FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 30 November 2009 Date of latest renewal: 09 September 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 30 Novembru 2009 Data tal-aħħar tiġdid: 09 Settembru 2014
English: The mean absolute oral bioavailability is 41 % (range 25-63 %).
Maltese: Il-medja assoluta ta' bijodisponibilità orali hija ta' 41 % (medda 25-63 %).
English: Film coat: poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc.
Maltese: Kisja: poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc.
English: Poly(vinyl alcohol) Titanium dioxide (E171) Macrogol 3350
Maltese: Il-kisi tar-rita Poly(vinyl alcohol) Titanium dioxide (E171) Macrogol 3350
English: Brampton Road, Hampden Park, Eastbourne East Sussex, BN22 9AG United Kingdom
Maltese: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Ir-Renju Unit
English: Common (≥ 1/100 and
Maltese: Komuni (≥ 1/100 u
English: Microcrystalline cellulose Calcium hydrogen phosphate anhydrous Croscarmellose sodium Magnesium stearate
Maltese: Microcrystalline cellulose Calcium hydrogen phosphate, anidru Croscarmellose sodium Magnesium stearate
English: In vitro studies
Maltese: Studji in vitro:
English: 2031GA HaarlemThe Netherlands
Maltese: 2031GA Haarlem
English: Rare (≥ 1/10,000 and <1/1,000)
Maltese: Rari (≥ 1/10,000 u
English: The active substance is sildenafil.
Maltese: Is-sustanza attiva hi sildenafil.
English: Teva Operations Poland Sp.z.o.o.
Maltese: Teva Operations Poland Sp.z.o.o. ul Mogilska 80.
English: Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.
Maltese: Sildenafil (100 mg) ma affettwax il-farmakokinetika fi stat stabbli tal-inibituri ta' HIV protease, saquinavir u ritonavir, it-tnejn li huma sustrati CYP3A4.
English: Myopia,
Maltese: Diplopja,
English: • Serious skin reactions - this occurs rarely.
Maltese: • Reazzjonijiet serji tal-ġilda - dan iseħħ rari
English: Brampton Road, Hampden Park, Eastbourne East Sussex
Maltese: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne,
English: 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 %).
Maltese: Fil-provi kollha, il-proporzjon ta' pazjenti li rrappurtaw titjib b'sildenafil kienu kif ġejjin: problema ta' erezzjoni tal-pene psikoġenetika (84 %), problemi tal-erezzjoni mħallta (77 %), problema ta' erezzjoni organika (68 %), anzjani (67 %), dijabetiċi (59 %), mard iskimiku tal-qalb (69 %), pressjoni għolja (68 %), TURP (61 %), prostatektomija radikali (43 %), korriment fl-ispina dorsali (83 %),
English: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, croscarmellose sodium, magnesium stearate.
Maltese: Qalba tal-pillola: microcrystalline cellulose, calcium hydrogen phosphate anidru, croscarmellose sodium, magnesium stearate
English: Uncommon (≥ 1/1,000 and
Maltese: Mhux komuni (≥ 1/1,000 u
English: In these study populations, mean additional reductions of supine blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, and mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were observed.
Maltese: F'dawn il-popolazjonijiet tal-istudji, kien osservat tnaqqis addizzjonali medju tal-pressjoni meta kienu mimdudin ta' 7/7 mmHg, 9/5 mmHg u 8/4 mmHg rispettivament u meta bilwieqfa tnaqqis addizzjonali medju ta' 6/6 mmHg, 11/4 mmHg u 4/5 mmHg.
English: The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h.
Maltese: N-desmethyl jiġi mmetabolizzat iżjed, b'half-life terminali ta' madwar 4 h.
English: Sildenafil Teva potentiates the hypotensive effect of nitrates (see section 4.3).
Maltese: Sildenafil Teva iħarrax l-effett ipotensiv ta' nitrati (ara sezzjoni 4.3).
English: 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
Maltese: dijabete mellitus (20.3 %), mard iskemiku tal-qalb (5.8 %), iperlipidemja (19.8 %), korrimenti flispina dorsali (0.6 %), dipressjoni (5.2 %), b'resezzjoni transuretrali tal-prostata (3.7 %), u prostatektomija radikali(3.3 %).
