natgillin/translations-raw huggingface dataset:
I bivirkningsovervågningen efter markedsføringen er der indsamlet bivirkninger i en periode på mere end 9 år.
Adverse reactions from post-marketing surveillance has been gathered covering an estimated period > 9 years.
I tabellen nedenfor er alle medicinsk vigtige bivirkninger, som er opstået i kliniske undersøgelser med en hyppighed større end placebo, anført efter organklasse og frekvens (meget almindelig:
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),
(≥1/ 10), almindelig (≥1/ 100 og < 1/ 10), ikke almindelig (≥1/ 1000 og < 1/ 100), sjælden (≥1/ 10. 000 og < 1/ 1000).
17 common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000).
17 Tabel 1:
Table 1:
Not known
Not known General disorders and administration site Uncommon Investigations
Almene symptomer og reaktioner på administrationsstedet Ikke almindelig
Priapism, Prolonged erection conditions Chest pain, Fatigue
Pludselig døvhed.
Sudden deafness.
I et lille antal post- marketing forsøg og kliniske forsøg med alle PDE- hæmmere, herunder sildenafil, er der set pludselig nedsættelse eller tab af hørelse.
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.
4. 9 Overdosering
18 4.9 Overdose
Doser på
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.
18 200 mg giver ikke øget effekt, men incidensen af bivirkninger (hovedpine, flushing, svimmelhed, dyspepsi, tilstopning af næsen, synsforstyrrelser) øges.
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.
Sildenafil er en potent og selektiv hæmmer af cGMP - specifik fosfodiesterase type 5 (PDE5) i corpus cavernosum, hvor PDE5 er ansvarlig for nedbrydningen af cGMP.
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.
Når NO/ cGMP- vejen er aktiveret, som det sker ved seksuel stimulation, fører sildenafils hæmning af PDE5 til øgede cGMP- niveauer i corpus cavernosum.
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.
I en penis- pletysmografiundersøgelse (RigiScan) hos fastende patienter var den gennemsnitlige tid til indsættende effekt for dem, som fik erektioner med 60% stivhed (nok til gennemførelse af samleje) 25 minutter (fra 12- 37 minutter), når de fik sildenafil.
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.
I en anden RigiScan- undersøgelse var sildenafil stadig i stand til at give erektion efter seksuel stimulation 4- 5 timer efter dosisindtagelse.
In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation 4-5 hours post-dose.
I en klinisk undersøgelse af de hæmodynamiske virkninger efter en enkelt oral dosis på 100 mg sildenafil hos 14 patienter med alvorlig koronararteriesygdom (CAD) (> 70% stenoser i mindst 1 koronararterie) faldt det gennemsnitlige hvilende systoliske og diastoliske blodtryk med henholdsvis 7% og 6% sammenlignet med baseline.
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.
19 I en dobbelt- blind, placebo- kontrolleret motions stress undersøgelse, hvori 144 patienter med erektil dysfunktion og stabil angina tog deres sædvanlige medicin mod angina pectoris (undtaget nitrater), blev der ikke set klinisk relevante forskelle i tiden indtil angina blev en begrænsende faktor for sildenafil sammenlignet med placebo.
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).
Distribution:
20 Distribution:
440 ng/ ml (CV 40%).
After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/ ml (CV 40%).
18 ng/ ml (38 nM).
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).
20 Hos raske forsøgspersoner, som fik sildenafil (100 mg som enkeltdosis), fandtes mindre end 0, 0002% (gennemsnitlig 188 ng) af indgivet dosis i ejakulatet 90 minutter efter indgift.
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.
Hos frillige forsøgspersoner med svært nedsat nyrefunktion (kreatininclearance < 30 ml/ min) reduceres sildenafil - clearance, hvilket fører til gennemsnitlige stigninger i AUC og Cmax på henholdsvis 100% og 88% sammenlignet med forsøgspersoner i samme alderskategori uden nedsat nyrefunktion.
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.
Hypromellose titandioxid (E171) lactose triacetin indigotin I (E132)
Film coat: hypromellose titanium dioxide (E171) lactose triacetin indigo carmine aluminium lake (E132)
PVC/ aluminium folie blisterplader i kartoner med 2, 4, 8 eller 12 tabletter eller i en sekundær varmeforseglet kortpakning.
PVC/ Aluminium foil blisters in cartons or secondary heat sealed card packaging of 2, 4, 8 or 12 tablets.
