Eroxia

I N S T R U C T I O N for medical use of the medicinal product EROXIA

Composition:

Active substance: 1 suppository contains benzalkonium chloride 18.9 mg;

Excipients: hard fat.

Dosage form. Vaginal suppositories.

Main physicochemical properties: white or white with a slight yellowish tint suppository.

Pharmacotherapeutic group. Local contraceptives. ATC code G02BB03.

Pharmacological properties.

Pharmacodynamics.

Benzalkonium chloride has both spermicidal and antiseptic properties.

The active substance causes disruption of the spermatozoa membrane. Destruction of spermatozoa occurs in two stages: first, the flagellum is destroyed, followed by the head.

The effectiveness of the product varies depending on how strictly the application instructions are followed.

It does not affect the normal microflora (Lactobacillus species, including Döderlein's bacilli, are preserved).

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

Experimental studies have demonstrated the antiseptic activity of benzalkonium chloride:

• In vitro, the drug is active against pathogens of sexually transmitted infections, including: Neisseria gonorrhoeae, Chlamydia spp., Herpes simplex type 2, HIV, Trichomonas vaginalis, Staphylococcus aureus. However, the 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 a potential effectiveness in preventing certain sexually transmitted infections, but there is no direct evidence confirming this preventive effect.

Pharmacokinetics.

The active ingredient does not penetrate through the vaginal mucosa due to lack of absorption and is eliminated together with physiological discharges or upon washing with water.

Clinical characteristics.

Indications.

Eroxya is a local contraceptive (spermicide) for preventing pregnancy, which, like other contraceptive methods, does not completely exclude the possibility of pregnancy. The effectiveness of the spermicide depends on strict adherence to the instructions for medical use. Eroxya can be used either alone or in combination with other contraceptive methods to enhance contraceptive efficacy.

This contraceptive method is intended for all women of reproductive age. Eroxya is particularly advisable in the following cases:

• when there are temporary or permanent contraindications to the use of oral contraceptives or intrauterine devices (intrauterine coil);
• after childbirth, during breastfeeding, after termination of pregnancy, or during the premenopausal period;
• when episodic prevention of pregnancy is required;
• as an adjunct to oral contraception in case of missed tablet intake or delayed intake (in this case, Eroxya should additionally be used until the end of the menstrual cycle);
• as an adjunct in barrier contraception (vaginal diaphragm, cervical cap), or when using an intrauterine device (especially during long-term concurrent use of certain medications, e.g., non-steroidal anti-inflammatory drugs).

Contraindications.

This medicinal product should not be used in cases of hypersensitivity to benzalkonium chloride or excipients, in the presence of vaginitis, ulceration, or irritation of the vaginal and cervical mucosa.

This drug should not be administered to patients:

• with psychological problems or simple refusal of any intervention involving genital organs, as this may lead to improper use of the drug;
• individuals who cannot understand or accept this type of contraception.

Interaction with other medicinal products and other types of interactions.

Combinations to be avoided:

+ medicinal products administered vaginally:

any intravaginal treatment may inactivate the spermicidal effect of the local contraceptive;

+ soap-based products:

this spermicide is destroyed by soap-based products — 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, conducted with various commercial brands, revealed no changes in the physical characteristics of the tested condoms.

Special precautions for use.

The product is an effective means of preventing pregnancy provided it is used correctly during each sexual act. However, this contraceptive method is somewhat less effective than 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 strict adherence to the usage instructions; therefore, it is essential to clearly explain to the patient how to use the product and to ensure she has fully understood the instructions.

This contraceptive method should not be used by individuals who are unable to understand or follow the usage instructions.

Conditions to be observed when using Eroxil:

• Insert the suppository deeply into the vagina systematically before each sexual act, regardless of the phase of the menstrual cycle;
• Do not use soap to wash the genital organs within 2 hours before and 2 hours after intercourse, as soapy water, even in minimal amounts, 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 taking baths, swimming in bodies of water, pools, etc., as the contraceptive effect may be reduced;
• Discontinue use of Eroxil if symptoms of genital tract disorders appear or worsen;
• If intravaginal treatments are being used, discontinue Eroxil until the end of the treatment period. During this time, an alternative contraceptive method should be used.

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

Use during pregnancy or breastfeeding.

Pregnancy. Clinical epidemiological studies have not shown any developmental abnormalities in isolated cases of using this spermicide during early pregnancy. Its use during pregnancy is not recommended.

Breastfeeding. Since the small amount of the product that may pass into breast milk does not cause any harmful effects, breastfeeding is permitted.

Ability to influence reaction rate while driving or operating machinery.

No effects on the ability to drive a vehicle or operate machinery have been observed.

Method of Administration and Dosage

Administer intravaginally.

Apply systematically before each act of intercourse, regardless of the phase of the menstrual cycle.

While lying down, insert 1 vaginal suppository deeply into the vagina 5 minutes prior to intercourse.

In case of repeated intercourse, administer another suppository.

Duration of contraceptive effect — 4 hours.

External genital hygiene with clean water (excluding soap-based products) is permitted immediately before and after intercourse.

Children

The Eroksia preparation must not be used in children.

Overdose

No cases of overdose have been reported.

Adverse reactions.

Reproductive system and breast

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

Immune system

Frequency unknown: allergic reactions.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 15 °C.

Keep out of reach of children.

Packaging. 5 suppositories in strips. 2 strips in a cardboard box.

Supply category. Over-the-counter.

Manufacturer. JSC "Monfarm".

Manufacturer's address and location of its business activities.

8, Zavodska St., Avramivka, Uman district, Cherkasy region, 19161, Ukraine.