FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal and urinary disorders Uncommon renal impairment including acute renal failure micturition disorder, pollakiuria
Slovenian: Bolezni sečil Občasni ledvična okvara, tudi akutna ledvična odpoved motnje mokrenja, polakiurija
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: Rare nocturia
Slovenian: Redki nokturia
English: Uncommon asthenia, chest pain, fatigue, oedema pain
Slovenian: Občasni astenija, bolečina v prsih, utrujenost, edem bolečina
English: The overall incidence of adverse reactions with Twynsta in the clinical trial programme was low with only 12.7 % of patients on treatment experiencing adverse reactions.
Slovenian: Skupna pojavnost neželenih učinkov je bila v kliničnih preskušanjih zdravila Twynsta majhna.
English: Gastric lavage may be worthwhile in some cases.
Slovenian: V nekaterih primerih bo morda koristno izpiranje želodca.
English: Rare tachycardia
Slovenian: Redki tahikardija
English: Very rare leukocytopenia, thrombocytopenia
Slovenian: Zelo redki levkocitopenija, trombocitopenija
English: Mood changes, impaired vision, ringing in the ears, shortness of breath, sneezing/running nose, 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, 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: How to store Twynsta
Slovenian: Shranjevanje zdravila Twynsta
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 (RAAS).
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 (RAAS), poveča nevarnost hude hipotenzije in zmanjšanja ledvičnega delovanja.
English: Most cases of abnormal liver function and liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Slovenian: 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 učinkov.
English: Twynsta with food and drink Low blood pressure may be aggravated by alcohol.
Slovenian: Stanje z nizkim krvnim tlakom lahko poslabša alkohol.
English: INFORMATION IN BRAILLE Twynsta 80 mg/5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Twynsta 80 mg/5 mg
English: INFORMATION IN BRAILLE Twynsta 40 mg/5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Twynsta 40 mg/5 mg
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: INFORMATION IN BRAILLE Twynsta 40 mg/10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Twynsta 40 mg/10 mg
English: INFORMATION IN BRAILLE Twynsta 80 mg/10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Twynsta 80 mg/10 mg
English: The blood pressure lowering effect of telmisartan/amlodipine can be increased by concomitant use of other antihypertensive medicinal products.
Slovenian: Sočasno jemanje drugih antihipertenzivov lahko poveča antihipertenzivni učinek telmisartana/amlodipina.
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, 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: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 40 mg/10 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 40 mg/10 mg
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/10 mg tablets
Slovenian: IME ZDRAVILA Twynsta 40 mg/10 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/10 mg tablets
Slovenian: IME ZDRAVILA Twynsta 80 mg/10 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/5 mg tablets
Slovenian: IME ZDRAVILA Twynsta 80 mg/5 mg tablete
English: After 8 weeks of treatment, each of the combinations was statistically significantly superior to both amlodipine monotherapy doses in reducing systolic and diastolic blood pressures ( 13.6/ 9.4 mmHg, 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: Ear and labyrinth disorders Uncommon vertigo tinnitus
Slovenian: Ušesne bolezni, vključno z motnjami labirinta Občasni vrtoglavica tinitus
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/5 mg tablets
Slovenian: IME ZDRAVILA Twynsta 40 mg/5 mg tablete
English: Twynsta 80 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled with Twynsta 40 mg/5 mg .
Slovenian: Zdravilo Twynsta 80 mg/5 mg je indicirano pri odraslih bolnikih, pri katerih krvnega tlaka ne moremo ustrezno uravnati z zdravilom Twynsta 40 mg/5 mg.
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: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): 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: Twynsta 80 mg/10 mg is indicated in adults whose blood pressure is not adequately controlled on on Twynsta 40 mg/10 mg or Twynsta 80 mg/5 mg.
Slovenian: Zdravilo Twynsta 80 mg/10 mg je indicirano pri odraslih bolnikih, pri katerih krvnega tlaka ne moremo ustrezno uravnati z zdravilom Twynsta 40 mg/10 mg ali zdravilom Twynsta 80 mg/5 mg.
English: Twynsta 80 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled on Twynsta 40 mg/10 mg or Twynsta 80 mg/5 mg.
Slovenian: Tablete Twynsta po 80 mg/10 mg lahko prejemajo bolniki, pri katerih krvnega tlaka ni mogoče ustrezno uravnati z zdravilom Twynsta po 40 mg/10 mg ali zdravilom Twynsta po 80 mg/5 mg.
