FrancophonIA/ELRC3.0 huggingface dataset:
English: These pharmacologicallymediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
Icelandic: Komið var í veg fyrir þessar lyfjamiðluðu aukaverkanir, sem þekktar eru úr forklínískum rannsóknum bæði á ACE-hemlum og angíótensín II viðtakahemlum, með gjöf saltvatns til drykkjar.
English: • Heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris).
Icelandic: Brjóstverkur frá hjarta einnig í hvíld eða við lágmarksáreynslu (hvikul hjartaöng).
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan.
Icelandic: Greint hefur verið frá afturkræfri aukningu á litíumþéttni í sermi og eitrunum vegna samhliða meðferðar með litíum og ACE-hemlum, og einnig með angíótensín II blokkum, þ.m.t. telmisartani.
English: What Onduarp contains - The active substances are telmisartan and amlodipine.
Icelandic: Virku innihaldefnin eru telmisartan og amlodipin.
English: Onduarp 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg.
Icelandic: 40 mg/10 mg töflur má gefa sjúklingum þegar ekki næst fullnægjandi stjórnun á blóðþrýstingi með amlodipini 10 mg.
English: - The other ingredients are colloidal anhydrous silica, brilliant blue FCF (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine,
Icelandic: - Önnur innihaldsefni eru vatnsfrí kísilkvoða, brilliant blue FCF (E133), svart járnoxíð (E172),
English: Haemodynamic studies and exercise based controlled clinical trials in NYHA Class II-IV heart failure patients have shown that amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction and clinical symptomatology.
Icelandic: Blóðaflfræðilegar rannsóknir og klínískar samanburðarrannsóknir byggðar á álagsprófum hjá sjúklingum með hjartabilun í NYHA-flokki II-IV hafa sýnt að amlodipin leiddi ekki til klínískrar versnunar samkvæmt álagsþoli, útfallshlutfalli vinstri slegils og klínískum einkennum.
English: Therefore, the dose of simvastatin in patients on amlodipine should be limited to 20 mg daily.
Icelandic: Þess vegna skal takmarka skammta simvastatins við 20 mg á sólarhring hjá sjúklingum sem fá amlodipin.
English: Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Icelandic: Ekki má nota telmisartan samhliða aliskireni hjá sjúklingum með skerta nýrnastarfsemi (GFR < 60 ml/mín/1,73 m2) (sjá kafla 4.3).
English: The elimination half-life is not changed in patients with renal impairment.
Icelandic: Helmingunartími útkilnaðar er óbreyttur hjá sjúklingum með skerta nýrnastarfsemi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg/5 mg
Icelandic: YTRI UMBÚÐUM YTRI MERKIMIÐI Á FJÖLPAKKNINGU MEÐ 360 (4 PAKKNINGAR MEÐ 90 x 1 TÖFLUR)
English: The most prominent manifestations of telmisartan overdose are expected to be hypotension and tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also been reported.
Icelandic: Gert er ráð fyrir að mest áberandi einkenni ofskömmtunar telmisartans séu lágur blóðþrýstingur og hraðtaktur, en hægtaktur, sundl, aukning kreatíníns í sermi og bráð nýrnabilun hafa einnig verið skráð.
English: Diabetic patients treated with insulin or antidiabetics In these patients hypoglycaemia may occur under telmisartan treatment.
Icelandic: Hjá þessum sjúklingum getur blóðsykursfall átt sér stað við meðferð með telmisartani.
English: However, lower plasma concentrations were observed in patients with renal insufficiency undergoing dialysis.
Icelandic: Hins vegar var plasmaþéttni minni hjá sjúklingum með skerta nýrnastarfsemi sem voru í blóðskilun.
English: Telmisartan and amlodipine are not dialysable.
Icelandic: Telmisartan og amlodipin skiljast ekki út með blóðskilun.
English: • Haemodynamically unstable heart failure after acute myocardial infarction
Icelandic: Blóðaflfræðilega óstöðug hjartabilun eftir brátt hjartadrep
English: In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals.
