natgillin/translations-raw huggingface dataset:
What Brilique looks like and contents of the pack The orodispersible tablets are round, flat, bevelled edged, white to pale pink, marked with a “90” above “TI” on one side. 
Izgled zdravila Brilique in vsebina pakiranja Orodisperzibilne tablete so okrogle, ploščate, bele do bledo rožnate orodisperzibilne tablete s poševnim robom z oznako "90" nad "TI" na eni strani.
All-cause mortality, MI (excl. silent MI) or stroke 
Možganska kap Umrljivost zaradi vseh vzrokov, MI (izklj.
Creatinine levels may increase during treatment with ticagrelor. 
Med zdravljenjem s ticagrelorjem se koncentracija kreatinina lahko poveča.
For ticagrelor, 0.9% of patients discontinued study drug because of dyspnoea compared with 0.1% taking clopidogrel. 
Zaradi dispneje je zdravljenje s ticagrelorjem prekinilo 0,9 % bolnikov, zdravljenje s klopidogrelom pa 0,1 % bolnikov.
• PVC-PVDC/Al perforated unit dose transparent blister of 10 tablets; cartons of 100x1 tablets (10 blisters). 
• Prosojen perforiran pretisni omot za enkratni odmerek iz PVC-PVDC/Al z 10 tabletami; škatle s 100x1 tableto (10 pretisnih omotov).
ICH: Intracranial haemorrhage. 
IKK: Intrakranialna krvavitev.
CV death, total MI, stroke, SRI, RI, TIA or other ATE All-cause mortality Definite stent thrombosis 
nemi MI) ali možganska kap KV smrt, vsi MI, možganska kap, RPI, PI, TIA ali drugi ATD
Use of ticagrelor is contraindicated in patients with severe hepatic impairment (see sections 4.2 and 4.3). 
Pri bolnikih s hudo okvaro jeter je uporaba ticagrelorja kontraindicirana (glejte poglavji 4.2 in 4.3).
Ticagrelor is a mild CYP3A4 inhibitor. 
Ticagrelor blago zavira CYP3A4.
Tablet film-coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide black (E172), iron oxide red (E172). 
Filmska obloga tablete: hipromeloza (E464), titanov dioksid (E171), makrogol 400, črni železov oksid (E172), rdeči železov oksid (E172).
What Brilique is used for 
Za kaj uporabljamo zdravilo Brilique
Hyperuricaemia d Gout/Gouty Arthritis 
Presnovne in prehranske motnje hiperurikemija d protin/protinski artritis
In patients with stable coronary artery disease (CAD) on ASA, ticagrelor demonstrates a rapid onset of pharmacological effect as demonstrated by a mean inhibition of platelet aggregation (IPA) for ticagrelor at 0.5 hours after 180 mg loading dose of about 41%, with the maximum IPA effect of 89% by 2-4 hours post dose, and maintained between 2-8 hours. 
To se kaže s povprečno 41 % zavrtjem agregacije trombocitov (IPAinhibition of platelet aggregation) 0,5 ure po 180-mg polnilnem odmerku ticagrelorja in največjim učinkom IPA 89 % v 2 do 4 urah po odmerku in se ohrani od 2 do 8 ur.
Clopidogrel 
Ticagrelor Klopidogrel
TIMI Major or Minor 
Hude ali blage po TIMI
Discontinuation of treatment due to bleeding was more common with ticagrelor 60 mg compared to ASA therapy alone (6.2% and 1.5%, respectively). 
Prekinitev zdravljenja zaradi krvavitev je bila med uporabo 60 mg ticagrelorja pogostejša (6,2 %) kot med uporabo same ASA (1,5 %).
Tablet film-coating: hypromellose (E464), titanium dioxide (E171), talc, macrogol 400, iron oxide yellow (E172). 
Filmska obloga tablete: hipromeloza (E464), titanov dioksid (E171), smukec, makrogol 400, rumeni železov oksid (E172).
Round, flat, bevelled edged, white to pale pink, orodispersible tablets marked with ‘90' above ‘TI' on one side and plain on the other. 
Okrogla, ploščata, bela do bledo rožnata orodisperzibilna tableta s poševnimi robovi, z oznako "90" nad "TI" na eni strani in brez oznak na drugi strani.
Brilique helps stop the clumping of platelets. 
Zdravilo Brilique pomaga preprečiti sprijemanje trombocitov.