English: The safety profile of sildenafil is based on 9,570 patients in 74 double-blind placebo-controlled clinical studies.
Maltese: Sommarju tal-profil tas-sigurtà Is-sigurtà ta' sildenafil hija bbażata fuq 9,570 pazjent f'74 studju kliniku double-blind bi plaċebo bħala kontroll.
English: This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50 % that of the parent drug.
Maltese: Dan il-metabolit għandu profil selettiv ta' phosphodiesterase simili għal sildenafil u potenza in vitro għal PDE5 ta' madwar 50 % ta' dik tal-mediċina mhux mibdula.
English: No significant interactions were shown when sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.
Maltese: Ma kienx hemm interazzjonijiet sinifikanti meta sildenafil (50 mg) kien mogħti wkoll ma' tolbutamide (250 mg) jew warfarin (40 mg), li t-tnejn huma mmetabolizzati b'CYP2C9.
English: Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route).
Maltese: Il-metaboliżmu ta' sildenafil isehh l-aktar permezz tal-iżoformi ta' ċitokromju P450 (CYP) 3A4 (rotta ewlenija ) u 2C9 (rotta minuri).
English: Sildenafil Teva with food and drink and alcohol
Maltese: Sildenafil Teva ma' ikel, xorb u alkoħol
English: 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.
Maltese: 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.
English: • Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000 people)
Maltese: • Erezzjonijiet prolongati u kultant bl-uġigħ - dan iseħħ rari (jista' jaffettwa sa persuna 1 minn kull 1,000)
English: How to store Sildenafil Teva
Maltese: Tiħux Sildenafil Teva
English: Sildenafil Teva 100 mg film-coated tablets EU/1/09/584/014
Maltese: Sildenafil Teva 100 mg pilloli miksija b'rita EU/1/09/584/014
English: 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).
Maltese: Fit-tabella ta' hawn taħt, ir-reazzjonijiet avversi ta' importanza medika, li sehhew fl-istudji klinici b'inċidenza iktar milli bil-plaċebo, huma mnizzla skont il-klassi tal-organi u l-frekwenzi (komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000).
English: Sildenafil Teva should not be given to individuals under the age of 18.
Maltese: Sildenafil Teva m'għandux jingħata lil individwi taħt l-età ta' 18-il sena.
English: Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Maltese: 120 minuta (medjan 60 minuta) ta' doża orali fi stat sajjem.
English: Cimetidine (800 mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56 % increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Maltese: Cimetidine (800 mg), inibitur ta' ċitokromju P450 u inibitur ta' CYP3A4 mhux speċifiku, wassal għal żieda ta' 56 % fil-konċentrazzjonijiet ta' sildenafil fil-plażma meta ngħata flimkien ma' sildenafil (50 mg) lil voluntiera b'sahhithom.
English: Sildenafil Teva 50 mg film-coated tablets EU/1/09/584/008
Maltese: Sildenafil Teva 50 mg pilloli miksija b'rita EU/1/09/584/008
English: Sildenafil Teva 25 mg film-coated tablets EU/1/09/584/002
Maltese: Sildenafil Teva 25 mg pilloli miksija b'rita EU/1/09/584/002
English: Pooling of the following classes of antihypertensive medication: diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrallyacting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking sildenafil compared to placebo treatment.
Maltese: Ġabra tal-klassijiet li ġejjin ta' mediċini li jaġixxu kontra l-pressjoni għolja; dijuretiċi, beta-blokers, inibituri ta' ACE, antagonisti ta' angiotensin II, prodotti mediċinali kontra l-pressjoni għolja (vażodilataturi u li jaħdmu fuq is-sistema ċentrali), adrenergic neurone blockers, imblokkaturi tal-kanal tal-kalċju u imblokkaturi alpha-adrenoceptor, ma wrew ebda differenza fil-profil ta' effetti f'pazjenti li ħadu sildenafil mqabblin ma' kura bil-plaċebo.
