FrancophonIA/ELRC3.0 huggingface dataset:
English: Denmark Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, The Netherlands
Danish: Danmark Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, Holland
English: Investigations Rare: Hyperkalaemia, elevation of ALT
Danish: Undersøgelser Sjælden: Hyperkaliæmi, stigning i ALAT.
English: • Severe renal impairment (i.e. creatinine clearance <30 ml/min)
Danish: Svær leverinsufficiens (dvs kreatininclearance <30 ml/min).
English: • Weakness, tiredness, chest pain,
Danish: • Svaghed, træthed, smerter i brystet
English: Use in patients with hepatic impairment Losartan/HCTZ is contraindicated in patients with severe hepatic impairment (see section 4.3.
Danish: Patienter med leverinsufficiens Losartan/hydrochlorthiazid er kontraindiceret til patienter med svær leverinsufficiens (se pkt.
English: Losartan and hydrochlorothiazide is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by losartan potassium or hydrochlorothiazide alone.
Danish: Losartan og hydrochlorthiazid anvendes ikke til initial behandling men til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med losartankalium eller hydrochlorthiazid alene.
English: As with any antihypertensive agents, excessive blood pressure decrease in patients with ischaemic cardiovascular and cerebrovascular disease could result in a myocardial infarction or stroke.
Danish: Koronar hjertesygdom og cerebrovaskulær sygdom Som det er tilfældet med andre antihypertensiva kan et kraftigt fald i blodtrykket hos patienter med iskæmisk kardiovaskulær og cerebrovaskulær sygdom medføre myokardieinfarkt eller stroke.
English: In clinical trials with losartan potassium salt and hydrochlorothiazide, no adverse events peculiar to this combination of substances were observed.
Danish: Der er i kliniske undersøgelser med losartankalium-hydrochlorthiazid ikke observeret bivirkninger specielt associeret til kombinationsbehandlingen.
English: The maximum dose is one tablet of Cozaar Comp 100 mg/25 mg once daily.
Danish: Maksimal daglig dosis er én Cozaar Comp. 100 mg/25 mg tablet én gang dagligt.
English: Renal and urinary disorders Uncommon: Glycosuria, interstitial nephritis, renal dysfunction, renal failure
Danish: Nyrer og urinveje Ikke almindelig: Glukosuri, interstitiel nefritis, renal dysfunktion, nyresvigt.
English: Uncommon: Alopecia, dermatitis, dry skin, erythema, flushing, photosensitivity, pruritus, rash, urticaria, sweating
Danish: Ikke almindelig: Alopeci, dermatitis, tør hud, erythema, flushing, fotosensitivitet, pruritus, udslæt, urticaria, svedtendens.
English: Please also inform your doctor when it is planned to apply iodine contrast media about taking Cozaar Comp.
Danish: Informer også lægen om, at de tager Cozaar Comp., hvis De skal have et jodholdigt kontrastmiddel.
English: Psychiatric disorders Uncommon: Insomnia
Danish: Psykiske forstyrrelser Ikke almindelig: Søvnløshed.
English: Belgium Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B-1180 Brussels
Danish: Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B1180 Bruxelles
English: The efficacy and safety are established for the indication “treatment of essential hypertension in patients whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy”.
Danish: Virkningen og sikkerheden er påvist for indikationen “behandling af essentiel hypertension hos patienter, hvis blodtryk ikke reguleres tilstrækkeligt med hydrochlorthiazid eller losartan som monoterapi”.
English: Uncommon: Anxiety, anxiety disorder, panic disorder, confusion, depression, abnormal dreams, sleep disorder, somnolence, memory impairment
Danish: Ikke almindelig: angst, angstforstyrrelser, panikangst, forvirring, depression, unormale drømme, søvnforstyrrelser, somnolens, hukommelsessvækkelse.
