Viagra

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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 

 

VIAGRA 25 mg film-coated tablets 

 

VIAGRA 50 mg film-coated tablets 

 

VIAGRA 100 mg film-coated tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg of sildenafil.  

 

Excipient with known effect 

 

VIAGRA 25 mg tablets 

Each tablet contains 0.834 mg lactose (as monohydrate). 

 

VIAGRA 50 mg tablets 

Each tablet contains 1.667 mg lactose (as monohydrate). 

 

VIAGRA 100 mg tablets 

Each tablet contains 3.334 mg lactose (as monohydrate). 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Film-coated tablet. 

 

VIAGRA 25 mg tablets 

Blue, rounded diamond-shaped tablets, marked “PFIZER” on one side and “VGR 25” on the other. 

 

VIAGRA 50 mg tablets 

Blue, rounded, diamond-shaped tablets, marked “PFIZER” on one side and “VGR 50” on the other.  

 

VIAGRA 100 mg tablets 

Blue, rounded diamond-shaped tablets, marked “PFIZER” on one side and “VGR 100” on the other. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

VIAGRA is indicated in adult men with erectile dysfunction, which is the inability to achieve or 

maintain a penile erection sufficient for satisfactory sexual performance.  

 

In order for VIAGRA to be effective, sexual stimulation is required. 

 



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4.2 Posology and method of administration 

 

Posology 

 

Use in adults 

The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. 

Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg. The 

maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once 

per day. If VIAGRA is taken with food, the onset of activity may be delayed compared to the fasted 

state (see section 5.2).  

 

Special populations 

 

Elderly 

Dosage adjustments are not required in elderly patients (≥ 65 years old). 

 

 Renal impairment 

The dosing recommendations described in ‘Use in adults’ apply to patients with mild to moderate 

renal impairment (creatinine clearance = 30-80 mL/min). 

 

Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance  

<30 mL/min) a 25 mg dose should be considered. Based on efficacy and tolerability, the dose may 

be increased step-wise to 50 mg up to 100 mg as necessary. 

 

Hepatic impairment 

Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg 

dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise 

to 50 mg up to 100 mg as necessary. 

 

Paediatric population 

VIAGRA is not indicated for individuals below 18 years of age.  

 

Use in patients taking other medicinal products 

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). 

 

In order to minimise the potential of developing postural hypotension in patients receiving 

alpha-blocker treatment, patients should be stabilised on alpha-blocker therapy prior to initiating 

sildenafil treatment. In addition, initiation of sildenafil at a dose of 25 mg should be considered (see 

sections 4.4 and 4.5). 

 

Method of administration 

 

For oral use. 

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients  listed in section 6.1. 

 

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, 



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and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is 

therefore contraindicated. 

 

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 4.5). 

 

Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for 

whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as 

unstable angina or severe cardiac failure). 

 

VIAGRA is contraindicated in patients who have loss of vision in one eye because of non-arteritic 

anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in 

connection or not with previous PDE5 inhibitor exposure (see section 4.4). 

 

The safety of sildenafil has not been studied in the following sub-groups of patients and its use is 

therefore contraindicated: severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), 

recent history of stroke or myocardial infarction and known hereditary degenerative retinal 

disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal 

phosphodiesterases).  

 

4.4 Special warnings and precautions for use 

 

A medical history and physical examination should be undertaken to diagnose erectile dysfunction 

and determine potential underlying causes, before pharmacological treatment is considered.  

 

Cardiovascular risk factors 

 

Prior to initiating any treatment for erectile dysfunction, physicians should consider the 

cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual 

activity. Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood 

pressure (see section 5.1). Prior to prescribing sildenafil, physicians should carefully consider 

whether their patients with certain underlying conditions could be adversely affected by such 

vasodilatory effects, especially in combination with sexual activity. Patients with increased 

susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g., aortic 

stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple 

system atrophy manifesting as severely impaired autonomic control of blood pressure. 

 

VIAGRA potentiates the hypotensive effect of nitrates (see section 4.3).  

 

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. Most, but not all, of these patients had pre-existing cardiovascular risk factors. 

Many events were 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. It is not possible to 

determine whether these events are related directly to these factors or to other factors. 

 

Priapism 

 

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 



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Peyronie’s disease), or in patients who have conditions which may predispose them to priapism 

(such as sickle cell anaemia, multiple myeloma or leukaemia). 

 

Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. 

In the event of an erection that persists longer than 4 hours, the patient should seek immediate 

medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss 

of potency could result. 

 

Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction 

 

The safety and efficacy of combinations of sildenafil with other PDE5 Inhibitors, or other 

pulmonary arterial hypertension (PAH) treatments containing sildenafil (REVATIO), or  other 

treatments for erectile dysfunction have not been studied. Therefore the use of such combinations 

is not recommended. 

 

Effects on vision 

 

Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil 

and other PDE5 inhibitors (see section 4.8). 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). Patients should 

be advised that in the event of any sudden visual defect, they should stop taking VIAGRA and 

consult a physician immediately (see section 4.3). 

 

Concomitant use with ritonavir 

 

Co-administration of sildenafil with ritonavir is not advised (see section 4.5).  

 

Concomitant use with alpha-blockers 

 

Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the 

co-administration may lead to symptomatic hypotension in a few susceptible individuals (see section 

4.5). This is most likely to occur within 4 hours post sildenafil dosing. In order to minimise the 

potential for developing postural hypotension, patients should be hemodynamically stable on 

alpha-blocker therapy prior to initiating sildenafil treatment. Initiation of sildenafil at a dose of 25 mg 

should be considered (see section 4.2). In addition, physicians should advise patients what to do in 

the event of postural hypotensive symptoms. 

 

Effect on bleeding 

 

Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium 

nitroprusside in vitro. There is no safety information on the administration of sildenafil to patients 

with bleeding disorders or active peptic ulceration. Therefore sildenafil should be administered to 

these patients only after careful benefit-risk assessment. 

 

The film coating of the tablet contains lactose. VIAGRA should not be administered to men with 

rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose 

malabsorption. 

 

Women 

 

VIAGRA is not indicated for use by women. 

 



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4.5 Interaction with other medicinal products and other forms of interaction 

 

Effects of other medicinal products on sildenafil 

 

In vitro studies 

Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major 

route) and 2C9 (minor route). Therefore, inhibitors of these isoenzymes may reduce sildenafil 

clearance and inducers of these isoenzymes may increase sildenafil clearance. 

 

In vivo studies  

Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance 

when co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine). 

Although no increased incidence of adverse events was observed in these patients, when sildenafil is 

administered concomitantly with CYP3A4 inhibitors, a starting dose of 25 mg should be considered. 

 

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. 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. This is consistent with ritonavir’s marked effects 

on a broad range of P450 substrates. Sildenafil had no effect on ritonavir pharmacokinetics. Based 

on these pharmacokinetic results co-administration of sildenafil with ritonavir is not advised (see 

section 4.4) and in any event the maximum dose of sildenafil should under no circumstances exceed 

25 mg within 48 hours. 

 

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. Sildenafil had no effect on saquinavir 

pharmacokinetics (see section 4.2). Stronger CYP3A4 inhibitors such as ketoconazole and 

itraconazole would be expected to have greater effects.  

 

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). In normal healthy male volunteers, there was no evidence of an effect of 

azithromycin (500 mg daily for 3 days) on the AUC, Cmax, tmax, elimination rate constant, or 

subsequent half-life of sildenafil or its principal circulating metabolite. 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. 

 

Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest 

increases in plasma levels of sildenafil. 

 

Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the 

bioavailability of sildenafil. 

 

Although specific interaction studies were not conducted for all medic inal 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). In a study of healthy male volunteers, co-administration of the endothelin 

antagonist, bosentan, (an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19) at 



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steady state (125 mg twice a day) with sildenafil at steady state (80 mg three times a day) resulted 

in 62.6% and 55.4% decrease in sildenafil AUC and Cmax, respectively. Therefore, concomitant 

administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases 

in plasma concentrations of sildenafil. 

 

Nicorandil is a hybrid of potassium channel activator and nitrate. Due to the nitrate component it 

has the potential to result in a serious interaction with sildenafil. 

 

Effects of sildenafil on other medicinal products 

 

In vitro studies 

Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 

(IC50 > 150 μM). Given sildenafil peak plasma concentrations of approximately 1 μM after 

recommended doses, it is unlikely that VIAGRA will alter the clearance of substrates of these 

isoenzymes. 

 

There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such 

as theophylline or dipyridamole. 

 

In vivo studies 

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).  

 

Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 

inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment 

the hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of 

the combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, 

including sildenafil, is contraindicated (see section 4.3). 

 

Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to 

symptomatic hypotension in a few susceptible individuals. This is most likely to occur within 4 

hours post sildenafil dosing (see sections 4.2 and 4.4). 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. 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. When sildenafil 

and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there 

were infrequent reports of patients who experienced symptomatic postural hypotension. These 

reports included dizziness and light-headedness, but not syncope.  

 

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. 

 

Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid 

(150 mg). 

 

Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with 

mean maximum blood alcohol levels of 80 mg/dl. 

 

Pooling of the following classes of antihypertensive medication: diuretics, beta-blockers, ACE 

inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and 



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centrally-acting), 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. In a specific interaction study, where sildenafil (100 mg) was co-administered 

with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood 

pressure of 8 mmHg. The corresponding additional reduction in supine diastolic blood pressure was 

7 mmHg. These additional blood pressure reductions were of a similar magnitude to those seen 

when sildenafil was administered alone to healthy volunteers (see section 5.1). 

 

Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, 

saquinavir and ritonavir, both of which are CYP3A4 substrates.  

 

In healthy male volunteers, sildenafil at steady state (80 mg t.i.d.) resulted in a 49.8% increase in 

bosentan AUC and a 42% increase in bosentan Cmax (125 mg b.i.d.). 

 

4.6 Fertility, pregnancy and lactation 

 

VIAGRA is not indicated for use by women. 

 

There are no adequate and well-controlled studies in pregnant or breast-feeding women.  

 

No relevant adverse effects were found in reproduction studies in rats and rabbits following oral 

administration of sildenafil. 

 

There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in 

healthy volunteers (see section 5.1). 

 

4.7 Effects on ability to drive and use machines 

 

VIAGRA may have a minor influence on the ability to drive and use machines.  

 

As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be 

aware of how they react to VIAGRA, before driving or operating machinery.  

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

The safety profile of VIAGRA is based on 9,570 patients in 74 double-blind placebo-controlled 

clinical studies. The most commonly reported adverse reactions in clinical studies among sildenafil 

treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, 

visual disturbance, cyanopsia and vision blurred. 

 

Adverse reactions from post-marketing surveillance has been gathered covering an estimated period 

>10 years. 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. 

 

Tabulated list of adverse reactions 

 

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). Within each frequency grouping, undesirable effects are presented in order of decreasing 

seriousness. 



