qanastek/EMEA-V3 huggingface dataset:
This finding is consistent with the low affinity of tadalafil for PDE6 compared to PDE5.
Din is - sejba hija konsistenti ma ’ l- affinita ’ baxxa ta ’ tadalafil għal PDE6 meta mqabbel ma ’ PDE5.
Across all clinical studies, reports of changes in colour vision were rare (< 0.1%).
Fl- istudji kliniċi kollha, ir- rapporti tat- tibdil fil- viżjoni tal- kulur kienu rari (< 0. 1%).
In two of these studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely clinical relevance.
Saru tliet studji fl- irġiel biex ikun stmat l- effett potenzjali fuq l- ispermatoġenesi ta ’ CIALIS 10 mg (studju wieħed ta ’ 6 xhur) u 20 mg (studju wieħed ta ’ 6 xhur u studju wieħed ta ’ 9 xhur) mogħtija kuljum.. F’ tnejn minn dawn l- istudji ġew osservati tnaqqis fl- għadd u fil- konċentrazzjoni ta ’ sperma relatati ma ’ kura b’ tadalafil ta ’ relevanza klinika improbabbli.
These effects were not associated with changes in other parameters such as motility, morphology and FSH.
Dawn l- effetti ma ġewx assoċjati ma ’ tibdil fil- parametri l- oħra bħal motilità, morfoloġija u FSH.
Tadalafil at doses of 2.5, 5, and 10 mg taken once a day has been evaluated in 3 clinical studies involving 853 patients of various ages (range 21-82 years) and ethnicities, with erectile dysfunction of various severities (mild, moderate, severe) and etiologies.
Tadalafil f’ dożi ta ’ 2. 5, 5, u 10 mg meħuda darba kuljum kien evalwat f’ 3 studji kliniċi li fihom ħadu sehem 853 pazjent, ta ’ etajiet (marġni ta ’ 21- 82 sena) u razzez differenti, b’ disfunzjoni erettili li kellhom gradi ta ’ severità (ħafif, moderat, gravi) u etjoloġiji varji.
Most patients in all three studies were responders to previous on-demand treatment with PDE5 inhibitors.
Il- parti l- kbira tal- pazjenti kienu rrispondew qabel għall- kura bl- inibituri PDE5 fejn id- doża kienet tittieħed biss meta jkun hemm it - talba.
In the two primary efficacy studies of general populations, the mean per-subject proportion of successful attempts were 57 and 67% on CIALIS 5mg, 50% on CIALIS 2.5mg as compared to 31 and 37% with placebo.
Fiż- żewġ studji ta ’ effikaċja primarja fuq popolazzjonijiet ġenerali, il- proporzjon ta ’ tentattivi ta ’ suċċess għal kull pazjent kienu medja ta ’ 57 u 67% għal dawk fuq CIALIS 5 mg, 50% għal dawk fuq CIALIS 2. 5 mg meta mqabbla ma ’ 31 u 37% li ħadu plaċebo.
In the study in patients with erectile dysfunction secondary to diabetes, the mean per-subject proportion of successful attempts were 41 and 46% on CIALIS 5mg and 2.5mg, respectively, as compared to 28% with placebo.
Fl- istudju f’ pazjenti li kellhom disfunzjoni erettili sekondarja għad- dijabete, il- proporzjon ta ’ tentattivi ta ’ suċċess għal kull pazjent kienu medja ta ’ 41 u 46% għal dawk fuq CIALIS 5 mg u 2. 5 mg rispettivament, meta mqabbel ma ’ 28% li ħadu plaċebo
In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with erectile dysfunction secondary to spinal cord injury, tadalafil significantly improved the erectile function leading to a mean per-subject proportion of successful attempts in patients treated with tadalafil 10 or 20 mg (flexible- dose, on demand) of 48% as compared to 17% with placebo.
9 Fi studju li dam 12- il ġimgħa u li ġie magħmul f’ 186 pazjent (142 tadalafil, 44 plaċebo) b’ disfunzjoni erettili kawża ta ’ trawma tan- nerv li jgħaddi minn ġos- sinsla, tadalafil b’ mod sinifikanti tejjeb il - funzjoni erettili li wassal għal medja f’ kull pazjent ta ’ proporzjon ta ’ tentattivi ta ’ suċċess f’ dawk ikkurati b’ tadalfil 10 mg jew 20 mg (doża flessibbli, meta jkun hemm il- bżonn) ta ’ 48% meta mqabbel ma ’ 17% bi plaċebo.
Absorption Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma concentration (Cmax) is achieved at a median time of 2 hours after dosing.
Assorbiment Tadalafil jiġi assorbit malajr jittieħed mill- ħalq u l- medja massima osservata ta ’ konċentrazzoni fil - plażma (Cmax) tintlaħaq f’ ħin medju ta ’ sagħtejn wara li tittieħed id- doża.
