qanastek/EMEA-V3 huggingface dataset:
Because CIALIS has not been studied in patients who have had a heart attack within the last three months or a stroke within the last six months, or those who have high blood pressure or heart disorders (irregular heart beat), these men should not use the medicine.
Billi CIALIS ma ġiex studjat f' pazjenti li kellhom attakk tal - qalb fl- aħħar tliet xhur jew puplesija fl- aħħar sitt xhur, jew li jkollhom pressjoni għolja jew disturbi tal- qalb (taħbit irregolari tal- qalb), dawn l- irġiel ma għandhomx jieħdu din il- mediċina.
For the full list of restrictions, see the Package Leaflet.
Għal- lista sħiħa ta 'restrizzjonijiet, ara l- Fuljett ta' Tagħrif.
Why has CIALIS been approved?
Għaliex ġie approvat CIALIS?
The Committee for Medicinal Products for Human Use (CHMP) decided that CIALIS’ s benefits are greater than its risks for the treatment of men with erectile dysfunction.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'CIALIS huma ogħla mir- riskji tiegħu fit- trattament ta' rġiel b' disfunzjoni erettili.
The Committee recommended that CIALIS be given marketing authorisation.
Il- Kumitat irrakkomanda li CIALIS jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about CIALIS:
Aktar tagħrif dwar CIALIS:
The European Commission granted a marketing authorisation valid throughout the European Union for CIALIS to Lilly ICOS Limited on 12 November 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal CIALIS lil Lilly ICOS Limited fit- 12 ta 'Novembru 2002.
The marketing authorisation was renewed on 12 November 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 12 ta 'Novembru 2007.
The full EPAR for CIALIS is available here.
L- EPAR sħiħ għal CIALIS jista 'jiġi kkonsultat hawn.
This summary was last updated in 11-2007.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Cialis
Qawwa
Film-coated tablet
Għamla farmaċewtika
EU/ 1/ 02/ 237/ 002
Mnejn jingħata
2 tablets
Il- pakkett
EU/ 1/ 02/ 237/ 003
Daqs tal - pakkett
EU/ 1/ 02/ 237/ 004
EU/ 1/ 02/ 237/ 001 EU/ 1/ 02/ 237/ 002 EU/ 1/ 02/ 237/ 003 EU/ 1/ 02/ 237/ 004 EU/ 1/ 02/ 237/ 005 EU/ 1/ 02/ 237/ 006 EU/ 1/ 02/ 237/ 007 EU/ 1/ 02/ 237/ 008
20 mg
10 mg 20 mg 20 mg 20 mg 20 mg 2. 5 mg 5 mg 5 mg
Oral use
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
blister (alu/ PVC/ PE/ Aclar)
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (alu/ PVC/ PE/ Aclar)
folja (alu/ PVC/ PE/ Aclar folja (alu/ PVC/ PE/ Aclar folja (alu/ PVC/ PE/ Aclar folja (alu/ PVC/ PE/ Aclar folja (alu/ PVC/ PE/ Aclar folja (alu/ PVC/ PE/ Aclar folja (alu/ PVC/ PE/ Aclar folja (alu/ PVC/ PE/ Aclar
blister (alu/ PVC/ PE/ PCTFE)
4 pilloli 2 pilloli 4 pilloli 8 pilloli 12- il pillola 28 pillola 14- il pillola 28 pillola
CIALIS 2.5 mg film-coated tablets
CIALIS 2. 5 mg pilloli miksijin b’ rita
Each tablet contains 2.5 mg tadalafil.
Kull pillola fiha 2. 5 mg tadalafil
Each coated tablet contains 92 mg of lactose monohydrate.
Kull pillola miksija fiha 92 mg lactose monohydrate.
Light orange-yellow and almond shaped tablets, marked "C 2 ½" on one side.
Pilloli oranġjo- sofor ċari u għandhom forma ta ’ lewża, immarkati "C 2½" fuq naħa waħda.
Treatment of erectile dysfunction.
Trattament ta ’ disfunzjoni erettili.
In order for tadalafil to be effective, sexual stimulation is required.
Sabiex tadalafil ikun effettiv, huwa meħtieġ stimolu sesswali.
CIALIS is not indicated for use by women.
CIALIS m’ huwiex indikat għall- użu min- nisa.
For oral use.
Għal użu orali.
CIALIS is available as 2.5, 5, 10, and 20 mg film-coated tablets.
CIALIS jiġi bħala pilloli miksija b’ rita ta ’ 2. 5, 5, 10 u 20 mg
Use in adult men In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food.
Użu f’ irġiel adulti Is- soltu, id- doża rakkmandata hija ta ’ 10 mg meħuda qabel attivita ’ sesswali prevista u ma ’ l- ikel jew fuq stonku vojt.
In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried.
F’ dawk il- pazjenti li ma jkollhomx effett adegwat b’ 10mg ta ’ tadalafil, tista ’ tiġi ppruvata doża ta ’ 20 mg.
It may be taken at least 30 minutes prior to sexual activity.
Tista ’ tittieħed għall- inqas 30 minuta qabel l- attivita ’ sesswali.
The maximum dose frequency is once per day.
Il- frekwenza ta ’ l- ogħla doża hija ta ’ darba kuljum.
Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.
Tadalfil 10 u 20 mg huwa intenzjonat għall- użu qabel attività sesswali prevista u mhux irrakkomandat għall- użu kontinwu ta ’ kuljum.
In responder patients to on-demand regimen who anticipate a frequent use of CIALIS (i. e., at least twice weekly) a once daily regimen with the lowest doses of CIALIS might be considered suitable, based on patient choice and the physician’ s judgement.
F’ pazjenti li qegħdin jirrispondu għat- tip ta ’ kura fejn jieħdu doża biss meta jkun hemm it- talba u li jaħsbu li se jkollhom użu frekwenti ta ’ CIALIS (jiġifieri, għallinqas darbtejn fil- ġimgħa) jista ’ jiġi kkunsidrat dożaġġ ta ’ darba kuljum bl- inqas dożi ta ’ CIALIS, skond l- għażla tal- pazjent u l- ġudizzju tat- tabib.
The dose may be decreased to 2.5 mg once a day based on individual tolerability.
