natgillin/translations-raw huggingface dataset:
Additional information on the individual components Adverse drug reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential undesirable effects with Copalia as well, even if not observed in clinical trials or during the post-marketing period.
Dodatne informacije o posameznih zdravilnih učinkovinah Neželeni učinki, opisani za katero od obeh zdravilnih učinkovin (za amlodipin ali valsartan) so lahko tudi neželeni učinki zdravila Copalia, tudi če niso bili ugotovljeni v kliničnih preskušanjih tega zdravila ali v obdobju po prihodu zdravila na trg..
Amlodipine Common Uncommon
Amlodipin pogosti občasni
Alopecia, altered bowel habits, dyspepsia, dyspnoea, rhinitis, gastritis, gingival hyperplasia, gynaecomastia, hyperglycaemia, impotence, increased urinary frequency, leucopenia, malaise, mood changes, myalgia, peripheral neuropathy, pancreatitis, hepatitis, thrombocytopenia, vasculitis, angioedema and erythema multiforme.
bruhanje alopecija, spremembe pri odvajanju blata, dispepsija, dispneja, rinitis, gastritis, hiperplazija dlesni, ginekomastija, hiperglikemija, impotenca, pogostejše odvajanje urina, levkopenija, splošno slabo počutje, spremembe razpoloženja, mialgija, periferna nevropatija, pankreatitis, hepatitis, trombocitopenija, vaskulitis, angioedem in multiformni eritem
Arrhythmia, myocardial infarction.
aritmija, miokardni infarkt.
Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed increased frequency, duration or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.
Redko je pri bolnikih, posebno pri tistih s hudo obstruktivno koronarno boleznijo, prišlo do zvečanja pogostnosti, trajanja ali izraženosti angine pektoris ali akutnega miokardnega infarkta ob začetku zdravljenja z zaviralcem kalcijevih kanalčkov ali ob zvečanju odmerka.
Arrhythmia (including ventricular tachycardia and atrial fibrillation) has also been reported.
Opisovali so tudi aritmije (vključno z ventrikularno tahikardijo in atrijsko fibrilacijo).
These adverse events may not be distinguishable from the natural history of the underlying disease.
Navedene neželene učinke je težko razlikovati od naravnega poteka osnovne bolezni.
Cholestatic jaundice, AST and ALT increase, purpura, rash and pruritus.
holestatski ikterus, zvišanje koncentracij AST in ALT, purpura, izpuščaj in srbenje.
Exceptional cases of extrapyramidal syndrome have been reported.
Izjemoma so opisovali primere ekstrapiramidnega sindroma.
7 4.9 Overdose
7 Valsartan pogostnost neznana
Symptoms There is no experience of overdose with Copalia.
Simptomi Izkušenj s prevelikim odmerjanjem zdravila Copalia ni.
Treatment If ingestion is recent, induction of vomiting or gastric lavage may be considered.
Zdravljenje Če je bolnik zdravilo zaužil pred kratkim, pride v poštev sprožitev bruhanja ali izpiranje želodca.
Pharmacotherapeutic group: angiotensin II antagonists, plain (valsartan), combinations with dihydropyridine derivatives (amlodipine), ATC code:
Farmakoterapevtska skupina: antagonisti angiotenzina II, monokomponentna zdravila (valsartan), kombinacije z dihidropiridinskimi derivati (amlodipin), oznaka ATC:
C09DB01
C09DB01.
Copalia combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Copalia vsebuje dve antihipertenzivni učinkovini s komplementarnima mehanizmoma delovanja za obvladanje krvnega tlaka pri bolnikih z esencialno hipertenzijo: amlodipin spada med zaviralce kalcijevih kanalčkov, valsartan pa med antagoniste angiotenzina II.
Amlodipine The amlodipine component of Copalia inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Amlodipin Amlodipin v zdravilu Copalia zavira transmembranski vstop kalcijevih ionov v srčne in žilne gladke mišice.
These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing.
Posledica je znižanje krvnega tlaka leže in stoje.
