natgillin/translations-raw huggingface dataset:
Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.
Priporočljiva je podvojitev odmerka na 2, 5 mg enkrat na dan po dveh tednih in nato na 5 mg po nadaljnjih dveh tednih.
The recommended initial dose is 2.5 mg of TRITACE once daily.
Priporočeni začetni odmerek je 2, 5 mg TRITACE enkrat na dan.
Titration and maintenance dose Depending on the patient’ s tolerability to the active substance, the dose is subsequently increased.
Titracija in vzdrževalni odmerek Odvisno od bolnikovega prenašanja zdravilne učinkovine se odmerek nato povečuje.
In patients with non- diabetic nephropathy as defined by macroproteinuria ≥ 3 g/ day.
Bolniki z nediabetično nefropatijo, opredeljeno kot prisotnost makroproteinurije ≥ 3 g/ dan.
Starting dose In patients stabilized on diuretic therapy, the recommended initial dose is 1.25 mg daily.
Začetni odmerek Priporočeni začetni odmerek za bolnike, stabilizirane z diuretičnim zdravljenjem, je 1, 25 mg na dan.
Titration and maintenance dose TRITACE should be titrated by doubling the dose every one to two weeks up to a maximum daily dose of 10 mg.
Titracija in vzdrževalni odmerek TRITACE je treba titrirati s podvajanjem odmerka na en do dva tedna, do največjega dnevnega odmerka 10 mg.
Two administrations per day are preferable.
Po možnosti je treba zdravilo vzeti dvakrat na dan.
Starting dose After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5 mg twice daily for three days.
Začetni odmerek Pri klinično in hemodinamsko stabilnem bolniku je 48 ur po miokardnem infarktu začetni odmerek 2, 5 mg dvakrat na dan tri dni.
If the initial 2.5 mg dose is not tolerated a dose of 1.25 mg twice a day should be given for two days before increasing to 2.5 mg and 5 mg twice a day.
Če bolnik ne prenese začetnega odmerka 2, 5 mg, je treba pred povečanjem na 2, 5 mg in 5 mg dvakrat na dan dva dni uporabiti odmerek 1, 25 mg dvakrat na dan.
If the dose cannot be increased to 2.5 mg twice a day the treatment should be withdrawn.
Če odmerka ni mogoče povečati na 2, 5 mg dvakrat na dan, je treba zdravljenje prekiniti.
Titration and maintenance dose The daily dose is subsequently increased by doubling the dose at intervals of one to three days up to the target maintenance dose of 5 mg twice daily.
Titracija in vzdrževalni odmerek Dnevni odmerek se nato povečuje s podvajanjem odmerka v presledkih od enega do treh dni, dokler ni dosežen ciljni vzdrževalni odmerek 5 mg dvakrat na dan.
The maintenance dose is divided in 2 administrations per day where possible.
Če je mogoče, je treba vzdrževalni odmerek razdeliti na jemanje 2- krat na dan.
If the dose cannot be increased to 2.5 mg twice a day treatment should be withdrawn.
Če odmerka ni mogoče povečati na 2, 5 mg dvakrat na dan, je treba zdravljenje prekiniti.
Should the decision be taken to treat these patients, it is recommended that therapy be started at 1.25 mg once daily and that particular caution be exercised in any dose increase.
Če se zdravnik odloči za zdravljenje takšnega bolnika, je priporočljivo, da se zdravljenje začne z 1, 25 mg enkrat na dan in da se vsako povečanje odmerka opravi posebej previdno.
23 Special populations
Bolniki z okvaro ledvic
Patients with renal impairment Daily dose in patients with renal impairment should be based on creatinine clearance (see section 5.2):
22 Bolnikom z okvaro ledvic je treba dnevni odmerek določiti glede na očistek kreatinina (glejte poglavje 5. 2):
- if creatinine clearance is ≥ 60 ml/ min, it is not necessary to adjust the initial dose (2.5 mg/ day);
- če je očistek kreatinina ≥ 60 ml/ min, začetnega odmerka (2, 5 mg/ dan) ni treba prilagoditi;
the maximal daily dose is 10 mg;
največji dnevni odmerek je 10 mg.
