natgillin/translations-raw huggingface dataset:
1, 9 (valsartan) og 2, 6 (amlodipin) gange de kliniske doser på 160 mg valsartan og 10 mg amlodipin.
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.
Ved højere eksponering blev der set sårdannelse og erosion af maveslimhinden hos både han - og hunrotter.
At higher exposures, there were ulceration and erosion of the stomach mucosa in both females and males.
De samme forandringer blev også set i gruppen, som fik valsartan alene (eksponering på 8, 5- 11, 0 gange den kliniske dosis på 160 mg valsartan).
Similar changes were also seen in the valsartan alone group (exposure 8.5– 11.0 times the clinical dose of 160 mg valsartan).
En øget forekomst og sværhedsgrad af renal tubulær basofili/ hyalinisering, dilation og cylindre i urinen, såvel som interstitial lymfocytinflammation og arteriolær medial hypertrofi blev set ved en eksponering på 8- 13 (valsartan) og 7- 8 (amlodipin) gange den kliniske dosis på 160 mg valsartan og 10 mg amlodipin.
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.
De samme forandringer blev også set i gruppen, som fik valsartan alene (eksponering på 8, 5- 11, 0 gange den kliniske dosis på 160 mg valsartan).
Similar changes were found in the valsartan alone group (exposure 8.5– 11.0 times the clinical dose of 160 mg valsartan).
12 (valsartan) og 10 (amlodipin) gange de kliniske doser på 160 mg valsartan og 10 mg amlodipin.
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.
Der var kun beskedne tegn på maternel toksicitet (moderat nedsættelse af kropsvægt) i dette forsøg.
There were only modest signs of maternal toxicity (moderate reduction of body weight) in this study.
12 Filmovertræk:
Coating:
Hypromellose Titandioxid (E171) Jernoxid, gul (E172) Macrogol 4000 Talcum
Hypromellose Titanium dioxide (E171) Iron oxide, yellow (E172) Macrogol 4000 Talc
PVC/ PVDC blister.
PVC/ PVDC blisters.
7, 14, 28, 30, 56, 90, 98 eller 280 filmovertrukne tabletter.
7, 14, 28, 30, 56, 90, 98 or 280 film-coated tablets.
PVC/ PVDC perforeret enkeltdosisblister.
PVC/ PVDC perforated unit dose blisters.
56, 98 eller 280 filmovertrukne tabletter og multipakninger, der indeholder 280 (4x70) filmovertrukne tabletter.
56, 98 or 280 film-coated tablets and multipacks containing 280 (4x70) film-coated tablets.
6. 6 Regler for destruktion og anden håndtering
12 6.6 Special precautions for disposal and other handling
EU/ 1/ 06/ 372/ 001 EU/ 1/ 06/ 372/ 002 EU/ 1/ 06/ 372/ 003 EU/ 1/ 06/ 372/ 004 EU/ 1/ 06/ 372/ 005 EU/ 1/ 06/ 372/ 006
EU/ 1/ 06/ 372/ 001 EU/ 1/ 06/ 372/ 002 EU/ 1/ 06/ 372/ 003 EU/ 1/ 06/ 372/ 004 EU/ 1/ 06/ 372/ 005 EU/ 1/ 06/ 372/ 006 EU/ 1/ 06/ 372/ 007 EU/ 1/ 06/ 372/ 008 EU/ 1/ 06/ 372/ 025 EU/ 1/ 06/ 372/ 026 EU/ 1/ 06/ 372/ 027 EU/ 1/ 06/ 372/ 034
Copalia 5 mg/ 160 mg filmovertrukne tabletter
Copalia 5 mg/ 160 mg film-coated tablets
Mørkegul, oval filmovertrukket tablet, præget med ” NVR ” på den ene side og ” ECE ” på den anden side.
Dark yellow, oval film-coated tablet, imprinted with “ NVR” on one side and “ ECE” on the other side.