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Table 1: Medically important adverse reactions reported at an incidence greater than 

placebo in controlled clinical studies and medically important adverse reactions reported 

through post-marketing surveillance 

 

System Organ 

Class 

Very 

common 

(  1/10) 

Common 

(  1/100 and 

<1/10) 

Uncommon 

(  1/1,000 and 

<1/100) 

Rare (  1/10,000 and 

<1/1,000) 

Infections and 

infestations 

  Rhinitis  

Immune system 

disorders 

  Hypersensitivity   

Nervous system 

disorders 

Headache Dizziness Somnolence, 

Hypoaesthesia 

Cerebrovascular accident, 

Transient ischaemic 

attack, Seizure,* Seizure 

recurrence,* Syncope 

Eye disorders  Visual colour 

distortions**, 

Visual 

disturbance, 

Vision blurred 

Lacrimation 

disorders***, Eye 

pain, Photophobia, 

Photopsia, Ocular 

hyperaemia, Visual 

brightness, 

Conjunctivitis 

Non-arteritic anterior 

ischaemic optic 

neuropathy (NAION)*, 

Retinal vascular 

occlusion*, Retinal 

haemorrhage, 

Arteriosclerotic 

retinopathy, Retinal 

disorder, Glaucoma, 

Visual field defect, 

Diplopia, Visual acuity 

reduced, Myopia, 

Asthenopia, Vitreous 

floaters, Iris disorder, 

Mydriasis, Halo vision, 

Eye oedema, Eye 

swelling, Eye disorder, 

Conjunctival hyperaemia, 

Eye irritation, Abnormal 

sensation in eye, Eyelid 

oedema, Scleral 

discoloration 

Ear and 

labyrinth 

disorders  

  Vertigo, Tinnitus Deafness 

Cardiac 

disorders 

  Tachycardia, 

Palpitations  

Sudden cardiac death*, 

Myocardial infarction, 

Ventricular arrhythmia*, 

Atrial fibrillation, Unstable 

angina 



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System Organ 

Class 

Very 

common 

(  1/10) 

Common 

(  1/100 and 

<1/10) 

Uncommon 

(  1/1,000 and 

<1/100) 

Rare (  1/10,000 and 

<1/1,000) 

Vascular 

disorders 

 Flushing, Hot 

flush 

Hypertension, 

Hypotension 

 

Respiratory, 

thoracic and 

mediastinal 

disorders 

 Nasal 

congestion 

Epistaxis, Sinus 

congestion 

Throat tightness, Nasal 

oedema, Nasal dryness 

Gastrointestinal 

disorders 

 Nausea, 

Dyspepsia 

Gastro oesophagael 

reflux disease, 

Vomiting, 

Abdominal pain 

upper, Dry mouth 

Hypoaesthesia oral 

Skin and 

subcutaneous 

tissue disorders 

  Rash Stevens-Johnson 

Syndrome (SJS)*, Toxic 

Epidermal Necrolysis 

(TEN)*  

Musculoskeletal 

and connective 

tissue disorders 

  Myalgia, Pain in 

extremity 

 

Renal and 

urinary 

disorders 

  Haematuria  

Reproductive 

system and 

breast disorders 

    Penile haemorrhage, 

Priapism*, 

Haematospermia, Erection 

increased 

General 

disorders and 

administration 

site conditions 

  Chest pain, 

Fatigue, Feeling 

hot 

Irritability 

Investigations   Heart rate 

increased 

 

*Reported during post-marketing surveillance only 

**Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia 

***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased 

 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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4.9 Overdose 

 

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. 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. 

 

In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is 

not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not 

eliminated in the urine. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

 

Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction, ATC Code: G04B E03. 

 

Mechanism of action 

 

Sildenafil is an oral therapy for erectile dysfunction. In the natural setting, i.e. with sexual 

stimulation, it restores impaired erectile function by increasing blood flow to the penis. 

 

The physiological mechanism responsible for erection of the penis involves the release of nitric 

oxide (NO) in the corpus cavernosum during sexual stimulation. 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. 

  

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 has a 

peripheral site of action on erections. Sildenafil has no direct relaxant effect on isolated human 

corpus cavernosum but potently enhances the relaxant effect of NO on this tissue. 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. Therefore sexual stimulation is required in 

order for sildenafil to produce its intended beneficial pharmacological effects.  

 

Pharmacodynamic effects 

 

Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection 

process. Its effect is more potent on PDE5 than on other known phosphodiesterases. There is a 

10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. 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. 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. 

  

Clinical efficacy and safety 

 

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. 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 



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minutes) on sildenafil. In a separate RigiScan study, sildenafil was still able to produce an erection in 

response to sexual stimulation 4-5 hours post-dose. 

 

Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do 

not translate into clinical effects. The mean maximum decreases in supine systolic blood pressure 

following 100 mg oral dosing of sildenafil was 8.4 mmHg. The corresponding change in supine 

diastolic blood pressure was 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. Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically 

relevant effects on 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. Mean pulmonary systolic blood pressure decreased by 9%. Sildenafil showed no effect on 

cardiac output, and did not impair blood flow through the stenosed coronary arteries. 

 

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). The results demonstrated no clinically relevant differences between sildenafil and 

placebo in time to limiting angina. 

 

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. The postulated mechanism for this change in colour discrimination 

is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina.  

Sildenafil has no effect on visual acuity or contrast sensitivity. 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).  

 

There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in 

healthy volunteers (see section 4.6). 

 

Further information on clinical trials 

In clinical trials sildenafil was administered to more than 8000 patients aged 19-87. 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%). 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).  

 

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. In controlled 

clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo.  

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%). The safety and efficacy of sildenafil was maintained in long-term studies. 

 



13 

 

Paediatric population 

 

The European Medicines Agency has waived the obligation to submit the results of studies with 

VIAGRA in all subsets of the paediatric population for the treatment of erectile dysfunction. See 4.2 

for information on paediatric use. 

 

5.2 Pharmacokinetic properties 

 

Absorption 

 

Sildenafil is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 

120 minutes (median 60 minutes) of oral dosing in the fasted state.  The mean absolute oral 

bioavailability is 41% (range 25-63%). After oral dosing of sildenafil AUC and Cmax increase in 

proportion with dose over the recommended dose range (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%. 

 

Distribution 

 

The mean steady state volume of distribution (Vd) for sildenafil is 105 l, indicating distribution into 

the tissues. After a single oral dose of 100 mg, the mean maximum total plasma concentration of 

sildenafil is approximately 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). Protein binding is independent of total 

drug concentrations.  

 

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. 

 

Biotransformation 

 

Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic 

microsomal isoenzymes. The major circulating metabolite results from N-demethylation of 

sildenafil. This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in 

vitro potency for PDE5 approximately 50% that of the parent drug. Plasma concentrations of this 

metabolite are approximately 40% of those seen for sildenafil. The N-desmethyl metabolite is further 

metabolised, with a terminal half-life of approximately 4 h. 

 

Elimination 

 

The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half-life of 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). 

 

Pharmacokinetics in special patient groups 

 

Elderly 

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). Due to age-differences in 



14 

 

plasma protein binding, the corresponding increase in free sildenafil plasma concentration was 

approximately 40%. 

 

Renal insufficiency 

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. 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. However, due to high inter-subject 

variability, these differences were not statistically significant.  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. In addition, N-desmethyl metabolite AUC and Cmax values were 

significantly increased by 200% and 79% respectively. 

 

Hepatic insufficiency 

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. The pharmacokinetics of sildenafil in patients with severely impaired 

hepatic function have not been studied. 

 

5.3 Preclinical safety data 

 

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 and development. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Tablet core:  

microcrystalline cellulose 

calcium hydrogen phosphate (anhydrous) 

croscarmellose sodium 

magnesium stearate 

 

Film coat:  

hypromellose 

titanium dioxide (E171) 

lactose monohydrate 

triacetin 

indigo carmine aluminium lake (E132) 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

5 years. 

 



15 

 

6.4 Special precautions for storage 

 

Do not store above 30oC.  

Store in the original package in order to protect from moisture.  

 

6.5 Nature and contents of container 

 

VIAGRA 25 mg film-coated tablets 

PVC/Aluminium blisters in cartons of 2, 4, 8 or 12 tablets.  

 

VIAGRA 50 mg film-coated tablets 

PVC/Aluminium blisters in cartons or secondary heat sealed card packaging of 2, 4, 8, 12 or 24 

tablets. 

 

VIAGRA 100 mg film-coated tablets 

PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets  

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal and other handling 

 

No special requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

8. MARKETING AUTHORISATION NUMBERS 

 

VIAGRA 25 mg film-coated tablets 

EU/1/98/077/002-004 

EU/1/98/077/013 

 

VIAGRA 50 mg film-coated tablets 

EU/1/98/077/006-008 

EU/1/98/077/014 

EU/1/98/077/016-019 

EU/1/98/077/024 

 

VIAGRA 100 mg film-coated tablets 

EU/1/98/077/010-012 

EU/1/98/077/015 

EU/1/98/077/025 

 

 



16 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 14 September 1998 

Date of latest renewal: 14 September 2008 

 

 

10. DATE OF REVISION OF THE TEXT 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 



17 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

VIAGRA 50 mg orodispersible tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil. 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Orodispersible tablet. 

 

Blue, rounded, diamond-shaped tablets, marked “V50” on one side and plain on the other. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

VIAGRA is indicated in adult men with erectile dysfunction, which is the inability to achieve or 

maintain a penile erection sufficient for satisfactory sexual performance.  

 

In order for VIAGRA to be effective, sexual stimulation is required.  

 

4.2 Posology and method of administration 

 

Posology 

 

Use in adults 

Viagra should be taken as needed approximately one hour before sexual activity. The recommended 

dose is 50 mg taken on an empty stomach as concomitant intake with food delays absorption and 

delays the effect of the orodispersible tablet (see section 5.2). 

Based on efficacy and tolerability, the dose may be increased to 100 mg. The maximum 

recommended dose is 100 mg. For patients requiring a dose increase to 100 mg, two 50 mg 

orodispersible tablets should be administered sequentially. The maximum recommended dosing 

frequency is once per day. If a dose of 25 mg is required, the use of the 25 mg film-coated tablets 

should be recommended. 

 

Special populations 

 

Elderly 

Dosage adjustments are not required in elderly patients (≥ 65 years old). 

  

Renal impairment 

The dosing recommendations described in ‘Use in adults’ apply to patients with mild to moderate 

renal impairment (creatinine clearance = 30-80 mL/min). 

 

Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance  



18 

 

<30 mL/min) a 25 mg dose should be considered. Based on efficacy and tolerability the dose may 

be increased step-wise to 50 mg up to 100 mg as necessary. 

 

Hepatic impairment 

Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg 

dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise 

to 50 mg up to 100 mg as necessary. 

 

Paediatric population 

VIAGRA is not indicated for individuals below 18 years of age.  

 

Use in patients taking other medicinal products 

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). 

 

In order to minimise the potential of developing postural hypotension in patients receiving 

alpha-blocker treatment, patients should be stabilised on alpha-blocker therapy prior to initiating 

sildenafil treatment. In addition, initiation of sildenafil at a dose of 25 mg should be considered (see 

sections 4.4 and 4.5). 

 

Method of administration 

 

For oral use. 

 

The orodispersible tablet should be placed in the mouth, on the tongue, and allowed to disintegrate 

before swallowing with or without water. It should be taken immediately upon removal from the 

blister. For patients requiring a second 50 mg orodispersible tablet to make a 100 mg dose, the 

second tablet should be taken upon full disintegration of the first tablet. 

 

There is a significant delay in absorption when orodispersible tablets are taken with a high fat meal 

compared to the fasted state (see section 5.2). It is recommended that orodispersible tablets be 

taken on an empty stomach. Orodispersible tablets can be taken with or without water. 

