risk at appropriate intervals (see sections 4.4 and 4.5).
Għandhom jiġu imkejla il- livelli tal- potassium fis- serum b’ mod perjodiku sabiex jiġi magħruf jekk hemmx żbilanċ tal- elettroliti f’ pazjenti li għandhom riskju f’ intervalli xierqa (ara sezzjonijiet 4. 4 u 4. 5).
8 Additional information on individual components Adverse reactions previously reported with one of the individual components may occur with Rasilez HCT even if not observed in clinical trials.
Tagħrif ieħor dwar il- komponenti individwali Reazzjonijiet avversi li kienu rrappurtati qabel b’ wieħed mill- komponenti individwali jistgħu jseħħu b’ Rasilez HCT anki jekk ma dehrux waqt provi kliniċi.