F’ dawn il- pazjenti, id- doża rakkomandata hija ta ’ 5 mg meħuda darba kuljum u bejn wieħed u ieħor għandha dejjem tittieħed fl- istess ħin tal- ġurnata.
The appropriateness of continued use of the daily regimen should be reassessed periodically.
Id- doża tista ’ titnaqqas għal 2. 5 mg darba kuljum skond it- tollerabilità individwali.
Use in men with impaired renal function
Kemm hu xieraq l- użu kontinwu ta ’ skeda ta ’ dożaġġ ta ’ kuljum għandu jiġi vvalutat kull tant żmien Użu f’ irġiel anzjani Mhux meħtieġ tibdil tad- doża f’ pazjenti anzjani.
2 Dose adjustments are not required in patients with mild to moderate renal impairment.
2 Użu f’ irġiel b’ indeboliment fil- funzjoni renali Mhux meħtieġ tibdil tad- doża f’ pazjenti b’ indeboliment renali ħafif jew moderat.
For patients with severe renal impairment 10 mg is the maximum recommended dose.
Għall- pazjenti b’ indeboliment renali sever 10 mg hija d- doża massima rakkomandata.
Once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment. (See sections 4.4 and 5.2).
Dożaġġ ta ’ darba kuljum ta ’ tadalafil m’ huwiex rakkomandat f’ pazjenti b’ indeboliment renali sever. (Ara sezzjonijiet 4. 4 u 5. 2).
Use in men with impaired hepatic function The recommended dose of CIALIS is 10 mg taken prior to anticipated sexual activity and with or without food.
Użu f’ irġiel b’ indeboliment fil- funzjoni tal- fwied Id- doża rakkmandata ta ’ CIALIS hija ta ’ 10 mg meħuda qabel attivita ’ sesswali prevista u mingħajr rigward għall- ikel.
There is limited clinical data on the safety of CIALIS in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/ risk evaluation should be undertaken by the prescribing physician.
Tagħrif kliniku dwar is- sigurtà ta ’ CIALIS f’ pazjenti b’ indeboliment epatiku sever (Child Pugh Class C) huwa limitat; għalhekk jekk jiġi miktub mit- tabib, dan għandu jagħmel evalwazzjoni bir- reqqa tal- benefiċċju/ riskju għal kull pazjent.
Once-a-day dosing has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/ risk evaluation should be undertaken by the prescribing physician.
M’ hemm ebda tagħrif disponibbli dwar it- teħid ta ’ dożi ta ’ tadalafil ogħla minn 10 mg f’ pazjenti b’ indeboliment epatiku. Dożaġġ ta ’ darba kuljum ma ġiex evalwat f’ pazjenti b’ indeboliment epatiku; għalhekk jekk jiġi miktub mit- tabib, dan għandu jagħmel evalwazzjoni bir- reqqa tal- benefiċċju/ riskju għal kull pazjent.
(See section 5.2).
(Ara sezzjoni 5. 2)
Use in men with diabetes Dose adjustments are not required in diabetic patients.
Użu f’ irġiel bid- dijabete Mhux meħtieġ tibdil tad- doża f’ pazjenti dijabetiċi.
Use in children and adolescents CIALIS should not be used in individuals below 18 years of age.
Użu fi tfal u adolexxenti CIALIS m’ għandux jintuża f’ persuni li għandhom inqas minn 18- il sena.
In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates.
Fi studji kliniċi, tadalafil intwera li jkabbar l- effetti ipotensivi tan- nitrati.
This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/ cGMP pathway.
Dan huwa maħsub li jirriżulta mill- effetti kkombinati ta ’ nitrati u tadalafil fir- rotta ta ’ nitric oxide/ cGMP.
Therefore, administration of CIALIS to patients who are using any form of organic nitrate is contraindicated.
Għalhekk l- għoti ta ’ CIALIS lil pazjenti li qed jużaw kwalunkwe forma ta 'nitrat organiku huwa kontra- indikat.
(See section 4.5).
(Ara sezzjoni 4. 5).
Agents for the treatment of erectile dysfunction, including CIALIS, must not be used in men with cardiac disease for whom sexual activity is inadvisable.
Sustanzi għat- trattament ta ’ disfunzjoni erettili, inkluż CIALIS, ma jistgħux jiġi uzati f’ irġiel li jbatu minn mard kardijaku li għalihom l- attivita ’ sesswali mhix rakkmandata.
Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.
It- tobba għandhom iqisu r - riskju potenzjali kardijaku ta ’ attivita ’ sesswali f’ pazjenti li għandhom mard kardjovaskulari pre - eżistenti.
The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated:
Il- gruppi ta ’ pazjenti b’ mard kardjovaskulari għadhom ma ġewx inklużi fil- provi kliniċi u l- użu ta ’ tadalafil huwa għalhekk kontra- indikat:
- patients with myocardial infarction within the last 90 days,
- Pazjenti li kellhom infart kardijaku fl- aħħar 90 jum,
- patients with unstable angina or angina occurring during sexual intercourse,
- Pazjenti li jbatu minn anġina li mhix stabbli jew anġina li sseħħ waqt il- kopulazzjoni sesswali,
- patients with New York Heart Association Class 2 or greater heart failure in the last 6 months,
- Pazjenti li jbatu minn insuffiċjenza tal- qalb meqjusa mill- Assoċjazzjoni tal- Qalb ta ’ New York
- patients with uncontrolled arrhythmias, hypotension (< 90/ 50 mm Hg), or uncontrolled
- Pazjenti b’ taħbit irregolari tal- qalb mhux kontrollat, pressjoni baxxa (< 90/ 50 mm Hg), jew
hypertension,
pressjoni għolja mhux kontrollata,
- patients with a stroke within the last 6 months.
- Pazjenti li kellhom puplesija fl- aħħar 6 xhur.
CIALIS is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
CIALIS huwa kontra- indikat f’ pazjenti li tilfu d- dawl f’ għajn waħda minħabba newropatija ottika iskemika anterjuri li m’ hijiex arteritika (NAION), indipendetement mill- fatt jekk dan l- episodju kienx marbut jew le ma ’ użu preċedenti ta ’ inibitur ta ’ PDE5 (ara sezzjoni 4. 4).
