natgillin/translations-raw huggingface dataset:
Der blev udført et randomiseret, dobbelt-blindt, placebo-kontrolleret studie med 267 patienter med PAH, som var stabiliseret på intravenøs epoprostenol. 
A randomised, double-blind, placebo controlled study was conducted in 267 patients with PAH who were stabilised on intravenous epoprostenol.
Studiepopulationen bestod af 68 (25%) mænd og 209 (75%) kvinder med en gennemsnitsalder på 49 år (alder 18-81 år) og baseline 6 minutters gangtest med en distance på mellem 100 og 450 meter inklusive (gennemsnit: 344 meter). 
The study population consisted of 68 (25%) men and 209 (75%) women with a mean age of 49 years (range: 18-81 years) and baseline 6-minute walk test distance between 100 and 450 metres inclusive (mean: 344 metres).
CYP3A4-induktorer ser ud til at have en betydelig indvirkning på farmakokinetikken af sildenafil hos patienter med pulmonal arteriel hypertension, hvilket er bekræftet i et in-vivo interaktionsstudie med CYP3A4-induktoren bosentan. 
CYP3A4 inducers seemed to have a substantial impact on the pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, which was confirmed in the in vivo interaction study with CYP3A4 inducer bosentan.
Hos rotteunger, som blev behandlet præ- og postnatalt med 60 mg/kg sildenafil, ses en mindre kuldstørrelse, en lavere fødselsvægt på dag 1 og et fald i overlevelse efter 4 dage ved eksponering, som er cirka 50 gange den forventede humane dosis på 20 mg 3 gange dagligt. 
In pups of rats which were pre- and postnatally treated with 60 mg/kg sildenafil, a decreased litter size, a lower pup weight on day 1 and a decreased 4-day survival were seen at exposures which were approximately fifty times the expected human exposure at 20 mg three times a day.
En statistisk signifikant stigning i 6MWD blev set i alle 3 sildenafil-dosis-grupper sammenlignet med placebo. 
A statistically significant increase in 6MWD was observed in all 3 sildenafil dose groups compared to those on placebo.
Hos patienter med pulmonal arteriel hypertension er den gennemsnitlige orale biotilgængelighed for sildenafil efter 80 mg 3 gange dagligt 43% (90% CI: 27-60%) højere sammenlignet med de lavere doser. 
In pulmonary arterial hypertension patients, the oral bioavailability of sildenafil after 80 mg three times a day was on average 43% (90% CI: 27%-60%) higher compared to the lower doses.
Granpidam indeholder lactose 
Granpidam contains lactose
Samlet set var bivirkningerne generelt ens i de to behandlingsgrupper (sildenafil plus bosentan i forhold til bosentan alene) og stemte overens med den kendte sikkerhedsprofil for sildenafil anvendt som monoterapi (se pkt. 
Overall, the adverse events were generally similar between the two treatment groups (sildenafil plus bosentan vs. bosentan alone), and consistent with the known safety profile of sildenafil when used as monotherapy (see sections 4.4 and 4.5).
Andre lægemiddelformer kan være bedre egnet til patienter ved legemsvægt 20 kg eller derunder og yngre patienter som ikke kan synke tabletter. 
Other pharmaceutical forms may be more appropriate for administration to patients ≤ 20 kg and other younger patients who are not able to swallow tablets.
Grapefrugtjuice er en svag CYP3A4-hæmmer af tarmvæggens metabolisme, og kan give en mindre stigning i plasmakoncentrationen af sildenafil. 
Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil.
175 patienter (63%) inkluderes med diagnosen primær pulmonal hypertension, 84 (30%) med diagnosen PAH forbundet med bindevævssygdom og 18 (7%) af patienterne med diagnosen PAH efterfulgt kirurgisk intervention af medført hjertelidelser. 
175 patients (63%) included were diagnosed with primary pulmonary hypertension, 84 (30%) were diagnosed with PAH associated with connective tissue disease and 18 (7%) of the patients were diagnosed with PAH following surgical repair of congenital heart lesions.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Accord Healthcare S.L.U. 