English: • Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
Danish: • Gulsot (gulfarvning af øjne og hud), betændelse i bugspytkirtlen
English: The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin activity and increases aldosterone secretion, with consequent increases in urinary potassium and bicarbonate loss, and decreases in serum potassium.
Danish: Hydrochlorthiazids diuretiske virkning reducerer plamavolumen, øger plasmareninaktiviteten og øger aldosteronsekretionen med deraf følgende stigning i urinkalium og tab af bikarbonat samt fald i serumkalium.
English: • Treatment of hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide.
Danish: • Behandling af hypertension hos patienter, hvis blodtryk ikke reguleres tilstrækkeligt med losartan eller hydrochlorthiazid.
English: Merck Sharp & Dohme Ltd., Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom
Danish: Merck Sharp & Dohme Ltd., Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU, Storbritannien
English: Hepato-biliary disorders Not known: Liver function abnormalities
Danish: Lever og galdeveje Ikke kendt: Abnorm leverfunktion.
English: • Hypersensitivity to losartan, sulphonamide-derived substances (as hydrochlorothiazide) or to any of the excipients
Danish: Overfølsomhed over for losartan, sulfonamid-afledte stoffer (som hydrochlorthiazid) eller over for et eller flere af hjælpestofferne.
English: Losartan and hydrochlorothiazide tablets are not recommended for haemodialysis patients.
Danish: Losartan/hydrochlorthiazid-tabletter bør ikke anvendes til patienter i hæmodialyse.
English: Luxembourg Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B-1180 Brussels, Belgium
Danish: Luxemburg Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B1180 Bruxelles, Belgien
English: • Diarrhoea, abdominal pain, nausea, indigestion,
Danish: • Diarré, mavesmerter, kvalme, fordøjelsesbesvær
English: General disorders and administration site conditions Common: Asthenia, fatigue, chest pain
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig: Asteni, fatigue, smerter i brystet.
English: General disorders and administration site conditions Uncommon: Fever, dizziness
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke almindelig: Feber, svimmelhed.
English: Cozaar Comp is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone.
Danish: Cozaar Comp. er indiceret til behandling af essentiel hypertension hos patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret på losartan eller hydrochlorthiazid alene.
English: Cozaar Comp. and Cozaar Comp Forte (losartan/hydrochlorothiazide) have been included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Danish: Cozaar Comp. og Cozaar Comp Forte (losartan/hydrochlorthiazid) er blevet medtaget på listen over produkter, hvis produktresuméer skal harmoniseres.
English: Angiooedema
Danish: Angioødem
English: Dosage adjustment of uricosuric medicinal products may be necessary since hydrochlorothiazide may raise the level of serum uric acid.
Danish: Lægemidler til behandling af arthritis urica (probenecid, sulfinpyrazon og aalopurinol) Dosisjustering af urikosuriske lægemidler kan være nødvendig, da hydrochlorthiazid kan øge koncentrationen af serumurinsyre.
English: The maximum daily dose is 2 tablets per day of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets
Danish: Den højeste daglige dosis er 2 tabletter af losartan/hydrochlorthiazid 50 mg/12,5 mg filmovertrukne tabletter eller 1 tablet dagligt af losartan/hydrochlorthiazid 100 mg/25 mg filmovertrukne tabletter.
English: LIST OF EXCIPIENTS Lactose-monohydrate.
Danish: LISTE OVER HJÆLPESTOFFER Lactosemonohydrat.
English: • Pins and needles or similar sensations, pain in the extremities, trembling, migraine, fainting,
Danish: • Stikken og prikken eller lignende fornemmelser, smerter i arme og ben, rysten, migræne, besvimelse
English: • if you have heart failure
Danish: • hvis De har nedsat hjertefunktion
English: Uncommon: Agranulocytosis, aplastic anaemia, haemolytic anaemia, leukopenia, purpura, thrombocytopenia
Danish: Ikke almindelig: Agranulocytose, aplastisk anæmi, hæmolytisk anæmi, leukopeni, purpura, trombocytopeni.
