qanastek/EMEA-V3 huggingface dataset:
Should exposure to ACE inhibitor have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Jekk iseħħ xi espożizzjoni għall- inibituri ACE mit- tieni trimester tat- tqala, hu rakkomandat li ssir ultrasownd tal- funzjoni renali u tal- kranju.
Newborns whose mothers have taken ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalaemia (see also sections 4.3 and 4.4).
Trabi ta ’ ommijiet li ħadu l- inbituri ACE għandhom jiġu osservati mill- viċin għall- ipotensjoni oligurja u iperkalimja (ara wkoll sezzjonijiet 4. 3 u 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.
Peress li m’ hemmx tagħrif biżżejjed dwar l- użu ta ’ ramipril waqt it- treddigħ (ara sezzjoni 5. 2) ramipril mhux rakkomandat u jkunu preferibbli kuri alternattivi b’ passat stabbilit aħjar ta ’ sikurezza għal waqt it- treddigħ specjalment waqt it- treddigħ ta ’ tarbija tat- twelid jew ta ’ tarbija li twieldet qabel iż- żmien.
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).
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni Xi effetti avversi (eż. sintomi ta ’ tnaqqis fil- pressjoni tad- demm bħal l- isturdament) jistgħu jnaqqsu l - abbiltà tal- pazjenti li jikkonċentra u jirreaġixxi u għalhekk ikunu ta ’ riskju f’ sitwazzjonijiet fejn dawn l- abbiltajiet ikunu ta ’ importanza partikulari (eż. tħaddem karozza jew magni).
This can happen especially at the start of treatment, or when changing over from other preparations.
Dan speċjalment jista ’ jiġri fil- bidu tal- kura jew meta tbiddel minn fuq preparazzjonijiet oħra.
After the first dose or subsequent increases in dose it is not advisable to drive or operate machinery for several hours.
Hu rakkomandat li wara l- ewwel doża jew wara żidiet sussegwenti fid- doża, m’ għandekx issuq jew tħaddem magni għal bosta sigħat.
UNDESIRABLE EFFECTS
4. 8 Effetti mhux mixtieqa
The safety profile of ramipril includes persistent dry cough and reactions due to hypotension.
L- analiżi tas- siġurtà ta ’ ramipril jinkludi sogħla persistenti u reazzjonijiet minħabba l- ipotensjoni.
Serious adverse reactions include angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/ agranulocytosis.
Reazzjonijiet avversi serji jinkludu anġjoedima, iperkalimja, indeboliment renali jew epatiku, pankreatite, reazzjonijiet severi fil- ġilda u newtropinja/ agranuloċitosi
Adverse reactions frequency is defined using the following convention:
Il- frekwenza tar- reazzjonijiet avversi huma mfissra bl- użu tal- konvenzjoni li ġejja:
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Komuni ħafna (≥1/ 10); Komuni (≥1/ 100 sa < 1/ 10); Mhux komuni (≥1/ 1, 000 sa < 1/ 100); Rari (≥1/ 10, 000 sa < 1/ 1, 000); Rari ħafna (< 1/ 10, 000), mhux magħruf (ma tistax tittieħed stima mid- data disponibbli) > F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
Cardiac disorders
Rari Disturbi fil -
Uncommon Myocardial ischaemia including angina pectoris or myocardial infarction,
Mhux komuni Iskemija
27
Rari ħafna
Rare
Mhux magħruf
Very rare
26
Not known
qalb
tachycardia, arrhythmia, palpitations, oedema peripheral Blood and lymphatic system disorders
Disturbi tad - demm u tas - sistema limfatika
White blood cell count decreased (including neutropenia or agranulocytosis), red blood cell count decreased, haemoglobin decreased, platelet count decreased
Tnaqqis fl - għadd taċ - ċelluli bojod tad- demm (inkluż newtropinja jew agranuloċitożi, tnaqqis fl - għadd taċ - ċelluli ħomor tad- demm, tnaqqis fl - emoglobina, tnaqqis fl - għadd tal - plejtlits
Bone marrow failure, pancytopenia, haemolytic anaemia
Insuffiċjenza fil - funzjoni tal - mudullun, panċitopenja, anemija emolitika
Headache, dizziness
Uġigħ ta ’ ras, sturdament
Vertigo, paraesthesia, ageusia, dysgeusia,
Vertigo, parestiżja, agewżja, disgewżja
Tremor, balance disorder
tregħid, disturbi fil - bilanċ,
Cerebral ischaemia including ischaemic stroke and transient ischaemic attack, psychomotor skills impaired, burning sensation, parosmia
Iskemija ċerbrali li tinkludi puplesija iskemika u attakk iskemiku ta ’ qasir żmien, tnaqqis fl - abbiltajiet psikomotorji, sensazzjoni ta ’ ħruq, parosmja
Visual disturbance including blurred vision
Disturbi fil- viżta li tinkludi viżta mċajpra,
Hearing impaired, tinnitus
Diffikultà fis - smigħ, tinnitus
Non-productive tickling cough, bronchitis, sinusitis, dyspnoea
Sogħla niexfa b’ tagħrix fil - griżmejn, bronkite, sinusite, diffikultà biex tieħu n- nifs
Bronchospasm including asthma aggravated, nasal congestion
Bronkospażmu li tinkludi l - aggravar tal - ażma, konġestjoni nażali
Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting
Infjammazzjoni gastro- intestinali, disturbi diġestivi,
Pancreatitis (cases of fatal outcome have been very exceptionally reported with ACE inhibitors), pancreatic enzymes increased, small bowel angioedema,
Pankreatite (bl - inibituri ACE, b’ mod
Aphtous stomatitis
Ulċeri fil- ħalq,
abdominal pain upper including gastritis, constipation, dry mouth
dwejjaq addominali, dispepsja, dijarea, dardir, rimettar
28
eċċezzjonali ħafna ġew irrapportati xi każijiet li kellhom eżitu fatali), żieda fl - enzimi pankreatiċi, anġjoedima fl - intestin iż- żgħir uġigħ fin- naħa ta ’ fuq tal- addome li tinkludi gastrite, stitikezza, ħalq xott
Renal and urinary disorders
Disturbi fil - kliewi u fis - sistema urinarja
worsening of a pre-existing proteinuria, blood urea increased, blood creatinine increased
Indeboliment renali li tinkludi insuffiċjenza renali akuta, żieda fl- ammont tal- awrina, jiżdied l- ammont li diġa ’ kien hemm ta ’ proteina fl - awrina, żieda fl- ammont ta ’ urea fid - demm, żieda fl - ammont ta ’ krejatinina fid - demm
Skin and subcutaneous tissue disorders
Disturbi fil - ġilda u fit - tessuti ta ’ taħt il- ġilda
Rash in particular maculo-papular
Raxx b’ mod partikulari makulo - papulari
Angioedema; very exceptionally, the airway obstruction resulting from angioedema may have a fatal outcome; pruritus, hyperhidrosis
Anġjoedima: b’ mod eċċezzjonali ħafna, l - ostrużżjoni fil - pajp tan- nifs minħabba l - anġjoedima jista ’ jkollu riżultat fatali; prurite, iperidrożi
Exfoliative dermatitis, urticaria, onycholysis,
Dermatite esfoljattiva, urtikarja, onikolożi (jinqala ’ d - difer minn postu)
Photosensitivit y reaction
Reazzjoni ta ’ fotosensitt ività
Toxic epidermal necrolysis, Stevens- Johnson syndrome, erythema multiforme, pemphigus, psoriasis aggravated, dermatitis psoriasiform, pemphigoid or lichenoid exanthema or enanthema, alopecia
Nekroliżi epidermali tossika, sindrome Stevens- Johnson, eritema multiforme, pemfigus, psorjasi li tmur għall- agħar, dermatite psorjasiforme, pemfigojd jew eksantema liċenojde jew enantema, alopeċja
Muscle spasms, myalgia
Spażmi fil- muskoli, mijalġja
Metabolism and nutrition disorders
Disturbi fil - metaboliżmu u
Blood potassium increased
Żieda fil- livell ta ’ potassju.
