Twynsta 40mg/5mg 28compr (2023)

Afectiune Afectiuni cardiovasculare Mod de administrare Doze
Doza recomandata de Twynsta comprimate este de un comprimat pe zi.

Doza maxima recomandata este Twynsta 80 mg/10 mg un comprimat pe zi. Twynsta este indicata pentru tratamentul de lunga durata.

Terapie in asociere
Twynsta 40 mg/5 mg comprimate poate fi administrata la pacientii a caror tensiune arteriala nu este controlata adecvat numai cu amlodipina 5 mg in monoterapie.

Pentru fiecare pacient in parte, inainte de a se lua in considerare schimbarea cu combinatia in doza fixa se recomanda stabilirea treptata a dozelor pentru fiecare dintre substantele componente (adica amlodipina si telmisartan). Atunci cand este adecvat din punct de vedere clinic poate fi luata in considerare schimbarea directa a monoterapiei cu combinatia in doza fixa.

Pacientilor carora li s-a administrat amlodipina 10 mg si care au manifestat orice tip de reactii adverse care au impus limitarea dozei, cum este edemul, li se poate schimba tratamentul cu Twynsta 40 mg/5 mg administrat o data pe zi reducand doza de amlodipina fara scaderea raspunsului anti-hipertensiv asteptat

Terapie de substitutie
Pacientilor carora li se administreaza telmisartan si amlodipina sub forma de comprimate separate li se pot administra comprimate de Twynsta, care contin aceste substante active in aceleasi doze intr-un singur comprimat, care se administreaza o data pe zi, pentru cresterea confortului si compliantei la administrare a tratamentului.

Grupe speciale de pacienti

Varstnici
Nu este necesara ajustarea dozei la varstnici. La pacientii foarte varstnici sunt disponibile putine date.

Insuficienta renala
La pacientii cu insuficienta renala usoara pana la moderata nu este necesara ajustarea dozelor. La pacientii cu cu insuficienta renala severa sau care efectueaza sedinte de hemodializa experienta disponibila este limitata. Se recomanda prudenta la administrarea Twynsta acestor tip de pacienti deoarece amlodipina si temisartanul nu sunt dializabile.

Insuficienta hepatica
Twynsta trebuie administrat cu prudenta pacientilor cu insuficienta hepatica usoara pana la moderata. Pentru telmisartan doza nu trebuie sa depaseasca 40 mg o data pe zi.
Twynsta este contraindicat la pacientii cu insuficienta hepatica severa.

Copii si adolescenti
Siguranta si eficacitatea administrarii Twynsta la copii si adolescenti cu varsta sub 18 ani nu sunt stabilite. Nu sunt disponibile date cu privire la administrarea la aceasta grupa de varsta.

Mod de administrare
Twynsta poate fi administrat cu sau fara alimente. Se recomanda administrarea Twynsta cu o cantitate suficienta de lichid.

Substanta activa COMBINATII (TELMISARTANUM+AMLODIPINUM) Simptome Hipertensiune arteriala Sarcina si alaptare Sarcina
Nu exista date adecvate cu privire la utilizarea Twynsta la gravide. Nu au fost efectuate studii de toxicitate asupra functiei reproductive la animale.

Telmisartan
Tratamentul cu antagonisti ai receptorilor angiotensinei II nu este recomandat in timpul primului trimestru de sarcina. Tratamentul cu antagonisti ai receptorilor angiotensinei II este contraindicat in timpul celui de al doilea si al treilea trimestru de sarcina.

Studiile la animale au evidentiat efecte toxice asupra functiei de reproducere.

Dovezile epidemiologice legate de riscul de teratogenitate ca urmare a expunerii la inhibitori ai ECA in timpul primului trimestru de sarcina nu au fost concludente; cu toate acestea, o crestere usoara a riscului nu poate fi exclusa. in timp ce nu exista date epidemiologice controlate asupra riscului tratamentului cu antagonisti ai receptorilor angiotensinei II, pot exista riscuri similare pentru aceasta clasa de medicamente. Cu exceptia cazurilor in care continuarea terapiei cu antagonisti ai receptorilor angiotensinei II este considerata esentiala, pacientele care intentioneaza sa ramana gravide trebuie trecute pe tratamente antihipertensive alternative, care au un profil de siguranta bine stabilit in cazul administrarii lor in timpul sarcinii. in momentul in care sarcina este diagnosticata, tratamentul cu antagonisti ai receptorilor angiotensinei II trebuie oprit imediat si, daca este necesar, trebuie inceput tratamentul alternativ.

