FrancophonIA/ELRC3.0 huggingface dataset:
English: 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
Slovenian: V skladu s smernico CHMP o sistemih za obvladovanje tveganja za zdravila za uporabo v humani medicini je treba posodobljen RMP predložiti hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Riprazo in one or more subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Riprazo za eno ali več podskupin pediatrične populacije pri hipertenziji (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: If you forget to take a dose of Riprazo, take it as soon as you remember and then take the next dose at its usual time.
Slovenian: Če pozabite vzeti odmerek zdravila Riprazo, ga vzemite takoj, ko se spomnite nanj in nato vzemite naslednji odmerek ob običajnem času.
English: The adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, 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) and not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki (preglednica 1) so razvrščeni po skupinah glede na pogostnost, najpogostejši najprej, po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The safety and efficacy of Riprazo in children aged below 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Riprazo pri otrocih, starih manj kot 18 let, nista bili dokazani.
English: The blood pressure lowering effect is present within two weeks after beginning treatment.
Slovenian: Zdravilo začne zniževati krvni tlak v roku dveh tednov od začetka zdravljenja.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: • POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: You should take this medicine with a light meal once a day, preferably at the same time each day.
Slovenian: To zdravilo je treba jemati z lahkim obrokom enkrat na dan, najbolje vsak dan ob istem času.
English: Special caution is necessary in patients with a hypersensitivity predisposition.
Slovenian: Posebna previdnost je potrebna pri bolnikih, ki so nagnjeni k preobčutljivosti.
English: - Hereditary or idiopathic angioedema.
Slovenian: - Dedni ali idiopatski angioedem.
English: A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people).
Slovenian: Do teh resnih neželenih učinkov je prišlo le pri majhnem številu bolnikov (lahko se pojavijo pri največ 1 od 1.000 ljudi).
English: You may need to stop Riprazo.
Slovenian: Morda boste morali prenehati z jemanjem zdravila Riprazo.
English: • Deadlines for submission of the APOLLO study results.
Slovenian: • časovne roke za oddajo rezultatov študije APOLLO,
English: If you take more Riprazo than you should If you have accidentally taken too many Riprazo tablets, consult a doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Riprazo, kot bi smeli Če ste pomotoma vzeli več tablet zdravila Riprazo, kot bi smeli, se takoj posvetujte z zdravnikom.
English: The MAH shall submit an updated risk management plan (RMP) that adequately describes all the safety concerns, the pharmacovigilance activities and the interventions designed to identify, characterise, prevent or minimise the risks within a month following the Commission Decision of the renewal procedure (EMEA/H/C/853/R/068).
Slovenian: Imetnik dovoljenja za promet z zdravilom bo predložil posodobljen načrt za obvladovanje tveganja (RMP), ki bo ustrezno opisoval vse, kar zadeva varnost, farmakovigilančne aktivnosti in ukrepe, z namenom ugotavljanja, karakterizacije, preprečevanja ali zmanjševanja tveganja v obdobju 1 meseca po Odločbi Komisije o postopku podaljšanja dovoljenja za promet (EMEA/H/C/853/R/068).
English: Riprazo has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Slovenian: Varnost zdravila Riprazo so ocenjevali pri več kot 7.800 bolnikih, med drugim pri več kot 2.300 bolnikih, ki so bili zdravljeni več kot 6 mesecev, in pri več kot 1.200 bolnikih, ki so bili zdravljeni več kot 1 leto.
English: Non-steroidal anti-inflammatory drugs (NSAIDs)
Slovenian: Nesteroidna protivnetna zdravila (NSAID)
English: The use of Riprazo in children and adolescents up to 18 years of age is not recommended.
Slovenian: Otroci in mladostniki Uporaba zdravila Riprazo pri otrocih in mladostnikih, ki so stari manj kot 18 let, ni priporočena.
English: If you become pregnant while taking this medicine, stop taking it immediately and talk to your doctor.
Slovenian: Če zanosite v času jemanja tega zdravila, ga takoj prenehajte jemati in se pogovorite s svojim zdravnikom.
English: Therefore aliskiren is not expected to affect the systemic exposure of substances that inhibit, induce or are metabolised by these enzymes.