- if creatinine clearance is between 30-60 ml/ min, it is not necessary to adjust the initial dose
- če je očistek kreatinina med 30 in 60 ml/ min, začetnega odmerka ni treba prilagoditi
(2.5 mg/ day); the maximal daily dose is 5 mg;
(2, 5 mg/ dan); največji dnevni odmerek je 5 mg.
- if creatinine clearance is between 10-30 ml/ min, the initial dose is 1.25 mg/ day and the maximal
- če je očistek kreatinina med 10 in 30 ml/ min, je začetni odmerek 1, 25 mg/ dan; največji dnevni
daily dose is 5 mg;
odmerek je 5 mg.
- in haemodialysed hypertensive patients: ramipril is slightly dialysable; the initial dose is
- hipertenzivni bolniki na hemodializi: ramipril se rahlo dializira; začetni odmerek je 1, 25 mg/ dan
1.25 mg/ day and the maximal daily dose is 5 mg; the medicinal product should be administered few hours after haemodialysis is performed.
Zdravilo je treba uporabiti nekaj ur po hemodializi.
Patients with hepatic impairment (see section 5.2) In patients with hepatic impairment, treatment with TRITACE must be initiated only under close medical supervision and the maximum daily dose is 2.5 mg TRITACE.
Bolniki z okvaro jeter (glejte poglavje 5. 2) Bolnikom z okvaro jeter je treba zdravljenje s TRITACE uvesti pod natančnim zdravniškim nadzorom; največji dnevni odmerek za takšne bolnike je 2, 5 mg TRITACE.
Elderly Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients.
Starejši Začetni odmerek mora biti manjši, nadaljnja titracija pa bolj postopna, ker obstaja večja možnost neželenih učinkov, zlasti pri zelo starih in slabotnih bolnikih.
A reduced initial dose of 1.25 mg ramipril should be considered.
V poštev pride manjši začetni odmerek 1, 25 mg ramiprila.
Paediatric population TRITACE is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Pediatrična populacija TRITACE ni priporočljivo uporabljati pri otrocih in mladostnikih do 18. leta starosti, ker o njegovi varnosti in učinkovitosti v tej skupini ni dovolj podatkov.
CONTRAINDICATIONS
4. 3 Kontraindikacije
- Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin
- Preobčutljivost za zdravilno učinkovino, katerokoli pomožno snov ali katerikoli zaviralec ACE
Converting Enzyme) inhibitors (see section 6.1)
(angiotenzinske konvertaze) (glejte poglavje 6. 1).
- History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or
- Anamneza angioedema (hereditarnega, idiopatičnega ali angioedema zaradi zaviralcev ACE ali
AIIRAs)
AIIRA v preteklosti).
- Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see
- Zunajtelesna zdravljenja, med katerimi pride kri v stik z negativno nabitimi površinami (glejte
section 4.5)
poglavje 4. 5).
- Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
- Pomembna obojestranska stenoza ledvičnih arterij ali stenoza ledvične arterije edine delujoče ledvice
- 2nd and 3rd trimester of pregnancy (see sections 4.4 and 4.6)
- 2. in 3. trimesečje nosečnosti (glejte poglavji 4. 4 in 4. 6).
- Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.
- Ramiprila se ne sme uporabljati pri bolnikih s hipotenzijo ali hemodinamsko nestabilnimi stanji.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
4. 4 Posebna opozorila in previdnostni ukrepi
Special populations Pregnancy:
Posebne populacije
ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Med nosečnostjo se ne sme uvesti zaviralcev ACE, kakršen je ramipril, ali antagonistov receptorjev angiotenzina II (AIIRA).
