FrancophonIA/ELRC3.0 huggingface dataset:
English: If any of the above applies to you, do not take Copalia HCT and talk to your doctor.
Danish: Hvis noget af ovenstående gælder for dig, må du ikke tage Copalia HCT, og du skal tale med din læge.
English: Copalia HCT is contraindicated in patients with hypercalcaemia and should only be used after correction of any pre-existing hypercalcaemia.
Danish: Copalia HCT er kontraindiceret til patienter med hyperkalcæmi og bør kun anvendes efter korrektion af præeksisterende hyperkalcæmi.
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.
Danish: Efter oral administration af Copalia HCT hos voskne raske personer, opnås peak plasma koncentrationer af amlodipin, valsartan og hydrochlorthiazid efter henholdsvis 6-8 timer, 3 timer, og 2 timer.
English: Due to the hydrochlorothiazide component, Copalia HCT is contraindicated in symptomatic hyperuricaemia.
Danish: På grund af indholdet af hydrochlorthiazid er Copalia HCT kontraindiceret ved symptomatisk hyperurikæmi.
English: In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Copalia HCT were dizziness and hypotension (0.7%).
Danish: De mest almindelige årsager til, at behandlingen blev afbrudt, var i dette kontrollerede kliniske studie med Copalia HCT svimmelhed og hypotension (0,7 %).
English: • rifampicin (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
Danish: • rifampicin (bruges fx til behandling af tuberkulose); erythromycin, clarithromycin (antibiotika),
English: Elderly patients, particularly those taking the maximum dose of Copalia HCT (10 mg/320 mg/25 mg), should have their blood pressure checked regularly.
Danish: Ældre patienter, især dem, der tager den højeste dosis af Copalia HCT (10 mg/320 mg/25 mg) skal regelmæssigt have deres blodtryk kontrolleret.
English: The safety profile of Copalia HCT presented below is based on clinical studies performed with Copalia HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide.
Danish: Copalia HCT's sikkerhedsprofil, som er præsenteret herunder, er baseret på kliniske afprøvninger udført med Copalia HCT og de kendte sikkerhedsprofiler af de individuelle komponenter amlodipin, valsartan og hydrochlorthiazid.
English: • ACE inhibitors or aliskiren -(see also information under the headings “Do not take Copalia HCT” and “Warnings and precautions”).
Danish: • ACE-hæmmere eller aliskiren (se også information under overskrifterne ”Tag ikke Copalia
English: If patients taking Copalia HCT suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired.
Danish: Hos patienter, der tager Copalia HCT, og som får bivirkninger som svimmelhed, hovedpine, træthed eller kvalme, kan reaktionsevnen blive påvirket.
English: The amlodipine component of Copalia HCT inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Danish: Amlodipin-komponenten i Copalia HCT hæmmer den transmembranale indstrømning af calciumioner i hjertets og karvæggens glatte muskulatur.
English: There is no experience of overdose with Copalia HCT.
Danish: Der er ingen erfaring med overdosering af Copalia HCT.
English: Copalia HCT is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan and hydrochlorothiazide and who may benefit from taking one tablet containing all three substances.
Danish: Copalia HCT bruges til at behandle forhøjet blodtryk hos voksne patienter, hvis blodtryk allerede er kontrolleret med amlodipin, valsartan og hydrochlorthiazid, og som kan drage fordel af at tage én tablet, som indeholder alle tre stoffer.
English: Frequency Copalia HCT
Danish: Frekvens Copalia HCT
English: if you experience dizziness and/or fainting during treatment with Copalia HCT, tell your doctor as soon as possible.
Danish: - hvis du bliver svimmel og/eller besvimer under behandlingen med Copalia HCT, skal du fortælle det til din læge med det samme.
English: Patients taking Copalia HCT and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Danish: Patienter, som fører motorkøretøj eller betjener maskiner under behandling med Copalia HCT, skal være opmærksomme på, at der lejlighedsvis kan optræde svimmelhed eller træthed.
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.
Danish: Copalia HCT kombinerer tre antihypertensive stoffer, som kontrollerer blodtrykket hos patienter med essentiel hypertension ved komplementære virkningsmekanismer: amlodipin tilhører klassen kaldet calciumantagonister, valsartan tilhører klassen kaldet angiotensin II-antagonister og hydrochlorthiazid tilhører klassen kaldet thiazid-diuretika.
English: Copalia HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide.
Danish: Copalia HCT tabletter indeholder tre stoffer, som kaldes amlodipin, valsartan og hydrochlorthiazid.
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.
