natgillin/translations-raw huggingface dataset:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Actavis logo 
IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Actavis logo
Some side effects can be serious and need immediate medical attention: You should see your doctor immediately if you experience any of the following symptoms: 
Neke nuspojave mogu biti teške i zahtijevaju hitnu liječničku skrb:
Hepatic function abnormal/liver disorder3 Skin and subcutaneous tissue disorders Uncommon: Rare: 
Abnormalna funkcija jetre/poremećaj rada jetre 3 Poremećaji kože i potkožnog tkiva Manje često:
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). 
Poznato je da izloženost antagonistima receptora angiotenzina II tijekom drugog i trećeg tromjesečja inducira fetotoksičnost u ljudi (smanjenje funkcije bubrega, oligohidramnij, usporena osifikacija kostiju lubanje) i neonatalnu toksičnost (zatajenje bubrega, hipotenzija, hiperkalemija) (vidjeti dio
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to <1/1,000), and acute renal failure. 
Teške nuspojave obuhvaćaju anafilaktičku reakciju i angioedem koji se mogu rijetko pojaviti (≥ 1/10
The adjusted DBP changes from baseline were -8.4 (1.5) mm Hg, -4.5 (1.6) mm Hg and -3.5 (2.1) mm Hg respectively. 
Prilagođene promjene DKT-a u odnosu na početnu vrijednost bile su - 8,4 (1,5) mm Hg, - 4,5 (1,6)
Fertility In preclinical studies, no effects of telmisartan on male and female fertility were observed. 
U nekliničkim ispitivanjima učinci lijeka Telmisartan Actavis na plodnost muškaraca i žena nisu uočeni.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Second and third trimesters of pregnancy (see sections 4.4 and 4.6) - Biliary obstructive disorders - Severe hepatic impairment 
- Drugo i treće tromjesečje trudnoće (vidjeti dijelove 4.4 i 4.6) - Bilijarni opstruktivni poremećaji
Reykjavikurvegi 76-78, IS-220 Hafnafjordur ICELAND 
Reykjavikurvegi 76-78, IS-220 Hafnafjordur ISLAND
The blood pressure lowering effects of two doses of telmisartan were assessed in 76 hypertensive, largely overweight patients aged 6 to < 18 years (body weight ≥ 20 kg and ≤ 120 kg, mean 74.6 kg), after taking telmisartan 1 mg/kg (n = 29 treated) or 2 mg/kg (n = 31 treated) over a four-week treatment period. 
Sigurnost i djelotvornost telmisartana nije utvrđena u djece i adolescenata mlađih od 18 godina Učinci snižavanja krvnog tlaka dviju doza telmisartana ocjenjivani su na 76 hipertenzivnih bolesnika s uvelike pretjeranom težinom u dobi od 6 do < 18 godina (tjelesna težina ≥ 20 kg i ≤ 120 kg, srednja vrijednost 74,6 kg), nakon uzimanja telmisartana 1 mg/kg (n = 29 liječenih) ili 2 mg/kg (n = 31
White, oval, biconvex tablets with logo T1 on one side. 
Bijele, ovalne, bikonveksne tablete s oznakom T1 na jednoj strani.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for blister 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za blister
If you forget to take Telmisartan Actavis 
Ako ste zaboravili uzeti Telmisartan Actavis
Slow heart beat (bradycardia), dizziness, higher levels of creatinine in the blood and sudden kidney failure have also been reported. 
Također su zabilježeni usporeni otkucaji srca (bradikardija), omaglica, povišene razine kreatinina u krvi i iznenadno zatajenje bubrega.
Reykjavíkurvegur 76-78, IS-220 Hafnarfjördur Iceland 
Reykjavíkurvegur 76-78, IS-220 Hafnarfjördur Island
ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events. 
