Fakel chewing tablets 50 mg. №1

Description

Fakel Storage
active substance: sildenafil;

1 tablet contains 50 mg or 100 mg of sildenafil (as sildenafil citrate);

excipients: potassium polyacryline; magnesium stearate; colloidal anhydrous silica; aspartame (E 951); croscarmellose sodium; peppermint flavor (maltodextrin, modified corn starch, peppermint oil); lactose monohydrate; povidone.

Fakel Dosage form
Chewable tablets.

Basic physical and chemical properties:

tablets of 50 mg: white, triangular, biconvex tablets with embossing “50” on one side;

tablets of 100 mg: white, triangular, biconvex tablets with embossing “100” on one side.

Fakel Pharmacotherapeutic group
Remedies used for erectile dysfunction. Sildenafil. ATX code G04B E03.

Pharmacological properties

Pharmacodynamics.

Fakel® is a drug for oral use, intended for the treatment of erectile dysfunction. During sexual arousal, the drug restores reduced erectile function by increasing blood flow to the penis.

The physiological mechanism that causes an erection involves the release of nitric oxide (NO) in the corpora cavernosa during sexual arousal. The released nitric oxide activates the enzyme guanylate cyclase, which stimulates an increase in the level of cyclic guanosine monophosphate (cGMP), which, in turn, causes the smooth muscles of the corpora cavernosa to relax, promoting blood flow.

Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase 5 (PDE5) in corpora cavernosa, where PDE5 is responsible for the breakdown of cGMP. The effects of sildenafil on erection are peripheral. Sildenafil does not have a direct relaxing effect on isolated human corpora cavernosa, but potently enhances the relaxing effect of NO on this tissue. Upon activation of the NO / cGMP metabolic pathway, which occurs during sexual stimulation, inhibition of PDE5 by sildenafil leads to an increase in cGMP levels in the corpora cavernosa. Thus, sexual arousal is required for sildenafil to produce the desired pharmacological effect.

Indication
Fakel® is recommended for men with erectile dysfunction, which is defined as the inability to achieve or maintain a penile erection necessary for successful sexual intercourse.

Sexual arousal is required for Fakel® to work effectively.

Contraindication
Hypersensitivity to the active substance or to any of the excipients.
Concomitant use with nitric oxide donors (such as amyl nitrite) or nitrates in any form is contraindicated, as sildenafil is known to affect the metabolic pathways of nitric oxide / cyclic guanosine monophosphate (cGMP) and potentiate the hypotensive effect of nitrates.
Concomitant use of PDE5 inhibitors (including sildenafil) with guanylate cyclase stimulants such as riociguate is contraindicated as it may lead to symptomatic hypotension (see Interaction with other medicinal products and other forms of interaction).
Conditions in which sexual activity is not recommended (eg, severe cardiovascular disorders such as unstable angina or severe heart failure).
Contraindicated in patients with loss of vision in one eye due to non-arterial anterior ischemic optic neuropathy, regardless of whether this pathology is associated with previous use of PDE5 inhibitors.
Presence of diseases such as severe hepatic impairment, hypotension (blood pressure below 90/50 mm Hg), recent stroke or myocardial infarction and known inherited retinal degenerative diseases such as retinitis pigmentosa (a small number of such patients have genetic retinal phosphodiesterase disorders), as the safety of sildenafil has not been studied in such subgroups of patients.