qanastek/EMEA-V3 huggingface dataset:
32 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.
32 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.
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.
33 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.
33 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.
Hepatic impairment Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
34 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.
34 Moderate P-gp inhibitors Co-administration of aliskiren 300 mg with ketoconazole 200 mg resulted in a 76% increase in aliskiren AUC but P-gp inhibitors such as ketoconazole are expected to increase tissue concentrations more than plasma concentrations.
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.
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.
35 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.
35 Medicinal products affected by serum potassium disturbances:
Prodotti mediċinali effettwati minn disturbi tal- potassium fis- serum:
Grapefruit juice:
36 Meraq tal- grejpfrut:
In some patients with
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.
36 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.
Curare derivatives (e. g. tubocurarine):
37 Derivati curare (eż. tubocurarine):
37 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
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).
38 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).
38 Serum potassium:
Potassium fis- serum:
Serum potassium:
39 Potassium fis- serum:
39 Blood and lymphatic system disorders
Disturbi tad- demm u tas- sistema limfatika
Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis.
40 Doża eċċessiva b’ hydrochlorothiazide hija assoċjata ma ’ nuqqas ta ’ elettroliti (ipokalimja, ipoklorimja, iponatrimja) u deidratazzjoni li tiġi minn dijureżi eċċessiva.
Rasilez HCT combines two antihypertensive compounds to control blood pressure in patients with essential hypertension:
Rasilez HCT jikkombina żewġ sustanzi kontra l- pressjoni għolja biex jikkontrolla il- pressjoni tad - demm f’ pazjenti bi pressjoni għolja naturali:
In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of aliskiren 150 mg was well tolerated.
41 Fi studju ta ’ 3 xhur fuq 302 pazjenti b’ insuffiċjenza tal- qalb stabbli u mhux severa, li kollha kemm huma kienu qed jirċievu terapija standard għall- insuffiċjenza tal- qalb stabbli, iż- żieda ta ’ aliskiren 150 mg kienet tollerata sew.
41 Hydrochlorothiazide The site of action of thiazide diuretics is primarily in the renal distal convoluted tubule.
Hydrochlorothiazide Is- sit ta ’ fejn jaħdmu d- dijuretiċi thiazide huwa l- aktar it- tubu distali konvolut renali.
The mode of action of thiazides is through inhibition of the Na+Cl- symporter by competing for the Cl- site, thereby affecting electrolyte reabsorption mechanisms: directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly by this diuretic action reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Il- mod ta ’ kif jaħdmu d- dijuretiċi thiazide huwa permezz tal- inibizzjoni tas- simportatur Na+Cl - billi jikkompeti għas- sit tas- Cl -, b’ hekk jeffettwa il- mekkaniżmi li bihom jerġgħu jiġu assorbiti l- elettroliti: iżid direttament l- eskrezzjoni ta ’ sodium u chloride b’ madwar l- istess ammont, u indirettament b’ din l- azzjoni dijuretika billi jnaqqas il - volum tal- plażma, b’ konsegwenza ta ’ żidiet fl- attività tar- renin fil- plażma, sekrezzjoni ta ’ aldosterone u telf tal- potassium fl- awrina tnaqqis tal- potassium fis- serum.
In a study in 880 randomised patients not adequately responsive to aliskiren 300 mg treatment, the combination of aliskiren/ hydrochlorothiazide 300 mg/ 25 mg produced systolic/ diastolic blood pressure reductions of 15.8/ 11.0 mmHg, which were significantly greater than aliskiren 300 mg monotherapy.
42 Fi studju fuq 880 pazjent randomized li ma wrewx rispons xieraq għal kura b’ aliskiren 300 mg, it - taħlita aliskiren/ hydrochlorothiazide 300 mg/ 25 mg ikkawżat tnaqqis fil- pressjoni sistolika/ dijastolika tad- demm ta ’ 15. 8/ 11. 0 mmHg, li kienet akbar b’ mod sinifikanti minn monoterapija b’ aliskiren 300 mg.
In this difficult-to-treat population, Rasilez HCT provided a blood pressure reduction (systolic/ diastolic) of 15.8/ 11.9 mmHg compared to 15.4/ 11.3 mmHg for
F’ din il- popolazzjoni li hi diffiċli biex tikkura, Rasilez HCT ikkawza tnaqqis fil- pressjoni (sistolika/ dijastolika) ta ’ 15. 8/ 11. 9 mmHg imqabbel ma ’ 15. 4/ 11. 3 mmHg għal irbesartan/ hydrochlorothiazide, 13. 6/ 10. 3 mmHg għal amlodipine/ hydrochlorothiazide u 8. 6/ 7. 9 mmHg għal monoterapija b’ hydrochlorothiazide, b’ sigurtà simili għal monoterapija b’ hydrochlorothiazide.
Concomitant administration with food has been reported to both increase and decrease the systemic availability of hydrochlorothiazide compared with the fasted state.
43 Kien irrappurtat li meta jingħata mal- ikel id- disponibilità ta ’ hydrochlorothiazide tiżdied kif ukoll tonqos meta mqabbla mal- istat sawmi.
