EROTEXT

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EROTEX (EROTEX)

Composition:

Active substance: benzalkonium chloride;

1 suppository contains 18.9 mg of benzalkonium chloride;

Excipients: lavender oil or rose oil or lemon oil, lipophilic base.

Dosage form. Vaginal suppositories.

Main physicochemical properties: white with a slightly yellowish tint, aromatic odor, bullet-shaped suppositories.

Pharmacotherapeutic group. Local contraceptives. Intravaginal contraceptives.

ATC code G02BB.

Pharmacological properties.

Pharmacodynamics.

Benzalkonium chloride is a cationic surfactant, whose spermicidal properties are associated with its ability to disrupt spermatozoa membranes. Upon contact with benzalkonium chloride, spermatozoa undergo immediate immobilization, followed by disruption of their cell membrane and separation of flagella from the heads. The contraceptive action of the medicinal product Erotext is also achieved through thickening of cervical mucus and formation of a film, thereby reducing the ability of spermatozoa to penetrate through the external os of the cervix.

Contraceptive efficacy is measured by the Pearl index; for benzalkonium chloride in suppository form, it is less than 1, meaning that with correct use and adherence to all requirements, the frequency of unintended pregnancy is approximately 1% per year.

The drug does not affect libido or fertility and has a reversible effect upon discontinuation.

Erotext also has antiseptic and antimicrobial effects and reduces the risk of sexually transmitted infections, although it does not completely eliminate this risk.

Pharmacokinetics.

The drug is not absorbed through the vaginal mucosa but only adheres to its walls, is easily removed by rinsing with clean water or is eliminated together with normal vaginal secretions. It acts locally and does not enter the systemic circulation. The duration of the local action of Erotext is 4 hours.

Clinical characteristics.

Indications.

Local contraception for all women of reproductive age. The product can be used both independently and in combination with other methods, which enhances their contraceptive effect. The use of Erotex is particularly appropriate when the advantages of local contraception are indisputable:

• in the presence of permanent or temporary contraindications to oral contraception or intrauterine devices (after childbirth, during breastfeeding, after termination of pregnancy, during menopause);
• when occasional prevention of pregnancy is required (irregular sexual activity);
• during use of oral contraceptives, if the woman has forgotten or delayed taking a tablet (in this case, additional use of Erotex is necessary at any time during the cycle);
• as an adjunct to barrier contraception (vaginal diaphragm) or in the presence of an intrauterine device, especially when simultaneously using certain medicinal products (e.g., non-hormonal anti-inflammatory drugs).

Contraindications.

Hypersensitivity to the components of the medicinal product, vaginitis, ulcers and irritation of the vaginal and cervical mucosa. Inability to properly use vaginal suppositories in patients with mental disorders and in individuals who do not allow any interventions on genital organs or are unable to understand and consent to this type of contraception.

Interaction with other medicinal products and other forms of interaction.

During use of Erotex, it is not recommended to use other vaginal medicinal forms simultaneously in order to avoid interactions and reduction of contraceptive efficacy.

Soap and other hygiene products based on soap inactivate benzalkonium chloride, leading to loss of its contraceptive effect.

The medicinal product is chemically incompatible with iodine-containing preparations.

Special precautions for use.

The contraceptive effectiveness of the Eroteks drug largely depends on strict adherence to the application instructions!

To achieve maximum effectiveness, remember and follow these rules:

• The drug must be used before each sexual intercourse, regardless of the phase of the menstrual cycle (using the drug only during "unsafe days" reduces the method's effectiveness);
• In case of repeated sexual intercourse, another Eroteks suppository must be inserted (one suppository per sexual act!);
• For genital hygiene, soap or other soap-based products are prohibited within 2 hours before and 2 hours after sexual intercourse, as even minor residues may destroy the active ingredient of Eroteks. Only clean water should be used!
• Do not douche the vagina within 2 hours after sexual intercourse.
• Eroteks must not be used without a physician's approval if any vaginal disorders or infections are present.

Use during pregnancy or breastfeeding.

The drug is a contraceptive and should not be used during pregnancy. When pregnancy occurs despite benzalkonium chloride contraception, no adverse effects on pregnancy course have been observed.

Benzalkonium does not penetrate into breast milk; therefore, Eroteks may be used during breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Method of Administration and Dosage.

1. Remove the suppository from the protective packaging.
2. In a lying position, insert it as deeply as possible into the vagina at least 5 minutes before sexual intercourse. During this time, the active spermicidal ingredient will be evenly distributed within the vagina.
3. In the case of repeated sexual intercourse, another Erotex suppository must be inserted (one suppository per sexual intercourse).

When using the Erotex preparation, it should be noted that the suppositories have a moderate moisturizing effect.

Children.

Erotex should not be used in children.

Overdose.

No cases of overdose have been reported.

Side effects.

Allergic reactions may occur in patients who are hypersensitive to benzalkonium chloride. In isolated cases, local irritation, pricking sensation, warmth at the site of application, contact dermatitis, itching, burning sensation in the vagina or in the partner's penis, and pain during urination may occur. If any adverse effects occur, use of the medicinal product should be discontinued. No systemic side effects have been reported.

Shelf life.

2 years. Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature between 2 °C and 15 °C. Keep out of reach of children.

Packaging.

5 suppositories in a strip made of polyvinyl chloride film, 2 strips per cardboard box.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

Ukrainian-Spanish joint venture "Sperco Ukraine".

Manufacturer's address and place of business.

21027, Ukraine, Vinnytsia, 600-richchya St., 25.

Tel.: + 38(0432)52-30-36. E-mail: [email protected]

www.sperco.ua