контрактне виробництво
свічки контактне виробництво
виробництво торгова марка
EROXIA
Release form
Vaginal suppositories.
For children
Not applicable
For pregnant women
It is not advisable to use during pregnancy
For nursing mothers
Not contraindicated
For drivers
Not contraindicated
Storage temperature
until 15 °C
INSTRUCTION
storage
active substance: 1 suppository contains benzalkonium chloride 18.9 mg; excipient: solid fat.
Medicinal form
Vaginal suppositories. Main physicochemical properties: suppository white or white with a slightly yellowish tint.
Pharmacotherapeutic group
Contraceptives for local use. ATX code G02B B03.
Pharmacological properties
Pharmacodynamics. Benzalkonium chloride has the properties of both a spermicide and an antiseptic. The active substance causes the sperm membrane to rupture. The destruction of the sperm occurs in two stages: first, the flagellum is destroyed, and then the head. The effectiveness of the tool varies depending on how clearly the instructions for use are followed. Does not affect the saprophytic microflora (Doderlein rods are preserved). Since Eroxia is not a hormonal drug, its use does not affect the menstrual cycle, libido, or fertility. Experimental studies have established the antiseptic activity of benzalkonium chloride: • in vitro, the drug shows activity against pathogens of sexually transmitted infections, in particular: Neisseria gonorrhoeae, Chlamydia spp., Herpes simplex type 2, HIV, Trichomonas vaginalis, Staphylococcus aureus. However, the tool is inactive against Mycoplasma spp. and has low activity against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum; • separate in vivo data indicate possible effectiveness 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 through the mucous membrane of the vagina due to the lack of absorption and is removed together with physiological secretions or when washing with water.
Indication
Local contraception. Eroxia is a local contraceptive (spermicide) to prevent pregnancy, which, like other methods of contraception, does not completely eliminate it. The effectiveness of the spermicide depends on compliance with the instructions for medical use. Eroxia can be used both alone and together with other contraceptives to enhance the contraceptive effect. This method of contraception is intended for all women of reproductive age. It is especially advisable to use Eroksia: • in case of temporary or permanent contraindications to the use of oral contraceptives or intrauterine means (intrauterine spiral); • after childbirth, during breastfeeding, after termination of pregnancy or during premenopause; • if episodic pregnancy prevention is necessary; • as an adjunct to oral contraception in case of skipping a pill or taking it later than necessary (in this case, it is necessary to additionally use Eroxia until the end of the menstrual cycle); • as an auxiliary means for barrier contraception (vaginal diaphragm, cervical cap), when using an intrauterine spiral (especially with long-term simultaneous use of certain drugs, for example, non-steroidal anti-inflammatory drugs).
Contraindication
This medicine should not be used in case of hypersensitivity to benzalkonium chloride or excipients, vaginitis, ulcers and irritation of the mucous membrane of the vagina and cervix. This drug should not be used by patients: - with psychological problems or a simple reluctance to 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 that should be avoided: + medical preparations with a vaginal method of administration: any intravaginal treatment is likely to inactivate the spermatocidal effect of the local contraceptive; + soaps: this spermicide is destroyed by soaps - any use of soapy solutions must be avoided because they, even in minimal amounts, destroy the active substance. A compatibility study between the vaginal suppository and latex, conducted with different brands, did not reveal any changes in the physical characteristics of the tested condoms.
Features of use
The drug is an effective means to prevent pregnancy, provided it is used correctly during each sexual act. However, this method of contraception is somewhat inferior in effectiveness to such methods of contraception as hormonal contraception, intrauterine spiral, diaphragm, cervical cap or condom. The effectiveness of spermicides decreases if the rules of use are not followed. The effectiveness of the contraceptive effect depends significantly on careful compliance with the rules of use, so it is important to clearly explain to the patient how to use the product and make sure that she understands everything correctly. Persons who cannot understand or accept the instructions for use should not use this contraceptive. Conditions that should be met when using Eroxis: • systematically insert the suppository deep into the vagina before each sexual act, regardless of the phase of the menstrual cycle; • do not use soap to wash the genitals 2 hours before and 2 hours after sex, because soapy water, even in small amounts, destroys the active substance. For both partners, only external washing of the genitals with clean water is possible; • it is necessary to postpone douching with clean water for at least 2 hours to avoid the risk of washing out the drug; • avoid taking a bath, swimming in a reservoir, a pool, etc., because the effect of the contraceptive may be weakened; • stop using Eroxis when the symptoms of genital lesions appear or worsen; • in the case of treatment with intravaginal means, stop using Eroxis until the end of the treatment. During this period, you need to choose another method of contraception. This contraceptive 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. Pregnancy. Clinical epidemiological studies have not revealed any malformations in single cases of the use of this spermicide in early pregnancy. It is not advisable to use during pregnancy. Breast-feeding. Since a small amount of the drug that can get into breast milk does not lead to any harmful effects, breastfeeding is allowed. The ability to influence the speed of reaction when driving vehicles or other mechanisms. Any influence on the ability to drive vehicles or work with other mechanisms was not observed.
Methods of application
Method of application and dosage. Administer intravaginally. Apply systematically before each sexual act, regardless of the phase of the menstrual cycle. While lying down, insert 1 vaginal suppository deep into the vagina 5 minutes before intercourse. In case of repeated intercourse, insert another suppository. The duration of the contraceptive effect is 4 hours. Immediately before and after sexual intercourse, only the external toilet of the genitals with clean water (excluding soap) is possible. Children. The drug Eroksia should not be used by children.
Overdose
No cases of overdose were found.
Side effects
From the reproductive system and mammary glands Rare (≥1/10,000 to <1/1,000): itching, burning sensation or local irritation in one or both partners. From the side of the immune system Frequency is unknown: allergic manifestations.
Expiration date
2 years
Storage conditions
In the original package at a temperature not higher than 15 ºС. Keep out of the reach of children.
Packaging
5 suppositories in strips. 2 strips in a cardboard pack.
Leave category
Without a prescription.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.