43 Linearity The increase in mean AUC is linear and dose proportional in the therapeutic range.
Il- kwalità lineari Iż- zieda fil- medja tal- AUC hija lineari u fi proporzjon mad- doża fil- medda terapewtika.
Aliskiren/ hydrochlorothiazide Following oral administration of Rasilez HCT tablets, the median peak plasma concentration time is within 1 hour for aliskiren and 2.5 hours for hydrochlorothiazide.
Aliskiren/ hydrochlorothiazide Wara li jingħataw pilloli ta ’ Rasilez HCT, il- medji tal- ħin tal- quċċati tal- konċentrazzjoni huwa fi żmien siegħa għal aliskiren u 2. 5 siegħa għal hydrochlorothiazide.
44 There was no evidence that this finding was enhanced in the aliskiren/ hydrochlorothiazide combination as it was only apparent at a minimal severity in all animals.
Ma kienx hemm evidenza li din is- sejba kienet akbar fit- taħlita aliskiren/ hydrochlorothiazide minħabba li dehret biss f’ qawwa minima fl - annimali kollha.
Talc Hypromellose Macrogol Titanium dioxide (E171) Red iron oxide (E172) Black iron oxide (E172)
Talc Hypromellose Macrogol Titanium dioxide (E171) Red iron oxide (E172) Black iron oxide (E172)
6.5 Nature and contents of container
45 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Rasilez HCT 300 mg/ 25 mg film-coated tablets
Rasilez HCT 300 mg/ 25 mg pilloli miksijin b’ rita
Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Kull pillola miksija b’ rita fiha 300 mg aliskiren (bħala hemifumarate) u 25 mg hydrochlorothiazide.
Light yellow, biconvex, ovaloid film-coated tablet imprinted with “ CVV” on one side and “ NVR” on the other.
Pillola safra ċara, konvessa miż- żewġ naħat, b’ għamla ovali miksija b’ rita stampata b ’ “ CVV ” fuq naħa u “ NVR ” fuq l- oħra.
Rasilez HCT 300 mg / 25 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or hydrochlorothiazide 25 mg alone or by Rasilez HCT 300 mg/ 12.5 mg or Rasilez HCT 150 mg/ 25 mg.
Rasilez HCT 300 mg/ 25 mg jista ’ jingħata f’ pazjenti li jkollhom il- pressjoni tad- demm li ma tkunx ikkontrollata kif jixraq b’ aliskiren 300 mg jew hydrochlorothiazide 25 mg waħidhom jew b’ Rasilez HCT 300 mg/ 12. 5 mg jew b’ Rasilez HCT 150 mg/ 25 mg.
47 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.
47 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.
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.
48 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.
48 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.
Hepatic impairment Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
49 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.
49 Moderate P-gp inhibitors Co-administration of aliskiren 300 mg with ketoconazole 200 mg resulted in a 76% increase in aliskiren AUC but P-gp inhibitors such as ketoconazole are expected to increase tissue concentrations more than plasma concentrations.
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.
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.
50 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.
50 Medicinal products affected by serum potassium disturbances:
Prodotti mediċinali effettwati minn disturbi tal- potassium fis- serum:
Grapefruit juice:
51 Meraq tal- grejpfrut:
51 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.
Curare derivatives (e. g. tubocurarine):
52 Derivati curare (eż. tubocurarine):
52 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
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).
53 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).
53 Serum potassium:
Potassium fis- serum:
Serum potassium:
54 Potassium fis- serum:
54 Blood and lymphatic system disorders
Disturbi tad- demm u tas- sistema limfatika
Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis.
55 Doża eċċessiva b’ hydrochlorothiazide hija assoċjata ma ’ nuqqas ta ’ elettroliti (ipokalimja, ipoklorimja, iponatrimja) u deidratazzjoni li tiġi minn dijureżi eċċessiva.
55 Rasilez HCT combines two antihypertensive compounds to control blood pressure in patients with essential hypertension:
Rasilez HCT jikkombina żewġ sustanzi kontra l- pressjoni għolja biex jikkontrolla il- pressjoni tad - demm f’ pazjenti bi pressjoni għolja naturali:
In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of aliskiren 150 mg was well tolerated.
56 Fi studju ta ’ 3 xhur fuq 302 pazjenti b’ insuffiċjenza tal- qalb stabbli u mhux severa, li kollha kemm huma kienu qed jirċievu terapija standard għall- insuffiċjenza tal- qalb stabbli, iż- żieda ta ’ aliskiren 150 mg kienet tollerata sew.
56 approximately equal extent, and indirectly by this diuretic action reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Il- mod ta ’ kif jaħdmu d- dijuretiċi thiazide huwa permezz tal- inibizzjoni tas- simportatur Na+Cl - billi jikkompeti għas- sit tas- Cl -, b’ hekk jeffettwa il- mekkaniżmi li bihom jerġgħu jiġu assorbiti l- elettroliti: iżid direttament l- eskrezzjoni ta ’ sodium u chloride b’ madwar l- istess ammont, u indirettament b’ din l- azzjoni dijuretika billi jnaqqas il - volum tal- plażma, b’ konsegwenza ta ’ żidiet fl- attività tar- renin fil- plażma, sekrezzjoni ta ’ aldosterone u telf tal- potassium fl- awrina tnaqqis tal- potassium fis- serum.
