Vizarsin

1

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



2

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 25 mg film-coated tablets
Vizarsin 50 mg film-coated tablets
Vizarsin 100 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains sildenafil citrate equivalent to 25 mg, 50 mg or 100 mg sildenafil.

Excipient with known effect:
Vizarsin 25 mg film-coated tablets
Each film-coated tablet contains 1.9 mg lactose (as monohydrate).

Vizarsin 50 mg film-coated tablets
Each film-coated tablet contains 3.8 mg lactose (as monohydrate).

Vizarsin 100 mg film-coated tablets
Each film-coated tablet contains 7.6 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet.

Vizarsin 25 mg film-coated tablets: White, oblong tablets, marked “25” on one side.
Vizarsin 50 mg film-coated tablets: White, oblong tablets, marked “50” on one side.
Vizarsin 100 mg film-coated tablets: White, oblong tablets, marked “100” on one side.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Vizarsin 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 Vizarsin to be effective, sexual stimulation is required.

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 Vizarsin 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).



3

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

Use in patients using other medicines:
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).

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).

Vizarsin 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

4.4 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 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, 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 Vizarsin and consult a physician 
immediately (see section 4.3).

Concomitant use with ritonavir



5

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

Vizarsin is not indicated for use by women.

Excipients

Vizarsin contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase
deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’.

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 



6

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 M). Given sildenafil peak plasma concentrations of approximately 1 M after 
recommended doses, it is unlikely that sildenafil 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 



7

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

Vizarsin 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

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 Vizarsin, before driving or operating machinery.

4.8 Undesirable effects



8

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 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
( 1/1000 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,



9

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 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 



10

listed in Appendix V.

4.9 Overdose

Symptoms
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.

Management
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.

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.



11

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.

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).



12

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 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



13

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 (E460)
Calcium hydrogen phosphate
Croscarmellose sodium
Hypromellose (E464)
Magnesium stearate (E470b)

Film coating:
Lactose monohydrate
Hypromellose (E464)
Titanium dioxide (E171)
Triacetin (E1518)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

5 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Blister (PVC-foil/Alu-foil): 1 film-coated tablet, in a box.
Blister (perforated unit dose blister, PVC-foil/Alu-foil): 4 x 1, 8 x 1 or 12 x 1 film-coated tablet, in a 
box.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7. MARKETING AUTHORISATION HOLDER

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

8. MARKETING AUTHORISATION NUMBER(S)

Vizarsin 25 mg film-coated tablets
1 film-coated tablet: EU/1/09/551/001
4 x 1 film-coated tablet: EU/1/09/551/002



14

8 x 1 film-coated tablet: EU/1/09/551/003
12 x 1 film-coated tablet: EU/1/09/551/004

Vizarsin 50 mg film-coated tablets
1 film-coated tablet: EU/1/09/551/005
4 x 1 film-coated tablet: EU/1/09/551/006
8 x 1 film-coated tablet: EU/1/09/551/007
12 x 1 film-coated tablet: EU/1/09/551/008

Vizarsin 100 mg film-coated tablets
1 film-coated tablet: EU/1/09/551/009
4 x 1 film-coated tablet: EU/1/09/551/010
8 x 1 film-coated tablet: EU/1/09/551/011
12 x 1 film-coated tablet: EU/1/09/551/012

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 21 September 2009
Date of latest renewal: 16 May 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



15

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 25 mg orodispersible tablets
Vizarsin 50 mg orodispersible tablets
Vizarsin 100 mg orodispersible tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each orodispersible tablet contains 25 mg, 50 mg or 100 mg sildenafil.

Excipients with known effect:
Vizarsin 25 mg orodispersible tablets
Each orodispersible tablet contains 0.375 mg aspartame (E951) and 0.00875 mg sorbitol (E420).

Vizarsin 50 mg orodispersible tablets
Each orodispersible tablet contains 0.75 mg aspartame (E951) and 0.0175 mg sorbitol (E420).

Vizarsin 100 mg orodispersible tablets
Each orodispersible tablet contains 1.5 mg aspartame (E951) and 0.035 mg sorbitol (E420).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Orodispersible tablet.

Vizarsin 25 mg orodispersible tablets: White to almost white, round, slightly biconvex tablets, with 
possible darker spots.
Vizarsin 50 mg orodispersible tablets: White to almost white, round, slightly biconvex tablets, with 
possible darker spots.
Vizarsin 100 mg orodispersible tablets: White to almost white, round, slightly biconvex tablets, with 
possible darker spots.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Vizarsin 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 Vizarsin to be effective, sexual stimulation is required.

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 Vizarsin is taken with food, the onset of activity may be delayed compared to the fasted state 
(see section 5.2).

Special populations



16

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

Use in patients using other medicines:
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, where it will rapidly disperse in
saliva, so it can be easily swallowed. It can be taken with or without liquid. Removal of the intact 
orodispersible tablet from the mouth is difficult. Since the orodispersible tablet is fragile, it should be 
taken immediately on opening the blister.

The orodispersible tablets may be used as an alternative to Vizarsin film-coated tablets for patients 
who have difficulty to swallow film-coated tablets.

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 



17

unstable angina or severe cardiac failure).

Vizarsin 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 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, or other treatments for erectile 
dysfunction have not been studied. Therefore the use of such combinations is not recommended.



18

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 Vizarsin 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

Vizarsin is not indicated for use by women.

Excipients

Vizarsin contains aspartame (E951). Aspartame is a source of phenylalanine. It may be harmful for 
patient with phenylketonuria (PKU). This medicine should be used with caution in patients with 
phenylketonuria.
Vizarsin contains sorbitol (E420). The additive effect of concomitantly administered products 
containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into 
account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of 
other medicinal products for oral use administered concomitantly.