Anorexia, decreased appetite,
Anoressija, tnaqqis fl- aptit
Blood sodium decreased
Tnaqqis fil- livell ta ’ sodju fid- demm
Hypotension,
n- nutrizzjoni
Flushing Vascular
28
Vascular Hypotension, Flushing Vascular
Glikosurja, alkalożi metabolika, ipoklorimja, ipomagnesimja, iperkalċimja, deidratazzjoni minħabba hydrochlorothiazide
disorders
Disturbi vaskulari
orthostatic blood pressure decreased, syncope
Ipotensjoni, tnaqqis fil- pressjoni tad - demm ortostatika, sinkope
stenosis, hypoperfusion, vasculitis
Ħmura fil- wiċċ
phenomenon
Stenożi vaskulari, ipoperfużjoni, vaskulite
General disorders and
Fenomenu ta ’ Raynaud,
Chest pain, fatigue
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
Pyrexia
Uġigħ fis- sider, gheja,
Asthenia
Deni
29
Astinja
Anaphylactic or anaphylactoid reactions, antinuclear antibody increased
Reazzjonijiet anafilattiċi jew li jixbħuhom, żieda fl - antikorpi antinukleari
Hepatic enzymes and/ or bilirubin conjugated increased,
Żieda fl- enzimi epatiċi u/ jew żieda fil- bilirubin konġjugat
Jaundice cholestatic, hepatocellular damage
Suffejra kolestatika, dannu epatoċellulari
Acute hepatic failure, cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional).
Insuffiċjenza epatika akuta, epatite kolestatika jew ċitolitika (każijiet b’ eżitu fatali kienu eċċeżżjonali ħafna)
Reproductive system and breast disorders
Disturbi fis - sistema riproduttiva u fis- sider
Transient erectile impotence, libido decreased
Impotenza erettili għal żmien qasir, tnaqqis fil- libido,
Gynaecomastia
Gajnikomastja (żvilupp eċċessiv tas - sider fir- raġel)
Depressed mood, anxiety, nervousness, restlessness, sleep disorder including somnolence
Tħossok imdejjaq, ansjetà, nervożità, irrekwitezza disturbi fl- irqad inkluż ħedla ta ’ ngħas
Confusional state
Stat konfużjonarju
Disturbance in attention
Disturbi fl- attenzjoni
OVERDOSE
4. 9 Doża eċċessiva
Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.
Sintomi assoċjati ma ’ doża eċċessiva ta ’ inibituri ACE jistgħu jinkludu vasodilatazzjoni periferali eċċessiva (b’ ipotensjoni kbira, xokk), bradikardija, disturbi fl- elettroliti u insuffiċjenza renali.
The patient should be closely monitored and the treatment should be symptomatic and supportive.
Il- pazjent għandu jiġi segwit sew u l- kura għandha tkun sintomatika u ta ’ support.
Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including, administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration.
Miżuri rakkomandati jinkludu detossifikazzjoni primarja (lavaġ gastriku, l- għoti ta ’ assorbenti) u miżuri biex jerġgħu jġibu lura l- istabbilità emodinamika li jinkludu l- għoti ta ’ agonisti adrenerġiċi alfa 1 jew l - għoti ta ’ anġjotensin II (anġjotensinamid).
Ramiprilat, the active metabolite of ramipril is poorly removed from the general circulation by haemodialysis.
L- emodijaliżi ma tantx ineħħi ramiprilat, il- metabolit attiv ta ’ ramipril, miċ- ċirkolazzjoni ġenerali.
PHARMACODYNAMIC PROPERTIES
5. 1 Tagħrif farmakodinamiku
In plasma and
Ramiprilat, il- metabolit attiv tal- prodrug ramipril jinibixxi l- enzima dipeptidylcarboxypeptidase I (sinonimi: enzima li tikkonverti anġjotensin; kininase II).
30 tissue this enzyme catalyses the conversion of angiotensin I to the active vasoconstrictor substance angiotensin II, as well as the breakdown of the active vasodilator bradykinin.
Fil- plażma u fit- tessuti, din l- enzima tikkatalizza l- konverżjoni ta ’ anġjotensin I fil- vasoristrettatur attiv anġjotensin II, kif ukoll tikkawża d- dekomponiment tal- vasodilatatur attiv bradykinin.
Reduced angiotensin II formation and inhibition of bradykinin breakdown lead to vasodilatation.
Tnaqqis fil- produzzjoni ta ’ anġjotensin II u l - inibizzjoni tad- dekomponiment ta ’ bradykinin iwasslu għal vasodilatazzjoni.
Since angiotensin II also stimulates the release of aldosterone, ramiprilat causes a reduction in aldosterone secretion.
Peress li anġjotensin II jistimula l- ħruġ ta ’ aldosterone, ramiprilat jikkawża tnaqqis fis- sekrezzjoni ta ’ aldosterone.
The average response to ACE inhibitor monotherapy was lower in black (Afro- Caribbean) hypertensive patients (usually a low-renin hypertensive population) than in non-black patients.
Bħala medja, ir- rispons għall- inibitur ACE bħala monterapija kienet inqas f’ pazjenti suwed (Afro- Karibew) ipertensivi (ħafna drabi popolazzjoni ipertensiva b’ ammont baxx ta ’ renin) milli f’ pazjenti li mhumiex suwed.
Antihypertensive properties:
Karatteristiċi antiipertensivi:
Generally, there are no major changes in renal plasma flow and glomerular filtration rate.