MARKETING AUTHORISATION HOLDER Accord Healthcare S.L.U.
I 3 specifikke lægemiddel-interaktionsstudier blev alfa-blokkeren doxazosin (4 mg og 8 mg) og sildenafil (25 mg, 50 mg eller 100 mg) anvendt samtidigt hos patienter med benign prostatahyperplasi (BPH) stabiliseret på doxazosinbehandling. 
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.
PVC/alu-blister med 300 tabletter. 
PVC/Alu blisters of 300 tablets.
Tilfælde af non-arteritis anterior iskæmisk opticusneuropati, der er en sjælden tilstand, er både rapporteret spontant og i et observationsstudie i forbindelse med indtagelse af sildenafil og andre PDE5-hæmmere (se pkt. 
Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Milde og forbigående ændringer i farveskelnen (blå/grøn) ses hos visse patienter ved brug af Farnsworth-Munsell 100 skærtest 1 time efter indtagelse af 100 mg, men der ses ingen effekt 2 timer efter indtagelsen. 
Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
CYP3A4-hæmmere (som f.eks. clarithromycin, telithromycin og nefazodon) forventes at have en effekt, der ligger imellem ritonavir og CYP3A4-hæmmere (som f.eks. saquinavir eller erythromycin), formodet en 7-gange øgning i eksponering. 
CYP3A4 inhibitors like clarithromycin, telithromycin and nefazodone are expected to have an effect in between that of ritonavir and CYP3A4 inhibitors like saquinavir or erythromycin, a seven-fold increase in exposure is assumed.
Af de 277 forsøgspersoner, som deltog i pivotalstudiet, indgik 259 i det langvarige forlængelsesstudie. 
Of the 277 subjects treated in the pivotal study, 259 entered a long-term extension study.
Følgende alvorlige bivirkninger blev betragtet som behandlingsrelaterede: enterocolitis, kramper, overfølsomhed, stridor, hypoxi, neurosensorisk døvhed og ventrikulær arytmi. 
The following serious adverse events were considered to be treatment related, enterocolitis, convulsion, hypersensitivity, stridor, hypoxia, neurosensory deafness and ventricular arrhythmia.
Hos pædiatriske patienter i alderen 1-17 år er den anbefalede dosis til patienter ≤20 kg 10 mg 3 gange dagligt, og til patienter ≥20 kg er dosis 20 mg 3 gange dagligt. 
For paediatric patients aged 1 year to 17 years old, the recommended dose in patients ≤20 kg is 10 mg three times a day and for patients >20 kg is 20 mg three times a day.
Effekten af sildenafil er ikke fastslået hos patienter med alvorlig pulmonal arteriel hypertension (funktionsklasse IV). 
The efficacy of sildenafil has not been established in patients with severe pulmonary arterial hypertension (functional class IV).
Forsøgspersonerne (38% drenge og 62% piger) havde en legemsvægt ≥8 kg, primær pulmonal hypertension (PPH) (33%) eller PAH sekundært til kongenit hjertesygdom (systemisk-pulmonal shunt 37%, kirurgisk intervention 30%). 
Subjects (38% male and 62% female) had a body weight ≥8 kg, and had primary pulmonary hypertension (PPH) [33%], or PAH secondary to congenital heart disease [systemic-to-pulmonary shunt 37%, surgical repair 30%].
Ud af de 94 forsøgspersoner, som rapporterede en alvorlig bivirkning, var 14/55 (25,5%) forsøgspersoner i lavdosis-gruppen, 35/74 (47%) i middeldosis-gruppen og 45/100 (45%) i højdosisgruppen. 
Of the 94 subjects reporting a serious adverse event, 14/55 (25.5%) subjects were in the low dose group, 35/74 (47.3%) in the medium dose group, and 45/100 (45%) in the high dose group.