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 



19

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 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 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 



20

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.).

4.6 Fertility, pregnancy and lactation

Vizarsin is not indicated for use by women.

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

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



21

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

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 Vizarsin, 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 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
( 1/1000 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,

Non-arteritic anterior 
ischaemic optic 
neuropathy 
(NAION)*,
Retinal vascular 
occlusion*,
Retinal haemorrhage,



22

Visual brightness,
Conjunctivitis

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 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,



23

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

Symptoms
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.

Management
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.

Pharmacodynamic effects

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



24

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 
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 



25

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.

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 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 to126% and up to 73% respectively, 
compared to age-matched volunteers with no renal impairment. However, due to high inter-subject 



26

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

Hydroxypropylcellulose (E463)
Mannitol (E421)
Aspartame (E951)
Neohesperidin-dihydrochalcone (E959)
Spearmint oil
Peppermint oil (containing sorbitol (E420))
Crospovidone
Calcium silicate
Magnesium stearate (E470b)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Vizarsin 25 mg orodispersible tablets
2 years

Vizarsin 50 mg, 100 mg orodispersible tablets
3 years

6.4 Special precautions for storage

Do not store above 30C.
Store in the original package in order to protect from moisture.

6.5 Nature and contents of container

Vizarsin 25 mg orodispersible tablets
Blister (peel open blister, Oriented Polyamide/Aluminium/PVC//PET/Aluminium): 1 orodispersible 
tablet, in a box.
Blister (peel open perforated unit dose blister, Oriented 
Polyamide/Aluminium/PVC//PET/Aluminium): 2 x 1, 4 x 1, 8 x 1 or 12 x 1 orodispersible tablet, in a 



27

box.

Vizarsin 50 mg, 100 mg orodispersible tablets
Blister (peel open blister, Oriented Polyamide/Aluminium/PVC//PET/Aluminium): 1 orodispersible 
tablet, in a box.
Blister (peel open perforated unit dose blister, Oriented 
Polyamide/Aluminium/PVC//PET/Aluminium): 2 x 1, 4 x 1, 8 x 1, 12 x 1 or 24 x 1 orodispersible 
tablet, in a box.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7. MARKETING AUTHORISATION HOLDER

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

8. MARKETING AUTHORISATION NUMBER(S)

Vizarsin 25 mg orodispersible tablets
1 orodispersible tablet: EU/1/09/551/013
2 x 1 orodispersible tablet: EU/1/09/551/014
4 x 1 orodispersible tablet: EU/1/09/551/015
8 x 1 orodispersible tablet: EU/1/09/551/016
12 x 1 orodispersible tablet: EU/1/09/551/017

Vizarsin 50 mg orodispersible tablets
1 orodispersible tablet: EU/1/09/551/018
2 x 1 orodispersible tablet: EU/1/09/551/019
4 x 1 orodispersible tablet: EU/1/09/551/020
8 x 1 orodispersible tablet: EU/1/09/551/021
12 x 1 orodispersible tablet: EU/1/09/551/022
24 x 1 orodispersible tablet: EU/1/09/551/028

Vizarsin 100 mg orodispersible tablets
1 orodispersible tablet: EU/1/09/551/023
2 x 1 orodispersible tablet: EU/1/09/551/024
4 x 1 orodispersible tablet: EU/1/09/551/025
8 x 1 orodispersible tablet: EU/1/09/551/026
12 x 1 orodispersible tablet: EU/1/09/551/027
24 x 1 orodispersible tablet: EU/1/09/551/029

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 21 September 2009
Date of latest renewal: 16 May 2014

10. DATE OF REVISION OF THE TEXT



28

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu



29

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



30

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

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

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
Germany

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 (PSURs)

The requirements for submission of PSURs 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.



31

ANNEX III

LABELLING AND PACKAGE LEAFLET



32

A. LABELLING



33

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 25 mg film-coated tablets
sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains sildenafil citrate equivalent to 25 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains lactose.
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

1 film-coated tablet
4 x 1 film-coated tablet
8 x 1 film-coated tablet
12 x 1 film-coated tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

9. SPECIAL STORAGE CONDITIONS



34

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 film-coated tablet: EU/1/09/551/001
4 x 1 film-coated tablet: EU/1/09/551/002
8 x 1 film-coated tablet: EU/1/09/551/003
12 x 1 film-coated tablet: EU/1/09/551/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Vizarsin 25 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



35

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 25 mg film-coated tablets
sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER



36

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 50 mg film-coated tablets
sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains sildenafil citrate equivalent to 50 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains lactose.
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

1 film-coated tablet
4 x 1 film-coated tablet
8 x 1 film-coated tablet
12 x 1 film-coated tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

9. SPECIAL STORAGE CONDITIONS



37

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 film-coated tablet: EU/1/09/551/005
4 x 1 film-coated tablet: EU/1/09/551/006
8 x 1 film-coated tablet: EU/1/09/551/007
12 x 1 film-coated tablet: EU/1/09/551/008

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Vizarsin 50 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



38

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 50 mg film-coated tablets
sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER



39

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 100 mg film-coated tablets
sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains sildenafil citrate equivalent to 100 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains lactose.
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

1 film-coated tablet
4 x 1 film-coated tablet
8 x 1 film-coated tablet
12 x 1 film-coated tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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

9. SPECIAL STORAGE CONDITIONS



40

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 film-coated tablet: EU/1/09/551/009
4 x 1 film-coated tablet: EU/1/09/551/010
8 x 1 film-coated tablet: EU/1/09/551/011
12 x 1 film-coated tablet: EU/1/09/551/012

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Vizarsin 100 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



41

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 100 mg film-coated tablets
sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER



42

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for monolingual and bilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 25 mg orodispersible tablets
sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each orodispersible tablet contains 25 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains aspartame (E951) and peppermint oil (sorbitol (E420)).
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Orodispersible tablet

1 orodispersible tablet
2 x 1 orodispersible tablet
4 x 1 orodispersible tablet
8 x 1 orodispersible tablet
12 x 1 orodispersible tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Oral use. Dissolve in the mouth.

for 1 tablet per blister:

for 4 tablets per blister:

1. Hold the blister at the edges and separate one blister cell from the rest of the blister by gently 
tearing along the perforations around it.