Trial) uspoređivalo je učinke telmisartana, ramiprila i kombinacije telmisartana i ramiprila na kardiovaskularne ishode u 25 620 bolesnika u dobi od 55 godina ili starijim, s anamnezom koronarne arterijske bolesti, moždanog udara, TIA-e, periferne arterijske bolesti ili šećernom bolešću tipa 2 s dokazanim oštećenjima ciljnih organa (npr.retinopatija, hipertrofija lijeve klijetke, makro- ili mikroalbuminurija), koja je populacija s rizikom pojave kardiovaskularnih događaja.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): 
Ostala stanja sa stimulacijom sustava renin-angiotenzin-aldosteron
PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING Label for tablet container 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU Naljepnica za spremnik s tabletama
Telmisartan Actavis may also be used in combination with diuretics (‘water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with telmisartan. 
Telmisartan Actavis se također može primjenjivati u kombinaciji s diureticima (tablete za mokrenje), kao što je hidroklorotiazid za koji se pokazalo da ima dodatan učinak snižavanja krvnog tlaka s telmisartanom.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). 
Dvostruka blokada sustava renin-angiotenzin-aldosteron (RAAS) Postoje dokazi da istodobna primjena ACE inhibitora, blokatora angiotenzin II receptora ili aliskirena povećava rizik od hipotenzije, hiperkalemije i smanjene bubrežne funkcije (uključujući akutno zatajenje bubrega).
Alternatively, telmisartan may be used in combination with thiazidetype diuretics such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with telmisartan. 
Kao alternativa, telmisartan se može primjenjivati u kombinaciji s tiazidnim diureticima, kao što je hidroklorotiazid, za koji se pokazalo da ima dodatan učinak na snižavanje krvnog tlaka s telmisartanom.
- The other ingredients are magnesium stearate, croscarmellose sodium, mannitol, povidone, 
- Pomoćne tvari su: magnezijev stearat, umrežena karmelozanatrij, manitol, povidon, pelete kalijevog hidroksida.
Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption 
Pruritus, hiperhidroza, osip Angioedem (također sa smrtnim ishodom), ekcem, eritem, urtikarija, osip od lijeka, toksični osip kože
NAME OF THE MARKETING AUTHORISATION HOLDER Actavis logo 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Actavis logo
When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 
Kada se utvrdi trudnoća, liječenje antagonistima receptora angiotenzina II mora se trenutno prekinuti te, ako je potrebno, započeti s primjenom drugog lijeka (vidjeti dijelove 4.3
White, round, flat tablets with logo T on one side. 
Bijele, okrugle, plosnate tablete s oznakom T na jednoj strani.
Corticosteroids (systemic route) Reduction of the antihypertensive effect. 
Kortikosteroidi (sistemski put primjene)
White, oval, biconvex tablets with a break line and logo T on one side. 
Bijele, ovalne, bikonveksne tablete s razdjelnom linijom i oznakom T na jednoj strani.
PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING Carton for tablet container 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU Kutija za spremnik s tabletama
The tablet container contains a desiccant, do not eat the desiccant. 
Spremnik s tabletama sadrži sredstvo za sušenje koje se ne smije pojesti.
The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (> 70 years) 
- Šećerna bolest, poremećaj rada bubrega, dob (>70 godina).
The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated patients, respectively. 
u bolesnika liječenih telmisartanom odnosno 11,8% u bolesnika liječenih ramiprilom.
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. 
brzo oticanje kože i sluznice (angioedem); ove nuspojave su rijetke (mogu se javiti u manje od 1 na 1000 osoba), ali su iznimno teške i bolesnici trebaju prekinuti uzimati lijek te odmah posjetiti svog liječnika.
Medicinal products or therapeutic class 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 klase lijekova koji mogu izazvati hiperkalemiju su nadomjesci soli koje sadrže kalij, diuretici koji štede kalij, ACE-inhibitori, antagonisti receptora angiotenzina II, nesteroidni protuupalni (antiinflamatorni) lijekovi (NSAIL, uključujući selektivne COX-2 inhibitore), heparin, imunosupresivi (ciklosporin ili takrolimus) i trimetoprim.
How to take Telmisartan Actavis 
Kako čuvati Telmisartan Actavis
What Telmisartan Actavis looks like and contents of the pack 80 mg tablets are white, oval, biconvex with logo T1 on one side 
Kako Telmisartan Actavis izgleda i sadržaj pakiranja Telmisartan Actavis 80 mg tablete su bijele, ovalne, bikonveksne s oznakom T1 na jednoj strani.