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients  listed in section 6.1. 

 

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.  

 

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 4.5). 

 

Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for 

whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as 

unstable angina or severe cardiac failure). 

 



19 

 

VIAGRA is contraindicated in patients who have loss of vision in one eye because of non-arteritic 

anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in 

connection or not with previous PDE5 inhibitor exposure (see section 4.4).  

 

The safety of sildenafil has not been studied in the following sub-groups of patients and its use is 

therefore contraindicated: severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), 

recent history of stroke or myocardial infarction and known hereditary degenerative retinal 

disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal 

phosphodiesterases).  

 

4.4 Special warnings and precautions for use 

 

A medical history and physical examination should be undertaken to diagnose erectile dysfunction 

and determine potential underlying causes, before pharmacological treatment is considered.  

 

Cardiovascular risk factors 

 

Prior to initiating any treatment for erectile dysfunction, physicians should consider the 

cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual 

activity. Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood 

pressure (see section 5.1). Prior to prescribing sildenafil, physicians should carefully consider 

whether their patients with certain underlying conditions could be adversely affected by such 

vasodilatory effects, especially in combination with sexual activity. Patients with increased 

susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g., aortic 

stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple 

system atrophy manifesting as severely impaired autonomic control of blood pressure.  

 

VIAGRA potentiates the hypotensive effect of nitrates (see section 4.3). 

 

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. Most, but not all, of these patients had pre-existing cardiovascular risk factors. 

Many events were 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. It is not possible to 

determine whether these events are related directly to these factors or to other factors.  

 

Priapism 

 

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). 

 

Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. 

In the event of an erection that persists longer than 4 hours, the patient should seek immediate 

medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss 

of potency could result. 

 

Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction 

 

The safety and efficacy of combinations of sildenafil with other PDE5 Inhibitors, or other 

pulmonary arterial hypertension (PAH) treatments containing sildenafil (REVATIO), or  other 



20 

 

treatments for erectile dysfunction have not been studied. Therefore the use of such combinations 

is not recommended. 

 

Effects on vision 

 

Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil 

and other PDE5 inhibitors (see section 4.8). 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). Patients should 

be advised that in the event of any sudden visual defect, they should stop taking VIAGRA and 

consult a physician immediately (see section 4.3). 

 

Concomitant use with ritonavir 

 

Co-administration of sildenafil with ritonavir is not advised (see section 4.5).  

 

Concomitant use with alpha-blockers 

 

Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the 

co-administration may lead to symptomatic hypotension in a few susceptible individuals (see section 

4.5). This is most likely to occur within 4 hours post sildenafil dosing. In order to minimise the 

potential for developing postural hypotension, patients should be hemodynamically stable on 

alpha-blocker therapy prior to initiating sildenafil treatment. Initiation of sildenafil at a dose of 25 mg 

should be considered (see section 4.2). In addition, physicians should advise patients what to do in 

the event of postural hypotensive symptoms. 

 

Effect on bleeding 

 

Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium 

nitroprusside in vitro. There is no safety information on the administration of sildenafil to patients 

with bleeding disorders or active peptic ulceration. Therefore sildenafil should be administered to 

these patients only after careful benefit-risk assessment.  

 

Women 

 

VIAGRA is not indicated for use by women. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

Effects of other medicinal products on sildenafil 

 

In vitro studies 

Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major 

route) and 2C9 (minor route). Therefore, inhibitors of these isoenzymes may reduce sildenafil 

clearance and inducers of these isoenzymes may increase sildenafil clearance. 

 

In vivo studies  

Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance 

when co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine).  

Although no increased incidence of adverse events was observed in these patients, when sildenafil is 

administered concomitantly with CYP3A4 inhibitors, a starting dose of 25 mg should be considered. 

 



21 

 

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. 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. This is consistent with ritonavir’s marked effects 

on a broad range of P450 substrates. Sildenafil had no effect on ritonavir pharmacokinetics. Based 

on these pharmacokinetic results co-administration of sildenafil with ritonavir is not advised (see 

section 4.4) and in any event the maximum dose of sildenafil should under no circumstances exceed 

25 mg within 48 hours. 

 

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. Sildenafil had no effect on saquinavir 

pharmacokinetics (see section 4.2). Stronger CYP3A4 inhibitors such as ketoconazole and 

itraconazole would be expected to have greater effects.  

 

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). In normal healthy male volunteers, there was no evidence of an effect of 

azithromycin (500 mg daily for 3 days) on the AUC, Cmax, tmax, elimination rate constant, or 

subsequent half-life of sildenafil or its principal circulating metabolite. 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. 

 

Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest 

increases in plasma levels of sildenafil. 

 

Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the 

bioavailability of sildenafil. 

 

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). In a study of healthy male volunteers, co-administration of the endothelin 

antagonist, bosentan, (an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19) at 

steady state (125 mg twice a day) with sildenafil at steady state (80 mg three times a day) resulted 

in 62.6% and 55.4% decrease in sildenafil AUC and Cmax, respectively. Therefore, concomitant 

administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases 

in plasma concentrations of sildenafil. 

 

Nicorandil is a hybrid of potassium channel activator and nitrate. Due to the nitrate component it 

has the potential to result in a serious interaction with sildenafil. 

 

Effects of sildenafil on other medicinal products 

 

In vitro studies 

Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 

(IC50 >150 μM). Given sildenafil peak plasma concentrations of approximately 1 μM after 

recommended doses, it is unlikely that VIAGRA will alter the clearance of substrates of these 

isoenzymes. 



22 

 

 

There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such 

as theophylline or dipyridamole. 

 

In vivo studies 

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).  

 

Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 

inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment 

the hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of 

the combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, 

including sildenafil, is contraindicated (see section 4.3). 

 

Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to 

symptomatic hypotension in a few susceptible individuals. This is most likely to occur within 4 

hours post sildenafil dosing (see sections 4.2 and 4.4). 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. 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. When sildenafil 

and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there 

were infrequent reports of patients who experienced symptomatic postural hypotension. These 

reports included dizziness and light-headedness, but not syncope.  

 

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. 

 

Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid 

(150 mg). 

 

Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with 

mean maximum blood alcohol levels of 80 mg/dl. 

 

Pooling of the following classes of antihypertensive medication: diuretics, beta-blockers, ACE 

inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and 

centrally-acting), 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. In a specific interaction study, where sildenafil (100 mg) was co-administered 

with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood 

pressure of 8 mmHg. The corresponding additional reduction in supine diastolic blood pressure was 

7 mmHg. These additional blood pressure reductions were of a similar magnitude to those seen 

when sildenafil was administered alone to healthy volunteers (see section 5.1). 

 

Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, 

saquinavir and ritonavir, both of which are CYP3A4 substrates.  

 

In healthy male volunteers, sildenafil at steady state (80 mg t.i.d.) resulted in a 49.8% increase in 

bosentan AUC and a 42% increase in bosentan Cmax (125 mg b.i.d.). 

 



23 

 

4.6 Fertility, pregnancy and lactation 

 

VIAGRA is not indicated for use by women. 

 

There are no adequate and well-controlled studies in pregnant or breast-feeding women.  

No relevant adverse effects were found in reproduction studies in rats and rabbits following oral 

administration of sildenafil. 

 

There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in 

healthy volunteers (see section 5.1). 

 

4.7 Effects on ability to drive and use machines 

 

VIAGRA may have a minor influence on the ability to drive and use machines.   

 

As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be 

aware of how they react to VIAGRA, before driving or operating machinery.  

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

The safety profile of VIAGRA is based on 9,570 patients in 74 double-blind placebo-controlled 

clinical studies. The most commonly reported adverse reactions in clinical studies among sildenafil 

treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, 

visual disturbance, cyanopsia and vision blurred. 

 

Adverse reactions from post-marketing surveillance has been gathered covering an estimated period 

>10 years. 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. 

 

Tabulated list of adverse reactions 

 

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).. Within each frequency grouping, undesirable effects are presented in order of 

decreasing seriousness. 

 

Table 1: Medically important adverse reactions reported at an incidence greater than 

placebo in controlled clinical studies and medically important adverse reactions reported 

through post-marketing surveillance  

 

System Organ 

Class 

Very 

common 

(  1/10) 

Common 

(  1/100 and 

<1/10) 

Uncommon 

(  1/1,000 and 

<1/100) 

Rare 

(  1/10,000 and <1/1,000) 

Infections and 

infestations 

  Rhinitis  

Immune system 

disorders 

  Hypersensitivity  



24 

 

System Organ 

Class 

Very 

common 

(  1/10) 

Common 

(  1/100 and 

<1/10) 

Uncommon 

(  1/1,000 and 

<1/100) 

Rare 

(  1/10,000 and <1/1,000) 

Nervous system 

disorders 

Headache Dizziness Somnolence, 

Hypoaesthesia 

Cerebrovascular accident,  

Transient ischaemic attack, 

Seizure*, Seizure 

recurrence,* Syncope 

Eye disorders  Visual colour 

distortions**, 

Visual 

disturbance, 

Vision blurred 

Lacrimation 

disorders***, 

Eye pain, 

Photophobia, 

Photopsia, 

Ocular 

hyperaemia, 

Visual 

brightness, 

Conjunctivitis 

Non-arteritic anterior 

ischaemic optic neuropathy 

(NAION)*, Retinal 

vascular occlusion*, 

Retinal haemorrhage, 

Arteriosclerotic 

retinopathy, Retinal 

disorder, Glaucoma, Visual 

field defect, Diplopia, 

Visual acuity reduced, 

Myopia, Asthenopia, 

Vitreous floaters, Iris 

disorder, Mydriasis, Halo 

vision, Eye oedema, Eye 

swelling, Eye disorder, 

Conjunctival hyperaemia, 

Eye irritation, Abnormal 

sensation in eye, Eyelid 

oedema, Scleral 

discoloration 

Ear and 

labyrinth 

disorders  

  Vertigo, 

Tinnitus 

Deafness 

Cardiac 

disorders 

  Tachycardia, 

Palpitations  

Sudden cardiac death*, 

Myocardial infarction, 

Ventricular arrhythmia*, 

Atrial fibrillation, Unstable 

angina 

Vascular 

disorders 

 Flushing, Hot 

flush 

Hypertension, 

Hypotension 

 

Respiratory, 

thoracic and 

mediastinal 

disorders 

 Nasal 

congestion 

Epistaxis, Sinus 

congestion 

Throat tightness, Nasal 

oedema, Nasal dryness 

Gastrointestinal 

disorders 

 Nausea, 

Dyspepsia 

Gastro 

oesophagael 

reflux disease, 

Vomiting, 

Abdominal pain 

upper, Dry 

Hypoaesthesia oral 



25 

 

System Organ 

Class 

Very 

common 

(  1/10) 

Common 

(  1/100 and 

<1/10) 

Uncommon 

(  1/1,000 and 

<1/100) 

Rare 

(  1/10,000 and <1/1,000) 

mouth 

Skin and 

subcutaneous 

tissue disorders 

  Rash Stevens-Johnson 

Syndrome (SJS)*, Toxic 

Epidermal Necrolysis 

(TEN)* 

Musculoskeletal 

and connective 

tissue disorders 

  Myalgia, Pain in 

extremity 

 

Renal and 

urinary 

disorders 

  Haematuria  

Reproductive 

system and 

breast disorders 

   Penile haemorrhage, 

Priapism*, 

Haematospermia, Erection 

increased 

General 

disorders and 

administration 

site conditions 

  Chest pain, 

Fatigue, Feeling 

hot 

Irritability 

Investigations   Heart rate 

increased 

 

*Reported during post-marketing surveillance only 

**Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia 

***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased 

 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 

 

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. 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. 