Absolute bioavailability of tadalafil following oral dosing has not been determined.
Il- biodisponibilita ’ assoluta ta ’ tadalafil wara doża orali ma ġietx determinata.
The rate and extent of absorption of tadalafil are not influenced by food, thus CIALIS may be taken with or without food.
Ir- rata u l- grad ta ’ l- assorbiment ta ’ tadalafil mhumiex influwenzati bl- ikel, għalhekk CIALIS jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
The time of dosing (morning versus evening) had no clinically relevant effects on the rate and extent of absorption.
Il- ħin tad- doża (filgħodu versu filgħaxija) ma kellu l- ebda effetti klinikament rilevanti fuq ir- rata u l- grad ta ’ l- assorbiment.
Distribution The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues.
Distribuzzjoni Il- volum medju tad- distribuzzjoni huwa madwar 63 l, li jindika li tadalafil jiġi distribwit fit- tessuti.
At therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins.
F’ konċentrazzjonijiet terapewtiċi, 94% ta ’ tadalafil fil- plażma jkun marbut mal- proteini.
Protein binding is not affected by impaired renal function.
L- irbit mal - proteini mhuwiex effettwat mill- funzjoni tal- kliewi.
Less than 0.0005% of the administered dose appeared in the semen of healthy subjects.
Inqas minn 0. 0005% tad- doża mogħtija dehret fis- semen ta ’ individwi b’ saħħithom.
Biotransformation Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform.
Biotrasformazzjoni Tadalafil huwa prinċipalment metabolizzat permezz ta ’ l- iżoforma ċitokromju P450 (CYP) 3A4.
The major circulating metabolite is the methylcatechol glucuronide.
Il - metabolu prinċipali ċirkolanti huwa methylcatechol glucuronide.
This metabolite is at least 13,000-fold less potent than tadalafil for PDE5.
Dan il- metabolu huwa mill- inqas 13, 000- il darba inqas qawwi minn tadalafil għal PDE5.
Consequently, it is not expected to be clinically active at observed metabolite concentrations.
Konsegwentement, mhuwiex mistenni li jkun klinikament attiv fil- konċentrazzjonijiet osservati tal- metabolu.
Elimination The mean oral clearance for tadalafil is 2.5 l/ h and the mean half-life is 17.5 hours in healthy subjects.
Eliminazzjoni It- tneħħija medja orali ta ’ tadalafil hija 2. 5 l/ siegħa u l- half- life medja hija ta ’ 17. 5 sigħat f’ individwi b’ saħħithom.
Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces (approximately 61% of the dose) and to a lesser extent in the urine (approximately 36% of the dose).
Tadalafil jitneħħa prinċipalment bħala metaboli mhux attivi, l- aktar fl- ippurgar (madwar 61% tad - doża) u b’ ammont inqas fl- awrina (madwar 36% tad- doża).
Linearity/ non-linearity Tadalafil pharmacokinetics in healthy subjects are linear with respect to time and dose.
Linearita ’ / mhux- linearita ’ Il- farmakokinetiċi ta ’ tadalafil f’ individwi b’ saħħithom huma lineari fir- rigward tal- ħin u tad- doża.
Over a dose range of 2.5 to 20 mg, exposure (AUC) increases proportionally with dose.
Fi skala ta ’ doża minn 2. 5 sa 20 mg, l- esponiment (AUC) jiżdied b’ mod proporzjonali għad- doża.
Steady-state plasma concentrations are attained within 5 days of once-daily dosing.
Livelli kostanti fil- plażma jinlaħqu fi żmien 5 ijiem mit- teħid ta ’ doża ta ’ darba kuljum.
Pharmacokinetics determined with a population approach in patients with erectile dysfunction are similar to pharmacokinetics in subjects without erectile dysfunction.
Il- farmakokinetiċi determinati f’ popolazzjoni magħżula b’ pazjenti b’ disfunzjoni erettili huma simili għall- farmakokinetiċi f’ individwi mingħajr disfunzjoni erettili.
Special Populations
Pazjenti speċjali
Elderly Healthy elderly subjects (65 years or over), had a lower oral clearance of tadalafil, resulting in 25% higher exposure (AUC) relative to healthy subjects aged 19 to 45 years.
Anzjani Anzjani b’ saħħithom (65 sena jew akbar) kellhom tneħħija aktar baxxa ta ’ tadalafil meħud oralment, li rriżulta f 25% aktar esponiment (AUC) meta mqabbel ma ’ individwi b’ saħħithom ta ’ eta ’ minn 19 sa 45 sena.
This effect of age is not clinically significant and does not warrant a dose adjustment.
