natgillin/translations-raw huggingface dataset:
Electrocardiographic effects: Dose and plasma concentration-related increases in the QTc interval (about 6 msec at 1000 mg twice daily), reductions in T wave amplitude, and in some cases notched
Djelovanje na elektrokardiogram: Kod bolesnika liječenih Ranexom uočeno je produljenje QTc intervala, ovisno o dozi i koncentraciji u plazmi (oko 6 msec kod doze od 1000 mg dvaput dnevno), smanjenje amplitude T vala i, u nekim slučajevima, šiljastih T valova.
Examples of such drugs include certain antihistamines (e.g. terfenadine, astemizole, mizolastine), certain antiarrhythmics (e.g. quinidine, disopyramide, procainamide), erythromycin, and tricyclic antidepressants (e.g. imipramine, doxepin, amitriptyline).
Primjeri takvih lijekova uključuju određene antihistaminike (npr. terfenadin, astemizol, mizolastin), određene antiaritmike (npr. kinidin, disopiramid, prokainamid), eritromicin i triciklične antidepresive (npr. imipramin, doksepin, amitriptilin).
Nederland Menarini Benelux NV/SA Tel: +32 (0)2 721 4545
Menarini Benelux NV/SA Tel: +32 (0)2 721 4545
Of the most commonly reported, the following events occurred more often with Ranexa (placebo-corrected frequencies) in elderly (≥ 75 years of age) than younger patients (< 75 years of age): constipation (8% versus 5%), nausea (6% versus 3%), hypotension (5% versus 1%), and vomiting (4% versus 1%).
Među najčešće zabilježenim nuspojavama, slijedeće su se nuspojave pojavljivale češće kod primjene Ranexe (učestalosti su korigirane u odnosu na placebo) kod starijih (≥ 75 godina života) nego kod mlađih bolesnika (< 75 godina života): konstipacija (8% u odnosu na 5%), mučnina (6% u odnosu na 3%),
Congestive heart failure (CHF): Dose titration in patients with moderate to severe CHF (NYHA Class III-IV) should be exercised with caution (see sections 4.4 and 5.2).
Kongestivno zatajenje srca: Kod bolesnika s umjerenim do teškim kongestivnim zatajenjem srca (NYHA klasa III-IV) treba pažljivo prilagođavati dozu (vidjeti dijelove 4.4 i 5.2).
Ranexa is contraindicated in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.3 and 5.2).
Ranexa je kontraindicirana kod bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min) (vidjeti dijelove 4.3 i 5.2).
which is approximately equal to a 2- to 7-msec increase over the plasma concentration range for ranolazine 500 to 1000 mg twice daily.
1000 ng/ml, što je otprilike jednako povećanju od 2 do 7 msec iznad raspona koncentracije ranolazina u plazmi kod doze 500 do 1000 mg dvaput dnevno.
This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti s produljenim oslobađanjem, tj.
• Concomitant administration of moderate CYP3A4 inhibitors (see sections 4.2 and 4.5).
• Kod istovremene primjene umjerenih inhibitora CYP3A4 (vidjeti dijelove 4.2 i 4.5).
Digoxin: An increase in plasma digoxin concentrations by an average of 1.5-fold has been reported when Ranexa and digoxin are co-administered.
Digoksin: kod istovremene primjene Ranexe i digoksina zabilježeno je povećanje koncentracija digoksina u plazmi prosječno 1,5 puta.
The slope is higher in patients with clinically significant hepatic impairment.
Promjene su bile veće kod bolesnika s klinički značajnom oštećenom jetrenom funkcijom.
CHF: CHF NYHA Class III and IV were estimated to have about 1.3-fold higher plasma concentrations.
klase III i IV imaju oko 1,3 puta veće koncentracije u plazmi.
In a large outcome study (MERLIN-TIMI 36) in 6,560 patients with UA/NSTEMI ACS, there was no difference in the risk of all-cause mortality (relative risk ranolazine:placebo 0.99), sudden cardiac death (relative risk ranolazine:placebo 0.87), or the frequency of symptomatic documented arrhythmias (3.0% versus 3.1%) between Ranexa and placebo when added to standard medical therapy (including beta-blockers, calcium channel blockers, nitrates, anti-platelet agents, lipid-lowering medicinal products, and ACE inhibitors).