 

In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is 

not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not 

eliminated in the urine. 

 

 



26 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

 

Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction, ATC Code: G04B E03. 

 

Mechanism of action 

 

Sildenafil is an oral therapy for erectile dysfunction. In the natural setting, i.e. with sexual 

stimulation, it restores impaired erectile function by increasing blood flow to the penis. 

 

The physiological mechanism responsible for erection of the penis involves the release of nitric 

oxide (NO) in the corpus cavernosum during sexual stimulation. 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. 

  

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 has a 

peripheral site of action on erections. Sildenafil has no direct relaxant effect on isolated human 

corpus cavernosum but potently enhances the relaxant effect of NO on this tissue. 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. Therefore sexual stimulation is required in 

order for sildenafil to produce its intended beneficial pharmacological effects.  

 

Pharmacodynamic effects 

 

Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection 

process. Its effect is more potent on PDE5 than on other known phosphodiesterases. There is a 

10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. 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. 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. 

  

Clinical efficacy and safety 

 

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. 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. In a separate RigiScan study, sildenafil was still able to produce an erection in 

response to sexual stimulation 4-5 hours post-dose. 

 

Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do 

not translate into clinical effects. The mean maximum decreases in supine systolic blood pressure 

following 100 mg oral dosing of sildenafil was 8.4 mmHg. The corresponding change in supine 

diastolic blood pressure was 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. Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically 

relevant effects on ECG. 

 



27 

 

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. Mean pulmonary systolic blood pressure decreased by 9%. Sildenafil showed no effect on 

cardiac output, and did not impair blood flow through the stenosed coronary arteries. 

 

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). The results demonstrated no clinically relevant differences between sildenafil and 

placebo in time to limiting angina. 

 

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. The postulated mechanism for this change in colour discrimination 

is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina.  

Sildenafil has no effect on visual acuity or contrast sensitivity. 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).  

 

There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in 

healthy volunteers (see section 4.6). 

 

Further information on clinical trials 

In clinical trials sildenafil was administered to more than 8000 patients aged 19-87. 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%). 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).  

 

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. In controlled 

clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo.  

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%). The safety and efficacy of sildenafil was maintained in long-term studies.  

 

Paediatric population 

 

The European Medicines Agency has waived the obligation to submit the results of studies with 

VIAGRA in all subsets of the paediatric population for the treatment of erectile dysfunction. See 4.2 

for information on paediatric use.  

 

5.2 Pharmacokinetic properties 

 

Absorption 

 

Sildenafil is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 

120 minutes (median 60 minutes) of oral dosing in the fasted state.  The mean absolute oral 



28 

 

bioavailability is 41% (range 25-63%). After oral dosing of sildenafil AUC and Cmax increase in 

proportion with dose over the recommended dose range (25-100 mg). 

 

When film-coated tablets are taken with food, the rate of absorption of sildenafil is reduced with a 

mean delay in tmax of 60 minutes and a mean reduction in Cmax of 29%. 

 

In a clinical study in 36 healthy males 45 years or older, 50 mg orodispersible tablets administered 

without water were observed to be bioequivalent to the 50 mg film-coated tablets. In the same 

study, the AUC was unchanged but the mean Cmax was 14% lower when 50 mg orodispersible 

tablets were administered with water compared to 50 mg film-coated tablet. 

 

When orodispersible tablets is taken with a high fat meal, the rate of absorption of sildenafil is 

reduced, median Tmax is delayed by about 3.4 hours and mean Cmax and AUC are reduced 

respectively by about 59% and 12%, compared to administration of orodispersible tablets under 

fasting conditions (See Section 4.2). 

 

Distribution 

 

The mean steady state volume of distribution (Vd) for sildenafil is 105 l, indicating distribution into 

the tissues. After a single oral dose of 100 mg, the mean maximum total plasma concentration of 

sildenafil is approximately 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). Protein binding is independent of total 

drug concentrations.  

 

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. 

 

Biotransformation 

 

Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic 

microsomal isoenzymes. The major circulating metabolite results from N-demethylation of 

sildenafil. This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in 

vitro potency for PDE5 approximately 50% that of the parent drug. Plasma concentrations of this 

metabolite are approximately 40% of those seen for sildenafil. The N-desmethyl metabolite is further 

metabolised, with a terminal half-life of approximately 4 h. 

 

Elimination 

 

The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half-life of 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). 

 

Pharmacokinetics in special patient groups 

 

Elderly 

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). Due to age-differences in 

plasma protein binding, the corresponding increase in free sildenafil plasma concentration was 

approximately 40%. 

 



29 

 

Renal insufficiency 

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. 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. However, due to high inter-subject 

variability, these differences were not statistically significant. 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. In addition, N-desmethyl metabolite AUC and Cmax values were 

significantly increased by 200% and 79% respectively. 

 

Hepatic insufficiency 

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. The pharmacokinetics of sildenafil in patients with severely impaired 

hepatic function have not been studied. 

 

5.3 Preclinical safety data 

 

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 and development. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Microcrystalline cellulose 

Silica, hydrophobic colloidal 

Croscarmellose sodium 

Magnesium stearate 

Indigo carmine aluminium lake (E132) 

Sucralose  

Mannitol 

Crospovidone 

Polyvinyl acetate 

Povidone 

 

Flavouring contains: 

Maltodextrin 

Dextrin 

 

Natural flavouring contains: 

Maltodextrin 

Glycerol (E422)  

Propylene glycol (E1520) 

 

Lemon flavouring contains:  

Maltodextrin 

Alpha-tocopherol (E307) 

 



30 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

3 years. 

 

6.4 Special precautions for storage 

 

This medicinal product does not require any special temperature storage conditions. 

Store in the original package in order to protect from moisture.  

 

6.5 Nature and contents of container 

 

Aluminium blisters in cartons of 2, 4, 8 or 12 tablets. Not all pack sizes may be marketed.  

 

6.6 Special precautions for disposal and other handling 

 

No special requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

8. MARKETING AUTHORISATION NUMBERS  

 

EU/1/98/077/020-023 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 14 September 1998 

Date of latest renewal: 14 September 2008 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 



31 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE  

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

 AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

 EFFECTIVE USE OF THE MEDICINAL PRODUCT 



32 

 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer(s) responsible for batch release 

 

Fareva Amboise  

Zone Industrielle 

29 route des Industries 

37530 Pocé-sur-Cisse 

France 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to medical prescription 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

• Periodic Safety Update Reports  

 

The requirements for submission of periodic safety update reports for this medic inal product are 

set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 

Directive 2001/83/EC and any subsequent updates published on the European medicines web-

portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

• Risk Management Plan (RMP) 

 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 

agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 

subsequent updates of the RMP. 

 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile or 

as the result of an important (pharmacovigilance or risk minimisation) milestone being 

reached. 

 

 



33 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



34 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 



35 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

OUTER CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

VIAGRA 25 mg film-coated tablets 

Sildenafil  

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose.  

See package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

2 film-coated tablets 

4 film-coated tablets 

8 film-coated tablets 

12 film-coated-tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

For oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



36 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30C. 

Store in the original package in order to protect from moisture.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Marketing Authorisation Holder: 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/98/077/013 (2 film-coated tablets) 

EU/1/98/077/002 (4 film-coated tablets) 

EU/1/98/077/003 (8 film-coated tablets) 

EU/1/98/077/004 (12 film-coated tablets) 

 

 

13. BATCH NUMBER 

 

Batch 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

VIAGRA 25 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



37 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



38 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

OUTER CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

VIAGRA 50 mg film-coated tablets 

Sildenafil 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose. 

See package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

2 film-coated tablets 

4 film-coated tablets 

8 film-coated tablets 

12 film-coated tablets 

24 film-coated tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

For oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 



39 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30C. 

Store in the original package in order to protect from moisture.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Marketing Authorisation Holder: 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/98/077/014 (2 film-coated tablets) 

EU/1/98/077/006 (4 film-coated tablets) 

EU/1/98/077/007 (8 film-coated tablets) 

EU/1/98/077/008 (12 film-coated tablets) 

EU/1/98/077/024 (24 film-coated tablets) 

 

 

13. BATCH NUMBER 

 

Batch 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

VIAGRA 50 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



40 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



41 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

SECONDARY HEAT SEALED CARD PACKAGING 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

VIAGRA 50 mg film-coated tablets 

Sildenafil 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose. 

See package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

2 film-coated tablets 

4 film-coated tablets 

8 film-coated tablets 

12 film-coated tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

For oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



42 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30C. 

Store in the original package in order to protect from moisture.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Marketing Authorisation Holder: 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/98/077/016 (2 film-coated tablets) 

EU/1/98/077/017 (4 film-coated tablets) 

EU/1/98/077/018 (8 film-coated tablets) 

EU/1/98/077/019 (12 film-coated tablets) 

 

 

13. BATCH NUMBER 

 

Batch 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

VIAGRA 50 mg  

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



43 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



44 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

VIAGRA 100 mg film-coated tablets 

Sildenafil 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose 

See package leaflet for further information 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

2 film-coated tablets 

4 film-coated tablets 

8 film-coated tablets 

12 film-coated tablets 

24 film-coated tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

For oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 



45 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30C. 

Store in the original package in order to protect from moisture. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Marketing Authorisation Holder: 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/98/077/015 (2 film-coated tablets) 

EU/1/98/077/010 (4 film-coated tablets) 

EU/1/98/077/011 (8 film-coated tablets) 

EU/1/98/077/012 (12 film-coated tablets) 

EU/1/98/077/025 (24 film-coated tablets) 

 

 

13. BATCH NUMBER 

 

Batch 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

VIAGRA 100 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



46 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



47 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

 

OUTER CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

VIAGRA 50 mg orodispersible tablets 

Sildenafil 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

2 orodispersible tablets 

4 orodispersible tablets 

8 orodispersible tablets 

12 orodispersible tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Dissolve in the mouth. 

Recommend tablet be taken on an empty stomach. 

Read the package leaflet before use. 

Oral use. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



48 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store in the original package in order to protect from moisture.  

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Marketing Authorisation Holder: 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/98/077/020 (2 orodispersible tablets) 

EU/1/98/077/021 (4 orodispersible tablets) 

EU/1/98/077/022 (8 orodispersible tablets) 

EU/1/98/077/023 (12 orodispersible tablets) 

 

 

13. BATCH NUMBER 

 

Batch 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

VIAGRA 50 mg orodispersible tablets 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 



49 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



50 

 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

VIAGRA 25 mg tablets 

Sildenafil 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Batch 

 

 

5. OTHER 

 

 



51 

 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

VIAGRA 50 mg tablets 

Sildenafil 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer 

 

 

3. EXPIRY DATE 

 

EXP  

 

 

4. BATCH NUMBER 

 

Batch  

 

 

5. OTHER 

 

 



52 

 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS  

 

BLISTER 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

VIAGRA 100 mg tablets 

Sildenafil 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Batch 

 

 

5. OTHER 

 



53 

 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

VIAGRA 50 mg orodispersible tablets 

Sildenafil 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Batch 

 

 

5. OTHER 

 

 



54 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET  



55 

 

Package leaflet: Information for the patient 

 

VIAGRA 25 mg film-coated tablets 

Sildenafil  

 

Read all of this leaflet carefully before you start taking this medicine  because it contains 

important information for you. 

