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LEVITRA 5 mg / 10 mg / 20 mg (Refer to SmPC
before prescribing.) Composition: Active ingredient:
5 mg / 10 mg / 20 mg vardenafil (as hydrochloride
trihydrate). Excipients: Crospovidone, Magnesium
Stearate, Microcrystalline cellulose, colloidal anhydrous
Silica, Macrogol 400, Hypromellose, Titanium dioxide
(E171), Ferric oxide yellow (E171), Ferric Oxide red
(E172). Indications: Treatment of erectile dysfunction.
To be effective,sexual stimulation is required.Not for use
by women. Contraindications: Coadministration with
nitrates or nitric oxide donors (such as amyl nitrite) in any
form; patients who have loss of vision in one eye
because of NAION; men for whom sexual activity is
inadvisable (e.g. severe cardiovascular disorders);
severe hepatic impairment; endstage renal disease
requiring dialysis; hypotension; recent stroke or
myocardial infarction; unstable angina; known
hereditary retinal degenerative disorders; concomitant
use of potent HIV protease inhibitors such as ritonavir
and indinavir, concomitant use of potent CYP3A4
inhibitors (ketoconazole and itraconazole (oral form)) in
men older than 75 years; hypersensitivity to vardenafil
or to any of the excipients.Warnings and Precautions:
Cardiovascular status should be considered. Patients
with anatomical deformation of the penis or conditions
which predispose to priapism (such as sickle cell
anaemia, multiple myeloma or leukaemia) should be
treated with caution. Combination with other treatments
for erectile dysfunction is not recommended.
Concomitant use with potent CYP3A4 inhibitors
(itraconazole and ketoconazole (oral form)) should
be avoided. A dose of 5 mg vardenafil must not be
exceeded when given concomitantly with erythromycin.
Patients on stable alpha-blocker therapy: initiate
vardenafil therapy at a starting dose of 5 mg and
consider a time separation of dosing.Prolongation of QTc
interval – avoid use in patients with relevant risk factors.
Advise patients that in the case of sudden visual defect
to stop taking Levitra and consult a physician. Avoid
grapefruit juice.Administration to patients with bleeding
disorders or active peptic ulceration only after careful
benefit-risk-assessment. Undesirable Effects: Most
common: flushing, headache. Other system organ
classes effected: immune system disorders, psychiatric
Duration of erection:
disorders, nervous disorders, eye disorders, cardiac
disorders, vascular disorders, respiratory, thoracic and
mediastinal disorders,gatrointestinal disorders,skin and
the NEWefficacy
subcutaneous tissue disorders, musculoskeletal and
connective tissue disorders, reproductive system and
breast disorders. Serious cardiovascular events, parameter in ED
including cerebrovascular haemorrhage,sudden cardiac
death, transient ischeamic attack, unstable angina and
ventricular arrhythmia reported post marketing in
temporal association with another medicinal product in
this class. Legal Category: Medicinal product subject
to medical prescription. Marketing Authorisation
Holder: Bayer AG, D-51368 Leverkusen, Germany.
BSP.GM.MHC.04.2009.0032.
* Two independent placebo-controlled clinical
studies demonstrated that Levitra
®
(vardenafil HCI)
results in a significantly prolonged erection
(1,2)
,
which is a prerequisite for an increase in the
Men with erectile dysfunction (ED)
duration of intercourse.
experience a significant reduction
in duration of erection.
1,2
1.Rosenberg MT et al. Improvement in duration of
erection following phosphodiesterase type 5 inhibitor
93% of men rate hardness of erection
therapy with vardenafil in men with erectile
dysfunction: the ENDURANCE study. Int J Clin Pract
and duration of erection as equally important
2009; 63(1):27-34.
features for prolonging sexual pleasure.
3
2.Miner M et al. Vardenafil in men with stable statin Restore the performance.
therapy and dyslipidemia. J Sex Med. 2008;
Levitra
®
is the only PDE
5
inhibitor that has Restore the relationship.
5(6):1455-67.
3. Taylor H and Leitman R.Men with erectile dysfunction
been clinically shown to extend the duration
(ED) want improved relations with their partners
of erection*,even in men with underlying
Harris Interactive online survey 2001; 1; 14. medical conditions.
1,2