FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Croatian: 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).
English: 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.
Croatian: Ove farmakološki posredovane nuspojave, poznate iz pretkliničkih studija i uz inhibitore enzima angiotenzin-konvertaze i uz antagoniste angiotenzina II, spriječene su oralnim nadomjescima soli.
English: 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.
Croatian: 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.
English: Use in patients with heart failure
Croatian: Primjena kod bolesnika sa zatajenjem srca
English: Telmisartan and amlodipine are not dialysable.
Croatian: Telmisartan i amlodipin se ne uklanjaju dijalizom.
English: 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
Croatian: 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.
English: Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Onduarp containing the same component doses.
Croatian: Odrasli bolesnici koji primaju telmisartan i amlodipin kao zasebne tablete mogu, umjesto toga, uzimati Onduarp tablete koje sadrže jednake doze komponenti.
English: Interactions common to the combination No drug interaction studies have been performed.
Croatian: Interakcije koje su česte uz ovu kombinaciju Ispitivanja interakcija lijekova nisu izvođena.
English: 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.
Croatian: 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.
English: Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Croatian: Ukoliko dođe do izlaganja antagonistima receptora angiotenzina II od drugog tromjesečja nadalje, preporučuje se ultrazvučna kontrola bubrežne funkcije i lubanje.
English: - 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).
Croatian: - 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).
English: Common side effects (may affect up to 1 in 10 people): Dizziness, ankle swelling (oedema).
Croatian: Česte nuspojave (mogu se javiti kod do 1 na 10 osoba): Omaglica, otečenost gležnjeva (edem).
English: Onduarp is used to treat high blood pressure - in adult patients whose blood pressure is not controlled enough with amlodipine.
Croatian: Onduarp se primjenjuje u liječenju visokog krvnog tlaka - kod odraslih bolesnika čiji krvni tlak nije adekvatno reguliran amlodipinom.
English: Leukocytopenia, thrombocytopenia
Croatian: Leukopenija, trombocitopenija
English: PHARMACEUTICAL FORM AND CONTENTS 28 tablets
Croatian: 28 tableta
English: 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).
Croatian: 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).
English: The maximum recommended dose is Onduarp 80 mg/10 mg, one tablet per day.
Croatian: Maksimalna preporučena doza je jedna tableta Onduarpa 80 mg/10 mg dnevno.
English: Metabolism and nutrition disorders Very rare:
Croatian: Poremećaji metabolizma i prehrane Vrlo rijetko:
English: How to store Onduarp
Croatian: Kako čuvati Onduarp
English: 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.
Croatian: 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.
English: Upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis Sepsis including fatal outcome1
Croatian: Infekcije gornjih dišnih puteva uključujući faringitis i sinusitis, Infekcije mokraćnog sustava uključujući cistitis
English: - 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.
Croatian: - 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.
English: Rare side effects (may affect up to 1 in 1,000 people): Confusion.
Croatian: Rijetke nuspojave (mogu pogoditi do 1 na 1000 osoba): Konfuzija.
English: Caution is advised when using Onduarp in such patients as amlodipine and telmisartan are not dialysable (see also section
Croatian: 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).
English: PHARMACEUTICAL FORM AND CONTENTS Component of a multipack comprising 4 packs, each containing 90 x 1 tablets
Croatian: Sastavni dio višestrukog pakovanja s 4 pakovanja, od kojih svako sadrži 90 x 1 tabletu.
English: In patients with mild to moderate hepatic impairment Onduarp should be administered with caution.
Croatian: Kod bolesnika s blagim do umjerenim oštećenjem jetre, Onduarp se primjenjuje s oprezom.
English: Japanese patients are more likely to experience this side effect.
Croatian: Japanski bolesnici će vjerojatno češće imati ove nuspojave u odnosu na ostale bolesnike.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 4 packs, each containing 90 x 1 tablets
Croatian: Višestruko pakovanje s 4 pakovanja, od kojih svako sadrži 90 x 1 tabletu.
English: 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
Croatian: 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).
English: 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.
Croatian: 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.
English: Due to the slow onset of action, acute hypotension is not a feature of amlodipine administration.
Croatian: Zbog polaganog nastupa djelovanja terapija amlodipinom nije praćena akutnom hipotenzijom.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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%).
English: To be taken into account with concomitant use
Croatian: Što je potrebno imati na umu pri istovremenoj primjeni
English: Telmisartan and Amlodipine are not removed by haemodialysis.
Croatian: Telmisartan i amlodipin se ne uklanjaju hemodijalizom.
English: Sorbitol (E420)
Croatian: Sadrži sorbitol (E420).
English: Vascular disorders hypotension, orthostatic hypotension, flushing
Croatian: Poremećaji krvožilnog sustava hipotenzija, ortostatska hipotenzija, rumenilo
English: • Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets').
Croatian: • Lijekovi koji mogu povisiti vrijednosti kalija u krvi kao što su zamjenske soli koje sadrže kalij,
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORIZATION
Croatian: OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: 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
Croatian: 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).
English: 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.
Croatian: Brzina i opseg apsorpcije Onduarpa su ekvivalentni bioraspoloživosti telmisartana i amlodipina kada se primjenjuju zasebno.
English: Musculoskeletal and connective tissue disorders Rare:
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Rijetko:
English: Nervous system disorders Very rare:
Croatian: Poremećaji živčanog sustava Vrlo rijetko:
English: Furthermore low blood pressure may be aggravated by alcohol.
Croatian: Nadalje, niži krvni tlak može biti pogoršan uzimanjem alkohola, što se može manifestirati omaglicama prilikom ustajanja.
English: The elimination half-life is not changed in patients with renal impairment.
Croatian: Poluvrijeme eliminacije nije promijenjen kod bolesnika s oštećenjem bubrega.
English: 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.
Croatian: Prema ambulantnim mjerenjima krvnog tlaka, antihipertenzivni učinak se zadržava konstantno tijekom 24 sata od doziranja, te uključuje posljednja 4 sata prije sljedeće doze.
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1
Croatian: • Preosjetljivost na djelatne tvari, na derivate dihidropiridina ili neku od pomoćnih tvari
English: Renal impairment and kidney transplantation
Croatian: Oštećenje bubrega i presađivanje bubrega
English: Musculoskeletal and connective tissue disorders arthralgia, muscle spasms (cramps in legs), myalgia back pain, pain in extremity (leg pain)
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva artralgija, grčevi mišića (grčevi u nogama), mialgija bol u leđima, bol u udovima (bol u nogama)
English: Onduarp should therefore be used with caution in these patients.
Croatian: Stoga je potreban oprez u primjeni Onduarpa kod takvih bolesnika.
English: Very rare side effects (may affect up to 1 in 10,000 people):
Croatian: Vrlo rijetke nuspojave (mogu pogoditi do 1 na 10 000 osoba):
English: Gastro-intestinal disorders abdominal pain, diarrhoea, nausea vomiting, gingival hypertrophy, dyspepsia, dry mouth
Croatian: Poremećaji probavnog sustava abdominalna bol, proljev, mučnina povraćanje, hipertrofija desni, dispepsija, suhoća usta
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Alopecia, purpura, skin discolouration, hyperhidrosis Angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity
Croatian: Angioedem, polimorfni eritem, urtikarija, eksfolijativni dermatitis, Stevens-Johnsonov sindrom, fotoosjetljivost
English: You should see your doctor immediately if you experience any of the following symptoms:
Croatian: Ako primijetite neke od sljedećih simptoma, potrebno je odmah se javiti liječniku:
English: Skin and subcutaneous tissue disorders pruritus eczema, erythema, rash
Croatian: Poremećaji kože i potkožnog tkiva pruritus ekcem, eritem, osip
English: 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.
Croatian: : 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.
English: The elimination half-life of telmisartan is not changed in patients with hepatic impairment.
Croatian: Poluvrijeme eliminacije telmisartana ostao je nepromijenjen kod bolesnika s oštećenjem jetre.
English: 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.
Croatian: 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.
English: Colloidal anhydrous silica Brilliant blue FCF (E 133) Ferric oxide black (E172) Ferric oxide yellow (E172) Magnesium stearate Maize starch
Croatian: 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)
English: • 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,
Croatian: • Niski krvni tlak (hipotenzija), vjerojatno uslijed dehidracije (prekomjerni gubitak vode iz tijela)
English: Micturition disorder, pollakiuria
Croatian: Poremećaji mokrenja, polakizurija
English: Add on therapy Onduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine.
Croatian: Onduarp je indicirana u liječenju odraslih osoba kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka amlodipinom.
English: 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.
Croatian: 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.
English: (It is also better to avoid Onduarp in early pregnancysee Warnings and precautions and Pregnancy section.)
Croatian: • ako ste trudni dulje od 3 mjeseca (Također treba izbjegavati Onduarp u ranoj trudnoći pogledajte odlomak „Budite posebno oprezni” i „Trudnoća“).
English: Potassium sparing diuretics or potassium supplements Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss.
Croatian: Antagonisti receptora angiotenzina II, kao što je telmisartan, smanjuju gubitak kalija induciran diureticima.
English: Amlodipine bioavailability is not affected by food ingestion.
Croatian: Hrana ne utječe na bioraspoloživost amlodipina.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: Diabetic patients treated with insulin or antidiabetics In these patients hypoglycaemia may occur under telmisartan treatment.
Croatian: U ovoj skupini bolesnika može doći do pojave hipoglikemije tijekom liječenja telmisartanom.
English: 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.
Croatian: 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.
English: Onduarp 80 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with Onduarp 40 mg/5 mg.
Croatian: Onduarp 80 mg/5 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka s Onduarpom 40 mg/5 mg.