Slovenian: Zato ni pričakovati, da bi aliskiren vplival na sistemsko izpostavljenost učinkovinam, ki zavirajo ali inducirajo te encime oziroma so njihovi substrati.
English: You should not take this medicine together with grapefruit juice.
Slovenian: Tega zdravila ne jemljite skupaj z grenivkinim sokom.
English: What Riprazo is and what it is used for
Slovenian: Kaj je zdravilo Riprazo in za kaj ga uporabljamo
English: Riprazo has negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Riprazo ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Serious adverse reactions include anaphylactic reaction and angioedema which have been reported in post-marketing experience and may occur rarely (less than 1 case per 1,000 patients).
Slovenian: Resni neželeni učinki vključujejo anafilaktično reakcijo in angioedem, o katerih so poročali na podlagi izkušenj po prihodu zdravila na trg, pojavljata pa se redko (manj kot 1 primer na 1.000 bolnikov).
English: In experimental animals, it has been shown that P-gp is a major determinant of Riprazo bioavailability.
Slovenian: Na poskusnih živalih se je pokazalo, da je P-gp glavna determinanta biološke uporabnosti zdravila Riprazo.
English: Riprazo has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged
Slovenian: Zdravilo Riprazo so proučevali pri 1.864 bolnikih, starih 65 let ali več, in pri 426 bolnikih, starih 75 let ali več.
English: The increase may be higher with higher aliskiren doses.
Slovenian: Zvišanje je lahko še večje pri višjih odmerkih aliskirena.
English: If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če menite, da ste noseči, ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Riprazo was not teratogenic in rats or rabbits (see section 5.3).
Slovenian: Zdravilo Riprazo ni bilo teratogeno pri podganah ali kuncih (glejte poglavje 5.3).
English: If anaphylactic reactions or angioedema occur, Riprazo should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Slovenian: Če pride do anafilaktične reakcije ali angioedema, je treba zdravljenje z zdravilom Riprazo takoj prekiniti in poskrbeti za ustrezno zdravljenje in spremljanje bolnika, dokler znaki in simptomi niso v celoti in trajno odpravljeni.
English: Although this has not been investigated for aliskiren, it is known that P-gp also controls tissue uptake of a variety of substrates and P-gp inhibitors can increase the tissue-to-plasma concentration ratios.
Slovenian: Čeprav tega niso proučevali pri aliskirenu, je znano, da P-gp uravnava tudi privzem različnih snovi v tkiva in da zaviralci P-gp lahko povečajo razmerja koncentracij med tkivi in plazmo.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; renin inhibitor, ATC code: C09XA02
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na renin-angiotenzinski sistem, zaviralci renina, oznaka ATC: C09XA02
English: If symptomatic hypotension should occur, supportive treatment should be initiated.
Slovenian: Zdravljenje Če pride do simptomatske hipotenzije, je treba uvesti podporno zdravljenje.
English: Anaphylactic reactions, hypersensitivity reactions
Slovenian: anafilaktične reakcije, preobčutljivostne reakcije
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
English: Riprazo was secreted in the milk of lactating rats.
Slovenian: Zdravilo Riprazo se je izločalo v mleko doječih podgan.
English: Therefore, because of the risk of therapeutic failure, grapefruit juice should not be taken together with Riprazo.
Slovenian: Ker bi torej lahko prišlo do zmanjšanja terapevtskega učinka, se grenivkinega soka ne sme uživati skupaj z zdravilom Riprazo.
English: In the event of severe and persistent diarrhoea, Riprazo therapy should be stopped (see section 4.8).
Slovenian: V primeru hude ali persistentne driske je treba zdravljenje z zdravilom Riprazo prekiniti (glejte poglavje 4.8).
English: Riprazo should be taken with a light meal once a day, preferably at the same time each day.
Slovenian: Zdravilo Riprazo je treba jemati z lahkim obrokom enkrat na dan, najbolje vsak dan ob istem času.
English: Tabulated list of adverse reactions:
Slovenian: Tabelarični pregled neželenih učinkov:
English: Riprazo with food and drink
Slovenian: Zdravilo Riprazo skupaj s hrano in pijačo
English: • A description and timelines for the new study replacing APOLLO and designed to elucidate efficacy and safety in the elderly, including gastrointestinal cancer as a pre-specified endpoint.
