Description
Description
Tablets, film-coated pink, biconvex, rhomboid shape with cut and rounded edges, engraved with “50” on one side.
On a cross-section, the tablet core is white or almost white.
Indications
Treatment of erectile dysfunction characterized by an inability to achieve or maintain an erection of the penis sufficient for satisfactory intercourse.
Sildenafil is only effective in the presence of sexual stimulation.
Contraindications
1. Hypersensitivity to sildenafil or any other component of the drug. Use in patients receiving nitric oxide donors, organic nitrates or nitrites in any form continuously or intermittently, since sildenafil enhances the hypotensive effect of nitrates (see section “Interaction with other drugs”).
2. Use in patients for whom sexual activity is undesirable (for example, with severe cardiovascular diseases such as severe heart failure, unstable angina).
3. Arterial hypotension (blood pressure less than 90/50 mm RT. Art.).
4. Severe chronic renal failure.
5. A cerebrovascular accident or myocardial infarction over the past six months.
6. Severe impairment of liver function.
7. Hereditary degenerative diseases of the retina, including retinitis pigmentosa. Concomitant use of ritonavir.
The safety and effectiveness of sildenafil when used together with other treatments for erectile dysfunction have not been studied, so the use of such
combinations is not recommended (see section “Special Instructions”).
According to the registered testimony, sildenafil is not intended for use by children of
under 18 years of age. According to the registered indication, sildenafil is not intended for
use in women.
Precautions
1. Arterial hypertension (BP> 170/100 mmHg).
2. Heart failure.
3. Life-threatening arrhythmias.
4. Anatomical deformation of the penis (angulation, cavernous fibrosis or Peyronie s disease) (see section Special instructions ).
5. Diseases predisposing to the development of priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocythemia) (see section “Special instructions”). Patients with a history of anterior non-arteritic ischemic neuropathy of the optic nerve in history.
6. Diseases accompanied by bleeding.
7. Exacerbation of peptic ulcer of the stomach and duodenum.
8. Concomitant use of alpha-blockers.
Use during pregnancy and during breastfeeding
According to the registered indication, the drug is not intended for use in women.
Composition
Tablets 50 mg
Active ingredient:
sildenafil citrate – 70.2 mg (in terms of sildenafil – 50.0 mg).
Excipients:
corn starch – 156.0 mg, microcrystalline cellulose – 74.0 mg,
magnesium stearate – 5.0 mg,
talc – 5.0 mg, colloidal silicon dioxide – 3.0 mg,
sodium carboxymethyl starch – 10.0 mg.
Film coating pink – 10.0 mg: titanium dioxide – 1.1 mg,
dye iron oxide red – 1.6 mg,
hypromellose – 3.2 mg,
macrogol – 3.7 mg,
talc – 0, 4 mg
Dosage and Administration
Inside.
The recommended dose for most adult patients is 50 mg for approximately – an hour before sexual activity. Given the effectiveness and tolerability, the dose can be increased to 100 mg. The maximum recommended dose is 100 mg. The maximum recommended frequency of use is once a day.
Elderly patients
Sildenafil dose adjustment not required.
Side effects of
Usually, side effects of sildenafil are mild or moderate in
. Fixed dose studies have shown that the incidence of some
adverse events increases with increasing dose.
General disorders: chest pain, general weakness, irritability,
feeling of heat, feeling of fatigue. Allergic reactions: hypersensitivity reactions (including skin rash), Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome). Disorders from the central and peripheral nervous system: drowsiness, stroke, fainting, hypesthesia, transient ischemic attack, convulsions, including recurrent.
Disorders from the cardiovascular system: tachycardia, increase or decrease in blood pressure, myocardial infarction, atrial fibrillation, ventricular arrhythmia, unstable angina, hot flashes and palpitations, sudden death. Violations of the respiratory system: nosebleeds, nasal sinus congestion, tightness in the throat, dry nasal mucosa, swelling of the nasal mucosa.
Digestive disorders: vomiting, nausea, dry oral mucosa, dyspepsia, abdominal pain, gastroesophageal reflux disease, oral mucosal hypesthesia.
Disorders of the organ of vision: eye pain, redness of the eyes / injection of the sclera, conjunctival lesions, impaired lacrimation, anterior ischemic optic neuropathy, retinal vascular occlusion, visual field defects, photophobia, photopsia, diplopia, glaucoma, decreased visual acuity, myopia, asthenopia, retinal edema, retinal vascular disease, eye discomfort, mydriasis, blurred vision, blurred vision, retinal hemorrhage, atherosclerotic retinopathy, eye irritation, eyelid edema, discoloration EASURES.
Hearing impairment: vertigo, tinnitus, deafness, tinnitus. Disturbances from the side of the musculoskeletal system: myalgia, pain in the limbs.
Reproductive system disorders: prolonged erection and / or priapism, hematospermia and bleeding from the penis.
Disorders from the genitourinary system: hematuria.
Overdose of
With a single dose of the drug up to 800 mg, adverse events were
comparable to those with the drug at lower doses, but were more common.
Storage conditions
At a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Shelf life
3 years.
Do not use after expiration date.
Active substance
sildenafil
Dosage form
tablet