A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
Wieħed għandu jħares lejn il- passat mediku u għandu jsir eżami fiżiku biex issir id- dijanjosi ta ’ disfunzjoni erettili u biex jiġu identifikati l- fatturi li potenzjalment qed jikkawżawha, qabel ma jiġi kkunsidrat it- trattament farmakoloġiku.
Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.
Qabel ma jinbeda kwalunkwe trattament għal disfunzjoni erettili, it- tobba għandhom jikkunsidraw l - istat kardjovaskulari tal- pazjenti tagħhom, peress illi hemm grad ta ’ riskju kardijaku assoċjat ma ’ l - attivita ’ sesswali.
Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1) and as such potentiate the hypotensive effect of nitrates (see section 4.3).
Tadalafil għandu karatteristiċi vasodilatorji, li jirriżultaw fi tnaqqis ħafif u
3 In patients receiving concomitant antihypertensive medicines, tadalafil may induce a blood pressure decrease.
3 temporajnu fil- pressjoni tad- demm (ara sezzjoni 5. 1) u b’ hekk jikkawża l- effett ipotensiv tan- nitrati (ara sezzjoni 4. 3).
When initiating daily treatment with tadalafil, appropriate clinical considerations should be given to a possible dose adjustment of the antihypertensive therapy.
F’ pazjenti li fl- istess ħin qegħdin jieħdu mediċini kontra l- pressjoni għolja fid- demm, tadalafil jista ’ jikkawża tnaqqis fil- pressjoni tad- demm.
Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/ or in clinical trials.
Avvenimenti kardjovaskulari serji, inklużi infart kardijaku, mewt kardijaku għal għarrieda, angina pectoris instabbli, taħbit irregolari tal- ventrikoli tal- qalb, puplesija, attakki iskemiċi transitorji, uġigħ fis- sider, palpitazzjonijiet u takikardija, ġew irrappurtati wara t- tqegħid fis- suq u/ jew f’ provi kliniċi Il - parti l- kbira tal- pazjenti li ġew irrappurtati li kellhom dawn l- effetti kellhom fatturi ta ’ riskju kardjovaskulari li kienu jeżistu minn qabel.
However, it is not possible to definitively determine whether these events are related directly to these risk factors, to CIALIS, to sexual activity, or to a combination of these or other factors.
Madanakollu, mhuwiex possibbli li jiġi determinat b’ mod definitiv jekk dawn l- effetti humiex relatati direttament ma ’ dawn il- fatturi ta ’ riskju, ma ’ CIALIS, ma ’ attività sesswali, jew ma ’ taħlita ta ’ dawn il- fatturi jew ta ’ fatturi oħra.
Visual defects and cases of NAION have been reported in connection with the intake of CIALIS and other PDE5 inhibitors.
Difetti fil- vista u każijiet ta ’ NAION ġew irrappurtati b’ konnessjoni mat- teħid ta ’ CIALIS u inibituri oħra ta ’ PDE5.
The patient should be advised that in case of sudden visual defect, he should stop taking CIALIS and consult a physician immediately (see section 4.3).
Il- pazjent għandu jingħata parir li f’ każ ta ’ difett fil- vista għal għarrieda, għandu jieqaf jieħu CIALIS u jikkonsulta tabib minnufih (ara sezzjoni 4. 3).
Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of CIALIS is not recommended in patients with severe renal impairment.
Minħabba ż- żieda fl- espożizzjoni ta ’ tadalafil( AUC), esperjenza klinika limitata u l- fatt li t- tneħħija m’ hijiex affetwata mid- dijaliżi, doża ta ’ darba kuljum ta ’ CIALIS m’ hijiex rakkomandata f’ pazjenti b’ indeboliment renali sever.
Once-a-day administration has not been evaluated in patients with hepatic insufficiency.
Hemm informazzjoni klinika limitata dwar is- sigurta 'ta' teħid ta ’ doża waħda ta’ CIALIS f’ pazjenti b’ insuffiċjenza severa tal- fwied (Child- Pugh Klassi C); It- teħid ta ’ doża darba kuljum ma ġietx evalwata f’ pazjenti b’ insuffiċjenza epatika.
If CIALIS is prescribed, a careful individual benefit/ risk evaluation should be undertaken by the prescribing physician.
Jekk CIALIS jinkiteb mit- tabib, għandha ssir stima bir - reqqa tal- benefiċċji/ riskji għall- individwu mit- tabib li jippreskrivih.
Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance.
Pazjenti li jkollhom erezzjonijiet li jdumu għal 4 sigħat jew aktar għandhom ikunu avżati li għandhom ifittxu assistenza medika minnufih.
If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Jekk il- prijapiżmu ma jiġix ittrattat minnufih, jistgħu jirriżultaw ħsara fit- tessut penili u mpotenza permanenti.
Agents for the treatment of erectile dysfunction, including CIALIS, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Medicini li jintuzaw għat- tratament ta ’ disfunzjoni erettili, inkluż Cialis, għandhom jintuzaw b’ kawtela f’ pazjenti b’ diformazzjoni anatomika tal- pene (bħal angolazzjoni, fibrozi kavernożali jew il - marda ta ’ Peyronie), jew f’ pazjenti li għandhom kundizzjonijiet li jistgħu jippredisponuhom għal prijapiżmu (bħal sickle cell enemija, majeloma multipla jew lewkimja).
The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment.
L- evalwazzjoni tad- disfunzjoni erettili għandha tinkludi investigazzjoni għal fatturi li potenzjalment qed jikkawżawha u l- identifikazzjoni ta ’ trattament xieraq wara eżaminazzjoni medika xierqa.
It is not known if CIALIS is effective in patients who have undergone pelvic surgery or radical non-nerve- sparing prostatectomy.
Mhuwiex magħruf jekk CIALIS huwiex effettiv f’ pazjenti li għaddew minn kirurġija pelvika jew tneħħija radikali tal- prostata mingħajr ebda rigwar għan- nervituri.
The combination of tadalafil and doxazosin is not recommended.
Għalhekk mhuwiex irrakkomandat li tadalafil jingħata flimkien ma ’ doxazin.
Caution should be exercised when prescribing CIALIS to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicines are combined (see section 4.5).
