FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no experience on the use of Copalia HCT in pregnant women.
Icelandic: Engin reynsla er af notkun Copalia HCT hjá þunguðum konum.
English: Copalia HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide.
Icelandic: Í Copalia HCT töflum eru þrjú virk innihaldsefni sem nefnast amlodipin, valsartan og hýdróklórtíazíð.
English: Concomitant use of Copalia HCT with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Icelandic: Ekki má nota Copalia HCT samhliða lyfjum sem innihalda aliskiren hjá sjúklingum með sykursýki eða skerta nýrnastarfsemi (GFR <60 ml/mín./1,73 m2) (sjá kafla 4.5 og 5.1).
English: The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Copalia HCT (amlodipine/valsartan/HCT) and amlodipine, valsartan and HCT individually.
Icelandic: Eftirtaldar aukaverkanir, sem tilgreindar eru samkvæmt MedDRA flokkun eftir líffærum og tíðni, tengjast Copalia HCT (amlodipin/valsartan/HCT) og amlodipini, valsartani og HCT hverju fyrir sig.
English: Based on the existing data with the components, the use of Copalia HCT is not recommended during first trimester and contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Icelandic: Samkvæmt fyrirliggjandi gögnum um innihaldsefnin er notkun Copalia HCT ekki ráðlögð á fyrsta þriðjungi meðgöngu og lyfið má alls ekki nota á öðrum og þriðja þriðjungi meðgöngu (sjá kafla 4.3 og 4.4).
English: In sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur after initiation of treatment with Copalia HCT.
Icelandic: Hjá sjúklingum með natríumskort og/eða minnkað blóðrúmmál, svo sem þeim sem fá stóra skammta af þvagræsilyfjum, getur lágur blóðþrýstingur með einkennum komið fyrir þegar meðferð með Copalia HCT er hafin.
English: The safety of Copalia HCT has been evaluated at its maximum dose of 10 mg/320 mg/25 mg in one controlled short-term (8 weeks) clinical study with 2,271 patients, 582 of whom received valsartan in combination with amlodipine and hydrochlorothiazide.
Icelandic: Lagt hefur verið mat á öryggi Copalia HCT við hámarksskammt þess, sem er 10 mg/320 mg/25 mg, í einni skammtíma (8 vikna) klínískri samanburðarrannsókn hjá 2.271 sjúklingi, þar af fengu 582 valsartan í samsetningu með amlodipini og hýdróklórtíazíði.
English: Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Copalia HCT, 10 mg/320 mg/25 mg.
Icelandic: Gæta skal varúðar hjá sjúklingum með hjartabilun og kransæðasjúkdóm, sérstaklega við hámarksskammt Copalia HCT, 10 mg/320 mg/25 mg.
English: No formal interaction studies with other medicinal products have been performed with Copalia HCT.
Icelandic: Ekki hafa verið gerðar neinar formlegar rannsóknir á milliverkunum við önnur lyf með Copalia HCT.
English: In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan, and therefore, Copalia HCT is not suitable in this group of patients (see sections 4.2, 4.3 and 5.2).
Icelandic: Hjá sjúklingum með vægt til í meðallagi skerta lifrarstarfsemi án gallteppu, er hámarks ráðlagður skammtur 80 mg af valsartani og því hentar Copalia HCT ekki þessum sjúklingum (sjá kafla 4.2, 4.3 og 5.2).
English: When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to Copalia HCT, the lowest available dose of the amlodipine component should be used.
Icelandic: Þegar skipt er um meðferð hjá öldruðum sjúklingum með háþrýsting, þar sem við á (sjá kafla 4.1), yfir á meðferð með Copalia HCT, skal nota þann styrkleika Copalia HCT sem inniheldur lægsta skammtinn af amlodipini.
English: Copalia HCT should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Icelandic: Gæta skal varúðar við notkun Copalia HCT við háþrýstingi hjá sjúklingum með nýrnaslagæðarþrengsli öðrum megin eða báðum megin eða hjá sjúklingum sem eru með eitt nýra og nýrnaslagæðarþrengsli vegna þess að þvagefni í blóði og kreatínín í sermi geta aukist hjá slíkum sjúklingum.