U velikom istraživanju ishoda (MERLIN-TIMI 36) na 6560 bolesnika s nestabilnom anginom ili akutnim koronarnim sindromom bez elevacije ST-segmenta (NSTEMI) nije bilo razlike u riziku od smrtnosti od svih uzroka (relativni rizik ranolazin:placebo 0,99), nagle srčane smrti (relativni rizik ranolazin:placebo 0,87) niti učestalosti simptomatskih dokumentiranih aritmija (3,0% u odnosu na 3,1%) između Ranexe i placeba kad su bili korišteni kao dodatna terapija uz standardnu (uključujući beta-blokatore, blokatore kalcijevih kanala, nitrate, antitrombocitne lijekove, hipolipemike i ACE inhibitore).
The 500 mg tablets are light orange and are engraved with 500 on one side.
Tablete od 500 mg su svijetlonarančaste s utisnutim 500 s jedne strane.
AUTHORISATION
PRIMJENU
The potent CYP2D6 inhibitor paroxetine, at a dose of 20 mg once daily, increased steady-state plasma concentrations of ranolazine 1000 mg twice daily by an average of 1.2-fold.
Paroxetin, snažni inhibitor CYP2D6, u dozi od 20 mg jednom dnevno, povećao je koncentraciju ranolazina u stanju dinamičke ravnoteže, primijenjenog dvaput dnevno u dozi od 1000 mg, prosječno 1,2 puta.
Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) (see sections 4.2 and 4.5).
Istovremena primjena snažnih inhibitora CYP3A4 (npr. itrakonazola, ketokonazola, vorikonazola, posakonazola, inhibitora HIV proteaze, klaritromicina, telitromicina, nefazodona) (vidjeti dijelove 4.2 i 4.5).
A population-based analysis of combined data from patients and healthy volunteers demonstrated that the slope of the plasma concentration-QTc relationship was estimated to be 2.4 msec per 1000 ng/ml,
Analiza temeljena na kombiniranim podacima dobivenim iz populacije bolesnika i zdravih dobrovoljaca pokazala je da je krivulja odnosa koncentracije u plazmi i QTc-a procijenjena na 2,4 msec na
Musculoskeletal and connective tissue disorders Uncommon: pain in extremity, muscle cramp, joint swelling, muscular weakness.
Manje često: bolovi u ekstremitetima, grčevi u mišićima, oticanje zglobova, mišićna slabost.
What Ranexa looks like and contents of the pack Ranexa prolonged-release tablets are oval shaped tablets.
Ranexa tablete s produljenim oslobađanjem ovalnog su oblika.
Uncommon: dyspnoea, cough, epistaxis.
Manje često: dispneja, kašalj, epistaksa.
- Keep this leaflet.
- Sačuvajte ovu uputu o lijeku.
Dose limitation of atorvastatin and appropriate clinical monitoring may be considered when taking Ranexa.
Kod bolesnika koji uzimaju Ranexu treba razmotriti ograničenje doze atorvastatina i odgovarajuće kliničko praćenje bolesnika.
Ranexa should not be used in patients treated with CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort) (see section 4.5).
Ranexa se ne smije koristiti kod bolesnika liječenih induktorima CYP3A4 (npr. rifampicinom, fenitoinom, fenobarbitalom, karbamazepinom, gospinom travom) (vidjeti dio 4.5).
The 750 mg tablets are pale green and are engraved with 750 on one side.
Tablete od 750 mg su blijedozelene s utisnutim 750 s jedne strane.
INFORMATION IN BRAILLE Ranexa 375 mg
Ranexa 375 mg
Combining ranolazine with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) is contraindicated (see section 4.3).
Kombinacija ranolazina sa snažnim inhibitorima CYP3A4 (npr. itrakonazolom, ketokonazolom, vorikonazolom, posakonazolom, inhibitorima HIV proteaze, klaritromicinom, telitromicinom, nefazodonom) je kontraindicirana (vidjeti dio 4.3).
INFORMATION IN BRAILLE Ranexa 500 mg
Ranexa 500 mg
Initiation of treatment with Ranexa should be avoided during administration of inducers of CYP3A4 (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort) (see section 4.4).
Treba izbjegavati početak liječenja Ranexom tijekom primjene induktora CYP3A4 (npr. rifampicina, fenitoina, fenobarbitala, karbamazepina, gospine trave) (vidjeti dio 4.4).
Hepatic impairment: Careful dose titration is recommended in patients with mild hepatic impairment (see sections 4.4 and 5.2).