Plasma concentrations correlate with effect in both young and elderly patients.
Tega znižanja krvnega tlaka med kronično uporabo ne spremljata pomembna sprememba srčne frekvence ali plazemske koncentracije kateholaminov.
In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow, without change in filtration fraction or proteinuria.
Plazemska koncentracija korelira z učinkom, tako pri mladih kot pri starejših bolnikih.
As with other calcium channel blockers, haemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine have
8 Pri hipertenzivnih bolnikih z normalnim delovanjem ledvic terapevtski odmerki amlodipina zmanjšajo žilni upor v ledvicah ter povečajo hitrost glomerularne filtracije in efektivni ledvični pretok plazme, ne da bi spremenili filtracijsko frakcijo ali proteinurijo.
8 generally demonstrated a small increase in cardiac index without significant influence on dP/ dt or on left ventricular end diastolic pressure or volume.
Tako kot pri drugih zaviralcih kalcijevih kanalčkov so hemodinamske meritve delovanja srca v mirovanju in med obremenitvijo (ali stimulacijo s spodbujevalnikom) pri bolnikih z normalnim delovanjem prekatov, ki so dobivali amlodipin, na splošno pokazale majhno povečanje srčnega indeksa, a brez pomembnega vpliva na dP/ dt in končni diastolični tlak ali volumen levega prekata.
Valsartan Valsartan is an orally active, potent and specific angiotensin II receptor antagonist.
Valsartan Valsartan je peroralno aktiven, močan in specifičen antagonist angiotenzina II.
Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000-fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Valsartan nima delnega agonističnega učinka na receptorjih AT1, njegova afiniteta za receptorje AT1 pa je veliko (približno 20. 000- krat) večja kot za receptorje AT2.
In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (p < 0.05) lower in patients treated with valsartan than in those treated with an ACE inhibitor (2.6% versus 7.9%, respectively).
V kliničnih preskušanjih, v katerih so valsartan primerjali z zaviralcem ACE, je bila pojavnost suhega kašlja med prejemniki valsartana značilno manjša kot pri prejemnikih zaviralca ACE (2, 6% med prvimi, 7, 9% med drugimi, p < 0, 05).
In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced coughing, compared to 68.5% of those treated with an ACE inhibitor (p < 0.05).
V kliničnem preskušanju pri bolnikih z anamnezo suhega kašlja med terapijo z zaviralcem ACE se je kašelj pojavil pri 19, 5% preiskovancev, ki so dobivali valsartan, 19, 0% tistih, ki so prejemali tiazidni diuretik, in 68, 5% preiskovancev, ki so dobivali zaviralec ACE (p < 0, 05).
Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Valsartan se ne veže oz. ne zavira drugih hormonskih receptorjev ali ionskih kanalčkov, pomembnih za srčno- žilno regulacijo.
In most patients, after administration of a single oral dose, onset of antihypertensive activity occurs within 2 hours, and the peak drop in blood pressure is achieved within 4– 6 hours.
Pri večini bolnikov se antihipertenzivni učinek pojavi v 2 urah po aplikaciji posamičnega peroralnega odmerka, največji padec krvnega tlaka pa je dosežen v 4 do 6 urah.
During repeated administration, the maximum reduction in blood pressure with any dose is generally attained within 2– 4 weeks and is sustained during long-term therapy.
Med večkratno uporabo je največje znižanje krvnega tlaka pri vseh odmerkih praviloma doseženo v 2 do 4 tednih in se med dolgotrajnim zdravljenjem ohrani.
Amlodipine/ Valsartan Over 1,400 hypertensive patients received Copalia once daily in two placebo-controlled trials.
Amlodipin/ valsartan V dveh s placebom kontroliranih preskušanjih je Copalijo enkrat na dan dobivalo več kot 1. 400 hipertenzivnih bolnikov.
Adults with mild to moderate uncomplicated essential hypertension (mean sitting diastolic blood pressure ≥ 95 and < 110 mmHg) were enrolled.