TIMI Minor Bleed: Clinically apparent with 30-50 g/L decrease in haemoglobin. 
Blaga krvavitev po TIMI: Klinično opazna z znižanjem hemoglobina 30-50 g/l.
Round, biconvex, pink tablets marked with ‘60' above ‘T' on one side and plain on the other. 
Okrogla, bikonveksna, rožnata tableta z oznako "60" nad "T" na eni strani in brez oznak na drugi strani.
Therefore, appropriate clinical and/or laboratory monitoring is recommended when giving narrow therapeutic index P-gp dependent medicinal products like digoxin concomitantly with ticagrelor. 
Zato je med sočasno uporabo ticagrelorja in zdravil, ki so odvisna od P-gp in imajo ozek terapevtski indeks (kakršno je digoksin), priporočljiv ustrezen klinični in/ali laboratorijski nadzor (glejte poglavje 4.4).
Fatal/Life-threatening 
Smrtne/smrtno nevarne Druge hude po PLATO
Reproductive system and breast disorders 
Motnje reprodukcije in dojk krvavitve v reproduktivnih organih
Relative to ASA alone, ticagrelor 60 mg twice daily significantly reduced the primary composite endpoint of CV death, MI and stroke. 
Ticagrelor 60 mg dvakrat na dan je v primerjavi s samo ASA značilno zmanjšal primarni sestavljeni opazovani dogodek kardiovaskularne smrti, miokardnega infarkta in možganske kapi.
However, more PLATO combined Major + Minor bleeding occurred with ticagrelor compared with clopidogrel. 
Med uporabo ticagrelorja pa se je pojavilo več hudih + blagih krvavitev po PLATO kot med uporabo klopidogrela.
Co-administration of ticagrelor with tolbutamide resulted in no change in the plasma levels of either medicinal product, which suggests that ticagrelor is not a CYP2C9 inhibitor and unlikely to alter the CYP2C9 mediated metabolism of medicinal products like warfarin and tolbutamide. 
To kaže, da ticagrelor ne zavira CYP2C9 in tako ni verjetno, da bi spremenil presnovo drugih zdravil, npr. varfarina in tolbutamida, s CYP2C9.
During the Holter substudy in PLATO, more patients had ventricular pauses >3 seconds with ticagrelor than with clopidogrel during the acute phase of their ACS. 
V holterski podštudiji PLATO je imelo med akutno fazo AKS ventrikularne pavze, ≥ 3 sekund, več bolnikov, ki so dobivali ticagrelor, kot bolnikov, ki so dobivali klopidogrel.
In patients with ACS, it is recommended that renal function is also checked one month after initiating the treatment with ticagrelor, paying special attention to patients ≥75 years, patients with moderate/severe renal impairment and those receiving concomitant treatment with an angiotensin receptor blocker (ARB). 
Posebno pozornost je treba nameniti bolnikom, starim ≥ 75 let, bolnikom z zmerno/hudo okvaro ledvic in tistim, ki sočasno prejemajo antagoniste receptorjev angiotenzina.
The PEGASUS TIMI-54 study was a 21,162 patient, event-driven, randomised, double-blind, placebo-controlled, parallel group, international multicentre study to assess the prevention of atherothrombotic events with ticagrelor given at 2 doses (either 90 mg twice daily or 60 mg twice daily) combined with low dose ASA (75-150 mg), compared to ASA therapy alone in patients with history of MI and additional risk factors for atherothrombosis. 
Njen namen je bil oceniti preprečevanje aterosklerotičnih dogodkov s ticagrelorjem, uporabljenim v dveh odmerkih (ali 90 mg dvakrat na dan ali 60 mg dvakrat na dan) v kombinaciji z nizkim odmerkom ASA (75-150 mg), v primerjavi s samo ASA pri bolnikih z anamnezo miokardnega infarkta in dodatnimi dejavniki tveganja za aterotrombozo.
Blood disorder bleedings 
Bolezni sečil krvavitev v sečilih
Higher exposures to ticagrelor and the active metabolite were observed in women compared to men. 
Pri ženskah so v primerjavi z moškimi ugotovili večjo izpostavljenost ticagrelorju in njegovemu aktivnemu presnovku.
