Description
Description
Tablets, coated with a blue film coating, biconvex, rhomboid shape with cut and rounded edges, engraved with “1005 SAO one.
On a cross-section, the tablet core is white or almost white.
Pharmacotherapeutic group: erectile dysfunction treatment tool – PDE5 inhibitor.
Indications
Treatment of erectile dysfunction characterized by an inability to achieve or maintain an erection of the penis, sufficient for satisfactory sexual 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 continuously or intermittently nitric oxide donors, organic nitrates or nitrites in any form, since sildenafil enhances the hypotensive effect of nitrates (see the 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 carried 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
Active ingredient:
sildenafil citrate – 140.5 mg (in terms of sildenafil – 100.0 MG).
Excipients:
corn starch – 223.0 mg,
microcrystalline cellulose – 110.0 mg,
magnesium stearate – 8.0 mg,
talc – 5.0 mg,
silicon dioxide colloidal – 3.0 mg,
sodium carboxymethyl starch – 10.0 mg.
Film coating blue – 12.0 mg:
titanium dioxide – 1.3 mg,
brilliant blue dye – 1.9 mg,
hypromellose – 3.8 mg,
macrogol – 4.5 mg,
talc – 0, 5 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 frequency of some adverse events increases with increasing dose.
General disorders: chest pain, general weakness, irritability,
feeling of heat, feeling of tiredness. 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.
Disorders of the digestive system: vomiting, nausea, dry oral mucosa, dyspepsia, abdominal pain, gastroesophageal p nasal sinus congestion, a feeling of tightness in the throat, dryness of the nasal mucosa, swelling of the nasal mucosa.
Disorders of the digestive system: vomiting, nausea, dry oral mucosa, dyspepsia, abdominal pain, gastroesophageal p nasal sinus congestion, a feeling of tightness in the throat, dryness of the nasal mucosa, swelling of the nasal mucosa.
Disorders of the digestive system: vomiting, nausea, dry oral mucosa, dyspepsia, abdominal pain, gastroesophageal peflux disease, hypesthesia of the oral mucosa.
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.
Terms stored
Shelf life
Shelf life 3 years.
Do not use after expiration date.
active ingredient
sildenafil
Dosage form
tablet