natgillin/translations-raw huggingface dataset:
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide 
Dafiro HCT 5 mg/160 mg/12,5 mg filmom obložene tablete Dafiro HCT 10 mg/160 mg/12,5 mg filmom obložene tablete Dafiro HCT 5 mg/160 mg/25 mg filmom obložene tablete Dafiro HCT 10 mg/160 mg/25 mg filmom obložene tablete Dafiro HCT 10 mg/320 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required. 
U bolesnika sa šećernom bolešću može biti potrebno prilagoditi dozu inzulina ili peroralnih hipoglikemijskih lijekova.
A total of 2,271 patients with moderate to severe hypertension (mean baseline systolic/diastolic blood pressure was 170/107 mmHg) received treatments of amlodipine/valsartan/hydrochlorothiazide 10 mg/320 mg/25 mg, valsartan/hydrochlorothiazide 320 mg/25 mg, amlodipine/valsartan 10 mg/320 mg, or hydrochlorothiazide/amlodipine 25 mg/10 mg. At study initiation patients were assigned lower doses of their treatment combination and were titrated to their full treatment dose by week 2. 
Ukupno je 2271 bolesnik s umjerenom do teškom hipertenzijom (početna srednja vrijednost sistoličkog/dijastoličkog krvnog tlaka bila je 170/107 mmHg) liječen amlodipinom/valsartanom/hidroklorotiazidom od 10 mg/320 mg/25 mg, valsartanom/hidroklorotiazidom od 320 mg/25 mg, amlodipinom/ valsartanom od 10 mg/320 mg, odnosno hidroklorotiazidom/amlodipinom od 25 mg/10 mg.
30 film-coated tablets 
30 filmom obloženih tableta
if you have liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to the build up of bile in the liver (cholestasis). 
ako imate bolest jetre, oštećenje žučnih kanalića u jetri (bilijarna ciroza) koje dovodi do nakupljanja žuči u jetri (kolestaza). ako imate teške probleme s bubrezima ili ako ste na dijalizi.
Methyldopa 
Metildopa
Dafiro HCT individual component 
Pojedinačna komponenta Dafiro HCTa
98 film-coated tablets 
98 filmom obloženih tableta
90 film-coated tablets 
90 filmom obloženih tableta
• increased number of times of passing urine 
• povećan broj mokrenja
Very rare Not known Very rare 
Vrlo rijetko Nepoznato Vrlo rijetko
Grapefruit and grapefruit juice should not be consumed by people who are prescribed Dafiro HCT. 
Bolesnici kojima je propisan Dafiro HCT ne smiju konzumirati grejp ili sok od grejpa.
Rare (may affect up to 1 in 1,000 people): 
Rijetko(mogu se javiti u do 1 na 1000 osoba):
Not known Rare 
Nepoznato Rijetko
Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue, has been reported in patients treated with valsartan. 
U bolesnika koji su liječeni valsartanom prijavljena je pojava angioedema, uključujući oticanje grkljana i glotisa, koji uzrokuje opstrukciju dišnih puteva i/ili oticanje lica, usnica, ždrijela i/ili jezika.
As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. 
U podložnih pojedinaca mogu se očekivati promjene bubrežne funkcije kao posljedica inhibicije renin-angiotenzin-aldosteronskog sustava.
Prompt medical or surgical treatment may need to be considered if the intraocular pressure remains uncontrolled. 
Ako očni tlak ostane nekontroliran, mogla bi se pokazati potreba za neodložnom liječničkim ili kirurškim liječenjem.
Aortic and mitral valve stenosis 
Stenoza aortnog i mitralnog zaliska
How to store Dafiro HCT 
Kako čuvati Dafiro HCT
• medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir); 
• lijekovi koji se primjenjuju za liječenje HIV infekcije/SIDA (npr. ritonavir, indinavir,
What Dafiro HCT looks like and contents of the pack Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side. 
Kako Dafiro HCT izgleda i sadržaj pakiranja Dafiro HCT 5 mg/160 mg/12,5 mg filmom obložene tablete su bijele, ovalne tablete s oznakom „NVR“ na jednoj strani i „VCL“ na drugoj strani.