Oštećenje funkcije jetre: Preporučuje se pažljivo prilagođavanje doze kod bolesnika s blagim oštećenjem jetrene funkcije (vidjeti dijelove 4.4 i 5.2).
Reproductive system and breast disorders Rare: erectile dysfunction.
Rijetko: erektilna disfunkcija.
Swallow whole.
Menarini Kft.
Österreich A. Menarini Pharma GmbH.
Menarini Pharma GmbH.
Ranexa 1000 mg twice daily increased plasma concentrations of simvastatin lactone, simvastatin acid by about 2 fold.
Ranexa primijenjena u dozi od 1000 mg dvaput dnevno povisila je koncentracije simvastatin laktona u plazmi, simvastatinske kiseline oko 2 puta.
Drugs transported by the Organic Cation Transporter-2 (OCT2): Plasma exposure of metformin (1000 mg twice daily) increased 1.4- and 1.8-fold in subjects with type 2 diabetes mellitus when coadministered with RANEXA 500 mg and 1000 mg twice daily respectively.
Organic Cation Transporter-2, OCT2): Kod bolesnika s diabetesom mellitusom tipa 2 se izloženost metforminu u plazmi (u dozi od 1000 mg, dvaput dnevno) povećala 1,4 odnosno 1,8 puta kada su istodobno uzimali
Uncommon: hot flush, hypotension.
Manje često: navale vrućine, hipotenzija.
Light orange oval-shaped tablet engraved with 500 on one side.
Svijetlonarančaste ovalne tablete s utisnutim natpisom 500 s jedne strane.
EU/1/08/462/003 60 tablets in blister pack EU/1/08/462/004 60 tablets in bottle EU/1/08/462/009 30 tablets in blister pack EU/1/08/462/010 100 tablets in blister pack
EU/1/08/462/003 60 tableta u blister pakiranju EU/1/08/462/004 60 tableta u bočici EU/1/08/462/009 30 tableta u blister pakiranju EU/1/08/462/010 100 tableta u blister pakiranju
Uncommon: increased blood creatinine, increased blood urea, prolonged QT corrected interval,
Manje često: povišen kreatinin u krvi, povišena urea u krvi, produljen korigirani QT interval, povišen broj trombocita ili leukocita, smanjenje tjelesne težine.
Ranexa resulted in significant decreases in the number of angina attacks per week and consumption of short-acting nitroglycerin compared to placebo.
U usporedbi s placebom Ranexa je dovela do značajnog tjednog smanjenja broja napadaja angine pektoris i korištenja nitroglicerina kratkog djelovanja.
Pale blue oval-shaped tablet engraved with 375 on one side.
Blijedoplave ovalne tablete s utisnutim natpisom 375 s jedne strane.
Eye disorders Uncommon: blurred vision, visual disturbance, diplopia.
Poremećaji oka Manje često: zamagljen vid, poremećaji vida, diplopija.
Ranexa 375 mg prolonged-release tablets Ranexa 500 mg prolonged-release tablets Ranexa 750 mg prolonged-release tablets
Uputa o lijeku: Informacije za bolesnika Ranexa 375 mg tablete s produljenim oslobađanjem Ranexa 500 mg tablete s produljenim oslobađanjem Ranexa 750 mg tablete s produljenim oslobađanjem ranolazin
These effects of ranolazine on the surface electrocardiogram are believed to result from inhibition of the fast-rectifying potassium current, which prolongs the ventricular action potential, and from inhibition of the late sodium current, which shortens the ventricular action potential.
koji produljuje akcijski potencijal ventrikula i inhibicije kasnog protoka natrija, koji skraćuje akcijski potencijal ventrikula.
Uncommon: fatigue, peripheral oedema.
Manje često: umor, periferni edemi.
INFORMATION IN BRAILLE Ranexa 750 mg
Ranexa 750 mg
How to take RANEXA
Kako uzimati Ranexu
Rhabdomyolysis has been associated with high doses of simvastatin and cases of rhabdomyolysis have been observed in patients receiving Ranexa and simvastatin, in postmarketing experience.
Nakon stavljanja lijeka u promet primijećeni su slučajevi rabdomiolize kod bolesnika koji dobivaju Ranexu i simvastatin.
