natgillin/translations-raw huggingface dataset:
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3). 
Poznato je da izloženost antagonistu receptora angiotenzina II tijekom drugog i trećeg tromjesečja trudnoće inducira fetotoksičnost u ljudi (smanjena bubrežna funkcija, oligohidramnij, usporenje osifikacije lubanje) i neonatalnu toksičnost (zatajenje bubrega, hipotenzija, hiperkalijemija) (vidjeti dio 5.3).
Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. 
Amlodipin je inhibitor ulaska (dotoka) kalcijevih iona dihidropiridinske skupine (blokator sporih kanala ili antagonist kalcijevih iona), i inhibira transmembranski ulaz iona kalcija u srčani mišić i glatke mišiće krvnih žila.
The antihypertensive efficacy of telmisartan is comparable to that of substances representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril). 
Antihipertenzivni učinak telmisartana usporediv je s antihipertenzivnim učinkom drugih skupina antihipertenziva (pokazalo se u kliničkim ispitivanjima usporedbe telmisartana s amlodipinom, atenololom, enalaprilom, hidroklorotiazidom i lizinoprilom).
• Biliary obstructive disorders and severe hepatic impairment 
• Bilijarna opstrukcija i teško oštećenje jetre
Telmisartan is metabolised by conjugation to the glucuronide of the parent compound. 
Telmisartan se metabolizira konjugacijom izvorne tvari na glukuronid.
• Diabetes. 
• Dijabetes.
The most common adverse reactions include dizziness and peripheral oedema. 
Najčešće nuspojave uključuju omaglicu i periferni edem.
If you forget to take Onduarp 
Ako ste zaboravili uzeti Onduarp
heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. 
imunosupresivi (npr. ciklosporin ili takrolimus) i antibiotik trimetoprim.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. 
Aortalna i mitralna stenoza zaliska, opstruktivna hipertrofična kardiomiopatija Kao i uz druge vazodilatatore, potreban je osobit oprez kod bolesnika koji pate od aortne ili mitralne stenoze, ili opstruktivne hipertrofične kardiomiopatije.
Amlodipine has been safely administered with digoxin, warfarin, atorvastatin, sildenafil, anti-acid medicinal products (aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, ciclosporin, antibiotics and oral hypoglycaemic medicinal products. 
Amlodipin se sigurno primjenjuje uz digoksin, varfarin, atorvastatin, sildenafil, antacidne lijekove (aluminijev hidroksid, magenzijev hidroksid, simetikon), cimetidon, ciklosporin, antibiotike i oralne hipoglikemijske lijekove.
The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years) - Combination with one or more other medicinal products that affect the renin-angiotensin-aldosterone system and/or potassium supplements. 
Glavni rizični faktori za hiperkalijemiju koje je potrebno razmotriti su: - Dijabetes melitus, oštećenje bubrega, dob (>70 godina) - Kombinacija s jednim ili više drugih lijekova koji utječu na sustav renin-angiotenzin-aldosteron i/ili dodacima koji sadržavaju kalij.
In a subset of 1050 patients with moderate to severe hypertension (DBP ≥100 mmHg) 32.7 - 51.8 % responded sufficiently to monotherapy of either telmisartan or amlodipine. 
U podskupini od 1050 bolesnika s umjerenom do teškom hipertenzijom (DKT≥100 mmHg) 32,7-51,8% je reagiralo dostatno na monoterapiju, bilo telmisartanom ili amlodipinom.
Non-steroidal anti-inflammatory medicinal products NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists. 
NSAIL-i (tj. acetilsalicilna kiselina u protuupalnim režimima doziranja, COX-2 inhibitori i neselektivni NSAIL-i) mogu smanjiti antihipertenzivan učinak antagonista receptora angiotenzina II.
As a consequence of inhibiting the renin-angiotensin-aldosterone system, hypotension, syncope, hyperkalaemia and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system. 
Kao posljedica inhibicije sustava renin-angiotenzin-aldosteron, prijavljene su hipotenzija, sinkopa, hiperkalemija i promjene bubrežne funkcije (uključujući akutno bubrežno zatajenje) kod osjetljivih pojedinaca, osobito u slučaju kombinacije lijekova koji utječu na taj sustav.
When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started. 
Kada se dijagnosticira trudnoća, liječenje antagonistima receptora angiotenzina II se mora odmah prekinuti, te ako je potrebno početi s alternativnom terapijom.