Wieħed għandu joqgħod attent meta jikteb riċetta għal CIALIS lill- pazjenti li qed jużaw inibituri qawwijin ta 'CYP3A4 (ritonavir, saquinavir, ketoconazole, itraconazole, u erythromycin) għaliex kien osservat esponiment akbar għal tadalafil (AUC) meta l- mediċini jingħataw flimkien (Ara sezzjoni 4. 5).
The safety and efficacy of combinations of CIALIS and other treatments for erectile dysfunction have not been studied.
Is- sigurta ’ u l- effikaċja farmaċewtika ta ’ CIALIS flimkien ma ’ trattamenti oħrajn għal disfunzjoni erettili ma kinux studjati.
Therefore, the use of such combinations is not recommended.
Għalhekk l- użu m’ huwiex irrakkomandat.
CIALIS contains lactose monohydrate.
CIALIS fih l- lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti bi problemi ereditarji rari ta ’ intoleranza għall- galactose, ta ’ nuqqas ta ’ Lapp lactase jew ta ’ malassorbiment ta’ glucose- galactose m’ għandhomx jieħdu dan il - prodott mediċinali.
4 4.5 Interaction with other medicinal products and other forms of interaction
4 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Interaction studies were conducted with 10 mg and/ or 20 mg tadalafil, as indicated below.
Saru studji ta ’ interazzjoni dwar tadalafil ta ’ 10 mg u/ jew 20 mg, kif indikat hawn taħt.
With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out.
Rigward dawk l- istudji ta ’ interazzjoni fejn ġiet użata biss id- doża ta ’ 10 mg tadalafil, ma jistgħux jiġu esklużi għal kollox interazzjonijiet klinikament rilevanti li jistgħu iseħħu f’ dożi ogħla.
Effects of other substances on tadalafil
Effetti ta 'sustanzi oħrajn fuq tadalafil
Tadalafil is principally metabolised by CYP3A4.
Tadalafil huwa prinċipalment metaboliżżat minn CYP3A4.
A selective inhibitor of CYP3A4, ketoconazole (200 mg daily), increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax values for tadalafil alone.
Inibitur selettiv ta ’ CYP3A4, ketoconazole (200 mg kuljum), żied l- esponiment għal tadalafil (10- mg) (AUC) b’ darbtejn u Cmax bi 15%, relattivament għall- AUC u għal valuri ta ’ Cmax għal tadalafil biss.
Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold and Cmax by 22%.
Ketoconazole (400 mg kuljum) żied l- esponiment għal tadalafil (20- mg) (AUC) b’ erba darbiet u Cmax bi 22%.
Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in Cmax.
Ritonavir, inibitur ta ’ l - enżima protease (200 mg darbtejn kuljum), li huwa inibitur ta ’ CYP3A4, CYP2C9, CYP2C19, u CYP2D6, żied l- esponiment għal tadalafil (20- mg) (AUC) b’ darbtejn bl- ebda tibdil f’ Cmax.
Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice should be co-administered with caution as they would be expected to increase plasma concentrations of tadalafil (see section 4.4) Consequently the incidence of the undesirable effects listed in section 4.8 might be increased.
Għalkemm ma ġewx studjati interazzjonijiet speċifiċi, inibituri oħra tal- enżima protease, bħal saquinavir, u inibituri oħrajn ta 'CYP3A4, bħal erythromycin, clarithromycin, itraconazole u meraq tal - grejpfrut għandhom jingħataw flimkien b’ kawtela minħabba li huma mistennija li jżidu l - konċentrazzjonijiet ta ’ tadalafil fil- plażma (ara sezzjoni 4. 4) Konsegwentement l- inċidenza tal- effetti mhux mixtieqa elenkati fis- sezzjoni 4. 8 tista ’ tiżdied.
The role of transporters (for example p-glycoprotein) in the disposition of tadalafil is not known.
Ir- rwol tat- trasportaturi (bħal p- glikoproteina) fid- dispożizzjoni ta ’ tadalafil mhuwiex magħruf.
There is thus the potential of drug interactions mediated by inhibition of transporters.
Għalhekk hemm il- potenzjal ta ’ interazzjonijiet tal- mediċina minħabba inibizzjoni tat- trasportaturi
A CYP3A4 inducer, rifampicin, reduced tadalafil AUC by 88%, relative to the AUC values for tadalafil alone (10 mg).
Rifampicin, induttur ta ’ CYP3A4, naqqas l- AUC ta ’ tadalafil bi 88%, relattivament għall- valuri tal - AUC għal tadalafil waħdu (10 mg).
This reduced exposure can be anticipated to decrease the efficacy of tadalafil; the magnitude of decreased efficacy is unknown.
Wieħed jista ’ jistenna li dan it- tnaqqis fl- espożizzjoni jnaqqas l - effikaċja ta ’ tadalafil: kemm ikun kbir dan it- tnaqqis fl- effikaċja m’ huwiex magħruf.
Other inducers of CYP3A4 such as phenobarbital, phenytoin and carbamazepine, may also decrease plasma concentrations of tadalafil.
Indutturi oħrajn ta ’ CYP3A4 bħall- phenobarbital, phenytoin u carbamazepine, jistgħu wkoll inaqqsu il - konċentrazzjonijiet ta ’ tadalafil fil- plażma.
Effects of tadalafil on other medicinal products
Effetti ta ’ tadalafil fuq prodotti mediċinali oħrajn
In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates.
Fl- istudji kliniċi, tadalafil (5, 10 u 20 mg) deher li jkabbar l- effetti ipotensivi tan- nitrati.
Therefore, administration of CIALIS to patients who are using any form of organic nitrate is contraindicated (see section 4.3).
Għalhekk l - għoti ta ’ CIALIS lil pazjenti li qed jużaw kwalunkwe forma ta ’ nitrat organiku huwa kontra- indikat (Ara sezzjoni 4. 3).
Based on the results of a clinical study in which 150 subjects receiving daily doses of tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose.
Ibbażat fuq ir- riżultati ta ’ studju kliniku li fih 150 individwu irċievew doża ta ’ 20 mg tadalafil kuljum għal 7 ijiem u 0. 4 mg nitrogliċerina taħt l- ilsien f’ ħinijiet diversi, din l - interazzjoni damet aktar minn 24 siegħa u ma dehritx aktar meta għaddew 48 siegħa minn l- aħħar doża ta ’ tadalafil.