Vključeni so bili odrasli z blago do zmerno, nezapleteno esencialno hipertenzijo (srednji diastolični krvni tlak sede ≥95 in < 110 mm Hg).
Patients with high cardiovascular risks – heart failure, type I and poorly controlled type II diabetes and history of myocardial infarction or stroke within one year – were excluded.
Izključeni so bili bolniki z velikim srčnožilnim tveganjem - s srčnim popuščanjem, z diabetesom tipa 1 ali s slabo urejenim diabetesom tipa 2, ali z miokardnim infarktom, ali možgansko kapjo v zadnjem letu.
A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure < 90 mmHg at the end of the trial) in patients not adequately controlled on valsartan 160 mg in 75% of patients treated with amlodipine/ valsartan 10 mg/ 160 mg and 62% of patients treated with amlodipine/ valsartan 5 mg/ 160 mg, compared to 53% of patients remaining on valsartan 160 mg.
Pokazalo je, da se je krvni tlak normaliziral (najnižji diastolični krvni tlak sede < 90 mm Hg na koncu preskušanja) pri 75% bolnikov, ki so dobivali amlodipin/ valsartan 10 mg/ 160 mg, pri 62% bolnikov, ki so dobivali amlodipin/ valsartan 5 mg/ 160 mg in pri 53% bolnikov, ki so ostali na 160 mg valsartana.
The addition of amlodipine 10 mg and 5 mg produced an additional reduction in systolic/ diastolic blood pressure of 6.0/ 4.8 mmHg and 3.9/ 2.9 mmHg, respectively, compared to patients who remained on valsartan 160 mg only.
V primerjavi z bolniki, ki so ostali samo na 160 mg valsartana, je dodatek 10 mg amlodipina dodatno znižal sistolični krvni tlak za 6, 0 mm Hg in diastoličnega za 3, 9 mm Hg, 5 mg amlodipina pa sistolični krvni tlak za 4, 8 mm Hg in diastoličnega za 2, 9 mm Hg.
9 A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure < 90 mmHg at the end of the trial) in patients not adequately controlled on amlodipine 10 mg in 78% of patients treated with amlodipine/ valsartan 10 mg/ 160 mg, compared to 67% of patients remaining on amlodipine 10 mg.
Pokazalo je, da se je krvni tlak normaliziral (najnižji diastolični krvni tlak sede < 90 mm Hg na koncu preskušanja) pri 78% bolnikov, ki so dobivali amlodipin/ valsartan 10 mg/ 160 mg, in pri 67% bolnikov, ki so ostali na 10 mg amlodipina.
The addition of valsartan 160 mg produced an additional reduction in systolic/ diastolic blood pressure of 2.9/ 2.1 mmHg compared to patients who remained on amlodipine 10 mg only.
V primerjavi z bolniki, ki so ostali samo na 10 mg amlodipina, je dodatek 160 mg valsartana dodatno znižal sistolični krvni tlak za 2, 9 mm Hg in diastoličnega za 2, 1 mm Hg.
Copalia was also studied in an active-controlled study of 130 hypertensive patients with diastolic blood pressure ≥ 110 mmHg and < 120 mmHg.
Copalijo so raziskali tudi v študiji, kontrolirani z učinkovino, pri 130 hipertenzivnih bolnikih, ki so imeli diastolični krvni tlak ≥110 mm Hg in < 120 mm Hg.
In this study (baseline blood pressure 171/ 113 mmHg), an Copalia regimen of 5 mg/ 160 mg titrated to 10 mg/ 160 mg reduced sitting blood pressure by 36/ 29 mmHg as compared to 32/ 28 mmHg with a regimen of lisinopril/ hydrochlorothiazide 10 mg/ 12.5 mg titrated to 20 mg/ 12.5 mg.
V tej študiji (izhodiščni krvni tlak 171/ 113 mm Hg) je shema z zdravilom Copalia 5 mg/ 160 mg, titrirana do 10 mg/ 160 mg, znižala krvni tlak sede za 36/ 29 mm Hg; v primerjavi s tem je shema lizinopril/ hidroklorotiazid 10 mg/ 12, 5 mg, titrirana do 20 mg/ 12, 5 mg, znižala krvni tlak za 32/ 28 mm Hg.