Furthermore it was shown that some patients not adequately controlled with Onduarp 40 mg/10 mg had additional blood pressure reduction by uptitration to Onduarp 80 mg/10 mg. 
Nadalje, pokazano je da neki bolesnici koji nisu bili odgovarajuće kontrolirani uz Onduarp 40 mg/10 mg, podizanjem doze na Onduarp 80mg/10 mg imaju dodatno sniženje krvnog tlaka.
Other conditions with stimulation of the renin-angiotensin-aldosterone system In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8). 
Kod bolesnika čiji vaskularni tonus i funkcija bubrega većinom ovise o aktivnosti sustava reninangiotenzin-aldosteron (npr. bolesnici s teškim kongestivnim zatajenjem srca ili fundamentalnom bolešću bubrega, uključujući stenozu bubrežne arterije), liječenje proizvodima koji utječu na ovaj sustav povezano je s akutnom hipotenzijom, hiperazotemijom, oligurijom, ili, rijetko, akutnim zatajenjem bubrega (vidjeti dio 4.8).
The pharmacokinetics of amlodipine are not significantly influenced by renal impairment. 
Farmakokinetika amlodipina ne utječe značajno na oštećenje bubrega.
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the co-administration of angiotensin II receptor antagonists and medicinal products that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. 
Kod pojedinih bolesnika s kompromitiranom bubrežnom funkcijom (npr. dehidrirani bolesnici ili starije osobe s kompromitiranom bubrežnom funkcijom), koadministracija antagonista receptora angiotenzina II i lijekova koji inhibiraju ciklooksigenazu može rezultirati daljnjom deterioracijom bubrežne funkcije, uključujući moguće akutno zatajenje bubrega koje je obično reverzibilno.
Onduarp is available in a folding box containing 28 tablets in aluminium/aluminium blisters and in a folding box containing 360 (4 x 90 x 1) tablets in aluminium/aluminium perforated unit dose blisters. 
Onduarp je dostupan u kutiji koja sadrži 28 tableta u aluminij/aluminij blisterima i u kutiji koja sadrži 360 (4 x 90 x 1) tableta u aluminij/aluminij perforiranim blisterima djeljivim na jedinične doze.
• Heart trouble. 
• Problemi sa srcem.
No clear evidence of a teratogenic effect was observed, however at toxic dose levels of telmisartan an effect on the postnatal development of the offspring such as lower body weight and delayed eye opening was observed. 
Ne postoje dokazi teratogenog učinka, ali studije na životinjama pokazale su potencijalni štetni učinak toksičnih doza telmisartana na postnatalni razvoj mladunčadi, kao što su manja tjelesna težina i odgođeno otvaranje očiju.
Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 28 tablets or aluminium/aluminium perforated unit dose blisters (PA/Al/PVC/Al) in multipacks containing 360 (4 packs of 90 x 1) tablets. 
Aluminij/aluminij blisteri (PA/Al/PVC/Al) u kutiji koja sadrži 28 tableta ili aluminij/aluminij perforirani blisteri djeljivi na jedinične doze (PA/Al/PVC/Al) u kutiji koja sadrži višestruka pakovanja koja sadrže 360 (4 pakovanja od 90 x 1) tableta.
Telmisartan is highly bound to plasma protein in renal-insufficient subjects and cannot be removed by dialysis. 
Telmisartan se uveliko veže za proteine plazme kod osoba s insuficijencijom bubrega, te se ne može ukloniti dijalizom.
In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals. 
U pretkliničkim studijama sigurnosti, doze čije izlaganje je usporedivo s dozama unutar kliničkog terapijskog raspona izazvale su smanjene parametre crvenih zrnaca (eritrocita, hemoglobina, hematokrita) i promjene u renalnoj hemodinamici (povišeni dušik iz ureje i kreatinin u krvi ), kao i porast kalija u serumu kod normotenzivnih životinja.
• NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen), 
• NSAIL-i (nesteroidni protuupalni lijekovi, npr. acetilsalicilna kiselina ili ibuprofen), heparin,
Investigations hepatic enzymes increased blood uric acid increased 
Pretrage povišene vrijednosti jetrenih enzima povišene vrijednosti mokraćne kiseline u krvi
If you stop taking Onduarp 
Ako prekinete koristiti Onduarp
Each tablet contains 168.64 mg sorbitol (E420). 
Jedna tableta sadržava 168,64 mg sorbitola (E420).
- Intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis, worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extensive trauma). 