Thus, in a patient prescribed any dose of CIALIS (2.5 mg-20 mg), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of CIALIS before nitrate administration is considered.
Għalhekk, f’ pazjent li għalih ġie preskritt xi doża ta ’ CIALIS (2. 5 mg- 20 mg), fejn l- għoti tan- nitrat jitqies medikalment neċessarju f’ sitwazzjoni prekarja għall- ħajja, għall- inqas 48 siegħa għandhom jitħallew jgħaddu minn l- aħħar doża ta ’ CIALIS qabel ma jingħataw in- nitrati.
In such circumstances, nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring.
F’ dawn iċ - ċirkostanzi, in- nitrati għandhom biss jingħataw taħt sorveljanza medika stretta, b’ sorveljanza xierqa emodinamika.
In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive agents was examined.
Fi studji ta 'farmakoloġija klinika, il- potenzjal biex tadalafil iżid l- effetti ipotensivi ta ’ l- mediċini li jintużaw kontra l- pressjoni għolja kien eżaminat.
Major classes of antihypertensive agents were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/ or alpha-blockers).
Klassijiet ewlenin ta ’ mediċini li jintużaw kontra l - pressjoni għolja kienu studjati, inklużi dawk li jimblukkjaw il- passaġġi tal- kalċjum (amlodipine), inibituri ta ’ l- enżimi li jbiddlu l- angiotensin (ACE) (enalapril), dawk li jimblukkaw ir- riċetturi beta - adrenerġiċi (metoprolol), id- djuretiċi ta’ t- tip thiazide (bendrofluazide), u dawk li jimblukkaw ir - riċetturi ta ’ l- angiotensin II (tipi u dożi varji, waħedhom jew flimkien ma ’ thiazides, dawk li jimblukkaw il- passaġġi tal- kalċjum, blokkaturi- beta, u/ jew blokkaturi- alpha).
Tadalafil (10 mg except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes.
Tadalafil (10 mg ħlief fi studji b’ imblokkaturi tar- reċetturi angiotensin II u amlodipine fejn intużat doża ta ’ 20 mg) ma kellu l - ebda interazzjoni klinikalment sinifikanti ma ’ l- ebda waħda minn dawn il- klassijiet.
In another clinical pharmacology study tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives.
Fi studju ieħor ta ’ farmakoloġija klinika, kien studjat tadalafil (20 mg) flimkien ma ’ sa 4 klassijiet ta ’ mediċini li jintużaw kontra l- pressjoni għolja.
In subjects taking multiple antihypertensives, the ambulatory-blood-pressure changes appeared to relate to the degree of blood-pressure control.
F’ pazjenti li jieħdu mediċini multipli kontra l- pressjoni għolja, it - tibdiliet ambulatorji fil- pressjoni tad- demm dehru li kienu relatati mal- grad ta ’ kontroll tal- pressjoni tad- demm.
In this regard, study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen in healthy subjects.
F’ dan ir- rigward, l- individwi ta ’ l- istudju li l- pressjoni tad- demm tagħhom kienet
In study subjects whose blood pressure was not controlled, the reduction was greater although this reduction was not associated with hypotensive symptoms in the majority of subjects.
Fl- individwi ta ’ l- istudju li l- pressjoni tad- demm tagħhom ma kenitx ikkontrollat, it- tnaqqis kien akbar minkejja li dan it- tnaqqis ma kienx assoċjat mas- sintomi ta ’ pressjoni baxxa fil- maġġoranza tal- individwi.
In patients receiving concomitant antihypertensive medicines, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of alpha blockers -see below-) is, in general, minor and not likely to be clinically relevant.
F’ pazjenti li jirċievu mediċini għall- pressjoni għolja flimkien ma’ tadalafil 20 mg, dan jista ’ jinduċi tnaqqis fil- pressjoni tad- demm, li (bl- eċċezzjoni ta 'imblokkaturi tar- riċetturi alpha – ara hawn taħt -) huwa ġeneralment ħafif u x ’ aktarx ma jkunx klinikament rilevanti.
Analysis of phase 3 clinical trial data showed no difference in adverse events in patients taking
L- analiżi ta ’ informazzjoni tal - prova klinika tal- fażi 3 ma wriet l- ebda differenza fl- avvenimenti avversi f’ pazjenti li jieħdu tadalafil waħdu jew flimkien ma ’ mediċini għall- pressjoni għolja.
However, appropriate clinical advice should be given to patients regarding a possible decrease in blood pressure when they are treated with antihypertensive medicines.
Madankollu, għandu jingħata parir kliniku xieraq lil pazjenti rigward il- possibilta` ta ’ tnaqqis fil- pressjoni tad- demm meta jkunu qed jieħdu mediċini għal kontra l- pressjoni għolja.
The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner.
It- teħid flimkien ta ’ doxazin (4 u 8 mg kuljum) u tadalafil (doża ta ’ 5 mg kuljum u doża waħda ta ’ 20 mg) iżid b’ mod sinifikanti l- effett ta ’ tnaqqis fil- pressjoni tad- demm ta ’ dan l- imblokkatur tar - reċetturi alpha.
This effect lasts at least twelve hours and may be symptomatic, including syncope.
Dan l- effett idum għallinqas 12- il siegħa u jista ’ jkun sintomatiku u jinkludi s- sinkope.
Therefore this combination is not recommended (see section 4.4).
Għalhekk din il- kombinazzjoni m’ hijiex irrakkomandata (ara sezzjoni 4. 4).
In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin.
F’ studji ta ’ interazzjoni magħmula fuq numru limitat ta ’ volontiera b’ saħħithom, dawn l- effetti ma ġewx irrapportati b’ alfuzosin u tamsulozin.
However, caution should be exercised when using tadalafil in patients treated with any alpha-blockers, and notably in the elderly.
Madankollu għandha tittieħed l- kawtela meta tadalafil jintuża f’ pazjenti li qegħdin jiġu kkurati b’ xi imblokkatur tar- reċetturi alpha u speċjalment fl- anzjani.
Treatments should be initiated at minimal dosage and progressively adjusted.
It- trattamenti għandhom jinbdew b’ dożaġġ minimu u bil- mod il- mod jiġu aġġustati.
Alcohol concentrations (mean maximum blood concentration 0.08%) were not affected by co- administration with tadalafil (10 mg or 20 mg).
