Levitra

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



2 

1. NAME OF THE MEDICINAL PRODUCT 
 
Levitra 5 mg film-coated tablets 
Levitra10 mg film-coated tablets 
Levitra 20 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet of 5 mg film-coated tablets contains 5 mg of vardenafil (as hydrochloride). 
Each tablet of 10 mg film-coated tablets contains 10 mg of vardenafil (as hydrochloride). 
Each tablet of 20 mg film-coated tablets contains 20 mg of vardenafil (as hydrochloride). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet. 
 
Levitra 5 mg film-coated tablets 
Orange round tablets marked with the BAYER-cross on one side and “5” on the other side. 
 
Levitra 10 mg film-coated tablets 
Orange round tablets marked with the BAYER-cross on one side and “10” on the other side. 
 
Levitra 20 mg film-coated tablets 
Orange round tablets marked with the BAYER-cross on one side and “20” on the other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or 
maintain a penile erection sufficient for satisfactory sexual performance. 
 
In order for Levitra to be effective, sexual stimulation is required. 
 
4.2 Posology and method of administration 
 
Posology 
Use in adult men 
The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity. 
Based on efficacy and tolerability the dose may be increased to 20 mg or decreased to 5 mg. The 
maximum recommended dose is 20 mg. The maximum recommended dosing frequency is once per day. 
Levitra can be taken with or without food. The onset of activity may be delayed if taken with a high fat 
meal (see section 5.2). 
 
Special populations 
Elderly (>65 years old) 
Dose adjustments are not required in elderly patients. However, an increase to a maximum 20 mg dose 
should be carefully considered depending on the individual tolerability (see sections 4.4 and 4.8). 
 
Hepatic impairment 
A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment 
(Child-Pugh A-B). Based on tolerability and efficacy, the dose may subsequently be increased.  



3 

The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is 
10 mg (see sections 4.3 and 5.2). 
 
Renal impairment 
No dose adjustment is required in patients with mild to moderate renal impairment. 
In patients with severe renal impairment (creatinine clearance <30 ml/min), a starting dose of 5 mg 
should be considered. Based on tolerability and efficacy the dose may be increased to 10 mg and 20 mg. 
 
Paediatric population 
Levitra is not indicated for individuals below 18 years of age. There is no relevant indication for use of 
Levitra in children. 
 
Use in patients using other medicinal products 
Concomitant use of CYP3A4 inhibitors 
When used in combination with the CYP3A4 inhibitors such as erythromycin or clarithromycin, the 
dose of vardenafil should not exceed 5 mg (see section 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. 
 
The co-administration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form 
is contraindicated (see sections 4.5 and 5.1). 
 
Levitra is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior 
ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with 
previous phosphodiesterase 5 (PDE5) inhibitor exposure (see section 4.4). 
 
Medicinal products for the treatment of erectile dysfunction should generally 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 [New York Heart Association III or IV]). 
 
The safety of vardenafil has not been studied in the following sub-groups of patients and its use is 
therefore contraindicated until further information is available: 
- severe hepatic impairment (Child-Pugh C), 
- end stage renal disease requiring dialysis, 
- hypotension (blood pressure <90/50 mmHg), 
- recent history of stroke or myocardial infarction (within the last 6 months), 
- unstable angina and known hereditary retinal degenerative disorders such as retinitis pigmentosa. 
 
Concomitant use of vardenafil with the potent CYP3A4 inhibitors ketoconazole and itraconazole (oral 
form) is contraindicated in men older than 75 years. 
 
Concomitant use of vardenafil with HIV protease inhibitors such as ritonavir and indinavir is 
contraindicated, as they are very potent inhibitors of CYP3A4 (see section 4.5). 
 
The co-administration of PDE5 inhibitors, including vardenafil, with guanylate cyclase stimulators, 
such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 
4.5). 
 
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. 



4 

 
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 (see section 
4.3). Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure 
(see section 5.1). Patients with left ventricular outflow obstruction, e.g., aortic stenosis and idiopathic 
hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 
phosphodiesterase inhibitors. 
 
Serious cardiovascular events including sudden death, tachycardia, myocardial infarction, ventricular 
tachy-arrythmia, angina pectoris, and cerebrovascular disorders (including transient ischaemic attack 
and cerebral haemorrhage), have been reported in temporal association with vardenafil. Most of the 
patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, 
it is not possible to definitively determine whether these events are related directly to these risk factors, 
to vardenafil, to sexual activity, or to a combination of these or other factors. 
 
Medicinal products for the treatment of erectile dysfunction 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). 
 
The safety and efficacy of combinations of Levitra film-coated tablets with Levitra orodispersible 
tablets or other treatments for erectile dysfunction have not been studied. Therefore, the use of such 
combinations is not recommended. 
 
Tolerability of the maximum dose of 20 mg may be lower in elderly patients (≥65 years old) (see 
sections 4.2 and 4.8). 
 
Concomitant use of alpha-blockers 
The concomitant use of alpha-blockers and vardenafil may lead to symptomatic hypotension in some 
patients because both are vasodilators. Concomitant treatment with vardenafil should only be initiated if 
the patient has been stabilised on his alpha-blocker therapy. In those patients who are stable on 
alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5 mg 
film-coated tablets. Vardenafil may be administered at any time with tamsulosin or with alfuzosin. With 
other alpha-blockers a time separation of dosing should be considered when vardenafil is prescribed 
concomitantly (see section 4.5). In those patients already taking an optimized dose of vardenafil, 
alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose 
may be associated with further lowering of blood pressure in patients taking vardenafil. 
 
Concomitant use of CYP3A4 inhibitors  
Concomitant use of vardenafil with potent CYP3A4 inhibitors such as itraconazole and ketoconazole 
(oral form) should be avoided as very high plasma concentrations of vardenafil are reached if the 
medicinal products are combined (see sections 4.5 and 4.3). 
 
Vardenafil dose adjustment might be necessary if moderate CYP3A4 inhibitors such as erythromycin 
and clarithromycin, are given concomitantly (see sections 4.5 and 4.2). 
 
Concomitant intake of grapefruit or grapefruit juice is expected to increase the plasma concentrations of 
vardenafil. The combination should be avoided (see section 4.5). 
 
Effect on QTc interval 
Single oral doses of 10 mg and 80 mg of vardenafil have been shown to prolong the QTc interval by a 
mean of 8 msec and 10 msec, respectively. And single doses of 10 mg vardenafil co-administered 
concomitantly with 400 mg gatifloxacin, an active substance with comparable QT effect, showed an 
additive QTc effect of 4 msec when compared to either active substance alone. The clinical impact of 
these QT changes is unknown (see section 5.1). 
The clinical relevance of this finding is unknown and cannot be generalised to all patients under all 
circumstances, as it will depend on the individual risk factors and susceptibilities that may be present at 



5 

any time in any given patient. Medicinal products that may prolong QTc interval, including vardenafil, 
are best avoided in patients with relevant risk factors, for example, hypokalaemia, congenital QT 
prolongation, concomitant administration of antiarrhythmic medicinal products in Class 1A (e.g. 
quinidine, procainamide), or Class III (e.g. amiodarone, sotalol). 
 
Effect on vision 
Visual defects and cases of non-arteritic ischemic optic neuropathy (NAION) have been reported in 
connection with the intake of Levitra and other PDE5 inhibitors. Analyses of observational data suggest 
an increased risk of acute NAION in men with erectile dysfunction following exposure to PDE5 
inhibitors such as vardenafil, tadalafil and sildenafil (see section 4.8). As this may be relevant for all 
patients exposed to vardenafil the patient should be advised that in the case of sudden visual defect, he 
should stop taking Levitra and consult immediately a physician (see section 4.3). 
 
Effect on bleeding 
In vitro studies with human platelets indicate that vardenafil has no antiaggregatory effect on its own, 
but at high (super-therapeutic) concentrations vardenafil potentiates the antiaggregatory effect of the 
nitric oxide donor sodium nitroprusside. In humans vardenafil had no effect on bleeding time alone or in 
combination with acetylsalicyclic acid (see section 4.5). There is no safety information available on the 
administration of vardenafil to patients with bleeding disorders or active peptic ulceration. Therefore 
vardenafil should be administered to these patients only after careful benefit-risk assessment. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Effects of other medicinal products on vardenafil 
In vitro studies 
Vardenafil is metabolised predominantly by hepatic enzymes via cytochrome P450 (CYP) isoform 3A4, 
with some contribution from CYP3A5 and CYP2C isoforms. Therefore, inhibitors of these isoenzymes 
may reduce vardenafil clearance. 
 
In vivo studies 
Co-administration of the HIV protease inhibitor indinavir (800 mg three times a day), a potent CYP3A4 
inhibitor, with vardenafil (10 mg film-coated tablets) resulted in a 16-fold increase in vardenafil AUC 
and a 7-fold increase in vardenafil Cmax. At 24 hours, the plasma levels of vardenafil had fallen to 
approximately 4% of the maximum vardenafil plasma level (Cmax). 
 
Co-administration of vardenafil with ritonavir (600 mg twice daily) resulted in a 13-fold increase in 
vardenafil Cmax and a 49-fold increase in vardenafil AUC0-24 when co-administered with vardenafil 
5 mg. The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a 
highly potent CYP3A4 inhibitor, which also inhibits CYP2C9. Ritonavir significantly prolonged the 
half-life of vardenafil to 25.7 hours (see section 4.3). 
 
Co-administration of ketoconazole (200 mg), a potent CYP3A4 inhibitor, with vardenafil (5 mg) 
resulted in a 10-fold increase in vardenafil AUC and a 4-fold increase in vardenafil Cmax (see section 
4.4). 
 
Although specific interaction studies have not been conducted, the concomitant use of other potent 
CYP3A4 inhibitors (such as itraconazole) can be expected to produce vardenafil plasma levels 
comparable to those produced by ketoconazole. Concomitant use of vardenafil with potent CYP3A4 
inhibitors such as itraconazole and ketoconazole (oral use) should be avoided (see sections 4.3 and 4.4). 
In men older than 75 years the concomitant use of vardenafil with itraconazole or ketoconazole is 
contraindicated (see section 4.3). 
 
Co-administration of erythromycin (500 mg three times a day), a CYP3A4 inhibitor, with vardenafil 
(5 mg) resulted in a 4-fold increase in vardenafil AUC and a 3-fold increase in Cmax. Although a specific 
interaction study has not been conducted, the co-administration of clarithromycin can be expected to 
result in similar effects on vardenafil AUC and Cmax. When used in combination with a moderate 
CYP3A4 inhibitor such as erythromycin or clarithromycin, vardenafil dose adjustment might be 



6 

necessary (see sections 4.2 and 4.4). Cimetidine (400 mg twice daily), a non-specific cytochrome P450 
inhibitor, had no effect on vardenafil AUC and Cmax when co-administered with vardenafil (20 mg) to 
healthy volunteers. 
 
Grapefruit juice being a weak inhibitor of CYP3A4 gut wall metabolism, may give rise to modest 
increases in plasma levels of vardenafil (see section 4.4). 
 
The pharmacokinetics of vardenafil (20 mg) was not affected by co-administration with the 
H2-antagonist ranitidine (150 mg twice daily), digoxin, warfarin, glibenclamide, alcohol (mean 
maximum blood alcohol level of 73 mg/dl) or single doses of antacid (magnesium hydroxide/aluminium 
hydroxide). 
 
Although specific interaction studies were not conducted for all medicinal products, population 
pharmacokinetic analysis showed no effect on vardenafil pharmacokinetics of the following 
concomitant medicinal products: acetylsalicylic acid, ACE-inhibitors, beta-blockers, weak CYP3A4 
inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin). 
 
Effects of vardenafil on other medicinal products 
There are no data on the interaction of vardenafil and non-specific phosphodiesterase inhibitors such as 
theophylline or dipyridamole. 
 
In vivo studies 
No potentiation of the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) was observed 
when vardenafil (10 mg) was given at varying time intervals (1 h to 24 h) prior to the dose of 
nitroglycerin in a study in 18 healthy male subjects. Vardenafil 20 mg film-coated tablets potentiated the 
blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) taken 1 and 4 hours after vardenafil 
administration to healthy middle aged subjects. No effect on blood pressure was observed when 
nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg film-coated 
tablets. However, there is no information on the possible potentiation of the hypotensive effects of 
nitrates by vardenafil in patients, and concomitant use is therefore contraindicated (see section 4.3). 
 
Nicorandil is a hybrid of potassium channel opener and nitrate. Due to the nitrate component it has the 
potential to have serious interaction with vardenafil. 
 
Since alpha-blocker monotherapy can cause marked lowering of blood pressure, especially postural 
hypotension and syncope, interaction studies were conducted with vardenafil. In two interaction studies 
with healthy normotensive volunteers after forced titration of the alpha-blockers tamsulosin or terazosin 
to high doses, hypotension (in some cases symptomatic) was reported in a significant number of subjects 
after co-administration of vardenafil. Among subjects treated with terazosin, hypotension was observed 
more frequently when vardenafil and terazosin were given simultaneously than when the dosing was 
separated by a time interval of 6 hours. 
 
Based on the results of interaction studies conducted with vardenafil in patients with benign prostatic 
hyperplasia (BPH) on stable tamsulosin, terazosin or alfuzosin therapy: 
 
• When vardenafil (film-coated tablets) was given at doses of 5, 10 or 20 mg on a background of 

stable therapy with tamsulosin, there was no symptomatic reduction in blood pressure, although 
3/21 tamsulosin treated subjects exhibited transient standing systolic blood pressures of less than 
85 mmHg. 

• When vardenafil 5 mg (film-coated tablets) was given simultaneously with terazosin 5 or 10 mg, 
one of 21 patients experienced symptomatic postural hypotension. Hypotension was not observed 
when vardenafil 5 mg and terazosin administration was separated by 6 hours. 

• When vardenafil (film-coated tablets) was given at doses of 5 or 10 mg on a background of stable 
therapy with alfuzosin, compared to placebo, there was no symptomatic reduction in blood 
pressure.   

 



7 

Therefore, concomitant treatment should be initiated only if the patient is stable on his alpha-blocker 
therapy. In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at the 
lowest recommended starting dose of 5 mg. Levitra may be administered at any time with tamsulosin or 
alfuzosin. With other alpha-blockers a time separation of dosing should be considered when vardenafil 
is prescribed concomitantly (see section 4.4). 
 