Den procentvise reduktion i PVR (11,2%, 12,9%, 23,3%) efter 12 uger for sildenafil 20 mg, 40 mg og 80 mg 3 gange dagligt var proportionelt større end reduktionen i systemisk vaskulær modstand (SVR) (7,2%, 5,9%, 14,4%). 
The percent reduction at 12 weeks for sildenafil 20 mg, 40 mg and 80 mg TID in PVR (11.2%, 12.9%, 23.3%) was proportionally greater than the reduction in systemic vascular resistance (SVR) (7.2%, 5.9%, 14.4%).
Patienter på alle doser af sildenafil opnåede en statistisk signifikant reduktion i middel pulmonalt arterielt tryk (mPAP) og pulmonal vaskulær modstand (PVR) sammenlignet med dem, der fik placebo. 
Patients on all sildenafil doses achieved a statistically significant reduction in mean pulmonary arterial pressure (mPAP) and pulmonary vascular resistance (PVR) compared to those on placebo.
Farmakokinetikken af sildenafil er ikke undersøgt hos patienter med alvorlig nedsat leverfunktion. 
The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied.
Hos patienter med pulmonal arteriel hypertension er de gennemsnitlige steady-state koncentrationer 2050% højere end de undersøgte doser på 20-80 mg 3 gange dagligt sammenlignet med raske frivillige forsøgspersoner. 
In patients with pulmonary arterial hypertension, the average steady state concentrations were 20-50% higher over the investigated dose range of 20-80 mg three times a day compared to healthy volunteers.
Forsigtighed tilrådes derfor ved samtidig anvendelse. 
Therefore, caution is recommended in case of co-administration.
Samtidig administration af PDE5-hæmmere, inklusive sildenafil, med guanylatcyklase-stimulatorer, som f.eks. riociguat, er kontraindikeret, da det kan føre til symptomatisk hypotension (se pkt. 
The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section
Almene symptomer og reaktioner på administrationsstedet Almindelig pyreksi *Disse bivirkninger/hændelser er rapporteret hos patienter, der tager sildenafil til behandling af erektil dysfunktion (MED). 
Common pyrexia *These adverse events/reactions have been reported in patients taking sildenafil for the treatment of male erectile dysfunction (MED).
I denne population var Kaplan-Meier-estimater for 1, 2 og 3 års overlevelse hhv. 96 %, 91 % og 82 %. 
In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 96%, 91% and 82%, respectively.
Filmovertræk: 
Film coat:
Metabolisme og ernæring Almindelig væskeophobning 
Metabolism and nutrition disorders Common fluid retention
Den estimerede forskel mellem den gennemsnitlige sildenafildosis og placebo var 11,33% (95% CI: 1,72-20,94) (se tabel 2). 
The estimated difference between the medium sildenafil dose and placebo was 11.33% (95% CI: 1.72 to 20.94) (see Table 2).
Tabel 2: Procentvis ændring i maksimal VO2 fra baseline i sildenafilgrupperne korrigeret for placebo 
Table 2: Placebo Corrected % Change from Baseline in Peak VO2 by Active Treatment Group
Sildenafils eksponering var 5 gange højere ved dosis på 80 mg 3 gange dagligt sammenlignet med en eksponering med en dosis på 20 mg 3 gange dagligt. 
Sildenafil exposure was 5-fold higher at a dose of 80 mg three times a day compared to the exposure at a dose of 20 mg three times a day.
Filmovertræk: Hypromellose (15cp) (E464), titandioxid (E171), lactosemonohydrat, triacetin. 
Film coat: hypromellose (15cp) (E464), titanium dioxide (E171), lactose monohydrate, triacetin.
Enkelte orale doser af sildenafil på op til 100 mg gav ingen klinisk relevant effekt på EKG hos raske frivillige forsøgspersoner. 
Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on ECG.
Svær hypotension (blodtryk <90/50 mmHg) ved initiering. 
Recent history of stroke or myocardial infarction, Severe hypotension (blood pressure <90/50 mmHg) at initiation.