EU/ 1/ 98/ 077/ 006- 008 EU/ 1/ 98/ 077/ 14 EU/ 1/ 98/ 077/ 016- 019
EU/ 1/ 98/ 077/ 006-008 EU/ 1/ 98/ 077/ 014 EU/ 1/ 98/ 077/ 016-019
VIAGRA 100 mg filmovertrukne tabletter.
VIAGRA 100 mg film-coated tablets
Hver tablet indeholder 100 mg sildenafil som citrat.
Each tablet contains 100 mg of sildenafil (as citrate) Excipient:
Blå, runde rhombeformede tabletter, mærket “ PFIZER ” på den ene side og ” VGR 100 ” på den anden side.
Blue, rounded diamond-shaped tablets, marked “ PFIZER ” on one side and “ VGR 100 ” on the other.
Anvendelse hos børn og unge:
24 Use in children and adolescents:
24 Anvendelse hos patienter, som får anden medicin:
Use in patients using other medicines:
4. 5).
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)
Mange hændelser er rapporteret som opstået under eller kort tid efter samleje.
Many events were
Få hændelser er rapporteret som opstået kort tid efter brugen af VIAGRA uden seksuel aktivitet.
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 Præparater til behandling af erektil dysfunktion, inklusive sildenafil, bør anvendes med forsigtighed hos patienter med anatomisk deformitet af penis (som f. eks. vinkling, kavernøs fibrose eller Peyronie’ s sygdom), eller hos patienter med lidelser, som kan prædisponere til priapisme (som f. eks. seglcelleanæmi, multipelt myelom eller leukæmi).
Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’ s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Samtidig indgift med HIV- proteasehæmmeren, ritonavir, som er en meget potent P450- hæmmer, ved steady state (500 mg 2 gange dagligt) og enkeltdosis af sildenafil (100 mg) gav en stigning i sildenafils Cmax på 300% (4 gange) og en stigning i sildenafils plasma AUC på 1. 000% (11 gange).
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.
200 ng/ ml sammenlignet med ca.
At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/ ml, compared to approximately 5 ng/ ml
5 ng/ ml, når sildenafil bliver givet alene.
26 when sildenafil was administered alone.
26 Samtidig indgift med HIV- proteasehæmmeren saquinavir, en CYP3A4- hæmmer, ved steady state (1200 mg 3 gange dagligt) og enkeltdosis sildenafil (100 mg) gav en stigning i sildenafils Cmax på 140% og en stigning i sildenafils plasma AUC på 210%.
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.
Ved indgift af en enkeltdosis sildenafil 100 mg sammen med erythromycin, en specifik CYP3A4 - hæmmer, i steady state (500 mg 2 gange dagligti 5 dage) sås en 182% stigning i optagelsen af sildenafil (AUC).
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).
Skønt der ikke er foretaget specifikke interaktionsundersøgelser for alle lægemidler, viste populationsfarmakokinetiske analyser, at sildenafils farmakokinetik ikke blev påvirket ved samtidig indgift med CYP2C9- hæmmere (som tolbutamid, warfarin, fenytoin), CYP2D6- hæmmere (som selektive serotonin re- uptake hæmmere, tricykliske antidepressiva), tiazider og beslægtede diuretika, loop - og kaliumbesparende diuretika, ACE- hæmmere, calciumblokkere, beta- adrenerge receptorantagonister eller stoffer, som inducerer CYP450- metabolisme (som rifampicin, barbiturater).
Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant medication 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).
Det er mest sandsynligt, at dette indtræder inden for 4 timer efter indtagelse af sildenafildosen (se pkt.
In three specific drug-drug interaction studies, the
I 3 specifikke lægemiddel - lægemiddel interaktionsundersøgelser 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.
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.
27 Der ses ingen signifikante interaktioner ved indgift af sildenafil (50 mg) sammen med tolbutamid (250 mg) eller warfarin (40 mg), som begge metaboliseres af CYP2C9.
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.
Den samme reduktion i diastolisk blodtryk i liggende stilling var 7 mmHg.
The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg.
Disse yderligere blodtryksreduktioner var af tilsvarende størrelsesorden, som når sildenafil blev givet alene til raske frivillige forsøgspersoner (se pkt.
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).
(≥1/ 10), almindelig (≥1/ 100 og < 1/ 10), ikke almindelig (≥1/ 1000 og < 1/ 100), sjælden (≥1/ 10. 000 og < 1/ 1000).
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).
Derudover er frekvensen af medicinsk vigtige bivirkninger rapporteret efter markedsføring er angivet som ikke kendt.
In addition, the frequency of medically important adverse reactions reported from post-marketing experience is included as not known.
28 Tabel 1:
Table 1:
Not known
Myalgia
Almene symptomer og reaktioner på administrationsstedet Ikke almindelig
Not known General disorders and administration site Uncommon Not known Investigations
Brystsmerter, træthed
Priapism, Prolonged erection conditions Chest pain, Fatigue
* Øre og labyrint:
29 * Ear disorders:
29 200 mg giver ikke øget effekt, men incidensen af bivirkninger (hovedpine, flushing, svimmelhed, dyspepsi, tilstopning af næsen, synsforstyrrelser) øges.
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.
Nitrogenoxyd aktiverer derefter enzymet guanylatcyklase, hvilket resulterer i øgede koncentrationer af cyklisk guanosinmonofosfat (cGMP), som fører afslapning af den glatte muskulatur i corpus cavernosum og tillader blodet at strømme til.
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.
Disse blodtryksfald svarer til sildenafils vasodilatatoriske virkning, sandsynligvis som følge af øgede cGMP- niveauer i den glatte muskulatur i karrene.
30 vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle.
I en klinisk undersøgelse af de hæmodynamiske virkninger efter en enkelt oral dosis på 100 mg sildenafil hos 14 patienter med alvorlig koronararteriesygdom (CAD) (> 70% stenoser i mindst 1 koronararterie) faldt det gennemsnitlige hvilende systoliske og diastoliske blodtryk med henholdsvis 7% og 6% sammenlignet med baseline.
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.
30 I en dobbelt- blind, placebo- kontrolleret motions- stress- undersøgelse, hvori 144 patienter med erektil dysfunktion og stabil angina tog deres sædvanlige medicin mod angina pectoris (undtaget nitrater), blev der ikke set klinisk relevante forskelle i tiden indtil angina blev en begrænsende faktor for sildenafil sammenlignet med placebo.
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).
Distribution:
31 Distribution:
31 Hos raske forsøgspersoner, som fik sildenafil (100 mg som enkeltdosis), fandtes mindre end 0, 0002% (gennemsnitlig 188 ng) af indgivet dosis i ejakulatet 90 minutter efter indgift.
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.
Hypromellose titandioxid (E171) lactose triacetin indigotin I (E132)
Hypromellose titanium dioxide (E171) lactose triacetin indigo carmine aluminium lake (E132)
EU/ 1/ 98/ 077/ 010- 012 EU/ 1/ 98/ 077/ 15
EU/ 1/ 98/ 077/ 010-012 EU/ 1/ 98/ 077/ 015
FREMSTILLER( E) ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Pfizer PGM Zone Industrielle, 29 route des Industries 37530 Pocé- sur- Cisse Frankrig
Pfizer PGM Zone Industrielle, 29 route des Industries 37530 Pocé-sur-Cisse France
Indehaveren af markedsføringstilladelsen skal oplyse Europa- Kommissionen om markedsføringsplanen for det lægemiddel, der er godkendt i henhold til denne beslutning.
Not applicable.
38 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING / CARTON
25 mg sildenafil (som citrat)
25 mg sildenafil (as citrate)
Forseglet pakning Må ikke anvendes, hvis pakningen har været åbnet
Sealed Pack Do not use if box has been opened
(2 filmovertrukne tabletter) (4 filmovertrukne tabletter) (8 filmovertrukne tabletter) (12 filmovertrukne tabletter)
(2 film-coated tablets) (4 film-coated tablets) (8 film-coated tablets) (12 film-coated tablets)
40 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre emballage/ karton
OUTER PACKAGING / CARTON
50 mg sildenafil (som citrat)
50 mg sildenafil (as citrate)
Se indlægssedlen for yderligere information.
Contains lactose See package leaflet for further information
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 EU/ 1/ 98/ 077/ 006 EU/ 1/ 98/ 077/ 007 EU/ 1/ 98/ 077/ 008
42 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Ydre emballage/ sekundær varmeforseglet kortpakning
OUTER PACKAGING / SECONDARY HEAT SEALED CARD PACKAGING
Lægemidlets navn
NAME OF THE MEDICINAL PRODUCT
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 EU/ 1/ 98/ 077/ 017 EU/ 1/ 98/ 077/ 018 EU/ 1/ 98/ 077/ 019
(2 filmovertrukne tabletter (4 filmovertrukne tabletter) (8 filmovertrukne tabletter) (12 filmovertrukne tabletter)
(2 film-coated tablets) (4 film-coated tablets) (8 film-coated tablets) (12 film-coated tablets)
44 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
100 mg sildenafil (som citrat)
100 mg sildenafil (as citrate)
45 Opbevares i den originale yderpakning for at beskytte mod fugt.
SPECIAL STORAGE CONDITIONS
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 EU/ 1/ 98/ 077/ 010 EU/ 1/ 98/ 077/ 011 EU/ 1/ 98/ 077/ 012
PRIMÆR EMBALLAGE/ BLISTER
PRIMARY PACKAGING/ BLISTER
VIAGRA 100 mg filmovertrukne tabletter Sildenafil
VIAGRA 100 mg film coated tablets Sildenafil
49 BILAG III
49 B.
ETIKETTERING OG INDLÆGSSEDDEL
PACKAGE LEAFLET
INDLÆGSSEDDEL
50 PACKAGE LEAFLET:
VIAGRA 25 mg filmovertrukne tabletter Sildenafilcitrat
VIAGRA 25 mg film-coated tablets Sildenafil citrate
Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel.
Read all of this leaflet carefully before you start taking this medicine. − Keep this leaflet.
- Spørg din læge eller apotek, hvis der er mere, du vil vide.
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.
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som
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.
VIAGRAS virkning og hvad du skal bruge det til 2.
What VIAGRA is and what it is used for 2.
Det skal du vide, før du begynder at tage VIAGRA 3.
Before you take VIAGRA 3.
Sådan skal du tager VIAGRA 4.
How to take VIAGRA 4.
Sådan opbevarer du VIAGRA 6.
How to store VIAGRA 6.
VIAGRAS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
WHAT VIAGRA IS AND WHAT IT IS USED FOR
VIAGRA hører til en gruppe medicin, som kaldes fosfodiesterase type 5 (PDE5) - hæmmere, som medvirker til at afslappe blodkarrene i penis og tillade blodet at strømme ind i penis ved seksuel stimulation.
It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited.
VIAGRA bør kun anvendes, når der er konstateret erektil dysfunktion.
You should not take VIAGRA if you do not have erectile dysfunction.
VIAGRA er til behandling af mænd med erektil dysfunktion, af og til kendt som impotens, hvilket er manglende evne til at opnå og/ eller opretholde erektion tilstrækkelig til at gennemføre tilfredsstillende seksuel aktivitet.
This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE VIAGRA
BEFORE YOU TAKE VIAGRA
- Hvis du tager medicin, som kaldes nitrater, da samtidig brug kan medføre kraftigt blodtryksfald.
− If you are taking medicines called nitrates, as the combination may cause a potentially dangerous decrease in your blood pressure.
Fortæl det til lægen, hvis du tager denne type medicin, der bruges til at lindre angina pectoris (eller ” brystsmerter ”).
Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “ chest pain”).
- Hvis du bruger præparater, som kaldes nitrogenoxiddonorer som amylnitrit (“ poppers ”), da
− 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.
- Hvis du er overfølsom (allergisk) over for sildenafil eller et af de øvrige indholdsstoffer i
− If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of VIAGRA.
- Hvis du har alvorlige hjerte - eller leverproblemer.
− If you have a severe heart or liver problem.
- Hvis du for nyligt har haft slagtilfælde eller hjerteanfald, eller hvis du har lavt blodtryk.
− If you have recently had a stroke or a heart attack, or if you have low blood pressure.
- Hvis du har visse alvorlige arvelige øjensygdomme (som retinitis pigmentosa).
− If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
- Hvis du på noget tidspunkt tidligere har haft tab af synet på grund af non- arteritis anterior
51 − If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).
52 Vær ekstra forsigtig med at bruge VIAGRA
Take special care with VIAGRA
Fortæl din læge − hvis du har en abnormitet af de røde blodlegemer (seglcelleanæmi), blodkræft (leukæmi), knoglemarvskræft (multipelt myelom)
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).
− hvis du har en deformitet af penis eller Peyronies sygdom.
− If you have a deformity of your penis or Peyronie’ s Disease.
− hvis du har problemer med hjertet.
− If you have problems with your heart.
Din læge skal så omhyggeligt undersøge, om dit hjerte kan tåle den ekstra anstrengelse, det er, at have sex.
Your doctor should in that case carefully check whether your heart can take the additional strain of having sex.
− hvis du for tiden har mavesår eller blødningsforstyrrelser (som f. eks. hæmofili).
− If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).
− hvis du oplever pludselige nedsættelser af synet eller tab af synet, skal du stoppe med at tage VIAGRA og straks søge læge.
− If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your doctor immediately.