No significant interactions were shown when warfarin (25 mg), which is metabolised by CYP2C9, or 
digoxin (0.375 mg) was co-administered with vardenafil (20 mg film-coated tablets). The relative 
bioavailability of glibenclamide (3.5 mg) was not affected when co-administered with vardenafil 
(20 mg). In a specific study, where vardenafil (20 mg) was co-administered with slow release nifedipine 
(30 mg or 60 mg) in hypertensive patients, there was an additional reduction on supine systolic blood 
pressure of 6 mmHg and supine diastolic blood pressure of 5 mmHg accompanied with an increase in 
heart rate of 4 bpm. 
 
When vardenafil (20 mg film-coated tablets) and alcohol (mean maximum blood alcohol level of 
73 mg/dl) were taken together, vardenafil did not potentiate the effects of alcohol on blood pressure and 
heart rate and the pharmacokinetics of vardenafil were not altered. 
 
Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid 
(2 x 81 mg). 
 
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 vardenafil, is 
contraindicated (see section 4.3). 
 
4.6 Fertility, pregnancy and lactation 
 
Levitra is not indicated for use by women. There are no studies of vardenafil in pregnant women. 
There are no fertility data available. 
 
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 abnormal vision have been reported in clinical trials with vardenafil, patients should be 
aware of how they react to Levitra, before driving or operating machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The adverse reactions reported with Levitra film-coated tablets or 10 mg orodispersible tablets in 
clinical trials were generally transient and mild to moderate in nature. The most commonly reported 
adverse drug reaction occurring in ≥ 10% of patients is headache. 
 
Tabulated list of adverse reactions 
Adverse reactions are listed according to the MedDRA frequency convention: 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) and not 
known (can not be estimated from available data). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 



8 

The following adverse reactions have been reported: 
 
System Organ 
Class 

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) 

Not known  
(cannot be 
estimated from 
the available 
data) 

Infection and 
infestations 

   Conjunctivitis  

Immune 
system 
disorders 

  Allergic 
oedema and 
angioedema  

Allergic reaction   

Psychiatric 
disorders 

  Sleep disorder Anxiety  

Nervous 
system 
disorders 

Headache Dizziness Somnolence 
Paraesthesia 
and 
dysaesthesia 

Syncope 
Seizure  
Amnesia 
Transient 
ischaemic attack 

Cerebral 
haemorrhage 

Eye disorders    Visual 
disturbance  
Ocular 
hyperaemia 
Visual colour 
distortions  
Eye pain and 
eye discomfort  
Photophobia 

Increase in 
intraocular 
pressure 
Lacrimation 
increased 

Non-arteritic 
anterior 
ischemic optic 
neuropathy 
Visual defects 

Ear and 
labyrinth 
disorders 

  Tinnitus 
Vertigo 

 Sudden 
deafness 

Cardiac 
disorders  

  Palpitation 
Tachycardia 

Myocardial 
infarction 
Ventricular 
tachy-arrhythmias 
Angina pectoris 

Sudden death 

Vascular 
disorders  

 Flushing  Hypotension  
Hypertension 

 

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Nasal 
congestion  

Dyspnoea 
Sinus 
congestion 

Epistaxis  



9 

System Organ 
Class 

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) 

Not known  
(cannot be 
estimated from 
the available 
data) 

Gastrointesti-
nal disorders  

 Dyspepsia  Gastro-oesopha
geal reflux 
disease  
Gastritis 
Gastrointestinal 
and abdominal 
pain 
Diarrhoea 
Vomiting 
Nausea 
Dry mouth  

  

Hepatobiliary 
disorders 

  Increase in 
transaminases 

Increase in 
gamma-glutamyl 
transferase 

 

Skin and 
subcutaneous 
tissue 
disorders 

  Erythema 
Rash 

Photosensitivity 
reaction 

 

Musculoskele-
tal and 
connective 
tissue 
disorders 

  Back pain  
Increase in 
creatine 
phosphokinase 
Myalgia  
Increased 
muscle tone and 
cramping 

  

Renal and 
urinary 
disorders 

    Haematuria 

Reproductive 
system and 
breast 
disorders 

  Increase in 
erection  

Priapism Penile 
Haemorrhage 
Haematosper-
mia 

General 
disorders and 
administra-
tion site 
conditions 

  Feeling unwell  Chest pain   

 
Description of selected adverse reactions 
Penile haemorrhage, haematospermia and haematuria have been reported in clinical trials and 
spontaneous post-marketing data with the use of all PDE5 inhibitors, including vardenafil. 
 



10 

At a dose of 20 mg Levitra film-coated tablets, elderly (≥65 years old) patients had higher frequencies of 
headaches (16.2% versus 11.8%) and dizziness (3.7% versus 0.7%) than younger patients (<65 years 
old). In general, the incidence of adverse reactions (especially “dizziness”) has been shown to be slightly 
higher in patients with a history of hypertension. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system listed 
in Appendix V. 
 
4.9 Overdose 
 
In single dose volunteer studies, doses up to and including 80 mg vardenafil (film-coated tablets) per 
day were tolerated without exhibiting serious adverse reactions. 
 
When vardenafil was administered in higher doses and more frequently than the recommended dose 
regimen (40 mg film-coated tablets twice daily) cases of severe back pain have been reported. This was 
not associated with any muscle or neurological toxicity. 
 
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not 
expected to accelerate clearance, as vardenafil is highly bound to plasma proteins and not significantly 
eliminated in the urine. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC code: G04BE09. 
 
Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction. 
In the natural setting, i.e. with sexual stimulation, it restores impaired erectile function by increasing 
blood flow to the penis. 
 
Penile erection is a haemodynamic process. During sexual stimulation, nitric oxide is released. It 
activates the enzyme guanylate cyclase, resulting in an increased level of cyclic guanosine 
monophosphate (cGMP) in the corpus cavernosum. This in turn results in smooth muscle relaxation, 
allowing increased inflow of blood into the penis. The level of cGMP is regulated by the rate of 
synthesis via guanylate cyclase and by the rate of degradation via cGMP hydrolysing 
phosphodiesterases (PDEs). 
 
Vardenafil is a potent and selective inhibitor of the cGMP specific phosphodiesterase type 5 (PDE5), the 
most prominent PDE in the human corpus cavernosum. Vardenafil potently enhances the effect of 
endogenous nitric oxide in the corpus cavernosum by inhibiting PDE5. When nitric oxide is released in 
response to sexual stimulation, inhibition of PDE5 by vardenafil results in increased corpus cavernosum 
levels of cGMP. Sexual stimulation is therefore required for vardenafil to produce its beneficial 
therapeutic effects. 
 
In vitro studies have shown that vardenafil is more potent on PDE5 than on other known 
phosphodiesterases (>15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to 
PDE11, and >1000-fold relative to PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 and PDE10). 
 
In a penile plesthysmography (RigiScan) study, vardenafil 20 mg produced erections considered 
sufficient for penetration (60% rigidity by RigiScan) in some men as early as 15 minutes after dosing. 
The overall response of these subjects to vardenafil became statistically significant, compared to 
placebo, 25 minutes after dosing. 

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


11 

 
Vardenafil causes mild and transient decreases in blood pressure which, in the majority of the cases, do 
not translate into clinical effects. The mean maximum decreases in supine systolic blood pressure 
following 20 mg and 40 mg vardenafil were – 6.9 mmHg under 20 mg and – 4.3 mmHg under 40 mg of 
vardenafil, when compared to placebo. These effects are consistent with the vasodilatory effects of 
PDE5-inhibitors and are probably due to increased cGMP levels in vascular smooth muscle cells. Single 
and multiple oral doses of vardenafil up to 40 mg produced no clinically relevant changes in the ECGs 
of normal male volunteers. 
 
A single dose, double blind, crossover, randomised trial in 59 healthy males compared the effects on the 
QT interval of vardenafil (10 mg and 80 mg), sildenafil (50 mg and 400 mg) and placebo. Moxifloxacin 
(400 mg) was included as an active internal control. Effects on the QT interval were measured one hour 
post-dose (average tmax for vardenafil). The primary objective of this study was to rule out a greater than 
10 msec effect (i.e. to demonstrate lack of effect) of a single 80 mg oral dose of vardenafil on QTc 
interval compared to placebo, as measured by the change in Fridericia's correction formula 
(QTcF=QT/RR1/3) from baseline at the 1 hour post-dose time point. The vardenafil results showed an 
increase in QTc (Fridericia) of 8 msec (90% CI: 6-9) and 10 msec (90% CI: 8-11) at 10 and 80 mg doses 
compared to placebo and an increase in QTci of 4 msec (90% CI: 3-6) and 6 msec (90% CI: 4-7) at 10 
and 80 mg doses compared to placebo, at one hour post-dose. At tmax, only the mean change in QTcF for 
vardenafil 80 mg was out of the study established limit (mean 10 msec, 90% CI: 8-11). When using the 
individual correction formulae, none of the values were out of the limit. 
 
In a separate post-marketing study of 44 healthy volunteers, single doses of 10 mg vardenafil or 50 mg 
sildenafil were co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT 
effect. Both vardenafil and sildenafil showed an increase of Fridericia QTc effect of 4 msec (vardenafil) 
and 5 msec (sildenafil) when compared to either drug alone. The actual clinical impact of these QT 
changes is unknown. 
 
Further information on clinical trials with vardenafil 10 mg orodispersible tablets 
Efficacy and safety of vardenafil 10 mg orodispersible tablets were separately demonstrated in a broad 
population in two studies including 701 randomized erectile dysfunction patients who were treated up to 
12 weeks. The distribution of patients in the predefined subgroups was covering elderly patients (51%), 
patients with history of diabetes mellitus (29%), dyslipidemia (39%) and hypertension (40%). 
 
In pooled data from the two vardenafil 10 mg orodispersible tablets trials, IIEF-EF domain scores were 
significantly higher with vardenafil 10 mg orodispersible tablet versus placebo. 
 
A percentage of 71% of all sexual attempts reported in the clinical trials had successful penetration 
compared to 44% of all attempts in the placebo group. These results were also reflected in subgroups, in 
elderly patients (65%), in patients with history of diabetes mellitus (63%), patients with history of 
dyslipidemia (66%) and hypertension (70%) of all sexual attempts reported had successful penetration. 
 
About 63% of all reported sexual attempts with vardenafil 10 mg orodispersible tablets were successful 
in terms of erection maintenance compared to about 26% of all placebo-controlled sexual attempts. In 
the predefined subgroups 57% (elderly patients), 56% (patients with history of diabetes mellitus), 59% 
(patients with history of dyslipidemia) and 60% (patients with history of hypertension) of all reported 
attempts with vardenafil 10 mg orodispersible tablets were successful in terms of maintenance of 
erection. 
 
Further information on clinical trials 
In clinical trials vardenafil was administered to over 17,000 men with erectile dysfunction (ED) aged 
18 - 89 years, many of whom had multiple co-morbid conditions. Over 2,500 patients have been treated 
with vardenafil for six months or longer. Of these, 900 patients have been treated for one year or longer. 
 
The following patient groups were represented: elderly (22%), patients with hypertension (35%), 
diabetes mellitus (29%), ischaemic heart disease and other cardiovascular diseases (7%), chronic 
pulmonary disease (5%), hyperlipidaemia (22%), depression (5%), radical prostatectomy (9%). The 



12 

following groups were not well represented in clinical trials: elderly (>75 years, 2.4%), and patients with 
certain cardiovascular conditions (see section 4.3). No clinical trials in CNS diseases (except spinal cord 
injury), patients with severe renal or hepatic impairment, pelvic surgery (except nerve-sparing 
prostatectomy) or trauma or radiotherapy and hypoactive sexual desire or penile anatomic deformities 
have been performed. 
 
Across the pivotal trials, treatment with vardenafil (film-coated tablets) resulted in an improvement of 
erectile function compared to placebo. In the small number of patients who attempted intercourse up to 
four to five hours after dosing the success rate for penetration and maintenance of erection was 
consistently greater than placebo. 
 
In fixed dose studies (film-coated tablets) in a broad population of men with erectile dysfunction, 68% 
(5 mg), 76% (10 mg) and 80% (20 mg) of patients experienced successful penetrations (SEP 2) 
compared to 49% on placebo over a three month study period. The ability to maintain the erection 
(SEP 3) in this broad ED population was given as 53% (5 mg), 63% (10 mg) and 65% (20 mg) 
compared to 29% on placebo. 
 
In pooled data from the major efficacy trials, the proportion of patients experiencing successful 
penetration on vardenafil were as follows: psychogenic erectile dysfunction (77-87%), mixed erectile 
dysfunction (69-83%), organic erectile dysfunction (64-75%), elderly (52-75%), ischaemic heart 
disease (70-73%), hyperlipidaemia (62-73%), chronic pulmonary disease (74-78%), depression 
(59-69%), and patients concomitantly treated with antihypertensives (62-73%). 
 
In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile 
function domain score, the ability to obtain and maintain an erection long enough for successful 
intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg. The 
response rates for the ability to obtain and maintain an erection was 61% and 49% on 10 mg and 64% 
and 54% on 20 mg vardenafil compared to 36% and 23% on placebo for patients who completed three 
months treatment. 
 
In a clinical trial in post-prostatectomy patients, vardenafil significantly improved the erectile function 
domain score, the ability to obtain and maintain an erection long enough for successful intercourse and 
penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg. The response rates for the 
ability to obtain and maintain an erection was 47% and 37% on 10 mg and 48% and 34% on 20 mg 
vardenafil compared to 22% and 10% on placebo for patients who completed three months treatment. 
 
In a flexible-dose clinical trial in patients with Spinal Cord Injury, vardenafil significantly improved the 
erectile function domain score, the ability to obtain and maintain an erection long enough for successful 
intercourse and penile rigidity compared to placebo. The number of patients who returned to a normal 
IIEF domain score (>26) were 53% on vardenafil compared to 9% on placebo. The response rates for the 
ability to obtain and maintain an erection were 76% and 59% on vardenafil compared to 41% and 22% 
on placebo for patients who completed three months treatment which were clinically and statistically 
significant (p<0.001). 
 
The safety and efficacy of vardenafil was maintained in long-term studies. 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies in all subsets 
of the paediatric population in the treatment of the erectile dysfunction. See section 4.2 for information 
on paediatric use. 
 
5.2 Pharmacokinetic properties   
 
Bioequivalence studies have shown that vardenafil 10 mg orodispersible tablet is not bioequivalent to 
vardenafil 10 mg film-coated tablets. Therefore the orodispersible formulation should not be used as an 
equivalent to vardenafil 10 mg film-coated tablets. 
 



13 

Absorption 
In vardenafil film-coated tablets, vardenafil is rapidly absorbed with maximum observed plasma 
concentrations reached in some men as early as 15 minutes after oral administration. However, 90% of 
the time, maximum 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 15%. After oral dosing of 
vardenafil AUC and Cmax increase almost dose proportionally over the recommended dose range 
(5 – 20 mg). 
 