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 1.000 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: Nervous system disorders Common dizziness
Slovenian: Bolezni živčevja Pogostni omotica
English: Twynsta 40 mg/10 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 10 mg alone.
Slovenian: Zdravilo Twynsta 40 mg/10 mg je indicirano pri odraslih bolnikih, pri katerih krvnega tlaka ne moremo ustrezno uravnati s samim amlodipinom po 10 mg.
English: Twynsta 40 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone.
Slovenian: Zdravilo Twynsta po 40 mg/5 mg lahko prejemajo bolniki, pri katerih krvnega tlaka ni mogoče ustrezno uravnati s samim amlodipinom po 5 mg.
English: Impairment of fertility
Slovenian: Škodljivi učinki na plodnost
English: Twynsta 80 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with Twynsta 40 mg/5 mg.
Slovenian: Tablete Twynsta po 80 mg/5 mg lahko prejemajo bolniki, pri katerih krvnega tlaka ni mogoče ustrezno uravnati z zdravilom Twynsta po 40 mg/5 mg.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 40 mg/10 mg
Slovenian: Pretisni omot za enkratni odmerek z 10 tabletami - 40 mg/10 mg
English: Twynsta 40 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 5 mg alone.
Slovenian: Zdravilo Twynsta 40 mg/5 mg je indicirano pri odraslih bolnikih, pri katerih krvnega tlaka ne moremo ustrezno uravnati s samim amlodipinom po 5 mg.
English: Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Slovenian: Ena tableta vsebuje 40 mg telmisartana in 5 mg amlodipina (v obliki amlodipinijevega besilata).
English: Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Slovenian: Ena tableta vsebuje 80 mg telmisartana in 10 mg amlodipina (v obliki amlodipinijevega besilata).
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, increased muscle tension.
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, povečana mišična napetost.
English: Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Slovenian: Ena tableta vsebuje 80 mg telmisartana in 5 mg amlodipina (v obliki amlodipinijevega besilata).
English: Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Slovenian: Ena tableta vsebuje 40 mg telmisartana in 10 mg amlodipina (v obliki amlodipinijevega besilata).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 40 mg/5 mg
Slovenian: Pretisni omot za enkratni odmerek z 10 tabletami - 40 mg/5 mg
English: What Twynsta looks like and contents of the pack Twynsta 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 white layer.
Slovenian: Tablete Twynsta po 80 mg/5 mg so modre in bele dvoslojne tablete ovalne oblike z oznako A3 in znakom podjetja na belem sloju.
English: The recommended dose is one tablet a day.
Slovenian: Priporočeni odmerek zdravila Twynsta je ena tableta na dan. Tableto poskušajte vzeti vsak dan ob isti uri.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/5 mg tablets telmisartan/amlodipine
Slovenian: IME ZDRAVILA Twynsta 80 mg/5 mg tablete telmisartan/amlodipin
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/5 mg tablets telmisartan/amlodipine
Slovenian: IME ZDRAVILA Twynsta 40 mg/5 mg tablete telmisartan/amlodipin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/648/007 (360 (4 x 90 x 1) tablet)
English: What Twynsta looks like and contents of the pack Twynsta 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 white layer.
Slovenian: Tablete Twynsta po 40 mg/5 mg so modre in bele dvoslojne tablete ovalne oblike z oznako A1 in znakom podjetja na belem sloju.
English: Blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the white layer.
Slovenian: Modra in bela dvoslojna tableta ovalne oblike z oznako A1 in znakom podjetja na belem sloju.
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 1.000 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, potreba po mokrenju ponoči, slabo počutje (bolehnost), povečana raven sečne kisline v krvi.
English: What Twynsta looks like and contents of the pack Twynsta 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 white layer.
Slovenian: Tablete Twynsta po 80 mg/10 mg so modre in bele dvoslojne tablete ovalne oblike z oznako A4 in znakom podjetja na belem sloju.
English: Twynsta 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg alone.