English: The usual maintenance dose of Cozaar Comp is one tablet of Cozaar Comp 50 mg/12.5 mg (losartan 50 mg/HCTZ 12.5 mg) once daily.
Danish: Normal vedligeholdelsesdosis for Cozaar Comp. er én Cozaar Comp. 50 mg/12,5 mg tablet (losartan 50 mg/hydrochlorthiazid 12,5 mg) én gang dagligt.
English: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, United Kingdom
Danish: Storbritannien Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Storbritannien
English: Luxembourg Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Danish: Luxemburg Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180
English: Marketing Authorisation Holder and Manufacturer <To be completed nationally>
Danish: Indehaveren af markedsføringstilladelsen Fremstiller <Udfyldes nationalt>
English: • Insomnia, headache, dizziness,
Danish: • Søvnløshed, hovedpine, svimmelhed
English: • Hives, itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss,
Danish: • Nældefeber, kløe, betændelse i huden, udslæt, rødme af huden, lysfølsomhed, tør hud, rødmen, svedtendens, hårtab
English: Immune system disorders Rare:
Danish: Immunsystemet Sjælden: Anafylaktisk reaktion.
English: This can be increased to 2 tablets once daily of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or changed to 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets (a stronger strength) per day.
Danish: Dosis kan øges til 2 tabletter af losartan/hydrochlorthiazid 50 mg/12,5 mg filmovertrukne tabletter én gang dagligt, eller dosis kan ændres til 1 tablet af losartan/hydrochlorthiazid 100 mg/25 mg filmovertrukne tabletter (en højere styrke) pr. dag.
English: Losartan-Hydrochlorothiazide
Danish: Losartan-hydrochlorthiazid
English: Belgium Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Danish: Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180
English: What Cozaar Comp contains
Danish: Cozaar Comp. indeholder
English: • Muscle pain or cramps, leg pain, back pain,
Danish: • Muskelsmerter eller muskelkramper, smerter i benene, rygsmerter
English: Further, as a result of its diuretic effect, hydrochlorothiazide increases plasma renin activity, increases aldosterone secretion, decreases serum potassium, and increases the levels of angiotensin II.
Danish: Som resultat af den diuretiske virkning af hydrochlorthiazid øges plasmareninaktiviteten og aldosteronsekretionen, serumkalium falder, og koncentrationen af angiotensin-II reduceres.
English: Angiotensin II binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart)
Danish: Angiotensin-II bindes til den AT1-receptor, som findes i mange væv (f.eks. vaskulær glat muskulatur, binyrerne, nyrerne og hjertet), og frembringer mange betydningsfulde biologiske reaktioner, herunder vasokonstriktion og frigørelse af aldosteron.
English: Metabolism and nutrition disorders Uncommon: Anorexia, gout
Danish: Metabolisme og ernæring Ikke almindelig: Anoreksi, arthritis urica.
English: - Treatment of essential hypertension in patients whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy
Danish: - Behandling af essentiel hypertension hos patienter, hvis blodtryk ikke reguleres tilstrækkeligt med hydrochlorthiazid eller losartan som monoterapi
English: Uncommon: Transient blurred vision, xanthopsia Vascular disorders
Danish: Øjne Ikke almindelig: Forbigående sløret syn, xantopsi.
English: Merck Sharp & Dohme GmbH Donau-City-Straße 6
Danish: Merck Sharp & Dohme GmbH Donau-City-Straße 6, 1220 Wien Østrig
English: Film coated tablets
Danish: Filmovertrukken tablets
English: Cozaar Comp 50 mg/12.5 mg Each tablet contains 63.13 mg lactose monohydrate.
Danish: Cozaar Comp. 50 mg/12,5 mg Hver tablet indeholder 63,13 mg lactosemonohydrat.
English: PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 100 filmovertrukne tabletter
English: Cozaar Comp 100 mg/25 mg Each tablet contains 126.26 mg lactose monohydrate.