Copalia 5 mg/ 160 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 5 mg eller valsartan 160 mg alene.
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.
15 Børn og unge Copalia bør ikke anvendes til børn under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
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.
16 Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med mildt til moderat nedsat nyrefunktion (GFR > 30 ml/ min/ 1, 73 m2).
Renal impairment No dosage adjustment of Copalia is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
Primær hyperaldosteronisme Patienter med primær hyperaldosteronisme bør ikke behandles med angiotensin II- antagonisten, valsartan, da deres renin- angiotensin- system er påvirket af den primære lidelse.
15 Primary hyperaldosteronism Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.
17 Interaktioner forbundet med valsartan Samtidig brug frarådes Lithium Der er rapporteret reversible øgede serumkoncentrationer og toksicitet af lithium ved samtidig brug af ACE- hæmmere.
Interactions linked to valsartan Concomitant use not recommended Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
Kaliumbesparende diuretika, kaliumtilskud, kaliumholdige salterstatninger eller anden medicin, som øger kaliumniveauet Hvis der i kombination med valsartan udskrives et lægemiddel, som påvirker kaliumniveauet, bør kaliumindholdet i plasma monitoreres.
16 Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.
18 Det anbefales at udføre ultralydsscanning for at tjekke nyrefunktionen og kraniet, hvis fosteret har været udsat for AIIA fra andet trimester.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Data fra et begrænset antal graviditeter, hvorunder amlodipin eller andre calciumantagonister blev brugt, indikerer ingen utilsigtede hændelser for fosterets helbred.
17 indicate no adverse effects of amlodipine and other calcium receptor antagonists on the health of the foetus.
19 Sygdomme i bevægeapparatet og bindevæv
Musculoskeletal and connective tissue disorders
20 Amlodipin Almindelig Usædvanlig
Amlodipine Common Uncommon
21 Amlodipin Amlodipin- delen af Copalia hæmmer den transmembrane indtrængning af calciumioner i hjertets og karvæggens glatte muskulatur.
Amlodipine The amlodipine component of Copalia inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
I hæmodynamiske studier har amlodipin ikke været forbundet med negativ inotropisk effekt, når det blev givet til mennesker eller levende dyr i det terapeutiske dosisinterval.
20 generally demonstrated a small increase in cardiac index without significant influence on dP/ dt or on left ventricular end diastolic pressure or volume.
Til sammenligning blev der set en normalisering af blodtrykket hos 67% af patienterne, som forblev på amlodipin 10 mg.
21 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.
23 Copalia er ikke undersøgt i andre patientgrupper end hypertension.
Copalia has not been studied in any patient population other than hypertension.
Distribution:
22 Distribution:
24 Ældre (65 år og derover) Tiden til maksimal plasmakoncentration af amlodipin er den samme for yngre og ældre patienter.
Elderly (age 65 years or over) Time to peak plasma amlodipine concentrations is similar in young and elderly patients.
12 (valsartan) og 10 (amlodipin) gange de kliniske doser på 160 mg valsartan og 10 mg amlodipin.
23 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.
25 Filmovertræk:
Coating:
6. 6 Regler for destruktion og anden håndtering
24 6.6 Special precautions for disposal and other handling
EU/ 1/ 06/ 372/ 009 EU/ 1/ 06/ 372/ 010 EU/ 1/ 06/ 372/ 011 EU/ 1/ 06/ 372/ 012 EU/ 1/ 06/ 372/ 013 EU/ 1/ 06/ 372/ 014
EU/ 1/ 06/ 372/ 009 EU/ 1/ 06/ 372/ 010 EU/ 1/ 06/ 372/ 011 EU/ 1/ 06/ 372/ 012 EU/ 1/ 06/ 372/ 013 EU/ 1/ 06/ 372/ 014 EU/ 1/ 06/ 372/ 015 EU/ 1/ 06/ 372/ 016 EU/ 1/ 06/ 372/ 028 EU/ 1/ 06/ 372/ 029 EU/ 1/ 06/ 372/ 030 EU/ 1/ 06/ 372/ 035
Copalia 10 mg/ 160 mg filmovertrukne tabletter
Copalia 10 mg/ 160 mg film-coated tablets
Lysegul, oval filmovertrukket tablet, præget med ” NVR ” på den ene side og ” UIC ” på den anden side.