Dan l- effett ta ’ l- eta mhuwiex klinikament sinifikanti u ma jeħtieġx tibdil fid- doża.
Renal insufficiency In clinical pharmacology studies using single-dose tadalafil (5 mg-20 mg), tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/ min) or moderate (creatinine clearance 31 to 50 ml/ min) renal impairment and in subjects with end-stage renal disease on dialysis.
Insuffiċjenza renali Fl- istudji tal- farmakoloġija klinika fejn intużat doża waħda ta 'tadalafil (5 mg- 20 mg), l- esponiment għal tadalafil (AUC) kien madwar id- doppju f’ individwi b’ indeboliment ħafif fil- kliewi (tneħħija tal - krejatinina 51 sa 80 ml/ min) jew moderat (tneħħija tal- krejatinina 31 sa 50 ml/ min) u f’ individwi fuq id- dijaliżi bi stat terminali tal- funzjoni tal- kliewi.
In haemodialysis patients, Cmax was 41% higher than that observed in healthy subjects.
Fil- pazjenti fuq l- emodjaliżi, Cmax kien 41% ogħla minn dak osservat f’ individwi b’ saħħithom.
Haemodialysis contributes negligibly to tadalafil elimination.
L- emodjaliżi tikkontribwixxi ftit li xejn għat- tneħħija tat - tadalafil.
Hepatic insufficiency Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered.
10 Insuffiċjenza epatika L- esponiment għal tadalafil (AUC) f’ individwi b’ insuffiċjenza ħafifa u moderata tal- fwied (Child - Pugh Klassi A u B) huwa komparabbli ma 'l- espożizzjoni f’ individwi b’ saħħithom meta tingħata doża ta' 10 mg.
There is limited clinical data on the safety of CIALIS in patients with severe hepatic insufficiency (Child-Pugh Class C).
L- informazzjoni klinika dwar is- sigurta ’ ta ’ CIALIS f’ pazjenti b’ insuffiċjenza epatika gravi (Child- Pugh Klassi C) hija limitata.
If CIALIS is prescribed once-a-day, a careful individual benefit/ risk evaluation should be undertaken by the prescribing physician.
M’ hemm l- ebda tagħrif disponibbli dwar l- għoti ta ’ doża ta ’ tadalafil darba kuljum lill- pazjenti b’ indeboliment epatiku. Jekk tabib jippreskrivi CIALIS b’ doża ta ’ darba kuljum għandha ssir evalwazzjoni b’ attenzjoni fuq bażi individwali tal- benefiċċji/ riskji mit- tabib li jkun ghamel ir- riċetta..
10 Patients with diabetes Tadalafil exposure (AUC) in patients with diabetes was approximately 19% lower than the AUC value for healthy subjects.
Pazjenti bid- dijabete L- esponiment għal tadalafil (AUC) f’ individwi bid- dijabete kien madwar 19% inqas mill- valur ta 'AUC f’ individwi b’ saħħithom.
This difference in exposure does not warrant a dose adjustment.
Din id- differenza fl- espożizzjoni ma teħtieġx tibdil fid- doża.
5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurta ’ tal- medicina
There was no evidence of teratogenicity, embryotoxicity or foetotoxicity in rats or mice that received up to 1000 mg/ kg/ day tadalafil.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin Ma kien hemm ebda evidenza ta ’ teratoġeniċita 'jew ta ’ effett tossiku fuq l- embriju jew il- fetu f’ firien jew ġrieden li rċevew sa 1000 mg/ kg/ jum tadalafil.
In a rat pre- and postnatal development study, the no observed effect dose was 30 mg/ kg/ day.
Fi studju ta ’ l- iżvilupp ta ’ qabel u wara t- twelid tal- firien, id- doża li fiha ma ġie osservat l- ebda effett kienet ta ’ 30 mg/ kg/ jum.
In the pregnant rat the AUC for calculated free drug at this dose was approximately 18 times the human AUC at a 20 mg dose.
F’ fara tqila, l- AUC għal mediċina ħielsa kkalkulata f’ din id- doża kienet madwar 18- il darba akbar minn l- AUC fil- bniedem f’ doża ta ’ 20 mg.
There was no impairment of fertility in male and female rats.
Ma kien hemm l- ebda ħsara fil- fertilita ’ tal- firien maskili u femminili.
In dogs given tadalafil daily for 6 to 12 months at doses of 25 mg/ kg/ day (resulting in at least a 3-fold greater exposure [range 3.7 – 18.6] than seen in humans given a single 20 mg dose) and above, there was regression of the seminiferous tubular epithelium that resulted in a decrease in spermatogenesis in some dogs.