In patients not adequately controlled on amlodipine 5 mg, amlodipine/ valsartan 5 mg/ 80 mg may achieve blood pressure control similar to amlodipine 10 mg with less oedema.
Pri bolnikih, ki niso ustrezno urejeni s 5 mg amlodipina, lahko kombinacija amlodipin/ valsartan 5 mg/ 80 mg doseže podobno urejenost krvnega tlaka kot 10 mg amlodipina, a z manj edemi.
In patients adequately controlled on amlodipine 10 mg but who experience unacceptable oedema, amlodipine/ valsartan 5 mg/ 80 mg may achieve similar blood pressure control with less oedema.
Pri bolnikih, ki so ustrezno urejeni z 10 mg amlodipina, a imajo nesprejemljive edeme, lahko kombinacija amlodipin/ valsartan 5 mg/ 80 mg doseže podobno urejenost krvnega tlaka z manj edemi.
Age, gender and race did not influence the response to Copalia.
Starost, spol in rasa niso vplivali na odziv na Copalijo.
Copalia has not been studied in any patient population other than hypertension.
Copalia ni raziskana pri nobeni drugi populaciji razen pri hipertenzivnih bolnikih.
Valsartan has been studied in patients with post myocardial infarction and heart failure.
5. 2 Farmakokinetične lastnosti
Amlodipine Absorption:
Amlodipin Absorpcija:
After oral administration of therapeutic doses of amlodipine alone, peak plasma concentrations of amlodipine are reached in 6– 12 hours.
Po peroralni uporabi terapevtskih odmerkov samega amlodipina ta doseže največjo koncentracijo v plazmi v 6 do 12 urah.
Absolute bioavailability has been calculated as between 64% and 80%.
Izračunana absolutna biološka uporabnost je med 64 in 80%.
Volume of distribution is approximately 21 l/ kg.
Volumen porazdelitve je približno 21 l/ kg.
In vitro studies with amlodipine have shown that approximately 97.5% of circulating drug is bound to plasma proteins in hypertensive patients.
Študije amlodipina in vitro so pokazale, da je pri hipertenzivnih bolnikih na beljakovine v plazmi vezanega približno 97, 5% zdravila v obtoku.
Amlodipine is extensively (approximately 90%) metabolised in the liver to inactive metabolites.
Amlodipin se v jetrih v veliki meri (približno 90%) presnovi v neaktivne presnovke.
Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours.
Eliminacija amlodipina iz plazme je dvofazna s terminalnim razpolovnim časom eliminacije približno 30 do 50 ur.
Steady-state plasma levels are reached after continuous administration for 7– 8 days.
Plazemska koncentracija v stanju dinamičnega ravnovesja je dosežena po 7 do 8 dneh neprekinjene uporabe.
Ten per cent of original amlodipine and 60% of amlodipine metabolites are excreted in urine.
V urin se izloči 10% matičnega amlodipina in 60% amlodipinovih presnovkov.
Valsartan Absorption:
10 Valsartan Absorpcija:
Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2– 4 hours.
Po peroralni uporabi samega valsartana ta doseže največjo koncentracijo v plazmi v 2 do 4 urah.
Mean absolute bioavailability is 23%.
Povprečna absolutna biološka uporabnost je 23%.
Valsartan shows multiexponential decay kinetics (t½α < 1 h and t½ß about 9 h).
Valsartan kaže multieksponentno kinetiko upadanja (t½α < 1 uro in t½ß približno 9 ur).
Food decreases exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%, although from about 8 h post dosing plasma valsartan concentrations are similar for the fed and fasted groups.
Hrana zmanjša izpostavljenost (merjeno z AUC) valsartanu za okrog 40% in njegovo največjo koncentracijo v plazmi (Cmax) za okrog 50%, vendar pa je od približno 8. ure po odmerjanju plazemska koncentracija valsartana podobna pri skupini, ki je jedla, in pri tisti, ki ni jedla.