When vardenafil film-coated tablets are taken with a high fat meal (containing 57% fat), the rate of 
absorption is reduced, with an increase in the median tmax of 1 hour and a mean reduction in Cmax of 20%. 
Vardenafil AUC is not affected. After a meal containing 30% fat, the rate and extent of absorption of 
vardenafil (tmax, Cmax and AUC) are unchanged compared to administration under fasting conditions. 
 
Vardenafil is rapidly absorbed after administration of Levitra 10 mg orodispersible tablets without 
water. The median time to reach Cmax varied between 45 to 90 minutes and was similar or slightly 
delayed (by 8 to 45 min) compared to the film-coated tablets. Mean vardenafil AUC was increased by 
21 to 29% (middle aged and elderly ED patients) or 44% (young healthy subjects) with 10 mg 
orodispersible tablets compared to film-coated tablets as a result of local oral absorption of a small 
amount of drug in the oral cavity. There was no consistent difference in mean Cmax between 
orodispersible tablets and film-coated tablets. 
 
In subjects taking vardenafil 10 mg orodispersible tablets with a high fat meal no effect on vardenafil 
AUC and tmax was observed, while vardenafil Cmax was reduced by 35% in the fed condition. Based on 
these results vardenafil 10 mg orodispersible tablets can be taken with or without food. 
 
If vardenafil 10 mg orodispersible tablets are taken with water, the AUC is reduced by 29%, Cmax 
remains unchanged and median tmax is shortened by 60 minutes compared to intake without water. 
Vardenafil 10 mg orodispersible tablets must be taken without liquid. 
 
Distribution 
The mean steady state volume of distribution for vardenafil is 208 l, indicating distribution into the 
tissues.  
 
Vardenafil and its major circulating metabolite (M1) are highly bound to plasma proteins 
(approximately 95% for vardenafil or M1). For vardenafil as well as M1, protein binding is independent 
of total drug concentrations. 
Based on measurements of vardenafil in semen of healthy subjects 90 minutes after dosing, not more 
than 0.00012% of the administered dose may appear in the semen of patients. 
 
Biotransformation 
Vardenafil in film-coated tablets is metabolised predominantly by hepatic metabolism via cytochrome 
P450 (CYP) isoform 3A4 with some contribution from CYP3A5 and CYP2C isoforms. 
 
In humans the one major circulating metabolite (M1) results from desethylation of vardenafil and is 
subject to further metabolism with a plasma elimination half-life of approximately 4 hours. Parts of M1 
are in the form of the glucuronide in systemic circulation. Metabolite M1 shows a phosphodiesterase 
selectivity profile similar to vardenafil and an in vitro potency for phosphodiesterase type 5 of 
approximately 28% compared to vardenafil, resulting in an efficacy contribution of about 7%. 
 
The mean terminal half-life of vardenafil in patients receiving Levitra 10 mg orodispersible tablets 
ranged between 4 – 6 hours. The elimination half-life of the metabolite M1 is between 3 to 5 hours, 
similar to parent drug. 
 
Elimination 
The total body clearance of vardenafil is 56 l/h with a resultant terminal half-life of approximately 
4-5 hours. After oral administration, vardenafil is excreted as metabolites predominantly in the faeces 



14 

(approximately 91-95% of the administered dose) and to a lesser extent in the urine (approximately 
2-6% of the administered dose). 
 
Pharmacokinetics in special patient groups 
Elderly 
Hepatic clearance of vardenafil in healthy elderly volunteers (65 years and over) was reduced as 
compared to healthy younger volunteers (18 - 45 years). On average elderly males taking vardenafil 
film-coated tablets had a 52% higher AUC, and a 34% higher Cmax than younger males (see section 4.2). 
 
Vardenafil AUC and Cmax in elderly patients (65 years or over) taking vardenafil orodispersible tablets 
were increased by 31 to 39% and 16 to 21%, respectively, in comparison to patients aged 45 years and 
below. Vardenafil was not found to accumulate in the plasma in patients aged 45 years and below or 65 
years or over following once-daily dosing of vardenafil 10 mg orodispersible tablets over ten days. 
 
Renal impairment 
In volunteers with mild to moderate renal impairment (creatinine clearance 30 – 80 ml/min), the 
pharmacokinetics of vardenafil were similar to that of a normal renal function control group. In 
volunteers with severe renal impairment (creatinine clearance <30 ml/min) the mean AUC was 
increased by 21% and the mean Cmax decreased by 23%, compared to volunteers with no renal 
impairment. No statistically significant correlation was observed between creatinine clearance and 
vardenafil exposure (AUC and Cmax) (see section 4.2). Vardenafil pharmacokinetics has not been 
studied in patients requiring dialysis (see section 4.3). 
 
Hepatic impairment 
In patients with mild to moderate hepatic impairment (Child-Pugh A and B), the clearance of vardenafil 
was reduced in proportion to the degree of hepatic impairment. In patients with mild hepatic impairment 
(Child-Pugh A), the mean AUC and Cmax increased 17% and 22% respectively, compared to healthy 
control subjects. In patients with moderate impairment (Child-Pugh B), the mean AUC and Cmax 
increased by 160% and 133% respectively, compared to healthy control subjects (see section 4.2). The 
pharmacokinetics of vardenafil in patients with severely impaired hepatic function (Child-Pugh C) has 
not been studied (see section 4.3). 
 
Additional information 
In vitro data suggest that effects of vardenafil on P-glycoprotein substrates more sensitive than digoxin 
cannot be excluded. Dabigatran etexilate is an example for highly sensitive intestinal P-glycoprotein 
substrates. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core: 
Crospovidone 
Magnesium stearate 
Microcrystalline cellulose 
Silica, colloidal anhydrous 
 



15 

Film coat: 
Macrogol 400 
Hypromellose 
Titanium dioxide (E171) 
Ferric oxide yellow (E172) 
Ferric oxide red (E172) 
 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
PP/Aluminium foil blisters in cartons of 2, 4, 8, 12 and 20 tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal  
 
No special requirements for disposal. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/03/248/001-004, 021 
EU/1/03/248/005-008, 022 
EU/1/03/248/009-012, 023 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 6 March 2003 
 
Date of latest renewal: 6 March 2008 
 
 



16 

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 

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


17 

1. NAME OF THE MEDICINAL PRODUCT 
 
Levitra 10 mg orodispersible tablets  
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each orodispersible tablet contains 10 mg of vardenafil (as hydrochloride). 
 
Excipients:  
7.96 mg sorbitol (E420), and 1.80 mg aspartame (E951) per orodispersible tablet. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Orodispersible tablet.  
White round tablets. 
 
 
4. CLINICAL PARTICULARS   
 
4.1 Therapeutic indications 
 
Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or 
maintain a penile erection sufficient for satisfactory sexual performance. 
 
In order for Levitra to be effective, sexual stimulation is required.  
 
4.2 Posology and method of administration 
 
Posology  
Levitra 10 mg orodispersible tablets are not bioequivalent to Levitra 10 mg film-coated tablets (see 
section 5.1). The maximum dose for Levitra orodispersible tablet is 10 mg/day. 
 
Use in adult men 
Levitra 10 mg orodispersible tablets are taken as needed approximately 25 to 60 minutes before sexual 
activity.  
 
Special populations 
Elderly (≥65 years old) 
Dose adjustments are not required in elderly patients. However, an increase to a maximum dose of 
Levitra 20 mg film-coated tablets should be carefully considered depending on the individual 
tolerability (see sections 4.4 and 4.8). 
 
Hepatic impairment 
Levitra 10 mg orodispersible tablets are not indicated as a starting dose in patients with mild hepatic 
impairment (Child-Pugh A).  
 
Patients with mild hepatic impairment should start treatment with Levitra 5 mg film-coated tablets. 
Based on tolerability and efficacy, the dose may be increased to Levitra 10 mg and 20 mg film-coated 
tablets, or Levitra 10 mg orodispersible tablets.  
 
The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is 
Levitra 10 mg as film-coated tablets (see section 5.2). 
 



18 

Levitra 10 mg orodispersible tablets are not for use in patients with moderate (Child-Pugh B) and severe 
hepatic impairment (Child-Pugh C; see section 4.3). 
 
Renal impairment 
No dose adjustment is required in patients with mild to moderate renal impairment. 
In patients with severe renal impairment (creatinine clearance <30 ml/min) a starting dose of Levitra 
5 mg film-coated tablets should be considered. Based on tolerability and efficacy, the dose may be 
increased to Levitra 10 mg and 20 mg film-coated tablets, or Levitra 10 mg orodispersible tablets. 
Levitra orodispersible tablet is not for use in patients with end-stage renal failure (see section 4.3). 
 
Paediatric population 
Levitra orodispersible tablets are not indicated for individuals below 18 years of age. There is no 
relevant indication for use of Levitra orodispersible tablets in children and adolescents. 
 
Use in patients using other medicinal products 
Concomitant use of moderate or potent CYP3A4 inhibitors 
Vardenafil dose adjustment is necessary if moderate or potent CYP3A4 inhibitors are given 
concomitantly (see section 4.5). 
 
Method of administration 
For oral use. 
The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disintegrate, 
and then swallowed. Levitra orodispersible tablets must be taken without liquid and immediately upon 
release from the blister. 
Levitra orodispersible tablets can be taken with or without food.  
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
The co-administration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form 
is contraindicated (see sections 4.5 and 5.1). 
 
Levitra is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior 
ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with 
previous phosphodiesterase 5 (PDE5) inhibitor exposure (see section 4.4). 
 
Medicinal products for the treatment of erectile dysfunction should generally 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 [New York Heart Association III or IV]). 
 
The safety of vardenafil has not been studied in the following sub-groups of patients and its use is 
therefore contraindicated until further information is available: 
- severe hepatic impairment (Child-Pugh C), 
- end stage renal disease requiring dialysis, 
- hypotension (blood pressure <90/50 mmHg), 
- recent history of stroke or myocardial infarction (within the last 6 months), 
- unstable angina, and known hereditary retinal degenerative disorders such as retinitis pigmentosa. 
 
Concomitant use of vardenafil with the potent CYP3A4 inhibitors ketoconazole and itraconazole (oral 
form) is contraindicated in men older than 75 years. 
 
Concomitant use of vardenafil with HIV protease inhibitors such as ritonavir and indinavir is 
contraindicated, as they are very potent inhibitors of CYP3A4 (see section 4.5). 
 



19 

The co-administration of PDE5 inhibitors, including vardenafil, with guanylate cyclase stimulators, 
such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 
4.5). 
 
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. 
 
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 (see section 
4.3). Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure 
(see section 5.1). Patients with left ventricular outflow obstruction, e.g. aortic stenosis and idiopathic 
hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 
phosphodiesterase inhibitors. 
  
Serious cardiovascular events including sudden death, tachycardia, myocardial infarction, ventricular 
tachy-arrythmia, angina pectoris, and cerebrovascular disorders (including transient ischaemic attack 
and cerebral haemorrhage), have been reported in temporal association with vardenafil. Most of the 
patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, 
it is not possible to definitively determine whether these events are related directly to these risk factors, 
to vardenafil, to sexual activity, or to a combination of these or other factors. 
 
Medicinal products for the treatment of erectile dysfunction 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). 
 
The safety and efficacy of combinations of Levitra orodispersible tablets with Levitra film-coated 
tablets or other treatments for erectile dysfunction have not been studied. Therefore the use of such 
combinations is not recommended. 
 
Tolerability of the maximum dose of Levitra 20 mg film-coated tablets may be lower in elderly patients 
(≥65 years old) (see sections 4.2 and 4.8). 
 
Concomitant use of alpha-blockers 
The concomitant use of alpha-blockers and vardenafil may lead to symptomatic hypotension in some 
patients because both are vasodilators. Concomitant treatment with vardenafil should only be initiated if 
the patient has been stabilised on his alpha-blocker therapy. In those patients who are stable on 
alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5 mg 
film-coated tablets. Patients treated with alpha-blockers should not use Levitra 10 mg orodispersible 
tablets as a starting dose. Vardenafil may be administered at any time with tamsulosin or with alfuzosin. 
With other alpha-blockers a time separation of dosing should be considered when vardenafil is 
prescribed concomitantly (see section 4.5). In those patients already taking an optimised dose of 
vardenafil, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in 
alpha-blocker dose may be associated with further lowering of blood pressure in patients taking 
vardenafil.  
 
Concomitant use of CYP3A4 inhibitors 
Concomitant use of vardenafil with potent CYP3A4 inhibitors such as itraconazole and ketoconazole 
(oral form) should be avoided as very high plasma concentrations of vardenafil are reached if the 
medicinal products are combined (see sections 4.5 and 4.3). 
 
Vardenafil dose adjustment might be necessary if moderate CYP3A4 inhibitors such as erythromycin 
and clarithromycin, are given concomitantly (see section 4.2 and 4.5). 
 



20 

Concomitant intake of grapefruit or grapefruit juice is expected to increase the plasma concentrations of 
vardenafil. The combination should be avoided (see section 4.5). 
 
Effect on QTc interval 
Single oral doses of 10 mg and 80 mg of vardenafil have been shown to prolong the QTc interval by a 
mean of 8 msec and 10 msec, respectively. And single doses of 10 mg vardenafil co-administered 
concomitantly with 400 mg gatifloxacin, an active substance with comparable QT effect, showed an 
additive QTc effect of 4 msec when compared to either active substance alone. The clinical impact of 
these QT changes is unknown (see section 5.1). 
 
The clinical relevance of this finding is unknown and cannot be generalised to all patients under all 
circumstances, as it will depend on the individual risk factors and susceptibilities that may be present at 
any time in any given patient. Medicinal products that may prolong QTc interval, including vardenafil, 
are best avoided in patients with relevant risk factors, for example, hypokalaemia, congenital QT 
prolongation, concomitant administration of antiarrhythmic medicinal products in Class IA (e.g. 
quinidine, procainamide), or Class III (e.g. amiodarone, sotalol). 
 
Effect on vision 
Visual defects and cases of non-arteritic ischemic optic neuropathy (NAION) have been reported in 
connection with the intake of Levitra and other PDE5 inhibitors. Analyses of observational data suggest 
an increased risk of acute NAION in men with erectile dysfunction following exposure to PDE5 
inhibitors such as vardenafil, tadalafil and sildenafil (see section 4.8). As this may be relevant for all 
patients exposed to vardenafil the patient should be advised that in the case of sudden visual defect, he 
should stop taking Levitra orodispersible tablets and consult immediately a physician (see section 4.3). 
 