• severely decreased urine output 
• izrazito smanjeno mokrenje
Aplastic anaemia 
Aplastična anemija
• irregular heart beat 
• nepravilni rad srca
• medicines used for oesophageal ulceration and inflammation (carbenoxolone); 
• lijekovima koji se koriste za liječenje čira ili upale jednjaka (karbenoksolon);
Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets 
Dafiro HCT 10 mg/320 mg/25 mg filmom obložene tablete
• medicines for the treatment of gout, such as allopurinol; 
• lijekovima za liječenje gihta, kao što je alopurinol;
The triple combination therapy was statistically superior to each of the three dual combination treatments in reduction of diastolic and systolic blood pressures. 
Sniženje dijastoličkog i sistoličkog krvnoga tlaka postignuto trojnom kombinacijskom terapijom bilo je statistički superiornije od onoga postignutog bilo kojim od tri dvojna kombinacijska liječenja.
Co-administration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol. 
Istodobna primjena s tiazidnim diureticima, uključujući hidroklorotiazid, može povećati incidenciju reakcija preosjetljivosti na alopurinol.
Frequency Dafiro HCT 
Učestalost Dafiro HCT
Blood potassium decreased Uncommon Blood potassium increased 
Povišena dušična urea u krvi Manje često Povišena mokraćna kiselina u krvi
• pain 
• bol
Pack sizes: 56, 98 or 280 film-coated tablets Multipacks of 280 tablets, comprising 4 cartons, each containing 70 tablets. 
PVC/PVDC perforirani blisteri djeljivi na jedinične doze za bolničku primjenu: Veličina pakiranja: 56, 98 ili 280 filmom obloženih tableta Višestruka pakiranja od 280 tableta, koja sadrže 4 kutije, od kojih svaka sadrži 70 tableta.
There is limited experience with the use of Dafiro HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease. 
U bolesnika sa zatajenjem srca i bolešću koronarnih arterija postoji ograničeno iskustvo s primjenom Dafiro HCT-a, posebno u najvišoj dozi.
Concomitant administration of thiazide diuretics with substances that also have a blood pressure lowering effect (e.g. by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic hypotension. 
smanjenjem aktivnosti simpatičkoga živčanog sustava ili direktnom vazodilatacijom) može potencirati ortostatsku hipotenziju.
• inflammation of blood vessels 
• upala krvnih žila
Acute angle-closure glaucoma 
Akutni glaukom zatvorenog kuta
70x1 film-coated tablets. 
Ne smije se prodavati zasebno. 70x1 filmom obložene tablete.
• increase of lipids in the blood 
• povišenje masnoća u krvi
Amantadine 
Amantadin
Hypotension 
Hipomagnezijemija
• decrease of potassium in the blood 
• sniženje kalija u krvi
• constipation 
• ukočenost
if you experience dizziness and/or fainting during treatment with Dafiro HCT, tell your doctor as soon as possible. 
Nemojte više nikad uzimati Dafiro HCT. ako tijekom liječenja Dafiro HCT-om osjetite omaglicu i/ili nesvjesticu, o tome što prije obavijestite svoga liječnika.
• skin discolouration 
• svrbljiva koža
• visual impairment 
• poremećaj mokrenja
(haemolytic anaemia) 
(jedinična doza)
Dafiro HCT should be discontinued if hypercalcaemia develops during treatment. 
Ako se tijekom liječenja Dafiro HCT-om razvije hiperkalcijemija, liječenje treba prekinuti.
This can lead to permanent vision impairment, if not treated. 
Ako se ne liječi, može dovesti do trajnog oštećenja vida.
Absorption of thiazide diuretics, including hydrochlorothiazide, is decreased by cholestyramine or colestipol. 
Kolestiramin ili kolestipol smanjuju apsorpciju tiazidnih diuretika, uključujući hidroklorotiazid.