In a study in 880 randomised patients not adequately responsive to aliskiren 300 mg treatment, the combination of aliskiren/ hydrochlorothiazide 300 mg/ 25 mg produced systolic/ diastolic blood pressure reductions of 15.8/ 11.0 mmHg, which were significantly greater than aliskiren 300 mg monotherapy.
57 Fi studju fuq 880 pazjent randomized li ma wrewx rispons xieraq għal kura b’ aliskiren 300 mg, it - taħlita aliskiren/ hydrochlorothiazide 300 mg/ 25 mg ikkawżat tnaqqis fil- pressjoni sistolika/ dijastolika tad- demm ta ’ 15. 8/ 11. 0 mmHg, li kienet akbar b’ mod sinifikanti minn monoterapija b’ aliskiren 300 mg.
Concomitant administration with food has been reported to both increase and decrease the systemic availability of hydrochlorothiazide compared with the fasted state.
58 Kien irrappurtat li meta jingħata mal- ikel id- disponibilità ta ’ hydrochlorothiazide tiżdied kif ukoll tonqos meta mqabbla mal- istat sawmi.
58 Aliskiren/ hydrochlorothiazide Following oral administration of Rasilez HCT tablets, the median peak plasma concentration time is within 1 hour for aliskiren and 2.5 hours for hydrochlorothiazide.
Aliskiren/ hydrochlorothiazide Wara li jingħataw pilloli ta ’ Rasilez HCT, il- medji tal- ħin tal- quċċati tal- konċentrazzjoni huwa fi żmien siegħa għal aliskiren u 2. 5 siegħa għal hydrochlorothiazide.
6.5 Nature and contents of container
60 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
61 ANNEX II
61 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
ID- DETENTUR TAL- AWTORIZZAZZJONI GĦALL - MANIFATTURA, RESPONSABBLI GĦAR- RILAXX TAL - LOTT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
ID- DETENTUR TAL- AWTORIZZAZZJONI GĦALL- MANIFATTURA, RESPOSABBLI GĦAR- RILAXX TAL- LOTT
Name and address of the manufacturer responsible for batch release
L- isem u l- indirizz tal- manifattur responsabbli għar- rilaxx tal- lott
Via Provinciale Schito 131 IT-80058 Torre Annunziata/ NA Italy
Via Provinciale Schito 131 IT- 80058 Torre Annunziata/ NA L- Italja
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TAL- AWTORIZZAZZONI GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UŻU IMPOSTI FUQ ID- DETENTUR TAL- AWTORIZZAZZJNI GĦAT- TQEGĦID FIS- SUQ
Medicinal product subject to medical prescription.
Prodott Mediċinali li jingħata bir- riċetta tat- tabib.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR L- UŻU SIGUR U EFFIKAĊI TAL- PRODOTT MEDIĊINALI
Not applicable.
Ma japplikawx.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 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.
Sistema ta ’ farmakoviġilanza L- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 1. 0 ippreżentata fil - Modulu 1. 8. 1. tal- Applikazzjoni għall- Awtorizzazzjoni tat- Tqegħid fis- Suq, tkun imwaqqfa u operattiva qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan għall- Ġestjoni tar- Riskju L- MAH jobbliga ruħu li jwettaq l- istudji u l- farmakoviġilanza addizzjonali speċifikati fid- dettall fil - Pjan tal- Farmakoviġilanza, kif maqbul fil- verżjoni 4. 0 tal- Pjan tal- Ġestjoni tar- Riskju (RMP) ippreżentat fil- Modulu 1. 8. 2. tal- Applikazzjoni għall- Awtorizzazzjoni tat- Tqegħid fis- Suq, u kull aġġornament sussegwenti tal- RMP maqbul mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tas- CHMP dwar is- Sistemi tal- Ġestjoni tar- Riskju għall- prodotti mediċinali għall- użu mill- bniedem, l- RMP aġġornat għandu jiġi ppreżentat fl- istess ħin mar- Rapport Perjodiku tal- Aġġornament tas- Sigurezza (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.
Minbarra dan, għandu jiġi ppreżentat RMP aġġornat • Meta tasal informazzjoni ġdida li tista ’ taffettwa l- Ispeċifikazzjonijiet tas- Sigurezza, il- Pjan tal - Farmakoviġilanza jew l- attivitajiet tal- minimizzazzjoni tar- riskju kurrenti • Fi żmien 60 jum minn xi riżultat verament importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju) • Fuq talba tal- EMEA.
63 ANNEX III
63 ANNESS III
FOLDING BOX FOR UNIT PACK CONTAINING PVC/ PCTFE BLISTERS
KAXXA LI TINTLEWA GĦALL- PAKKETT B’ WIEĦED LI FIH FOLJI TAL- PVC/ PCTFE
Rasilez HCT 150 mg/ 12.5 mg film-coated tablets Aliskiren/ hydrochlorothiazide
Rasilez HCT 150 mg/ 12. 5 mg pilloli miksijin b’ rita Aliskiren/ hydrochlorothiazide
Contains lactose and wheat starch.
