qanastek/EMEA-V3 huggingface dataset:
Not known Ear and labyrinth disorders
Mhux magħruf Disturbi fil- widnejn u fis- sistema labirintika
Non-arteritic anterior ischaemic optic neuropathy (NAION), Retinal vascular occlusion, Visual field defect
Newropatija anterjuri iskimika, mhux tal- arterja tal- għajn (NAION), sadd fis- sistema vaskulari ġewwa r- retina, difett fil- kamp visiv.
Uncommon Rare Vascular disorders
Mhux komuni Rari Disturbi vaskulari
Vertigo, Tinnitus Deafness*
Vertigo, żanżin fil- widnejn Nuqqas ta ’ smigħ *
Common Rare Cardiac disorders
Komuni Rari Disturbi fil- qalb Mhux komuni
Flushing Hypertension, Hypotension
Fwawar Pressjoni għolja, pressjoni baxxa Palpitazzjonijiet, Takikardija
Uncommon Rare Not known
Rari Mhux magħruf Disturbi respiratorji, toraċiċi u medjastinali
Palpitations, Tachycardia Myocardial infarction, Atrial fibrillation Ventricular arrhythmia, Unstable angina, Sudden cardiac death
Attakk tal- qalb, fibbrillazzjoni fl- atriju tal- qalb Arritmja ventrikulari, infart mijokardijaku, anġina instabbli, mewt sobtu minħabba mard tal- qalb
Respiratory, thoracic and mediastinal disorders Common Rare Gastrointestinal disorders
Komuni Rari Disturbi gastro- intestinali
Nasal congestion Epistaxis
Konġestjoni nażali Epistassi (tinfaġar)
Dyspepsia Vomiting, Nausea, Dry mouth
Dispepsja Rimettar, dardir, ħalq xott
Skin, subcutaneous and soft tissue disorders Uncommon
7 Klassi tal- Organu
Skin rash
Reazzjonijiet Kuntrarji
Musculoskeletal and connective tissue disorders Uncommon Reproductive system and breast disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni
Myalgia
Raxx
Not known
Disturbi muskolu- skeltrali u tal- connective tissue Uġigħ fil- muskoli / Majalġja Mhux komuni Disturbi fis- sistema riproduttiva u fis- sider Mhux magħruf
Priapism, Prolonged erection
Prijapriżmu, erezzjoni prolongata
General disorders and administration site conditions Uncommon Investigations
Disturbi ġenerali u kundizzjonijiet ta 'mnejn jingħata Mhux komuni Investigazzjonijiet Mhux komuni
Sudden
Uġigħ fis- sider, għeja Żieda fir- rata ta ’ tħabbit tal- qalb
decrease or loss of hearing has been reported in a small
* Distrubi fil- widnejn: telf ta ’ smigħ f’ daqqa.
number of post-marketing and clinical trials cases with the use of all PDE5 inhibitors, including sildenafil.
Tnaqqis f’ daqqa jew telf ta ’ smigħ ġie rrappurtat f’ numru żgħir ta ’ każi wara t- tqegħid fis- suq u fi ’ studji kliniċi, bl- użu ta ’ l- inibituri PDE5 kollha, inkluż sildenafil.
In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased.
Fi studji ta ’ voluntiera b’ doża waħda, ta ’ dożi sa 800 mg, reazzjonijiet avversi kienu simili għal dawk li ġraw b’ dożi iżgħar, iżda r- rati ta ’ inċidenza u s- severità żdiedu.
Doses of 200 mg did not result in increased efficacy but the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased.
Dożi ta ’ 200 mg ma rriżultawx f’ żieda fl- effiċjenza iżda l- inċidenza ta ’ reazzjonijiet avversi (uġigħ ta ’ ras, ħmura, sturdament, dispepsja, konġestjoni nażali, vista mibdula) żdiedet.
Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.
Dijaliżi tal - kliewi mhux mistennija li tħaffef il- clearance għax sildenafil huwa marbut b’ mod qawwi ma ’ proteini tal- plażma u mhux eliminat fl- urina.
Drugs used in erectile dysfunction.
Pilloli użati għal problema ta ’ l- erezzjoni tal- pene.
Sildenafil is an oral therapy for erectile dysfunction.
Sildenafil huwa terapija orali għal problema ta ’ l- erezzjoni tal- pene.
In the natural setting, i. e. with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis.
F’ Ċirkustanzi naturali; b’ stimulazzjoni sesswali jneħħi l- problema tal- funzjoni erettili billi jżid l- ammont ta ’ demm li jidħol fil- pene.
The physiological mechanism responsible for erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation.
Il- mekkaniżmu fiżjoloġiku responsabbli għal erezzjoni tal- pene jinvolvi il- ħruġ ta ’ nitric oxide (NO) fil- corpus cavernosum waqt stimulazzjoni sesswali.
Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Nitric oxide mbagħad jattiva l- enżima guanylate cyclase, li tirriżulta f’ livelli miżjuda ta ’ cyclic guanosine monophosphate (cGMP), li tipproduċi rilassament tal- muskoli lixxi fil- corpus cavernosum u tikkawża d- dħul tad- demm.
Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for degradation of cGMP.
Sildenafil huwa inibitur potenti u selettiv ta ’ cGMP specific phosphodiesterase type 5 (PDE5) fil - corpus cavernosum, fejn PDE5 huwa responsabbli għad- degradazzjoni ta ’ cGMP.
Sildenafil has a peripheral site of action on erections.
Sildenafil għandu sit periferali ta ’ azzjoni fuq erezzjonijiet.
Sildenafil has no direct relaxant effect on isolated human corpus cavernosum but potently enhances the relaxant effect of NO on this tissue.
Sildenafil m’ għandu l- ebda effett rilassanti dirett fuq corpus cavernosum uman iżolat iżda bil- qawwa jsaħħaħ l- effett rilassanti ta ’ NO fuq dan it- tessut.
