FrancophonIA/ELRC3.0 huggingface dataset:
English: Pressor amines (e.g. noradrenaline, adrenaline): Hydrochlorothiazide may reduce the response to pressor amines such as noradrenaline.
Maltese: Pressor amines (eż. noradrenalina, adrenalina): Hydrochlorothiazide jista' jnaqqas ir-rispons ta' amini pressivi bħan-noradrenalina.
English: Riprazo HCT is available in packs containing 7, 14, 28, 30, 50, 56, 90,or 98 tablets.
Maltese: Riprazo HCT jiġi f'pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 90 jew 98 pillola.
English: Riprazo HCT was studied in a placebo-controlled trial including 2,762 hypertensive patients with diastolic blood pressure ≥ 95 mmHg and < 110 mmHg (mean baseline blood pressure of 153.6/99.2 mmHg).
Maltese: Riprazo HCT kien studjat fi prova ikkontrollata bi plaċebo li kienet tinkludi 2,762 pazjent bilpressjoni għolja bil-pressjoni dijastolika ≥ 95 mmHg u < 110 mmHg (pressjoni medja tal-linja bażi ta' 153.6/99.2 mmHg).
English: Riprazo HCT 150 mg/12.5 mg film-coated tablets Riprazo HCT 150 mg/25 mg film-coated tablets Riprazo HCT 300 mg/12.5 mg film-coated tablets Riprazo HCT 300 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Maltese: Riprazo HCT 150 mg/12.5 mg pilloli miksijin b'rita Riprazo HCT 150 mg/25 mg pilloli miksijin b'rita Riprazo HCT 300 mg/12.5 mg pilloli miksijin b'rita Riprazo HCT 300 mg/25 mg pilloli miksijin b'rita Aliskiren/hydrochlorothiazide
English: Investigations Very common:
Maltese: Investigazzjonijiet Komuni:
English: The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
Maltese: Il-potenzjal ta' interazzjonijiet fis-sit P-gp x'aktarx li jkun jiddependi millgrad ta' inibizzjoni ta' dan it-trasportatur.
English: Warfarin: The effects of aliskiren on warfarin pharmacokinetics have not been evaluated.
Maltese: L-effetti ta' aliskiren fuq il-farmakokinetika ta' warfarin ma kienux evalwati.
English: Hepatobiliary disorders Rare:
Maltese: Disturbi psikjatriċi Rari:
English: Single-packs (perforated unit dose blister) containing 56 x 1 tablets.
Maltese: Pakketti b'wieħed (folja mtaqqba b'doża waħda) li jkun fihom 56 x 1 pillola.
English: Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq Novartis Europharm Limited Wimblehurst Road
English: The safety of Riprazo 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.
Maltese: Is-sigurtà ta' Riprazo 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.
English: Multi-packs containing 90, 98 or 280 tablets.
Maltese: Pakketti b'ħafna li jkun fihom 90, 98 jew 280 pillola.
English: (asthenia)
Maltese: (ara s-sezzjoni dwar it-Tqala).
English: 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
Maltese: 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
English: - vitamin D and calcium salts.
Maltese: Vitamina D u mluħa tal-kalċju:
English: Angioedema Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni:
English: The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent Pglycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated (see section 4.5).
Maltese: L-użu konkomittanti ta' aliskiren ma' ciclosporin u itraconazole, żewġ inibituri ta' Pglycoprotein (P-gp) qawwija ħafna, u inibituri ta' P-gp qawwija oħrajn (eż. quinidine), huwa kontra-indikat (ara sezzjoni 4.5).
English: No pharmacokinetic data are available in the paediatric population.
Maltese: M'hemmx dejta farmakokinetika għall-popolazzjoni pedjatrika.
English: P-glycoprotein interactions: 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.
Maltese: Interazzjonijiet ma' glikoproteina P: 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.
English: Cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, vasculitis necrotising and toxic epidermal necrolysis
Maltese: Reazzjonijiet fil-ġilda bħal f'lupus erythematosus, riattivazzjoni ta' lupus erythematosus fil-ġilda, vaskulite li tinnekrotizza u nekroliżi epidermali tossika
English: Vascular disorders Uncommon:
Maltese: Disturbi vaskulari Komuni:
English: Increases in cholesterol and triglycerides
Maltese: Żieda fil-kolesterol u t-trigliċeridi
English: Immune system disorders Rare:
Maltese: Anemija aplastika Disturbi fis-sistema immuni Rari ħafna:
English: The following adverse reactions have been reported in patients treated with thiazide diuretics alone, including hydrochlorothiazide:
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrappurtati f'pazjenti li ngħataw kura b'dijuretiċi thiazide biss, inkluż hydrochlorothiazide:
English: 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), black iron oxide (E172).
