FrancophonIA/ELRC3.0 huggingface dataset:
English: Mood changes, impaired vision, ringing in the ears, shortness of breath, sneezing/running nose, change of bowel habit, hair loss, unusual bruising and bleeding (red blood cell damage), skin discolouration, increased sweating, difficulty passing urine, increased need to pass urine especially at night, enlarging of male breasts, pain, weight increased, weight decreased.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): spremembe razpoloženja, motnje vida, zvonjenje v ušesih, zasoplost, kihanje ali nahod, spremenjeno iztrebljanje, izpadanje las, neobičajne modrice ali krvavitve (poškodba rdečih krvničk), razbarvanost kože, povečano znojenje, težavno mokrenje, povečana potreba po mokrenju, zlasti ponoči; povečanje prsi pri moških, bolečina, povečana telesna masa, zmanjšana telesna masa.
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.
Slovenian: zaspanost, migrena, glavobol, mravljinci ali neobčutljivost v dlaneh ali stopalih, občutek vrtenja (vrtoglavica), počasen srčni utrip, palpitacije (zaznavanje bitja srca), nizek krvni tlak (hipotenzija), omotica med vstajanjem (ortostatska hipotenzija), rdečica, kašelj, želodčna bolečina (trebušna bolečina), driska, siljenje na bruhanje (navzea), srbenje, bolečina v sklepih, mišični krči, mišična bolečina, nezmožnost erekcije, oslabelost, bolečina v prsih, utrujenost, oteklina (edem), zvišana raven jetrnih encimov.
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).
Slovenian: Po 8 tednih zdravljenja sta obe kombinaciji statistično značilno učinkoviteje od monoterapije z amlodipinom znižali diastolični in sistolični krvni tlak (-11,1/-9,2 mm Hg, -11,3/-9,3 mm Hg pri 40 mg/10 mg, 80 mg/10 mg v primerjavi z -7,4/-6,5 mm Hg pri amlodipinu po 10 mg); odstotek normalizacije diastoličnega krvnega tlaka je bil večji kot pri monoterapiji (63,7 % in 66,5% pri odmerkih po 40 mg/10 mg in 80 mg/10 mg v primerjavi z 51,1 % pri amlodipinu v odmerkih po 10 mg).
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.
Slovenian: Med sočasnim dajanjem litija in zaviralcev angiotenzin-konvertaze ter, antagonistov receptorjev angiotenzina II, vključno s telmisartanom, so poročali o reverzibilnem povečanju ravni litija v serumu in toksičnih pojavih.
English: Fertility
Slovenian: tinitus
English: INFORMATION IN BRAILLE Onduarp 40 mg/5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Onduarp 40 mg/5 mg
English: Potassium sparing diuretics or potassium supplements Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss.
Slovenian: Antagonisti receptorjev angiotenzina II, kot je telmisartan, zmanjšajo izgubo kalija, ki jo povzročajo diuretiki.
English: Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by e.g. vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Slovenian: Pri bolnikih z zmanjšanim volumnom in/ali zmanjšano količino natrija zaradi intenzivnega diuretičnega zdravljenja, omejitve količine soli v hrani, driske ali bruhanja, se zlasti po prvem odmerku lahko pojavi simptomatična hipotenzija.
English: INFORMATION IN BRAILLE Onduarp 80 mg/5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Onduarp 80 mg/5 mg
English: INFORMATION IN BRAILLE Onduarp 40 mg/10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Onduarp 40 mg/10 mg
English: INFORMATION IN BRAILLE Onduarp 80 mg/10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Onduarp 80 mg/10 mg
English: Colloidal anhydrous silica Brilliant blue FCF (E 133) Ferric oxide black (E172) Ferric oxide yellow (E172) Magnesium stearate Maize starch
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi koloidni brezvodni silicijev dioksid briljantno modro FCF (E 133) črni železov oksid (E 172) rumeni železov oksid (E 172) magnezijev stearat koruzni škrob meglumin mikrokristalna celuloza povidon K25 predgelirani škrob natrijev hidroksid sorbitol (E 420)
English: Respiratory, thoracic and mediastinal disorders cough
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj
English: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Slovenian: Pri bolnikih z obojestransko zožitvijo ledvične arterije ali zožitvijo arterije samo ene delujoče ledvice zdravljenje z zdravili, ki delujejo na renin-angiotenzin-aldosteronski sistem, poveča nevarnost hude hipotenzije in zmanjšanja ledvičnega delovanja.
English: Try to take the tablet at the same time each day.
Slovenian: Priporočeniodmerek zdravila Onduarp je ena tableta na dan. Tableto poskušajte vzeti vsak dan ob isti uri.