L- għoti ta ’ ramipril jikkawża tnaqqis kbir fir- reżistenza arterjali periferali. Normalment, ma jkunx hemm tibdil kbir fil- fluss tad- demm fil- kliewi u fir- rata tal- filtrazzjoni glomerulari.
Administration of ramipril to patients with hypertension leads to a reduction in supine and standing blood pressure without a compensatory rise in heart rate.
L- għoti ta ’ ramipril f’ pazjenti bl- ipertensjoni jwassal għal tnaqqis fil- pressjoni tad- demm kemm ta ’ dik meta tkun mimdud u kemm ta ’ meta tkun bil- wieqfa mingħajr ma jkun hemm żieda kumpensatorja fir- rata tat - tħabbit tal- qalb.
In most patients the onset of the antihypertensive effect of a single dose becomes apparent 1 to 2 hours after oral administration.
Wara t- teħid b’ mod orali, f’ ħafna mill- pazjenti, l- effett antiipertensiv wara doża waħda jibda jinħass wara siegħa jew sagħtejn.
The peak effect of a single dose is usually reached 3 to 6 hours after oral administration.
Wara doża waħda li tittieħed b’ mod orali, il- massimu tal- effett normalment jintlaħaq wara 3 sa 6 sigħat.
The antihypertensive effect of a single dose usually lasts for 24 hours.
L- effett antiipertensiv ta ’ doża waħda normalment idum għal 24 siegħa.
The maximum antihypertensive effect of continued treatment with ramipril is generally apparent after 3 to 4 weeks.
Normalment, il- massimu tal- effett antiipertensiv ta ’ kura kontinwu jinħass wara 3 sa 4 ġimgħat.
It has been shown that the antihypertensive effect is sustained under long term therapy lasting 2 years.
Ġie muri li f’ kura għal tul ta ’ żmien ta ’ sentejn, l- effett antiipertensiv baqa ’ sostnut.
Abrupt discontinuation of ramipril does not produce a rapid and excessive rebound increase in blood pressure.
Twaqqif f’ daqqa ta ’ ramipril ma rriżultax f’ żieda eċċessiva u ta ’ malajr fil- pressjoni tad- demm għal kif kienet qabel.
In addition to conventional therapy with diuretics and optional cardiac glycosides, ramipril has been shown to be effective in patients with functional classes II-IV of the New-York Heart Association.
Minbarra t- terapija konvenzjonali bid- dijuretiċi u jekk tkun trid il- glikosidi kardijaċi, ġie muri li ramipril hu effettiv f’ pazjenti b’ kategoriji funzjonali II- IV tal- Assoċjazzjoni tal- Qalb ta’ New York.
The drug had beneficial effects on cardiac haemodynamics (decreased left and right ventricular filling pressures, reduced total peripheral vascular resistance, increased cardiac output and improved cardiac index).
Il - mediċina kellha effetti ta ’ benefiċċju fuq l- emodinamika kardijaka (tnaqqis fil- pressjoni meta jimtlew il- ventrikuli tax- xellug u tal- lemin, tnaqqis fir- reżistenza vaskulari totali periferika, żieda fil- volum ta ’ demm li joħroġ mill- qalb u titjib fl- indiċi kardijaku).
It also reduced neuroendocrine activation.
Naqqset ukoll l- attivazzjoni newroendokrinika.
Cardiovascular prevention/ Nephroprotection;
Prevenzjoni kardjovaskulari/ protezzjoni tal- kliewi:
A preventive placebo-controlled study (the HOPE-study), was carried out in which ramipril was added to standard therapy in more than 9,200 patients.
Sar studju ta ’ prevenzjoni kkontrollat bil- plaċebo (l- istudju HOPE), fejn ramipril ġie miżjud ma ’ terapija standard f’ 9, 200 pazjent.
Patients with increased risk of cardiovascular disease following either atherothrombotic cardiovascular disease (history of coronary heart disease, stroke or peripheral vascular disease) or diabetes mellitus with at least one additional risk factor (documented microalbuminuria, hypertension, elevated total cholesterol level, low high-density lipoprotein cholesterol level or cigarette smoking) were included in the study.
Ġew inklużi fl- istudju, pazjenti b’ żieda fir- riskju ta ’ mard kardjovaskulari wara jew mard kardjovaskulari aterotrombotiku (passat mediku ta ’ mard koronarju tal - qalb, attakk ta ’ puplesija, jew mard vaskulari periferiku) jew dijabete mellitus b’ għallinqas fattur ieħor ta ’ riskju (evidenza ta ’ mikroalbuminurja, ipertensjoni, livell għoli tat- total ta ’ kolesterol, livell baxx tal- lipoproteina tal- kolesterol b’ densita għolja jew tipjip).
The study showed that ramipril statistically significantly decreases the incidence of myocardial infarction, death from cardiovascular causes and stroke, alone and combined (primary combined events).
L- istudju wera li ramipril b’ mod statistikament sinifikanti jnaqqas l- inċidenza ta ’ infart mijokardijaku, mewt minn kawżi kardjovaskulari u puplusija, waħidhom jew ikkombinati (avvenimenti primarji kkombinati).
The HOPE study:
30 L- istudju HOPE:
Main results
Ir- riżultati l- aktar importanti
Placebo relative risk (95% interval)
Plaċebo riskju relattiv (95% intervall kunfidenza)
confidence
ta ’
p-value
p- value
Primary combined events Myocardial infarction Death from cardiovascular causes Stroke
Avvenimenti primarji kkombinati Infart mijokardijaku
14.0 9.9 6.1 3.4
14. 0 9. 9
17.8 12.3 8.1 4.9
< 0. 001 < 0. 001
0.78 (0.70-0.86) 0.80 (0.70-0.90) 0.74 (0.64-0.87) 0.68 (0.56-0.84)
Mewt minn kawżi kardjovaskulari 6. 1 Attakk ta ’ puplesija 3. 4
< 0.001 < 0.001 < 0.001 < 0.001
0. 74 (0. 64- 0. 87) 0. 68 (0. 56- 0. 84)
Secondary endpoints
< 0. 001 < 0. 001
31
Avvenimenti finali sekondarji
Death from any cause Need for Revascularisation Hospitalisation for unstable angina
Mewt minn kull kawża Bżonn ta ’ Vaskularizzazzjoni mill - ġdid
10.4 16.0 12.1
12. 2 18. 3
12.2 18.3 12.3
0. 005 0. 002
0.84 (0.75-0.95) 0.85 (0.77-0.94) 0.98 (0.87-1.10)
Teħid fl- isptar minħabba anġina li mhix stabbli
0.005 0.002 NS
NS
Hospitalisation for heart failure Complications related to diabetes
Teħid fl- isptar minħabba insuffiċjenza tal- qalb
3.2 6.4
3. 5
3.5 7.6
0. 25
0.88 (0.70-1.10) 0.84 (0.72-0.98)
Kumplikazzjonijiet li għandhom x’ jaqsmu mad- dijabete
0.25 0.03
0. 84 (0. 72- 0. 98)
The MICRO-HOPE study, a predefined substudy from HOPE, investigated the effect of the addition of ramipril 10 mg to the current medical regimen versus placebo in 3,577 patients at least ≥ 55 years old (with no upper limit of age), with a majority of type 2 diabetes (and at least another CV risk factor), normotensive or hypertensive.