Danish: Cozaar Comp. 100 mg/25 mg Hver tablet indeholder 126,26 mg lactosemonohydrat.
English: Cozaar Comp 100 mg/12.5 mg also contain: white color concentrate [or the individual ingredients of the concentrate: hydroxypropyl cellulose (E463), hypromellose (E464) and titanium dioxide (E171)] and carnauba wax (E903).
Danish: Cozaar Comp. 100 mg/12,5 mg indeholder også: Hvidt farvekoncentrat [eller de enkelte indholdsstoffer i koncentratet: Hydroxypropylcellulose (E463), hypromellose (E464) og titandioxid (E171)] samt carnaubavoks (E903).
English: You must not take Cozaar Comp if you are breast-feeding.
Danish: De må ikke tage Cozaar Comp., hvis De ammer.
English: • if you have had gout
Danish: • hvis De har urinsur gigt
English: Cozaar Comp tablets should be swallowed with a glass of water Cozaar Comp may be administered with or without food.
Danish: Cozaar Comp. kan administreres med eller uden mad.
English: Cozaar Comp 50 mg/12.5 mg, Cozaar Comp 100 mg/25 mg:
Danish: Cozaar Comp. 50 mg/12,5 mg, Cozaar Comp. 100 mg/12,5 mg, Cozaar Comp. 100 mg/25 mg:
English: PHARMACEUTICAL FORM AND CONTENTS 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 film-coated tablets.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 eller 280 filmovertrukne tabletter.
English: Cozaar Comp 100 mg/12.5 mg Each tablet contains 88.40 mg lactose monohydrate.
Danish: Cozaar Comp. 100 mg/12,5 mg Hver tablet indeholder 88,40 mg lactosemonohydrat.
English: Common: Headache, dizziness
Danish: Almindelig: Hovedpine, svimmelhed.
English: Musculoskeletal and connective tissue disorders Common: Muscle cramp, back pain, leg pain, myalgia Uncommon: Arm pain, joint swelling, knee pain, musculoskeletal pain, shoulder pain, stiffness, arthralgia, arthritis, coxalgia, fibromyalgia, muscle weakness
Danish: Ikke almindelig: Smerter i armene, ledhævelse, smerter i knæene, knogle-, led- og muskelsmerter, skuldersmerter, stivhed, arthralgi, arthritis, koksalgi, fibromyalgi, muskelsvaghed.
English: The diuretic action of HCTZ reduces plasma volume, with consequent increase in plasma renin activity, increase in adolsterone secretion, increase in urinary K+ and HCO-3 loss, and decrease in plasma K+.
Danish: Den diuretiske virkning af hydrochlorthiazid reducerer plasmavolumenet med deraf følgende stigning i plasmareninaktiviteten, stigning i adolsteronudskillelsen, stigning i urinkalium og bikarbonattab samt fald i plasmakalium.
English: Losartan is an orally active angiotensin II (Ang- II) receptor antagonist acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade.
Danish: Losartan er en oralt aktiv angiotensin II-receptorantagonist, der påvirker AT1-receptor-undertypen.
English: • Constipation, wind, stomach upsets, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
Danish: • Forstoppelse, luftafgang fra tarmen, mavegener, mavekramper, opkastning, tør mund, betændelse i spytkirtlen, tandpine
English: • if you have ‘aortic or mitral valve stenosis' (narrowing of the valves of the heart) or
Danish: • hvis De har "aorta- eller mitralklapstenose" (forsnævring af hjerteklapperne) eller "hypertrofisk kardiomyopati" (en sygdom der medfører fortykkelse af hjertemusklen)
English: Hyzaar Forte 100/25 mg 100 mg losartan potassium25 mg hydrochlorothiazide
Danish: Hyzaar Forte 100/25 mg 100 mg losartankalium25 mg hydrochlorthiazid
English: PHARMACEUTICAL FORM AND CONTENTS 14, 15, 28, 30, 50, 56, 84, 90, 98, or 280 film coated-tablets.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 14, 15, 28, 30, 50, 56, 84, 90, 98 eller 280 filmovertrukne tabletter.
