Contraceptives for topical use

EROXIA

Indications

Contraceptives for topical use. ATC code G02В В03

Registration certificate     No. UA/12185/01/01 

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INSTRUCTION

for medical use of the medicinal product

 

EROXIA

 

Composition:

active substance: 1 suppository contains 18.9 mg of benzalkonium chloride; 

exipients: solid fat.

 

Pharmaceutical form. Vaginal suppositories.

Basic physical and chemical properties: a white or slightly yellowish white suppository.

 

Pharmacotherapeutic group. Contraceptives for topical use. ATC code G02В В03.

 

Pharmacological properties.

Pharmacodynamics.

Benzalkonium chloride has both spermicidal and antiseptic properties.

The active substance causes the sperm membrane rupture. Destruction of sperm cell occurs in two stages: first, the flagellum is destroyed, and then - the head.

The effectiveness of remedy varies depending on how clearly the instructions for use are followed.

The product does not affect the saprophytic microflora (bacillus Doderlein are preserved).

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

Experimental studies have found the antiseptic activity of benzalkonium chloride:

in vitro the drug is active against sexually transmitted pathogens, in particular: Neisseria gonorrhoeae, Chlamydia spp., Herpes simplex type 2, HIV, Trichomonas vaginalis, Staphylococcus aureus. However, the drug 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 the prevention of some sexually transmitted diseases, but there is no direct evidence of this preventive effect.

Pharmacokinetics.

The active substance does not penetrate the vaginal mucosa due to lack of absorption and is removed along with physiological secretions or by rinsing with water.

 

Clinical particulars.

Indications.

Local contraception.

Eroxia is a local contraceptive (spermicide) to prevent pregnancy, which, like other methods of contraception, does not exclude it completely. The effectiveness of spermicide depends on following the instructions for medical use. Eroxia can be used alone or with other contraceptives to enhance the contraceptive effect.

This method of contraception is intended for all women of childbearing age. It is especially advisable to use Eroxia:

  • in case of temporary or permanent contraindications to use oral contraceptives or intrauterine device (intrauterine device);
  • after childbirth, during breastfeeding period, and after abortion or during premenopause;
  • in case of need of episodic prevention of pregnancy;
  • as an adjunct to oral contraception in case of missed to take a tablet or took it later than necessary (in this case, you must additionally use Eroxia until the end of the menstrual cycle);
  • as an adjunct to barrier contraception (vaginal diaphragm, cervical cap), when using an IUD (especially with long-term concomitant use of certain drugs, such as nonsteroidal anti-inflammatory drugs).

 

Contraindications.

This drug should not be used in case of hypersensitivity to benzalkonium chloride or excipients, vaginitis, ulcers and irritation of the mucous membranes of the vagina and cervix.

Do not use this drug to the following category of patients:

  • - patients with psychological problems or those with a simple reluctance of any intervention on the genitals, as this may lead to improper use of the drug;
  • - persons who cannot understand and accept this type of contraception.

 

Interaction with other medicinal products and other forms of interaction.

Combinations to be avoided:

+ medicinal products with vaginal route of administration:

any intravaginal treatment is likely to inactivate the spermicidal action of a local contraceptive;

+ soaps:

this spermicide is destroyed by soaps – it is necessary to avoid any use of soap solutions, because they, even in minimal quantities, destroy the active substance.

A study of compatibility between vaginal suppository and latex, conducted with different brands, has not revealed any changes in the physical characteristics of the tested condoms.

 

Precautions for use.

The drug is an effective remedy of preventing pregnancy, provided it is used properly during each sexual intercourse. However, this method of contraception is somewhat inferior in effectiveness to contraceptives such as hormonal contraception, IUD, diaphragm, cervical cap or condom. The effectiveness of spermicides is reduced by non-compliance with the rules of application.

The effectiveness of contraceptive action depends on careful compliance with the rules of application, so it is important to clearly explain to the patient how to use the medicinal product, and make sure that the patient understands everything correctly.

People who cannot understand or accept the rules of application should not use this contraceptive.

The conditions for using Eroxia are as follows:

  • systematically insert the suppository deep into the vagina before each sexual intercourse, regardless of the menstrual cycle phase;
  • do not use soap for washing the genitals 2 hours before and 2 hours after sex, because soapy water, even in small quantities, destroys the active substance. For both partners, only external washing of the genitals with clean water is possible;
  • it is necessary to postpone irrigation with clean water for at least 2 hours to avoid the risk of drug washout;
  • avoid taking a bath, swimming in a pond, pool, etc., because the effect of contraception may be weakened;
  • stop using Eroxia if symptoms of genital lesions occurred or became aggravated;
  • in case of treatment with intravaginal drugs, you need to stop using Eroxia until the end of treatment. During this period, you need to choose another method of contraception.

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

 

Pregnancy and lactation.

Pregnancy. Clinical epidemiological studies have not revealed any malformations in single cases of use of this spermicide in early pregnancy. It is not recommended to use during pregnancy.

Breastfeeding. Because a small amount of the drug that can get into breast milk does not cause any harmful effects, breastfeeding is allowed.

 

Effects on ability to drive and use machines.  

No effects on the ability to drive or use machines were observed.

 

Method of administration and dosage.

The suppository must be administrated intravaginally.

Use systematically before each sexual intercourse, regardless of the menstrual cycle phase.

In the supine position, insert 1 vaginal suppository deep into the vagina 5 minutes before intercourse.

In case of repeated sexual intercourse, insert another suppository.

Duration of contraceptive action - 4 hours.

Immediately before and after sexual intercourse, only external genitalia washing with clean water (excluding soaps) is allowed.

 

Children.

Eroxia should not be used for children.

 

Overdose.

No cases of overdose were reported.

 

Adverse reactions.

Reproductive system and mammary glands disorders

Rare (≥1/10.000 to <1/1000): itching, burning or local irritation in one or both partners.

Immune system disorders

Frequency not known: allergic reactions.

 

Shelf life. 2 years.

 

Storage conditions.

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

Keep out of reach of children.

 

Packaging. 5 suppositories in strips. 2 strips in a packaging.

 

Terms of dispensing. Without prescription.

 

Manufacturer. PJSC «Monofarm».

 

Manufacturer’s registered address.  

8, Zavodska str., Monastyryshche, Cherkasy oblast, 19100, Ukraine.

 

Date of last update.