Erotox
Ukraine
Table of Contents
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.
Pharmaceutical form. Vaginal suppositories.
Main physicochemical properties: white suppositories with a slightly yellowish tint, with a fragrant odor, bullet-shaped.
Pharmacotherapeutic group. Local contraceptives. Intravaginal contraceptives.
ATC code G02B B.
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 Eroteks 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, this index is less than 1, meaning that with correct use and adherence to all instructions, the rate of unintended pregnancy is approximately 1% per year.
The product does not affect libido or fertility and has a reversible effect upon discontinuation.
Eroteks also has antiseptic and antimicrobial properties and reduces the risk of sexually transmitted infections, although it does not completely eliminate this risk.
Pharmacokinetics
The product is not absorbed through the vaginal mucosa but only adsorbs onto its walls. It is easily removed by douching 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 effect of Eroteks is 4 hours.
Clinical characteristics.
Indications.
Local contraception for all women of reproductive age. The product may be used both independently and in combination with other methods, thereby enhancing their contraceptive effect. 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 device (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 a woman has forgotten or delayed taking a tablet (in such cases, additional use of Erotex is recommended at any time during the cycle);
- as an adjunct to barrier contraception (vaginal diaphragm) or in the presence of an intrauterine device, especially when certain medicinal products are used simultaneously (e.g., nonsteroidal anti-inflammatory drugs).
Contraindications.
Hypersensitivity to the components of the medicinal product, vaginitis, ulcers or irritation of the vaginal and cervical mucosa. Inability to properly use vaginal suppositories in patients with mental disorders or in individuals who do not allow any interventions on genital organs or who 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, concomitant application of other vaginal medicinal products is not recommended 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.
Usage Instructions
The contraceptive effectiveness of the Eroteks drug largely depends on strict adherence to the application guidelines!
To achieve maximum efficacy, remember and strictly 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 one sexual act!);
- For genital hygiene, soap or other soap-based products must not be used 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 diseases are present.
Use during pregnancy or breastfeeding.
The drug is a contraceptive and should not be used during pregnancy. When pregnancy occurs despite using benzalkonium chloride as a contraceptive, no adverse effects on the course of pregnancy have been observed.
Benzalkonium does not penetrate into breast milk; therefore, Eroteks may be used during breastfeeding.
Ability to influence reaction speed when driving or operating machinery.
No effect.
Method of Administration and Dosage.
- Remove the suppository from its protective packaging.
- While lying down, 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.
- 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 lubricating 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 application site, contact dermatitis, itching, burning in the vagina or in the partner's penis, and painful urination are possible. 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 from 2 °C to 15 °\u200bC. Keep out of reach of children.
Packaging.
5 suppositories in a strip made of polyvinyl chloride film, 2 strips in a cardboard box.
Availability category.
Over-the-counter (without prescription).
Manufacturer.
Ukrainian-Spanish joint venture "Sperco Ukraine".
Manufacturer's address and place of business.
21027, Ukraine, Vinnytsia, 600-richchia St., 25.
Tel.: + 38(0432)52-30-36. E-mail: [email protected]
www.sperco.ua