− Keep this leaflet. You may need to read it again. 

− If you have any further questions, ask your doctor, pharmacist or nurse. 

− This medicine has been prescribed for you only. Do not pass it on to others. It may harm 

them, even if their signs of illness are the same as yours. 

− If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 

possible side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

1. What VIAGRA is and what it is used for 

2. What you need to know before you take VIAGRA 

3. How to take VIAGRA 

4. Possible side effects 

5. How to store VIAGRA 

6. Contents of the pack and other information 

 

 

1. What VIAGRA is and what it is used for 

 

VIAGRA contains the active substance sildenafil which belongs to a group of medicines called 

phosphodiesterase type 5 (PDE5) inhibitors. 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 will only help 

you to get an erection if you are sexually stimulated.  

 

VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. 

This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.  

 

 

2. What you need to know before you take VIAGRA 

 

Do not take VIAGRA 

− If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in 

section 6). 

 

− If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in 

your blood pressure. Tell your doctor if you are taking any of these medicines which are 

often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your 

doctor or pharmacist. 

 

− If you are using any of the medicines known as nitric oxide donors such as amyl nitrite 

(“poppers”), as the combination may also lead to a dangerous fall in your blood pressure. 

 

− If you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., 

high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., 

high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Viagra 



56 

 

have been shown to increase the hypotensive effects of this medicine. If you are taking 

riociguat or are unsure tell your doctor. 

 

− If you have a severe heart or liver problem. 

 

− If you have recently had a stroke or a heart attack, or if you have low blood pressure.  

 

− If you have certain rare inherited eye diseases (such as retinitis pigmentosa). 

  

− If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy 

(NAION). 

 

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before taking VIAGRA 

− If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of 

blood cells), multiple myeloma (cancer of bone marrow). 

 

− If you have a deformity of your penis or Peyronie’s Disease.  

 

− If you have problems with your heart. Your doctor should carefully check whether your 

heart can take the additional strain of having sex. 

 

− If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).  

 

− If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your 

doctor immediately. 

 

You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.  

You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing 

sildenafil or any other PDE5 inhibitors. 

 

You should not take VIAGRA if you do not have erectile dysfunction. 

 

You should not take VIAGRA if you are a woman. 

 

Special considerations for patients with kidney or liver problems 

You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a 

lower dose for you.  

 

Children and adolescents 

VIAGRA should not be given to individuals under the age of 18. 

 

Other medicines and VIAGRA 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

VIAGRA tablets may interfere with some medicines, especially those used to treat chest pain. In the 

event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken 

VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells 

you that you can. 

 



57 

 

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of 

these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, 

pharmacist or nurse if you are taking any of these medicines that are often used for the relief of 

angina pectoris (or “chest pain”). 

 

You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors 

such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood 

pressure. 

 

Tell your doctor or pharmacist if you are already taking riociguat.  

 

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your 

doctor may start you on the lowest dose (25 mg) of VIAGRA. 

 

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate 

enlargement may experience dizziness or light-headedness, which may be caused by low blood 

pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms 

when taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking 

VIAGRA. To reduce the chance that these symptoms might happen, you should be on a regular 

daily dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a lower 

dose (25 mg) of VIAGRA. 

 

VIAGRA with food and drink  and alcohol 

VIAGRA can be taken with or without food. However, you may find that VIAGRA takes longer to 

start working if you take it with a heavy meal. 

 

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit 

from your medicine, you are advised not to drink excessive amounts of alcohol before taking 

VIAGRA. 

 

Pregnancy, breast-feeding and fertility 

VIAGRA is not indicated for use by women. 

 

Driving and using machines 

VIAGRA can cause dizziness and can affect vision. You should be aware of how you react to 

VIAGRA before you drive or use machinery. 

 

VIAGRA contains lactose 

If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, 

contact your doctor before taking VIAGRA. 

 

 

3. How to take VIAGRA 

 

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your 

doctor or pharmacist if you are not sure. The recommended starting dose is 50 mg. 

 

You should not take VIAGRA more than once a day. 

 

Do not take VIAGRA film-coated tablets in combination with VIAGRA orodispersible tablets.  

 



58 

 

You should take VIAGRA about one hour before you plan to have sex. Swallow the tablet whole 

with a glass of water.  

 

If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.  

 

VIAGRA will only help you to get an erection if you are sexually stimulated. The amount of time 

VIAGRA takes to work varies from person to person, but it normally takes between half an hour 

and one hour. You may find that VIAGRA takes longer to work if you take it with a heavy meal.  

 

If VIAGRA does not help you to get an erection, or if your erection does not last long enough for 

you to complete sexual intercourse you should tell your doctor. 

 

If you take more VIAGRA than you should: 

You may experience an increase in side effects and their severity. Doses above 100 mg do not 

increase the efficacy. 

 

You should not take more tablets than your doctor tells you to.  

 

Contact your doctor if you take more tablets than you should. 

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or 

nurse. 

 

 

4. Possible side effects  

 

Like all medicines, this medicine can cause side effects although not everybody gets them. The side 

effects reported in association with the use of VIAGRA are usually mild to moderate and of a short 

duration. 

 

If you experience any of the following serious side effects stop taking VIAGRA and see k 

medical help immediately: 

 

• An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people) 

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the 

eyelids, face, lips or throat. 

 

• Chest pains - this occurs uncommonly 

 If this occurs during or after intercourse 

  - Get in a semi-sitting position and try to relax. 

  - Do not use nitrates to treat your chest pain. 

 

•  Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 

1,000 people) 

  If you have an erection which lasts for more than 4 hours, you should contact a doctor 

 immediately. 

 

•  A sudden decrease or loss of vision - this occurs rarely 

 

•  Serious skin reactions - this occurs rarely  

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, 

genitals and around the eyes, fever. 



59 

 

 

•  Seizures or fits - this occurs rarely  

 

Other side effects: 

 

Very common (may affect more than 1 in 10 people): headache.  

 

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a 

sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual 

disturbance, stuffy nose and dizziness. 

 

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. 

 

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, 

temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb 

mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal 

sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing 

halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile 

bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable 

and sudden decrease or loss of hearing. 

 

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have 

been reported rarely. Of note, most, but not all, of the men who experienced these side effects had 

heart problems before taking this medicine. It is not possible to determine whether these events  

were directly related to VIAGRA. 

 

Reporting of side effects 

If you get any side effects, talk to you doctor or pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. You can also report side effects directly via the national 

reporting system listed in Appendix V. By reporting side effects you can help provide more 

information on the safety of this medicine. 

 

 

5. How to store VIAGRA 

 

Keep this medicine out of the sight and reach of children. 

Do not store above 30oC.  

 

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 

The expiry date refers to the last day of that month. 

Store in the original package, in order to protect from moisture.  

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how 

to throw away medicines you no longer use. These measures will help protect the environment. 

 

 



60 

 

6. Contents of the pack and other information 

 

What VIAGRA contains 

− The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as the citrate salt). 

− The other ingredients are: 

− Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous),  

  croscarmellose sodium, magnesium stearate,  

− Film coat:  hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, 

indigo   carmine aluminium lake (E132) 

 

What VIAGRA looks like and contents of the pack  

VIAGRA film-coated tablets are blue, with a rounded-diamond shape. They are marked “PFIZER” 

on one side and “VGR 25” on the other side. The tablets are provided in blister packs containing 2, 

4, 8 or 12 tablets. Some pack sizes may not be marketed in your country.  

 

Marketing Authorisation Holder and Manufacturer 

The marketing authorisation holder of VIAGRA is Pfizer Europe MA EEIG, Boulevard de la Plaine 

17, 1050 Bruxelles, Belgium. 

The manufacturer of VIAGRA is Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 

Pocé-sur-Cisse, France. 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder. 

 

België /Belgique / Belgien 

Pfizer S.A./ N.V. 

Tél/Tel: +32 (0)2 554 62 11 

 

Luxembourg/Luxemburg 

Pfizer S.A. 

Tél/Tel: +32 (0)2 554 62 11 

 

България  

Пфайзер Люксембург САРЛ, Клон България 

Тел.: +359 2 970 4333 

 

Magyarország 

Pfizer Kft.  

Tel.: + 36 1 488 37 00  

Česká republika 

Pfizer s.r.o.  

Tel: +420-283-004-111 

 

Malta 

Vivian Corporation Ltd. 

Tel: +356 21344610 

Danmark 

Pfizer ApS 

Tlf: +45 44 20 11 00 

 

Nederland 

Pfizer bv 

Tel: +31 (0)10 406 43 01 

Deutschland 

Pfizer OFG Germany GmbH 

Tel: +49 (0)800 5500634 

Norge 

Pfizer AS 

Tlf: +47 67 52 61 00 

 

Eesti 

Pfizer Luxembourg SARL Eesti filiaal 

Tel: +372 666 7500 

 

Österreich 

Pfizer Corporation Austria Ges.m.b.H. 

Tel: +43 (0)1 521 15-0 

 



61 

 

Ελλάδα 

UPJOHN HELLAS ΕΠΕ 

Τηλ.: +30 2100 100 002 

 

Polska 

Pfizer Polska Sp. z o.o.,  

Tel.: +48 22 335 61 00 

 

España 

Pfizer GEP, S.L. 

Tel: +34 91 490 99 00 

Portugal 

Laboratórios Pfizer, Lda.  

Tel: +351 21 423 5500 

 

France 

Pfizer PFE France 

Tél: +33 (0)1 58 07 34 40 

 

România 

Pfizer România S.R.L. 

Tel: +40 (0)21 207 28 00 

 

Hrvatska 

Pfizer Croatia d.o.o. 

Tel: + 385 1 3908 777 

 

Slovenija 

Pfizer Luxembourg SARL, Pfizer, podružnica za 

svetovanje s področja farmacevtske dejavnosti, 

Ljubljana 

Tel: + 386(0)152 11 400 

 

Ireland 

Pfizer Healthcare Ireland 

Tel: 1800 633 363 (toll free) 

Tel: +44 (0)1304 616161 

Slovenská republika 

Pfizer Luxembourg SARL, organizačná zložka 

Tel: +421–2–3355 5500 

 

 

Ísland 

Icepharma hf. 

Sími: + 354 540 8000 

 

Suomi/Finland 

Pfizer Oy 

Puh/Tel: +358(0)9 43 00 40 

 

Italia 

Pfizer Established Medicine Italy S.r.l. 

Tel: +39 06 33 18 21 

 

Sverige  

Pfizer AB 

Tel: +46 (0)8 550 520 00 

 

Κύπρος 

PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH), 

Τηλ: +357 22 817690 

 

United Kingdom 

Pfizer Limited 

Tel: +44 (0)1304 616161 

 

Latvija 

Pfizer Luxembourg SARL filiāle Latvijā 

Tel: +371 670 35 775 

 

 

Lietuva 

Pfizer Luxembourg SARL, filialas Lietuvoje 

Tel. +3705 2514000 

 

 

 

This leaflet was last revised in {MM/YYYY}. 

 

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 



62 

 

Package leaflet: Information for the patient 

 

VIAGRA 50 mg film-coated tablets 

Sildenafil 

 

 

Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 

− Keep this leaflet. You may need to read it again. 

− If you have any further questions, ask your doctor, pharmacist or nurse.  

− This medicine has been prescribed for you only. Do not pass it on to others. It may harm 

them, even if their signs of illness are the same as yours.  

− If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 

possible side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

1. What VIAGRA is and what it is used for 

2. What you need to know before you take VIAGRA 

3. How to take VIAGRA 

4. Possible side effects 

5. How to store VIAGRA 

6. Contents of the pack and other information 

 

 

1. What VIAGRA is and what it is used for 

 

VIAGRA contains the active substance sildenafil which belongs to a group of medicines called 

phosphodiesterase type 5 (PDE5) inhibitors. 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 will only help 

you to get an erection if you are sexually stimulated.  

VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. 

This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.  

 

 

2. What you need to know before you take VIAGRA 

 

Do not take VIAGRA 

− If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in 

section 6). 

 

− If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in 

your blood pressure. Tell your doctor if you are taking any of these medicines which are 

often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your 

doctor or pharmacist. 

 

− If you are using any of the medicines known as nitric oxide donors such as amyl nitrite 

(“poppers”), as the combination may also lead to a dangerous fall in your blood pressure. 

 

− If you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., 

high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., 

high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Viagra 



63 

 

have been shown to increase the hypotensive effects of this medicine. If you are taking 

riociguat or are unsure tell your doctor. 

 

− If you have a severe heart or liver problem. 

 

− If you have recently had a stroke or a heart attack, or if you have low blood pressure.  

 

− If you have certain rare inherited eye diseases (such as retinitis pigmentosa). 

 

− If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy 

(NAION). 

 

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before taking VIAGRA  

− If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of 

blood cells), multiple myeloma (cancer of bone marrow). 

 

− If you have a deformity of your penis or Peyronie’s Disease.  

 

− If you have problems with your heart. Your doctor should carefully check whether your 

heart can take the additional strain of having sex. 

 

− If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).  

 

− If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your 

doctor immediately. 

 

You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.  

You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing 

sildenafil or any other PDE5 inhibitors. 

 

You should not take VIAGRA if you do not have erectile dysfunction. 

 

You should not take VIAGRA if you are a woman. 

 

Special considerations for patients with kidney or liver problems 

You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a 

lower dose for you.  

 

Children and adolescents 

VIAGRA should not be given to individuals under the age of 18. 

 

Other medicines and VIAGRA 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

VIAGRA tablets may interfere with some medicines, especially those used to treat chest pain. In the 

event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken 

VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells 

you that you can. 

 



64 

 

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of 

these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, 

pharmacist or nurse if you are taking any of these medicines that are often used for the relief of 

angina pectoris (or “chest pain”). 

 

You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors 

such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood 

pressure. 

 

Tell your doctor or pharmacist if you are already taking riociguat.  

 

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your 

doctor may start you on the lowest dose (25 mg) of VIAGRA. 

 

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate 

enlargement may experience dizziness or light-headedness, which may be caused by low blood 

pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms 

when taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking 

VIAGRA. In order to reduce the chance that these symptoms might happen, you should be on a 

regular daily dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a 

lower dose (25 mg) of VIAGRA. 

 

VIAGRA with food and drink  and alcohol 

VIAGRA can be taken with or without food. However, you may find that VIAGRA takes longer to 

start working if you take it with a heavy meal. 

 

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit 

from your medicine, you are advised not to drink excessive amounts of alcohol before taking 

VIAGRA. 

 

Pregnancy, breast-feeding and fertility 

VIAGRA is not indicated for use by women. 

 

Driving and using machines 

VIAGRA can cause dizziness and can affect vision. You should be aware of how you react to 

VIAGRA before you drive or use machinery. 

 

VIAGRA contains lactose 

If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, 

contact your doctor before taking VIAGRA. 

 

 

3. How to take VIAGRA 

 

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your 

doctor or pharmacist if you are not sure. The recommended starting dose is 50 mg. 

 

You should not take VIAGRA more than once a day.  

 

Do not take VIAGRA film-coated tablets in combination with VIAGRA orodispersible tablets.  

 

You should take VIAGRA about one hour before you plan to have sex. Swallow the tablet whole 

with a glass of water.  



65 

 

 

If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.  

 

VIAGRA will only help you to get an erection if you are sexually stimulated. The amount of time 

VIAGRA takes to work varies from person to person, but it normally takes between half an hour 

and one hour. You may find that VIAGRA takes longer to work if you take it with a heavy meal.  

 

If VIAGRA does not help you to get an erection, or if your erection does not last long enough for 

you to complete sexual intercourse you should tell your doctor.  

 

If you take more VIAGRA than you should: 

You may experience an increase in side effects and their severity. Doses above 100 mg do not 

increase the efficacy.  

 

You should not take more tablets than your doctor tells you to.  

 

Contact your doctor if you take more tablets than you should. 

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or 

nurse. 

 

 

4. Possible side effects  

 

Like all medicines, this medicine can cause side effects although not everybody gets them. The side 

effects reported in association with the use of VIAGRA are usually mild to moderate and of a short 

duration. 

 

If you experience any of the following serious side effects stop taking VIAGRA and seek 

medical help immediately: 

 

• An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people) 

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the 

eyelids, face, lips or throat. 

 

• Chest pains - this occurs uncommonly  

If this occurs during or after intercourse 

  - Get in a semi-sitting position and try to relax. 

 - Do not use nitrates to treat your chest pain. 

 

• Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 

1,000 people) 

If you have an erection which lasts for more than 4 hours, you should contact a doctor 

immediately. 

 

• A sudden decrease or loss of vision - this occurs rarely 

 

•  Serious skin reactions - this occurs rarely 

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, 

genitals and around the eyes, fever. 

 

•  Seizures or fits - this occurs rarely  



66 

 

 

Other side effects: 

 

Very common (may affect more than 1 in 10 people): headache.  

 

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a 

sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual 

disturbance, stuffy nose and dizziness. 

 

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. 

 

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, 

temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb 

mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal 

sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing 

halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile 

bleeding, presence of blood in semen,dry nose, swelling of the inside of the nose, feeling irritable 

and sudden decrease or loss of hearing. 

 

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have 

been reported rarely. Of note, most, but not all, of the men who experienced these side effects had 

heart problems before taking this medicine. It is not possible to determine whether these events 

were directly related to VIAGRA.  

 

Reporting of side effects 

If you get any side effects, talk to you doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store VIAGRA 

 

Keep this medicine out of the sight and reach of children. 

Do not store above 30oC. 

 

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 

The expiry date refers to the last day of that month. 

Store in the original package, in order to protect from moisture.  

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how 

to throw away medicines you no longer use. These measures will help protect the environment. 

 

 



67 

 

6. Contents of the pack and other information 

 

What VIAGRA contains 

− The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as the citrate salt). 

− The other ingredients are: 

− Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous),  

  croscarmellose sodium, magnesium stearate,  

− Film coat:  hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, 

indigo   carmine aluminium lake (E132) 

 

What VIAGRA looks like and contents of the pack  

VIAGRA film-coated tablets are blue, with a rounded-diamond shape. They are marked “PFIZER” 

on one side and “VGR 50” on the other side. The tablets are provided in blister packs containing 2, 

4, 8, 12 or 24 tablets in a carton or card packaging. Some pack sizes may not be marketed in your 

country. 

 

Marketing Authorisation Holder and Manufacturer 

The marketing authorisation holder of VIAGRA is Pfizer Europe MA EEIG, Boulevard de la Plaine 

17, 1050 Bruxelles, Belgium. 

 

The manufacturer of VIAGRA is Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 

Pocé-sur-Cisse, France. 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder. 

 

België /Belgique / Belgien 

Pfizer S.A./ N.V. 

Tél/Tel: +32 (0)2 554 62 11 

 

Luxembourg/Luxemburg 

Pfizer S.A.  

Tél/Tel: +32 (0)2 554 62 11 

 

България  

Пфайзер Люксембург САРЛ, Клон България 

Тел.: +359 2 970 4333 

 

Magyarország 

Pfizer Kft.  

Tel.: + 36 1 488 37 00  

Česká republika 

Pfizer s.r.o.  

Tel: +420-283-004-111 

 

Malta 

Vivian Corporation Ltd. 

Tel: +356 21344610 

Danmark 

Pfizer ApS 

Tlf: +45 44 20 11 00 

 

Nederland 

Pfizer bv 

Tel: +31 (0)10 406 43 01 

Deutschland 

Pfizer OFG Germany GmbH 

Tel: +49 (0)800 5500634 

Norge 

Pfizer AS 

Tlf: +47 67 52 61 00 

 

Eesti 

Pfizer Luxembourg SARL Eesti filiaal 

Tel: +372 666 7500 

 

Österreich 

Pfizer Corporation Austria Ges.m.b.H. 

Tel: +43 (0)1 521 15-0 

 



68 

 

Ελλάδα 

UPJOHN HELLAS ΕΠΕ 

Τηλ.: +30 2100 100 002 

 

Polska 

Pfizer Polska Sp. z o.o.,  

Tel.: +48 22 335 61 00 

 

España 

Pfizer GEP, S.L. 

Tel: +34 91 490 99 00 

Portugal 

Laboratórios Pfizer, Lda.  

Tel: +351 21 423 5500 

 

France 

Pfizer PFE France 

Tél: +33 (0)1 58 07 34 40 

 

România 

Pfizer România S.R.L. 

Tel: +40 (0)21 207 28 00 

 

Hrvatska 

Pfizer Croatia d.o.o. 

Tel: + 385 1 3908 777 

 

Slovenija 

Pfizer Luxembourg SARL, Pfizer, podružnica za 

svetovanje s področja farmacevtske dejavnosti, 

Ljubljana 

Tel: + 386(0)152 11 400 

 

Ireland 

Pfizer Healthcare Ireland 

Tel: 1800 633 363 (toll free) 

Tel: +44 (0)1304 616161 

Slovenská republika 

Pfizer Luxembourg SARL, organizačná zložka 

Tel: +421–2–3355 5500 

 

 

Ísland 

Icepharma hf. 

Sími: + 354 540 8000 

 

Suomi/Finland 

Pfizer Oy 

Puh/Tel: +358(0)9 43 00 40 

 

Italia 

Pfizer Established Medicine Italy S.r.l. 

Tel: +39 06 33 18 21 

 

Sverige  

Pfizer AB 

Tel: +46 (0)8 550 520 00 

 

Κύπρος 

PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH), 

Τηλ: +357 22 817690 

 

United Kingdom 

Pfizer Limited 

Tel: +44 (0)1304 616161 

 

 

Latvija 

Pfizer Luxembourg SARL filiāle Latvijā 

Tel: +371 670 35 775 

 

 

Lietuva 

Pfizer Luxembourg SARL, filialas Lietuvoje 

Tel. +3705 2514000 

 

 

 

This leaflet was last revised in {MM/YYYY}. 

 

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 

 



69 

 

Package leaflet: Information for the patient 

 

VIAGRA 100 mg film-coated tablets 

Sildenafil 

 

 

Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 

− Keep this leaflet. You may need to read it again. 

− If you have any further questions, ask your doctor, pharmacist or nurse.  

− This medicine has been prescribed for you only. Do not pass it on to others. It may harm 

them, even if their signs of illness are the same as yours.  

− If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 

possible side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

1. What VIAGRA is and what it is used for 

2. What you need to know before you take VIAGRA 

3. How to take VIAGRA 

4. Possible side effects 

5. How to store VIAGRA 

6. Contents of the pack and other information 

 

 

1. What VIAGRA is and what it is used for 

 

VIAGRA contains the active substance sildenafil which belongs to a group of medicines called 

phosphodiesterase type 5 (PDE5) inhibitors. 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 will only help 

you to get an erection if you are sexually stimulated.  

 

VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. 

This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. 

 

 

2. What you need to know before you take VIAGRA 

 

Do not take VIAGRA 

− If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in 

section 6). 

 

− If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in 

your blood pressure. Tell your doctor if you are taking any of these medicines which are 

often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your 

doctor or pharmacist. 

 

− If you are using any of the medicines known as nitric oxide donors such as amyl nitrite 

(“poppers”), as the combination may also lead to a dangerous  fall in your blood pressure. 

 

− If you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., 

high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., 

high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Viagra 



70 

 

have been shown to increase the hypotensive effects of this medicine. If you are taking 

riociguat or are unsure tell your doctor. 

 

− If you have a severe heart or liver problem. 

 

− If you have recently had a stroke or a heart attack, or if you have low blood pressure.  

 

− If you have certain rare inherited eye diseases (such as retinitis pigmentosa). 

 

− If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy 

(NAION). 

 

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before taking VIAGRA  

− If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of 

blood cells), multiple myeloma (cancer of bone marrow). 

 

− If you have a deformity of your penis or Peyronie’s Disease.  

 

− If you have problems with your heart. Your doctor should carefully check whether your 

heart can take the additional strain of having sex. 

 

− If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).  

 

− If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your 

doctor immediately. 

 

You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.  

You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing 

sildenafil or any other PDE5 inhibitors. 

 

You should not take VIAGRA if you do not have erectile dysfunction. 

 

You should not take VIAGRA if you are a woman. 

 

Special considerations for patients with kidney or liver problems 

You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a 

lower dose for you.  

 

Children and adolescents 

VIAGRA should not be given to individuals under the age of 18. 

 

Other medicines and VIAGRA 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

VIAGRA tablets may interfere with some medicines, especially those used to treat chest pain. In the 

event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken 

VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells 

you that you can. 

 



71 

 

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of 

these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, 

pharmacist or nurse if you are taking any of these medicines that are often used for the relief of 

angina pectoris (or “chest pain”). 

 

You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors 

such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood 

pressure. 

 

Tell your doctor or pharmacist if you are already taking riociguat.  

 

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your 

doctor may start you on the lowest dose (25 mg) of VIAGRA. 

 

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate 

enlargement may experience dizziness or light-headedness, which may be caused by low blood 

pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms 

when taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking 

VIAGRA. To reduce the chance that these symptoms might happen, you should be on a regular 

daily dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a lower 

dose (25 mg) of VIAGRA. 

 

VIAGRA with food and drink  and alcohol 

VIAGRA can be taken with or without food. However, you may find that VIAGRA takes longer to 

start working if you take it with a heavy meal. 

 

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit 

from your medicine, you are advised not to drink excessive amounts of alcohol before taking 

VIAGRA. 

 

Pregnancy, breast-feeding and fertility 

VIAGRA is not indicated for use by women. 

 

Driving and using machines 

VIAGRA can cause dizziness and can affect vision. You should be aware of how you react to 

VIAGRA before you drive or use machinery. 

 

VIAGRA contains lactose 

If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, 

contact your doctor before taking VIAGRA. 

 

 

3. How to take VIAGRA 

 

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your 

doctor or pharmacist if you are not sure. The recommended starting dose is 50 mg. 

 

You should not take VIAGRA more than once a day. 

 

Do not take VIAGRA film-coated tablets in combination with VIAGRA orodispersible tablets.  

 



72 

 

You should take VIAGRA about one hour before you plan to have sex. Swallow the tablet whole 

with a glass of water.  

 

If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.  

 

VIAGRA will only help you to get an erection if you are sexually stimulated. The amount of time 

VIAGRA takes to work varies from person to person, but it normally takes between half an hour 

and one hour. You may find that VIAGRA takes longer to work if you take it with a heavy meal.  

 

If VIAGRA does not help you to get an erection, or if your erection does not last long enough for 

you to complete sexual intercourse you should tell your doctor.  

 

If you take more VIAGRA than you should: 

You may experience an increase in side effects and their severity. Doses above 100 mg do not 

increase the efficacy.  

 

You should not take more tablets than your doctor tells you to.  

 

Contact your doctor if you take more tablets than you should. 

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or 

nurse. 

 

 

4. Possible side effects  

 

Like all medicines, this medicine can cause side effects although not everybody gets them. The side 

effects reported in association with the use of VIAGRA are usually mild to moderate and of a short 

duration. 

 

If you experience any of the following serious side effects stop taking VIAGRA and seek 

medical help immediately: 

 

• An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people) 

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the 

eyelids, face, lips or throat. 

 

• Chest pains - this occurs uncommonly 

If this occurs during or after intercourse  

  - Get in a semi-sitting position and try to relax. 

  - Do not use nitrates to treat your chest pain. 

 

•  Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 

1,000 people)  

 If you have an erection which lasts for more than 4 hours, you should contact a doctor  

 immediately. 

 

•  A sudden decrease or loss of vision - this occurs rarely  

 

•  Serious skin reactions - this occurs rarely  

 Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, 

 genitals and around the eyes, fever. 



73 

 

 

•  Seizures or fits - this occurs rarely 

 

Other side effects: 

 

Very common (may affect more than 1 in 10 people): headache. 

 

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a 

sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual 

disturbance, stuffy nose and dizziness. 

 

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. 

 

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, 

temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb 

mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal 

sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing 

halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile 

bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable 

and sudden decrease or loss of hearing. 

 

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have 

been reported rarely. Of note, most, but not all, of the men who experienced these side effects had 

heart problems before taking this medicine. It is not possible to determine whether these events 

were directly related to VIAGRA.  

 

Reporting of side effects 

If you get any side effects, talk to you doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store VIAGRA 

 

Keep this medicine out of the sight and reach of children. 

Do not store above 30oC. 

 

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 

The expiry date refers to the last day of that month. 

Store in the original package, in order to protect from moisture.  

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how 

to throw away medicines you no longer use. These measures will help protect the environment. 

 

 



74 

 

6. Contents of the pack and other information 

 

What VIAGRA contains 

− The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as the citrate 

salt). 

− The other ingredients are: 

− Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous),  

  croscarmellose sodium, magnesium stearate,  

− Film coat:  hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin, 

indigo   carmine aluminium lake (E132) 

 

What VIAGRA looks like and contents of the pack  

VIAGRA film-coated tablets are blue, with a rounded-diamond shape. They are marked “PFIZER” 

on one side and “VGR 100” on the other side. The tablets are provided in blister packs containing 2, 

4, 8, 12 or 24 tablets. Some pack sizes may not be marketed in your country. 

 

Marketing Authorisation Holder and Manufacturer 

The marketing authorisation holder of VIAGRA is Pfizer Europe MA EEIG, Boulevard de la Plaine 

17, 1050 Bruxelles, Belgium. 

 

The manufacturer of VIAGRA is Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 

Pocé-sur-Cisse, France. 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder. 

 

België /Belgique / Belgien 

Pfizer S.A./ N.V. 

Tél/Tel: +32 (0)2 554 62 11 

 

Luxembourg/Luxemburg 

Pfizer S.A. 

Tél/Tel: +32 (0)2 554 62 11 

 

България  

Пфайзер Люксембург САРЛ, Клон България 

Тел.: +359 2 970 4333 

 

Magyarország 

Pfizer Kft.  

Tel.: + 36 1 488 37 00  

Česká republika 

Pfizer s.r.o.  

Tel: +420-283-004-111 

 

Malta 

Vivian Corporation Ltd. 

Tel: +356 21344610 

Danmark 

Pfizer ApS 

Tlf: +45 44 20 11 00 

 

Nederland 

Pfizer bv 

Tel: +31 (0)10 406 43 01 

Deutschland 

Pfizer OFG Germany GmbH 

Tel: +49 (0)800 5500634 

Norge 

Pfizer AS 

Tlf: +47 67 52 61 00 

 

Eesti 

Pfizer Luxembourg SARL Eesti filiaal 

Tel: +372 666 7500 

 

Österreich 

Pfizer Corporation Austria Ges.m.b.H. 

Tel: +43 (0)1 521 15-0 

 



75 

 

Ελλάδα 

UPJOHN HELLAS ΕΠΕ 

Τηλ.: +30 2100 100 002 

 

Polska 

Pfizer Polska Sp. z o.o.,  

Tel.: +48 22 335 61 00 

 

España 

Pfizer GEP S.L. 

Tel: +34 91 490 99 00 

Portugal 

Laboratórios Pfizer, Lda.  

Tel: +351 21 423 5500 

 

France 

Pfizer PFE France 

Tél: +33 (0)1 58 07 34 40 

 

România 

Pfizer România S.R.L. 

Tel: +40 (0)21 207 28 00 

 

Hrvatska 

Pfizer Croatia d.o.o. 

Tel: + 385 1 3908 777 

 

Slovenija 

Pfizer Luxembourg SARL, Pfizer, podružnica za 

svetovanje s področja farmacevtske dejavnosti, 

Ljubljana 

Tel: + 386(0)152 11 400 

 

Ireland 

Pfizer Healthcare Ireland 

Tel: 1800 633 363 (toll free) 

Tel: +44 (0)1304 616161 

Slovenská republika 

Pfizer Luxembourg SARL, organizačná zložka 

Tel: +421–2–3355 5500 

 

 

Ísland 

Icepharma hf. 

Sími: + 354 540 8000 

 

Suomi/Finland 

Pfizer Oy 

Puh/Tel: +358(0)9 43 00 40 

Italia 

Pfizer Established Medicine Italy S.r.l. 

Tel: +39 06 33 18 21 

 

Sverige  

Pfizer AB 

Tel: +46 (0)8 550 520 00 

 

Κύπρος 

PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH), 

Τηλ: +357 22 817690 

 

United Kingdom 

Pfizer Limited 

Tel: +44 (0)1304 616161 

 

Latvija 

Pfizer Luxembourg SARL filiāle Latvijā 

Tel: +371 670 35 775 

 

 

Lietuva 

Pfizer Luxembourg SARL, filialas Lietuvoje 

Tel. +3705 2514000 

 

 

 

This leaflet was last revised in {MM/YYYY}. 

 

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 



76 

 

 

Package leaflet: Information for the patient 

 

VIAGRA 50 mg orodispersible tablets 

Sildenafil  

 

 

Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 

− Keep this leaflet. You may need to read it again. 

− If you have any further questions, ask your doctor, pharmacist or nurse. 

− This medicine has been prescribed for you only. Do not pass it on to others. It may harm 

them, even if their signs of illness are the same as yours. 

− If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 

possible side effects not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

1. What VIAGRA is and what it is used for 

2. What you need to know before you take VIAGRA 

3. How to take VIAGRA 

4. Possible side effects 

5. How to store VIAGRA 

6. Contents of the pack and other information 

 

 

1. What VIAGRA is and what it is used for 

 

VIAGRA contains the active substance sildenafil which belongs to a group of medicines called 

phosphodiesterase type 5 (PDE5) inhibitors. 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 will only help 

you to get an erection if you are sexually stimulated.  

VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. 

This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. 

 

 

2. What you need to know before you take VIAGRA 

 

Do not take VIAGRA 

− If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in 

section 6). 

 

− If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in 

your blood pressure. Tell your doctor if you are taking any of these medicines which are 

often given for relief of angina pectoris (or “chest pain”).  If you are not certain, ask your 

doctor or pharmacist. 

 

− If you are using any of the medicines known as nitric oxide donors such as amyl nitrite 

(“poppers”), as the combination may also lead to a dangerous fall in your blood pressure. 

 

− If you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., 

high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., 



77 

 

high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Viagra 

have been shown to increase the hypotensive effects of this medicine. If you are taking 

riociguat or are unsure tell your doctor. 

 

− If you have a severe heart or liver problem. 

 

− If you have recently had a stroke or a heart attack, or if you have low blood pressure.  

 

− If you have certain rare inherited eye diseases (such as retinitis pigmentosa). 

  

− If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy 

(NAION). 

 

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before taking VIAGRA  

− If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of 

blood cells), multiple myeloma (cancer of bone marrow). 

 

− If you have a deformity of your penis or Peyronie’s Disease.  

 

− If you have problems with your heart. Your doctor should carefully check whether your 

heart can take the additional strain of having sex. 

 

− If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).  

 

− If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your 

doctor immediately. 

 

You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.  

You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing 

sildenafil or any other PDE5 inhibitors. 

 

You should not take VIAGRA if you do not have erectile dysfunction. 

 

You should not take VIAGRA if you are a woman. 

 

Special considerations for patients with kidney or liver problems 

You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a 

lower dose for you.  

 

Children and adolescents 

VIAGRA should not be given to individuals under the age of 18. 

 

Other medicines and VIAGRA 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. 

 

VIAGRA tablets may interfere with some medicines, especially those used to treat chest pain. In the 

event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken 

VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells 

you that you can. 

 



78 

 

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of 

these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, 

pharmacist or nurse if you are taking any of these medicines that are often used for the relief of 

angina pectoris (or “chest pain”). 

 

You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors 

such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood 

pressure. 

 

Tell your doctor or pharmacist if you are already taking riociguat.  

 

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your 

doctor may start you on the lowest dose (25 mg film-coated tablets) of VIAGRA. 

 

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate 

enlargement may experience dizziness or light-headedness, which may be caused by low blood 

pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms 

when taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking 

VIAGRA. To reduce the chance that these symptoms might happen, you should be on a regular 

daily dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a lower 

dose (25 mg film-coated tablets) of VIAGRA. 

 

VIAGRA with alcohol 

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit 

from your medicine, you are advised not to drink excessive amounts of alcohol before taking 

VIAGRA. 

 

Pregnancy, breast-feeding and fertility 

VIAGRA is not indicated for use by women. 

 

Driving and using machines 

VIAGRA can cause dizziness and can affect vision. You should be aware of how you react to 

VIAGRA before you drive or use machinery. 

 

 

3. How to take VIAGRA 

 

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your 

doctor or pharmacist if you are not sure. 

 

The recommended starting dose is 50 mg. 

 

You should not take VIAGRA more than once a day.  

 

Do not take VIAGRA orodispersible tablets in combination with film-coated tablets containing 

sildenafil including VIAGRA film-coated tablets. 

 

You should take VIAGRA about one hour before you plan to have sex. The amount of time 

VIAGRA takes to work varies from person to person, but it normally takes between half an hour 

and one hour. 

 

Place the orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds, then 

swallow with saliva or water. 



79 

 

 

The orodispersible tablets should be taken on an empty stomach as you may find that it takes longer 

to start working if you take it with a heavy meal. 

 

If you require a second 50 mg orodispersible tablet to make a 100 mg dose, you should wait until 

the first one has completely disintegrated and you have swallowed it before taking the second 

orodispersible tablet. 

 

If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist. 

 

VIAGRA will only help you to get an erection if you are sexually stimulated. 

 

If VIAGRA does not help you to get an erection, or if your erection does not last long enough for 

you to complete sexual intercourse you should tell your doctor. 

 

If you take more VIAGRA than you should: 

You may experience an increase in side effects and their severity. Doses above 100 mg do not 

increase the efficacy.  

 

You should not take more tablets than your doctor tells you to.  

 

Contact your doctor if you take more tablets than you should. 

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or 

nurse. 

 

 

4. Possible side effects  

 

Like all medicines, this medicine can cause side effects although not everybody gets them. The side 

effects reported in association with the use of VIAGRA are usually mild to moderate and of a short 

duration. 

 

If you experience any of the following serious side effects stop taking VIAGRA and seek 

medical help immediately: 

 

• An allergic reaction – (this occurs uncommonly may affect up to 1 in 100 people) 

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the 

eyelids, face, lips or throat. 

 

• Chest pains - this occurs uncommonly  

If this occurs during or after intercourse: 

  - Get in a semi-sitting position and try to relax. 

  - Do not use nitrates to treat your chest pain. 

 

•  Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 

1,000 people) 

If you have an erection which lasts for more than 4 hours, you should contact a doctor 

immediately. 

 

•  A sudden decrease or loss of vision - this occurs rarely 

 



80 

 

•  Serious skin reactions - this occurs rarely 

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, 

genitals and around the eyes, fever. 

 

•  Seizures or fits - this occurs rarely 

 

Other side effects: 

 

Very common (may affect more than 1 in 10 people): headache.  

 

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a 

sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual 

disturbance, stuffy nose and dizziness. 

 

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. 

 

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, 

temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb 

mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal 

sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing 

halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile 

bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable 

and sudden decrease or loss of hearing.  

 

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have 

been reported rarely. Of note, most, but not all, of the men who experienced these side effects had 

heart problems before taking this medicine. It is not possible to determine whether these events 

were directly related to VIAGRA.  

 

Reporting of side effects 

If you get any side effects, talk to you doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects you can help provide more information on the 

safety of this medicine. 

 

 

5. How to store VIAGRA 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 

The expiry date refers to the last day of that month. 

This medicinal product does not require any special temperature storage conditions. 

Store in the original package, in order to protect from moisture.  

 



81 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how 

to throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What VIAGRA contains 

− The active substance is sildenafil. Each orodispersible tablet contains 50 mg of sildenafil (as 

the citrate salt). 

− The other ingredients are: 

− microcrystalline cellulose, silica hydrophobic colloidal, croscarmellose sodium, magnesium 

stearate, indigo carmine aluminium lake (E132), sucralose, mannitol, crospovidone, 

polyvinyl acetate, povidone, 

− flavouring containing: maltodextrin and dextrin, 

− natural flavouring containing: maltodextrin, glycerol (E422) and propylene glycol (E1520), 

− lemon flavouring containing: maltodextrin and alpha-tocopherol (E307)). 

 

What VIAGRA looks like and contents of the pack  

VIAGRA orodispersible tablets are blue, diamond shape, marked “V50” on one side. The 

orodispersible tablets are provided in blister packs containing 2, 4, 8 or 12 tablets. Some pack sizes 

may not be marketed in your country. 

 

Marketing Authorisation Holder and Manufacturer 

The marketing authorisation holder of VIAGRA is Pfizer Europe MA EEIG, Boulevard de la Plaine 

17, 1050 Bruxelles, Belgium. 

The manufacturer of VIAGRA is Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 

Pocé-sur-Cisse, France. 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder. 

 

België /Belgique / Belgien 

Pfizer S.A./ N.V. 

Tél/Tel: +32 (0)2 554 62 11 

 

Luxembourg/Luxemburg 

Pfizer S.A. 

Tél/Tel: +32 (0)2 554 62 11 

 

България  

Пфайзер Люксембург САРЛ, Клон България 

Тел.: +359 2 970 4333 

 

Magyarország 

Pfizer Kft.  

Tel.: + 36 1 488 37 00  

Česká republika 

Pfizer s.r.o.  

Tel: +420-283-004-111 

 

Malta 

Vivian Corporation Ltd. 

Tel: +356 21344610 

Danmark 

Pfizer ApS 

Tlf: +45 44 20 11 00 

 

Nederland 

Pfizer bv 

Tel: +31 (0)10 406 43 01 

Deutschland 

Pfizer OFG Germany GmbH 

Tel: +49 (0)800 5500634 

Norge 

Pfizer AS 

Tlf: +47 67 52 61 00 

 



82 

 

Eesti 

Pfizer Luxembourg SARL Eesti filiaal 

Tel: +372 666 7500 

 

Österreich 

Pfizer Corporation Austria Ges.m.b.H. 

Tel: +43 (0)1 521 15-0 

 

Ελλάδα 

UPJOHN HELLAS ΕΠΕ 

Τηλ.: +30 2100 100 002 

 

Polska 

Pfizer Polska Sp. z o.o.,  

Tel.: +48 22 335 61 00 

 

España 

Pfizer GEP, S.L. 

Tel: +34 91 490 99 00 

Portugal 

Laboratórios Pfizer, Lda.  

Tel: +351 21 423 5500 

 

France 

Pfizer PFE France 

Tél: +33 (0)1 58 07 34 40 

 

România 

Pfizer România S.R.L. 

Tel: +40 (0)21 207 28 00 

 

Hrvatska 

Pfizer Croatia d.o.o. 

Tel: + 385 1 3908 777 

 

Slovenija 

Pfizer Luxembourg SARL, Pfizer, podružnica za 

svetovanje s področja farmacevtske dejavnosti, 

Ljubljana 

Tel: + 386(0)152 11 400 

 

Ireland 

Pfizer Healthcare Ireland 

Tel: 1800 633 363 (toll free) 

Tel: +44 (0)1304 616161 

 

Slovenská republika 

Pfizer Luxembourg SARL, organizačná zložka 

Tel: +421–2–3355 5500 

 

Ísland 

Icepharma hf. 

Sími: + 354 540 8000 

 

Suomi/Finland 

Pfizer Oy 

Puh/Tel: +358(0)9 43 00 40 

 

Italia 

Pfizer Established Medicine Italy S.r.l. 

Tel: +39 06 33 18 21 

 

Sverige  

Pfizer AB 

Tel: +46 (0)8 550 520 00 

 

Κύπρος 

PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH), 

Τηλ: +357 22 817690 

 

United Kingdom 

Pfizer Limited 

Tel: +44 (0)1304 616161 

 

Latvija 

Pfizer Luxembourg SARL filiāle Latvijā 

Tel: +371 670 35 775 

 

 

Lietuva 

Pfizer Luxembourg SARL, filialas Lietuvoje 

Tel. +3705 2514000 

 

 

 

This leaflet was last revised in {MM/YYYY}. 

 



83 

 

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 

 

 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET