natgillin/translations-raw huggingface dataset:
Animal reproductive toxicity studies with telmisartan/amlodipine have not been performed.
Nisu provedene studije reproduktivne toksičnosti na životinjama s kombinacijom telmisartan/amlodipin.
Cardiac disorders Uncommon bradycardia, palpitations
Srčani poremećaji Manje često bradikardija, palpitacije
The elimination half-life of telmisartan is not changed in patients with hepatic impairment.
Poluvijek eliminacije telmisartana ostao je nepromijenjen kod bolesnika s oštećenjem jetre.
ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients with diabetic nephropathy.
ACE inhibitori i blokatori receptora angiotenzina II stoga se ne smiju istodobno primjenjivati u bolesnika s dijabetičkom nefropatijom.
Very rare hyperglycaemia
Vrlo rijetko hiperglikemija
In another multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 947 patients with mild to severe hypertension who were not adequately controlled on amlodipine 10 mg received Twynsta (40 mg/10 mg or 80 mg/10 mg) or amlodipine alone (10 mg).
U drugoj multicentričnoj, randomiziranoj, dvostruko-slijepoj, aktivno kontroliranoj studiji na paralelnim skupinama, ukupno 947 bolesnika s blagom do umjerenom hipertenzijom koji nisu bili odgovarajuće kontrolirani amlodipinom 10 mg primalo je Twynstu (40 mg/10 mg ili 80 mg/10 mg) ili samo amlodipin (10 mg).
Administration of Twynsta with grapefruit or grapefruit juice is not recommended since bioavailability may be increased in certain patients resulting in increased blood pressure lowering effects.
Ne preporučuje se istodobna primjena lijeka Twynsta i grejpa ili soka od grejpa jer bioraspoloživost u nekih bolesnika može biti povećana te može rezultirati pojačanjem hipotenzivnog učinka.
Each tablet contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Jedna tableta sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
Other antihypertensive agents acting on the renin-angiotensin-aldosterone system (RAAS) Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Drugi antihipertenzivni lijekovi koji djeluju na renin-angiotenzin-aldosteronski sustav (RAAS) Podaci iz kliničkih ispitivanja pokazali su da je dvostruka blokada renin-angiotenzin-aldosteronskog sustava (RAAS) kombiniranom primjenom ACE inhibitora, blokatora receptora angiotenzina II ili aliskirena povezana s većom učestalošću štetnih događaja kao što su hipotenzija, hiperkalemija i smanjena bubrežna funkcija (uključujući akutno zatajenje bubrega) u usporedbi s primjenom samo jednog lijeka koji djeluje na RAAS (vidjeti dijelove 4.3, 4.4 i 5.1)
In a subset of 1050 patients with moderate to severe hypertension (DBP ≥100 mmHg) 32.7-51.8 % responded sufficiently to monotherapy of either telmisartan or amlodipine.
U podskupini od 1050 bolesnika s umjerenom do teškom hipertenzijom (DKT ≥ 100 mmHg) 32,7-51,8 % je reagiralo dostatno na monoterapiju, bilo telmisartanom ili amlodipinom.
Twynsta contains sodium
Twynsta sadrži natrij
In a further multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 1097 patients with mild to severe hypertension who were not adequately controlled on amlodipine 5 mg received Twynsta (40 mg/5 mg or 80 mg/5 mg) or amlodipine alone (5 mg or 10 mg).
U daljnjoj multicentričnoj, randomiziranoj, dvostruko-slijepoj, aktivno kontroliranoj studiji na paralenim skupinama, ukupno je 1097 bolesnika s blagom do umjerenom hipertenzijom koji nisu bili odgovarajuće kontrolirani amlodipinom 5 mg primalo Twynstu (40 mg/5 mg ili 80 mg/5 mg) ili samo amlodipin (5 mg ili 10 mg).
