natgillin/translations-raw huggingface dataset:
Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients resulting in increased blood pressure lowering effects (see section 
Ne preporučuje se istovremena primjena amlodopina s grejpom ili sokom od grejpa jer kod pojedinih bolesnika može doći do povećane bioraspoloživosti koja rezultira povećanim učinkom snižavanja krvnog tlaka (vidjeti dio 4.5).
A placebo controlled study (PRAISE) designed to evaluate patients in NYHA Class III-IV heart failure receiving digoxin, diuretics and ACE inhibitors has shown that amlodipine did not lead to an increase in risk of mortality or combined mortality and morbidity with heart failure. 
Placebom kontrolirano ispitivanje (PRAISE) u kojem su ocjenjivani bolesnici sa srčanim zatajanjem NYHA klase III-IV i koji su primali digoksin, diuretike i ACE inhibitore pokazalo je da amlodipin ne dovodi do povećanog rizika od smrtnosti ili kombinacije mortaliteta i pobola u bolesnika sa zatajenjem srca.
Due to the slow onset of action, acute hypotension is not a feature of amlodipine administration. 
Zbog polaganog nastupa djelovanja terapija amlodipinom nije praćena akutnom hipotenzijom.
In the factorial design trial the oedema rates were 1.3 % with Onduarp 40 mg/5 mg and 80 mg/5 mg, 8.8 % with Onduarp 40 mg/10 mg and 80 mg/10 mg and 18.4 % with Amlodipine 10 mg. 
U ispitivanju s faktorijalnim dizajnom, stope edema bile su 1,3% uz Onduarp 40 mg/5 mg i 80 mg/5 mg, te 8,8% uz Onduarp 40 mg/10 mg i 80 mg/10 mg, kao i 18,4% uz amlodipin 10 mg.
Oedema rates were significantly lower with 40 mg/5 mg and 80 mg/5 mg compared to amlodipine 10 mg (4.4% versus 24.9 %, respectively). 
Stopa edema bila je značajno niža uz 40 mg/5 mg i 80 mg/5 mg u usporedbi s amlodipinom 10 mg (4,4% u odnosu na 24,9%).
To be taken into account with concomitant use 
Što je potrebno imati na umu pri istovremenoj primjeni
Telmisartan and Amlodipine are not removed by haemodialysis. 
Telmisartan i amlodipin se ne uklanjaju hemodijalizom.
Sorbitol (E420) 
Sadrži sorbitol (E420).
Vascular disorders hypotension, orthostatic hypotension, flushing 
Poremećaji krvožilnog sustava hipotenzija, ortostatska hipotenzija, rumenilo
• Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets'). 
• Lijekovi koji mogu povisiti vrijednosti kalija u krvi kao što su zamjenske soli koje sadrže kalij,
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORIZATION 
OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and 
Kada se trudnoća dijagnosticira, liječenje antagonistima receptora angiotenzina II se mora trenutno prekinuti, i ako je potrebno, nastaviti liječenje prikladnim drugim lijekom (vidjeti dijelove 4.3 i 4.6).
Pharmacokinetic of the fixed dose combination (FDC) The rate and extent of absorption of Onduarp are equivalent to the bioavailability of telmisartan and amlodipine when administered as individual tablets. 
Brzina i opseg apsorpcije Onduarpa su ekvivalentni bioraspoloživosti telmisartana i amlodipina kada se primjenjuju zasebno.
Musculoskeletal and connective tissue disorders Rare: 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Rijetko:
Nervous system disorders Very rare: 
Poremećaji živčanog sustava Vrlo rijetko:
Furthermore low blood pressure may be aggravated by alcohol. 
Nadalje, niži krvni tlak može biti pogoršan uzimanjem alkohola, što se može manifestirati omaglicama prilikom ustajanja.
The elimination half-life is not changed in patients with renal impairment. 