English: How to store Onduarp
Slovenian: Shranjevanje zdravila Onduarp
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets
Slovenian: IME ZDRAVILA Onduarp 80 mg/5 mg tablete
English: Nervous system disorders Very rare:
Slovenian: Bolezni živčevja Zelo redki:
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.
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1000 bolnikov): povečanje števila nekaterih belih krvničk (eozinofilija), majhno število krvnih ploščic (trombocitopenija), alergijske reakcije (npr. izpuščaj, srbenje, oteženo dihanje, piskanje, otekanje obraza ali nizek krvni tlak), nizka raven krvnega sladkorja (pri bolnikih s sladkorno boleznijo), motnje vida, hitro bitje srca, želodčne motnje, nenormalno jetrno delovanje*, koprivnica (urtikarija), izpuščaj zaradi zdravila, vnetje kit, gripi podobna bolezen (na primer mišična bolečina, splošno slabo počutje), zmanjšana količina hemoglobina (krvne beljakovine), zvišana raven kreatin-fosfokinaze v krvi.
English: Cardiac disorders Very rare:
Slovenian: Srčne bolezni Zelo redki:
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets
Slovenian: IME ZDRAVILA Onduarp 80 mg/10 mg tablete
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.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): okužbe sečil, okužbe zgornjih dihalnih poti (npr. bolečine v grlu, vnetje sinusov, navaden prehlad), pomanjkanje rdečih krvničk (anemija), visoka raven kalija v krvi, zasoplost, napenjanje, povečano znojenje, ledvična okvara, tudi nenadna odpoved delovanja ledvic, zvišana raven kreatinina.
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).
Slovenian: Srednje spremembe sistoličnega ali diastoličnega krvnega tlaka so bile pri zdravljenju s kombinacijo, ki je vsebovala 5 mg amlodipina (-22,2/-17,2 mm Hg pri odmerku po 40 mg/5 mg; -22,5/-19,1 mm Hg pri odmerku po 80 mg/5 mg) primerljive z doseženimi z 10-mg odmerkom amlodipina ali celo večje (-21,0/-17,6 mm Hg) in povezane z značilno manjšim odstotkom edemov (1,4 % pri odmerku po 40 mg/5 mg; 0,5 % pri odmerku po 80 mg/5 mg; 17,6 % pri odmerku amlodipina po 10 mg)..
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets
Slovenian: IME ZDRAVILA Onduarp 40 mg/10 mg tablete
English: Dual blockade of the renin-angiotensin-aldosterone system The use of telmisartan in combination with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Slovenian: Dvojno zaviranje renin-angiotenzin-aldosteronskega sistema Uporaba kombinacije telmisartana in aliskirena je kontraindicirana pri bolnikih s sladkorno boleznijo ali ledvično okvaro (GFR < 60 ml/min/1,73 m2) (glejte poglavje 4.3).
English: Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours consistent with once daily dosing.
Slovenian: Njegova končna razpolovna doba izločanja je približno 30 do 50 ur, kar se ujema z odmerjanjem enkrat na dan. Koncentracije v plazmi v stanju dinamičnega ravnovesja se vzpostavijo po 7 do 8 dneh neprekinjenega jemanja.
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets
Slovenian: IME ZDRAVILA Onduarp 40 mg/5 mg tablete
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 40 mg/5 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 40 mg/5 mg
English: Onduarp is used to treat high blood pressure - in adult patients whose blood pressure is not controlled enough with amlodipine.
Slovenian: Zdravilo Onduarp je namenjeno zdravljenju visokega krvnega tlaka: - pri odraslih bolnikih, katerim amlodipin ne zadošča za uravnavanje krvnega tlaka, - pri odraslih bolnikih, ki že jemljejo telmisartan in amlodipin ločeno in želijo jemati enaka odmerka v eni tableti.
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.
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): zmanjšano število belih krvničk (levkopenija), majhno število krvnih ploščic (trombocitopenija), alergijske reakcije (npr. izpuščaj, srbenje, oteženo dihanje, piskanje, otekanje obraza ali nizek krvni tlak), prevelika količina sladkorja v krvi , posamični primeri nenadzorovanih sunkovitih kratkih gibov, srčni napad, nepravilno bitje srca, vnetje krvnih žil, vnetje trebušne slinavke, vnetje želodčne sluznice (gastritis), vnetje jeter, porumenela koža (zlatenica), zvišana raven jetrnih encimov z zlatenico, hitro otekanje kože in sluznic (angioedem), hude kožne reakcije, koprivnica (urtikarija), hude alergijske reakcije z nastajanjem mehurjev na koži in sluznicah (eksfoliativni dermatitis, Stevens-Johnsonov sindrom), povečana občutljivost kože za sončne žarke.