Icelandic: Í forklínískum rannsóknum ollu skammtar, sem gáfu sambærilega útsetningu fyrir lyfinu og verður á klínísku skammtabili, lækkun gilda fyrir rauð blóðkorn (fækkun rauðra blóðkorna, lækkun hemóglóbíns og lækkun blóðkornahlutfalls) breytingum á blóðflæði nýrna (hækkun BUN (blood urea nitrogen) og kreatíníns), sem og hækkun kalíums í sermi hjá dýrum með eðlilegan blóðþrýsting.
English: Non-steroidal anti-inflammatory medicinal products NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
Icelandic: Bólgueyðandi gigtarlyf (þ.e. acetýlsalicýlsýra í bólgueyðandi skömmtum, COX-2 hemlar og ósértæk bólgueyðandi gigtarlyf) geta dregið úr blóðþrýstingslækkandi áhrifum angíótensín II blokka.
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets
Icelandic: Upplýsingar fyrir notanda lyfsins Onduarp 80 mg/5 mg töflur
English: The small reduction in AUC for telmisartan is not expected to cause a reduction in the therapeutic efficacy.
Icelandic: Ekki er búist við að sú litla minnkun sem verður á AUC fyrir termisartan dragi úr verkun meðferðar.
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/005 (28 tablets) EU/1/11/729/006 (36 (4 x 90 x 1) tablets)
Icelandic: MARKAÐSLEYFISNÚMER EU/1/11/729/005 (28 töflur) EU/1/11/729/006 (36 (4 x 90 x 1) töflur)
English: Urinary bladder infection, feeling sad (depression), feeling anxious, sleeplessness, fainting, nerve damage in the hands or feet, reduced sense of touch, taste abnormalities, trembling, vomiting, enlarged gums, discomfort in the abdomen, dry mouth, eczema (a skin disorder), redness of skin, rash, back pain, leg pain, urge to urinate during the night, feeling unwell (malaise), increased levels of uric acid in the blood.
Icelandic: Sýking í þvagblöðru, depurð (þunglyndi), kvíði, svefnleysi, yfirlið, taugaskemmdir í höndum eða fótum, minnkað snertiskyn, truflanir á bragðskyni, skjálfti, uppköst, ofvöxtur í tannholdi, óþægindi í kviðarholi, munnþurrkur, exem (húðkvilli), hörundsroði, útbrot, bakverkir, verkir í fótleggjum, þvaglátsþörf að nóttu, lasleiki, hækkuð gildi þvagsýru í blóðinu.
English: The observed mean changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg (−22.2/−17.2 mmHg with 40 mg/5 mg; −22.5/−19.1 mmHg with 80 mg/5 mg) were comparable to or greater than those seen with amlodipine 10 mg (−21.0/−17.6 mmHg) and associated with significant lower oedema rates (1.4% with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 10 mg).
Icelandic: Meðalbreytingar sem fram komu á blóðþrýstingi í slagbili/lagbili af samsettri meðferð með 5 mg af amlodipini (-22,2/-17,2 mmHg með 40 mg/5 mg; -22,5/-19,1 mmHg með 80 mg/5 mg) voru sambærilegar eða meiri en þær breytingar sem komu fram með 10 mg af amlodipini (-21,0/-17,6 mmHg) og drógu einnig marktækt úr tíðni bjúgs (1,4% af 40 mg/5 mg; 0,5% af 80 mg/5 mg; 17,6% með 10 mg af amlodipini).
English: The maximum plasma concentration (Cmax) and, to a smaller extent, the area under the plasma concentration-time curve (AUC), increase disproportionately with dose.
Icelandic: Hámarksplasmaþéttni (Cmax) og að minna leyti AUC-gildi aukast með skammti, en þó ekki hlutfallslega.
English: The safety and tolerability of Onduarp has been evaluated in five controlled clinical studies with over 3500 patients, over 2500 of whom received telmisartan in combination with amlodipine.