Poluvrijeme eliminacije nije promijenjen kod bolesnika s oštećenjem bubrega.
The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours before the next dose as shown by ambulatory blood pressure measurements. 
Prema ambulantnim mjerenjima krvnog tlaka, antihipertenzivni učinak se zadržava konstantno tijekom 24 sata od doziranja, te uključuje posljednja 4 sata prije sljedeće doze.
• Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1 
• Preosjetljivost na djelatne tvari, na derivate dihidropiridina ili neku od pomoćnih tvari
Renal impairment and kidney transplantation 
Oštećenje bubrega i presađivanje bubrega
Musculoskeletal and connective tissue disorders arthralgia, muscle spasms (cramps in legs), myalgia back pain, pain in extremity (leg pain) 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva artralgija, grčevi mišića (grčevi u nogama), mialgija bol u leđima, bol u udovima (bol u nogama)
Onduarp should therefore be used with caution in these patients. 
Stoga je potreban oprez u primjeni Onduarpa kod takvih bolesnika.
Very rare side effects (may affect up to 1 in 10,000 people): 
Vrlo rijetke nuspojave (mogu pogoditi do 1 na 10 000 osoba):
Gastro-intestinal disorders abdominal pain, diarrhoea, nausea vomiting, gingival hypertrophy, dyspepsia, dry mouth 
Poremećaji probavnog sustava abdominalna bol, proljev, mučnina povraćanje, hipertrofija desni, dispepsija, suhoća usta
Haemodynamic studies and exercise based controlled clinical trials in NYHA Class II-IV heart failure patients have shown that amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction and clinical symptomatology. 
Hemodinamička ispitivanja i kontrolirana klinička ispitivanja temeljena na tjelesnoj aktivnosti bolesnika sa srčanim zatajenjem NYHA klase II-IV pokazala su da amlodipin ne uzrokuje kliničko pogoršanje na osnovu mjerenja podnošenja tjelesnih aktivnosti, istisne frakcije lijeve klijetke te kliničkih simptoma.
Hyperkalaemia may be fatal in the elderly, in patients with renal insufficiency, in diabetic patients, in patients concomitantly treated with other medicinal products that may increase potassium levels, and/or in patients with intercurrent events. 
Kod starijih osoba, bolesnika s insuficijencijom bubrega, dijabetičara, osoba koje se istovremeno liječe drugim lijekovima koji mogu povisiti vrijednosti kalija, i/ili bolesnika s interkurentnim događajima, hiperkalijemija može biti fatalna.
Alopecia, purpura, skin discolouration, hyperhidrosis Angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity 
Angioedem, polimorfni eritem, urtikarija, eksfolijativni dermatitis, Stevens-Johnsonov sindrom, fotoosjetljivost
You should see your doctor immediately if you experience any of the following symptoms: 
Ako primijetite neke od sljedećih simptoma, potrebno je odmah se javiti liječniku:
Skin and subcutaneous tissue disorders pruritus eczema, erythema, rash 
Poremećaji kože i potkožnog tkiva pruritus ekcem, eritem, osip
Blood creatine phosphokinase increased, haemoglobin decreased 1: the event may be a chance finding or related to a mechanism currently not known 2: most cases of hepatic function abnormal / liver disorder from post-marketing experience with telmisartan occurred in Japanese patients. 
: događaj može biti slučajno otkriće ili povezan s trenutno nepoznatim mehanizmom : većina slučajeva abnormalne jetrene funkcije/poremećaja jetre iz iskustva nakon stavljanja lijeka u promet u vezi s telmisartanom se javilo kod Japanskih bolesnika.
The elimination half-life of telmisartan is not changed in patients with hepatic impairment. 
Poluvrijeme eliminacije telmisartana ostao je nepromijenjen kod bolesnika s oštećenjem jetre.
Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty of breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), impaired vision, fast heart beat, upset stomach, abnormal liver function*, hives (urticaria), medicine rash, inflammation of the tendons, flu-like illness (for example muscle pain, feeling generally unwell), decreased haemoglobin (a blood protein), increased levels of creatinine phosphokinase in the blood. 
Povećanje broja nekih bijelih krvnih stanica (eozinofilija), niski broj trombocita (trombocitopenija), alergijske reakcije (npr. osip, svrbež, teškoće pri disanju, piskanje, otečenost lica i niski krvni tlak), niske razine šećera u krvi (kod bolesnika s dijabetesom), oštećeni vid, ubrzano kucanje srca, želučane tegobe, poremećaj jetrene funkcije*, koprivnjača (urtikarija), medikamentni osip, upala tetiva, bolest slična gripi (na primjer bol mišića, opće loše osjećanje), smanjena koncentracija hemoglobina (protein u krvi), povišene vrijednosti kreatinin fosfokinaze u krvi.
Colloidal anhydrous silica Brilliant blue FCF (E 133) Ferric oxide black (E172) Ferric oxide yellow (E172) Magnesium stearate Maize starch 
6.1 Popis pomoćnih tvari silicijev dioksid, koloidni, bezvodni Brilliant blue FCF (E 133) željezov oksid, crni (E172) željezov oksid, žuti (E172) magnezijev stearat kukuruzni škrob meglumin celuloza, mikrokristalična povidon K25 škrob, prethodno geliran natrijev hidroksid sorbitol (E420)
• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets'), low-salt diet, diarrhoea, 
• Niski krvni tlak (hipotenzija), vjerojatno uslijed dehidracije (prekomjerni gubitak vode iz tijela)
Micturition disorder, pollakiuria 
Poremećaji mokrenja, polakizurija
Add on therapy Onduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine. 
Onduarp je indicirana u liječenju odraslih osoba kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka amlodipinom.
Reduced number of white blood cells (leucopenia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), excess sugar in blood , uncontrollable twitching or jerking movements, heart attack, irregular heart beat, inflammation of the blood vessels, inflamed pancreas, inflammation of the stomach lining (gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of hepatic enzymes with jaundice, rapid swelling of skin and mucosa (angioedema), severe skin reactions, hives (urticaria), severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson-Syndrome), increased sensitivity of the skin to sun. 
Smanjeni broj bijelih krvnih stanica (leukopenija), niski broj trombocita (tromobcitopenija), alergijska reakcija (npr. osip, svrbež, tegobe pri disanju, hroptanje, otečenost lica i niski krvni tlak), povećane vrijednosti šećera u krvi, nekontrolirani pokreti grčenja ili trzanja, srčani udar, nepravilno kucanje srca, upala krvnih žila, upala gušterače, upala želučane sluznice (gastritis), upala jetre, žutilo kože (žutica), povišene vrijednosti jetrenih enzima sa žuticom, brzo oticanje kože i sluznice (angioedem), teške reakcije kože, koprivnjača (urtikarija), teške alergijske reakcije s erupcijama mjehurića po koži i membranama sluznice (eksfolijativni dermatitis, Stevens-Johnsonov sindrom), pojačana osjetljivost kože na sunce.
(It is also better to avoid Onduarp in early pregnancysee Warnings and precautions and Pregnancy section.) 
• ako ste trudni dulje od 3 mjeseca (Također treba izbjegavati Onduarp u ranoj trudnoći pogledajte odlomak „Budite posebno oprezni” i „Trudnoća“).
Potassium sparing diuretics or potassium supplements Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss. 
Antagonisti receptora angiotenzina II, kao što je telmisartan, smanjuju gubitak kalija induciran diureticima.
Amlodipine bioavailability is not affected by food ingestion. 
Hrana ne utječe na bioraspoloživost amlodipina.