PHARMACEUTICAL FORM Prolonged-release tablet
Tableta s produljenim oslobađanjem
Titanium dioxide
celuloza, mikrokristalična natrijev hidroksid titanijev dioksid
In male and female rats, oral administration of ranolazine that produced exposures (AUC) 3.6-fold or 6.6-fold higher than expected in humans, respectively, had no effect on fertility.
Kod mužjaka i ženki štakora, peroralna primjena ranolazina koja je dovela do izloženosti (AUC) 3,6
Tell your doctor or pharmacist before you take Ranexa if you use: - certain medicines to treat a bacterial infection (erythromycin), or a fungal infection (fluconazole), a medicine used to prevent rejection of a transplanted organ (ciclosporin), or if you are taking some heart tablets such as diltiazem or verapamil.
- određene lijekove za liječenje bakterijske infekcije (eritromicin) ili gljivične infekcije (flukonazol), lijek za sprječavanje odbacivanja presađenog organa (ciklosporin) ili ako uzimate neke tablete za srce kao što su diltiazem ili verapamil.
Five-hundred and sixty-five patients were randomised to receive an initial dose of Ranexa 500 mg twice daily or placebo for 1 week, followed by 6 weeks of treatment with Ranexa 1000 mg twice daily or placebo, in addition to concomitant treatment with amlodipine 10 mg once daily.
Petsto šezdeset pet bolesnika nasumce je odabrano da primaju početnu dozu Ranexe 500 mg dvaput dnevno ili placebo tijekom 1 tjedna, nakon čega je slijedilo 6
METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
NAČIN I PUT(EVI) PRIMJENE LIJEKA
- If you get any side effects talk to your doctor.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
In a large outcome study (MERLIN-TIMI 36) in 6,560 patients with UA/NSTEMI ACS, there was no difference between Ranexa and placebo in the risk of all-cause mortality (relative risk ranolazine:placebo 0.99), sudden cardiac death (relative risk ranolazine:placebo 0.87), or the frequency of symptomatic documented arrhythmias (3.0% versus 3.1%).
U velikom istraživanju ishoda (MERLIN-TIMI 36) na 6560 bolesnika s nestabilnom anginom ili akutnim koronarnim sindromom bez elevacije ST-segmenta (NSTEMI), nije bilo razlike između Ranexe i placeba u pogledu mortaliteta svih uzroka (relativni rizik ranolazin:placebo 0,99), nagle srčane smrti (relativni rizik ranolazin:placebo 0,87) niti učestalosti simptomatski dokumentiranih aritmija (3,0% u odnosu na 3,1%).
Menarini Kft. Tel.: +36 23501301
Tel.: +36 23501301
Pale green oval-shaped tablet engraved with 750 on one side.
Blijedozelene ovalne tablete s utisnutim natpisom 750 s jedne strane.
Posology Ranexa is available as 375 mg, 500 mg, and 750 mg prolonged-release tablets.
Ranexa je dostupna u obliku tableta s produljenim oslobađanjem od 375 mg, 500 mg i 750 mg.
Limit the dose of simvastatin to 20 mg once daily in patients taking any dose of Ranexa.
Kod bolesnika koji uzimaju bilo koju dozu Ranexe treba ograničiti dozu simvastatina na 20 mg jednom dnevno.
The risk of all cause mortality, CV death or major adverse cardiovascular events (MACE) and heart failure hospitalisation was similar between treatment groups in the overall population; however, MACE were reported more frequently in patients ≥ 75 years treated with ranolazine compared with placebo (17.0% vs 11.3%, respectively); in addition there was a numerical increase in all cause mortality in patients ≥ 75 years (9.2% vs. 5.1%, p = 0.074).
≥75 godina liječenih ranolazinom u odnosu na placebo (17,0% u odnosu na 11,3%); dodatno, brojčano se povećala smrtnost od bilo kojeg uzroka kod bolesnika u dobi ≥75 godina (9,2% u odnosu na 5,1%), p=0,074).
Methacrylic acid-ethyl acrylate copolymer (1:1) Microcrystalline cellulose
karnauba vosak hipromeloza magnezijev stearat metakrilatna kiselina/etilakrilat kopolimer (1:1)
• Mild hepatic impairment (see sections 4.2 and 5.2).
• Kod blagog oštećenja jetrene funkcije (vidjeti dijelove 4.2 i 5.2).
There was a 2.5- to 3-fold increase in steady-state AUC as the dose was increased from 500 mg to 1000 mg twice daily.
