Hezkue - Oral Spray Sildenafil

Contraindications

Hypersensitivity to the active substance or excipients. 

Co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form. 

Co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as Riociguat. 

Not to 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). 

Contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was related to previous PDE5 inhibitor exposure. 

The safety of Sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa.

Warnings and Precautions

Cardiovascular risk factors: Consider cardiovascular status and whether any underlying conditions could be adversely affected by the vasodilatory effects of sildenafil, especially in combination with sexual activity, prior to initiating treatment.  

Priapism: Use with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease), and in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). 

Effects on vision: Patients should be advised that in the event of any sudden visual defect, they should stop taking Hezkue® and consult a physician immediately. 

Concomitant use with ritonavir is not advised. 

Concomitant use with alpha-blockers: Caution advised when administered to patients taking an alpha blocker.  Initiation of sildenafil at a dose of 25 mg should be considered. Patients should be advised what to do in the event of postural hypotensive symptoms. 

Effect on bleeding: Sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration. Sildenafil should be administered to these patients only after careful benefit-risk assessment. 

Women: Not indicated for use by women. 

Undesirable Events

Very Common: Headache 

Common: Dizziness, visual colour distortions (chloropsia, chromatopsia, cyanopsia, erythropsia and xanthopsia), visual disturbance, vision blurred, flushing, nasal congestion, nausea, dyspepsia.