Maltese: 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).
English: 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).
Maltese: 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).
English: - pain killers such as non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors).
Maltese: Mediċini anti-infjammatorji mhux sterojdi (NSAIDs) inklużi inibituri selettivi cyclooxygenase-2 (inibituri COX-2), aċidu aċetilsaliċiliku, u NSAIDs mhux selettivi:
English: Impotence General disorders and administration site conditions Not known:
Maltese: Impotenza Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Mhux magħruf:
English: Multi-packs (perforated unit dose blister) containing 98 x 1 tablets.
Maltese: Pakketti b'ħafna (folja mtaqqba b'doża waħda) li jkun fihom 98 x 1 pillola.
English: The other ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171).
Maltese: Is-sustanzi l-oħra huma cellulose microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, titanium dioxide (E171).
English: Very rare: Psychiatric disorders Rare: Nervous system disorders Rare: Eye disorders Rare: Not known: Cardiac disorders Rare: Vascular disorders Common: Respiratory, thoracic and mediastinal disorders Very rare:
Maltese: Disturbi fis-sistema nervuża Komuni: Disturbi vaskulari Mhux komuni: Disturbi gastro-intestinali Komuni: Disturbi fis-sistema immuni Rari:
English: Riprazo HCT tablets contain two active substances, called aliskiren and hydrochlorothiazide.
Maltese: Il-pilloli ta' Riprazo HCT fihom żewġ sustanzi attivi, li jisimhom aliskiren u hydrochlorothiazide.
English: Treatment with Aliskiren up to 300 mg resulted in an overall incidence of adverse reactions similar to placebo.
Maltese: Kura b'aliskiren sa 300 mg wasslet għal frekwenza ta' reazzjonijiet avversi simili għall-plaċebo.
English: Coating:
Maltese: Dijarea:
English: Muscle spasm Renal and urinary disorders Not known:
Maltese: Rilassanti tal-muskoli skeletriċi li mhumiex depolarizzanti:
English: Due to the hydrochlorothiazide component, Riprazo HCT is contraindicated in symptomatic hyperuricaemia (see section 4.3).
Maltese: Minħabba l-komponent ta' hydrochlorothiazide, Riprazo HCT hu kontraindikat f'iperurikemija sintomatika (ara sezzjoni 4.3).
English: HOW TO STORE RIPRAZO HCT
Maltese: X'fih Riprazo HCT
English: Treatment with Riprazo HCT had an overall incidence of adverse experiences at doses up to 300 mg/25 mg similar to placebo.
Maltese: Kura b'Riprazo HCT kellha frekwenza globali ta' esperjenzi avversi b'dożi sa' 300 mg/25 mg simili għall-plaċebo.
English: P-gp potent inhibitors: 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.
Maltese: Inibituri potenti ta' P-gp: 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.
English: There have also been reports of peripheral oedema, increase in blood creatinine and severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN) and oral mucosal reactions.
Maltese: Kien hemm ukoll rapporti ta' edima periferali, żieda fil-kreatinina fid-demm u reazzjonijiet avversi serji fuq il-ġilda (SCARs), inkluża n-nekroliżi epidermali tossika (TEN) u reazzjonijiet mukużi fil-ħalq.
English: Ion exchange resins: Absorption of thiazide diuretics, including hydrochlorothiazide, is decreased by cholestyramine or colestipol.
Maltese: L-assorbiment ta' dijuretiċi thiazide, inkluż hydrochlorthiazide, jonqos permezz ta' kolestiramina jew kolestipol.
English: Riprazo HCT is contraindicated in patients with anuria or severe renal impairment (GFR < 30 ml/min/1.73 m2) and the concomitant use of Riprazo HCT with ARBs or ACEIs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m
Maltese: Riprazo HCT huwa kontraindikat f'pazjenti li jbatu minn anurja jew indeboliment renali sever (GFR < 30 ml/min/1.73 m2) u l użu konkomitanti ta' Riprazo HCT ma' ARBs jew ACEIs huwa kontra-indikat f'pazjenti b'indeboliment renali (GFR < 60 ml/min/1.73 m2) (ara sezzjoni 4.3).
