Sildenafil Actavis

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



2 

1. NAME OF THE MEDICINAL PRODUCT 
 
Sildenafil Actavis 25 mg film-coated tablets 
 
Sildenafil Actavis 50 mg film-coated tablets 
 
Sildenafil Actavis 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: 
 
Sildenafil Actavis 25 mg tablets 
Each tablet contains 62.38 mg lactose (as monohydrate). 
 
Sildenafil Actavis 50 mg tablets 
Each tablet contains 124.76 mg lactose (as monohydrate). 
 
Sildenafil Actavis 100 mg tablets 
Each tablet contains 249.52 mg lactose (as monohydrate). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet. 
 
Sildenafil Actavis 25 mg film-coated tablets  
Sildenafil Actavis 25 mg film-coated tablets are blue elliptical, biconvex, 10.0 x 5.0 mm and marked 
“SL25” on one side. 
 
Sildenafil Actavis 50 mg film-coated tablets  
Sildenafil Actavis 50 mg film-coated tablets are blue elliptical, biconvex, 13.0 x 6.5 mm and marked 
“SL50” on one side. 
 
Sildenafil Actavis 100 mg film-coated tablets  
Sildenafil Actavis 100 mg film-coated tablets are blue elliptical, biconvex, 17.0 x 8.5 mm and marked 
“SL100” on one side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Sildenafil Actavis 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 Sildenafil Actavis to be effective, sexual stimulation is required. 
 
4.2 Posology and method of administration 
 
Posology 
 



3 

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 Sildenafil Actavis 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 to100 mg as necessary. 
 
Paediatric population 
Sildenafil Actavis 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, 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). 
 



4 

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). 
 
Sildenafil Actavis 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. 
 
Sildenafil Actavis 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 sildenafil. 
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 sildenafil 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 treatments for 



5 

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 Sildenafil Actavis 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 Sildenafil Actavis tablet contains lactose monohydrate. Sildenafil Actavis should not be 
administered to men with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or 
glucose-galactose malabsorption. 
 
Women 
 
Sildenafil Actavis 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. 
 



6 

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 Sildenafil Actavis 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. 
 



7 

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.). 
 
4.6 Fertility, pregnancy and lactation 
 
Sildenafil Actavis 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. 
 



8 

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 
 
No studies on the effects on the ability to drive and use machines have been performed. 
 
As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware 
of how they react to Sildenafil Actavis, before driving or operating machinery. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The safety profile of sildenafil 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 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)).  
 
In addition, the frequency of medically important adverse reactions reported from post-marketing 
experience is included as not known.  
 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 



9 

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 
(≥ 1/1000 and 
<1/100) 

Rare 
(≥ 1/10000 and 
<1/1000 
 

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 



10 

System Organ 
Class 

Very 
common 
(≥ 1/10) 

Common 
(≥ 1/100 and 
<1/10) 

Uncommon 
(≥ 1/1000 and 
<1/100) 

Rare 
(≥ 1/10000 and 
<1/1000 
 
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 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 



11 

System Organ 
Class 

Very 
common 
(≥ 1/10) 

Common 
(≥ 1/100 and 
<1/10) 

Uncommon 
(≥ 1/1000 and 
<1/100) 

Rare 
(≥ 1/10000 and 
<1/1000 
 

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. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction, ATC Code: G04BE03. 
 
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. 



12 

 
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. 
 
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 



13 

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 the 
reference medicinal product containing sildenafil 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). 
 



14 

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%. 
 
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 126% and 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 
79% and 200% 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: 
Lactose monohydrate  
Microcrystalline cellulose 
Povidone K29-32 
Croscarmellose sodium 
Magnesium stearate 
 
Film-coat: 
Hypromellose 
Titanium dioxide (E171) 
Macrogol 6000 
Indigo carmine aluminium lake (E132) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 



15 

 
6.4 Special precautions for storage 
 
Store below 30°C. 
 
6.5 Nature and contents of container 
 
Sildenafil Actavis 25 mg film-coated tablets 
PVC-PVDC/Aluminium blisters in cartons of 1, 2, 4, 8, 12 or 24 tablets. 
 
Sildenafil Actavis 50 mg film-coated tablets 
PVC-PVDC/Aluminium blisters in cartons of 1, 2, 4, 8, 12 or 24 tablets. 
 
Sildenafil Actavis 100 mg film-coated tablets 
PVC-PVDC/Aluminium blisters in cartons of 1, 2, 4, 8, 12 or 24 tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
Reykjavíkurvegi 76-78 
IS-220 Hafnarfjörður 
Iceland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
Sildenafil Actavis 25 mg film-coated tablets 
EU/1/09/595/001 
EU/1/09/595/002 
EU/1/09/595/003 
EU/1/09/595/004 
EU/1/09/595/005 
EU/1/09/595/016 
 
Sildenafil Actavis 50 mg film-coated tablets 
EU/1/09/595/006 
EU/1/09/595/007 
EU/1/09/595/008 
EU/1/09/595/009 
EU/1/09/595/010 
EU/1/09/595/017 
 