When the NO/ cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by sildenafil results in increased corpus cavernosum levels of cGMP.
Meta l - pathway NO/ cGMP tiġi attivata, bħal ma jiġri bi stimulazzjoni sesswali, inibizzjoni ta ’ PDE5 minn sildenafil tirriżulta f’ livelli aktar għoljin ta ’ cGMP fil- corpus cavernosum.
Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects.
Għalhekk stimulazzjoni sesswali hija neċessarja biex l- effetti terapewtiċi ta ’ sildenafil ikunu ta ’ ġid.
Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process.
Studji in vitro wrew li sildenafil huwa selettiv għal PDE5, li huwa nvolut fil- proċess ta ’ l- erezzjoni.
At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE2, 3, 4, 7, 8, 9, 10 and 11.
Bl- ogħla dożi rakkomandati, hemm selettività ta ’ 80- darba fuq PDE1, u aktar minn 700- darba fuq PDE2, 8 3, 4, 7, 8, 9, 10 u 11.
In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.
B’ mod partikulari, sildenafil għandu selettività ta ’ aktar minn 4, 000- darba għal PDE5 fuq PDE3, is- cAMP – specific phosphodiesterase isoform involut fil- kontroll tal- kontrattilità.
Two clinical studies were specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation.
Żewġ studji kliniċi kienu disinjati speċifikament biex jeżaminaw il- perijodu ta ’ ħin wara d- dożaġġ li matulu sildenafil jista ’ jipproduċi erezzjoni bi tweġiba għal stimulazzjoni sesswali.
In a penile plethysmography (RigiScan) study of fasted patients, the median time to onset for those who obtained erections of 60%
Fi studju tal- pene bil- plestismografu (RigiScan) f’ pazjenti sajmin, il- ħin medjan biex jibdew l- erezzjonijiet għal dawk li kisbu 60% riġidità (suffiċjenti għal rapport sesswali) kien 25 minuta (medda bejn 12- 37 minuta) b’ sildenafil.
In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation 4-5 hours post-dose.
Fi studju RigiScan separat, sildenafil kien għadu kapaċi jipproduċi erezzjoni bi tweġiba għal stimulazzjoni sesswali 4- 5 sigħat wara d- doża.
Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects.
Sildenafil jikkaġuna tnaqqis ħafif u temporanju fil- pressjoni tad- demm li, fil- maġġoranza tal- każi ma jissarfux f’ effetti kliniċi.
The mean maximum decreases in supine systolic blood pressure following 100 mg oral dosing of sildenafil was 8.4 mmHg.
L- ogħla tnaqqis medju fil- pressjoni sistolika f’ pożizzjoni minduda wara 100 mg ta ’ sildenafil doża orali kien ta ’ 8. 4 mmHg.
The corresponding change in supine diastolic blood pressure was 5.5 mmHg.
Il- bidla korrispondenti fil- pressjoni dijastolika f’ pożizzjoni minduda kienet 5. 5 mmHg.
These decreases in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle.
Dan it- tnaqqis fil- pressjoni tad- demm huwa konsistenti ma ’ l - effetti ta ’ vażodilatazzjoni ta ’ sildenafil, probabilment minħabba żieda fil- livelli ta ’ cGMP fil- muskoli lixxi vaskulari.
Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on ECG.
Dożi orali singli ta ’ sildenafil sa 100 mg f’ voluntiera b’ saħħithom ma għamlu l- ebda effett klinikalment relevanti fuq l- ECG.
In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (> 70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline.
Fi studju ta ’ l- effetti imodinamiċi ta ’ doża waħda orali ta ’ 100 mg sildenafil f’ 14- il pazjenti b’ mard sever ta ’ l- arterji tal- qalb (CAD) (> 70% stenożi f’ ta mill- anqas arterja waħda tal- qalb), il- pressjoni medja tad- demm sistolika u dijastolika waqt is- serħan naqsu b’ 7% u 6% rispettivament mqabbla mal - linja bażi.
No clinical relevant differences were demonstrated in time to limiting angina for sildenafil when compared with placebo in a double blind, placebo controlled exercise stress trial in 144 patients with erectile dysfunction and chronic stable angina, who were taking on a regular basis anti-anginal medications (except nitrates).
Ma ntwerewx differenzi klinikalment relevanti ta ’ ħin li jillimita l- anġina għal sildenafil mqabbel mal - plaċebo fi prova double blind, kontrollata bil- plaċebo, ta ’ stress ta ’ eżerċizzju f’ 114 pazjenti bi problema ta ’ erezzjoni tal- pene u anġina kronika stabbli, li kienu qed jieħdu medikazzjoni kontra l - anġina (bl- eċċezzjoni ta ’ nitrati) fuq bażi regolari.
There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers.
Ma kienx hemm effett fuq il- morfoloġija jew motilità ta ’ l- isperma wara dożi orali ta ’ 100 mg il - waħda ta ’ sildenafil f’ voluntiera b’ saħħithom.
Further information on clinical trials In clinical trials sildenafil was administered to more than 8000 patients aged 19-87.
Fi provi kliniċi sildenafil ġie amministrat lil aktar minn- 8000 pazjent ta ’ età 19 - 87 sena.
The following patient groups were represented: elderly (19.9%), patients with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%).
Kienu rappreżentati dawn il- gruppi ta ’ pazjenti li ġejjin: anzjani (19. 9%), pazjenti bi pressjoni għolja (30. 9%), dijabetiċi (20. 3%), b’ mard iskimiku tal- qalb (5. 8%), iperlipidimja (19. 8%), ħsara fis- sinsla tad- dahar (0. 6%), dipressjoni (5. 2%), b’ resezzjoni transuretrali tal- prostata (3. 7%), prostatectomy radikali (3. 3%).
The following groups were not well represented or excluded from clinical trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or hepatic impairment and patients with certain cardiovascular conditions (see section 4.3).
