Filap coated tablets 50 mg. №4

Description

Filap Storage
active substance: sildenafilum;

1 film-coated tablet contains sildenafil citrate, which is equivalent to sildenafil 50 mg or 100 mg;

Excipients: microcrystalline cellulose; calcium hydrogen phosphate anhydrous; croscarmellose sodium; magnesium stearate; film coating: opadraj red 06B 55000: (hypromellose, ponso 4R (E 124), macrogol 400, titanium dioxide (E 171), iron oxide red (E 172), indigo carmine (E 132)).

Filap Dosage form
Coated tablets.

Basic physical and chemical properties:

50 mg tablets: red, film-coated, round-shaped tablets with “S22” embossing on one side and smooth on the other;

100 mg tablets: Red, film-coated, round-shaped tablets with “S23” embossing on one side and smooth on the other.

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

Pharmacological properties

Pharmacodynamics.

Sildenafil is an oral drug used to treat erectile dysfunction. In the presence of sexual stimulation, the drug restores weakened erectile function by increasing blood flow to the penis.

The physiological mechanism responsible for penile erection involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. Nitric oxide then activates the enzyme guanylate cyclase, causing an increase in the level of cyclic guanosine monophosphate (cGMP), which leads to the relaxation of smooth muscles in the corpus cavernosum and provides blood flow.

Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for the cleavage of cGMP. Sildenafil affects erection through peripheral mechanisms of action. Sildenafil does not have a direct relaxing effect on the isolated human corpus cavernosum, but potently enhances the relaxing effect of NO on this tissue. If sexual stimulation occurs when the NO / cGMP metabolic pathway is activated, inhibition of PDE5 by sildenafil causes an increase in cGMP levels in the corpus cavernosum. Thus, sexual stimulation is necessary to obtain the expected positive pharmacological effect of sildenafil.

Indication
Treatment of men with erectile dysfunction, manifested by the inability to achieve or maintain an erection of the penis, sufficient for successful sexual intercourse.

Philap needs sexual arousal to be effective.

Contraindication
Hypersensitivity to sildenafil 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.
Erectile dysfunction treatments, including sildenafil, should not be used in men for whom sexual activity is undesirable (eg, patients with severe cardiovascular disease such as unstable angina or severe heart failure).
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).
Sildenafil citrate is contraindicated in patients who have lost vision in one eye due to non-arteritic anterior ischemic ophthalmoneuropathy (NPION), regardless of whether such episodes have been associated with previous use of PDE5 inhibitors.
The safety of sildenafil has not been studied in the following subgroups of patients, therefore its use is contraindicated: in severe hepatic impairment, hypotension (blood pressure <90/50 mm Hg), recent myocardial infarction and known hereditary degenerative diseases of the retina. retinitis (a smaller proportion of such patients have a genetic defect of retinal phosphodiesterase).