qanastek/EMEA-V3 huggingface dataset:
The most common undesirable effects with ivabradine are dose dependent and related to the pharmacological effect of the medicinal product.
Effetti mhux mixtieqa l- aktar komuni b’ ivabradine huma dawk li jiddependu mid- doża u relatati ma ’ l- effett farmakoloġiku tal- prodott mediċinali.
The following adverse effects or events have been reported during clinical trials and are ranked using the following frequency: very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1000 ,< 1/100); rare (> 1/ 10000 ,< 1/1000); very rare (< 1/10000); not known (cannot be estimated from the available data).
L- effetti mhux mixtieqa jew sitwazzjonijiet li ġew irrapporatati waqt provi kliniċi huma kklassifikati bl- użu ta ’ din il- frekwenza: komuni ħafna (> 1/ 10); komuni (> 1/ 100, < 1/ 10); mhux komuni (> 1/ 1000, < 1/ 100); rari (> 1/ 10000, < 1/ 1000); rari ħafna (< 1/ 10000); mhux magħruf (ma tistax tittieħed stima mid- data disponibbli)
Uncommon:
Investigazzjonijiet Mhux komuni
- Eosinophilia
- Eosinofilja
- Elevated creatinine in blood
- Kreatinina fid- demm elevata
Cardiac disorders:
Mard tal- qalb:
3.3% of patients particularly within the first 2 to 3 months of treatment initiation.
0. 5% tal- pazjenti
0.5% of patients experienced a severe bradycardia below or equal to 40 bpm.
kellhom bradikardija qawwija taħt jew daqs 40 bpm.
- Palpitations, supraventricular extrasystoles
- Żieda fl- extra sistoli ventrikulari
The following events reported during clinical trials were of similar incidence than comparators and/ or possibly related to the underlying disease: sinus arrhythmia, unstable angina, angina pectoris aggravated, atrial fibrillation, myocardial ischaemia, myocardial infarction and ventricular tachycardia.
Dawn il- kundizzjonijiet ġew irrapportati waqt provi kliniċi fl- istess inċidenza bħal ta ’ mediċini simili u/ jew kienu possibilment relatati ma ’ marda kurrenti: sinus arritmija, anġina mhux stabbli, angina pectoris aggravata, fibrillazzjoni ta ’ l- atriju, iskemija mijokardijaka, infart mijokardijaku, takikardija ventrikulari.
Eye disorders:
Mard ta ’ l- għajnejn:
Very common:
Komuni ħafna
- Luminous phenomena (phosphenes): reported by 14.5% of patients, described as a transient
- Fenomeni mudwali (ċrieki ta’ dawl): irrapportati minn 14. 5% tal- pazjenti, jiddeskrivu luminożita
enhanced brightness in a limited area of the visual field.
qawwija ta ’ dawl temporanju limitat fil- qasam viżiv.
They are usually triggered by sudden variations in light intensity.
Is- soltu dawn jiġu kkawżati minn varjazzjoni f’ daqqa ta ’ qawwa fid- dawl.
The onset of phosphenes is generally within the first two months of treatment after which they may occur repeatedly.
Ġeneralment iċ- ċrieki ta ’ dawl jibdew jidhru fl- ewwel xahrejn tal- bidu tal- kura u wara jistgħu jigru ripetutament.
Phosphenes were generally reported to be of mild to moderate intensity.
Iċ- ċrieki ta ’ dawl kienu fil- biċċa l - kbira irraportati li huma ta ’ intensita` moderata.
All phosphenes resolved during or after treatment, of which a majority (77.5%) resolved during treatment.
Iċ- ċrieki ta ’ dawl kollha jgħaddu waqt jew wara l- kura, il- biċċa l- kbira tagħhom (77. 5%) waqt il- kura.
Fewer than 1% of patients changed their daily routine or discontinued the treatment in relation with phosphenes.
Inqas minn 1% tal- pazjenti biddlu ir- rutina tagħhom ta ’ kuljum jew waqfu l- kura minħabba iċ- ċrieki ta’ dawl.
- Blurred vision
- Vista mċajpra
Gastrointestinal disorders:
Mard gastro- intestinali:
- Nausea
- nawsija
- Constipation
- stitikezza
- Diarrhoea
- dijarea
General disorders and administration site conditions:
Mard ġenerali u kondizzjonijiet ta ’ mnejn jingħata:
- Headache, generally during the first month of treatment.
- Uġigħ ta ’ ras, ġeneralment fl- ewwel xahar tal- kura.
- Dizziness, possibly related to bradycardia.
- Sturdament, possibilment relatat ma ’ bradikardija.
- Dyspnoea
- Qtugħ ta ’ nifs
- Muscle cramps
- Bugħawwieġ
Overdose may lead to severe and prolonged bradycardia (see section 4.8).
Doża eċċessiva tista ’ twassal għall- bradikardija severa u fit- tul (ara sezzjoni 4. 8).
Severe bradycardia should be treated symptomatically in a specialised environment.
Bradikardija severa trid tiġi kkurata b’ mod sintomatiku f’ ambjent speċjalizzat.
In the event of bradycardia with poor haemodynamic tolerance, symptomatic treatment including intravenous beta- stimulating agents such as isoprenaline may be considered.
F’ każ ta ’ bradikardija b’ tolleranza emodinamika, kura sintomatika inkluż mediċini beta stimulanti fil- vina bħal isoprenaline tista ’ tiġi ikkunsidrata.
Pharmacotherapeutic group: other cardiac preparations, ATC code:
Kategorija farmakoterapewtika: prodotti mediċinali oħra kardijaċi, Kodiċi ATC:
Ivabradine is a pure heart rate lowering agent, acting by selective and specific inhibition of the cardiac pacemaker If current that controls the spontaneous diastolic depolarisation in the sinus node and regulates heart rate.
L- effetti kardijaċi huma speċifiċi fuq is -
The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarisation.
7 sinus node b’ ebda effett fuq il- ħin biex igħaddi l- istimulu intra- atrijali, atrijuventrikulari jew intraventrikulari, l- anqas fuq it- tagħfis mijokardijaku u l- anqas fuq ir- ripolarizzazzjoni ventrikulari.
7 Ivabradine can interact also with the retinal current Ih which closely resembles cardiac If.
Ivabradine jista ’ jkollu interazzjoni ma ’ current IH retinali li jixbaħ ħafna lil If kardijaku.
It participates in the temporal resolution of the visual system, by curtailing the retinal response to bright light stimuli.
Jieħu sehem fit- tiswija temporanja tas- sistema viżiva billi jillimita r- rispons retinali għal stimoli għal dawl qawwi.
Under triggering circumstances (e. g. rapid changes in luminosity), partial inhibition of Ih by ivabradine underlies the luminous phenomena that may be occasionally experienced by patients.