- Interkurentni događaji, osobito dehidracija, akutna dekompenzacija srca, metabolička acidoza, pogoršanje bubrežne funkcije, iznenadno pogoršanje stanja bubrega (npr. infektivne bolesti), liza stanica (npr. akutna ishemija uda, rabdomioliza, produljena trauma).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
Ime i adresa nositelja odobrenja
Onduarp once daily produces effective and consistent reductions in blood pressure across the 24-hour therapeutic dose range. 
Jednokratna dnevna primjena Onduarpa dovodi do učinkovitog i stalnog sniženja krvnog tlaka tijekom 24-satnog terapijskog raspona doziranja.
Therefore it is not expected to potentiate bradykinin-mediated adverse reactions. 
Stoga se ne očekuju nuspojave posredovane bradikininom.
Each tablet contains 337.28 mg sorbitol (E420). 
Jedna tableta sadržava 337,28 mg sorbitola (E420).
In an 8-week multicenter, randomised, double-blind, placebo-controlled, parallel group factorial study in 1461 patients with mild to severe hypertension (mean seated diastolic blood pressure ≥95 and ≤119 mmHg), treatment with each combination dose of Onduarp resulted in significantly greater diastolic and systolic blood pressure reductions and higher control rates compared to the respective monotherapy components. 
U 8-tjednoj, multicentričnoj, randomiziranoj, dvostruko-slijepoj, placebom kontroliranoj, faktorijalnoj studiji na paralelnim skupinama na 1461 bolesnika s blagom do umjerenom hipertenzijom (prosječni dijastolički krvni tlak u sjedećem položaju ≥95 i ≤119 mmHg), liječenje svakom od kombiniranih doza Onduarpa rezultiralo je značajno većim sniženjem dijastoličkog i sistoličkog krvnog tlaka te višom stopom kontrole u usporedbi s relevantnim monoterapijskim komponentama.
With concomitant use with the CYP3A4 inhibitor erythromycin in young patients and diltiazem in elderly patients respectively, the plasma concentration of amlodipine increased by 22 % and 50 % respectively. 
Uz istovremenu primjenu s CYP3A4 inhibitorom, eritromicinom kod mladih osoba te diltiazema kod starijih osoba, koncentracije amlodipina u plazmi povećale su se za 22 % i 50 %, po istom redoslijedu.
Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. 
Osim ako se produljeno liječenje antagonistima receptora angiotenzina II ne smatra neophodnom, bolesnice koje planiraju trudnoću moraju nastaviti liječenje pogodnim drugim antihipertenzivima koji imaju utvrđen profil sigurnosti za primjenu u trudnoći.
Japanese patients are more likely to experience these adverse reactions. 
Japanski bolesnici će vjerojatno češće imati ove nuspojave u odnosu na ostale bolesnike
Other medicines and Onduarp 
Uzimanje drugih lijekova uz Onduarp
Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. 
Kod bolesnika s bilijarnom opstrukcijom ili insuficijencijom jetre može se očekivati smanjen klirens.
Angioedema (with fatal outcome), drug eruption, toxic skin eruption, urticaria 
Angioedem (s fatalnim ishodom), medikamentni osip, toksične erupcije na koži, urtikarija
Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening. 
Amlodipin blokira ulazak kalcija u stijenke krvnih žila, što zaustavlja stezanje krvnih žila.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE lIJEKA U PROMET
In patients with hypertension, once daily dosing provides clinically significant reductions of blood pressure in both the supine and standing positions throughout the 24 hour interval. 
Kod bolesnika s hipertenzijom, jedna dnevna doza osigurava klinički značajno sniženje krvnog tlaka u ležećem i uspravnom položaju, tijekom 24 satnog razdoblja.
How to take Onduarp 
Kako uzimati Onduarp
Posology The recommended dose of Onduarp is one tablet per day. 
Doziranje Preporučena doza Onduarpa je jedna tableta dnevno.
In another multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 947 patients with mild to severe hypertension who were not adequately controlled on amlodipine 10 mg received Onduarp (40 mg/10 mg or 80 mg/10 mg) or amlodipine alone (10 mg). 
U drugoj multicentričnoj, randomiziranoj, dvostruko-slijepoj, aktivno kontroliranoj studiji na paralelnim skupinama, ukupno 947 bolesnika s blagom do umjerenom hipertenzijom koji nisu bili odgovarajuće kontrolirani amlodipinom 10 mg primalo je Onduarp (40 mg/10 mg ili 80 mg/10 mg) ili samo amlodipin (10 mg).