Light yellow, oval film-coated tablet, imprinted with “ NVR” on one side and “ UIC” on the other side.
Copalia 10 mg/ 160 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 10 mg eller valsartan 160 mg alene eller med Copalia 5 mg/ 160 mg.
Copalia 10 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Copalia 5 mg/ 160 mg.
28 Børn og unge Copalia bør ikke anvendes til børn under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
26 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.
29 Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med mildt til moderat nedsat nyrefunktion (GFR > 30 ml/ min/ 1, 73 m2).
Renal impairment No dosage adjustment of Copalia is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
Primær hyperaldosteronisme Patienter med primær hyperaldosteronisme bør ikke behandles med angiotensin II- antagonisten, valsartan, da deres renin- angiotensin- system er påvirket af den primære lidelse.
27 Primary hyperaldosteronism Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.
30 Interaktioner forbundet med valsartan Samtidig brug frarådes Lithium Der er rapporteret reversible øgede serumkoncentrationer og toksicitet af lithium ved samtidig brug af ACE- hæmmere.
Interactions linked to valsartan Concomitant use not recommended Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
Kaliumbesparende diuretika, kaliumtilskud, kaliumholdige salterstatninger eller anden medicin, som øger kaliumniveauet Hvis der i kombination med valsartan udskrives et lægemiddel, som påvirker kaliumniveauet, bør kaliumindholdet i plasma monitoreres.
28 Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.
31 Det anbefales at udføre ultralydsscanning for at tjekke nyrefunktionen og kraniet, hvis fosteret har været udsat for AIIA fra andet trimester.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Dyreforsøg indikerer, at kombinationen af valsartan/ amlodipin har reproduktionstoksicitet på linie med det, der er beskrevet for valsartan og andre angiotensin II- antagonister (se pkt.
Animal studies indicates that the valsartan/ amlodipine has reproductive toxicity in line with what has been described for valsartan and
5. 3).
29 other angiotensin II antagonists (see section 5.3).
Data fra et begrænset antal graviditeter, hvorunder amlodipin eller andre calciumantagonister blev brugt, indikerer ingen utilsigtede hændelser for fosterets helbred.
Data on a limited number of exposed pregnancies indicate no adverse effects of amlodipine and other calcium receptor antagonists on the health of the foetus.
32 Sygdomme i bevægeapparatet og bindevæv
Musculoskeletal and connective tissue disorders
Almene lidelser og reaktioner på indgivelsesstedet
30 General disorders and administration site conditions
33 Amlodipin Almindelig Usædvanlig
Amlodipine Common Uncommon
4. 9 Overdosering
31 4.9 Overdose
34 Amlodipin Amlodipin- delen af Copalia hæmmer den transmembrane indtrængning af calciumioner i hjertets og karvæggens glatte muskulatur.
Amlodipine The amlodipine component of Copalia inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
I hæmodynamiske studier har amlodipin ikke været forbundet med negativ inotropisk effekt, når det blev givet til mennesker eller levende dyr i det terapeutiske dosisinterval.
32 generally demonstrated a small increase in cardiac index without significant influence on dP/ dt or on left ventricular end diastolic pressure or volume.
Til sammenligning blev der set en normalisering af blodtrykket hos 67% af patienterne, som forblev på amlodipin 10 mg.
33 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.
36 Copalia er ikke undersøgt i andre patientgrupper end hypertension.
Copalia has not been studied in any patient population other than hypertension.