F’ każijiet li jikkaġunaw dawn iċ- ċirkustanzi (eż. tibdil f’ daqqa ta ’ luminożita`), impedizzjoni parzjali ta ’ IH b’ ivabradine jispjega l- fenomeni mudwali li kultant jista ’ jkollu l- pazjent.
Luminous phenomena (phosphenes) are described as a transient enhanced brightness in a limited area of the visual field (see section 4.8).
Fenomeni mudwali (ċrieki tad- dawl) huma meqjusa bħala luminożita` qawwija ta ’ dawl temporanju f’ parti limitata tal - qasam viżiv (ara sezzjoni 4. 8).
The main pharmacodynamic property of ivabradine in humans is a specific dose dependent reduction in heart rate.
Il- karatteristika farmakodinamika prinċipali ta ’ ivabradine fil- bniedem hija tnaqqis fir- rata tat- taħbit tal- qalb dipendenti minn doża speċifika.
Analysis of heart rate reduction with doses up to 20 mg twice daily indicates a trend towards a plateau effect which is consistent with a reduced risk of severe bradycardia below 40 bpm (see section 4.8).
Analiżi ta ’ tnaqqis fir- rata tat- taħbit tal- qalb b’ doża sa 20 mg darbtejn kuljum tindika tendenza lejn effett ta ’ plateau konsistenti ma ’ riskju inqas ta ’ bradikardija severa ta ’ inqas minn 40 bpm (ara sezzjoni 4. 8).
At usual recommended doses, heart rate reduction is approximately 10 bpm at rest and during exercise.
B’ dożi irrikmandati s- soltu, t- tnaqqis fir- rata tat- taħbit tal- qalb hu ta ’ madwar 10 bpm waqt il- mistrieħ u waqt l- eżerċizzju fiżiku.
This leads to a reduction in cardiac workload and myocardial oxygen consumption.
Dan iwassal għal tnaqqis fuq l- ammont ta ’ xogħol kardijaku u fuq il - konsum ta ’ ossiġinu mijokardijaku.
Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation:
Ivabradine m’ għandux effett fuq il- ħin biex igħaddi l- istimulu intrakardijaku, fuq il- kontrazzjoni (l- ebda effett negattiv inotropiku) u l- anqas fuq ir- ripolarizzazzjoni ventrikulari:
- in clinical electrophysiology studies, ivabradine had no effect on atrioventricular or intraventricular
- fi studji kliniċi elettrofiżjoloġiċi, ivabradine ma kellux effett fuq il- ħin atrijuventrikulari jew
conduction times or corrected QT intervals;
intraventrikulari biex igħaddi l- istimulu u l- anqas fuq l- intervall QT ikkoregut;
- in patients with left ventricular dysfunction (left ventricular ejection fraction (LVEF) between 30
- f’ pazjenti b’ anomilija ventrikulari fuq ix- xellug (frazjoni ventrikulari li toħroġ mix- xellug
and 45%), ivabradine did not have any deleterious influence on LVEF.
(LVEF) bejn 30 u 45%), ivabradine ma kellu ebda influenza ta ’ ħsara fuq LVEF.
The antianginal and anti-ischaemic efficacy of Corlentor was studied in four double-blind randomised trials (two versus placebo, and one each versus atenolol and amlodipine).
L- effikaċja kontra l- anġina u kontra l- iskemija ta ’ Corlentor ġiet studjata f’ erba ’ provi randomised għamja doppji (tnejn versus placebo, wieħed versus atenolol u wieħed versus amlodipine).
These trials included a total of 3,222 patients with chronic stable angina pectoris, of whom 2,168 received ivabradine.
F’ dawn il - provi ħadu sehem 3, 222 pazjent b’ angina pectoris kronika stabbli, li minnhom 2, 168 ħadu ivabradine.
Ivabradine 5 mg twice daily was shown to be effective on exercise test parameters within 3 to 4 weeks of treatment.
Deher li ivabradine 5 mg darbtejn kuljum kien effettiv fuq il- parametri tat- test ta ’ eżerċizzju fiżiku wara 3- 4 ġimgħat ta ’ kura.
Efficacy was confirmed with 7.5 mg twice daily.
L- effikaċja ġiet ikkonfermata b’ doża ta ’ 7. 5 mg darbtejn kuljum.
In particular, the additional benefit over 5 mg twice daily was established in a reference-controlled study versus atenolol: total exercise duration at trough was increased by about 1 minute after one month of treatment with 5 mg twice daily and further improved by almost 25 seconds after an additional 3-month period with forced titration to 7.5 mg twice daily.
Benefiċċju ieħor ta ’ aktar minn 5 mg darbtejn kuljum ġie stabbilit fi studu reference- controlled versus atenolol: tul ta ’ ħin ta ’ eżerċizzju żdied bi kważi minuta wara xahar ta ’ kura b’ doża ta ’ 5 mg darbtejn kuljum u reġa żdied kważi 25 sekonda wara 3 xhur oħra ta ’ kura b’ doża mgħaġġla ta ’ 7. 5 mg darbtejn kuljum.
In this study, the antianginal and anti-ischaemic benefits of ivabradine were confirmed in patients aged 65 years or more.
F’ dan l- istudju, il- benefiċċji ta ’ ivabradine kontra l- anġina u kontra l- iskemija ġew ikkonfermati f’ pazjenti ta ’ 65 sena jew iżjed.
The efficacy of 5 and 7.5 mg twice daily was consistent across studies on exercise test parameters (total exercise duration, time to limiting angina, time to angina onset and time to 1mm ST segment depression) and was associated with a decrease of about 70% in the rate of angina attacks.
L- effikaċja ta ’ dożi ta ’ 5 mg u 7. 5 mg darbtejn kuljum kienet konsistenti fi studji fuq il- parametri tat- test ta ’ eżerċizzju fiżiku (tul totali ta ’ ħin ta ’ eżerċizzju fiżiku, ħin ta’ tul ta ’ anġina, ħin ta ’ bidu ta ’ anġina, ħin ta ’ dipressjoni ta ’ 1mm fil- parti ST) u kien assoċċjat ma tnaqqis ta ’ madwar 70% fir- rata ta’ l- attakki tal- anġina.
The twice-daily dosing regimen of ivabradine gave uniform efficacy over 24 hours.
Id- doża ta’ darbtejn kuljum ta ’ ivabradine tat- effikaċja konistenti tul 24 siegħa.
In a 725-patients randomised placebo-controlled study, ivabradine did not show additional efficacy on top of amlodipine at the trough of drug activity (12 hours after oral intake) while an additional efficacy was shown at peak (3-4 hours after oral intake).
Fi studji kliniċi randomised kontrollati bil- placebo fuq 725 pazjenti ivabradine ma kellux effikaċja aktar minn amlodipine fl- attivita tal- mediċina fl- inqas ħin (12– il siegħa wara li jittieħed mil- ħalq) waqt li kien hemm aktar effikaċja fl- aqwa ħin (3- 4 sigħat wara li jittieħed mil- ħalq).