Este cunoscut faptul ca expunerea la tratamentul cu antagonisti ai receptorilor angiotensinei II in perioada trimestrului doi si trei de sarcina induce fetotoxicitate la om (diminuarea functiei renale, oligohidroamnios, intarziere a procesului de osificare a craniului) si toxicitate neonatala (insuficienta renala, hipotensiune arteriala, hiperkaliemie).
Daca expunerea la antagonisti ai receptorilor angiotensinei II a aparut din perioada trimestrului doi de sarcina, se recomanda investigarea ecografica a functiei renale si a craniului. Nou-nascutii ale caror mame au utilizat antagonisti ai receptorilor angiotensinei II trebuie tinuti sub atenta observatie din cauza hipotensiunii arteriale.

Amlodipina
Datele obtinute dintr-un numar limitat de sarcini expuse nu au indicat daca amlodipina sau alti antagonisti ai receptorilor de calciu au un efect nociv asupra sanatatii fatului. Cu toate acestea, poate exista un risc de travaliu prelungit.

Alaptarea
Deoarece nu sunt disponibile informatii in legatura cu utilizarea telmisartan si/sau amlodipina in timpul alaptarii, nu este recomandata administrareaTwynsta si sunt de preferat tratamente alternative cu profil de siguranta mai bine stabilit, mai ales in cazul alaptarii unui nou-nascut sau unui prematur.

Fertilitatea
Nu sunt disponibile date din studiile clinice controlate cu combinatii de doze fixe sau cu componente individuale.

Nu au fost efectuate studii separate privind efectele toxicitatii asupra reproducerii cu combinatii de telmisartan si amlodipina.
in studiile preclinice nu au fost observate efecte ale temisartanului asupra fertilitatii masculine si feminine.
De asemenean nu au fost raportate efecte ale amlodipinei asupra fertilitatii masculine si feminine.

In cadrul studiilor preclinice sau in vitro au fost observate modificari biochimice reversibile la nivelul interiorului capului spermatozoizilor produse de blocantele canalelor de calciu, care pot pot afecta fecundarea. Nu a fost stabilita relevanta clinica a acestor date.

Reactii adverse Combinatia in doza fixa

Cele mai frecvente reactii adverse includ ametelile si edemul periferic. Rar (la mai putin de 1 caz din 1000 pacienti) pot apare sincope grave.

Siguranta si tolerabilitatea Twynsta au fost evaluate in cadrul a cinci studii clinice controlate in care au fost inrolati peste 3500 pacienti, dintre care peste 2500 au fost tratati cu telmisartan in combinatie cu amlodipina.

In fiecare grup de clasificare privind frecventa, reactiile adverse sunt prezentate in ordinea descrescatoare a gravitatii.

Aparate, sisteme si organe

Infectii si infestari
Rare: cinstita

Tulburari psihice
Rare: depresie, anxietate, insomnie

Tulburari ale sistemului nervos
Frecvente: ameteli
Mai putin frecvente: somnolenta, migrena, cefalee, parestezie

Tulburari acustice si vestibulare
Mai putin frecvente: vertij

Tulburari cardiace
Mai putin frecvente: bradicardie, palpitatii

Tulburari vasculare
Mai putin frecvente: hipotensiune arteriala, hipotensiune arteriala ortostatica, eritem facial tranzitoriu

Tulburari respiratorii, toracice si mediastinale
Mai putin frecvente: tuse

Tulburari gastro-intestinale
Mai putin frecvente: durere abdominala, diaree, greata
Rare: varsaturi, hipertrofie gingivala, dispepsie, xerostomie

Afectiuni cutanate si ale tesutului subcutanat
Mai putin frecvente: prurit
Rare: eczema, eritem, eruptii cutanate tranzitorii

Tulburari musculo-scheletice si ale tesutului conjunctiv
Mai putin frecvente: artralgie, spasme tranzitorii (crampe la nivelul membrelor inferioare), mialgie
Rare: dorsalgie, durere la nivelul extremitatilor (la nivelul membrelor inferioare)

Tulburari renale si ale cailor urinare
Rare:nicturie

Tulburari ale aparatului genital si sanului
Mai putin frecvente: disfunctie erectila

Tulburari generale si la nivelul locului de administrare
Frecvente: edem periferic

Informatii suplimentare in legatura cu componentele individuale

Reactiile adverse raportate anterior in legatura cu una dintre componentele individuale (telmisartan sau amlodipina) sunt reactii adverse potentiale si in cazul TWYNSTA, chiar daca nu au fost observate in studiile clinice sau in perioada dupa punerea pe piata.