Unless continued ACE inhibitor/ AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Če nadaljnje zdravljenje z zaviralci ACE/ AIIRA ni nujno, je treba bolnice, ki načrtujejo nosečnost, prevesti na druga antihipertenzivna zdravila, katerih varnostne značilnosti med nosečnostjo so ugotovljene.
When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6). o Patients at particular risk of hypotension
Zdravljenje z zaviralci ACE/ AIIRA je treba prekiniti takoj po ugotovitvi nosečnosti in uvesti drugo zdravljenje, če je primerno (glejte poglavji 4. 3 in 4. 6).
- Patients with strongly activated renin-angiotensin-aldosterone system
- Bolniki z močno aktiviranim sistemom renin- angiotenzin- aldosteron
Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase.
Pri bolnikih z močno aktiviranim sistemom renin- angiotenzin- aldosteron obstaja možnost akutnega, izrazitega padca krvnega tlaka in poslabšanja delovanja ledvic zaradi zavrtja ACE, zlasti če je zaviralec ACE ali sočasni diuretik uporabljen prvič ali prvič v večjem odmerku.
24 Significant activation of renin-angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in:
Pomembno aktivacijo sistema renin- angiotenzin- aldosteron je treba pričakovati npr. pri bolnikih s:
- patients with severe hypertension
- hudo hipertenzijo
- patients with decompensated congestive heart failure
- dekompenziranim kongestivnim srčnim popuščanjem
- patients with haemodynamically relevant left ventricular inflow or outflow impediment (e. g.
- hemodinamsko pomembno motnjo dotoka v levi prekat ali iztoka iz njega (npr. stenozo aortne
stenosis of the aortic or mitral valve)
ali mitralne zaklopke)
- patients with unilateral renal artery stenosis with a second functional kidney
- z enostransko stenozo ledvične arterije in drugo funkcionalno ledvico
- patients in whom fluid or salt depletion exists or may develop (including patients with
- s pomanjkanjem soli, tekočine ali možnostjo pojava pomanjkanja (vključno z bolniki, ki
diuretics)
dobivajo diuretike)
- patients with liver cirrhosis and/ or ascites
- cirozo jeter in/ ali ascitesom
- patients undergoing major surgery or during anaesthesia with agents that produce
- velikimi operacijami ali med anestezijo z anestetiki, ki povzročijo hipotenzijo.
hypotension.
Takšni bolniki potrebujejo zdravniški nadzor, vljučno s kontroliranjem krvnega tlaka.
- Patients at risk of cardiac or cerebral ischemia in case of acute hypotension
- Bolniki s tveganjem za ishemijo srca ali možganov v primeru akutne hipotenzije
The initial phase of treatment requires special medical supervision.
Med uvodnim obdobjem zdravljenja je potreben poseben zdravniški nadzor.
o Elderly patients See section 4.2.
o Starejši bolniki Glejte poglavje 4. 2.
Surgery It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.
Operacije Če je mogoče, je treba zdravljenje z zaviralci angiotenzinske konvertaze, kakršen je ramipril, prekiniti en dan pred operacijo.
Monitoring of renal function Renal function should be assessed before and during treatment and dosage adjusted especially in the initial weeks of treatment.
Spremljanje delovanja ledvic Pred zdravljenjem in med njim je treba spremljati delovanje ledvic in odmerek ustrezno prilagoditi, zlasti v prvih tednih zdravljenja.
Particularly careful monitoring is required in patients with renal impairment (see section 4.2).
Bolniki z okvaro ledvic potrebujejo posebej natančno spremljanje (glejte poglavje 4. 2).
Angioedema Angioedema has been reported in patients treated with ACE inhibitors including ramipril (see section 4.8).
Angioedem Med zdravljenjem z zaviralci ACE, vključno z ramiprilom, je bil opisan angioedem (glejte poglavje 4. 8).