• low level of sodium in the blood 
• niska razina natrija u krvi
Agranulocytosis, bone marrow failure 
Agranulocitoza, zatajenje koštane srži
EU/1/09/574/042 98 film-coated tablets 
EU/1/09/574/042 98 filmom obloženih tableta
• swelling of the gums 
• oticanje zglobova
• sleeplessness 
• omaglica
EU/1/09/574/043 280 film-coated tablets 
EU/1/09/574/043 280 filmom obloženih tableta
• visual disturbances 
• smetnje vida
EU/1/09/574/007 280 film-coated tablets 
EU/1/09/574/007 280 filmom obloženih tableta
EU/1/09/574/006 98 film-coated tablets 
EU/1/09/574/006 98 filmom obloženih tableta
Diarrhoea 
Letargija
EU/1/09/574/031 280 film-coated tablets 
EU/1/09/574/031 280 filmom obloženih tableta
EU/1/09/574/004 56 film-coated tablets 
EU/1/09/574/004 56 filmom obloženih tableta
Hypromellose, substitution type 2910 (3 mPa.s) Macrogol 4000 
Ovojnica hipromeloza zamjenski tip 2910 (3 mPas) titanijev dioksid (E171) makrogol 4000 talk
Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side. 
Dafiro HCT 10 mg/160 mg/12,5 mg filmom obložene tablete su blijedo žute, ovalne tablete s oznakom „NVR“ na jednoj strani i „VDL“ na drugoj strani.
EU/1/09/574/055 280 film-coated tablets 
EU/1/09/574/055 280 filmom obloženih tableta
EU/1/09/574/018 98 film-coated tablets 
EU/1/09/574/018 98 filmom obloženih tableta
• dry mouth 
• zadah iz usta
fever (erythema multiforme) 
Dantrolen (infuzija)
Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VFL” on the other side. 
Dafiro HCT 10 mg/320 mg/25 mg filmom obložene tablete su žuto-smeđe, ovalne tablete s oznakom „NVR“ na jednoj strani i „VFL“ na drugoj strani.
EU/1/09/574/019 280 film-coated tablets 
EU/1/09/574/019 280 filmom obloženih tableta
EU/1/09/574/041 90 film-coated tablets 
EU/1/09/574/041 90 filmom obloženih tableta
EU/1/09/574/016 56 film-coated tablets 
EU/1/09/574/016 56 filmom obloženih tableta
Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade 
Dafiro HCT 10 mg/320 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets 
Dafiro HCT 10 mg/160 mg/25 mg filmom obložene tablete
EU/1/09/574/049 14 film-coated tablets 
EU/1/09/574/049 14 filmom obloženih tableta
EU/1/09/574/005 90 film-coated tablets 
EU/1/09/574/005 90 filmom obloženih tableta
EU/1/09/574/026 28 film-coated tablets 
EU/1/09/574/026 28 filmom obloženih tableta
EU/1/09/574/030 98 film-coated tablets 
EU/1/09/574/030 98 filmom obloženih tableta
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets 
Dafiro HCT 5 mg/160 mg/12,5 mg filmom obložene tablete
EU/1/09/574/001 14 film-coated tablets 
EU/1/09/574/001 14 filmom obloženih tableta
EU/1/09/574/040 56 film-coated tablets 
EU/1/09/574/040 56 filmom obloženih tableta
EU/1/09/574/038 28 film-coated tablets 
EU/1/09/574/038 28 filmom obloženih tableta
Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “VEL” on the other side. 
Dafiro HCT 5 mg/160 mg/25 mg filmom obložene tablete su žute, ovalne tablete s oznakom „NVR“ na jednoj strani i „VEL“ na drugoj strani.
Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets 
Dafiro HCT 10 mg/160 mg/12,5 mg filmom obložene tablete
Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets 
Dafiro HCT 5 mg/160 mg/25 mg filmom obložene tablete
EU/1/09/574/054 98 film-coated tablets 
EU/1/09/574/054 98 filmom obloženih tableta
EU/1/09/574/052 56 film-coated tablets 
EU/1/09/574/052 56 filmom obloženih tableta
EU/1/09/574/025 14 film-coated tablets 
EU/1/09/574/025 14 filmom obloženih tableta
EU/1/09/574/029 90 film-coated tablets 
EU/1/09/574/029 90 filmom obloženih tableta
EU/1/09/574/027 30 film-coated tablets 
EU/1/09/574/027 30 filmom obloženih tableta
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan and 25 mg hydrochlorothiazide. 