Telmisartan:

Infectii si infestari
Mai putin frecvente: Infectie la nivelul cailor respiratorii superioare, incluzand faringita si sinuzita, infectie de tract urinar, incluzand cistita
Rare: Sepsis, inclusiv cu final letal*

Tulburari hematologice si limfatice
Mai putin frecvente: Anemie
Rare: Trombocitopenie, eozinofilie

Tulburari ale sistemului imunitar
Rare: Hipersensibilitate, reactii anafilactice

Tulburari metabolice si de nutritie
Mai putin frecvente: Hiperkaliemie
Rare: Hipoglicemie (la pacienti cu diabet zaharat)

Tulburari oculare
Rare: Tulburari de vedere

Tulburari cardiace
Rare: Tahicardie

Tulburari respiratorii, toracice si mediastinale
Mai putin frecvente: Dispnee

Tulburari gastro-intestinale
Mai putin frecvente: Flatulenta
Rare: Disconfort gastric

Tulburari hepatobiliare
Rare: Functie hepatica anormala, tulburari hepatice2

Afectiuni cutanate si ale tesutului subcutanat
Mai putin frecvente: Hiperhidroza
Rare: Angioedem (cu final fatal), eruptie cutanata provocata de medicament, eruptie cutanata toxica, urticarie

Tulburari musculo-scheletice si ale tesutului conjunctiv
Rare: Durere la nivelul tendoanelor (simptome asemanatoare tendinitei)

Tulburari renale si ale cailor urinare
Mai putin frecvente: Insuficienta renala incluzand insuficienta renala acuta

Tulburari generale si la nivelul locului de administrare
Rare: Simptomatologie asemanatoare gripei

Investigatii diagnostice
Mai putin frecvente: Cresterea a creatinemiei
Rare: Cresterea concentratiei plasmatice de fosfokinaza, scaderea concentratiei de hemoglobina

*1 evenimentul poate fi o descoperire intamplatoare sau poate fi legat de un mecanism necunoscut in prezent.
*2 cele mai frecvente cazuri de functie hepatica anormala/tulburari hepatice din experienta dupa punerea pe piata cu telmisartan au aparut la pacienti japonezi. Acestia sunt mai predispusi la manifestarea acestor reactii adverse.

Amlodipina

Tulburari hematologice si limfatice
Foarte rare: leucopenie, trombocitopenie

Tulburari ale sistemului imunitar
Foarte rare: Hipersensibilitate

Tulburari metabolice si de nutritie
Foarte rare: Hiperglicemia

Tulburari psihice
Mai putin frecvente: Modificari ale dispozitiei
Rare: Confuzie

Tulburari ale sistemului nervos
Foarte rare: Sindrom extrapiramidal

Tulburari oculare
Mai putin frecvente: Tulburari de vedere

Tulburari acustice si vestibulare
Mai putin frecvente: Tinitus

Tulburari cardiace
Foarte rare: Infarct miocardic, aritmie, tahicardie ventriculara, fibrilatie atriala

Tulburari vasculare
Foarte rare: Vasculita

Tulburari respiratorii, toracice si mediastinale
Mai putin frecvente: Dispnee, rinita

Tulburari gastro-intestinale
Mai putin frecvente: Modificari ale obiceiurilor legate de tranzitul intestinal
Foarte rare: Pancreatita, gastrita

Tulburari hepatobiliare
Foarte rare: Hepatita, icter, crestere a valorilor serice ale enzimelor hepatice (cel mai frecvent cu colestaza)

Afectiuni cutanate si ale tesutului subcutanat
Mai putin frecvente: Alopecie, purpura, modificare a culorii pielii, hiperhidroza
Foarte rare: Angioedem, eritem polimorf, urticarie, dermatita exfoliativa, sindrom Stevens-Johnson, fotosensibilitate

Tulburari renale si ale cailor urinare
Mai putin frecvente: Tulburari de mictiune, polakiurie

Tulburari ale aparatului genital si sanului
Mai putin frecvente: Ginecomastie

Tulburari generale si la nivelul locului de administrare
Mai putin frecvente: Durere

Investigatii diagnostice
Mai putin frecvente: Crestere sau scadere in greutate

Precautii Insuficienta hepatica
Telmisartanul este eliminat in principal in bila. Se asteapta ca la pacientii cu afectiuni biliare obstructive sau insuficienta hepatica severa, clearance-ul hepatic al telmisartanului sa fie redus.
Suplimentar, similar tuturor antagonistilor de calciu, timpul de injumatatire plasmatica al amlodipinei este prelungit la pacientii cu disfunctie hepatica iar la acesti pacienti nu au fost stabilite recomandari de doze. De aceea, Twynsta trebuie utilizata cu precautie in cazul acestor pacienti

Hipertensiune arteriala renovasculara
Exista un risc crescut de hipotensiune arteriala severa si insuficienta renala la pacientii cu stenoza bilaterala a arterelor renale sau cu stenoza a arterei renale a rinichiului unic functional, tratati cu medicamente care afecteaza sistemul renina-angiotensina-aldosteron.

Insuficienta renala si transplant renal
Este recomandata monitorizarea periodica a concentratiilor plasmatice ale potasiului si creatininei serice atunci cand se administreaza Twynsta la pacientii cu insuficienta renala. Nu exista experienta in ceea ce priveste administrarea Twynsta la pacientii cu transplant renal recent.
Telmisartanul si amlodipina nu sunt dializabile.