Indeholder lactosemonohydrat. 
Contains lactose monohydrate.
Hvis De oplever pludseligt nedsat syn eller synstab, skal De stoppe med at tage Granpidam og straks kontakte Deres læge (se også afsnit 4). 
If you experience sudden decrease or loss of vision, stop taking Granpidam and contact your doctor immediately (see also section 4).
Hos raske ældre frivillige forsøgspersoner (65 år og derover) ses en reduceret clearance af sildenafil, som medfører ca. 90% højere plasmakoncentration af sildenafil og den aktive N-desmethylmetabolit, sammenlignet med yngre frivillige forsøgspersoner (18-45 år). 
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).
Granpidam bør pga. manglende data ikke anvendes til gravide, medmindre det er strengt nødvendigt. 
Due to lack of data, Granpidam should not be used in pregnant women unless strictly necessary.
I pivotalstudiet blev i alt 207 patienter behandlet med sildenafil, og status for patienternes langtidsoverlevelse blev vurderet i mindst 3 år. 
A total of 207 patients were treated with sildenafil in the pivotal study, and their long term survival status was assessed for a minimum of 3 years.
Patienter på sildenafil opnåede en statistisk signifikant reduktion i middel pulmonalt arterielt tryk (mPAP) sammenlignet med dem, der fik placebo. 
Patients on sildenafil achieved a statistically significant reduction in mean Pulmonary Arterial Pressure (mPAP) compared to those on placebo.
Brugen af prostacyclin, prostacyclin analoger og endothelinreceptorantagonister som tillægsbehandling samt arginin-tilskud var ikke tilladt. 
The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as add-on therapy, and neither was arginine supplementation.
Bivirkninger rapporteret efter markedsføring er anført i kursiv. 
Reports from post-marketing experience are included in italics.
Efter kronisk dosering på 80 mg 3 gange dagligt til patienter med pulmonal arteriel hypertension ses en mindre effekt i blodtryksreduktionen (en reduktion i både systolisk og diastolisk tryk på 2 mmHg). 
After chronic dosing of 80 mg three times a day to patients with pulmonary arterial hypertension lesser effects in blood pressure reduction were observed (a reduction in both systolic and diastolic pressure of 2 mmHg).
Ved ordination af sildenafil skal lægen omhyggeligt overveje, om patienter med visse underliggende tilstande vil kunne blive påvirket af sildenafils lette til moderate vasodilaterende effekt, f.eks. hypotensive eller dehydrerede patienter eller patienter med svær venstre ventrikel udløbsobstruktion eller autonom dysfunktion (se pkt. 
When prescribing sildenafil, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by sildenafil's mild to moderate vasodilatory effects, for example patients with hypotension, patients with fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction (see section 4.4).
Sikkerhed og effekt af sildenafil ved samtidig anvendelse af andre lægemidler til pulmonal arteriel hypertension (f.eks. ambrisentan, iloprost) er ikke undersøgt i kontrollerede kliniske studier. 
The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension (e.g. ambrisentan, iloprost) has not been studied in controlled clinical trials.
Det primære endepunkt var procentvis ændring i maksimalt iltforbrug (VO2) fra baseline til uge 16 bestemt ved CPET-test af forsøgspersonerne i de kombinerede doseringsgrupper (se tabel 2). 
The primary endpoint was the placebo-corrected percentage change in peak VO2 from baseline to week 16 assessed by CPET testing in the combined dose groups (Table 2).
I denne population var Kaplan-Meier-estimater for 1-, 2- og 3-års overlevelse hhv. 92%, 81% og 74%. 
In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 92%, 81% and 74%, respectively.
Den anbefalede dosis er 20 mg 3 gange dagligt. 
The recommended dose is 20 mg three times a day (TID).
alfa-blokker (f.eks. doxazosin) til behandling af for højt blodtryk eller vandladningsbesvær ved forstørret blærehalskirtel (prostata), da kombination af disse to lægemidler kan give symptomer på grund af blodtryksnedsættelse (f.eks. svimmelhed). 
- Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms resulting in the lowering of your blood pressure (e.g. dizziness, light headedness).
PDE5-hæmmere, såsom sildenafil, har vist sig at øge den blodtrykssænkende virkning af denne medicin. 
PDE5 inhibitors, such as sildenafil have been shown to increase the hypotensive effects of this medicine.
Når PDE5-hæmmere, herunder sildenafil, anvendes til behandling af rejsningsproblemer hos mænd, er der med ukendt hyppighed set bivirkninger, der påvirker synet: delvist, pludseligt, midlertidigt eller permanent nedsat syn eller synstab på det ene eller begge øjne. 
When used to treat male erectile dysfunction (ED), the following visual side effects have been reported with PDE5 inhibitors, including sildenafil at an unknown frequency; partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes.
Sildenafil (50 mg) øger ikke den af acetylsalicylsyre (150 mg) forlængede blødningstid. 
Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg).
Tabletkerne: Mikrokrystallinsk cellulose, vandfrit calciumhydrogenfosfat, croscarmellosenatrium, hypromellose (5cp) (E464), magnesiumstearat. 
Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, hypromellose (5cp) (E464), magnesium stearate
En større procentdel af patienterne på alle 3 sildenafil-doser (28%, 36% og 42% af patienterne, der fik hhv. 20 mg, 40 mg og 80 mg 3 gange dagligt) viste forbedring på mindst en WHO-funktionsklasse efter 12 uger sammenlignet med placebo (7%). 
A greater percentage of patients on each of the sildenafil doses (i.e. 28%, 36% and 42% of subjects who received sildenafil 20 mg, 40 mg and 80 mg TID doses, respectively) showed an improvement by at least one WHO functional class at week 12 compared to placebo (7%).
Bivirkninger, der blev rapporteret hos >10% af 229 forsøgspersoner, der blev behandlet med sildenafil (alle dosisgrupper, inklusive 9 patienter, som ikke fortsatte i det langvarige studie), var infektion i øvre luftveje (31%), hovedpine (26%), opkastning (22%), bronkitis (20%), pharyngitis (18%), pyreksi (17%), diarré (15%) samt influenza og epistaxis (12% hver). 
Adverse reactions reported in >10% of 229 subjects treated with sildenafil (combined dose group, including 9 patients that did not continue into the long-term study) were upper respiratory infection (31%), headache (26%), vomiting (22%), bronchitis (20%), pharyngitis (18%), pyrexia (17%), diarrhoea (15%), and influenza, epistaxis (12% each).
Psykiske forstyrrelser Almindelig søvnløshed, angst 
Psychiatric disorders Common insomnia, anxiety
PVC/alu-blister med 90 tabletter. 
PVC/Alu blisters of 90 tablets.
Almindelig cellulitis, influenza, bronkitis, sinuitis, rinitis, gastroenteritis 
Infections and infestations Common cellulitis, influenza, bronchitis, sinusitis, rhinitis, gastroenteritis
Sildenafil havde ingen effekt på slagvolumen og nedsatte ikke blodcirkulationen i de forsnævrede koronararterier. 
Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries.
De mest almindeligt rapporterede bivirkninger (større eller lig med 10%) for sildenafil sammenlignet med placebo er hovedpine, ansigtsrødme, dyspepsi, diarré og smerter i ekstremiteterne. 
The most commonly reported adverse reactions that occurred (greater or equal to 10%) on sildenafil compared to placebo were headache, flushing, dyspepsia, diarrhoea and pain in extremity.
I et placebo-kontrolleret studie med sildenafil til patienter i alderen 1-17 år med pulmonal arteriel hypertension blev i alt 174 patienter behandlet med enten lavdosis (10 mg til patienter >20 kg, ingen patienter ≤20 kg fik lavdosis), middeldosis (10 mg til patienter ≥8-20 kg, 20 mg til patienter ≥2045 kg, 40 mg til patienter >45 kg) eller højdosis (20 mg til patienter ≥8-20 kg, 40 mg til patienter ≥2045 kg, 80 mg til patienter >45 kg) sildenafil og 60 blev behandlet med placebo. 