Danish: Sikkerheden af Copalia HCT er blevet vurderet ved den maksimale dosis på 10 mg/320 mg/25 mg i et kontrolleret, kortvarigt (8 uger) klinisk studie med 2.271 patienter, af hvilke 582 fik valsartan i kombination med amlodipin og hydrochlorthiazid.
English: Copalia HCT individual component
Danish: Copalia HCT enkelte komponenter
English: if you have or have had heart failure or coronary artery disease, particularly if you are prescribed the maximum dose of Copalia HCT (10 mg/320 mg/25 mg).
Danish: - hvis du har eller har haft hjertevigt eller sygdom i kranspulsåren, specielt hvis du får ordineret den højeste dosis af Copalia HCT (10 mg/320 mg/25 mg).
English: If excessive hypotension occurs with Copalia HCT, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Danish: Hvis der forekommer udtalt hypotension med Copalia HCT, skal patienten placeres i liggende rygstilling, og om nødvendigt skal der gives intravenøs infusion af isotonisk natriumchlorid.
English: No dose adjustment of Copalia HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion (GFR ≥30 ml/min/1,73 m
English: The maximum recommended dose of Copalia HCT is 10 mg/320 mg/25 mg.
Danish: Den maksimalt anbefalede dosis af Copalia HCT er 10 mg/320 mg/25 mg.
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.
Danish: Når Copalia HCT anvendes hos patienter med nedsat nyrefunktion, anbefales regelmæssig monitorering af serumelektrolytter herunder kalium, samt serum-kreatinin og serum-urinsyre.
English: Copalia HCT is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn, or was born prematurely.
Danish: Hvis du ønsker at amme, kan din læge vælge en anden behandling til dig, især hvis dit barn er nyfødt eller født for tidligt.
English: (It is also recommended to avoid Copalia HCT in early pregnancy - see Pregnancy section.)
Danish: Copalia HCT tidligt i graviditeten - se afsnittet om Graviditet).
English: In case severe or rapid hyponatraemia develops during Copalia HCT therapy, the treatment should be discontinued until normalisation of natraemia.
Danish: Hvis svær eller pludselig hyponatriæmi opstår under behandling med Copalia HCT, bør behandlingen seponeres, indtil natriumbalancen er normaliseret.
English: There is limited experience with the use of Copalia HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease.
Danish: Der er begrænset erfaring med brug af Copalia HCT til patienter med hjertesvigt og lidelser i kranspulsåren, især med den maksimale dosis.
English: In the 8-week controlled clinical study, changes in laboratory parameters observed with the combination of Copalia HCT were minor and consistent with the pharmacological mechanism of action of the monotherapy agents.
Danish: Ændringerne i laboratorieværdier, som blev set i det kontrollerede kliniske studie af 8 ugers varighed, var små og i overensstemmelse med de farmakologiske virkningsmekanisme for komponenterne i monoterapi.
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.
Danish: Følgende bivirkninger, som er opstillet efter systemorganklasser i henhold til MedDRA og hyppighed gælder for Copalia HCT (amlodipin/valsartan/hydrochlorthiazid) og amlodipin, valsartan og HCT individuelt.
English: No formal interaction studies with other medicinal products have been performed with Copalia HCT.
Danish: Der er ikke udført formelle interaktionsstudier af Copalia HCT i kombination med andre lægemidler.
English: if your doctor has told you that you have a narrowing of the valves in your heart (called “aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “obstructive hypertrophic cardiomyopathy”).
Danish: - hvis din læge har fortalt dig, at du har en forsnævring af hjerteklappen (dette kaldes ”aorta eller mitralklapstenose”) eller hvis du har en unormal fortykkelse af hjertemusklen (dette kaldes
English: If hypokalaemia develops during hydrochlorothiazide therapy, Copalia HCT should be discontinued until stable correction of the potassium balance.
Danish: Hvis hypokaliæmi opstår under behandling med hydrochlorthiazid, bør Copalia HCT seponeres, indtil kaliumbalancen er genoprettet og stabil.
English: What you need to know before you take Copalia HCT
Danish: Det skal du vide, før du begynder at tage Copalia HCT
English: Treatment with Copalia HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia.
Danish: Behandling med Copalia HCT bør kun påbegyndes efter korrektion af hypokaliæmi og eventuel samtidig forekommende hypomagnesiæmi.
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.
Danish: Reduktionen i systolisk/diastolisk blodtryk med Copalia HCT var 7,6/5,0 mmHg større end med valsartan/hydrochlorthiazid; 6,2/3,3 mmHg større end med, amlodipin/valsartan og 8,2/5,3 mmHg større end med amlodipin/hydrochlorthiazid.
English: There are no clinical studies on fertility with Copalia HCT.
Danish: Der er ikke udført fertilitetsstudier med Copalia HCT.