L- istudju MICRO- HOPE, sottostudju ddeterminat minn qabel minn HOPE, investiga l- effett taż- żieda ta ’ 10 mg ta ’ ramipril mal- iskeda medika kurrenti kontra plaċebo f’ 3, 577 pazjent li kellhom għallinqas ≥ 55 sena (bla ebda limitu massimu ta ’ età), bil- parti l- kbira bid- dijabete tat- tip 2 (u għallinqas riskju kardjovaskulari ieħor), normotensivi jew ipertensivi.
The primary analysis showed that 117 (6.5%) participants on ramipril and 149 (8.4%) on placebo developed overt nephropathy, which corresponds to a RRR 24%; 95% CI [3-40], p = 0.027.
L- analiżi primarja wriet li 117 – il partiċipant (6. 5%) fuq ramipril u 149 partiċipant (8. 4%) fuq plaċebo żviluppaw nefropatija evidenti li tikkorispondi għal RRR ta ’ 24% Cl [3- 40], p = 0. 027.
The REIN study, a multicenter randomized, double-blind parallel group, placebo-controlled study aimed at assessing the effect of treatment with ramipril on the rate of decline of glomerular function rate (GFR) in 352 normotensive or hypertensive patients (18-70 years old) suffering from mild (i. e. mean urinary protein excretion > 1 and < 3 g/ 24 h) or severe proteinuria (≥ 3 g/ 24 h) due to chronic non-diabetic nephropathy.
L- istudju REIN, studju arbitrarju, magħmul f’ ħafna ċentri, ikkontrollat bil- plaċebo, b’ grupp parallel double- blind, bl- għan li janalizza l- effett ta ’ kura b’ ramipril fuq ir- rata ta ’ tnaqqis fil- funzjoni glomerulari (GFR) f’ 352 pazjent normotensiv jew ipertensiv (18- 70 sena) li jbatu minn proteinurja ħafifa (jiġifieri medja ta ’ tneħħija ta ’ proteina urinarja > 1 u < 3 g/ 24 siegħa) jew gravi (≥ 3 g/ 24 siegħa) minħabba nefropatija kronika li mhix kawża tad - dijabete.
Both subpopulations were prospectively stratified.
Dan iż- żewġ popolazzjonijiet partikulari kienu mqassma f’ saffi b’ mod prospettiv.
The main analysis of patients with the most severe proteinuria (stratum prematurely disrupted due to benefit in ramipril group) showed that the mean rate of GFR decline per month was lower with ramipril than with placebo; -0.54 (0.66) vs. -0.88 (1.03) ml/ min/ month, p = 0.038.
L- aktar analiżi importanti tal- pazjenti bl- aktar proteinurja gravi (saff li twaqqaf ħesrem qabel it- tmiem minħabba benefiċċju fil- grupp ta ’ ramipril) uriet li r=rata medja ta ’ tnaqqis fil- GFR kull xahar kien inqas b’ ramipril milli bil- plaċebo; - 0. 54 (0. 66) vs. - 0. 88 (1. 03) ml/ min/ xahar, p = 0. 038.
The intergroup difference was thus 0.34 [0.03-0.65] per month, and around 4 ml/ min/ year; 23.1% of the patients in the ramipril group reached the combined secondary endpoint of doubling of baseline serum creatinine concentration and/ or end-stage renal disease (ESRD) (need for dialysis or renal transplantation) vs.
Għalhekk id - differenza bejn il- gruppi kien ta ’ 0. 34 [0. 03- 0. 65] kull xahar, u madwar 4 ml/ min/ sena; 23. 1% tal - pazjenti tal- grupp ta ’ ramipril laħqu l- avveniment finali sekondarju kkombinat ta ’ rdoppjar tal - konċentrazzjoni tal- krejatinina fis- serum mill- linja bażi u/ jew l- aħħar stadju tal- mard renali (ESRD) (bżonn ta ’ dijaliżi jew trapjant renali) vs.
45.5% in the placebo group (p = 0.02).
45. 5% fil- grupp tal- plaċebo (p=0. 02).
Secondary prevention after acute myocardial infarction
Prevenzjoni sekondarja wara infart mijokardijaku akut
The AIRE study included more than 2,000 patients with transient/ persistent clinical signs of heart failure after documented myocardial infarction.
L- istudju AIRE kien jinkludi iżjed minn 2, 000 pazjent b’ sinjali kliniċi momentanji/ persistenti ta ’ insuffiċjenza tal- qalb wara infart mijokardijaku dokumentat.
The ramipril treatment was started 3 to 10 days after the acute myocardial infarction.
Il- kura b’ ramipril nbeda 3 sa 10 ijiem wara l- infart mijokardijaku akut.
The study showed that after an average follow-up time of 15 months the mortality in ramipril-treated patients was 16.9% and in the placebo treated patients was 22.6%.
L- istudju wera li wara medja ta ’ 15- il xahar għat- tieni viżta għand l - ispeċjalista, il- mortalità fil- pazjenti kkurati b’ ramipril kienet ta ’ 16. 9% u f’ dawk ikkurati bil- plaċebo ta ’ 22. 6%.
This means an absolute mortality reduction of 5.7% and a relative risk reduction of 27% (95% CI [11-40%]).
Dan ifisser tnaqqis assolut fil- mortalità ta ’ 5. 7% u tnaqqis relattiv fir- riskju ta ’ 27% (95% Cl [11- 40%]).
PHARMACOKINETIC PROPERTIES
5. 2 Tagħrif farmakokinetiku
Pharmacokinetics and Metabolism Absorption
Farmakokinetika u Metaboliżmu
Following oral administration ramipril is rapidly absorbed from the gastrointestinal tract: peak plasma concentrations of ramipril are reached within one hour.
Wara t- teħid b’ mod orali, ramipril jiġi assorbit malajr mill- passaġġ gastrointestinali; l- ogħla konċentrazzjonijiet fil- plażma ta ’ ramipril jinlaħqu fi żmien siegħa.
Based on urinary recovery, the extent of absorption is at least 56% and is not significantly influenced by the presence of food in the gastrointestinal tract.