Ivabradine efficacy was fully maintained throughout the 3- or 4-month treatment periods in the efficacy trials.
L- effikaċja t ’ ivabradine baqgħet tinżamm matul il- perjodi ta ’ 3 - jew 4 xhur ta ’ kura waqt il- provi ta ’ l- effikaċja.
There was no evidence of pharmacological tolerance (loss of efficacy) developing during treatment nor of rebound phenomena after abrupt treatment discontinuation.
Ma kienx hemm evidenza li kien hemm tolleranza farmakoloġika (nuqqas ta ’ effikaċja) li żviluppat waqt il- kura u l- anqas ta ’ fenomeni li reġgħu dehru b’ aktar qawwa meta l- kura ġiet imwaqqfa f’ daqqa waħda.
The antianginal and anti-ischaemic effects of ivabradine were associated with dose-dependent reductions in heart rate and with a significant decrease in rate pressure product (heart rate x systolic blood pressure) at rest and during exercise.
L- effetti kontra l- anġina u kontra l- iskemija ta ’ ivabradine kellhom x’ jaqsmu mat- tnaqqis fir- rata tat- taħbit tal- qalb marbut mad- doża bi tnaqqis sinifikanti fil- valur tal - multiplikazzjonijiet tar- rata mal- pressjoni (rata ta ’ taħbit tal- qalb x pressjoni sistolika) waqt il- mistrieħ u waqt eżerċizzju fiżiku.
The effects on blood pressure and peripheral vascular resistance were minor and not clinically significant.
L- effetti fuq il- pressjoni u fuq resistenza periferali vaskulari kienu minimi u klinikament mhux sinifikanti.
A sustained reduction of heart rate was demonstrated in patients treated with ivabradine for at least one year (n = 713).
Tnaqqis sostenut fir- rata tat- taħbit tal- qalb deher f’ pazjenti kkurati b’ ivabradine għal ta ’ l- inqas sena (n = 713).
No influence on glucose or lipid metabolism was observed.
Ma gie osservat ebda effett fuq il- metaboliżmu tal- glucose jew tal- lipidi.
The antianginal and anti-ischaemic efficacy of ivabradine was preserved in diabetic patients (n = 457) with a similar safety profile as compared to the overall population.
8 L- effikaċja ta ’ ivabradine kontra l- anġina u kontra l- iskemija inżammet f’ pazjenti dijabetiċi (n = 457) bl- istess profil ta ’ sigurta` meta mqabbla mal- popolazzjoni inġenerali.
5.2 Pharmacokinetic properties 8 Under physiological conditions, ivabradine is rapidly released from tablets and is highly water-soluble (> 10 mg/ ml).
F’ kundizzjonijiet fiżjoloġiċi, ivabradine jiġi merħi malajr mill- pilloli u jinħall mill- ewwel fl- ilma (> 10 mg/ ml).
Ivabradine is the S-enantiomer with no bioconversion demonstrated in vivo.
Ivabradine huwa S- enantiomer u ma wera l- ebda biokonverżjoni in vivo.
The N- desmethylated derivative of ivabradine has been identified as the main active metabolite in humans.
Id- derivattiv N- desmethylated ta ’ ivabradine gie iddentifikat bħala s- sustanza attiva maggura ffurmata fil - metaboliżmu fil- bniedem.
Absorption and bioavailability Ivabradine is rapidly and almost completely absorbed after oral administration with a peak plasma level reached in about 1 hour under fasting condition.
Assorbiment u biodisponibilita` Ivabradine jiġi assorbit malajr u kważi kollu wara li jittieħed mill- ħalq u jilħaq l- ogħla livell tal - plażma f’ madwar 1 siegħa meta l- pazjent ikun sajjem.
The absolute bioavailability of the film-coated tablets is around 40%, due to first-pass effect in the gut and liver.
Il- biodisponibilta` totali tal- pilloli miksija b’ rita hi ta ’ madwar 40% minħabba l- effett li igħaddi mill- ewwel mill- istonku u mill- fwied.
Food delayed absorption by approximately 1 hour, and increased plasma exposure by 20 to 30%.
L- ikel jittardja l- assorbiment b’ xi siegħa, u l- esponiment fil- plażma jiżdied b’ 20% - 30%.
The intake of the tablet during meals is recommended in order to decrease intra-individual variability in exposure (see section 4.2).
Hu aħjar li l - pilloli jittieħdu ma ’ l- ikel biex b’ hekk tonqos il- varjabilta` intra- individwali fil- kxif (ara sezzjoni 4. 2).
Distribution Ivabradine is approximately 70% plasma protein bound and the volume of distribution at steady-state is close to 100 l in patients.
Distribuzzjoni Ivabradine huwa bejn wieħed u ieħor 70% marbut mal- protejina tal- plażma u l- volum ta ’ distribuzzjoni fiss huwa viċin ta ’ 100 1 f’ pazjenti.
The maximum plasma concentration following chronic administration at the recommended dose of 5 mg twice daily is 22 ng/ ml (CV=29%).
L- ogħla konċentrazzjoni fil - plażma meta jingħata fit- tul f’ doża rakkomandata ta ’ 5 mg darbtejn kuljum hija ta ’ 22 ng/ ml (CV = 29%).
The average plasma concentration is 10 ng/ ml (CV=38%) at steady-state.
Il- medja ta ’ konċentrazzjoni fil- plażma fissa hija ta ’ 10 ng/ ml (CV = 38%).
Biotransformation Ivabradine is extensively metabolised by the liver and the gut by oxidation through cytochrome P450 3A4 (CYP3A4) only.
Biotrasformazzjoni Ivabradine jiġi metabolizzat b’ mod estensiv mill- fwied u mill- istonku permess ta ’ ossidazzjoni biċ - ċitokromu P450 3A4 (CYP3A4) biss.
The major active metabolite is the N-desmethylated derivative (S 18982) with an exposure about 40% of that of the parent compound.
Is- sustanza attiva prinċipali ffurmata fil- metaboliżmu hi d - derivattiv N- desmethylated (S18982) ma ’ kxif ta ’ madwar 40% tal- prodott mediċinali oriġinali.
The metabolism of this active metabolite also involves CYP3A4.
Il - metaboliżmu ta ’ din is- sustanza attiva ffurmata fil- metaboliżmu wkoll tinvolvi CYP3A4.
Ivabradine has low affinity for CYP3A4, shows no clinically relevant CYP3A4 induction or inhibition and is therefore unlikely to modify CYP3A4 substrate metabolism or plasma concentrations.
Ivabradine għandu affinita` baxxa għal CYP3A4, m’ għandux induzzjoni u l- anqas impedizzjoni klinikament relevanti ta ’ CYP3A4 u għalhekk mhux mistenni li jbiddel il- livell ta ’ sustanza li tiġi metaboliżżata minn CYP3A4 jew il- konċentrazzjonijiet fil- plażma.