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see sections 4.3 and 4.4). 
Novorođenčad čije su majke uzimale antagoniste receptora angiotenzina II se moraju pažljivo promatrati radi moguće hipotenzije (vidjeti dijelove 4.3 i 4.4).
Animal reproductive toxicity studies with Onduarp have not been performed. 
Nisu provedene studije reproduktivne toksičnosti na životinjama.
The concomitant use of amlodipine and grapefruit or grapefruit juice is still not recommended in patients as the bioavailability of amlodipine may increase in some and may result in increased hypotensive effects. 
Istovremena primjena amlodipina i grejpa ili soka od grejpa se još uvijek ne preporučuje kod bolesnika jer se bioraspoloživost amlodipina u nekim slučajevima može povećati te može rezultirati povećanjem hipotenzivnog učinka.
No posology adjustment is required for patients with mild to moderate renal impairment. 
Nije potrebno prilagođavanje doze za bolesnike s blagim do umjerenim oštećenjem bubrega.
• Kidney disease or kidney transplant. 
• Bolest bubrega ili transplatacija bubrega.
Close monitoring of renal function is advisable if co-administration is considered necessary. 
Preporučuje se pažljivo praćenje bubrežne funkcije u slučaju da se istovremena primjena smatra nužnom.
In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo (see section 5.1). 
U dugotrajnoj, placebom kontroliranoj studiji (PRAISE-2) s amlodipinom na bolesnicima sa zatajenjem srca neishemijskog porijekla NYHA grupa III i IV, amlodipin je bio povezan s većim brojem prijava plućnog edema usprkos neznačajnoj razlici u incidenciji pogoršanja zatajenja srca u usporedbi s placebom (vidjeti dio 5.1).
These pharmacologicallymediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation. 
Ove farmakološki posredovane nuspojave, poznate iz pretkliničkih studija i uz inhibitore enzima angiotenzin-konvertaze i uz antagoniste angiotenzina II, spriječene su oralnim nadomjescima soli.
Medicinal products with blood pressure lowering potential Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including Onduarp, e.g. baclofen, amifostine, neuroleptics or antidepressants. 
Na osnovi njihovih famakoloških svojstava, može se očekivati da sljedeći lijekovi mogu potencirati hipotenzivni učinak svih antihipertenzivnih lijekova, uključujući Onduarp, npr. baklofen, amifostin, neuroleptici, ili antidepresivi.
Use in patients with heart failure 
Primjena kod bolesnika sa zatajenjem srca
Telmisartan and amlodipine are not dialysable. 
Telmisartan i amlodipin se ne uklanjaju dijalizom.
Patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Onduarp containing the same component doses in one tablet once daily, e.g. to enhance convenience or compliance 
Bolesnici koji primjenjuju telmisartan i amlodipin iz zasebnih tableta mogu, umjesto toga, uzimati tablete Onduarp koje sadrže jednake doze komponenti u jednoj tableti jedanput dnevno, npr. radi lakšeg uzimanja ili bolje suradljivosti u liječenju.
Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Onduarp containing the same component doses. 
Odrasli bolesnici koji primaju telmisartan i amlodipin kao zasebne tablete mogu, umjesto toga, uzimati Onduarp tablete koje sadrže jednake doze komponenti.
Interactions common to the combination No drug interaction studies have been performed. 
Interakcije koje su česte uz ovu kombinaciju Ispitivanja interakcija lijekova nisu izvođena.
In patients not controlled on amlodipine 5 mg the oedema rates were 4.4 % for 40 mg/5 mg and 80 mg/5 mg and 24.9 % for amlodipine 10 mg. 
Kod bolesnika kod kojih nije postignuta kontrola amlodipinom 5 mg, stopa edema bila je 4,4% za 40 mg/5 mg i 80 mg/5 mg, te 24,9% za amlodipin 10 mg.
Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. 
Ukoliko dođe do izlaganja antagonistima receptora angiotenzina II od drugog tromjesečja nadalje, preporučuje se ultrazvučna kontrola bubrežne funkcije i lubanje.
- The other ingredients are colloidal anhydrous silica, brilliant blue FCF (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, sorbitol (E420). 
- Pomoćne tvari su bezvodni koloidni silicijev dioksid, brilliant blue FCF (E133), crni željezov oksid (E172), žuti željezov oksid (E172), magnezijev stearat, kukuruzni škrob, meglumin, mikrokristalična celuloza, povidon K25, prethodno geliran škrob, natrijev hidroksid, sorbitol (E420).
Common side effects (may affect up to 1 in 10 people): Dizziness, ankle swelling (oedema). 
Česte nuspojave (mogu se javiti kod do 1 na 10 osoba): Omaglica, otečenost gležnjeva (edem).
Onduarp is used to treat high blood pressure - in adult patients whose blood pressure is not controlled enough with amlodipine. 
Onduarp se primjenjuje u liječenju visokog krvnog tlaka - kod odraslih bolesnika čiji krvni tlak nije adekvatno reguliran amlodipinom.
Leukocytopenia, thrombocytopenia 
Leukopenija, trombocitopenija
PHARMACEUTICAL FORM AND CONTENTS 28 tablets 
28 tableta
In a further multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 1097 patients with mild to severe hypertension who were not adequately controlled on amlodipine 5 mg received Onduarp (40 mg/5 mg or 80 mg/5 mg) or amlodipine alone (5 mg or 10 mg). 
U daljnjoj multicentričnoj, randomiziranoj, dvostruko-slijepoj, aktivno kontroliranoj studiji na paralelnim skupinama, ukupno je 1097 bolesnika s blagom do umjerenom hipertenzijom koji nisu bili odgovarajuće kontrolirani amlodipinom 5 mg primalo Onduarp (40 mg/5 mg ili 80 mg/5 mg) ili sam amlodipin (5 mg ili 10 mg).
The maximum recommended dose is Onduarp 80 mg/10 mg, one tablet per day. 
Maksimalna preporučena doza je jedna tableta Onduarpa 80 mg/10 mg dnevno.
Metabolism and nutrition disorders Very rare: 
Poremećaji metabolizma i prehrane Vrlo rijetko:
How to store Onduarp 
Kako čuvati Onduarp
In a follow-up, long term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure without clinical symptoms or objective findings suggestive of underlying ischaemic disease, on stable doses of ACE inhibitors, digitalis, and diuretics, amlodipine had no effect on total cardiovascular mortality. 
U dugotrajnoj, placebom kontroliranoj studiji praćenja (PRAISE-2) amlodipina kod bolesnika sa zatajenjem srca NYHA klase III i IV bez kliničkih simptoma ili objektivnog nalaza koji ukazuje na ishemijsku bolest u podlozi, na stabilnim dozama ACE inhbitora, digitalisa i diuretika, nije zabilježen utjecaj amlodipina na ukupni kardiovaskularni mortalitet.
Upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis Sepsis including fatal outcome1 
Infekcije gornjih dišnih puteva uključujući faringitis i sinusitis, Infekcije mokraćnog sustava uključujući cistitis
- in adult patients who already receive telmisartan and amlodipine from separate tablets and who wish to take instead the same doses in one tablet for convenience. 
- kod odraslih bolesnika koji već primjenjuju telmisartan i amlodipin kao zasebne tablete, a koji žele, radi lakšeg uzimanja, umjesto toga, uzimati jednake doze lijekova u jednoj tableti.
Rare side effects (may affect up to 1 in 1,000 people): Confusion. 
Rijetke nuspojave (mogu pogoditi do 1 na 1000 osoba): Konfuzija.
Caution is advised when using Onduarp in such patients as amlodipine and telmisartan are not dialysable (see also section 
Kod takvih bolesnika preporučuje se oprez u primjeni Onduarpa, s obzirom da se niti amlodipin niti telmisartan ne uklanjaju dijalizom (također vidjeti dio 4.4).
PHARMACEUTICAL FORM AND CONTENTS Component of a multipack comprising 4 packs, each containing 90 x 1 tablets 
Sastavni dio višestrukog pakovanja s 4 pakovanja, od kojih svako sadrži 90 x 1 tabletu.
In patients with mild to moderate hepatic impairment Onduarp should be administered with caution. 
Kod bolesnika s blagim do umjerenim oštećenjem jetre, Onduarp se primjenjuje s oprezom.
Japanese patients are more likely to experience this side effect. 
Japanski bolesnici će vjerojatno češće imati ove nuspojave u odnosu na ostale bolesnike.
PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 4 packs, each containing 90 x 1 tablets 
Višestruko pakovanje s 4 pakovanja, od kojih svako sadrži 90 x 1 tabletu.