English: Gastrointestinal disorders Uncommon: Sialoadenitis, spasms, stomach irritation, nausea, vomiting, diarrhoea, constipation
Danish: Mave-tarmkanalen Ikke almindelig: Sialoadenitis, spasmer, maveirritation, kvalme, opkastning, diarré, forstoppelse.
English: PHARMACEUTICAL FORM AND CONTENTS 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7, 14, 28, 30, 50, 56, 84, 90, 98 eller 280 filmovertrukne tabletter.
English: Take special care with Cozaar Comp • if you have previously suffered from swelling of the face, lips, throat or tongue
Danish: • hvis De tidligere har haft hævelse af ansigt, læber, svælg eller tunge
English: Uncommon: Facial oedema, fever
Danish: Ikke almindellig: Faciale ødemer, feber.
English: COZAAR COMP film-coated Tablets losartan potassium and hydrochlorothiazide
Danish: COZAAR COMP. filmovertrukne tabletter losartankalium og hydrochlorthiazid
English: Cozaar Comp 50 mg/12.5 mg and Cozaar Comp 100 mg/25 mg also contain titanium dioxide (E171), quinoline yellow aluminum lake (E104) and carnauba wax (E903).
Danish: Cozaar Comp. 50 mg/12,5 mg og Cozaar Comp. 100 mg/25 mg indeholder også titandioxid (E171), quinolingult (E104) og carnaubavoks (E903).
English: Cozaar Comp 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.
Danish: Cozaar Comp. 50 mg/12,5 mg indeholder 4,24 mg (0,108 mEq) kalium.
English: Cozaar Comp 50 mg/12.5 mg> contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Danish: Cozaar Comp. 50 mg/12,5 mg indeholder 50 mg losartankalium og 12,5 mg hydrochlorthiazid som aktive indholdsstoffer.
English: Cozaar Comp 100 mg/25 mg> contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.
Danish: Cozaar Comp. 100 mg/25 mg indeholder 100 mg losartankalium og 25 mg hydrochlorthiazid som aktive indholdsstoffer.
English: The CHMP concluded that the indication for the initial therapy of hypertension with the fixed dose combination (FDC) does not have a positive benefit-risk ratio, and therefore is not acceptable.
Danish: CHMP fandt, at der ikke var et positivt benefit/risk-forhold for indikationen for initial behandling af hypertension med fastdosiskombinationen.
English: • Refractory hyponatraemia
Danish: Refraktær hyponatriæmi.
English: FORTZAAR® 100/25 mg, comprimate filmate
Danish: FORTZAAR® 100 mg/25 mg, comprimate filmate
English: Renal and urinary disorders Uncommon: Nocturia, urinary frequency, urinary tract infection
Danish: Nyrer og urinveje Ikke almindelig: Nykturi, hyppig vandladning, urinvejsinfektion.
English: Each tablet contains 100 mg of losartan (as potassium salt) and 25 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Danish: Hver tablet indeholder 100 mg losartan (som kaliumsalt) og 25 mg hydrochlorthiazid som de aktive indholdsstoffer.
English: Cozaar Comp 100 mg/12.5 mg mg and Cozaar Comp 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium.
Danish: Cozaar Comp. 100 mg/12,5 mg og Cozaar Comp. 100 mg/25 mg indeholder 8,48 mg (0,216 mEq) kalium.
English: • if you take diuretics (water pills)
Danish: • hvis De tager vanddrivende medicin
English: Cozaar Comp 100 mg/25 mg also contain:, Titanium dioxide (E171), Quinoline yellow aluminum lake (E104), and Carnauba wax (E903)
Danish: Cozaar Comp. 100 mg/25 mg indeholder også: Titandioxid (E171), quinolingult (E104) og carnaubavoks (E903).