Brilique 90 mg orodispersible tablets 
Brilique 90 mg orodisperzibilne tablete
Patients self-identified as black had an 18% lower bioavailability of ticagrelor compared to Caucasian patients, in clinical pharmacology studies, the exposure (Cmax and AUC) to ticagrelor in Japanese subjects was approximately 40% (20% after adjusting for body weight) higher compared to that in Caucasians. 
V kliničnih farmakoloških študijah je bila izpostavljenost (Cmax in AUC) ticagrelorju pri japonskih preiskovancih približno 40 % večja (20 % večja po korekciji za telesno maso) kot pri belcih.
• Bleeding gums 
• krvavitev iz dlesni
Psychiatric disorders 
Psihiatrične motnje zmedenost
Mean serum uric acid increased approximately 15% with ticagrelor compared to approximately 7.5% with clopidogrel and after treatment was stopped, decreased to approximately 7% on ticagrelor but with no decrease observed for clopidogrel. 
Povprečna koncentracija sečne kisline v serumu se je s ticagrelorjem povečala za približno 15 % in s klopidogrelom za približno 7,5 %.
Higher exposures to ticagrelor (approximately 25% for both Cmax and AUC) and the active metabolite were observed in elderly (≥75years) ACS patients compared to younger patients by the population pharmacokinetic analysis. 
Pri starejših osebah (≥ 75 let) z AKS so v primerjavi z mlajšimi s populacijsko farmakokinetično analizo ugotovili večjo izpostavljenost ticagrelorju (približno 25 % za Cmax in AUC) in njegovemu aktivnemu presnovku.
• Bleeding from your stomach lining (ulcer) 
• slabost v želodcu (siljenje na bruhanje)
Brilique 60 mg twice daily is the recommended dose when an extended treatment is required for patients with a history of MI of at least one year and a high risk of an atherothrombotic event (see section 5.1). 
60 mg zdravila Brilique dvakrat na dan je priporočen odmerek, če je potrebno podaljšano zdravljenje pri bolnikih, ki imajo anamnezo miokardnega infarkta vsaj eno leto in veliko tveganje za aterotrombotične dogodke (glejte poglavje 5.1) Zdravljenje se lahko pri bolnikih z ASA in velikim tveganjem za aterotrombotične dogodke začne brez prekinitve kot nadaljevalno zdravljenje po začetnem enoletnem zdravljenju z 90 mg zdravila Brilique ali drugim zaviralcem receptorjev adenozindifosfata (ADP).
However, no evidence of clinically significant adverse reactions was observed in the PLATO trial after concomitant administration with one or more medicinal products known to induce bradycardia (e.g. 96% beta blockers, 33% calcium channel blockers diltiazem and verapamil and 4% digoxin) (see section 4.5). 
Vendar pa v preskušanju PLATO po sočasni uporabi z enim ali več zdravili, za katera je znano, da povzročajo bradikardijo (npr. 96 % antagonisti adrenergičnih receptorjev beta, 33 % zaviralca kalcijevih kanalčkov diltiazem in verapamil ter 4 % digoksin) niso ugotovili klinično pomembnih neželenih učinkov (glejte poglavje 4.5).
Ear haemorrhage 
Okvara ledvic
However, no evidence of clinically significant adverse reactions was observed in the PLATO trial after concomitant administration with one or more medicinal products known to induce bradycardia (e.g. 96% beta blockers, 33% calcium channel blockers diltiazem and verapamil and 4% digoxin). 
Vendar pa v preskušanju PLATO po sočasni uporabi z enim ali več zdravili, za katera je znano, da povzročajo bradikardijo (npr. 96 % antagonisti adrenergičnih receptorjev beta, 33 % zaviralca kalcijevih kanalčkov diltiazem in verapamil ter 4 % digoksin) niso ugotovili klinično pomembnih neželenih učinkov.
Each film-coated tablet contains 60 mg ticagrelor. 
Ena filmsko obložena tableta vsebuje 60 mg ticagrelorja.
On a background of daily ASA, ticagrelor 90 mg twice daily showed superiority to 75 mg daily clopidogrel in preventing the composite endpoint of CV death, MI or stroke, with the difference driven by CV death and MI. 