2. Pull up the edge of the foil and peel the foil off completely.

I

iii

UII
/
*
H

L
J
4

'
I
'



43

3. Tip the tablet out onto your hand.
4. Put the tablet on the tongue as soon as it is removed from the packaging.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 orodispersible tablet: EU/1/09/551/013
2 x 1 orodispersible tablet: EU/1/09/551/014
4 x 1 orodispersible tablet: EU/1/09/551/015
8 x 1 orodispersible tablet: EU/1/09/551/016
12 x 1 orodispersible tablet: EU/1/09/551/017

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE



44

16. INFORMATION IN BRAILLE

Vizarsin 25 mg orodispersible tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



45

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER for monolingual and bilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 25 mg orodispersible tablets
sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

1. BEND AND TEAR
2. PEEL



46

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for monolingual and bilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 50 mg orodispersible tablets
sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each orodispersible tablet contains 50 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains aspartame (E951) and peppermint oil (sorbitol (E420)).
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Orodispersible tablet

1 orodispersible tablet
2 x 1 orodispersible tablet
4 x 1 orodispersible tablet
8 x 1 orodispersible tablet
12 x 1 orodispersible tablet
24 x 1 orodispersible tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Oral use. Dissolve in the mouth.

for 1 tablet per blister:

for 4 tablets per blister:

1. Hold the blister at the edges and separate one blister cell from the rest of the blister by gently 

r 
p9k.
fl\\

uIII i' IIy/ 
I

I 
iLiJ4 I

II /\ ç\\



47

tearing along the perforations around it.
2. Pull up the edge of the foil and peel the foil off completely.
3. Tip the tablet out onto your hand.
4. Put the tablet on the tongue as soon as it is removed from the packaging.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 orodispersible tablet: EU/1/09/551/018
2 x 1 orodispersible tablet: EU/1/09/551/019
4 x 1 orodispersible tablet: EU/1/09/551/020
8 x 1 orodispersible tablet: EU/1/09/551/021
12 x 1 orodispersible tablet: EU/1/09/551/022
24 x 1 orodispersible tablet: EU/1/09/551/028

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE



48

16. INFORMATION IN BRAILLE

Vizarsin 50 mg orodispersible tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



49

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER for monolingual and bilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 50 mg orodispersible tablets
sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

1. BEND AND TEAR
2. PEEL



50

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for monolingual and bilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 100 mg orodispersible tablets
sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each orodispersible tablet contains 100 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains aspartame (E951) and peppermint oil (sorbitol (E420)).
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Orodispersible tablet

1 orodispersible tablet
2 x 1 orodispersible tablet
4 x 1 orodispersible tablet
8 x 1 orodispersible tablet
12 x 1 orodispersible tablet
24 x 1 orodispersible tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Oral use. Dissolve in the mouth.

for 1 tablet per blister:

for 4 tablets per blister:

1. Hold the blister at the edges and separate one blister cell from the rest of the blister by gently 

r 
p9k.
fl\\

uIII i' IIy/ 
I

I 
iLiJ4 I

II /\ ç\\



51

tearing along the perforations around it.
2. Pull up the edge of the foil and peel the foil off completely.
3. Tip the tablet out onto your hand.
4. Put the tablet on the tongue as soon as it is removed from the packaging.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 orodispersible tablet: EU/1/09/551/023
2 x 1 orodispersible tablet: EU/1/09/551/024
4 x 1 orodispersible tablet: EU/1/09/551/025
8 x 1 orodispersible tablet: EU/1/09/551/026
12 x 1 orodispersible tablet: EU/1/09/551/027
24 x 1 orodispersible tablet: EU/1/09/551/029

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE



52

16. INFORMATION IN BRAILLE

Vizarsin 100 mg orodispersible tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



53

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER for monolingual and bilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 100 mg orodispersible tablets
sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

1. BEND AND TEAR
2. PEEL



54

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for trilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 25 mg orodispersible tablets
sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each orodispersible tablet contains 25 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains aspartame (E951) and peppermint oil (sorbitol (E420)).
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Orodispersible tablet

1 orodispersible tablet
2 x 1 orodispersible tablet
4 x 1 orodispersible tablet
8 x 1 orodispersible tablet
12 x 1 orodispersible tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

for 1 tablet per blister:

for 4 tablets per blister:

1. Hold the blister at the edges and separate one blister cell from the rest of the blister by gently 
tearing along the perforations around it.

2. Pull up the edge of the foil and peel the foil off completely.
3. Tip the tablet onto your hand and place it on the tongue.

