Contraindications : התוויות נגד

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).

Vardenafil Inovamed 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 CYP3A4 inhibitors such as such as erythromycin or clarithromycin is contraindicated (as the dose of vardenafil should not exceed 5 mg, see section 4.2).

Concomitant use of vardenafil with potent CYP3A4 inhibitors such as itraconazole and ketoconazole (oral form) is contraindicated as very high plasma concentrations of vardenafil are reached if the medicinal products are combined (see section 4.5).

The concomitant use of alpha-blockers with vardenafil may lead to symptomatic hypotension in some patients because both are vasodilators. In those patients who are stable on alpha-blocker therapy, concomitant treatment with vardenafil is contraindicated (as the starting dose of vardenafil should not exceed 5 mg, see section 4.5).

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).