Ob vsakodnevnem jemanju ASA je bil ticagrelor v odmerku 90 mg dvakrat na dan superioren od 75 mg klopidogrela na dan pri preprečevanju sestavljenega opazovanega dogodka (kardiovaskularna
Both 60 mg twice daily and 90 mg twice daily regimens of ticagrelor in combination with ASA were superior to ASA alone in the prevention of atherothrombotic events (composite endpoint: CV death, MI and stroke), with a consistent treatment effect over the entire study period, yielding a 16% RRR and 1.27% ARR for ticagrelor 60 mg and a 15% RRR and 1.19% ARR for ticagrelor 90 mg. 
Shemi s ticagrelorjem 60 mg dvakrat na dan in 90 mg dvakrat na dan v kombinaciji z ASA sta bili za preprečevanje aterotrombotičnih dogodkov (sestavljeni opazovani dogodek: kardiovaskularna smrt, miokardni infarkt in možganska kap) superiorni nad samo ASA z doslednim terapevtskim učinkom med celotnim obdobjem študije.
Marketing Authorisation Holder: AstraZeneca AB SE-151 85 Södertälje Sweden 
Imetnik dovoljenja za promet: AstraZeneca AB SE-151 85 Södertälje Švedska
Brilique 60 mg film-coated tablets 
Brilique 60 mg filmsko obložene tablete
Each orodispersible tablet contains 90 mg ticagrelor. 
Ena orodisperzibilna tableta vsebuje 90 mg ticagrelorja.
Subcutaneous or dermal bleeding h, Rash, 
Bolezni kože in podkožja podkožne ali kožne krvavitve h, izpuščaj, srbenje
• Diarrhoea or indigestion 
• driska ali težave s prebavo
No clinically relevant effect on oral contraceptive efficacy is expected when levonorgestrel and ethinyl estradiol are co-administered with ticagrelor. 
Med sočasno uporabo levonorgestrela in etinilestradiola s ticagrelorjem ni pričakovati klinično pomembnega vpliva na učinkovitost peroralnih kontraceptivov.
Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2). 
Okvara ledvic Bolnikom z okvaro ledvic odmerka ni treba prilagoditi (glejte poglavje 5.2).
Intracranial haemorrhage 
tumorske krvavitve
Brilique is not likely to affect your ability to drive or use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Brilique vplivalo na sposobnost upravljanja vozil in strojev.
Tablet coating Titanium dioxide (E171) Iron oxide black (E172) Iron oxide red (E172) Macrogol 400 
Obloga tablete titanov dioksid (E171) črni železov oksid (E172) rdeči železov oksid (E172) makrogol 400 hipromeloza (E464)
Musculoskeletal connective tissue and bone 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva krvavitev v mišice
Calcium hydrogen phosphate dihydrate Magnesium stearate (E470b) Sodium starch glycolate type A Hydroxypropylcellulose (E463) 
Jedro tablete manitol (E421) kalcijev hidrogenfosfat dihidrat magnezijev stearat (E470b) natrijev karboksimetilškrob (vrsta A) hidroksipropilceluloza (E463)
Each film-coated tablet contains 90 mg ticagrelor. 
Ena filmsko obložena tableta vsebuje 90 mg ticagrelorja.
Ticagrelor has not been studied in patients with severe hepatic impairment and there is no pharmacokinetic information in patients with moderate hepatic impairment. 
Ticagrelor ni raziskan pri bolnikih s hudo okvaro jeter.
Brilique 60 mg tablets ticagrelor 
Brilique 60 mg tablete ticagrelor
Brilique 90 mg film-coated tablets 
Brilique 90 mg filmsko obložene tablete
There was no evidence of benefit (no reduction in the primary composite endpoint of CV death, MI and stroke, but an increase in major bleeding) when ticagrelor 60 mg twice daily was introduced in clinically stable patients >2 years from the MI, or more than one year after stopping previous ADP receptor inhibitor treatment (see also section 4.2). 
Če so 60 mg ticagrelorja dvakrat na dan uvedli klinično stabilnim bolnikom več kot 2 leti po miokardnem infarktu ali več kot eno leto po prenehanju zdravljenja s predhodnim zaviralcem receptorjev ADP, niso ugotovili koristi (nobenega zmanjšanja primarnega sestavljenega opazovanega dogodka, ki je obsegal kardiovaskularno smrt, miokardni infarkt in možgansko kap, a porast hudih krvavitev) (glejte tudi poglavje 4.2).