Skont l- ammont irkuprat mill - awrina, it- total li jiġi assorbit hu mill- inqas 56% u mhuwiex affettwat b’ mod sinifikanti mill- presenza tal- ikel fil- passaġġ gastrointestinali.
The bioavailability of the active metabolite ramiprilat after oral administration of 2.5 mg and 5 mg ramipril is 45%.
Il- bijodisponibilità tal- metabolit attiv ramiprilat wara t- teħid b’ mod orali ta ’ 2. 5 mg u ta ’ 5 mg hu ta ’ 45%.
Peak plasma concentrations of ramiprilat, the sole active metabolite of ramipril are reached 2-4 hours after ramipril intake.
L- ogħla konċentrazzjonijiet fil- plażma ta ’ ramiprilat, l- uniku metabolit attiv ta ’ ramipril, jintlaħqu bejn sagħtejn u erba ’ sigħat wara t- teħid ta ’ ramipril.
Steady state plasma concentrations of ramiprilat after once daily dosing with the usual doses of ramipril are reached by about the fourth day of treatment.
Wara dożaġġ ta ’ darba kuljum bid- dożi tas- soltu ta ’ ramipril, il- konċentrazzjonijiet fissi ta ’ ramiprilat fil- plażma jintlaħqu mar- raba ’ ġurnata ta ’ kura.
Distribution The serum protein binding of ramipril is about 73% and that of ramiprilat about 56%.
Distribuzzjoni L- irbit ta ’ ramipril mal- proteini fis- serum hu ta ’ madwar 73% u dak ta ’ ramiprilat ta ’ madwar 56%.
32 Metabolism Ramipril is almost completely metabolised to ramiprilat, and to the diketopiperazine ester, the diketopiperazine acid, and the glucuronides of ramipril and ramiprilat.
Metaboliżmu Ramipril jiġi kważi metabolizzat għal kollox f’ ramiprilat, u fl- ester diketopiperazine, fl- aċidu diketopiperazine u fil- glukuronidi ta ’ ramipril u ramiprilat.
Elimination Excretion of the metabolites is primarily renal.
Eliminazzjoni It- tneħħija tal- metaboliti huwa primarjament renali.
Plasma concentrations of ramiprilat decline in a polyphasic manner.
Il- konċentrazzjonijiet ta ’ ramiprilat fil- plażma jonqsu b’ mod polifażiku.
Because of its potent, saturable binding to ACE and slow dissociation from the enzyme, ramiprilat shows a prolonged terminal elimination phase at very low plasma concentrations.
F’ konċentrazzjonijiet baxxi ħafna fil- plażma, ramiprilat, minħabba l- irbit qawwi u saturabbli ma ’ ACE u d- dissoċjazzjoni ta ’ bilmod minn mal- enzima, għandu fażi mtawla ta ’ eliminazzjoni terminali.
After multiple once-daily doses of ramipril, the effective half-life of ramiprilat concentrations was 13- 17 hours for the 5-10 mg doses and longer for the lower 1.25-2.5 mg doses.
Wara dożi multipli ta ’ ramipril darba kuljum, il- half- life effettiv tal- konċentrazzjonijiet ta ’ ramiprilat kien ta ’ 13- 17- il siegħa għad- dożi ta ’ 5- 10 mg u itwal għad- dożi iżgħar ta ’ 1. 25- 2. 5 mg.
This difference is related to the saturable capacity of the enzyme to bind ramiprilat.
Din id- differenza hija minħabba l - kapaċità ta ’ saturazzjoni tal- enzima biex tintrabat ma ’ ramiprilat.
However the effect of multiple doses is not known.
Ma nstabux traċċi ta ’ ramipril jew il - metaboliti tiegħu fil- ħalib tal- omm wara doża waħda li ttieħdet b’ mod orali. Madankollu, l- effett ta ’ dożi multipli mhux magħruf.
Patients with renal impairment (see section 4.2) Renal excretion of ramiprilat is reduced in patients with impaired renal function, and renal ramiprilat clearance is proportionally related to creatinine clearance.
Pazjenti b’ indeboliment renali (ara sezzjoni 4. 2) It- tneħħija renali ta ’ ramiprilat hija mnaqqsa f’ pazjenti b’ indeboliment fil- funzjoni renali u t- tneħħija renali ta ’ ramiprilat hija relatata proporzjonalment mat- tneħħija tal- krejatinina.
This results in elevated plasma concentrations of ramiprilat, which decrease more slowly than in subjects with normal renal function.
Dan jirriżulta f’ konċentrazzjonijiet ogħla fil- plażma li jonqsu aktar bilmod meta mqabbla ma ’ pazjenti b’ funzjoni renali normali.
Patients with hepatic impairment (see section 4.2) In patients with impaired liver function, the metabolism of ramipril to ramiprilat was delayed, due to diminished activity of hepatic esterases, and plasma ramipril levels in these patients were increased.
Pazjenti b’ indeboliment tal- fwied (ara sezzjoni 4. 2) F’ pazjenti b’ indeboliment fil- funzjoni tal- fwied, il- metaboliżmu ta ’ ramipril għal ramiprilat ġie mtawwal minħabba t- tnaqqis fl- attività tal- esterases epatiċi u l- livelli ta ’ ramipril fil- plażma ta ’ dawn il- pazjenti żdiedu.
Peak concentrations of ramiprilat in these patients, however, are not different from those seen in subjects with normal hepatic function.
Madankollu, l- ogħla konċentrazzjonijiet ta ’ ramiprilat f’ dawn il- pazjenti mhumiex differenti minn dawk li nsibu f’ pazjenti b’ funzjoni epatika normali.
PRECLINICAL SAFETY DATA
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Oral administration of ramipril has been found to be devoid of acute toxicity in rodents and dogs.
Instab li l- għoti orali ta ’ ramipril m’ għandu ebda tossiċità akuta fl- annimali gerriema u l- klieb.
Indications of plasma electrolyte shifts and changes in blood picture have been found in the 3 species.
Studji fejn l- għoti mill- ħalq kien kroniku ġew magħmula fil- firien, klieb u xadini. Fit- tliet speċi instabu indikazzjonijiet ta ’ ċaqliq fl- elettroliti fil- plażma u tibdil fil- komponenti tad- demm.
Rats, dogs and monkeys tolerated daily doses of 2, 2.5 and 8 mg/ kg/ d respectively without harmful effects.
Bħala riżultat tal - effett farmakodinamiku ta ’ ramipril, ġie nnotat tkabbir sew fl- apparat ġukstoglomerulari fil- kelb u fix - xadina minn dożi ta ’ kuljum ta ’ 250 mg/ kg/ kuljum. Il- firien, klieb u xadini ttoleraw mingħajr effetti ħżiena dożi ta ’ kuljum ta ’ 2, 2. 5 u 8 mg/ kg/ ġurnata rispettivament.
