natgillin/translations-raw huggingface dataset:
Do not use any Dafiro HCT pack that is damaged or shows signs of tampering.
Dafiro HCT se ne smije upotrijebiti ukoliko primjetite da je pakiranje oštećeno ili su vidljivi znakovi otvaranja.
Monitoring of potassium should be undertaken as appropriate.
Po potrebi se može provesti praćenje kalija.
if you have a high level of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching).
ako imate nisku razinu natrija u krvi (sa ili bez simptoma kao što su umor, smetenost, trzanje mišića, konvulzije). ako imate visoku razinu kalcija u krvi (sa ili bez simptoma kao što su mučnina, povraćanje, zatvor, bol u želucu, učestalo mokrenje, žeđ, slabost i trzanje mišića).
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan and therefore Dafiro HCT is not suitable in this group of patients (see sections 4.3, 4.4 and 5.2).
U bolesnika s blagim do umjerenim oštećenjem jetre, bez kolestaze, najviša preporučena doza valsartana je 80 mg te Dafiro HCT stoga nije pogodan za ovu skupinu bolesnika (vidjeti dijelove 4.3, 4.4 i 5.2).
• high level of uric acid in the blood
• visoka razina mokraćne kiseline u krvi
Dafiro HCT should be used only after correction of any pre-existing sodium and/or volume depletion.
Dafiro HCT smije se primjenjivati tek nakon korigiranja snižene razine natrija i/ili volumena tekućine.
Valsartan Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Valsartan Diuretici koji štede kalij, nadomjesci kalija, zamjene soli koje sadrže kalij i ostale tvari koje mogu povećati razine kalija
Amlodipine dose recommendations have not been established in patients with mild to moderate hepatic impairment.
Preporučena doza amlodipina nije utvrđena u bolesnika s blagim do umjerenim oštećenjem jetre.
Dafiro HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
Dafiro HCT je kontraindiciran u bolesnika s teškim oštećenjem bubrega, anurijom ili u bolesnika na dijalizi (vidjeti dio 4.3).
Medicinal products affecting serum sodium level
Lijekovi koji utječu na razinu natrija u serumu
Amlodipine/Valsartan/Hydrochlorothiazide
Amlodipin/Valsartan/Hidroklorotiazid
Due to the valsartan component, Dafiro HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Zbog komponente valsartana, Dafiro HCT je kontraindiciran u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
Serum levels of calcium should be periodically monitored during treatment with thiazides.
Tijekom liječenja s tiazidima potrebno je periodički pratiti razine kalcija u serumu.
Treatment with Dafiro HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia.
Liječenje Dafiro HCT-om smije se započeti tek nakon korigiranja hipokalijemije i eventualne prateće hipomagnezijemije.
If you forget to take Dafiro HCT
Ako ste zaboravili uzeti Dafiro HCT
If you stop taking Dafiro HCT
Ako prestanete uzimati Dafiro HCT
• purple skin patches
• ljubičaste mrlje na koži
• inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)
• upala krvnih žila sa simptomima poput osipa, ljubičastih mrlja na koži, vrućica (vaskulitis)
Ciclosporin
Ciklosporin
This is a disease in which the adrenal glands make too much of the hormone aldosterone If this applies to you, the use of Dafiro HCT is not recommended.
To je bolest kod koje nadbubrežne žlijezde stvaraju previše hormona aldosterona.
• difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress,
• teškoće pri disanju s vrućicom, kašalj, zviždanje u plućima, nedostatak zraka (respiratorni distres, plućni edem, pneumonitis)
Due to the valsartan component, Dafiro HCT is contraindicated in patients with hepatic impairment (see sections 4.2 and 4.3).
Zbog valsartanske komponente Dafiro HCT je kontraindiciran u bolesnika s oštećenjem jetre (vidjeti djelove 4.2 i 4.3).
Hypochloraemic alkalosis
Hipokloremijska alkaloza
• yellowing of the skin (jaundice)
• žutilo kože (žutica)
No information is available regarding the use of valsartan during breast-feeding.
Nisu dostupne informacije o primjeni valsartana i/ili amlodipina tijekom dojenja.
Thiazide diuretics, including hydrochlorothiazide, may enhance the hyperglycaemic effect of diazoxide.
Tiazidni diuretici, uključujući hidroklorotiazid, mogu pojačati hiperglikemijski učinak diazoksida.
Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Dafiro HCT, 10 mg/320 mg/25 mg.
Savjetuje se oprez u bolesnika sa zatajenjem srca i bolešću koronarnih arterija, posebno u najvišoj dozi Dafiro HCT-a, 10 mg/320 mg/25 mg.
Non cardiac chest pain
• bol u prsnom košu
• tingling or numbness
• trnci ili obamrlost
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
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
There are no clinical studies on fertility with Dafiro HCT.
Ne postoje klinička ispitivanja djelovanja Dafiro HCT-a na plodnost.
• itchy rash and other types of rash
• osip praćen svrbežom i druge vrste osipa
Dafiro HCT should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Bolesnici u kojih se razvije angioedem trebaju odmah prekinuti primjenu Dafiro HCT-a i više ga ne smiju ponovo uzimati.
• anticholinergic agents (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia);
• antikolinergijski lijekovi (lijekovi koji se koriste za liječenje raznih poremećaja, poput grčeva u probavnom sustavu, grča mokraćnog mjehura, astme, bolesti kretanja, grčeva mišića,
Rhinitis
Rinitis
• confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic alkalosis)
• smetenost, umor, grčevi i trzanje mišića, ubrzano disanje (hipokloremijska alkaloza)
• weight increase
• povećanje tjelesne težine
Ion exchange resins
Ionsko-izmjenjivačke smole
• abnormal liver function test
• poremećeni nalazi pretraga jetrene funkcije
How to take Dafiro HCT
Kako uzimati Dafiro HCT
Thiazides, including hydrochlorothiazide, may increase the risk of adverse reactions caused by amantadine.
Tiazidi, uključujući hidroklorotiazid, mogu povećati rizik od nuspojava uzrokovanih amantadinom.
• fast heart beat
• ubrzani otkucaji srca
Thiazide-induced hypokalaemia or hypomagnesaemia may occur as undesirable effects, favouring the onset of digitalis-induced cardiac arrhythmias.
Glikozidi digitalisa Hipokalijemija ili hipomagnezijemija izazvani tiazidima mogu se javiti kao nuspojave koje pogoduju nastupu srčanih aritmija izazvanih digitalisom.
• facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
• osip lica, bol u zglobovima, poremećaj mišića, vrućica (eritematozni lupus)
Very rare (may affect up to 1 in 10,000 people):
Vrlo rijetko (mogu se javiti u do 1 na 10 000 osoba):
Excessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Dafiro HCT (10 mg/320 mg/25 mg) compared to 1.8% of valsartan/hydrochlorothiazide (320 mg/25 mg) patients, 0.4% of amlodipine/valsartan (10 mg/320 mg) patients, and 0.2% of hydrochlorothiazide/amlodipine (25 mg/10 mg) patients in a controlled trial in patients with moderate to severe uncomplicated hypertension.
U kontroliranom ispitivanju provedenom u bolesnika s umjerenom do teškom nekompliciranom hipertenzijom, izrazita hipotenzija, uključujući ortostatsku hipotenziju, viđena je u 1,7% bolesnika liječenih najvišom dozom Dafiro HCT-a (10 mg/320 mg/25 mg) u usporedbi s 1,8% bolesnika liječenih valsartanom/hidroklorotiazidom (320 mg/25 mg), 0,4% bolesnika liječenih amlodipinom/valsartanom (10 mg/320 mg) i 0,2% bolesnika liječenih hidroklorotiazidom/amlodipinom (25 mg/10 mg).
Medicinal products affecting serum potassium level
Lijekovi koji utječu na razinu kalija u serumu
Thiazides, including hydrochlorothiazide, potentiate the action of curare derivatives.
Tiazidi, uključujući hidroklorotiazid, pojačavaju djelovanje derivata kurarea.
• severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• teške kožne reakcije, uključujući intezivan kožni osip, koprivnjaču, crvenilo kože po čitavom tijelu, jaki svrbež, stvaranje mjehurića, ljuštenje i oticanje kože, upalu sluznica (Stevens
Caution is indicated in long-term administration of these medicinal products.
U slučaju dugotrajne primjene tih lijekova nužan je oprez.
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