Icelandic: Öryggi notkunar Onduarp og hve vel það þolist hefur verið metið í fimm klínískum samanburðarrannsóknum sem tóku til fleiri en 3.500 sjúklinga.
English: The oedema related events (peripheral oedema, generalised oedema, and oedema) were consistently lower in patients who received Onduarp as compared to patients who received amlodipine 10 mg.
Icelandic: Tíðni bjúgs (útlimabjúgs, almenns bjúgs og bjúgs) var staðfastlega minni hjá sjúklingum sem fengu
English: microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, sorbitol
Icelandic: Örkristallaður sellulósi, Póvídón (K25), Forgelatíneruð sterkja, Natríumhýdroxíð, Sorbitól (E420).
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Icelandic: II blokka á öðrum og síðasta þriðjungi meðgöngu (sjá kafla 4.3 og 4.4).
English: Patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance.
Icelandic: Búast má við minnkaðri úthreinsun telmisartans hjá sjúklingum með gallteppusjúkdóma eða skerta lifrarstarfsemi.
English: Other medicines and Onduarp
Icelandic: Notkun annarra lyfja samhliða Onduarp
English: Leukocytopenia, thrombocytopenia
Icelandic: Brisbólga, magabólga
English: Gastro-intestinal disorders abdominal pain, diarrhoea, nausea vomiting, gingival hypertrophy, dyspepsia, dry mouth
Icelandic: Uppköst, ofvöxtur í tannholdi, meltingartruflanir, munnþurrkur
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets telmisartan/amlodipine
Icelandic: HEITI LYFS Onduarp 40 mg/5 mg töflur telmisartan/amlodipin
English: Micturition disorder, pollakiuria Reproductive system and breast disorders Uncommon:
Icelandic: Hraðtaktur Öndunarfæri, brjósthol og miðmæti Sjaldgæfar:
English: Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of spinning (vertigo), slow heart rate, palpitations (awareness of your heart beat), low blood pressure (hypotension), dizziness on standing up (orthostatic hypotension), flushing, cough, stomach ache (abdominal pain), diarrhoea, feeling sick (nausea), itching, joint pain, muscle cramps, muscle pain, inability to obtain an erection, weakness, chest pain, tiredness, swelling (oedema), increased levels of hepatic enzymes.
Icelandic: Syfja, mígreni, höfuðverkur, náladofi eða dofi í höndum eða fótum, svimi, hægur hjartsláttur, hjartsláttarónot, lágþrýstingur, svimi þegar staðið er upp (stöðubundinn lágþrýstingur), roði, hósti, kviðverkir, niðurgangur, ógleði, kláði, liðverkir, vöðvakrampar, vöðvaverkir, erfiðleikar við að ná stinningu, slappleiki, brjóstverkir, þreyta, bjúgur, hækkuð gildi lifrarensíma.
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Icelandic: Vitað er að notkun angíótensín II blokka á öðrum og síðasta þriðjungi meðgöngu hefur eiturverkanir á fóstur (skert starfsemi nýrna, legvatnsbrestur, skert beinmyndun höfuðkúpu) og eiturverkanir á nýbura (nýrnabilun, lágur blóðþrýstingur, blóðkalíumhækkun).
English: ketoconazole).
Icelandic: Hjartakvilli.
English: INFORMATION IN BRAILLE Onduarp 80 mg/10 mg
Icelandic: MEÐ BLINDRALETRI Onduarp 80 mg/10 mg
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/003 (28 tablets) EU/1/11/729/004 (360 (4 x 90 x 1) tablets)
Icelandic: MARKAÐSLEYFISNÚMER EU/1/11/729/003 (28 töflur) EU/1/11/729/004 (360 (4 x 90 x 1) töflur)
English: Due to the slow onset of action, acute hypotension is not a feature of amlodipine administration.