Inversely, potent inhibitors and inducers may substantially affect ivabradine plasma concentrations (see section 4.5).
Bil- maqlub impedituri u mediċini li jġiegħlu iċ - CYP3A4 jaħdem iżjed qawwi jistgħu jaffetwaw sostanzjalment il- konċentrazzjonijiet tal- plażma ta ’ ivabradine (ara sezzjoni 4. 5).
Elimination Ivabradine is eliminated with a main half-life of 2 hours (70-75% of the AUC) in plasma and an effective half-life of 11 hours.
Eliminazzjoni Ivabradine jitneħħa b’ half- life prinċipali ta ’ 2 siegħat (70- 75% ta ’ l- AUC) fil- plażma u half- life effettiva ta ’ 11– il siegħa.
The total clearance is about 400 ml/ min and the renal clearance is about 70 ml/ min.
It- tneħħija totali hu ta ’ madwar 400 ml/ min u t- tneħħija renali hija ta ’ madwar 70 ml/ min.
Excretion of metabolites occurs to a similar extent via faeces and urine.
L- eliminazzjoni tas- sustanzi metabollizati ssir bl- istess ammont via l- ippurgar u l - awrina.
About 4% of an oral dose is excreted unchanged in urine.
Madwar 4% tad- doża meħuda mill- ħalq titneħħa mingħajr ma tinbidel fl- awrina.
Linearity/ non linearity The kinetics of ivabradine is linear over an oral dose range of 0.5 – 24 mg.
Għamla lineari/ mhux lineari Il- kinetika ta ’ ivabradine hija lineari fuq medda ta ’ doża mill- ħalq ta ’ 0. 5- 24 mg.
Special populations
Popolazzjoni speċjali
- Elderly: no pharmacokinetic differences (AUC and Cmax) have been observed between elderly (≥
- Anzjani: ma kienx hemm differenza farmakokinetika (AUC u Cmax) bejn anzjani (≥ 65 sena) jew
65 years) or very elderly patients (≥ 75 years) and the overall population (see section 4.2).
anzjani ħafna (≥ 75 sena) u l- popolazzjoni inġenerali (ara sezzjoni 4. 2).
- Renal insufficiency: the impact of renal impairment (creatinine clearance from 15 to 60 ml/ min) on
- Indeboliment renali: l- impatt ta ’ indeboliment renali (tneħħija tal- krejatinina minn 15 sa 60 ml/ min)
ivabradine pharmacokinetic is minimal, in relation with the low contribution of renal clearance (about 20%) to total elimination for both ivabradine and its main metabolite S 18982 (see section 4.2).
fuq il- farmakokinetika ta ’ ivabradine hija minimali, b’ relazzjoni għal kontribut baxx ta ’ tneħħija renali (madwar 20%) ta ’ l- eliminazzjoni totali kemm ta ’ ivabradine kif ukoll tas- sustanza prinċipali tagħha fil- metaboliżmu S18982 (ara sezzjoni 4. 2).
- Hepatic impairment: in patients with mild hepatic impairment (Child Pugh score up to 7) unbound
- Indeboliment tal- fwied: f’ pazjenti b’ indebolimet ħafif tal- fwied (Child Pugh sa ’ 7 punti) l’ AUC ta ’
AUC of ivabradine and the main active metabolite were about 20% higher than in subjects with normal hepatic function.
ivabradine maħlul u l- prodott attiv tal- metabolizmu principali kienu madwar 20% ogħla milli f’ pazjenti fejn il- fwied kien jaħdem normali.
Data are insufficient to draw conclusions in patients with moderate hepatic impairment.
M’ hemmx informazzjoni biżżejjed għal tagħrif fuq pazjenti b’ indeboliment moderat tal- fwied.
No data are available in patients with severe hepatic impairment (see sections 4.2 and 4.3).
M’ hemmx informazzjoni biżżejjed fuq pazjenti b’ indeboliment sever tal- fwied (ara sezzjoni 4. 2 u 4. 3).
Pharmacokinetic/ pharmacodynamic (PK/ PD) relationship PK/ PD relationship analysis has shown that heart rate decreases almost linearly with increasing ivabradine and S 18982 plasma concentrations for doses of up to 15-20 mg twice daily.
Ir- relazzjoni farmakokinetika/ farmakodinamika (PK/ PD)
At higher doses, the decrease in heart rate is no longer proportional to ivabradine plasma concentrations and tends to reach a plateau.
9 Analiżi ta ’ relazzjoni PK/ PD wriet li r- rata tat- taħbit tal- qalb tonqos b’ mod kważi lineari meta tizdied l- konċentrazzjonijiet fil- plażma, ta ’ ivabradine u ta ’ S18982 għal dożi sa 15- 20 mg darbtejn kuljum.
High exposures to ivabradine that may occur when ivabradine is given in
F’ dożi ogħla t- tnaqqis fir- rata tat- taħbit tal- qalb mhux iktar proporzjonali għal konċentrazzjonijiet fil - plażma ta ’ ivabridine u hemm tendenza li jilħaq livell ta ’ plateau.
9 combination with strong CYP3A4 inhibitors may result in an excessive decrease in heart rate although this risk is reduced with moderate CYP3A4 inhibitors (see sections 4.3, 4.4 and 4.5).
Esponiment qawwi fil- bniedem għal ivabradine li jista ’ jiġri meta ivabradine jingħata flimkien ma ’ impedituri qawwija ta ’ CYP3A4 jista ’ jwassal għal tnaqqis eċċessiv fir- rata tat- taħbit tal- qalb għalkemm ir- riskju jonqos b’ impedituri moderati ta ’ CYP3A4 (ara sezzjonijiet 4. 3, 4. 4 u 4. 5).
Reproductive toxicity studies showed no effect of ivabradine on fertility in male and female rats.
Studji ta ’ l- effett tossiku fuq is- sistema riproduttiva wrew li ivabradine ma għandu l- ebda effett fuq il - fertitilita` ta ’ firien maskili u femminili.
When pregnant animals were treated during organogenesis at exposures close to therapeutic doses, there was a higher incidence of foetuses with cardiac defects in the rat and a small number of foetuses with ectrodactylia in the rabbit.
Meta annimali tqal ġew ikkurati waqt l- iżvilupp tal- organi għal- esponimenti viċin id- dożi terapewtiċi, kien hemm inċidenza ikbar ta ’ feti b’ difetti tal- qalb fil - firien u numru żgħir ta ’ feti b’ ektrodaktilja fil- fniek.
In dogs given ivabradine (doses of 2, 7 or 24mg/ kg/ day) for one year, reversible changes in retinal function were observed but were not associated with any damage to ocular structures.
Fi klieb li ngħataw ivabradine (dożi ta ’ 2, 7 jew 24 mg/ kg/ jum) għal sena, ġie osservat tibdil riversibbli fil- funzjoni retinali iżda ma kellux x’ jaqsam ma ’ l- ebda bidla fl- istrutturi ta ’ l- għajnejn.