Effect on bleeding 
In vitro studies with human platelets indicate that vardenafil has no antiaggregatory effect on its own, 
but at high (super-therapeutic) concentrations vardenafil potentiates the antiaggregatory effect of the 
nitric oxide donor sodium nitroprusside. In humans vardenafil had no effect on bleeding time alone or in 
combination with acetylsalicylic acid (see section 4.5). There is no safety information available on the 
administration of vardenafil to patients with bleeding disorders or active peptic ulceration. Therefore 
vardenafil should be administered to these patients only after careful benefit-risk assessment. 
 
Aspartame 
This medicine contains 1.80 mg aspartame in each 10 mg orodispersible tablet. Aspartame is a source of 
phenylalanine. It may be harmful for people with phenylketonuria (PKU), a rare genetic disorder in 
which phenylalanine builds up because the body cannot remove it properly. 
 
Sorbitol 
This medicine contains 7.96 mg sorbitol in each 10 mg orodispersible tablet.   
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Effects of other medicinal products on vardenafil 
In vitro studies 
Vardenafil is metabolised predominantly by hepatic enzymes via cytochrome P450 (CYP) isoform 3A4, 
with some contribution from CYP3A5 and CYP2C isoforms. Therefore, inhibitors of these isoenzymes 
reduce vardenafil clearance. 
 
In vivo studies 
Co-administration of the HIV protease inhibitor indinavir (800 mg three times a day), a potent CYP3A4 
inhibitor, with vardenafil (10 mg film-coated tablets) resulted in a 16-fold increase in vardenafil AUC 
and a 7-fold increase in vardenafil Cmax. At 24 hours, the plasma levels of vardenafil had fallen to 
approximately 4% of the maximum vardenafil plasma level (Cmax).  
 
Co-administration of vardenafil with ritonavir (600 mg twice daily) resulted in a 13-fold increase in 
vardenafil Cmax and a 49-fold increase in vardenafil AUC0-24 when co-administered with vardenafil 



21 

5 mg. The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a 
highly potent CYP3A4 inhibitor, which also inhibits CYP2C9. Ritonavir significantly prolonged the 
half-life of vardenafil to 25.7 hours (see section 4.3).  
 
Co-administration of ketoconazole (200 mg), a potent CYP3A4 inhibitor, with vardenafil (5 mg) 
resulted in a 10-fold increase in vardenafil AUC and a 4-fold increase in vardenafil Cmax (see section 
4.4). 
 
Although specific interaction studies have not been conducted, the concomitant use of other potent 
CYP3A4 inhibitors (such as itraconazole) can be expected to produce vardenafil plasma levels 
comparable to those produced by ketoconazole. Concomitant use of vardenafil with potent CYP3A4 
inhibitors such as itraconazole and ketoconazole (oral use) should be avoided (see sections 4.3 and 4.4). 
In men older than 75 years the concomitant use of vardenafil with itraconazole or ketoconazole is 
contraindicated (see section 4.3). 
 
Co-administration of erythromycin (500 mg three times a day), a CYP3A4 inhibitor, with vardenafil 
(5 mg) resulted in a 4-fold increase in vardenafil AUC and a 3-fold increase in Cmax. Although a specific 
interaction study has not been conducted, the co-administration of clarithromycin can be expected to 
result in similar effects on vardenafil AUC and Cmax. When used in combination with a moderate 
CYP3A4 inhibitor such as erythromycin or clarithromycin, vardenafil dose adjustment might be 
necessary (see sections 4.2 and 4.4). 
 
Cimetidine (400 mg twice daily), a non-specific cytochrome P450 inhibitor, had no effect on vardenafil 
AUC and Cmax when co-administered with vardenafil (20 mg) to healthy volunteers. 
 
Grapefruit juice being a weak inhibitor of CYP3A4 gut wall metabolism, may give rise to modest 
increases in plasma levels of vardenafil (see section 4.4). 
 
The pharmacokinetics of vardenafil (20 mg) was not affected by co-administration with the 
H2-antagonist ranitidine (150 mg twice daily), digoxin, warfarin, glibenclamide, alcohol (mean 
maximum blood alcohol level of 73 mg/dl) or single doses of antacid (magnesium hydroxide/aluminium 
hydroxide). 
 
Although specific interaction studies were not conducted for all medicinal products, population 
pharmacokinetic analysis showed no effect on vardenafil pharmacokinetics of the following 
concomitant medicinal products: acetylsalicylic acid, ACE-inhibitors, beta-blockers, weak CYP3A4 
inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin). 
 
Effects of vardenafil on other medicinal products 
There are no data on the interaction of vardenafil and non-specific phosphodiesterase inhibitors such as 
theophylline or dipyridamole. 
 
In vivo studies 
No potentiation of the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) was observed 
when vardenafil (10 mg) was given at varying time intervals (1 h to 24 h) prior to the dose of 
nitroglycerin in a study in 18 healthy male subjects. Vardenafil 20 mg film-coated tablets potentiated the 
blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) taken 1 and 4 hours after vardenafil 
administration to healthy middle aged subjects. No effect on blood pressure was observed when 
nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg film-coated 
tablets. However, there is no information on the possible potentiation of the hypotensive effects of 
nitrates by vardenafil in patients, and concomitant use of Levitra orodispersible tablets and nitrates is 
therefore contraindicated (see section 4.3). 
 
Nicorandil is a hybrid of potassium channel opener and nitrate. Due to the nitrate component it has the 
potential to have serious interaction with vardenafil. 
 



22 

Since alpha-blocker monotherapy can cause marked lowering of blood pressure, especially postural 
hypotension and syncope, interaction studies were conducted with vardenafil. In two interaction studies 
with healthy normotensive volunteers after forced titration of the alpha-blockers tamsulosin or terazosin 
to high doses, hypotension (in some cases symptomatic) was reported in a significant number of subjects 
after co-administration of vardenafil. Among subjects treated with terazosin, hypotension was observed 
more frequently when vardenafil and terazosin were given simultaneously than when the dosing was 
separated by a time interval of 6 hours. 
 
Based on the results of interaction studies conducted with vardenafil in patients with benign prostatic 
hyperplasia (BPH) on stable tamsulosin, terazosin or alfuzosin therapy: 
 
• When vardenafil (film-coated tablets) was given at doses of 5, 10 or 20 mg on a background of 

stable therapy with tamsulosin, there was no symptomatic reduction in blood pressure, although 
3/21 tamsulosin treated subjects exhibited transient standing systolic blood pressures of less than 
85 mmHg. 

• When vardenafil 5 mg (film-coated tablets) was given simultaneously with terazosin 5 or 10 mg, 
one of 21 patients experienced symptomatic postural hypotension. Hypotension was not observed 
when vardenafil 5 mg and terazosin administration was separated by 6 hours. 

• When vardenafil (film-coated tablets) was given at doses of 5 or 10 mg on a background of stable 
therapy with alfuzosin, compared to placebo, there was no symptomatic reduction in blood 
pressure.   

 
Therefore, concomitant treatment should be initiated only if the patient is stable on his alpha-blocker 
therapy. In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at the 
lowest recommended starting dose of 5mg. Levitra may be administered at any time with tamsulosin or 
alfuzosin. With other alpha-blockers a time separation of dosing should be considered when vardenafil 
is prescribed concomitantly (see section 4.4). 
 
Levitra 10 mg orodispersible tablets should not be taken as starting dose in patients treated with 
alpha-blockers (see section 4.4).  
 
No significant interactions were shown when warfarin (25 mg), which is metabolised by CYP2C9, or 
digoxin (0.375 mg) was co-administered with vardenafil (20 mg film-coated tablets). The relative 
bioavailability of glibenclamide (3.5 mg) was not affected when co-administered with vardenafil 
(20 mg). In a specific study, where vardenafil (20 mg) was co-administered with slow release nifedipine 
(30 mg or 60 mg) in hypertensive patients, there was an additional reduction on supine systolic blood 
pressure of 6 mmHg and supine diastolic blood pressure of 5 mmHg accompanied with an increase in 
heart rate of 4 bpm.  
 
When vardenafil (20 mg film-coated tablets) and alcohol (mean maximum blood alcohol level of 
73 mg/dl) were taken together, vardenafil did not potentiate the effects of alcohol on blood pressure and 
heart rate and the pharmacokinetics of vardenafil were not altered. 
 
Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid 
(2 x 81 mg). 
 
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 vardenafil, is 
contraindicated (see section 4.3). 
 
4.6 Fertility, pregnancy and lactation 
 
Levitra is not indicated for use by women. There are no studies of vardenafil in pregnant women. 
There are no fertility data available. 



23 

 
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 abnormal vision have been reported in clinical trials with vardenafil, patients should be 
aware of how they react to Levitra orodispersible tablets, before driving or operating machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The adverse reactions reported with Levitra film-coated tablets or 10 mg orodispersible tablets in 
clinical trials were generally transient and mild to moderate in nature. The most commonly reported 
adverse drug reaction occurring in ≥ 10% of patients is headache. 
 
Tabulated list of adverse reactions 
Adverse reactions are listed according to the MedDRA frequency convention: 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) and not 
known (can not be estimated from available data). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 
The following adverse reactions have been reported: 
 
System Organ 
Class 

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) 

Not known  
(cannot be 
estimated from 
the available 
data) 

Infection and 
infestations 

   Conjunctivitis  

Immune 
system 
disorders 

  Allergic 
oedema and 
angioedema  

Allergic reaction   

Psychiatric 
disorders 

  Sleep disorder Anxiety  

Nervous 
system 
disorders 

Headache Dizziness Somnolence 
Paraesthesia 
and 
dysaesthesia 

Syncope 
Seizure  
Amnesia 
Transient 
ischaemic attack 

Cerebral 
haemorrhage 

Eye disorders    Visual 
disturbance  
Ocular 
hyperaemia 
Visual colour 
distortions  
Eye pain and 
eye discomfort  
Photophobia 

Increase in 
intraocular 
pressure 
Lacrimation 
increased 

Non-arteritic 
anterior ischemic 
optic neuropathy 
Visual defects 

Ear and   Tinnitus  Sudden deafness 



24 

System Organ 
Class 

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) 

Not known  
(cannot be 
estimated from 
the available 
data) 

labyrinth 
disorders 

Vertigo 

Cardiac 
disorders  

  Palpitation 
Tachycardia 

Myocardial 
infarction 
Ventricular 
tachy-arrhythmias 
Angina pectoris 

Sudden death 

Vascular 
disorders  

 Flushing  Hypotension  
Hypertension 

 

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Nasal 
congestion  

Dyspnoea 
Sinus 
congestion 

Epistaxis  

Gastrointesti-
nal disorders  

 Dyspepsia  Gastro-oesopha
geal reflux 
disease  
Gastritis 
Gastrointestinal 
and abdominal 
pain 
Diarrhoea 
Vomiting 
Nausea 
Dry mouth  

  

Hepatobiliary 
disorders 

  Increase in 
transaminases 

Increase in 
gamma-glutamyl 
transferase 

 

Skin and 
subcutaneous 
tissue 
disorders 

  Erythema 
Rash 

Photosensitivity 
reaction 

 

Musculoskele-
tal and 
connective 
tissue 
disorders 

  Back pain  
Increase in 
creatine 
phosphokinase 
Myalgia  
Increased 
muscle tone and 
cramping 

  

Renal and 
urinary 
disorders 

    Haematuria 



25 

System Organ 
Class 

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) 

Not known  
(cannot be 
estimated from 
the available 
data) 

Reproductive 
system and 
breast 
disorders 

  Increase in 
erection  

Priapism Penile 
Haemorrhage 
Haematospermia 

General 
disorders and 
administra-
tion site 
conditions 

  Feeling unwell  Chest pain   

 
Description of selected adverse reactions 
Penile haemorrhage, haematospermia and haematuria have been reported in clinical trials and 
spontaneous post-marketing data with the use of all PDE5 inhibitors, including vardenafil. 
 
At a dose of 20 mg Levitra film-coated tablets, elderly (≥ 65 years old) patients had higher frequencies 
of headaches (16.2% versus 11.8%) and dizziness (3.7% versus 0.7%) than younger patients (<65 years 
old). In general, the incidence of adverse reactions (especially “dizziness”) has been shown to be slightly 
higher in patients with a history of hypertension. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system listed 
in Appendix V. 
 
4.9 Overdose 
 
In single dose volunteer studies, doses up to and including 80 mg vardenafil (film-coated tablets) per 
day were tolerated without exhibiting serious adverse reactions.   
 
When vardenafil was administered in higher doses and more frequently than the recommended dose 
regimen (40 mg film-coated tablets twice daily) cases of severe back pain have been reported. This was 
not associated with any muscle or neurological toxicity. 
 
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not 
expected to accelerate clearance, as vardenafil is highly bound to plasma proteins and not significantly 
eliminated in the urine. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC code: G04BE09. 
 
Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction. 
In the natural setting, i.e. with sexual stimulation it restores impaired erectile function by increasing 
blood flow to the penis. 
 
Penile erection is a haemodynamic process. During sexual stimulation, nitric oxide is released. It 
activates the enzyme guanylate cyclase, resulting in an increased level of cyclic guanosine 

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


26 

monophosphate (cGMP) in the corpus cavernosum. This in turn results in smooth muscle relaxation, 
allowing increased inflow of blood into the penis. The level of cGMP is regulated by the rate of 
synthesis via guanylate cyclase and by the rate of degradation via cGMP hydrolysing 
phosphodiesterases (PDEs).  
 
Vardenafil is a potent and selective inhibitor of the cGMP specific phosphodiesterase type 5 (PDE5), the 
most prominent PDE in the human corpus cavernosum. Vardenafil potently enhances the effect of 
endogenous nitric oxide in the corpus cavernosum by inhibiting PDE5. When nitric oxide is released in 
response to sexual stimulation, inhibition of PDE5 by vardenafil results in increased corpus cavernosum 
levels of cGMP. Sexual stimulation is therefore required for vardenafil to produce its beneficial 
therapeutic effects. 
 
In vitro studies have shown that vardenafil is more potent on PDE5 than on other known 
phosphodiesterases (>15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to 
PDE11, and >1000-fold relative to PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 and PDE10).  
 
In a penile plesthysmography (RigiScan) study, vardenafil 20 mg produced erections considered 
sufficient for penetration (60% rigidity by RigiScan) in some men as early as 15 minutes after dosing. 
The overall response of these subjects to vardenafil became statistically significant, compared to 
placebo, 25 minutes after dosing. 
 