Brilique 60 mg film-coated tablets ticagrelor 
Brilique 60 mg filmsko obložene tablete ticagrelor
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema krvavitve zaradi bolezni krvi trombotična trombocitopenična purpura
Safety Endpoints 
Opazovani dogodki varnosti
Brilique 90 mg orodispersible tablets ticagrelor 
Brilique 90 mg orodisperzibilne tablete ticagrelor
What Brilique looks like and contents of the pack Film-coated tablet (tablet): The tablets are round, biconvex, pink, film-coated marked with a “60” above “T” on one side. 
Filmsko obložena tableta (tableta): Tablete so okrogle, na obeh straneh izbočene, rožnate filmsko obložene tablete z oznako "60" nad "T" na eni strani.
As a precautionary measure, the use of ticagrelor in patients with uric acid nephropathy is discouraged. 
Iz previdnosti zato ticagrelorja ni priporočljivo uporabljati pri bolnikih z urično nefropatijo.
Patients with an increased risk of bradycardic events (e.g. patients without a pacemaker who have sick sinus syndrome, 2 
V glavno študijo varnosti in učinkovitosti ticagrelorja niso bili vključeni bolniki s tveganjem bradikardnih dogodkov (npr. bolniki brez srčnega spodbujevalnika in z boleznijo sinusnega vozla, AV-blokom 2. ali 3. stopnje ali sinkopo zaradi bradikardije).
Diarrhoea, Nausea, Dyspepsia, Constipation 
navzea, dispepsija, zaprtost retroperitonealna krvavitev
Titanium dioxide (E171) Iron oxide yellow (E172) Macrogol 400 
Obloga tablete smukec titanov dioksid (E171) rumeni železov oksid (E172) makrogol 400 hipromeloza (E464)
• Bruising 
• srbenje
Do not take Brilique if: 
Ne jemljite zdravila Brilique
No dose adjustment is necessary for patients with mild hepatic impairment (see section 5.2). 
Bolnikom z blago okvaro jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
Talk to your doctor before taking this medicine if you are breast-feeding. 
Preden vzamete to zdravilo, se morate posvetovati z zdravnikom če dojite.
The superiority of ticagrelor over clopidogrel in reducing major CV events was not significantly affected by patient CYP2C19 or ABCB1 genotype. 
Genotip CYP2C19 ali ABCB1 ni bistveno vplival na superiornost ticagrelorja v primerjavi s klopidogrelom za zmanjšanje hudih kardiovaskularnih dogodkov.
No dose adjustment is required in elderly (see section 5.2). 
Starejši bolniki Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
Brilique 90 mg film-coated tablets ticagrelor 
Brilique 90 mg filmsko obložene tablete ticagrelor
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja krvavitev v dihalih
Ticagrelor is well tolerated in single doses up to 900 mg. Gastrointestinal toxicity was dose-limiting in a single ascending dose study. 
Bolniki ticagrelor dobro prenašajo v enkratnih odmerkih do 900 mg.
Stroke 
Operacija
See a doctor straight away if you notice any of the following - you may need urgent medical treatment: 
Morda boste potrebovali nujno zdravniško pomoč:
What Brilique looks like and contents of the pack Film-coated tablet (tablet): The tablets are round, biconvex, yellow, film-coated marked with a “90” above “T” on one side. 
Filmsko obložena tableta (tableta): Tablete so okrogle, na obeh straneh izbočene, rumene filmsko obložene tablete z oznako "90" nad "T" na eni strani.
Therefore, only Brilique 60 mg twice daily co-administered with ASA is recommended for the prevention atherothrombotic events (CV death, MI and stroke) in patients with a history of MI and a high risk of developing an atherothrombotic event. 
Zato je pri bolnikih z anamnezo miokardnega infarkta in velikega tveganja za aterotrombotične dogodke za preprečevanje aterotrombotičnih dogodkov (kardiovaskularna smrt, miokardni infarkt in možganska kap) priporočljivo uporabljati le zdravilo Brilique 60 mg dvakrat na dan skupaj z ASA.
ICH 
IKK
Patients self-identified as black had an 18% lower bioavailability of ticagrelor compared to Caucasian patients, in clinical pharmacology studies, the exposure (Cmax and AUC) to ticagrelor in 
Bolniki, ki so se opredelili za črnce, so imeli 18 % manjšo biološko uporabnost ticagrelorja kot bolniki-belci.