Dawn il- gruppi li ġejjin ma kienux rappreżentati tajjeb jew esklużi mill- provi kliniċi: pazjenti b’ kirurġija tal- pelvis, pazjenti wara radjuterapija, pazjenti bi ħsara severa tal- kliewi jew fwied u pazjenti b’ ċertu kundizzjonijiet kardjovaskulari (ara sezzjoni 4. 3).
In fixed dose studies, the proportions of patients reporting that treatment improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg) compared to 25% on placebo.
Fi studji ta ’ doża fissa, il- proporzjon ta ’ pazjenti li rrappurtaw li l- kura tejbet l- erezzjonijiet tagħhom kienu 62% (25 mg), 74% (50 mg), u 82% (100 mg) mqabbla ma ’ 25% fuq il- plaċebo.
In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo.
Fi provi kliniċi kontrollati, r- rata ta ’ diskontinwazzjoni minħabba sildenafil kienet baxxa u simili ma ’ tal- plaċebo.
Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%).
9 Fil- provi kollha, il- proporzjon ta ’ pazjenti li rrapurtaw titjib bil- sildenafil kienu kif ġejjin: problema ta ’ erezzjoni tal- pene psikoġenika (84%), problemi ta ’ l- erezzjoni mħallta (77%), problema ta ’ erezzjoni organika (68%), anzjani (67%), dijabetiċi (59%), mard iskimiku tal- qalb (69%), pressjoni għolja (68%), TURP (61%), prostatectomy radikali (43%), korriment fis- sinsla tad- dahar (83%), dipressjoni (75%).
The safety and efficacy of sildenafil was maintained in long-term studies.
Sildenafil żamm l’ effikaċja u s- sigurtà tiegħu fi studji li damu żmien twil.
The mean absolute oral bioavailability is 41% (range 25-63%).
Il- medja assoluta ta ’ biodisponibilità orali hija 41% (medda 25- 63%).
After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range (25-100 mg).
Wara doża orali ta ’ sildenafil l- AUC u Cmax jiżdiedu fi proporzjon mad- doża fuq il- medda rakkomandata tad- doża (25 - 100 mg).
When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in tmax of 60 minutes and a mean reduction in Cmax of 29%.
Meta sildenafil jittieħed ma ’ l- ikel, ir- rata ta ’ assorbiment titnaqqas b’ dewmien medju fit- tmax ta ’ 60 minuta u tnaqqis medju fis- Cmax ta ’ 29%.
The mean steady state volume of distribution (Vd) for sildenafil is 105 l, indicating distribution into the tissues.
Distribuzzjoni: Il- medja tal- volum ta ’ distribuzzjoni fi stat fiss (Vd) għal sildenafil huwa 105 l, li jindika distribuzzjoni fit- tessut.
After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/ ml (CV 40%).
Wara doża orali waħda ta ’ 100 mg, l- ogħla konċentrazzjoni medja totali ta ’ plażma ta ’ sildenafil hija bejn wieħed u ieħor 440 ng/ ml (CV 40%).
Since sildenafil (and its major circulating N- desmethyl metabolite) is 96% bound to plasma proteins, this results in the mean maximum free plasma concentration for sildenafil of 18 ng/ ml (38 nM).
Minħabba li sildenafil (u l- metabolu fiċ- ċirkolazzjoni ewlenieni tiegħu N- desmethyl) huwa 96% marbut ma ’ proteini tal - plażma, dan jirriżulta fl- ogħla konċentrazzjoni ta ’ plażma ħielsa għal sildenafil ta ’ 18 ng/ ml (38nM).
Protein binding is independent of total drug concentrations.
Ir- rabta mal- proteini hija indipendenti mill- konċentrazzjonijiet totali tal- pillola.
In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002% (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing.
F’ voluntiera b’ saħħithom li ħadu sildenafil (100 mg doża waħda), anqas minn 0. 0002% (medja 188 ng) tad- doża amministrata kienet preżenti fl- isperma 90 minuta wara d- doża.
Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.
Sildenafil huwa mnaddaf primarjament mill- iżo- enżimi mikrożomali CYP3A4 (rotta ewlenija) u CYP2C9 (rotta minuri) tal- fwied.
Plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil.
Konċentrazzjonijiet tal- plażma ta ’ dan il- metabolu huma bejn wieħed u ieħor 40% ta ’ dawk li ntwerew għal sildenafil.
The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h.
Il - metabolu N- desmethyl jiġi metabolizzat iżjed, b’ half life terminali ta ’ bejn wieħed u ieħor 4 h.
The total body clearance of sildenafil is 41 l/ h with a resultant terminal phase half-life of 3-5 h.
Il- clearance totali tal- ġisem ta ’ sildenafil huwa 41 l/ h li jirriżulta f’ half life fil- fażi terminali ta ’ 3- 5 h.
After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).
Wara jew amministrazzjoni orali jew fil- vina, sildenafil jitneħħa bħala metaboli b’ mod predominanti fl- ippurgar (bejn wieħed u ieħor 80% tad- doża orali amministrata) u f’ proporzjon anqas fl- urina (bejn wieħed u ieħor 13% tad- doża orali amministrata).
Pharmacokinetics in special patient groups
Farmakokinetiċi fi gruppi speċjali ta ’ pazjenti
Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Voluntiera anzjani b’ saħħithom (65 sena jew iżjed) kellhom clearance mnaqqas ta ’ sildenafil, li jirriżulta f’ bejn wieħed u ieħor 90% konċentrazzjonijiet ogħla fil- plażma ta ’ sildenafil u l- metabolu attiv N- desmethly mqabbel ma ’ dawk li nstabu f’ voluntiera żagħżagħ b’ saħħithom (18- 45 sena).
Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately 40%.
Minħabba differenzi relatati ma ’ l- età fl- irbit tal- proteini tal- plażma, ż- żieda korrispondenti fil - konċentrazzjoni fil- plażma ta ’ sildenafil ħieles kienet bejn wieħed u ieħor 40%.