I

r 
p9k.
fl\\

U
1
I

I

/c 
'

I'\/r 
I

I 
ILiJ4



55

4. Dissolve in the mouth.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 orodispersible tablet: EU/1/09/551/013
2 x 1 orodispersible tablet: EU/1/09/551/014
4 x 1 orodispersible tablet: EU/1/09/551/015
8 x 1 orodispersible tablet: EU/1/09/551/016
12 x 1 orodispersible tablet: EU/1/09/551/017

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE



56

Vizarsin 25 mg orodispersible tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



57

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER for trilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 25 mg orodispersible tablets
sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

1. Tear
2. Peel



58

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for trilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 50 mg orodispersible tablets
sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each orodispersible tablet contains 50 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains aspartame (E951) and peppermint oil (sorbitol (E420)).
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Orodispersible tablet

1 orodispersible tablet
2 x 1 orodispersible tablet
4 x 1 orodispersible tablet
8 x 1 orodispersible tablet
12 x 1 orodispersible tablet
24 x 1 orodispersible tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

for 1 tablet per blister:

for 4 tablets per blister:

1. Hold the blister at the edges and separate one blister cell from the rest of the blister by gently 
tearing along the perforations around it.

LH14I jçJ
I
 /\

I"K{i:2i



59

2. Pull up the edge of the foil and peel the foil off completely.
3. Tip the tablet onto your hand and place it on the tongue.
4. Dissolve in the mouth.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 orodispersible tablet: EU/1/09/551/018
2 x 1 orodispersible tablet: EU/1/09/551/019
4 x 1 orodispersible tablet: EU/1/09/551/020
8 x 1 orodispersible tablet: EU/1/09/551/021
12 x 1 orodispersible tablet: EU/1/09/551/022
24 x 1 orodispersible tablet: EU/1/09/551/028

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE



60

16. INFORMATION IN BRAILLE

Vizarsin 50 mg orodispersible tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



61

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER for trilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 50 mg orodispersible tablets
sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

1. Tear
2. Peel



62

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for trilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 100 mg orodispersible tablets
sildenafil

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each orodispersible tablet contains 100 mg sildenafil.

3. LIST OF EXCIPIENTS

Contains aspartame (E951) and peppermint oil (sorbitol (E420)).
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Orodispersible tablet

1 orodispersible tablet
2 x 1 orodispersible tablet
4 x 1 orodispersible tablet
8 x 1 orodispersible tablet
12 x 1 orodispersible tablet
24 x 1 orodispersible tablet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

for 1 tablet per blister:

for 4 tablets per blister:

1. Hold the blister at the edges and separate one blister cell from the rest of the blister by gently 
tearing along the perforations around it.

LH14I jçJ
I
 /\

I"K{i:2i



63

2. Pull up the edge of the foil and peel the foil off completely.
3. Tip the tablet onto your hand and place it on the tongue.
4. Dissolve in the mouth.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

1 orodispersible tablet: EU/1/09/551/023
2 x 1 orodispersible tablet: EU/1/09/551/024
4 x 1 orodispersible tablet: EU/1/09/551/025
8 x 1 orodispersible tablet: EU/1/09/551/026
12 x 1 orodispersible tablet: EU/1/09/551/027
24 x 1 orodispersible tablet: EU/1/09/551/029

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE



64

16. INFORMATION IN BRAILLE

Vizarsin 100 mg orodispersible tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



65

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER for trilingual packaging

1. NAME OF THE MEDICINAL PRODUCT

Vizarsin 100 mg orodispersible tablets
sildenafil

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

1. Tear
2. Peel



66

B. PACKAGE LEAFLET



67

Package leaflet: Information for the user

Vizarsin 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 or pharmacist.
- 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 or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Vizarsin is and what it is used for
2. What you need to know before you take Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Contents of the pack and other information

1. What Vizarsin is and what it is used for

Vizarsin 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. Vizarsin will only help 
you to get an erection if you are sexually stimulated.

Vizarsin 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 Vizarsin

Do not take Vizarsin
- 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 Vizarsin 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.



68

- 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 or pharmacist before taking Vizarsin:
- 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 Vizarsin and contact your doctor 
immediately.

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

You should not use Vizarsin with treatments for pulmonary arterial hypertension (PAH) containing 
sildenafil or any other PDE5 inhibitors.

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

You should not take Vizarsin 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
Vizarsin should not be given to individuals under the age of 18.

Other medicines and Vizarsin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

Vizarsin 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 
Vizarsin and when you did. Do not take Vizarsin with other medicines unless your doctor tells you 
that you can.

You should not take Vizarsin 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 Vizarsin 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.



69

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 Vizarsin.

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 Vizarsin with alpha-blockers. This is most likely to happen within 4 hours after taking Vizarsin. 
To reduce the chance that these symptoms might happen, you should be on a regular daily dose of 
your alpha-blocker before you start Vizarsin. Your doctor may start you on a lower dose (25 mg) of 
Vizarsin.

Vizarsin with food, drink and alcohol
Vizarsin can be taken with or without food. However, you may find that Vizarsin 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 Vizarsin.

Pregnancy and breast-feeding
Vizarsin is not indicated for use by women.

Driving and using machines
Vizarsin can cause dizziness and can affect vision. You should be aware of how you react to Vizarsin
before you drive or use machinery.

Vizarsin contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’.

3. How to take Vizarsin

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 Vizarsin more than once a day.

You should take Vizarsin 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 Vizarsin is too strong or too weak, talk to your doctor or pharmacist.

Vizarsin will only help you to get an erection if you are sexually stimulated. The amount of time 
Vizarsin takes to work varies from person to person, but it normally takes between half an hour and 
one hour. You may find that Vizarsin takes longer to work if you take it with a heavy meal.

If Vizarsin 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 Vizarsin than you should
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase 
the efficacy.



70

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 or pharmacist.

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 Vizarsin are usually mild to moderate and of a short 
duration.

If you experience any of the following serious side effects stop taking Vizarsin 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 
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 1000 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, 



71

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 Vizarsin.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Vizarsin

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 box and blister after EXP. The 
expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Vizarsin contains
- The active substance is sildenafil. Each film-coated tablet contains sildenafil citrate equivalent 

to 25 mg sildenafil.
- The other ingredients are:

Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, 
croscarmellose sodium, hypromellose (E464), magnesium stearate (E470b).

Film coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin 
(E1518).

See section 2 “Vizarsin contains lactose and sodium”.

What Vizarsin looks like and contents of the pack
Vizarsin 25 mg film-coated tablets are white, oblong and marked “25” on one side.

Vizarsin 25 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in 
boxes of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in a perforated unit dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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

België/Belgique/Belgien
KRKA Belgium, SA.

Lietuva
UAB KRKA Lietuva



72

Tél/Tel: +32 (0) 487 50 73 62 Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: +32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KERN PHARMA, S.L.
Tel: + 34 93 700 25 25

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 293 91 80

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: +358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom
Consilient Health (UK) Ltd.
Tel: + 44(0)203 751 1888



73

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu



74

Package leaflet: Information for the user

Vizarsin 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 or pharmacist.
- 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 or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Vizarsin is and what it is used for
2. What you need to know before you take Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Contents of the pack and other information

1. What Vizarsin is and what it is used for

Vizarsin 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. Vizarsin will only help 
you to get an erection if you are sexually stimulated.

Vizarsin 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 Vizarsin

Do not take Vizarsin
- 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 Vizarsin 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.



75

- 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 or pharmacist before taking Vizarsin:
- 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 Vizarsin and contact your doctor 
immediately.

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

You should not use Vizarsin with treatments for pulmonary arterial hypertension (PAH) containing 
sildenafil or any other PDE5 inhibitors.

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

You should not take Vizarsin 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
Vizarsin should not be given to individuals under the age of 18.

Other medicines and Vizarsin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

Vizarsin 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 
Vizarsin and when you did. Do not take Vizarsin with other medicines unless your doctor tells you 
that you can.

You should not take Vizarsin 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 Vizarsin 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.



76

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 Vizarsin.

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 Vizarsin with alpha-blockers. This is most likely to happen within 4 hours after taking Vizarsin. 
To reduce the chance that these symptoms might happen, you should be on a regular daily dose of 
your alpha-blocker before you start Vizarsin. Your doctor may start you on a lower dose (25 mg) of 
Vizarsin.

Vizarsin with food, drink and alcohol
Vizarsin can be taken with or without food. However, you may find that Vizarsin 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 Vizarsin.

Pregnancy and breast-feeding
Vizarsin is not indicated for use by women.

Driving and using machines
Vizarsin can cause dizziness and can affect vision. You should be aware of how you react to Vizarsin
before you drive or use machinery.

Vizarsin contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’.

3. How to take Vizarsin

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 Vizarsin more than once a day.

You should take Vizarsin 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 Vizarsin is too strong or too weak, talk to your doctor or pharmacist.

Vizarsin will only help you to get an erection if you are sexually stimulated. The amount of time 
Vizarsin takes to work varies from person to person, but it normally takes between half an hour and 
one hour. You may find that Vizarsin takes longer to work if you take it with a heavy meal.

If Vizarsin 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 Vizarsin than you should
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase 
the efficacy.



77

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 or pharmacist.

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 Vizarsin are usually mild to moderate and of a short 
duration.

If you experience any of the following serious side effects stop taking Vizarsin 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 
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 1000 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, 



78

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 Vizarsin.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Vizarsin

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 box and blister after EXP. The 
expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Vizarsin contains
- The active substance is sildenafil. Each film-coated tablet contains sildenafil citrate equivalent 

to 50 mg sildenafil.
- The other ingredients are:

Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, 
croscarmellose sodium, hypromellose (E464), magnesium stearate (E470b).

Film coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin 
(E1518).

See section 2 “Vizarsin contains lactose and sodium”.

What Vizarsin looks like and contents of the pack
Vizarsin 50 mg film-coated tablets are white, oblong and marked “50” on one side.

Vizarsin 50 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in 
boxes of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in a perforated unit dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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

België/Belgique/Belgien
KRKA Belgium, SA.

Lietuva
UAB KRKA Lietuva



79

Tél/Tel: +32 (0) 487 50 73 62 Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: +32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KERN PHARMA, S.L.
Tel: + 34 93 700 25 25

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 293 91 80

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: +358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom
Consilient Health (UK) Ltd.
Tel: + 44(0)203 751 1888



80

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu



81

Package leaflet: Information for the user

Vizarsin 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 or pharmacist.
- 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 or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Vizarsin is and what it is used for
2. What you need to know before you take Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Contents of the pack and other information

1. What Vizarsin is and what it is used for

Vizarsin 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. Vizarsin will only help 
you to get an erection if you are sexually stimulated.

Vizarsin 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 Vizarsin

Do not take Vizarsin
- 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 Vizarsin 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.



82

- 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 or pharmacist before taking Vizarsin:
- 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 Vizarsin and contact your doctor 
immediately.

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

You should not use Vizarsin with treatments for pulmonary arterial hypertension (PAH) containing 
sildenafil or any other PDE5 inhibitors.

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

You should not take Vizarsin 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
Vizarsin should not be given to individuals under the age of 18.

Other medicines and Vizarsin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

Vizarsin 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 
Vizarsin and when you did. Do not take Vizarsin with other medicines unless your doctor tells you 
that you can.

You should not take Vizarsin 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 Vizarsin 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.



83

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 Vizarsin.

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 Vizarsin with alpha-blockers. This is most likely to happen within 4 hours after taking Vizarsin. 
To reduce the chance that these symptoms might happen, you should be on a regular daily dose of 
your alpha-blocker before you start Vizarsin. Your doctor may start you on a lower dose (25 mg) of 
Vizarsin.

Vizarsin with food, drink and alcohol
Vizarsin can be taken with or without food. However, you may find that Vizarsin 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 Vizarsin.

Pregnancy and breast-feeding
Vizarsin is not indicated for use by women.

Driving and using machines
Vizarsin can cause dizziness and can affect vision. You should be aware of how you react to Vizarsin
before you drive or use machinery.

Vizarsin contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’.

3. How to take Vizarsin

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 Vizarsin more than once a day.

You should take Vizarsin 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 Vizarsin is too strong or too weak, talk to your doctor or pharmacist.

Vizarsin will only help you to get an erection if you are sexually stimulated. The amount of time 
Vizarsin takes to work varies from person to person, but it normally takes between half an hour and 
one hour. You may find that Vizarsin takes longer to work if you take it with a heavy meal.

If Vizarsin 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 Vizarsin than you should
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase 
the efficacy.



84

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 or pharmacist.

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 Vizarsin are usually mild to moderate and of a short 
duration.

If you experience any of the following serious side effects stop taking Vizarsin 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 
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 1000 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, 



85

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 Vizarsin.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Vizarsin

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 box and blister after EXP. The 
expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Vizarsin contains
- The active substance is sildenafil. Each film-coated tablet contains sildenafil citrate equivalent 

to 100 mg sildenafil.
- The other ingredients are:

Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, 
croscarmellose sodium, hypromellose (E464), magnesium stearate (E470b).

Film coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin 
(E1518).

See section 2 “Vizarsin contains lactose and sodium”.

What Vizarsin looks like and contents of the pack
Vizarsin 100 mg film-coated tablets are white, oblong and marked “100” on one side.

Vizarsin 100 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in 
boxes of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in a perforated unit dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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

België/Belgique/Belgien
KRKA Belgium, SA.

Lietuva
UAB KRKA Lietuva



86

Tél/Tel: +32 (0) 487 50 73 62 Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: +32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KERN PHARMA, S.L.
Tel: + 34 93 700 25 25

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 293 91 80

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: +358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom
Consilient Health (UK) Ltd.
Tel: + 44(0)203 751 1888



87

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu



88

Package leaflet: Information for the user

Vizarsin 25 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 or pharmacist.
- 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 or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Vizarsin is and what it is used for
2. What you need to know before you take Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Contents of the pack and other information

1. What Vizarsin is and what it is used for

Vizarsin 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. Vizarsin will only help 
you to get an erection if you are sexually stimulated.

Vizarsin 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 Vizarsin

Do not take Vizarsin
- 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 Vizarsin 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.



89

- 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 or pharmacist before taking Vizarsin:
- 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 Vizarsin and contact your 
doctor immediately.

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

You should not use Vizarsin with treatments for pulmonary arterial hypertension (PAH) containing 
sildenafil or any other PDE5 inhibitors.

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

You should not take Vizarsin 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
Vizarsin should not be given to individuals under the age of 18.

Other medicines and Vizarsin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

Vizarsin 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 
Vizarsin and when you did. Do not take Vizarsin with other medicines unless your doctor tells you 
that you can.

You should not take Vizarsin 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 Vizarsin 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.



90

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 Vizarsin.

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 Vizarsin with alpha-blockers. This is most likely to happen within 4 hours after taking Vizarsin. 
To reduce the chance that these symptoms might happen, you should be on a regular daily dose of 
your alpha-blocker before you start Vizarsin. Your doctor may start you on a lower dose (25 mg) of 
Vizarsin.

Vizarsin with food, drink and alcohol
Vizarsin can be taken with or without food. However, you may find that Vizarsin takes longer to start 
working if you take it with a heavy meal. Your mouth should be empty before taking the tablet.

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 Vizarsin.

Pregnancy and breast-feeding
Vizarsin is not indicated for use by women.

Driving and using machines
Vizarsin can cause dizziness and can affect vision. You should be aware of how you react to Vizarsin 
before you drive or use machinery.

Vizarsin contains aspartame (E951) and sorbitol (E420)
This medicine contains 0.375 mg aspartame in each orodispersible tablet. Aspartame is a source of 
phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which 
phenylalanine builds up because the body cannot remove it properly.
This medicine contains 0.00875 mg sorbitol in each orodispersible tablet. Sorbitol is a source of 
fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not 
receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side 
effects. You must tell your doctor before receiving this medicine if you have HFI.

3. How to take Vizarsin

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 Vizarsin more than once a day.

Do not take Vizarsin orodispersible tablets with any other forms of Vizarsin.

You should take Vizarsin about one hour before you plan to have sex.

Vizarsin are fragile. They should not be pushed through the foil in the blister pack as this will cause 
damage to the tablet. Do not handle the tablets with wet hands as the tablets may break up. Remove a 
tablet from the package as follows:

For 1 tablet per blister:



91

For 4 tablets per blister:

1. Hold the blister at the edges and separate one blister cell from the rest of the blister by gently 
tearing along the perforations around it.

2. Pull up the edge of the foil and peel the foil off completely.
3. Tip the tablet out onto your hand.
4. Put the tablet on the tongue as soon as it is removed from the packaging.

In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed with or 
without water. The mouth should be empty before placing the tablet on the tongue.

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

Vizarsin will only help you to get an erection if you are sexually stimulated. The amount of time 
Vizarsin takes to work varies from person to person, but it normally takes between half an hour and 
one hour. You may find that Vizarsin takes longer to work if you take it with a heavy meal.

If Vizarsin 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 Vizarsin 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 or pharmacist.

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 Vizarsin are usually mild to moderate and of a short 
duration.