English: - arthritis medicines.
Maltese: - anġjoedima ereditarja.
English: 24 months
Maltese: 24 xahar
English: The adverse drug reactions previously reported with one of the individual components of Riprazo HCT (aliskiren and hydrochlorothiazide) and listed in the respective paragraphs on the individual components may occur with Riprazo HCT.
Maltese: Ir-reazzjonijiet avversi tal-mediċina rrappurtati qabel b'wieħed mill-komponenti individwali ta' Riprazo HCT (aliskiren u hydrochlorothiazide) u elenkati fil-paragrafi rispettivi dwar il-komponenti individwali jistgħu jseħħu b'Riprazo HCT.
English: Medicinal products affected by serum potassium disturbances: Periodic monitoring of serum potassium is recommended when Riprazo HCT is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Maltese: Prodotti mediċinali effettwati minn disturbi tal-potassium fis-serum: Monitoraġġ perjodiku talpotassium fis-serum huwa irrikkmandat meta Riprazo HCT jingħata ma' prodotti mediċinali effettwati minn disturbi tal-potassium fis-serum (eż. digitalis glycosides, anti-arritmijaċi).
English: In another clinical trial, the efficacy and safety of Riprazo HCT were also assessed in 489 obese hypertensive patients who did not respond to hydrochlorothiazide 25 mg (baseline systolic/diastolic blood pressure 149.4/96.8 mmHg).
Maltese: Fi prova klinika oħra, l-effikaċja u s-sigurtà ta' Riprazo HCT ħċ kienet evalwata f'489 pazjent obeż bi pressjoni għolja li ma wrewx rispons għal hudrochlorothiazide 25 mg (linja bażi tal-pressjoni sistolika/dijastolika tad-demm 149.4/96.8 mmHg).
English: When administered in hypertensive patients with markedly elevated blood pressure (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), Riprazo HCT in doses from 150 mg/12.5 mg to 300 mg/25 mg administered without up-titration from monotherapy demonstrated significantly greater systolic/diastolic blood pressure control rates (< 140/90 mmHg) as compared to the respective monotherapies.
Maltese: Meta tingħata f'pazjenti li jsofru minn pressjoni għolja u li għandhom pressjoni għolja ħafna (pressjoni sistolika ≥ 160 mmHg u/jew pressjoni dijastolika ≥ 100 mmHg), dożi ta' Riprazo HCT minn 150 mg/12.5 mg sa 300 mg/25 mg mogħtija mingħajr titrazzjoni tad-doża aktar minn monoterapija wrew rati ta' kontroll tal-pressjoni sistolika/dijastolika tad-demm (< 140/90 mmHg) meta imqabbla ma' monoterapiji rispettivi.
English: Therefore, caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors (clarithromycin, telithromycin, erythromycin, amiodarone).
Maltese: Għalhekk għandha issir kawtela meta aliskiren jingħata ma' ketoconazole, verapamil jew inibituri moderati oħrajn ta' Pgp (clarithromycin, telithromycin, erythromycin, amiodarone).
English: No dosage adjustment is necessary in patients with mild to moderate renal impairment (GFR ≥ 30 ml/min/1.73 m
Maltese: M'hemmx bżonn ta' aġġustar tad-dożaġġ f'pazjenti b'indeboliment renali minn ħafif għal moderat (GFR ≥ 30 ml/min/1.73 m
English: The rate and extent of absorption of Riprazo HCT are equivalent to the bioavailability of aliskiren and hydrochlorothiazide when administered as individual monotherapies.
Maltese: Ir-rata u l-livell ta' assorbiment ta' Riprazo HCT huma ekwivalenti għal biodisponibilità ta' aliskiren u hydrochlorothiazide meta jingħataw bħala monoterapiji individwali.
English: Co-administration of aliskiren 300 mg with ketoconazole 200 mg or verapamil 240 mg resulted in a 76% or 97% increase in aliskiren AUC, respectively.
Maltese: L-għotja fl-istess ħin ta' aliskiren 300 mg ma' ketoconazole 200 mg jew verapamil 240 mg wasslet għal żieda ta' 76% jew 97% fl-AUC ta' aliskiren, rispettivament.
English: Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
Maltese: Reazzjonijiet avversi ġeneralment kienu ħfief fin-natura tagħhom u rarament kienu jeħtieġu twaqqif tat-terapija.