Hipovolemie intravasculara
La pacientii cu hipovolemie si/sau depletie de sodiu ca urmare a unei terapii diuretice intensive, restrictiei de sare din dieta, diareei sau varsaturilor poate sa apara hipotensiune arteriala simptomatica, in special dupa administrarea primei doze. Asemenea situatii trebuie corectate inainte de administrarea de telmisartan. Daca in cazul administrarii Twynsta apare hipotensiune arteriala, pacientul trebuie asezat in clinostatism, cu picioarele ridicate si, daca este necesar, trebuie sa i se administreze intravenos perfuzie cu solutie salina izotona. Tratamentul poate fi continuat de indata ce tensiunea arteriala a fost stabilizata.

Dubla blocare a sistemului renina-angiotensina-aldosteron
La pacientii cu predispozitie,au fost raportate hipotensiune arteriala si modificari ale functiei renale (incluzand insuficienta renala acuta) ca o consecinta a inhibarii sitemului renina-angiotensina-aldosteron, mai ales daca se administreaza concomitent medicamente care afecteaza acest sistem.
Twynsta poate fi administrat cu alte medicamente antihipertensive dar, cu toate acestea, dubla blocare a sistemului renina-angiotensina-aldosteron (de exemplu prin adaugarea unui inhibitor al enzimei de conversie a angiotensinei (ECA) la tratamentul cu antagonisti ai receptorilor angiotensinei II) nu este recomandata la pacienti care au deja tensiunea arteriala controlata medicamentos si, ca urmare, trebuie limitata la cazuri individuale bine definite, la care functia renala este strict monitorizata.

Alte situatii care implica stimularea sistemului renina-angiotensina-aldosteron
La pacientii la care tonusul vascular si functia renala depind predominant de activitatea sistemului renina-angiotensina-aldosteron (de exemplu, pacienti cu insuficienta cardiaca congestiva severa sau cu boala renala preexistenta, incluzand stenoza de artera renala), tratamentul cu medicamente care afecteaza acest sistem s-a asociat cu hipotensiune arteriala acuta, hiperazotemie, oligurie sau, rareori,
insuficienta renala acuta.

Hiperaldosteronism primar
in general, pacientii cu hiperaldosteronism primar nu raspund, la tratamentul cu medicamente antihipertensive care actioneaza prin inhibarea sistemului renina-angiotensina. De aceea, nu se recomanda administrarea de telmisartan.

Stenoza de valva aortica si mitrala, cardiomiopatie hipertrofica obstructiva
Ca si in cazul utilizarii altor vasodilatatoare, este necesara precautie speciala la pacientii diagnosticati cu stenoza aortica, stenoza mitrala sau de cardiomiopatie hipertrofica obstructiva.

Angina pectorala instabila, infarct miocardic acut
Nu exista date care sa sustina administrarea Twynsta in cazul anginei pectorale instabile si in timpul sau in decurs de o luna de la producerea unui infarct miocardic.

Insuficienta cardiaca
intr-un studiu pe termen lung controlat placebo (PRAISE-2), in cadrul caruia a fost administrata amlodipina la pacienti cu insuficienta cardiaca de etiologie non-ischemica de tip NYHA III si IV, amlodipina a fost asociata cu un numar crescut de raportari de edeme pulmonare, in ciuda diferentei
nesemnificative in ceea ce priveste incidenta agravarii insuficientei cardiace comparativ cu placebo.

Hiperkaliemie
Utilizarea medicamentelor care afecteaza sistemul renina-angiotensina-aldosteron poate cauza hiperkaliemie. Hiperkaliemia poate fi letala la pacientii varstnici, la cei cu insuficienta renala, la pacientii cu diabet zaharat, la pacientii carora li se administreaza concomient un alt medicament care poate creste concentratia plasmatica a potasiului si/sau la pacientii cu evenimente recurente.

inainte de a lua in considerare administrarea concomitenta a medicamentelor care afecteaza sistemul
renina-angiotensina-aldosteron, trebuie evaluat raportul risc/ beneficiu.
Principalii factori de risc pentru hiperkaliemie care trebuie luati in considerare sunt:
- Diabetul zaharat, insuficienta renala, varsta (> 70 de ani)
- Asocierile cu unul sau mai multe medicamente care afecteaza sistemul renina-angiotensina-aldosteron si/sau suplimente cu potasiu. Medicamentele sau clasele terapeutice de medicamente care pot produce hiperkaliemie sunt substituentii de sare care contin potasiu, diureticele care economisesc potasiul, inhibitori ai ECA, antagonisti ai receptorilor angiotensinei II, medicamente antiinflamatoare ne-steroidiene, (AINS, incluzand inhibitori selectivi ai COX-2), heparina, imunosupresoare (ciclosporina, tacrolimus) si trimetoprim.
- Evenimentele recurente, mai ales deshidratare, decompensare cardiaca acuta, acidoza metabolica, agravare a disfunctiei renale, agravare brusca a statusului renal (de exemplu boli infectioase), liza celulara (de exemplu ischemie acuta la nivelul membrelor, rabdomioliza,
trauma extinsa).