Vardenafil causes mild and transient decreases in blood pressure which, in the majority of the cases, do 
not translate into clinical effects. The mean maximum decreases in supine systolic blood pressure 
following 20 mg and 40 mg vardenafil were – 6.9 mmHg under 20 mg and – 4.3 mmHg under 40 mg of 
vardenafil, when compared to placebo. These effects are consistent with the vasodilatory effects of 
PDE5-inhibitors and are probably due to increased cGMP levels in vascular smooth muscle cells. Single 
and multiple oral doses of vardenafil up to 40 mg produced no clinically relevant changes in the ECGs 
of normal male volunteers.  
 
A single dose, double blind, crossover, randomised trial in 59 healthy males compared the effects on the 
QT interval of vardenafil (10 mg and 80 mg), sildenafil (50 mg and 400 mg) and placebo. Moxifloxacin 
(400 mg) was included as an active internal control. Effects on the QT interval were measured one hour 
post-dose (average tmax for vardenafil). The primary objective of this study was to rule out a greater than 
10 msec effect (i.e. to demonstrate lack of effect) of a single 80 mg oral dose of vardenafil on QTc 
interval compared to placebo, as measured by the change in Fridericia's correction formula 
(QTcF=QT/RR1/3) from baseline at the 1 hour post-dose time point. The vardenafil results showed an 
increase in QTc (Fridericia) of 8 msec (90% CI: 6-9) and 10 msec (90% CI: 8-11) at 10 and 80 mg doses 
compared to placebo and an increase in QTci of 4 msec (90% CI: 3-6) and 6 msec (90% CI: 4-7) at 10 
and 80 mg doses compared to placebo, at one hour post-dose. At tmax, only the mean change in QTcF for 
vardenafil 80 mg was out of the study established limit (mean 10 msec, 90% CI 8-11). When using the 
individual correction formulae, none of the values were out of the limit. 
 
In a separate post-marketing study of 44 healthy volunteers, single doses of 10 mg vardenafil or 50 mg 
sildenafil were co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT 
effect. Both vardenafil and sildenafil showed an increase of Fridericia QTc effect of 4 msec (vardenafil) 
and 5 msec (sildenafil) when compared to either drug alone. The actual clinical impact of these QT 
changes is unknown. 
 
Further information on clinical trials with vardenafil 10 mg orodispersible tablets 
Efficacy and safety of vardenafil 10 mg orodispersible tablets were separately demonstrated in a broad 
population in two studies including 701 randomized erectile dysfunction patients who were treated up to 
12 weeks. The distribution of patients in the predefined subgroups was covering elderly patients (51%), 
patients with history of diabetes mellitus (29%), dyslipidemia (39%) and hypertension (40%).   
 
In pooled data from the two vardenafil 10 mg orodispersible tablets trials, IIEF-EF domain scores were 
significantly higher with vardenafil 10 mg orodispersible tablet versus placebo. 
 



27 

A percentage of 71% of all sexual attempts reported in the clinical trials had successful penetration 
compared to 44% of all attempts in the placebo group. These results were also reflected in subgroups, in 
elderly patients (65%), in patients with history of diabetes mellitus (63%), patients with history of 
dyslipidemia (66%) and hypertension (70%) of all sexual attempts reported had successful penetration. 
 
About 63% of all reported sexual attempts with vardenafil 10 mg orodispersible tablets were successful 
in terms of erection maintenance compared to about 26% of all placebo-controlled sexual attempts. In 
the predefined subgroups 57% (elderly patients), 56% (patients with history of diabetes mellitus), 59% 
(patients with history of dyslipidemia) and 60% (patients with history of hypertension) of all reported 
attempts with vardenafil 10 mg orodispersible tablets were successful in terms of maintenance of 
erection. 
 
Further information on clinical trials 
In clinical trials vardenafil was administered to over 17,000 men with erectile dysfunction (ED) aged  
18 - 89 years, many of whom had multiple co-morbid conditions. Over 2,500 patients have been treated 
with vardenafil for 6 months or longer. Of these, 900 patients have been treated for one year or longer.  
 
The following patient groups were represented: elderly (22%), patients with hypertension (35%), 
diabetes mellitus (29%), ischaemic heart disease and other cardiovascular diseases (7%), chronic 
pulmonary disease (5%), hyperlipidaemia (22%), depression (5%), radical prostatectomy (9%). The 
following groups were not well represented in clinical trials: elderly (>75 years, 2.4%), and patients with 
certain cardiovascular conditions (see section 4.3). No clinical trials in CNS diseases (except spinal cord 
injury), patients with severe renal or hepatic impairment, pelvic surgery (except nerve-sparing 
prostatectomy) or trauma or radiotherapy and hypoactive sexual desire or penile anatomic deformities 
have been performed. 
 
Across the pivotal trials, treatment with vardenafil (film-coated tablets) resulted in an improvement of 
erectile function compared to placebo. In the small number of patients who attempted intercourse up to 
four to five hours after dosing the success rate for penetration and maintenance of erection was 
consistently greater than placebo.  
 
In fixed dose studies (film-coated tablets) in a broad population of men with erectile dysfunction, 68% 
(5 mg), 76% (10 mg) and 80% (20 mg) of patients experienced successful penetrations (SEP 2) 
compared to 49% on placebo over a three month study period. The ability to maintain the erection 
(SEP 3) in this broad ED population was given as 53% (5 mg), 63% (10 mg) and 65% (20 mg) 
compared to 29% on placebo. 
 
In pooled data from the major efficacy trials, the proportion of patients experiencing successful 
penetration on vardenafil were as follows: psychogenic erectile dysfunction (77-87%), mixed erectile 
dysfunction (69-83%), organic erectile dysfunction (64-75%), elderly (52-75%), ischaemic heart 
disease (70-73%), hyperlipidaemia (62-73%), chronic pulmonary disease (74-78%), depression 
(59-69%), and patients concomitantly treated with antihypertensives (62-73%). 
 
In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile 
function domain score, the ability to obtain and maintain an erection long enough for successful 
intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg. The 
response rates for the ability to obtain and maintain an erection was 61% and 49% on 10 mg and 64% 
and 54% on 20 mg vardenafil compared to 36% and 23% on placebo for patients who completed three 
months treatment. 
 
In a clinical trial in post-prostatectomy patients, vardenafil significantly improved the erectile function 
domain score, the ability to obtain and maintain an erection long enough for successful intercourse and 
penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg. The response rates for the 
ability to obtain and maintain an erection was 47% and 37% on 10 mg and 48% and 34% on 20 mg 
vardenafil compared to 22% and 10% on placebo for patients who completed three months treatment. 
 



28 

In a flexible-dose clinical trial in patients with Spinal Cord Injury, vardenafil significantly improved the 
erectile function domain score, the ability to obtain and maintain an erection long enough for successful 
intercourse and penile rigidity compared to placebo. The number of patients who returned to a normal 
IIEF domain score (>26) were 53% on vardenafil compared to 9% on placebo. The response rates for the 
ability to obtain and maintain an erection were 76% and 59% on vardenafil compared to 41% and 22% 
on placebo for patients who completed three months treatment which were clinically and statistically 
significant (p<0.001).  
 
The safety and efficacy of vardenafil was maintained in long-term studies. 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies in all subsets 
of the paediatric population in the treatment of the erectile dysfunction. See section 4.2 for information 
on paediatric use. 
 
5.2 Pharmacokinetic properties 
 
Bioequivalence studies have shown that vardenafil 10 mg orodispersible tablet is not bioequivalent to 
vardenafil 10 mg film-coated tablets. Therefore the orodispersible formulation should not be used as an 
equivalent to vardenafil 10 mg film-coated tablets.  
 
Absorption 
In vardenafil film-coated tablets, vardenafil is rapidly absorbed with maximum observed plasma 
concentrations reached in some men as early as 15 minutes after oral administration. However, 90% of 
the time, maximum 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 15%. After oral dosing of 
vardenafil AUC and Cmax increase almost dose proportionally over the recommended dose range 
(5 - 20 mg). 
 
When vardenafil film-coated tablets are taken with a high fat meal (containing 57% fat), the rate of 
absorption is reduced, with an increase in the median tmax of 1 hour and a mean reduction in Cmax of 20%. 
Vardenafil AUC is not affected. After a meal containing 30% fat, the rate and extent of absorption of 
vardenafil (tmax, Cmax and AUC) are unchanged compared to administration under fasting conditions. 
 
Vardenafil is rapidly absorbed after administration of Levitra 10 mg orodispersible tablets without 
water. The median time to reach Cmax varied between 45 to 90 minutes and was similar or slightly 
delayed (by 8 to 45 min) compared to the film-coated tablets. Mean vardenafil AUC was increased by 
21 to 29% (middle aged and elderly ED patients) or 44% (young healthy subjects) with 10 mg 
orodispersible tablets compared to film-coated tablets as a result of local oral absorption of a small 
amount of drug in the oral cavity. There was no consistent difference in mean Cmax between 
orodispersible tablets and film-coated tablets. 
 
In subjects taking vardenafil 10 mg orodispersible tablets with a high fat meal no effect on vardenafil 
AUC and tmax was observed, while vardenafil Cmax was reduced by 35% in the fed condition. Based on 
these results vardenafil 10 mg orodispersible tablets can be taken with or without food. 
 
If vardenafil 10 mg orodispersible tablets are taken with water, the AUC is reduced by 29%, Cmax 
remains unchanged and median tmax is shortened by 60 minutes compared to intake without water. 
Vardenafil 10 mg orodispersible tablets must be taken without liquid. 
 
Distribution 
The mean steady state volume of distribution for vardenafil is 208 l, indicating distribution into the 
tissues.  
 
Vardenafil and its major circulating metabolite (M1) are highly bound to plasma proteins 
(approximately 95% for vardenafil or M1). For vardenafil as well as M1, protein binding is independent 
of total drug concentrations.  



29 

 
Based on measurements of vardenafil in semen of healthy subjects 90 minutes after dosing, not more 
than 0.00012% of the administered dose may appear in the semen of patients. 
 
Biotransformation 
Vardenafil in film-coated tablets is metabolised predominantly by hepatic metabolism via cytochrome 
P450 (CYP) isoform 3A4 with some contribution from CYP3A5 and CYP2C isoforms. 
 
In humans the one major circulating metabolite (M1) results from desethylation of vardenafil and is 
subject to further metabolism with a plasma elimination half-life of approximately 4 hours. Parts of M1 
are in the form of the glucuronide in systemic circulation. Metabolite M1 shows a phosphodiesterase 
selectivity profile similar to vardenafil and an in vitro potency for phosphodiesterase type 5 of 
approximately 28% compared to vardenafil, resulting in an efficacy contribution of about 7%. 
 
The mean terminal half-life of vardenafil in patients receiving Levitra 10 mg orodispersible tablets 
ranged between 4 – 6 hours. The elimination half-life of the metabolite M1 is between 3 to 5 hours, 
similar to parent drug. 
 
Elimination 
The total body clearance of vardenafil is 56 l/h with a resultant terminal half-life of approximately 
4-5 hours. After oral administration, vardenafil is excreted as metabolites predominantly in the faeces 
(approximately 91-95% of the administered dose) and to a lesser extent in the urine (approximately 
2-6% of the administered dose). 
 
Pharmacokinetics in special patient groups 
Elderly 
Hepatic clearance of vardenafil in healthy elderly volunteers (65 years and over) was reduced as 
compared to healthy younger volunteers (18 - 45 years). On average elderly males taking vardenafil 
film-coated tablets had a 52% higher AUC, and a 34% higher Cmax than younger males (see section 4.2). 
 
Vardenafil AUC and Cmax in elderly patients (65 years or over) taking vardenafil orodispersible tablets 
were increased by 31 to 39% and 16 to 21%, respectively, in comparison to patients aged 45 years and 
below. Vardenafil was not found to accumulate in the plasma in patients aged 45 years and below or 65 
years or over following once-daily dosing of vardenafil 10 mg orodispersible tablets over ten days. 
 
Renal impairment 
In volunteers with mild to moderate renal impairment (creatinine clearance 30 - 80 ml/min), the 
pharmacokinetics of vardenafil were similar to that of a normal renal function control group. In 
volunteers with severe renal impairment (creatinine clearance <30 ml/min) the mean AUC was 
increased by 21% and the mean Cmax decreased by 23%, compared to volunteers with no renal 
impairment. No statistically significant correlation was observed between creatinine clearance and 
vardenafil exposure (AUC and Cmax) (see section 4.2). Vardenafil pharmacokinetics has not been 
studied in patients requiring dialysis (see section 4.3). 
 
Hepatic impairment 
In patients with mild to moderate hepatic impairment (Child-Pugh A and B), the clearance of vardenafil 
was reduced in proportion to the degree of hepatic impairment. In patients with mild hepatic impairment 
(Child-Pugh A), the mean AUC and Cmax increased by 17% and 22% respectively, compared to healthy 
control subjects. In patients with moderate impairment (Child-Pugh B), the mean AUC and Cmax 
increased by 160% and 133% respectively, compared to healthy control subjects (see section 4.2). The 
pharmacokinetics of vardenafil in patients with severely impaired hepatic function (Child-Pugh C) has 
not been studied (see section 4.3). 
 
Additional information 
In vitro data suggest that effects of vardenafil on P-glycoprotein substrates more sensitive than digoxin 
cannot be excluded. Dabigatran etexilate is an example for highly sensitive intestinal P-glycoprotein 
substrates. 



30 

 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Aspartame (E951) 
Peppermint flavour. 
Magnesium stearate. 
Crospovidone. 
Mannitol (E421) 
Silica colloidal hydrated. 
Sorbitol (E420) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
Store in the original package in order to protect from humidity and light. 
 
6.5 Nature and contents of container 
 
1 x 1 orodispersible tablet in alu/alu perforated unit dose blister, 
2 x 1 orodispersible tablets in alu/alu perforated unit dose blisters, 
4 x 1 orodispersible tablets in alu/alu perforated unit dose blisters, 
8 x 1 orodispersible tablets in alu/alu perforated unit dose blisters. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements for disposal. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/03/248/013-016 
 
 



31 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 6 March 2003 
 
Date of latest renewal: 6 March 2008 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu

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


32 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 
D. CONDITION OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 



33 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Bayer AG 
Kaiser-Wilhelm-Allee 
51368 Leverkusen 
Germany 
 
 
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) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 
marketing authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency;  
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 



34 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



35 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 



36 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levitra 5 mg film-coated tablets 
vardenafil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 5 mg vardenafil (as hydrochloride). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
2 film-coated tablets 
4 film-coated tablets 
8 film-coated tablets 
12 film-coated tablets 
20 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before 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 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



37 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/03/248/001 2 tablets 
EU/1/03/248/002 4 tablets 
EU/1/03/248/003 8 tablets 
EU/1/03/248/004 12 tablets 
EU/1/03/248/021 20 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levitra 5 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 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levitra 5 mg film-coated tablets 
vardenafil 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer (logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



39 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levitra 10 mg film-coated tablets 
vardenafil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 10 mg vardenafil (as hydrochloride). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
2 film-coated tablets 
4 film-coated tablets 
8 film-coated tablets 
12 film-coated tablets 
20 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before 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 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



40 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/03/248/005 2 tablets 
EU/1/03/248/006 4 tablets 
EU/1/03/248/007 8 tablets 
EU/1/03/248/008 12 tablets 
EU/1/03/248/022 20 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levitra 10 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 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levitra 10 mg film-coated tablets 
vardenafil 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer (logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



42 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levitra 20 mg film-coated tablets 
vardenafil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg vardenafil (as hydrochloride). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
2 film-coated tablets 
4 film-coated tablets 
8 film-coated tablets 
12 film-coated tablets 
20 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
Read the package leaflet before 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 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



43 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/03/248/009 2 tablets 
EU/1/03/248/010 4 tablets 
EU/1/03/248/011 8 tablets 
EU/1/03/248/012 12 tablets 
EU/1/03/248/023 20 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levitra 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



44 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levitra 20 mg film-coated tablets 
vardenafil 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer (logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



45 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levitra 10 mg orodispersible tablets 
vardenafil 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 10 mg vardenafil (as hydrochloride). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains aspartame (E951) and sorbitol (E420). 
Read the package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 x 1 orodispersible tablet 
2 x 1 orodispersible tablets 
4 x 1 orodispersible tablets 
8 x 1 orodispersible tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 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 
 
Store in the original package in order to protect from humidity and light. 
 
 



46 

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 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/03/248/013 1 tablet 
EU/1/03/248/014 2 tablets 
EU/1/03/248/015 4 tablets 
EU/1/03/248/016 8 tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levitra 10 mg   
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



47 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levitra 10 mg orodispersible tablets 
vardenafil  
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer (logo) 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot  
 
 
5. OTHER 
 
 



48 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



49 

Package Leaflet: Information for the user 
 

Levitra 5 mg film-coated tablets 
vardenafil 

 
Read all of this leaflet carefully before you start using 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 Levitra is and what it is used for 
2. What you need to know before you take Levitra 
3. How to take Levitra 
4. Possible side effects 
5. How to store Levitra 
6. Contents of the pack and other information 
 
 
1. What Levitra is and what it is used for 
 
Levitra contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors. 
They are used for the treatment of erectile dysfunction in adult men, a condition which implies 
difficulties in getting or keeping an erection. 
 
At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or 
psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel 
changes not enough blood stays in the penis to make it hard and keep it hard. 
 
Levitra will only work when you are sexually stimulated. It reduces the action of the natural chemical in 
your body which makes erections go away. Levitra allows an erection to last long enough for you to 
satisfactorily complete sexual activity. 
 
 
2. What you need to know before you take Levitra 
 
Do not take Levitra 
- If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 

6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of 
breath. 

- If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric 
oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect 
your blood pressure. 

- If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus 
(HIV) infections. 

- If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines. 
- If you have a severe heart or liver problem. 
- If you are having kidney dialysis. 
- If you have recently had a stroke or heart attack. 
- If you have or have had low blood pressure. 
- If your family has a history of degenerative eye diseases (such as retinitis pigmentosa). 



50 

- If you have ever had a condition involving loss of vision due to damage to the optic nerve from 
insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION). 

- 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 Levitra have been 
shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are 
unsure tell your doctor. 

 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Levitra. 
 
Take special care with Levitra 
- If you have heart trouble. It may be risky for you to have sex. 
- If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting 

your electrocardiogram. 
- If you have a physical condition affecting the shape of the penis. This includes conditions called 

angulation, Peyronie’s disease and cavernosal fibrosis. 
- If you have an illness that can cause erections which won’t go away (priapism). These include 

sickle cell disease, multiple myeloma and leukaemia. 
- If you have stomach ulcers (also called gastric or peptic ulcers). 
- If you have a bleeding disorder (such as haemophilia). 
- If you are using any other treatments for erection difficulties, including Levitra orodispersible 

tablets (see section Other medicines and Levitra). 
- If you experience sudden decrease or loss of vision, stop taking Levitra and contact your doctor 

immediately. 
 
Children and adolescents 
Levitra is not intended for use by children or adolescents under 18. 
 
Other medicines and Levitra 
Please tell your doctor or pharmacist if you are using, have recently used or might use any other 
medicines, including medicines obtained without a prescription. 
Some medicines may cause problems, especially these: 
- Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these 

medicines with Levitra could seriously affect your blood pressure. 
- Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or 

sotalol. 
- Ritonavir or indinavir, medicines for HIV. 
- Ketoconazole or itraconazole, anti-fungal medicines. 
- Erythromycin or clarithromycin, macrolide antibiotics. 
- Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the 

prostate (as benign prostatic hyperplasia). 
- Riociguat. 
 
Do not use Levitra film-coated tablets combined with any other treatment for erectile dysfunction, 
including Levitra orodispersible tablets. 
 
Levitra with food, drink and alcohol 
- You can take Levitra with or without food but preferably not after a heavy or high-fat meal as this 

may delay the effect. 
- Don’t drink grapefruit juice when you use Levitra. It can interfere with the usual effect of the 

medicine. 
- Alcoholic drink can make erection difficulties worse. 
 
Pregnancy and breast-feeding 
Levitra is not for use by women. 
 

http://en.wikipedia.org/wiki/Visual_loss
http://en.wikipedia.org/wiki/Visual_loss
http://en.wikipedia.org/wiki/Optic_nerve
http://en.wikipedia.org/wiki/Optic_nerve


51 

Driving and using machines 
Levitra might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is 
affected after taking Levitra don’t drive or operate any tools or machines. 
 
 
3. How to take Levitra 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure. The recommended dose is 10 mg. 
 
Take a Levitra tablet about 25 to 60 minutes before sexual activity. With sexual stimulation you may 
achieve an erection anywhere from 25 minutes up to four to five hours after taking Levitra. 
- Swallow one tablet with a glass of water. 
 
Do not take Levitra film-coated tablets with any other forms of Levitra. 
 
Do not take Levitra more than once a day. 
 
Tell your doctor if you think Levitra is too strong or too weak. He or she may suggest a switch to an 
alternative Levitra formulation with a different dose, depending on how well it works for you. 
 
If you take more Levitra than you should 
Men who take too much Levitra may experience more side effects or may get severe back pain. If you 
take more Levitra than you should, tell your doctor. 
 
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. Most of the 
effects are mild or moderate.  
 
Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been 
experienced by patients. Stop taking Levitra and contact your doctor immediately. 
Sudden decrease or loss of hearing has been reported. 
 
Cases of sudden death, fast or altered heart beat, heart attack, chest pain, and trouble in cerebral 
circulation (including temporarily decreased blood flow to parts of the brain and bleeding in the brain) 
have been reported in men taking vardenafil. Most 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 vardenafil. 
 
The chance of having a side effect is described by the following categories: 
 
Very common: 
may affect more than 1 in 10 users 
- Headache 
 
Common: 
may affect up to 1 in 10 users 
- Dizziness 
- Flushing 
- Blocked or runny nose 
- Indigestion 
 



52 

Uncommon: 
may affect up to 1 in 100 users 
- Swelling of skin and mucous tissue including swollen face, lips or throat 
- Sleep disorder 
- Numbness and impaired perception of touch  
- Sleepiness 
- Effects on vision, redness of the eye, effects on colour vision, eye pain and discomfort, light 

sensitivity 
- Ringing in the ears, vertigo  
- Fast heart beat or pounding heart  
- Breathlessness 
- Stuffy nose 
- Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling sick (nausea), dry mouth 
- Raised levels of liver enzymes in your blood 
- Rash, reddened skin 
- Back or muscle pain, increase in blood of a muscle enzyme (creatine phosphokinase), muscle 

stiffness 
- Prolonged erections 
- Malaise  
 
Rare: 
may affect up to 1 in 1,000 users 
- Inflammation of the eyes (conjunctivitis) 
- Allergic reaction  
- Anxiety 
- Fainting  
- Amnesia  
- Seizure 
- Increased pressure in the eye (glaucoma), lacrimation increased 
- Effects on the heart (such as heart attack, altered heart beat or angina) 
- High or low blood pressure  
- Nose bleed 
- Effect on results of blood tests to check liver function 
- Sensitivity of the skin to sun light 
- Painful erections 
- Chest pain 
- Temporarily decreased blood flow to parts of the brain 
 
Very rare or not known: 
may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data 
- Blood in the urine (Haematuria) 
- Penile bleeding (Penile Haemorrhage) 
- Presence of blood in the semen (Haematospermia) 
- Sudden death 
- Bleeding in the brain 
 
Reporting of side effects  
If you get any side effects, talk to your doctor. 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 Levitra 
 
Keep this medicine out of the sight and reach of children. 
 

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


53 

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date 
refers to the last day of that month. 
 
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 Levitra contains 
- The active substance is vardenafil. Each tablet contains 5 mg of vardenafil (as hydrochloride). 
- The other ingredients of the tablets are: 

Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous 
silica. 
Film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172), 
ferric oxide red (E172). 

 
What Levitra looks like and contents of the pack 
Levitra 5 mg film-coated tablets are orange with the BAYER cross on one side and the strength (5) on 
the other side. The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets. Not all pack 
sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder  
Bayer AG 
51368 Leverkusen 
Germany 
 
Manufacturer 
Bayer AG 
Kaiser-Wilhelm-Allee 
51368 Leverkusen 
Germany 
 
 



54 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Bayer SA-NV 
Tél/Tel: +32-(0)2-535 63 11 

Lietuva 
UAB Bayer 
Tel: +370 523 36 868 

България 
Байер България ЕООД 
Tел.: +359-(0)2-424 72 80 

Luxembourg/Luxemburg 
Bayer SA-NV 
Tél/Tel: +32-(0)2-535 63 11 

Česká republika 
Bayer s.r.o. 
Tel: +420 266 101 111 

Magyarország 
Bayer Hungária KFT 
Tel.: +36 14 87-4100 

Danmark 
Bayer A/S 
Tlf: +45 45 23 50 00 

Malta 
Alfred Gera and Sons Ltd. 
Tel: +35 621 44 62 05 

Deutschland 
Jenapharm GmbH & Co. KG 
Tel: +49 (0)3641-87 97 444 

Nederland 
Bayer B.V. 
Tel: +31-(0)297-28 06 66 

Eesti 
Bayer OÜ 
Tel: +372 655 85 65 

Norge 
Bayer AS 
Tlf: +47-23 13 05 00 

Ελλάδα 
Bayer Ελλάς ΑΒΕΕ 
Τηλ: +30 210 61 87 500 

Österreich 
Bayer Austria Ges. m. b. H. 
Tel: +43-(0)1-711 46-0 

España 
Bayer Hispania S.L. 
Tel: +34-93-495 65 00 

Polska 
Bayer Sp. z o.o. 
Tel.: +48 22 572 35 00 

France 
Bayer HealthCare 
Tél (N° vert) : +33-(0)800 87 54 54 

Portugal 
Bayer Portugal, Lda. 
Tel: +351 21 416 42 00 

Hrvatska 
Bayer d.o.o. 
Tel: + 385-(0)1-6599 900 

România 
SC Bayer SRL. 
Tel: +40-21-529 59 00 

Ireland 
Bayer Limited 
Tel: +353 1 216 3300 

Slovenija 
Bayer d. o. o. 
Tel: +386 (0)1 58 14 400 

Ísland 
Icepharma hf. 
Sími: +354-540 8000 

Slovenská republika 
Bayer, spol. s r.o. 
Tel: +421 2-59 21 31 11 

Italia 
Bayer S.p.A. 
Tel: +39 02 397 81 

Suomi/Finland 
Bayer Oy 
Puh/Tel: +358-20 785 21 

Κύπρος 
NOVAGEM Limited 
Τηλ: +357 22 48 38 58 

Sverige 
Bayer AB 
Tel: +46 (0)8 580 223 00 

Latvija 
SIA Bayer 
Tel: +371 67 845 563 

United Kingdom 
Bayer plc  
Tel: +44 (0) 118 206 3000 

 
This leaflet was last revised in {month YYYY}. 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

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


55 

Package Leaflet: Information for the user 
 

Levitra 10 mg film-coated tablets 
vardenafil 

 
 
Read all of this leaflet carefully before you start using 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 Levitra is and what it is used for 
2. What you need to know before you take Levitra 
3. How to take Levitra 
4. Possible side effects 
5. How to store Levitra 
6. Contents of the pack and other information 
 
 
1. What Levitra is and what it is used for 
 
Levitra contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors. 
They are used for the treatment of erectile dysfunction in adult men, a condition which implies 
difficulties in getting or keeping an erection. 
 
At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or 
psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel 
changes not enough blood stays in the penis to make it hard and keep it hard. 
 
Levitra will only work when you are sexually stimulated. It reduces the action of the natural chemical in 
your body which makes erections go away. Levitra allows an erection to last long enough for you to 
satisfactorily complete sexual activity. 
 
 
2. What you need to know before you take Levitra 
 
Do not take Levitra 
- If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 

6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of 
breath. 

- If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric 
oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect 
your blood pressure. 

- If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus 
(HIV) infections. 

- If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines. 
- If you have a severe heart or liver problem. 
- If you are having kidney dialysis. 
- If you have recently had a stroke or heart attack. 
- If you have or have had low blood pressure. 
- If your family has a history of degenerative eye diseases (such as retinitis pigmentosa). 



56 

- If you have ever had a condition involving loss of vision due to damage to the optic nerve from 
insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION). 

- 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 Levitra have been 
shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are 
unsure tell your doctor. 

 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Levitra. 
 
Take special care with Levitra 
- If you have heart trouble. It may be risky for you to have sex. 
- If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting 

your electrocardiogram. 
- If you have a physical condition affecting the shape of the penis. This includes conditions called 

angulation, Peyronie’s disease and cavernosal fibrosis. 
- If you have an illness that can cause erections which won’t go away (priapism). These include 

sickle cell disease, multiple myeloma and leukaemia. 
- If you have stomach ulcers (also called gastric or peptic ulcers). 
- If you have a bleeding disorder (such as haemophilia). 
- If you are using any other treatments for erection difficulties, including Levitra orodispersible 

tablets (see section Other medicines and Levitra). 
- If you experience sudden decrease or loss of vision, stop taking Levitra and contact your doctor 

immediately. 
 
Children and adolescents 
Levitra is not intended for use by children or adolescents under 18. 
 