Intestinal angioedema has been reported in patients treated with ACE inhibitors including TRITACE (see section 4.8).
Pri bolnikih, zdravljenih z zaviralci ACE, vključno s TRITACE, je bil opisan intestinalni angioedem (glejte poglavje 4. 8).
Anaphylactic reactions during desensitization The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens are increased under ACE inhibition.
Anafilaktične reakcije med desenzibilizacijo Med zavrtjem ACE se povečata verjetnost in izrazitost anafilaktičnih in anafilaktoidnih reakcij na strupe žuželk in druge alergene.
Hyperkalaemia Hyperkalaemia has been observed in some patients treated with ACE inhibitors including TRITACE.
Hiperkaliemija Pri nekaterih bolnikih, zdravljenih z zaviralci ACE, vključno s TRITACE, so zabeležili hiperkaliemijo.
If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).
Če presodite, da je sočasna uporaba naštetih zdravil primerna, je priporočljivo redno kontrolirati kalij v serumu (glejte poglavje 4. 5).
25 Neutropenia/ agranulocytosis Neutropenia/ agranulocytosis, as well as thrombocytopenia and anaemia, have been rarely seen and bone marrow depression has also been reported.
Nevtropenija/ agranulocitoza Redko so zabeležili nevtropenijo ali agranulocitozo, trombocitopenijo ali anemijo, opisana je bila tudi depresija kostnega mozga.
More frequent monitoring is advised in the initial phase of treatment and in patients with impaired renal function, those with concomitant collagen disease (e. g. lupus erythematosus or scleroderma), and all those treated with other medicinal products that can cause changes in the blood picture (see sections 4.5 and 4.8).
Pogostejše kontrole so priporočljive v uvodnem obdobju zdravljenja, pa tudi pri bolnikih z okvarjenim delovanjem ledvic, sočasno kolagensko boleznijo (npr. eritematoznim lupusom ali
Ethnic differences ACE inhibitors cause higher rate of angioedema in black patients than in non black patients.
Etnične razlike Zaviralci ACE pogosteje povzročijo angioedem pri bolnikih- črncih kot nečrncih.
As with other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black people than in non black patients, possibly because of a higher prevalence of hypertension with low renin level in the black hypertensive population.
Tako kot drugi zaviralci ACE lahko tudi ramipril manj učinkovito zniža krvni tlak pri bolnikih- črncih kot nečrncih, verjetno zaradi večje prevalence hipertenzije z majhno koncentracijo renina pri črni hipertenzivni populaciji.
Cough Cough has been reported with the use of ACE inhibitors.
Kašelj Med uporabo zaviralcev ACE je opisan kašelj.
Characteristically, the cough is non- productive, persistent and resolves after discontinuation of therapy.
Značilno je, da je ta kašelj neproduktiven, trdovraten in po prekinitvi zdravljenja izgine.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (e. g. polyacrylonitril membranes) and low density lipoprotein apheresis with dextran sulphate due to increased risk of severe anaphylactoid reactions (see section 4.3).
Zunajtelesna zdravljenja, med katerimi pride kri v stik z negativno nabitimi površinami, npr. dializa ali hemofiltracija z določenimi visokopretočnimi membranami (npr. poliakrilonitrilnimi membranami) in afereza lipoproteina majhne gostote z dekstranovim sulfatom, zaradi večjega tveganja za hude anafilaktoidne reakcije (glejte poglavje 4. 3).
Potassium salts, heparin, potassium-retaining diuretics and other plasma potassium increasing active substances (including Angiotensin II antagonists, trimethoprim, tacrolimus, ciclosporin):
Kalijeve soli, heparin, diuretiki, ki varčujejo s kalijem, in druge zdravilne učinkovine, ki zvišujejo kalij v plazmi (vključno z antagonisti angiotenzina II, trimetoprimom, takrolimusom, ciklosporinom):
Hyperkalaemia may occur, therefore close monitoring of serum potassium is required.