Fih lactose u wheat starch.
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets
7 pilloli miksijin b’ rita 14- il pillola miksija b’ rita 28 pillola miksija b’ rita 30 pillola miksija b’ rita 50 pillola miksija b’ rita 56 pillola miksija b’ rita 90 pillola miksija b’ rita 98 pillola miksija b’ rita
Rasilez HCT 150 mg/ 12.5 mg
Rasilez HCT 150 mg/ 12. 5 mg
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
67 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
FOLDING BOX FOR UNIT PACK CONTAINING PA/ ALU/ PVC BLISTERS
KAXXA LI TINTLEWA GĦALL- PAKKETT B’ WIEĦED LI FIH FOLJI PA/ ALU/ PVC
69 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
69 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTERS (PVC/ PCTFE OR PA/ ALU/ PVC) BLISTER (CALENDAR) (PVC/ PCTFE OR PA/ ALU/ PVC)
FOLJI (PVC/ PCTFE JEW PA/ ALU/ PVC) FOLJI (KALENDARJU) (PVC/ PCTFE JEW PA/ ALU/ PVC)
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
70 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PVC/ PCTFE BLISTERS
KARTUNA TAN- NOFS TAL- PAKKETTI B’ ĦAFNA (MINGĦAJR IL- KAXXA Ċ- ĊELESTI) LI JKUN FIHA IL- FOLJI PVC/ PCTFE
14 film-coated tablets Component of a multipack comprising 20 packs, each containing 14 tablets.
14- il pillola miksija b’ rita Jagħmel parti mill- pakkett b’ ħafna li jinkludi 20 pakkett, kull wieħed fih 14- il pillola.
49 film-coated tablets Component of a multipack comprising 2 packs, each containing 49 tablets.
49 pillola miksija b’ rita Jagħmel parti mill- pakkett b’ ħafna li jinkludi 2 pakketti, kull wieħed fih 49 pillola.
72 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
72 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PA/ ALU/ PVC BLISTERS
KARTUNA TAN- NOFS TAL- PAKKETTI B’ ĦAFNA (MINGĦAJR IL- KAXXA Ċ- ĊELESTI) LI JKUN FIHA IL- FOLJI PA/ ALU/ PVC
30 film-coated tablets Component of a multipack comprising 3 packs, each containing 30 tablets.
30 pillola miksija b’ rita Jagħmel parti mill- pakkett b’ ħafna li jinkludi 3 pakketti, kull wieħed fih 30 pillola.
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
74 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PVC/ PCTFE BLISTERS
KARTUNA TA ’ BARRA TAL- PAKKETTI B’ ĦAFNA (INKLUŻA L- KAXXA Ċ- ĊELESTI) LI JKUN FIHA L- FOLJI PVC/ PCTFE
98 film-coated tablets Multipack comprising 2 packs, each containing 49 tablets.
98 pillola miksija b’ rita Pakkett b’ ħafna li jinkludi 2 pakketti, kull wieħed fih 49 pillola.
280 film-coated tablets Multipack comprising 20 packs, each containing 14 tablets.
280 pillola miksija b’ rita Pakkett b’ ħafna li jinkludi 20 pakkett, kull wieħed fih 14- il pillola.
76 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
76 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PA/ ALU/ PVC BLISTERS
KARTUNA TA ’ BARRA TAL- PAKKETTI B’ ĦAFNA (INKLUŻA L- KAXXA Ċ- ĊELESTI) LI JKUN FIHA L- FOLJI PA/ ALU/ PVC
90 film-coated tablets Multipack comprising 3 packs, each containing 30 tablets.
90 pillola miksija b’ rita Pakkett b’ ħafna li jinkludi 3 pakketti, kull wieħed fih 30 pillola.
78 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
78 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Rasilez HCT 150 mg/ 25 mg film-coated tablets Aliskiren/ hydrochlorothiazide
Rasilez HCT 150 mg/ 25 mg pilloli miksijin b’ rita Aliskiren/ hydrochlorothiazide
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
80 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
82 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
82 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
83 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Rasilez HCT 150 mg/ 25 mg film-coated tablets Aliskiren/ hydrochlorothiazide
Rasilez HCT 300 mg/ 12. 5 mg pilloli miksijin b’ rita Aliskiren/ hydrochlorothiazide
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide.
Kull pillola miksija b’ rita fiha 300 mg aliskiren (bħala hemifumarate) u 12. 5 mg hydrochlorothiazide.