English: Mean pulmonary systolic blood pressure decreased by 9 %.
Maltese: Il-pressjoni medja sistolika tad-demm tal-pulmun naqset b'9 %.
English: 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).
Maltese: Minħabba li sildenafil (u l-metabolu ewlenieni tiegħu N-desmethyl fiċ-ċirkolazzjoni) huwa 96 % marbut ma' proteini tal-plażma, dan irriżulta fl-ogħla konċentrazzjoni ta' plażma ħielsa għal sildenafil b'18 ng/mL (38 nM).
English: BN22 9AG
Maltese: East Sussex, BN22 9AG Ir-Renju Unit
English: - If you are taking riociguat.
Maltese: • qed/a tieħu riociguat.
English: Table 1: Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through postmarketing surveillance
Maltese: Tabella 1: Reazzjonijiet avversi ta' importanza medika b'inċidenza ta' rapporti akbar minn plaċebo fi studji kliniċi kkontrollati, u reazzjonijiet avversi ta' importanza medika rrappurtati minn sorveljanza ta' wara t-tqegħid tal-prodott fis-suq Sistema tal
English: 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.
Maltese: Fi studju tal-pene bil-plestismografu (RigiScan) f'pazjenti sajmin, il-hin medjan biex jibdew l-erezzjonijiet għal dawk li kisbu 60 % rigidità (suffiċjenti għal rapport sesswali) kien 25 minuta (medda bejn 12-37 minuta) b'sildenafil.
English: 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.
Maltese: Fi studji b'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) imqabbla ma' 25 % tal-plaċebo.
English: Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant treatment on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates).
Maltese: phenytoin), inibituri ta' CYP2D6 (bħal selective serotonin reuptake inhibitors, antidipressanti triċikliċi), thiazide u dijuretiċi relatati, dijuretiċi loop u li jirristrinġu t-tnixxija ta' potassju, inibituri tal-enżima li tikkonverti l-angiotensin, imblokkaturi tal-kanal tal-kalċju, antagonisti beta-adrenoreceptor jew sensitizzaturi tal-metaboliżu CYP450 (bħal rifampicin, barbiturate).
English: Visual colour distortions**, Visual disturbance, Vision blurred
Maltese: Diffiklutà biex tagħraf il kuluri**, Disturbi filvista, Vista mċajpra
English: Sildenafil Teva contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Sildenafil Teva fih is-sustanza attiva sildenafil li jagħmel ma' grupp ta' mediċini li jissejħu impedituri ta' phosphodiesterase tip 5 (PDE5).
English: The dosing recommendations described in ‘Use in adults' apply to patients with mild to moderate renal impairment (creatinine clearance = 30 - 80 mL/min).
Maltese: Ir-rakkomandazzjonijiet ta' dożaggi mfissra f' “Użu fl-adulti” japplikaw għal pazjenti b'indeboliment ħafif għal moderat tal-kliewi (tneħħija ta' kreatinina = 30-80 mL/min).
English: 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 10 x 1 film-coated tablet 12 film-coated-tablets 24 film-coated tablets
Maltese: 2 pilloli miksija b'rita 4 pilloli miksija b'rita 8 pilloli miksija b'rita 10 x 1 pillola miksija b'rita 12-il pillola miksija b'rita 24-il pillola miksija b'rita
English: Sildenafil had no effect on saquinavir pharmacokinetics (see section 4.2).
Maltese: saquinavir (ara sezzjoni 4.2).
English: After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/mL(CV 40 %).
Maltese: Wara doża orali waħda ta' 100 mg, l-ogħla konċentrazzjoni medja totali fil plażma ta' sildenafil kienet madwar 440 ng/mL (CV 40 %).
English: There is a 10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina.
Maltese: Hemm selettività ta' għaxar darbiet għal PDE6 li huwa involut fil-passaġġ ta' phototransduction fir-retina.
English: In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors.
Maltese: Fi studji kliniċi, ġie muri li riociguat jżid l effetti ipotensivi tal-inibituri ta' PDE5.
English: 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.