Rare eczema, erythema, rash angioedema (with fatal outcome), drug eruption, toxic skin eruption, urticaria
Rijetko ekcem, eritem, osip angioedem (sa smrtnim ishodom), izbijanje kožnih promjena uzrokovano lijekom, izbijanje kožnih promjena uzrokovano toksičnim učinkom lijeka, urtikarija
Twynsta 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), 24.7/ 20.2 mmHg (40 mg/10 mg) and 26.4/ 20.1 mmHg (80 mg/10 mg).
Twynsta je, ovisno o rasponu doza, pokazala sniženje sistoličkog/dijastoličkog krvnog tlaka od -21,8/16,5 mmHg (40 mg/5 mg), -22,1/-18,2 mmHg (80 mg/5 mg), -24,7/-20,2 mmHg (40 mg/10 mg) i26,4/-20,1 mmHg (80 mg/10 mg).
Ear and labyrinth disorders Uncommon vertigo tinnitus
Poremećaji uha i labirinta Manje često vrtoglavica tinitus
Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Lijekovi ili terapijske skupine lijekova koji mogu dovesti do hiperkalijemije su zamjena za soli koje sadrže kalij, diuretici koji štede kalij, ACE inhibitori, antagonisti receptora angiotenzina II, nesteroidni protuupalni lijekovi (NSAIL-i, uključujući selektivne COX-2 inhibitore), heparin, imunosupresivi (ciklosporin ili takrolimus) i trimetoprim. - interkurentni događaji, osobito dehidracija, akutna dekompenzacija srca, metabolička acidoza, pogoršanje bubrežne funkcije, iznenadno pogoršanje stanja bubrega (npr. infektivne bolesti), liza stanica (npr. akutna ishemija uda, rabdomioliza, produljena trauma).
Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in
ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) i VA NEPHRON-D (eng. The Veterans Affairs Nephropathy in Diabetes)) ispitivala su primjenu kombinacije ACE inhibitora s blokatorom angiotenzin II receptora.
How to store Twynsta
Kako čuvati Twynstu
Hyperkalaemia may be fatal in the elderly, in patients with renal insufficiency, in diabetic patients, in patients concomitantly treated with other medicinal products that may increase potassium levels, and/or in patients with intercurrent events.
Kod starijih osoba, bolesnika s insuficijencijom bubrega, dijabetičara, osoba koje se istodobno liječe drugim lijekovima koji mogu povisiti vrijednosti kalija, i/ili bolesnika s interkurentnim događajima, hiperkalijemija može biti fatalna.
Respiratory, thoracic and mediastinal disorders Uncommon cough dyspnoea dyspnoea, rhinitis
Poremećaji dišnog sustava, prsišta i sredoprsja Manje često kašalj dispneja dispneja, rinitis
Musculoskeletal and connective tissue disorders Common ankle swelling
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često oticanje gležnjeva
Progressive scarring of lung tissue (interstitial lung disease [mainly pneumonia of the interstitium and pneumonia with excess eosinophils])
Vrlo rijetke nuspojave (mogu se javiti kod do 1 na 10000 osoba) Progresivno stvaranje ožiljaka na plućnom tkivu (intersticijska bolest pluća [uglavnom upala intersticija pluća i upala pluća s prekomjernim brojem eozinofila])
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.
Promjene raspoloženja, oštećeni vid, šum u ušima, nedostatak zraka, kihanje/curenje nosa, gubitak kose, neuobičajene modrice i krvarenja (oštećenje crvenih krvnih stanica), promjena boje kože, pojačano znojenje, otežano mokrenje, povećana potreba za mokrenjem osobito noću, povećanje grudi u muškaraca, bolovi, porast težine, smanjenje težine.
Rare tachycardia
Rijetko tahikardija
Colloidal anhydrous silica Brilliant blue FCF (E133) Ferric oxide black (E172) Ferric oxide yellow (E172) Magnesium stearate
6.1 Popis pomoćnih tvari silicijev dioksid, koloidni, bezvodni Brilliant blue FCF (E 133) željezov oksid, crni (E172) željezov oksid, žuti (E172) magnezijev stearat kukuruzni škrob meglumin celuloza, mikrokristalična povidon (K25) škrob, prethodno geliran (pripravljen od kukuruznog škroba) natrijev hidroksid sorbitol (E420)
Twynsta contains sorbitol This medicine contains 168.64 mg sorbitol in each tablet.
Ovaj lijek sadrži 168,64 mg sorbitola u jednoj tableti.
Vascular disorders Uncommon hypotension, orthostatic hypotension, flushing
Krvožilni poremećaji Manje često hipotenzija, ortostatska hipotenzija, crvenilo praćeno osjećajem vrućine
Rare hepatic function abnormal, liver disorder
Poremećaji jetre i žuči Rijetko poremećena jetrena funkcija, poremećaj jetre
• The active substances are telmisartan and amlodipine.
• Djelatne tvari su telmisartan i amlodipin.
Nervous system disorders Common dizziness
Poremećaji živčanog sustava Često omaglica
Patients with cardiac failure
Bolesnici sa zatajenjem srca
Very rare side effect (may affect up to 1 in 10,000 people):
Vrlo rijetke nuspojave (mogu se javiti kod do 1 na 10 000 osoba):
Uncommon asthenia, chest pain, fatigue, oedema pain
Manje često astenija, bol u prsima, umor, edem bol
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.
Povećanje broja nekih bijelih krvnih stanica (eozinofilija), niski broj trombocita (trombocitopenija), alergijske reakcije (npr. osip, svrbež, teškoće pri disanju, piskanje, otečenost lica i niski krvni tlak), niske razine šećera u krvi (kod bolesnika s dijabetesom), oštećeni vid, ubrzano kucanje srca, želučane tegobe, poremećaj jetrene funkcije, koprivnjača (urtikarija), medikamentni osip, upala tetiva, bolest slična gripi (na primjer bol mišića, opće loše osjećanje), smanjena koncentracija hemoglobina (protein u krvi), povišene vrijednosti kreatinin fosfokinaze u krvi.
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.
Smanjeni broj bijelih krvnih stanica (leukopenija), niski broj trombocita (tromobcitopenija), alergijska reakcija (npr. osip, svrbež, otežano disanje, piskanje pri disanju, otečenost lica ili niski krvni tlak), povećane vrijednosti šećera u krvi, nekontrolirani pokreti grčenja ili trzanja, srčani udar, nepravilno kucanje srca, upala krvnih žila, upala gušterače, upala želučane sluznice (gastritis), upala jetre, žutilo kože (žutica), povišene vrijednosti jetrenih enzima sa žuticom, brzo oticanje kože i sluznice (angioedem), teške reakcije kože, koprivnjača (urtikarija), teške alergijske reakcije s izbijanjem mjehurića po koži i membranama sluznice (eksfolijativni dermatitis, Stevens-Johnsonov sindrom), pojačana osjetljivost kože na sunce, povećana napetost mišića.
General disorders and administration site condition Common peripheral oedema
Opći poremećaji i reakcije na mjestu primjene Često periferni edem
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.
Twynsta 80 mg/10 mg je indicirana u liječenju odraslih osoba kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka s Twynstom 40 mg/10 mg ili Twynstom 80 mg/5 mg.
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).
Primijećene prosječne promjene sistoličkog/dijastoličkog krvnog tlaka uz kombiniranu terapiju s amlodipinom 5 mg (-22,2/17,2 mmHg s 40 mg/5 mg; -22,5/19,1 mmHg uz 80 mg/5 mg) bile su usporedive ili veće od onih primijećenih uz amolodipin 10 mg (-21,0/-17,6 mmHg) te povezane sa značajno nižom učestalošću edema (1,4 % uz 40 mg/5 mg; 0,5 % uz 80 mg/5 mg; 17,6 % uz amlodipin 10 mg).
Maize starch
• Gospina trava.
Tabulated list of adverse reactions
Tabličnini prikaz nuspojava
Gastric lavage may be worthwhile in some cases.
U nekim slučajevima može biti korisno ispiranje želuca.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/10 mg
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija - 80 mg/10 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 40 mg/10 mg
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 40 mg/10 mg
Renal and urinary disorders Uncommon renal impairment including acute renal failure micturition disorder, pollakiuria
Poremećaji bubrega i mokraćnog sustava Manje često oštećenje bubrega uključujući akutno zatajenje bubrega poremećaj mokrenja, polakizurija
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/5 mg
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 80 mg/5 mg
• Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets'), low-salt diet, diarrhoea, or vomiting.
ili gubitka soli zbog terapije diureticima (»tablete za izmokravanje»), prehrane s malim udjelom soli, proljeva, ili povraćanja.
Impairment of fertility
Smanjena plodnost
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 40 mg/5 mg
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 40 mg/5 mg
Very rare leukocytopenia, thrombocytopenia
Vrlo rijetko leukocitopenija, trombocitopenija
Uncommon arthralgia, muscle spasms (cramps in legs), myalgia
Manje često artralgija, spazam mišića (grčevi u nogama), mialgija
INFORMATION IN BRAILLE Twynsta 80 mg/5 mg
16. PODACI NA BRAILLEOVOM PISMU Twynsta 80 mg/5 mg
NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/10 mg tablets
NAZIV LIJEKA Twynsta 40 mg/10 mg tablete
Twynsta 40 mg/10 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 10 mg alone.
Twynsta 40 mg/10 mg je indicirana u liječenju odraslih osoba kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka monoterapijom amlodipinom od 10 mg.
INFORMATION IN BRAILLE Twynsta 80 mg/10 mg
16. PODACI NA BRAILLEOVOM PISMU Twynsta 80 mg/10 mg
NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/10 mg tablets
NAZIV LIJEKA Twynsta 80 mg/10 mg tablete
NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/5 mg tablets
NAZIV LIJEKA Twynsta 80 mg/5 mg tablete
NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/5 mg tablets
NAZIV LIJEKA Twynsta 40 mg/5 mg tablete
INFORMATION IN BRAILLE Twynsta 40 mg/5 mg
16. PODACI NA BRAILLEOVOM PISMU Twynsta 40 mg/5 mg
INFORMATION IN BRAILLE Twynsta 40 mg/10 mg
16. PODACI NA BRAILLEOVOM PISMU Twynsta 40 mg/10 mg
There is a risk of increased tacrolimus blood levels when co-administered with amlodipine but the pharmacokinetic mechanism of this interaction is not fully understood.
Postoji rizik od povišenih vrijednosti takrolimusa u krvi kada se uzima istodobno s amlodipinom.
Rare nocturia
Rijetko nokturija
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.
(angioedem), teške reakcije kože, koprivnjača (urtikarija), teške alergijske reakcije s izbijanjem mjehurića po koži i membranama sluznice (eksfolijativni dermatitis, Stevens-Johnsonov sindrom), pojačana osjetljivost kože na sunce, povećana napetost mišića.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
KVALITATIVNI I KVANTITAVNI SASTAV Jedna tableta sadržava 80 mg telmisartana i 5 mg amlodipina (u obliku amlodipinbesilata).
Twynsta 80 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled with Twynsta 40 mg/5 mg .
Twynsta 80 mg/5 mg je indicirana u liječenju odraslih osoba kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka uz Twynstu 40 mg/5 mg.
Twynsta 40 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 5 mg alone.
Twynsta 40 mg/5 mg je indicirana u liječenju odraslih osoba kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka monoterapijom amlodipinom od 5 mg.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
KVALITATIVNI I KVANTITAVNI SASTAV Jedna tableta sadržava 40 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
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).
Nakon 8 tjedana liječenja, sva kombinirana liječenja bila su statistički značajno superiorna monoterapiji amlodipinom u sniženju dijastoličkog i sistoličkog krvnog tlaka (11,1/-9,2 mmHg, -11,3/-9,3 mmHg uz 40 mg/10 mg, 80 mg/10 mg u odnosu na -7,4/-6,5 mmHg uz amlodipin 10 mg), te je postignuta viša stopa normalizacije dijastoličkog krvnog tlaka u usporedbi s monoterapijom (63,7 %, 66,5 % uz 40 mg/10 mg, 80 mg/10 mg u odnosu na 51,1% uz amlodipin 10 mg).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
KVALITATIVNI I KVANTITAVNI SASTAV Jedna tableta sadržava 80 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
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).
Nakon 8 tjedana liječenja, svaka od kombinacija bila je statistički superiorna u odnosu na obje monoterapijske doze amlodipina u snižavanju sistoličkog i dijastoličkog krvnog tlaka (-13,6/-9,4 mmHg, -15,0/-10,6 mmHg uz 40 mg/5 mg, 80 mg/5 mg u odnosu na -6,2/5,7 mmHg, -11,1/-8,0 mmHg uz amlodipin 5 mg i 10 mg, a postignuta je viša stopa kontrole dijastoličkog krvnog tlaka u usporedbi s relevantnim monoterapijama (56,7 %, 63,8 % uz 40 mg/5 mg i 80 mg/5 mg u odnosu na 42 %, 56,7 % uz amlodipin 5 mg i 10 mg).
Twynsta 40 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg alone.
Twynstu 40 mg/5 mg mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka monoterapijom amlodipinom od 5 mg.
Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Svaka tableta sadržava 40 mg telmisartana i 5 mg amlodipina (u obliku amlodipinbesilata).
NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/5 mg tablets telmisartan/amlodipine
NAZIV LIJEKA Twynsta 80 mg/5 mg tablete telmisartan/amlodipin
Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Svaka tableta sadržava 80 mg telmisartana i 5 mg amlodipina (u obliku amlodipinbesilata).
NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/10 mg tablets telmisartan/amlodipine
NAZIV LIJEKA Twynsta 80 mg/10 mg tablete telmisartan/amlodipin
Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Svaka tableta sadržava 80 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/10 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister sa 7 tableta - 80 mg/10 mg
Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Svaka tableta sadržava 40 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/10 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister sa 7 tableta - 40 mg/10 mg
Package leaflet: Information for the user Twynsta 80 mg/10 mg tablets Telmisartan/Amlodipine
Uputa o lijeku: Informacije za korisnika Twynsta 80 mg/10 mg tablete telmisartan/amlodipin
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/10 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister djeljiv na jedinične doze sa 10 tableta - 80 mg/10 mg
Package leaflet: Information for the user Twynsta 40 mg/10 mg tablets Telmisartan/Amlodipine
Uputa o lijeku: Informacije za korisnika Twynsta 40 mg/10 mg tablete telmisartan/amlodipin
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/5 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister sa 7 tableta - 80 mg/5 mg
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.
Twynsta 40 mg/5 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A1 i logom tvrtke na bijelom sloju.
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/1/10/648/001 (14 tableta) EU/1/10/648/002 (28 tableta) EU/1/10/648/003 (30 x 1 tableta) EU/1/10/648/004 (56 tableta) EU/1/10/648/005 (90 x 1 tableta) EU/1/10/648/006 (98 tableta)
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 40 mg/10 mg
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister djeljiv na jedinične doze sa 10 tableta - 40 mg/10 mg
Twynsta 80 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with Twynsta 40 mg/5 mg.
Twynsta 80 mg/5 mg tablete mogu primjenjivati bolesnici kod kojih nije postignuta odgovarajuća kontrola krvnog tlaka s Twynstom 40 mg/5 mg.