English: Cozaar Comp100 mg/12.5 mg mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Danish: Cozaar Comp. 100 mg/12,5 mg indeholder 100 mg losartankalium og 12,5 mg hydrochlorthiazid som aktive indholdsstoffer.
English: Cozaar Comp is contraindicated for patients with severe hepatic impairment (see section 4.3 and
Danish: Cozaar Comp. bør ikke anvendes til patienter med svær leverinsufficiens (se pkt.
English: Each tablet contains 50 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Danish: Hver tablet indeholder 50 mg losartan (som kaliumsalt) og 12,5 mg hydrochlorthiazid som de aktive indholdsstoffer.
English: Each tablet contains 100 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Danish: Hver tablet indeholder 100 mg losartan (som kaliumsalt) og 12,5 mg hydrochlorthiazid som de aktive indholdsstoffer.
English: • Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder,
Danish: Almindelig: Hoste, øvre luftvejsinfektion, stoppet næse, sinuitis, sinuslidelser.
English: and Cozaar Comp 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.
Danish: Og Cozaar Comp. 100 mg/25 mg indeholder 8,48 mg (0,216 mEq) kalium.
English: Forte
Danish: Hjerte
English: 6.6 Special precautions for disposal <and other handling> No special requirements.
Danish: 6.6 Regler for destruktion og anden håndtering
English: FORTZAAR (Losartan/Hydrochlorothiazide)
Danish: FORTZAAR (Losartan/Hydrochlorthiazide)
English: Cozaar Comp 100 mg/25 mg is supplied as unscored film-coated tablets.
Danish: Cozaar Comp. 100 mg/25 mg fås som filmovertrukne tabletter uden delekærv.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar Comp 100 mg/25 mg film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar Comp. 100 mg/25 mg filmovertrukne tabletter
English: the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Cozaar Comp. and associated names (see Annex I).
Danish: - Graviditet og amning skal kontraindiceres, og den relevante ordlyd skal inkluderes i afsnit 4.3, 4.4 og 4.6 i produktresuméet samt i de relevante afsnit af indlægssedlen anbefaler CHMP ændring af den/de markedsføringstilladelse(r), hvis produktresuméer, etikettering og indlægsseddel er anført i bilag III til Cozaar Comp. og tilknyttede navne (se bilag I).
English: Hungary Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
Danish: Merck Sharp & Dohme Hungary Ltd
English: NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/25 mg Losartan and hydrochlorothiazide
Danish: LÆGEMIDLETS NAVN Cozaar Comp. 100 mg/25 mg Losartan og hydrochlorthiazid
English: COZAAR-Comp 100 mg/12.5 mg Filmcoated tablets
Danish: COZAAR-Comp 100 mg/12.5 mg Film-coated tablets
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar Comp 50 mg/12.5 mg film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar Comp. 50 mg/12,5 mg filmovertrukne tabletter
English: Common: Abdominal pain, nausea, diarrhoea, dyspepsia Uncommon: Constipation, dental pain, dry mouth, flatulence, gastritis, vomiting
Danish: Ikke almindelig: Konstipation, tandsmerter, tør mund, flatulens, gastritis, opkastning.
English: Hydrochlorothiazide has been shown to cause modest increases in uric acid; the combination of losartan and hydrochlorothiazide tends to attenuate the diuretic-induced hyperuricemia.
Danish: Kombinationen af losartan og hydrochlorthiazid kan have tilbøjelighed til at dæmpe diuretikainduceret hyperurikæmi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 100 mg losartan og 25 mg hydrochlorthiazid.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar Comp 100 mg/12.5 mg film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar Comp. 100 mg/12,5 mg filmovertrukne tabletter
English: Cosaar Plus - Filmtabletten 50 mg losartan potassium12.5 mg hydrochlorothiazide
Danish: Cosaar Plus - Filmtabletten 50 mg losartankalium