Brilique 90 mg tablets ticagrelor 
Brilique 90 mg tablete ticagrelor
TIMI-defined bleeding categories 
Kategorije krvavitev, opredeljene po TIMI Hude po TIMI
PLATO Major or Minor 
Hude ali blage po PLATO
PLATO-defined bleeding categories 
Kategorije krvavitev, opredeljene po PLATO Hude po PLATO
How to store Brilique 
Kako deluje zdravilo Brilique
Always take this medicine exactly as your doctor has told you. 
kot vam naroči zdravnik.
• perforated unit-dosed blisters in a carton of 100x1 tablets Not all pack sizes may be marketed. 
• perforiranih pretisnih omotih za enkratni odmerek v škatli s 100 x 1 tableto.
What Brilique is 
Kaj je zdravilo Brilique
• Nosebleed 
• podplutbe
Tablet coating Talc 
KOLEDARSKI PRETISNI OMOT
EXPIRY DATE 
Dnevi od randomizacije
Secondary endpoint 
Sekundarni opazovani dogodek
SOC Very common Common 
Zelo pogosti
Treatment with Brilique 90 mg twice daily is recommended for 12 months in ACS patients unless discontinuation is clinically indicated (see section 5.1). 
Zdravljenje z zdravilom Brilique je treba začeti z enim 180-mg polnilnim odmerkom (dve tableti po 90 mg) in ga nadaljevati z 90 mg dvakrat na dan. Zdravljenje z zdravilom Brilique 90 mg je pri bolnikih z AKS priporočljivo nadaljevati 12 mesecev, razen če je prenehanje z zdravljenjem klinično indicirano (glejte poglavje 5.1).
TIMI Requiring medical attention: Requiring intervention, OR leading to hospitalisation, OR prompting evaluation. 
Blage po TIMI: Klinično opazna z znižanjem hemoglobina od 30 do50 g/l TIMI s potrebo po medicinski oskrbi: Zahteva ukrepanje ALI povzroči sprejem v bolnišnico ALI zahteva ovrednotenje.
Dizziness, Syncope, Headache 
Bolezni živčevja omotica, sinkopa, glavobol intrakranialna krvavitev
Thus it is important to regularly measure blood pressure to verify if it is within the normal range. 
Torej je potrebno krvni tlak redno meriti, da bi lahko preverili, ali je v normalnem območju.
See also information under the heading “Do not take MicardisPlus”. 
Glejte tudi informacije pod naslovom “Ne jemljite zdravila MicardisPlus”.
Your doctor will normally advise you to stop taking MicardisPlus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of MicardisPlus. 
Zdravnik vam bo praviloma svetoval, da zdravilo MicardisPlus prenehate jemati, preden boste zanosili ali takoj, ko boste vedeli, da ste noseči, in vam svetoval, da namesto zdravila MicardisPlus jemljete drugo zdravilo.
Date of latest renewal: 23 April 2007 
Datum prve odobritve: 19. april 2002 Datum zadnjega podaljšanja: 23. april 2007
MicardisPlus can have influence on the ability to drive and use machines. 
Zdravilo MicardisPlus lahko vpliva na sposobnost vožnje in upravljanja strojev.
The European Medicines Agency has waived the obligation to submit the results of studies with MicardisPlus in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom MicardisPlus za vse podskupine pediatrične populacije s hipertenzijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
MicardisPlus with food and alcohol 
Zdravilo MicardisPlus skupaj s hrano in alkoholom
If you take more MicardisPlus than you should If you accidentally take too many tablets you may experience symptoms such as low blood pressure and rapid heartbeat. 
Če ste vzeli večji odmerek zdravila MicardisPlus, kot bi smeli Če pomotoma vzamete preveč tablet, se lahko pojavijo simptomi, kot so nizek krvni tlak in pospešen srčni utrip.
What MicardisPlus is and what it is used for 
Kaj je zdravilo MicardisPlus in za kaj ga uporabljamo
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:19 April 2002 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 19. april 2002 Datum zadnjega podaljšanja: 23. april 2007
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). 
Neželeni učinki so razvrščeni po pogostnosti, za katero veljajo naslednji kriteriji: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
There are no adequate data from the use of MicardisPlus in pregnant women. 
Ni zadostnih podatkov o uporabi zdravila MicardisPlus pri nosečnicah.
Some people feel dizzy or tired when taking MicardisPlus. 
Nekateri ljudje so med zdravljenjem z zdravilom MicardisPlus omotični ali utrujeni.