English: Patients with mild to moderate renal impairment may therefore receive the usual initial dose (see sections 4.2 and 4.4).
Danish: Patienter med let til moderat nedsat nyrefunktion kan derfor få normal startdosis (se pkt.
English: If you stop taking Copalia HCT
Danish: Hvis du holder op med at tage Copalia HCT
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.
Danish: De modsat rettede effekter af valsartan 320 mg og hydrochlorthiazid 25 mg på kaliumniveauet i serum balancerede næsten hinanden hos mange patienter i det kontrollerede studie.
English: This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Copalia HCT.
Danish: Det skyldes, at grapefrugt og grapefrugtjuice kan føre til en øget mængde af det aktive stof, amlodipin, i blodet.
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.
Danish: I uge 8 var gennemsnitsreduktionen i systolisk/diastolisk blodtryk 39,7/24,7 mmHg med Copalia HCT; 32,0/19,7 mmHg med valsartan/hydrochlorthiazid; 33,5/21,5 mmHg med amlodipin/valsartan, og 31,5/19,5 mmHg med amlodipin/hydrochlorthiazid.
English: Amlodipine/Valsartan/Hydrochlorothiazide
Danish: Amlodipin/Valsartan/Hydrochlorthiazid
English: If you forget to take Copalia HCT
Danish: Hvis du har glemt at tage Copalia HCT
English: Due to the valsartan component, Copalia HCT is contraindicated in patients with hepatic impairment (see sections 4.2 and 4.3).
Danish: På grund af indholdet af valsartan er Copalia HCT kontraindiceret til patienter med nedsat leverfunktion (se pkt 4.2 og 4.3).
English: When switching eligible elderly hypertensive patients (see section 4.1) to Copalia HCT, the lowest available dose of the amlodipine component should be used.
Danish: 4.1) med nedsat leverfunktion skiftes til Copalia HCT, skal den laveste tilgængelige amlodipinkombination anvendes.
English: Copalia HCT should be used only after correction of any pre-existing sodium and/or volume depletion.
Danish: Copalia HCT bør kun bruges efter korrektion af eventuel eksisterende væske- eller natriummangel.
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).
Danish: Den maksimale anbefalede dosis til patienter med let til moderat nedsat leverfunktion uden kolestase er 80 mg valsartan, og Copalia HCT er derfor ikke egnet til denne patientgruppe (se pkt.
English: Do not take Copalia HCT if you are more than 3 months pregnant.
Danish: Tag ikke Copalia HCT - hvis du er mere end 3 måneder henne i graviditeten (det anbefales også at undgå brug af
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).
Danish: - Samtidig brug af Copalia HCT og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m 2) (se pkt.
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.
Danish: Der skal udvises forsigtighed hos patienter med hjertesvigt og lidelser i kranspulsåren, især ved maksimumdosis af Copalia HCT, 10 mg/320 mg/25 mg.
English: If you take more Copalia HCT than you should If you have accidentally taken too many Copalia HCT tablets, talk to a doctor immediately.You may require medical attention.
Danish: Hvis du ved et uheld har taget for mange Copalia HCT-tabletter, skal du straks kontakte en læge.
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.
Danish: Der skal udvises forsigtighed, inklusive hyppigere monitorering af blodtrykket hos ældre patienter især ved den maksimale dosis af Copalia HCT, 10 mg/320 mg/25 mg, da der er begrænset tilgængelig data for denne patientpopulation.
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
Danish: Copalia HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter Copalia HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter Copalia HCT 5 mg/160 mg/25 mg filmovertrukne tabletter Copalia HCT 10 mg/160 mg/25 mg filmovertrukne tabletter Copalia HCT 10 mg/320 mg/25 mg filmovertrukne tabletter
English: Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimise the risk of skin cancer.
Danish: For at minimere risikoen for hudkræft bør patienterne rådes til at træffe forebyggende foranstaltninger som f.eks. at begrænse eksponeringen for sollys og UVstråler og, ved eksponering, at sørge for tilstrækkelig beskyttelse.
English: if you are allergic to amlodipine or to any other calcium channel blockers, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary infections), or any of the other ingredients of this medicine (listed in section 6).
Danish: hydrochlorthiazid, sulfonamid-afledte stoffer (medicin, som bruges til at behandle infektioner i brystet eller urinvejene), eller et af de øvrige indholdsstoffer i Copalia HCT (angivet i punkt 6).
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.