In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 ml/ min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
F’ voluntiera b’ indeboliment ħafif għal moderat tal- kliewi (clearance tal- creatinine = 30- 80ml/ min), il - farmakokinetiċi ta ’ sildenafil ma tbiddlux wara doża orali waħda ta ’ 50 mg.
The mean AUC and Cmax of the N-desmethyl metabolite increased 126% and 73% respectively, compared to age-matched volunteers with no renal impairment.
Il- medja ta ’ l- AUC u Cmax tal- metabolu N- desmethyl żdiedu b’ 126% u 73% rispettivament, mqabbel ma ’ voluntiera ta ’ l- istess età li ma kellhomx ħsara fil- kliewi.
However, due to high inter-subject variability, these differences were not statistically significant.
Madankollu, minħabba varjazzjonijiet kbar bejn is- suġġetti, dawn d- differenzi ma kienux statistikament sinifikanti.
In volunteers with severe renal impairment (creatinine clearance < 30 ml/ min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment.
F’ voluntiera b’ indeboliment sever tal- kliewi (clearance tal- creatinine < 30ml/ min), il- clearance ta ’ sildenafil naqset, u wasslet għal żidiet medji ta ’
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 79% and 200% respectively.
Barra minn dan, il- valuri ta ’ l- AUC u Cmax tal- metabolite N- desmethyl żdiedu b’ mod sinifikanti b’ 79% u 200% rispettivament.
10 Hepatic insufficiency:
Insuffiċjenza tal- fwied:
In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh A and B) sildenafil clearance was reduced, resulting in increases in AUC (84%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment.
F’ voluntiera b’ ċirożi ħafifa għal moderata tal- fwied (Child- Pugh A u B) il- clearance ta sildenafil tnaqqas, u rriżulta f’ żidiet fl- AUC (84%) u Cmax (47%) mqabbel ma ’ voluntiera ta ’ l- istess età li ma kellhomx ħsara fil- fwied.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Informazzjoni pri- klinika ma wrietx ebda riskju speċjali għan- nies bażata fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, tossisità ta ’ doża ripetuta, ġenotossiċità, potenzjal karċinoġeniku, u ħsara fis - sistema riproduttiva.
Tablet core: microcrystalline cellulose calcium hydrogen phosphate (anhydrous) croscarmellose sodium magnesium stearate
Qalba tal- pillola microcrystalline cellulose calcium hydrogen phosphate (anhydrous), croscarmellose sodium magnesium stearate
Film coat: hypromellose titanium dioxide (E171) lactose triacetin indigo carmine aluminium lake (E132)
Kisja tar- rita hypromellose titanium dioxide (E171) lactose triacetin indigo carmine aluminium lake (E132)
Do not store above 30oC.
Taħżinx f’ temperatura ogħla minn 30°C.
Store in the original package, in order to protect from moisture.
Aħżen fil- pakkett oriġinali, biex tilqa ’ mill- umidità.
PVC/ Aluminium foil blisters in cartons of 2, 4, 8 or 12 tablets.
Fojl ta ’ l- aluminju/ PVC f’ pakketti ta ’ 2, 4, 8 jew 12- il pillola.
Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom
Pfizer Ltd., Sandwich, Kent CT13 9NJ, Renju Unit.
14 September 1998 Date of last renewal:
Data ta ’ l- aħħar tiġdid:
26 August 2008
26 ta ’ Awwissu 2008
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu
VIAGRA 50 mg film-coated tablets
VIAGRA 50 mg Pilloli miksija b’ rita.
Each tablet contains 50 mg of sildenafil (as citrate) Excipient:
Sustanza mhux attiva:
Blue, rounded diamond-shaped tablets, marked “ PFIZER ” on one side and “ VGR 50 ” on the other.
Pilloli ta ’ 50 mg, ittundjati forma ta ’ djamant, immarkati “ PFIZER ” fuq naħa waħda u “ VGR 50 ” fuq l- oħra.
Use in patients with impaired hepatic function:
Użu f’ pazjenti b’ indeboliment tal- fwied:
13 Use in children and adolescents:
13 Użu fi tfal u adoloxxenti:
Use in patients using other medicines:
Użu f’ pazjenti fuq mediċini oħra:
Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of VIAGRA.
Wara li tqiegħedet fuq is- suq, ġew rappurtati każi kardjuvaskulari serji marbuta ma ’ l- użu fl- istess waqt ta ’ VIAGRA, fosthom infart mijokardijaku, anġina instabbli, mewt għal għarrieda tal- qalb, arritmja ventrikulari, emorraġija ċerebrovaskulari, attakk iskimiku transitorju, pressjoni għolja u pressjoni baxxa.
Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly
Ħafna każi ġew rappurtati li ġraw matul jew ftit wara rapport sesswali u
14 after the use of VIAGRA without sexual activity.
14 ftit ġew rappurtati li ġraw wara l- użu ta ’ VIAGRA mingħajr attività sesswali.
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
Ko- amministrazzjoni ta ’ l- inibitur ta ’ HIV protease ritonavir, li huwa inibitur potenti ħafna tal- P450, fi stat stabbli (500 mg darbtejn kuljum) ma ’ sildenafil (100 mg doża waħda) irriżultat f’ żieda ta ’ 300% (4 darbiet) fis- Cmax ta ’ sildenafil u żieda ta ’ 1000% (11- il darba) fl- AUC tal- plażma ta ’ sildenafil.
At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/ ml, compared to approximately 5 ng/ ml when sildenafil was administered alone.
F’ 24
15 range of P450 substrates.
15 siegħa, l- livelli tal- plażma ta ’ sildenafil kienu għadhom bejn wieħed u ieħor 200ng/ ml, imqabblin ma ’ bejn wieħed u ieħor 5ng/ ml meta sildenafil ingħata waħdu.