91 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
91 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Rasilez HCT 300 mg/ 12.5 mg film-coated tablets Aliskiren/ hydrochlorothiazide
Rasilez HCT 300 mg/ 12. 5 mg pilloli miksijin b’ rita Aliskiren/ hydrochlorothiazide
Rasilez HCT 300 mg/ 12.5 mg
Rasilez HCT 300 mg/ 12. 5 mg
95 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
95 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
96 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
96 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
98 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
98 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
100 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
100 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
102 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
102 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
104 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
104 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Rasilez HCT 300 mg/ 25 mg film-coated tablets Aliskiren/ hydrochlorothiazide
Rasilez HCT 300 mg/ 25 mg pilloli miksijin b’ rita Aliskiren/ hydrochlorothiazide
106 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
106 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
108 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
108 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
113 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
113 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
115 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
115 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
118 PACKAGE LEAFLET:
118 FULJETT TA ’ TAGĦRIF:
Rasilez HCT 150 mg/ 12.5 mg film-coated tablets Rasilez HCT 150 mg/ 25 mg film-coated tablets Rasilez HCT 300 mg/ 12.5 mg film-coated tablets Rasilez HCT 300 mg/ 25 mg film-coated tablets Aliskiren/ hydrochlorothiazide
Rasilez HCT 150 mg/ 12. 5 mg pilloli miksijin b’ rita Rasilez HCT 150 mg/ 25 mg pilloli miksijin b’ rita Rasilez HCT 300 mg/ 12. 5 mg pilloli miksijin b’ rita Rasilez HCT 300 mg/ 25 mg pilloli miksijin b’ rita Aliskiren/ hydrochlorothiazide
What Rasilez HCT is and what it is used for 2.
X’ inhu Rasilez HCT u għalxiex jintuża 2.
Before you take Rasilez HCT 3.
Qabel ma tieħu Rasilez HCT 3.
How to take Rasilez HCT 4.
Kif għandek tieħu Rasilez HCT 4.
How to store Rasilez HCT 6.
Kif taħżen Rasilez HCT 6.
WHAT RASILEZ HCT IS AND WHAT IT IS USED FOR
X’ INHU RASILEZ HCT U GĦALXIEX JINTUŻA 1.
Rasilez HCT tablets contain two active substances, called aliskiren and hydrochlorothiazide.
Il- pilloli ta ’ Rasilez HCT fihom żewġ sustanzi attivi, li jisimhom aliskiren u hydrochlorothiazide.
Both of these substances help to control high blood pressure (hypertension).
It - tnejn li huma jgħinu sabiex tikkontrolla il- pressjoni għolja (ipertensjoni).
Aliskiren is a substance that belongs to a new group of medicines called renin inhibitors.
Aliskiren huwa sustanza li tagħmel parti minn klassi ġdida ta ’ mediċini li jissejjħu inibituri ta ’ renin.
These reduce the amount of angiotensin II the body can make.
Dawn inaqqsu l- ammont ta ’ angiotensin II li l- ġisem jista ’ jipproduċi.
Angiotensin II causes blood vessels to tighten, which makes blood pressure higher.
B’ angiotensin II il- vini tad - demm jidjiequ u l- pressjoni tad- demm togħla.
Lowering the amount of angiotensin II allows the blood vessels to relax; this lowers blood pressure.
Bit- tnaqqis ta ’ angiotensin II, il- vini tad- demm jistrieħu, u l- pressjoni tad- demm titbaxxa.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics.
Hydrochlorothiazide jagħmel parti minn grupp ta ’ mediċini li jissejħu dijuretiċi thiazide.
Hydrochlorothiazide increases urine output, which also lowers blood pressure.
Hydrochlorothiazide iżid l- ammont ta ’ awrina li tgħaddi, li ukoll tbaxxi il- pressjoni tad- demm.
Lowering the blood pressure to a normal level reduces the risk of developing these disorders.
Billi tbaxxi l- pressjoni tad- demm għal- livelli normali jitnaqqas ir- riskju li tiżviluppa dawn id- disturbi.
Rasilez HCT is used to treat high blood pressure.
Rasilez HCT jintuża biex tiġi ikkurata l- pressjoni għolja tad- demm.
BEFORE YOU TAKE RASILEZ HCT
QABEL MA TIEĦU RASILEZ HCT
- if you are allergic (hypersensitive) to aliskiren or hydrochlorothiazide, to sulphonamide-derived
Tieħux Rasilez HCT jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal aliskiren jew hydrochlorothiazide, – derivati ta ’ sulphonamide (mediċini li jintużaw għal- kura ta ’ infezzjonijiet fis- sider jew tal - awrina) jew sustanzi oħra ta ’ Rasilez HCT.
- if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for
Jekk taħseb li tista ’ tkun allerġiku/ a, tieħux Rasilez HCT u staqsi lit- tabib tiegħek għall- parir. – jekk diġà għaddejt minn anġjoedima (tbatija biex tieħu n- nifs, jew biex tibla ’, jew nefħa tal - wiċċ, idejn u saqajn, għajnejn u/ jew l- ilsien) meta ħadt aliskiren. – jekk qiegħda bejn it- tielet u d- disa ’ xahar tat- tqala.
If any of the above applies to you, do not take Rasilez HCT and talk to your doctor.
119 – jekk qed tredda ’. – jekk għandek problemi serji tal- fwied jew tal- kliewi. – jekk il- livell ta ’ potassium jew sodium fid- demm tiegħek huwa baxx wisq minkejja l- kura, jew jekk il- livell ta ’ calcium fid- demm tiegħek huwa għoli wisq minkejja l- kura. – jekk qed tieħu ciclosporin (mediċina li tintuża f’ każ ta ’ trapjant sabiex jiġi evitat li l- organu jiġi riġettat jew għal kundizzjonijiet oħra, eż. artrite rewmatojde jew dermatite atopika) jew verapamil (mediċina li tintuża biex tbaxxi l- pressjoni tad- demm, biex tirranġa r- ritmu tal- qalb jew għall- kura ta ’ anġina pektoris) jew quinidine (mediċina li tintuża biex tirranġa r- ritmu tal - qalb).
- if you have a high level of cholesterol or triglycerides in your blood.
Jekk xi waħda minn dawn ta ’ hawn fuq tgħodd għalik, tieħux Rasilez HCT u kellem lit- tabib tiegħek.
drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Rasilez HCT).
Oqgħod attent ħafna b’ Rasilez HCT − jekk tbati minn problemi tal- kliewi, inkluż jekk kellek trapjant tal- kliewi. − jekk tbati minn problemi tal- fwied. − jekk tbati minn problemi tal- qalb. − Jekk tbati minn anġjoedima (tbatija biex tieħu n- nifs, jew biex tibla ’, jew nefħa tal- wiċċ, idejn u saqajn, għajnejn u/ jew l- ilsien). − jekk għandek id- dijabete (zokkor għoli fid- demm). − jekk għandek livell għoli ta ’ kolesterol jew trigliċeridi fid- demm tiegħek. − jekk għandek il- livell ta ’ potassium, sodium jew magnesium fid- demm tiegħek ikunu baxxi jew jekk għandek livell għoli ta ’ calcium fid- demm tiegħek. − jekk tbati minn marda li tissejjaħ lupus erythematosus (magħrufa wkoll bħala “ lupus ” jew “ SLE ”). − jekk tbati minn allerġija jew ażżma. − jekk qiegħed/ qiegħda fuq dieta baxxa mill- melħ − jekk għandek sinjali u sintomi bħal għatx anormali, ħalq xott, dgħjufija ġenerali, ngħas, uġigħ fil- muskoli jew bugħawwieġ, dardir, jew il- qalb tħabbat mgħaġġla b’ mod anormali li tista ’ tindika effett eċċessiv ta; hydrochlorothiazide (li jinsab f’ Rasilez HCT).
Tell your doctor if any of the above applies to you.
Għid lit- tabib tiegħek jekk xi waħda minn dawn ta ’ hawn fuq tgħodd għalik.
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
- potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines.
Huwa importanti b’ mod partikolari li tgħid lit- tabib tiegħek jekk qed tuża il- mediċini li ġejjin: − mediċini li fihom lithium li jintuża għall- kura ta ’ ċerti tipi ta ’ mard psikjatriku. − supplimenti tal- potassium, melħ tal- ikel sostitut li jkun fih il- potassium jew mediċini li ma jħallux il- potassium jintilef. − dijuretiċi oħrajn (pilloli tal- pipì). − ċerti porog. − mediċini li jintużaw għal- kura tal- gotta. − supplimenti tal- vitamina D terapewtiċi. − mediċini sabiex tikkontrolla ir- ritmu tal- qalb. − mediċini għall- kura tad- dijabete (sustanzi orali jew insulini). − mediċini biex tbaxxi l- pressjoni tad- demm. − sterojdi. − mediċini għal- kura tal- kanċer. − mediċini li jneħħu l- uġigħ. − mediċini għall- artrite.
- some medicines used to treat infections, such as ketoconazole, amphotericin or penicillin G.
120 It- tabib tiegħek jista ’ jkollu bżonn jibdillek id- doża u/ jew jieħu xi prekawzjonijiet oħra jekk qed tieħu xi waħda mill- mediċini li ġejjin: − furosemide, mediċina li tagħmel parti minn dawk magħrufin bħala dijuretiċi, jew pilloli “ tal - pipi ”, li jintużaw biex jiżdied l- ammont ta ’ awrina li tagħmel. − xi mediċina li tintuża biex tikkura infezzjonijiet, bħal ketoconazole, amphotericin jew penicillin G.
120 Taking Rasilez HCT with food and drink You should take Rasilez HCT with a light meal once a day, preferably at the same time each day.
Meta tieħu Rasilez HCT mal- ikel u max- xorb Għandek tieħu Rasilez HCT ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin kuljum.
You should not take Rasilez HCT together with grapefruit juice.
M’ għandekx tieħu Rasilez HCT mal- meraq tal- grejpfrut.
Pregnancy and breast-feeding Do not take Rasilez HCT if you are pregnant.
Tqala u treddigħ Tieħux Rasilez HCT jekk ħriġt tqila.
Do not breast-feed if you are taking Rasilez HCT.
Treddax jekk qed tieħu Rasilez HCT.
Driving and using machines As with many other medicines used to treat high blood pressure, this medicine may make you feel dizzy.
Sewqan u tħaddim ta ’ magni Bħall - ħafna mediċini oħrajn li jintużaw biex ibaxxu l- pressjoni, b’ din il- mediċina tista ’ tħossok sturdut.
If you experience this symptom, do not drive or use tools or machines.
Jekk iġġarrab dan is- sintomu, issuqx u tħaddimx għodod jew magni.