These data are consistent with the pharmacological effect of ivabradine related to its interaction with hyperpolarisation-activated Ih currents in the retina, which share extensive homology with the cardiac pacemaker If current.
Din l- informazzjoni hija konsistenti ma ’ l- effett farmakoloġiku ta ’ ivabradine relatat ma ’ l- interazzjoni tiegħu ma ’ iperpolarizzata- attivata tal- kurrenti Ih fir- retina, li jaqsmu omoloġija estensiva ma ’ kurrent If tal- pacemaker tal- qalb.
Other long-term repeat dose and carcinogenicity studies revealed no clinically relevant changes.
Studji kliniċi fit- tul tad- doża ripetuta u tal- karċinoġenita` ma kixfu l- ebda tibdiliet klinikament relevanti.
Core Lactose monohydrate Magnesium stearate (E 470 B) Maize starch Maltodextrin Silica, colloidal anhydrous (E 551)
Qalba Lactose monohydrate Magnesium stearate (E 470 B) Maize starch Maltodextrin Silica, colloidal anhydrous (E 551)
Film-coating Hypromellose (E 464) Titanium dioxide (E171) Macrogol 6000 Glycerol (E 422) Magnesium stearate (E 470 B) Yellow iron oxide (E172) Red iron oxide (E172)
Il- kisja b’ rita Hypromellose (E 464) Titanium dioxide (E171) Macrogol 6000 Glycerol (E 422) Magnesium stearate (E 470 B) Iron oxide isfar (E172) Iron oxide aħmar (E172)
6.2 Incompatibilities
10 6. 2 Inkompatibilitajiet
Aluminium/ PVC blister packed in cardboard boxes.
Folji ta ’ Aluminium/ PVC ippakkjati f’ kaxxi tal- kartun.
Pack sizes Calendar packs containing 14, 28, 56, 84, 98, 100 or 112 film-coated tablets.
Id- daqs tal- pakkett Pakketti bil- ġranet li fihom 14, 28, 56, 84, 98, 100 jew 112 pilloli miksija b’ rita.
10 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Corlentor 7.5 mg film-coated tablets
Corlentor 7. 5 mg pilloli miksija b’ rita.
One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Pillola waħda miksija b’ rita fiha 7. 5 mg ivabradine (ekwivalenti għal 8. 085 mg ivabradine hydrochloride)
61.215 mg lactose monohydrate For a full list of excipients, see section 6.1.
61. 21 mg lactose monohydrate Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Salmon-coloured, triangular, film-coated tablet engraved with “ 7.5 ” on one face and face.
Kulur is- salamun, triangulari, pillola miksija b’ rita b’ sinjal fuq naħa waħda imnaqqax “ 7. 5 ” u fuq in - naħa l- oħra
4.1 Therapeutic indications
Indikazzjonijiet terapewtiċi
4.2 Posology and method of administration
Pożoloġija u metodu ta ’ kif għandu jingħata
12 Hepatic impairment No dose adjustment is required in patients with mild hepatic impairment.
12 Indeboliment tal- fwied M’ hemmx bżonn ta ’ aġġustar fid- doża f’ pazjenti li jbatu minn indeboliment ħafif tal- fwied.
4.3 Contraindications
Kontra- indikazzjonijiet
4.4 Special warnings and precautions for use
Twissijiet speċjali u prekawzjonijiet għall- użu
If, during treatment, resting heart rate decreases persistently below 50 bpm or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward or treatment discontinued if heart rate below 50 bpm or symptoms of bradycardia persist (see section 4.2).
Jekk waqt il- kura ir- rata tat- taħbit tal- qalb mistrieħa tonqos b’ mod persistenti għal inqas minn 50 bpm jew il- pazjent iħoss xi sintomi relatati ma ’ bradikardija bħal sturdament, għeja kbira jew ipotensjoni, id- doża għandha tiġi mnaqqsa jew il- kura mwaqqfa jekk ir- rata tat- taħbit tal- qalb tkun inqas minn 50 bpm jew sintomi ta ’ bradikardija jippersistu (ara sezzjoni 4. 2).
13 Combination with other antianginal therapies Concomitant use of ivabradine with heart rate reducing calcium channel blockers such as verapamil or diltiazem is not recommended (see section 4.5).
13 Użu flimkien ta ’ mediċina ma ’ mediċini oħra kontra l- anġina Mhux irrakkomandat l- użu ta ’ ivabradine flimkien ma ’ calcium channel blockers li jbaxxu r- ritmu tat - taħbit tal- qalb bħal verapamil jew diltiazem (ara sezzjoni 4. 5).
Ivabradine is contra-indicated in patients with severe hypotension (blood pressure < 90/ 50 mmHg) (see section 4.3).
Ivabradine hu kontra- indikat f’ pazjenti b’ ipotenzjoni severa (pressjoni < 90/ 50mm Hg) (ara sezzjoni 4. 3).
Excipients Since tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
14 Sustanzi mhux attivi Minħabba li l- pilloli fihom il- lactose, pazjenti bi problemi ereditarji rari ta ’ intolleranza ta ’ galactose, defiċenzja ta ’ lactose ta ’ tip Lapp jew assorbiment ħażin ta ’ glucose- galactose m’ għandhomx jieħdu dan il- prodott mediċinali.
14 4.5 Interaction with other medicinal products and other forms of interaction
Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
perforatum [St John’ s Wort]) may decrease ivabradine exposure and activity.
15 esponiment u l- attivita` ta ’ ivabradine.
15 Other concomitant use Specific drug-drug interaction studies have shown no clinically significant effect of the following medicinal products on pharmacokinetics and pharmacodynamics of ivabradine: proton pump inhibitors (omeprazole, lansoprazole), sildenafil, HMG CoA reductase inhibitors (simvastatin), dihydropyridine calcium channel blockers (amlodipine, lacidipine), digoxin and warfarin.
Użu flimkien ieħor Studji speċifiċi li saru fuq jekk medicinali oħra ma jaqblux ma ’ dan il- prodott urew li m’ hemm l- ebda effett klinikament sinifikanti tal- prodotti mediċinali msemmija hawn taħt fuq il- farmokokinetika u l - farmakodinamika ta ’ ivabradine: impedituri proton pump (omeprazole, lansoprazole), sildenafil, impedituri HMG COA reductase (simvastatin), dihydropyridine calcium channel blockers (amlodipine, lacidipine), digoxin u warfarin.