A. MANUFACTUER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim). 
Rizik od hiperkalemije se povećava u slučaju kombinacije s drugim lijekovima koji također mogu izazvati hiperkalemiju (nadomjesci soli koji sadrže kalij, diuretici koji štede kalij, ACE-inhibitori, antagonisti receptora angiotenzina II, nesteroidni protuupalni lijekovi (NSAIL, uključujući selektivne COX-2 inhibitore), heparin, imunosupresivi (ciklosporin ili takrolimus) i trimetoprim).
Anaphylactic reaction , hypersensitivity Metabolism and nutrition disorders Uncommon: 
Anafilaktička reakcija, preosjetljivost Poremećaji metabolizma i prehrane Manje često:
What Telmisartan Actavis looks like and contents of the pack 20 mg tablets are white, round, flat with logo T on one side 
Kako Telmisartan Actavis izgleda i sadržaj pakiranja Tablete od 20 mg su bijele, okrugle, plosnate s oznakom T na jednoj strani.
Al/Al blisters: Pack sizes: 14, 28, 30, 56, 84, 90, 98 or 100 tablets. 
Veličine pakiranja: 14, 28, 30, 56, 84, 90, 98 ili 100 tableta.
Telmisartan Actavis tablets are used to treat essential hypertension (high blood pressure) in adults. 
Telmisartan Actavis tablete se primjenjuju u liječenju esencijalne hipertenzije (visoki krvni tlak) u odraslih osoba. „Esencijalna“ znači da visoki krvni tlak nije izazvan niti jednim drugim uzrokom.
Eosinophilia , thrombocytopenia 
Anemija Eozinofilija, trombocitopenija
What Telmisartan Actavis looks like and contents of the pack 40 mg tablets are white, oval, biconvex, with a break line and logo T on one side. 
Kako Telmisartan Actavis izgleda i sadržaj pakiranja Tablete od 40 mg su bijele, ovalne, bikonveksne s razdjelnom linijom s oznakom T na jednoj strani.
may lead to excessive loss of body water and low blood pressure (hypotension). 
Telmisartan Actavis, mogu dovesti do prekomjernog gubitka vode u tijelu te niskog krvnog tlaka (hipotenzija).
Clinical efficacy and safety 
Klinička djelotvornost i sigurnost Liječenje esencijalne hipertenzije
There was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.87 (95% CI 0.76-1.00, p = 0.048)], There was no evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95% CI 0.85-1.24). 
Dokazana je korist liječenja telmisartanom u usporedbi s placebom u prethodno određenom sekundarnom složenom ishodu od kardiovaskularne smrti, nefatalnog infarkta miokarda i nefatalnog moždanog udara [0,87 (95% CI 0,76 - 1,00, p = 0,048)].
- Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors (angiotensinconverting enzyme inhibitors, to treat high blood pressure), angiotensin II receptor antagonists (to treat high blood pressure), NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin (a medicine for thinning the blood), immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim. 
diuretici koji štede kalij (određene tablete za mokrenje), ACE-inhibitori (inhibitori angiotenzin konvertirajućeg enzima za liječenje visokog krvnog tlaka), antagonisti receptora angiotenzina II (za liječenje visokog krvnog tlaka), NSAIL (nesteroidni protuupalni lijekovi, npr. aspirin ili ibuprofen), heparin (lijek za razrjeđivanje krvi), imunosupresivi (npr. ciklosporin ili takrolimus) te antibiotik trimetoprim.
Anaphylactic reaction, hypersensitivity Metabolism and nutrition disorders Uncommon: 
Anafilaktička reakcija, preosjetljivost Poremećaji metabolizma i prehrane
Interstitial lung disease4 
Dispneja, kašalj Bolest plućnog intersticija4
Potassium sparing diuretics or potassium supplements Angiotensin II receptor antagonists such as telmisartan attenuate diuretic induced potassium loss. 
Antagonisti receptora angiotenzina II, kao što je telmisartan, ublažavaju gubitak kalija induciranog diureticima.