Other medicines and Levitra 
Please tell your doctor or pharmacist if you are using, have recently used or might use any other 
medicines, including medicines obtained without a prescription. 
Some medicines may cause problems, especially these: 
- Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these 

medicines with Levitra could seriously affect your blood pressure. 
- Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or 

sotalol. 
- Ritonavir or indinavir, medicines for HIV. 
- Ketoconazole or itraconazole, anti-fungal medicines. 
- Erythromycin or clarithromycin, macrolide antibiotics. 
- Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the 

prostate (as benign prostatic hyperplasia).  
- Riociguat. 
 
Do not use Levitra film-coated tablets combined with any other treatment for erectile dysfunction, 
including Levitra orodispersible tablets. 
 
Levitra with food, drink and alcohol 
- You can take Levitra with or without food but preferably not after a heavy or high-fat meal as this 

may delay the effect. 
- Don’t drink grapefruit juice when you use Levitra. It can interfere with the usual effect of the 

medicine. 
- Alcoholic drink can make erection difficulties worse. 
 
Pregnancy and breast-feeding 
Levitra is not for use by women. 
 

http://en.wikipedia.org/wiki/Visual_loss
http://en.wikipedia.org/wiki/Visual_loss
http://en.wikipedia.org/wiki/Optic_nerve
http://en.wikipedia.org/wiki/Optic_nerve


57 

Driving and using machines 
Levitra might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is 
affected after taking Levitra don’t drive or operate any tools or machines. 
 
 
3. How to take Levitra 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure. The recommended dose is 10 mg. 
 
Take a Levitra tablet about 25 to 60 minutes before sexual activity. With sexual stimulation you may 
achieve an erection anywhere from 25 minutes up to four to five hours after taking Levitra. 
- Swallow one tablet with a glass of water 
 
Do not take Levitra film-coated tablets with any other forms of Levitra. 
 
Do not take Levitra more than once a day. 
 
Tell your doctor if you think Levitra is too strong or too weak. He or she may suggest a switch to an 
alternative Levitra formulation with a different dose, depending on how well it works for you. 
 
If you take more Levitra than you should 
Men who take too much Levitra may experience more side effects or may get severe back pain. If you 
take more Levitra than you should, tell your doctor. 
 
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. Most of the 
effects are mild or moderate.  
 
Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been 
experienced by patients. Stop taking Levitra and contact your doctor immediately. 
Sudden decrease or loss of hearing has been reported. 
 
Cases of sudden death, fast or altered heart beat, heart attack, chest pain, and trouble in cerebral 
circulation (including temporarily decreased blood flow to parts of the brain and bleeding in the brain) 
have been reported in men taking vardenafil. Most 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 vardenafil. 
 
The chance of having a side effect is described by the following categories: 
 
Very common: 
may affect more than 1 in 10 users 
- Headache 
 
Common: 
may affect up to 1 in 10 users 
- Dizziness 
- Flushing 
- Blocked or runny nose 
- Indigestion 
 



58 

Uncommon: 
may affect up to 1 in 100 users 
- Swelling of skin and mucous tissue including swollen face, lips or throat 
- Sleep disorder 
- Numbness and impaired perception of touch 
- Sleepiness 
- Effects on vision, redness of the eye, effects on colour vision, eye pain and discomfort, light 

sensitivity 
- Ringing in the ears, vertigo  
- Fast heart beat or pounding heart  
- Breathlessness 
- Stuffy nose 
- Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling sick (nausea), dry mouth 
- Raised levels of liver enzymes in your blood 
- Rash, reddened skin 
- Back or muscle pain, increase in blood of a muscle enzyme (creatine phosphokinase), muscle 

stiffness 
- Prolonged erections 
- Malaise 
 
Rare: 
may affect up to 1 in 1,000 users 
- Inflammation of the eyes (conjunctivitis) 
- Allergic reaction  
- Anxiety 
- Fainting 
- Amnesia  
- Seizure 
- Increased pressure in the eye (glaucoma), lacrimation increased 
- Effects on the heart (such as heart attack, altered heart beat or angina) 
- High or low blood pressure  
- Nose bleed 
- Effect on results of blood tests to check liver function 
- Sensitivity of the skin to sun light 
- Painful erections 
- Chest pain 
- Temporarily decreased blood flow to parts of the brain 
 
Very rare or not known: 
may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data 
- Blood in the urine (Haematuria) 
- Penile bleeding (Penile Haemorrhage) 
- Presence of blood in the semen (Haematospermia) 
- Sudden death 
- Bleeding in the brain 
 
Reporting of side effects  
If you get any side effects, talk to your doctor. 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 Levitra 
 
Keep this medicine out of the sight and reach of children. 
 

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


59 

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date 
refers to the last day of that month. 
 
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 Levitra contains 
- The active substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride). 
- The other ingredients of the tablets are: 

Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous 
silica. 
Film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172), 
ferric oxide red (E172). 

 
What Levitra looks like and contents of the pack 
Levitra 10 mg film-coated tablets are orange with the BAYER cross on one side and the strength (10) on 
the other side. The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets. Not all pack 
sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
Bayer AG 
51368 Leverkusen 
Germany 
 
Manufacturer 
Bayer AG 
Kaiser-Wilhelm-Allee 
51368 Leverkusen 
Germany 
 



60 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Bayer SA-NV 
Tél/Tel: +32-(0)2-535 63 11 

Lietuva 
UAB Bayer 
Tel: +370 523 36 868 

България 
Байер България ЕООД 
Tел.: +359-(0)2-424 72 80 

Luxembourg/Luxemburg 
Bayer SA-NV 
Tél/Tel: +32-(0)2-535 63 11 

Česká republika 
Bayer s.r.o. 
Tel: +420 266 101 111 

Magyarország 
Bayer Hungária KFT 
Tel.: +36 14 87-4100 

Danmark 
Bayer A/S 
Tlf: +45 45 23 50 00 

Malta 
Alfred Gera and Sons Ltd. 
Tel: +35 621 44 62 05 

Deutschland 
Jenapharm GmbH & Co. KG 
Tel: +49 (0)3641-87 97 444 

Nederland 
Bayer B.V. 
Tel: +31-(0)297-28 06 66 

Eesti 
Bayer OÜ 
Tel: +372 655 85 65 

Norge 
Bayer AS 
Tlf: +47-23 13 05 00 

Ελλάδα 
Bayer Ελλάς ΑΒΕΕ 
Τηλ: +30 210 61 87 500 

Österreich 
Bayer Austria Ges. m. b. H. 
Tel: +43-(0)1-711 46-0 

España 
Bayer Hispania S.L. 
Tel: +34-93-495 65 00 

Polska 
Bayer Sp. z o.o. 
Tel.: +48 22 572 35 00 

France 
Bayer HealthCare 
Tél (N° vert) : +33-(0)800 87 54 54 

Portugal 
Bayer Portugal, Lda. 
Tel: +351 21 416 42 00 

Hrvatska 
Bayer d.o.o. 
Tel: + 385-(0)1-6599 900 

România 
SC Bayer SRL. 
Tel: +40-21-529 59 00 

Ireland 
Bayer Limited 
Tel: +353 1 216 3300 

Slovenija 
Bayer d. o. o. 
Tel: +386 (0)1 58 14 400 

Ísland 
Icepharma hf. 
Sími: +354-540 8000 

Slovenská republika 
Bayer, spol. s r.o. 
Tel: +421 2-59 21 31 11 

Italia 
Bayer S.p.A. 
Tel: +39 02 397 81 

Suomi/Finland 
Bayer Oy 
Puh/Tel: +358-20 785 21 

Κύπρος 
NOVAGEM Limited 
Τηλ: +357 22 48 38 58 

Sverige 
Bayer AB 
Tel: +46 (0)8 580 223 00 

Latvija 
SIA Bayer 
Tel: +371 67 845 563 

United Kingdom 
Bayer plc  
Tel: +44 (0) 118 206 3000 

 
This leaflet was last revised in {month YYYY}. 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

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


61 

Package Leaflet: Information for the user 
 

Levitra 20 mg film-coated tablets 
vardenafil 

 
 
Read all of this leaflet carefully before you start using 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 Levitra is and what it is used for 
2. What you need to know before you take Levitra 
3. How to take Levitra 
4. Possible side effects 
5. How to store Levitra 
6. Contents of the pack and other information 
 
 
1. What Levitra is and what it is used for 
 
Levitra contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors. 
They are used for the treatment of erectile dysfunction in adult men, a condition which implies 
difficulties in getting or keeping an erection. 
 
At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or 
psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel 
changes not enough blood stays in the penis to make it hard and keep it hard. 
 
Levitra will only work when you are sexually stimulated. It reduces the action of the natural chemical in 
your body which makes erections go away. Levitra allows an erection to last long enough for you to 
satisfactorily complete sexual activity. 
 
 
2. What you need to know before you take Levitra 
 
Do not take Levitra 
- If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 

6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of 
breath. 

- If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric 
oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect 
your blood pressure. 

- If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus 
(HIV) infections. 

- If you are over 75 years of age and are taking ketaconazole or itraconazole, anti-fungal medicines. 
- If you have a severe heart or liver problem. 
- If you are having kidney dialysis. 
- If you have recently had a stroke or heart attack. 
- If you have or have had low blood pressure. 
- If your family has a history of degenerative eye diseases (such as retinitis pigmentosa). 



62 

- If you have ever had a condition involving loss of vision due to damage to the optic nerve from 
insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION). 

- 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 Levitra have been 
shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are 
unsure tell your doctor. 

 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Levitra. 
 
Take special care with Levitra 
- If you have heart trouble. It may be risky for you to have sex. 
- If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting 

your electrocardiogram. 
- If you have a physical condition affecting the shape of the penis. This includes conditions called 

angulation, Peyronie’s disease and cavernosal fibrosis. 
- If you have an illness that can cause erections which won’t go away (priapism). These include 

sickle cell disease, multiple myeloma and leukaemia. 
- If you have stomach ulcers (also called gastric or peptic ulcers). 
- If you have a bleeding disorder (such as haemophilia). 
- If you are using any other treatments for erection difficulties, including Levitra orodispersible 

tablets (see section Other medicines and Levitra). 
- If you experience sudden decrease or loss of vision, stop taking Levitra and contact your doctor 

immediately. 
 
Children and adolescents 
Levitra is not intended for use by children or adolescents under 18. 
 
Other medicines and Levitra 
Please tell your doctor or pharmacist if you are using, have recently used or might use any other 
medicines, including medicines obtained without a prescription. 
Some medicines may cause problems, especially these: 
- Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these 

medicines with Levitra could seriously affect your blood pressure. 
- Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or 

sotalol. 
- Ritonavir or indinavir, medicines for HIV. 
- Ketoconazole or itraconazole, anti-fungal medicines 
- Erythromycin or clarithromycin, macrolide antibiotics 
- Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the 

prostate (as benign prostatic hyperplasia).  
- Riociguat. 
 
Do not use Levitra film-coated tablets combined with any other treatment for erectile dysfunction, 
including Levitra orodispersible tablets. 
 
Levitra with food, drink and alcohol 
- You can take Levitra with or without food but preferably not after a heavy or high-fat meal as this 

may delay the effect. 
- Don’t drink grapefruit juice when you use Levitra. It can interfere with the usual effect of the 

medicine. 
- Alcoholic drink can make erection difficulties worse. 
 
Pregnancy and breast-feeding 
Levitra is not for use by women. 
 

http://en.wikipedia.org/wiki/Visual_loss
http://en.wikipedia.org/wiki/Visual_loss
http://en.wikipedia.org/wiki/Optic_nerve
http://en.wikipedia.org/wiki/Optic_nerve


63 

Driving and using machines 
Levitra might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is 
affected after taking Levitra don’t drive or operate any tools or machines. 
 
 
3. How to take Levitra 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure. The recommended dose is 10 mg. 
 
Take a Levitra tablet about 25 to 60 minutes before sexual activity. With sexual stimulation you may 
achieve an erection anywhere from 25 minutes up to four to five hours after taking Levitra. 
- Swallow one tablet with a glass of water. 
 
Do not take Levitra film-coated tablets with any other forms of Levitra. 
 
Do not take Levitra more than once a day. 
 
Tell your doctor if you think Levitra is too strong or too weak. He or she may suggest a switch to an 
alternative Levitra formulation with a different dose, depending on how well it works for you. 
 
If you take more Levitra than you should 
Men who take too much Levitra may experience more side effects or may get severe back pain. If you 
take more Levitra than you should, tell your doctor. 
 
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. Most of the 
effects are mild or moderate.  
 
Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been 
experienced by patients. Stop taking Levitra and contact your doctor immediately. 
Sudden decrease or loss of hearing has been reported. 
 
Cases of sudden death, fast or altered heart beat, heart attack, chest pain, and trouble in cerebral 
circulation (including temporarily decreased blood flow to parts of the brain and bleeding in the brain) 
have been reported in men taking vardenafil. Most 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 vardenafil. 
 
The chance of having a side effect is described by the following categories: 
 
Very common: 
may affect more than 1 in 10 users 
- Headache 
 
Common: 
may affect up to 1 in 10 users  
- Dizziness 
- Flushing 
- Blocked or runny nose  
- Indigestion 
 



64 

Uncommon: 
may affect up to 1 in 100 users  
- Swelling of skin and mucous tissue including swollen face, lips or throat 
- Sleep disorder 
- Numbness and impaired perception of touch 
- Sleepiness 
- Effects on vision, redness of the eye, effects on colour vision, eye pain and discomfort, light 

sensitivity 
- Ringing in the ears, vertigo  
- Fast heart beat or pounding heart  
- Breathlessness 
- Stuffy nose 
- Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting; feeling sick (nausea), dry mouth 
- Raised levels of liver enzymes in your blood 
- Rash, reddened skin 
- Back or muscle pain, increase in blood of a muscle enzyme (creatine phosphokinase), muscle 

stiffness 
- Prolonged erections 
- Malaise 
 
Rare: 
may affect up to 1 in 1,000 users  
- Inflammation of the eyes (conjunctivitis) 
- Allergic reaction  
- Anxiety 
- Fainting 
- Amnesia  
- Seizure 
- Increased pressure in the eye (glaucoma), lacrimation increased 
- Effects on the heart (such as heart attack, altered heart beat or angina) 
- High or low blood pressure  
- Nose bleed 
- Effect on results of blood tests to check liver function 
- Sensitivity of the skin to sun light 
- Painful erections 
- Chest pain 
- Temporarily decreased blood flow to parts of the brain 
 
Very rare or not known: 
may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data 
- Blood in the urine (Haematuria) 
- Penile bleeding (Penile Haemorrhage) 
- Presence of blood in the semen (Haematospermia) 
- Sudden death 
- Bleeding in the brain 
 
Reporting of side effects  
If you get any side effects, talk to your doctor. 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 Levitra 
 
Keep this medicine out of the sight and reach of children. 
 