Important information about some of the ingredients of Rasilez HCT Rasilez HCT contains lactose (milk sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Rasilez HCT Rasilez HCT fih lactose (zokkor tal- ħalib).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib qallek li għandek intolleranza għal ċerti tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
Rasilez HCT contains wheat starch.
Rasilez HCT fih il- wheat starch (lamtu tal- qamħ).
It is suitable for people with coeliac disease.
Indikat għan- nies li jbatu minn mard tas- coeliac.
HOW TO TAKE RASILEZ HCT
KIF GĦANDEK TIEĦU RASILEZ HCT
Always take Rasilez HCT exactly as your doctor has told you.
Dejjem għandek tieħu Rasilez HCT eżatt skond il- parir tat- tabib tiegħek.
The usual dose of Rasilez HCT is one tablet a day.
Id- doża ta ’ Rasilez HCT li ssoltu tingħata hija pillola waħda kuljum.
You should take Rasilez HCT with a light meal once a day, preferably at the same time each day.
Għandek tieħu Rasilez HCT ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin kuljum.
You should not take Rasilez HCT together with grapefruit juice.
M’ għandekx tieħu Rasiler HCT flimkien mal- meraq tal- grejpfrut.
During your treatment, your doctor may adjust your dose depending on your blood pressure response.
Waqt il- kura tiegħek, it- tabib tiegħek jista ’ jaġġusta d- doża tiegħek skond ir- rispons tal- pressjoni tad- demm tiegħek.
Rasilez HCT may have been prescribed to you because your previous treatment did not lower your blood pressure enough.
Rasilez HCT jista ’ jkun ġie ordnat lilek minħabba li l- kura li ingħatajt qabel ma baxxietlekx il - pressjoni tad- demm tiegħek biżżejjed.
If this is the case, your doctor will tell you how to switch from that treatment to Rasilez HCT.
Jekk dan huwa l- każ, it- tabib tiegħek ser jgħidlek kif taqleb minn dik il- kura għal Rasilez HCT.
If you take more Rasilez HCT than you should If you have accidentally taken too many Rasilez HCT tablets, talk to a doctor immediately.
Jekk tieħu Rasilez HCT aktar milli suppost Jekk bi żball ħadt wisq pilloli Rasilez HCT, ikkonsulta mat- tabib tiegħek minnufih.
If you forget to take Rasilez HCT If you forget to take a dose of this medicine, take it as soon as you remember and then take the next dose at its usual time.
Jekk tinsa tieħu Rasilez HCT Jekk tinsa tieħu doża ta ’ din il- mediċina, ħuda malli tiftakar u imbagħad ħu d- doża li jmiss fil- ħin tagħha tas- soltu.
If it is almost time for your next dose you should simply take the next tablet at the usual time.
Jekk ikun kważi wasal il- ħin tad- doża li jmissek għandek sempliċiment tieħu il - pillola li jmiss fil- ħin tas- soltu.
Do not stop taking this medicine, even if you are feeling well (unless your doctor tells you to do so).
121 Tieqafx tieħu din il- mediċina, anki jekk tkun qed tħossok tajjeb/ tajba (sakemm it- tabib tiegħek ma jgħidlekx biex tagħmel dan).
Like all medicines, Rasilez HCT can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Rasilez HCT jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu jseħħu b’ ċerti frekwenzi, li huma ddefiniti kif ġej: komuni ħafna: jaffettwaw aktar minn persuna 1 minn kull 10 li jużawh komuni: jaffettwaw minn persuna waħda sa 10 persuni minn kull 100 li jużawh mhux komuni: jaffettwaw minn persuna waħda sa 10 persuni minn kull 1, 000 li jużawh rari: jaffettwaw minn persuna waħda sa 10 persuni minn kull 10, 000 li jużawh rari ħafna: jaffettwaw anqas minn persuna waħda minn kull 10, 000 li jużawh mhux magħuf: ma tistax tittieħed stima tal- frekwenza mid- data disponibbli.
Side effects reported in clinical studies for patients treated with Rasilez HCT were:
Effetti sekondarji irrappurtati fi provi kliniċi għal pazjenti b’ Rasilez HCT kienu:
- Common:
- Komuni:
As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Bħal ma jgħodd għall- kwalunkwe taħlita ta ’ żewġ sustanzi attivi, effetti sekondarji assoċjati ma ’ kull komponent individwali ma jistgħux jiġu esklużi.
In patients taking aliskiren alone, in addition to the side effects listed above, angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/ or tongue) (rare), skin rash (uncommon) and kidney problems (unknown) have also been reported.
F’ pazjenti li jieħdu aliskiren waħdu, minbarra l- effett sekondarju elenkat hawn fuq, anġjoedima (tbatija biex tieħu n- nifs, jew biex tibla ’, jew nefħa tal- wiċċ, idejn u saqajn, għajnejn u/ jew ilsien) (rari), raxx tal- ġilda (mhux komuni) u problemi fil- kliewi (mhux magħrufa) kienu rrappurtati wkoll.
The other component of Rasilez HCT (hydrochlorothiazide) has been associated rarely with other more serious side effects mainly affecting the blood, the skin or the kidneys.