English: • ringing in the ears
Icelandic: Suð fyrir eyrum
English: Due to the valsartan component, Copalia HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Icelandic: Vegna valsartan innihaldsins má ekki nota Copalia HCT handa sjúklingum með alvarlega skerta lifrarstarfsemi (sjá kafla 4.3).
English: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 5 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/320 mg/25 mg film-coated tablets
Icelandic: Copalia HCT 5 mg/160 mg/12,5 mg filmuhúðaðar töflur Copalia HCT 10 mg/160 mg/12,5 mg filmuhúðaðar töflur Copalia HCT 5 mg/160 mg/25 mg filmuhúðaðar töflur Copalia HCT 10 mg/160 mg/25 mg filmuhúðaðar töflur Copalia HCT 10 mg/320 mg/25 mg filmuhúðaðar töflur
English: Excessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Copalia 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.
Icelandic: Verulegur lágþrýstingur, þar með talið réttstöðulágþrýstingur, kom fram hjá 1,7% sjúklinga sem fengu meðferð með hámarksskammti af Copalia HCT (10 mg/320 mg/25 mg) samanborið við 1,8% sjúklinga sem fengu valsartan/hýdróklórtíazíð (320 mg/25 mg), 0,4% sjúklinga sem fengu amlodipin/valsartan (10 mg/320 mg) og 0,2% sjúklinga sem fengu hýdróklórtíazíð/amlodipin (25 mg/10 mg) í samanburðarrannsókn hjá sjúklingum með í meðallagi alvarlegan eða alvarlegan háþrýsting án fylgikvilla.
English: Before switching to Copalia HCT patients should be controlled on stable doses of the monocomponents taken at the same time.
Icelandic: Áður en skipt er yfir á meðferð með Copalia HCT á að hafa náðst stjórn á blóðþrýstingi sjúklings á stöðugum skammti af hverju innihaldsefni fyrir sig þegar þau eru tekin á sama tíma.
English: In the controlled trial of Copalia HCT, the counteracting effects of valsartan 320 mg and hydrochlorothiazide 25 mg on serum potassium approximately balanced each other in many patients.
Icelandic: á Copalia HCT jöfnuðust mótverkandi áhrif valsartans 320 mg og hýdróklórtíazíðs 25 mg á kalíum í sermi, um það bil út hjá mörgum sjúklingum.
English: Following oral administration of Copalia HCT in normal healthy adults, peak plasma concentrations of amlodipine, valsartan and hydrochlorothiazide are reached in 6-8 hours, 3 hours, and 2 hours, respectively.
Icelandic: Copalia HCT hjá heilbrigðum fullorðnum einstaklingum næst hámarks plasmaþéttni amlodipins á 6-8 klukkustundum, valsartans á 3 klukkustundum og hýdróklórtíazíðs á 2 klukkustundum.
English: There is no experience of overdose with Copalia HCT.
Icelandic: Engar upplýsingar liggja fyrir um ofskömmtun með Copalia HCT.
English: In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan and therefore Copalia HCT is not suitable in this group of patients (see sections 4.3, 4.4 and 5.2).
Icelandic: Um sjúklinga sem eru með vægt til í meðallagi skerta lifrarstarfsemi án gallteppu gildir að ráðlagður hámarksskammtur af valsartan er 80 mg og því hentar Copalia HCT ekki þeim sjúklingum (sjá kafla 4.3, 4.4 og 5.2).
English: Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Copalia HCT, 10 mg/320 mg/25 mg, since available data in these patient populations is limited.
Icelandic: Gæta skal varúðar hjá sjúklingum með hjartabilun og kransæðasjúkdóm, sérstaklega við hámarksskammt Copalia HCT, 10 mg/320 mg/25 mg, þar sem upplýsingar um þessa sjúklinga eru takmarkaðar.
English: If you forget to take Copalia HCT
Icelandic: Ef gleymist að nota Copalia HCT
English: Do not take Copalia HCT if you are more than 3 months pregnant.
Icelandic: Ekki má nota Copalia HCT eftir þriðja mánuð meðgöngu.
English: When Copalia HCT is used in patients with renal impairment periodic monitoring of serum electrolytes (including potassium), creatinine and uric acid serum levels is recommended.