Fi klieb li ngħataw tadalafil kuljum għal 6 sa 12- il xahar f’ dożi ta ’ 25 mg/ kg/ jum (li jirriżulta f’ esponiment mill- inqas 3 darbiet akbar [skala 3. 7 – 18. 6] milli jidher fil- bnedmin li ngħataw doża waħda ta ’ 20 mg) u aktar, kien hemm rigressjoni tal- epitelju tubulari seminiferu li rriżulta fi tnaqqis tal- ispermatoġenesi f’ xi klieb.
See also section 5.1.
Ara wkoll sezzjoni 5. 1
Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
Qalba tal- pillola: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), talc.
Kisja b’ rita: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide isfar (E172), iron oxide aħmar (E172) talc.
6.3 Shelf life
11 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
Aluminium/ PVC/ PE/ PCTFE blisters in cartons of 28 film-coated tablets.
Folji ta 'l- aluminju/ PVC/ PE/ PCTFE f‘ kartuni ta' 28 pillola miksijin b’ rita.
11 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Grootslag 1-5, NL-3991 RA, Houten The Netherlands
Grootslag 1- 5, Nl- 3991 RA, Houten L- Olanda
EU/ 1/ 02/ 237/ 006
EU/ 1/ 02/ 237 /
12 November 2002 Date of last renewal:
Data ta ’ l- ewwel awtorizzazzjoni: 12 ta ’ Novembru 2002 Data ta ’ l- aħħar tiġdid:
12 November 2007
12 ta ’ Novembru 2007
CIALIS 5 mg film-coated tablets
CIALIS 5 mg pilloli miksijin b’ rita
Each tablet contains 5 mg tadalafil.
Kull pillola fiha 5 mg tadalafil.
Each coated tablet contains 127 mg lactose monohydrate.
Kull pillola miksija fiha 127 mg lactose monohydrate.
Light yellow and almond shaped tablets, marked "C 5" on one side.
Pilloli ta ’ kulur isfar ċar u għandhom forma ta ’ lewża, immarkati "C 5 ” fuq naħa waħda.
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
13 Dose adjustments are not required in patients with mild to moderate renal impairment.
13 Użu f’ irġiel b’ indeboliment fil- funzjoni tal- kliewi Mhux meħtieġ tibdil tad- doża f’ pazjenti b’ indeboliment renali ħafif jew moderat.
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).
14 In patients receiving concomitant antihypertensive medicines, tadalafil may induce a blood pressure decrease.
14 temporajnu fil- pressjoni tad- demm (ara sezzjoni 5. 1) u b’ hekk jikkawża l- effett ipotensiv tan- nitrati (ara sezzjoni 4. 3).
15 4.5 Interaction with other medicinal products and other forms of interaction
15 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
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.
Konsegwentement l- inċidenza tal- effetti mhux mixtieqa elenkati fit- sezzjoni 4. 8 tista ’ tiżdied.
For tadalafil no clinical data on exposed pregnancies are available 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).
17 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.
Adverse reactions are alos 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.
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 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))
Ear and labyrinth disorders Sudden deafness2 1 System Organ Class:
Disturbi fil- widnejn u fis- sistema labirintika Truxija f’ daqqa2 18 Sistema tal- Klassifika ta ’ l- Organi:
18 System Organ Class:
Sistema tal- Klassifika ta ’ l- Organi:
(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).
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).
20 In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with erectile dysfunction secondary to spinal cord injury, tadalafil significantly improved the erectile function leading to a mean per-subject proportion of successful attempts in patients treated with tadalafil 10 or 20 mg (flexible- dose, on demand) of 48% as compared to 17% with placebo.
20 Fi studju li dam 12- il ġimgħa u li ġie magħmul f’ 186 pazjent (142 tadalafil, 44 plaċebo) b’ disfunzjoni erettili kawża ta ’ trawma tan- nerv li jgħaddi minn ġos- sinsla, tadalafil b’ mod sinifikanti tejjeb il - funzjoni erettili li wassal għal medja f’ kull pazjent ta ’ proporzjon ta ’ tentattivi ta ’ suċċess f’ dawk ikkurati b’ tadalfil 10 mg jew 20 mg (doża flessibbli, meta jkun hemm il- bżonn) ta ’ 48% meta mqabbel ma ’ 17% bi plaċebo.
Renal insufficiency In clinical pharmacology studies using single-dose tadalafil (5mg -20 mg), tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/ min) or moderate (creatinine clearance 31 to 50 ml/ min) renal impairment and in subjects with end-stage renal disease on dialysis.
Insuffiċjenza renali Fl- istudji tal- farmakoloġija klinika fejn intużat doża waħda ta 'tadalafil (5 mg- 20 mg), l- esponiment għal tadalafil (AUC) kien madwar id- doppju f’ individwi b’ indeboliment ħafif fil- kliewi (tneħħija tal - krejatinina 51 sa 80 ml/ min) jew moderat (tneħħija tal- krejatinina 31 sa 50 ml/ min) u f’ individwi fuq id- dijaliżi bi stat terminali tal- funzjoni tal- kliewi.