Maltese: Peress li mhux ir-reazzjonijiet avversi kollha huma rapportati lid-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq u inklużi fid-database tas-sigurtà, il-frekwenzi ta' dawn ir reazzjonijiet ma jistgħux jiġu stabbiliti b'mod affidabbli.
English: Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140 % increase in sildenafil Cmax and a 210 % increase in sildenafil AUC.
Maltese: L-għoti wkoll tal-inibitur ta' HIV protease saquinavir, inibitur ta' CYP3A4, fi stat stabbli (1200 mg tlett darbiet kuljum) ma' sildenafil (100 mg doża waħda) irrizulta f żieda ta' 140 % fis-Cmax ta' sildenafil u żieda ta' 210 % fl-AUC ta' sildenafil.
English: A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal medicinal products (except nitrates).
Maltese: Prova ta' stress waqt l-eżerċizzju, double-blind, ikkontrollata bi plaċebo, evalwat 144 pazjent b'disfunzjoni erettili u anġina stabbli kronika li regolarment irċivew mediċini kontra l-anġina (ħlief nitrati).
English: Sildenafil Teva 25 mg film-coated tablets Sildenafil Teva 50 mg film-coated tablets Sildenafil Teva 100 mg film-coated tablets
Maltese: Sildenafil Teva 25 mg pilloli miksija b'rita Sildenafil Teva 50 mg pilloli miksija b'rita Sildenafil Teva 100 mg pilloli miksija b'rita
English: EU/1/09/584/002 EU/1/09/584/003 EU/1/09/584/004 EU/1/09/584/005 EU/1/09/584/006
Maltese: EU/1/09/584/002 EU/1/09/584/003 EU/1/09/584/004
English: When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182 % increase in sildenafil systemic exposure (AUC).
Maltese: Meta doża waħda ta' 100 mg sildenafil ġiet amministrata ma' erythromycin, inibitur moderat ta' CYP3A4 fi stat stabbli (500 mg darbtejn kuljum għal ħamest ijiem), kien hemm żieda ta' 182 % fl-espożizzjoni sistemika (AUC) ta' sildenafil.
English: These decreases in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle.
Maltese: Dan it-tnaqqis fil-pressjoni tad-demm huwa konsistenti mal-effetti ta' vażodilatazzjoni ta' sildenafil, probabbilment minħabba żieda fil-livelli ta' cGMP fil-muskoli vaskulari melliesa.
English: The mean AUC and Cmax of the N-desmethyl metabolite increased up to 126 % and up to 73 % respectively, compared to age-matched volunteers with no renal impairment.
Maltese: Il-medja tal-AUC u Cmax tal-metabolit N-desmethyl żdidiet sa b'126 % u sa 73 % rispettivament, meta mqabbla ma'
English: Sildenafil Teva 100 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets.
Maltese: Sildenafil Teva 100 mg pilloli miksija b'rita Strixxa tal-PVC/Aluminju f'kartun ta' 2, 4, 8, 12 jew 24 pillola.
English: 10 x 1 tablet in PVC/Aluminium perforated unit dose blisters.
Maltese: Folji tal-PVC/Aluminju pperforati li fihom 10 x 1 pilloli ta' doża waħda.
English: In three specific drug-drug interaction studies, the 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.
Maltese: Fi tliet studji speċifiċi għal interazzjoni bejn żewġ prodotti mediċinali, l-alpha-blocker doxazocin (4 mg u 8 mg) u sildenafil (25 mg, 50 mg u
English: 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.
Maltese: Fi studju tal-effetti emodinamiċi ta' doża orali waħda ta' 100 mg sildenafil f'14-il pazjenti b'mard sever tal-arterji tal-qalb (CAD) (> 70 % stenożi f' ta' mill-anqas arterja waħda tal-qalb), il-pressjoni medja sistolika u dijastolika tad-demm waqt is-serħan naqset b'7 % u 6 % rispettivament meta mqabbla mal-linja bażi.
English: The mean maximum decreases in supine systolic blood pressure following 100 mg oral dosing of sildenafil was 8.4 mmHg.