Pojavi se lahko hiperkaliemija, zato je treba natančno kontrolirati kalij v serumu.
Antihypertensive agents (e. g. diuretics) and other substances that may decrease blood pressure (e. g. nitrates, tricyclic antidepressants, anaesthetics, acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin):
Antihipertenzivna zdravila (npr. diuretiki) in druge snovi, ki lahko znižajo krvni tlak (npr. nitrati, triciklični antidepresivi, anestetiki, akutno pitje alkohola, baklofen, alfuzosin, doksazosin, prazosin, tamsulosin, terazosin):
Potentiation of the risk of hypotension is to be anticipated (see section 4.2 for diuretics)
Pričakovati je treba večje tveganje hipotenzije (glejte poglavje 4. 2 za diuretike).
Vasopressor sympathomimetics and other substances (e. g. isoproterenol, dobutamine, dopamine, epinephrine) that may reduce the antihypertensive effect of TRITACE:
Vazopresorski simpatikomimetiki in druge snovi (npr. izoproterenol, dobutamin, dopamin, adrenalin), ki lahko zmanjšajo antihipertenzivni učinek TRITACE:
Blood pressure monitoring is recommended.
Priporočljivo je nadziranje krvnega tlaka.
Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count:
Alopurinol, imunosupresivi, kortikosteroidi, prokainamid, citostatiki in druge snovi, ki lahko spremenijo število krvnih celic:
Increased likelihood of haematological reactions (see section 4.4).
Večja verjetnost hematoloških reakcij (glejte poglavje 4. 4).
Lithium salts:
Soli litija:
Excretion of lithium may be reduced by ACE inhibitors and therefore lithium toxicity may be increased.
Zaviralci ACE lahko zmanjšajo izločanje litija in toksični učinki litija se zato lahko povečajo.
Antidiabetic agents including insulin:
Antidiabetična zdravila, vključno z insulinom:
Hypoglycaemic reactions may occur.
Pojavi se lahko hipoglikemična reakcija.
26 Non-steroidal anti-inflammatory drugs and acetylsalicylic acid:
Nesteroidna protivnetna zdravila in acetilsalicilna kislina:
Reduction of the antihypertensive effect of TRITACE is to be anticipated.
Pričakovati je mogoče zmanjšanje antihipertenzivnega učinka TRITACE.
TRITACE is not recommended during the first trimester of pregnancy (see section 4.4) and contraindicated during the second and third trimesters of pregnancy (see section 4.3).
4. 6 Nosečnost in dojenje
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
25 Epidemiološke ugotovitve o tveganju za teratogene učinke po izpostavljenosti zaviralcem ACE v prvem trimesečju nosečnosti niso dokončne, toda majhnega povečanja tveganja ni mogoče izključiti.
(See also 5.3'Preclinical safety data ').
Znano je, da zaviralci ACE/ antagonisti receptorjev angiotenzina II (AIIRA) v drugem in tretjem trimesečju pri človeku delujejo toksično na plod (zmanjšano delovanje ledvic, oligohidramnij, zapoznela osifikacija lobanje) in novorojenčka (odpoved ledvic, hipotenzija, hiperkaliemija) (glejte tudi poglavje 5. 3, "Predklinični podatki o varnosti").
Newborns whose mothers have taken ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalaemia (see also sections 4.3 and 4.4).
Novorojenčke mater, ki so jemale zaviralce ACE, je treba natančno nadzirati glede hipotenzije, oligurije in hiperkaliemije (glejte tudi poglavji 4. 3 in 4. 4).
Because insufficient information is available regarding the use of ramipril during breastfeeding (see section 5.2), ramipril is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
To še posebej velja pri dojenju novorojenčkov ali nedonošenčkov.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Some adverse effects (e. g. symptoms of a reduction in blood pressure such as dizziness) may impair the patient’ s ability to concentrate and react and, therefore, constitute a risk in situations where these abilities are of particular importance (e. g. operating a vehicle or machinery).