English: Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients resulting in increased blood pressure lowering effects (see section
Slovenian: Hkratnega uživanja grenivke ali pitja grenivkinega soka z amlodipinom bolnikom še vedno ne priporočajo, ker se pri nekaterih lahko poveča amlodipinova biološka uporabnost, kar poveča njegove hipotenzivne učinke (gljete poglavje 4.5).
English: Vasculitis Respiratory, thoracic and mediastinal disorders Uncommon:
Slovenian: vaskulitis Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni:
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.
Slovenian: do IV. stopnje po NYHA, se po dajanju amlodipina klinično stanje bolnikov ni poslabšalo, kar so pokazale meritve prenašanja napora, iztisne frakcije levega prekata in klinična simptomatika.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/5 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 80 mg/5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/10 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 80 mg/10 mg
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) The combination of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients (see sections
Slovenian: Dvojno zaviranje renin-angiotenzin-aldosteronskega sistema (RAAS) Uporaba kombinacije telmisartana in aliskirena je kontraindicirana pri bolnikih s sladkorno boleznijo ali ledvično okvaro (GFR < 60 ml/min/1,73 m2), pri drugih bolnikih pa je ne priporočajo (glejte poglavji 4.3, 4.4).
English: Anaemia Thrombocytopenia, eosinophilia
Slovenian: trombocitopenija, eozinofilija
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.
Slovenian: Izgled zdravila Onduarp in vsebina pakiranja Tablete Onduarp po 40 mg/5 mg so modre in bele dvoslojne tablete ovalne oblike z oznako A1 na eni strani in znak podjetja na drugi strani.
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,
Slovenian: črni železov oksid (E 172), rumeni železov oksid (E 172), magnezijev stearat, koruzni škrob,
English: Blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the other side.
Slovenian: Modra in bela dvoslojna tableta ovalne oblike z oznako A2 in logom podjetja na drugi strani.
English: Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as besylate).
Slovenian: Ena tableta vsebuje 40 mg telmisartana in 5 mg amlodipina (kot besilat).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/5 mg
Slovenian: Pretisni omot s 7 tabletami - 40 mg/5 mg
English: Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as besylate).
Slovenian: Ena tableta vsebuje 80 mg telmisartana in 10 mg amlodipina (kot besilat).
English: Pain
Slovenian: bolečina
English: Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as besylate).
Slovenian: Ena tableta vsebuje 80 mg telmisartana in 5 mg amlodipina (kot besilat).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/10 mg
Slovenian: Pretisni omot s 7 tabletami - 40 mg/10 mg
English: • if you suffer from low heart output because of a serious heart problem.
Slovenian: • če imate nenadno poslabšanje črpalne sposobnosti srca z odpovedjo krvnega obtoka,
English: Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as besylate).
Slovenian: Ena tableta vsebuje 40 mg telmisartana in 10 mg amlodipina (kot besilat).
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.
Slovenian: Izgled zdravila Onduarp in vsebina pakiranja Tablete Onduarp po 40 mg/10 mg so modre in bele dvoslojne tablete ovalne oblike z oznako A2 na eni strani in znak podjetja na drugi strani.
English: The recommended dose is one tablet a day.
Slovenian: Priporočeni odmerek zdravila Onduarp je ena tableta na dan. Tableto poskušajte vzeti vsak dan ob isti uri.
English: Onduarp showed dose-related reductions in systolic/diastolic blood pressure across the therapeutic dose range of −21.8/−16.5 mmHg (40 mg/5 mg), −22.1/−18.2 mmHg (80 mg/5 mg),
Slovenian: Zdravilo Onduarp je odvisno od velikosti odmerkov, ki so bili znotraj terapevtskega razpona odmerjanja, znižalo sistolični in diastolični krvni tlak, in sicer za -21,8/-16,5 mm Hg (40 mg/5 mg), -22,1/-18,2 mm Hg (80 mg/5 mg), -24,7/-20,2 mm Hg (40 mg/10 mg) in -26,4/-20,1 mm Hg (80 mg/10 mg).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/5 mg
Slovenian: Pretisni omot za enkratni odmerek z 10 tabletami - 80 mg/5 mg
English: Hepatic function abnormal, liver disorder2 Skin and subcutaneous tissue disorders Uncommon: Rare:
Slovenian: Bolezni jeter, žolčnika in žolčevodov Redki:
English: Read the package leaflet for further information.