INFORMATION IN BRAILLE Telmisartan Actavis 40 mg 
16. PODACI NA BRAILLEOVOM PISMU Telmisartan Actavis 40 mg
INFORMATION IN BRAILLE Telmisartan Actavis 20 mg 
16. PODACI NA BRAILLEOVOM PISMU Telmisartan Actavis 20 mg
Reduction of cardiovascular morbidity in adults with: - manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or - type 2 diabetes mellitus with documented target organ damage 
Smanjenje kardiovaskularnog morbiditeta u odraslih osoba s: - manifestnom aterotrombotskom kardiovaskularnom bolešću (anamneza koronarne bolesti srca,
INFORMATION IN BRAILLE Telmisartan Actavis 80 mg 
16. PODACI NA BRAILLEOVOM PISMU Telmisartan Actavis 80 mg
Hypotension2, orthostatic hypotension Respiratory, thoracic and mediastinal disorders Uncommon: 
Hipotenzija 2, ortostatska hipotenzija
In the "Prevention Regimen For Effectively avoiding Second Strokes" (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70% vs. 0.49% [RR 1.43 (95% confidence interval 1.00- 2.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33%) vs. patients taking placebo (0.16%) [RR 2.07 (95% confidence interval 1.14 3.76)]. 
1,00 - 2,06)]; incidencija smrtnih slučajeva od sepse bila je povećana za bolesnike koji su uzimali telmisartan (0,33%) u odnosu na bolesnike koji su uzimali placebo (0,16%) [RR 2,07 (95% interval pouzdanosti 1,14 - 3,76)].
If you take more Telmisartan Actavis than you should It is important to keep to the dose as prescribed by your doctor. 
Važno je da se pridržavate doze koju Vam je propisao liječnik.
Each tablet contains 40 mg telmisartan. 
Jedna tableta sadrži 40 mg telmisartana.
In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily. 
doza telmisartana može se povisiti na maksimalno 80 mg jednom dnevno.
Each tablet contains 20 mg telmisartan. 
Jedna tableta sadrži 20 mg telmisartana.
6.5 Nature and contents of container 
6.5 Vrsta i sadržaj spremnika Al/Al blisteri:
Each tablet contains 80 mg telmisartan. 
Jedna tableta sadrži 80 mg telmisartana.
itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood. 
ubrzani otkucaji srca (tahikardija), suhoća usta, nadražaj želuca, poremećaj osjeta okusa (disgeuzija), abnormalna funkcija jetre (vjerojatnost da će iskusiti ovu nuspojavu, veća je za bolesnike iz Japana), brzo oticanje kože i sluznice koji mogu dovesti do smrtnog ishoda (angioedem također sa smrtnim ishodom), ekcem (poremećaj kože), crvenilo kože, koprivnjača (urtikarija), težak osip od lijeka, bol u zglobovima (artralgija), bol u udovima, bol tetiva, simptomi nalik gripi, snižen hemoglobin (krvni protein), povišena razina mokraćne kiseline, povišeni jetreni enzimi ili kreatin fosfokinaza u krvi.
Magnesium stearate Croscarmellose sodium Mannitol 
6.1 Popis pomoćnih tvari magnezijev stearat karmelozanatrij, umrežena manitol povidon pelete kalijevog hidroksida
Somnolence 
Vrtoglavica
Before considering the concomitant use of medicinal products that affect the renin-angiotensinaldosterone system, the benefit risk ratio should be evaluated. 
Prije razmatranja istodobne primjene lijekova koji utječu na sustav renin-angiotenzin-aldosteron,
Immune system disorders Rare: 
Poremećaji imunološkog sustava
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood. 