Reproduction toxicology studies in the rat, rabbit and monkey did not disclose any teratogenic properties.
Studji tossikoloġiċi fuq is- sistema riproduttiva fil- far, fil- fenek u fix- xadina ma wrew ebda karatteristika teratoġenika.
Fertility was not impaired either in male or in female rats.
Ma kienx hemm indeboliment fil- fertilità kemm fil- firien irġiel u kemm fil- firien nisa.
The administration of ramipril to female rats during the fetal period and lactation produced irreversible renal damage (dilatation of the renal pelvis) in the offspring at daily doses of 50 mg/ kg body weight or higher.
L- għoti ta ’ ramipril f’ dożi ta ’ 50 mg/ kg ta ’ piż tal- ġisem jew iżjed lill- firien nisa waqt il- perijodu fetali jew ta ’ treddigħ irriżulta f’ dannu renali irriversibbli (dilatazzjoni tal- pelvis renali) fil- frieħ.
Extensive mutagenicity testing using several test systems has yielded no indication that ramipril possesses mutagenic or genotoxic properties.
32 Testijiet estensivi ta ’ mutaġeniċità bl- użu ta ’ bosta sistemi ta ’ testijiet ma ta ebda indikazzjoni li ramipril għandu karatteristiċi mutaġeniċi jew genetossiċi.
LIST OF EXCIPIENTS
6. 1 Lista ta ’ sustanzi mhux attivi
INCOMPATIBILITIES
6. 2 Inkompatibilitajiet
33 SHELF LIFE
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
SPECIAL PRECAUTIONS FOR STORAGE
6. 4 Prekawzjonijiet speċjali għall- ħażna
NATURE AND CONTENTS OF CONTAINER
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
SPECIAL PRECAUTIONS FOR DISPOSAL
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema < u għal immaniġġar ieħor >
MARKETING AUTHORISATION HOLDER
[Ara Anness I - Biex timtela mill- pajjiż partikolari]
[See Annex I - To be completed nationally] {Name and address} {tel} {fax} {e-mail}
[Isem u indirizz] {telefon} {fax} {e- mail}
34 LABELLING
34 TIKKETTA
TRITACE and associated names (see Annex I) 1.25 mg tablets TRITACE and associated names (see Annex I) 2.5 mg tablets TRITACE and associated names (see Annex I) 5 mg tablets TRTACE and associated names (see Annex I) 10 mg tablets
TRITACE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 1. 25 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 2. 5 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 5 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 10 mg
[See Annex I - to be completed nationally]
[Ara Anness I - Biex timtela mill- pajjiż partikolari]
Tablet Hard Capsule
Pillola Kapsula iebsa
Oral use.
Għall- użu orali
[To be completed nationally]
[- Biex timtela mill- pajjiż partikolari]
{Name and address} {Tel} {fax} {e-mail}
{Isem u indirizz} {telefon} {fax} {e- mail}
37 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
TRITACE and associated names (see Annex I) 1.25 mg capsules TRITACE and associated names (see Annex I) 2.5 mg capsules TRITACE and associated names (see Annex I) 5 mg capsules TRITACE and associated names (see Annex I) 10 mg capsules
TRITACE u ismijiet assoċjati miegħu (Ara Anness I) kapsuli ibsin ta ’ 1. 25 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) kapsuli ibsin ta ’ 2. 5 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) kapsuli ibsin ta ’ 5 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) kapsuli ibsin ta ’ 10 mg
[See Annex I - To be completed nationally] {Name}
[Ara Anness I - Biex timtela mill- pajjiż partikolari] {Isem}
38 PACKAGE LEAFLET
38 FULJETT TA ’ TAGĦRIF
TRITACE and associated names (see Annex I) 1.25 mg hard capsules TRITACE and associated names (see Annex I) 2.5 mg hard capsules TRITACE and associated names (see Annex I) 5 mg hard capsules TRITACE and associated names (see Annex I) 10 mg hard capsules [See Annex I – To be completed nationally]
TRITACE u ismijiet assoċjati miegħu (Ara Anness I) kapsuli ibsin ta ’ 1. 25 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) kapsuli ibsin ta ’ 2. 5 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) kapsuli ibsin ta ’ 5 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) kapsuli ibsin ta ’ 10 mg
It may harm them even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What TRITACE is and what it is used for 2.
X’ inhu TRITACE u għalxiex jintuża 2.
Before you take TRITACE 3.
Qabel ma tieħu TRITACE 3.
How to take TRITACE 4.
Kif għandek tieħu TRITACE 4.
How to store TRITACE 6.
Kif taħżen TRITACE 6.
WHAT TRITACE IS AND WHAT IT IS USED FOR
X’ INHU TRITACE U GĦALXIEX JINTUŻA
TRITACE contains a medicine called ramipril.
TRITACE fih mediċina li tissejjaħ ramipril.
This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
Din tagħmel parti minn grupp ta 'mediċini li jissejħu inibituri ta' ACE (Inibituri ta 'l- Enzima li Tikkonverti Angiotensin).
TRITACE works by: • Decreasing your body’ s production of substances that could raise your blood pressure • Making your blood vessels relax and widen • Making it easier for your heart to pump blood around your body.
TRITACE jaħdem billi: • Inaqqas il- produzzjoni mill- ġisem ta 'sustanzi li jistgħu jgħollulek il- pressjoni • Jirrilassa u jwessa' l- kanali tad- demm • Jiffaċilita l- ippumpjar tad- demm mill- qalb madwar ġismek kollu.
TRITACE can be used: • To treat high blood pressure (hypertension) • To reduce the risk of you having a heart attack or stroke • To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes) • To treat your heart when it cannot pump enough blood to the rest of your body (heart failure) • As treatment following heart attack (myocardial infarction) complicated with heart failure.
TRITACE jista 'jintuża: • Biex jikkura l- pressjoni għolja (ipertensjoni) • Biex inaqqasslek ir- riskju li jkollok attakk tal- qalb jew puplesija • Biex inaqqass ir- riskju jew jittardja l- iggravar ta' problemi tal- kliewi (għandek jew m' għandekx id- dijabete) • Biex jikkuralek qalbek meta ma tkunx tista 'tippompja biżżejjed demm għall- bqija ta' ġismek (insuffiċjenza tal- qalb) • Bħala kura wara attakk tal- qalb (infart mijokardijaku) ikkumplikat b' insuffiċjenza tal- qalb.
BEFORE YOU TAKE TRITACE
QABEL MA TIEĦU TRITACE
Signs of an allergic reaction may include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue • If you have ever had a serious allergic reaction called “ angioedema”.