La acesti pacienti trebuie monitorizata strict concentratia plasmatica a potasiului.

Sorbitol
Acest medicament contine sorbitol (E420). Pacientii cu afectiuni ereditare rare de intoleranta la fructoza nu trebuie sa utilizeze Twynsta.

Altele
Ca si in cazul utilizarii oricarui alt medicament antihipertensiv, reducerea excesiva a tensiunii arteriale la pacientii cu cardiopatie ischemica sau boli cardiovasculare ischemice poate determina infarct miocardic sau accident vascular cerebral.

Interactiuni In studiile clinice nu au fost observate interactiuni intre cele doua substante active ale acestei combinatii in doza fixa.

Interactiuni comune combinatiei

Nu s-au efectuat studii privind interactiunile cu alte medicamente.

in cazul administrarii concomitente trebuie luate in considerare:

Alte medicamente antihipertensive
Efectul de scadere a tensiunii arteriale al Twynsta poate fi sporit de administrarea concomitenta cu alte medicamente antihipertensive.

Medicamente cu potential de scadere a tensiunii arteriale
Pe baza proprietatilor lor farmacologice se asteapta ca urmatoarele medicamente sa potenteze efectul hipotensiv al tuturor medicamentelor antihipertensive, incluzand Twynsta, de exemplu baclofen, amifostina, medicamente neuroleptice sau antidepresive. in plus, hipotensiunea arteriala ortostatica poate fi agravata de alcoolul etilic.

Corticosteroizi (administrare sistemica)
Scaderea efectului antihipertensiv.

Interactiuni legate de telmisartan

Administrarea concomitenta nu este recomandata

Diuretice care economisesc potasiul sau suplimentele de potasiu
Antagonistii receptorilor angiotensinei II, cum este telmisartanul, atenueaza pierderea de potasiu indusa de medicamentele diuretice.
Diureticele care economisesc potasiul, de exemplu spironolactona, eplerenona, triamteren sau amilorid, suplimentele de potasiu sau substituentii de sare care contin potasiu pot produce o crestere semnificativa a concentratiei plasmatice a potasiului. in cazul in care administrarea concomitenta este recomandata, ca urmare a hipokaliemiei diagnosticate, aceste medicamente trebuie utilizate cu prudenta si trebuie monitorizata frecvent concentratia plasmatica a potasiului.

Litiu
in cazul administrarii concomitente de litiu si inhibitori ai enzimei de conversie ai angiotensinei, ca si in cazul utilizarii concomitente cu antagonisti ai receptorilor angiotensinei II (incluzand telmisartan), s-au raportat cresteri reversible ale concentratiilor plasmatice de litiu si ale toxicitatii acestuia. Daca aceasta administrare concomitenta se dovedeste necesara, se recomanda monitorizarea cu atentie a concentratiei plasmatice a litiului in timpul utilizarii concomitente.

Administrare concomitenta care necesita prudenta

Medicamente antiinflamatoare nesteroidiene
AINS (adica acid acetilsalicilic in doze terapeutice antiinflamatoare, inhibitori ai COX-2 si AINS neselectivi) pot determina reducerea efectului antihipertensiv al antagonistilor receptorilor angiotensinei II.
La unii pacienti cu functie renala compromisa (de exemplu pacienti deshidratati sau pacienti varstnici cu functia renala compromisa), administrarea concomitenta de antagonisti ai receptorilor angiotensinei II cu medicamente care inhiba ciclooxigenaza poate determina o deteriorare suplimentara a functiei renale, incluzand insuficienta renala acuta posibila, care este de obicei reversibila. De aceea, este necesara precautie in cazul utilizarii concomitente, in special la varstnici. Dupa initierea terapiei concomitente si, in continuare periodic, pacientii trebuie hidratati corespunzator si se va lua in considerare monitorizarea functiei renale.

Ramipril
in cadrul unui studiu clinic, administrarea concomitenta de telmisartan si ramipril a dus la cresterea de pana la 2,5 ori a valorilor ASC0-24 si Cmax ale ramiprilului si ramiprilatului. Relevanta clinica a acestor observatii este necunoscuta.

Interactiuni legate de amlodipina

Administrare concomitenta care necesita prudenta

Inhibitori CYP3A4: in cazul administrarii concomitente cu inhibitorul CYP3A4 eritromicina la pacientii tineri si cu diltiazem la pacientii varstnici, concentratia plasmatica a amlodipinei creste cu 22%, respectiv 50%. Cu toate acestea, relevanta clinica a acestei descoperiri este nesigura. Nu se poate
spune cu certitudine ca inhibitorii puternici ai CYP3A4 (adica ketoconazol, itraconazol, ritonavir) ar putea creste concentratia plasmatica a amlodipinei la o valoare mai mare comparativ cu cea determinata de administrarea de diltiazem. Amlodipina trebuie administrata cu prudenta concomitent
cu inhibitori ai CYP3A4. Cu toate acestea, nu au fost raportate evenimente adverse care pot fi atribuite acestor interactiuni.

