Eroceptin-pharmex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EROCEPTIN-PHARMEX (Eroceptin-Pharmex)

Composition:

Active substance: benzalkonium chloride;

1 suppository contains benzalkonium chloride 18.9 mg;

Excipients: hydroxypropylcellulose, hard fat.

Dosage form. Suppositories.

Main physicochemical properties: smooth suppositories of white or almost white color. No inclusions are observed in longitudinal section. Presence of a cup-shaped depression and an air channel is permitted. A fatty odor may be present.

Pharmacotherapeutic group. Agents affecting the genitourinary system and sex hormones. Other gynecological agents. Local contraceptives. Intravaginal contraceptives.

ATC code G02BB.

Pharmacological properties.

Pharmacodynamics.

Benzalkonium chloride is a quaternary ammonium compound with spermicidal and antiseptic properties. Its contraceptive action is associated with the ability to disrupt spermatozoa membranes. After contact with the active substance, benzalkonium chloride causes immediate immobilization of spermatozoa due to significant disruption of the sperm membrane surface tension, loss of the flagellum, lysis of the sperm head membrane with its destruction, and subsequently detachment of the head. The contraceptive effect is enhanced by benzalkonium chloride-induced coagulation and thickening of cervical mucus, thus creating an additional barrier preventing semen from entering the uterine cavity.

It does not affect saprophytic microflora (Lactobacillus acidophilus, i.e. Doderlein's bacilli, are preserved).

Since Eroceptin-Farmeks is not a hormonal drug, its use does not affect the menstrual cycle, libido, or fertility.

The drug also exerts antiseptic and antimicrobial effects and reduces the risk of sexually transmitted infections, although it does not completely eliminate this risk:

• In vitro, the drug shows activity against pathogens of sexually transmitted infections, including: Neisseria gonorrhoeae, Chlamydia spp., Herpes simplex type 2, HIV, Trichomonas vaginalis, Staphylococcus aureus. However, the medicinal product is inactive against Mycoplasma spp. and has low activity against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi, and Treponema pallidum;
• Some in vivo data suggest possible efficacy in preventing certain sexually transmitted diseases, but there is no direct evidence confirming this preventive effect.

Contraceptive efficacy is measured by the Pearl Index. Clinical studies have demonstrated that for benzalkonium chloride, this index is less than 1. Thus, with correct use and adherence to all instructions, the rate of unintended pregnancy is approximately 1% per year.

Discontinuation of Eroceptin-Farmeks has a reversible effect.

Pharmacokinetics.

Numerous studies have shown that the drug does not penetrate into blood plasma or breast milk (when used at recommended doses) due to the absence of absorption of benzalkonium chloride by the vaginal mucosa. This indicates that the drug's action is exclusively local.

Clinical characteristics.

Indications.

Local contraception. This contraceptive agent can be used by all women of reproductive age. The product may be used both independently and in combination with other methods, which enhances their contraceptive effect.

The use of Eroceptin-Farmex is especially appropriate:

• when there are temporary or permanent contraindications to oral contraception or intrauterine devices, for example, after childbirth, during breastfeeding, after termination of pregnancy, and in the premenopausal period;
• when occasional prevention of pregnancy is needed (irregular sexual activity);
• when using oral contraceptives, if a woman has forgotten to take a tablet (in this case, Eroceptin-Farmex should be additionally used on any day of the cycle);
• as an adjunct to barrier contraception (vaginal diaphragm, cervical cap) or in the presence of an intrauterine device, particularly when certain medicinal products are used concomitantly (e.g., nonsteroidal anti-inflammatory drugs).

Contraindications.

Hypersensitivity (allergic reactions or irritant effects) to the components of the drug, vaginitis, ulcers, and irritation of the vaginal and cervical mucosa.

This drug should not be used in patients:

• with psychological problems or simple unwillingness to any intervention involving genital organs, as this may lead to incorrect use of the drug;
• individuals unable to understand and accept this type of contraception.

Interaction with other medicinal products and other forms of interaction.