English: Blood and lymphatic system disorders Rare:
Maltese: Disturbi tad-demm u tas-sistema limfatika Rari:
English: If blood pressure remains uncontrolled after 2-4 weeks of therapy, the dose may be titrated up to a maximum of Riprazo HCT 300 mg/25 mg daily.
Maltese: Jekk il-pressjoni tibqa' ma tkunx ikkontrollata wara 2-4 ġimgħat ta' kura, d-doża tista' tiġi titrata sa massimu ta' Riprazo HCT 300 mg/25 mg kuljum.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu
English: Furosemide: When aliskiren was co-administered with furosemide, the AUC and Cmax of furosemide were reduced by 28% and 49%, respectively.
Maltese: Meta aliskiren ingħata ma' furosemide, l-AUC u Cmax ta' furosemide tnaqqsu b'28% u 49% rispettivament.
English: In this population, Riprazo HCT 150 mg/12.5 mg to 300 mg/25 mg provided dose-dependent systolic/diastolic blood pressure reduction from 20.6/12.4 mmHg to 24.8/14.5 mmHg, which were significantly superior to the respective monotherapies.
Maltese: F'din il-popolazzjoni, Riprazo HCT 150 mg/12.5 mg sa 300 mg/25 mg ipprovdiet tnaqqis fil-pressjoni sistolika/dijastolika tad-demm minn 20.6/12.4 mmHg sa 24.8/14.5 mmHg, li kienu superjuri b'mod sinifikanti għal monoterapiji rispettivi.
English: EU/1/11/680/070 EU/1/11/680/071 EU/1/11/680/072 EU/1/11/680/073 EU/1/11/680/074 EU/1/11/680/075 EU/1/11/680/076
Maltese: EU/1/11/680/070 EU/1/11/680/071 EU/1/11/680/072 EU/1/11/680/073 EU/1/11/680/074
English: Amantadine: Thiazides, including hydrochlorothiazide, may increase the risk of adverse reactions caused by amantadine.
Maltese: It-thiazides, inkluż hydrochlorthiazide, jistgħu jżidu r-riskju ta' reazzjonijiet avversi kkawżati minn amantadina.
English: In this study, Riprazo HCT in doses from 150 mg/12.5 mg to 300 mg/25 mg produced dose-dependent blood pressure reductions (systolic/diastolic) from 17.6/11.9 mmHg to 21.2/14.3 mmHg, respectively, compared to 7.5/6.9 mmHg with placebo.
Maltese: F'dan l-istudju, Riprazo HCT f'dożi minn 150 mg/12.5 mg sa 300 mg/25 mg ikkawżaw tnaqqis fil-pressjoni tad-demm (sistolika/dijastolika) minn 17.6/11.9 mmHg sa 21.
English: Renal artery stenosis and renovascular hypertension No controlled clinical data are available on the use of Riprazo HCT in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Maltese: Stenożi tal-arterja renali u pressjoni renovaskulari għolja M'hemmx tagħrif kliniku kkontrollat dwar l-użu ta' Riprazo HCT f'pazjenti bi stenożi tal-arterja renali unilaterali jew bilaterali, jew fi stenożi f'kilwa waħda.
English: Beta blockers and diazoxide: Concomitant use of thiazide diuretics, including hydrochlorothiazide, with beta blockers may increase the risk of hyperglycaemia.
Maltese: L-użu konkomitanti ta' dijuretiċi thiazide, inkluż hydrochlorthiazide, ma' imblukkaturi beta jista' jżid ir-riskju ta' ipergliċemija.
English: or an “angiotensin 2 receptor blocker” such as valsartan, telmisartan, irbesartan etc. - if you are on a low-salt diet. - if you have signs and symptoms such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Riprazo HCT).
Maltese: “imblukkatur tar-riċetturi ta' angiotensin 2” bħal valsartan, telmisartan, irbesartan, eċċ. 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'Riprazo HCT). jekk ikollok reazzjonijiet fil-ġilda bħal raxx wara esponiment għax-xemx. jekk ikollok tnaqqis fil-vista jew uġigħ fl-għajn.
English: In this difficult-to-treat population, Riprazo HCT provided a blood pressure reduction (systolic/diastolic) of 15.8/11.9 mmHg compared to 15.4/11.3 mmHg for irbesartan/hydrochlorothiazide, 13.6/10.3 mmHg for amlodipine/hydrochlorothiazide and 8.6/7.9 mmHg for hydrochlorothiazide monotherapy, with similar safety to hydrochlorothiazide monotherapy.