Konċentrazzjonijiet ta ’ l- alkoħol (medja massima tal- konċentrazzjoni fid- demm 0. 08%) ma kinux affettwati mit- teħid ta ’ tadalafil magħhom (10 mg jew 20 mg).
In addition, no changes in tadalafil concentrations were seen 3 hours after co-administration with alcohol.
Minbarra dan, l- ebda tibdil fil - konċentrazzjonijiet ta ’ tadalafil ma dehru 3 sigħat wara t- teħid ma ’ l- alkoħol.
Alcohol was administered in a manner to maximize the rate of alcohol absorption (overnight fast with no food until 2 hours after alcohol).
L- alkoħol ingħata b’ mod li r- rata ta ’ l- assorbiment ta ’ l- alkoħol tkun massima (sajjem tul il- lejl bl- ebda ikel sa sagħtejn wara li ttieħed l- alkoħol).
Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/ kg or approximately 180 ml of 40% alcohol [vodka] in an 80-kg male) but in some subjects, postural dizziness and orthostatic hypotension were observed.
Tadalafil (20 mg) ma żiedx il- medja tat- tnaqqis ta ’ pressjoni tad- demm prodotta mill- alkoħol (0. 7 g/ kg jew madwar 180 ml ta ’ 40% alkoħol [vodka] f’ irġiel ta ’ 80 kg) iżda f’ xiindividwi, kienu osservati sturdament dovut għat- tibdil fil- pożizzjoni tal- persuna u pressjoni baxxa ortostatika.
When tadalafil was administered with lower doses of alcohol (0.6 g/ kg), hypotension was not observed and dizziness occurred with similar frequency to alcohol alone.
Meta tadalafil ngħata ma ’ dożi aktar baxxi ta ’ l- alkoħol (0. 6 g/ kg), ma deherx li kien hemm pressjoni baxxa u l- isturdament seħħ bi frekwenza simili għal meta ttieħed l- alkoħol waħdu.
The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg).
L - effett ta ’ l- alkoħol fuq il- funzjoni konjitiva ma żdiedx bit- tadalafil (10 mg).
Tadalafil has been demonstrated to produce an increase in the oral bioavailability of ethinylestradiol; a similar increase may be expected with oral administration of terbutaline, although the clinical consequence of this is uncertain.
Intwera li Tadalafil iżid il- bijodisponibilita ’ orali ta ’ ethinylestradiol; żieda simili tista ’ tkun mistennija bit- teħid orali ta ’ terbutaline, għalkemm il- konsegwenza klinika ta ’ din mhix ċerta.
When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a clinical pharmacology study, there was no pharmacokinetic interaction.
Meta tadalafil 10 mg ingħata ma ’ theophylline (inibitur mhux selettiv tal- phosphodiesterase) fi studju ta ’ farmakoloġija klinika, ma kienx hemm interazzjoni farmakokinetika.
The only pharmacodynamic effect was a small (3.5 bpm) increase in heart rate.
L- uniku effett farmakodinamiku kien żieda żgħira (3. 5 bpm) fir- rata tat- taħbit tal- qalb.
Although this effect is minor and was of no clinical significance in this study, it should be considered when co-administering these medicines.
Minkejja li dan l- effett huwa effett minimu u ma kienx ta ’ sinifikat kliniku f’ dan l- istudju, għandu jitqies meta dawn il- mediċini jingħataw flimkien.
Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal products metabolised by CYP450 isoforms.
Tadalafil mhux mistenni li b’ mod klinikament sinifikanti jinibixxi jew jinduċi it- tneħħija ta ’ prodotti mediċinali metabolizzati minn iżoformi ta ’ CYP450.
Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19.
Xi studji kkonfermaw li tadalafil ma jinibixxix jew ma jistimulax iżoformi ta ’ CYP450, iklużi CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 u CYP2C19.
Tadalafil (10 mg and 20 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin.
Tadalafil (10 mg 20 mg) ma kellu l- ebda effett klinikament sinifikanti fuq l- espożizzjoni (AUC) għal S- warfarin jew R- warfarin (substrat ta ’ CYP2C9), u tadalafil lanqas ma affettwa tibdil fil- ħin tal - protrombin indott mill- warfarin.
Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid.
Tadalafil (10 u 20 mg) ma żiedx iż- żieda fil- ħin ta ’ fsada ikkawżata minn acetyl salicylic acid.
Specific interaction studies with antidiabetic agents were not conducted.
Ma sarux studji ta ’ interazzjonijiet speċifiċi ma ’ mediċini antidjabetiċi.
CIALIS is not indicated for use by women.
CIALIS m’ huwiex indikat għall- użu minn nisa.
For tadalafil no clinical data on exposed pregnancies are available.
6 Għall- tadalafil m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp ta 'l- embriju/ fetu, ħlas jew żvilupp wara t - twelid (ara sezzjoni 5. 3).
6 No studies on the effect on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to CIALIS, before driving or operating machinery.
Minkejja li l- frekwenza ta ’ sturdament fir- rapporti fl- ambitu ta ’ plaċebo u tadalafil fi provi kliniċi kienet simili, il- pazjenti għandhom ikunu konxji dwar kif jirreaġixxu għal CIALIS, qabel ma jsuqu jew iħaddmu l- magni.
The most commonly reported adverse reactions were headache and dyspepsia.
L- aktar reazzjonijiet avversi komuni li ġew irrapportati kienu uġigħ ta ’ ras u dispepsja.
The adverse reactions reported were transient, and generally mild or moderate.
Ir- reazzjonijiet avversi li ġew irrapportati kienu temporanji u ħafna drabi ħfief jew moderati.
Adverse reaction data are limited in patients over 75 years of age.
Huwa limitat it- tagħrif dwar reazzjonijiet avversi f’ pazjenti ’ l fuq minn 75 sena.
The table below lists the adverse reactions reported during placebo-controlled clinical trials for registration in patients treated with CIALIS on demand and daily dosing.
It- tabella hawn taħt turi r- reazzjonijiet avversi rrapportati waqt studji kliniċi kkontrollati bi plaċebo għar- reġistrazzjoni f’ pazjenti kkurati b’ CIALIS meta jkun hemm il- bżonn u f’ dożaġġ ta ’ kuljum.