When a single 100 mg dose of sildenafil was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
Meta doża waħda ta ’ 100 mg sildenafil ġiet amministrata ma ’ erythromycin, inibitur ta ’ CYP3A4 speċifiku, fi stat stabbli (500 mg darbtejn kuljum għal 5 jiem), kien hemm żieda ta ’ 182% fis- systemic exposure (AUC) ta ’ sildenafil.
Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals.
16 Amministrazzjoni ta ’ sildenofil lil pazjenti taħt il- kura b’ alpha blockers tista ’ tirriżulta fi pressjoni baxxa sintomatika fi ftit individwi suxxettibbli.
16 simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
Fi tlett studji speċifiċi għal interazzjoni bejn żewġ prodotti mediċinali, alpha blocker doxazocin (4mg u 8mg) u sildenafil (25mg, 50mg u 100mg) ġew amministrati fl- istess ħin lil pazjenti bi tkabbir benin tal- prostata (BPH), stabilizzati fuq kura ta ’ doxazocin.
The safety profile of VIAGRA is based on 8691 patients who received the recommended dosing regimen in 67 placebo-controlled clinical studies.
Is- sigurta ’ ta ’ VIAGRA hija bbażata fuq 8691 pazjenti li ħadu id- dużaġġ irrakkomandat f’ 67 studji kliniċi kontrollati bi plaċebo.
The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, visual disorders, nasal congestion, dizziness and visual colour distortion.
L- aktar reazzjonijiet avversi li ġew irrappurtati minn fost il- pazjenti li użaw sildenafil fl- istudji kliniċi kienu uġigħ ta ’ ras, fwawar, dispepsja, viżjoni mibdula, sadda tal - imnifsejn, sturdament u diffikulta` biex tagħraf il- kuluri
Adverse reactions from post-marketing surveillance has been gathered covering an estimated period > 9 years.
Reazzjonijiet avversi ġew miġbura waqt is- sorveljanza ta ’ wara t- tqegħid tal- prodott fis- suq, fuq medda ta ’ > 9snin.
Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.
Minħabba li mhux ir- reazzjonijiet avversi kollha huma rrappurtati lid- Detentur ta ’
In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (≥ 1/ 10),
17 l- Awtorizzazzjoni għat- Tqegħid fis- Suq, u mniżżla fil- ġabra kumulattiva tad- dejta, il- frekwenzi ta ’ dawn ir- reazzjonijiet ma jistgħux ikunu magħrufa fiċ- ċert.
17 common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000).
Fit- tabella ta ’ hawn taħt, ir- reazzjonijiet avversi ta ’ importanza medika, li seħħew fl- istudji kliniċi b’ inċidenza ta ’ iktar minn bil- plaċebo, huma mniżżla skond il- klassi ta ’ l- organi u l- frekwenzi (komuni ħafna (≥1/ 10), komuni (≥1/ 100 to < 1/ 10), mhux komuni (≥1/ 1, 000 to < 1/ 100), rari (≥1/ 10, 000 to < 1/ 1, 000).
Non-arteritic anterior ischaemic optic neuropathy (NAION), Retinal vascular occlusion, Visual field defect
Newropatija anterjuri iskimika, mhux tal- arterja tal- għajn (NAION), sadd fis- sistema vaskulari ġewwa r- retina, difett fil - kamp visiv.
Skin, subcutaneous and soft tissue disorders Uncommon
18 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Skin rash
Mhux komuni
Musculoskeletal and connective tissue disorders Uncommon Reproductive system and breast disorders
Disturbi muskolu- skeltrali u tal- connective tissue
Myalgia
Mhux komuni
Not known General disorders and administration site Uncommon Investigations
Uġigħ fil- muskoli / Majalġja
Priapism, Prolonged erection conditions Chest pain, Fatigue
Disturbi fis- sistema riproduttiva u fis- sider
Uncommon
Mhux magħruf
Heart rate increased
Prijapriżmu, erezzjoni prolongata
Sudden deafness.
* Distrubi fil- widnejn: telf ta ’ smigħ f’ daqqa.
Sudden decrease or loss of hearing has been reported in a small number of post-marketing and clinical trials cases with the use of all PDE5 inhibitors, including sildenafil.
Tnaqqis f’ daqqa jew telf ta ’ smigħ ġie rrappurtat f’ numru żgħir ta ’ każi wara t- tqegħid fis- suq u fi ’ studji kliniċi, bl- użu ta ’ l- inibituri PDE5 kollha, inkluż sildenafil.
18 4.9 Overdose
4. 9 Doża eċċessiva
At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE2, 3, 4, 7, 8, 9, 10 and 11.
Bl- ogħla dożi rakkomandati, hemm selettività ta ’ 80- darba fuq PDE1, u aktar minn 700- darba fuq PDE2,
In a penile plethysmography (RigiScan) study of fasted patients, the median time to onset for those who obtained erections of 60% rigidity (sufficient for sexual intercourse) was 25 minutes (range 12-37 minutes) on sildenafil.
Fi studju tal- pene bil- plestismografu (RigiScan) f’ pazjenti sajmin, il- ħin medjan biex jibdew l- erezzjonijiet għal dawk li kisbu 60% riġidità (suffiċjenti għal rapport sesswali) kien 25 minuta (medda bejn 12- 37 minuta) b’ sildenafil.
19 In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (> 70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline.
Fi studju ta ’ l- effetti imodinamiċi ta ’ doża waħda orali ta ’ 100 mg sildenafil f’ 14- il pazjenti b’ mard sever ta ’ l- arterji tal- qalb (CAD) (> 70% stenożi f’ ta mill- anqas arterja waħda tal- qalb), il- pressjoni medja tad- demm sistolika u dijastolika waqt is- serħan naqsu b’ 7% u 6% rispettivament mqabbla mal - linja bażi.
Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%).