Inductori ai CYP3A4: nu exista date disponibile in ceea ce priveste efectul inductorilor CYP3A4 asupra amlodipinei. Administrarea concomitenta cu inductori ai CYP3A (adica rifampicina, Hypericum perforatum) poate duce la o scadere a concentratiei plasmatice a amlodipinei.

Grapefruit si suc de grapefruit: in cazul administrarii concomitente a 240 ml suc de grapefruit cu o doza orala unica de 10 mg amlodipina la 20 de voluntari sanatosi nu a fost observat un efect semnificativ asupra proprietatilor farmacocinetice ale amlodipinei Administrarea concomitenta de
amlodipina si grapefruit sau suc de grapefruit nu este totusi recomandata pacientilor deoarece biodisponibilitatea amlodipinei poate creste in unele cazuri si acest lucru poate duce la amplificarea efectelor hipotensive.

Administrare concomitenta care trebuie luata in considerare

Altele
Amlodipina a fost administrata concomitent in siguranta cu digoxina, warfarina, atorvastatina, sildenafil, medicamente antiacide (hidroxid de aluminiu, hidroxid de magneziu, simeticona), cimetidina, ciclosporina, antibiotice si medicamente hipoglicemiante cu administrare orala. Atunci
cand amlodipina si sildenafilul au fost administrate in asociere, fiecare medicament si-a exercitat independent efectul de scadere a tensiunii arteriale.

Indicatii terapeutice Tratamentul hipertensiunii arteriale esentiale la adulti.

Terapie in asociere
Administrarea Twynsta este indicata la pacientii a caror tensiune arteriala nu este controlata adecvat cu amlodipina.

Terapie de substitutie
Pacientilor adulti la care tensiunea arteriala esentiala este controlata adecvat si carora li se administraza telmisartan si amlodipina sub forma de monoterapie li se pot administra in schimb comprimate de Twynsta care contin in compozitie aceleasi doze.

Grupa farmacoterapeutica Antagonisti ai receptorilor angiotensinei II/Blocante ale canalelor de calciu Forma prezentare Comprimate Forma farmaceutica Comprimate Forma ambalare medicament Cutie x1 blister, 28compr Concentratie 40mg/5mg Brand Boehringer Contraindicatii Hipersensibilitate la substantele active, la derivatii de dihidropiridina sau la oricare dintre excipienti.
Trimestrele doi si trei de sarcina.
Afectiuni biliare obstructive si insuficienta hepatica severa.
soc (incluzand soc cardiogen)
Hipotensiune arteriala severa
Obstructie a fluxului sanguin de la nivelul ventriculului stang (de exemplu stenoza aortica de grad mare).
Insuficienta cardiaca cu instabilitate hemodinamica dupa infarct miocardic acut. Produs RX DA

FAQs

What is TWYNSTA 40 mg used for? ›

Twynsta is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over). 'Essential' means that the hypertension has no obvious cause. Twynsta is used in patients whose blood pressure is not adequately controlled by amlodipine alone.

What is the best time of day to take TWYNSTA? ›

Take Twynsta at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it. It does not matter if you take Twynsta before or after food.

Is TWYNSTA a good blood pressure medication? ›

Telmisartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow. Twynsta is used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

What is the generic version of TWYNSTA? ›

TELMISARTAN-AMLODIPINE (Generic for TWYNSTA)

Should telmisartan 40 mg be taken in the morning or at night? ›

Telmisartan administered at bedtime, as opposed to morning dosing, improved the sleep time-relative blood pressure decline toward a more dipper pattern without loss in 24-hour efficacy. Nocturnal BP regulation is significantly better achieved with bedtime dosing of telmisartan.

What are the side effects of the medication TWYNSTA? ›

Tell your doctor right away if you have any serious side effects, including: fainting, fast/pounding/irregular heartbeat, signs of kidney problems (such as change in the amount of urine), symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat).

What should you not take with blood pressure medicine? ›

Some common types of OTC medicines you may need to avoid include:
  • Decongestants, such as those that contain pseudoephedrine.
  • Pain medicines (NSAIDs), such as ibuprofen and naproxen.
  • Cold and influenza (flu) medicines. ...
  • Some antacids and other stomach medicines. ...
  • Some natural health products.

Which is the best medicine for high blood pressure? ›

the ACE inhibitor lisinopril (Prinivil, Zestril) tops the list, followed by amlodipine besylate (Norvasc), a calcium channel blocker, and. generic hydrochlorothiazide (HCTZ).