Svaka filmom obložena tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 320 mg valsartana i 25 mg hidroklorotiazida.
Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172) 
Ovojnica hipromeloza zamjenski tip 2910 (3 mPas) makrogol 4000 talk titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Dafiro HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited. 
Zbog ograničenog broja dostupnih podataka u ovoj populaciji bolesnika, u starijih bolesnika se preporučuje oprez, uključujući češće praćenje krvnog tlaka, posebno pri najvišoj dozi Dafiro HCT-a, 10 mg/320 mg/25 mg.
• low level of potassium in the blood 
• niska razina kalija u krvi
EU/1/09/574/003 30 film-coated tablets 
EU/1/09/574/003 30 filmom obloženih tableta
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172). 
Drugi sastojci su mikrokristalična celuloza, krospovidon (tip A), koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza (zamjenski tip 2910 (3 mPas)), makrogol 4000, talk, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172).
EU/1/09/574/015 30 film-coated tablets 
EU/1/09/574/015 30 filmom obloženih tableta
• severe upper stomach ache (inflammation of the pancreas) 
• jaka bol u gornjem dijelu trbuha (upala gušterače)
EU/1/09/574/037 14 film-coated tablets 
EU/1/09/574/037 14 filmom obloženih tableta
EU/1/09/574/053 90 film-coated tablets 
EU/1/09/574/053 90 filmom obloženih tableta
EU/1/09/574/002 28 film-coated tablets 
EU/1/09/574/002 28 filmom obloženih tableta
EU/1/09/574/014 28 film-coated tablets 
EU/1/09/574/014 28 filmom obloženih tableta
Each tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan and 25 mg hydrochlorothiazide. 
Jedna tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 320 mg valsartana i 25 mg hidroklorotiazida.
EU/1/09/574/017 90 film-coated tablets 
EU/1/09/574/017 90 filmom obloženih tableta
EU/1/09/574/051 30 film-coated tablets 
EU/1/09/574/051 30 filmom obloženih tableta
Dafiro 10 mg/320 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. 
Dafiro HCT 10 mg/320 mg/25 mg filmom obložene tablete Djelatne tvari u Dafiro HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
EU/1/09/574/039 30 film-coated tablets 
EU/1/09/574/039 30 filmom obloženih tableta
Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side. 
Dafiro HCT 10 mg/160 mg/25 mg filmom obložene tablete su žuto-smeđe, ovalne tablete s oznakom „NVR“ na jednoj strani i „VHL“ na drugoj strani.
EU/1/09/574/013 14 film-coated tablets 
EU/1/09/574/013 14 filmom obloženih tableta
EU/1/09/574/044 56 x 1 film-coated tablet (unit dose) EU/1/09/574/045 98 x 1 film-coated tablet (unit dose) EU/1/09/574/046 280 x 1 film-coated tablet (unit dose) 
EU/1/09/574/044 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/045 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/046 280 x 1 filmom obloženih tableta (jedinična doza)
EU/1/09/574/028 56 film-coated tablets 
EU/1/09/574/028 56 filmom obloženih tableta
Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. 
Dafiro HCT 5 mg/160 mg/25 mg filmom obložene tablete Djelatne tvari u Dafiro HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
EU/1/09/574/050 28 film-coated tablets 
EU/1/09/574/050 28 filmom obloženih tableta
Coordination abnormal 
• poremećaj koordinacije
Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade 
Dafiro HCT 5 mg/160 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
EU/1/09/574/008 56 x 1 film-coated tablet (unit dose) EU/1/09/574/009 98 x 1 film-coated tablet (unit dose) EU/1/09/574/010 280 x 1 film-coated tablet (unit dose) 
EU/1/09/574/008 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/009 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/010 280 x 1 filmom obloženih tableta (jedinična doza)
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, yellow iron oxide (E172). 