Distribution:
34 Distribution:
37 Ældre (65 år og derover) Tiden til maksimal plasmakoncentration af amlodipin er den samme for yngre og ældre patienter.
Elderly (age 65 years or over) Time to peak plasma amlodipine concentrations is similar in young and elderly patients.
12 (valsartan) og 10 (amlodipin) gange de kliniske doser på 160 mg valsartan og 10 mg amlodipin.
35 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.
38 Filmovertræk:
Coating:
Hypromellose Titandioxid (E171) Jernoxid, gul (E172) Jernoxid, rød (E172) Macrogol 4000 Talcum
Hypromellose Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172) Macrogol 4000 Talc
6. 6 Regler for destruktion og anden håndtering
36 6.6 Special precautions for disposal and other handling
39 EU/ 1/ 06/ 372/ 022 EU/ 1/ 06/ 372/ 023 EU/ 1/ 06/ 372/ 024 EU/ 1/ 06/ 372/ 031 EU/ 1/ 06/ 372/ 032 EU/ 1/ 06/ 372/ 033 EU/ 1/ 06/ 372/ 036
EU/ 1/ 06/ 372/ 017 EU/ 1/ 06/ 372/ 018 EU/ 1/ 06/ 372/ 019 EU/ 1/ 06/ 372/ 020 EU/ 1/ 06/ 372/ 021 EU/ 1/ 06/ 372/ 022 EU/ 1/ 06/ 372/ 023 EU/ 1/ 06/ 372/ 024 EU/ 1/ 06/ 372/ 031 EU/ 1/ 06/ 372/ 032 EU/ 1/ 06/ 372/ 033 EU/ 1/ 06/ 372/ 036
40 BILAG II
37 ANNEX II
42 BILAG III
39 ANNEX III
44 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Copalia 5 mg/ 80 mg filmovertrukne tabletter amlodipin/ valsartan
Copalia 5 mg/ 80 mg film-coated tablets amlodipine/ valsartan
7 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 56 filmovertrukne tabletter 90 filmovertrukne tabletter 98 filmovertrukne tabletter 280 filmovertrukne tabletter
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets 280 film-coated tablets
7 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 56 filmovertrukne tabletter 90 filmovertrukne tabletter 98 filmovertrukne tabletter 280 filmovertrukne tabletter 56 x 1 filmovertrukket tablet (enhedsdosis) 98 x 1 filmovertrukket tablet (enhedsdosis) 280 x 1 filmovertrukket tablet (enhedsdosis)
7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets 280 film-coated tablets 56 x 1 film-coated tablet (unit dose) 98 x 1 film-coated tablet (unit dose) 280 x 1 film-coated tablet (unit dose)
46 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
70 filmovertrukne tabletter Del af multipakning, som indeholder 4 kartoner med hver 70 tabletter.
70 film-coated tablets Component of a multipack comprising 4 cartons, each containing 70 tablets.
280 filmovertrukne tabletter (4x70)
280 film-coated tablets (4x70)
48 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
280 filmovertrukne tabletter Multipakning som indeholder 4 kartoner, hver med 70 tabletter.
280 film-coated tablets Multipack comprising 4 cartons, each containing 70 tablets.
49 11.
11.
50 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
47 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
51 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
48 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Copalia 5 mg/ 160 mg filmovertrukne tabletter amlodipin/ valsartan
Copalia 5 mg/ 160 mg film-coated tablets amlodipine/ valsartan
53 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
55 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
52 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
56 11.
11.
58 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Copalia 10 mg/ 160 mg filmovertrukne tabletter amlodipin/ valsartan
Copalia 10 mg/ 160 mg film-coated tablets amlodipine/ valsartan
60 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
62 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
63 11.
11.
64 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
61 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
65 B.
62 B.
- Lægen har ordineret Copalia til dig personligt.
- This medicine has been prescribed for you.
Copalias virkning og hvad du skal bruge det til 2.