10 Distribution:
Porazdelitev:
Valsartan is highly bound to serum proteins (94– 97%), mainly serum albumin.
Valsartan je močno vezan na beljakovine v serumu (94- 97%), predvsem na albumin v serumu.
Valsartan is not transformed to a high extent as only about 20% of dose is recovered as metabolites.
Valsartan se ne spremeni v veliki meri, kajti le okrog 20% odmerka se pojavi v obliki presnovkov.
A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC).
V plazmi so ugotovili majhno koncentracijo hidroksipresnovka (manj kot 10% AUC valsartana).
Valsartan is primarily eliminated in faeces (about 83% of dose) and urine (about 13% of dose), mainly as unchanged drug.
Valsartan se v prvi vrsti izloči v blato (okrog 83% odmerka) in urinu (okrog 13% odmerka), v glavnem v obliki nespremenjenega zdravila.
Following intravenous administration, plasma clearance of valsartan is about 2 l/ h and its renal clearance is 0.62 l/ h (about 30% of total clearance).
Po intravenski uporabi je plazemski očistek valsartana okrog 2 l/ uro, njegov ledvični očistek pa je 0, 62 l/ uro (okrog 30% celotnega očistka).
Amlodipine/ Valsartan Following oral administration of Copalia, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6– 8 hours, respectively.
Amlodipin/ valsartan Po peroralni uporabi zdravila Copalia doseže valsartan največjo koncentracijo v plazmi v 3 urah, amlodipin pa v 6 do 8 urah.
The rate and extent of absorption of Copalia are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Delež in obseg absorpcije zdravila Copalia sta enakovredna biološki uporabnosti valsartana in amlodipina, uporabljenega v ločenih tabletah.
Special populations Paediatric patients (age below 18 years) No pharmacokinetic data are available in the paediatric population.
Posebne populacije Pediatrični bolniki (starost do 18 let) Farmakokinetičnih podatkov za pediatrično populacijo ni.
Elderly (age 65 years or over) Time to peak plasma amlodipine concentrations is similar in young and elderly patients.
Starejši (starost 65 let in več) Čas do največje koncentracije amlodipina v plazmi je pri mlajših in starejših bolnikih podoben.
Mean systemic AUC of valsartan is higher by 70% in the elderly than in the young therefore caution is required when increasing the dosage.
Povprečna sistemska AUC valsartana je pri starejših za 70% večja kot pri mladih, zato je pri večanju odmerka potrebna previdnost.
Renal impairment The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
Med delovanjem ledvic in sistemsko izpostavljenostjo valsartanu niso ugotovili korelacije.
As expected for a compound where renal clearance accounts for only 30% of total plasma clearance, no correlation was seen between renal function and systemic exposure to valsartan.
To je tudi pričakovano pri spojini, pri kateri ledvični očistek predstavlja le 30% celotnega očistka iz plazme.
Hepatic impairment Patients with hepatic insufficiency have decreased clearance of amlodipine with resulting increase of approximately 40– 60% in AUC.
Okvara jeter Bolniki z insuficienco jeter imajo znižan očistek amlodipina; posledica je zvišanje AUC za približno 40- 60%.
Caution should be exercised in patients with liver disease (see section 4.2).
Previdnost je potrebna pri bolnikih z boleznijo jeter (glejte poglavje 4. 2).
Histopathological signs of inflammation of the glandular stomach was seen in male rats at an exposure of about 1.9 (valsartan) and 2.6 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Neželeni učinki, ki so bili ugotovljeni v študijah na živalih in bi lahko bili klinično pomembni: histopatološke znake vnetja glandularnega želodca so pri podganjih samcih zabeležili pri izpostavljenosti, ki je bila okrog 1, 9- krat večja za valsartan in 2, 6- krat večja za amlodipin, kot ob kliničnih odmerkih 160 mg valsartana in 10 mg amlodipina.
Similar changes were also seen in the valsartan alone group (exposure 8.5– 11.0 times the clinical dose of 160 mg valsartan).