20 Fil- provi kollha, il- proporzjon ta ’ pazjenti li rrapurtaw titjib bil- sildenafil kienu kif ġejjin: problema ta ’ erezzjoni tal- pene psikoġenika (84%), problemi ta ’ l- erezzjoni mħallta (77%), problema ta ’ erezzjoni organika (68%), anzjani (67%), dijabetiċi (59%), mard iskimiku tal- qalb (69%), pressjoni għolja (68%), TURP (61%), prostatectomy radikali (43%), korriment fis- sinsla tad- dahar (83%), dipressjoni (75%).
Sildenafil is rapidly absorbed.
Assorbiment Sildenafil jiġi assorbit malajr.
In volunteers with severe renal impairment (creatinine clearance < 30 ml/ min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment.
F’ voluntiera b’ indeboliment sever tal- kliewi (clearance tal- creatinine < 30ml/ min), il- clearance ta ’ sildenafil naqset, u wasslet għal żidiet medji ta ’ l- AUC u Cmax ta ’ 100% u 88% rispettivament mqabbla ma ’ voluntiera tal- istess età li ma kellhomx
PVC/ Aluminium foil blisters in cartons or secondary heat sealed card packaging of 2, 4, 8 or 12 tablets.
Fojl ta ’ l- aluminju/ PVC f’ pakketti tal- kartun jew pakkett sekondarju ssiġillat bis- sħana, ta ’ 2, 4, 8 jew 12- il pillola.
VIAGRA 100 mg film-coated tablets
VIAGRA 100 mg Pilloli miksija b’ rita.
Each tablet contains 100 mg of sildenafil (as citrate) Excipient:
Sustanza mhux attiva:
Blue, rounded diamond-shaped tablets, marked “ PFIZER ” on one side and “ VGR 100 ” on the other.
Pilloli ta ’ 100 mg, ittundjati forma ta ’ djamant, immarkati “ PFIZER ” fuq naħa waħda u “ VGR 100 ” fuq l- oħra.
24 Use in children and adolescents:
24 Użu fi tfal u adoloxxenti:
With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5)
Bl- eċċezzjoni ta ’ ritonavir li miegħu ma maqbilx li jingħata li jingħata sildenafil (ara sezzjoni 4. 4) doża tal- bidu ta ’ 25 mg għandha tiġi kunsidrata f’ pazjenti li fl- istess ħin ikunu fuq kura ta ’ inibituri ta ’ CYP3A4 (ara sezzjoni 4. 5).
Many events were
Ħafna każi ġew rappurtati li ġraw matul jew ftit wara rapport sesswali u
25 reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of VIAGRA without sexual activity.
25 ftit ġew rappurtati li ġraw wara l- użu ta ’ VIAGRA mingħajr attività sesswali.
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mgtwice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
Ko- amministrazzjoni ta ’ l- inibitur ta ’ HIV protease ritonavir, li huwa inibitur potenti ħafna tal- P450, fi stat stabbli (500 mg darbtejn kuljum) ma ’ sildenafil (100 mg doża waħda) irriżultat f’ żieda ta ’ 300% (4 darbiet) fis- Cmax ta ’ sildenafil u żieda ta ’ 1000% (11- il darba) fl- AUC tal- plażma ta ’ sildenafil.
At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/ ml, compared to approximately 5 ng/ ml
F’ 24
26 when sildenafil was administered alone.
26 siegħa, l- livelli tal- plażma ta ’ sildenafil kienu għadhom bejn wieħed u ieħor 200ng/ ml, imqabblin ma ’ bejn wieħed u ieħor 5ng/ ml meta sildenafil ingħata waħdu.
Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals.
27 Amministrazzjoni ta ’ sildenofil lil pazjenti taħt il- kura b’ alpha blockers tista ’ tirriżulta fi pressjoni baxxa sintomatika fi ftit individwi suxxettibbli.
In three specific drug-drug interaction studies, the
Dan jista ’ jseħħ l- aktar sa 4 sigħat wara li tittieħed id - doża ta ’ sildenofil (ara sezzjonijiet 4. 2 u 4. 4).
27 alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
Fi tlett studji speċifiċi għal interazzjoni bejn żewġ prodotti mediċinali, alpha blocker doxazocin (4mg u 8mg) u sildenafil (25mg, 50mg u 100mg) ġew amministrati fl- istess ħin lil pazjenti bi tkabbir benin tal- prostata (BPH), stabilizzati fuq kura ta ’ doxazocin.
These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers (see section(see section 5.1).
Dan it- tnaqqis ulterjuri fil- pressjoni tad - demm kien jixbah lil dak li seħħ meta sildenafil ġie amministrat waħdu lil voluntiera b’ saħħithom (ara sezzjoni 5. 1).
Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.
28 l- Awtorizzazzjoni għat- Tqegħid fis- Suq, u mniżżla fil- ġabra kumulattiva tad- dejta, il- frekwenzi ta ’ dawn ir- reazzjonijiet ma jistgħux ikunu magħrufa fiċ- ċert.
28 In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000).
Fit- tabella ta ’ hawn taħt, ir- reazzjonijiet avversi ta ’ importanza medika, li seħħew fl- istudji kliniċi b’ inċidenza ta ’ iktar minn bil- plaċebo, huma mniżżla skond il- klassi ta ’ l- organi u l- frekwenzi (komuni ħafna (≥1/ 10), komuni (≥1/ 100 to < 1/ 10), mhux komuni (≥1/ 1, 000 to < 1/ 100), rari (≥1/ 10, 000 to < 1/ 1, 000).
Skin, subcutaneous and soft tissue disorders Uncommon
29 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Not known General disorders and administration site Uncommon Not known Investigations
Uġigħ fil- muskoli / Majalġja
29 * Ear disorders:
Mhux komuni Investigazzjonijiet Mhux komuni
These decreases in blood pressure are consistent with the
Il- bidla korrispondenti fil- pressjoni dijastolika f’ pożizzjoni minduda kienet 5. 5 mmHg.
30 vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle.
Dan it- tnaqqis fil- pressjoni tad- demm huwa konsistenti ma ’ l - effetti ta ’ vażodilatazzjoni ta ’ sildenafil, probabilment minħabba żieda fil- livelli ta ’ cGMP fil- muskoli lixxi vaskulari.
Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%).
31 Fil- provi kollha, il- proporzjon ta ’ pazjenti li rrapurtaw titjib bil- sildenafil kienu kif ġejjin: problema ta ’ erezzjoni tal- pene psikoġenika (84%), problemi ta ’ l- erezzjoni mħallta (77%), problema ta ’ erezzjoni organika (68%), anzjani (67%), dijabetiċi (59%), mard iskimiku tal- qalb (69%), pressjoni għolja (68%), TURP (61%), prostatectomy radikali (43%), korriment fis- sinsla tad- dahar (83%), dipressjoni (75%).
Hypromellose titanium dioxide (E171) lactose triacetin indigo carmine aluminium lake (E132)
Kisja tar- rita hypromellose titanium dioxide (E171) lactose triacetin indigo carmine aluminium lake (E132)
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
35 A DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Pfizer PGM Zone Industrielle, 29 route des Industries 37530 Pocé-sur-Cisse France
Pfizer PGM Zone Industrielle, 29 route des Industries 37530 Pocé- sur- Cisse Franza
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET OĦRA
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING / CARTON
38 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA ’ BARRA / KARTUNA
VIAGRA 25 mg film-coated tablets Sildenafil
VIAGRA 25 mg pilloli miksija b’ rita Sildenafil
25 mg sildenafil (as citrate)
25mg sildenafil (bħala citrate)
See package leaflet for further information
Fih lactose Ara l- fuljett ta ’ tagħrif għal aktar informazzjoni
2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated-tablets
2 pilloli miksijin b’ rita 4 pilloli miksijin b’ rita 8 pilloli miksijin b’ rita 12- il pillola miksijin b’ rita
Read the package leaflet before use
Għal użu orali Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Sealed Pack Do not use if box has been opened
Tużax jekk il- kaxxa tkun miftuħa.
Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali biex tilqa ’ mill- umidità.
Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom
Sandwich Kent, CT13 9NJ Renju Unit
EU/ 1/ 98/ 077/ 013 EU/ 1/ 98/ 077/ 002 EU/ 1/ 98/ 077/ 003 EU/ 1/ 98/ 077/ 004
EU/ 1/ 98/ 077/ 013 (2 pilloli miksijin b’ rita) EU/ 1/ 98/ 077/ 002 (4 pilloli miksijin b’ rita) EU/ 1/ 98/ 077/ 003 (8 pilloli miksijin b’ rita) EU/ 1/ 98/ 077/ 004 (12- il pillola miksijin b’ rita)
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
40 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA ’ BARRA / KARTUNA
VIAGRA 50 mg film-coated tablets Sildenafil
VIAGRA 50 mg pilloli miksija b’ rita Sildenafil
50 mg sildenafil (as citrate)
50 mg sildenafil (bħala citrate)
Contains lactose See package leaflet for further information
Fih lactose Ara l- fulljett ta ’ tagħrif għal aktar informazzjoni
EU/ 1/ 98/ 077/ 014 EU/ 1/ 98/ 077/ 006 EU/ 1/ 98/ 077/ 007 EU/ 1/ 98/ 077/ 008
EU/ 1/ 98/ 077/ 014 (2 pilloli miksijin b’ rita) EU/ 1/ 98/ 077/ 006 (4 pilloli miksijin b’ rita) EU/ 1/ 98/ 077/ 007 (8 pilloli miksijin b’ rita) EU/ 1/ 98/ 077/ 008 (12- il pillola miksijin b’ rita)
OUTER PACKAGING / SECONDARY HEAT SEALED CARD PACKAGING
PAKKETT TA ’ BARRA/ PAKKETT SEKONDARJU SSIĠILLAT BIS- SĦANA
Contains lactose See package leaflet for further information
Fih lactose Ara l- fuljett ta ’ tagħrif għal aktar informazzjoni
EU/ 1/ 98/ 077/ 016 EU/ 1/ 98/ 077/ 017 EU/ 1/ 98/ 077/ 018 EU/ 1/ 98/ 077/ 019
EU/ 1/ 98/ 077/ 016 (2 pilloli miksijin b’ rita) EU/ 1/ 98/ 077/ 017 (4 pilloli miksijin b’ rita) EU/ 1/ 98/ 077/ 018 (8 pilloli miksijin b’ rita) EU/ 1/ 98/ 077/ 019 (12- il pillola miksijin b’ rita)
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
44 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER PACKAGING / CARTON
PAKKETT TA ’ BARRA / KARTUNA
VIAGRA 100 mg film-coated tablets Sildenafil
VIAGRA 100 mg pilloli miksija b’ rita Sildenafil
100 mg sildenafil (as citrate)
100 mg sildenafil (bħala citrate)
EU/ 1/ 98/ 077/ 015 EU/ 1/ 98/ 077/ 010 EU/ 1/ 98/ 077/ 011 EU/ 1/ 98/ 077/ 012
EU/ 1/ 98/ 077/ 015 (2 pilloli miksijin b’ rita) EU/ 1/ 98/ 077/ 010 (4 pilloli miksijin b’ rita) EU/ 1/ 98/ 077/ 011 (8 pilloli miksijin b’ rita) EU/ 1/ 98/ 077/ 012 (12- il pillola miksijin b’ rita)
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
PRIMARY PACKAGING/ BLISTER
PAKKETT EWLIENI/ FOLJA
VIAGRA 25 mg film-coated tablets Sildenafil
VIAGRA 25 mg, pilloli miksijin b’ rita Sildenafil
VIAGRA 50 mg film-coated tablets Sildenafil
VIAGRA 50 mg, pilloli miksijin b’ rita Sildenafil
VIAGRA 100 mg film coated tablets Sildenafil
VIAGRA 100 mg, pilloli miksijin b’ rita Sildenafil
VIAGRA 25 mg film-coated tablets Sildenafil citrate
VIAGRA 25 mg pilloli miksijin b’ rita Sildenafil (bħala citrate)
You may need to read it again. − If you have any further questions, please ask your doctor or pharmacist. − This medicine has been prescribed for you.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
It may harm them, even if their symptoms are the same as yours. − If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What VIAGRA is and what it is used for 2.
X’ inhu VIAGRA u għalxiex jintuża 2.
Before you take VIAGRA 3.
Qabel ma tieħu VIAGRA 3.
How to take VIAGRA 4.
Kif għandek tieħu VIAGRA 4.
How to store VIAGRA 6.
Kif taħżen VIAGRA 6.
WHAT VIAGRA IS AND WHAT IT IS USED FOR
X’ INHU VIAGRA U GĦALXIEX JINTUŻA
VIAGRA belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
VIAGRA tagħmel ma ’ grupp ta ’ mediċinali msejjħa inibituri ta ’ phosphodiesterase type 5 (PDE5).
It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited.
Hija taħdem billi tgħin tirrilassa l- blood vessels li jġorru d- demm għal pene u tippermetti d- demm biex jidħol fil- pene meta tkun eċċitat sesswalment.
VIAGRA will only help you to get an erection if you are sexually stimulated.
VIAGRA tgħinek biss biex tikseb erezzjoni jekk inti tiġi stimulat sesswalment.
You should not take VIAGRA if you do not have erectile dysfunction.
Inti m’ għandekx tieħu VIAGRA jekk inti m’ għandekx problema ta ’ l- erezzjoni tal- pene.
You should not take VIAGRA if you are a woman.
Inti m’ għandekx tieħu VIAGRA jekk inti mara.
VIAGRA is a treatment for men with erectile dysfunction, sometimes known as impotence.
VIAGRA hija kura għal rġiel bi problema ta ’ erezzjoni tal- pene, kultant imsejjħa “ impotenza ”.
This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.
Dan jiġri meta raġel ma jkunx jista ’ jikseb, jew iżomm, pene erett u iebes li jkun adattat għal attività sesswali.
BEFORE YOU TAKE VIAGRA
QABEL MA TIEĦU VIAGRA
Do not take VIAGRA
Tieħux VIAGRA
− If you are taking medicines called nitrates, as the combination may cause a potentially dangerous decrease in your blood pressure.
Jekk inti qed tieħu mediċini li huma msejħa nitrati, minħabba li flimkien jistgħu jikkawżaw − pressjoni baxxa li tista ’ tkun ta ’ ħsara.
Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “ chest pain”).
Għid lit- tabib tiegħek jekk inti qed tieħu xi waħda minn dawn il- mediċini li jingħataw spiss biex itaffu l- anġina.
− If you are using any of the drugs known as nitric oxide donors such as amyl nitrite (“ poppers”), as the combination may also lead to a potentially dangerous decrease in your blood pressure.
Jekk inti qed tieħu mediċini li huma magħrufin li jiġġeneraw nitric oxide, bħal amyl nitrite − (“ poppers ”), dawn ukoll jistgħu jikkawżaw pressjoni baxxa potenzjalment ta ’ ħsara jekk jittieħdu mal- Viagra.
− If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of VIAGRA.
Jekk inti allerġiku (tbati minn sensittivita eċċessiva) għal sildenafil jew sustanzi oħra ta ’ − VIAGRA.
− If you have a severe heart or liver problem.
Jekk għandek problema serja tal- fwied jew tal- qalb. −
− If you have recently had a stroke or a heart attack, or if you have low blood pressure.
Jekk inti dan l- aħħar kellek puplesija jew attakk tal- qalb, jew jekk inti għandek pressjoni baxxa. −
− If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
51 Jekk inti għandek ċertu mard rari ereditarju tal- għajnejn (bħal retinitis pigmentosa). −
51 − If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).
Jekk qatt tlift il- vista minħabba newropatija anterjuri iskimika, mhux arteritika tal- għajn − (NAION)
Take special care with VIAGRA
Oqgħod attent ħafna b’ VIAGRA
Tell your doctor − If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).
(kanċer taċ- celloli tad- demm), multiple myeloma (kanċer tal- mudullun)
− If you have a deformity of your penis or Peyronie’ s Disease.
- jekk inti għandek deformità tal- pene tiegħek, jew il- marda msejħa ta ’ Peyronie.
− If you have problems with your heart.
- jekk inti għandek problemi b’ qalbek.
Your doctor should in that case carefully check whether your heart can take the additional strain of having sex.
F’ dak il- każ it- tabib tiegħek għandu jiċċekja bir- reqqa jekk
− If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).
qalbek tkunx tiflaħ għall- isforz żejjed li jkollok waqt rapport sesswali.
− If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your doctor immediately.
- jekk fil- preżent inti għandek ulċera fl- istonku, jew problemi ta ’ tnixxija tad- demm (bħal
You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.
- jekk għall- għarrieda jkollok tnaqqis fil- vista jew titlef il- vista, tiħux iktar VIAGRA u kellem lit -
Special considerations for children and adolescents VIAGRA should not be given to individuals under the age of 18.
Inti m’ għandekx tuża VIAGRA ma ’ xi kura oħra kemm mill- ħalq u kemm lokalizzarta għal problema ta ’ l- erezzjoni tal- pene.
Your doctor may decide on a lower dose for you.
Konsiderazzjonijiet speċjali għat- tfal u adoloxxenti VIAGRA m’ għandhiex tingħata lil individwi taħt l- età ta ’ 18- il sena.
Taking other medicines:
It- tabib tiegħek jista ’ jiddeċiedi li jnaqqaslek id- doża.
Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, inkluż mediċini mixtrijin mingħajr riċetta.
VIAGRA tablets may interfere with some medicines, especially those used to treat chest pain.
Il- pilloli VIAGRA għandhom mnejn jaffettwaw xi mediċini oħra, speċjalment dawk użati għal kura ta ’ l- uġigħ tas- sider.