Icelandic: Vegna þess að verkun hefst rólega veldur gjöf amlodipins ekki skyndilegu blóðþrýstingsfalli.
English: Micturition disorder, pollakiuria
Icelandic: Truflanir á þvaglátum, tíð þvaglát
English: Renal and urinary disorders Uncommon:
Icelandic: Lifur og gall Koma örsjaldan fyrir:
English: Musculoskeletal and connective tissue disorders Rare:
Icelandic: Æxlunarfæri og brjóst Sjaldgæfar:
English: After 8 weeks of treatment, each of the combination treatments was statistically significantly superior to amlodipine monotherapy in reducing diastolic and systolic blood pressure (−11.1/−9.2 mmHg, −11.3/ −9.3 mmHg with 40 mg/10 mg, 80 mg/10 mg versus −7.4/−6.5 mmHg with amlodipine 10 mg) and higher diastolic blood pressure normalisation rates compared to monotherapy were achieved (63.7 %, 66.5 % with 40 mg/10 mg, 80 mg/10 mg versus 51.1 % with amlodipine 10 mg).
Icelandic: Eftir 8 vikna meðferð höfðu báðir styrkleikar samsetta lyfsins tölfræðilega marktæka yfirburði yfir báða styrkleika amlodipins einlyfjameðferðar í að lækka slagbils- og lagbilsþrýsting (-13,6/-9,4 mmHg, -15,0/-10,6 mmHg með 40 mg/5 mg, 80 mg/5 mg á móti -6,2/-5,7 mmHg, -11,1/-8,0 mmHg með amlodipini 5 mg og 10 mg og hærri tíðni stjórnunar á blóðþrýstingi í lagbili samanborið við einlyfjameðferðirnar í hvoru tilviki fyrir sig (56,7%, 63,8% með 40 mg/5 mg og 80 mg/5 mg á móti 42%, 56,7% með amlodipini 5 mg og 10 mg).
English: In dogs, renal tubular dilation and atrophy were observed.
Icelandic: Hjá hundum varð víkkun og rýrnun á nýrnapíplum.
English: INFORMATION IN BRAILLE Onduarp 40 mg/5 mg
Icelandic: HEITI LYFS Onduarp 40 mg/5 mg töflur
English: Reduced number of white blood cells (leucopenia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), excess sugar in blood , uncontrollable twitching or jerking movements, heart attack, irregular heart beat, inflammation of the blood vessels, inflamed pancreas, inflammation of the stomach lining (gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of hepatic enzymes with jaundice, rapid swelling of skin and mucosa (angioedema), severe skin reactions, hives (urticaria), severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson-Syndrome), increased sensitivity of the skin to sun.
Icelandic: Hvítkornafæð, blóðflagnafæð, ofnæmiseinkenni (t.d. útbrot, kláði, öndunarörðugleikar, más, bólga í andliti eða lágþrýstingur), blóðsykurshækkun, óviðráðanlegar hreyfingar með rykkjum eða kippum, hjartaáfall, hjartsláttaróregla, æðabólga, brisbólga, magabólga, lifrarbólga, gula, hækkun lifrarensíma með gulu, ofsabjúgur (hröð bjúgmyndun í húð og slímhúð), alvarleg húðviðbrögð, ofsakláði, alvarleg ofnæmisviðbrögð með blöðrumyndun á húð og slímhúð (húðbólga með flögnun, Stevens-Johnson heilkenni), ljósnæmi.
English: Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty of breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), impaired vision, fast heart beat, upset stomach, abnormal liver function*, hives (urticaria), medicine rash, inflammation of the tendons, flu-like illness (for example muscle pain, feeling generally unwell), decreased haemoglobin (a blood protein), increased levels of creatinine phosphokinase in the blood.