Slovenian: • opis in časovni potek nove študije, ki bo nadomestila študijo APOLLO, in je zasnovana za oceno učinkovitosti in varnosti pri starejših, vključno z gastrointestinalnim rakom kot vnaprej določenim ciljem,
English: Lowering the blood pressure to a normal level reduces the risk
Slovenian: Zniževanje krvnega tlaka na normalne vrednosti zmanjšuje tveganje, da bi prišlo do navedenih bolezni.
English: Patients should be informed to report to the physician any signs suggestive of allergic reactions, in particular difficulties in breathing or swallowing, swelling of face, extremities, eyes, lips or tongue.
Slovenian: Bolnikom je treba naročiti, da zdravnika takoj obvestijo o kakršnihkoli znakih, ki kažejo na alergijsko reakcijo, zlasti če opažajo težave pri dihanju ali požiranju, otekanje v obraz, okončine, oči, ustnice ali jezik.
English: There are no clinical data on fertility.
Slovenian: Plodnost Kliničnih podatkov o vplivu na plodnost ni.
English: Aliskiren is metabolised minimally by the cytochrome P450 enzymes.
Slovenian: Aliskiren se v zelo majhni meri presnavlja z encimi citokromi P450.
English: The recommended dose of Riprazo is 150 mg once daily.
Slovenian: Priporočeni odmerek zdravila Riprazo je 150 mg enkrat dnevno.
English: Do not take this medicine if you are pregnant or breast-feeding (see section Do not take Riprazo).
Slovenian: Če ste noseči ali dojite, ne jemljite tega zdravila (glejte poglavje Ne jemljite zdravila Riprazo).
English: Therefore, caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors (clarithromycin, telithromycin, erythromycin, amiodarone).
Slovenian: Zato je potrebna previdnost pri sočasni uporabi aliskirena s ketokonazolom, z verapamilom ali z drugimi zmernimi zaviralci P-gp (s klaritomicinom, s telitromicinom, z eritromicinom, z amiodaronom).
English: In clinical studies in hypertensive patients, Riprazo had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Slovenian: V kliničnih študijah s hipertenzivnimi bolniki zdravilo Riprazo ni klinično pomembno vplivalo na vrednosti celokupnega holesterola, holesterola lipoproteinov visoke gostote (HDL holesterola), trigliceridov na tešče, glukoze na tešče in sečne kisline.
English: Riprazo tablets contain an active substance called aliskiren.
Slovenian: Tablete zdravila Riprazo vsebujejo zdravilno učinkovino z imenom aliskiren.
English: In controlled clinical trials, angioedema and hypersensitivity reactions occurred rarely during treatment with aliskiren with rates comparable to treatment with placebo or comparators.
Slovenian: V kontroliranih kliničnih preskušanjih je med zdravljenjem z aliskirenom redko prišlo do angioedema in preobčutljivostnih reakcij in sicer s pogostnostjo, ki je bila primerljiva z zdravljenjem s placebom ali primerjalnimi zdravili.
English: The antihypertensive effect is substantially present within two weeks (85-90%) after initiating therapy
Slovenian: Antihipertenzivni učinek se v precejšnji meri izrazi v dveh tednih (85 - 90 %) po začetku zdravljenja z odmerkom 150 mg enkrat dnevno.
English: - History of angioedema with aliskiren.
Slovenian: - Anamneza angioedema zaradi aliskirena.
English: As for any medicine that acts directly on the RAAS, Riprazo should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Slovenian: Tako kot velja za katerokoli drugo zdravilo, ki deluje neposredno na sistem renin-angiotenzin-aldosteron, tudi zdravila Riprazo ne smete uporabljati v prvem trimesečju nosečnosti oziroma pri ženskah, ki načrtujejo nosečnost, poleg tega je kontraindiciran v drugem in tretjem trimesečju nosečnosti (glejte poglavje 4.3).