Drugi sastojci su mikrokristalična celuloza, krospovidon (tip A), koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza (zamjenski tip 2910 (3 mPas)), makrogol 4000, talk, žuti željezov oksid (E172).
EU/1/09/574/056 56 x 1 film-coated tablet (unit dose) EU/1/09/574/057 98 x 1 film-coated tablet (unit dose) EU/1/09/574/058 280 x 1 film-coated tablet (unit dose) 
EU/1/09/574/056 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/057 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/058 280 x 1 filmom obloženih tableta (jedinična doza)
EU/1/09/574/032 56 x 1 film-coated tablet (unit dose) EU/1/09/574/033 98 x 1 film-coated tablet (unit dose) EU/1/09/574/034 280 x 1 film-coated tablet (unit dose) 
EU/1/09/574/032 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/033 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/034 280 x 1 filmom obloženih tableta (jedinična doza)
Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade 
Dafiro HCT 10 mg/160 mg/25 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. 
Dafiro HCT 10 mg/160 mg/25 mg filmom obložene tablete Djelatne tvari u Dafiro HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
fever (toxic epidermal necrolysis) 
Johnsonov sindrom, toksičnu epidermalnu nekrolizu) ili druge alergijske reakcije
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide. 
Svaka filmom obložena tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 25 mg hidroklorotiazida.
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. 
Dafiro HCT 5 mg/160 mg/12,5 mg filmom obložene tablete Djelatne tvari u Dafiro HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade 
Dafiro HCT 5 mg/160 mg/12,5 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. 
Dafiro HCT 10 mg/160 mg/12,5 mg filmom obložene tablete Djelatne tvari u Dafiro HCT-u su amlodipin (u obliku amlodipinbesilata), valsartan i hidroklorotiazid.
Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide. 
Svaka filmom obložena tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 25 mg hidroklorotiazida.
Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade 
Dafiro HCT 10 mg/160 mg/12,5 mg filmom obložene tablete amlodipin/valsartan/hidroklorotiazid
EU/1/09/574/020 56 x 1 film-coated tablet (unit dose) EU/1/09/574/021 98 x 1 film-coated tablet (unit dose) EU/1/09/574/022 280 x 1 film-coated tablet (unit dose) 
EU/1/09/574/020 56 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/021 98 x 1 filmom obloženih tableta (jedinična doza) EU/1/09/574/022 280 x 1 filmom obloženih tableta (jedinična doza)
• skin reddening 
• promjena boje kože
• anxiety 
• pospanost
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172). 
Drugi sastojci su mikrokristalična celuloza, krospovidon (tip A), koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza (zamjenski tip 2910 (3 mPas)), makrogol 4000, talk, titanijev dioksid (E171), žuti željezov oksid (E172).
EU/1/09/574/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/574/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose) 
EU/1/09/574/060 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/574/059 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171). 
Drugi sastojci su mikrokristalična celuloza, krospovidon (tip A), koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza (zamjenski tip 2910 (3 mPas)), makrogol 4000, talk, titanijev dioksid (E171).
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide. 
Svaka filmom obložena tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 12,5 mg hidroklorotiazida.
EU/1/09/574/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/574/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose) 
EU/1/09/574/048 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/574/047 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide. 
Svaka filmom obložena tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 12,5 mg hidroklorotiazida.
Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide. 
Jedna tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 25 mg hidroklorotiazida.
• stiffness 
• drhtanje
Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide. 
Jedna tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 12,5 mg hidroklorotiazida.
EU/1/09/574/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/574/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose) 
EU/1/09/574/012 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/574/011 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
EU/1/09/574/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/574/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose) 
EU/1/09/574/036 280 filmom obloženih tableta (višestruko pakiranje, 20 kutija od 14 tableta) EU/1/09/574/035 280 filmom obloženih tableta (višestruko pakiranje, 4 kutije od 70 tableta)
Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide. 
Jedna tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 25 mg hidroklorotiazida.
Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide. 
Jedna tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata), 160 mg valsartana i 12,5 mg hidroklorotiazida.
Renal dysfunction 
Bubrežna disfunkcija