Sildenafil Actavis 100 mg film-coated tablets 
EU/1/09/595/011 
EU/1/09/595/012 
EU/1/09/595/013 
EU/1/09/595/014 
EU/1/09/595/015 
EU/1/09/595/018 
 



16 

 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 10 December 2009 
Date of latest renewal: 4 September 2014  
 
 
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 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER 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 

 



18 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Actavis Ltd. 
BLB 016 Bulebel Industrial Estate 
Zejtun ZTN 3000 
Malta 
 
Actavis ehf. 
Reykjavíkurvegi 78 
IS-220 Hafnarfjörður 
Iceland 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
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 medicinal 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) 
 
Not applicable. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



19 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sildenafil Actavis 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 monohydrate. 
See leaflet for further information. 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 film-coated tablet 
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 
 
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 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store below 30°C. 
 
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 



22 

 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/595/001 [1 film-coated tablet] 
EU/1/09/595/002 [2 film-coated tablets] 
EU/1/09/595/003 [4 film-coated tablets] 
EU/1/09/595/004 [8 film-coated tablets] 
EU/1/09/595/005 [12 film-coated tablets] 
EU/1/09/595/016 [24 film-coated tablets] 
 
13. BATCH NUMBER 
 
Lot 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Sildenafil Actavis 25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



23 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sildenafil Actavis 25 mg tablets 
sildenafil 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Logo 
 
3. EXPIRY DATE 
 
EXP 
 
4. BATCH NUMBER 
 
Lot 
 
5. OTHER 
 



24 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sildenafil Actavis 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 monohydrate. 
See leaflet for further information. 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 film-coated tablet 
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 
 
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 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store below 30°C. 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 



25 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/595/006 [1 film-coated tablet] 
EU/1/09/595/007 [2 film-coated tablets] 
EU/1/09/595/008 [4 film-coated tablets] 
EU/1/09/595/009 [8 film-coated tablets] 
EU/1/09/595/010 [12 film-coated tablets] 
EU/1/09/595/017 [24 film-coated tablets] 
 
13. BATCH NUMBER 
 
Lot 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Sildenafil Actavis 50 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



26 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sildenafil Actavis 50 mg tablets 
sildenafil 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Logo 
 
3. EXPIRY DATE 
 
EXP 
 
4. BATCH NUMBER 
 
Lot 
 
5. OTHER 
 
  



27 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sildenafil Actavis 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 monohydrate. 
See leaflet for further information. 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 film-coated tablet 
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 
 
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 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store below 30°C. 
 
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 



28 

 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/595/011 [1 film-coated tablet] 
EU/1/09/595/012 [2 film-coated tablets] 
EU/1/09/595/013 [4 film-coated tablets] 
EU/1/09/595/014 [8 film-coated tablets] 
EU/1/09/595/015 [12 film-coated tablets] 
EU/1/09/595/018 [24 film-coated tablets] 
 
13. BATCH NUMBER 
 
Lot 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Sildenafil Actavis 100 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



29 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sildenafil Actavis 100 mg tablets 
sildenafil 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Logo 
 
3. EXPIRY DATE 
 
EXP 
 
4. BATCH NUMBER 
 
Lot 
 
5. OTHER 
 
  



30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



31 

Package leaflet: Information for the patient 
 

Sildenafil Actvis 25 mg, 50 mg and 100 mg film-coated tablets 
Sildenafil Actavis 25 mg film-coated tablets 
Sildenafil Actavis 50 mg film-coated tablets 
Sildenafil Actavis 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 Sildenafil Actavis is and what it is used for 
2. What you need to know before you take Sildenafil Actavis 
3. How to take Sildenafil Actavis 
4. Possible side effects 
5. How to store Sildenafil Actavis 
6. Contents of the pack and other information 
 
 
1. What Sildenafil Actavis is and what it is used for 
 
Sildenafil Actavis 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. Sildenafil Actavis 
will only help you to get an erection if you are sexually stimulated.  
Sildenafil Actavis 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 Sildenafil Actavis 
 
Do not take Sildenafil Actavis 
 
- 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 Sildenafil 
Actavis have been shown to increase the hypotensive effects of this medicine. If you are taking 
riociguat or are unsure tell your doctor. 

 



32 

- 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 Sildenafil Actavis 
 
- 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 Sildenafil Actavis and contact 

your doctor immediately. 
 
You should not use Sildenafil Actavis with any other oral or local treatments for erectile dysfunction. 
 
You should not use Sildenafil Actavis with treatments for pulmonary arterial hypertension (PAH) 
containing sildenafil or any other PDE5 inhibitors. 
 
You should not take Sildenafil Actavis if you do not have erectile dysfunction. 
 
You should not take Sildenafil Actavis 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 
Sildenafil Actavis should not be given to individuals under the age of 18. 
 
Other medicines and Sildenafil Actavis 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Sildenafil Actavis 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 Sildenafil Actavis and when you did. Do not take Sildenafil Actavis with other medicines unless 
your doctor tells you that you can. 
 
You should not take Sildenafil Actavis 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”). 
 



33 

You should not take Sildenafil Actavis 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 Sildenafil Actavis. 
 
