Benatex - instructions for use, dose, side effects, contraindications

Excipients: glycerol (glycerin distilled), poloxamer (poloxamer 407, lutrol F 127), macrogol glyceryl hydroxy stearate (polyoxyl 40 hydrogenated castor oil, cremophor - RH 40); purified water - up to 1 g.

Description:

Colorless transparent gel with a weak specific odor. At a temperature below 20 ° C it has a fluidity.

Pharmacotherapeutic group:Contraceptive for topical use

ATX: & nbsp

D.08.A.J.01 Benzalkonium chloride

G.02.B.B Intravaginal contraceptives

Pharmacodynamics:

Spermicidal action is due to the ability to damage the membranes of spermatozoa (at the beginning of the flagella, then the head), which makes it impossible to fertilize the damaged sperm. The effect of the drug develops after 3 minutes after insertion into the vagina.

In vitro Benzalkonium chloride is active against Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Hgreed simplex 2 tipa, Staphylococcus aureus. He has an impact on Mycoplasma spp. and has little effect on Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum. The gel of Benatex® does not affect the normal microflora of the vagina (including the Dodderlein's stick) and the hormonal cycle.

Pharmacokinetics:

Virtually not absorbed with intravaginal injection, removed by simple washing with water and with normal physiological secretions.

Indications:

Local contraception for women of reproductive age (including if there are contraindications to the use of oral contraceptives or intrauterine contraception, in the postpartum period, lactation, after pregnancy termination, perimenopause, irregular sexual intercourse, missed or late receipt of continuously used oral contraceptives).

Contraindications:

Hypersensitivity to the components of the drug, colpitis, ulceration and irritation of the mucous membrane of the vagina and cervix.

Pregnancy and lactation:

The drug is a contraceptive, during pregnancy is not used. When pregnancy comes on the background of contraception benzalkoniya chloride, no effect on the course of pregnancy.

Is not excreted in breast milk,etein the period lactation.

Dosing and Administration:

Intravaginal. The gel is injected into the vagina with the help of a dispenser-applicator. Install the dosing device at the end of the tube. Fill it completely (to the annular mark or to the stop of the piston) so that air bubbles do not form. Disconnect it from the tube.Before sexual intercourse, insert the gel deep into the vagina with a dosing device, slowly pressing the piston. Introduction is easier to make lying. Remove the metering device. The drug starts in 3 minutes and lasts at least 6 hours. Be sure to enter a new portion of the gel before each second sexual intercourse.

Single dose: one portion of the gel is designed for one sexual act.

The multiplicity of use is determined by the tolerability of the drug and the frequency of sexual acts. It is possible to use the Benatex gel together with a condom, a vaginal diaphragm or an intrauterine device.

Side effects:

Allergic reactions, contact dermatitis, itching and burning in the vagina and / or penis partner, painful urination.

Overdose:

Due to low systemic absorption, an overdose is unlikely.

AT Currently, symptoms of an overdose are not described.

Interaction:

Any medicinal product, as well as soap and solutions containing it, administered intravaginally, can reduce the spermicidal effect of the drug.

Iodine-containing drugs, used intravaginally, inactivate the drug.

Special instructions:

To increase the efficiency, careful compliance with the method of application of the preparation is necessary. The gel of Benatex® does not have a damaging effect on products made of latex (condom, vaginal diaphragm).

Avoid washing or irrigation of the vagina with soapy water, since it can destroy even the residual amounts of the active substance of the Benatex® gel. The external toilet of the genital organs for 2 hours before sexual intercourse and within 2 hours after sexual intercourse is possible only with pure water.

With Benatex® gel injected into the vagina, you can not take baths, swim in the sea, pool and water bodies within 2 hours after sexual intercourse because of the danger of reducing the subsequent contraceptive effect.

Be sure to enter a new dose of Benatex® gel before every second sexual intercourse. Introduce the dosing device with a portion of the gel so that it penetrates as deeply as possible into the vagina, preferably in the "lying on the back" position.

Do not use the drug for colpitis, ulceration and irritation of the mucous membrane of the vagina and cervix, tk. in these cases, this drug is contraindicated.

In the event that it becomes necessary to treat diseases of the vagina and / or the appointment of some otherof the drug vaginally, it is necessary to wait until the end of treatment before restarting (starting) contraception with the help of Benatex® gel.

Form release / dosage:

Vaginal gel 1,2%.

Packaging:By 30 g, 50 g, 72 g and 100 g in tubes of aluminum or polyethylene laminate. Each tube together with the dispenser-applicator and instructions for medical use of the drug is placed in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-008786/10

Date of registration:26.08.2010

Expiration Date:Unlimited

The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia

Manufacturer: & nbsp

NIZHFARM, JSC Russia

Information update date: & nbsp22.01.2017

Illustrated instructions

Instructions

Benatex® (Benatex®)