4.6 Pregnancy and lactation
Tqala u Treddigħ
4.7 Effects on ability to drive and use machines
Effetti fuq il- ħila biex issuq u tħaddem magni
4.8 Undesirable effects
Effetti mhux mixtieqa
Cardiac disorders:
16 Mard tal- qalb:
- AV 1st degree block
- Imblokk AV 1 grad
- Ventricular extrasystoles
- Żieda fl- extra sistoli ventrikulari
16 Uncommon:
Mhux komuni
- Palpitations, supraventricular extrasystoles
- Palpitazzjonijiet, żieda fl- extra sistoli supra ventrikulari
4.9 Overdose
Doża eċċessiva
Temporary cardiac electrical pacing may be instituted if required.
Jista jsir użu temporanju minn pacing tal- qalb bl- elettriku jekk jkun jinħtieg.
5.1 Pharmacodynamic properties
Tagħrif farmakodinamiku
Ivabradine is a pure heart rate lowering agent, acting by selective and specific inhibition of the cardiac pacemaker If current that controls the spontaneous diastolic depolarisation in the sinus node and regulates heart rate.
Ivabradine hu prodott mediċinali li jnaqqas ir- rata tat- taħbit tal- qalb b’ mod pur billi jimpedixxi b’ mod selettiv u speċifiku il- pejsmejker current If kardijaku li jikkontrolla d- depolorazzjoni dijastolika spontanja fis- sinus node u jirregola r- rata tat- taħbit tal- qalb.
The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarisation.
L- effetti kardijaċi huma speċifiċi fuq is - sinus node b’ ebda effett fuq il- ħin biex igħaddi l- istimulu intra- atrijali, atrijuventrikulari jew intraventrikulari, l- anqas fuq it- tagħfis mijokardijaku u l- anqas fuq ir- ripolarizzazzjoni ventrikulari.
17 Ivabradine can interact also with the retinal current Ih which closely resembles cardiac If.
Ivabradine jista ’ jkollu interazzjoni ma ’ current IH retinali li jixbaħ ħafna lil If kardijaku.
The antianginal and anti-ischaemic effects of ivabradine were associated with dose-dependent reductions in heart rate and with a significant decrease in rate pressure product (heart rate x systolic blood pressure) at rest and during exercise.
18 x’ jaqsmu mat- tnaqqis fir- rata tat- taħbit tal- qalb marbut mad- doża bi tnaqqis sinifikanti fil- valur tal - multiplikazzjonijiet tar- rata mal- pressjoni (rata ta ’ taħbit tal- qalb x pressjoni sistolika) waqt il- mistrieħ u waqt eżerċizzju fiżiku.
The antianginal and anti-ischaemic efficacy of ivabradine was preserved in diabetic patients (n = 457) with a similar safety profile as compared to the overall population.
L- effikaċja ta ’ ivabradine kontra l- anġina u kontra l- iskemija inżammet f’ pazjenti dijabetiċi (n = 457) bl- istess profil ta ’ sigurta` meta mqabbla mal- popolazzjoni inġenerali.
5.2 Pharmacokinetic properties 18 Under physiological conditions, ivabradine is rapidly released from tablets and is highly water-soluble (> 10 mg/ ml).
F’ kundizzjonijiet fiżjoloġiċi, ivabradine jiġi merħi malajr mill- pilloli u jinħall mill- ewwel fl- ilma (> 10 mg/ ml).
ivabradine pharmacokinetic is minimal, in relation with the low contribution of renal clearance (about 20%) to total elimination for both ivabradine and its main metabolite S 18982 (see section 4.2).
19 renali (madwar 20%) ta ’ l- eliminazzjoni totali kemm ta ’ ivabradine kif ukoll tas- sustanza prinċipali tagħha fil- metaboliżmu S18982 (ara sezzjoni 4. 2).
Pharmacokinetic/ pharmacodynamic (PK/ PD) relationship PK/ PD relationship analysis has shown that heart rate decreases almost linearly with increasing ivabradine and S 18982 plasma concentrations for doses of up to 15-20 mg twice daily.
Ir- relazzjoni farmakokinetika/ farmakodinamika (PK/ PD) Analiżi ta ’ relazzjoni PK/ PD wriet li r- rata tat- taħbit tal- qalb tonqos b’ mod kważi lineari meta tizdied l- konċentrazzjonijiet fil- plażma, ta ’ ivabradine u ta ’ S18982 għal dożi sa 15- 20 mg darbtejn kuljum.
19 combination with strong CYP3A4 inhibitors may result in an excessive decrease in heart rate although this risk is reduced with moderate CYP3A4 inhibitors (see sections 4.3, 4.4 and 4.5).
Esponiment qawwi fil- bniedem għal ivabradine li jista ’ jiġri meta ivabradine jingħata flimkien ma ’ impedituri qawwija ta ’ CYP3A4 jista ’ jwassal għal tnaqqis eċċessiv fir- rata tat- taħbit tal- qalb għalkemm ir- riskju jonqos b’ impedituri moderati ta ’ CYP3A4 (ara sezzjonijiet 4. 3, 4. 4 u 4. 5).
6.2 Incompatibilities
20 6. 2 Inkompatibilitajiet
20 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
21 ANNEX II
21 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
22 A MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Wicklow, Ireland Przedsiebiorstwo Farmaceutyczne ANPHARM S. A., ul.
Wicklow, Ireland Przedsiebiorstwo Farmaceutyczne ANPHARM S. A., ul.
Annopol 6B – 03-236 Warszawa, Poland
Annopol 6B – 03- 236 Warszawa, Poland
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta ’ tagħrif tal- prodott mediċinali hemm l- isem u l- indirizz tal- manifattur responsabbli mill- ħrug tal- lott konċernat.
23 ANNEX III
23 ANNESS III
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING {CARTON}
25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Corlentor 5 mg film-coated tablets ivabradine
Corlentor 5 mg pilloli miksija b’ rita ivabradine
One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine hydrochloride)
Pillola waħda miksija b’ rita fiha 5 mg ivabradine (ekwivalenti ghal 5. 390 mg ivabradine hydrochloride)
See package leaflet for the other excipients.
Fiha lactose monohydrate Ara l- fuljett ta ’ tagħrif għas- sustanzi mhux attivi.