S povećanjem doze od 500 mg na 1000 mg dvaput dnevno, došlo je do povećanja AUC u stanju dinamičke ravnoteže od 2,5 do 3 puta.
Concomitant treatment with CYP3A4 and P-glycoprotein (P-gp) inhibitors: Careful dose titration is recommended in patients treated with moderate CYP3A4 inhibitors (e.g. diltiazem, fluconazole, erythromycin) or P-gp inhibitors (e.g. verapamil, ciclosporin) (see sections 4.4 and 4.5).
Istodobna primjena s inhibitorima CYP3A4 i P-glikoproteina (P-gp): Preporučuje se pažljivo prilagođavanje doze kod bolesnika liječenih umjerenim inhibitorima CYP3A4 (npr. diltiazemom,
România Berlin-Chemie A. Menarini S.R.L.
Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release
Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
EU/1/08/462/001 60 tablets in blister pack EU/1/08/462/002 60 tablets in bottle EU/1/08/462/007 30 tablets in blister pack EU/1/08/462/008 100 tablets in blister pack
EU/1/08/462/007 30 tableta u blister pakiranju EU/1/08/462/008 100 tableta u blister pakiranju
T waves, have been observed in patients treated with Ranexa.
Uočena je povećana incidencija štetnih događaja kod bolesnika liječenih ranolazinom u ispitivanju
Additional excipients for 375 mg tablet: Macrogol
Dodatne pomoćne tvari u tabletama od 375 mg:
• Mild to moderate renal impairment (creatinine clearance 30-80 ml/min) (see sections 4.2, 4.8,
• Kod blagog do umjerenog oštećenja funkcije bubrega (klirens kreatinina 30-80 ml/min)
STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 375 mg ranolazine.
Jedna tableta s produljenim oslobađanjem sadržava 375 mg ranolazina.
NAME OF THE MEDICINAL PRODUCT Ranexa 500 mg prolonged-release tablets Ranolazine
Ranexa 500 mg tablete s produljenim oslobađanjem ranolazin
NAME OF THE MEDICINAL PRODUCT Ranexa 750 mg prolonged-release tablets Ranolazine
Ranexa 750 mg tablete s produljenim oslobađanjem ranolazin
STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 500 mg ranolazine.
Jedna tableta s produljenim oslobađanjem sadržava 500 mg ranolazina.
EU/1/08/462/005 60 tablets in blister pack EU/1/08/462/006 60 tablets in bottle EU/1/08/462/011 30 tablets in blister pack EU/1/08/462/012 100 tablets in blister pack
EU/1/08/462/011 30 tableta u blister pakiranju EU/1/08/462/012 100 tableta u blister pakiranju
NAME OF THE MEDICINAL PRODUCT Ranexa 375 mg prolonged-release tablets Ranolazine
Ranexa 375 mg tablete s produljenim oslobađanjem ranolazin
Dose limitation of other statins, metabolised by CYP3A4 (e.g. lovastatin), may be considered when taking Ranexa.
Kod bolesnika koji uzimaju Ranexu treba razmotriti ograničenje doza drugih statina koji se metaboliziraju CYP3A4 enzimima (npr. lovastatin).
STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 750 mg ranolazine.
Jedna tableta s produljenim oslobađanjem sadržava 750 mg ranolazina.
Do not use the following medicines if you take Ranexa: - certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections
Nemojte uzimati sljedeće lijekove ako uzimate Ranexu: - određene lijekove za liječenje bakterijskih infekcija (klaritromicin, telitromicin), gljivičnih infekcija (itrakonazol, ketokonazol, vorikonazol, posakonazol), HIV infekcije (inhibitori proteaza), depresije (nefazodon) ili poremećaja srčanog ritma (npr. kinidin, dofetilid ili sotalol).
Additional excipients for 500 mg tablet: Macrogol
Dodatne pomoćne tvari u tabletama od 500 mg:
Inflammation of pancreas or intestine
Poremećaji kože i potkožnog tkiva
What Ranexa contains
Kako Ranexa izgleda i sadržaj pakiranja
In the population pharmacokinetic analysis, a 1.2-fold increase in ranolazine exposure was estimated in subjects with moderate impairment (creatinine clearance 40 ml/min).
1,2 puta kod ispitanika s umjerenim oštećenjem bubrega (klirens kreatinina 40 ml/min).