Icelandic: Þegar Copalia HCT er notað hjá sjúklingum með skerta nýrnastarfsemi, er ráðlagt að hafa reglulegt eftirlit með þéttni blóðsalta í sermi (þar með talið kalíums), kreatíníns og þvagsýru.
English: In case severe or rapid hyponatraemia develops during Copalia HCT therapy, the treatment should be discontinued until normalisation of natraemia.
Icelandic: Ef veruleg eða hröð blóðnatríumlækkun kemur fram meðan á meðferð með Copalia HCT stendur, skal stöðva meðferð þar til þéttni natríums í blóði er aftur orðin eðlileg.
English: Therefore, Copalia HCT is not recommended in this population.
Icelandic: Því er ekki ráðlagt að nota Copalia HCT hjá þessum sjúklingum.
English: Copalia HCT should be discontinued if hypercalcaemia develops during treatment.
Icelandic: Stöðva skal meðferð með Copalia HCT ef blóðkalsíumhækkun kemur fram meðan á meðferð stendur.
English: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 5 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Icelandic: Copalia HCT 5 mg/160 mg/12,5 mg filmuhúðaðar töflur Copalia HCT 10 mg/160 mg/12,5 mg filmuhúðaðar töflur Copalia HCT 5 mg/160 mg/25 mg filmuhúðaðar töflur Copalia HCT 10 mg/160 mg/25 mg filmuhúðaðar töflur Copalia HCT 10 mg/320 mg/25 mg filmuhúðaðar töflur amlodipin/valsartan/hýdróklórtíazíð
English: Frequency Copalia HCT
Icelandic: Tíðni Copalia HCT
English: Amlodipine/Valsartan/Hydrochlorothiazide
Icelandic: Amlodipin/valsartan/hýdróklórtíazíð
English: Amlodipine/valsartan/hydrochlorothiazide
Icelandic: Amlodipin/Valsartan/Hýdróklórtíazíð
English: The European Medicines Agency has waived the obligation to submit the results of studies with Copalia HCT in all subsets of the paediatric population in essential hypertension (see section 4.2 for information on paediatric use).
Icelandic: á Copalia HCT hjá öllum undirhópum barna við frumkomnum háþrýstingi (sjá upplýsingar í kafla 4.2 um notkun handa börnum).
English: Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Copalia HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited.
Icelandic: Gæta skal varúðar og fylgjast oftar með blóðþrýstingi hjá öldruðum sjúklingum, sérstaklega við hámarksskammt Copalia HCT, 10 mg/320 mg/25 mg, þar sem fyrirliggjandi gögn um þennan sjúklingahóp eru takmörkuð.
English: The use of Copalia HCT during breastfeeding is not recommended.
Icelandic: Ekki er mælt með að nota Copalia HCT meðan barn er haft á brjósti.
English: Other medicines and Copalia HCT
Icelandic: Notkun annarra lyfja samhliða Copalia HCT
English: Copalia HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
Icelandic: Ekki má nota Copalia HCT handa sjúklingum með verulega skerta nýrnastarfsemi, þvagþurrð eða sem eru í skilunarmeðferð (sjá kafla 4.3).
English: Clinically significant hypotension due to Copalia HCT overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Icelandic: Klínískt marktækur lágþrýstingur vegna ofskömmtunar með Copalia HCT krefst inngrips til stuðnings við hjarta og blóðrás, þ.m.t. ört eftirlit með hjartastarfsemi og öndun, útlimum haldið í hárri stellingu og eftirlit með blóðrúmmáli og þvagmyndun.
English: The reductions in systolic/diastolic blood pressure with Copalia HCT were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide, 6.2/3.3 mmHg greater than with amlodipine/valsartan, and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide.
Icelandic: Copalia HCT var 7,6/5,0 mmHg meiri en hjá þeim sem fengu valsartan/hýdróklórtíazíð, 6,2/3,3 mmHg meiri en hjá þeim sem fengu amlodipin/valsartan og 8,2/5,3 mmHg meiri en hjá þeim sem fengu amlodipin/hýdróklórtíazíð.
English: How to take Copalia HCT
Icelandic: Hvernig nota á Copalia HCT
English: Treatment with Copalia HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia.