Hepatic insufficiency Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered.
21 Insuffiċjenza epatika L- esponiment għal tadalafil (AUC) f’ individwi b’ insuffiċjenza ħafifa u moderata tal- fwied (Child - Pugh Klassi A u B) huwa komparabbli ma 'l- espożizzjoni f’ individwi b’ saħħithom meta tingħata doża ta' 10 mg.
There is limited clinical data on the safety of CIALIS in patients with severe hepatic insufficiency (Child-Pugh
L- informazzjoni klinika dwar is- sigurta ’ ta ’ CIALIS f’ pazjenti b’ insuffiċjenza epatika gravi (Child- Pugh Klassi C) hija limitata.
Patients with diabetes Tadalafil exposure (AUC) in patients with diabetes was approximately 19% lower than the AUC value for healthy subjects.
Pazjenti bid- dijabete L- esponiment għal tadalafil (AUC) f’ individwi bid- dijabete kien madwar 19% inqas mill- valur ta 'AUC f’ individwi b’ saħħithom.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.
Kisja b’ rita: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide isfar (E172), talc.
22 6.4 Special precautions for storage
22 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not store above 25°C.
Taħżinx f’ temperatura ’ l fuq minn 30°C.
Aluminium/ PVC/ PE/ PCTFE blisters in cartons of 14 or 28 film-coated tablets.
Folji ta 'l- aluminju/ PVC/ PE/ PCTFE f‘ kartuni ta' 14 jew 28 pillola miksijin b’ rita.
Not all packs sizes may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
EU/ 1/ 02/ 237/ 007-008
EU/ 1/ 02/ 237 /
12 November 2002 Date of last renewal:
12 ta ’ Novembru 2002 Data ta ’ l- aħħar tiġdid:
CIALIS 10 mg film-coated tablets
CIALIS 10 mg pilloli miksijin b’ rita
Each tablet contains 10 mg tadalafil.
Kull pillola fiha 10 mg tadalafil.
Each coated tablet contains 179 mg lactose monohydrate.
Kull pillola miksija fiha 179 mg lactose monohydrate.
Light yellow and almond shaped tablets, marked "C 10" on one side.
Pilloli sofor ċari u għandhom forma ta ’ lewża, immarkati "C 10" fuq naħa waħda.
CIALIS is not indicated for use by women.
CIALIS mhuwiex indikat għall- użu min- nisa.
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 antiċipata u ma ’ l- ikel jew fuq stonku vojt.
The maximum dose frequency is once per day.
Il- frekwenza massima tad- dożi hija darba kuljum.
In these patients the recommended dose is 5 mg taken once a day at approximately the same time of day.
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 dose may be decreased to 2.5 mg once a day based on individual tolerability.
Id- doża tista ’ titnaqqas għal 2. 5 mg darba kuljum skond it- tollerabilità individwali.
The appropriateness of continued use of the daily regimen should be reassessed periodically.
Kemm hu xieraq l- użu kontinwu ta ’ skeda ta ’ dożaġġ ta ’ kuljum għandu jiġi vvalutat kull tant żmien Użu f’ irġiel anzjani
24 Use in elderly men Dose adjustments are not required in elderly patients.
24 Mhux meħtieġ tibdil tad- doża f’ pazjenti anzjani.
Use in men with impaired renal function Dose adjustments are not required in patients with mild to moderate renal impairment.
Użu f’ irġiel b’ indeboliment fil- funzjoni tal- kliewi Mhux meħtieġ tibdil tad- doża f’ pazjenti b’ indeboliment renali ħafif jew moderat.
(See sectiones 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).
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.
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.
25 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
Tadalafil għandu karatteristiċi vasodilatorji, li jirriżultaw fi tnaqqis ħafif u temporajnu fil- pressjoni tad- demm (ara sezzjoni 5. 1) u b’ hekk jikkawża l- effett ipotensiv tan- nitrati (ara sezzjoni 4. 3).
25 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).
F’ pazjenti li fl- istess ħin qegħdin jieħdu mediċini kontra l- pressjoni għolja fid- demm, tadalafil jista ’ jikkawża tnaqqis fil- pressjoni tad- demm.
There is limited clinical data on the safety of single-dose administration of CIALIS in patients with severe hepatic insufficiency (Child-Pugh Class C).
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.
4.5 Interaction with other medicinal products and other forms of interaction
26 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 b’ 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.
26 Effects of other substances on tadalafil
Effetti ta 'sustanzi oħrajn fuq tadalafil
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.
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 this regard, study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen in healthy subjects.
Fl- individwi
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.
27 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.
Analysis of phase 3 clinical trial data showed no difference in adverse events in patients taking tadalafil with or without antihypertensive medicines.
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.
27 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.
For tadalafil no clinical data on exposed pregnancies are available.
28 Għall- tadalafil m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
28 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
No studies on the effect on the ability to drive and use machines have been performed. 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.
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))
(≥ 1/ 100 to <  1/ 10)(≥ 1/ 1000 to <  1/ 100)
Mhux komuni (≥1/ 1000 sa < 1/ 100)
Ear and labyrinth disorders Sudden deafness2 1 System Organ Class:
Disturbi fil- widnejn u fis- sistema labirintika Truxija f’ daqqa2 29 Sistema tal- Klassifika ta ’ l- Organi:
29 System Organ Class:
Sistema tal- Klassifika ta ’ l- Organi:
(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).
Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness to CIALIS.
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 at doses of 2 to 100 mg has been evaluated in 16 clinical studies involving 3250 patients, including patients with erectile dysfunction of various severities (mild, moderate, severe), etiologies, ages (range 21-86 years), and ethnicities.
Tadalafil f’ dożi ta ’ 2 sa 100 mg kien evalwat f’ 16- il studju kliniku li involva aktar minn 3250 pazjent, inklużi pazjenti b’ disfunzjoni erettili ta ’ gradi varji (ħafif, moderat, gravi), etjoloġiji varji, etajiet varji (skala 21- 86 sena), u etniċitajiet varji.
Most patients reported erectile dysfunction of at least 1 year in duration.
Il- parti l- kbira tal- pazjenti kellhom disfunzjoni erettili li damet għall- inqas sena.
In the primary efficacy studies of general populations, 81% of patients reported that CIALIS improved their erections as compared to 35% with placebo.
Fl- istudji dwar effikaċja primarja ta ’ popolazzjonijiet ġenerali, 81% tal- pazjenti sabu illi CIALIS tejjeb l- erezzjonijiet tagħhom meta mqabbel ma ’ 35% li ħadu l- plaċebo.
Also, patients with erectile dysfunction in all severity categories reported improved erections whilst taking CIALIS (86%, 83%, and 72% for mild, moderate, and severe, respectively, as compared to 45%, 42%, and 19% with placebo).
Barra minn hekk, pazjenti b’ disfunzjoni erettili fil- kategoriji kollha ta ’ severita ’ kellhom erezzjonijiet imtejbin meta ħadu CIALIS (86%, 83%, u 72% għal disfunzjoni ħafifa, moderata, u gravi, rispettivament, meta mqabbel ma ’ 45%, 42%, u 19% li ħadu l- plaċebo).
In the primary efficacy studies, 75% of intercourse attempts were successful in CIALIS treated patients as compared to 32% with placebo.
Fl- istudji dwar effikaċja primarja, 75% tal- attentati għall- kopulazzjoni kienu b’ suċċess f’ pazjenti li ħadu CIALIS meta mqabbel ma ’ 32% li ħadu l - plaċebo.
31 In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with erectile dysfunction secondary to spinal cord injury, tadalafil significantly improved the erectile function leading to a mean per-subject proportion of successful attempts in patients treated with tadalafil 10 or 20 mg (flexible- dose, on demand) of 48% as compared to 17% with placebo.
31 Fi studju li dam 12- il ġimgħa u li ġie magħmul f’ 186 pazjent (142 tadalafil, 44 plaċebo) b’ disfunzjoni erettili kawża ta ’ trawma tan- nerv li jgħaddi minn ġos- sinsla, tadalafil b’ mod sinifikanti tejjeb il - funzjoni erettili li wassal għal medja f’ kull pazjent ta ’ proporzjon ta ’ tentattivi ta ’ suċċess f’ dawk ikkurati b’ tadalfil 10 mg jew 20 mg (doża flessibbli, meta jkun hemm il- bżonn) ta ’ 48% meta mqabbel ma ’ 17% bi plaċebo.
Biotransformation Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform.
Bijotrasformazzjoni Tadalafil huwa prinċipalment metabolizzat permezz ta ’ l- iżoforma ċitokromju P450 (CYP) 3A4.
Special Populations
Popolazzjonijiet Speċjali
Renal insufficiency In clinical pharmacology studies using single-dose tadalafil (5mg - 20 mg), tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/ min) or moderate (creatinine clearance 31 to 50 ml/ min) renal impairment and in subjects with end-stage renal disease on dialysis.