Maltese: 3 mmHg għal amlodipine/hydrochlorothiazide u 8.6/7.9 mmHg għal monoterapija b'hydrochlorothiazide, b'sigurtà simili għal monoterapija b'hydrochlorothiazide.
English: Risk Management Plan (RMP)
Maltese: Sistema ta' l-immaniġġar tar-riskju (RMP)
English: Multipack comprising 3 packs, each containing 30 tablets.
Maltese: Pakkett b'ħafna li jinkludi 3 pakketti, kull wieħed fih 30 pillola.
English: Findings during repeat-dose toxicity studies in animals were consistent with the known local irritation potential or the expected pharmacological effects of aliskiren.
Maltese: Is-sejbiet waqt studji ta' tossiċità f'annimali minn dożi ripetuti kienu konsistenti mal-irritazzjoni lokali li hi magħrufa jew mal-effetti farmakoloġiċi mistennija ta' aliskiren.
English: Serum potassium: 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.
Maltese: 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.
English: - Each Riprazo HCT 300 mg/25 mg film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide.
Maltese: Kull pillola miksija b'rita ta' Riprazo HCT 300 mg/25 mg fiha 300 mg aliskiren (bħala ilhemifumarate) u 25 mg hydrochlorothiazide.
English: You may need to stop Riprazo HCT.
Maltese: Jista' jkun li jkollok twaqqaf Riprazo HCT.
English: • Tingling or numbness
Maltese: • Dardir u rimettar
English: 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).
Maltese: 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).
English: EU/1/11/680/050 EU/1/11/680/051 EU/1/11/680/052 EU/1/11/680/053 EU/1/11/680/054 EU/1/11/680/055 EU/1/11/680/056
Maltese: EU/1/11/680/051 EU/1/11/680/052 EU/1/11/680/053 EU/1/11/680/054
English: Excipients
Maltese: Iperkalimja
English: Riprazo HCT 300 mg/12.5 mg film-coated tablets Aliskiren/hydrochlorothiazide
Maltese: Riprazo HCT 300 mg/12.5 mg pilloli miksijin b'rita Aliskiren/hydrochlorothiazide
English: Concomitant use of Riprazo HCT with ARBs or ACEIs is contraindicated in patients with diabetes mellitus (see section 4.3).
Maltese: L-użu konkomitanti ta' Riprazo HCT ma' ARBs jew ACEIs huwa kontraindikat f'pazjenti b'dijabete mellitus (ara sezzjoni 4.3).
English: EU/1/11/680/021 EU/1/11/680/022 EU/1/11/680/023 EU/1/11/680/024 EU/1/11/680/025 EU/1/11/680/026
Maltese: EU/1/11/680/021 EU/1/11/680/022 EU/1/11/680/023 EU/1/11/680/024
English: Riprazo HCT 150 mg/12.5 mg film-coated tablets Aliskiren/hydrochlorothiazide
Maltese: Riprazo HCT 150 mg/12.5 mg pilloli miksijin b'rita Aliskiren/hydrochlorothiazide
English: Riprazo 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.
Maltese: Riprazo 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.
English: - Each Riprazo HCT 150 mg/25 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrocholorothiazide.
Maltese: Kull pillola miksija b'rita ta' Riprazo HCT 150 mg/25 mg fiha 150 mg aliskiren (bħala ilhemifumarate) u 25 mg hydrochlorothiazide.
English: Riprazo HCT 150 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Maltese: Riprazo HCT 150 mg/25 mg pilloli miksijin b'rita Aliskiren/hydrochlorothiazide
English: What Riprazo HCT contains - Each Riprazo HCT 150 mg/12.5 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrocholorothiazide.
Maltese: Kull pillola miksija b'rita ta' Riprazo HCT 150 mg/12.5 mg fiha 150 mg aliskiren (bħala ilhemifumarate) u 12.5 mg hydrochlorothiazide.
English: Riprazo HCT 300 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Maltese: Riprazo HCT 300 mg/25 mg pilloli miksijin b'rita Aliskiren/hydrochlorothiazide
English: P-gp substrates or weak inhibitors: No relevant interactions with atenolol, digoxin, amlodipine or cimetidine have been observed.
Maltese: Ma dehru l-ebda interazzjonijiet rilevanti ma' atenolol, digoxin, amlodipine jew cimetidine.