Sirbida^® (Capsules) Instructions for Use

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Or

MiraxBioPharma JSC (Russia)

ATC Code

G04BE (Drugs for the treatment of erectile dysfunction)

Dosage Form

Sirbida®

Capsules: 4, 7, 8, 10, 12, 14, 16, 20, 21, 28, 30, 40, 60 or 120 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size 0, with a violet body and a violet cap, opaque; the capsule contents are a powder ranging from light yellowish-brown to dark greenish-brown with darker and lighter specks; a characteristic odor may be present.

Excipients: potato starch – 99 mg, magnesium stearate – 1 mg.

Capsule body composition azorubine (carmoisine) dye (E122) – 0.12%, patent blue V dye (E131) – 0.017%, titanium dioxide (E171) – 2%, gelatin – up to 100%.
Capsule cap composition azorubine (carmoisine) dye (E122) – 0.12%, patent blue V dye (E131) – 0.017%, titanium dioxide (E171) – 2%, gelatin – up to 100%.

4 pcs. – blister packs (1) – cardboard cartons.
4 pcs. – blister packs (2) – cardboard cartons.
4 pcs. – blister packs (3) – cardboard cartons.
4 pcs. – blister packs (4) – cardboard cartons.
7 pcs. – blister packs (1) – cardboard cartons.
7 pcs. – blister packs (2) – cardboard cartons.
7 pcs. – blister packs (3) – cardboard cartons.
7 pcs. – blister packs (4) – cardboard cartons.
10 pcs. – blister packs (1) – cardboard cartons.
10 pcs. – blister packs (2) – cardboard cartons.
10 pcs. – blister packs (3) – cardboard cartons.
10 pcs. – blister packs (4) – cardboard cartons.
20 pcs. – polymer jars (1) – cardboard cartons.
30 pcs. – polymer jars (1) – cardboard cartons.
60 pcs. – polymer jars (1) – cardboard cartons.
120 pcs. – polymer jars (1) – cardboard cartons.

Clinical-Pharmacological Group

Herbal preparation with general tonic effect and stimulating influence on sexual activity

Pharmacotherapeutic Group

Herbal erectile dysfunction treatment agent

Pharmacological Action

A combined herbal medicinal product. It provides comprehensive support for male health due to the biologically active components in its composition.

The herbal complex has a stimulating, general tonic effect, positively influences testosterone levels, contributes to the restoration of impaired erectile function, and the restoration and enhancement of sexual function; it stimulates libido; provides an increase in activity and performance.

Indications

Treatment and prevention of erectile dysfunction; for the restoration and enhancement of sexual function, stimulation of sexual desire, as well as the prevention of their disorders; physical and emotional strain, convalescence after somatic and infectious diseases, to increase the body’s performance.

ICD codes

Dosage Regimen

Take orally with a sufficient amount of water.

For treatment and prevention of erectile dysfunction, take 1 capsule twice daily.

For restoration and enhancement of sexual function and to stimulate libido, take 1 capsule twice daily.

For use during physical and emotional strain or to increase performance, take 1 capsule twice daily.

For convalescence after somatic or infectious diseases, take 1 capsule twice daily.

The standard course duration is 10 days.

Courses may be repeated if necessary, following consultation with a physician.

Take the capsules with meals to improve tolerability.

Do not exceed the recommended daily dose.

This product requires sexual stimulation to facilitate an erection; it does not cause spontaneous erection.

If no therapeutic effect is achieved after a full course, consult a specialist.

Adverse Reactions

Possible allergic reactions, increased blood pressure, tachycardia, headache, hypoglycemia, sleep disorders, nosebleed.

Contraindications

Hypersensitivity to the components of this product; anatomical deformation of the penis (including angulation, cavernous fibrosis, or Peyronie’s disease); arterial hypertension; convulsive conditions (including epilepsy); tendency to bleeding; chronic heart failure in the stage of decompensation; unstable angina; myocardial infarction, stroke, or life-threatening arrhythmias within the last 6 months; impaired liver function; age under 18 years.

With caution

Chronic heart failure. Elderly age.

Use in Pregnancy and Lactation

This product is intended for use in men.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

It contributes to the onset of an erection only in the presence of sexual stimulation. This product does not cause a spontaneous erection without erotic stimulation.

To diagnose erectile disorders, determine their possible causes, and choose adequate treatment, it is necessary to collect a complete medical history and conduct a thorough examination.

Drugs intended for the treatment of erectile disorders should not be prescribed to men for whom sexual activity is undesirable.

When using this product, patients of both sexes should provide for methods of effective contraception.

If the result is not achieved after the completed course of therapy, it is recommended to consult a specialist.

Drug Interactions

It enhances the effect of psychostimulants and analeptics (including caffeine, camphor).

It exhibits antagonism when interacting with drugs that depress the central nervous system (antiepileptic drugs, neuroleptics, tranquilizers, sedatives).

It enhances the effect of hypoglycemic drugs, warfarin.

Increases the risk of developing resistance to “loop” diuretics.

Enhancement of the effect of antianginal agents is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.