In the placebo-controlled study of sildenafil in patients 1 to 17 years of age with pulmonary arterial hypertension, a total of 174 patients were treated three times a day with either low (10 mg in patients >20 kg; no patients ≤20 kg received the low dose), medium (10 mg in patients ≥8-20 kg; 20 mg in patients ≥20-45 kg; 40 mg in patients >45 kg) or high dose (20 mg in patients ≥8-20 kg; 40 mg in patients ≥20-45 kg; 80 mg in patients >45 kg) regimens of sildenafil and 60 were treated with placebo.
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Accord 
NAME OF THE MARKETING AUTHORISATION HOLDER Accord
Sildenafil (50 mg) forstærker ikke den hypotensive effekt af alkohol hos raske frivillige forsøgspersoner med gennemsnitlige maksimale koncentrationer af alkohol i blodet på 80 mg/dl (0,8 ‰). 
Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.
FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE 
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
For patienter med 6MWD < 325 meter ved baseline blev der set bedre effekt ved højere doser (placebo-korrigeret stigning på 58 meter, 65 meter og 87 meter for hhv. 20 mg, 40 mg og 80 mg 3 gange dagligt). 
For patients with a baseline 6MWD <325 m improved efficacy was observed with higher doses (placebo-corrected improvements of 58 metres, 65 metres and 87 metres for 20 mg, 40 mg and 80 mg doses TID, respectively).
Mave-tarmkanalen Meget almindelig diarré, dyspepsi 
Gastrointestinal disorders Very common diarrhoea, dyspepsia
Prækliniske studier viste en additiv systemisk blodtrykssænkende virkning, når PDE5-hæmmere blev kombineret med riociguat. 
Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
Kontakt lægen, før De tager Granpidam, hvis De har sygdom forårsaget af blokeret eller forsnævret vene i lungerne og ikke en blokeret eller forsnævret arterie. 
- have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.
Er De usikker, så spørg lægen eller på apoteket. 
If you are not certain, ask your doctor or pharmacist.
I dette studie var 63 af 234 (27%) af patienterne <7 år (sildenafil lavdosis=2, middeldosis=17, højdosis=28, placebo=16), og 171 af 234 (73%) af patienterne var >7 år (sildenafil lavdosis=40, middeldosis=37, højdosis=49, placebo=44 se nedenfor). 
In this trial, 63 of 234 (27%) patients were <7 years old (sildenafil low dose = 2; medium dose = 17; high dose = 28; placebo = 16) and 171 of 234 (73%) patients were 7 years or older (sildenafil low dose = 40; medium dose = 38; and high dose = 49; placebo = 44).
Almindelig migræne, tremor, paræstesi, brændende følelse, hypæstesi 
Common migraine, tremor, paraesthesia, burning sensation, hypoaesthesia
Samtidig administration af orale antikonceptiva (30 µg ethinylestradiol og 150 µg levonorgestrel) påvirker ikke sildenafils farmakokinetik. 
Co-administration of oral contraceptives (ethinyloestradiol 30 µg and levonorgestrel 150 µg) did not affect the pharmacokinetics of sildenafil.
I tilfælde af overdosering bør der gives symptomatisk behandling efter behov. 
In cases of overdose, standard supportive measures should be adopted as required.
Der blev givet doser på op til 80 mg 3 gange dagligt (4 gange den anbefalede dosis på 20 mg 3 gange dagligt) og efter 3 år blev 87% af 183 patienter behandlet med sildenafil 80 mg 3 gange dagligt. 
Doses up to 80 mg three times a day (4 times the recommended dose of 20 mg three times a day) were administered and after 3 years 87% of 183 patients on study treatment were receiving sildenafil 80 mg TID.