Tieħux TRITACE: • Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal ramipril għal xi mediċini oħra li huma inibituri ta 'ACE jew għal xi sustanzi ta ’ TRITACE mniżżla f' Sezzjoni 6 Is- sinjali ta' reazzjoni allerġika jistgħu jinkludu raxx, problemi biex tibla 'jew tieħu n- nifs, nefħa f' xufftejk, f' wiċċek, f' griżmejk jew f' ilsienek • Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) Jekk qatt xi darba kellek reazzjoni allerġika serja msejħa "anġjoedima".
The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing • If you are having dialysis or any other type of blood filtration.
Is- sinjali jinkludu ħakk, urtikarja, marki ħomor fl- idejn, saqajn u griżmejn, nefħa tal- griżmejn u l- ilsien, nefħa madwar l- għajnejn u x- xufftejn, diffikultà biex tieħu nifs u tibla '• Jekk qiegħed/ qegħda tagħmel dijalisi jew xi tip ieħor ta' filtrazzjoni tad- demm.
Depending on the machine that is used, TRITACE may not be suitable for you • If you have kidney problems where the blood supply to your kidney is reduced (renal artery stenosis) • During the last 6 months of pregnancy (see section below on “ Pregnancy and breast-feeding”) • If your blood pressure is abnormally low or unstable.
Skont il- magna li qed tintuża, TRITACE u jista 'ma jkunx adattat għalik • Jekk għandek problemi tal- kliewi fejn il- provvista tad- demm għall- kliewi hija mnaqqsa (stenosi ta' l- arterja renali) • Waqt l- aħħar 6 xhur ta ’ tqala (ara is- sezzjoni hawn taħt "Tqala u treddigħ") • Jekk il- pressjoni tad- demm tiegħek hija baxxa b' mod mhux normali jew instabbli.
Your doctor will need to make this assessment.
It- tabib tiegħek irid jagħmel din il- valutazzjoni.
Do not take TRITACE if any of the above apply to you.
Tieħux TRITACE jekk xi waħda minn dawn ta 'hawn fuq tapplika għalik.
If you are not sure, talk to your doctor before taking TRITACE.
Jekk għandek xi dubju, kellem lit- tabib tiegħek qabel ma tieħu TRITACE
Take special care with TRITACE Check with your doctor or pharmacist before taking your medicine: • If you have heart, liver or kidney problems • If you have lost a lot of body salts or fluids (through being sick (vomiting), having diarrhoea, sweating more than usual, being on a low salt diet, taking diuretics (water tablets) for a long time or having had dialysis) • If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitization) • If you are going to receive an anaesthetic.
Ikkonsulta mat- tabib jew spiżjar tiegħek qabel ma tieħu l- mediċina tiegħek: • Jekk għandek problemi tal- qalb, fwied jew kliewi • Jekk tlift ammont kbir ta 'melħ tal- ġisem jew fluwidi (għax kont ma tiflaħx (tirrimetti), kellek id- dijarea, għereqt aktar mis- soltu, qiegħed/ qegħda fuq dieta bi ftit melħ, qiegħed/ qegħda tieħu dijuretiċi (pilloli ta' l- ilma) għal żmien twil jew kellek dijalisi) • Jekk ser tieħu kura biex tnaqqas allerġija għal tingiż tan- naħal jew żunżan (tneħħija ta 'sensittività) • Jekk ser tirċievi anestesija minħabba operazzjoni jew proċedura dentali.
You may need to stop your TRITACE treatment one day beforehand; ask your doctor for advice • If you have high amounts of potassium in your blood (shown in blood test results) • If you have collagen vascular disease such as scleroderma or systemic lupus erythematosus • You must tell your doctor if you think that you are (or might become) pregnant.
Ġurnata qabel jista ’ jkollok bżonn twaqqaf il- kura b’ TRITACE; staqsi t- tabib għal parir. • Jekk għandek ammonti kbar ta 'potassium fid- demm (muri fir- riżultati tat- testijiet tad- demm) • Jekk għandek mard vaskulari ta' collagen bħal skleroderma jew lupus eritematosu sistemiku. • Għandek tgħid lit- tabib jekk taħseb li inti (jew li tista ’ ssir) tqila.
TRITACE is not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section “ Pregnancy and breast-feeding”.
TRITACE mhux rakkomandat fl- ewwel tliet xhur ta ’ tqala u jista ’ jikkawża ħsara serji lit- tarbija tiegħek wara tliet xhur ta ’ tqala (ara s- sezzjoni hawn taħt "Tqala u treddigħ").
Children TRITACE is not recommended for use in children and adolescents below 18 years of age because there is no information available in this population.
Tfal TRITACE mhux rakkomandat fit- tfal u fl- adolexxenti taħt it- 18- il sena għax il- mediċina qatt ma ntużat f’ dawn il- gruppi ta ’ etajiet.
If any of the above apply to you (or you are not sure), talk to your doctor before taking TRITACE.
Jekk xi waħda minn dawn ta 'hawn fuq tapplika għalik (jew għandek xi dubju), kellem lit- tabib tiegħek qabel ma tieħu TRITACE.
Taking TRITACE with other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (including herbal medicines).
Meta tieħu TRITACE ma 'mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed/ qegħda tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta (inklużi medicini mill- ħxejjex).
This is because TRITACE can affect the way some other medicines work.
Dan għaliex TRITACE jista 'jaffettwa l- mod kif jaħdmu mediċini oħra.
Also some medicines can affect the way TRITACE works.
Barra minn hekk, xi mediċini jistgħu jaffettwaw il - mod kif jaħdem TRITACE.
Please tell your doctor if you are taking any of the following medicines.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed/ qegħda tieħu xi mediċini minn dawn li ġejjin.
They can make TRITACE work less well: • Medicines used to relieve pain and inflammation (e. g.
B' dawn TRITACE jista 'jaħdem inqas: • Mediċini li jintużaw biex itaffu l- uġigħ u l- infjammazzjoni (eż.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin) • Medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline.
41 • Mediċini li jintużaw għall- kura tal- pressjoni baxxa, xokk, insuffiċjenza kardijaka, ażma jew allerġiji bħal ephedrine, noradrenaline jew adrenaline.
Your doctor will need to check your blood pressure.
It- tabib tiegħek ikollu bżonn jiċċekkja l - pressjoni tad- demm tiegħek.
They can increase the chance of getting side effects if you take them with TRITACE:
Jistgħu jżiedu l- probabbilità li jseħħu effetti sekondarji jekk teħodhom ma 'TRITACE: • Mediċini li jintużaw biex itaffu l- uġigħ u l- infjammazzjoni (eż.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin) • Medicines for cancer (chemotherapy) • Medicines to stop the rejection of organs after a transplant such as ciclosporin • Diuretics (water tablets) such as furosemide • Medicines which can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (for thinning blood) • Steroid medicines for inflammation such as prednisolone • Allopurinol (used to lower the uric acid in your blood) • Procainamide (for heart rhythm problems).