Icelandic: Aukning á ákveðinni gerð af hvítum blóðkornum (eosínfíklafjöld), blóðflagnafæð, ofnæmiseinkenni (t.d. útbrot, kláði, öndunarörðugleikar, hvæsandi öndun, bólga í andliti eða lágþrýstingur), lágur blóðsykur (hjá sjúklingum með sykursýki), sjóntruflanir, hraður hjartsláttur, magaóþægindi, óeðlileg lifrarstarfsemi*,ofsakláði, svæsin lyfjaútbrot, bólga í sinum, flensulík einkenni (t.d. vöðvaverkur, almenn vanlíðan), minnkun á blóðrauða (hemóglóbíni), aukning kreatínfosfókínasa í blóði.
English: Metabolism and nutrition disorders Uncommon:
Icelandic: Efnaskipti og næring Koma örsjaldan fyrir:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/5 mg
Icelandic: PAKKAÐ SAMAN - MEÐ BLUE BOX - 80 mg/5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/10 mg
Icelandic: PAKKAÐ SAMAN - MEÐ BLUE BOX - 80 mg/10 mg
English: Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels in the blood, shortness of breath, bloating, increased sweating, kidney damage including sudden inability of the kidneys to work, increased levels of creatinine.
Icelandic: Þvagfærasýking, sýking í efri hluta öndunarfæra (t.d. hálsbólga, skútabólga, kvef), skortur á rauðum blóðkornum (blóðleysi), blóðkalíumhækkun, mæði, uppþemba, aukin svitamyndun, nýrnaskemmdir þar á meðal skyndileg bráð nýrnabilun, aukning á kreatíníni í blóði.
English: Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as besylate).
Icelandic: Hver tafla inniheldur 40 mg telmisartan og 10 mg amlodipin (sem besýlat).
English: - Intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis, worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extensive trauma).
Icelandic: - Samhliða sjúkdómsástand, sérstaklega vökvaskortur, bráð hjartabilun, efnaskiptablóðsýring, versnun nýrnastarfsemi, skyndileg versnun á ástandi nýrna (t.d. vegna smitsjúkdóma), frumulýsa (t.d. bráð blóðþurrð í útlim, rákvöðvalýsa eða miklir áverkar).
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets telmisartan/amlodipine
Icelandic: 80 mg/10 mg töflur telmisartan/amlodipin
English: INFORMATION IN BRAILLE Onduarp 40 mg/10 mg
Icelandic: HEITI LYFS Onduarp 40 mg/10 mg töflur
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 40 mg telmisartan og 5 mg amlodiopin (sem amlodipin besilat).
English: In a follow-up, long term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure without clinical symptoms or objective findings suggestive of underlying ischaemic disease, on stable doses of ACE inhibitors, digitalis, and diuretics, amlodipine had no effect on total cardiovascular mortality.
Icelandic: Við langtímaeftirfylgni hafði amlodipin engin áhrif á heildardánartíðni af völdum hjarta- og æðasjúkdóma í samanburðarrannsókn á því og lyfleysu (PRAISE-2) hjá sjúklingum með hjartabilun í NYHA-flokki III-IV án klínískra einkenna eða hlutlægra greininga sem bentu til undirliggjandi blóðþurrðarsjúkdóms á stöðugum skömmtum af ACE-hemlum digitalis og þvagræsilyfjum.
English: What Onduarp looks like and contents of the pack Onduarp 40 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the other side.
Icelandic: 40 mg/5 mg tafla er blá og hvít sporöskjulaga tveggja laga tafla með áþrykktu vörunúmerinu A1 og merki fyrirtækisins á hinni hliðinni.
English: INFORMATION IN BRAILLE Onduarp 80 mg/5 mg
Icelandic: HEITI LYFS Onduarp 80 mg/5 mg töflur
English: Potassium sparing diuretics or potassium supplements Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss.
Icelandic: Angiotensin II viðtakablokkar, svo sem telmisartan, draga úr kalíumtapi af völdum þvagræsilyfja.
English: Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as besylate).
Icelandic: Hver tafla inniheldur 80 mg telmisartan og 10 mg amlodipin (sem besýlat).