Maltese: 100 mg ta' doża orali ta' sildenafil kienet ta' 8.4 mmHg.
English: Dizziness
Maltese: Prijapiżmu
English: Vertigo, Tinnitus
Maltese: Imnieħer xott
English: 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 %.
Maltese: Meta sildenafil jittieħed mal-ikel, ir-rata ta' assorbiment titnaqqas b'dewmien medju fit-tmax ta' 60 minuta u tnaqqis medju fis-Cmax ta' 29 %.
English: vision blurred.
Maltese: Mhux applikabbli.
English: Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
Maltese: B'mod konsistenti mal-effetti magħrufa ta' sidenafil fuq il-passaġġ nitric oxide/cGMP (ara sezzjoni 5.1), intwera li sildenafil iħarrax l-effetti ta' nitrati li jnaqqsu l-pressjoni u għaldaqstant il-koamministrazzjoni ta' sildenafil u donaturi ta' nitric oxide jew nitrati hija kontraindikata (ara sezzjoni 4.3).
English: Sildenafil Teva 50 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets.
Maltese: Sildenafil Teva 50 mg pilloli miksija b'rita Strixxa tal-PVC/Aluminju f'kartun ta' 2, 4, 8, 12 jew 24 pillola.
English: Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna minn kull 100): rimettar, raxx tal-ġilda, irritazzjoni talgħajnejn, għajnejn ħomor/għajnejn kulur id-demm, uġigħ fl-għajnejn, tara teptip ta' dawl, luminożità fil-vista, sensittività għad-dawl, għajnejn idemmgħu, taħbit tal-qalb mgħaġġel, taħbit tal-qalb rapidu, pressjoni tad-demm għolja, pressjoni tad-demm baxxa, uġigħ fil-muskoli, tħossok bi ngħas, tnaqqis fis-sens tal-mess, vertiġini, tisfir fil-widnejn, ħalq xott, imnifsejn imblukkati jew misdudin, infjammazzjoni tar-rita tal-imnieħer (sintomi jinkludu flissjoni, għatis u imnieħer misdud), uġigħ filparti ta' fuq tal-addome, mard ta' rifluss gastro-esofaġeali (sintomi jinkludu ħruq ta' stonku), preżenza tad-demm fl-awrina, uġigħ fid-dirgħajn jew fir-riġlejn, fsada mill-imnieħer, tħossok taħraq u ma tiflaħx
English: Other medicines and Sildenafil Teva
Maltese: Mediċini oħra u Sildenafil Teva
English: How to store Sildenafil Teva Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in the visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).
Maltese: (n=9), sildenafil (doża waħda, 100 mg) ma wera ebda tibdil sinifikanti fit-testijiet fuq il-vista li saru (kemm tkun akuta l-vista, Amsler grid, diskriminazzjoni ta' kulur ta' dwal tat-traffiku simulati, Humphrey perimeter u photostress).
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200 % and 79 % respectively.
Maltese: Barra minn dan, il-valuri tal-AUC u s-Cmax tal-metabolit N-desmethyl żdiedu b'mod sinifikanti b'200 % u 79 % rispettivament.
English: • Seizures or fits - this occurs rarely
Maltese: • Puplesiji jew aċċessjonijiet - dan iseħħ rari
English: Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.
Maltese: B'mod konsistenti mal-effetti magħrufa tiegħu fuq il-medda ta' nitric oxide/cyclic guanosine monophosphate (cGMP) (ara sezzjoni 5.1), sildenafil intwera li jsaħħaħ l-effetti ipotensivi ta' nitrati, u l-amministrazzjoni konġunta b'donaturi ta' nitric oxide (bħal amyl nitrite) jew nitrati f'xi għamla oħra għalhekk kontraindikata.
English: Due to the nitrate component it has the potential to result in a serious interaction with sildenafil.
Maltese: Minħabba l-komponent ta' nitrate, hemm il-potenzjal li jirriżulta f'interazzjoni serja ma' sildenafil.
English: Myalgia, Pain in extremity
Maltese: Mijalġja, Uġigħ fl estremitajiet