Slovenian: Podrobnejše informacije so v priloženem navodilu.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/5 mg
Slovenian: Pretisni omot s 7 tabletami - 80 mg/5 mg
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets telmisartan/amlodipine
Slovenian: IME ZDRAVILA Onduarp 40 mg/5 mg tablete telmisartan/amlodipin
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/10 mg
Slovenian: Pretisni omot za enkratni odmerek z 10 tabletami - 80 mg/10 mg
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.
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1000 bolnikov): okužba sečnega mehurja, žalost (depresija), tesnoba, nespečnost, omedlevica, okvara živcev v dlaneh ali stopalih, zmanjšan otip, nenormalen okus, tresenje, bruhanje, povečanje dlesni, nelagodje v trebuhu, suha usta, ekcem (kožno obolenje), pordela koža, izpuščaj, bolečina v hrbtu, bolečina v nogi, bolečina v nogah, potreba po mokrenju ponoči, slabo počutje (bolehnost), zvišana raven sečne kisline v krvi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/004 (360 (4 x 90 x 1) tablets)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/729/004 (360 (4 x 90 x 1) tablet)
English: −15.0/−10.6 mmHg with 40 mg/5 mg, 80 mg/5 mg versus −6.2/−5.7 mmHg, −11.1/−8.0 mmHg with amlodipine 5 mg and 10 mg and higher diastolic blood pressure control rates compared to the respective monotherapies were achieved (56.7 %, 63.8 % with 40 mg/5 mg and 80 mg/5 mg versus 42 %, 56.7 % with amlodipine 5 mg and 10 mg).
Slovenian: Po 8 tednih zdravljenja sta obe kombinaciji statistično značilno učinkoviteje znižali sistolični in diastolični krvni tlak kot odmerka amlodipina (-13,6/-9,4 mm Hg, -15,0/-10,6 mm Hg pri 40 mg/5 mg, 80 mg/5 mg v primerjavi z -6,2/-5,7 mm Hg, -11,1/-8,0 mm Hg pri amlodipinu po 5 mg in 10 mg), odstotek uravnanega diastoličnega krvnega tlaka pa je bil večji v primerjavi z monoterapijama (56,7 %, 63,8 % pri kombinacijah 40 mg/5 mg in 80 mg/5 mg v primerjavi z 42 %, 56,7 % pri amlodipinu v odmerkih po 5 mg in 10 mg).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/006 (360 (4 x 90 x 1) tablets)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/729/006 (360 (4 x 90 x 1) tablet)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg/10 mg
Slovenian: VMESNA OVOJNINA PRI SKUPINSKEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - BREZ MODREGA OKENCA - 80 mg/10 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg/5 mg
Slovenian: VMESNA OVOJNINA PRI SKUPINSKEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - BREZ MODREGA OKENCA - 80 mg/5 mg
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets telmisartan/amlodipine
Slovenian: IME ZDRAVILA Onduarp 80 mg/5 mg tablete telmisartan/amlodipin
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets telmisartan/amlodipine
Slovenian: IME ZDRAVILA Onduarp 40 mg/10 mg tablete telmisartan/amlodipin
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/10 mg
Slovenian: Pretisni omot s 7 tabletami - 80 mg/10 mg
English: Blood creatine phosphokinase increased, haemoglobin decreased 1: the event may be a chance finding or related to a mechanism currently not known 2: most cases of hepatic function abnormal / liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Slovenian: 1 dogodek je lahko naključen ali povezan s še neznanim mehanizmom2 o večini primerov nenormalnega jetrnega delovanja ali jetrne bolezni so v obdobju po začetku trženja telmisartana poročali pri japonskih bolnikih, pri katerih tudi sicer obstaja večja verjetnost teh neželenih reakcij
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 40 mg telmisartana in 5 mg amlodipina (v obliki amlodipinijevega besilata).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 40 mg telmisartana in 10 mg amlodipina (v obliki amlodipinijevega besilata).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 80 mg telmisartana in 5 mg amlodipina (v obliki amlodipinijevega besilata).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 80 mg telmisartana in 10 mg amlodipina (v obliki amlodipinijevega besilata).
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets telmisartan/amlodipine
Slovenian: IME ZDRAVILA Onduarp 80 mg/10 mg tablete telmisartan/amlodipin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 40 mg/10 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA 40 mg/10 mg
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/001 (28 tablets)
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/11/729/001 (28 tablet)
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/10 mg
Slovenian: ZUNANJE OZNAČEVANJE PRI SKUPINSKEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - Z MODRIM OKENCEM - 80 mg/10 mg