Mediċini Anti- infjammatorji Mhux Sterojdi (NSAIDs) bħal ibuprofen jew indometacin u aspirina) • Mediċini għall- kanser (kimoterapija) • Mediċini li jwaqqfu r- riġettar ta 'organi ttrapjantati bħal ciclosporin • Dijuretiċi (pilloli ta' l- ilma) bħal furosemide • Mediċini li jistgħu jżidu l- ammont ta 'potassium fid- demm tiegħek bħal spironolactone, triamterene, amiloride, melħ ta' potassium u eparina (għat- traqqiq tad- demm) • Mediċini sterojdi għall- infjammazzjoni bħal prednisolone • Allopurinol (jintuża biex ibaxxi l- aċidu uriku fid- demm tiegħek) • Procainamide (għal problemi fir- ritmu tal- qalb).
They may be affected by TRITACE: • Medicines for diabetes such as oral glucose lowering medicines and insulin.
Dawn jistgħu jiġu affettwati minn TRITACE: • Mediċini għad- dijabete bħall- insulina u mediċini orali li jbaxxu glucose.
TRITACE may lower your blood sugar amounts.
TRITACE jista 'jbaxxilek iz- zokkor fid- demm.
Check your blood sugar amounts closely while taking TRITACE • Lithium (for mental health problems).
Iċċekkja b' attenzjoni z- zokkor fid- demm waqt li tkun qiegħed/ qegħda tieħu TRITACE • Lithium (għal problemi ta 'saħħa mentali).
TRITACE may increase the amount of lithium in your blood.
TRITACE jista 'jżid l- ammont ta' lithium fid- demm tiegħek.
Your lithium amount will need to be closely checked by your doctor.
L- ammont ta 'lithium irid jiġi ċċekkjat b' attenzjoni mit- tabib tiegħek.
Taking TRITACE with food and alcohol • Drinking alcohol with TRITACE may make you feel dizzy or light-headed.
Meta tieħu TRITACE ma ’ l- ikel u max- xorb • Ix- xorb alkoħoliku ma TRITACE jista 'jagħmlek sturdut.
If you are concerned about how much you can drink while you are taking TRITACE, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects. • TRITACE may be taken with or without food.
Jekk trid tkun taf kemm tista 'tixrob waqt li tkun qiegħed/ qegħda tieħu TRITACE, kellem lit- tabib tiegħek billi mediċini li jintużaw biex ibaxxu l- pressjoni tad- demm u l- alkoħol jistgħu jkollhom effetti miżjuda. • TRITACE jista' jittieħed ma 'l- ikel jew le.
Pregnancy and breast-feeding You must tell your doctor if you think that you are (or might become) pregnant You should not take TRITACE in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby.
M’ għandekx tieħu TRITACE fl- ewwel 12- il ġimgħa ta ’ tqala u m’ għandekx tieħdu wara t- tlettax- il ġimgħa għax l- użu tiegħu waqt it- tqala jista ’ jkun ta ’ periklu għat- tarbija.
If you become pregnant while on TRITACE, tell your doctor immediately.
Jekk issir tqila waqt li qeda tieħu TRITACE għid lit- tabib tiegħek minnufih.
A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.
Għandek taqleb għal kura alternattiva aktar adattata qabel ma tippjana li toħroġ tqila.
You should not take TRITACE if you are breast-feeding.
M’ għandekx tieħu TRITACE jekk qeda tredda ’.
Ask your doctor or pharmacist for advice before taking any medicine.
Qabel ma tieħu xi mediċina staqsi lit- tabib jew lill- ispiżjar għal parir.
Driving and using machines You may feel dizzy, while taking TRITACE.
Sewqan u tħaddim ta ’ magni Tista 'tħossok sturdut waqt li tkun qed tieħu TRITACE.
This is more likely to happen when you start taking TRITACE or start taking a higher dose.
Dan huwa aktar probabbli meta tibda tieħu TRITACE jew tibda tieħu doża akbar.
If this happens, do not drive or use any tools or machines.
Jekk dan iseħħ, issuqx jew tagħmilx użu minn għodda jew tħaddem magni.
HOW TO TAKE TRITACE
KIF GĦANDEK TIEĦU TRITACE
Always take TRITACE exactly as your doctor has told you.
42 Dejjem għandek tieħu TRITACE skont il- parir eżatt tat- tabib.
Taking this medicine • Take this medicine by mouth at the same time of the day each day. • Swallow the tablets/ capsules whole with liquid. • Do not crush or chew the tablets/ capsules.
Meta tieħu din il- mediċina Ħu din il- mediċina mill- ħalq fl- istess ħin kuljum. • Ibla 'l- pilloli/ kapsuli sħaħ ma ’ xi likwidu. • Tfarrakx u tomogħdx il- pilloli/ kapsuli. •
42 • Your doctor will adjust the amount you take until your blood pressure is controlled. • The maximum dose is 10 mg once daily. • If you are already taking diuretics (water tablets), your doctor may stop or reduce the amount of the diuretic you take before beginning treatment with TRITACE.
Kura tal- pressjoni għolja • Normalment id- doża tal- bidu hija 1. 25 mg jew 2. 5 mg darba kuljum. • It- tabib tiegħek jaġġusta l- ammont li tieħu sakemm il- pressjoni tiġi kkontrollata. • Id- doża massima hija 10 mg darba kuljum. • Jekk diġà qiegħed/ qegħda tieħu dijuretiċi (pilloli ta 'l- ilma), it- tabib jista' jwaqqaflek jew inaqqaslek l- ammont tad- dijuretiku li qed tieħu qabel ma tibda l- kura b '< TRITACE u ismijiet assoċjati miegħu >.
To reduce the risk of you having a heart attack or stroke • The usual starting dose is 2.5 mg once daily. • Your doctor may then decide to increase the amount you take. • The usual dose is 10 mg once daily.
Biex jitnaqqaslek ir- riskju ta 'attakk tal- qalb jew puplesija • Normalment id- doża tal- bidu hija 2. 5 mg darba kuljum. • It- tabib tiegħek imbagħad jista' jiddeċiedi li jżidlek l- ammont li tieħu. • Normalment id- doża hija 10 mg kuljum.
Treatment to reduce or delay the worsening of kidney problems • You may be started on a dose of 1.25 mg or 2.5 mg once daily. • Your doctor will adjust the amount you are taking. • The usual dose is 5 mg or 10 mg once daily.
Kura biex jitnaqqas jew jittardja l- iggravar ta 'problemi tal- kliewi • Tista' tinbeda b' doża ta '1. 25 mg jew 2. 5 mg darba kuljum. • It- tabib tiegħek jaġġusta l- ammont li tieħu. • Normalment id- doża hija 5 mg jew 10 mg kuljum.