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 sildenafil with alpha-blockers. This is most likely to happen within 4 hours after taking 
Sildenafil Actavis. To reduce the chance that these symptoms might happen, you should be on a 
regular daily dose of your alpha-blocker before you start Sildenafil Actavis. Your doctor may start you 
on a lower dose (25 mg) of Sildenafil Actavis. 
 
Sildenafil Actavis with food and drink and alcohol 
Sildenafil Actavis can be taken with or without food. However, you may find that Sildenafil Actavis 
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 
Sildenafil Actavis. 
 
Pregnancy, breast-feeding and fertility 
Sildenafil Actavis is not indicated for use by women. 
 
Driving and using machines 
Sildenafil Actavis can cause dizziness and can affect vision. You should be aware of how you react to 
Sildenafil Actavis before you drive or use machinery. 
 
Sildenafil Actavis 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 Sildenafil Actavis. 
 
 
3. How to take Sildenafil Actavis 
 
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 Sildenafil Actavis more than once a day. 
 
You should take Sildenafil Actavis about one hour before sexual activity. Swallow the tablet whole 
with a glass of water. 
 
If you feel that the effect of Sildenafil Actavis is too strong or too weak, talk to your doctor or 
pharmacist. 
 
Sildenafil Actavis will only help you to get an erection if you are sexually stimulated. The amount of 
time Sildenafil Actavis takes to work varies from person to person, but it normally takes between half 
an hour and one hour. You may find that Sildenafil Actavis takes longer to work if you take it with a 
heavy meal. 
 
If Sildenafil Actavis 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. 



34 

 
If you take more Sildenafil Actavis 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 sildenafil are usually mild to moderate and of a short 
duration. 
 
If you experience any of the following serious side effects stop taking Sildenafil Actavis 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 
 
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 



35 

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 sildenafil. 
 
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 Sildenafil Actavis 
 
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 after EXP. The expiry date 
refers to the last day of that month. 
 
Store below 30°C. 
 
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 Sildenafil Actavis contains 
- The active substance is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil (as 

citrate). 
- The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate). 
- The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate). 
- The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate). 
- The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone K29-32, 

croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), 
macrogol 6000, indigo carmine aluminium lake (E132). 

 
What Sildenafil Actavis looks like and contents of the pack 
 
Film-coated tablet 
 
Sildenafil Actavis 25 mg film-coated tablets are blue elliptical, biconvex, 10.0 x 5.0 mm and marked 
“SL25” on one side. 
Sildenafil Actavis 50 mg film-coated tablets are blue elliptical, biconvex, 13.0 x 6.5 mm and marked 
“SL50” on one side. 



36 

Sildenafil Actavis 100 mg film-coated tablets are blue elliptical, biconvex, 17.0 x 8.5 mm and marked 
“SL100” on one side. 
 
The tablets are provided in blister packs containing 1, 2, 4, 8, 12 or 24 tablets. 
 
Some pack sizes may not be marketed in your country. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf. 
Reykjavíkurvegi 76-78 
IS-220 Hafnarfjörður 
Iceland 
 
Manufacturer 
Actavis Ltd. 
BLB 016 Bulebel Industrial Estate 
Zejtun ZTN 3000 
Malta 
 
Actavis ehf. 
Reykjavíkurvegi 78 
IS-220 Hafnarfjörður 
Iceland 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Actavis Group PTC ehf. 
IJsland/Islande/Island 
Tél/Tel: +354 5503300 
 

Lietuva 
UAB Sicor Biotech 
Tel: +370 52660203 
 

България 
Актавис ЕАД 
Teл: +359 24899585 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande/Island 
Tél/Tel: +354 5503300 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251007111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel: +36 12886400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44985511 
 

Malta 
Actavis Ltd. 
Tel: +356 21693533 
 

Deutschland 
PUREN Pharma GmbH & Co. KG 
Tel: +49 895589090 
 

Nederland 
Aurobindo Pharma B.V. 
Tel: +31 355429933 
 

Eesti 
UAB Sicor Biotech Eesti filiaal 
Tel: +372 6610801 
 

Norge 
Teva Norway AS 
Tlf: +47 66775590 
 



37 

Ελλάδα 
Specifar ABEE 
Τηλ: +30 2105401500 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070 
 

España 
Aurovitas Spain, S.A.U. 
Tel: +34 916308645 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 223459300 
 

France 
Arrow Génériques 
Tél: +33 472726072 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 13720000 
 

România 
Teva Pharmaceuticals S.R.L. 
Tel: +40 212306524 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 214619040 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 
 

Ísland 
Actavis Group PTC ehf. 
Sími: +354 5503300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 
 

Italia 
Aurobindo Pharma (Italia) s.r.l. 
Tel: +39 0296392601 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 201805900 
 

Κύπρος 
A. Potamitis Medicare Ltd 
Τηλ: +357 22583333 
 

Sverige 
Teva Sweden AB 
Tel: +46 42121100 
 

Latvija 
UAB Sicor Biotech filiāle Latvijā 
Tel: +371 67323666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1271385257 
 

 
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/. 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER 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