English: - A commitment to submit the final study report of the epidemiological
Slovenian: • zavezo o oddaji končnega poročila študije o epidemiološki študiji ishemičnega kolitisa,
English: In clinical studies Riprazo has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated GFR < 30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
Slovenian: V kliničnih študijah zdravila Riprazo niso raziskovali pri hipertenzivnih bolnikih s hudo okvaro ledvic (kreatinin v serumu ≥ 150 μmol/l oziroma 1,70 mg/dl pri ženskah in ≥ 177 μmol/l oziroma 2,00 mg/dl pri moških in/ali ocenjeno GFR < 30 ml/min/1,73 m2), pri bolnikih, ki so se že zdravili z dializo, pri bolnikih z nefrotskim sindromom ali z renovaskularno hipertenzijo.
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Riprazo.
Slovenian: V kontroliranih kliničnih preskušanjih je bila uporaba zdravila Riprazo občasno povezana s klinično pomembnimi spremembami standardnih laboratorijskih parametrov.
English: If any of these affect you severely, tell your doctor.
Slovenian: Če vas kateri od navedenih učinkov huje prizadene, obvestite svojega zdravnika.
English: It is therefore recommended that the effects be monitored when initiating and adjusting furosemide therapy to avoid possible under-utilisation in clinical situations of
Slovenian: Zato je pri uvedbi in prilagajanju zdravljenja s furosemidom priporočljivo spremljanje učinkov, da ne bi uporabljali premajhnih odmerkov v stanjih volumske preobremenitve.
English: If pregnancy is detected during therapy, Riprazo should be discontinued accordingly.
Slovenian: V primeru, da se med zdravljenjem z zdravilom Riprazo izkaže, da je ženska noseča, je treba zdravljenje v skladu s tem prekiniti.
English: In the majority of patients aged 65 years or older, the 300 mg dose of Riprazo shows no additional benefit in reducing blood pressure compared to the 150 mg dose.
Slovenian: Pri večini bolnikov, starih 65 let ali več, 300 mg odmerek zdravila Riprazo ni pokazal nobenih dodatnih koristi v zniževanju krvnega tlaka v primerjavi s 150 mg odmerkom.
English: Its use is therefore not recommended in women who are breast-feeding.
Slovenian: Iz tega razloga uporaba zdravila Riprazo ni priporočena za matere, ki dojijo.
English: • A description and timelines for the new observational study on incidence of colorectal hyperplasia in aliskiren-treated patients.
Slovenian: • opis in časovni potek za novo opazovalno študijo glede incidence kolorektalne hiperplazije pri bolnikih, zdravljenih z alaskirenom.
English: If co-medication with an agent affecting the level of serum potassium is considered necessary, caution is advisable.
Slovenian: Če je sočasna uporaba zdravila, ki vpliva na koncentracijo kalija v serumu, neizogibna, je priporočena previdnost.
English: Do not take Riprazo if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis), itraconazole (a medicine used to treat fungal infections) or quinidine (a medicine used to correct heart rhythm).
Slovenian: Ne jemljite zdravila Riprazo, če jemljete ciklosporin (zdravilo, ki se ga uporablja pri presaditvah za preprečevanje zavrnitve organa ali pri drugih boleznih, na primer pri revmatoidnem artritisu ali atopijskem dermatitisu), itrakonazol (zdravilo za zdravljenje glivičnih okužb) ali kinidin (zdravilo za uravnavanje srčnega ritma).
English: A single dose 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.
Slovenian: V študiji medsebojnega delovanja zdravil z enkratnim odmerjanjem pri zdravih osebah se je pokazalo, da ciklosporin (200 in 600 mg) zviša Cmax aliskirena (75 mg) približno 2,5-krat, AUC pa približno 5-krat.
English: - Co-administration of aliskiren with either metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of Riprazo.
Slovenian: - Ob sočasni uporabi aliskirena z metforminom (↓28 %), amlodipinom (↑29 %) ali s cimetidinom (↑19 %) sta se Cmax ali AUC zdravila Riprazo spremenila za 20 % do 30 %.
English: At steady state meals with low fat content reduce Cmax by 76% and AUC0tau by 67% in hypertensive patients.
Slovenian: Obroki z majhno vsebnostjo maščob pri hipertenzivnih bolnikih v stanju dinamičnega ravnovesja zmanjšajo Cmax za 76 % in AUC0-tau za 67 %.
English: Aliskiren belongs to a class of medicines called renin inhibitors.
Slovenian: Aliskiren sodi v skupino zdravil z imenom zaviralci renina.
