FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore caution should be exercised when aliskiren is administered with moderate P-gp inhibitors such as ketoconazole or verapamil (see section
Danish: Der skal derfor udvises forsigtighed, hvis aliskiren gives sammen med moderate P-gp-hæmmere som ketoconazol eller verapamil (se pkt.
English: In healthy subjects, itraconazole (100 mg) increases AUC and Cmax of aliskiren (150 mg) by 6.5-fold and 5.8-fold, respectively.
Danish: Hos raske personer øger itraconazol (100 mg) AUC og Cmax af aliskiren (150 mg) henholdsvis 6,5 gange og 5,8 gange.
English: Medicinal products affecting serum potassium levels Concomitant use of other agents affecting the RAAS, of NSAIDs or of agents that increase serum potassium levels (e.g. potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, heparin) may lead to increases in serum potassium.
Danish: Samtidig brug af andre stoffer, som påvirker RAAS, af NSAID'er eller af stoffer, som øger serumkalium (fx kaliumbesparende diuretika, kaliumtilskud, kaliumholdige salterstatninger, heparin), kan medføre stigning i serumkalium.
English: Haemoglobin and haematocrit: Small decreases in haemoglobin and haematocrit (mean decreases of approximately 0.05 mmol/l and 0.16 volume percent, respectively) were observed.
Danish: Hæmoglobin og hæmatokritværdi: Der blev observeret små fald i hæmoglobin og hæmatokritværdi (gennemsnitligt fald på henholdsvis ca. 0,05 mmol/l og 0,16 volumenprocent).
English: Co-administration of Sprimeo had no significant impact on atorvastatin, metformin or amlodipine pharmacokinetics.
Danish: Samtidig administration af Sprimeo havde ingen signifikant indvirkning på atorvastatins, metformins eller amlodipins farmakokinetik.
English: In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Sprimeo 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 Sprimeo 300 mg en yderligere blodtryksnedsættende effekt, som var sammenlignelig med tillægsbehandling af irbesartan 300 mg eller amlodipin 10 mg.
English: In the event that any signs of renal failure occur, aliskiren should be promptly discontinued.
Danish: Hvis der opstår tegn på nyresvigt, skal aliskirenbehandling afbrydes med det samme.
English: Iron oxide, black (E 172) Iron oxide, red (E 172) Titanium dioxide (E 171)
Danish: Jernoxid, sort (E172) Jernoxid, rød (E172) Titandioxid (E171)
English: Co-administration with aliskiren 150 mg resulted in a 61% decrease in aliskiren AUC and coadministration with aliskiren 300 mg resulted in a 38% decrease in aliskiren AUC.
Danish: Indtagelse sammen med aliskiren 150 mg resulterede i en reduktion i AUC for aliskiren på 61 %, og indtagelse sammen med aliskiren 300 mg resulterede i en reduktion i AUC for aliskiren på 38 %.
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 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: Sprimeo monotherapy studies have shown blood pressure lowering effects comparable to other classes of antihypertensive agents including ACEI and ARB.
Danish: Undersøgelser af Sprimeo-monoterapi har vist en blodtrykssænkende effekt, som er sammenlignelig med andre klasser af antihypertensiva, herunder ACE-hæmmere og angiotension-II-antagonister.
English: Packs containing 56 and 98 (2x49) tablets are perforated unit-dose blisters.
Danish: Pakninger indeholdende 56 og 98 (2x49) tabletter er perforerede enkeltdosisblister.
English: Serum potassium: Increases in serum potassium have been observed with aliskiren and these may be exacerbated by concomitant use of other agents acting on the RAAS or by NSAIDs.
Danish: Serumkalium: Der er set stigning i serumkalium med aliskiren, og den kan blive mere udtalt ved samtidig brug af andre stoffer, som virket på RAAS, eller af NSAID'er.
English: A number of these patients had a history of angioedema or symptoms suggestive of angioedema which in some cases was associated with the administration of other medicines known to cause angioedema, including RAAS blockers (ACE inhibitors or ARBs).
Danish: Et antal af disse patienter havde en anamnese med angioødem eller symptomer, der tydede på angioødem, som i nogle tilfælde havde efterfulgt brug af anden medicin, der er kendt for at forårsage angioødem, inklusive RAAS-blokkere (ACE-hæmmere eller ARB'er).
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 Sprimeo.
Danish: Symptomatisk hypotension kan forekomme hos patienter med markant væske- og/eller natriummangel (f.eks. patienter, som får høje doser af diuretika) efter initiering af behandling med Sprimeo.
English: Characteristics in patients
Danish: Patientkarakteristika
English: A number of these patients had a history of angioedema or symptoms suggestive of angioedema, which in some cases followed use of other medicines that can cause angioedema, including RAAS blockers (angiotensin converting enzyme inhibitors or angiotensin receptor blockers) (see section 4.8).
Danish: Et antal af disse patienter havde en anamnese med angioødem eller symptomer, der tydede på angioødem, som i nogle tilfælde havde efterfulgt brug af anden medicin, der kan forårsage angioødem, inklusive RAAS-blokkere (angiotensin-konverteringsenzym-hæmmere eller angiotensinreceptorblokkere) (se pkt.
English: Cases of angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have also been reported in post-marketing experience.
Danish: Tilfælde af angioødem eller symptomer, som tyder på angioødem (hævet ansigt, læber, svælg og/eller tunge) er også rapporteret efter markedsføring.
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Sprimeo til dig personligt.
English: The increased incidence of non-fatal stroke was greater in patients with renal insufficiency.
Danish: Forekomsten af ikke-letal apopleksi var højere blandt patienter med nyreinsufficiens.
English: The pharmacokinetics of aliskiren were not significantly affected in patients with mild to severe liver disease.
Danish: Aliskirens farmakokinetik blev ikke signifikant påvirket hos patienter med let til svær leversygdom.
English: Film-coated tablet
Danish: Filmovertrukket tablet
English: What Sprimeo contains - The active substance is aliskiren (as hemifumarate) 300 mg. - The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol,
Danish: Sprimeo indeholder - Aktivt stof: aliskiren (som hemifumarat) 300 mg. - Øvrige indholdsstoffer: crospovidon, hypromellose, magnesiumstearat, macrogol,
English: 56 film-coated tablets (perforated unit-dose blister)
Danish: 56 filmovertrukne tabletter (perforeret enkeltdosisblister)
English: Consequently, no adjustment of the initial dose of aliskiren is required in patients with mild to severe hepatic impairment.
Danish: Derfor er justering af initialdosen af aliskiren ikke nødvendig hos patienter med let til svært nedsat leverfunktion.
English: What Sprimeo contains - The active substance is aliskiren (as hemifumarate) 150 mg. - The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol,
Danish: Sprimeo indeholder - Aktivt stof: aliskiren (som hemifumarat) 150 mg. - Øvrige indholdsstoffer: crospovidon, hypromellose, magnesiumstearat, macrogol,
English: or an “angiotensin 2 receptor blocker” such as valsartan, telmisartan, irbesartan etc. - ketoconazole, a medicine used to treat fungal infections.
Danish: eller en ”angiotensin-II receptorblokker”, som fx valsartan, telmisartan, irbesartan osv. - ketoconazol, medicin, der bruges til at behandle svampeinfektioner.
English: Patients with a history of angioedema may be at increased risk of experiencing angioedema during treatment with aliskiren (see sections 4.3 and 4.8).
Danish: Patienter med angioødem i anamnesen kan have forøget risiko for at få angioødem under behandling med aliskiren (se pkt.
English: Common (affecting less than 1 in 10 patients): Diarrhoea, joint pain (arthralgia), high level of potassium in the blood, dizziness.
Danish: Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 patienter): Diarré, ledsmerter, højt indhold af kalium i blodet, svimmelhed.
English: Combination therapy studies are available for Sprimeo added to the diuretic hydrochlorothiazide, the calcium channel blocker amlodipine and the beta blocker atenolol.
Danish: Der er undersøgelser af kombinationsbehandling tilgængelige, hvor Sprimeo er kombineret med diuretikummet hydrochlorthiazid, calciumantagonisten amlodipin og betablokkeren atenolol.
English: Do not breast-feed if you are taking Sprimeo.
Danish: Du må ikke amme, hvis du tager Sprimeo.
English: Over the 12 week period, aliskiren monotherapy lowered systolic/diastolic blood pressure by 14.0/5.1 mmHg, compared to 11.6/3.6 mmHg for ramipril, consistent with aliskiren being non-inferior to ramipril at the dosages chosen and the differences in systolic and diastolic blood pressure were statistically significant.
Danish: Over 12-ugers-perioden sænkede aliskirenmonoterapi systolisk/diastolisk blodtryk med 14,0/5,1 mmHg sammenlignet med 11,6/3,6 mmHg for ramipril i overensstemmelse med aliskirens non-inferioritet til ramipril ved de valgte doser.
English: or an “angiotensin 2 receptor blocker” such as valsartan, telmisartan, irbesartan etc.
Danish: eller en ”angiotensin-II receptorblokker”, som fx valsartan, telmisartan, irbesartan osv.
English: The pharmacokinetics of aliskiren were evaluated in patients with varying degrees of renal insufficiency.
Danish: Aliskirens farmakokinetik blev evalueret hos patienter med varierende grader af nedsat nyrefunktion.
English: Increases in serum potassium have been observed with aliskiren in post-marketing experience and these may be exacerbated by concomitant use of other agents acting on the RAAS or by non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Der er efter markedsføringen set stigning i serumkalium med aliskiren: denne stigning kan blive mere udtalt ved samtidig brug af andre stoffer, der virker på RAAS, eller ved samtidig brug af non-steroide anti-inflammatoriske lægemidler (NSAID'er).
English: Rash, severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN) and oral mucosal reactions
Danish: Udslæt, svære kutane bivirkninger inklusive toksisk epidermal nekrolyse (TEN) og bivirkninger fra mundslimhinden
English: - if you have diabetes mellitus or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.
Danish: - hvis du tager nogen af følgende typer medicin, som anvendes til at behandle for højt blodtryk: en ”angiotensin-konverteringsenzym (ACE)-hæmmer, som fx enalapril, lisinopril, ramipril osv.
English: (see sections 4.3, 4.4 and 5.1).
Danish: 4.3, 4.4 og 5.1).
English: - if you have experienced the following forms of angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue): angioedema when taking aliskiren.
Danish: - hvis du har oplevet følgende former for angioødem (svært ved at trække vejret eller synke eller har haft hævet ansigt, hænder og fødder, øjenomgivelser, læber og/eller tunge): angioødem når du har taget aliskiren.
English: In the event of any signs suggesting a hypersensitivity reaction/angioedema (in particular difficulties in breathing or swallowing, rash, itching, hives or swelling of the face, extremities, eyes, lips and/or tongue, dizziness) patients should discontinue treatment and contact the physician (see section 4.4).
Danish: Ved tegn tydende på en overfølsomhedsreaktion/angioødem (specielt besvær med vejrtrækning eller synkning, udslæt, kløe, urticaria eller hævelse i ansigt, ekstremiteter, øjne, læber og/eller tunge, svimmelhed) skal patienten afbryde behandlingen og kontakte lægen (se pkt.
English: Aliskiren was evaluated for cardiovascular and/or renal benefit in a double-blind placebo controlled randomised trial in 8,606 patients with type 2 diabetes and chronic kidney disease (evidenced by proteinuria and/or GFR < 60 ml/min/1.73 m2) with or without cardiovascular disease.
Danish: Aliskirens eventuelle gavnlige virkning på hjerte-kar og/eller nyrer blev undersøgt i et dobbeltblindt, placebokontrolleret, randomiseret studie hos 8.606 patienter med type 2-diabetes og kronisk nyresygdom (vist ved proteinuri og/eller GFR < 60 ml/min./1,73m2) med eller uden hjerte-karsygdom.
English: As with other agents acting on the renin-angiotensin system, NSAIDs may reduce the antihypertensive effect of aliskiren.
Danish: Non-steroide anti-inflammatoriske lægemidler (NSAID) Som for andre stoffer, der virker på renin-angiotensin-systemet, kan NSAID reducere aliskirens antihypertensive effekt.
English: an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.
Danish: en ”angiotensin-konverteringsenzym (ACE)-hæmmer”, som fx enalapril, lisinopril, ramipril osv.
English: Uncommon (affecting less than 1 in 100 patients): Skin rash (this may also be a sign of allergic reactions or angioedema - see “Rare” side effects below), kidney problems including acute renal failure (severely decreased urine output), swelling of hands, ankles or feet (peripheral oedema), severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin, blistering of the lips, eyes or mouth, skin peeling, fever), low blood pressure.