Infekcije mokraćnih puteva, infekcije gornjih dišnih puteva (npr. grlobolja, upala sinusa, obična prehlada), nedostatak crvenih krvnih stanica (anemija), visoke razine kalija, otežano spavanje, osjećaj tuge (depresija), nesvjestica (sinkopa), osjećaj vrtnje (vrtoglavica), usporen rad srca (bradikardija), nizak krvni tlak (hipotenzija) u korisnika liječenih zbog visokog krvnog tlaka, omaglica pri ustajanju
NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 40 mg tablets 
NAZIV LIJEKA Telmisartan Actavis 40 mg tablete
NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 40 mg tablets telmisartan 
NAZIV LIJEKA Telmisartan Actavis 40 mg tablete telmisartan
NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 80 mg tablets telmisartan 
NAZIV LIJEKA Telmisartan Actavis 80 mg tablete telmisartan
NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 20 mg tablets 
NAZIV LIJEKA Telmisartan Actavis 20 mg tablete
PHARMACEUTICAL FORM Tablet 
14. NAČIN IZDAVANJA LIJEKA
Blood and the lymphatic system disorders Uncommon: 
Poremećaji krvi i limfnog sustava
NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 20 mg tablets telmisartan 
NAZIV LIJEKA Telmisartan Actavis 20 mg tablete telmisartan
NAME OF THE MEDICINAL PRODUCT Telmisartan Actavis 80 mg tablets 
NAZIV LIJEKA Telmisartan Actavis 80 mg tablete
6.6 Special precautions for disposal and other handling 
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Nema posebnih zahtjeva.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 80 mg telmisartana.
Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5% CI 0.901.08), p (non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo. 
(97,5% CI 0,90 - 1,08), p (neinferiornost) = 0,0004], u primarnom ishodu referentnog ispitivanja HOPE (The Heart Outcomes
MARKETING AUTHORISATION NUMBER(S) EU/1/10/639/029 (30 tablets container) EU/1/10/639/030 (250 tablets container) 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/639/029 (spremnik s 30 tableta) EU/1/10/639/030 (spremnik s 250 tableta)
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 40 mg telmisartana.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg telmisartan. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 20 mg telmisartana.
Most cases of hepatic function abnormal / liver disorder from post-marketing experience occurred in patients in Japan, who are more likely to experience these adverse reactions. 
abnormalna funkcija jetre (vjerojatnost da će iskusiti ovu nuspojavu, veća je za bolesnike iz Japana),
MARKETING AUTHORISATION NUMBER(S) EU/1/10/639/019 (30 tablets container) EU/1/10/639/020 (250 tablets container) 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/639/019 (spremnik s 30 tableta) EU/1/10/639/020 (spremnik s 250 tableta)
MARKETING AUTHORISATION NUMBER(S) EU/1/10/639/009 (30 tablets container) EU/1/10/639/010 (250 tablets container) 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/639/009 (spremnik s 30 tableta) EU/1/10/639/010 (spremnik s 250 tableta)
Tachycardia 
Bradikardija Tahikardija
Take Telmisartan Actavis every day for as long as your doctor prescribes it in order to keep your blood pressure controlled. 
Ako prestanete uzimati Telmisartan Actavis Kako biste držali svoj tlak pod kontrolom, uzimajte Telmisartan Actavis svaki dan toliko dugo koliko
EU/1/10/639/001 (14 tablets blister) EU/1/10/639/002 (28 tablets blister) EU/1/10/639/003 (30 tablets blister) EU/1/10/639/004 (56 tablets blister) EU/1/10/639/005 (84 tablets blister) EU/1/10/639/006 (90 tablets blister) EU/1/10/639/007 (98 tablets blister) EU/1/10/639/008 (100 tablets blister) 
EU/1/10/639/005 (blister s 84 tablete) EU/1/10/639/006 (blister s 90 tableta) EU/1/10/639/007 (blister s 98 tableta) EU/1/10/639/008 (blister sa 100 tableta)
Common side effects (may affect up to 1 in 10 people): Low blood pressure (hypotension) in users treated for reduction of cardiovascular events. 
Nizak krvni tlak (hipotenzija) u bolesnika liječenih zbog smanjivanja kardiovaskularnih događaja.
EU/1/10/639/011 (14 tablets blister) EU/1/10/639/012 (28 tablets blister) EU/1/10/639/013 (30 tablets blister) EU/1/10/639/014 (56 tablets blister) EU/1/10/639/015 (84 tablets blister) EU/1/10/639/016 (90 tablets blister) EU/1/10/639/017 (98 tablets blister) EU/1/10/639/018 (100 tablets blister) 
EU/1/10/639/015 (blister s 84 tablete) EU/1/10/639/016 (blister s 90 tableta) EU/1/10/639/017 (blister s 98 tableta) EU/1/10/639/018 (blister sa 100 tableta)