After 8 weeks of treatment, each of the combination treatments was statistically significantly superior to amlodipine monotherapy in reducing diastolic and systolic blood pressure (−11.1/−9.2 mmHg, −11.3/−9.3 mmHg with 40 mg/10 mg, 80 mg/10 mg versus −7.4/−6.5 mmHg with amlodipine 10 mg) and higher diastolic blood pressure normalisation rates compared to monotherapy were achieved (63.7 %, 66.5 % with 40 mg/10 mg, 80 mg/10 mg versus 51.1 % with amlodipine 10 mg). 
Nakon 8 tjedana liječenja, sva kombinirana liječenja bila su statistički značajno superiorna monoterapiji amlodipinom u sniženju dijastoličkog i sistoličkog krvnog tlaka (11,1/-9,2 mmHg, -11,3/-9,3 mmHg uz 40 mg/10 mg, 80 mg/10 mg u odnosu na -7,4/-6,5 mmHg uz amlodipin 10 mg), te je postignuta viša stopa normalizacije dijastoličkog krvnog tlaka u usporedbi s monoterapijom (63,7%, 66,5% uz 40 mg/10 mg, 80 mg/10 mg u odnosu na 51,1% uz amlodipin 10 mg).
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels in the blood, shortness of breath, bloating, increased sweating, kidney damage including sudden inability of the kidneys to work, increased levels of creatinine. 
Infekcije mokraćnog sustava, infekcije gornjih dišnih puteva (npr. upala grla, upala sinusa, obična prehlada), smanjen broj crvenih krvnih stanica (anemija), visoke vrijednosti kalija u krvi, nedostatak zraka, nadutost, pojačano znojenje, oštećenje bubrega uključujući naglo zatajivanje rada bubrega, povišene vrijednosti kreatinina.
Diabetic patients treated with insulin or antidiabetics In these patients hypoglycaemia may occur under telmisartan treatment. 
U ovoj skupini bolesnika može doći do pojave hipoglikemije tijekom liječenja telmisartanom.
Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of spinning (vertigo), slow heart rate, palpitations (awareness of your heart beat), low blood pressure (hypotension), dizziness on standing up (orthostatic hypotension), flushing, cough, stomach ache (abdominal pain), diarrhoea, feeling sick (nausea), itching, joint pain, muscle cramps, muscle pain, inability to obtain an erection, weakness, chest pain, tiredness, swelling (oedema), increased levels of hepatic enzymes. 
Pospanost, migrena, glavobolja, trnci ili ukočenost ruku ili stopala, osjećaj vrtnje (vrtoglavica), usporeni otkucaji srca, palpitacije (osjećaj lupanja srca), niski krvni tlak (hipotenzija), omaglica prilikom ustajanja (ortostatska hipotenzija), crvenilo uz osjećaj vrućine, kašalj, bolovi u želucu (abdominalna bol), proljev, osjećaj mučnine, svrbež, bol u zglobovima, grčevi u mišićima, bolovi u mišićima, nesposobnost postizanja erekcije, slabost, bol u prsima, umor, otečenost (edem), povišene vrijednosti jetrenih enzima.
Onduarp 80 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with Onduarp 40 mg/5 mg. 
Onduarp 80 mg/5 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka s Onduarpom 40 mg/5 mg.
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan. 
Tijekom istovremene primjene litija s inhibitorima enzima angiotenzin-konvertaze i s antagonistima receptora angiotenzina II, uključujući telmisartan, prijavljena su reverzibilna povećanja koncentracije litija u serumu i toksičnost.
NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim (Logo) 
Boehringer Ingelheim (logo)
Mood changes, impaired vision, ringing in the ears, shortness of breath, sneezing/running nose, change of bowel habit, hair loss, unusual bruising and bleeding (red blood cell damage), skin discolouration, increased sweating, difficulty passing urine, increased need to pass urine especially at night, enlarging of male breasts, pain, weight increased, weight decreased. 