Does it matter if I take my blood pressure medicine in the morning or at night? ›

The results of our study showed that there was no significant difference in the number of people who had a heart attack, stroke or died between the two groups - 362 in the morning group versus 390 in the evening. This indicates blood pressure medication is equally effective whether taken in the morning or evening.

Does telmisartan cause frequent urination? ›

Common side effects of telmisartan/hydrochlorothiazide include frequent urination, sinus pain and congestion, and dizziness.

Which is better for high blood pressure losartan or amlodipine? ›

Amlodipine has an average rating of 4.1 out of 10 from a total of 788 ratings on Drugs.com. 25% of reviewers reported a positive effect, while 57% reported a negative effect. Losartan has an average rating of 4.5 out of 10 from a total of 556 ratings on Drugs.com.

Is TWYNSTA FDA approved? ›

Approval Date: 10/16/2009.

What is the price of TWYNSTA? ›

A generic version of Twynsta (amlodipine/telmisartan) is available. See amlodipine/telmisartan prices (from $62.45 for 30 tablets).
...
Oral Tablet.
QuantityPer unitPrice
30$8.40$251.88

Why was telmisartan discontinued? ›

The product is being recalled due to a market complaint received which stated that one bottle labelled as 30-count Telmisartan Tablets, USP, 20 mg incorrectly contained 30 tablets of Telmisartan Tablets, USP, 40mg.

Which is better amlodipine or telmisartan? ›

Amlodipine is a calcium channel blocker that relaxes (widens) blood vessels and improves blood flow. Telmisartan is an angiotensin II receptor antagonist that keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Can you eat bananas with telmisartan? ›

Telmisartan Interactions with Food and Herbs

Potassium rich foods: Avoid food items that are rich in potassium like noni juice, bananas, nuts and sweet potatoes when you are taking telmisartan as it might lead to hyperkalemia or high blood potassium levels.

Is 40 mg of blood pressure medicine a lot? ›

For high blood pressure: Adults—At first, 40 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day.

What is normal blood pressure by age? ›

What is Normal Blood Pressure by Age?
WomenMen
18-39 years110/68 mm Hg119/70 mm Hg
40-59 years122/74 mm Hg124/77 mm Hg
60+ years139/68 mm Hg133/69 mm Hg
Nov 4, 2022

What drug interacts with TWYNSTA? ›

What Drugs, Substances, or Supplements Interact with Twynsta? Twynsta may interact with aliskiren, lithium, ramipril, drugs that may increase potassium levels, cough-and-cold products, diet aids, or NSAIDs. Tell your doctor all medications and supplements you use.

Why is telmisartan better than losartan? ›

Effect on blood pressure: Telmisartan may be better at reducing blood pressure than losartan. Telmisartan also has better 24-hour coverage than losartan because it lasts longer in the body.

Is telmisartan bad for kidneys? ›

Warnings for people with certain health conditions

For people with severe heart failure: Telmisartan may reduce the amount of urine you produce or increase your risk for kidney injury. For people with kidney problems: Telmisartan may reduce the amount of urine you produce or increase your risk for kidney injury.

What is the number one food that causes high blood pressure? ›

Salt or sodium

Salt, or specifically the sodium in salt, is a major contributor to high blood pressure and heart disease. This is because of how it affects fluid balance in the blood. Table salt is around 40 percent sodium. Some amount of salt is important for health, but it's easy to eat too much.

What foods should you avoid while taking telmisartan? ›

Potassium supplements, potassium-containing salt substitutes (No Salt, Morton Salt Substitute, and others), and even high-potassium foods (including Noni juice) should be avoided by those taking telmisartan, unless directed otherwise by their doctor.

What is the safest blood pressure medicine with least side effects? ›

While the class of blood pressure-lowering medicines called angiotensin-converting enzyme (ACE) inhibitors may be prescribed more commonly, angiotensin receptor blockers (ARBs) work just as well and may cause fewer side effects.

Does drinking water lower blood pressure? ›

Still, you can make lifestyle changes to bring your blood pressure down. Something as simple as keeping yourself hydrated by drinking six to eight glasses of water every day improves blood pressure. Water makes up 73% of the human heart,¹ so no other liquid is better at controlling blood pressure.

What is normal blood pressure for a 70 year old? ›

Normal blood pressure for most adults is defined as a systolic pressure of less than 120 and a diastolic pressure of less than 80.

Why is my blood pressure still high with medication? ›

Your doctor may want to check for things like an overactive thyroid, sleep apnea, kidney dysfunction, or adrenal gland disorders, which can elevate blood pressure. Timing is everything. Consider taking your medication at a different time of day than you do now.

Can I take 2 blood pressure pills if my blood pressure is high? ›

Taking more than one medicine

Taking a low dose of two medications rather than a high dose of one, can also help to avoid side effects, as side effects can sometimes be caused by the dose. Sometimes a medication will work well to begin with, but with time your blood pressure might creep up again.