If you experience any of the following serious side effects stop taking Vizarsin 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

__



92

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 
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 1000 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 Vizarsin.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Vizarsin

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



93

Do not use this medicine after the expiry date which is stated on the box and blister after EXP. The 
expiry date refers to the last day of that month.

Do not store above 30C.
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.

6. Contents of the pack and other information

What Vizarsin contains
- The active substance is sildenafil. Each orodispersible tablet contains 25 mg sildenafil.
- The other ingredients are hydroxypropylcellulose (E463), mannitol (E421), aspartame (E951), 

neohesperidin-dihydrochalcone (E959), spearmint oil, peppermint oil (containing sorbitol 
(E420)), crospovidone, calcium silicate and magnesium stearate (E470b).
See section 2 “Vizarsin contains aspartame (E951) and sorbitol (E420)”.

What Vizarsin looks like and contents of the pack
White to almost white, round, slightly biconvex tablets, with possible darker spots.

Vizarsin orodispersible tablets are available in boxes of 1 orodispersible tablet in blisters and also in 
boxes of 2 x 1, 4 x 1, 8 x 1 or 12 x 1 orodispersible tablet in a perforated unit dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: +32 (0) 487 50 73 62 (BE)

Eesti Norge



94

KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KERN PHARMA, S.L.
Tel: + 34 93 700 25 25

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 293 91 80

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: +358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom
Consilient Health (UK) Ltd.
Tel: + 44(0)203 751 1888

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu



95

Package leaflet: Information for the user

Vizarsin 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 or pharmacist.
- 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 or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Vizarsin is and what it is used for
2. What you need to know before you take Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Contents of the pack and other information

1. What Vizarsin is and what it is used for

Vizarsin 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. Vizarsin will only help 
you to get an erection if you are sexually stimulated.

Vizarsin 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 Vizarsin

Do not take Vizarsin
- 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 Vizarsin 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.



96

- 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 or pharmacist before taking Vizarsin:
- 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 Vizarsin and contact your 
doctor immediately.

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

You should not use Vizarsin with treatments for pulmonary arterial hypertension (PAH) containing 
sildenafil or any other PDE5 inhibitors.

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

You should not take Vizarsin 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
Vizarsin should not be given to individuals under the age of 18.

Other medicines and Vizarsin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

Vizarsin 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 
Vizarsin and when you did. Do not take Vizarsin with other medicines unless your doctor tells you 
that you can.

You should not take Vizarsin 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 Vizarsin 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.



97

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 Vizarsin.

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 Vizarsin with alpha-blockers. This is most likely to happen within 4 hours after taking Vizarsin. 
To reduce the chance that these symptoms might happen, you should be on a regular daily dose of 
your alpha-blocker before you start Vizarsin. Your doctor may start you on a lower dose (25 mg) of 
Vizarsin.

Vizarsin with food, drink and alcohol
Vizarsin can be taken with or without food. However, you may find that Vizarsin takes longer to start 
working if you take it with a heavy meal. Your mouth should be empty before taking the tablet.

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 Vizarsin.

Pregnancy and breast-feeding
Vizarsin is not indicated for use by women.

Driving and using machines
Vizarsin can cause dizziness and can affect vision. You should be aware of how you react to Vizarsin 
before you drive or use machinery.

Vizarsin contains aspartame (E951) and sorbitol (E420)
This medicine contains 0.75 mg aspartame in each orodispersible tablet. Aspartame is a source of 
phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which 
phenylalanine builds up because the body cannot remove it properly.
This medicine contains 0.0175 mg sorbitol in each orodispersible tablet. Sorbitol is a source of 
fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not 
receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side 
effects. You must tell your doctor before receiving this medicine if you have HFI.

3. How to take Vizarsin

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 Vizarsin more than once a day.

Do not take Vizarsin orodispersible tablets with any other forms of Vizarsin.

You should take Vizarsin about one hour before you plan to have sex.

Vizarsin are fragile. They should not be pushed through the foil in the blister pack as this will cause 
damage to the tablet. Do not handle the tablets with wet hands as the tablets may break up. Remove a 
tablet from the package as follows:

For 1 tablet per blister:



98

For 4 tablets per blister:

1. Hold the blister at the edges and separate one blister cell from the rest of the blister by gently 
tearing along the perforations around it.

2. Pull up the edge of the foil and peel the foil off completely.
3. Tip the tablet out onto your hand.
4. Put the tablet on the tongue as soon as it is removed from the packaging.

In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed with or 
without water. The mouth should be empty before placing the tablet on the tongue.

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

Vizarsin will only help you to get an erection if you are sexually stimulated. The amount of time 
Vizarsin takes to work varies from person to person, but it normally takes between half an hour and 
one hour. You may find that Vizarsin takes longer to work if you take it with a heavy meal.

If Vizarsin 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 Vizarsin 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 or pharmacist.

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 Vizarsin are usually mild to moderate and of a short 
duration.

If you experience any of the following serious side effects stop taking Vizarsin 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

__



99

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 
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 1000 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 Vizarsin.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Vizarsin

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



100

Do not use this medicine after the expiry date which is stated on the box and blister after EXP. The 
expiry date refers to the last day of that month.

Do not store above 30C.
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.

6. Contents of the pack and other information

What Vizarsin contains
- The active substance is sildenafil. Each orodispersible tablet contains 50 mg sildenafil.
- The other ingredients are hydroxypropylcellulose (E463), mannitol (E421), aspartame (E951), 

neohesperidin-dihydrochalcone (E959), spearmint oil, peppermint oil (containing sorbitol 
(E420)), crospovidone, calcium silicate and magnesium stearate (E470b).
See section 2 “Vizarsin contains aspartame (E951) and sorbitol (E420)”.