Danish: Ikke almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 1.000 patienter): Hududslæt (dette kan også være symptomer på en overfølsomhedsreaktion eller angioødem - se ”Sjældne” bivirkninger herunder), nyreproblemer inklusive akut nyresvigt (svært nedsat urinproduktion), hævede hænder, ankler eller fødder (væskeansamlinger), alvorlige hudreaktioner (toksisk epidermal nekrolyse og/eller bivirkninger fra slimhinden i munden - rød hud, blæredannelse omkring læber, øjne eller mund, hudafskalning, feber), lavt blodtryk.
English: Co-administration of ketoconazole (200 mg) or verapamil (240 mg) with aliskiren (300 mg) resulted in a 76% or 97% increase in aliskiren AUC, respectively.
Danish: Administration af ketoconazol (200 mg) eller verapamil (240 mg) sammen med aliskiren (300 mg) resulterede i henholdsvis 76 % og 97 % stigning i aliskirens AUC.
English: Where there is involvement of the tongue, glottis or larynx adrenaline should be administered.
Danish: Hvis tunge, glottis og svælg er påvirket, skal der gives adrenalin.
English: When administered with atorvastatin, steady-state Sprimeo AUC and Cmax increased by 50%.
Danish: Ved samtidig administration med atorvastatin steg AUC og Cmax for Sprimeo ved steady state med 50 %.
English: Co-administration of aliskiren 300 mg with ketoconazole 200 mg or verapamil 240 mg resulted in a 76% or 97% increase in aliskiren AUC, respectively.
Danish: Samtidig administration af aliskiren 300 mg og ketoconazol 200 mg eller verapamil 240 mg resulterede i henholdsvis 76 % og 97 % stigning i aliskirens AUC.
English: Sprimeo may be used alone or in combination with other antihypertensive agents with the exception of use in combination with angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m
Danish: Sprimeo kan anvendes alene eller kombineres med andre antihypertensiva dog ikke i kombination med angiotensin-konverteringsenzym (ACE)-hæmmere eller angiotensin-II receptorblokkere (ARB) hos patienter med diabetes mellitus eller nedsat nyrefunktion (glomerulær filtrationsrate (GFR) < 60 ml/min./1,73 m
English: These include potassium sparing diuretics, potassium supplements.
Danish: Dette gælder også kaliumbesparende diuretika og kaliumtilskud.
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 Sprimeo.
Danish: Du skal sørge for at finde ud af, hvordan du reagerer på Sprimeo, før du kører bil, betjener maskiner eller udfører andre aktiviteter, som kræver koncentration.
English: The recommended starting dose of aliskiren in elderly patients is 150 mg. No clinically meaningful additional blood pressure reduction is observed by increasing the dose to 300 mg in the majority of elderly patients.
Danish: Hos størstedelen af de ældre patienter er der ikke set klinisk relevant ekstra blodtryksreduktion ved at øge dosis til 300 mg.
English: Other inducers of P-gp (St. John's wort) might decrease the bioavailability of Sprimeo.
Danish: Andre P-gp-induktorer (perikon) kan muligvis nedsætte Sprimeos biotilgængelighed.
English: Consistent with standard medical practice, periodic determination of renal function including serum electrolytes is advised if co-administration is considered necessary.
Danish: Hvis samtidig brug skønnes nødvendig, tilrådes regelmæssig kontrol af nyrefunktionen inklusive serumelektrolytter i overensstemmelse med standardpraksis.
English: Arthralgia has been reported in post-marketing experience.
Danish: Efter markedsføring er der rapporteret artralgi.
English: Moderate P-gp inhibitors
Danish: Moderate P-gp-hæmmere
English: The change in plasma levels of aliskiren in the presence of ketoconazole or verapamil 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: Ændring af aliskirens plasmaniveau ved tilstedeværelse af ketoconazol eller verapamil forventes at ligge inden for det område, der ville være opnået, hvis aliskirendosis blev fordoblet.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 56 filmovertrukne tabletter 90 filmovertrukne tabletter 98 filmovertrukne tabletter
English: Therefore, concomitant use of aliskiren and P-gp potent inhibitors is contraindicated (see section 4.3).
Danish: Derfor er samtidig administration af aliskiren og potente P-gp-hæmmere kontraindiceret (se pkt.
English: History of angioedema with aliskiren.
Danish: Angioødem forårsaget af aliskiren i anamnesen.
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), itraconazole (a medicine used to treat fungal infections) or quinidine (a medicine used to correct heart rhythm).
Danish: Bruges også til andre tilstande f.eks. gigt eller hudeksem), itraconazol (medicin, der bruges til behandling af svampeinfektioner) eller quinidin (medicin, som bruges til at korrigere hjerterytmen).
English: However, the use of aliskiren is not recommended in patients with severe renal impairment (see section 4.4).
Danish: Anvendelse af aliskiren til patienter med stærkt nedsat nyrefunktion frarådes dog (se pkt.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets
Danish: 7 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 56 filmovertrukne tabletter
English: microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171),
Danish: mikrokrystallinsk cellulose, povidon, kolloid vandfri silica, talcum, titandioxid (E171), sort jernoxid (E172), rød jernoxid (E172).
English: POSSIBLE SIDE EFFECTS
Danish: BIVIRKNINGER
English: As for any medicine that acts directly on the RAAS, Sprimeo 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: Sprimeo bør, som andre præparater, der virker direkte på RAAS, ikke anvendes under 1. trimester i graviditeten (se pkt.
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 Sprimeo, skal du henvende dig til den lokale repræsentant:
English: P-gp potent inhibitors
Danish: Potente P-gp-hæmmere
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 90 film-coated tablets
Danish: 7 filmovertrukne tabletter 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 56 filmovertrukne tabletter 90 filmovertrukne tabletter
English: Depending on how you respond to the treatment your doctor may prescribe a higher dose of one 300 mg tablet once daily.
Danish: Lægen kan ordinere en højere dosis på en tablet på 300 mg én gang daglig, alt efter hvordan du reagerer på behandlingen.
English: If you take more Sprimeo than you should
Danish: Hvis du har taget for meget Sprimeo
English: HOW TO TAKE SPRIMEO
Danish: SÅDAN SKAL DU TAGE SPRIMEO
English: - if you experience angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).
Danish: - hvis du oplever, at du har svært ved at trække vejret eller at synke eller har hævet ansigt, hænder og fødder, øjenomgivelser, læber og/eller tunge (angioødem).
English: When administered with atorvastatin (80 mg), steady-state aliskiren (300 mg) AUC and Cmax increased by
Danish: Ved samtidig administration af aliskiren (300 mg) og atorvastatin (80 mg) blev AUC og Cmax for aliskiren øget med 50 % ved steady state.
English: The pharmacokinetics of aliskiren were evaluated in patients with end stage renal disease receiving haemodialysis.
Danish: Aliskirens farmakokinetik blev evalueret hos hæmodialyse-patienter med nyresygdom i slutstadie (ESRD).
English: Haemoglobin decreased, haematocrit decreased
Danish: Fald i hæmoglobinværdi, fald i hæmatokritværdi
English: Light-pink, biconvex, round tablet, imprinted “IL” on one side and “NVR” on the other side.
Danish: Lys pink, udadbuet, rund tablet, præget med ”IL” på den ene side og ”NVR” på den anden side.
English: In this leaflet:
Danish: Oversigt over indlægssedlen:
English: Sprimeo 150 mg film-coated tablets Aliskiren
Danish: Sprimeo 150 mg filmovertrukne tabletter Aliskiren
English: Therefore, if administration of aliskiren in ESRD patients receiving haemodialysis is considered necessary, no dose adjustment is warranted in these patients.
Danish: Derfor er dosisjustering ikke påkrævet, hvis administration af aliskiren til ESRD-patienter i hæmodialyse skønnes nødvendig.
English: 84 film-coated tablets
Danish: 84 filmovertrukne tabletter
English: Sprimeo 300 mg film-coated tablets Aliskiren
Danish: Sprimeo 300 mg filmovertrukne tabletter Aliskiren
English: 49 film-coated tablets
Danish: 49 filmovertrukne tabletter
English: Rare (affecting less than 1 in 1,000 patients): Allergic reactions (hypersensitivity) and angioedema (the symptoms of which can include difficulties in breathing or swallowing, rash, itching, hives or swelling of the face, hands and feet, eyes, lips and/or tongue, dizziness), increased level of creatinine in the blood.
Danish: Overfølsomhedsreaktioner (allergiske reaktioner) og angioødem (symptomerne kan være besvær med at trække vejret eller med at synke, udslæt, kløe, nældefeber, hævet ansigt, hænder og fødder, øjenomgivelser, læber og/eller tunge eller svimmelhed), forhøjet indhold af kreatinin i blodet.
English: Sprimeo 150 mg film-coated tablets
Danish: Sprimeo 150 mg filmovertrukne tabletter