When is the best time to check your blood pressure? ›

Take it first in the morning before eating or taking any medications. Take it again in the evening. Each time you measure, take two or three readings to make sure your results are the same. Your health care provider might recommend taking your blood pressure at the same times each day.

How many times is normal to urinate in the night? ›

Over two-thirds of men and women over 70 urinate at least once per night, and up to 60 percent go twice or more each night. In a nutshell, the study shows that it is very common for most people to wake up once a night, and it becomes more common as you get older.

Is peeing every 30 minutes normal? ›

If you feel the need to pee much more than that, or if you're getting up every hour or 30 minutes to go, you might be frequently urinating. This can still be considered “normal,” though, especially if you're drinking lots of fluids or taking certain medications. What matters most is what's typical for you.

Does telmisartan cause fatigue? ›

Angiotensin II receptor blockers (ARBs) treat high blood pressure and heart failure. Dizziness is a common side effect of ARBs. You may also experience headaches, fatigue, and other symptoms. A telmisartan dosage usually starts at 40 mg per day.

Why is lisinopril better than losartan? ›

If you have CKD, ACE inhibitors like lisinopril are typically recommended over ARBs like losartan. That's because there's more data supporting their benefits for the kidneys. ACE inhibitors have also been shown to lower the risk of death from all causes in people with CKD, including death related to heart disease.

What if I forgot to take my blood pressure medication this morning? ›

If you forget to take one or more doses: take your next dose at the normal time and in the normal amount. Do not take any more than your doctor prescribed. If you miss one dose, skip it and continue with your normal schedule.

What happens if you miss your blood pressure medicine for 3 days? ›

If you miss more than one dose, you might experience headaches, nausea, nervousness, increased heart rate, etc. This usually occurs between 1.5 to 3 days after the last dose, but it may occur earlier. In some cases, a phenomenon known as rebound hypertension may occur.

When is the best time to drink Twynsta? ›

Take Twynsta at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it. It does not matter if you take Twynsta before or after food.

What is the brand name for Twynsta? ›

TWYNSTA (telmisartan/amlodipine) tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents to lower blood pressure.

What two blood pressure pills did the FDA recall? ›

Quinapril Has Been Recalled Multiple Times

In April 2022, for example, Pfizer removed five lots of Accupril (quinapril HCl) tablets. In October, Aurobindo Pharma USA recalled two lots of quinapril-hydrochlorothiazide tablets.

What is the generic version of Twynsta? ›

TELMISARTAN-AMLODIPINE (Generic for TWYNSTA)

What is Twynsta 40 mg used for? ›

Twynsta is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over). 'Essential' means that the hypertension has no obvious cause. Twynsta is used in patients whose blood pressure is not adequately controlled by amlodipine alone.

What are other names for Twynsta? ›

telmisartan/amlodipine (Rx)
  • Classes: ARB/CCB Combos;
  • Antianginal Agents;
  • Calcium Channel Blockers, Dihydropyridines.

Is Twynsta a good blood pressure medication? ›

Telmisartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow. Twynsta is used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

Does telmisartan cause weight gain? ›

Although telmisartan was reported to reduce the visceral fat, it did not influence body weight or body mass index either in the Ongoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial or in the Prevention Regimen for Effectively Avoiding Second Strokes study.

Is telmisartan 40 mg better than losartan? ›

Both telmisartan and losartan were found to be safe and well tolerated. Conclusions: Telmisartan 40/80 mg is superior to losartan 50/100 mg in controlling DBP and SBP during the last 6 h of the 24-h dosing interval.

Which medicine is best for high blood pressure? ›

Angiotensin-converting enzyme (ACE) inhibitors reduce blood pressure by relaxing your blood vessels. Common examples are enalapril, lisinopril, perindopril and ramipril.

What is the best combination with telmisartan? ›

Combining telmisartan with hydrochlorothiazide enhances the antihypertensive activity of telmisartan in almost two-thirds of hypertensive patients with mild to moderate hypertension.

What blood pressure medication is better than amlodipine? ›

  • Hydrochlorothiazide.
  • Metoprolol.
  • Atenolol.
  • Norvasc.
  • Carvedilol.
  • Furosemide.

How much BP does telmisartan 40 mg reduce? ›

Telmisartan 20 to 160 mg once daily produced mean reductions in supine trough systolic blood pressure and diastolic blood pressure of up to 15.5 and 10.5 mm Hg, respectively. Maximum blood pressure reduction occurred with a dosage of 40 to 80 mg/day.

What is the best time in a day to take telmisartan 40 mg? ›

You may take this medicine with or without food. This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the dose at the same time each day.

What are the side effects of the blood pressure medicine telmisartan? ›

Side Effects
  • Changes in vision.
  • dizziness, lightheadedness, or fainting.
  • fast heartbeat.
  • large hives.
  • painful urination or changes in urinary frequency.
  • swelling in the hands, lower legs, and feet.

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