FrancophonIA/ELRC3.0 huggingface dataset:
English: Tekturna has negligible influence on the ability to drive and use machines.
Danish: Tekturna har en ubetydelig indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: Therefore, caution should be exercised when aliskiren is administered with ketoconazole or other moderate pgp inhibitors (itraconazol, clarithromycin, telithromycin, erythromycin, amiodarone).
Danish: Der skal derfor udvises forsigtighed, hvis aliskiren gives sammen ketoconazol eller andre moderate P-gp-hæmmere (itraconazol, clarithromycin, telithromycin, erythromycin, amiodaron).
English: Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Tekturna.
Danish: Inducere af P-gp (prikbladet perikum, rifampicin) kan derfor nedsætte biotilgængeligheden af Tekturna.
English: Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate, ramipril and hydrochlorothiazide.
Danish: Stoffer, som er undersøgt i kliniske farmakokinetiske studier inkluderer acenocoumarol, atenolol, celecoxib, pioglitazon, allopurinol, isosorbid-5-mononitrat, ramipril og hydrochlortiazid.
English: Co-administration of aliskiren with either valsartan (↓28%), metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of Tekturna.
Danish: Samtidig administration af aliskiren med enten valsartan (↓28 %), metformin (↓28 %), amlodipin (↑29 %) eller cimetidin (↑19 %) resulterede i en ændring af Cmax eller AUC for Tekturna på mellem 20 % og 30 %.
English: P-gp substrates or weak inhibitors
Danish: P-gp-substrater eller svage hæmmere
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: ke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: In the event of any signs suggesting an allergic reaction (in particular difficulties in breathing, or swallowing, or swelling of the face, extremities, eyes, lips and/or tongue) patients should discontinue treatment and contact the physician (see section 4.4).
Danish: I tilfælde af tegn tydende på en allergisk reaktion (særligt besvær med vejrtrækning eller synkning, hævelse i ansigtet, ekstremiteterne, øjne, læber og/eller tunge), bør atienten afbryde behandlingen og kontakte lægen (se pkt.
English: The recommended dose of Tekturna is 150 mg once daily.
Danish: Den anbefalede dosis af Tekturna er 150 mg én gang dagligt.
English: In diabetic hypertensive patients, Tekturna monotherapy was safe and effective.
Danish: Hos hypertensive patienter med diabetes var monoterapi med ekturna både sikker og effektiv.
English: In controlled clinical trials, angioedema occurred rarely during treatment with Tekturna with rates comparable to treatment with placebo or hydrochlorothiazide.
Danish: I kontrollerede kliniske studier forekom angioødem sjældent under behandling med Tekturna, og havde sammenlignelig hyppighed med placebo eller hydrochlorthiazid.
English: Rare (affecting less than 1 in 1,000 patients): Angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).
Danish: Sjældne bivirkninger (forekommer hos mellem 1 og 10 ud af 10.000 patienter): Angioødem (besvær med at trække vejret eller med at synke eller hævet ansigt, hænder og fødder, øjenomgivelser, læber og/eller tunge).
English: Compared to a diuretic (hydrochlorothiazide - HCTZ), Tekturna 300 mg lowered systolic/diastolic blood pressure by 17.0/12.3 mmHg, compared to 14.4/10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Danish: Sammenlignet med et diuretikum (hydrochlortiazid - HCTZ) sænkede Tekturna 300 mg det systoliske/diastoliske blodtryk med 17,0/12,3 mmHg sammenlignet med 14,4/10,5 mmHg for HCTZ 25 mg efter 12 ugers behandling.
English: Δημητριάδης και Παπαέλληνας Λτδ Τηλ: +357 22 690 690
Danish: έλληνας Λτδ ηλ: +357 22 690 690
English: If pregnancy is detected during therapy, Tekturna should be discontinued accordingly.
Danish: Hvis der opstår graviditet under behandlingen, skal Tekturna seponeres som konsekvens heraf.
English: Patients receiving other medicinal products inhibiting the renin-angiotensin system (RAS), and/or those with reduced kidney function and/or diabetes mellitus are at an increased risk of hyperkalaemia during aliskiren therapy.
Danish: Patienter, som anvender andre lægemidler der hæmmer renin-angiotensin systemet (RAS), og/eller har nedsat nyrefunktion og/eller diabetes mellitus har en øget risiko for hyperkalæmi under behandling med aliskiren.
English: Novartis (Hellas) A.E.B.E.
Danish: Novartis (Hellas) A.E.B.E Τ
English: Yet, P-gp inhibitors are expected to increase tissue concentrations more than plasma concentrations.
Danish: Alligevel forventes det, at P-gp-hæmmere øger vævskoncentrationerne mere end plasmakoncentrationerne.
English: Hypromellose Macrogol
Danish: Silica, kolloid vandfri Hypromellose Macrogol
English: In a 6-month study of 599 patients with hypertension, type 2 diabetes mellitus, and nephropathy, all of whom were receiving losartan 100 mg and optimised antihypertensive background therapy, addition of Tekturna 300 mg achieved a 20% reduction versus placebo in urinary albumin:creatinine ratio (UACR), i.e. from 58 mg/mmol to 46 mg/mmol.
Danish: I et 6 måneders studie med 599 hypertensionspatienter med type 2 diabetes mellitus og nefropati, der alle fik 100 mg losartan sammen med optimal antihypertensiv standardbehandling, opnåede ved tillæ af Tekturna 300 mg en 20 % reduktion i forhold til placebo i urin-albumin-kreatininforholdet (UACR), dvs. fra 58 mg/mmol til 46 mg/mmol.
English: Common (affecting less than 1 in 10 patients): Diarrhoea.
Danish: Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 patienter): Diarré.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON TIL MULTPAKNING (INKLUSIV BLUE BOX)
English: microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171),
Danish: mikrokrystallinsk cellulose, povidon, kolloid vandfri silica, talcum, titandioxid (E171), sort
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Tekturna til dig personligt.
English: In clinical studies Tekturna has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated glomerular filtration rate (GFR) < 30 ml/min), history of dialysis, nephrotic syndrome or renovascular hypertension.
Danish: Tekturna er ikke undersøgt i kliniske studier med hypertensive patienter, der har svært nedsat nyrefunktion (serumkreatinin ≥ 150 μmol/l eller 1,70 mg/dl hos kvinder og ≥ 177 μmol/l eller 2,00 mg/dl hos mænd og/eller estimeret glomerulær filtrationsrate (GFR) < 30 ml/min.
English: No effect on QT interval was reported in a randomised, double-blind, placebo, and active-controlled study using standard and Holter electrocardiography.
Danish: Kardiel elektrofysiologi ngen effekt på QT-intervallet blev rapporteret i et randomiseret, dobbeltblin det, placebo og aktivt kontrolleret studie ved anvendelse af standard og Holter elektrokardiografi.
English: Tekturna did not affect the serum concentration of creatinine but was associated with an increased frequency (4.2% vs. 1.9% for placebo) of serum potassium concentration ≥6.0 mmol/l, although this was not statistically significant.
Danish: Tekturna påvirked øget frekvens (4,2 % vs. 1,9 % for placebo) af serum-kaliumkoncentrationen ≥ 6,0 mmol, selvom det ikke var statistisk signifikant.
English: Tekturna induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide and to ramipril.
Danish: Tekturna inducerede en additiv blodtrykssænkende virkning ved kombination med hydrochlorthiazid og ramipril.
English: The concomitant use of aliskiren with ciclosporin, a highly potent P-gp inhibitor, and other potent Pgp inhibitors (quinidine, verapamil), is contraindicated (see section 4.5).
Danish: Brug af aliskiren sammen med ciclosporin, en yderst potent P-gp-hæmmer, og andre potente P-gphæmmere (quinidin, verapamil) er kontraindiceret (se pkt.
English: Co-administration of aliskiren 300 mg with ketoconazole 200 mg resulted in a 76% increase in aliskiren AUC but P-gp inhibitors such as ketoconazole are expected to increase tissue concentrations more than plasma concentrations.
Danish: Samtidig administration af aliskiren 300 mg og ketoconazol 200 mg resulterede i en 76 % stigning i aliskirens AUC, men P-gp-hæmmere som ketoconazol kan forventes at øge vævskoncentrationerne mere end plasmakoncentrationerne.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL DELPAKNING (UDEN BLUE BOX)
English: Reducing the amount of angiotensin II allows the blood vessels to relax, which lowers blood pressure.
Danish: Når mængden af ngiotensin-II mindskes, kan blodkarrene slappe af, og det sænker blodtrykket.
English: The usual starting dose is one 150 mg tablet once daily.
Danish: fø Startdosis er normalt en tablet på 150 mg én gang daglig.
English: Tekturna should be taken with a light meal once a day, preferably at the same time each day.
Danish: Tekturna bør tages med et let måltid mad én gang daglig, fortrinsvis på samme tidspunkt hver dag.
English: Not all pack sizes may be marketed.
Danish: P kke alle pakningsstørrelser er nødvendigvis markedsført.
English: In hypertensive patients, once-daily administration of Tekturna at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Danish: Hos hypertensive patienter gav administration af Tekturna en gang dagligt i doser på 150 mg og 300 mg dosisafhængige reduktioner i både det systoliske og det diastoliske blodtryk, som blev opretholdt over hele dosisintervallet på 24 timer (med vedvarende gavnlig virkning tidligt om morgenen) med en gennemsnitlig peak/trough ratio for diastolisk respons på op til 98 % for 300-mgdosen.
English: EXPIRY DATE
Danish: UDLØBSDATO dløbsdato
English: Vistor hf. ími: +354 535 7000
Danish: Sími: +354 535 7000
English: Based on experience with the use of other substances that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other substances that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium.
Danish: Baseret på erfaringer med andre stoffer, som påvirker renin-angiotensin-systemet kan samtidig brug af kaliumbesparende diuretika, kaliumtilskud, kaliumholdige salterstatninger eller andre stoffer, som kan øge koncentrationen af kalium i serum (f.eks. heparin), føre til øget serumkalium.
English: Combination therapy studies are available for Tekturna added to the diuretic hydrochlorothiazide, the ACEI ramipril, the calcium channel blocker amlodipine, the angiotensin receptor antagonist valsartan, and the beta blocker atenolol.
Danish: Der er undersøgelser af kombinationsbehandling tilgængelige hvor Tekturna er kombineret med diuretikaet hydrochlorthiazid, ACE-hæmmeren ramipril, calciumkanal-blokkeren amlodipin og angiotensinreceptor-antogonisten valsartan og betablokeren atenolol.
English: Therefore caution should be exercised when aliskiren is administered with moderate P-gp inhibitors such as ketoconazole (see section 4.5).
Danish: Der skal derfor udvises forsigtighed, hvis aliskiren gives sammen med moderate P-gp-hæmmere som ketoconazol (se pkt.
English: Novartis Healthcare A/S Tlf: +45 39 16 84 00
Danish: Novartis Healthcare A Tlf: +45 39 16 84 00
English: B-type natriuretic peptide (BNP) levels were reduced by 25% in the Tekturna arm compared to placebo.
Danish: Type B natriuretisk peptid (BNP)niveauet blev nedsat med 25 % i Tektu af denne reduktion er dog ikke kendt.
English: Co-administration of ketoconazole (200 mg) with aliskiren (300 mg) resulted in an 80% increase in plasma levels of aliskiren (AUC and Cmax).
Danish: Administration af ketoconazol (200 mg) sammen med aliskiren (300 mg) resulterede i en 80 % stigning af plasmaniveauerne for aliskiren (AUC og Cmax).
English: Therefore as with any agent acting on the RAS system, routine monitoring of electrolytes and renal function is indicated in patients with diabetes mellitus, kidney disease, or heart failure.
Danish: Derfor er rutinemæssig monitorering af elektrolytter og nyrefunktion som ved andre stoffer, der virker på RAS-systemet, indiceret i patienter med diabetes mellitus, nyresygdom eller hjertesvigt.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: If you take more Tekturna than you should
Danish: Hvis du har taget for meget Tekturna
English: What Tekturna contains - The active substance is aliskiren (as hemifumarate) 300 mg. - The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol,
Danish: Tekturna indeholder - Aktivt stof: aliskiren (som hemifumarat) 300 mg. - Øvrige indholdsstoffer: crospovidon, hypromellose, magnesiumstearat, macrogol,
English: Linearity/non-linearity Exposure to aliskiren increased more than in proportion to the increase in dose.
Danish: Eksponeringen med aliskiren øgedes mere end proportionelt sammenlignet med stigningen i dosis.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/408/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/07/408/007
English: Tekturna monotherapy studies have shown blood pressure lowering effects comparable to other classes of antihypertensive agents including ACEI and ARB.
Danish: Undersøgelser af Tekturna-monoterapi har vist en blodtrykssænkende effekt, som er sammenlignelig med andre klasser af antihypertensiva, herunder ACE-hæmmere og angiotension-II-antagonister.
English: Coadministration of Tekturna had no significant impact on atorvastatin, valsartan, metformin or amlodipine pharmacokinetics.
Danish: Samtidig administration af Tekturna havde ingen signifikant indvirkning på atorvastatins, valsartans, metformins eller amlodipins farmakokinetik.
English: What Tekturna contains - The active substance is aliskiren (as hemifumarate) 150 mg. - The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol,
Danish: Tekturna indeholder - Aktivt stof: aliskiren (som hemifumarat) 150 mg. - Øvrige indholdsstoffer: crospovidon, hypromellose, magnesiumstearat, macrogol,
English: No adjustment of the initial dosage of Tekturna is required in patients with mild to severe renal impairment, however caution should be exercised in patients with severe renal impairment.
Danish: Det er ikke nødvendigt at justere initialdosen af Tekturna hos patienter med mildt til svært nedsat nyrefunktion, men der skal udvises forsigtighed hos patienter med svært nedsat nyrefunktion.
English: In diabetic hypertensive patients, Tekturna provided additive blood pressure reductions when added to ramipril, while the combination of Tekturna and ramipril had a lower incidence of cough (1.8%) than ramipril (4.7%).
Danish: Hos hypertensive patienter med kombination af Tekturna og ramipril havde en lavere incidens af hoste (1,8 %) end ramipril (4,7 %).
English: As with other agents acting on the renin-angiotensin system, angioedema has been reported in patients treated with aliskiren.
Danish: Som ved andre stoffer, der virker på renin-angiotensin-systemet, er angioødem blevet rapporteret hos patienter, som behandles med aliskiren.
English: - if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis) or verapamil (a medicine used to lower blood pressure, to correct hearth rhythm or to treat angina pectoris) or quinidine (a medicine used to correct heart rhythm).
Danish: hvis du tager ciclosporin (medicin, der bruges til organtransplantatio n for at undgå afstødning af handle angina pectoris) eller quinidin (medicin, som bruges til at korrigere hjerterytmen).
English: In clinical studies in hypertensive patients, Tekturna had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Danish: I kliniske studier af hypertensive patienter havde Tekturna ingen klinisk signifikant virkning på total kolesterol, HDL-kolesterol, fastende triglycerider, fa
English: Medicinal product subject to medical prescription.
Danish: Lægemidlet må kun udleveres efter recept
English: You should take Tekturna with a light meal once a day, preferably at the same time each day.
Danish: Du bør tage Tekturna sammen med et let måltid mad, én gang daglig, fortrinsvis på samme tidspunkt hver dag.
English: In patients with marked volume- and/or salt-depletion (e.g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Tekturna.
Danish: Symptomatisk hypotension kan forekomme hos patienter med markant væske- og/eller natriummange (f.eks. patienter, som får høje doser af diuretika) efter initiering af behandling med Tekturna.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Tekturna, skal du henvende dig til den lokale repræsentant:
English: The incidence of cough was similar in placebo (0.6%) and Tekturna treated (0.9%) patients.
Danish: For patienter, der blev behandlet med placebo (0,6 %) svarede incidensen af hoste til incidensen for patienter, der blev behandlet med Tekturna (0,9 %).
English: In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Tekturna 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
Danish: Hos patienter, som ikke responderede tilstrækkeligt på 5 mg af calciumantagonisten amlodipin, havde kombinationen med Tekturna 150 mg en blodtrykssænkende virkning, som svarede til den opnåede virkning ved at amlodipindosen blev øget til 10 mg, men med en lavere incidens af ødem (aliskiren 150 mg/amlodipin 5 mg 2,1 % kontra amlodipin 10 mg 11,2 %).
English: Tekturna is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Danish: Tekturna er tilgængelig i pakninger, der indeholder 7, 14, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter.
English: When administered with atorvastatin, steady-state Tekturna AUC and Cmax increased by 50%.
Danish: Ved samtidig administration med atorvastatin steg AUC og Cmax for Tekturna ved steady state med 50 %.
English: A single dose drug interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold.
Danish: Et interaktionsforsøg med raske frivillige personer, hvor dosis blev administreret en gang, har vist, at ciclosporin (200 og 600 mg) øger Cmax af aliskiren 75 mg cirka 2,5 gange og AUC cirka 5 gange.
English: INFORMATION IN BRAILLE Tekturna 300 mg
Danish: Tekturna 300 mg
English: Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Danish: Portugal os Farmacêuticos, S.A. Novartis Farma - Produt Tel: +351 21 000 8600
English: In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Tekturna 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
Danish: Hos adipøse patienter med utilstrækkelig respons på HCTZ 25 mg gav tillægsbehandling med Tekturna 300 mg en yderligere blodtryksnedsættende effekt, som var sammenlignelig med tillægsbehandling af irbesartan 300 mg eller amlodipin 10 mg.
English: Novartis Pharma Services Inc. Tel: +40 21 31299 01
Danish: Novartis Pharma Servi Tel: +40 21 31299 01
English: As for any medicine that acts directly on the RAS, Tekturna should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Danish: Tekturna bør, som andre præparater, der virker direkte på RAS, ikke anvendes under 1. trimester i graviditeten (se pkt.
English: - if you have already experienced angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue) when taking aliskiren.
Danish: - hvis du på et tidspunkt har haft svært ved at trække vejret eller at synke eller har haft hævet ansigt, hænder og fødder, øjenomgivelser, læber og/eller tunge (angioødem), når du har taget
English: If co-medication is considered necessary, caution is advisable.
Danish: Der bør udvises forsigtighed, hvis samtidig medicinering betragtes som nødvendig.
English: This effect is also seen with other agents acting on the reninangiotensin system, such as angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers.
Danish: Denne virkning ses også med andre stoffer, som virker på renin-angiotensin-systemet, f.eks. ACE-hæmmere og angiotensin-II-antagonister.
English: With cessation of treatment, blood pressure gradually returned towards baseline levels over a period of several weeks, with no evidence of a rebound effect for blood pressure or PRA.
Danish: ør basisniveauet over flere uger, og der var gen tegn på reboundeffekt for blodtrykket eller PRA.
English: INFORMATION IN BRAILLE Tekturna 150 mg
Danish: Tekturna 150 mg
English: Take special care with Tekturna - if you are taking a diuretic (a type of medicine also known as “water” tablets which increases the amount of urine you produce).
Danish: et diuretikum (kaldes også vanddrivende tabletter, som øger den mængde urin, du - hvis du har nedsat nyrefunktion.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Danish: ig (pharmacovigilance er risikominimerings) milepæl er nået.
English: Uncommon (affecting less than 1 in 100 patients): Skin rash.
Danish: Ikke almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 1.000 patienter): Hududslæt.
English: The change in plasma levels of aliskiren in the presence of ketoconazole is expected to be within the range that would be achieved if the dose of aliskiren were doubled; aliskiren doses of up to 600 mg, or twice the highest recommended therapeutic dose, have been found to be well tolerated in controlled clinical trials.
Danish: Aliskirendoser på op til 600 mg eller det dobbelte af den højeste anbefalede terapeutiske dosis er fundet at være veltolererede i kontrollerede kliniske forsøg.
English: Packs containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets are multi-packs.
Danish: Pakninger, der indeholder 84 (3x28), 90 (3x30), 98 (2x49) eller 280 (20x14) tabletter er multipakninger.
English: Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of Tekturna.
Danish: Du skal sørge for at finde ud af, hvordan du reagerer på Tekturna, før du kører bil, betjener maskiner eller udfører andre a ag altid Tekturna nøjagtigt efter lægens anvisning.
English: Treatment with Tekturna resulted in an overall incidence of adverse reactions similar to placebo up to 300 mg.
Danish: Behandling med Tekturna udviste en samlet incidens af bivirkninger svarende til placebo for behandling med op til 300 mg. Bivirkningerne var generelt milde og forbigående og det har kun sjældent været nødvendigt at seponere behandlingen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX FOR UNIT PACK
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL ENKELTPAKNING