Insuffiċjenza renali Fl- istudji tal- farmakoloġija klinika fejn intużat doża waħda ta 'tadalafil (5 mg- 20 mg), l- esponiment għal tadalafil (AUC) kien madwar id- doppju f’ individwi b’ indeboliment ħafif fil- kliewi (tneħħija tal - krejatinina 51 sa 80 ml/ min) jew moderat (tneħħija tal- krejatinina 31 sa 50 ml/ min) u f’ individwi fuq id- dijaliżi bi stat terminali tal- funzjoni tal- kliewi.
32 Hepatic insufficiency Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered.
32 Insuffiċjenza epatika L- esponiment għal tadalafil (AUC) f’ individwi b’ insuffiċjenza ħafifa u moderata tal- fwied (Child - Pugh Klassi A u B) huwa komparabbli ma 'l- espożizzjoni f’ individwi b’ saħħithom meta tingħata doża ta' 10 mg.
There is limited clinical data on the safety of CIALIS in patients with severe hepatic insufficiency (Child-Pugh Class C).
L- informazzjoni klinika dwar is- sigurta ’ ta ’ CIALIS f’ pazjenti b’ insuffiċjenza gravi tal - fwied (Child- Pugh Klassi C); hija limitata.
If CIALIS is prescribed, a careful individual benefit/ risk evaluation should be undertaken by the prescribing physician.
Jekk jiġi preskritt Cialis, għandha ssir evalwazzjoni b’ attenzjoni tal- benefiċċji/ riskji għall- individwu mit- tabib li jippreskrivih.
There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment.
M’ hemm l- ebda informazzjoni disponibbli dwar it- teħid ta ’ dożi ogħla minn 10 mg ta ’ tadalafil minn pazjenti b’ indeboliment tal- fwied.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.
Kisja b’ rita: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.
Not applicable.
Ma jgħoddx.
33 6.4 Special precautions for storage
33 6. 4 Prekawzjonijiet speċjali għall- ħażna
Aluminium/ PVC/ PE/ PCTFE blisters in cartons of 4 film-coated tablets.
Folji ta 'l- aluminju/ PVC/ PE/ PCTFE f‘ kartuni ta' 4 pillola miksijin b’ rita.
CIALIS 20 mg film-coated tablets
CIALIS 20 mg pilloli miksijin b’ rita
Each tablet contains 20 mg tadalafil.
Kull pillola fiha 20 mg tadalafil.
Each coated tablet contains 245 mg lactose monohydrate.
Kull pillola miksija fiha 245 mg lactose monohydrate.
Yellow and almond shaped tablets, marked "C 20" on one side.
Pilloli sofor u għandhom forma ta ’ lewża, immarkati "C 20" fuq naħa waħda.
Tadalafil 10 mg 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.
The appropriateness of continued use of the daily regimen should be reassessed periodically.
Kemm hu xieraq l- użu kontinwu ta ’ skeda ta ’ dożaġġ ta ’ kuljum għandu jiġi vvalutat kull tant żmien
35 Use in elderly men Dose adjustments are not required in elderly patients.
35 Użu f’ irġiel anzjani Mhux meħtieġ tibdil tad- doża f’ pazjenti anzjani.
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.
36 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.
36 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).
F’ pazjenti li fl- istess ħin qegħdin jieħdu mediċini kontra l- pressjoni għolja fid- demm, tadalafil jista ’ jikkawża tnaqqis fil- pressjoni tad- demm.
4.5 Interaction with other medicinal products and other forms of interaction
37 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
37 Effects of other substances on tadalafil
Effetti ta 'sustanzi oħrajn fuq tadalafil
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).
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).
Consequently the incidence of the undesirable effects listed in section 4.8 might be increased.
Konsegwentement l- inċidenza tal- effetti mhux mixtieqa elenkati fit- sezzjoni 4. 8 tista ’ tiżdied.
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).
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 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.
38 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.
38 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.
For tadalafil no clinical data on exposed pregnancies are available.
39 Għall- tadalafil m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
39 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
The most commonly reported adverse reactions are headache and dyspepsia.
L- aktar reazzjonijiet avversi komuni li ġew irrapportati kienu uġigħ ta ’ ras u dispepsja.
Ear and labyrinth disorders Sudden deafness2 System Organ Class:
Disturbi fil- widnejn u fis- sistema labirintika Truxija f’ daqqa2 40 Sistema tal- Klassifika ta ’ l- Organi:
Cardiac disorders1
Disturbi fil- qalb
40 System Organ Class:
Sistema tal- Klassifika ta ’ l- Organi:
42 In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with erectile dysfunction secondary to spinal cord injury, tadalafil significantly improved the erectile function leading to a mean per-subject proportion of successful attempts in patients treated with tadalafil 10 or 20 mg (flexible- dose, on demand) of 48% as compared to 17% with placebo.