Promjene raspoloženja, oštećeni vid, šum u ušima, nedostatak zraka, kihanje/curenje nosa, promjenaučestalosti stolice, gubitak kose, neuobičajene modrice i krvarenje (oštećenje crvenih krvnih stanica), promjena boje kože, pojačano znojenje, otežano mokrenje, povećana potreba za mokrenjem osobito noću, povećanje dojki u muškaraca, bolovi, porast težine, smanjenje težine.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/10 mg 
BLISTER DJELJIV NA JEDINIČNE DOZE SA 10 TABLETA - 80 mg/10 mg
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5). 
Istodobna primjena telmisartana s aliskirenom je kontraindicirana kod bolesnika s dijabetes melitusom ili oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dijelove 4.2, 4.4, 4.5).
Onduarp 40 mg/5 mg tablets may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone. 
Onduarp 40 mg/5 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka monoterapijom amlodipina 5 mg.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) The combination of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients (see sections 
Dvostruka blokada sustava renin-angiotenzin-aldosteron (RAAS) Kombinacija telmisartana s aliskirenom je kontraindicirana kod bolesnika s dijabetes melitusom ili oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) te se ne preporučuje kod drugih bolesnika (vidjeti dijelove 4.3, 4.4).
Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3). 
Istodobna primjena telmisartana s aliskirenom je kontraindicirana kod bolesnika s oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dio 4.3).
INFORMATION IN BRAILLE Onduarp 40 mg/10 mg 
Onduarp 40 mg/10 mg
INFORMATION IN BRAILLE Onduarp 40 mg/5 mg 
Onduarp 40 mg/5 mg
INFORMATION IN BRAILLE Onduarp 80 mg/5 mg 
Onduarp 80 mg/5 mg
Cardiac disorders Rare: 
Poremećaji srca Rijetko:
INFORMATION IN BRAILLE Onduarp 80 mg/10 mg 
Onduarp 80 mg/10 mg
Cardiac disorders Very rare: 
Poremećaji srca Vrlo rijetko:
Urinary bladder infection, feeling sad (depression), feeling anxious, sleeplessness, fainting, nerve damage in the hands or feet, reduced sense of touch, taste abnormalities, trembling, vomiting, enlarged gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, back pain, leg pain, urge to urinate during the night, feeling unwell (malaise), increased levels of uric acid in the blood. 
Infekcija mokraćnog mjehura, osjećaj tuge (depresija), osjećaj tjeskobe, pospanost, nesvjestica, oštećenje živca u rukama ili stopalima, smanjen osjet dodira, poremećaj okusa, drhtanje, povraćanje, povećane desni, neugoda u trbuhu, suhoća usta, egzem (poremećaj kože), crvenilo kože, osip, bol u leđima, bol u nogama, žurna potreba mokrenja tijekom noći, opće loše osjećanje (malaksalost), povišene vrijednosti mokraćne kiseline u krvi.
Onduarp 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg. 
Onduarp 40 mg/10 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka monoterapijom amlodipina 10 mg.
Dual blockade of the renin-angiotensin-aldosterone system The use of telmisartan in combination with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3). 
Dvostruka blokada sustava renin-angiotenzin-aldosteron Primjena telmisartana u kombinaciji s aliskirenom je kontraindicirana kod bolesnika s dijabetes melitusom ili oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dio 4.3).