Icelandic: Einungis skal hefja meðferð með Copalia HCT eftir að blóðkalíumlækkun og sérhver samfarandi blóðmagnesíumlækkun hefur verið leiðrétt.
English: If any of the above applies to you, do not take Copalia HCT and talk to your doctor.
Icelandic: Ef eitthvað af framangreindu á við skal ekki nota Copalia HCT og hafa samband við lækninn.
English: If you stop taking Copalia HCT
Icelandic: Ef hætt er að nota Copalia HCT
English: There are no clinical studies on fertility with Copalia HCT.
Icelandic: Engar klínískar frjósemisrannsóknir hafa verið gerðar með Copalia HCT.
English: Copalia HCT should be used only after correction of any pre-existing sodium and/or volume depletion.
Icelandic: Copalia HCT skal aðeins nota eftir að natríumskortur og/eða minnkað blóðrúmmál hefur verið leiðrétt.
English: Copalia HCT 10 mg/320 mg/25 mg film-coated tablets
Icelandic: Copalia HCT 10 mg/320 mg/25 mg filmuhúðaðar töflur
English: At week 8, the mean reductions in systolic/diastolic blood pressure were 39.7/24.7 mmHg with Copalia HCT, 32.0/19.7 mmHg with valsartan/hydrochlorothiazide, 33.5/21.5 mmHg with amlodipine/valsartan, and 31.5/19.5 mmHg with amlodipine/hydrochlorothiazide.
Icelandic: Á 8. viku var meðal lækkun á slagbils-/þanbilsþrýstingi 39,7/24,7 mmHg hjá þeim sem fengu Copalia HCT, 32,0/19,7 mmHg hjá þeim sem fengu valsartan/hýdróklórtíazíð, 33,5/21,5 mmHg hjá þeim sem fengu amlodipin/valsartan og 31,5/19,5 mmHg hjá þeim sem fengu amlodipin/hýdróklórtíazíð.
English: Due to the valsartan component, Copalia HCT is contraindicated in patients with hepatic impairment (see sections 4.2 and 4.3).
Icelandic: Skert lifrarstarfsemi er frábending við notkun Copalia HCT vegna þess að það inniheldur valsartan (sjá kafla 4.2 og 4.3).
English: If hypokalaemia develops during hydrochlorothiazide therapy, Copalia HCT should be discontinued until stable correction of the potassium balance.
Icelandic: Ef blóðkalíumlækkun kemur fram meðan á meðferð með hýdróklórtíazíði stendur, skal stöðva meðferð með Copalia HCT þar til kalíumþéttni hefur verið leiðrétt og hún helst stöðug.
English: If Copalia HCT is used during breast-feeding, doses should be kept as low as possible.
Icelandic: Ef konur sem hafa barn á brjósti nota Copalia HCT skal nota eins litla skammta og hægt er.
English: Copalia HCT combines three 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 and hydrochlorothiazide belongs to the thiazide diuretics class of medicines.
Icelandic: Amlodipin tilheyrir flokki kalsíumgangaloka, valsartan tilheyrir flokki angíótensín II viðtakablokka og hýdróklórtíazíð tilheyrir þvagræsilyfjum af flokki tíazíða.
English: What Copalia HCT looks like and contents of the pack Copalia 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.
Icelandic: Lýsing á útliti Copalia HCT og pakkningastærðir Copalia HCT 5 mg/160 mg/12,5 mg filmuhúðaðar töflur eru hvítar, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „VCL“ á hinni hliðinni.
English: Copalia HCT is contraindicated in patients with hypercalcaemia and should only be used after correction of any pre-existing hypercalcaemia.
Icelandic: Sjúklingar með blóðkalsíumhækkun mega ekki nota Copalia HCT og einungis skal nota það eftir að blóðkalsíumhækkun sem er til staðar hefur verið leiðrétt.
English: Known interactions with the following agents
Icelandic: Þekktar milliverkanir við eftirtalin lyf
English: Due to the hydrochlorothiazide component, Copalia HCT is contraindicated in symptomatic hyperuricaemia.
Icelandic: Vegna hýdróklórtíazíðhlutans, má ekki nota Copalia HCT þegar þvagsýruhækkun í blóði með einkennum er til staðar.
English: What Copalia HCT contains
Icelandic: Copalia HCT inniheldur
English: Copalia 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.
Icelandic: Copalia HCT 10 mg/320 mg/25 mg filmuhúðaðar töflur eru gulbrúnar, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „VFL“ á hinni hliðinni.
English: Grapefruit and grapefruit juice should not be consumed by people who are prescribed Copalia HCT.
Icelandic: Notkun Copalia HCT með mat, drykk eða áfengi Þeir sem hafa fengið ávísað Copalia HCT eiga ekki að neyta greipaldins eða greipaldinsafa.
English: Copalia 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.
Icelandic: Copalia HCT 5 mg/160 mg/25 mg filmuhúðaðar töflur eru gular, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „VEL“ á hinni hliðinni.
English: EU/1/09/575/042 98 film-coated tablets
Icelandic: EU/1/09/575/042 98 filmuhúðaðar töflur
English: EU/1/09/575/043 280 film-coated tablets
Icelandic: EU/1/09/575/043 280 filmuhúðaðar töflur
English: Copalia HCT 5 mg/160 mg/25 mg film-coated tablets
Icelandic: Copalia HCT 5 mg/160 mg/25 mg filmuhúðaðar töflur
English: EU/1/09/575/004 56 film-coated tablets
Icelandic: EU/1/09/575/004 56 filmuhúðaðar töflur
English: Copalia 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.
Icelandic: Copalia HCT 10 mg/160 mg/12,5 mg filmuhúðaðar töflur eru fölgular, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „VDL“ á hinni hliðinni.
English: EU/1/09/575/007 280 film-coated tablets
Icelandic: EU/1/09/575/007 280 filmuhúðaðar töflur
English: Copalia HCT 10 mg/160 mg/25 mg film-coated tablets
Icelandic: Copalia HCT 10 mg/160 mg/25 mg filmuhúðaðar töflur
English: Copalia HCT 10 mg/320 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Icelandic: Copalia HCT 10 mg/320 mg/25 mg filmuhúðaðar töflur Virku innihaldsefnin í Copalia HCT eru amlodipin (sem amlodipinbesylat), valsartan og hýdróklórtíazíð.
English: EU/1/09/575/031 280 film-coated tablets
Icelandic: EU/1/09/575/031 280 filmuhúðaðar töflur
English: EU/1/09/575/006 98 film-coated tablets
Icelandic: EU/1/09/575/006 98 filmuhúðaðar töflur
English: Copalia HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Icelandic: Copalia HCT 10 mg/320 mg/25 mg filmuhúðaðar töflur amlodipin/valsartan/hýdróklórtíazíð
English: EU/1/09/575/001 14 film-coated tablets
Icelandic: EU/1/09/575/001 14 filmuhúðaðar töflur
English: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets
Icelandic: Copalia HCT 5 mg/160 mg/12,5 mg filmuhúðaðar töflur
English: EU/1/09/575/030 98 film-coated tablets
Icelandic: EU/1/09/575/030 98 filmuhúðaðar töflur
English: Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets
Icelandic: Copalia HCT 10 mg/160 mg/12,5 mg filmuhúðaðar töflur
English: EU/1/09/575/055 280 film-coated tablets
Icelandic: EU/1/09/575/055 280 filmuhúðaðar töflur
English: EU/1/09/575/019 280 film-coated tablets
Icelandic: EU/1/09/575/019 280 filmuhúðaðar töflur
English: EU/1/09/575/041 90 film-coated tablets
Icelandic: EU/1/09/575/041 90 filmuhúðaðar töflur
English: EU/1/09/575/005 90 film-coated tablets
Icelandic: EU/1/09/575/005 90 filmuhúðaðar töflur
English: EU/1/09/575/018 98 film-coated tablets
Icelandic: EU/1/09/575/018 98 filmuhúðaðar töflur
English: EU/1/09/575/049 14 film-coated tablets
Icelandic: EU/1/09/575/049 14 filmuhúðaðar töflur
English: EU/1/09/575/052 56 film-coated tablets
Icelandic: EU/1/09/575/052 56 filmuhúðaðar töflur
English: EU/1/09/575/040 56 film-coated tablets
Icelandic: EU/1/09/575/040 56 filmuhúðaðar töflur
English: EU/1/09/575/016 56 film-coated tablets
Icelandic: EU/1/09/575/016 56 filmuhúðaðar töflur
English: EU/1/09/575/029 90 film-coated tablets
Icelandic: EU/1/09/575/029 90 filmuhúðaðar töflur
English: EU/1/09/575/054 98 film-coated tablets
Icelandic: EU/1/09/575/054 98 filmuhúðaðar töflur
English: EU/1/09/575/026 28 film-coated tablets
Icelandic: EU/1/09/575/026 28 filmuhúðaðar töflur
English: EU/1/09/575/027 30 film-coated tablets
Icelandic: EU/1/09/575/027 30 filmuhúðaðar töflur
English: EU/1/09/575/025 14 film-coated tablets
Icelandic: EU/1/09/575/025 14 filmuhúðaðar töflur
English: EU/1/09/575/038 28 film-coated tablets
Icelandic: EU/1/09/575/038 28 filmuhúðaðar töflur
English: Copalia 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.
Icelandic: Copalia HCT 10 mg/160 mg/25 mg filmuhúðaðar töflur eru gulbrúnar, sporöskjulaga töflur, auðkenndar með „NVR“ á annarri hliðinni og „VHL“ á hinni hliðinni.
English: EU/1/09/575/053 90 film-coated tablets
Icelandic: EU/1/09/575/053 90 filmuhúðaðar töflur
English: EU/1/09/575/003 30 film-coated tablets
Icelandic: EU/1/09/575/003 30 filmuhúðaðar töflur
English: EU/1/09/575/037 14 film-coated tablets
Icelandic: EU/1/09/575/037 14 filmuhúðaðar töflur
English: EU/1/09/575/051 30 film-coated tablets
Icelandic: EU/1/09/575/051 30 filmuhúðaðar töflur
English: EU/1/09/575/039 30 film-coated tablets
Icelandic: EU/1/09/575/039 30 filmuhúðaðar töflur
English: EU/1/09/575/002 28 film-coated tablets
Icelandic: EU/1/09/575/002 28 filmuhúðaðar töflur
English: EU/1/09/575/014 28 film-coated tablets
Icelandic: EU/1/09/575/014 28 filmuhúðaðar töflur
English: Copalia HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Icelandic: Copalia HCT 5 mg/160 mg/25 mg filmuhúðaðar töflur amlodipin/valsartan/hýdróklórtíazíð
English: Copalia HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Icelandic: Copalia HCT 5 mg/160 mg/25 mg filmuhúðaðar töflur Virku innihaldsefnin í Copalia HCT eru amlodipin (sem amlodipinbesylat), valsartan og hýdróklórtíazíð.
English: EU/1/09/575/013 14 film-coated tablets
Icelandic: EU/1/09/575/013 14 filmuhúðaðar töflur
English: EU/1/09/575/017 90 film-coated tablets
Icelandic: EU/1/09/575/017 90 filmuhúðaðar töflur
English: EU/1/09/575/028 56 film-coated tablets
Icelandic: EU/1/09/575/028 56 filmuhúðaðar töflur
English: EU/1/09/575/044 56 x 1 film-coated tablet (unit dose) EU/1/09/575/045 98 x 1 film-coated tablet (unit dose) EU/1/09/575/046 280 x 1 film-coated tablet (unit dose)
Icelandic: EU/1/09/575/044 56 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/575/045 98 x 1 filmuhúðuð tafla (stakskammtar) EU/1/09/575/046 280 x 1 filmuhúðuð tafla (stakskammtar)
English: Copalia HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Icelandic: Copalia HCT 10 mg/160 mg/25 mg filmuhúðaðar töflur amlodipin/valsartan/hýdróklórtíazíð
English: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Icelandic: Copalia HCT 5 mg/160 mg/12,5 mg filmuhúðaðar töflur Virku innihaldsefnin í Copalia HCT eru amlodipin (sem amlodipinbesylat), valsartan og hýdróklórtíazíð.
English: This is a disease in which the adrenal glands make too much of the hormone aldosterone If this applies to you, the use of Copalia HCT is not recommended.
Icelandic: Það er sjúkdómur sem felur í sér að nýrnahetturnar framleiða of mikið af hormóninu aldósteróni.