Slovenian: Tablete Twynsta po 40 mg/10 mg lahko prejemajo bolniki, pri katerih krvnega tlaka ni mogoče ustrezno uravnati s samim amlodipinom po 10 mg.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/10 mg tablets telmisartan/amlodipine
Slovenian: IME ZDRAVILA Twynsta 80 mg/10 mg tablete telmisartan/amlodipin
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets)
Slovenian: EU/1/10/648/022 (14 tablet) EU/1/10/648/023 (28 tablet) EU/1/10/648/024 (30 x 1 tableta) EU/1/10/648/025 (56 tablet) EU/1/10/648/026 (90 x 1 tableta) EU/1/10/648/027 (98 tablet)
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg /10 mg tablets telmisartan/amlodipine
Slovenian: IME ZDRAVILA Twynsta 40 mg/10 mg tablete telmisartan/amlodipin
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets)
Slovenian: EU/1/10/648/008 (14 tablet) EU/1/10/648/009 (28 tablet) EU/1/10/648/010 (30 x 1 tableta) EU/1/10/648/011 (56 tablet) EU/1/10/648/012 (90 x 1 tableta) EU/1/10/648/013 (98 tablet)
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets)
Slovenian: EU/1/10/648/015 (14 tablet) EU/1/10/648/016 (28 tablet) EU/1/10/648/017 (30 x 1 tableta) EU/1/10/648/018 (56 tablet) EU/1/10/648/019 (90 x 1 tableta) EU/1/10/648/020 (98 tablet)
English: Blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the white layer.
Slovenian: Modra in bela dvoslojna tableta ovalne oblike z oznako A3 in znakom podjetja na belem sloju.
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets) EU/1/10/648/028 (360 (4 x 90 x 1) tablets)
Slovenian: EU/1/10/648/022 (14 tablet) EU/1/10/648/023 (28 tablet) EU/1/10/648/024 (30 x 1 tableta) EU/1/10/648/025 (56 tablet) EU/1/10/648/026 (90 x 1 tableta) EU/1/10/648/027 (98 tablet) EU/1/10/648/028 (360 (4 x 90 x 1) tablet)
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Slovenian: EU/1/10/648/001 (14 tablet) EU/1/10/648/002 (28 tablet) EU/1/10/648/003 (30 x 1 tableta) EU/1/10/648/004 (56 tablet) EU/1/10/648/005 (90 x 1 tableta) EU/1/10/648/006 (98 tablet) EU/1/10/648/007 (360 (4 x 90 x 1) tablet)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/648/014 (360 (4 x 90 x 1) tablet)
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Slovenian: EU/1/10/648/008 (14 tablet) EU/1/10/648/009 (28 tablet) EU/1/10/648/010 (30 x 1 tableta) EU/1/10/648/011 (56 tablet) EU/1/10/648/012 (90 x 1 tableta) EU/1/10/648/013 (98 tablet) EU/1/10/648/014 (360 (4 x 90 x 1) tablet)
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets)
Slovenian: EU/1/10/648/001 (14 tablet) EU/1/10/648/002 (28 tablet) EU/1/10/648/003 (30 x 1 tableta) EU/1/10/648/004 (56 tablet) EU/1/10/648/005 (90 x 1 tableta) EU/1/10/648/006 (98 tablet)
English: What Twynsta looks like and contents of the pack Twynsta 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 white layer.
Slovenian: Tablete Twynsta po 40 mg/10 mg so modre in bele dvoslojne tablete ovalne oblike z oznako A2 in znakom podjetja na belem sloju.
English: Blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the white layer.
Slovenian: Modra in bela dvoslojna tableta ovalne oblike z oznako A4 in znakom podjetja na belem sloju.
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Slovenian: EU/1/10/648/015 (14 tablet) EU/1/10/648/016 (28 tablet) EU/1/10/648/017 (30 x 1 tableta) EU/1/10/648/018 (56 tablet) EU/1/10/648/019 (90 x 1 tableta) EU/1/10/648/020 (98 tablet) EU/1/10/648/021 (360 (4 x 90 x 1) tablet)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/648/021 (360 (4 x 90 x 1) tablet)
English: There is no experience regarding the administration of telmisartan/amlodipine in patients with a recent kidney transplant.
Slovenian: Pri bolnikih z nedavno presajeno ledvico ni izkušenj z uporabo telmisartana/amlodipina.
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 - 40 mg/10 mg
Slovenian: VMESNA OVOJNINA PRI SKUPINSKEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - BREZ MODREGA OKENCA - 40 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 - 40 mg/5 mg
Slovenian: VMESNA OVOJNINA PRI SKUPINSKEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - BREZ MODREGA OKENCA - 40 mg/5 mg