Adverse reactions are also included that have been reported from postmarketing surveillance in patients taking CIALIS on demand.
Huma wkoll inklużi reazzjonijiet avversi li ġew irrapportati minn sorveljanza wara li l- prodott tqiegħed fis- suq f’ pazjenti li qed jieħdu CIALIS meta jkun hemm il- bżonn.
Adverse reactions Frequency estimate:
Reazzjonijiet avversi Stima tal- frekwenza:
Very common (≥ 1/ 10), Common (≥ 1/ 100 to <  1/ 10), Uncommon (≥ 1/ 1000 to <  1/ 100), Rare (≥ 1/ 10,000 to <  1/ 1000), Very Rare (<  1/ 10,000) and Not known (events not reported in registration trials cannot be estimated from postmarketing spontaneous reports).
Komuni ħafna (≥ 1/ 10), Komuni (≥ 1/ 100 sa < 1/ 10), Mhux komuni (≥ 1/ 1000 sa < 1/ 100), Rari (≥ 1/ 10, 000 sa < 1/ 1000), Rari Ħafna (< 1/ 10, 000) u Mhux magħruf (ma tistax tittieħed stima mir- rapporti spontanji wara li l- prodott tqiegħed fis- suq għall- avvenimenti li ma ġewx irrapportati f’ studji ta ’ reġistrazzjoni))
Very common
F’ kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla f’ ordni ta ’ l- iżjed serju sa dak l - inqas serju.
Uncommon
Mhux magħruf Rari
Not known
Komuni ħafna (≥1/ 10)
(≥ 1/ 10)
Komuni (≥1/ 100 sa < 1/ 10)
(≥ 1/ 100 to <  1/ 10) (≥ 1/ 1000 to <  1/ 100)
Mhux komuni (≥1/ 1000 sa < 1/ 100)
(≥ 1/ 10,000 to <  1/ 1000)
(≥1/ 10, 000 sa < 1/ 1000)
System Organ Class:
Sistema tal- Klassifika ta ’ l- Organi:
Immune system disorders Hypersensitivity reactions System Organ Class:
Disturbi fis- Sistema Immuni Reazzjonijiet ta ’ sensittività eċċessiva Sistema tal- Klassifika ta ’ l- Organi:
Nervous System disorders Headache
Disturbi fis- Sistema Nervuża Uġigħ ta ’ ras
Dizziness
Sturdament
Stroke1, Syncope, Transient ischaemic attacks1, Migraine
Attakk ta ’ puplesija1, Sinkope, Attakki iskemiċi tranżitorji1, Emikranja
Seizures, Transient amnesia
Konvulżjonijiet, Amnesija tranżitorja
Eye disorders
Newropatija
Blurred vision, Sensations described as eye pain, Swelling of eyelids, Conjunctival hyperaemia
Sensazzjonijiet deskritti bħala uġigħ fl- għajn, Nefħa fil- kpiepel ta ’ l- għajnejn, iperimja tal - konġuntiva
Visual field defect
viżiv
Non-arteritic anterior ischemic optic neuropathy (NAION), Retinal vascular occlusion
ottika iskemika anterjuri li m’ hijiex arteritika (NAION) Okklużjoni vaskulari tar - retina
Ear and labyrinth disorders Sudden deafness2 1 System Organ Class:
Disturbi fil- widnejn u fis- sistema labirintika 7 Truxija f’ daqqa2 Sistema tal- Klassifika ta ’ l- Organi:
Palpitations
Palpitazzjonijiet
Myocardial infarction
Infart mijokardijaku
Unstable angina pectoris, Ventricular arrhythmia
Angina pectoris instabbli, Arritmja ventrikulari
7 System Organ Class:
Sistema tal- Klassifika ta ’ l- Organi:
Flushing
Ħmura fil- wiċċ
Hypotension (more commonly reported when tadalafil is given to patients who are already taking antihypertensive agents), Hypertension
Ipotensjoni (irrapportata l - iżjed meta tadalafil jingħata lill- pazjenti li diġà jkunu qed jieħdu sustanzi antipertensivi), Ipertensjoni
Respiratory, thoracic and mediastinal disorders Nasal congestion Epistaxis System Organ Class:
Disturbi respiratorji, toraċiċi u medjastinali Imnieħer miżdud Epistassi Sistema tal- Klassifika ta ’ l- Organi:
Gastrointestinal disorders Dyspepsia
Disturbi gastro- intestinali
System Organ Class:
Dispepsja
Stevens-Johnson syndrome, Exfoliative dermatitis
Uġigħ addominali, Mard ta ’ rifluss gastro- esofagali
Musculoskeletal, connective tissue and bone disorders Back pain, Myalgia System Organ Class:
Disturbi muskolu- skeltrali u tal- connective tissue Uġigħ tad- dahar, Mijalġja Sistema tal- Klassifika ta ’ l- Organi:
Reproductive system and breast disorders
Disturbi fis- sistema riproduttiva u fis- sider
Prolonged erections
Erezzjoni fit- tul
Priapism
Prijapiżmu
General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata (1)
Chest pain1
Uġigħ fis- sider1
Facial oedema
Edima fil- wiċċ
Sudden cardiac death1
Mewta kardijaka għal għarrieda1
(1) Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors (see section 4.4).
Il- parti l- kbira tal- pazjenti li ġew irrappurtati li kellhom dawn l- avvenimenti kellhom fatturi ta ’ riskju kardjovaskulari li kienu jeżistu minn qabel (ara sezzjoni 4. 4).
(2) Sudden decrease or loss of hearing has been reported in a small number of postmarketing and clinical trial cases with the use of all PDE5 inhibitors, including tadalafil.
(2) F’ numru żgħir ta ’ każijiet, f’ studji kliniċi kif ukoll wara t- tqegħid fis- suq, ġie rrapportat nuqqas jew telf tas- smigħ f’ daqqa ma ’ l- użu ta ’ kull wieħed mill- inibituri ta ’ PDE5, inkluż tadalafil.
A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo.
Ġiet rrapportata inċidenza ftit iżjed ogħla ta ’ anormalitajiet fl- ECG, l- iżjed bradikardija sinusojde, f’ pazjenti kkurati b’ tadalafil darba kuljum meta mqabbel ma ’ plaċebo.