English: In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Riprazo 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
Slovenian: Pri debelih bolnikih s hipertenzijo, ki se niso zadostno odzvali na zdravljenje s hidroklorotiazidom 25 mg, je dodatek zdravila Riprazo 300 mg povzročil dodatno znižanje krvnega tlaka, ki je bilo primerljivo z dodatkom irbesartana 300 mg ali amlodipina 10 mg.
English: - if you have diabetes mellitus or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.
Slovenian: - če imate sladkorno bolezen ali okvarjeno delovanje ledvic in jemljete zdravilo iz katere od naslednjih skupin zdravil za zdravljenje visokega krvnega tlaka: “zaviralci encima angiotenzinske konvertaze” kot so enalapril, lizinopril, ramipril in podobno,
English: Co-administration of ketoconazole (200 mg) or verapamil (240 mg) with aliskiren (300 mg) resulted in a 76% or 97% increase in aliskiren AUC, respectively.
Slovenian: Sočasna uporaba ketokonazola (200 mg) ali verapamila (240 mg) z aliskirenom (300 mg) je povzročila povečanje AUC aliskirena za 76 % oziroma 97 %.
English: Rare (may affect up to 1 in 1,000 people): Severe allergic reaction (anaphylactic reaction), allergic reactions (hypersensitivity) and angioedema (the symptoms of which can include difficulties in breathing or swallowing, rash, itching, hives or swelling of the face, hands and feet, eyes, lips and/or tongue, dizziness), increased level of creatinine in the blood, red skin (erythema).
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 ljudi): huda alergijska reakcija (anafilaktična reakcija) alergijske reakcije (preobčutljivost) in angioedem (med njegovimi simptomi so lahko oteženo dihanje ali požiranje, izpuščaj, srbenje, koprivnica ali otekanje v obraz, roke in stopala, oči, ustnice in/ali jezik, omotica), zvišana raven kreatinina v krvi, rdečina (eritem).
English: The effects of Riprazo on warfarin pharmacokinetics have not been evaluated.
Slovenian: Varfarin Učinkov zdravila Riprazo na farmakokinetične lastnosti varfarina niso ocenjevali.
English: United Kingdom Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370
Slovenian: Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370
English: Beneficial effects of Riprazo on mortality and cardiovascular morbidity and target organ damage are
Slovenian: Ugodni vplivi zdravila Riprazo na umrljivost, kardiovaskularno obolevnost in prizadetost tarčnih organov trenutno niso znani.
English: Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected (see other P-gp references in section 4.5).
Slovenian: Zato je mogoče pričakovati povečano izpostavljenost aliskirenu v času sočasne uporabe tistih zaviralcev CYP3A4, ki zavirajo tudi P-gp (glejte druge navedbe v povezavi s P-gp v poglavju 4.5).
English: In patients with marked volume- and/or salt-depletion (e.g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Riprazo.
Slovenian: Bolniki s primanjkljajem natrija in/ali volumna telesnih tekočin Pri bolnikih s hudim primanjkljajem natrija in/ali hipovolemijo (na primer pri tistih, ki prejemajo velike odmerke diuretikov) lahko po uvedbi zdravljenja z zdravilom Riprazo pride do simptomatske hipotenzije.
English: Your doctor may prescribe Riprazo together with other medicines used to
Slovenian: Zdravnik vam lahko predpiše zdravilo Riprazo skupaj z drugimi zdravili za zdravljenje visokega krvnega tlaka.
English: In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Riprazo 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
Slovenian: Pri bolnikih, ki se niso zadostno odzvali na zdravljenje z zaviralcem kalcijevih kanalčkov amlodipinom v odmerku 5 mg, je dodatek zdravila Riprazo v odmerku 150 mg povzročil učinek zniževanja krvnega tlaka, ki je bil podoben, kot če bi zvišali odmerek amlodipina na 10 mg, vendar je bila incidenca edemov pri tem nižja (aliskiren 150 mg/amlodipin 5 mg: 2,1 %; v primerjavi z amlodipinom 10 mg: 11,2 %).
English: - if you are allergic to aliskiren or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Riprazo - če ste alergični na aliskiren ali katero koli sestavino tega zdravila (navedeno v poglavju 6).