Il- komponent l- ieħor ta ’ Rasilez HCT (hydrochlorothiazide) kien assoċjat rarament ma ’ effetti sekondarji oħrajn aktar serji l- aktar li jaffettwaw id- demm, il- ġilda jew il- kliewi.
While these side effects were not observed with Rasilez HCT, occurrence of such side effects cannot be excluded.
Fil- waqt li dawn l- effetti sekondarji ma dehrux b’ Rasilez HCT, ma jistax jiġi eskluż li dawn l- effetti sekondarji jistgħu jseħħu.
HOW TO STORE RASILEZ HCT
KIF TAĦŻEN RASILEZ HCT
Do not use Rasilez HCT after the expiry date which is stated on the carton.
Tużax Rasilez HCT wara d- data ta ’ skadenza li tidher fuq il- kartuna.
Store in the original package in order to protect from moisture.
Żommu fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
- Each Rasilez HCT 150 mg/ 12.5 mg film-coated tablet contains 150 mg aliskiren (as
X’ fih Rasilez HCT − Kull pillola miksija b’ rita ta ’ Rasilez HCT 150 mg/ 12. 5 mg fiha 150 mg aliskiren (bħala il - hemifumarate) u 12. 5 mg hydrochlorothiazide.
The other ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171).
Is- sustanzi l- oħra huma cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171). − Kull pillola miksija b’ rita ta ’ Rasilez HCT 150 mg/ 25 mg fiha 150 mg aliskiren (bħala il - hemifumarate) u 25 mg hydrochlorothiazide.
The other ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
Is- sustanzi l- oħra huma cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172). − Kull pillola miksija b’ rita ta ’ Rasilez HCT 300 mg/ 12. 5 mg fiha 300 mg aliskiren (bħala il - hemifumarate) u 12. 5 mg hydrochlorothiazide.
The other ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171), red
Is- sustanzi l- oħra huma cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172). − Kull pillola miksija b’ rita ta ’ Rasilez HCT 300 mg/ 25 mg fiha 300 mg aliskiren (bħala il - hemifumarate) u 25 mg hydrochlorothiazide.
The other ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
Is- sustanzi l- oħra huma cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
What Rasilez HCT looks like and contents of the pack Rasilez HCT 150 mg/ 12.5 mg film-coated tablets are white, oval film-coated tablets imprinted with “ LCI” on one side and “ NVR” on the other.
Id- Dehra ta ’ Rasilez HCT u l- kontenuti tal- pakkett Rasilez HCT 150 mg/ 12. 5 mg pilloli miksijin b’ rita huma pilloli miksijin b’ rita bojod, ovali stampati b ’ “ LCI ” fuq naħa u “ NVR ” fuq l- oħra.
Rasilez HCT 150 mg/ 25 mg film-coated tablets are pale yellow, oval film-coated tablets imprinted with “ CLL” on one side and “ NVR” on the other.
Rasilez HCT 150 mg/ 25 mg pilloli miksijin b’ rita huma pilloli miksijin b’ rita jagħtu fl- isfar, ovali stampati b ’ “ CLL ” fuq naħa u “ NVR ” fuq l- oħra.
Rasilez HCT 300 mg/ 12.5 mg film-coated tablets are violet white, oval film-coated tablets imprinted with “ CVI” on one side and “ NVR” on the other.
Rasilez HCT 300 mg/ 12. 5 mg pilloli miksijin b’ rita huma pilloli miksijin b’ rita vjola bojod, ovali stampati b ’ “ CVI ” fuq naħa u “ NVR ” fuq l- oħra.
Rasilez HCT 300 mg/ 25 mg film-coated tablets are light yellow, oval film-coated tablets imprinted with “ CVV” on one side and “ NVR” on the other.
Rasilez HCT 300 mg/ 25 mg pilloli miksijin b’ rita huma pilloli miksijin b’ rita sofor ċari, ovali stampati b ’ “ CVV ” fuq naħa u “ NVR ” fuq l- oħra.
Rasilez HCT is available in packs containing 7, 14, 28, 30, 50, 56, 90, or 98 tablets.
Rasilez HCT jiġi f’ pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 90 jew 98 pillola.
Packs containing 90 (3x30), 98 (2x49) or 280 (20x14) tablets are multi-packs.
Pakketti li fihom 90 (3x30), 98 (2x49) jew 280 (20x14) pillola huma pakketti b’ ħafna.
Not all pack sizes or strengths may be available in your country.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jew il- qawwiet kollha jkunu għal skop kummerċjali f’ pajjiżek.
Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Id- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
123 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq:
Latvija Novartis Pharma Services Inc.
124 Latvija Novartis Pharma Services Inc.
124
125
pre-filled syringe 0.5 ml (glass)
siringa mimlija 0. 5 ml għal- lest (ħġieġ)
pre-filled syringe 0.8 ml (glass)
siringa mimlija 0. 8 ml għal- lest (ħġieġ)
Ratiograstim 30 MIU/ 0.5 ml solution for injection or infusion
Ratiograstim 30 MIU/ 0. 5ml soluzzjoni għall- injezzjoni jew infużjoni