Most of these ECG abnormalities were not associated with adverse reactions.
Il- parti l- kbira ta ’ dawn l- anormalitajiet fl- ECG ma kienux assoċjati ma ’ reazzjonijiet avversi.
Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients.
Dożi singli sa 500 mg ngħataw lill- individwi b’ saħħithom, u dożi multipli sa 100 mg kuljum ingħataw lill- pazjenti.
Adverse events were similar to those seen at lower doses.
L- avvenimenti avversi kienu simili għal dawk li dehru bf’ dożi aktar baxxi.
In cases of overdose, standard supportive measures should be adopted as required.
F’ każijiet ta ’ dożi eċċessivi, il- miżuri supportivi indikati għandhom jittieħdu skond il- ħtieġa.
Haemodialysis contributes negligibly to tadalafil elimination.
L- emodjalisi tikkontribwixxi fit- tneħħija ta ’ tadalafil b’ mod negliġibbli.
Drugs used in erectile dysfunction, ATC Code:
Mediċini użati għad- disfunzjoni erettili, Kodiċi ATC:
8 Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Tadalafil huwa inibitur riversibbli, selettiv ta ’ cyclic guanosine monophosphate (cGMP) speifikament phosphodiesterase tip 5 (PDE5).
When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum.
Meta l- istimolu sesswali jikkawża ħruġ lokali ta’ nitric oxide, l - inibizzjoni ta ’ PDE5 permezz ta ’ tadalafil tipproduċi livelli ogħla ta ’ cGMP fil- corpus cavernosum.
This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection.
Dan jirriżulta f’ rilassament tal- muskoli involontarji u mogħdija ta ’ demm fit- tessut tal- pene, u b’ hekk jipproduċi erezzjoni.
Tadalafil has no effect in the absence of sexual stimulation.
Tadalafil m’ għandu l- ebda effett jekk ma jkunx hemm stimolu sesswali.
Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5.
Studji in vitro wrew li tadalafil huwa inibitur selettiv ta ’ PDE5.
PDE5 is an enzyme found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum.
PDE5 hija enżima li tinsab fil- muskoli involontarji tal- corpus cavernosum, fil- muskoli involuntarji vaskolari u vixxerali, fil- muskoli skeletali, plejtlits, fil- kliewi, fil- pulmuni u fiċ- ċervellett.
The effect of tadalafil is more potent on PDE5 than on other phosphodiesterases.
L- effett ta ’ tadalafil huwa aktar qawwi fuq PDE5 milli fuq phosphodiesterases oħrajn.
Tadalafil is > 10,000-fold more potent for PDE5 than for PDE1, PDE2, and PDE4, enzymes which are found in the heart, brain, blood vessels, liver, and other organs.
Tadalafil huwa > 10, 000 darba aktar potenti għal PDE5 milli għalPDE1, PDE2 u PDE4, li huma enżimi li jinsabu fil- qalb, fil- moħħ, fil- vini u l- arterji, fil- fwied u f’ organi oħra.
Tadalafil is > 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
Tadalafil huwa > 10, 000 darba aktar potenti għal PDE5 milli għal PDE3, li hija enżima li tinsab fil- qalb u fil- vini u l- arterji.
This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac contractility.
Din is- selettivita ’ għal PDE5 fuq il- PDE3 hija importanti għaliex PDE3 hija enżima li hija involuta fil- kontrattilita ’ kardijaka.
Additionally, tadalafil is approximately 700-fold more potent for PDE5 than for PDE6, an enzyme which is found in the retina and is responsible for phototransduction.
Minbarra dan, tadalafil huwa madwar 700 darba aktar potenti għal PDE5 milli għal PDE6, li hija enżima li tinsab fir- retina u li hija responsabbli għall- fototransduzzjoni.
Tadalafil is also > 10,000-fold more potent for PDE5 than for PDE7 through PDE10.
Tadalafil huwa wkoll > 10, 000 darba aktar potenti għal PDE5 milli għal PDE7 permezz ta ’ PDE10.
Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness to CIALIS on demand.
Saru tliet studji kliniċi fuq 1054 pazjent f’ ambjent tad- dar biex ikun definit iż- żmien ta ’ rispons għal CIALIS meta jkun hemm it- talba.
Tadalafil demonstrated statistically significant improvement in erectile function and the ability to have successful sexual intercourse up to 36 hours following dosing, as well as patients’ ability to attain and maintain erections for successful intercourse compared to placebo as early as 16 minutes following dosing.
Tadalafil wera titjib statistikament sinifikanti fil- funzjoni erettili u fl- abilita ’ li jkun hemm kopulazzjoni sesswali b’ suċċess sa 36 siegħa wara li tittieħed id- doża, kif ukoll fl- abilita ’ tal- pazjenti li jkollhom u jżommu erezzjoni għal kopulazzjoni b’ suċċess meta mqabbel ma ’ plaċebo wara 16 minuta mit- teħid tad- doża.
Tadalafil administered to healthy subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (mean maximal decrease of 1.6/ 0.8 mm Hg, respectively), in standing systolic and diastolic blood pressure (mean maximal decrease of 0.2/ 4.6 mm Hg, respectively), and no significant change in heart rate.
Tadalafil li ngħata lill- individwi b’ saħħithom, meta mqabbel ma ’ plaċebo, ma pproduċa l- ebda differenza sinifikanti fil- pressjoni sistolika u dijastolika meħuda meta l- individwu kien mimdud fuq dahru (medja massima ta ’ tnaqqis ta ’ 1. 6/ 0. 8 mm Hg, rispettivament), fil- pressjoni sistolika u dijastolika meħuda meta l- individwu kien bilwieqfa (medja massima ta ’ tnaqqis ta ’ 0. 2/ 4. 6 mm Hg, rispettivament), u l- ebda tibdil sinifikanti fir- rata tat- taħbit tal- qalb.
In a study to assess the effects of tadalafil on vision, no impairment of colour discrimination (blue/ green) was detected using the Farnsworth-Munsell 100-hue test.
Fi studju li sar biex ikunu ttestjati l- effetti ta ’ tadalafil fuq il- viżjoni, fejn intuża t- test Farnsworth - Munsell ta ’ 100- lewn, ma deherx li kien hemm problemi biex jintgħarfu l- kuluri (blu/ aħdar).