Danish: I et kontrolleret studie af patienter med moderat til svær ukompliceret hypertension blev der set udtalt hypotension, inklusive ortostatisk hypotension hos 1,7 % af patienterne, som blev behandlet med den maksimale dosis af Copalia HCT (10 mg/320 mg/25 mg) sammenlignet med 1,8 % af patienterne, som blev behandlet med valsartan/hydrochlorthiazid (320 mg/25 mg), 0,4 % af patienterne, som blev behandlet med amlodipin/valsartan (10 mg/320 mg) og 0,2 % af patienterne, som blev behandlet med hydrochlorthiazid/amlodipin (25 mg/10 mg).
English: What Copalia HCT contains
Danish: Copalia HCT indeholder:
English: Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Macrogol 4000
Danish: Hypromellose, substitutionstype 2910 (3 mPa.s) Titandioxid (E 171)
English: Copalia HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
Danish: Copalia HCT er kontraindiceret hos patienter med svært nedsat nyrefunktion, patienter med anuri og patienter i dialyse (se pkt.
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.
Danish: Dette er en sygdom, hvor dine binyrer producerer for meget af hormonet aldosteron.
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
Danish: Copalia HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter Copalia HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter Copalia HCT 5 mg/160 mg/25 mg filmovertrukne tabletter Copalia HCT 10 mg/160 mg/25 mg filmovertrukne tabletter Copalia HCT 10 mg/320 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
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.
Danish: Der skal udvises forsigtighed over for patienter med hjertesvigt og lidelser i kranspulsåren, især ved den maksimale dosis af Copalia HCT, 10 mg/320 mg/25 mg, da der kun er begrænsede data tilgængelige fra disse patientgrupper.
English: Grapefruit and grapefruit juice should not be consumed by people who are prescribed Copalia HCT.
Danish: Brug af Copalia HCT sammen med mad, drikke og alkohol Du må ikke indtage grapefrugt og grapefrugtjuice, mens du får ordineret Copalia HCT.
English: Due to the valsartan component, Copalia HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Pga. indholdet af valsartan er Copalia HCT kontraindiceret til patienter med stærkt nedsat leverfunktion (se pkt.
English: The use of Copalia HCT during breastfeeding is not recommended.
Danish: Brug af Copalia HCT frarådes under amning.
English: Copalia HCT 10 mg/320 mg/25 mg film-coated tablets
Danish: Copalia HCT 10 mg/320 mg/25 mg filmovertrukne tabletter
English: How to take Copalia HCT
Danish: Sådan skal du tage Copalia HCT
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.
Danish: Copalia HCT 10 mg/320 mg/25 mg filmovertrukne tabletter er brun-gule, ovale tabletter præget med ”NVR” på den ene side og ”VFL” på den anden side.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Copalia HCT Fortæl altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
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.
Danish: Copalia HCT 5 mg/160 mg/25 mg filmovertrukne tabletter er gule, ovale tabletter præget med ”NVR” på den ene side og ”VEL” på den anden side.
English: EU/1/09/575/007 280 film-coated tablets
Danish: EU/1/09/576/007 280 filmovertrukne tabletter
English: EU/1/09/575/004 56 film-coated tablets
Danish: EU/1/09/576/004 56 filmovertrukne tabletter
English: EU/1/09/575/042 98 film-coated tablets
Danish: EU/1/09/576/042 98 filmovertrukne tabletter
English: Copalia HCT 10 mg/160 mg/25 mg film-coated tablets
Danish: Copalia HCT 10 mg/160 mg/25 mg filmovertrukne tabletter
English: EU/1/09/575/001 14 film-coated tablets
Danish: EU/1/09/576/001 14 filmovertrukne tabletter
English: EU/1/09/575/006 98 film-coated tablets
Danish: EU/1/09/576/006 98 filmovertrukne tabletter
English: EU/1/09/575/043 280 film-coated tablets
Danish: EU/1/09/576/043 280 filmovertrukne tabletter
English: Copalia HCT 5 mg/160 mg/25 mg film-coated tablets
Danish: Copalia HCT 5 mg/160 mg/25 mg filmovertrukne tabletter
English: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets
Danish: Copalia HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter
English: Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets
Danish: Copalia HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter
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.
Danish: Copalia HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter er svagt gule, ovale tabletter præget med ”NVR” på den ene side og ”VDL” på den anden side.
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.
Danish: Copalia HCT 10 mg/320 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: EU/1/09/575/031 280 film-coated tablets
Danish: EU/1/09/576/031 280 filmovertrukne tabletter
English: EU/1/09/575/005 90 film-coated tablets
Danish: EU/1/09/576/005 90 filmovertrukne tabletter
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.
Danish: Der kan opstå symptomatisk hypotension efter indledning af behandling med Copalia HCT hos patienter med væske- og/eller natriummangel, som fx patienter, der får høje doser diuretika.