Zato so nevarni v okoliščinah, v katerih so te zmožnosti posebej pomembne (npr. pri upravljanju vozil ali strojev).
UNDESIRABLE EFFECTS
4. 8 Neželeni učinki
Serious adverse reactions include angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/ agranulocytosis.
Med resnimi neželenimi učinki so angioedem, hiperkaliemija, okvara ledvic ali jeter, pankreatitis, hude kožne reakcije in nevtropenija/ agranulocitoza.
Adverse reactions frequency is defined using the following convention:
Neželeni učinki so opredeljeni po naslednjem dogovoru:
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).
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), ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
Uncommon Myocardial ischaemia including angina pectoris or myocardial infarction,
Občasni ishemija miokarda, vključno z angino pektoris ali miokardnim infarktom, tahikardija, aritmija, palpitacije, periferni edemi
27
redki
Very rare
Ni znano odpoved
Not known
eozinofilija
tachycardia, arrhythmia, palpitations, oedema peripheral Blood and lymphatic system disorders
kostnega mozga, pancitopenija, hemolitična
Eosinophilia
26
White blood cell count decreased (including neutropenia or agranulocytosis), red blood cell count decreased, haemoglobin decreased, platelet count decreased
anemija agranulocitozo), zmanjšanje števila eritrocitov, znižanje hemoglobina, zmanjšanje števila trombocitov Bolezni živčevja
Bone marrow failure, pancytopenia, haemolytic anaemia
glavobol,
Nervous system disorders
vrtoglavica,
Headache, dizziness
tremor, motnja
Vertigo, paraesthesia, ageusia, dysgeusia,
parestezije, agevzija, dizgevzija,
Tremor, balance disorder
ravnotežja
Cerebral ischaemia including ischaemic stroke and transient ischaemic attack, psychomotor skills impaired, burning sensation, parosmia
ishemija, vključno z ishemično možgansko kapjo in tranzitorno ishemično atako, okvara psihomotoričnih sposobnosti, pekoč občutek, parozmija
Visual disturbance including blurred vision
motnje vida, vključno z zamegljenim vidom
Conjunctivitis
konjunktivitis okvara sluha, tinitus
Ear and labyrinth disorders
Bolezni dihal,
Hearing impaired, tinnitus
neproduktiven
Respiratory, thoracic and mediastinal disorders
bronhospazem,
Non-productive tickling cough, bronchitis, sinusitis, dyspnoea
dražeč kašelj,
Bronchospasm including asthma aggravated, nasal congestion
vključno s
Gastrointestinal disorders
mediastinalnega
Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting
poslabšanjem
Pancreatitis (cases of fatal outcome have been very exceptionally reported with ACE inhibitors), pancreatic enzymes increased, small bowel angioedema,
prostora
Glossitis
sinuzitis,
Aphtous stomatitis
Bolezni prebavil
abdominal pain upper including gastritis, constipation, dry mouth
vnetje prebavil, prebavne motnje, nelagodje v trebuhu, dispepsija, driska, navzea, bruhanje
28
glositis
Renal and urinary disorders
aftozni stomatitis
Renal impairment including renal failure acute, urine output increased,
27 zaprtje, suha usta okvara ledvic, Bolezni sečil vključno z akutno odpovedjo ledvic, večje izločanje urina, poslabšanje obstoječe proteinurije, zvišanje sečnine v krvi, zvišanje kreatinina v krvi
worsening of a pre-existing proteinuria, blood urea increased, blood creatinine increased
fotosenzibilnostna toksična eksfoliativni Bolezni kože in
Skin and subcutaneous tissue disorders
izpuščaj,
Rash in particular maculo-papular
dermatitis,
Angioedema; very exceptionally, the airway obstruction resulting from angioedema may have a fatal outcome; pruritus, hyperhidrosis
reakcija