Podobne spremembe so ugotovili 11 tudi v skupini, ki je dobivala samo valsartan (od 8, 5 - do 11- krat večja izpostavljenost kot ob kliničnem odmerku 160 mg valsartana).
An increased incidence and severity of renal tubular basophilia/ hyalinisation, dilation and casts, as well as interstitial lymphocyte inflammation and arteriolar medial hypertrophy were found at an exposure of 8– 13 (valsartan) and 7– 8 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Pri izpostavljenosti, ki je bila za valsartan od 8 - do 13- krat večja in za amlodipin od 7 - do 8- krat večja kot ob kliničnih odmerkih 160 mg valsartana in 10 mg amlodipina, so ugotovili večjo pojavnostjo in izrazitost bazofilije/ hialinizacije, dilatacije in cilindrov ledvičnih tubulov ter intersticijskega limfocitnega vnetja in hipertrofije arteriolarne medije.
Similar changes were found in the valsartan alone group (exposure 8.5– 11.0 times the clinical dose of 160 mg valsartan).
Podobne spremembe so ugotovili v skupini, ki je dobivala samo valsartan (od 8, 5 - do 11- krat večja izpostavljenost kot ob kliničnem odmerku 160 mg valsartana).
11 In an embryo-foetal development study in the rat, increased incidences of dilated ureters, malformed sternebrae, and unossified forepaw phalanges were noticed at exposures of about 12 (valsartan) and 10 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
V študiji embriofetalnega razvoja pri podganah so pri izpostavljenosti, ki je bila za valsartan okrog 12- krat in za amlodipin okrog 10- krat večja kot ob kliničnih odmerkih 160 mg valsartana in 10 mg amlodipina, ugotovili večjo incidenco razširjenih ureterjev, malformirane sternebre in nezakostenele falange sprednjih tac.
The no-observed-effect-level for developmental effects was observed at 3- (valsartan) and 4- (amlodipine) fold the clinical exposure (based on AUC).
4- kratni (amlodipin) klinični izpostavljenosti (na podlagi AUC).
Hypromellose Titanium dioxide (E171) Iron oxide, yellow (E172) Macrogol 4000 Talc
Obloga: hipromeloza titanov dioksid (E171) rumeni železov oksid (E172) makrogol 4000 smukec
PVC/ PVDC blisters.
PVC/ PVDC pretisni omoti.
7, 14, 28, 30, 56, 90, 98 or 280 film-coated tablets.
7, 14, 28, 30, 56, 90, 98 ali 280 filmsko obloženih tablet.
PVC/ PVDC perforated unit dose blisters.
PVC/ PVDC perforirani pretisni omoti za enkratni odmerek.
56, 98 or 280 film-coated tablets and multipacks containing 280 (4x70) film-coated tablets.
56, 98 ali 280 filmsko obloženih tablet in skupna pakiranja, ki vsebujejo 280 (4 x 70) filmsko obloženih tablet.
12 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Copalia 5 mg/ 160 mg film-coated tablets
Copalia 5 mg/ 160 mg filmsko obložene tablete
Dark yellow, oval film-coated tablet, imprinted with “ NVR” on one side and “ ECE” on the other side.
Temnorumene, ovalne filmsko obložene tablete, ki imajo na eni strani oznako “ NVR ” in na drugi “ ECE ”.
Copalia 5 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Copalijo 5 mg/ 160 mg lahko uporabite pri bolnikih, pri katerih krvni tlak ni ustrezno urejen samo s 5 mg amlodipina ali 160 mg valsartana.
14 Children and adolescents Copalia is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
14 Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti zdravila Copalia ni priporočljivo uporabljati pri bolnikih, mlajših od 18 let.
Renal impairment No dosage adjustment of Copalia is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
15 Okvara ledvic Pri bolnikih z blago do zmerno okvaro ledvic (hitrost glomerulne filtracije > 30 ml/ min/ 1, 73 m2) odmerka zdravila Copalia ni treba prilagajati.