42 Fi studju li dam 12- il ġimgħa u li ġie magħmul f’ 186 pazjent (142 tadalafil, 44 plaċebo) b’ disfunzjoni erettili kawża ta ’ trawma tan- nerv li jgħaddi minn ġos- sinsla, tadalafil b’ mod sinifikanti tejjeb il - funzjoni erettili li wassal għal medja f’ kull pazjent ta ’ proporzjon ta ’ tentattivi ta ’ suċċess f’ dawk ikkurati b’ tadalfil 10 mg jew 20 mg (doża flessibbli, meta jkun hemm il- bżonn) ta ’ 48% meta mqabbel ma ’ 17% bi plaċebo.
Renal insufficiency In clinical pharmacology studies using single-dose tadalafil (5-20 mg), tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/ min) or moderate (creatinine clearance 31 to 50 ml/ min) renal impairment and in subjects with end-stage renal disease on dialysis.
Insuffiċjenza renali Fl- istudji tal- farmakoloġija klinika fejn intużat doża waħda ta 'tadalafil (5 mg- 20 mg), l- esponiment għal tadalafil (AUC) kien madwar id- doppju f’ individwi b’ indeboliment ħafif fil- kliewi (tneħħija tal - krejatinina 51 sa 80 ml/ min) jew moderat (tneħħija tal- krejatinina 31 sa 50 ml/ min) u f’ individwi fuq id- dijaliżi bi stat terminali tal- funzjoni tal- kliewi.
43 Hepatic insufficiency Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered.
43 Insuffiċjenza epatika L- esponiment għal tadalafil (AUC) f’ individwi b’ insuffiċjenza ħafifa u moderata tal- fwied (Child - Pugh Klassi A u B) huwa komparabbli ma 'l- espożizzjoni f’ individwi b’ saħħithom meta tingħata doża ta' 10 mg.
44 6.4 Special precautions for storage
44 6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not store above 30°C.
Taħżinx f’ temperatura ’ l fuq minn 30°C
6.5 Nature and contents of container
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fiħ
Aluminium/ PVC/ PE/ PCTFE blisters in cartons of 2, 4, 8 and 12 film-coated tablets.
Folji ta 'l- aluminju / PVC/ PE/ PCTFE f’ kartuni ta' 2, 4, 8 u 12- il pillola miksijin b’ rita.
Not all packs sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
45 ANNEX II
45 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE B.
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
46 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Name and address of the manufacturers responsible for batch release
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott
Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spanja
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 għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli għall- ħruġ tal- lott konċernat
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL – FORNIMENT U L - UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Medicinal product subject to medical prescription
Prodott medicinali jingħata bir- riċetta tat- tabib.
• CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
The Marketing Authorisation Holder must ensure that the system of pharmacovigilance, as described in version 1 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq irid jassigura li s- sistema ta ’ farmakoviġilanza, kif deskritt fil- verżjoni 1 ippreżentat fit- Taqsima 1. 8. 1 ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq, qiegħda preżenti u qiegħda taħdem qabel ma jpoġġi l- prodott fuq is- suq u waqt li l - prodott qiegħed fis- suq.
Risk Management Plan
Pjan dwar l- Immaniġġar tar- Riskju
The Marketing Authorisation Holder commits to performing the studies additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1 of the Risk Management Plan (RPM) presented in Module 1.8.2. of the Marketing Authorisation and subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq jintrabat li jagħmel l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza mniżżlin fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni ’ l tal- Pjan dwar l- Immaniġġar tar- Riskju (PIR) ippreżentat fit- Taqsima 1. 8. 2 ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq u f’ kull aġġornament tal- PIR li jista ’ jkun hemm u li jkun qabel miegħu is- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report.
meta jkun hemm informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjonijiet tas - Sigurtà, fuq il- Pjan ta ’ Farmakoviġilanza jew fuq l- attivitajiet li jnaqqsu ir- riskju li jkunu jgħoddu f’ dak il- mument.
In addition, an updated RMP should be submitted • when new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimization activities. • within 60 days of an important (pharmacovigilance or risk minimization) milestone being reached. • at the request of the EMEA.
fi żmien 60 ġurnata minn meta jkun deċiż xi avveniment importanti (ta ’ farmakoviġilanza jew tat- tnaqqis tar- riskju)
The Marketing Authorisation Holder will continue to submit yearly PSURs unless otherwise specified by the CHMP.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq se jkompli jissottometti l- PSUR’ s kull sena sakemm ma jirċivix speċifikazzjonijiet differenti mis- CHMP.
47 ANNEX III
47 ANNESS III
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT
KITBA FUQ IL- KARTUNA TA ’ BARRA
CIALIS 2.5 mg film-coated tablets tadalafil
CIALIS 2. 5 mg pilloli miksijin b’ rita Tadalafil
Each tablet contains 2.5 mg tadalafil
Kull pillola fiha 2. 5 mg tadalafil