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


65 

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date 
refers to the last day of that month. 
 
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 Levitra contains 
 
- The active substance is vardenafil. Each tablet contains 20 mg of vardenafil (as hydrochloride). 
- The other ingredients of the tablets are: 

Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous 
silica. 
Film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172), 
ferric oxide red (E172). 

 
What Levitra looks like and contents of the pack 
Levitra 20 mg film-coated tablets are orange with the BAYER cross on one side and the strength (20) on 
the other side. The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets. Not all pack 
sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder  
Bayer AG 
51368 Leverkusen 
Germany 
 
Manufacturer 
Bayer AG 
Kaiser-Wilhelm-Allee 
51368 Leverkusen 
Germany 
 
 



66 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Bayer SA-NV 
Tél/Tel: +32-(0)2-535 63 11 

Lietuva 
UAB Bayer 
Tel: +370 523 36 868 

България 
Байер България ЕООД 
Tел.: +359-(0)2-424 72 80 

Luxembourg/Luxemburg 
Bayer SA-NV 
Tél/Tel: +32-(0)2-535 63 11 

Česká republika 
Bayer s.r.o. 
Tel: +420 266 101 111 

Magyarország 
Bayer Hungária KFT 
Tel.: +36 14 87-4100 

Danmark 
Bayer A/S 
Tlf: +45 45 23 50 00 

Malta 
Alfred Gera and Sons Ltd. 
Tel: +35 621 44 62 05 

Deutschland 
Jenapharm GmbH & Co. KG 
Tel: +49 (0)3641-87 97 444 

Nederland 
Bayer B.V. 
Tel: +31-(0)297-28 06 66 

Eesti 
Bayer OÜ 
Tel: +372 655 85 65 

Norge 
Bayer AS 
Tlf: +47-23 13 05 00 

Ελλάδα 
Bayer Ελλάς ΑΒΕΕ 
Τηλ: +30 210 61 87 500 

Österreich 
Bayer Austria Ges. m. b. H. 
Tel: +43-(0)1-711 46-0 

España 
Bayer Hispania S.L. 
Tel: +34-93-495 65 00 

Polska 
Bayer Sp. z o.o. 
Tel.: +48 22 572 35 00 

France 
Bayer HealthCare 
Tél (N° vert) : +33-(0)800 87 54 54 

Portugal 
Bayer Portugal, Lda. 
Tel: +351 21 416 42 00 

Hrvatska 
Bayer d.o.o. 
Tel: + 385-(0)1-6599 900 

România 
SC Bayer SRL. 
Tel: +40-21-529 59 00 

Ireland 
Bayer Limited 
Tel: +353 1 216 3300 

Slovenija 
Bayer d. o. o. 
Tel: +386 (0)1 58 14 400 

Ísland 
Icepharma hf. 
Sími: +354-540 8000 

Slovenská republika 
Bayer, spol. s r.o. 
Tel: +421 2-59 21 31 11 

Italia 
Bayer S.p.A. 
Tel: +39 02 397 81 

Suomi/Finland 
Bayer Oy 
Puh/Tel: +358-20 785 21 

Κύπρος 
NOVAGEM Limited 
Τηλ: +357 22 48 38 58 

Sverige 
Bayer AB 
Tel: +46 (0)8 580 223 00 

Latvija 
SIA Bayer 
Tel: +371 67 845 563 

United Kingdom 
Bayer plc  
Tel: +44 (0) 118 206 3000 

 
This leaflet was last revised in {month YYYY}. 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

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


67 

 
Package Leaflet: Information for the user 

 
Levitra 10 mg orodispersible tablets 

vardenafil 
 
Read all of this leaflet carefully before you start using 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 Levitra is and what it is used for 
2. What you need to know before you take Levitra 
3. How to take Levitra 
4. Possible side effects 
5. How to store Levitra 
6. Contents of the pack and other information 
 
 
1. What Levitra is and what it is used for 
 
Levitra contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors. 
They are used for the treatment of erectile dysfunction in adult men, a condition which implies 
difficulties in getting or keeping an erection. 
 
At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or 
psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel 
changes not enough blood stays in the penis to make it hard and keep it hard. 
 
Levitra will only work when you are sexually stimulated. It reduces the action of the natural chemical in 
your body which makes erections go away. Levitra allows an erection to last long enough for you to 
satisfactorily complete sexual activity. 
 
 
2. What you need to know before you take Levitra 
 
Do not take Levitra 
- If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 

6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of 
breath. 

- If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric 
oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect 
your blood pressure.  

- If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus 
(HIV) infections. 

- If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines. 
- If you have a severe heart or liver problem. 
- If you are having kidney dialysis. 
- If you have recently had a stroke or heart attack. 
- If you have or have had low blood pressure. 
- If your family has a history of degenerative eye diseases (such as retinitis pigmentosa). 



68 

- If you have ever had a condition involving loss of vision due to damage to the optic nerve from 
insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION). 

- 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 Levitra have been 
shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are 
unsure tell your doctor. 

 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Levitra. 
 
Take special care with Levitra  
- If you have heart trouble. It may be risky for you to have sex. 
- If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting 

your electrocardiogram. 
- If you have a physical condition affecting the shape of the penis. This includes conditions called 

angulation, Peyronie’s disease and cavernosal fibrosis. 
- If you have an illness that can cause erections which won’t go away (priapism). These include 

sickle cell disease, multiple myeloma and leukaemia. 
- If you have stomach ulcers (also called gastric or peptic ulcers). 
- If you have a bleeding disorder (such as haemophilia). 
- If you are using any other treatments for erection difficulties, including Levitra film-coated 

tablets (see section Other medicines and Levitra). 
- If you experience sudden decrease or loss of vision, stop taking Levitra and contact your doctor 

immediately. 
 
Children and adolescents 
Levitra is not intended for use by children or adolescents under 18. 
 
Other medicines and Levitra 
Please tell your doctor or pharmacist if you are using, have recently used or might use any other 
medicines, including medicines obtained without a prescription. 
Some medicines may cause problems, especially these: 
- Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these 

medicines with Levitra could seriously affect your blood pressure. 
- Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or 

sotalol. 
- Ritonavir or indinavir, medicines for HIV. 
- Ketoconazole or itraconazole, anti-fungal medicines. 
- Erythromycin or clarithromycin, macrolide antibiotics. 
- Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the 

prostate (as benign prostatic hyperplasia).  
- Riociguat. 
 
Do not use Levitra orodispersible tablets combined with any other treatment for erectile dysfunction, 
including Levitra film-coated tablets. 
 
Levitra with food, drink and alcohol 
- You can take Levitra orodispersible tablets with or without food but do not take this medicine with 

any liquid. 
- Don’t drink grapefruit juice when you use Levitra. It can interfere with the usual effect of the 

medicine. 
- Alcoholic drink can make erection difficulties worse. 
 
Pregnancy and breast-feeding 
Levitra is not for use by women. 
 



69 

Driving and using machines 
Levitra might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is 
affected after taking Levitra don’t drive or operate any tools or machines. 
 
Levitra 10 mg orodispersible tablets contain Aspartame and Sorbitol. 
- Aspartame: This medicine contains 1.80 mg aspartame in each 10 mg 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. 
 

- Sorbitol: This medicine contains 7.96 mg sorbitol in each 10 mg orodispersible tablet.  
 
 
3. How to take Levitra 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure. The recommended dose is 10 mg. 
 
Take a Levitra tablet about 25 to 60 minutes before sexual activity. With sexual stimulation you may 
achieve an erection anywhere from 25 minutes up to four to five hours after taking Levitra. 
 
- Do not remove the orodispersible tablet from the blister until you are going to take it. With dry 

hands press gently to release the tablet on your hand. Do not crush the tablet.  
- Place the entire orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds, 

then swallow with saliva. The orodispersible tablet must be taken without any liquid. 
 

 
 

Do not take Levitra orodispersible tablets with any other forms of Levitra. 
 
Do not take Levitra more than once a day. 
 
Tell your doctor if you think Levitra is too strong or too weak. He or she may suggest a switch to an 
alternative Levitra formulation with a different dose, depending on how well it works for you. 
 
If you take more Levitra than you should 
Men who take too much Levitra may experience more side effects or may get severe back pain. If you 
take more Levitra than you should, tell your doctor. 
 
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. Most of the 
effects are mild or moderate.  
 
Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been 
experienced by patients. Stop taking Levitra and contact your doctor immediately. 
Sudden decrease or loss of hearing has been reported. 
 
Cases of sudden death, fast or altered heart beat, heart attack, chest pain, and trouble in cerebral 
circulation (including temporarily decreased blood flow to parts of the brain and bleeding in the brain) 



70 

have been reported in men taking vardenafil. Most 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 vardenafil. 
 
The chance of having a side effect is described by the following categories: 
 
Very common: 
may affect more than 1 in 10 users 
- Headache 
 
Common: 
may affect up to 1 in 10 users  
- Dizziness 
- Flushing  
- Blocked or runny nose 
- Indigestion 
 
Uncommon: 
may affect up to 1 in 100 users  
- Swelling of skin and mucous tissue including swollen face, lips or throat 
- Sleep disorder 
- Numbness and impaired perception of touch 
- Sleepiness 
- Effects on vision, redness of the eye, effects on colour vision, eye pain and discomfort, light 

sensitivity 
- Ringing in the ears, vertigo 
- Fast heart beat or pounding heart 
- Breathlessness 
- Stuffy nose 
- Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling sick (nausea), dry mouth 
- Raised levels of liver enzymes in your blood 
- Rash, reddened skin 
- Back or muscle pain, increase in blood of a muscle enzyme (creatine phosphokinase), muscle 

stiffness  
- Prolonged erections 
- Malaise 
 
Rare: 
may affect up to 1 in 1,000 users  
- Inflammation of the eyes (conjunctivitis)  
- Allergic reaction 
- Anxiety 
- Fainting 
- Amnesia 
- Seizure 
- Increased pressure in the eye (glaucoma), lacrimation increased 
- Effects on the heart (such as heart attack, altered heart beat or angina) 
- High or low blood pressure 
- Nose bleed 
- Effect on results of blood tests to check liver function 
- Sensitivity of the skin to sun light 
- Painful erections 
- Chest pain 
- Temporarily decreased blood flow to parts of the brain 
 



71 

Very rare or not known: 
may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data 
- Blood in the urine (Haematuria) 
- Penile bleeding (Penile Haemorrhage) 
- Presence of blood in the semen (Haematospermia) 
- Sudden death 
- Bleeding in the brain 
 
Reporting of side effects  
If you get any side effects, talk to your doctor. 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 Levitra 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date 
refers to the last day of that month. 
 
Store in the original package in order to protect from humidity and light. 
 
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 Levitra contains 
- The active substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride). 
- The other ingredients of the tablets are:  
Magnesium stearate, aspartame (E951), peppermint flavour, mannitol (E421), sorbitol (E420), 
crospovidone and silica colloidal hydrated. See section 2 “Levitra 10 mg orodispersible tablets contain 
Aspartame and Sorbitol”. 
 
What Levitra looks like and contents of the pack 
Levitra 10 mg orodispersible tablets are round and white. They are provided in packs of:  
1 x 1 orodispersible tablet in alu/alu perforated unit dose blister, 
2 x 1 orodispersible tablets in alu/alu perforated unit dose blisters, 
4 x 1 orodispersible tablets in alu/alu perforated unit dose blisters, 
8 x 1 orodispersible tablets in alu/alu perforated unit dose blisters. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder  
Bayer AG 
51368 Leverkusen 
Germany 
 
Manufacturer 
Bayer AG 
Kaiser-Wilhelm-Allee 
51368 Leverkusen 
Germany 

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


72 

 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Bayer SA-NV 
Tél/Tel: +32-(0)2-535 63 11 

Lietuva 
UAB Bayer 
Tel: +370 523 36 868 

България 
Байер България ЕООД 
Tел.: +359-(0)2-424 72 80 

Luxembourg/Luxemburg 
Bayer SA-NV 
Tél/Tel: +32-(0)2-535 63 11 

Česká republika 
Bayer s.r.o.  
Tel: +420 266 101 111 

Magyarország 
Bayer Hungária KFT 
Tel.: +36 14 87-4100 

Danmark 
Bayer A/S 
Tlf: +45 45 23 50 00 

Malta 
Alfred Gera and Sons Ltd. 
Tel: +35 621 44 62 05 

Deutschland 
Jenapharm GmbH & Co. KG 
Tel: +49 (0)3641-87 97 444 

Nederland 
Bayer B.V. 
Tel: +31-(0)297-28 06 66 

Eesti 
Bayer OÜ 
Tel: +372 655 85 65 

Norge 
Bayer AS 
Tlf: +47-23 13 05 00 

Ελλάδα 
Bayer Ελλάς ΑΒΕΕ 
Τηλ: +30 210 61 87 500 

Österreich 
Bayer Austria Ges. m. b. H. 
Tel: +43-(0)1-711 46-0 

España 
Bayer Hispania S.L. 
Tel: +34-93-495 65 00 

Polska 
Bayer Sp. z o.o. 
Tel.: +48 22 572 35 00 

France 
Bayer HealthCare 
Tél (N° vert) : +33-(0)800 87 54 54 

Portugal 
Bayer Portugal, Lda. 
Tel: +351 21 416 42 00 

Hrvatska 
Bayer d.o.o. 
Tel: + 385-(0)1-6599 900 

România 
SC Bayer SRL.  
Tel: +40-21-529 59 00 

Ireland 
Bayer Limited 
Tel: +353 1 216 3300 

Slovenija 
Bayer d. o. o. 
Tel: +386 (0)1 58 14 400 

Ísland 
Icepharma hf. 
Sími: +354-540 8000 

Slovenská republika 
Bayer, spol. s r.o. 
Tel: +421 2-59 21 31 11 

Italia 
Bayer S.p.A. 
Tel: +39 02 397 81 

Suomi/Finland 
Bayer Oy 
Puh/Tel: +358-20 785 21 

Κύπρος 
NOVAGEM Limited 
Τηλ: +357 22 48 38 58 

Sverige 
Bayer AB 
Tel: +46 (0)8 580 223 00 

Latvija 
SIA Bayer 
Tel: +371 67 845 563 

United Kingdom 
Bayer plc  
Tel: +44 (0) 118 206 3000 

 
This leaflet was last revised in {month YYYY}. 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

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

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D.  CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET