natgillin/translations-raw huggingface dataset:
In post-marketing experience, renal dysfunction and cases of acute renal failure have been reported in patients at risk (see section 4.4). 
Nakon stavljanja lijeka u promet u rizičnih bolesnika prijavljena je disfunkcija bubrega i slučajevi akutnog zatajivanja bubrega (vidjeti dio 4.4).
In the majority of patients aged 65 years or older, the 300 mg dose of aliskiren shows no additional benefit in reducing blood pressure compared to the 150 mg dose. 
U većine bolesnika u dobi od 65 godina ili starijih, doza aliskirena od 300 mg ne pokazuje nikakvu dodatnu korist u snižavanju krvnog tlaka u usporedbi s dozom od 150 mg.
56 x 1 film-coated tablet 
56 x 1 filmom obloženih tableta
90 film-coated tablets (3x30) 
90 filmom obloženih tableta (3x30)
Results from an in vitro MDR1 human tissue study suggested an age and tissue dependent pattern of MDR1 (P-gp) transporter maturation. 
Rezultati iz in vitro ispitivanja MDR1 u ljudskom tkivu ukazali su na obrazac sazrijevanja MDR1 (P
280 film-coated tablets (20x14) 
280 filmom obloženih tableta (20x14)
Common (may affect up to 1 in 10 people): Diarrhoea, joint pain (arthralgia), high level of potassium in the blood, dizziness. 
Često (mogu se javiti u do 1 na 10 osoba): Proljev, bol u zglobovima (artralgija), povišena razina kalija u krvi, omaglica.
Unit packs containing 56x1 tablets in perforated unit dose blisters. 
Jedinična pakiranja koja sadrže 56x1 tabletu u perforiranim blisterima s jediničnim dozama.
The usual recommended starting dose of aliskiren in elderly patients is 150 mg. 
Uobičajena početna doza aliskirena koja se preporučuje u starijih bolesnika iznosi 150 mg.
If co-administration with an agent affecting the level of serum potassium is considered necessary, routine monitoring of potassium levels would be advisable. 
Ako se istodobna primjena s lijekom koji utječe na razinu kalija u serumu smatra nužnom, savjetuje se redovno praćenje razina kalija.
No effect on QT interval was reported in a randomised, double-blind, placebo, and active-controlled study using standard and Holter electrocardiography. 
U randomiziranom, dvostruko-slijepom, placebom i aktivno kontroliranom kliničkom ispitivanju, u kojem je korištena standardna i Holter elektrokardiografija, nije prijavljen učinak na QT-interval.
Increases in serum potassium have been observed with aliskiren in post-marketing experience and these may be exacerbated by concomitant use of other agents acting on the RAAS or by non-steroidal anti-inflammatory drugs (NSAIDs). 
Nakon stavljanja aliskirena u promet opažena su povišenja kalija u serumu, što može biti pogoršano istodobnom primjenom drugih lijekova koji djeluju na RAAS ili nesteroidnih prouupalnih lijekova (NSAIL-ova).
Combination therapy studies are available for aliskiren added to the diuretic hydrochlorothiazide, the calcium channel blocker amlodipine and the beta blocker atenolol. 
blokatoru kalcijevih kanala amlodipinu i beta-blokatoru atenololu.
Rasilez 150 mg film-coated tablets are available in the following packs: - Unit packs containing 7, 14, 28, 30, 50, 56, 90 or 98 tablets - Unit packs containing 56x1 tablets in perforated unit-dose blisters - Multipacks containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets - Multipacks containing 98 (2x49x1) tablets in perforated unit-dose blisters 
Rasilez 150 mg filmom obložene tablete su dostupne u sljedećim pakiranjima: - Jedinična pakiranja koja sadrže: 7, 14, 28, 30, 50, 56, 90 ili 98 tableta - Jedinična pakiranja koja sadrže 56x1 tableta u perforiranim blisterima s jediničnim dozama
84 film-coated tablets (3x28) 
84 filmom obložene tablete (3x28)
Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association (NYHA) functional class III-IV) (see section 5.1). 
York Heart Association (NYHA) funkcionalni stupanj III-IV) (vidjeti dio 5.1).
After multiple doses of furosemide (60 mg/day) co-administered with aliskiren (300 mg/day) to patients with heart failure the urinary sodium excretion and the urine volume were reduced during the first 4 hours by 31% and 24%, respectively, as compared to furosemide alone. 
primijenjenih istodobno s aliskirenom (300 mg/dan) bolesnicima sa zatajanjem srca izlučivanje natrija mokraćom i volumen mokraće bili su smanjenji tijekom prva 4 sata za 31% odnosno za 24%, u usporedbi s bolesnicima koji su primali furosemid zasebno.
Aliskiren was not teratogenic in rats or rabbits (see section 5.3). 
Aliskiren nije bio teratogen u štakora ili kunića
The incidence of adjudicated stroke was not significantly different between the aliskiren and enalapril groups (4.4% versus 4.0%; HR 1.12, 95% CI 0.848, 1.485) or between the combination and enalapril groups (3.7% versus 4.0%; HR 0.93, 95% CI 0.697, 1.251). 
Incidencija utvrđenog moždanog udara nije bila značajno različita između skupine na aliskirenu i one na enalaprilu (4,4% naspram 4,0%; omjer hazarda 1,12; interval pouzdanosti od 95% 0,848, 1,485) ili između skupine na kombinaciji odnosno enalaprilu (3,7% naspram 4,0%; omjer hazarda 0,93; interval pouzdanosti od 95% 0,697,
PHARMACEUTICAL FORM AND CONTENTS Multipack: 280 (20 packs of 14) film-coated tablets Multipack: 98 (2 packs of 49 x 1) film-coated tablets 
OBLIK I SADRŽAJ Višestruko pakiranje: 280 (20 pakiranja od 14) filmom obloženih tableta Višestruko pakiranje: 98 (2 pakiranja od 49 x 1) filmom obloženih tableta
However, since aliskiren has been shown to be a substrate for the organic anion-transporting polypeptide 1A2 (OATP1A2) (see section “Organic anion transporting polypeptide (OATP” below) inhibitors), there is a potential for aliskiren to reduce plasma torasemide exposure by an interference with the absorption process. 
Međutim, budući da se pokazalo da je aliskiren supstrat za polipeptidni prijenosnik organskih aniona 1A2 (OATP1A2) (vidjeti dio
Optional titration of the respective study drug doses to the next highest weight-based dose level was available by doubling the dose with each of the two allowed dose titrations, up to 600 mg (highest studied dose in adults) for aliskiren and 40 mg for enalapril in the ≥80 to ≤150 kg weight group, if medically necessary to control the mean sitting systolic blood pressure (i.e. msSBP should be less than the 90th percentile for age, gender and height). 
Titracija doza ispitivanog lijeka na sljedeću najvišu razinu doze temeljene na tjelesnoj težini bila je dostupna udvostručenjem doze sa svakom od dvije dopuštene titracije doze, do 600 mg (najviša ispitivana doza u odraslih) za aliskiren i 40 mg za enalapril u grupi tjelesne težine ≥80 do ≤150 kg, ako je bilo medicinski neophodno za kontrolu srednje vrijednosti sistoličkog krvnog tlaka u sjedećem položaju (tj. srednja vrijednost sistoličkog krvnog tlaka u sjedećem položaju treba biti niža od 90-e percentile za dob, spol i visinu).Ukupno, srednja dob bolesnika bila je 11,8 godina s 48,6% bolesnika u dobnoj skupini od 6-11 godina i 51,4% u dobnoj skupini od 12-17 godina.
The pharmacokinetics of aliskiren were evaluated in patients with end stage renal disease receiving haemodialysis. 
Farmakokinetika aliskirena bila je ocjenjivana u bolesnika na hemodijalizi u završnom stadiju bubrežne bolesti.
No overall clinically relevant adverse impact on paediatric patients aged 6 to 17 years was observed after treatment with aliskiren for up to one year based on physical development, assessed in patients with primary or secondary hypertension, and neurocognitive development assessed only in patients with secondary hypertension (19 patients: 9 previously treated with aliskiren and 10 previously treated with enalapril) (see section 4.2, 4.8, 5.1 and 5.2). 
ocijenjenog u bolesnika s primarnom ili sekundarnom hipertenzijom i neurokognitivnog razvoja ocijenjenog samo u bolesnika sa sekundarnom hipertenzijom (19 bolesnika: 9 prethodno liječenih aliskirenom i 10 prethodno liječenih enalaprilom) (vidjeti dijelove 4.2, 4.8, 5.1 i 5.2).
In a juvenile toxicity study in 8-day-old rats, aliskiren administration at 100 mg/kg/day and 300 mg/kg/day (2.3- and 6.8-fold the maximum recommended human dose) was associated with high mortality and severe morbidity. 
100 mg/kg/dan i 300 mg/kg/dan (2,3 i 6,8 puta više od najveće preporučene doze u ljudi) bila je povezana s visokim mortalitetom i teškim morbiditetom.
Mean weight was 68.0 kg with 57.7% of patients having BMI greater than or equal to the 95th percentile for age and gender. 
Srednja tjelesna težina je bila 68,0 kg s 57,7% bolesnika s indeksom tjelesne mase (BMI, engl.
98 film-coated tablets (2x49) 
98 filmom obloženih tableta (2x49)
These observed changes, however, did not correlate with the severity of renal impairment. 
Ove opažene promjene nisu bile u korelaciji s težinom oštećenja bubrežne funkcije.
Aliskiren has been evaluated for safety in a randomised, double-blind, 8-week study in 267 hypertensive patients aged 6 to 17 years, mostly overweight/obese, followed by an extension study including 208 patients treated for 52 weeks. 
Sigurnost aliskirena je procijenjena u randomiziranom, dvostruko-slijepom, 8-tjednom ispitivanju u kojem je sudjelovalo 267 hipertenzivnih bolesnika u dobi od 6 do 17 godina, uglavnom s prekomjernom težinom/pretili, nakon čega je slijedio nastavak ispitivanja koji je obuhvatio
In a pooled analysis of efficacy and safety data from clinical studies up to 12 months duration, there was no statistically significant difference in blood pressure reduction between aliskiren 300 mg and aliskiren 150 mg in elderly patients (≥ 65 years). 
U skupnoj analizi podataka o djelotvornosti i sigurnosti iz kliničkih ispitivanja trajanja do 12 mjeseci, nije bilo statistički značajne razlike u smanjenju krvnog tlaka između aliskirena
Multipack: 84 (3 packs of 28) film-coated tablets Multipack: 90 (3 packs of 30) film-coated tablets Multipack: 98 (2 packs of 49) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets 
Višestruko pakiranje: 84 (3 pakiranja od 28) filmom obložene tablete Višestruko pakiranje: 90 (3 pakiranja od 30) filmom obloženih tableta Višestruko pakiranje: 98 (2 pakiranja od 49) filmom obloženih tableta Višestruko pakiranje: 280 (20 pakiranja od 14) filmom obloženih tableta
Aliskiren is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2). 
Aliskiren se ne preporučuje bolesnicima s teškim oštećenjem bubrežne funkcije (GFR <30 ml/min/1,73 m2).
In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with aliskiren 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg. 
dodatno liječenje aliskirenom u dozi od 300 mg dovelo je do dodatnog sniženja krvnoga tlaka koje se moglo usporediti s dodatnim liječenjem od 300 mg irbesartana ili 10 mg amlodipina.
In this study, aliskiren at a target dose of 300 mg was compared to enalapril at a target dose of 20 mg when added to standard of care which included a beta blocker (and a mineralocorticoid receptor antagonist in 37% of patients) and a diuretic as needed. 
20 mg kada se dodaju standardu skrbi koji uključuje beta-blokator (i antagonist mineralokortikoidnih receptora u 37% bolesnika) i diuretik po potrebi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PCTFE/PVC BLISTERS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SREDNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA) KOJA SADRŽI PCTFE/PVC BLISTERE
Rasilez 300 mg film-coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side. 
Rasilez 300 mg filmom obložene tablete su svijetlocrvene, bikonveksne, ovalne tablete, s utisnutom oznakom „IU“ na jednoj i „NVR“ na drugoj strani.
No adjustment of the initial dosage of treatment is required in patients with mild to moderate renal impairment (see sections 4.2 and 4.4). 
bolesnika s blagim do teškim oštećenjem bubrežne funkcije nije potrebna prilagodba početne doze liječenja (vidjeti dijelove 4.2 i 4.4).
14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 90 film-coated tablets 98 film-coated tablets 
14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 56 filmom obloženih tableta 56 x 1 filmom obloženih tableta 90 filmom obloženih tableta 98 filmom obloženih tableta
In patients after 104 weeks (at LT Visit 19 [Week 156]), there were LS mean decreases from Baseline in weight and BMI in both treatment groups, with a slightly larger decrease in the aliskiren compared to the enalapril treatment group. 
došlo do smanjenja u srednjim vrijednostima (dobivenim metodom najmanjih kvadrata) u odnosu na početne vrijednosti težine i BMI-a u obje liječene skupine, s blago većim smanjenjem u skupini liječenoj aliskirenom u usporedbi sa skupinom liječenom enalaprilom.
Name and address of the manufacturer(s) responsible for batch release Noden Pharma DAC 
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Noden Pharma DAC
It is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min/1.73 m2). 
Ne preporučuje se bolesnicima s teškim oštećenjem bubrežne funkcije (brzina glomerularne filtracije (GFR) <30 ml/min/1,73 m2).
Rasilez 150 mg film-coated tablets Rasilez 300 mg film-coated tablets 
Rasilez 150 mg filmom obložene tablete Rasilez 300 mg filmom obložene tablete
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 
7 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 56 filmom obloženih tableta 90 filmom obloženih tableta
Unit packs containing 7, 14, 28, 30, 50 or 56 tablets. 
Jedinična pakiranja koja sadrže 7, 14, 28, 30, 50 ili 56 tableta.
Renal dysfunction 
Disfunkcija bubrega
PHARMACEUTICAL FORM AND CONTENTS Multipack: 84 (3 packs of 28) film-coated tablets Multipack: 98 (2 packs of 49) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets 
OBLIK I SADRŽAJ Višestruko pakiranje: 84 (3 pakiranja od 28) filmom obložene tablete Višestruko pakiranje: 98 (2 pakiranja od 49) filmom obloženih tableta Višestruko pakiranje: 280 (20 pakiranja od 14) filmom obloženih tableta
(95.4% Confidence Interval: 0.987, 1.218, 2-sided p=0.0787). 
Završni rezultati ispitivanja pokazali su omjer hazarda za primarni ishod od 1,097 u korist placeba (95,4% interval pouzdanosti: 0,987, 1,218, 2-strani p=0,0787).
It is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2). 
Ne preporučuje se u bolesnika s teškim oštećenjem bubrežne funkcije (GFR <30 ml/min/1,73 m2).
Digoxin and verapamil bioavailability may be slightly decreased by Rasilez. 
Rasilez može blago smanjiti bioraspoloživost digoksina i verapamila.
Co-administration of aliskiren with either metformin (↓28%), amlodipine (↑29%) or cimetidine 
Istodobna primjena aliskirena bilo s metforminom (↓28%), amlodipinom (↑29%) ili cimetidinom (↑19%) rezultirala je promjenom Cmax ili AUC-u Rasileza između 20% i 30%.
Pharmacokinetic interaction with other medicinal products Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide. 
atenolol, celekoksib, pioglitazon, alopurinol, izosorbid-5-mononitrat i hidroklorotiazid.
angioedema without any known cause. 
angioedem tijekom uzimanja aliskirena. nasljedni angioedem. angioedem nepoznatog uzroka.
Unit packs containing 14, 28, 30, 50, 56, 90 or 98 tablets. 
Jedinična pakiranja koja sadrže 14, 28, 30, 50, 56, 90 ili 98 tableta.
Multipacks containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets. 
Višestruka pakiranja koja sadrže 84 (3x28), 90 (3x30), 98 (2x49) ili 280 (20x14) tableta.
What Rasilez looks like and contents of the pack Rasilez 150 mg film-coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side. 
Rasilez 150 mg filmom obložene tablete su svijetloružičaste, bikonveksne, okrugle tablete, s utisnutom oznakom „IL“ na jednoj i „NVR“ na drugoj strani.
Following intravenous administration, the mean plasma clearance is approximately 
Nakon intravenske primjene srednja vrijednost klirensa iz plazme je približno 9 l/h.
Hypotension Respiratory, thoracic and mediastinal disorders Uncommon: 
Poremećaji dišnog sustava, prsišta i sredoprsja Manje često:
PA/Alu/PVC - Alu blisters: 
SADRŽI PA/AL/PVC BLISTERE
Rasilez 300 mg film-coated tablets Each film-coated tablet contains 300 mg aliskiren (as hemifumarate). 
Rasilez 300 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 300 mg aliskirena (u obliku aliskirenhemifumarata).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SREDNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA) KOJA SADRŽI PA/AL/PVC BLISTERE
Multipacks containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets. 
Višestruka pakiranja koja sadrže 84 (3x28), 98 (2x49) ili 280 (20x14) tableta.
Unit packs containing 7, 14, 28, 30, 50, 56 or 90 tablets. 
Jedinična pakiranja koja sadrže 7, 14, 28, 30, 50, 56 ili 90 tableta.
Light-red, biconvex, ovaloid tablet, imprinted “IU” on one side and “NVR” on the other side. 
Svijetlocrvena, bikonveksna, ovalna tableta, s utisnutom oznakom „IU“ na jednoj i „NVR“ na drugoj strani.
49 x 1 film-coated tablets. 
Ne prodaje se zasebno. 49 x 1 filmom obloženih tableta.
What Rasilez contains - The active substance is aliskiren (as hemifumarate). 
- Djelatna tvar je aliskiren (u obliku aliskirenhemifumarata).
Anaphylactic reactions, hypersensitivity reactions 
Reakcije preosjetljivosti uključujući anafilaktičke reakcije i angioedem
Although aliskiren has known local (gastrointestinal tract) irritation potential, safety margins obtained in humans at the dose of 300 mg during a study in healthy volunteers were considered to be appropriate at 9-11-fold based on faecal concentrations or 6-fold based on mucosa concentrations in comparison with 250 mg/kg/day in the rat carcinogenicity study. 
300 mg, odgovaraju 9-11 puta većoj dozi na temelju koncentracija u stolici, ili 6 puta većoj dozi na temelju koncentracija u sluznici, u usporedbi s 250 mg/kg/dan u ispitivanju kancerogenosti u štakora.
Light-pink, biconvex, round tablet, imprinted “IL” on one side and “NVR” on the other side. 
Svijetloružičasta, bikonveksna, okrugla tableta, s utisnutom oznakom „IL“ na jednoj i „NVR“ na drugoj strani.
P-gp interactions 
Istodobna primjena zahtijeva oprez P-gp interakcije
At the end of this extension study, changes in msSBP from baseline were similar with aliskiren compared to enalapril (-7.63 mmHg vs. -7.94 mmHg) in the full analysis set. 
Body Mass Index) većim ili jednakim 95-oj percentili za dob i spol.Na kraju ovog nastavka ispitivanja, promjene u srednjoj vrijednosti sistoličkog krvnog tlaka u sjedećem položaju u odnosu na početne vrijednosti bile su slične za aliskiren u usporedbi s enalaprilom (-7,63 mmHg naspram -7,94 mmHg) koristeći potpuni skup podataka za analizu.
Rasilez 300 mg film-coated tablets 
Rasilez 300 mg filmom obložene tablete
Dizziness Ear and labyrinth disorders Not known: 
Poremećaji uha i labirinta
Rasilez 150 mg film-coated tablets - Each tablet contains 150 mg aliskiren (as hemifumarate). 
Rasilez 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg aliskirena (u obliku aliskirenhemifumarata).
aliskiren at doses of 75 mg, 150 mg and 300 mg provided statistically significant superior reduction in blood pressure (both systolic and diastolic) when compared to placebo. 
U 8-tjednom ispitivanju u kojem je sudjelovalo 754 hipertenzivnih starijih (≥65 godina) i vrlo starih bolesnika (30% ≥75 godina) aliskiren u dozama od 75 mg, 150 mg i 300 mg dovodio je do statistički značajnog superiornog sniženja krvnog tlaka (i sistoličkog i dijastoličkog) u usporedbi s placebom.
Rasilez 150 mg film-coated tablets 
Rasilez 150 mg filmom obložene tablete
Dual blockade of the RAAS with aliskiren, ARBs or ACEIs Clinical trial data has shown that dual blockade of the RAAS through the combined use of ACEIs, ARBs or aliskiren is associated with a higher frequency of adverse events such as hypotension, stroke, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1). 
Podaci iz kliničkih ispitivanja pokazali su da je dvostruka blokada RAAS-a kombiniranom primjenom ACEI-a, ARB-a ili aliskirena povezana s većom učestalošću štetnih događaja kao što su hipotenzija,
Black iron oxide (E 172) Red iron oxide (E 172) 
A magnezijev stearat mikrokristalična celuloza povidon K-30 koloidni bezvodni silicijev dioksid hipromeloza supstitucijski tip 2910 (3 mPa·s) makrogol 4000 talk crni željezov oksid (E 172) crveni željezov oksid (E 172) titanijev dioksid (E 171)
NAME OF THE MEDICINAL PRODUCT Rasilez 300 mg film-coated tablets aliskiren 
Rasilez 300 mg filmom obložene tablete aliskiren
NAME OF THE MEDICINAL PRODUCT Rasilez 150 mg film-coated tablets aliskiren 
Rasilez 150 mg filmom obložene tablete aliskiren
hereditary angioedema. 
I i angiotenzina II.
through height and weight measurement, with added neurocognitive and renal function evaluations as follow-up measures performed only in patients with secondary hypertension (19 patients: 9 previously treated with aliskiren and 10 previously treated with enalapril). 
do 17 godina s primarnom ili sekundarnom hipertenzijom, bili su uključeni u 52 do 104 tjedna neintervencijskog opservacijskog nastavka ispitivanja bez terapije oblikovanog za procjenu dugoročnog rasta i razvoja, mjerenjem težine i visine, s dodatnim procjenama neurokognitivne i bubrežne funkcije kao mjera praćenja provedenih samo u bolesnika sa sekundarnom hipertenzijom (19 bolesnika: 9 prethodno liječenih aliskirenom i 10 prethodno liječenih enalaprilom).
Co-administration of grapefruit juice with aliskiren 150 mg resulted in a 61% decrease in aliskiren AUC and co-administration with aliskiren 300 mg resulted in a 38% decrease in aliskiren AUC. 
Istodobna primjena soka od grejpa s aliskirenom150 mg rezultirala je smanjenjem AUC-a aliskirena za 61%,
Investigations Common: 
Tablični popis nuspojava:
Crospovidone, type A 
Krospovidon tip
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX FOR UNIT PACK CONTAINING PCTFE/PVC BLISTERS 
KUTIJA JEDINIČNOG PAKIRANJA KOJA SADRŽI PCTFE/PVC BLISTERE
MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/039 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/039
Aliskiren 
Varfarin
MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/001 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/001
MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/017 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/017
MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/029 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/029
MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/031 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/031
MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/011 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/011
- if you have experienced the following forms of angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue): angioedema when taking aliskiren. 
Ako mislite da biste mogli biti alergični, obratite se liječniku za savjet. - ako ste imali bilo koji od sljedećih oblika angioedema (teškoće pri disanju ili gutanju, ili oticanje lica, ruku i nogu, očiju, usnica i/ili jezika):
MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/021 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/021
MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/007 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/405/007
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 300 mg aliskiren (as hemifumarate). 
Jedna filmom obložena tableta sadrži 300 mg aliskirena (u obliku aliskirenhemifumarata).