14 film-coated tablets [28 film-coated tablets] [56 film-coated tablets] [84 film-coated tablets] [98 film-coated tablets] [100 film-coated tablets] [112 film-coated tablets]
14 – il pillola miksija b’ rita [28 pillola miksija b’ rita] [56 pillola miksija b’ rita] [84 pillola miksija b’ rita] [98 pillola miksija b’ rita] [100 pillola miksija b’ rita] [112 – il pillola miksija b’ rita]
Les Laboratoires Servier 22, rue Garnier 92200 Neuilly-sur-Seine France
Les Laboratoires Servier 22, rue Garnier 92200 Neuilly- sur- Seine France
EU/ 1/ 05/ 317/ 001 [EU/ 1/ 05/ 317/ 002] [EU/ 1/ 05/ 317/ 003] [EU/ 1/ 05/ 317/ 004] [EU/ 1/ 05/ 317/ 005] [EU/ 1/ 05/ 317/ 006] [EU/ 1/ 05/ 317/ 007]
EU1/ 05/ 317/ 001 [EU1/ 05/ 317/ 002] [EU1/ 05/ 317/ 003] [EU1/ 05/ 317/ 004] [EU1/ 05/ 317/ 005] [EU1/ 05/ 317/ 006] [EU1/ 05/ 317/ 007]
27 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
{BLISTER}
{Folja}
EXP {MM/ YYYY}
EXP [XX/ SSSS]
LOT {number}
LOT {numru}
Abbreviations for days of the week
Ġranet tal- gimgħa
MON TUE WED THU FRI SAT SUN
IT- TNEJN IT- TLIETA L- ERBGHA IL- ĦAMIS IL- ĠIMGĦA IS- SIBT IL- ĦADD
28 PARTICULARS TO APPEAR ON THE OUTER PACKAGING {CARTON}
28 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Corlentor 7.5 mg film-coated tablets ivabradine
Corlentor 7. 5 mg pilloli miksija b’ rita ivabradine
One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine hydrochloride)
Pillola waħda miksija b’ rita fiha 7. 5 mg ivabradine (ekwivalenti ghal 8. 085 mg ivabradine hydrochloride)
EU/ 1/ 05/ 317/ 008 [EU/ 1/ 05/ 317/ 009] [EU/ 1/ 05/ 317/ 010] [EU/ 1/ 05/ 317/ 011] [EU/ 1/ 05/ 317/ 012] [EU/ 1/ 05/ 317/ 013] [EU/ 1/ 05/ 317/ 014]
EU1/ 05/ 317/ 008 [EU1/ 05/ 317/ 009] [EU1/ 05/ 317/ 010] [EU1/ 05/ 317/ 011] [EU1/ 05/ 317/ 012] [EU1/ 05/ 317/ 013] [EU1/ 05/ 317/ 014]
CORLENTOR 7.5 mg
CORLENTOR 7. 5 mg
30 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
INFORMATION FOR THE USER Corlentor 5 mg film-coated tablets Corlentor 7.5 mg film-coated tablets ivabradine
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA Corlentor 5 mg pilloli miksija b’ rita Corlentor 7. 5 mg pilloli miksija b’ rita ivabradine
- If any of the side effects gets serious, or if you notice side effects not listed in this leaflet, please
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
1.
F’ dan il- fuljett 1.
What Corlentor is and what it is used for 2.
X’ inhu Corlentor u għalxiex jintuża 2.
Before you take Corlentor 3.
Qabel ma tieħu Corlentor 3.
How to take Corlentor 4.
Kif għandek tieħu Corlentor 4.
Possible side effects 5 How to store Corlentor 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen Procolaran 6.
WHAT CORLENTOR IS AND WHAT IT IS USED FOR
X’ INHU CORLENTOR U GĦALXIEX JINTUŻA
Corlentor is a heart medicine used to treat stable angina pectoris which causes chest pain, when beta- blockers (like atenolol, propranolol, metoprolol, etc, for high blood pressure, heart rhythm disorders, or angina pectoris) are not suitable.
Corlentor huwa mediċina għall- mard tal- qalb li jintuża f’ każ ta ’ anġina pectoris stabbli li tikkaġuna uġigħ fis- sider, meta beta- blockers (bħal atenolol, propranolol, metoprolol, eċċ., għal pressjoni għolja, problemi fir- ritmu tat- taħbit tal- qalb, jew anġina pectoris) m’ humiex adattati.
Stable angina is a heart disease which happens when the heart does not receive enough oxygen.
X’ inhi angina pectoris stabbli (magħrufa normalment bħala “ anġina ”) Anġina stabbli hija marda tal- qalb li tiġi meta l- qalb ma tkunx qed tieħu ossiġinu biżżejjed.
It usually appears between 40 and 50 years of age.
Dan jigri l - aktar fl- eta` ta ’ bejn l- 40 u l- 50 sena.
The most common symptom of angina is chest pain or discomfort.
Is- sintomu l- aktar komuni ta ’ anġina hu uġigħ fis- sider jew diqa.
Angina is more likely to happen when the heart beats faster in situations such as exercise, emotion, exposure to the cold or after eating.
Hemm possibilta` aktar ta ’ attakk ta ’ anġina meta l- qalb tkun tħabbat aktar mgħaġġla bħal waqt eżerċizzju fiżiku, f’ emozzjoni, minħabba kesħa jew wara l- ikel.
This increase in heart rate can cause the chest pain in people who suffer from angina.
Din iż- żieda fir- rata tat taħbit tal- qalb tista ’ tikkaġuna uġigħ fis- sider lil min ibati minn anġina.
How does Corlentor work?
Kif jaħdem Corlentor?
Corlentor mainly works by reducing the heart rate by a few beats per minute.
Corlentor jaħdem billi jnaqqas ir- rata tat- taħbit tal- qalb bi ftit taħbit fil- minuta.
This lowers the heart’ s need for oxygen especially in the situations when an angina attack is more likely to happen.
Dan inaqqas il- bżonn tal- qalb għal ossiġnu speċjalment f’ ċirkostanzi meta hemm aktar possibilta` ta ’ attakk ta ’ anġina.
In this way Corlentor helps to control and reduce the number of angina attacks.
B’ hekk Corlentor igħin biex jikkontrolla u jnaqqas l- attakki ta ’ anġina.
BEFORE YOU TAKE CORLENTOR
QABEL MA TIEĦU CORLENTOR
Do not take Corlentor:
Tieħux Corlentor
- if you are allergic (hypersensitive) to ivabradine or any of the other ingredients of Corlentor;
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal ivabradine jew sustanzi oħra ta ’
- if your resting heart rate before treatment is too slow (below 60 beats per minute);
- jekk ir- rata tat- taħbit tal- qalb waqt il- mistrieħ hija baxxa ħafna (inqas minn 60– il taħbita fil -
- if you are suffering from cardiogenic shock (a heart condition treated in hospital);
- jekk qed tbati minn xokk kardjoġeniku (kondizzjoni tal- qalb li tiġi ikkurata fl- isptar)
- if you suffer from a heart rhythm disorder;
- jekk tbati minn problemi fir- ritmu tat- taħbit tal- qalb;
- if you are having a heart attack;
- jekk qed ikollok attakk tal- qalb;
- if you suffer from very low blood pressure;
- jekk tbati minn pressjoni baxxa ħafna;
- if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and
- jekk tbati minn anġina mhux stabbli (tant qawwija li l- uġigħ fis- sider ikun spiss ħafna anke meta
with or without exertion);
mhemmx eżerċizzju fiżiku);
- if you suffer from severe heart failure (when your heart fails to work properly);
- jekk tbagħti minn qalb għajjiena (meta qalbek ma taħdimx sewwa);
- if you have a pacemaker;
- jekk għandek pacemaker;
- if you suffer from severe liver problems;
- jekk tbati minn problemi severi tal- fwied;
itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or
- jekk qed tieħu mediċini għall- kura ta ’ infezzjoni fungali (bħal ketoconazole, itraconazole),
33 erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine to treat depression) (see “ Taking other medicines”);
antibijotiċi ta ’ tip macrolide (bħal josamycin, clarithromycin, telithromycin jew erythtromycin meħuda mill- ħalq), mediċini għall- kura ta ’ infezzjonijiet b’ HIV (bħal nelfinavir, ritonavir) jew nefazodone (mediċina għall- kura tad- dipressjoni) (ara taħt “ Meta tieħu mediċini oħra ”);
- if you are pregnant;
- jekk int tqila;
- if you are breast-feeding.
