Erotex (Suppositories) Instructions for Use

Marketing Authorization Holder

Sperko Ukraine SP (Ukraine)

ATC Code

G02BB (Intravaginal contraceptives)

Active Substance

Benzalkonium chloride (Rec.INN registered by WHO)

Dosage Form

Erotex

Vaginal suppositories 18.9 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

5 pcs. – contour cell packs (1) – cardboard boxes.
5 pcs. – contour cell packs (2) – cardboard boxes.

Clinical-Pharmacological Group

Vaginal contraceptive with spermicidal action

Pharmacotherapeutic Group

Contraceptive agent for topical application

Pharmacological Action

Benzalkonium chloride is a surface-active cationic substance whose spermicidal action is due to its ability to damage sperm membranes (first in the flagella, then in the heads), which makes fertilization by damaged sperm impossible.

The effect develops 5 minutes after insertion into the vagina. It does not affect the normal vaginal microflora (including Döderlein’s bacillus) or hormonal levels.

In vitro, it is active against Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Herpes simplex type 2, Staphylococcus aureus.

It has no effect on Mycoplasma spp. and has a weak effect on Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum.

Pharmacokinetics

It is practically not absorbed after intravaginal administration, is adsorbed on the mucosa of the vagina and cervix, and is removed by simple washing with water and with normal physiological secretions.

Indications

Local contraception for women of reproductive age (including in the presence of contraindications to the use of oral contraceptives or intrauterine contraception; in the postpartum period, lactation; after termination of pregnancy; perimenopause; irregular sexual contacts; missed or delayed intake of regularly used oral contraceptives).

ICD codes

Dosage Regimen

Administer intravaginally only.

Insert one suppository deep into the vagina while lying on your back.

Perform insertion no later than 5 minutes before sexual intercourse.

The duration of action is up to 4 hours.

Use one suppository per single sexual act.

Mandatorily insert a new suppository for every repeated act of intercourse.

Do not rely on a single suppository for multiple acts, even within the 4-hour effective window.

Ensure the suppository is inserted correctly for maximum contraceptive effect.

Adverse Reactions

Allergic reactions, contact dermatitis, itching and burning in the vagina and/or on the partner’s penis, painful urination.

If any adverse side reaction occurs, consult a doctor as soon as possible.

Contraindications

Hypersensitivity to the drug components, vaginitis, ulceration and irritation of the vaginal and cervical mucosa.

With caution.

Pregnancy The drug is a contraceptive and is not used during pregnancy. If pregnancy occurs while using benzalkonium chloride for contraception, no effect on the course of pregnancy has been found.

Lactation period It is not excreted in breast milk and can be used during lactation.

Use in Pregnancy and Lactation

Pregnancy The drug is a contraceptive and is not used during pregnancy. If pregnancy occurs while using benzalkonium chloride for contraception, no effect on the course of pregnancy has been found.

Lactation period It is not excreted in breast milk and can be used during lactation.

Special Precautions

To increase effectiveness, it is necessary to strictly follow the method of application of the drug.

It can be used in combination with a vaginal diaphragm, condom, or intrauterine contraceptives.

Avoid washing or irrigating the vagina with soapy water, as soap destroys the active substance of the drug (external toileting is only possible with clean water). Do not use douching for 2 hours after sexual intercourse!

Drug Interactions

Any medication, as well as soap and solutions containing it, introduced intravaginally, can reduce the spermicidal effect of the drug.

Iodine solutions (including 0.1% iodonate solution) inactivate the drug.

Storage Conditions

At a temperature from +2°C (35.6°F) to +15°C (59°F).

Keep out of reach of children.

Shelf Life

Shelf life. 2 years. Do not use after the expiration date.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.