Slovenská republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o Tel: +421 2 544 30 730
Berlin-Chemie/A.Menarini Ceska republika s.r.o. Tel: +420 267 199 333
Dehydration
Dojenje
NAME OF THE MEDICINAL PRODUCT Ranexa 750 mg prolonged-release tablets
Ranexa 750 mg tablete s produljenim oslobađanjem
A lack of ability to urinate
• poteškoće s gutanjem
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of ranolazine.
Jedna tableta sadrži 500 mg ranolazina.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 750 mg of ranolazine.
Jedna tableta sadrži 750 mg ranolazina.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 375 mg of ranolazine.
Jedna tableta sadrži 375 mg ranolazina.
In addition to these adverse events, diplopia, lethargy, and syncope were observed in an intravenous overdose study in healthy volunteers.
U intravenskom ispitivanju predoziranja kod zdravih dobrovoljaca, pored tih nuspojava uočena je diplopija, letargija i sinkopa.
NAME OF THE MEDICINAL PRODUCT Ranexa 500 mg prolonged-release tablets
Ranexa 500 mg tablete s produljenim oslobađanjem
NAME OF THE MEDICINAL PRODUCT Ranexa 375 mg prolonged-release tablets
Ranexa 375 mg tablete s produljenim oslobađanjem
Talk to your doctor before taking Ranexa: - if you have mild or moderate kidney problems.
Obratite se svom liječniku prije nego počnete uzimati Ranexu:
In an oral high-dose tolerability study in angina patients, the incidence of dizziness, nausea, and vomiting increased in a dose-dependent manner.
U istraživanju podnošljivosti visokih peroralno primijenjenih doza kod bolesnika od angine pektoris,
Skin and subcutaneous tissue disorders Uncommon: pruritus, hyperhydrosis.
Manje često: pruritus, hiperhidroza.
C]-ranolazine.
Često: astenija.
Lot
Lietuva
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Tel: +39-055 56801
Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39-055 56801
Ranexa may cause side effects such as dizziness (common), blurred vision (uncommon), confusional state (uncommon), hallucination (uncommon), double vision (uncommon), coordination problems
konfuzno stanje (manje često), halucinacije (manje često), dvoslike (manje često), poteškoće s koordinacijom pokreta (rijetko) koje mogu utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
(itraconazole, ketoconazole, voriconazole, posaconazole), HIV infection (protease inhibitors),
(npr. itrakonazolom, ketokonazolom, vorikonazolom, posakonazolom, inhibitorima HIV proteaze, klaritromicinom, telitromicinom, nefazodonom) je kontraindicirana (vidjeti dio 4.3).
- if you are elderly.
I DOHVATA DJECE
Many feel normal.
Mnogi se osjećaju normalno.
if you are unable to produce urine (anuria).
NAVOĐENJE DJELATNE(IH) TVARI
In some cases you may have to stop using one of the medicines.
U nekim slučajevima ćete možda morati prekinuti uzimati jedan od lijekova.
Swallow the tablet whole with a glass of water.
Progutajte cijelu tabletu s čašom vode.
It is best to take the tablet at the same time each day.
Tabletu je najbolje uzeti svaki dan u isto vrijeme.
Talk to your doctor before drinking alcohol.
Porazgovarajte sa svojim liječnikom prije konzumacije alkohola.
This is especially important if you are using any of the medicines listed below:
To je posebno važno ako uzimate bilo koji od niže navedenih lijekova:
In other patients, one or the other effect may be dominant.
U drugih bolesnika, jedan od ovih dvaju učinaka može biti dominantan.
antipsychotics, antiepileptics;
antipsihotici, antiepileptici;
Shock (including cardiogenic shock).
Šok (uključujući kardiogeni šok).
If you experience these symptoms, do not drive or use tools or machines.
Ako osjetite ove simptome, nemojte voziti ni koristiti alate ili strojeve.
Other side effects may include:
Ostale nuspojave mogu uključivati:
Always take this medicine, even if you are feeling well People who have high blood pressure often do not notice any signs of the problem.
Redovito uzimajte ovaj lijek, čak i ako se osjećate dobro Osobe s povišenim krvnim tlakom često ne osjećaju bilo kakve znakove ovog problema.
Morning is the best time.
Najbolje je to učiniti ujutro.
There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Postoji ograničeno iskustvo s hidroklorotiazidom tijekom trudnoće, posebno tijekom prvog tromjesečja.