- jekk qed tredda ’.
Take special care with Corlentor:
Oqgħod attent ħafna b’ Corlentor
- if you suffer from a heart rhythm disorder,
- jekk tbati minn problemi fir- ritmu tat- taħbit tal- qalb
- if you have symptoms such as tiredness or shortness of breath (this could mean that your heart is
- jekk għandek sintomi ta ’ għejja jew qtugħ ta ’ nifs (dan jista ’ jfisser li għandek il- qalb qed tħabbat
slowing down too much),
bil- mod ħafna),
- if you are already taking diltiazem, verapamil,
- jekk ġa qed tieħu diltiazem, verapamil,
- if you are taking QT prolonging medicines to treat either heart rhythm disorders or other
- jekk tieħu mediċini li jtawlu il- QT biex tikkura problemi fir- ritmu tat- taħbit tal- qalb jew
conditions (see the products listed in “ Taking other medicines”),
kundizzjonijiet oħra (ara il- prodotti fil- lista taħt “ Meta tieħu mediċini oħra ”),
- if you suffer from sustained atrial fibrillation (a type of irregular heartbeat),
- jekk tbati minn fibrillazzjoni ta ’ l- atriju sostenut (tip ta ’ taħbit irregolari tal- qalb),
- if you have had a recent stroke (cerebral attack),
- jekk riċentament kellek puplesija (attakk ċerebrali),
- if you suffer from mild to moderate low blood pressure,
- jekk tbati ħafif għal moderat minn pressjoni baxxa,
- if you suffer from chronic heart failure (when your heart fails to work properly),
- jekk tbati minn qalb għajjiena kronika, (meta qalbek ma tkunx qed taħdem sewwa),
- if you suffer from chronic retinal disease,
- jekk tbati minn xi mard kroniku fir- retina
- if you suffer from moderate liver problems,
- jekk tbati minn problemi moderati tal- fwied,
- if you suffer from severe renal problems.
- jekk tbati minn problemi qawwija tal- kliewi,
If any of the above applies to you, talk to your doctor before or while taking Corlentor.
Jekk xi ħaġa msemmija hawn fuq tolqot lilek, kellem lit- tabib tiegħek qabel jew waqt li tkun qed tieħu Corlentor.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Corlentor or monitoring should be required:
Kun ċert li tgħarraf lit- tabib tiegħek jekk qed tieħu xi mediċini hawn taħt imsemmija, għax ikun hemm bżonn ta ’ aġġustar fid- doża ta ’ Corlentor jew għandek bżonn tkun taħt osservazzjoni:
- diltiazem, verapamil (for high blood pressure or angina pectoris)
- diltiazem, verapamil (għall- pressjoni għolja jew angina pectoris)
- fluconazole (an antifungal agent)
- fluconazole (antifungali)
- rifampicin (an antibiotic)
- rifampicin (antibijotiku)
- barbiturates (for difficult sleeping or epilepsy)
- barbiturates (għal min ibati biex jorqod jew għall- epilepsija)
- phenytoin (for epilepsy)
- phenytoin (għall- epilepsija)
- Hypericum perforatum or St John’ s Wort (herbal treatment for depression)
John’ s Wort (kura bil- ħxejjex għad- dipressjoni)
- QT prolonging medicines to treat either heart rhythm disorders or other conditions such as:
- mediċini li jtawlu l- QT għall- kura ta ’ problemi fir- ritmu tal- qalb jew kundizzjonijiet oħra bħal:
- quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders)
- quinidine, disopyramide, ibutilide, sotalol, amiodarone (għall- kura ta ’ problemi fir- ritmu tat -
- bepridil (to treat angina pectoris)
- bepridil (kura għal angina pectoris)
- certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide,
- xi mediċini għall- kura ta ’ ansjeta`, skiżofrenija jew psikożi oħra (bħal pimozide, ziprasidone,
ziprasidone, sertindole)
sertindole)
- anti-malarial medicines (such as mefloquine or halofantrine)
- mediċini kontra l- malarja (bħal mefloquine jew halofantrine)
- erythromycin IV (an antibiotic)
- erythromycin IV (antibijotiku)
- pentamidine (an antiparasitic medicine)
- pentamidine (mediċina antiparassitika)
- cisapride (against the gastro-oesophageal reflux)
- cisapride (għal kontra r- rifluss gastro- esofogali)
Limit your consumption of grapefruit juice during treatment with Corlentor.
Meta tieħu Corlentor ma ’ l- ikel u max- xorb Naqqas milli tieħu il- ġjus tal- grejpfrut meta tkun qed tieħu Corlentor.
Do not take Corlentor if you are pregnant or planning a pregnancy (see “ Do not take Corlentor ”).
Tqala u Treddigħ Tieħux Corlentor jekk qed tredda ’ jew qed tippjana biex toħroġ tqila (ara taħt “ Tieħux Corlentor ”).
If you are pregnant and have taken Corlentor, talk to your doctor.
Jekk int tqila u ħadt Corlentor, għid lit- tabib tegħek.
Do not take Corlentor if you are breast-feeding (see “ Do not take Corlentor ”).
Tieħux Corlentor jekk qed tredda (ara taħt “ Tieħux Corlentor ”).
Ask your doctor or pharmacist for advice before taking any medicine.
Staqsi lit- tabib jew lill- ispiżjar tiegħek għall- parir qabel ma tieħu xi mediċina.
Possible side effects ”).
34 Corlentor jista ’ jikkaġunalek fenomeni viżivi mudwali temporanji (ara taħt “ Effetti Sekondarji li jista ’ jkollu ”).
If this happens to you, be careful when driving or using machines at times when there could be sudden changes in light intensity, especially when driving at night.
Jekk jiġrilek hekk, oqgħod attent waqt is- sewqan jew waqt li tkun qed taħdem fuq magni fil - ħin meta jista ’ jkun hemm tibdil fil- qawwa tad- dawl għal għarrieda, speċjalment meta tkun qed issuq bil- lejl.
Corlentor contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Corlentor Corlentor fih il- lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib kien qallek li għandek intolleranza għal xi ħlewwiet għid lit- tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE CORLENTOR
KIF GĦANDEK TIEĦU CORLENTOR