Combinations to be avoided:

• medicinal products administered vaginally:

any intravaginal treatment may likely inactivate the spermicidal action of the local contraceptive;

• soap-containing products:

this spermicide is destroyed by soap-containing products; therefore, any use of soap solutions should be avoided, as even minimal amounts may inactivate the active ingredient.

Studies on the compatibility between the vaginal suppository and latex, performed with various commercial brands, showed no changes in the physical characteristics of the tested condoms.

Instructions for Use

The effectiveness of contraception depends on the correct use of the product for each sexual intercourse.

However, this contraceptive method is somewhat less effective compared to other contraceptive methods such as hormonal contraception, intrauterine devices, diaphragms, cervical caps, or condoms. The effectiveness of spermicides decreases if the instructions for use are not strictly followed.

The efficacy of the contraceptive effect greatly depends on careful adherence to the usage instructions; therefore, it is essential to clearly explain to the patient how to use the product and to ensure she fully understands the directions.

The following conditions must be observed when using the medicinal product Eroceptin-Farmex:

• Insert one suppository deeply into the vagina before each act of sexual intercourse, regardless of the phase of the menstrual cycle;
• Insert the suppository while lying down to ensure its deep placement within the vagina;
• Wait for complete dissolution (at least 5 minutes) to ensure full release of the active ingredient;
• Insert a new suppository before each subsequent act of sexual intercourse;
• Avoid using soap to wash the genital area within 2 hours before and 2 hours after sexual intercourse, as even a minimal amount of soapy water may destroy the active ingredient. For both partners, only external washing of the genitals with clean water is permitted;
• Postpone douching with clean water for at least 2 hours to avoid the risk of washing out the product;
• Avoid bathing, swimming in bodies of water, pools, etc., as the contraceptive effect may be reduced;
• Discontinue use of Eroceptin-Farmex if symptoms of genital tract disorders appear or worsen;
• If undergoing intravaginal treatment, discontinue use of Eroceptin-Farmex until the end of the treatment period. During this time, an alternative contraceptive method should be used.

This contraceptive product does not protect against sexually transmitted infections (STIs) or the human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS).

Use during pregnancy or breastfeeding.

The product is a contraceptive and should not be used during pregnancy. Clinical and epidemiological studies have not shown any developmental abnormalities associated with accidental use of this product in early pregnancy.

Breastfeeding. Since a negligible amount of the product may pass into breast milk and is not associated with any harmful effects, breastfeeding is permitted.

Ability to influence reaction rate when driving or operating machinery.

No effect on the ability to drive or operate machinery has been observed.

Method of Administration and Dosage.

Remove the pessary from the protective packaging. In a lying position, insert the pessary as deeply as possible into the vagina. The pessary dissolves within 5 minutes and remains effective for 4 hours, providing protection for one act of intercourse. If intercourse is repeated, a new pessary of Eroceptin-Farmeks must be inserted. Application details are illustrated in the figures below:

1. Diagram of female anatomy.
2. Carefully remove the pessary from the protective packaging.
3. Lie down.
4. Insert the pessary as deeply as possible into the vagina.

The number of pessaries that can be used within 24 hours is unlimited.

Children.

Eroceptin-Farmeks is not intended for use in children.

Overdose.

Cases of overdose have not been reported.

Side effects.

The following adverse reactions have been reported with the use of benzalkonium chloride in various systems:

Reproductive system and breast.

Rare (≥1/10000 to <1/1000): itching, burning sensation or local irritation in one or both partners, dysuria.

Immune system.

Frequency unknown: allergic reactions.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

5 pessaries in a blister, 1 or 2 blisters per cardboard pack.

Availability category. Over-the-counter.

Manufacturer.

LLC "FARMEKS GROUP", Ukraine.

Manufacturer's address and location of business activity.

100, Shevchenka Street, Boryspil, Kyiv region, Ukraine, 08301.

All cases of adverse reactions should be reported to the manufacturer:

LLC "FARMEKS GROUP", Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka Street, building 100,

Phone: +38(044)391-19-19, Fax: +38(044)391-19-18, or via the form on the website:

http://www.pharmex.com.ua/kontakty/farmakonadzor