What Vizarsin looks like and contents of the pack
White to almost white, round, slightly biconvex tablets, with possible darker spots.

Vizarsin orodispersible tablets are available in boxes of 1 orodispersible tablet in blisters and also in 
boxes of 2 x 1, 4 x 1, 8 x 1, 12 x 1 or 24 x 1 orodispersible tablet in a perforated unit dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: +32 (0) 487 50 73 62 (BE)

Eesti Norge



101

KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KERN PHARMA, S.L.
Tel: + 34 93 700 25 25

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 293 91 80

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: +358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom
Consilient Health (UK) Ltd.
Tel: + 44(0)203 751 1888

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu



102

Package leaflet: Information for the user

Vizarsin 100 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 or pharmacist.
- 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 or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Vizarsin is and what it is used for
2. What you need to know before you take Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Contents of the pack and other information

1. What Vizarsin is and what it is used for

Vizarsin 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. Vizarsin will only help 
you to get an erection if you are sexually stimulated.

Vizarsin 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 Vizarsin

Do not take Vizarsin
- 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 Vizarsin 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.



103

- 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 or pharmacist before taking Vizarsin:
- 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 Vizarsin and contact your 
doctor immediately.

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

You should not use Vizarsin with treatments for pulmonary arterial hypertension (PAH) containing 
sildenafil or any other PDE5 inhibitors.

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

You should not take Vizarsin 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
Vizarsin should not be given to individuals under the age of 18.

Other medicines and Vizarsin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

Vizarsin 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 
Vizarsin and when you did. Do not take Vizarsin with other medicines unless your doctor tells you 
that you can.

You should not take Vizarsin 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 Vizarsin 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.



104

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 Vizarsin.

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 Vizarsin with alpha-blockers. This is most likely to happen within 4 hours after taking Vizarsin. 
To reduce the chance that these symptoms might happen, you should be on a regular daily dose of 
your alpha-blocker before you start Vizarsin. Your doctor may start you on a lower dose (25 mg) of 
Vizarsin.

Vizarsin with food, drink and alcohol
Vizarsin can be taken with or without food. However, you may find that Vizarsin takes longer to start 
working if you take it with a heavy meal. Your mouth should be empty before taking the tablet.

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 Vizarsin.

Pregnancy and breast-feeding
Vizarsin is not indicated for use by women.

Driving and using machines
Vizarsin can cause dizziness and can affect vision. You should be aware of how you react to Vizarsin 
before you drive or use machinery.

Vizarsin contains aspartame (E951) and sorbitol (E420)
This medicine contains 1.5 mg aspartame in each orodispersible tablet. Aspartame is a source of 
phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which 
phenylalanine builds up because the body cannot remove it properly.
This medicine contains 0.035 mg sorbitol in each orodispersible tablet. Sorbitol is a source of fructose. 
If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this 
medicine. Patients with HFI cannot break down fructose, which may cause serious side effects. You 
must tell your doctor before receiving this medicine if you have HFI.

3. How to take Vizarsin

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 Vizarsin more than once a day.

Do not take Vizarsin orodispersible tablets with any other forms of Vizarsin.

You should take Vizarsin about one hour before you plan to have sex.

Vizarsin are fragile. They should not be pushed through the foil in the blister pack as this will cause 
damage to the tablet. Do not handle the tablets with wet hands as the tablets may break up. Remove a 
tablet from the package as follows:

For 1 tablet per blister:



105

For 4 tablets per blister:

1. Hold the blister at the edges and separate one blister cell from the rest of the blister by gently 
tearing along the perforations around it.

2. Pull up the edge of the foil and peel the foil off completely.
3. Tip the tablet out onto your hand.
4. Put the tablet on the tongue as soon as it is removed from the packaging.

In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed with or 
without water. The mouth should be empty before placing the tablet on the tongue.

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

Vizarsin will only help you to get an erection if you are sexually stimulated. The amount of time 
Vizarsin takes to work varies from person to person, but it normally takes between half an hour and 
one hour. You may find that Vizarsin takes longer to work if you take it with a heavy meal.

If Vizarsin 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 Vizarsin 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 or pharmacist.

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 Vizarsin are usually mild to moderate and of a short 
duration.

If you experience any of the following serious side effects stop taking Vizarsin 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

__



106

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 
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 1000 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 Vizarsin.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Vizarsin

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



107

Do not use this medicine after the expiry date which is stated on the box and blister after EXP. The 
expiry date refers to the last day of that month.

Do not store above 30C.
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.

6. Contents of the pack and other information

What Vizarsin contains
- The active substance is sildenafil. Each orodispersible tablet contains 100 mg sildenafil.
- The other ingredients are hydroxypropylcellulose (E463), mannitol (E421), aspartame (E951), 

neohesperidin-dihydrochalcone (E959), spearmint oil, peppermint oil (containing sorbitol 
(E420)), crospovidone, calcium silicate and magnesium stearate (E470b).
See section 2 “Vizarsin contains aspartame (E951) and sorbitol (E420)”.

What Vizarsin looks like and contents of the pack
White to almost white, round, slightly biconvex tablets, with possible darker spots.

Vizarsin orodispersible tablets are available in boxes of 1 orodispersible tablet in blisters and also in 
boxes of 2 x 1, 4 x 1, 8 x 1, 12 x 1 or 24 x 1 orodispersible tablet in a perforated unit dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: +32 (0) 487 50 73 62 (BE)

Eesti Norge



108

KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KERN PHARMA, S.L.
Tel: + 34 93 700 25 25

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 293 91 80

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: +358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom
Consilient Health (UK) Ltd.
Tel: + 44(0)203 751 1888

This leaflet was last revised in

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