English: Myocardial infarction, arrhythmia, ventricular tachycardia, atrial fibrillation
Icelandic: Onduarp, t.d. baclofen, amifostin, geðrofslyf og þunglyndislyf.
English: Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as besylate).
Icelandic: Hver tafla inniheldur 40 mg telmisartan og 5 mg amlodipin (sem besýlat).
English: Cardiac disorders Rare:
Icelandic: Meltingarfæri Sjaldgæfar:
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets telmisartan/amlodipine
Icelandic: HEITI LYFS Onduarp 80 mg/5 mg töflur telmisartan/amlodipin
English: What Onduarp looks like and contents of the pack Onduarp 80 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the other side.
Icelandic: 80 mg/10 mg tafla er blá og hvít sporöskjulaga tveggja laga tafla með áþrykktu vörunúmerinu A4 og merki fyrirtækisins á hinni hliðinni.
English: Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Icelandic: Þekkt áhrif angiótensíns II eru tengd AT1 undirflokki viðtaka sem telmisartan binst sterklega og hrindir angiótensíni II frá.
English: What Onduarp looks like and contents of the pack Onduarp 80 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the other side.
Icelandic: 80 mg/5 mg tafla er blá og hvít sporöskjulaga tveggja laga tafla með áþrykktu vörunúmerinu A3 og merki fyrirtækisins á hinni hliðinni.
English: Microcrystalline cellulose
Icelandic: Bólgueyðandi gigtarlyf (NSAID)
English: Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as besylate).
Icelandic: Hver tafla inniheldur 80 mg telmisartan og 5 mg amlodipin (sem besýlat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 80 mg telmisartan og 10 mg amlodiopin (sem amlodipin besilat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 80 mg telmisartan og 5 mg amlodiopin (sem amlodipin besilat).
English: Amlodipine In patients taking amlodipine alone the following additional side effects have been reported:
Icelandic: Greint hefur verið frá eftirfarandi aukaverkunum til viðbótar þegar amlodipin hefur verið tekið eitt og sér:
English: Nervous system disorders somnolence, migraine, headache, paraesthesia syncope, peripheral neuropathy, hypoaesthesia, dysgeusia, tremor
Icelandic: Svefnhöfgi, mígreni, höfuðverkur, húðskynstruflanir
English: • Severe hypotension
Icelandic: Alvarlegur lágþrýstingur
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets telmisartan/amlodipine
Icelandic: 40 mg/10 mg töflur telmisartan/amlodipin
English: What Onduarp looks like and contents of the pack Onduarp 40 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the other side.
Icelandic: 40 mg/10 mg tafla er blá og hvít sporöskjulaga tveggja laga tafla með áþrykktu vörunúmerinu A2 og merki fyrirtækisins á hinni hliðinni.
English: Metabolism and nutrition disorders Very rare:
Icelandic: Stoðkerfi og stoðvefur Mjög sjaldgæfar:
English: Renovascular hypertension
Icelandic: Aukning lifrarensíma
English: Blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the other side.
Icelandic: Bláar og hvítar sporöskjulaga tveggja laga töflur með áþrykktu vörunúmerinu A1 og merki fyrirtækisins á hinni hliðinni.
English: Add on therapy
Icelandic: HEITI LYFS
English: Add on therapy Onduarp is indicated in adults whose blood pressure is not adequately controlled on amlodipine.
Icelandic: Onduarp er ætlað fullorðnum sjúklingum þegar ekki hefur náðst fullnægjandi stjórn á blóðþrýstingi með amlodipini einu sér.
English: Other antihypertensive medicinal products
Icelandic: Önnur blóðþrýstingslækkandi lyf
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/006 (360 (4 x 90 x 1) tablets)
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/11/729/006 (360 (4 x 90 x 1) töflur)
English: No clinical relevance has been established.
Icelandic: Klínískt mikilvægi þessa er ekki ljóst.
English: Additional information on individual components
Icelandic: Aðrar upplýsingar um hvort lyf fyrir sig