What Copalia is and what it is used for 2.
Det skal du vide, før du begynder at tage Copalia 3.
Before you take Copalia 3.
Sådan skal du tage Copalia 4.
How to take Copalia 4.
Sådan opbevarer du Copalia 6.
How to store Copalia 6.
COPALIAS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
WHAT COPALIA IS AND WHAT IT IS USED FOR
Amlodipin forhindrer
Both of these substances help to control high blood pressure. − Amlodipine belongs to a group of substances called “ calcium channel blockers”.
- Valsartan tilhører en gruppe stoffer, som hedder ” angiotensin II- receptorantagonister ”.
Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening. − Valsartan belongs to a group of substances called “ angiotensin-II receptor antagonists”.
Copalia bruges til at behandle forhøjet blodtryk hos patienter, som ikke kan få deres blodtryk passende kontrolleret med enten amlodipin eller valsartan alene.
Copalia is used to treat high blood pressure in patients whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE COPALIA
BEFORE YOU TAKE COPALIA
Hvis du
Do not take Copalia − if you are allergic (hypersensitive) to amlodipine or other medicines of the dihydropyridine type, − if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Copalia.
- hvis du har alvorlige leverlidelser, som f. eks. biliær cirrhose eller cholestasi.
If you think you may be allergic, talk to your doctor before taking Copalia. − if you have severe liver problems, such as biliary cirrhosis or cholestasis. − if you have severe kidney problems or if you are having dialysis. − during the last 6 months of pregnancy, see “ Pregnancy and breastfeeding”.
- hvis du har alvorlige nyrelidelser, eller hvis du er i dialysebehandling.
If any of the above applies to you, do not take Copalia and talk to your doctor.
Hvis noget af ovenstående gælder for dig, skal du ikke tage Copalia og du skal underrette din læge.
64 Take special care with Copalia − if you have been sick (vomiting or diarrhoea). − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − 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”).
67 Vær ekstra forsigtig med at tage Copalia
If any of these apply to you, tell your doctor before taking Copalia.
- hvis du har været syg (opkastning eller diarré).
You must tell your doctor if you think that you are (or might become) pregnant.
Disse forhøjer den
Copalia is not recommended in early pregnancy and may cause serious harm to your baby if taken after 3 months of pregnancy (see section “ Pregnancy and breast-feeding”).
mængde urin, du producerer.
The use of Copalia in children and adolescents is not recommended.
- hvis du tager anden medicin eller andre stoffer, som øger mængden af kalium i dit blod (f. eks.
Also tell your doctor if you have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.
nogle typer diuretika, kaliumtilskud eller salterstatninger, som indeholder kalium).
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
- hvis du har haft hjertesvigt.
Your doctor may need to change the dose or take other precautions.
mitralklapstenose ”).
In some cases you may have to stop taking one of the medicines.
Copalia frarådes i den tidlige periode af graviditet.
This applies especially to the medicines listed below: − lithium (a medicine used to treat some types of depression); − potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; − anticonvulsant agents (e. g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone), rifampicin, St.
Copalia kan forårsage alvorlig skade på din baby, hvis det tages efter tredje måned af graviditeten (se afsnittet om ” Graviditet og amning ”).
John’ s wort; − nitroglycerin and other nitrates, or other substances called “ vasodilators”; − medicines used for HIV/ AIDS (e. g. ritonavir) or for treatment of fungal infections (e. g. ketoconazole).
Brug af Copalia til børn og unge frarådes.
Taking Copalia with food and drink You can take Copalia with or without food.
Du skal også fortælle din læge, hvis du har fået en nyretransplantation eller hvis du har fået at vide, at du har forsnævret blodtilførelse til nyrerne.
Copalia and older people Caution is required when increasing the dosage.
Brug af anden medicin Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
Pregnancy and breast-feeding You must tell your doctor if you think you are (or might become) pregnant.