Meglumine 
Dispneja
NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets 
Onduarp 80 mg/10 mg tablete
NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets 
Onduarp 80 mg/5 mg tablete
NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets 
Onduarp 40 mg/5 mg tablete
NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets 
Onduarp 40 mg/10 mg tablete
Change of bowel habit Pancreatitis, gastritis 
Pankreatitis, gastritis
MARKETING AUTHORISATION NUMBERS EU/1/11/729/005 (28 tablets) EU/1/11/729/006 (36 (4 x 90 x 1) tablets) 
EU/1/11/729/005 (28 tableta) EU/1/11/729/006 (36 (4 x 90 x 1) tableta)
Replacement therapy 
Zamjenska terapija
MARKETING AUTHORISATION NUMBERS EU/1/11/729/003 (28 tablets) EU/1/11/729/004 (360 (4 x 90 x 1) tablets) 
EU/1/11/729/003 (28 tableta) EU/1/11/729/004 (360 (4 x 90 x 1) tableta)
Uncommon side effects (may affect up to 1 in 100 people): 
Manje česte nuspojave (mogu pogoditi do 1 na 100 osoba):
General disorders and administration site conditions peripheral oedema asthenia, chest pain, fatigue, oedema malaise 
Opći poremećaji i poremećaji mjesta primjene periferni edem astenija, bol u prsištu, umor, edem malaksalost
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/5 mg 
BLISTER DJELJIV NA JEDINIČNE OD 10 TABLETA - 80 mg/5 mg
Onduarp showed dose-related reductions in systolic/diastolic blood pressure across the therapeutic dose range of −21.8/−16.5 mmHg (40 mg/5 mg), −22.1/−18.2 mmHg (80 mg/5 mg), 
Onduarp je, ovisno o rasponu doza, pokazala sniženje sistoličkog/dijastoličkog krvnog tlaka od -21,8/16,5 mmHg (40 mg/5 mg), -22,1/-18,2 mmHg (80 mg/5 mg), -24,7/-20,2 mmHg (40 mg/10 mg) i26,4/-20,1 mmHg (80 mg/10 mg).
After 8 weeks of treatment, each of the combination treatments was statistically significantly superior to amlodipine monotherapy in reducing diastolic and systolic blood pressure (−11.1/−9.2 mmHg, −11.3/ −9.3 mmHg with 40 mg/10 mg, 80 mg/10 mg versus −7.4/−6.5 mmHg with amlodipine 10 mg) and higher diastolic blood pressure normalisation rates compared to monotherapy were achieved (63.7 %, 66.5 % with 40 mg/10 mg, 80 mg/10 mg versus 51.1 % with amlodipine 10 mg). 
Nakon 8 tjedana liječenja, svaka od kombinacija bila je statistički superiorna u odnosu na obje monoterapijske doze amlodipina u snižavanju sistoličkog i dijastoličkog krvnog tlaka (-13,6/-9,4 mmHg, -15,0/-10,6 mmHg uz 40 mg/5 mg, 80 mg/5 mg u odnosu na -6,2/5,7 mmHg, -11,1/-8,0 mmHg uz amlodipin 5 mg i 10 mg, a postignuta je viša stopa kontrole dijastoličkog krvnog tlaka u usporedbi s relevantnim monoterapijama (56,7%, 63,8% uz 40 mg/5 mg i 80 mg/5 mg u odnosu na 42%, 56,7% uz amlodipin 5 mg i 10 mg).
Onduarp 80 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled on Onduarp 40 mg/10 mg or Onduarp 80 mg/5 mg. 
Onduarp 80 mg/10 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka s Onduarpom 40 mg/10 mg.
The observed mean changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg (−22.2/−17.2 mmHg with 40 mg/5 mg; −22.5/−19.1 mmHg with 80 mg/5 mg) were comparable to or greater than those seen with amlodipine 10 mg (−21.0/−17.6 mmHg) and associated with significant lower oedema rates (1.4 % with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 10 mg). 
Primijećene prosječne promjene sistoličkog/dijastoličkog krvnog tlaka uz kombiniranu terapiju s amlodipinom 5 mg (-22,2/17,2 mmHg s 40 mg/5 mg; -22,5/-19,1 mmHg uz 80 mg/5 mg) bile su usporedive ili veće od onih primijećenih uz amolodipin 10 mg (-21,0/-17,6 mmHg) te povezane sa značajno nižom učestalošću edema (1,4% uz 40 mg/5 mg; 0,5% uz 80mg/5 mg; 17,6% uz amlodipin 10 mg).